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Stanley N. Cohen Papers 1948-2016
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Series 11: Cohen/Boyer Patent: Process for producing biologically functional molecular chimeras, 1972-2003 [series]:
95 1
Cohen/Boyer original patent certificate, 1980
95 2
Cohen/Boyer patent copies and photograph of Cohen/Boyer at ceremony [photograph], 1980
95 3
Cohen/Boyer patent information, 1974

Unsigned letter dated November 21, 1974 from SNC, "Associate Professor Head, Division of Clinical Pharmacology" to Bertram I. Rowland; text: addresses enclosed for Annie Chang, John Morrow and Charles Yanofsky; "I must ask that you state in your covering letter to the co-authors that rights to the invention have been (will be?) assigned to Stanford University and the University of California. As we have discussed previously, I am eager to avoid any misinterpretations by colleagues of my motives in agreeing to assist Stanford in proceeding with obtaining a patent for this invention. Your disclaimer statement makes no mention whatsoever of Stanford or UC, and gives the impression that Berg [sic] and I are proceeding (for self profit?) obtaining a patent on this process for our own use."

Signed, undated letter from Bertram I. Rowland to SNC, at top right of page is handwritten "11/4/74" [there is no horizontal line through the number 7, so not by SNC, and November 4, 1974 is the filing date of the original patent application] and also at top right of page "File -- SN Cohen" handwritten by SNC; text of letter: "Enclosed please find Amendment" to patent application; attached seven-page AMENDMENT is dated "June 9, 1975 . . . . In response to the Office Action of March 31, 1975, please make the following amendments . . . ." signed by Bertram I. Rowland, no date on signature [This document seems to be filed in the wrong folder. The contents are from 1975, not 1974]

Signed memo dated October 18, 1974 from Niels Reimers to Russ Meyer, cc SNC, "Reimers file" handwritten by SNC at top right of page; text: "Professor Stanley Cohen, Clinical Pharmacology, has offered to make a donation of the share of royalty income which he would otherwise receive from licensing of the gene transplant process. Professor Cohen's desire would be to have the income allocated to a medical research fund in memory of his father. can you please advise me how Professor Cohen's most generous offer may be handled so that he can at least receive a tax benefit. . . ."

Signed memo dated October 18, 1974 from Niels Reimers to Bill Carpenter, "SN Cohen" handwritten by SNC at top right of page; contents are catalogued in Row 374

Unsigned letter dated September 26, 1974 from SNC to Burt Rowland [sic]; text: "I have enclosed copies of papers describing clinical use for the antibiotic inactivating enzymes synthesized by R factors. In reviewing the situation, I find that the enzyme used clinically for assaying serum kanamycin levels as well as gentamycin levels, is made by the gentamycin resistance determinant on this R factor. Unfortunately, I haven't been able to find a specific clinical paper describing use of the kanamycin monophosphotransferase enzyme clinically, or use of the streptomycin inactivating enzyme clinically (these are two genes that we've put into E. coli). However, if necessary we could very easily put in a gentamycin resistance gene to make the enzyme used in these clinical studies. I would prefer to stick with what we have if possible.. Solution used for the shearing experiment was TEN buffer . . ."; no attachments to letter in file

Four copies of unsigned letter dated September 6, 1974 from SNC to Dick Roblin, Massachusetts General Hospital; text: "I had intended to include a copy of this memo with the letter I sent to you yesterday. It indicates the voluntary restrictions that have been observed in distribution of the pSC101 plasmid. Also, I have just been told by a reliable source that Miles Laboratories is now including a "warning" with all shipments of restriction enzymes, stating that the enzyme is sold under conditions that it will not be used for the "introduction of any viral genes" (?? T4?) or "any antibiotic resistance genes" (wow!) into bacteria. The "warning" indicates that the Miles policy is a response to the published recommendations of the NAS Committee."; no attachments to letter in file

Three copies of unsigned letter dated September 5, 1974 from SNC to Dick Roblin, Massachusetts General Hospital; letter contents are catalogued in Rows 64 and 285

Signed two-page letter dated November 15, 1974 from Bertram I. Rowland to SNC and Herbert W. Boyer; text: "necessary to obtain a disclaimer of invention from the co-authors. Accompanying this letter is the type of disclaimer which will be forwarded to each of the co-authors", asks for latest address for Annie C.Y. Chang, John F. Morrow, Howard M. Goodman, Robert B. Helling, Vickers Hershfield, Charles Yanofsky, Michael A. Lovett, and Donald R. Helinski, "Also, if you wish, I could forward to you my cover letter and the disclaimer, so that you might add additional remarks should you so chose [sic]. My cover letter will explain the situation to the co-authors, so that they will understand that they are not foregoing any scientific recognition, but rather that they do not fulfill the requirement of an inventor under the Patent Law. . . ."; attachment: two-page "DISCLAIMER"; text: "I, [ ], do hereby declare as follows: I am a co-author of the following publications: I have reviewed the claims of the subject application and do not believe that I am an inventor of the inventions claimed. . . ."

Letter dated September 17, 1974 from Josephine Opalka, not signed but stamped in signature space: "ORIGINAL SIGNED BY JOSEPHINE OPALKA" to Stefano Vivona, American Cancer Society, Inc., cc Stanley Bateman, Herbert W. Boyer, Sue Clark, Niels Reimers, stamped at bottom "STANFORD UNIVERSITY SEP 18 1974 TECHNOLOGY LICENSING", in upper right corner, "xcc Cohen Latker" handwritten and "File -- Reimers" handwritten by SNC, "Re: ACS Grant No. NP-112-B (Goodman) A PROCESS FOR CONSTRUCTION OF BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS--Cohen-Boyer"; text: "Thank you for your letter of September 12, 1974 in which you reported to me the Society's decision to permit disposition of the referenced invention in accordance with the policy and practices of the Department of Health, Education and Welfare. . . ."

Signed memo dated September 4, 1974 from Bill Carpenter to SNC, "Reimers file" handwritten by SNC near top of page; text: confirms their meeting on September 11, "As I mentioned, we are investigating the commercial potential of the gene transplant process, which will guide us in our licensing efforts. Our focus should therefore be on what developments will be necessary before the process could ever be commercially applied, and what those applications might be. Further, we will also want to carefully consider the situation in light of recent questions that have been raised as to potential hazards of future experimentation . . . . After our meeting, I plan to visit Dr. Boyer at U.C.S.F. to get his thoughts on these questions as well."

Small, signed handwritten note dated August 28, 1974 from Niels Reimers to SNC; text: "Stan Attached are resumes of Bert Rowland and Mike Zimmerman (and Mike's former associates Dubb & Moore). . . ."; stapled behind note are four resumes: 1) Bertram I. Rowland (one page), with "Reimers file" handwritten by SNC 2) Hubert E. Dubb (four pages), 3) C. Michael Zimmerman (two pages), and 4) Gerald L. Moore (three pages)

Signed letter dated August 22, 1974 from Stefano Vivona, American Cancer Society, Inc. to Josephine Opalka, above text is stamp "RECEIVED AUG 26 1974 BOARD OF PATENTS", near top of page is handwritten "copy -- Niels Reimers", at bottom left of page is stamp "STANFORD UNIVERSITY AUG 29 1974 TECHNOLOGY LICENSING", in top right corner of page are "xcc Cohen Kirk fS74-" and handwritten by SNC "Reimers file"; text acknowledges receipt of her August 19, 1974 letter to Dr. Mason, "Your request has been forwarded to our legal representatives for a decision. . . ."

Unsigned letter dated August 21, 1974 from Clive S. Liston, Patent and Copyright Manager to Jesse E. Lasken, National Science Foundation, cc SNC, H.J. Latker, J. Opalka, N.J. Reimers, "Reference: Grant No. GB 30581, Subject: Invention Disclosure S74-44; text: "Enclosed is a copy of the subject invention . . . mentions support for the research from Stanford, University of California, National Institutes of Health, American Cancer Society "as well as the National Science Foundation. Since the National Institutes of Health appears to be the predominant interest agency, Stanford has elected to file a patent application pursuant to the DHEW/Stanford Institutional Patent Agreement.", Reimers "is arranging for the appropriate clearances and releases, and will contact you regarding further action."

Unsigned letter dated August 20, 1974 from Clive S. Liston, Patent and Copyright Manager to Norman J. Latker, Department of Health, Education and Welfare, cc SNC, J.E. Lasken, J. Opalka, N.J. Reimers, "Reference: Grant No. 5 R01 AI08619, Subject: Invention Disclosure S74-44; text: "Enclosed is a copy of the subject invention . . . mentions support for the research from Stanford, University of California, National Institutes of Health, National Science Foundation, and American Cancer Society, "The National Institutes of Health is believed to be to be the predominant interest agency in this case, and Stanford has elected to file a patent application pursuant to the DHEW/Stanford Institutional Patent Agreement.", Reimers "is arranging for the appropriate clearances from the University of California and the National Science Foundation, and will contact you regarding further action."; attachment stapled behind letter is catalogued in next row

Stapled to August 20, 1974 letter from Clive S. Liston is p. 2 of a signed letter dated August 20, 1974 from Niels J. Reimers to Norman J. Latker, Department of Health, Education and Welfare, cc SNC, J.E. Lasken, R.P. Mason, J. Opalka; text of p. 2 "By a copy of this letter, the NSF, which also has been provided the invention disclosure, is asked to release its interest to the NIH and that the NIH administer the invention on behalf of the Government, in view of the lesser support of the NSF. Because of the tremendous significance of this invention, we will plan to immediately proceed to file a patent application, particularly in view of the early publication in November 1973. It was not until this May, however, that the implications of this invention were realized by the scientific community. We intend to exercise great care in the administration of this invention, insofar as is feasible within the constraints of the patent grant which may be issued, to ensure against misuse of the invention. They key to protection against misuse, however, is not related to patent rights. It is the restraint that individuals of the international scientific community must exercise against uncontrolled experimentation. . . . "

Page one of a signed, two-page letter dated August 20, 1974 from Niels J. Reimers to Norman J. Latker, Department of Health, Education and Welfare, cc SNC, J.E. Lasken, R.P. Mason, J. Opalka, "Reimers file" handwritten by SNC in upper right corner of page; text of p. 1 "Re; NIH Grant: AI 08619", you already have received the invention disclosure, "We hereby elect to administer the invention pursuant to the University's Institutional Patent Agreement. There are some modest complications of which you should be made aware.", details collaboration with Boyer and all other sources of funding besides NIH, have requested other funders to release their patent rights to NIH and permit NIH to administer, mentions "attached letter of August 19, 1974 from Ms. Josephine Opalka" re UC agreeing that Stanford can administer patent if UC gets a release from ACS; no attachments to letter in file

Unsigned two-page letter dated August 20, 1974 form Niels J. Reimers to Norman J. Latker, DHEW; this document contains both pp. 1 and 2 of the letter catalogued in two previous rows

Unsigned letter dated August 2, 1974 from Niels J. Reimers to Josephine Opalka, cc SNC, "N Reimers file" handwritten by SNC at top right of p. 1; text: thanks for July 30 letter, gives "My recommendation for handling the situation with respect to the various research sponsors . . . .In so far as the appropriate arrangement between Stanford and U.C., I propose that royalties, if any be split equally between U.C. and Stanford after deducting a percentage that we can agree upon to cover patent filing and licensing expenses of Stanford."; this appears to be the letter Opalka referred to in her letter to Reimers of July 11, 1975, the latter is catalogued in Row 384

Signed letter dated June 26, 1974 from Niels J. Reimers to Josephine Opalka, cc SNC, "Reimers N set up file" handwritten by SNC in top right corner; text: enclosed is copy of disclosure no. S74-44, "Dr. Cohen has advised me that he does not plan to claim any royalties to which he would be otherwise entitled according to NIH and Stanford policy. Dr. Cohen understands that appropriate steps with regard to possible patent protection may be in order to ensure this work is developed for public use and benefit because, as you are aware, it is difficult to encourage development of new processes or other inventions without some form of proprietary protection to encourage a company to invest risk capital in development of new products or processes for the public. . . .", have to promptly disclose invention to NSF and HEW, "I ask that you give me an early call after you have had a chance to discuss the disclosure with Dr. Boyer."

Stanford University Invention Disclosure, SEL Form No. 207; submitted, signed, and dated by SNC on June 24, 1974, "Title A Process for Construction of Biologically Functional Molecular Chimeras Inventor/s S.N. Cohen, H.W. Boyer", "RECORDS (a) Conception Discussion between S.N. Cohen and H.W. Boyer, Plasmid Meeting Hawaii, November 1972. Follow up discussions early 1973. Put in SNC grants January & Feb. 1973. (b) Construction/tests/useage [sic] Experiments - winter & spring of 1973. (c) Publications/notes 1) Nov. 1973 -- PNAS 70, 3240. Construction of Biologically Functional Bacterial Plasmids in vitro 2) April 1974 -- PNAS 71, 1030. Genome Construction Between Bacterial Species in vitro 3) May 1974 -- PNAS 71, 1743. Replication of Eukaryotic DNA in E. coli (d) Oral Disclosures Many seminars and oral presentations from December 1973. Also symposium presentations - to be published. ATTACHMENTS Reprints of Papers 1 & 2 & 3"

Unsigned letter dated October 29, 1973 from SNC to Robert Helling, University of Michigan, "PATENT - COHEN BOYER" handwritten by Karen Carpenter at top of page; text: "I have enclosed negatives I used in making slides covering the material in our PNAS paper. . . . I'm sure these will be satisfactory for your needs. Things here are moving well as we try to pull data together for the Xenopus story. I'm interested in learning just how many partial digest plasmids you have run through in checking for one with an intact ribosomal DNA sequence. We've been through only 5, and haven't found even a pSC101 with any ribosomal DNA on it --- let alone an intact repeat sequence. I would appreciate your sending these negatives back to me just as soon as your photographer completes your slides."

Undated two-page form letter from Bertram I. Rowland, cc SNC and Herbert W. Boyer, "Cohen/Boyer" handwritten at top of p. 1, SNC handwrote "File - Reimers" in upper right of p. 1; contents same as January 28, 1975 form letter catalogued in Row 152 [This document seems to be filed in the wrong folder. The contents are from 1975, not 1974].

Stanford University Patent Agreement, Form SU-18, signed and dated by SNC on September 1, 1972; folded with it is photocopy of "Page 1 of 2 Pages" of unsigned ASSIGNMENT form [signed and unsigned versions of this ASSIGNMENT form also catalogued in Rows 312, 355, and 366]

41-page "PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS", ". . . This application is a continuation-in-part of application Serial No. 687,430 filed May 17, 1976 which was a continuation-in-part of application Serial No. 520,691, filed November 4, 1974, now abandoned.", contains 10 claims; attached to it is unsigned two-page DECLARATION AND POWER OF ATTORNEY [signed version of form catalogued in Row 312 and older signed version of slightly different form (only 13 lawyers listed) catalogued in Row 355]; [These documents seems to be filed in the wrong folder. The contents are from 1976 or later, not 1974].

Butterfly clamp holding nine items: 1) USPTO Office Action, from A. E. Tanenholtz to Townsend & Townsend, stamped "RECEIVED APR 5 1975 TOWNSEND AND TOWNSEND", "This application has been examined."." Part I, "Notice of References Cited, Form PTO-892." [this Notice is not in the file], Part II, "SUMMARY OF ACTION Claims 1-9 are allowed. . . . Claims 10-26 are rejected."; "PATENT - COHEN BOYER" handwritten by Karen Carpenter at top of page; [This document seems to be filed in the wrong folder. The contents are from 1975, not 1974].

Butterfly clamp holding nine items, continued: 2) undated "NOTIFICATION OF REJECTION(S) AND/OR OBJECTION(S) (35 USC 132)", detailing opinion on Claims 10-26, stamped "ALVIN E. TANENHOLTZ EXAMINER ART UNIT 172"; [This document seems to be filed in the wrong folder. The contents are from 1975, not 1974].

Butterfly clamp holding nine items, continued: 3) 14-page "Brief Biography of Scientific Contributions Relating to Recombinant DNA (in historical perspective)", "Patent office File" handwritten by SNC at top of p. 1; extensive handwritten edits by SNC of the bibliographic details of the references; [This document seems to be filed in the wrong folder. It cites references as recent as 1978].

Butterfly clamp holding nine items, continued: 4) 14-page "Brief Biography of Scientific Contributions Relating to Recombinant DNA (in historical perspective)", small handwritten edits by SNC to text on pp. 11-12; [This document seems to be filed in the wrong folder. It cites references as recent as 1978].

Butterfly clamp holding nine items, continued: 5) photocopy of New Scientist, July 8, 1982, p. 75, containing article, "Genetic engineers stitched up over patent rights" by Paula Dwyer; "Patent file" handwritten by SNC at top right of page

Butterfly clamp holding nine items, continued: 6) photocopy of New Scientist, November 4, 1982, p. 277, containing article, "Stanford battles for cash from DNA patent . . ." by Paula Dwyer; "Patent file" handwritten by SNC at top right of page

Butterfly clamp holding nine items, continued: 7) photocopied pages from book, Recombinant DNA: The Untold Story by John Lear, Crown Publishers, Inc., New York, 1978; a) pp. 69-70, with "Cohen - Boyer patent file" handwritten by SNC at top of p. 69, b) pp. 83-85, c) copy of inside cover with title

Butterfly clamp holding nine items, continued: 8) one-page "CORRECTION TO SENATE REPORT NO. 9", signed by Erin Hutchinson, who wrote "Prof. Cohen" at top right, below it "Patent" handwritten by someone else, and below them "File" handwritten by SNC; text: "In Senate Report No. 9, published in Campus Report of March 9, 1977, it was reported that Professor S. Cohen and a Berkeley colleague had filed a patent application following a disclosure arising from work in the field of recombinant DNA. That Report should have said that Stanford University had filed a patent application following a disclosure arising from work on recombinant DNA which had been carried out by Professor S. Cohen and Professor H. Boyer, University of California at San Francisco."

Butterfly clamp holding nine items, continued: 9) undated handwritten note, "Pat, from Esther", clipped in front of six handwritten pages listing people who had requested pSC101 between 1973 and 1982 and "S.N. Cohen Lab Cultures Contrib. Directly or Indirectly to PRC" between 1976 and 1982

95 4
Cohen/Boyer patent information, 1975

Signed letter dated November 11, 1975 from Bertram I. Roland to SNC, "C/O Dr. David Hopwood, Department of Genetics, John Innes Institute", "Re: Pat. Appln. . . . Would you please execute the enclosed assignment which must be notarized by a counsel. When you return it to me, I will have Boyer execute the assignment."; two attachments: 1) "ASSIGNMENT" with SNC's name typed below signature line, but no signature, listing both SNC and Boyer as Assignors, Title of Invention: Process and Composition for Biologically Functional Molecular Chimeras, and the Board of Trustees of the Leland Stanford Junior University as Assignee, form states that for $1.00 Assignors have "sold, assigned and transferred . . . . all right, title and interest in and to the said invention . . . " to Assignee [signed and unsigned versions of this ASSIGNMENT form also catalogued in Rows 312, 355, and 429]; and 2) four-page "AGREEMENT CONCERNING RIGHTS IN INVENTION" dated June 19, 1975 between SNC and the Board of Trustees of the Leland Stanford Junior University, signed by SNC and Niels Reimers, at top right of first page "SU-178" and handwritten by SNC, "SNC personal files", on p. 3 refers to "the agreement between Stanford and the Board of Regents [of the University of California] dated 1975", the Department of Genetics is not mentioned in this document, which says net royalties go 1/3 SNC for distribution equally to Stanford's Research Development Fund and School of Medicine Dean's Fellowship Fund; 1/3 to the Department of Medicine; and the final 1/3 "shall be expended in the discretion of the Board of Trustees to further the objects and purposes of Stanford"

Signed two-page letter dated November 7, 1975 from John Wicklatz, General Mills Chemicals, Inc. to Niels J. Reimers, handwritten in upper right of p. 1, "xcc Cohen f S74-43", and in SNC's handwriting, "Reimers file"; text begins, "Many thanks for the information included in your letter of October 22. . . . With regard to Professor Cohen's work on "genetic engineering" which you mentioned, we would have to say this is of no interest to us for commercial development. I asked one of our biochemists who is familiar with the work to comment on it and he described it as a "revolutionary development". However, we are not in a position at present to take on a project of this sort which involves such a variety of far-reaching, but still incompletely defined, ramifications. As to courses you might take in licensing the above technology, we have no advice to offer. Our experience in licensing has never taken us into this field."

Small signed note dated October 6, 1975 from Jane Plagge to SNC, "Enclosed you're your records is a copy of the Agreement between the University of California and Stanford."; attached four-page "AGREEMENT CONCERNING ADMINISTRATION OF RIGHTS IN INVENTION" dated August 29, 1975 by and between University of California and Stanford, handwritten by SNC at top right is "Reimers file"; signed on p. 4 for Stanford by Niels Reimers and for the University of California by Constance W. Langton, Assistant Secretary, and David M. Blodgett, Assistant Counsel of the Regents; agreement states "the Invention shall be administered by Stanford" and that net revenues will be split in half between Stanford and UC, text elaborates: "Net revenues" as used in this Agreement shall mean the gross proceeds received by Stanford from the sale, licensing or other disposition of the Invention less (15%) of such gross proceeds to cover Stanford's indirect and overhead expenses, plus deduction of reasonable costs for preparing and filing patent applications and attorneys' fees."

Signed memo dated December 23, 1975 from Niels Reimers to SNC, "Reimers file" handwritten by SNC at top right of page; "Enclosed are copies of the memos about the recombinant DNA process by the Technology Licensing Business School Research Assistants. John Poitras and I will schedule a meeting with you after the first of the year to discuss these reports and where we go from here."; six attachments detailed in rows below

December 23, 1975 memo attachments: 1) Signed two-page memo dated August 13, 1975 from Ken Imatani to Niels Reimers re "File S74-43, Industrial Markets for Recombinant DNA Process; text details [p]rograms of extensive research and development for specific commercial applications", attached to memo is a table, "POTENTIAL COMMERCIAL APPLICATIONS OF RECOMBINANT DNA PROCESS"

December 23, 1975 memo attachments, continued: 2) signed memo dated August 6, 1975 from Ken Imatani to Niels Reimers re "Discussion with Dr Boyer for Future Development Work for Recombinant DNA Process", highlighted is section that begins, "In particular, Dr Boyer hopes to produce the angiotensin-2 hormone from a chemically synthesized replicon of its DNA . . . If this procedure is successful, the next logical extension would focus on the production of insulin."

December 23, 1975 memo attachments, continued: 3) signed memo dated August 5, 1975 from Ken Imatani to Niels Reimers re "signed memo dated August 6, 1975 from Ken Imatani to Niels Reimers re "Trip to Cutter Labs to Discuss Commercial Potential of Recombinant DNA Process"; Cutter Labs say the applications would be inappropriate for their business, however, quotes Dr. Victor Cabasso, Cutter's director of research and chairman of the Biological Section for the Pharmaceutical Manufacturers Association, "If I were a young man again, I would devote my entire life to research and development involving this process.", memo continues, "In addition, Dr Cabasso explained that an example demonstrating commercial use of the product would be required in order for a large pharmaceutical company to make a large capital investment in the process. He recommended seeking government support for a joint industry-university project"

December 23, 1975 memo attachments, continued: 4) one-page of comments dated July 1, 1975, referred to by Josephine Opalka in her July 11, 1975 letter catalogued in Row 384 as: "comments of one reviewer of the invention. The author's identity is held in confidence"; title at top of page: "IN CONFIDENCE Re: PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL DNA CHIMERAS--Cohen-Boyer; comments conclude, "In summary, it is my view that this is a somewhat ill-conceived patent application that disregards (albeit unintentionally) the contributions of other scientists and is very basic in its concepts and applications. While one can argue that the University should attempt to benefit from this scientific achievement, I am concerned that given the fundamental nature of the work and the number of scientists involved, either directly or indirectlly, that this patent will not reflect favorably on the public service ideals of the University."; this page of comments also catalogued in Row 385

December 23, 1975 memo attachments, continued: 5) signed memo dated October 18, 1974 from Bill Carpenter to Niels Reimers, cc Boyer and SNC; "Attached is a brief description of the technique developed by Drs. Boyer and Cohen, the development necessary for commercial application, licensing strategy, and potential dangers to humans. By copy of this memo, I am asking Dr. Boyer and Dr. Cohen to please bring to our attention anything that is incorrect or with which you may not agree."; attached two-page document, "The Plasmid Gene Transplantation Technique"; this memo and two-page attachment also catalogued in Row 410

December 23, 1975 memo attachments, continued: 6) two-page handwritten memo dated September 18, 1974 from BC [Bill Carpenter?], "To: 74-43", "Re: Dr. Herbert Boyer", recaps Boyer's comments on potential applications, also, "The Berg committee is concerned that researchers might try putting animal virus DNA into the plasmids -- Boyer thinks this must be done someday anyway, not sure it's so dangerous -- but it should be approached carefully.", circled in red pen is sentence: "Boyer not planning on signing away his own personal rights to the invention."

Letter dated December 9, 1975 from John K. Poitras, Associate Technology Licensing to Norman G. Brink, Merck Sharp & Dohme, cc SNC and Boyer, "Reimers file" handwritten by SNC at top right of page, note from SNC admin at bottom about trouble with Xerox; letter text: " . . . enclosing copies of the three technical papers describing the Recombinant DNA work." . . . . the Recombinant DNA work was sponsored under grants from the National Institutes of Health, the National Science Foundation, and the American Cancer Society. The latter two agencies have released their rights in the invention to the NIH so that the invention can be administered by Stanford pursuant to its Institutional Patent Agreement with the NIH. . . . We are very interested in moving rapidly to determine the applications of this widely significant technology. . . "; no attachments to letter in file

Signed letter dated October 3, 1975 from Kenneth Imatani, Research Assistant, Office of the Vice President for Business and Finance at Stanford to Harry Robinson, Merck & Company, bcc Boyer and SNC, "Reimers file" handwritten by SNC at top right of page; text, "As agreed in our conversation of yesterday, I am sending you two articles which describe both scientific and potential commercial applications of the recombinant DNA process. Also, attached is a table which identifies particular fields of industrial microbiology in which potential commercial applications may lie. The enclosed material is being provided on a non-confidential basis, and we would very much appreciate your comments on developing a plan for bringing this process forward to public use and benefit. . . ."; attached is signed letter dated September 30, 1975 from John A. Zderic, Syntex (U.S.A.) Inc. to Kenneth Imatani, handwritten at top right "1. NJR, 2. JKP, 3. FILE 74-43 xcc Boyer Cohen" and date stamped at bottom right, "STANFORD UNIVERSITY OCT ? 1975 TECHNOLOGY LICENSING"; re commercial applications, "Unfortunately, this is an area of science where Syntex currently has no work in progress, nor do we foresee that we will be in a position to enter this highly technical field in the near term future. . . ."

