# Appendix — Doolittle v. United States > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385004_0737%3A2 ## Record - **Collection:** Supreme Court brief - **Document type:** Appendix - **Published:** January 1, 1975 - **Citation:** 423 U.S. 1008 ## Text i —— ee | 76-5134 Tres “PILED IN THE oct 1s We Supreme Court of the United dtates sx. cer _ October Term, 1976 ea ee INTERNATIONAL RECTIFIER CORPORATION, ef al., Petitioners, VS. PFIZER, INC., Respondent. VOLUME Il APPENDIX. PETER R. COHEN, 9601 Wilshire Boulevard, Suite 200, Beverly Hills, Calif. 90210, (213) 278-4011, Attorney for Petitioner. Parker & Son, Inc., Law Printers, Los Angeles. Phone 724-6622 INDEX TO APPENDIX Page Findings of Fact, Conclusions of Law and Order... 1 Appeal From the United States District Court for the District of Minnesota .........................22.2c0000+- 95 Paragraph 8 of Examiner Adams Affidavit (Feb- SD Fis TE: seiisnsitsnnintendastitntindnaiiautannaicinnians 129 Blackwood, et al. Affidavit (March 27, 1975) .. 129 Blackwood—Affidavit (April 9, 1975) ........... 131 Paragraph 8 of Examiner Adams Affidavit (Feb- en ee ee 133 Paragraph 19 of Stephens Affidavit (March 27, TEPOMIED nisisadetinaindevennistaipudentiniinittiiettaiaiiuitlereiainies 134 Last Paragraph of Pfizer Exhibit 35 M (December 20, 1960) IN THE Supreme Court of the United States October Term, 1976 ERE iron INTERNATIONAL RECTIFIER CORPORATION, ef al., Petitioners, vs. PFIZER, INC., Respondent. APPENDIX. Findings of Fact, Conclusions of Law and Order. UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA FOURTH DIVISION 4-71 Civ. 435 and the following In Re Coordinated Pretrial Proceedings In Antibiotic Antitrust Actions 4-73 Civ. 188 PFizeR, INC., Plaintiff, | vs. INTERNATIONAL RECTIFIER CORPORATION, RACHELLE LABORATORIES ITALIA, S.p.A., RACHELLE LABORA- TORIES, INC., RACHELLE PHARMACEUTICALS INTER- NATIONAL, S.A., and USV PHARMACEUTICAL Cor- PORATION, Defendants. This matter comes before the Court upon defendants’ motion for partial summary judgment. INTRODUCTION This action was filed by Pfizer, Inc. (Pfizer) on January 11, 1973 against International Rectifier Corpo- ration and its four subsidiaries, Rachelle Laboratories ~ Italia, S.p.A., Rachelle Laboratories, Inc., Rachelle Pharmaceuticals International, $.A., and Rachelle Lab- oratories (Philippines), Inc. (collectively the Rectifier Defendauts) and USV Pharmaceutical Corporation anllien (Defendant USV) for alleged infringement of Pfizer's Blackwood, et al., Patent No. 3,200,149 (the Doxycy- cline Patent). Pfizer seeks damages from the defendants and injunctive relief. Defendants’ answers allege, among other things, that the Doxycycline Patent is invalid and unenforceable because of Pfizer’s fraud upon, and inequitable conduct before, the Patent Office. On January 10, 1973 this action, which was com- menced in the United States District Court for the Central District of California (Civil Action No. 73- 58-R), was transferred by the Multidistrict Panel pur- suant to the provisions of 28 U.S.C. $1047 to this Court for coordinated or consolidated pretrial proceed- ings with In Re Coordinated Pretrial Proceedings In Antibiotic Antitrust Actions, 4-71 Civ. 435 (D. Minn. filed August 1, 1971); six of which actions are now in trial. Pursuant to a September 28, 1972 order in 4-71 Civ. 435, and a further request for the production of documents by Defendant USV, Pfizer produced many thousands of documents to defendants commencing in mid-1973. In December 1973 Defendant USV initiated the deposition of numerous Pfizer employees. On May 29, 1974 Defendant USV filed the original motion for partial summary judgment (Original Mo- tion). On February 11, 1975 Defendant USV and the Rectifier Defendants filed a second motion for partial summary judgment which incorporated the grounds set forth in the Original Motion and added grounds thereto (Present Motion). Pfizer has opposed, and the parties have fully briefed, both motions. ~~ The Present Motion is based almost entirely on documents produced by Pfizer and the deposition testi- mony of Pfizer’s employees or agents. Pfizer has submit- ted numerous affidavits in opposition to the motions. Defendants have submitted one affidavit in support of the Present Motion. Hearings on the Original Motion, the Present Motion, and on evidentiary matters relating thereto were held on September 11 and 13, and October 10, 1974; and on January 24, 25 and 31, February 1 and April 11, 17, 18 and 21, 1975, after which the matter was submitted, The Present Motion charges Pfizer with fraud and inequitable conduct in the prosecution of the Doxycy- cline patent application before the Patent Office and with fraud on this Court. Pfizer denies these charges. Defendants contend and Pfizer denies that there is no genuine issue of any material fact concerning the questions of fraud and inequitable conduct in the prose- cution of the Doxycycline Patent application and fraud on the Court. The Court after having considered the documents, depositions and affidavits of the parties and the briefs and many oral arguments of the parties makes its findings of facts and conclusions of law as stated herein. The procedure to be utilized will be as follows: Before stating the uncontroverted facts, the Court will set forth the basic principles of law which it will apply. After setting forth the uncontre erted facts in each section the Court will then apply the conclusions of law which necessarily follow from the uncontroverted facts. The Court feels that this format will make it _ ea easier for those unfamiliar with the subject matter or any reviewing judicial body to follow the Court’s reasoning and the long and often complicated facts. The headings set forth in the Findings of Fact, and in the Conclusions of Law, are for convenience only and are not part of the Findings of Fact or Conclusions of Law. The facts set forth in the “Facts Respecting the Chronology of the Prosecution of the Doxycycline Application Before the Patent Office”, and “The Facts Respecting Technical Terms and Concepts”, are findings of fact. Finally, since it is often difficult to completely sepa- rate findings of fact from conclusions of law each is intended to include the other where appropriate. APPLICABLE PRINCIPLES OF LAW The grant of summary judgment is appropriate where there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law. Rule 56(c), F.R.Civ.P., provides in part that: The judgment sought shall be rendered forthwith if the pleadings, depositions, answers to interroga- tories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. Rule 56(c) is equally applicable in patent cases. Proler Steel Corp., Inc. v. Luria Brothers & Co., Inc., 417 F.2d 272 (9th Cir. 1969). See also, In Re Yarn Processing Patent Validity Litigation, 185 U.S.P.Q. 334 (S.D. Fla. 1975). Bobertz v. General Motors Corp. 228 F.2d 94 (6th Cir. 1955) cert. denied 352 enna U.S. 824 (1956). Technograph Printed Circuits Ltd. v. Methode Electronics, Inc., 356 F.2d 442, (7th Cir. 1966) cert. denied 384 U.S. 950 (1966). Research Corporation v. Nasco Industries, Inc., 501 F.2d 358 (7th Cir. 1974) cert. denied .... U.S. .... (........). In Ballantyne Instruments & Electronics Inc. v. Wag- ner, 345 F.2d 671 (6th Cir. 1965), the Court stated: The public interest in every patent case requires that suits involving the validity of patents should be speedily determined. Thus, wherever patent liti- gation can be expeditiously handled on motions for summary judgment it should be done provided the necessary safeguards to protect the rights of the litigants are observed. When a motion for summary judgment is made and supported as provided in this rule, [56(c)], an adverse party may not rest upon the mere allegations or denials of his pleading, but his response, by affidavits or as otherwise provided in this rule, must set forth specific facts showing that there is a genuine issue for trial. If he does not so respond, summary judgment, if appropriate, shall be entered against him. /d. at 672. In determining whether summary judgment is proper the Court may disregard an opposing party’s mere formal denials or generalized averments of fact, Law- horn v. Atlantic Refining Company, 299 F.2d 353, 357 (Sth Cir. 1962); Minnesota Mining & Mfg. Co. v. United States Rubber Co., 279 F.2d 409 (4th Cir. 1960); Liberty Leasing Co. Inc. v. Hillsum Sales Cor- poration, 380 F.2d 1013 (Sth Cir. 1967); U.S. v. 373.70 Carats Of Cut, Polished, Rough and Cleaved — = Diamonds, 148 F.Supp. 618 (E.D.N.Y. 1957), as the opposing narty is required to bring forth specific facts in order to raise a genuine issue of fact. F.R.Civ.P. 56(e); Bruce Construction Corp. v. United States, 242 F.2d 873 (Sth Cir. 1957); Saunders v. National Basket- ball Association, 348 F.Supp. 649 (N.D. Ill. 1972). The Court may disregard affidavits containing specu- lation Kern v. Tri-State Insurance Company, 386 F.2d 754 (8th Cir., 1967), or hearsay Lyon Ford Inc. v. Ford Motor Company, 342 F.Supp. 1339 (E.D. N.Y., 1971); Elasky v. Pennsylvania Railroad Com- pany, 215 F.Supp. 25 (D. Ohio 1962); Willetts v. General Tel. Directory Co., 38 F.R.D. 466 (S.D. N.Y. 1965), or opinions G.D. Searle & Co. v. Chas. Pfizer - & Co., 231 F.2d 316 (7th Cir. 1956), or factual and legal conclusions (Turner v. Lundquist, 377 F.2d 44 (9th Cir. 1967); Wagoner v. Mountain Savings & Loan Ass'n, 311 F.2d 403 (10th Cir., 1962); Riggs v. British Commonwealth Corporation, 459 F.2d 449 (10th Cir. 1972)). Thus, vague inferences contained in affidavits oppos- ing a motion for summary judgment are unavailing. Burnham Chemical Co. v. Borax Consolidated, Ltd., 170 F.2d 569 (9th Cir. 1948); Bishop v. Shaughnessy, 119 F.Supp. 62 (N.D. N.Y. 1950). Where the moving party creates inferences in affidavits and documents which are not denied by the opposing party, those inferences which are “properly drawn therefrom . . may support a motion for summary judgment” Lundeen v. Cordner, 356 F.2d 169 (8th Cir. 1966). The reason for these rules is clear. Where summary judgment is proper the opposing party should not be permitted to defeat summary judgment and put his a opponent to the expense of a trial by beclouding the absence of genuine, uncontroverted issues of material fact with generalizations, vague inferences, opinions, or factual or legal conclusions. It is the policy of the law, particularly in patent cases to discourage “dilatory court tactics” Lear Inc. v. Adkins 395 U.S. 653 (1969). Summary judgment is designed to do precisely that where there is no genuine issue of material fact. The fact that patent litigation involves technical mat- ters does not foreclose summary judgment. Where there is no need for expert testimony in order for the Court to understand the uncontroverted facts, the Court is fully capable of determining those uncontroverted facts and applying the law thereto. Bobertz v. General Motors Corp., supra. In Research Corporation v. Nasco Indus- tries Inc., supra, the Court of Appeals, for the Seventh Circuit, in affirming the grant of a motion for summary judgment, stated: There is nothing in Rule 56 to forbid the use of summary judgment procedures to determine whether a genuine issue of fact exists concerning the factual foundation for determination of the ultimate issue of law: obviousness. Although care must be exercised to assure that controverted fact issues are not ignored, see Tee-Pak, Inc. v. St. Regis Paper Co., 491 F.2d 1193, (6th Cir. 1974), * * * a suit concerning the validity of a patent over the prior art is not immune from disposition on motion for summary judgment even though, in addition to prior art patents, deposition testi- mony of the applicant and affidavits are involved, if no genuine issue of material fact is present. eitlitios A R, Inc. v. Electro-Voice, Inc., 311 F.2d 508, 511, (7th Cir. 1962). ‘Further, it is well settled that, in a proper case, the validity of a patent may be determined by use of summary judgment.’ Technograph Printed Circuits, Ltd. v. Methode Electronics, Inc., 356 F.2d 442, 446, (7th Cir. 1966), cert. denied 384 U.S. 950 (1966).... ‘Rule 56 applies to patent cases and is used in those instances where the structure and mode of operation of the accused devise may be readily comprehended by the court and compared with the invention described and claimed in the patent without need of technical explanation by expert witnesses.” Technograph Printed Circuits, Ltd. v. Methode Electronics, Inc., 356 F.2d 442, 447, (7th Cir. 1966) cert. denied 384 U.S. 950, (1966). [Emphasis added.] Jd. at 361-2. In the present case, there are over 150 uncontroverted facts whch appear from depositions, affidavits and documents. Although this case is complicated by reason of the sheer number of uncontroverted facts; the number of issues presented by those facts; and a change in the substantive law concerning prior art anticipation (35 U.S.C. §102) during the prosecution of the applica- tion, the technology necessary for a complete under- standing of the uncontroverted facts is not overly dif- ficult. For example, issues concerning stereochemistry, which are seemingly the most difficult technically, do not require the Court to understand the chemical reac- tions which produce Doxycycline, and the McCormick 6-deoxy products; or why, in Doxycycline, the methyl snl group (CH,) at the 6-position is “down” and in the McCormick 6-deoxy compound the methyl group (CH:) at the 6-position is “up”. To decide these issues the Court need only understand that the stereochemical drawings depict “down” with a dotted line and “up” with a solid line. None of this is in dispute. Once these simple technical concepts are understood, the remaining uncontroverted facts consist of no more than Pfizer’s knowledge, beliefs and uncertainties concerning absolute stereochemistry at the 5- and 6-positions at different points in time during the prosecution of the Doxycycline application and Pfizer’s representations to and withholdings from the Patent Office at certain points in time concerning its knowledge, beliefs and uncertainties concerning that stereochemistry. Thus, on the issues concerning stereochemistry the Court’s task is simply to apply the law to the uncontro- verted facts. Summary judgment is proper even where fraud or inequitable conduct is in issue. In 6 Moore’s Federal Practice 2554 (2nd Ed. 1965), Professor Moore states: But in whatever guise the issue of fraud may appear in an action, the general basic principles underlying summary judgment apply and, if they are met, the issue of fraud may be summarily adjudicated. Summary judgment is also appropriate in cases involv- ing fraud on the Patent Office. In Farmer Bros. Com- pany v. The Coca-Cola Company, 384 F.Supp. 595 (C.D. Cal. 1974), the Court granted summary judgment declaring a patent unenforceable because the patent owner had practiced a fraud on the Patent Office. eniliitiis The Court held that The patentees’ failure to be candid with and to make a full and fair disclosure to the Patent Office of all facts relating to . . . their alleged invention constitutes a breach of their duty to the Patent Office and thus renders the Farmer Brothers’ patent void and unenforceable. See also, Proler Steel Corp. v. Luria Bros. & Co., 417 F.2d 272, 273-4 (9th Cir. 1969); Ashcroft v. Papermate Mfg. Co., 434 F.2d 910, 911 (9th Cir., 1970). A patent applicant has an uncompromising duty of absolute candor and full and complete disclosure to the Patent Office of all facts which may be relevant to an issue of patentability. The Courts have found anything less to be fraudulent or inequitable conduct in procuring patent rights. In Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806 (1945), rehearing denied. 325 U.S. 893 (1944), the Supreme Court stated Those who have applications pending with the Patent Office or who are parties to Patent Office proceedings have an uncompromising duty to re- port to it all facts concerning possible fraud or inequitableness underlying the applications in issue. .. . This duty is not excused by reasonable doubts as to the sufficiency of the proof of the inequi- table conduct nor by resort to independent legal advice. /d. at 818. In applying an applicant’s duty of absolute candor and full and complete disclosure, the Court of Appeals for the Sixth Circuit has directed that == The Patent Office, not having testing facilities of its own, must rely upon information furnished by applicants and their attorneys. Pfizer and Cy- anamid, like all other applicants, stood before the Patent Office in a confidential relationship and owed the obligation of frank and truthful dis- closure. Charles Pfizer & Co., Inc. v. FTC, 401 F.2d 574, 579 (6th Cir. 1968), cert. denied 394 U.S. 920 (1969). Because of the public interest considerations under- lying the doctrine of absolute candor and full and complete disclosure before the Patent Office, it is not necessary to establish all of the elements of strict common law fraud. An Applicant commits “Fraud on the Patent Office” if he violates his uncompromising duty of absolute candor and full and complete dis- closure. A strict fiduciary duty is imposed on patent appli- cants which is analogous to that of a seller of securi- ties or any other person who alone has possession of facts bearing on the public interest. Monsanto Com- pany v. Rohm & Haas Company, 312 F.Supp. 778 (E.D. Pa. 1970), aff'd 456 F.2d 592 (3rd Cir. 1972), cert. denied 407 U.S. 934 (1972). In S.E.C. v. Capital Gains Research Bureau, 375 U.S. 180 (1964), the Supreme Court stated in an analogous fraud case that a breach of the duty of complete disclosure constitutes inequitable conduct and that it is not necessary to establish a specific subjective intent to defraud in order to obtain equitable relief. Nor is specific subjective intent a prerequisite to finding fraudulent or inequitable conduct before the Patent Office. In Monolith Portland Midwest Com- —_j2— pany v. Kaiser Aluminum & Chemical Corporation, 407 F.2d 288 (9th Cir. 1969), the patentee argued “that it believed in good faith” that the prior art did not anticipate its claims. The Court stated at page 295 that: Whatever theory Monolith may have had in mind about the legal effect of . . . [the prior art], it failed to disclose openly and fully the underlying facts to the Patent Office. At the least, Monolith knew that those facts might affect the patentability of the invention. Similarly, the specific subjective intent of the patentee was considered immaterial in Monsanto Company vy. Rohm & Haas Company, supra: We have concluded that the decisions of the Supreme Court require the highest degree of scien- tific candor on the part of patent applicants in their dealings with the patent office. We believe this standard forbids not only the affirmative mak- ing of false statements of material fact, but also the suppression of facts known to the applicant which are inconsistent with statements made by the applicant in pursuit of a patent. Id. at 739. . . . [We hold that even if Monsanto did not intend to deceive the Patent Office, the fact that it intentionally withheld facts which were material to the decision whether it was entitled to a patent is sufficient to bar the issuance of a patent to it. . . . We believe that all questions of materiality in dealings with the Patent Office ought to be resolved in favor of disclosure. Only such a standard can protect the public from the ee — —- = deadening competitive effect of improvidently issued patents. [Emphasis added.| Jd. at 799. See also Robbins Company v. Lawrence Manu- facturing Company, 482 F.2d 426 (9th Cir. 1973). Thus, Pfizer’s assertions of good faith belief, based on its scientists’, patent agents’ and attorneys’ subjective state of mind, in misrepresenting to and withholding relevant facts from the Patent Office does not create any genuine issue of material fact. Therefore, the good faith belief assertions set forth in the majority of the affidavits filed by Pfizer in opposition to the motion have been excluded from the findings of material un- controverted facts. See also United States v. Paul Harde- man, Inc., et al., 320 F.2d 115 (Sth Cir. 1963); and Robbins v. Gould, 278 F.2d 116 (Sth Cir. 1960). The requirement of absolute candor and full and complete disclosure in prosecuting patent applications precludes the withholding of “material” prior art, facts and beliefs from, as well as the affirmative misrepresen- tation of “materia!” prior art, facts and beliefs to, the Patent Office. Beckman Instruments, Inc. v. Chem- tronics, Inc., 428 F.2d 555 (Sth Cir. 1970); Monsanto Company v. Rohm & Haas Company, supra. Thus the Court held in Buzzelli v. Minnesota Min- ing & Mfg. Co., ........ F.Supp. ........ , 182 U.S.P.Q. 307 (E.D. Mich. 1974) that an applicant’s failure to cite to the Patent Office “the prior art most material and relevant to the subject matter claimed” renders the patent invalid and unenforceable. Similarly, the Court stated in Union Carbide Corp. v. Filtrol Corp., 357 F.Supp. 37 (C.D. Cal. 1971): —14— A patent applicant’s duty of disclosure to the Patent Office extends to prior art or facts known to him which would . . . have prevented the patent from issuing or would have restricted the scope of the claims. “Materiality” under Beckman and Monsanto, supra, does not require that the patent would not have issued as a matter of law “but for” the misrepresentation or concealment, but only that the misrepresesntation or withholding be relevant to an issue of patentability. Corning Glass Works v. Anchor Hocking Glass Corp., 253 F.Supp. 461 (D. Del. 1966), rev’d on other grounds, 374 F.2d 473 (3rd Cir. 1967), cert. denied, 389 U.S. 826 (1967); Monolith Portland Mid- west Co. v. Kaiser Aluminum & Chemical Corp., supra; SCM Corp. v. Radio Corporation of America, 318 F.Supp. 433 (S.D. N.Y. 1970); CPC International, Inc. v. Standard Brands Inc., ........ F.Supp. ........ ; 184 U.S.P.Q. 332 (D. Del. 1974); United States Mo- vidyn Corp. v. Hercules Incorporated, 388 F.Supp. 1146 (D. Minn. 1975). In most of these cases the testimony of the Examiner was unavailable; thus, the Courts have adopted the rule that even if the applicant misrepresents or with- holds facts which are not material in a “but for” sense, the Courts will refuse to enforce the patent if the applicant has misrepresented to the Patent Office facts which may be relevant to an issue of patentability. In this case the parties have submitted three affidavits of Examiner Adams but no affidavits or deposition testimony from the other two Examiners before whom the Doxycycline Patent was prosecuted. Thus, the rec- ord shows what Examiner Adams would have done MT: le cient comet ~~ eres = had he known certain facts misrepresented to or with- held from him, but does not show what the other two Examiners would have done if similarly apprised. Consequently, in applying the rule of the cases cited, supra, the Court will consider material, or, relevant, the facts which Examiner Adams would have been interested in and considered relevant to an issue of patentability. Otherwise stated, the Court will not substitute its judgment for Examiner Adams’ judgment in determin- ing relevance to an issue of patentability or in deter- mining what action Examiner Adams would have taken, whether or not the Court believes Examiner Adams to be right or wrong as a matter of law. The Court recognizes that there is only one reported decision on the use of an Examiner's testimony, as to what prior art or facts he would have considered relevant to an issue of patentability had he been ap- prised of them. Chas. Pfizer & Co. v. FTC, supra. In that case the Court held that the Examiner’s testi- mony as to what he would have done had certain facts been presented to him, even if based on present interpretation with no independent recollection, is ad- missible evidence. If the Examiner does not allow the claims sought, or for that matter any claims, and if the applicant believes that the Examiner is wrong, the applicant’s only proper remedy is by appeal. /.7.S. Rubber Co. v. Essex Rubber Co., 272 U.S. 429, 443 (1926). Any other rule would subvert the patent system and permit applicants to misrepresent or withhold facts which might be relevant to an issue of patentability in order to obtain a patent, and then gamble on whether ilies, or not a Court will at a later date agree that the facts withheld or misrepresented were not as a matter of law relevant to an issue of patentability. The decision in the first instance must be that of the Patent Office, not the applicant. Monsanto Co. v. Rohm & Haas Co., supra, Beckman Instruments Inc. v. Chemtronics Inc., supra. Although Examiner Adams’ affidavits are almost entirely based on hypothetical facts, where those hypo- thetical facts are in accord with the actual facts misrep- resented to or withheld from him, his recollection, or even his speculation (where he cannot separate his recollection of what he would have done from his speculation as to what he would have done had he known all of the true facts) is sufficient. It is common knowledge that the prosecution of a patent application may take several years, as in this case. It is also common knowledge that patent litigation may arise many years after the patent is granted, as in this case. In these circumstances it is not surpris- ing that an Examiner, who handles many applications at the same time, may not be able to recall with exactitude what he would have done had he known certain facts many years prior to the taking of his testimony. Thus, his present recollection or even his present recollection coupled with his present speculation as to what he would have done is often the best independent evidence available. Any other rule which fails to adopt the Examiner’s recollection or the combi- nation of his recollection and speculation would hardly discourage an applicant from misrepresenting or with- holding relevant facts. Chas. Pfizer & Co. v. FTC, supra. ==) Fam As to the other two Examiners, since their testimony is not before the Court, it cannot be determined with any certainty what they would have done had they known the true facts during the time. they were the Examiners for the Doxycycline application. Therefore, for the time period that they were so acting, the Court will regard as relevant those concealments or misrepre- sentations which may have been relevant to the statutory criterion for patentability. In summary, since the testimony of Examiners Berg and Modance is not before the Court, the Court, based on the uncontroverted facts, will determine materiality during the time they were acting on the Doxycycline application in the context of whether any withholding or misrepresentation was relevant to an issue of whether or not Doxycycline was patentable. However, the Court will accept as conclusive Examiner Adams’ affidavit testimony concerning relevance during the time he served in the Patent Office as the Examiner on the Doxycycline application. In this regard, were there no testimony from Examiner Adams, the Court would conclude as set forth in Conclusions D, H, J and L that the withholding or misrepresentation of prior art, facts or beliefs was relevant to an issue of whether or not doxycycline was patentable. Thus, in this alter- native circumstance, the Court would disagree with Examiner Adams’ affidavit testimony only on the issue of Pfizer’s false analogy as set forth in Conclusion F between doxycycline and the prior art “epimers”— and on that issue the Court would conclude from the uncontroverted facts that Pfizer’s false analogy was material to the issue of whether or not doxycycline was patentable under 35 U.S.C. §103 during the prose- cution of the Doxycycline application, = An applicant’s duty of absolute candor and full and complete disclosure to the Patent Office would be meaningless were not an applicant obligated to exer- cise reasonable diligence in discharging that duty. The Courts cannot, therefore, excuse the failure to exercise reasonable diligence in disclosing prior art or facts or beliefs which may be relevant to an issue of patent- ability, and which are known to the applicant, on the ground that the prior art or facts or beliefs are at some later date rendered moot by changes in the law or by later discovered facts. An applicant has a duty to report to the Patent Office all facts concerning fraud or inequitable con- duct. Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., supra. In this regard, Patent Office Rule 56 (37 C.F.R. §1.56) provides, in part, that: Any application in connection with which any fraud is practiced or attempted on the Patent Office, may be stricken from the files. The Patent Office Rules are to be broadly applied in the consideration of fraud or inequitable conduct during the prosecution of a patent application. Norton v. Curtiss, 433 F.2d 779 (C.C.P.A. 1970). Cumulative misrepresentation or withholding of prior art or facts during the prosecution of a patent applica- tion, if relevant at the time of the misrepresentation or withholding, but which eventually: become moot for one reason or another, may evidence a course of calculated reckless conduct as to the disclosure of the true and complete facts, which fails to satisfy an applicant’s duty of absolute candor and full and complete disclosure to the Patent Office, and may —19— be so inequitable as to render the patent unenforce- able. In Honeywell Inc. v. Sperry Rand Corp., .... F. Supp. ...., 180 U.S.P.Q. 673 (D. Minn. 1973), the Court said: If the conduct of the applicant is reprehensible it matters not that it was really unnecessary, and the patent is unenforceable. See also, Monolith Portland Midwest Co. v. Kaiser Aluminum Co., supra; Intermountain Research & Engr. Co. v. Hercules, .... F.Supp. ..... 171 U.S.P.Q. 577, 631 (C.D.Cal. 1971), aff'd .... F.2d .... (9th Cir., 1974; appeal Nos. 71-2797, 71-2938). Although fraud on the Patent Office must be proven by “clear, unequivocal and convincing” evidence, Schna- dig Corporation v. Gaines Manufacturing Co., 494 F.2d 383, 392 (6th Cir. 1974), this burden is clearly met where the uncontroverted evidence warrants the grant of a summary judgment as a matter of law. Fraud or inequitable conduct in obtaining a single claim of a patent renders the entire patent invalid or unenforceable. Marconi Wireless Telegraph v. United States, 320 U.S. 1, 57-58 (1943); Strong v. General Electric Co., 305 F.Supp. 1084 (N.D. Ga., 1969), aff'd 434 F.2d 1042 (Sth Cir. 1960), cert. denied 403 U.S. 906 (1970); Kearney & Trecker Corp. v. Giddings & Lewis, Inc., 452 F.2d 579, 596 (7th Cir. 1971), cert. denied 405 U.S. 1066 (1972): Chrom- alloy American Corp. v. Alloy Surfaces Co., 339 F. Supp. 859 (D. Del. 1972); East Chicago Machine Tool Corp. v. Stone Container Corp., .... F.Supp. ..... 181 U.S.P.Q. 744 (ND. Ill. 1974); Kearney & Trecker — = Corp. v. Cincinnati Milacron, .... F.Supp. ...., 184 U.S.P.Q. 134 (S.D. Ohio 1974). Oral disclosures to a Patent Examiner, which are not fairly summarized in an amendment filed in the Patent Office, may not be relied upon to satisfy a patent applicant’s duty of absolute candor and full and complete disclosure. Patent Office Rule 2 (37 C.F.R. §1.2) provides that: 2. Business to be transacted in writing. All business with the Patent Office should be trans- acted in writing. The personal attendance of appli- cants or their attorneys or agents at the Patent Office is unnecessary. The action of the Patent Office will be based exclusively on the written record in the Office. No attention will be paid to any alleged oral promise, stipulation, or under- standing in relation to which there is disagree- ment or doubt. | Emphasis added. | Patent Office Rule 133(b) (37 C.F.R. §1.133(b)) provides that: In every instance where reconsideration is re- quested in view of an interview with an examiner, a complete written statement of the reasons pre- sented at the interview as warranting favorable action must be filed by the applicant... . The Patent Office acts on written applications, and written amendments by written rejections made in “offi- cial actions” or written notices of allowance. The pur- pose of Patent Office Rules 2 and 133(b) is to insure that, if a patent is either granted or rejected, all of the reasons are set forth in the file wrapper and con- tents. The Rules are enacted pursuant to statutory onlin authority, 35 U.S.C. §6 and, therefore, if not incon- sistent with the patent statutes, have the force of law. Hadco Products, Inc. v. Lighting Corp. of America, Inc., 312 F.Supp. 1173 (E.D. Pa. 1970), Buzzelli v. Minnesota Mining & Mfg. Co., supra. The public is entitled to know from a file wrapper and contents each and every fact and argument pre- sented by the applicant and each and every reason why the Examiner rejected or allowed the application. See, In re Rubinfield, 270 F.2d 391, (C.C.P.A. 1959); Sperry Rand Corporation v. Bell Telephone Labora- tories, Inc., 171 F.Supp. 343 (S.D. N.Y. 1959); Gear- on v. United States, 121 F.Supp. 652 (Ct. Cl. 1954); Application of Kaghan et al., 387 F.2d 398 (C.C.P.A. 1967); and Halliburton Co. v. Dow Chemical Co., ‘onteibie F.Supp. ......... 