Unsigned letter dated October 3, 1975 from SNC to Bertram I. Rowland, cc Niels Reimers; text begins, "Niels has sent along the copy of your letter of October 2, and the accompanying rejection of our claims to the composition. The law may be "quite nebulous" in this area, but if it is primarily based on a "factual consideration" as you indicate, the patent examiner is totally wrong.", continues with details for 17 lines, and concludes, "Having spent so much time with you and with Stanford in attempting to provide the University with appropriate patent coverage, it is damned annoying to have the ignorance of the patent examiner on the subject present a problem of this sort."

Signed letter dated October 3, 1975 from Niels J. Reimers to Herbert W. Boyer and SNC, cc B. I Rowland; text: per attached letter from Bert Rowland, "the claims to the method allowed, but the claims to the composition rejected. My inclination is to go along with Bert's recommendation to let the patent issue with method claims only. We can then refile for the composition claims depending on whether we have a good argument to support the composition claims. I should observe from a "marketing" point of view, the composition claims are normally more valuable than method claims; thus it may be important to develop the "good argument"., any comments appreciated; attached is signed two-page letter dated October 2, 1975 from Bertram I. Rowland to Niels J. Reimers, cc SNC, handwritten at top of p. 1: "xcc Boyer Cohen 10/3" and date stamped at bottom of p. 1: "STANFORD UNIVERSITY OCT 3 1975 TECHNOLOGY LICENSING"; text: rec'd. "Office Action in the subject application, with the claims to the method allowed, but the claims to the composition rejected. . . . This area of the law is quite nebulous and is primarily based on a factual consideration. That is, what is the likelihood of an in vitro plasmid forming a homoduplex with an in vivo plasmid. The second consideration is how would one prove that the plasmid was formed in vivo or in vitro. . . . my recommendation is to allow the claims to the method issue as a patent and refile the application and continue prosecution as to the remaining claims. . . . I look forward to hearing from you."

October 2, 1975 letter catalogued in preceding row with "File Reimers" handwritten by SNC at top of p. 1; three attachments: 1) USPTO action cover sheet re STANLEY N. COHEN ET AL. "MAILED SEP 11 1975 GROUP 170" from A.E. Tanenholtz to Townsend and Townsend; "Responsive to communication filed 6-13-75 This action is made final."; Part I of form is unmarked, Part II lists Claims 1-12 allowed and Claims 13-26 rejected; attached is a two-page opinion dated September 16, 1981 by Alvin E. Tanenholtz, Primary Examiner with handwritten notes by SNC; 2) one-page opinion by Alvin E. Tanenholtz, examiner Art Unit 172 dated September 5, 1975, text: "Claim 23 is rejected as indefinite under 35 USC 112. Merely describing the plasmid in terms of what it can combine with is not a compete and adequate description of the plasmid. Claims 13-26 are rejected as unpatentable over each of Chakrabarty and Holloway under 35 USC 102 . . . This rejection is FINAL."; and 3) Townsend and Townsend letterhead envelope addressed to SNC, "Department of Pharmacology, Stanford University", stamped October 2, 1975

Unsigned letter dated "27 August, 1975" from SNC to Clayton Rich, Dean, School of Medicine, Stanford University, "NR47UH" typed at top of letter and "SNC personal" handwritten by SNC at top right of page; text, "Thank you for your recent kind note concerning the molecular cloning procedure and the assignment of my share of royalties to the Dean's Fellowship Fund and for the support of biomedical research at Stanford. I appreciate your taking the time to write. I am enjoying my sabbatical leave here, and am finding that this sabbatical is accomplishing what sabbaticals are supposed to do - - - I am having the opportunity to experience a change of pace and to look at things with a different perspective."

Signed letter dated August 6, 1975 from Clayton Rich to SNC, handwritten near top right are "SNC" and "c to SNC 8-8-75"; text: congratulates SNC "on your recent invention which undoubtly [sic] will be of great assistance in genetic research" thanks decision to name the Dean's Fellowship Fund to support postdoctoral fellows as a recipient of inventor's share and delighted Dept. of Medicine will receive half of University's share of net revenue

Three documents photocopied half size (5.5" X 8.5") and stapled to one half of a file folder: 1) Unsigned letter dated July 30, 1975 from Niels J. Reimers to Josephine Opalka, Office of the General Counsel, University of California, cc SNC and typewritten next to his name: "Enclosed with your copy of this letter to Miss Opalka is a copy of her letter to me of July 11 for your information only." signed "Niels", below that is handwritten: "Just saw your scientific [sic] American article! We also got the $25K from BD today!, at top right of page "Reimers file" handwritten by SNC; letter text: responding to "query in your letter of July regarding the difficulty our patent counsel has had in obtaining waiver of rights", summarizes situation: seven co-authors on papers with Cohen and Boyer, only one (unnamed) has signed waiver drawn up by Bert Rowland, "At present the patent examiner has not raised the issue of possible inventorship by the co-authors. Anticipating the patent examiner Mr Rowland has asked for affidavits detailing the inventorship situation" from Professors Cohen and Boyer . . ."

Three documents photocopied half size (5.5" X 8.5") and stapled to one half of a file folder, continued: 2) signed two-page letter dated July 11, 1975 from Josephine Opalka to Niels J. Reimers, date stamped "STANFORD UNIVERSITY JUL 14 1975 TECHNOLOGY LICENSING", "xcc Cohen" handwritten at top of p. 1 ; text: "Re: PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL DNA CHIMERAS--Cohen-Boyer I regret the delay in responding to your letter of May 2, 1975, with which you included signature copies of an Agreement covering the referenced invention. The reason for the extended delay is the departure from your original offer, expressed in your letter of August 2, 1974 . . . We interpreted your offer to mean that Stanford would assume all out-of-pocket expenses, deducting them and an appropriate overhead from future royalties prior to making distribution to U.C. Since the agreement you proffered provides for U.C.'s making out-of-pocket payments to Stanford to cover prosecution and related costs, I have had to place the invention in review procedure. This will result in our having to make some revisions in the Agreement. . . . I enclose for your information the comments of one reviewer of the invention. The author's identify is held in confidence . . . ", also has learned certain individuals at Stanford and U.C. have refused to sign waiver of rights. Insofar as this may influence our obtaining or retaining a valid patent, will you please let us have counsel's opinion as to the legal effect of these refusals."

Three documents photocopied half size (5.5" X 8.5") and stapled to one half of a file folder, continued: 3) one-page report catalogued in Row 373

Unsigned letter dated July 30, 1975 from Niels J Reimers to Josephine Opalka; same letter is catalogued in Row 383, only this one is full-size and has handwritten "c to SNC 8-1-75"

Signed letter dated July 23, 1975 from Niels J. Reimers to SNC at "Department of Genetics, John Innes Institute", in upper right of page, "Reimers file" handwritten by SNC; text, received your signed copies of the Agreement and enclosed your copy, "I have advised our accounting people to defer any payments to you until after January 1, 1976 per your request."

Full-size copy of July 11, 1975 two-page letter catalogued in Row 384, on this copy handwritten at top right of p. 1, "sent copy 7-29-75 c to SNC in Engl. 7-31-75, letter is stapled to copy of one page of comments dated July 1, 1975 catalogued in Row 373

Signed memo dated June 20, 1975 from Cassius L. Kirk, Jr. Staff Counsel, Stanford to Niels J. Reimers, "SUBJECT: Royalty Sharing Agreement with Dr. Cohen -- Biologically Functional Molecular DNA Chimeras"; text: attached are two execution copies and an extra copy of a revision of the proposed agreement with Dr. Cohen", endeavored to incorporate substance of changes you discussed re wording of subparagraph 3(a) and "[p]er your suggestion, paragraph 7 has been deleted."; attachment catalogued in Row 390

Attachment to June 20, 1975 memo catalogued in Row 389: signed memo dated June 19, 1975 from Cassius L. Kirk, Jr. to Niels J. Reimers, "SUBJECT: Royalty Sharing Agreement with Dr. Cohen"; text: enclosed draft of Royalty Sharing Agreement, "I have left blank the percentage of net royalty to be paid to a charitable organization designated by Dr. Cohen. I assume that Dr. Boyer will want to enter into a similar agreement and was not sure as to the percentage breakdown between Drs. Cohen and Boyer.", as noted in Kirk's April 29, 1975 memo to Reimers [catalogued in Row 395], " . . if Dr. Cohen retains the right to designate the disposition of the royalties he would otherwise have received, the IRS might consider the royalty income to be income of Dr. Cohen. . . . Should the invention turn out to be lucrative, it is conceivable that the amount of royalties contributed by Dr. Cohen would exceed 50 percent of his adjusted gross income. In such a situation, Dr. Cohen would have to pay income tax on a portion of the royalties contributed to charity. However, if Dr. Cohen and his attorney are not concerned about this possible exposure, I do not think the University need be."

Unsigned letter dated June 18, 1975 from SNC to Bertrand I. Roland [sic], handwritten at top right (not by SNC) is "Reimers"; text: thanks for sending copy of amendment filed for patent application, "In general, I think the arguments you have made are reasonable and appropriate. However, I think you could have been a bit stronger about the "improbability" of chimeras formed by natural means between organisms that ordinarily do not exchange genetic information. Based on all that is known in molecular biology, the likelihood of such an event occurring may be even less than "infinitely small". By definition, organisms that do not exchange genetic information cannot form molecular hybrids."

Unsigned letter dated June 9, 1975 from SNC to Niels Reimers; text, "As we discussed by telephone, I would like you to use your standard contract form in the assignment of the molecular cloning patent to Stanford by me, except as follows:" then 11 lines detailing distribution, also suggests idea for usage of funds going to Dept. of Medicine, "I plan to leave for England around June 23rd. We really need to complete arrangement prior to that time. . . ."

Three letters stapled together: 1) unsigned letter dated June 5, 1975 from SNC to Bert Roland [sic]; text, "I plan to leave for England on my sabbatical on June 20. I hope the information I provided for you in my recent letters will be suitable, but if not we should plan to talk before I leave."; 2) unsigned two-page letter dated May 20, 1975 from SNC to Bertrand I. Roland [sic], "Reimers file" handwritten by SNC at top right of p. 1; same text as copy of letter catalogued in Row 156, except that second-to-last paragraph typed twice in this letter and second instance crossed out; 3) another unsigned two-page letter dated May 20, 1975 from SNC to Bertrand I. Roland [sic]; text begins, "I've reviewed the information sent to you by the Patent Office Examiner. I'm not sure that I understand all of the points the examiner has made in connection with his rejection of our claims 10-26 of the patent, but want to respond on the basis of what I think he is saying.", rest of letter contains response

Signed letter dated May 12, 1976 from Bertram I. Rowland to SNC, paper has two large blue ink spots; text: re patent application, "Please find enclosed materials per your request."; no attachments to letter in file

Signed memo dated May 2, 1975 from Niels Reimers to SNC, CC C. L. Kirk, Jr.; text: two topics, attached memo from Cash Kirk and two alternate forms of waiver re royalty income, also three execution copies plus extra copy of Assignment of Application for Patent attached; three attachments: 1) signed memo dated April 29, 1975 from Cassius L. Kirk, Jr. to Niels Reimers, "SUBJECT: Release of Rights to Receive Royalty Income (Process and Composition for Biologically Functional Molecular DNA Chimeras", date stamped, "STANFORD UNIVERSITY APR 30 1975 TECHNOLOGY LICENSING"; text: "Attached are two forms of Waiver by Dr. Cohen of his right to receive royalty income from the above referenced invention. These forms include suggestions made by Gordy Weber in a telephone conversation this morning. . . You will note that the longer form contains a statement as to the understanding by Dr. Cohen as to the disposition to be made by the University of the royalty income which would otherwise have been received by him. Gordy advises that there is some risk that by including this paragraph the IRS might consider the royalty income to be income of Dr. Cohen. . . . Please have Dr. Cohen sign the original of either of the enclosed forms (but not both)."; this memo quoted in June 19, 1975 memo catalogued in Row 390; 2) unsigned longer waiver, this waiver also catalogued in Row 405; 3) unsigned shorter waiver

Two letters stapled together: 1) signed letter dated April 28, 1975 from Niels J. Reimers to Donald W. Carlin, Kraftco Corporation, cc H.W. Boyer and SNC, "File Reimers file" handwritten by SNC at top right of page; text: "You will recall my communication with you in November about the genetic engineering work from Stanford. Enclosed are copies of two articles from the December 1974 and April 1975 issues of Bioscience which will be useful for background regarding the genetic engineering work. Additionally, several practical applications are indicated. . . "; 2) signed letter dated April 28, 1975 from Niels J. Reimers to Bernard A. Shoor, Becton, Dickinson Electronic Laboratory, cc H.W. Boyer and SNC; text: same articles enclosed as in previous letter, mentions they contain "potential practical applications"

signed letter dated April 15, 1975 from Niels J. Reimers to Bernard A. Shoor, Becton, Dickinson Electronic Laboratory, cc SNC, "Reimers file" handwritten by SNC at top right of page; text: "You will recall our recent telephone conversation about the "genetic engineering" discovery from Stanford. . . . ", enclosed are three PNAS reprints "which describe the work. I also refer you to recent articles in Science (14 March 1975), Chemical and Engineering News (10 March 1975), and Chemical and Engineering News 3 February 1975) [sic]. . . . I will look forward to hearing from you about Becton, Dickinson's interest in this work."; no attachments to letter in file

Signed letter dated "18th February, 1975.", "Dictated by and signed on behalf of Dr. K. Murray." of University of Edinburgh to N.J. Reimers, "xcc Cohen Berg Massy" handwritten at top right of page, date stamped "STANFORD UNIVERSITY FEB 25 1975 TECHNOLOGY LICENSING"; text, "Thank you very much indeed for your letter of 3rd February and various enclosures clarifying the situation described by Dr. Morrow in his letter of January 23rd to me. It was very considerate of you to go to all this trouble."; paper has been dented at top by a paper clip, but no attachments in file

Signed memo dated February 10, 1975 from Niels Reimers to William Massy, cc H.W. Boyer, SNC, "File Reimers file" handwritten by SNC at top right of page; entire text: "Last Thursday I met with Paul Berg, David Hogness, Stan Cohen, Charles Yanofsky, and Ronald Davis in Professor Berg's office. The subject was the perception of Stanford's motives by the scientific community in filing a patent application for the "gene transplant" work, while at the same time advising the scientific community to "go slow" with respect to related research. A concern also was the scientific reputation of Dr. Cohen and Dr. Boyer of the University of California, a co-inventor with Dr. Cohen. Our patent attorney had innocently touched off the above concerns by sending out a letter to a number of Dr. Cohen's and Dr. Boyer's colleagues asking them to sign affidavits that they were not co-inventors. The letter gave the mistaken impression that Drs. Cohen and Boyer were personally filing the patent application and would receive material benefit. Hurry-up phone calls, letters and telegrams were sent out but not before the situation was made known to quite a number of people. We seem to have been able to defuse the situation with respect to Drs. Cohen and Boyer. Neither are claiming any financial return from any possible revenue which might be received from the invention. There continues some concern with respect to the perception of Stanford's and U.C.'s role in this matter and several courses of action were discussed. It was considered appropriate that a meeting be scheduled with you to discuss these possible solutions which include: 1) proceeding as before 2) turning the invention over to Research Corporation and 3) abandoning the patent. I'll be in touch with you later to schedule such a meeting."

Signed letter dated January 28, 1975 from Bertram I. Rowland to SNC, cc: Herbert W. Boyer, "Re: Pat. appln. for PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR DNA CHIMERAS - S. Cohen and H. Boyer"; text: "Enclosed is a copy of the letter I wrote to the co-authors of the above reference patent application clarifying the situation to them. A xerox copy of your letter dated January 22nd is also enclosed."; no attachments to letter in file

Signed letter dated January 23, 1975 from John F. Morrow, Carnegie Institution of Washington to SNC and Boyer, cc: Bertram I. Rowland, "Reimers file" handwritten by SNC at top right of page; letter catalogued in Row 154

Unsigned letter dated January 22, 1975 from SNC to Bertram I. Rowland; letter catalogued in Rows 153, 403, and 404

Signed letter dated January 22, 1975 from SNC to Bertram I. Rowland, stamped "RECEIVED JAN 24 1975 TOWNSEND AND TOWNSEND PENINSULA OFFICE"; letter catalogued in Rows 153, 402, and 404

Unsigned letter dated January 22, 1975 from SNC to Bertram I. Rowland, handwritten at bottom (not by SNC): "copies sent to: John F. Morrow, Charles Yanofsky, Herb Boyer, Donald Helinski"; letter catalogued in Rows 153, 402, and 403

Unsigned longer version of SNC's Waiver of right to receive royalty income, "Reimers file" handwritten by SNC at top right of page; this unsigned waiver also catalogued in Row 395

Two documents stapled together: 1) the extra copy of Assignment of Application for Patent referred to in May 2, 1975 memo catalogued in Row 395; three pages; pp. 1-2 "ASSIGNMENT OF APPLICATION FOR PATENT" with unsigned signature lines on p. 2 for Boyer, SNC, and Robert R. Augsburger, Vice President for Business and Finance, Stanford, p. 3 contains text for notarizing of all three signatures; 2) one-page unsigned Royalty Sharing Agreement described in the memo dated June 19, 1975 from Cassius L. Kirk, Jr. to Niels J. Reimers

95 5
Cohen/Boyer patent information, 1976

Signed five-page memo dated November 15, 1976 from Niels J. Reimers to SNC, Daniel Federman, I. Robert Lehman, Clayton Rich, Robert Rosenzweig, "Reimers file" handwritten by SNC in top right corner of p. 1, Subject: Genetic Engineering License; text begins, "This memo is intended as background for our meeting" November 24 at 1:30 p.m., "We anticipate receiving soon from NIH their release to license. Licensing will then be up to Stanford", sections of memo are: I. Property, II. Licensing Objectives, III. Licensing Negatives, IV. Industry Interaction, V. The Licensing Plan, and VI. Summary

Signed memo dated November 9, 1976 from Niels Reimers to Daniel Federman, cc SNC, "Reimers file" handwritten by SNC at top right; text begins, "Enclosed are copies of the memos that we spoke about concerning Stan's participating in licensing decisions on Recombinant DNA. Also enclosed is a copy of the CETUS August 21, 1976 "Letter to the Shareholders.", SNC has reaffirmed "his association with CETUS is as a scientific consultant on a fee-for-service basis only . . . . Stan would like to participate in the meeting which is scheduled" for November 24 at 1:30 p.m.; no attachments

Memo dated August 24, 1976 from John H. Rautischek to Betsy Clark, cc Niels Riemers [sic], Norm Latker, Chuck Herz, re "Invention disclosure NSF-75-17-GB-30581 Stanford University", in upper right "REIMERS file" handwritten by SNC; thanks for June 24th Nature article about Cohen-Boyer invention, "It is of interest that the NSF support from Herman Lewis' program was not mentioned in the article but perhaps we don't need the publicity."

News release dated July 19, 1976 from Stanford University Medical Center News Bureau, Contacts: Spyros Andreopoulos at Stanford, Michela Reichman at UCSF, "File - PATENT" handwritten by SNC in upper right, "SCIENCE WRITERS: The following story is distributed jointly with the University of California, San Francisco"; first sentence: "Stanford University and the University of California have filed an application to patent key elements of a new genetic engineering technique developed by scientists at both institutions."

Signed memo dated July 19, 1976 from SNC to Robert M. Rosenzweig, cc R. Augsburger, W. Massy, N. Riemers, C. Rich, SUBJECT: DNA Cloning Patent; text begins, "I wish I could agree with you that it is possible for me to completely detach myself from the University's decisions about the DNA cloning patent. . . . At the Miles Symposium where the patent issue was first raised publicly, I was able to effectively disarm critics in what could have been a very difficult situation. If instead of answering questions in an informed, honest and straightforward manner, I had responded by saying that I have "no knowledge or voice in the University's decision" as you have suggested, the public perception would surely have been that either I or the University, or both, have something to hide. . . . From my discussions with Neils Riemers [sic], it seems clear that the University administration will need to obtain advice on such matters [as patent policy] from faculty scientists, since scientific as well as purely business considerations are involved. . . . As I noted in my earlier memo to Neils Riemers [sic], I believe that any scientific advice I might provide to the Cetus Corporation can be disassociated entirely from input I provide to the University in connection with its licensing of this patent. . . ."

Signed letter dated July 9, 1976 from Robert M. Rosenzweig to Donald S. Fredrickson, bcc Richard W. Lyman, Bill Massy, Jim Siena, Clayton Rich, Paul Berg, David Hogness, Josh Lederberg, SNC, "Reimers file" handwritten by SNC at top right; "Thank you for your letter of July 6. I was pleased to know, as indeed Dr. Perpich had told me, that you have begun a careful review of patent policies with respect to recombinant DNA. . . . we have taken some pains to consult fairly widely about the wisdom and propriety of our proposed course of action and . . . have held off making irrevocable decisions until consultative processes had a chance to work. . . .[re NIH deliberations] Let me repeat my earlier offer to participate in those deliberations, or to arrange for participation by others at Stanford. Let me also urge that you act with both deliberation and dispatch. . . ."; attached is signed letter dated July 6, 1976 from Donald S. Fredrickson to Robert M. Rosenzweig, date stamped "RECEIVED JUL 8 1976 Vice President for Public Affairs"; text: responding to your letter of June 18, " . . . Dr. Joseph Perpich has told me of his conversation with you concerning the patent issues you raised in your letter and the accompanying memorandum. . . . I have undertaken a careful review of our patent policies with respect to recombinant DNA research. . . . Norman Latker, the patent counsel" for DHEW "may already have told you--in proceeding to obtain patents, Stanford has acted consistently within the terms of the institutional agreement Stanford has with the Department. I shall keep you informed of my policy review."

Signed memo dated July 7, 1976 from Robert M. Rosenzweig to SNC, cc R. Augsburger, W. Massy, N. Reimers, C. Rich, "Reimers file" handwritten by SNC in upper right of page; text begins "I have thought a good deal about your memorandum of June 14 to Niels Reimers. The questions you raise are not for me to decide--Clayton Rich, Bill Massy an Bob Augsburger have responsibilities more direct than mine. I cannot help but wonder, though, whether what you propose -- full knowledge of all aspects of licensing arrangement -- is the best way to achieve your aim -- avoiding damage to your professional reputation by virtue of association with unpopular University decisions. . . . If you can say to critics, "I had no knowledge of or voice in that decision" then I think you have effectively disarmed their criticism, at least as it applies to you. . . . I think you have a legitimate and important role in decision-making with respect to exploitation of the patent as a scientist and a member of the faculty. . . ."

Signed letter dated July 2, 1976 from Bertram I. Rowland to Niels J. Reimers, date stamped "STANFORD UNIVERSITY JUL 6 1976 TECHNOLOGY LICENSING", handwritten at top right 1. JKP 2. fS74-43 xcc Cohen Boyer" and in SNC's handwriting, "File - Reimers", "Applicant: STANLEY N. COHEN, et al., Serial No.: 687,430, Filing Date: 05/17/76, For: PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR DNA CHIMERAS, Our File No.: 5490-2-1; text begins, "The application above has been filed in the United States Patent and Trademark Office. . . ."

Signed memo dated June 30, 1976 from Robert M. Rosenzweig to R. Augsburger, P. Berg, S. Cohen, R.W. Lyman, W.F. Massy, N. Reimers, C. Rich, J. Siena, "File Reimer" handwritten by SNC at top right, "SUBJECT: Telephone Conversation with Joseph Perpich, Associate Director for Program Planning, NIH"; text begins: "On June 29 I called Donald Fredrickson, following my letter to him of June 18. Fredrickson was not available, but Dr. Perpich returned my call. . . . He said that NIH had received "several" letters inquiring about reports of patent activity in the Recombinant DNA area by Stanford and the University of Alabama, and so there was a need for them to consider the matter and decide what, if any, position NIH should take. . . . I made three points throughout", "1. We did not want the issue to be handled in such a way as to enable people to believe that we were acting in a secretive, sly, or underhanded way. . . . 2. We had a time problem with respect to one potential licensee . . . . 3. We are eager to have NIH's views on the soundest course to pursue, understanding, of course, that we might disagree with them when we know what they are. . . . "

Signed memo dated June 18, 1976 from Niels Reimers to Robert Rosenzweig, cc Stan Cohen, "Reimers file" handwritten by SNC at top right; text refers to attached June 14 memo from SNC re "possible appearance of a conflict of interest because of his role as a consultant with Cetus vs. his role as a confidant and advisor i the process of licensing to commercial entities . . . the association of Dr. Cohen and Dr. Lederberg with Cetus, the investment of other Stanford-related people in Cetus, as well as the investment of the University itself in Cetus, have been a matter of specific concern to representatives of a company with which we have been in contact . . . There is, of course, no issue if non-exclusive licensing only is followed. . . . I should also mention that we are not involving Herb Boyer in the business side of Recombinant DNA for even more obvious reasons. . . . would you please be kind enough to give Stan and me the benefit of your counsel?"; no attachments

Signed two-page letter dated June 18, 1976 from Robert M. Rosenzweig to Donald S. Fredrickson, cc R.W. Lyman, W.F. Massy, C. Rich, P. Berg, S. Cohen, "Reimers file" handwritten by SNC at top right of p. 1; text begins, "From Paul Berg and others I know that you are aware of the discussions taking place at Stanford now over the wisdom of proceeding (on behalf of Stanford and the University of California) with an application for patent protection for discoveries in the area of Recombinant DNA. As you know, we began to move in this direction with the knowledge and consent of NIH and NSF . . . The purpose of this letter is to solicit your views. . . .", refers to enclosed memo "in which I have attempted to summarize some of the major questions and address them in a way that makes sense to me, at least. . . . One point on which there is substantial unanimity among the officers of the University is that, if this line of work is to be developed in a way that provides income to the holder of a patent, there is no institution or group that has a stronger claim to that income than Stanford and the University of California . . ."; attached signed four-page memo dated June 4, 1976 from Robert M. Rosenzweig to "Those Interested in Recombinant DNA", "SUBJECT: Thoughts on the Patent Question", memo sections: I The Effect of Patents on the Conduct of Science, II Commercial Development and Basic Research, III The University's Financial Condition, IV Conflict of Interest and Public Policy, then: " . . . It will be clear to readers by now that my strong preference is to press for patent protection and a responsible licensing program. . . . I solicit the views of all who read this."

Photocopy of C&EN, June 7, 1976, p. 7, "File - Reimers" handwritten by SNC at top right, page 7 contains article, "Industry wary about genetic guidelines," no byline, text: NIH recombinant DNA guidelines "have been tailored to the conditions of research in universities and government laboratories and in some aspects may not be reasonable as guidelines for industry" according to some industry reps, "A modified version of the guidelines more useful to industry seems a good idea, both Dr. Fredrickson and industry representatives agree."

June 4, 1976 memo described above in Row 348, with "Please circulate around lab." and "Reimers" handwritten, not by SNC, at top of p. 1; eight sets of initials at top right of p. 1, including "SNC"

Five-page "SUPPLEMENTAL RESPONSE" to A. Tanenholtz, "Patent file" handwritten by SNC at top right of p. 1, signed on p. 5 by Bertram I. Rowland on October 4, 1977, handwritten "cc: Stanley Cohen, Herbert W. Boyer, Niels J. Reimers"; text begins, "Supplemental to the June 24 response to the Office Action of April 5, 1977, applicants, by their attorney, wish to submit the following remarks."

Four-page "RESPONSE UNDER RULE 116" to A. Tanenholtz, "Patent file" handwritten by SNC at top right of p. 1, signed on p. 4 by Bertram I. Rowland on October 25, 1977, typewritten cc: Stanley Cohen, Niels J. Reimers"; text begins, "In response to the FINAL REJECTION of October 3, 1977, the Examiner is earnestly requested to withdraw the rejections in view of the following remarks. Unfortunately, a supplemental reponse [sic] did not arrive at the Examiner's desk prior to his preparation of the FINAL REJECTION."

Four-page "SUPPLEMENTAL RESPONSE" to A. Tanenholtz with unsigned signature line on p. 4 for Bertram I. Rowland; text begins, "Supplemental to the June 24 response to the Office Action of April 5, 1977, applicants, by their attorney, wish to submit the following remarks. The courteous interview granted applicants' attorney is gratefully acknowledged."

Seven-page "AMENDMENT" to A. Tanenholtz, "Patent file" handwritten by SNC at top right of p. 1, signed on p. 7 by Bertram I. Rowland on June 24, 1977; text amends Claims 40 and 44, cancels Claim 45

Signed letter dated May 12, 1976 from Bertram I. Rowland to SNC, right margin has note handwritten by SNC, "db - please send enclosed to Bert Rowland at above address. Keep copy for our files" and written next to it in a different hand, "5-13-76", SNC notes at bottom of page, "P. 14 row" and "16 - J. Bact."; three attachments: 1) "ASSIGNMENT" signed but not dated by SNC, listing both SNC and Boyer as Assignors, Title of Invention: Process and Composition for Biologically Functional Molecular Chimeras, and the Board of Trustees of the Leland Stanford Junior University as Assignee, form states that for $1.00 Assignors have "sold, assigned and transferred . . . . all right, title and interest in and to the said invention . . . " to Assignee [signed and unsigned versions of this ASSIGNMENT form also catalogued in Rows 312, 366, and 429]; 2) "DECLARATION AND POWER OF ATTORNEY" signed by SNC on May 12, 1976 appointing 13 listed "attorney(s) and/or agent(s) to prosecute this application and transact all business in the Patent and Trademark Office connected therewith" (including Bertram I. Rowland) [newer signed version of slightly different form (21 lawyers listed) catalogued in Row 312 and unsigned 21-lawyer version of form catalogued in Row 430]; 3) undated 40-page "PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS"

Unsigned two-page letter dated April 28, 1976 from SNC to Bertram I. Roland [sic], at end of letter "c to P. Farley (CETUS) 5-5-76" handwritten, not by SNC or Karen Carpenter, 'COHEN-BOYER PATENT" handwritten at top of p. 1 by Karen Carpenter; text begins: "Enclosed is the information you requested. My lack of time right now limits completeness. I. General categories of composition. . . ." with brief scientific/technical answers numbered 1-2, 4-11

"Dictated but not read" letter dated April 22, 1976 from Bertram I. Rowland to SNC, cc Herbert Boyer, Niels Reimers, "Reimers - file" handwritten by SNC at top right; text contains five paragraphs of requests for scientific/technical information re patent application

Signed letter dated March 25, 1976 from John A. King, American Cyanamid Company to Niels J. Reimers, date stamped "STANFORD UNIVERSITY MAR 29 1976 TECHNOLOGY LICENSING", in top right, "xcc Cohen Poitras f S74-43" handwritten and handwritten by SNC, "file Reimers"; text: ". . . . Enclosed is a copy of King's notes on "Gene Transfer Process" from "my notes on the non-confidential conversation I had with NRDC people last Fall about the position of ICI on the gene transfer process work done at Edinburgh University. . . . "; attached Cyanamid "Memorandum II National Research Development Corp. JAK Visit of 9/3/75 Page -14- "U. Gene Transfer Process", "They told me that there had been filed, about a year ago, patent applications on the work of the two Murrays, at Edinburgh University, which had been sponsored by the Medical Research Council and which was tied up by and tied in with ICI on a gene transfer process using a phage as the carrier. . . ." text continues for total of 18 lines

Unsigned two-page letter dated March 1, 1976 from SNC to Bert Roland [sic], cc Niels Reimers; "In reference to your plans to resubmit a patent application to provide better coverage for Stanford, I have the following comments: 1) You indicated a need to define organisms that are "ordinarily unable to exchange genetic information" I believe this can be covered by the situation where DNA from one organism is not known to be able to propagate itself in the second organism. . . . 2) In organisms that can exchange genetic information biologically without the use of this methodology, I cannot think of any way to provide tight coverage against surreptitious attempts to get around Stanford's patent. . . . I am sorry that I can't be of more help regarding item 2. However, I think you should be able to get very tight coverage in the area of item 1, which I believe is where most of the financial rewards to Stanford will eventually be realized. . . ."; letter mentions "I have enclosed a copy of my Federation Proceedings review on Translocations" but there is no attachment to letter in file

Unsigned letter dated February 3, 1976 from SNC to Niels Reimers; re "Agreement concerning rights in DNA cloning procedure . . . It has come to my attention that a couple of other things need clarification in the above agreement: 1. The draft agreement dated June 19, 1975 has no termination date. . . . 2. I would like the agreement to contain a clause assigning all of my rights and privileges to my heirs or an assignee. . ."

Unsigned letter dated January 28, 1976 from SNC to Niels Reimers; re "Agreement concerning processing composition for biologically functional molecular DNA chimeras, described in U.S. Patent Application 520,691", "As a follow-up to my memo of January 6, 1976 on this subject, I would like to propose the following modifications in the above agreement:" then three changes described in 17 lines of text, then, "My request for these changes is motivated by personal and tax considerations. . . ."

Signed letter dated January 26, 1976 from Niels J. Reimers to Bertram I. Rowland, cc SNC and Boyer, "Reimers file" handwritten by SNC at top right of page; "Subject: Patent Application for "Process & Composition for Biologically Functional Molecular DNA Chimeras," your file 5490-2, Stanford file S74-43"; text: "Your recommendation regarding the prosecution o f the above patent application, as contained in your letter of January 21, 1976, and based upon discussions with Dr. Cohen, is to allow the application to issue and then refile. Please consider this letter as your authorization to refile--of course prior to the issuance of the above application."

Signed three-page letter dated January 21, 1976 from Bertram I. Rowland to Niels J. Reimers, cc SNC, "Reimers file" handwritten by SNC at top right of page; text begins, "After being somewhat elated with my progress in the subject application, after discussions with Stanley, my gratification diminished significantly. What I apparently thought was great progress in obtaining substantial coverage for the subject invention was being undermined by new scientific advances. Accompanying this letter are the new claims which the Examiner indicated he would be willing to allow." [no attachments to letter in file], next 33 lines discuss claims, including comment re Claim 23, "Stanley informs me of two problems with this claim. . . .", final paragraph begins: "It is possible to allow the subject application to issue, while refiling a modified version and expanding the discussion concerned with the differences between DNA segments which could not be joined in vivo and those which theoretically could be joined in vivo. . . ."

Unsigned letter dated January 6, 1976 from SNC to Niels Reimers, "File - Reimers" handwritten by SNC at top right of page; re "Licensing procedure for DNA cloning procedure"; text begins, "As we discussed today by telephone, I would like to propose some modifications in the licensing agreement that I signed and returned to you recently. These changes concern the sections on distribution of funds from the departmental and inventor's share of royalties.", comments that since "I have never received an executed copy of this agreement signed by you . . . I understand that modifications can still be readily carried out. . . ."; at bottom of page is typewritten, "Handwritten note attached: Niels, This seemed like one way to handle things without sticking you with the responsibility for re-opening the matter. Please let me know if you feel it presents any problem. Stan"

Newspaper clipping glued to 8-1/2" X 11" paper, with "Patent File" handwritten (not by SNC) at top right of page; "By Stanford, UC Patent Filed for Genetic 'Process'", no byline, pp. 1 and ?, Medical Center MEMO, Vol. 18, No. 6, 1976.; text: ". . . If awarded, the patent would cover commercial use of the process, said Niels Reimers, manager of Stanford's technology licensing program. It would not affect its use for academic or industrial research. . . . However, William F. Massy, acting vice-president and provost, stressed that Stanford has made no decision to exploit the technique commercially. "The matter is still under discussion with federal officials and being debated internally," he said. . . ."

95 6
Cohen/Boyer patent information, 1977

Signed letter dated December 5, 1978 from Bertram I. Rowland to SNC and Boyer, cc to Reimers, "BRANSON" handwritten by SNC in margin and above in, in another hand, "Debbie Branson"; text: please sign and return enclosed "Continuation-in-Part Patent Application"; stapled behind this letter is another signed letter, dated December 6, 1979 from SNC to Rowland, text: enclosed is Continuation-in-Part Patent Application "duly signed and notarized"

Undated 40-page "PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS", printed double-sided; attached behind it with a butterfly clamp is one sheet of paper with two forms printed on it: 1) on one side is "DECLARATION AND POWER OF ATTORNEY" signed by SNC on December 1, 1978 appointing 21 listed "attorney(s) and/or agent(s) who are partners and associates in the firm of Townsend and Townsend to prosecute this application and transact all business in the Patent and Trademark Office connected therewith" (including Bertram I. Rowland) [unsigned version of same form catalogued in Row 430 and older signed version of slightly different form (13 lawyers listed) catalogued in Row 355] ; 2) on the other side is "ASSIGNMENT" signed by SNC on December 1, 1978 and notarized by Debi Prunier, listing both SNC and Boyer as Assignors, Title of Invention: Process and Composition for Biologically Functional Molecular Chimeras, and the Board of Trustees of the Leland Stanford Junior University as Assignee, form states that for $1.00 Assignors have "sold, assigned and transferred . . . . all right, title and interest in and to the said invention . . . " to Assignee [signed and unsigned versions of this ASSIGNMENT form also catalogued in Rows 355, 366, and 429]

Signed letter dated December 1, 1978 from SNC to Bertram I. Rowland, cc to Niels J. Reimers, text: "Enclosed are two signed and notarized copies of the continuation-in-part patent application for the recombinant DNA process. You will need to get Herb Boyer's signature separately."; stapled behind it is signed letter from Bertram I. Rowland to Niels J. Reimers, date stamped "STANFORD UNIVERSITY NOV 9 1978 TECHNOLOGY LICENSING" with notes handwritten by SNC at top ("Rita Philip 76221") and bottom ("Debby Branson 77950"); text: "Enclosed are two copies of the captioned continuation-in-part application for review by you and the inventors. . . . . On November 7, 1978, we filed continuation application . . . of Application Serial No. 687,430 which was originally filed on May 17, 1976 . . . . The application was directed to the claims to compositions rejected by the Examiner."

Photocopy of nine-page "DECLARATION UNDER RULE 132" signed by SNC on October 28, 1982, "Final 10/28/82" handwritten by SNC at top right of first page

Unsigned 26-page AMENDMENT "In response to the Office Action of August 2, 1982" with signature line for Bertram I. Rowland; "To be revised" handwritten by SNC at top right of first page, on p. 10 is a post-it with illegible handwriting by SNC, on p. 17 is a post-it with "Make too b___ align of Hogness not prior" handwritten by SNC

Signed letter dated October 17, 1978 from Niels J. Reimers to Nature Magazine, cc to SNC, Norman Latker - HEW, Dr. Donald Fredrickson - NIH, at top right "Patent file" handwritten by SNC in pen and crossed out in pencil; text: comments re "article by John Douglas, "U. S. Geneticists Look to Europe for Research Facilities," in the September 21, 1978 issue", 1) lists sources of support for the original research: American Cancer Society, National Science Foundation, National Institutes of Health, University of California, and Stanford; and 2) "The existence of a patent per se does not inhibit research in the U.S. or elsewhere. The only basis on which this particular patent (if granted) might become a factor in the choosing of a site of research is that, as noted earlier in the article, industrial licensees of the patent will be required to follow the NIH safety guidelines for genetic engineering."

Memo dated September 27, 1978 from SNC to Niels Reimers; "I have reviewed your draft of a license agreement for companies . . . . I have no substantive modifications to suggest."; three attachments stapled to memo: 1) Signed memo dated September 19, 1978 from Robert M. Rosenzweig to Niels Reimers, cc S. Cohen, M. Hudnall, G. Lieberman, W. Massy, B. Rowland, Subject: Licenses for Cohen/Boyer work, handwritten by SNC in upper right is "Stanford Patent file"; text: he had reservations about licensing because of concern "that we not worsen the political climate in which the regulation of recombinant DNA research would be handled. My concerns in that area have greatly diminished in recent months as some balance has been restored to the public policy debate. . . . My present view, therefore, is that we should proceed to put into effect the best licensing program we can manage."; 2) Signed memo dated September 14, 1978 from Niels Reimers to SNC, Mike Hudnall, and Bert Rowland, cc to R. Rosenzweig, G. Lieberman, W. Massy, Subject: License for Cohen/Boyer Work; text: "Enclosed is your copy of a very rough first draft of a license for the Cohen/Boyer work. Each draft is numbered, and I would appreciate your not making any further distribution. Please be aware the earned royalty rate that I used is not at all firm. I particularly would like Bert's comments on basing royalties on products which may not be made by our licensee, Mike's comments on "safety guidelines," and Stan's on "End Products." . . . . After another drafting, I will probably go to one or more potential licensees on an informal basis to try it on them. . . . this scenario is of course contingent upon a formal decision by Stanford to license at all"; 3) nine-page "D R A F T AGREEMENT" for licensing Cohen/Boyer work, at top right of p. 1 is handwritten "Copy #3", on p. 3 a handwritten correction by SNC changing date of NIH Guidelines from December 1976 to July 23, 1976, and on same page after typewritten "licensee shall pay to Stanford the sum of" is a large gap in which "fifteen" handwritten by SNC, then typing resumes "thousand dollars . . ."

Signed letter dated June 1, 1978 from Kenneth R. Allen, Townsend and Townsend to SNC and Boyer, cc to Neils[sic] Reimers, at top right handwritten (not by SNC) "opened" and date stamped "JUN 6 1978" and in left margin near bottom handwritten (not by SNC) "Returned 6/8/78"; text, enclosed for signature and return "a further declaration which must be filed in this patent application in order to place it in a condition to be issued to Stanford"; no attachments

Signed letter dated May 2, 1978 from Bertram I. Rowland to SNC, cc to Neils [sic] Reimers, text: enclosed declaration "must be filed in this patent application in order to place it in a condition to be issued to Stanford", please sign and return; handwritten by SNC at bottom, "Please Xerox attached - Return original --> Bert Rowland"; attached is photocopy of two-page RESPONSE UNDER SECTION 152 OF THE ATOMIC ENERGY ACT OF 1954, signed by SNC on May 4, 1978, stating there was no "contract, subcontract or arrangement entered into with or for the benefit of the Nuclear Regulatory Commission" and that Stanford, UC, HEW, the ACS and NSF "all agreed that the invention was to be administered by Stanford"

43-page report, "THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS DEVELOPED UNDER DHEW SUPPORT: An Analysis by the Director, National Institutes of Health November 1977"; first page is photocopy of a letter dated March 2, 1978 from Donald S. Fredrickson to Robert M. Rosenzweig, text includes, " . . . it is my recommendation that at least for the present, recombinant DNA research inventions developed under DHEW-NIH support should continue to be administered within current DHEW patent agreements with the universities."; paper clipped to front of report is small photocopied note dated March 10,1978 from Donald S. Fredrickson, not addressed to anyone,, at top right of note date stamped "MAR 29 1978" and "Patent file" handwritten by SNC, text of note begins, "Enclosed is a copy of an analysis and decision on the patenting of recombinant DNA research inventions developed with DHEW support."

Signed letter dated March 17, 1978 from Niels J. Reimers to Bertram I. Rowland, cc to SNC and Herbert Boyer, "Patent file" handwritten by SNC at top right; Reimers states that the Atomic Energy Commission had no connection to the subject invention; SNC received support from the NIH and Stanford, Boyer was supported by the NSF, ACS and UC, concludes, "Bert, if you happen to find out what applications there are of this technology in "special nuclear material or atomic energy," I would be pleased to find out. I have not read in the literature nor heard from industry that such applications were contemplated or possible."; two attachments: 1) Signed letter dated March 14, 1978 from Bertram I. Rowland to Niels J. Reimers, date stamped "STANFORD UNIVERSITY MAR 15 1978 TECHNOLOGY LICENSING" asking for information on "sources of support for the subject invention", Rowland will then prepare statements for SNC and Boyer to sign; 2) USPTO communication "FILED May 17, 1976" from Benjamin R. Padgett, Special Laws Administration Group, sent to Townsend & Townsend, date stamped in upper left corner "PAT. & T.M. OFFICE MAILED FEB 1 1978 SECURITY GROUP LICENSING & REVIEW", also stamped at top of page, "RECEIVED 1978 FEB 16 PM 3:05 TOWNSEND & TOWNSEND", text states, "The subject matter of this application appears to be "useful in the production or utilization of special nuclear material or atomic energy" as recited in Section 152 of the Atomic Energy Act of 1954" and asks if any support from the Atomic Energy Commission, concludes, "This application will be reached for processing in about FORTY-FIVE DAYS. Final disposition thereof will be expedited if an appropriate statement is filed during this period."

Photocopy of article, "U.S. Approval: Stanford and UC Can License 'Gene-Splicing' by Charles Petit, San Francisco Chronicle, March 14, 1978, no page number provided, "Patent file" handwritten by SNC at top right of page

95 7
Cohen/Boyer patent information, 1978

Signed letter dated December 5, 1978 from Bertram I. Rowland to SNC and Boyer, cc to Reimers, "BRANSON" handwritten by SNC in margin and above in, in another hand, "Debbie Branson"; text: please sign and return enclosed "Continuation-in-Part Patent Application"; stapled behind this letter is another signed letter, dated December 6, 1979 from SNC to Rowland, text: enclosed is Continuation-in-Part Patent Application "duly signed and notarized"

Undated 40-page "PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS", printed double-sided; attached behind it with a butterfly clamp is one sheet of paper with two forms printed on it: 1) on one side is "DECLARATION AND POWER OF ATTORNEY" signed by SNC on December 1, 1978 appointing 21 listed "attorney(s) and/or agent(s) who are partners and associates in the firm of Townsend and Townsend to prosecute this application and transact all business in the Patent and Trademark Office connected therewith" (including Bertram I. Rowland) [unsigned version of same form catalogued in Row 430 and older signed version of slightly different form (13 lawyers listed) catalogued in Row 355] ; 2) on the other side is "ASSIGNMENT" signed by SNC on December 1, 1978 and notarized by Debi Prunier, listing both SNC and Boyer as Assignors, Title of Invention: Process and Composition for Biologically Functional Molecular Chimeras, and the Board of Trustees of the Leland Stanford Junior University as Assignee, form states that for $1.00 Assignors have "sold, assigned and transferred . . . . all right, title and interest in and to the said invention . . . " to Assignee [signed and unsigned versions of this ASSIGNMENT form also catalogued in Rows 355, 366, and 429]

Signed letter dated December 1, 1978 from SNC to Bertram I. Rowland, cc to Niels J. Reimers, text: "Enclosed are two signed and notarized copies of the continuation-in-part patent application for the recombinant DNA process. You will need to get Herb Boyer's signature separately."; stapled behind it is signed letter from Bertram I. Rowland to Niels J. Reimers, date stamped "STANFORD UNIVERSITY NOV 9 1978 TECHNOLOGY LICENSING" with notes handwritten by SNC at top ("Rita Philip 76221") and bottom ("Debby Branson 77950"); text: "Enclosed are two copies of the captioned continuation-in-part application for review by you and the inventors. . . . . On November 7, 1978, we filed continuation application . . . of Application Serial No. 687,430 which was originally filed on May 17, 1976 . . . . The application was directed to the claims to compositions rejected by the Examiner."

Photocopy of nine-page "DECLARATION UNDER RULE 132" signed by SNC on October 28, 1982, "Final 10/28/82" handwritten by SNC at top right of first page

Unsigned 26-page AMENDMENT "In response to the Office Action of August 2, 1982" with signature line for Bertram I. Rowland; "To be revised" handwritten by SNC at top right of first page, on p. 10 is a post-it with illegible handwriting by SNC, on p. 17 is a post-it with "Make too b___ align of Hogness not prior" handwritten by SNC

Signed letter dated October 17, 1978 from Niels J. Reimers to Nature Magazine, cc to SNC, Norman Latker - HEW, Dr. Donald Fredrickson - NIH, at top right "Patent file" handwritten by SNC in pen and crossed out in pencil; text: comments re "article by John Douglas, "U. S. Geneticists Look to Europe for Research Facilities," in the September 21, 1978 issue", 1) lists sources of support for the original research: American Cancer Society, National Science Foundation, National Institutes of Health, University of California, and Stanford; and 2) "The existence of a patent per se does not inhibit research in the U.S. or elsewhere. The only basis on which this particular patent (if granted) might become a factor in the choosing of a site of research is that, as noted earlier in the article, industrial licensees of the patent will be required to follow the NIH safety guidelines for genetic engineering."

Memo dated September 27, 1978 from SNC to Niels Reimers; "I have reviewed your draft of a license agreement for companies . . . . I have no substantive modifications to suggest."; three attachments stapled to memo: 1) Signed memo dated September 19, 1978 from Robert M. Rosenzweig to Niels Reimers, cc S. Cohen, M. Hudnall, G. Lieberman, W. Massy, B. Rowland, Subject: Licenses for Cohen/Boyer work, handwritten by SNC in upper right is "Stanford Patent file"; text: he had reservations about licensing because of concern "that we not worsen the political climate in which the regulation of recombinant DNA research would be handled. My concerns in that area have greatly diminished in recent months as some balance has been restored to the public policy debate. . . . My present view, therefore, is that we should proceed to put into effect the best licensing program we can manage."; 2) Signed memo dated September 14, 1978 from Niels Reimers to SNC, Mike Hudnall, and Bert Rowland, cc to R. Rosenzweig, G. Lieberman, W. Massy, Subject: License for Cohen/Boyer Work; text: "Enclosed is your copy of a very rough first draft of a license for the Cohen/Boyer work. Each draft is numbered, and I would appreciate your not making any further distribution. Please be aware the earned royalty rate that I used is not at all firm. I particularly would like Bert's comments on basing royalties on products which may not be made by our licensee, Mike's comments on "safety guidelines," and Stan's on "End Products." . . . . After another drafting, I will probably go to one or more potential licensees on an informal basis to try it on them. . . . this scenario is of course contingent upon a formal decision by Stanford to license at all"; 3) nine-page "D R A F T AGREEMENT" for licensing Cohen/Boyer work, at top right of p. 1 is handwritten "Copy #3", on p. 3 a handwritten correction by SNC changing date of NIH Guidelines from December 1976 to July 23, 1976, and on same page after typewritten "licensee shall pay to Stanford the sum of" is a large gap in which "fifteen" handwritten by SNC, then typing resumes "thousand dollars . . ."

Signed letter dated June 1, 1978 from Kenneth R. Allen, Townsend and Townsend to SNC and Boyer, cc to Neils[sic] Reimers, at top right handwritten (not by SNC) "opened" and date stamped "JUN 6 1978" and in left margin near bottom handwritten (not by SNC) "Returned 6/8/78"; text, enclosed for signature and return "a further declaration which must be filed in this patent application in order to place it in a condition to be issued to Stanford"; no attachments

Signed letter dated May 2, 1978 from Bertram I. Rowland to SNC, cc to Neils [sic] Reimers, text: enclosed declaration "must be filed in this patent application in order to place it in a condition to be issued to Stanford", please sign and return; handwritten by SNC at bottom, "Please Xerox attached - Return original --> Bert Rowland"; attached is photocopy of two-page RESPONSE UNDER SECTION 152 OF THE ATOMIC ENERGY ACT OF 1954, signed by SNC on May 4, 1978, stating there was no "contract, subcontract or arrangement entered into with or for the benefit of the Nuclear Regulatory Commission" and that Stanford, UC, HEW, the ACS and NSF "all agreed that the invention was to be administered by Stanford"

43-page report, "THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS DEVELOPED UNDER DHEW SUPPORT: An Analysis by the Director, National Institutes of Health November 1977"; first page is photocopy of a letter dated March 2, 1978 from Donald S. Fredrickson to Robert M. Rosenzweig, text includes, " . . . it is my recommendation that at least for the present, recombinant DNA research inventions developed under DHEW-NIH support should continue to be administered within current DHEW patent agreements with the universities."; paper clipped to front of report is small photocopied note dated March 10,1978 from Donald S. Fredrickson, not addressed to anyone,, at top right of note date stamped "MAR 29 1978" and "Patent file" handwritten by SNC, text of note begins, "Enclosed is a copy of an analysis and decision on the patenting of recombinant DNA research inventions developed with DHEW support."