182 U.S.P.Q. 178 (N.D. Okla. Oral disclosure of and discussion of prior art, facts or beliefs with a Patent Examiner in an interview which are not made of record does not satisfy the applicant’s absolute duty of full and complete disclosure. LaMaur v. DeMert and Dougherty, 265 F.Supp. 961 (N.D. Ill. 1965); Buzzelli v. Minnesota Mining & Mfg. Co., supra. Stated differently, an applicant is estopped to assert that he called prior art, facts or beliefs to the attention of the Patent Examiner where he makes no written record thereof in the formal prosecution record. Prior art, facts and beliefs which are known to the inventors or to the officers, patent agents or key scientists of a corporate applicant for a patent are imputed to the applicant and his attorneys who prose- cute the application as a matter of law. Thus, if any _ = of these persons misrepresents to, or withholds from, the Patent Office prior art, facts or beliefs which are relevant to an issue of patentability, the patent is invalid and unenforceable. Chas. Pfizer & Co., Inc. v. FTC, supra; Air Shields Inc. v. Air Reduction Co. Inc., 331 F.Supp. 673 (1971), affd 474 F.2d 1351 (7th Cir. 1973). Where a patentee in attempting to enforce a patent commits a fraud on the Court, the Court upon the discovery of that fraud, in the inherent exercise of its equitable powers, may hold the patent unenforceable, Hazel-Atlas Co. v. Hartford Empire Co., 322 USS. 238 (1944). See also, Keystone Driller Co. v. General Excavator Co., 290 U.S. 240 (1933); and Mas v. Coca-Cola Co., 163 F.2d 505 (4th Cir. 1947). In Mas, the Court stated at page 508: Although most cases in which the clean hands doctrine has been applied are cases in which the cause of action itself has arisen out of or been the fruit of unconscionable conduct, we do not understand that it is a pre-requisite to the applica- tion of the doctrine that the cause of action shall have so arisen. /t is sufficient to bar relief that plaintiff has been guilty of unconscionable conduct directly related to the cause of action, such as the fabrication of testimony, the subornation of perjury or other like attempt to perpetrate a fraud upon the court or take an unconscionable advan- tage of his adversary. . . . [Emphasis added. | 35 U.S.C. $285 provides that the Court can award reasonable attorneys fees to the prevailing party in an “exceptional” case whether or not the Court finds that the applicant committed fraud on the Patent Office. ~~ Monolith Portland Midwest Co. v. Kaiser Aluminum & Chemical Corp., supra; C. F. Strassheim Co. v. Gold Medal Furniture Co., 477 F.2d 818 (7th Cir. 1973). In the Strassheim case, supra, the Court awarded reasonable attorneys fees because of the patentee’s “se- rious lack of diligence” in representations made in prose- cuting the patent application and its “comparable lack of diligence in responding to discovery requests” which the Court characterized as “exceptional oversights” which were “critically important”. The Court said: We do note, hdwever, that there can be no question about the ready availability of the true facts to defendant’s executives and attorney when the patent application was filed. The failure to make an appropriate investigation at that time . reflects an extraordinary lack of diligence to which we consider it appropriate to attach legal significance. Defendant and its trial counsel also displayed a comparable lack of diligence in responding to discovery requests... . . . . |P|laintff's counsel requested that certain documents be produced for use at the deposition. Many other documents were produced .. . but none of the items in question was mentioned or brought to the attention of plaintiff's counsel. The Court may take judicial notice of the Patent Office rules in effect during the prosecution of the Doxycycline application and the relevant proceedings in the coordinated and consolidated actions. Federal Rules of Evidence, Art. II, Rule 201 subd. (b), (c) and (f). onlitine FINDINGS OF FACTS AND CONCLUSIONS OF LAW A. The Facts Respecting the Chronology of the Prose- cution of the Doxycycline Application Before the Patent Office 1. The Doxycycline Patent was granted on patent application Serial No. 106,146 filed in the names of Robert K. Blackwood, Hans H. Rennhard, John J. Beereboom and Charles R. Stephens as inventors on May 5, 1961 in the United States Patent Office (Doxy- cycline application) (DX 5).’ That application was called a “continuation-in-part” of prior application Serial No. 31,236 filed May 23, 1960 (parent application) (DX 5, p. 15). 2. The uncontroverted and material chronology of the Doxycycline application is as follows: (a) May 5, 1961: Pfizer files the Doxycycline application (DX 5, cover page and pp. 1-56). (b) October 26, 1961: The First Patent Office Action, by Examiner Adams (DX 5, pp. 58- 59). (c) On or about March 29, 1962: Interview between Pfizer Attorney Nicholas E. Oglesby (Oglesby) and Examiner Adams (Oglesby Affi- davit of March 18, 1975; p. 2, paragraphs 12- 14). 1The record reference for each uncontroverted fact as found herein is indicated after each numbered finding. “DX” refers to exhibits placed in evidence by Defendants and “PX” refers to exhibits placed in evidence by Plaintiff. “.... Affidavit” refers to the affidavits submitted by the parties. “.... deposition” refers to the depositions which are exhibits to the Original or the Present Motion. “Tr. ...” refers to the transcripts of hearings held before the Court. A _— = (d) April 26, 1962: Pfizer’s First Amendment and Supporting English and McBride Affidavits (DX 5, pp. 60-67). (e) October 30, 1962: The Second Patent Of- fice Action, by Examiner Berg (DX 5, pp. 68- 69). (f) On or about March 6, 1963: Interview between Oglesby and Examiner Berg (Oglesby Affidavit dated March 18, 1975, p. 3, paragraph 15). (g) April 30, 1963: Pfizer's Second Amend- ment and Exhibits thereto (DX 5, pp. 69-88). (h) On or about April 14, 1964: Telephone Interview between Oglesby and Examiner Modance (Oglesby Affidavit dated March 18, 1975, p. 4, paragraph 19). (1) On or about July 9, 1964: Interview be- tween Oglesby and Examiner Modance (Oglesby Affidavit dated March 18, 1975, p. 4, paragraph 20). (j) July 23, 1964: Pfizer’s Third Amendment (DX 5, pp. 89-90). (k) November 9, 1964: Pfizer's Fourth Amendment (DX 5, pp. 91-92). (1) January 19, 1965: Third and Final Patent Office Action, by Examiner Adams (DX 5, pp. 93-96). (m) February 23, 1965: Interview between Oglesby and Examiner Adams (Oglesby Affidavit dated March 18, 1975, pp. 13-14, paragraph 76). (n) March 5, 1965: Pfizer’s Fifth Amendment (DX 5, pp. 98-108). _— = (o) April 9, 1965: Notice of Allowance (DX 5, p. 110). (p) August 10, 1965: Doxycycline patent issued (DX 67). (q) The Doxycycline application was prosecuted by Oglesby who was then and is now a partner in the law firm of Connolly, Bove and Lodge, which firm transacts business before the Patent Office under the name of Connolly & Hutz (Ogles- by Affidavit dated July 30, 1974, paragraph 1, page 1; Pfizer Brief dated April 21, 1975, p. 1). B. The Facts Respecting Technical Terms and Con- cepts 3. Doxycycline (originally described by Pfizer in the Doxycycline application as “6-epi-6-deoxy-5-oxyte- tracycline” and later as “«-6-deoxy-5-oxytetracycline” ) is a member of the group of tetracycline derivatives known as 6-deoxy-tetracyclines (DX 67). In particular, doxycycline is identical to oxytetracycline (also known as 5-oxytetracycline; Pfizer's trademark for oxytetra- cycline is “Terramycin” ) its parent fermentation product except that the hydroxyl (OH) atom group (or sub- stituent) at the “6-position” of the oxytetracycline molecule has been removed and replaced with a hydro- gen (H) atom (von Wittenau Affidavit dated March 27, 1975, paragraphs 2 and 9). The stereochemical structure of doxycycline is depicted as follows (von Wittenau Affidavit, paragraph 9): le The stereochemical issues in this case involve only the methyl (CH;) group at the 6-position and the hydroxyl (OH) group at the 5-position which in the above drawing is depicted as follows: CH3 \, OH Ss. 7 ~ 6 5 In the preceding drawing the four connected hexagons are carbon rings and the dotted and solid lines connected to the rings are atom groups (or substituents) which are oriented in the third dimension behind and in front of the plane of the paper. Identifying numbers have been added to designate the 5- and 6-positions in the carbon rings which form the basic tetracycline nucleus. The atom groups (or substituents) connected to the tetracycline nucleus by dotted lines are all on the same side of the molecule. The atom groups (or substituents) connected to the tetracycline nucleus by solid lines are all on the opposite side of the molecule. Thus, at the 5- and 6-positions the solid = = lines showing the bonds to the hydrogen (H) atoms represent the dimension rising out of the paper, or “up”, and the dotted lines showing the bonds to the hydroxyl (OH) atom group and the methyl (CH;) atom group represent the dimension descending below the plane of the paper or “down”. 4. The identification of the positions of the atoms or atom groups of a chemical compound in space is called the “stereochemistry” or “stereochemical con- figuration” of that compound. The identification of the spatial relationship between an atom group at one position on the nucleus and another atom group at a different position on the nucleus of the same com- pound or at the same position on the nucleus of a different compound is referred to as the relative stereo- chemical configuration of the two atom groups (Tr. April 11, 1975, pp. 126-31). In other words, the relative configuration of the methyl group (CH;) at the 6-position and the hydroxyl group (OH) at the 5-position in the Doxycycline molecule is the same, because both of these atom groups are on the same side of the molecule. Knowledge of the relative stereo- chemical configuration of these two atom groups at these two positions does not teach whether both atom groups are “up” or both are “down”, but only that both are on the same side. Similarly, knowledge of the relative stereochemical configuration of two atom groups at the same position does not teach one which atom group is “up” and which atom group is “down”, but only that one is “up” and one is “down”. (Wood- ward Affidavit dated June 14, 1974, paragraph 4, page 5). 5. The absolute stereochemical configuration of a compound is the precise spatial orientation of the — = atom groups at the different positions of the molecule. Thus, knowledge of the absolute stereochemical con- figuration of Doxycycline tells us that the methyl group (CH;) at the 6-position is “down”, or, below the molecule as described above, whereas the hydrogen atom (H) at the same position is “up”, or above the molecule as described above (Tr. April 11, 1975, p. 127). In “up or down” terms the absolute configuration of the atom groups at the 5- and 6-positions in Doxy- cycline (the hydroxyl (OH) and methyl (CH,) groups, respectively), can be depicted in a simplified, non- technical line drawing as follows: 6 5 | (CH5) (OH) If in Doxycycline the hydroxyl group (OH) was up, the atom groups at the 5- and 6-positions would be depicted in a simple line drawing as follows: (OH) \s (CH3) As far as the issues in this case concern stereochem- istry there is no dispute concerning the carbon rings or the numbered positions in those carbon rings or the identification of, or orientation of the attached atom groups. The stereochemical issues involve only Pfizer's knowledge, beliefs and uncertainties concern- — ing the spatial orientation of the methyl group at the 6-position and the hydroxyl group at the 5-position® : —-= of Doxycycline, at different times during the four year prosecution of the Doxycycline application. (Woodward Affidavit dated June 14, 1974, paragraph 4, page 9). 