Signed letter dated March 17, 1978 from Niels J. Reimers to Bertram I. Rowland, cc to SNC and Herbert Boyer, "Patent file" handwritten by SNC at top right; Reimers states that the Atomic Energy Commission had no connection to the subject invention; SNC received support from the NIH and Stanford, Boyer was supported by the NSF, ACS and UC, concludes, "Bert, if you happen to find out what applications there are of this technology in "special nuclear material or atomic energy," I would be pleased to find out. I have not read in the literature nor heard from industry that such applications were contemplated or possible."; two attachments: 1) Signed letter dated March 14, 1978 from Bertram I. Rowland to Niels J. Reimers, date stamped "STANFORD UNIVERSITY MAR 15 1978 TECHNOLOGY LICENSING" asking for information on "sources of support for the subject invention", Rowland will then prepare statements for SNC and Boyer to sign; 2) USPTO communication "FILED May 17, 1976" from Benjamin R. Padgett, Special Laws Administration Group, sent to Townsend & Townsend, date stamped in upper left corner "PAT. & T.M. OFFICE MAILED FEB 1 1978 SECURITY GROUP LICENSING & REVIEW", also stamped at top of page, "RECEIVED 1978 FEB 16 PM 3:05 TOWNSEND & TOWNSEND", text states, "The subject matter of this application appears to be "useful in the production or utilization of special nuclear material or atomic energy" as recited in Section 152 of the Atomic Energy Act of 1954" and asks if any support from the Atomic Energy Commission, concludes, "This application will be reached for processing in about FORTY-FIVE DAYS. Final disposition thereof will be expedited if an appropriate statement is filed during this period."

Photocopy of article, "U.S. Approval: Stanford and UC Can License 'Gene-Splicing' by Charles Petit, San Francisco Chronicle, March 14, 1978, no page number provided, "Patent file" handwritten by SNC at top right of page.

95 8
Cohen/Boyer patent information, 1978

Binder clip holding three sets of documents, each group held together with a butterfly clamp. First butterfly clamp holds four items: 1) Photocopy of nine-page "DECLARATION UNDER RULE 132" signed by SNC on October 28, 1982

2) article by S.N. Cohen and A.C.Y. Chang, J. Bac., 1977

3) article by S. Chang and S.N. Cohen, PNAS, 1977

4) first page of article by S.N. Cohen et al., PNAS, 1973

Binder clip holding three sets of documents, each group held together with a butterfly clamp. Second butterfly clamp holds nine items: 1) last four pages of article by S. Chang and S.N. Cohen, PNAS, 1977

2) unsigned letter dated September 5, 1974 from SNC to Dick Roblin, Mass. General listing 32 people who have requested and received the pSC101 plasmid

3) unsigned two-page letter dated September 6, 1977 from SNC to Donald Fredrickson, Director, NIH enclosing a manuscript [not included in this file] in press with PNAS, "I have taken the unusual step of sending it to you prior to publication because I believe the findings have policy, as well as scientific, importance with regard to the regulation of recombinant DNA", " . . . along with virtually all of the other scientists who first raised these questions, I have since come to believe that our initial concerns were greatly overstated."

4) photocopy of two-page "DECLARATION UNDER RULE 132" signed by Herbert W. Boyer on October 21, 1982

5) photocopy of Gordon Research Conferences "Frontiers of Science" Application to attend "Conference on extrachromosomal Elements" July 6-10, 1981 at Tilton School, signed by Christine Miller on April 2, 1981

6) photocopy of three-page "DECLARATION UNDER RULE 132" signed by Stanley Falkow on October 22, 1982

7) article by Guerry, Van Embden and Falkow, J. Bac., 1974

8) three-page "DECLARATION UNDER RULE 132" signed October 1, 1982 by Bernard Weisblum

9) first three pages of article by Tanaka and Weisblum, J. Bac., pp. 354-362, 1975 (the rest of the article is in butterfly clamp catalogued in next row)

Binder clip holding three sets of documents, each group held together with a butterfly clamp. Third butterfly clamp holds 18 items: 1) last six pages of article by Tanaka and Weisblum, J. Bac., pp. 354-362, 1975 (first three pages is in butterfly clamp catalogued in previous row)

2) photocopy of two-page "DECLARATION UNDER RULE 132" signed by David S. Hogness on October 27, 1982

3) photocopy of three-page "DECLARATION UNDER RULE 132" signed by Donald R. Helinski on October 27, 1982

4) article by Hershfield, Boyer, Yanofsky, Lovett, and Helinski, PNAS, 1974

5) photocopy of four-page "DECLARATION UNDER RULE 132" signed by Bertram I. Rowland on October 29, 1982

6) unsigned letter dated October 25, 1979 from Bertram I. Rowland to Robert B. Helling, cc to Niels Reimers, "11/5" handwritten at bottom right of first page

7) almost illegible photocopy of "____ Withholding Exemption Certificate" and "Patent Agreement" stamped "RECEIVED GRADUATE DIVISION SAN FRANCISCO JUL 13 1972" signed by Robert B. Helling and Administrative Assistant H. Kay Stewart on July 6, 1972

8) U.C. Employment Form signed by Robert B. Helling on July 6, 1972, "Dr. Robert Helling is an Associate Professor from the University of Michigan, Ann Arbor, here on a year's sabbatical doing special research with Dr. H.W. Boyer. He is a Special Fellow with the NIH."

9) Page 1 of Dept. of Health, Education, and Welfare Public Health Service Facilities and Commitment Statement for Research Fellowship, comments of Sponsor, " . . . During his sabbatical leave I expect Dr. Helling to participate in one area of our research program designed to elucidate the mechanism of DNA-protein interaction. . . ."

10) another photocopy of form catalogued above in 8)

11) Dept. of Health, Education, and Welfare Public Health Service Research Fellowship Activation Notice re Fellow Robert B. Helling, award period "From 6/11/72 Through 8/10/73 (14 Months)", signed by Helling on June 12, 1972 and by Herbert W. Boyer on June 14, 1972

12) Dept. of Health, Education, and Welfare Public Health Service Notice of Research Fellowship Award to Robert B. Helling, sponsor Herbert W. Boyer, date issued May 26, 1972

13) another photocopy of form catalogued above in 11)

14) U.C. Change in Employment Status signed by H. Kay Stewart for Robert B. Helling "From 7/1/83 Through 8/31/73" without salary, "He is staying an additional two months to complete his research project."

15) Dept. of Health, Education, and Welfare Public Health Service Notice of Research Fellowship Award to Helling, date issued July 25, 1972

16) almost illegible photocopy of Robert B. Helling's Report of Gift Acceptance, date gift received July 31, 1972, "Your application for a Public Health Service Research Fellowship has been approved"

17) Dept. of Health, Education, and Welfare Public Health Service Research Fellowship Termination Notice regarding Robert B. Helling, scheduled termination date, August 10, 1973, summary of research undertaken lists Cohen, Chang, Boyer, and Helling, PNAS in press

18) SNC article, "The Stanford DNA Cloning Patent", 1982

95 9
Cohen/Boyer patent information, 1979

Unsigned copy of a four-page letter dated October 25, 1979 from Bertram I. Rowland to Robert B. Helling, cc to Niels Reimers; four markings near top of p.1 1) date stamped "STANFORD UNIVERSITY OCT 26 1979 TECHNOLOGY LICENSING", 2) handwritten "xcc Cohen Ditzel 1. JKP 2. S74-43", 3) a second date stamp at top of p. 1, "OCT 30 1979", and 4) "patent file" handwritten by SNC; letter begins, "Thank you very much for the courtesy of your conversation. Enclosed with this letter is a copy of the claims which are presently before the Patent Office, the claims having been rejected primarily because of the prior publications by the inventors in conjunction with others. As I explained to you, it has been Patent Office policy to treat a publication which includes an inventor as a reference as prima faciae [sic] evidence of co-inventorship. The burden then shifts to the applicant to establish that the co-authors are also not co-inventors. However, if a co-author will not cooperate, then the applicants must seek judicial help in requiring the co-author to prove that he is also a co-inventor. I think you will agree with me that this Patent Office policy has no real basis in fact, since considerations of inventorship based on patent principles are rarely involved in the considerations of co-authors. The concept of an inventor is a legal concept which is based on certain factual inquiries." Rowland outlines his understanding of the facts for approx. two pages, then "If after reading this letter, you still believe that you should be accorded inventorship, I would greatly appreciate it if you would write down the contributions you feel you made toward the ultimate success of the development as presently claimed. . . . In the alternative, after reconsideration if you believe you are not a co-inventor, I would greatly appreciate your signing a Disclaimer of Co-Inventorship as to the accompanying claims. Purely from my own personal viewpoint, if you truly believed yourself an inventor, you had the opportunity to file a patent application in your name in conjunction with the others whom you deemed were co-inventors. . . . At the present time, unless the Patent Office withdraws its rejection, the application will have to go to appeal. I believe the only course of action left to the applicants is to file a cause of action in the District of Columbia requesting the Court to order the Commissioner to issue the patent and deposing you, so that we can once and for all determine all the facts and obtain a judicially sanctioned inventive entity."; at end of letter, "Enclosures 1. Claims 1-17 2. Disclaimer", but no attachments to this copy of letter; another copy of this letter catalogued above

Signed letter dated October 2, 1979 from Bertram I. Rowland to Niels J. Reimers, cc to SNC and Boyer, stamped "OCT 3 1979" at top of page and "Patent file" handwritten by SNC at top right; text re proposed letter to Helling enclosed for comments or suggestions, when Rowland spoke to Helling, "by the end of the conversation, he seemed to be willing at least to rethink his position albeit reluctantly. I therefore have indited the enclosed epistle in the hopes that the gospel according to St. Bertram may have some positive effect."; two attachments: 1) unsigned, undated four-page draft of letter from Rowland to Helling, and 2) five pages of undated text which begins, "WHAT IS CLAIMED IS:" and describes 17 claims

Photocopy of three-page "DECLARATION UNDER RULE 131" signed by SNC on February 7, 1980, but not signed by Boyer, stamped "COPY" at top left, and "patent file" handwritten by SNC in upper right, post-it on front page with handwritten note, "from: Bert Rowland To: Dr. Cohen", on p. 2, line 19 the word "kanamycin" has been crossed out in pencil and "TC" handwritten above it; attached are five photocopied, undated lab notebook pages with handwritten notes by Annie Chang (same pages as in document catalogued in Rows 272 and 273)

Photocopy of nine-page "THIRD PRELIMINARY AMENDMENT" signed by Bertram I. Rowland on May 9, 1979, handwritten at top of p.1 "xcc Stan Cohen Roger Ditzel 1. JKP 2. f S74-43" and in SNC's handwriting "Patent file"

Two-page signed letter dated April 9, 1979 from Paul D. Flehr of Flehr, Hohback, Test, Albritton & Herbert to Niels J. Reimers, three markings near top of p.1 1) date stamped "STANFORD UNIVERSITY APR 10 1979 TECHNOLOGY LICENSING", 2) handwritten "xcc Herzenberg Rowland Hudnall Cohen S74-43 S77-17", 3) "Patent file" handwritten by SNC; "Since our letter of March 23, we have received letters from our Japanese and German associates with respect to patents in foreign countries covering microorganisms and their processes. . . . the Japanese Patent Office has recently prepared examination standards on this matter. . . . According to my interpretation, the Japanese standards will permit the patenting of new microorganisms and processes for producing them. . . . In all probability these standards will be used in other foreign countries, and therefore it is suggested that you keep them in mind in preparing and filing new applications.", quotes their German associate:, "in Germany (and as far as I am informed also in other Euorpean [sic] countries as well) new microorganisms and microbiological processes may be patentable . . . ."; attachment: unsigned letter dated "March, 1979" from Nakamura, Yamamoto, Takeda and Partners to "Gentelemen" [sic], "Enclosed is an English translation of the revised part of the Examination Standard. Although the revision is still referred to as a proposal, it is almost certain to be formally adopted in the near future and applied to all applications."; attached to the attachment is a six-page English-language "Examination Standard Relating to Inventions of Microorganism Per Se" from "Office of Examination Standards"

Four-page signed letter dated February 8, 1979 from Paul D. Flehr of Flehr, Hohback, Test, Albritton & Herbert to Niels J. Reimers, cc to Bertram I. Rowland, three markings near top of p.1 1) date stamped "STANFORD UNIVERSITY FEB 9 1979 TECHNOLOGY LICENSING", 2) handwritten "xcc Cohen 1. JKP 2. S74-43", 3) "File" handwritten by SNC; nine paragraphs summarizing February 2 conversation with Bert Rowland re "the various Cohen et al. applications" and seven paragraphs summarizing subsequent conversation with "Tom Kiley of Lyon & Lyon about his experiences in this field."

95 10
Cohen/Boyer patent information, 1980

Signed memo dated December 19, 1980 from SNC to Donald Kennedy, SUBJECT: Recombinant DNA Patent; re licensing the patent: ". . . . The purpose of this memo is to urge that the University charge a very low royalty rate (no more than 0.5 percent) for such licenses. I strongly support the view that the University license rate should be low enough to encourage industrial organizations to sign up, rather than fight the very broad patent or take their operations outside of the United States where the patent does not apply. The more companies that sign up, the more unlikely it will be that other organizations will be inclined to challenge the patent or will be successful in doing so . . . the basic patent underlies an entire industry having enormous potential for generating income for the University. . . . with even a 0.5 percent royalty, the University will do well, and will in fact maximize the likelihood of financial success with the patent . . . "

Two-page news release "mailed December 3, 1980" from Stanford University Medical Center News Bureau, no title; first sentence: "A broad patent covering the novel gene splicing and cloning methods developed by scientists at Stanford University School of Medicine and the University of California in San Francisco has been issued by the U.S. Patent Office in Washington.", News Bureau contact Spyros Andreopoulos; at right top of first page "12/3/80" handwritten and "file" handwritten by SNC

Handwritten memo dated December 2, 1980 from Niels Reimers "TO THE FILE", cc to SNC, "Subject: call from Bert Rowland", in upper right date stamped "DEC 5 1980" and "file" handwritten by SNC; completed text: "Method" patent allowed!-- assigned #4237,224. Product patent appl still in negotiation. Pressure on examiner to complete neg. so patent can be used as reference in other pending gene splicing cases."

Patent 4,237,224 printed on 7-3/4" X 11-3/8" paper

Photocopy of Patent 4,237,224 copied onto 8-1/2" X 11" paper; "With best wishes, Stan Cohen" handwritten by SNC at bottom of first page; large post-it on first page has "Hold for letter to Tom Kiley" handwritten by SNC

Signed two-page letter dated September 4, 1980 from Niels Reimers to M. Mangyo, Mitsubishi Chemical Industries Limited, bcc to SNC and H. Kaplan, in upper right "file" handwritten by SNC and also a date stamp "SEP 8 1980" with the "8" crossed out and "9" written above it; "Thank you for your letter of August 21 with accompanying information describing the Mitsubishi-Kasei Institute of Life Sciences. As you may be aware, we have had patent applications on file in the area of genetic engineering for some time. . . . Pending issuance of those patents for the Cohen/Boyer work, we have not developed licensing plans for subsequent discoveries including the invention by Nunberg, Chang et al (Japanese Patent application #130718/1979). We have found that for patents in the pharmaceutical industry, exclusive licenses usually are necessary to encourage development at private risk to products available to the public. However, for basic discoveries such as the Cohen/Boyer patents, we plan to license them non-exclusively.", also discusses hybridoma technology and upcoming Kaplan, Olsson paper in PNAS, "A patent application is on file, and we plan to issue non-exclusive licenses.", and re question about royalties, "For the basic Cohen/Boyer process, the royalties will be less than 1% ", for hybridoma license "royalties will likely by 2% ", and "For other developments, the royalties will likely be greater as we would anticipate issuing exclusive licenses in many instances."

Unsigned letter dated August 26, 1980 from Niels J. Reimers to Phil Tracy, Burroughs Wellcome Co., cc to Adrian Arima and SNC, at top is date stamp, "AUG 28 1980" and in upper right "file" handwritten by SNC; text begins, "Attached is the Interferon License Agreement, which you will note includes the changes that we had discussed, except for the "combination product." . . . "; at bottom is typewritten: "blind note to Stan: We need the invention assignment signed by you and your colleagues before we can proceed further. NJR", "Niels" handwritten next to typed "NJR"

Unsigned two-page letter dated March 6, 1980 from Bertram I. Rowland to Niels J. Reimers, cc to SNC and Boyer, at top is date stamp, "MAR 7 1980" and in upper right "file" handwritten by SNC; "TELECON WITH DICKSON OF NATURE RE: APPLICATION STATUS"; received phone call March 4 from Mr. Dickson of Nature "who indicated he had tried to reach you and had been unable to. He further informed me, that he was inquiring about the status of the patent applications filed on behalf of Cohen-Boyer. . . he believed there was a problem concerning inventorship. I asked him whether he had been in contact with Professing[sic] Helling, to which he did not respond.", Rowland says he believes Dickson had read his letter to Helling, and continues recapping talk "My primary points were that while the Patent Office had raised the issue of authorship, I believed it could be handled in the Patent Office with the Examiner. If we were unsuccessful in that effort, then we might have to go to Court, . . .", told Dickson "Helling had done nothing to support his statement that he was a co-inventor, rather he was acting merely as a spoiler.", also "I further stated, that the situation with molecular biology was an excellent opportunity for the universities to realize some return on their substantial investment in support of research in the area. . . . I reiterated a few times concerning Helling that "Helling is an honorable man." I further requested that I not be quoted in the article. . . Before talking to Mr. Dickson, I think it would be appropriate for you and me to have a conversation."

Three memos stapled together: 1) Signed memo dated February 12, 1980 from SNC to Niels Reimers, "I have heard several different versions of what the "new policy" for distribution of royalties might be. . . . and that some potential obstacles have arisen to the earlier proposal to have the portion currently received by the University "General Fund" go instead to the School of Medicine. . . . I am reluctant to enter into still another major royalty distribution agreement in the absence of a decision on the royalty matter." asks for info re timetable for resolution, at below typewritten text is handwritten note, not by SNC, "(no encl.) attached only for our info."; 2) Signed memo dated September 14, 1979 from SNC to Donald Kennedy, Provost, cc C. Robertson, A. Michaels, G. Lieberman, L. Crowley, "This memo is to indicate my understanding of your proposal regarding patent royalties." next 16 lines of memo provide details, then "Thus, distribution of patent royalties will continue "as is" except that the current "University" share will go entirely or in major part to the Medical School. On the basis of this above understanding, I am prepared to proceed in good faith with assignment of rights in connection with the Michaels, Robertson, Cohen project."; 3) Signed memo dated September 20, 1979 from Donald Kennedy, Provost to SNC, cc to L. Crowley, G. Lieberman, A. Michaels, C. Robertson, at top is date stamp, "SEP 24 1979" and in upper right "Patent" handwritten by SNC; text: 9/14 memo "is entirely in accord with my understanding of our discussions. I'm fully committed to the actions you list, and I'm glad we're ready to move forward."

Signed letter dated February 5, 1980 from Bertram I. Rowland to SNC and Boyer, "File" handwritten by SNC in upper right; text: enclosed for signature and return to Rowland are two copies of a Declaration under Rule 131 "which I am sending to each of you simultaneously. The Declaration has already been reviewed by Stanley and is hopefully accurate"; two attachments, 1) unsigned three-page "DECLARATION UNDER RULE 131" with signature lines for SNC and Boyer, 2) five photocopied, undated lab notebook pages with handwritten notes by Annie Chang

Signed letter dated January 16, 1980 from Bertram I. Rowland to SNC, "returned 1/31/80" handwritten on side and date stamped "JAN 17 1980" in upper right; text: enclosed is a Declaration under Rule 131 "would you please review and see if all the statement I make are correct."; two attachments, 1) photocopy of unsigned three-page "DECLARATION UNDER RULE 131" with signature lines for SNC and Boyer, and handwritten edits by SNC 2) five photocopied, undated lab notebook pages with handwritten notes by Annie Chang.

95 11
Cohen/Boyer patent information, 1981

Draft of two-page memo dated December 18, 1981 from Niels J. Reimers to SNC, cc at end of memo to Kenneth Melmon, Gerald Lieberman, Larry Crowley, Phil Hanawalt, Donald Kennedy; handwritten at top of first page: "DRAFT STAN -- If this is OK, I'll do a "final": (it isn't possible to transfer funds to gift accounts) Niels 12/21/81" and in SNC's handwriting: "Patent file"; text begins, "Following is the accounting which you requested of the 1981 royalty revenue resulting from licensing of the subject patent and patent application.", also mentions, "The Dean's Fellowship Fund is to be used to establish and support the Bernard Cohen Post-Doctoral Fellowships, in honor of your deceased father."

Unsigned letter dated December 16, 1981 from Roger G. Ditzel, Office of the Board of Patents, Systemwide Administration to Joseph P. Allen, Intellectual Property Owners, Inc., bcc to Neils Riemers [sic], Herbert Boyer, SNC, in upper right of page "file" handwritten by SNC; nominates Boyer and SNC as "Inventors of the Year", pursuant to a call for nominations in the December 1981, IPO News."; stapled behind letter is photocopy of IPO News, December 1981, p.1 with article "Entries sought for 'Inventor of the Year'", no author listed

Signed letter dated December 11, 1981 from Bertram I. Rowland to SNC, in upper right date stamped "DEC 12 1981" and "File" handwritten by SNC; text: ". . . Enclosing my proposed response to the patent office", deadline is December 18, " . . . If I do not hear from you by that time, I will automatically mail the response as is."; attached is unsigned 11-page "AMENDMENT" with signature line for Bertram I. Rowland and handwritten edits by SNC (some on back of sheet)

Signed memo dated December 7, 1981 from SNC to Niels Reimers; request for $62.00 (train and taxi fares) reimbursement for visit to U.S. Patent Office where he spoke with patent examiner Alvin E. Tanenholtz SNC thought discussion "was useful, and hopefully will facilitate the allowance of our claims."; attached is photocopy of December 2, 1981 Amtrak Passenger Receipt for $26.00, signed by SNC

Photocopy of 1981 INVENTOR OF THE YEAR AWARD from Peninsula Patent Law Association to SNC and Herbert W. Boyer for Patent 4,237,224

Signed memo dated November 5, 1981 from SNC to Niels Reimers; would like to have royalty "funds received in 1981 credited to my accounts of this year and then transferred to the University funds before December 31."

Photocopy of article, date stamped at top "OCT 1 1981", "file" handwritten by SNC in upper right, "Stanford to License Gene-Splicing Technique", no byline, Scientists Inst. For Public Information, July-August 1981, p. 6.

USPTO action cover sheet "DATE MAILED SEP 18 1981" from A.E. Tanenholtz to Bertram I. Rowland; Part I states that "Notice of References Cited by Examiner, PTO-892 is attached, Part II lists pending and rejected claims; two attachments: first a signed six-page opinion dated September 17, 1981 by Alvin E. Tanenholtz, Primary Examiner, and second a two-page Notice of References Cited, listing five references, dated September 14, 1981 and signed by Examiner Tanenholtz

To Examiner: A.E. Tanenholtz "In re the application of JACK N. NUNBERG, et al, Serial No. 950,100", four-page AMENDMENT signed on behalf of Bertram I. Rowland on June 9, 1981

Page 22 of 25-pagedisclosure "PROTEIN PRODUCTION AT SYNTHETIC START SITE" described in Row 246 of this spreadsheet; text of P. 22 begins, "WHAT IS CLAIMED IS: 1. A method for providing for the production in a unicellular host of a protein foreign to said host . . . "

Signed letter dated October 26, 1979 from "(Ms.) Ronni Lipsius, Foreign Department Townsend and Townsend" to Niels J. Reimers; date stamped "STANFORD UNIVERSITY OCT 29 1979 TECHNOLOGY LICENSING"; in upper right of page handwritten "xcc Cohen F ____", date stamped "NOV 1 1979" and "Patent file" handwritten by SNC; text says re "Serial No.: 79302019.9, Filing Date: September 27, 1979, Country: EPO (Belgium,France,W.Germany, Italy, Luxembourg,Netherlands,Sweden & Switzerland) For: Protein Production at Synthetic Start Site", "application has been officially filed and assigned a serial number in the Patent Office of the country indicated."; post-it attached to letter with "Save for my trip east." handwritten by SNC

Sheet of lined yellow paper with handwriting by SNC, "Pat -- get copy of my original patent & examiner's initial denial--and return to me with the attached. S."; below in another hand, "ribosomonial [sic] start site"

USPTO action cover sheet re Serial Number 950,100, Filing Date 10/10/78, First Named Applicant Jack H. Nunberg et al" "DATE MAILED OCT 7 1981" from A.E. Tanenholtz to Townsend and Townsend; "This action is made final."; Part I of form is unmarked, Part II lists Claims 6-11 withdrawn and Claims 1-5 rejected; attached is a two-page opinion dated September 16, 1981 by Alvin E. Tanenholtz, Primary Examiner with handwritten notes by SNC

pp. 23-25 followed by pp. 1-21 of 25-page disclosure "PROTEIN PRODUCTION AT SYNTHETIC START SITE" p. 22 is filed separately and described in Row 238 of this spreadsheet; at top of page 1, "SNC Patent file" handwritten by SNC; p. 1: "BACKGROUND OF THE INVENTION";.2: "SUMMARY OF THE INVENTION", p. 3: "DESCRIPTION OF THE SPECIFIC EMBODIMENTS", p. 13: "EXPERIMENTAL", p. 25: "ABSTRACT OF THE DISCLOSURE"

Two-pages of graphics, "Applicable Overhead Cost Pools � MDTC of Each Univeristy [sic] Functions = Rate; first page depicts, "PRE- A-21" and second page depicts, "POST- A-21"

Memo dated September 1, 1981 from Andy Barnes to Niels Reimers, "copies sent by TFM to:" Robert Beyers, Donald Kennedy, Gerald Lieberman, William Massy, Kent Peterson, cc to Stanley Cohen, Roger Ditzel, Laura Hofstadter, OTL Staff, date stamped "SEP 2 1981", "SUBJECT: Cohen-Boyer Gene-Splicing License"; text begins: "Today, the Green Cross Corporation of Osaka, Japan, became the first company to sign our gene-splicing license agreement.", rest of memo provides details

Signed memo dated August 25, 1981 from SNC to Lawrence G. Crowley, cc: Niels Reimers, "SUBJECT: Inventor's share of royalties from the recombinant DNA patent"; text, "I have been informed by Niels Reimers that the University expects to begin receiving funds during the next several months from firms licensing the recombinant DNA patent. As you know, I have specified that half the inventor's share of royalties be assigned at present to the Dean's Fellowship Fund in the Medical School, and that the other half be assigned to the General Research Fund of the University. I am writing now to ask that the Dean's Fellowship funds received from my patent royalties be used to establish and support the Bernard Cohen Postdoctoral Fellowships. . . . in honor of my deceased father."

Two photocopies of signed memo dated August 20, 1981 from SNC to Niels Reimers, "SUBJECT: Recombinant DNA patent"; requesting original patent document: "I wondered whether you have followed up with Bert Rowland the possibility that the original patent document issued by the Patent Office on the Recombinant DNA method could be given to me."

Photocopy of Nature, Vol. 292:485, August 6, 1981, containing article, "Stanford sells gene-splicing licences" by David Dickson; "Boyer Cohen patent" handwritten by SNC at top right

Photocopy of clipping of article, "Genetics engineers upset by licences," "By the staff of Nature", handwritten at top is "copy--Stan Cohen THE TIMES AUGUST 6, 1981 [no page number provided] TO --> Reimers" and handwritten by SNC in upper right corner: "Patent file"; article begins, "Stanford University, in Palo Alto, California, has startled the new biotechnology industry by advertising for applications for licences to use the patents it hold, jointly with the University of California at Los Angeles [sic], on some of the basic operations of genetic manipulation. The advertisement appears among the small ads in next week's Nature. The legal implications of this development are far from clear. . . "

Three-page advance of press release draft dated July 29, 1981, "FOR RELEASE MONDAY, AUGUST 3, 1981", Contacts: Bob Beyers or Laura Hofstader, "file" handwritten by SNC at top left; text begins, "An unprecedented effort to license the entire genetic engineering industry for use of its basic scientific technique has been started by Stanford's Office of Technology Licensing."; Stanford president Donald Kennedy quoted, "Funds generated through this licensing program will help replenish the basic research enterprise"; Niels Reimers quoted, "So far as I know, there's no precedent for this sort of license"; two handwritten edits by SNC: 1) "The invention itself stemmed from scientific collaborations begun by Cohen and Boyer in a Waikiki delicatessen in November 1972." changed to " . . . begun by a discussion between Cohen and Boyer in a Waikiki delicatessen . . ." and 2) "At first, Cohen didn't think the basic invention was patentable." changed to ". . . didn't think the basic invention should be patented."

Unsigned letter dated July 7, 1981 from Andrew C. Barnes to Stephen Goulden, Cetus Corporation, cc to Stan Cohen, date stamped "JUL 9 1981"; "Please find enclosed a copy of the latest draft of the Cohen/Boyer License Agreement for your information. The underlined portions in the agreement indicate items which have changed since the previous draft. . . . we plan to publicly announce the terms of the license at the end of this month."

Signed memo dated June 24, 1981 from Niels J. Reimers to SNC, in upper right are date stamp "JUN 29 1981" and "file" handwritten by SNC; "This is a very belated reponse [sic] to your request for the "original" of the patent of you and Herb Boyer. I had been advised that we must keep the original on file until the patent expires in the event of disputes regarding the patent. . . . the next time I make contact with a Patent Office official . . . I will see if there is a way around that requirement and let you know what I find out."

Signed memo dated May 13, 1981 from SNC to Niels Reimers, SUBJECT: DNA Patent, "file" written in upper right (not SNC's handwriting); " . . . Although the rights to this patent have been assigned to the University, as the inventor, I should like to have and keep as a souvenir the patent document itself. . . "

Signed memo dated May 13, 1981 from SNC to Niels Reimers, CC to L. Crowley, SUBJECT: Royalty Distribution for Recombinant DNA Patent"; text: " . . . Dr. Crowley's approval of the revised distribution of the department share of the recombinant DNA patent income was prospective, and was in the form of a statement he made to me indicating that he would go along with whatever arrangement Ken Melmon and I worked out with each other. My statement to you about Dr. Crowley's approval was not intended to imply that he had reviewed the outcome of the discussions that Ken Melmon and I have held on this matter."

Signed memo dated April 28, 1981 from Niels J. Reimers to Bob Vandagriff, cc to K. Melmon, L. Crowley, G. Lieberman, K. Carpenter, in upper right "SNC" handwritten by Karen Carpenter and "Patent file" handwritten by SNC; text re royalty distribution, Melmon and SNC have agreed, with approval of Crowley and Lieberman, "that the "department share" should be split equally between the Department of Medicine and the Department of Genetics"; summarizes "distribution of "net revenues" (as net revenues are defined in the attached Agreement Concerning Rights in Invention dated 19 June 1975)."; memo has two attachments: 1) signed memo dated March 27, 1981 from Kenneth L. Melmon to Niels Reimers, cc to Gerald Lieberman, Lawrence G. Crowley, SNC, date stamped "STANFORD UNIVERSITY MAR 31 1981 TECHNOLOGY LICENSING" and in bottom right handwritten (not by SNC) "p. 45 Faculty Handbook"; text relates that Melmon and SNC have "come to a reasonable conclusion that the funds generated from his recombinant DNA patent should be split 50/50 between the Department of Medicine and the Department of Genetics for the indefinite future. My hesitation in regard to the long-term future split with the Department of Genetics was no longer justified when I found that the inventor, indeed, does retain all rights to the patent. . . "; and 2) four-page "AGREEMENT CONCERNING RIGHTS IN INVENTION" dated June 19, 1975 between SNC and the Board of Trustees of the Leland Stanford Junior University, signed by SNC and Niels Reimers, at top right of first page handwritten, "S74-43" and at bottom right "original in safe 7/24/75" (neither written by SNC), on p. 3 refers to "the agreement between Stanford and the Board of Regents [of the University of California] dated August 29, 1975", the Department of Genetics is not mentioned in this document, which says net royalties go 1/3 SNC for distribution equally to Stanford's Research Development Fund and School of Medicine Dean's Fellowship Fund; 1/3 to the Department of Medicine; and the final 1/3 "shall be expended in the discretion of the Board of Trustees to further the objects and purposes of Stanford"

Signed memo dated February 4, 1981 from Donald Kennedy to SNC, Subject: Cohen-Boyer Patent, date stamped "FEB 6 1981"; Kennedy understands Reimers "has been in touch with you on his views on the royalty rate for licenses", that R's proposal is agreeable to SNC, and" that it has the property of flattening out at 1/2%, as you suggested. I, too, agree to his proposal and I believe that it accomplishes our objective of getting the scientific results out to the world as quickly as possible, and generating a fair return to Stanford."; handwritten by SNC at bottom of page, "Feb. 9, 1981 Discussion with Neils [sic] today indicates that initial royalties are 1% reduced to 0.75% > 10 X 106. Further reduction to 0.5% with higher volume. I indicated that I thought 0.5% across-the-board might be better but am not going to push. SNC"

Signed memo dated January 30, 1981 from Niels Reimers to SNC, cc to Kenneth L. Melmon, K.J. Carpenter; request that department's share of royalties be divided equally between Depts. Of Genetics and Medicine, "At the present tie, the departmental share of royalties is assigned entirely to the Department of Medicine, although I currently hold appointments in the two departments."

Signed memo dated January 19, 1981 from Donald Kennedy to SNC, date stamped "JAN 23 1981"; reply to SNC's "memo of December 19th concerning the Cohen-Boyer patent. I welcome your thoughtful advice that Stanford should charge a very low royalty rate for licenses related to this patent. . . . and I am in the process of attempting to get Niels Reimer's view on the right magnitude."

Issue of The Blue Sheet and its Supplement, Vol. 24, No. 1, January 7, 1981; Upper right of Supplement cover has "Patent file" handwritten by SNC; Supplement contains "COMPLETE TEXT OF STANFORD's DNA PROCESS PATENT", pp. S-2 - S-14.

95 12
Cohen/Boyer patent information, 1982

Unsigned form letter template from Katharine Ku to "[Adr]", cc to Roger Ditzel - UC, Adrian Arima - SU, Lucy Petitt - NSF, Leroy Randall - HHS, S. Cohen - SU, K. Ku - SU, "file" handwritten by SNC at top right, date stamped "JAN 4 1983", post-it attached with "file" handwritten by SNC, text begins, "We wish to verify the Patent Office has been asked to close the public patent prosecution process on the Cohen/Boyer "product" patent application. . . . your license covers both the issued "process" patent and any patent resulting from the "product" patent application."

Signed letter dated 15 December 1982 from Peter Newmark, Nature to SNC; text re Helling inventorship claims, concludes, "I am disappointed for our sake but glad for yours that discussion has now been driven underground."

Signed letter dated 6th December, 1982 from R.S. Crespi, Patents Controller, British Technology Group to Niels Reimers; at top of page handwritten "xcc/incl attach to Cohen Rowland Rosenzweig 3 file S74-43", date stamped "STANFORD UNIVERSITY DEC 10 1982 TECHNOLOGY LICENSING" and in SNC's handwriting "Patent file"; thanks for review of my book which appeared in TIBS, same issue contains "short article of mine on some basic patent points which I have illustrated by reference to Cohen-Boyer. I have tried to be quite neutral on the issues on your case, especially as I am not expert in your law."; attached photocopy of article, "Current issues in patent law" by R.S. Crespi, TIBS, December 1982, page numbers missing

Photocopy of article, "Biotechnology patent challenged" by Stephen Budiansky, Nature, Vol. 300, p. 303, November 25, 1982; re Robert, in upper right "Patent file" handwritten by SNC

One-page memo dated November 19, 1982 from Niels J. Reimers to Deborah Shapley, Editor, Nature Magazine, has "file" handwritten by SNC in upper right re Nature article "about Stanford's response (on the "second Cohen-Boyer patent") to the U.S. Patent Office (Nature, 11 November, p. 95), one is struck by the editorializing by the author . . . . the article makes it appear the universities have deliberately sought to exclude Dr. Helling from being a co-inventor. The facts are these.", then presents Stanford's and UC's position; stapled in front of memo is small sheet with OTL letterhead, date stamped "NOV 24 1982", typewritten "11/23/82 To: S. Cohen R. Ditzel B. Rowland For your files" signed K. Ku and handwritten below that: "Dr. Cohen -- I assume you received the full copy of the Response K2"

Issue of McGraw-Hill's Biotechnology Newswatch, Vol. 2, November 15, 1982; on p. 1 date stamped "NOV 29 1982", handwritten by SNC in upper right is "patent file"; on p. 5 article "Stanford's attorney yields no ground in rebutting rejection of second Cohen-Boyer patent application", no byline, handwritten by SNC in upper right of p. 5 is "patent file"; from 1st paragraph of text, "The response, prepared by Palo Alto patent attorney Bertram Rowland, with some assistance from co-inventor Stanley Cohen, attempts to shoot down the complex legal points raised by patent examiner Alvin Tanenholtz, without conceding a single one of 30 claims the application makes to products that results from the gene-splicing invention."

Unsigned letter dated November 9, 1982 from Katharine Ku to Editor, Stanford Daily; re November 8 article, "University Reapplying for Cloning Patent" . . . "I would like to correct and clarify a few specific points" then three paragraphs of text; stapled in front of letter is smaller sheet of OTL letterhead date stamped "NOV 15 1982", handwritten, "11/12/82 Dr. Cohen: Here's a copy of the letter I sent to the Editor -- they apparently deleted one paragraph because of lack of space. Niels & I feel it's best to drop the topic at this point -- Hope that is satisfactory to you Kathy Ku"; stapled on top of this is a newspaper clipping, "Cloning patent" by Katharine Ku, which is missing the second paragraph of text from Ku's letter

Issue of Nature, Vol. 300, November 11-17 1982

Clipping of article, "University defends patent on gene splicing, cloning", no byline, Campus Report, November 3, 1982, pp. 1,17. " File Cohen-Boyer Patent file" handwritten at top of article by SNC

Two-page draft of news article on letterhead of Stanford University Medical Center News Bureau with date "Nov. 1, 1982" at end, text contains handwritten spelling corrections (not in SNC's handwriting), the final version of this article appeared in Campus Report on November 3, 1982; handwritten at top "11/1/82", date stamped "NOV 5 1982" and "file" handwritten by SNC; business card of Spyros Andreopoulos stapled to top left; only edits to text are four corrections of typos, not in SNC's handwriting

Two-page memo on green tissue paper dated October 5, 1982 from Niels Reimers to Arthur Kornberg, handwritten at top right: "Stan -- FYI & ___ [looks like f13]. I think you were one I told a "penicillin myth". Niels 10/20/82; memo starts, "Thank you very much for the loan of In Search of Penicillin by David Wilson. . . . "There is an element of truth also with respect to the anti-patent position of some British scientists, but the ultimate reason patents were not filed was a matter of bureaucracy, not principle. . . . A frequent complaint of U.K. university scientists today is that they must delay publication because of patent matters. As you know, we have not, and will not, ask or encourage Stanford scientists to delay publication."

Letter dated October 25, 1982 from Bertram I. Rowland to SNC, "File" handwritten by SNC; enclosing "two copies of the declaration we discussed to be filed in the subject application" for review, signature and return; two copies of nine-page "DECLARATION UNDER RULE 132" attached, the first one has handwritten edits by SNC, also attached is manila envelope addressed to Rowland

Binder clip holding unsigned letter dated October 14, 1982 from Bertram I. Rowland ("dictated but not read") to Niels J. Reimers cc to SNC; enclosed is "proposed draft of a response to the Office Action in the subject application", Dave Hogness "informs me he has documentation which establishes his possession of pSC101 prior to November 4 . . . a declaration by Dave will be added."; attached are amendment and six declarations: 1) 19-page unsigned AMENDMENT with signature line for Rowland and handwritten edits by SNC, 2) unsigned nine-page "DECLARATION UNDER RULE 132" with signature line for SNC, 3) Unsigned two-page "DECLARATION UNDER RULE 132" with signature line for Herbert W. Boyer, 4) Unsigned three-page "DECLARATION UNDER RULE 132" with signature line for Stanley Falkow, with a handwritten comment by SNC, 5) Three-page "DECLARATION UNDER RULE 132" signed October 1, 1982 by Bernard Weisblum, 6) Unsigned three-page "DECLARATION UNDER RULE 132" with signature line for Donald Helinski, 7) Unsigned four-page "DECLARATION UNDER RULE 132" with signature line for Bertram I. Rowland

Signed letter dated September 14, 1982 form Bertram I. Rowland to SNC, in upper right date stamped "SEP 16 1982" and "file" handwritten by SNC; enclosed is "proposed declaration for use in the subject application in response to the outstanding Office Action. I am meeting with Mr. Tanenholtz on the 23rd, and would like to have in my possession a copy which is generally approved by you"; attached is unsigned nine-page "DECLARATION UNDER RULE 132" with signature line for SNC and handwritten comments by SNC

Clipping of article, article, "Patent Office Withdraws Cohen-Boyer Plasmid Patent from Slated Issue, Rejects All Claims" by Gerry J. Elman, Genetics Engineering News, Vol. 2, September/October 1982, pp. 1,28-30.

Memo dated August 16, 1982 from Niels J. Reimers to Julius Krevans, Herbert Boyer, Lawrence Crowley, SNC and Roger Ditzel, in upper right date stamped "AUG 18 1982" and "file" handwritten by SNC; re lunch reservations at California Culinary Academy on October 22 at noon

August 11, 1982 issue of Campus Report, containing article, "Genetic engineering patent must await further scrutiny," by Deborah Franklin, pp. 7,8;"8/11/82" and "file please" handwritten by SNC at top of p. 7

Typewritten draft of four-page letter dated August 9, 1982 from SNC to Bert Rowland, cc to Niels Reimers re "Comments on U.S. Patent Office Action of August 2, 1982

Photocopies of three newspaper articles, stapled together: 1) "Stanford, UC rebuffed in bid for patent," by Karen Klinger, San Jose Mercury, August 6, 1982, pp. 3A,3B; 2) "Questions delay Stanford's genetic engineering patent," by Mary T. Fortney, August 5, 1982, pp. B-1,B-3; 3) "U.S. Turns Down Gene-Splicing Patent Bid," no byline, San Francisco Chronicle, August 6, 1982, p. 28.

Two-page draft of news article on letterhead of Stanford University Medical Center News Bureau with date "Aug. 5, 1982" at end, text contains handwritten spelling corrections (not in SNC's handwriting), the final version of this article appeared in Campus Report on August 11, 1982; handwritten at top "8/5/82" and "file" handwritten by SNC

Memo dated August 4, 1982 from Niels J. Reimers to Julius Krevans, Herbert Boyer, Lawrence Crowley, SNC and Roger Ditzel, in upper right date stamped "AUG 9 1982" and handwritten note by SNC, "Pat -- please put on calendar" note also asks about Inventor's Hall of Fame plaques, typed at bottom, "P.S. If you would like a ride to the City, please let me know. Niels"; memo text re lunch reservations at California Culinary Academy on October 22 at 1:00 p.m.

Letter dated August 2, 1982 from Stephen Budiansky, Washington Reporter to SNC, handwritten by SNC in upper right: "Patent file"; letter written on 5" X 8.5" notepaper with Nature America letterhead which is taped to a blank 8.5" X 11" sheet of paper; "I appreciated your phoning today with your comments on my article in last week's Nature. . . . If you would like to air the points you raised with me before the Nature audience, you are more than welcome to send us a note for the "Correspondence" section."; letter refers to article, "Key biotechnology patent delayed" by Stephen Budiansky, Nature, Vol. 298, July 29, 1982, pp. 409-410.

USPTO action cover sheet "DATE MAILED AUG 02 1982" from A.E. Tanenholtz to Bertram I. Rowland, in upper right of page "file" handwritten by SNC; Part I states that "Notice of References Cited by Examiner, PTO-892 is attached, Part II lists pending and rejected claims; two attachments: first a signed nine-page opinion by Alvin E. Tanenholtz, Primary Examiner, . . . "the prosecution is reopened to set forth objections and rejections necessitated by the discovery of 1) the Cohen et al, Journal of Bacteriology article, 2) the letter to Dr. Donald Fredrickson from Dr. Stanley N. Cohen, 3) the Nature article of April 3, 1980 and 4) to ascertain further information for basing a judgement on the availability of pSC101." and second a list of Other References by Examiner Tanenholtz

Two photocopies of article, "Key biotechnology patent delayed" by Stephen Budiansky, Nature, Vol. 298, July 29, 1982, pp. 409-410., one of which has some handwritten notes

Memo dated June 30, 1982 from Niels J. Reimers to Distribution: Donald Kennedy, William Massy Gerald Lieberman, Kent Peterson, Adrian Arima, Spyros Andreopoulos, Stanley Cohen, Roger Ditzel (UC), Herbert Boyer (UC); An article discussing various "uncertainties" regarding the validity of the Cohen/Boyer patent(s) will appear in the next issue of Biotechnology Newswatch, patent attorney notified by Patent Office that "product" application being withdrawn for further consideration

Memo dated June 22, 1982 from SNC to Niels Reimers, cc D. Purpura, D. Mendelow, K.J. Carpenter; "Subject: Patent Income"; "At a recent meeting of the Department of Genetics faculty concerns were raised about University policies regarding 1) timing of the crediting of patent income to departmental accounts, and 2) maintenance of a fixed "off-the-top" payment for the Office of Technology Licensing regardless of the amount or duration of patent royalties. . . . I am conveying these views to you in response to a departmental resolution that I do so."; "Kathy Roberts" handwritten at bottom of page

Letter dated March 18, 1982 from Evretechnika, Patent and Trademark Attorneys, Athens, Greece to SNC offering to file genetic engineering patent in Greece

Letter dated January 14, 1982 from SNC to Thomas D. Kiley, Genentech, Inc. re "Enclosed is a copy of the Cohen-Boyer patent signed by me."; two attachments: 1) Letter dated March 16, 1981 from Kiley to SNC, date stamped "APR 1 1981", asking SNC to autograph copy of patent already signed by Boyer, handwritten text of January 14, 1982 on front and back of this letter, 2) Unsigned photocopy of Patent 4,237,224, issued Dec. 2, 1980.

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Cohen/Boyer patent information, 1983

Unsigned letter dated April 15, 1983 from Bertram I. Rowland to Niels J. Reimers, cc to Dr. Cohen and Dr. Boyer, text, "Enclosed for your information are copies of statements filed in the Patent Office by Helling and his attorney"; attached are two letters, 1) signed letter dated March 17, 1983 from James H. Dautremont, Intellectual Property Counsel, The University of Michigan to Honorable Commissioner of Patents and Trademarks; text describes letter from Robert B. Helling seeking to be named a joint inventor of SN959288; 2) signed and notarized letter dated March 16, 1983 from Robert B. Helling to Alvin E. Tanenholtz, Primary Examiner, USPTO, text states Helling's claims to be a joint inventor, notarized by Mike Dutzer on March 18, 1983, no attachments to Helling's letter

Signed letter from Peter Matlock to Stephen Jones, Austgen-Biojet, Re: S74, "Gene-splicing and S80-131, "Bioconversion Reactor", cc to P. McCarty, A. Bachmann, S. Cohen, K. Ku, in upper right date stamped "APR 22 1983" and handwritten by SNC, "Cohen-Boyer patent"; text includes, "If Austgen-Biojet is no longer interested in either of these technologies, then please inform us so that we may make alternate arrangements."

Signed letter dated April 19, 1983 from Bertram I. Rowland to SNC, "Enclosed is the latest revised declaration for your signature."; attached is six-page "DECLARATION" signed by SNC on April 20, 1983

Signed letter dated April 13, 1983 from Bertram I. Rowland to SNC and Boyer, "file" handwritten by SNC at top; text begins, "Enclosed for your review and comments are a draft of the proposed amendment in the subject case and copies of the three declarations that will accompany it."; attached unsigned six-page SNC Declaration has handwritten edits by SNC on pp. 1,5

Unsigned four-page David Hogness "DECLARATION UNDER RULE 132"; handwritten by SNC at top of first page, "where does he ___ Adv each of ____ to practice"

Unsigned six-page SNC "DECLARATION"

Unsigned four-page Boyer "DECLARATION"

Unsigned 32-page "AMENDMENT" with signature line for Bertram I. Rowland; paper clipped behind it is unsigned six-page SNC "DECLARATION"; both documents have handwritten edits by SNC

Signed letter dated March 4, 1983 from Katharine Ku to David Milligan, Abbott Laboratories; text contains summary by Ku for licensees of recently received Patent Office Action "on the pending "product" patent application"; in upper right, "Cohen" handwritten, date stamp, "MAR 07 1983", and "Cohen-Boyer patent file" handwritten by SNC

Signed three-page letter dated March 9, 1983 from SNC to Bertram Rowland, "The following is my response to the questions raised by Mr. Rannenholz [sic] in the U.S. Patent Office Action as of January 21, 1983."; no attachments

Signed letter dated February 28, 1983 from Katharine Ku to Jack Feather, The Cambridge Plan; in upper right "S. Cohen" handwritten, and in SNC's handwriting, "Cohen-Boyer patent file"; text begins, "We would like to acknowledge receipt of Cambridge Plan's letter of intent to terminate the License Agreement governing patent rights under U.S. patent No. 4,237,224."

Unsigned form letter template from Katharine Ku to "[Adr]", "chron" handwritten at top right, "FEB 25 1983" date stamped, post-it attached with "Cohen-Boyer Patent file" handwritten by SNC, stapled to front of letter is small note signed Kathy Ku, "2/23/83 Prof. Cohen: Thought you might like to see this royalty calculation form. So far, 54 licensees have paid . . ."; text of form letter begins, "Enclosed is a one-page reporting form for calculating royalties for 1982. . . . Since this is the first use of this reporting form, we would appreciate your reviewing it carefully."; attached are two copies of the yellow one-page form, "Determination of Royalties (Recombinant DNA License" for Calendar Year 1982, form #TL-101

USPTO cover sheet form mailed January 21, 1983, responsive to communication filed on "Nov. 1 and 4 1982": Part I: "Notice of References Cited by Examiner, PTO-892", "Notice of Art Cited by Applicant, PTO-1449, and "Interview summary with Mr. Deutremont [sic] and copy of letter to Robert B. Helling" and Part II lists claims pending and rejected; stapled to the front of cover sheet is large post-it with handwriting "From: Bert Rowland For: Dr. Stanley Cohen 1-24-83" crossed out and in SNC's handwriting, "Patent file", date stamped "JAN 25 1983"; stapled behind cover sheet are six documents listed in the rows below

First document stapled behind cover sheet is a 12-page opinion with stamp at end, "ALVIN E. TANENHOLTZ PRIMARY EXAMINER ART UNIT 172"

Second document stapled behind cover sheet is undated, unsigned letter on USPTO stationery from Alvin E. Tanenholtz to Robert B. Helling, cc to James H. Deutremont [sic] and Bertram R. [sic] Rowland, letter has three paragraphs of questions for Helling

Third document stapled behind cover sheet is Examiner Interview Summary Record regarding phone interview of Bert Rowland on November 16, 1982, signed by Alvin E. Tanenholtz, re Helling inventorship claim, also "Told him I am still weighing the impact of the Hogness possession of pSC101 prior to statutory bar date."

Fourth document stapled behind cover sheet is a one-page summary of "Telephone Call to Alvin E. Tanenholtz from James H. Deutremont [sic] on November 23, 1982 regarding SN 959,288"

Fifth document stapled behind cover sheet is a Notice of References Cited, listing Wensick et al., 1974 and signed "Tanenholtz 1/20/83"

Sixth and last document stapled behind cover sheet is a List of Prior Art Cited by Applicant listing Lederberg, J., Toward Century 21: Technology, Society, and Human Values, pp. 39-52, 1970

Signed letter dated January 17, 1983 from Katharine Ku to David Milligan, Abbott Laboratories, "Prof. Cohen" and "cohn/Boyer" [sic] handwritten at top, date stamped "JAN 20 1983"; 1983 annual royalties due by February 1" and FYI, " . . . We have not yet received any official action from the Patent Office to our November 1, 1982 response for the DNA "product" patent application."