6. In the tetracycline nucleus there are six different positions (asymmetric centers), including the 5- and 6-positions, at which so-called “epimers” may be formed. At each of these positions the two atom groups attached to the nucleus may be oriented in one of two ways, at the 6-position the methyl (CH;) can be “down” and the hydrogen (H) “up”, or vice versa. One chemical compound may have the methyl “down” and the hydro- gen “up”, and a different chemical compound may have the methyl “up” and the hydrogen “down”. These two compounds which differ from one another only in the orientation of the atom groups at the same position are each known in the art as “epimers”, or each is the epimer of the other. (Woodward Affidavit dated June 14, 1974, paragraph 4, pp. 3, 4). In the art the term “epi” has been used as a prefix to identify the compound having the second configura- tion, i.e., if a compound with the methyl group “down” is first produced, and the compound with the methyl group in the “up” position is subsequently produced, it is given the “epi” prefix to distinguish it from the first compound produced (Woodward Affidavit dated June 14, 1974, paragraph 4, p. 4). As a result the term epimer as used in the art does not indicate the absolute stereochemistry of a compound, i.e., the “up-down” configuration of its atom groups. Thus, knowledge that a tetracycline bearing methyl and hydrogen groups at the 6-position is an epimer of another such compound indicates only that the other compound (which may also be an epimer) — a eee callie has the same groups oriented in the opposite manner— however, from this information one does not know on which epimer the methyl group is “up” and on which epimer it is “down”, but merely that it is “up” on one epimer and “down” on the other epimer. C. The Facts Respecting Pfizer’s Concealment of the Belgian Patent and Its Inability to Distinguish the Belgian Patent 1. The Doxycycline application disclosed a class of epimers of the 6-deoxytetracyclines (“Pfizer's 6- deoxytetracyclines”) including both those having a hy- droxyl (OH) group at the 5-position, and those having only hydrogen (H) atoms at that position (DX 5, p. 11). As filed, the Doxycycline application claimed only certain of Pfizer’s 6-deoxytetracyclines, i.e., those compounds— including doxycycline—having an hydrox- yl (or “oxy”) group at the 5-position (DX 5, pp. 53- 54). 2. Before filing the Doxycycline application Pfizer was aware of Belgian Patent No. 572,584 (“Belgian Patent”), (Frost letter to Oglesby dated March 17, 1961, DX 2, Pfizer Brief dated March 17, 1975, p. 23) which issued to McCormick et al. of American Cyanamid on April 30, 1959 (DX 1, a certified trans- lation is the sole exhibit to the Affidavit of von Witte- nau dated March 27, 1975). The Belgian Patent dis- closed the preparation of 6-deoxy-5-oxytetracycline (Mc- Cormick 6-deoxy compound), by hydrogenation of its parent fermentation produced tetracycline, i.e., oxytetra- cycline (DX 1, p. 2; Oglesby Affidavit dated July 30, 1974, paragraph 3, p. 2). The Belgian Patent further depicted a stereochemical formula (DX 1, p. 2) purporting to show the absolute stereochemical con- figuration of the McCormick 6-deoxy compound at —_— = the 5- and 6-positions (Pfizer Brief dated January 3, 1975, pp. 11-12), as follows: In a simple line drawing, the absolute stereochemical formula for the major atom groups, the methyl (CH;) and the hydroxyl (OH), at the 6- and 5-positions, respectively, as described in the Belgian Patent appear as follows: (OH) \° (CH,) 3. At the time the Doxycycline application was filed Pfizer believed that the stereochemical formula described in the Belgian Patent did not correctly depict the absolute stereochemical configuration of the Mc- Cormick 6-deoxy compound at the 6-position, Pfizer believed that in the McCormick 6-deoxy compound the methyl group (CH;) at the 6-position was “up” (DX 2, 3 and 20; Oglesby Affidavit dated March 18, 1975, paragraph 6, p. 2). 4. At the time the Doxycycline application was filed Pfizer believed that Doxycycline had the opposite absolute stereochemical configuration at the 6-position from the McCormick 6-deoxy compound (Oglesby Affi- davit dated March 18, 1975, paragraph 32, p. 2), —- Pfizer believed that in Doxycycline the methyl group (CH;) at the 6-position was “down” (DX 3). 5. At the time the Doxycycline application was filed Pfizer had an uncertain belief that the absolute stereochemical formula in the Belgian Patent did not correctly depict the absolute stereochemical configura- tion of the McCormick 6-deoxy compound at the 5- position, Pfizer had an uncertain belief that in the McCormick 6-deoxy compound the hydroxyl group (OH) at the 5-position was “down” (DX 3, p. 9 and DX 30; Woodward Affidavit dated June 14, 1974, pp. 7-8; Oglesby Affidavit dated July 30, 1974, para- graph 3, p. 2; Oglesby Affidavit dated March 18, 1975, paragraph 6, p. 2). 6. At the time the Doxycycline application was filed Pfizer had an uncertain belief that Doxycycline had the same absolute stereochemical configuration at the 5-position as the McCormick 6-deoxy compound (Oglesby Affidavit dated March 18, 1975, paragraph 5, p. 2), i.e., Pfizer had an uncertain belief that in both Doxycycline and the McCormick 6-deoxy com- pound the hydroxyl group (OH) at the 5-position was “down” (DX 3, p. 9; Oglesby deposition of March 6, 1974, pp. 231-2; Pfizer Brief dated August 8, 1974; Tr. September 11, 1974, pp. 131-132; Tr. April 17, 1975, p. 244; Tr. April 21, 1975, pp. 498-499). 7. Pfizer's belief as to the absolute stereochemical configuration of Doxycycline at the 6-position and its uncertain belief as to the absolute stereochemical con- figuration of Doxycycline at the 5-position was as fol- lows: In a simple line drawing Pfizer's belief and uncertain belief as to absolute stereochemical formula for the major atom groups at the 5- and 6-positions of Doxycy- cline was: " (OH) 8. At the time the Doxycycline application was filed Pfizer knew that Doxycycline had a relative stereo- chemical configuration in which at the 6-position the methy! group (CH;) was opposite (or reverse) to the methyl! group at the 6-position in the McCormick 6-deoxy compound, and Pfizer believed that Doxycy- cline had a relative stereochemical configuration in which at the 6-position the methyl group (CH;) was in the same position as the methyl group at the 6- position in the natural fermentation produced oxytetra- cycline compound (Woodward Affidavit dated June 14, 1974, paragraph 4, pp. 7-8; Tr. September 11, 1974, p. 129). 9. At the time the Doxycycline application was filed, Pfizer knew that Doxycycline had a relative stereo- chemical configuration in which at the 5-position the hydroxyl group (OH) was the same as the hydroxyl group in the McCormick 6-deoxy compound and in (CH) a oe Enea tee Se nic, _ wi ot ee = = the natural fermentation produced oxytetracycline com- pound (Oglesby Affidavit dated March 18, 1975). 10. At the time the Doxycycline application was filed, and based on its belief as to the absolute stereo- chemistry of Doxycycline at the 6-position and its uncer- tain belief as to the absolute stereochemistry of Doxy- cycline at the 5-position, and its establishment of the relative stereochemistry of Doxycycline at the 6-position, Pfizer understood that the absolute stereochemical for- mula depicted in the Belgian Patent was equally perti- nent prior art, if not more pertinent prior art, than the relative stereochemistry of the McCormick 6-deoxy compound. 11. At the time the Doxycycline application was filed Oglesby understood that it was his duty to bring the most pertinent prior art to the attention of the Patent Office with reasonable diligence (Tr. January 31, 1975, p. 422). 12. At the time the Doxycycline application was filed Oglesby understood that if the absolute stereo- chemical formula depicted in the Belgian Patent was the most pertinent prior art and if Pfizer had uncer- tainties as to the absolute stereochemical configura- tion of Doxycycline at the 5-position, it was his duty to disclose the Belgian Patent and those uncertainties to the Patent Office with reasonable diligence. (Tr. January 31, 1975, pp. 422-425). 13. At the time the Doxycycline application was filed Pfizer did not disclose the Belgian Patent or the absolute stereochemical formula depicted therein to the Patent Office. Rather, in the original specification Pfizer made no mention of the Belgian Patent or its absolute stereochemical formula, but compared Doxy- = x cycline only to the relative stereochemistry of “known 6-deoxytetracyclines”, that is, the compounds actually produced by the process of the Belgian Patent such as the McCormick 6-deoxy compound, stating that Doxycycline was the reverse of the “known 6-deoxy- tetracyclines” at the 6-position, thereby indicating rela- - tive stereochemistry only (DX 5, p. 1). 14. At the time the Doxycycline application was filed Pfizer believed that the absolute stereochemical configuration of Doxycycline was the same as the abso- lute stereochemical formula depicted in the Belgian Patent at the 6-position, and had an uncertain belief that the absolute stereochemical configuration of Doxy- cycline was the opposite of the absolute stereochemical formula depicted in the Belgian Patent at the 5-posi- tion. 15. At the time the Doxycycline application was filed Pfizer had not proven its belief that Doxycycline had an absolute stereochemical configuration in which the methyl group (CH;) at the 6-position was “down” or proven its uncertain belief that in Doxycycline the hydroxyl group (OH) at the 5S-position: was “down” (Stephens Affidavit dated March 27, 1975, paragraph 6, p. 1; Woodward Affidavit dated June 14, 1974, paragraph 4, p. 4; Pfizer Brief dated May 1, 1974, p. 6; Tr. September 11, 1974, p. 104). 16. At the time the Doxycycline application was filed and until on or about April 24, 1963, Pfizer believed that the “von Bramer Doctrine”, In re von Bramer, 127 F.2d 149 (C.C.P.A. 1942), precluded the grant of a patent on a chemical compound over a prior art reference which depicted that compound 2 occa AT st cea ee SCR oe , = = even though the prior art reference did not enable those having ordinary skill in the art to produce the compound depicted (DX 2; Pfizer Brief dated March 7, 1975, p. 25). 17. At the time the Doxycycline application was filed Pfizer understood that if its belief concerning the absolute stereochemical configuration of Doxycy- cline at the 6-position was correct the Belgian Patent depicted the absolute stereochemical configuration of Doxycycline at the 6-position and did not depict the McCormick 6-deoxy compound at the 6-position (Ogles- by Affidavit dated March 18, 1975, paragraphs 6 and 7, p. 2). 18. At the time the Doxycycline application was filed Pfizer understood that if its uncertain belief con- cerning the absolute stereochemical configuration of Doxycycline at the 5-position was correct the Belgian Patent did not depict the absolute stereochemical con- figuration of Doxycycline at the 5-position (Oglesby Affidavit dated March 18, 1975, paragraphs 5 and 6, p. 2), and conversely at the time the Doxycycline application was filed Pfizer understood that if its uncer- tain belief concerning the absolute stereochemical con- figuration of Doxycycline at the 5-position was incorrect the Belgian Patent depicted the absolute stereochemical configuration of Doxycycline at the 5-position (Wood- ward Affidavit dated June 14, 1974, paragraph 4, p. 9). 