95 14
Cohen/Boyer patent information, 1983

Handwritten "MEMO TO THE FILE" dated 12/21/83 from K2 to S74-43, cc to S. Cohen, UC re DNA Cloning; in upper right date stamped "DEC 27 1983" and "file" written by SNC; text: "Per Bert: "Formal matters re BR will be resolved early Jan -- Will likely receive Notice of Allowance in Feb Will possibly/probably get issued patent in March"

Four sheets of paper stapled together: 1) Unsigned letter from Katharine Ku to Daniel P. Weingarten, GIBCO Laboratories, Life Technologies, Inc., in upper right "S. Cohen" handwritten, stamped "DEC 29 1983" and "file" written by SNC; text: "We were surprised and puzzled by your letter of December 16. . . . All the current issues surrounding the pending patent application have been resolved."; 2) Signed letter dated December 16, 1983 from Weingarten to Neils [sic] Reimers, cc to M.J. Barrett, Ph.D. and K.E. Blackman, Ph.D.; in upper right, date stamped "DEC 29 1983" and below that stamped 'STANFORD UNIVERSITY DEC 20 1983 TECHNOLOGY LICENSING"; "I have spoken to Dr. Barrett about some of the issues you raised in our meeting in early October regarding the Cohen-Boyer patent. dr. Barrett called to my attention a letter he wrote to you dated January 7, 1983, which pointed out several significant errors in the submission by the authors under rule 131." asks if issues resolved; 3) Unsigned letter dated June 17, 1983 from Katharine Ku to James Barrett, President, Bethesda Research Laboratories, "file" written in top right, " . . . I had wanted to have the opportunity to respond in person to your letter of June 7, 1983, regarding the DNA cloning patent. The attorney handling the prosecution brought the information you presented forward to the Patent Office. It is now part of the record. For your information, I have excerpted the relevant portion from the recent response."; 4) Photocopy of 14 lines of printed text, handwritten in upper right is "Excerpt from Response to Jan 21, 1983 Office Action", text, "It is noted that consideration of the declaration under Rule 131 has been held in abeyance. . . . The error has to do with referring to pSC101, where the results which are reported refer to pSC105. However, once the issue concerning Professor Helling's inventorship is resolved, the declaration becomes moot, since the articles coauthored by Professor Helling would no longer be relevant. . . ."

Two stapled stacks of paper that have been paper-clipped together: 1) Legal documents: log sheet identical to one in second stack, except that this sheet has one newer activity, for CLIENT: Stanford University, TITLE: PROCESS AND COMPOSITIONS FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS, "Amendment / Petition to make special" Official Date and Forwarded to Client 9-20-83, in upper right stamped "STANFORD UNIVERSITY SEP 22 1983 TECHNOLOGY LICENSING", handwritten "Roger Stanley", date stamped "SEP 28 1983" and handwritten by SNC: "file Cohen-Boyer patent"; attached are two USPTO Forms, both signed by Bertram I. Rowland on September 20, 1983: five-page AMENDMENT "Cancel Claims 18, 20-22, 24-28, 30-37, 64, 77, 78, and 80-87, without prejudice to their renewal and in light of the following claims." then adds Claims 88-98; also attached is two-page PETITION TO MAKE SPECIAL 37 CRF [sic] �1.102, " . . .to make the application special, to allow for early issuance. As the Commission is aware, this application has assumed extreme public interest. . . . Furthermore, a number of novel issues were raised during the prosecution, which issues may help other patent counsel to evaluate patentable subject matter in the rapidly growing field of recombinant DNA technology. Also, this application was previously allowed, and allowance withdrawn at the last moment."

Two stapled stacks of paper that have been paper-clipped together: 2) second stapled stack of paper has cover sheet identical to the one mentioned above, except that there is one fewer line on the log sheet; newest item is "Office Action", Official Date 9-30-83, Forwarded to Client 9-16-83; stapled to log sheet is USPTO Form responsive to communication filed on 4/28/83 and 7/5/83, "Notice of References Cited by Examiner, PTO-892" and "Examiner Interview Summary Record"; lists pending, cancelled, allowed, and rejected claims, with four pages of details, list of references: Lobban thesis, 1972 and Hogness, 1975

Photocopy of article, "New Technique to Produce Proteins May Alter Biotechnology Industry," by Jerry E. Bishop, Wall Street Journal, November 10, 1983, page unknown; at top of page, handwritten {looks like Ku's handwriting}: "- not plasmid - no replication system - DNA doesn't replicate", and "11/2/83 Stanley: Niels said you'd like copy of this -- sounds fishy, eh? Kathy", date stamped "DEC 6 1983", "Cohen-Boyer patent file" handwritten by SNC; article describes new technique by Fred Russell Kramer of Columbia

Unsigned, undated form letter from Katharine Ku to DNA Licensees; handwritten at top; "Subject: License Agreement Between [1] and Stanford University Covering U.S. Patent No. 4,237,224 By Stanley N. Cohen and Herbert Boyer"; letter begins, "We wish to bring you up to date with respect to the prosecution of Patent Application Serial No. 959,288, the "product" application relating to the DNA cloning methods described in the U.S. patent indicated above. The Patent Office has notified us that the claims which cover recombinant plasmids and other vectors able to replicate in prokaryotic host organisms are allowable."; text also includes, "In a continuation application, we will continue prosecution with the Patent Office of claims with respect to yeast and other eukaryotic unicellular organisms as hosts. . . . An attachment lists the claims of the application that have been deemed allowable."; attached are unsigned letter dated December 12, 1983 with handwritten edits and writing at top of page, "Stanley - Please make the appropriate changes ASAP. Thanks. -- K." and written in SNC's handwriting, "Cohen/Boyer patent file" and two-page document listing Claims 88-98

Letter dated November 18, 1983 under letterhead of "Law Offices of Wegner & Bretschneider" in Washington, DC, which closes "Respectfully submitted, HAROLD C. WEGNER, PETITIONER by Ronald R. Snider Reg. No. 24,962 (signed by Snider)" to "Hon. Commissioner of Patents and Trademarks" requesting immediate decision re having patent file opened; attached are 1) memo dated September 14, 1983 from Linda S. Paine to Harold C. Wegner, "In summary, Mr. Tarring of the PTO Solicitor's Office had no firm idea of when he would review the Petition, but indicated that the status should be checked again in October." and 2) a page from 37 CFR [sic] �1.114 with underlining of "If there is no objection the petitioner is permitted to see the entire parent application"

Legal documents: log sheet, for CLIENT: Stanford University, TITLE: PROCESS AND COMPOSITIONS FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS, newest item is "Notice of Allowability", Official Date 10-11-83 and Forwarded to Client 10-18-83, in upper right stamped "STANFORD UNIVERSITY OCT 19 1983 TECHNOLOGY LICENSING", handwritten "cc: S. Cohen T. Crotte", date stamped "OCT 21 1983" and handwritten by SNC: "file"; attached are USPTO Form signed by primary examiner Alvin E. Tanenholtz allowing Claims 88-98, a one-page "Examiner's Amendment to the record" and "Examiner Interview Summary record that interview occurred 10/6/83 of Bert Rowland by Al Tanenholtz

Legal documents: log sheet, for CLIENT: Stanford University, TITLE: PROCESS AND COMPOSITIONS FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS, newest item is "Decision on Petition filed 9/21/83", Official Date 9-30-83 and Forwarded to Client 10-19-83, in upper right stamped "STANFORD UNIVERSITY OCT 20 1983 TECHNOLOGY LICENSING", handwritten "cc: S. Cohen", date stamped "OCT 26 1983" and handwritten by SNC: "file"; attached "Decision on Petition Filed September 21, 1983", mailed September 30, 1983, signed by Robert F. White of USPTO, "applicants' petition is hereby granted", Rowland's name and address typed at bottom of page

Signed letter dated March 17, 1983 from James H. Dautremont, Intellectual Property Counsel, The University of Michigan to Honorable Commissioner of Patents and Trademarks, front page has large red "CONFIDENTIAL" stamp; text describes letter from Robert B. Helling seeking to be named a joint inventor of SN959288; attached signed and notarized letter dated March 16, 1983 from Robert B. Helling to Alvin E. Tanenholtz, Primary Examiner, USPTO, front page has large red "CONFIDENTIAL" stamp, text states Helling's claims to be a joint inventor, notarized by Mike Dutzer on March 18, 1983, no attachments to Helling's letter

Legal documents: log sheet, for CLIENT: Stanford University, TITLE: PROCESS AND COMPOSITIONS FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS, newest item is "Office Action", Official Date 8-30-83 and Forwarded to Client 9-69-83, in upper right stamped "STANFORD UNIVERSITY SEP 20 1983 TECHNOLOGY LICENSING", date stamped SEP 22 1983" and handwritten by SNC: "File Cohen-Boyer patent"; attached USPTO Form responsive to communication filed on 4/28/83 and 7/5/83, "Notice of References Cited by Examiner, PTO-892" and "Examiner Interview Summary Record"; lists pending, cancelled, allowed, and rejected claims, with five pages of details, list of references: Lobban thesis, 1972 and Hogness, 1975

Signed letter dated September 7, 1983 from SNC to Bertram I. Rowland, "Enclosed is a reprint of my 1975 paper describing the co-transformation procedure claimed in the Columbia University patent. I think you will agree that the paper is pretty explicit in anticipating what Science and Nature report as Columbia's claims."; no enclosure

Unsigned 10-page letter under letterhead of "Law Offices of Wegner & Bretschneider" in Washington, DC from "Harold C. Wegner Reg. No. 25,258" to Honorable Commissioner of Patents and Trademarks, Attn: Solicitor (Henry Tarring, Esq.; Katharine Ku's business card stapled to top of first page and handwritten "Stanley Cohen", on top right of first page date stamped "AUG 29 1983" and handwritten by SNC "Cohen-Boyer patent"; letter text begins, "This is a request under 37 CFR �1.14(e)(2) for access to United States patent application Serial No. 959,288"

Signed letter dated August 4, 1983 from Katharine Ku to Daniel P. Weingarten, GIBCO Division, The Dexter Corporation, "Re: Stanford Docket S74-43, "DNA Cloning"" and "Stanford Docket S82-64, "DNA Hybridization Probes"; offers GIBCO/Dexter "a license to the Cohen/Boyer DNA cloning invention; particularly since Dexter recently acquired Bethesda Research Laboratories, we feel that BRL's and/or Dexter's activities no doubt involve recombinant DNA."

Signed letter from Katharine Ku to Brian McCarthy, California Biotechnology Inc., cc: J. Newman, M. Petit, S. Falkow, T. Merigan, F. Murad; in upper right, "S. Cohen" handwritten, date stamped "AUG 9 1983" and handwritten by SNC, "Cohen/Boyer patent"; text, "Stanford has many technologies which CBI may be interested in licensing," including "Stanford Docket S82-64, "DNA Hybridization Probes"; no attachment

Photocopy of a page from New Scientist, June 30, 1983 with article, "Decision due in billion-dollar patent row," by Barry Fox; stapled to front is small handwritten note, "7/11/83 Stanley: In case you haven't seen -- this article is just trying to sensationalize a non-issue (Ziff). Kathy", note date-stamped "JUL 14 1983" and handwritten by SNC, "Cohen/Boyer patent file"; article begins, "The US Patent Office will decide sometime in the coming month whether a short article, published in New Scientist 10 years ago, invalidates potentially the most valuable patent application ever filed."

Unsigned two-page form letter from Katharine Ku to "[Adr]" ; "Re: License Agreement covering Cohen/Boyer DNA Cloning Invention; U.S. Patent No. 4,237,224 and Application Serial No. 959,288; handwritten at top, "5/19 Stanley -- Is this acceptable? Please let me know if you have changes -- Kathy"; in SNC's handwriting, "not satisfactory -- file I have spoken with Kathy Ku" and handwritten comments by SNC and Ku; text begins, "We have recently submitted Stanford's Response to the present Office Action on pending patent application serial No. 959,288. The main points of the Office Action and the Response are summarized below"

Binder clip holding four documents. First document is 33-page "AMENDMENT" signed by Bertram I. Rowland on April 27, 1983

Binder clip holding numerous documents. Second document is six-page "DECLARATION" signed by SNC on April 20, 1983; attached are SNC articles, "The Stanford DNA Cloning Patent", 1982; "The manipulation of genes," 1975; "The transplantation and manipulation of genes in microorganisms," 1980;

Binder clip holding numerous documents. Third document is four-page "DECLARATION" signed by Herbert W. Boyer on April 19, 1983

Binder clip holding numerous documents. Fourth document is four-page "DECLARATION UNDER RULE 132" signed by David S. Hogness on April 26, 1983.

95 15
Cohen/Boyer patent information, 1984

News release dated August 28, 1984 from Stanford University Medical Center News Bureau, "Cohen-Boyer Genetic Engineering Products Patent Issues" News Bureau contact Laura Hofstadter; handwritten note stapled to first page "8/31/84 Stan: In case you didn't get this--Congratulations! Kathy"; post-it attached to first page, "file - Cohen/Boyer patent" handwritten by SNC

Letter dated December 31, 1984 from Katharine Ku to Mr. Lewin, Agricultural Genetics Co., Ltd. "Re: Stanford Docket S74-043, "DNA Cloning", "We are very pleased that Agricultural Genetics has decided to become a licensee"

Letter dated December 13, 1984 from Katharine Ku to Albert P. Halluin, Cetus Corporation "Re: Stanford Docket S74-043, "DNA Cloning"; "In response to your letter of December 3, 1984, the pending patent application claiming recombinant plasmids in unicellular eukaryotic hosts are covered by the original License Agreement. . . . The post-termination responsibilities of a licensee are detailed in Paragraph 8.6 of the License Agreement; no other residual rights or obligations rest with the licensee, including credits."; December 3, 1984 letter is attached

Clipping of article, "Cohen-Boyer Plasmid Patent: An Analysis of the Issues" by Bruni Kobbe, Genetic Engineering News, November/December 1984, pp. 3,11; post-it attached to first page, "Cohen/Boyer patent file" handwritten by SNC

Letter dated November 15, 1984 from Katharine Ku to Roger Ditzel, Patent, Trademark & Copyright Office, University of California, cc H. Boyer and SNC; "Re: Stanford Docket S74-043, "DNA Cloning", "this letter serves as the annual report setting forth the status of patent prosecution, commercial development, and licensing activity for the fiscal year ended August 31, 1984"

Letter dated December 31, 1984 from Katharine Ku to Donald Perella, Merck & Co, Inc. "Re: Stanford Docket S74-043, "DNA Cloning", "We are very pleased that Merck intends to become a licensee"

Letter dated December 31, 1984 from Katharine Ku to James Barrett, Bethesda Research Laboratories, Inc. "Re: Stanford Docket S74-043, "DNA Cloning", "We are very pleased that BRL/Life Technologies intends to become a licensee"

Photocopy of article "Cohen-Boyer Patent Finally Issued", by Colin Norman, Science, September 14, 1984, p. 1134.

Genetics Technology News, Vol. 4, No. 10, October 1984; "Second Cohen-Boyer Patent Issues", p. 1, no byline, five paragraphs; patent name, number an issue date listed in "Patents" section on p. 11

Photocopy of New Scientist, September 6, 1984, p. 7, containing article, "Gene patent granted: now the real fight begins", by Ian Anderson; "Millions of dollars are at stake, not to mention the future organisation of the genetic engineering industry."

Memo dated May 18, 1984 from Niels J. Reimers to "P. Berg, S. Cohen, A. Kornberg, J. Lieberman, D. Purpura, and I. Weissman", "SUBJECT: "Limits in the Handling of Genetic Engineering"; met with Wolf-Michael Catenhusen, of German Bundestag, involved with "special Bundestag committee set up to deal with "problems relating to new biotechniques." I thought you would be interested in the preliminary report of his committee . . . . Rather than leave the field to Jeremy Rifkin by default, a position paper by those involved in the field, perhaps along the line of Mr. Catenhusen's report, might be worth considering."; attached report (in English)

Letter dated May 16, 1984 from Dorothy Hinden, NIAID to SNC and Fred A. Gustafson, Stanford Sponsored Projects Office; "Frank E. Robbins, Law Office of Robbins and Laramie, Washington, D.C., has requested a copy of your successful grant applications and progress reports from 1969 to 1976 for R01-AI08619 to be used by Mr. Robbins in an evaluation of United States Patent 4,237,224 . . . Please advise us of any portions of your proposal that you believe should be withheld under the exemptions provided by the [Freedom of Information] Act." attached two-page printout "FOIA EXEMPTIONS USUALLY APPLICABLE TO GRANT INFORMATION"

Published copy of Patent 4,468,464, Date of Patent: August 28, 1984

Photocopy of article, "A patent on everything", no byline, The Economist, September 8, 1984, pp. 72,75. "The latest--and so far two most important--patents are so broad that other companies could be shut out of the industry unless they license the technology or take on an expensive legal fight."

Form letter template from Katharine Ku containing handwritten date "9/6/84" and handwritten note "9/6/84 Stan: If you're interested in the list of companies we are contacting, here 'tis. K" letter text says Patent 4,468,464 issued on August 28, 1984; "We understand that ___ has been using the basic technology of recombinant DNA in your research and development.", invites them to become licensees; attached to letter is 29-page "DNA Form Letter A Address List"

Issue of Science News, Vol. 126, September 8, 1984; stapled to front is note from editor Joel Greenberg, "You may be interested in the article on page 150 Any comments would be welcome."; attached to note is post-it with "Cohen/Boyer patent file" handwritten by SNC; article "Gene engineering: Patent for products" by J. A. Miller on p. 150

Two copies of Patent 4,468,464, with attached handwritten note referring to three copies, "9/4/84 Stan: Here are 3 copies for your file. I'm so excited that we got the hard copies -- Kathy"

Draft of news release from Stanford University Medical Center News Bureau, on first page of draft "Cohen/Boyer patent file" handwritten by SNC; "Cohen-Boyer Genetic Engineering Products Patent Issues", News Bureau contact Laura Hofstadter; small note attached to first page, "8-28-84 To Stan Cohen From Laura Hofstadter Draft attached of news release final version"

Draft of news release from Stanford University Medical Center News Bureau about newly issued Patent; small note attached to first page, "7-27-84 To Stan Cohen From Laura Hofstadter The latest version" with "file" handwritten by SNC; news release begins, "A patent covering genetically engineered molecules that can be used to generate biological products was issued today (Aug. 7)"; patent was issued August 28, 1984

Draft of news release from Stanford University Medical Center News Bureau about newly issued Patent; small note attached to first page, "July 19, 1984 To Stan Cohen From Laura Hofstadter This draft incorporates the changes you suggested. My notes from a discussion with Bert Rowland indicate that the patent does state plasmid explicitly, though he thinks it means any circular piece of DNA with a replication system and a structural gene from a source that doesn't normally exchange information with the host that recognizes that replication system. Would this mean viral vectors are included? L"; draft contains numerous handwritten comments by SNC

Draft of news release from Stanford University Medical Center News Bureau about newly issued Patent; letter clipped to front of draft: dated July 18, 1984 from Katharine Ku to Frank Adams, UOP, Inc., states minimum annual advance for 1984 not yet received, "this letter serves as written notice of termination to UOP by Stanford, effective October 15, 1984"; small note clipped to front of letter refers to the news release draft behind the letter; note reads, "July 17, 1984 To Stan Cohen From Laura Hofstadter In anticipation of news interest when the new patent is issued, I've drafted this news release. Niels, Kathy and Bert have already seen it. Please let me know if you find any factual errors--Thanks"

Letter dated June 27, 1984 from Katharine Ku to John Chester, National Science Foundation, at upper right of letter "File Cohen/Boyer patent" handwritten by SNC; "Thank you for your call in April, informing us of the request by Robbins and Laramie for information under FOIA . . . . As we discussed, there does not seem to be anything in the file that would be confidential. For your information, we expect the product patent to issue August 7 with U.S. Patent No. 4,464,473."; handwritten note at bottom of letter, "7/6/84 Stan: Niels said you were concerned about this letter. Chester reassured us that he would keep the information confidential. I'm sorry that I told him (in light of your reaction) but since NSF is a "sponsor", I had thought it was appropriate. I shall keep quiet till Aug 7! K."

Letter dated June 27, 1984 from Katharine Ku to John Chester, National Science Foundation, handwritten note in upper right, "Stanley Cohen FYI -- K2 " and "Cohen/Boyer patent file" handwritten by SNC; "Thank you for your call in April, informing us of the request by Robbins and Laramie for information under FOIA . . . . As we discussed, there does not seem to be anything in the file that would be confidential. For your information, we expect the product patent to issue August 7 with U.S. Patent No. 4,464,473."

Photocopy of "Gene Splicers Square Off in Patent Courts" by Jeffrey L. Fox, Science, Vol. 224: 584-586.; in upper left of page one "Cohen/Boyer patent file" handwritten by SNC

Legal documents: log sheet for CLIENT: Stanford University, TITLE: PROCESS AND COMPOSITIONS FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS, notice of Allowance and Request for Expedition, Official Date and Forwarded to Client 4-18-84; attached two-page USPTO Form, "Notice of Allowance and Issue Fee Due", addressed to Bertram I. Rowland, Issue Fee Due July 5, 1984, SC/Serial No. 05/959,288, Fee Due: $500.00; behind form is one-page "REQUEST FOR EXPEDITION", "for the following reasons: 1. This application has been made special due to its early filing date and its national importance; and 2. there have been numerous requests for public access to the file wrapper.", signed by Bertram I. Rowland on April 18, 1984

DECISION REFUSING REJECTION UNDER 37 CFR STAMPED, "COPY MAILED MAR 29 1984 COMMISSIONER'S OFFICE" Re Serial No. 05/959,288, "Dr. Helling's Assertion of Inventorship" and "The Inaccuracy Regarding The Method For Preparing Plasmid pSC101"; signed by Alfred L. Leavitt, Special Program Examiner and initialed by Conferee M.A. Antonakas

Handwritten note, "3/21/84 Bert says it's still in Leavitt's group ? to Tanenholtz by End of Month -- means we hope to get Notice of Allowance in May and will maybe issue in July or August. Sigh. K"

Letter dated March 15, 1984 from Roger G. Ditzel, Director of Patent, Trademark and Copyright Office at University of California to Katharine Ku, cc to SNC and Herbert W. Boyer; re Amendment No. 1 to Agreement Concerning Administration of Rights in Invention is enclosed. "The effective date of this Amendment is March 1, 1984."; no attachment

Letter dated March 14, 1984 from Katharine Ku to Albert P. Halluin, Cetus Corporation; refers to Halluin letter of February 27, "You expressed concerns about the validity/enforceability and scope of the claims of U.S. Serial No. 959,288."; attached are February 27, 1984 letter from Halluin to Ku and three drafts of a response from Ku, each draft with a note to SNC asking for his feedback

Letter dated March 7, 1984 from Katharine Ku to Roger Ditzel, "Re: Stanford Docket S74-43, "DNA Cloning", re Amendment No. 1 to Agreement Concerning Administration of Rights in Invention enclosed for UC signature; Amendment attached

Memo dated February 1, 1984 from Nancy Holt to Bert Rowland, "Enclosed is the signed declaration of Stan Cohen regarding" Biologically Functional Molecular Chimeras; attached to memo are signed letter dated January 30, 1984 from Bertram Rowland to SNC, "Enclosed for your signature is a ribbon copy of your declaration, revised in accordance with your changes of January 27, 1984." and three-page "DECLARATION OF STANLEY N. COHEN" re pSC101 signed by SNC on February 1, 1984

Binder clip holding numerous documents. First is memo dated January 27, 1984 from Nancy Holt to Bert Rowland, "Enclosed is the declaration for BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS as Stan Cohen has edited it; attached are two drafts of first two pages of declaration, one with extensive handwritten edits by SNC; after memo is letter dated January 25, 1984 from Bertram I. Rowland to SNC and Herbert Boyer, "Enclosed for your review and comments is the proposed response to be filed in the subject application." with three attachments, all of which are unsigned: 1) p. 3 of SNC Declaration (pp. 1-2 probably pages with handwritten edits), 2) two-page Boyer Declaration, 3) and 10-page "RESPONSE TO REQUIREMENT FOR INFORMATION" which begins, "In response to the Requirement for Information of January 6, 1984" and ends with signature line for Rowland. Letter dated December 16, 1977 from Bertram I. Rowland to Niels Reimers, cc SNC, recapping Rowland's interview with patent examiner Alvin E. Tanenholtz, ". . . while he was willing to allow claims which describe a basic method for producing transformants, he was not willing to allow any of the other claims" and mentions new work that questions whether pSC101 was the vector, "As to this matter as well as other matters, consideration should be given whether we should revise the application before refiling it as to the plasmid claims." Unsigned copies, with no attachments, of a January 20, 1975 form letter from Rowland to each of the following: Robert B. Helling, John F. Morrow, Annie C.Y. Chang, Charles Yanofsky, Howard M. Goodman, Vickers Hershfield, Michael A. Lovett, Donald R. Helinski, re "Pat. appln. for PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR DNA CHIMERAS - S. Cohen and H. Boyer . . . . You are a co-author and, therefore, I am requesting your cooperation in signing the accompanying disclaimer, disclaiming being a co-inventor." Unsigned copies of a January 28, 1975 form letter from Rowland to each of the following: Robert B. Helling, Annie C.Y. Chang, Charles Yanofsky, Howard M. Goodman, Vickers Hershfield, Donald R. Helinski, Michael A. Lovett, and John F. Morrow, each letter has a cc to SNC and Boyer, re "Pat. appln. for PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR DNA CHIMERAS - S. Cohen and H. Boyer"; "My prior letter has apparently been subject to an unintended misunderstanding. . . . In using the term "on behalf of" I intended that Professors Cohen and Boyer were the inventors, but did not intend that I was employed by them. The request for a patent application was initiated by Stanford University and the University of California who are the assignees and have the financial interest in the patent application. As I am sure you are well aware, the Universities are sorely stressed for funds and the patenting of research developments which have commercial potential is becoming an avenue for obtaining additional funds. In recognition of the needs of the University, when the research is funded by governmental agencies, the government normally allows the Universities to license patents covering government-sponsored research and receive the funds. . . . The issuance of the subject patent will in no wise inhibit any researcher, either academic or commercial, from carrying out additional research in the areas covered by the patent. Should a development be commercialized and come within the ambit of the subject patent, Stanford and UC would have the opportunity to receive royalties from such commercial use. I am enclosing a copy of the letter sent to me by Stan Cohen explaining his understanding of the purpose and intent of the Universities in filing the subject patent application. I would also like to add that prior to becoming a patent attorney, I received my doctorate in organic chemistry and was employed as a research chemist. I am personally sensitive to the interest and the needs of the academic community and am appreciative of their concerns."

95 16
Cohen/Boyer patent information, 1985

SECOND PRELIMINARY AMENDMENT re "PROCESS AND COMPOSITION FOR BIOLOGICALLY FUNCTIONAL MOLECULAR CHIMERAS", 24 pp., signature line on p. 24 is unsigned; text has handwritten comments by SNC

Memo dated November 8, 1985 from SNC to Kathy Ku; "Enclosed is a recent advertisement from Promega Biotech . . . I would imagine that this product falls under the Stanford patent, along with some of their other products--notwithstanding their claims to the contrary."; Attached photocopy of one-page ad for "ProtoBlotTM Immunoscreening System"

Two-page news release dated April 15, 1985 from Stanford University Medical Center News Bureau, on first page "4/21 Stan FYI - K2" handwritten in upper right, also "Cohen/Boyer file" handwritten by SNC; title: "11 Companies Sign on While Four Terminate Licensing Agreement with Stanford", News Bureau contact Laura Hofstadter; release ends, "Following is a list of the licensees as of April 12, 1985", with list of 73 companies

Letter dated November 1, 1985 from Katharine Ku to Irving Feit, Ciba-Geigy; "We are most pleased that Ciba-Geigy has decided to take the Cohen/Boyer DNA Cloning license . . . . As I mentioned, we are in the process of reevaluating the royalty structure of the Agreement so that this offer expires December 10, 1985."

Letter dated October 17, 1985 from Katharine Ku to Robert D. Weist, Applied Molecular Genetics, Inc.; Stanford awaiting signed copies of licensing agreement, "As you know, it is important for AmGen to be a licensee, particularly in light of AmGen's sales and advertising of recombinant DNA products and inquiries by other licensees. Adrian Arima, Stanford legal counsel, and I would like to discuss the issues with AmGen representatives to answer any questions of patent scope and interpretation of the license."

Letter dated December 14, 1984 from Thomas A. Mann, United States Biochemical Corp. to Katharine Ku; re license agreement, ". . . we would be very happy to meet with you to discuss the possible applicability of this patent to any of our activities."; three attachments: 1) handwritten notes "12/17 FG - Do we have info? K" and "9/5 Stan: FYI - I'll follow-up on this."; clipped to letter is OTL memo to file dated 9/6/85 by K Ku re "Telecon c Joe Sorge, Vector is behind schedule re recombinant "construction", in about 4-5 months, they'll be making/developing products and will take a C/B license then", note to SNC, "Stan - As long as Vector is going to take a license, it's probably not economically-wise to press them now. K"; 2) letter dated September 1, 1985 from James C. Gaither, Center for Biotechnology Research to Niels Reimers, OTL re "License Agreements between Stanford University and the Center for Biotechnology Research - Stanford Docket Nos. S81-78 and S81-79", "no significant progress has been made toward commercial use of products in the past year"; 3) cover letter dated August 26, 1985 from James C. Gaither to Niels Reimers re Stanford Docket No. S80-23 with "Quarterly Report Quarter Ended June 30, 1985" re licensed products and sublicenses: none of either

Letter dated September 3, 1985 from Katharine Ku to Albert P. Halluin, Esq., Cetus Corporation, "Stan Cohen FYI - K" handwritten in upper right, also "Cohen/Boyer patent file" handwritten by SNC; text: " . . . We have agreed to the following policy effective September 3, 1985 for Cetus/Stanford so-assigned inventions," with details; unsigned AGREED AND ACCEPTED signature line for Cetus; attached are letters both dated August 30, 1985 from Katharine Ku to Daniel R. Henderson, Microgenics Corp., and Frederic de Hoffman, Salk Institute Biotechnology/Industrial Associates, Inc. (SIBLA) inviting them to become Cohen/Boyer patent licensees; Microgenics letter: "Microgenics must be pleased to have the distinction of being the first company to receive FDA approval for a recombinant DNA clinical test."; SIBLA letter: "We wrote last year to offer SIBLA a license to the Cohen/Boyer patents but received no response."

News release dated August 23, 1985 from Stanford University Medical Center News Bureau, "Cetus Corp. Resumes Genetic Engineering License Agreement with Stanford" News Bureau contact Laura Hofstadter; Attn: Neils [sic] Reimers and Kathy Ku, handwritten "To: Stan Cohen" in upper right; Reimers quoted in story, "In effect, the license will continue exactly as before, as if there had been no termination," release also states, "Stanford agreed to reinstate the $250,000 in credits the company had earned.", now 74 licensees, "Over $3.5 million have been received since the licensing program was initiated in 1981."

Letter dated April 26, 1985 from Julius R. Krevans, M.D., Chancellor of UCSF to President Donald Kennedy of Stanford thanks for arranging luncheon to honor Boyer and Cohn [sic], handwritten note at bottom, "Stan - In case you didn't receive a copy, here 'tis. Kathy"

Letter dated April 23, 1985 from Niels Reimers to SNC; "By signature below, you agree to return upon our written request, to Stanford, the original of U.S. Patent No. 4,237,224, issued December 2, 1980. If it does become necessary to request the patent, be assured our intent will be to return it to your possession as soon as it is not needed."; AGREED AND ACCEPTED signed by SNC April 27, 1985

Letter dated November 29, 1984 from Katharine Ku to Allen W. Richmond, Phillips Research Center, "bcc: S. Cohen" handwritten in upper right, also "file - Cohen/Boyer patent" handwritten by SNC; "Re: Stanford Docket S74-43, "DNA Cloning"; "We are most pleased to return one fully executed copy of the License Agreement covering the above referenced invention. . . . Again, both Stanford and the University of California are delighted to have Phillips on board"; no attachment

Letter dated January 2, 1985 from Katharine Ku to Al. A. Jecminek, Triton Biosciences Inc., handwritten in upper right "Dr. Stan Cohen FYI, Kathy Happy New Year"; "Re: Stanford Docket S74-43, "DNA Cloning"; "We are pleased to return a fully executed copy of the License Agreement covering the Cohen/Boyer patents."; attached are three letters all dated January 2, 1985 from Katharine Ku: 1) to I.V. Karau, BASF Aktiengesellschaft, 2) to Herbert L. Heyneker, Genendor, Inc., and 3) to John H. Newman, California Biotechnology, Inc.; each letter expresses delight the company has become a Cohen/Boyer patent licensee

Letter dated January 4, 1985 from Katharine Ku to Nan Newell, Calgene, Inc. S. Cohen", handwritten in upper right, also "file" handwritten by SNC; Stanford Docket S74-43, "DNA Cloning", "We are pleased that Calgene has decided to become a licensee of the Cohen-Boyer patents. . . . Niels Reimers, our director, was agreeable to Calgene having the benefit of the 1984 offer since we have not yet announced our new terms."; "no attachments

Letter dated March 15, 1985 from Katharine Ku to Ed Pandolfino, Becton Dickinson Immunocytometry Systems, "Stan Cohen FYI - K2" handwritten in upper right, also "file" handwritten by SNC; "Re: Stanford Docket S74-043, "DNA Cloning", "Enclosed for your files is a fully executed copy of the License Agreement covering the Cohen-Boyer patents."; no attachments

Confidential memo dated March 14, 1985 from Kathy Ku "To: Stanford Docket File S74-043, "DNA Cloning", "SUBJECT: Meeting with Cetus on March 5, 1985" re termination of the Cohen/Boyer license

Letter dated March 14, 1985 from Katharine Ku to Albert P. Halluin, Cetus Corporation "to confirm our understanding of Cetus's reasons for terminating the License Agreement"

Letter dated February 13, 1985 from Katharine Ku to R. G. Schweikhardt, ZymoGenetics "Re: Stanford Docket S74-043, "DNA Cloning", "delighted to have ZymoGenetics as a licensee"

Letter dated February 14, 1985 from Katharine Ku to Richard W. Armentrout, Syntro Corporation "Re: Stanford Docket S74-043, "DNA Cloning", "delighted to have Syntro as a licensee"

Letter dated February 13, 1985 from Katharine Ku to M. James Barrett, Life Technologies, Inc. handwritten note in upper right, "2/13 Stan - If you helped in any way, thank you! Kathy"; "Re: Stanford Docket S74-043, "DNA Cloning", "very pleased to have Life Technologies as a licensee"

Letter dated January 31, 1985 from Katharine Ku to Nanette Newell, Calgene "Re: Stanford Docket S74-043, "DNA Cloning", "delighted to have Calgene as a licensee"

Letter dated January 18, 1985 from Katharine Ku to John Chester, National Science Foundation "Re: Stanford Docket S74-043, "DNA Cloning", request for SNC grant proposals prior to November 4, 1974, "In particular, we would like any research information" for Grant GB30581

Letter dated January 7, 1985 from Katharine Ku to Roger Ditzel, Patent, Trademark & Copyright Office, University of California, cc H. Boyer and SNC; "Re: Stanford Docket S74-043, "DNA Cloning", letter provides "brief summary of the licensing status"

Letter dated January 3, 1985 from Katharine Ku to Donald Perella, Merck & Co., Inc. "Re: Stanford Docket S74-043, "DNA Cloning", returning fully executed copy of licensing agreement; no attachment.

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Cohen/Boyer patent information, 1986

Letter dated February 1, 1988 from Katharine Ku to Sarah S. Friel, Centocor, at top right "Dr. Stan Cohen" handwritten; "file" handwritten by SNC; "Re: Stanford Docket S74-043, "DNA Cloning"; "Enclosed is a fully executed copy of the Agreement for your records. We are delighted Centocor is a Cohen-Boyer licensee. "; agreement is not attached to this letter, though photocopy shows paperclip

Letter dated January 29, 1988 from Katharine Ku to Steve Peltzman, Applied BioTechnology Inc., at top right "Stan Cohen FYI P.S. Austgen-Biojet terminated" handwritten, "file" written by SNC; "Re: Stanford Docket S74-043, "DNA Cloning", "We are delighted Applied BioTechnology will become a Cohen-Boyer licensee. Enclosed are two execution copies of the License Agreement for your signature.", agreement is not attached to this letter, though photocopy shows paperclip; stapled behind is another letter dated January 29, 1988 from Katharine Ku to Sarah S. Friel, Centocor, "Re: Stanford Docket S74-043, "DNA Cloning"; ". . . You indicated that you had the duplicate originals of the Agreement for signature; if you have any questions, please call me. Otherwise we will be expecting the executed Agreement and payment any day."; agreement is not attached to this letter, though photocopy shows paperclip

Letter dated December 11, 1986 from Katharine Ku to S. Guttmann and C.S. Morris of Sandoz AG in Switzerland, "Re: Stanford Docket S74-043, "DNA Cloning", "For companies who signed after July 1986 but before we changed the royalty terms, we were offering a Five-Thousand Dollar ($5,000) license issue fee. We inadvertently failed to offer Sandoz the same terms and thus Sandoz paid $10,000"

Form letter template from Katharine Ku with handwritten date "12/11/86" and handwritten "Dr. Stanley Cohen FYI--Kathy" in upper right; letter text about DNA probes, "We have been asked by one of our licensees to clarify the meaning of "intact gene" and "foreign gene" as used in the patents under the subject license and, in particular, with respect to DNA probes. . . . . please be advised that DNA probes are considered to be Licensed Products and their associated royalty obligations are payable."

One page spreadsheet "Annual Royalties" for Docket No: S74-043, Fiscal year: 1985-86; Gross Income $1,255,145.98 - Admin. Fee $188,271.90 - Current Expenses (Fiscal Year) $63,308.93; Net Income $1,003,565.15 divided 50/50 with UC; "Net Income to Stanford 501,782.57", divided 1/3 to SNC $167,260.86 + 1/3 to SNC's two departments (1/6 to Genetics $83,630.43, 1/6 to Medicine $83,630.43) + 1/3 to School of Medicine $167,260.86; stapled behind spreadsheet is small paper with OTL letterhead, a note dated November 21, 1986 from Sally Hines to SNC, "Per your secretary's request, attached are copies of the reports we send to UC each year on the DNA Cloning patents. These reports reflect all income and expenses." Behind note are stapled five one-page spreadsheets with Report for Distribution of License Revenue for Stanford Fiscal Year (September 1 - August 31) 1985-86 ("SH" in lower right); 1984-85 "Total License Revenues $857,190.82" ("F. Grolle" in lower right); 1983-84 "License Revenues $700,645.10" ("S. Hines" in lower right); 1982-83 "License Revenues $686,720.88" ("FG" in lower right); and "Report Through August 3, 1982", "Income $1,447,000" (no name attached to this spreadsheet)

Letter dated November 4, 1986 from Katharine Ku to C.S. Morris, Sandoz AG, at top right handwritten "bcc: Stan Cohen FYI--Kathy"; "Re: Stanford Docket S74-043, "DNA Cloning"; "We are pleased that Sandoz has decided to become a licensee of the Cohen-Boyer patents. Enclosed for execution are two signed copies of the License Agreement"; agreement is not attached to this letter

Clipping of article "Technology Licensing staff takes ideas to market," by Julia Sommer, Campus Report, June 11, 1986, p. 19. Paragraphs 15-20 about Cohen/Boyer patents, beginning: "Probably the most publicized technology licensing endeavor is OTL's genetics engineering licensing program, which is based on two patents and a patent application covering gene cloning techniques, and the recombinant molecules produced through these techniques, developed by Stanley Cohen of Stanford and Herbert Boyer of UC-San Francisco."

Letter dated October 17, 1986 from Katharine Ku to Scott G. Hallquist, Immunex Corp., at top right handwritten "Stan Cohen" and in SNC's handwriting "file"; "Re: Stanford Docket S74-043, "DNA Cloning"; text: "We are pleased that Immunex has decided to take the Cohen-Boyer license. . . . although Stanford has announced a change in royalty rates for new licensees, we are willing to license Immunex under the terms we had discussed previously."

24-page "Tissue Plasminogen Activator" report by Floyd Grolle, OTL, August 1986; upper right of cover page "Cohen/Boyer patent file" handwritten by SNC

Article "Licensing Program for Basic Gene Splicing Techniques, ACS Honors Cooperative UC-Stanford Biotechnology Licensing Program," While you were in, Vol. 4, p. 2, August 1986 (newsletter is "News for the Office of the President, University of California"); handwritten note "9/26/86 Stan Cohen FYI--Kathy"; American Chemical Society award to Stanford OTL and UC Office of Technology Transfer for "insightful and enlightened cooperative licensing of the Boyer/Cohen U.S. Patent No. 4,237,224"

Memo dated September 22, 1986 from Niels Reimers to Robert Street, Pat Devaney, Jim Rosse, Donald Kennedy, Kent Peterson, Bill Massy, David Korn, and Stanley Cohen, handwritten by SNC in upper right of memo is "File Cohen/Boyer patent"; re ACS award; "It was given following a "Symposium on Innovation to Regain the U.S. Competitive Edge." The attached paper, given during the symposium, may be of interest."; clipped to memo is "Licensing of Recombinant DNA Technology" by Niels Reimers

Memo dated September 15, 1986 from K. Ku to Don Dunner, Bert Rowland, Adrian Arima, and Aldo Test, "Subject: DNA Cloning"; upper right of memo has handwritten "Stan--FYI--Kathy" and "Cohen/Boyer patent file" handwritten by SNC; memo text includes "Enclosed is a draft letter for your review and comment. With respect to "foreign gene" and "DNA probes," we present three alternative positions we could publicly announce; we could, of course, not address those issues until it becomes necessary", also asks for comments on "announced changes to the earned royalty terms, effective October 1. There will be a flat 1% earned royalty on End Products and a flat 3% on Bulk Products (compared to the previous decreasing royalties based on sales volume)."; attached to memo is template of form letter with three alternative positions re "foreign gene" and "DNA probes"; Alt. 1 and Alt. 2 start "While to us it is clear that techniques of the patents are used to make DNA segments used for probes, we recognize that the patent wording could be more precised with respect to such coverage; but recall the term "DNA probe" was not available in 1974 when the patent was filed."; Alt. 1 continues, "Hence, please be advised that, pending action by the Patent Office on No. 602,294, royalty payments for DNA probes may be put into escrow."; Alt. 2 continues, "Hence, please be advised that no royalty payment for DNA probes will be required until the Patent Office has rendered a decision."; Alt. 3: "It is clear that techniques of the patents are used to make DNA segments used for probes. Hence, please be advised that DNA probes are considered to be Licensed Products and their associated royalty obligations are payable."

Memo dated September 2, 1986 from Niels Reimers to Jasper Williams, cc S. N. Cohen, W. F. Massy; upper right of memo has "file" handwritten by SNC; text discusses "Agreement wherein the University agrees to amend Stan Cohen's royalty-sharing Agreement insofar as his binding pledge to make an annual gift to a charitable organization. I should note that Stan has indicated that he still plans to make an annual gift of his share of royalties to a charitable organization, but does not wish to be bound to do so.", NR has drafted agreement for signature by Bill Massy, "I want to be sure that David Korn, Bill Massy, Bob Street, and Don Kennedy know about this before it is executed and have the opportunity to comment.", would let public know "in a low key way, perhaps as an additional paragraph to another news release. I'll be discussing the form of that with Spyros and Stan."; no attachment

Two-page memo dated September 12, 1986 from Niels Reimers to SNC, "SUBJECT: "Agreement dated June 19, 1975, Concerning Rights in Invention between Stanley N. Cohen and Stanford University (Stanford Docket S74-043)"; "That agreement was amended December 28, 1982, with respect to payment of the inventor's share of royalty income. Pursuant to your request, this memorandum will further amend the subject agreement insofar as your binding pledge to make an annual gift to a charitable organization"; memo signed by NR at bottom like a letter, below which "AGREED AND ACCEPTED" signature lines for "THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY" (unsigned) and SNC (signed September 21, 1986)

Undated draft of Niels Reimer article "Licensing of Recombinant DNA Technology"; upper right of first page has "file" handwritten by SNC; final version of paper given during 1986 "Symposium on Innovation to Regain the U.S. Competitive Edge";

Memo dated July 31, 1986 from Niels Reimers to SNC, "SUBJECT: Change to Royalty-Sharing Agreement"; "Attached is my draft of an Amendment to the Royalty Distribution agreement between yourself and Stanford that changes your "binding pledge" to make an annual gift of your royalty distribution to a charitable organization."; memo says copies of original Agreement and first Amendment attached, but they are not attached to this copy of memo; NR asks SNC to review draft and "I will want to have it reviewed by staff legal counsel, and I will review its subject matter with Drs. Korn, Kennedy and Street"; upper right of first page has "file - Cohen/Boyer patent" handwritten by SNC; attached three-page draft Agreement

Two-page memo dated August 18, 1986 from Niels Reimers to SNC; "Pursuant to your request, this letter will further amend the subject agreement insofar as your binding pledge to make an annual gift to a charitable organization."; post-it attached to front dated 8/18/86 "Please call Niels Reimers after reading this at 723-0651 and let him know if any changes need to be made."; "OK" at bottom of post-it handwritten by SNC

Letter dated August 14, 1986 from Katharine Ku to Claire Wake, Damon Biotech, Inc., "Re: Stanford Docket S74-043, "DNA Cloning"; "I consider the enclosed fully executed Agreement to be one of my (and your) major accomplishments this year!"; agreement is not attached to this letter; at top right handwritten "Dr. Stan Cohen" and "Cohen/Boyer patent file" handwritten by SNC; at bottom of letter "8/14 Stan: Damon & Microgenics are recent new licensees. We now have 79. K"; stapled to letter is two-page list "Cohen-Boyer Licensees . . . . as of 8-11-86" listing 79 licensees

Letter dated July 30, 1986 from Katharine Ku to Steven M. Odre, AmGen, "Re: Stanford Docket S74-043, "DNA Cloning"; " re "Assignment of the Cohen/Boyer DNA Cloning License by BioLogicals to AmGen"

Memo dated March 28, 1986 from SNC to David Korn, "SUBJECT: Royalties from the Cohen/Boyer Patent" thanks for update re 4 Postdoctoral Fellows supported by Bernard Cohen Postdoctoral Fellowship Fund; OTL estimates Cohen/Boyer patent royalties to Stanford and UC from 1986-1997 will total $106 million; "There are several issues regarding the Cohen/Boyer patent royalties and royalty distributions that I believe are worthwhile discussing with you if the financial return to the School of Medicine is to be maximized. Please let me know if and when you would like to have such a discussion."; attached "PRELIMINARY ESTIMATES OF COHEN-BOYER PRODUCT SALES 1986-1997" prepared by Floyd Grolle of OTL March 26, 1986, marked "CONFIDENTIAL"

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 4/29/86, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to that on seven documents cataloged in Rows 50-54, 65-66 of this spreadsheet, except that newest entry on this table is "Fee sheet/ Third Pre. Amend.", Official Date 4/25/86, Forwarded to Client 4/29/86; attached Transmittal Sheet dated April 25, 1986 and signed by Bertram I. Rowland, and three-page "THIRD PRELIMINARY AMENDMENT" adding new Claims 69-77, signed by Bertram I. Rowland on April 25, 1986

Letter dated March 28, 1986 from Michael F. Borun, Marshall O'Toole, et al. on behalf of Amgen to Katherine [sic] Ku; "For Dr. Stanley Cohen" handwritten in upper right, also "file" handwritten by SNC; enclosed $10,000 check "representing 1986 payment by Amgen as assignee of Bio Logicals, Inc."; copy of check not attached

Memo identical to one catalogued in Row 87 of this spreadsheet; no attachment

Letter dated February 18, 1986 from Charles E. Lipsey of Finnegan, Henderson, Farabow, Garrett & Dunner in Washington, DC to Katharine Ku; "Enclosed is a draft second Preliminary Amendment for your review.", "Error p.24" handwritten by SNC near bottom of letter; handwritten note from Katharine Ku clipped to letter, "2/25/86 Stan: Please review this as a contrast to Bert's version. . . ." attached SECOND PRELIMINARY AGREEMENT" cancels Claims 40-44 and adds Claims 45-62.

Letter dated February 18, 1986 from SNC to Bertram Rowland; "When we last met I mentioned to you a 1962 paper by W. Szybalski and E. H. Szybalska in which authors reported a system for accomplishing DNA-mediated heritable transformation of a biochemical trait into mammalian cells. You indicated that this information would be of use to you in extending the scope of the Cohen/Boyer patent(s)."; gives bibliographic info: PNAS, Vol. 48: 2026-2034.

Two-page letter dated January 6, 1986 from Bertram I. Rowland to SNC; "The following are some of my thoughts that I would like to discuss with you when we meet on Tuesday afternoon.", next six paragraphs detail his thoughts and questions; first page of letter has handwritten notes by SNC

Letter dated January 28, 1986 from Katharine Ku to John Demeter, Rohm & Haas Company; "Stan Cohen" handwritten in upper right, also "file" handwritten by SNC; "Enclosed is a fully executed copy of the DNA Cloning License Agreement for your records. You will be happy to know that the payment for this year is only $10,000, not $20,000, since your license issue fee will serve as the 1986 annual minimum royalty."

95 18
Cohen/Boyer patent information, undated

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 12/21/87, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; also attached documents: Conditional Petition for Extension of Time, signed by Bertram I. Rowland on 12/21/87 and nine-page Supplemental Amendment submitted to Patent Examiner A. Tanenholtz, signed by Bertram I. Rowland on 12/21/87

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 12/31/87, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to one of documents immediately preceding it in file, except for new line added to table on cover sheet: "Fee Sheet/Supplemental Amendment, official date 1/4/88, forwarded to client 12/31/87; attached nine-page Supplemental Amendment has several changes from 12/21/87 version and is signed by Bertram I. Rowland on 12/30/87

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 12/15/87, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to that on two documents immediately preceding it in file, except that newest entry on table is "Response/Declartion [sic] under 37 CFR 1.132", official date 12/15/87, forwarded to client 12/15/87; attached two-page Supplemental Amendment signed by Bertram I. Rowland on 12/15/87

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 8/13/87, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to that on three documents immediately preceding it in file, except that newest entry on table is "Supplemental Response/Declaration under 37 CFR 1.132, no official date or forwarded to client date entered on sheet; attached Conditional Petition for Extension of Time, signed by Bertram I. Rowland on 9/4/87, five-page Supplemental Amendment submitted to Patent Examiner A. Tanenholtz, signed by Donald R. Helinski on 8/18/87, and 13-page Donald R. Helinski CV

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 7/22/87, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to that on four documents immediately preceding it in file, except that newest entry on table is "Response", official date 7/17/87, forwarded to client 7/22/87; attached Conditional Petition for Extension of Time, letter to the Commissioner of Patents and Trademarks, and six-page Response all signed by Richard L. Neeley on 7/17/87; four-page Delcaration [sic] Under Rule 132 signed by Ronald W. Davis on 6/1/87; 13-page Ronald W. Davis CV; and one-page Supplemental Letter to the Commissioner of Patents and Trademarks, signed by Richard L. Neeley on 7/17/87 stating that "Various publications are being provided to the Examiner . . . . Other promised publications will be submitted as they become available."; photocopies of seven academic articles are attached, including SNC's Cohen et al., 1973 and Cohen et al., 1972

Butterfly clamp holding: printout of presentation by Floyd Grolle at OTL retreat in August 1993, "We wanted the OTL staff to realize the impact that these royalties make on Stanford's operations."; various articles from 1975-87 about Cohen-Boyer patent; 1989 and 1993 lists of licensees; and spreadsheet with 1990 revenue and projections of revenue 1991-97

Note from OTL dated 7/14/87, "Attached are copies of the response and delcaration [sic] for S74-043; unsigned copies of "Delcaration [sic] Under Rule 132" with signature line for Ronald W. Davis and "Response" with signature line for Bertram I. Rowland

Letter dated March 9, 1987 from Yoshi Kumagai of KIRIN USA, INC. to Sandra L. Shotwell of OTL, handwritten "cc S. Cohen"; handwritten notes in margin "S78-083", "S80-023", "Hollow fiber"; "I have forwarded the information to the headquarters of KIRIN in Tokyo and our staff is reviewing them carefully."