19. At the time the Doxycycline application was filed Pfizer, in claiming Doxycycline, resolved its uncer- tain belief concerning the absolute stereochemistry of Doxycycline at the 5-position in its own favor (Tr. April 17, 1975, p. 244). — = 20. At the time the Doxycycline application was filed, Pfizer believed that the absolute stereochemical formula depicted in the Belgian Patent correctly de- picted Pfizer’s 6-deoxytetracyclines which did not have a hydroxyl (OH) group at the 5-position but had two hydrogen (H) groups at the 5-position, one “up” and one “down”. Since the Belgian Patent described either a hydroxyl (OH) or a hydrogen (H) at the 5-position (DX 1) (depicted as “up” in the absolute stereochemical formula depicted in that patent) and since one of the two hydrogens at that position had to be “up” in Pfizer’s 6-deoxytetracyclines having two hydrogens at the 5-position, Pfizer knew that it could not distinguish those compounds from the absolute stereochemical formula depicted in the Belgian Patent. Thus Pfizer stated in the original specification of the Doxycycline application that Pfizer’s 6-deoxytetracy- clines having two hydrogen groups at the 5-position were “products of the present invention” (DX 5, p. 11), but did not claim them in the original claims (DX 5, pp. 52-54; DX 2; Pfizer Brief dated September 9, 1974; Pfizer Brief dated March 7, 1975, p. 25). 21. At the time the Doxycycline application was filed, Pfizer believed, based on its prosecution of the parent Doxycycline application (DX 21), that the Pat- ent Office might insist on the presentation of product- by-process claims if it revealed its uncertainties about absolute stereochemistry (DX 21, pp. 13, 38 and 47). Pfizer still believed that the Patent Office might insist on the presentation of product-by-process claims if it revealed its uncertainties about absolute stereochemistry on April 25, 1962, and still so believed on December 18, 1962. (DX 6; DX 8; Tr. January 31, 1975, pp. 420-421). ON I at (en ee —tten etter = SS 22. The last draft of the Doxycycline application dated May 2, 1961 stated, at Pfizer's patent agent Charles Knuth’s (Knuth) suggestion, that These new tetracyclines possess a definite micro- biological activity against a variety of Gram-posi- tive and Gram-negative microorganisms and are appropriately designated as 6-epi-6-deoxytetra- cyclines since the steric configuration of the 6- methyl group is opposite to that of the known 6-deoxytetracyclines. Thus, the nomenclature ‘6- epi’ as employed herein, is completely analogous to the accepted nomenclature for naming the known 4-epitetracyclines. However, it should be understood that inasmuch as the stereochemical relationship between the 6-methyl group of the known 6-deoxytetracyclines and the parent (6- oxygenated) tetracyclines has not yet been estab- lished, the same is true with respect to the re- lationship between the new substances and the parent tetracyclines. (Emphasis added; DX 23: DX 24). Pfizer deleted this italicized sentence from the last draft prior to filing the Doxycycline application. 23. In the original specification of the Doxycycline application Pfizer deliberately did not state whether Doxycycline had the same or the opposite stereochemical configuration at the 6-position from its naturally pro- duced parent fermentation product, oxytetracycline, and did not state whether or not the “known 6-deoxytetra- cyclines” (e.g., the McCormick 6-deoxy compound) had the same or the opposite stereochemical configura- tion at the 6-position from their naturally produced parent fermentation products, i.e., oxytetracycline (DX 2). — 24. In the original specification of the Doxycycline application Pfizer did not disclose any absolute stereo- chemistry, did not disclose its belief as to the absolute stereochemistry of the McCormick 6-deoxy compound and doxycycline at the 6-position or its uncertain belief as to the absolute stereochemistry of the McCormick 6-deoxy compound and Doxycycline at the 5-position, and did not disclose that it had not proven its said beliefs. (DX 5; Pfizer Brief dated August 8, 1974). 25. On or about March 29, 1962 Pfizer brought the Belgian Patent to the attention of the Patent Office during an interview by Oglesby with Examiner Adams (the March 1962 interview) (Oglesby Affidavit dated March 18, 1975, paragraph 12, p. 3). During the interview Oglesby informed Examiner Adams that Pfizer believed that the absolute stereochemical formula de- picted in the Belgian Patent was incorrect at the 5- position and that Pfizer further believed that the abso- lute stereochemical formula depicted in the Belgian Patent did not correctly depict the McCormick 6-deoxy compound at the 6-position (Oglesby Affidavit dated March 18, 1975, paragraphs 12, 13 and 14, p. 3). Oglesby did not reveal to Examiner Adams during that interview either Pfizer's belief that the stereo- chemical formula in the Belgian Patent depicted Doxy- cycline at the 6-position or Pfizer’s uncertain belief that Doxycycline could be distinguished at the 5-position from the absolute stereochemical formula depicted in the Belgian Patent (DX 7). 26. In its first amendment to the Doxycycline appli- cation on April 26, 1962, Pfizer did not disclose its — belief that the absolute stereochemical formula depicted in the Belgian Patent depicted Doxycycline at the 6- position or its uncertain belief that Doxycycline could be distinguished from the absolute stereochemical for- mula depicted in the Belgian Patent at the 5-position. In this amendment Oglesby referred to the fact of the March 1962 interview but did not state that he had informed Examiner Adams of the Belgian Patent and did not state that Pfizer believed that the stereo- chemical formula depicted in the Belgian Patent depict- ed Doxycycline at the 6-position or that Pfizer had an uncertain belief that the Belgian Patent did not depict Doxycycline at the 5-position (DX 5, pp. 65- 67). This amendment concluded with a reque.: for reconsideration and allowance of the claims (DX 5, p. 67). 27. On April 26, 1962 Oglesby wrote a memoran- dum to his files expressing concern that disclosure to the Patent Office of uncertainties regarding absolute stereochemistry might limit Piizer to product-by-process claims (DX 6, p. 2). 28. On October 30, 1962 the Patent Office in the second Office Action, by Examiner Berg, cited, inter alia, the Belgian Patent and rejected the compound (product) claims for Doxycycline and other compounds as anticipated under 35 U.S.C. §102 (DX 5, p. 68). 29. On December 17, 1962 Knuth informed Ogles- by of Pfizer's continued and increased uncertainty as to the absolute stereochemistry of Doxycycline at the 5-position, citing a publication; Muxfeldt, Angew. a Chem. Internat. Edit., pp. 372-381 (1962), (Muxfeldt publication) giving two possible alternative absolute stereochemical configurations for the natural parent fermentation produced oxytetracycline, one in which the hydroxyl group at the 5-position was “up” (as depicted in the Belgian Patent) and one in which it was “down” (DX 26). 30. In a memorandum to his files dated December 18, 1962 Oglesby noted Pfizer’s continued and increased uncertainty as to the absolute stereochemical configura- tion of Doxycycline at the 5-position, and outlined his proposed further strategy not to reveal Pfizer's increased uncertainty about the absolute stereochem- ical configuration of Doxycycline at the 5-position to the Patent Office unless other arguments failed to over- come the Examiner’s rejection based on the Belgian Patent (DX 8). 31. On or about March 6, 1963 Oglesby and Knuth interviewed Examiner Berg (March 1963 interview) and informed him that the Muxfeldt publication had created some uncertainty as to the absolute stereochemi- cal configuration of Doxycycline at the 5-position (Oglesby Affidavit dated March 18, 1975, paragraph 15, p. 3; Knuth Memo to his files dated March 12, 1963, DX 20). Examiner Berg responded that because of that uncertainty Pfizer could no longer rely on its belief that the absolute stereochemical formu- la depicted in the Belgian Patent did not depict Doxy- cycline at the 5-position, and indicated that the product (compound) claims would be rejected (Tr. January 31, 1975). 32. Shortly after the March 1963 interview Oglesby learned of the decision in In re Le Grice, 301 F.2d —_ 929, 133 U.S.P.Q. 365 (C.C.P.A. 1962) and, beginning about April 24, 1963, believed that Jn re Le Grice overruled the von Bramer Doctrine and mooted the possible use of the absolute stereochemical formula depicted in the Belgian Patent as an anticipation of Doxycycline (Oglesby Affidavit dated March 18, 1975, paragraph 17, p. 4). 33. On April 30, 1963 Pfizer filed a second amend- ment in the Doxycycline application (DX 5, pp. 69- 74). In the remarks accompanying this amendment, Oglesby referred to the fact of the March 1963 inter- view but he did not state that he had informed Exam- iner Berg of Pfizer's uncertainty as to the absolute stereochemical configuration of Doxycycline at the 5- position, or that Examiner Berg had stated that those uncertainties precluded Pfizer from relying on its belief that the absolute stereochemical formula depicted in the Belgian Patent at the 5-position did not depict Doxycycline and indicated that the product (compound ) claims would be rejected. 34. The April 30, 1963 amendment stated that the Belgian Patent “accidentally” depicted the absolute stereochemical configuration of. Pfizer's 6-deoxytetra- cyclines at the 6-position, and cited the Muxfeldt pub- lication and two other prior art publications (DX 5, pp. 70-71). Oglesby then argued that since- the Belgian Patent did not enable those skilled in the art to make the compounds depicted in the stereo- chemical formula under the Le Grice decision the Bel- gian Patent could not be relied on as an anticipation. Based on this argument Pfizer also added claims in the amendment directed to its 6-deoxytetracyclines which did not have an hydroxyl (OH) group at the — 5-position (and which had two hydrogen atoms (H) at the 5-position) and which Pfizer had not previously claimed because it believed they were anticipated by the Belgian Patent under the von Bramer Doctrine (see Finding 20, supra). Pfizer did not state or indicate in that amendment that Pfizer was uncertain as to the absolute stereochemical configuration of Doxycy- cline at the 5-position, either because of the disclosures of the three cited publications or for any other reason. The disclosures of the Muxfeldt publication are set forth in Finding 29, supra. Of the two remaining publications, one relates only to oxytetracycline, as did Muxfeldt, and the other, by Pfizer’s von Wittenauw et al. (DX 28), does not disclose any uncertainty at the 5-position. Pfizer did not state or indicate in the April 30, 1963 amendment, or disclose to the Patent Office at any other time during the prosecution of the Doxy- cycline application, that it knew that Doxycycline, the McCormick 6-deoxy compound and the natural fer- mentation produced oxytetracycline compound all had the same relative stereochemical configuration. 