Letter dated March 7, 1989 from Katharine Ku to James R. McBride, Becton Dickinson and Co., cc N. Mhatre, handwritten at top right "S. Cohen", "Re: Stanford Docket S74-043, "DNA Cloning"; text ". . . enclosed are two signed copies of the License Agreement covering the Cohen-Boyer patents."

95 19
Cohen/Boyer patent information, undated

Photocopy of Wensink et al., 1974, "A System for Mapping DNA Sequences in the Chromosomes of Drosophila melanogaster" Cell, 3:315.; references include Cohen et al., 1973 and Morrow et al., 1974

Photocopy of Mertz and Davis, 1972, "Cleavage of DNA by R1 Restriction Endonuclease Generates Cohesive Ends", PNAS, 69:3370.

Hershfield et al., 1974, "Plasmid ColE1 as a Molecular Vehicle for Cloning and Amplification of DNA", PNAS, 71:3455.; "We thank Dr. Stanley Cohen for plasmid pSC105 and for helpful suggestions."; references include Cohen et al., PNAS, 1972; Cohen and Chang, 1973; Cohen et al., 1973; and Morrow et al., 1974

One page of handwritten notes dated 3/4/87, has initials "KK" in upper left and "FG" in lower right, about licensee Amgen; list of products, "We want to keep an eye on them--will they report any sales?"

Letter dated February 2, 1987 from Paul T. Clark of Fish & Richardson to Katharine Ku; "Bob Carpenter of Integrated Genetics, Inc. has referred your letter to him of December 11, 1986 to us. . . . In the case of probes, we have advised our client that the Stanford patents cannot be stretched to cover their probes, and therefore no royalties on probes are due."

Letter dated April 25, 1985 from Katharine Ku to SNC; request to review attached declarations, "In addition, are you aware of any patent, printed publication, or public use which is more pertinent to the Boyer/Cohen invention than the Lobban thesis or the Mertz and Davis article, PNAS 69:3370-3374 (November 1972)?"; "Lastly, please provide the dates on which the experiments set forth in the laboratory notebook pages appended to the Cohen/Boyer Rule 132 declaration were conducted."; 10 attachments to letter: 1) memo dated April 25, 1985 from Niels Reimers to "Professors S. Cohen, R. Schimke, R. Davis, G. Ringold, L. Kedes, and J. Leavitt", cc to Adrian Arima, David Korn, Jerry Lieberman re "Licensing Proposal for Biotechnology "Tool" Patents", "most of you are aware I proposed, along with Roger Ditzel of UC, that universities pool all of their biotechnology tool patents for licensing to industry. . . The proposal made by Roger and me was not greeted with great enthusiasm by most industry or other universities. . . . Our plan is to group the biotechnology tools we now have in a single license", memo includes enclosures "Draft blanket license" and "Alternative royalty schedule for individual patent licensees"; 2) "Declaration Under Rule 131", unsigned with signature lines for SNC and Boyer; 3) five photocopied pages of lab notebook (SNC says it looks like Annie Chang's writing); 4) "Declaration of Stanley N. Cohen", re plasmid pSC101 signed by SNC on February 1, 1984; 5) "DECLARATION UNDER RULE 132" signed by SNC on October 28, 1982; 6) article by S.N. Cohen and A.C.Y. Chang, J. Bac., 1977; 7) article by S. Chang and S.N. Cohen, PNAS, 1977; 8) article by S.N. Cohen et al., PNAS, 1973; 9) letter dated September 5, 1974 from SNC to Dick Roblin, Mass. General listing 32 people who have requested and received the pSC101 plasmid; and 10) unsigned two-page letter dated September 6, 1977 from SNC to Donald Fredrickson, Director, NIH enclosing a manuscript [not included in this file] in press with PNAS, "I have taken the unusual step of sending it to you prior to publication because I believe the findings have policy, as well as scientific, importance with regard to the regulation of recombinant DNA", " . . . along with virtually all of the other scientists who first raised these questions, I have since come to believe that our initial concerns were greatly overstated." (this letter also catalogued in Rows 286 and 328)

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 1/23/87, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to that on six documents cataloged in Rows 50-54, 66 of this spreadsheet, except that newest entry on this table is "Office Action", official date 1/20/87, forwarded to client 1/23/87; post-it attached to cover sheet with handwritten note: "1/26/87 Stan - We finally got an Office Action & will be deciding how to proceed in next month or so - Kathy"; attached Office Action form from USPTO to Bertram I. Rowland, response due April 20, 1987, "Claims 45-77 are rejected", stapled to form is five-page text by Primary Examiner Alvin E. Tanenholtz explaining rejection, this text has numerous handwritten comments by SNC addressing the science and conclusions, such as "Not true, BPU replicates on plasmid--same mechanism", "B.S.--what evidence?", and "ignorant comment"; also attached are two pages of Form PTO-892, "Notice of References Cited", both filled out by hand and signed "Tanenholtz 1/8/87"

Legal documents from and patent documents prepared by Leydig, Voit & Mayer: log sheet "Attention: Kathy Ku" covering period 4-25-84 to 4/18/86, listing papers pertaining to "Process and Composition for Biologically functional molecular chimera", Stanford Docket S74-043, for client Stanford; cover sheet identical to that on seven documents cataloged in Rows 50-54,65 of this spreadsheet, except that newest entry on this table is "Preliminary Amendment w/ enclosures", official date 4/17/86, forwarded to client 4/18/86; attached are 29-page "Second Preliminary Amendment" signed by Bertram I. Rowland on 4/17/86; and five-page "Appendix 1 Claim Comparison" comparing "Serial No. 602,294 Claim 45" to "Patent No. 4,237,224 Claim 1"

Six-page Declaration signed by SNC on April 20, 1983 re contributions of Robert B. Helling "to the invention disclosed and claimed in application SN520,691", attached to Declaration are three SNC articles: "The Stanford DNA cloning patent", 1982; "The Transplantation and Manipulations of genes in Microorganisms: Harvey Lecture", 1979; and "The Manipulation of Genes", 1975.

95 20
Cohen/Boyer patent information, 1988-1991

Paperclip holding: 1) Small heavystock paper with undated handwritten note from "Susan" to SNC thanking SNC for speaking at Bert Rowland's memorial, mentions "He was always extrememly proud of what he considered his greatest professional accomplishment: writing the Cohen-Boyer patents.", also says that memorial was videotaped; 2) Three-page printout SNC's talk, "Bert Rowland Memorial comments. Stan Cohen" dated 11/26/10, talk has "File" handwritten by SNC at top right of p. 1 and all three pages have edits handwritten by SNC; and 3) in between pp. 2-3 of the talk is a printout of the program, "In Loving Memory of Bert June 26, 1930 - October 28, 2010"

Printout dated 5/21/98 of article "Stanford DNA 'enforcer' Grolle closes the $200M book on Cohen-Boyer", Joan O'C. Hamilton, Signals, published 11/25/97; five pages; business card of Katharine Ku, Director of OTL stapled to top right of first page, with handwritten "To Stan Cohen"; small yellow post-it attached to first page, "File--Cohen/Boyer patent" written by SNC

Spreadsheet titled, "COHEN-BOYER ROYALTIES DISTRIBUTION. . ..1980 THRU 1996-7"; business card of Katharine Ku, Director of OTL stapled to top left of page with handwritten "Prof Stan Cohen"; in upper right of page stamp "RECEIVED SEP 2? 1997" {perhaps SEP 22} and "Cohen/Boyer patent file" written by SNC; lower right of printout "9/15/97 "F. Grolle" "

Fax of article, "Tiger by the tail" by Niels Reimers, Journal of the Association of University Technology Managers, Vol. 5, 1995, pp. 25-47; reprinted from CHEMTECH, August 1987, 17(8), pp. 464-471; sent 11/29/95 from Stanford Tech. Lic.

"Stanford Technology Brainstorm, the Newsletter of Stanford University's Office of Technology Licensing (OTL)", Vol. 5, No. 2, Autumn 1996; stamped RECEIVED DEC 1? 1996 {perhaps DEC 17} in upper right; "Cohen/Boyer patent file" written by SNC in upper right; "IN THIS ISSUE . . . Cohen-Boyer Still a Strong Part of OTL's Licensing Activity"

Letter dated August 6, 1996 from SNC to Eugene Bauer, Dean of Stanford School of Medicine, re "proposal to establish a new School of Medicine academic program of lasting value, using funds provided by the Cohen/Boyer patent income"

Letter dated January 31, 1996 from Condoleezza Rice, Provost of Stanford University to SNC; response to January 23, 1996 memo from SNC to CR, cc to President Gerhard Casper and Dean Eugene Bauer re "Cohen/Boyer Patent Income"

Letter dated July 31, 1996, from David J. Aston, Associate Director, UC Office of Technology Transfer to Katharine Ku, Director of Stanford University Office of Technology Licensing, cc Terence A. Feuerborn, Executive Director UCOTT and Niels Reimers, Director, Office of Technology Management, UCSF, re "We do not believe that it would be appropriate to pursue a patent term extension by way of a private bill in the United States Congress."; handwritten in upper right "Stan Cohen FYI -- K2"

Four-page memo dated June 10, 1996, from Floyd Grolle, Office of Technology Licensing to SNC, stamped "RECEIVED JUN 13 1996" re "Cohen-Boyer Status Report" on royalties; "file" written in upper right by SNC

Robertson Stephens & Company Institutional Research Biotechnology Calendar, August-September 1995, dated August 1, 1995, "Cohen/Boyer patent file" handwritten by SNC in upper right of first page, 20 pages; clipped behind it is complimentary issue of BioWorld Financial Watch, Vol. 3, No. 42, containing article, "The Promise of Gene Therapy Still Lures Big Investors" by Jennifer Van Brunt, cover page and p. 13

Undated three-page article without a byline "Products in the U.S. Pipeline from the Pharmaceutical Manufacturers Association"; handwritten by SNC in upper right "file with material from Lampert"

One page of fax from Stanford Tech. Lic. sent September 29, 1995, labeled P.4 re status of Docket S 74-043, title, "Cohen/Boyer; Recombinant Technology" it is part of 13-page fax photographed in IMG_0062.jpg

Printout of United States Patent 4,237,224, "Process for Producing Biologically Functional Molecular Chimeras", Inventors: Cohen and Boyer, December 2, 1990

Fax from Stanford Tech. Lic. sent September 29, 1995 re status of Cohen intellectual property managed by OTL; 12 numbered pages stapled in random order; page 10 re Docket S78-077, "Protein Production At Synthetic Start Site", inventors Nunberg, Chang, Cohen and Schimke; pages 3,6,5,7,8,and 9 re Docket S74-043, title, "Cohen/Boyer; Recombinant Technology"; page 11 re Docket S92-106, "Use of tRNA Genes to Stabilize the Inheritance of Unstable Plasmids in Populations of Growing Cells", inventors Vogtli and Cohen; page 12 re Docket S93-160, "Method for Concurrent Disruption of Expression of Multiple Alleles of Eukaryotic Genes", inventors Li and Cohen; page 13 re Docket S93-161, "docket created to classify all of Cohen's many (over 70) IRPs on file with OTL"; page 1 cover sheet, from "Christina -- OTL" to "Stanley Cohen's Office" page 2 re Docket S73-061 "MEDIPHOR/MINERVA/MUMPS (Software)", inventor S. Cohen; page 4 is missing and is filed alone (photographed in IMG_0060.jpg)

Letter dated September 27, 1994 from SNC to Arian Arima, General Counsel's Office, Stanford University; small sheet with fax transmission report and two-page letter responding to September 23 memo (IMG_0064.jpg) re payment for invention incorrectly characterized as "royalty" when it is "an installment sale"

Memo dated September 23, 1994, from Adrian Arima, General Counsel's Office to SNC, cc Chris Canellos and Iris Brest, Controller's Office and Kathy Ku, OTL, "Subject: Payments on Patent" re "your request to characterize the payments on your invention as "installment payments for technology" rather than "royalties" as described in letter from Maggie Feinstein; two pages, not attached to each other

Letter dated January 10, 1994 from SNC to Floyd Grolle, OTL re funds paid to SNC in connection with Cohen-Boyer patent "The records of the University should indicate that the funds are given as payment for technology, instead of being termed "patent royalties" "

Memo dated September 13, 1994 from Maggie Feinstein, OTL Accountant to SNC, cc Floyd Grolle and Kathy Ku, "File Boyer/Cohen patent" written by SNC in upper right, re "FY 93-94 Installment Payment for Cohen-Boyer Technology"; text: per Chris Canellos a letter from SNC needed to ensure SNC's 1993-1994 "check reflects that it is an "Installment Payment for Technology" rather than a payment for "patent royalties.";

Letter dated April 12, 1994 from William T. Davis, Associate Director of University of California Office of Technology Transfer to Katharine Ku, Director of Stanford University Office of Technology Licensing, handwritten "To Stan Cohen" in upper right and in SNC's handwriting, "File"; text re "clear consensus that the University of California will not endorse or participate in any effort to extend the DNA Cloning patents"

Letter dated February 11, 1993 from Katharine Ku, Director of Stanford University Office of Technology Licensing to William Davis, Associate Director of University of California Office of Technology Transfer, cc to SNC, David Korn, and Larry Horton,stamped in upper right RECEIVED FEB 15 1993; "file" written by SNC in upper right; text re info provided to Stanford by Bertram Rowland, "Bert believes that the University of California would need to endorse and participant [sic] in any effort to extend the DNA Cloning patents"

Printout of United States Patent 4.468,464, "Biologically Functional Molecular Chimeras", Inventors: Cohen and Boyer, August 28, 1984

Memo dated November 15, 1993 from Kathy Ku to Dean David Korn, cc Peter Van Etten, Larry Horton, Stan Cohen, Floyd Grolle re Extension on Cohen/Boyer patents; stapled to memo is a two-page letter dated November 9, 1993 from Bertram I. Rowland to Katherine [sic] Ku re "Private Relief Bill to Patent Extension," Stanford reference S74-043 which begins, "I am enclosing a memorandum prepared by Bred Field describing his investigation of opportunities to obtain patent extensions"; attached to letter are a memo and a bill: five-page memo dated October 22, 1993 from Bret Field to Bert Rowland re "Private Relief Bill to Extend the Term a Patent [sic]" and the four-page text of a bill, "AS REFERRED IN THE SENATE H.R. 5475", Version 4 of "AN ACT Providing policies with respect to approval of bills providing for patent term extensions, and to extend certain patents" passed by the House of Representatives on August 4, 1992

Listing of Cohen-Boyer Licensees 10/12/92; 195 licensee companies

Two-page memo dated January 27, 1992, from Donald Kennedy, Stanford President to SNC, stamped "RECEIVED FEB-4 1992"; refers to recent conversation: "I was glad of the opportunity to talk with you about royalty matters." concludes "we should not return to the royalty arrangement described in your 1975 contract as you interpret it", recaps Stanford's royalty policy in 1975 and DK/SNC royalty discussion in 1979 or 1980 which led to new policy described in attached memo (three pages) dated April 17, 1980 from Niels Reimers to SNC, cc to Adrian Arima, Donald Kennedy, Gerald Lieberman, William Massy and Kent Peterson

Memo dated October 25, 1991 from David Korn, Vice President and Dean to SNC, "Patent file" handwritten by SNC in upper right corner, "Subject: Patent Royalties", responding to SNC memo of October 23; "the 15% tax generates funds well in excess of OTL expenses, but it was Bob Byer's [Dean of Research/Vice Provost Robert L. Byer] and Jim Rosse's [James Rosse, Provost] decision to use the overage as a research innovation seed fund under the authority of the Dean of Research . . . I would suggest that you bring your concern directly to the Provost's attention, perhaps copying me on any written communication, and see whether you can make more progress than I did."

Fax cover sheet dated October 4, 1991 from Mark Lampert to SNC "Attached is the letter which we sent to Stanford." and two-page letter dated September 6, 1991 from Greg Sabouri [no letterhead, no job title listed] to Jon Sandelin, Acting Director, Office of Technology Licensing; proposal that "(1) Oppenheimer will acquire from a 30% to an 80% interest in Stanford's portion of the Cohen-Boyer royalties. (2) The price will be based on a $70 million valuation of the entire royalty stream."

Two-page memo dated November 22, 1991 from Katharine Ku to SNC, cc R. Byer, P. Devaney, P. Van Etten, A. Arima; "Re: 15% OTL allocation"; "In response to your request that we interpret the royalty-sharing agreement as signed by you and Stanford in June, 1975 with respect to the OTL 15% deduction, I have conferred with the Dean of Research's office and the Legal Office. . . . It is our unanimous opinion that the fifteen percent allocation for OTL is a flat 15%, rather than a changing percentage up to 15%."; this document is immediately followed in the files by another copy of the same document (IMG_0083.jpg), identical except that on the first one the OTL letterhead and fax stamp are not visible at the top of each page

Memo dated November 22, 1991, faxed from STANFORD TECH. LIC. on November 22, 1991, from Katharine Ku to SNC, cc R. Byer, P. Devaney, P. Van Etten, A. Arima; "Re: 15% OTL allocation"; "In response to your request that we interpret the royalty-sharing agreement as signed by you and Stanford in June, 1975 with respect to the OTL 15% deduction, I have conferred with the Dean of Research's office and the Legal Office. . . . It is our unanimous opinion that the fifteen percent allocation for OTL is a flat 15%, rather than a changing percentage up to 15%."; two pages; this document is immediately preceded in the files by another copy of the same document (IMG_0082.jpg), identical except that on the first one the OTL letterhead and fax stamp are not visible at the top of each page

Spreadsheet with handwritten "10-1-91 FG" at lower right; in upper right of page are handwritten "10-18-91 To Stan Cohen: FYI from K Ku" and date stamp "OCT 23 1991"; contains two charts: "COHEN-BOYER ROYALTIES . . . ACTUAL & ESTIMATED" covering 1987-1991, and "LISTED BELOW ARE THE ESTIMATED COHEN-BOYER ROYALTIES FROM FISCAL 1991-92 THRU 1997-98"; this document is immediately followed in the files by another copy of the same document (IMG_0085.jpg), identical except that on the second one "Stan Cohen: FYI" is highlighted in yellow

Spreadsheet with handwritten "10-1-91 FG" at lower right; in upper right of page are handwritten "10-18-91 To Stan Cohen: FYI from K Ku" and date stamp "OCT 23 1991"; contains two charts: "COHEN-BOYER ROYALTIES . . . ACTUAL & ESTIMATED" covering 1987-1991, and "LISTED BELOW ARE THE ESTIMATED COHEN-BOYER ROYALTIES FROM FISCAL 1991-92 THRU 1997-98"; this document is immediately preceded in the files by another copy of the same document (IMG_0084.jpg), identical except that on the second one "Stan Cohen: FYI" is highlighted in yellow

Memo dated October 23, 1991, marked "Personal and Confidential", from SNC to David Korn, "Subject: Cohen/Boyer Patent Royalties: 15% deduction by the University"; "the fifteen percent deduction for the University is intended to be a "ceiling" sufficient to reimburse the University for its indirect costs, not an automatic deduction. . . . From my reading of the agreement, the funds being deducted by the University in excess of the true indirect costs of the OTL legitimately belong to the School of Medicine, the Departments of the Inventor (in the case of the Cohen/Boyer patent, Medicine and Genetics), and the Inventor."

Letter dated July 5, 1989 from Katharine Ku to Serle Mosoff, General Counsel of Enzo Biochemical, cc to D. Dunner, "file" written by SNC in upper right and date stamped "JUL 10 1989"; "Re: Stanford Docket S74-043, "DNA Cloning", "Thank you for the signed License Agreement originals covering the Cohen-Boyer patents.", handwritten at bottom of page, "bcc: Stan Cohen: They were difficult to get "onboard" but they finally signed. Kathy";

Memo dated January 13, 1989 from SNC to Sally Hines, OTL re Patent Royalties; request to assign rights to receive royalties from patents to "Stanley N. Cohen and Joanna L. Cohen Family Trust, Stanley N. Cohen, Trustee."

Letter dated March 7, 1989 from Katharine Ku to Thomas D. Zindrick, The Dow Chemical Co., at top right "To Stan Cohen" handwritten and date stamp "MAR 10 1989"; "file" written by SNC, "Re: Stanford Docket S74-043, "DNA Cloning"; "We are delighted Dow has joined as a Cohen-Boyer licensee. Enclosed is a fully executed copy of the Agreement"; agreement is not attached to this letter, though photocopy shows paperclip

Handwritten spreadsheet with "9-29-88 FG" written in lower right; stamped "CONFIDENTIAL"; "File Cohen/Boyer patent" written by SNC in upper right; "EXPECTED EARNED + MINIMUM ROYALTIES (FROM COHEN-BOYER LICENSE" columns for 1988-89, 1989-90, and 1990-91

Printout of United States Patent 4,740,470, "Biologically Functional Molecular Chimeras", Inventors: Cohen and Boyer, April 26, 1988

Letter dated October 6, 1988 from Katharine Ku to Joanne Thierstein, "Warner Lambert" [sic], at top right "Stan Cohen" handwritten, date stamped "OCT 11 1988", and "Cohen/Boyer patent file" written by SNC; "Re: Stanford Docket S74-043, "DNA Cloning"; "Enclosed is a fully executed License Agreement covering the DNA cloning technology. I am absolutely delighted your perseverance paid off and that Warner-Lambert is now a licensee of the Cohen-Boyer patents."; agreement is not attached to this letter, though photocopy shows paperclip

Letter dated March 20, 1989 from Katharine Ku to Hiroshi Iwai, Takara Shuzo Co., Ltd., at top right "3/20 Stan Cohen FYI--Kathy" handwritten, date stamp "MAR 22 1989", and "Cohen/Boyer patent file" written by SNC; "Re: Stanford Docket S74-043, "DNA Cloning"; "We are delighted to have Takara Shuzo become a Cohen-Boyer licensee. Enclosed for your files is a fully executed License Agreement covering the DNA cloning technology."; agreement is not attached to this letter

Handwritten note dated September 8, 1988 from Floyd Grolle to SNC, attached is "most recent "roster" of Cohen-Boyer licensees"; attached is two-page chart listing of 84 licensees "as of 9-1-88": columns are Licensee, Location, Credits, and Type

Two-page chart dated September 1, 1988, "Cohen-Boyer Licensees (Current & Former)" listing 84 current and 14 former licensees: columns are Licensee License Date, and Cancel Date

Photocopy of Science, August 19, 1988, p. 907, containing article "A Bit of Science History Is Lost" by Gregory Byrne about demise of The Waikiki Delicatessen, "the birthplace of modern biotechnology"; possibly sent to SNC by Floyd Grolle: "SCIENCE" handwritten in green ink at bottom of page and yellow post-it with "!!" in green ink are consistent with green ink and handwriting of Floyd Grolle on other documents in this collection

"PMA Report: Biotechnology Products in the Pipeline" from Biotechnology, Vol. 6, September 1988, p. 1004 ff., 4 pages; stapled behind is a copy of Science article "A Bit of History Is Lost" (IMG_0100.jpg)

Letter dated July 12, 1988 from Bertram I. Rowland to Kathy Ku, cc to "Inventor(s) with copy of patent; "I enclose the original and seven copies of the U.S. Letters Patent No. 4,740,470 which issued on April 26, 1988 . . . Please sign and return to me the enclosed copy of this letter to indicate receipt of this original Letters Patent", describes annuities due to keep patent in force and "Product made using the claims of the Patent can and should be marked with the patent number."; one copy of patent 4,740,470 attached

Draft of Stanford News Bureau article, "Third Stanford-UC Genetic Engineering Patent Granted"; refers to patent granted April 26, 1988 [No. 4,740,470]; an edit by SNC has been mostly erased; business card of Katharine Ku stapled to front page with handwritten "Congratulations, Stan K" written on card

Patent 4,740,470, "Biologically Functional molecular Chimeras" with Form PTO-194 stapled to front; form says "It will be accepted by the U.S. PATENT and TRADEMARK OFFICE in payment for copies"

Memo dated March 24, 1988 from Floyd Grolle to SNC "Subject: Sales and Royalties Estimates"; "best estimates covering STANFORD FISCAL YEARS 1987-88, 1988-89, and 1989-90" and "March 26, 1986, PRELIMINARY ESTIMATES OF COHEN-BOYER PRODUCT SALES"; attachments as described; stapled document is 10 pages: one five-page original (CONFIDENTIAL stamped in red on memo and tables) and one photocopy

Memo dated March 14, 1988 from Floyd Grolle to SNC "Below are our estimates of Cohen-Boyer royalties anticipated for the Stanford fiscal years of 1987-88, 1988-89, 1989-90, 1990-91 . . The final tabulations/payments for the 1987 calendar year are due April 1, 1988."

95 21
Oppenheimer & Co., Inc. 1991 Re: Cohen/Boyer Patent Royalties, 1991

Letter dated September 19, 1991 from Mark N. Lampert to SNC; "You and I met last year to discuss my interest in purchasing a portion of the royalties derived from the Cohen-Boyer patents. . . . Obtaining a slice of the Cohen-Boyer royalty stream is absolutely critical to the success of our business.", asks to meet again; phone messages from Lampert to SNC dated September 27, 1991 and October 10, 1991 in Joanie Driscoll's handwriting

Letter dated September 6, 1991 from Greg Sabouri to Jon Sandelin; stapled after letter is fax cover sheet.

 
Workpapers - Patent Application [subseries]:
81 40
Stanford/Cetus, 1976-1983
81 41-44
Nunberg/Chang/Cohen, 1977-2003
82 1-7
Nunberg/Chang/Cohen (cont'd), 1977-2003
82 8-9
Michaels/Robertson/Cohen, 1979-1984
82 10-11
Michaels/Robertson/Smith/Cohen, 1981-1984
82 12-13
Michaels/Robertson/Taylor/Cohen, 1981-1984
82 14-16
Cohen/Inloes/Matin, 1981-1984
 
Mediphor [subseries]:
82 17
Sago/Mario/Negri, 1972-1976
82 18
Stanford/B.D., 1974-1976
82 19
Stanford/H.P., 1974-1975
82 20
Stanford/B.W. agreement, 1980-1981
82 21-23
Cohen/Inloes/Matin, 1985-1987
 
Articles [subseries]:
2 19
"Cohen-Boyer patent issued" Stanford Medicine, Winter 1985
3 7
Article about expiration of Cohen-Boyer patent - Stanford magazine, January/February 1998