35. In December 1963 Pfizer scientist von Wit- tenau theorized that in Doxycycline the hydroxyl group (OH) at the 5-position was “up” (as shown in the Belgian Patent) and prepared a technical paper sum- marizing the basis for his theory and submitted it to Pfizer's Patent Department for pre-publication ap- proval (von Wittenau Affidavit dated March 27, 1975, paragraph 20, p. 4; DX 9). Von Wittenau’s theory — = created additional uncertainty at Pfizer as to the ab- solute stereochemical configuration of Doxycycline at the 5-position, and Pfizer deferred publication of the proposed von Wittenau paper pending review of von Wittenau’s theory with its consultant Dr. Woodward (DX 12). 36. On or about April 14, 1964 Oglesby contacted the Patent Office by telephone (the April 1964 inter- view) and advised Examiner Modance of the prospec- tive meeting with Woodward which was expected to “shed more conclusive light on the structure of the compounds under discussion” (DX 12, p. 4; Oglesby Affidavit dated March 18, 1975, p. 4, paragraph 19). During the April 1964 interview Oglesby was advised by Examiner Modance that the chemical section in the Patent Office (which section was acting on the Doxycycline application) still followed the von Bramer Doctrine notwithstanding the Le Grice decision (DX 12, p. 5). 37. As of April 14, 1964, because of Pfizer’s in- creased uncertainty as to the absolute stereochemical configuration of Doxycycline at the 5-position and the continued application of the von Bramer Doctrine by the chemical section of the Patent Office, Pfizer was still in doubt as to whether the Belgian Patent would be applied’ by the Patent Office as an anticipation of Doxycycline under 35 U.S.C. §102. Pfizer did not inform the Patent Office of its increased uncertainty as to the absolute stereochemical configuration of Doxy- cycline at the 5-position. — 38. By June of 1964, after the meeting with Dr. Woodward, Pfizer was still uncertain as to the absolute stereochemical configuration of Doxycycline at the 5- position which was, in the words of Pfizer patent agent Knuth, “completely up in the air again” (DX 13). 39. In June of 1964 Oglesby was still uncertain whether Examiner Modance would accept his Le Grice argument, notwithstanding a decision, Jn re Brown, 329 F.2d 1006 (C.C.P.A. 1964), casting yet further doubt on the von Bramer Doctrine (DX 14, p. 2). Oglesby concluded at that time that he wouid disclose Pfizer’s continued uncertainty as to the abolute stereo- chemical configuration of Doxycycline at the 5-position to Examiner Modance only if the Examiner was willing to follow the Le Grice and Brown decisions and thus disregard the absolute stereochemical formula depicted in the Belgian Patent as an anticipation under 35 U.S.C. § 102 (DX 14, p. 2). 40. On or about July 9, 1964 Oglesby in an inter- view with Examiner Modance (July 1964 interview) advised him that Pfizer was uncertain as to the absolute stereochemical configuration of Doxycycline at the 5- position (DX 15; Oglesby Affidavit dated March 18, 1975, paragraph 20). 41. In the third amendment filed on July 23, 1964 Pfizer made the fact of the July 1964 interview formally of record (DX 5, pp. 89-90) but did not state in the amendment that Pfizer was uncertain as to the absolute stereochemical configuration of Doxycycline at the 5-position or that Pfizer’s uncertainties as to the absolute stereochemical configuration of Doxycy- cline at the 5-position had been disclosed to or discussed with Examiner Modance. — = 42. During the prosecution of the Doxycycline ap- plication Examiner Adams was not interested in the absolute stereochemical configuration of either the Mc- Cormick 6-deoxy compound or Pfizer's 6-deoxytetra- cyclines because Examiner Adams did not know of Pfizer’s belief that the Belgian Patent depicted the absolute stereochemical formula of Doxycycline at the 6-position or Pfizer’s uncertainties as to whether the Belgian Patent depicted the absolute stereochemical formula of Doxycycline at the 5-position (Adams Affidavit dated October 9, 1974, paragraph 7, p. 4; Adams Affidavit dated February 3, 1975, paragraph 4, p. 2). 43. Had Examiner Adams known at any time be- tween the date of filing of the Doxycycline application and April 29, 1962 (the date that Examiner Adams left the Patent Office) that Pfizer was uncertain as to whether or not the Belgian Patent correctly depicted the absolute stereochemical configuration of Doxycy- cline at the 5-position, Examiner Adams would have rejected and product (compound) claims of the Doxy- cycline application as anticipated by the Belgian Patent under 35 U.S.C. §102 (Adams Affidavit dated February 3, 1975, paragraph 4, p. 2). Had Pfizer after such rejection not been able to establish by scientific proof, i.e., scientific evidence which quantitatively and qualita- tively would be regarded as convincing by a prudent, experienced chemist skilled in the art, that the absolute stereochemical formula in the Belgian Patent did not depict Moxycycline, Examiner Adams would at any time prior to April 29, 1962 (the date that Examiner Adams left the Patent Office) have issued a final rejection, again based on 35 U.S.C. §102 (Adams —483— Affidavit dated February 3, 1975, paragraph 4, p. 2; PX 9, paragraph 7, p. 7). 44. Pfizer did not know and did not prove at any time prior to on or about November 13, 1964 whether or not its uncertain belief that the Belgian Patent did not depict the absolute stereochemical con- figuration of Doxycycline at the 5-position was correct or incorrect (DX 12, 13 and 14). 45. On or about November 13, 1964 Pfizer first believed that in Doxycycline the absolute stereochemical configuration of the hydroxyl group (OH) at the 5- position was “down” (DX 4; Pfizer's Supplemental Response dated February 11, 1974 to Defendant USV’s Interrogatory dated July 13, 1973). 46. Pfizer did not at any time during the prosecu- tion of the Doxycycline application disclose to the Patent Office when it believed for the first time that in Doxycycline the absolute stereochemical configura- tion of the hydroxyl group (OH) at the 5-position was “down”. 47. With the exception of the March 1963, April 1964 and July 1964 interviews Pfizer did not at any time during the prosecution of the Doxycycline applica- tion disclose to the Patent Office that from the time of the filing of the Doxycycline application and until on or about November 13, 1964 it had either uncer- tainties or increased uncertainties, which it had not proven correct or incorrect, as to whether or not the Belgian Patent depicted the absolute stereochemical configuration of Doxycycline at the 5-position. —49— D. Conclusions of Law Concerning Pfizer’s Failure to Disclose the Belgian Patent and its Beliefs and Uncertainties Concerning the Stereochemistry of Doxycycline to the Patent Office 1. When Pfizer filed the Doxycycline application it deliberately withheld informing the Patent Office of the Belgian Patent. 2. When Pfizer filed the Doxycycline application it deliberately withheld from the Patent Office its belief that the Belgian Patent depicted Doxycycline at the 6-position and its uncertainty that the Belgian Patent did not depict Doxycycline at the 5-position. 3. When Pfizer filed the Doxycycline application it knew that the Belgian Patent was equally pertinent if not more pertinen: to the patentability of Doxycycline than the McCormick 6-deoxy compound, and was there- fore equally pertinent prior art, if not the most per- tinent prior art. 4. When Pfizer filed the Doxycycline application it had a duty to bring the Belgian Patent to the attention of the Patent Office with reasonable diligence. 5. When Pfizer filed the Doxycycline application it had a duty to disclose to the Patent Office its belief that the Belgian Patent depicted Doxycycline at the 6-position and its uncertain belief that the Belgian Patent did not depict Doxycycline at the 5-position with reasonable diligence. 6. When Pfizer filed the Doxycycline application the significance of the absolute stereochemical formula depicted in the Belgian Patent as an anticipation under 35 U.S.C. §102 or in limiting the product (compound) claims to produci-by-process claims under 35 U.S.C. —_—- §112, depended upon the disclosure of that depiction and Pfizer’s knowledge, belief or uncertain belief con- cerning the absolute stereochemical configuration of Doxycycline at the 5- and 6-positions. The Patent Office could not determine the significance of the absolute stereochemical formula depicted in the Belgian Patent unless Pfizer disclosed its belief that the Belgian Patent depicted Doxycycline at the 6-position and its uncertain belief that the Belgian Patent did not depict Doxycycline at the 5-position. (Tr. January 24, 1975, pp. 123- 124). 7. When Pfizer filed the Doxycycline application it deliberately disclosed only the relative stereochemistry of Doxycycline at the 6-position and the relative stereo- chemistry of the McCormick 6-deoxy compound at the 6-position in order to withhold from the Patent Office the significance of the Belgian Patent as an anticipation under 35 U.S.C. §102 or in limiting the product (compound) claims to product-by-process claims under 35 U.S.C. §112 based on its belief and uncertain belief concerning the absolute stereochemistry of Doxycycline at the 6- and 5-positions, respectively. 8. At the time Pfizer filed the Doxycycline applica- tion the Belgian Patent, coupled with Pfizer's belief and uncertain belief concerning the absolute stereochem- istry of Doxycycline at the 6- and 5-positions, respec- tively, was material to the issue of whether or not Doxycycline was anticipated under 35 U.S.C. §102, and was material to the issue of whether or not only product-by-process claims were allowable under 35 U.S.C. §112. 9. Pfizer is estopped to assert that it brought the Belgian Patent to the Examiner’s attention in the March 1962 interview because it failed to state in undies writing and of record that it brought the Belgian Patent co the attention of the Patent Office in that interview. Alternatively, if Pfizer is not estopped, then Pfizer deliberately failed to bring the Belgian Patent to the attention of the Patent Office until the March 1962 interview. 10. Pfizer is estopped to assert that it disclosed its uncertainties concerning the absolute stereochemistry of Doxycycline at the 5-position to the Patent Office in the March 1963, April 1964 and July 1964 inter- views because it failed to state in writing and of record that it made these disclosures to the Patent Office during those interviews. Alternatively, if Pfizer is not estopped, then Pfizer deliberately failed to disclose its uncertainties concerning the absolute stereochemistry of Doxycycline at the 5-position to the Patent Office until the March 1963 interview. 11. Pfizer is estopped to assert that it disclosed its beliefs concerning the absolute stereochemistry of Doxycycline at the 6-position to the Patent Office in the March 1963 interview because it failed to state in writing and of record that it made that disclosure to the Patent Office in that interview. Alternatively, if Pfizer is not estopped then Pfizer deliberately failed to disclose its belief concerning the absolute stereochem- istry of Doxycycline to the Patent Office until the March 1963 interview. 12. The Belgian Patent and Pfizer’s belief and un- certainties respecting the absolute stereochemistry of Doxycycline at the 6-position and 5-position, respec- tively (and, therefore, the relationship between Doxy- cycline and the absolute stereochemical formula depicted in the Belgian Patent) were material to the issues of whether or not Doxycycline was anticipated under —=— = 35 U.S.C. $102 or whether or not only product-by- process claims were allowable under 35 U.S.C. $112 for a period of more than three years after the Doxy- cycline application was filed and until on or after June, 1964 when the Patent Office Examiners in charge of the Doxycycline application accepted Pfizer’s argu- ment that the Le Grice and Brown decisions overruled the von Bramer Doctrine. 13. Regardless of the immateriality of the absolute stereochemistry depicted in the Belgian Patent and Pfiz- er’s beliefs and uncertainties concerning the absolute stereochemistry of Doxycycline at the 6- and 5-positions on or after June, 1964, and based on the estoppels set forth in Conclusions 9, 10 and 11, supra, Pfizer’s deliberate failure to bring the Belgian Patent to the attention of the Patent Office before the October 30, 1962 Official Action (citing the Belgian Patent) and its deliberate delay in disclosing its belief concerning the absolute stereochemistry of Doxycycline at the 6- position to the Patent Office until the April 30, 1965 amendment, and its intentional failure to disclose its uncertain belief concerning the absolute stereochemistry of Doxycycline at the 5-position to the attention of the Patent Office during the prosecution of the Doxy- cycline application, constitutes a breach of its duty to bring pertinent prior art and its belief and uncertain belief concerning the applicability of that prior art as an anticipation to the attention of the Patent Office with reasonable diligence. It also constitutes inequitable conduct which fails to satisfy an applicant’s uncom- promising duty of absolute candor and full and com- plete disclosure to the Patent Office of all pertinent prior art, facts and beliefs which may be relevant to an issue of patentability. — = Alternatively, if there is no estoppel Pfizer’s deliberate delay in bringing the Belgian Patent to the attention of the Examiner until March 1962 and its deliberate delay in disclosing its belief concerning the absolute stereochemistry of Doxycycline at the 6-position until March, 1963, and its deliberate delay in disclosing its uncertainties concerning the absolute stereochemistry of Doxycycline at the 5-position until March 1963, constitutes a breach of its duty to bring pertinent prior art and its belief and uncertain belief concerning the applicability of that prior art as an anticipation to the attention of the Patent Office with reasonable diligence, and also constitutes inequitable conduct which fails to satisfy an applicant’s uncompromising duty of absolute candor and full and complete disclosure to the Patent Office of all pertinent prior art, facts and beliefs which may be relevant to an issue of patentability. E. The Facts Respecting Pfizer's False Analogy Be- tween Doxycycline and the Prior Art “Epimers” of the Natural Fermentation Produced Tetra- cyclines 1. Prior to the grant of the Doxycycline patent Examiner Adams knew from the prior art that there were tetracycline epimers which were the opposite of the natural fermentation produced tetracyclines and which had lower antibacterial activities than tk» natural fermentation produced tetracyclines (Adams Affidavit dated February 3, 1975, p. 7, paragraph 12). 2. Prior to the grant of the Doxycycline patent Examiner Adams did not know of any tetracycline epimers which were the opposite of the natural fermenta- tion produced tetracyclines and which had antibacterial — activities superior to the natural fermentation produced tetracyclines (Adams Affidavit dated February 3, 1975, paragraph 12, p. 7). 3. Prior to the issuance of the Doxycycline patent there was no epimer which was the opposite of a natural fermentation produced tetracycline which had antibacterial activities superior to the natural fermenta- tion produced tetracyclines. 4. At all times during the prosecution of the Doxy- cycline application Pfizer believed that Doxycycline had the same stereochemical configuration at the 6- position as its parent natural fermentation produced tetracycline (both “down”), i.e., oxytetracycline (DX 30, 31 and 40). 5. The Doxycycline application describes the claimed compounds as “6-epi-6-deoxytetracyclines”, and states that “the nomenclature ‘6-epi’ as employed herein, is completely analogous to the accepted nomenclature for naming the known 4-epitetracyclines” (DX 5, p. 1). 6. The known 4-epi tetracyclines were epimers which were the opposite of natural fermentation pro- duced tetracyclines and were so recognized by those skilled in the art. 7. In a publication dated October 20, 1958 (80 JACS 5572) Cyanamid’s McCormick et al. disclosed and depicted Sa-epi-tetracyclines. The 5a-epi-tetracy- clines were epimers which were the opposite of the natural fermentation produced tetracyclines. 8. In the first rejection of the Doxycycline applica- tion on October 26, 1961, Examiner Adams cited the prior art references which described the 4- and 5a-epi-tetracyclines which he believed were (and in —_ = fact were) the opposite of natural fermentation pro- duced tetracyclines at other asymmetric centers of the nucleus and rejected Pfizer's product (compound) claims to Doxycycline and other compounds as obvious under 35 U.S.C. $103, stating that since “epimers” were well known at other positions in the tetracycline nucleus, Pfizer’s “epimers” were only a routine develop- ment (DX 5, pp. 58-59; Tr. April 17, 1975, p. 200). 9. In the first amendment filed April 26, 1962 Pfizer stated that Doxycycline was not a routine or obvious development, because the antibacterial activity of Doxycycline was superior to the antibacterial activity of the McCormick 6-deoxy compound “of normal as opposed to epimeric. configuration”, and further stated that such superiority was unexpected. To support the statement that the superiority of Doxycycline was un- expected, Pfizer compared Doxycycline (which it be- lieved to have the same configuration at the 6-position as the natural fermentation produced tetracyclines, i.e., “down”) with prior art “epimers” at other asymmetric centers on the nucleus (all of which it knew were the opposite of the natural fermentation produced tetra- cyclines, i.e., “up”) and stated that while the prior art “epimers” had less antibacterial activity than their “conventional” counterparts, Doxycycline had miore antibacterial activity than the prior McCormick 6-deoxy compound (DX 5, p. 66). 10. In his final rejection of the Doxycycline appli- cation on January 19, 1965, based in part on obvious- ness under 35 U.S.C. $103, Examiner Adams errone- ously concluded that Doxycycline had an absolute stereochemical configuration at the 6-position which was the opposite of the natural fermentation produced tetracyclines; stating that “. . . the claimed compounds —56—— have a methy! group in the 6-position which allegedly is oriented in a different manner than the corresponding compounds produced by fermentation methods,” and further stated that it was “well known . . . that epimerization at various positions reduced the antibiotic properties of the compound... .” (DX 5, pp. 93- 94). 11. In that rejection Examiner Adams erroneously stated that the stereochemical configuration of oxytetra- cycline, the McCormick 6-deoxy compound and Doxy- cycline at the 6-position were as follows: Oxytetracycline \ 5 (CH) McCormick 6-Deoxy Compound 6 5 (CH,) (CH,) 3 Doxycycline 5 On January 19, 1965 Pfizer believed that the absolute stereochemical configuration of oxytetracycline, the Mc- Cormick 6-deoxy compound and Doxycycline at the 6-position were as follows: —_ = 6 5 Oxytetracycline (CH) McCormick (CH | 6-Deoxy Compound - 5 Doxycycline | P 5 (cH 3) 12. In its fifth amendment dated March 5, 1965 responding to the January 19, 1965 final rejection, Pfizer stated that “the claimed compounds have a methyl group in the 6-position which is oriented in the opposite direction to that of the known 6-deoxytetra- cyclines [e.g., the McCormick 6-deoxy compound] pro- duced by hydrogenation of fermentation produced tetra- cyclines . . .” and that “the prior art catalytic hydro- genation of fermentation produced tetracyclines not only replaces the 6-OH substituent with a hydrogen substituent but also reverses the spatial orientation of the 6-methyl substituent, the orientation of the hydro- gen substituent being opposite thereto in the final prod- uct... .” (DX 5, pp. 100-101). 13. The language quoted in Finding E-12, supra, told the Patent Office that at the 6-position the relative configuration of Doxycycline was the opposite of the McCormick 6-deoxy compound which was the opposite of the natural fermentation produced tetracyclines. That = = language, while technically correct, does not state that Doxycycline and the natural fermentation produced tetracyclines have the same configuration at the 6- position, although it can be inferred that if the methyl group (CH:) at the 6-position has one epimer which is “up” and one epimer which is “down”, and if the relative configuration of Doxycycline is the opposite of the McCormick 6-deoxy compound; and the relative configuration of the McCormick 6-deoxy compound is the opposite of the natural fermentation produced tetracyclines; then in Doxycycline the methyl group at the 6-position must be “down” and the same as the natural fermentation produced tetracyclines. 14. In a draft of the March 5, 1965 amendment Pfizer stated that this rejection states the claimed compounds have a methyl group in the 6-position which allegedly is oriented in a different manner than the corres- ponding compounds produced by fermentation methods. Actually . . . the claimed compounds have a methyl group in the 6-position which is oriented in precisely the same manner as the corres- ponding 6-OH containing compounds produced by fermentation methods . .. . (DX 37). The above italicized statement was deleted from the March 5, 1965 amendment before filing. 15. On February 11, 1965 Knuth wrote to Oglesby and stated that in Doxycycline “. . . the 6-methyl group has the same configuration as that of the parent fermentation produced antibiotic” (DX 26). 16. In further response to the January 19, 1965 final rejection, Pfizer's March 5, 1965 amendment re- peated the representations set forth in its April 26, — 1962 amendment that the superior antibacterial activi- ties of Doxycycline were unexpected because of the low antibacterial activities of prior tetracycline “epi- mers” (DX 5, p. 104), but did not relate this statement to the language quoted in Finding E-12, supra. 17. At all times during the prosecution of the Doxycycline application including the date of allowance and the date of issuance, Examiner Adams believed that Doxycycline and the other claimed compounds had a stereochemical configuration at the 6-position opposite that of their parent natural fermentation pro- duced tetracyclines, e.g., oxytetracycline, and that the superior antibacterial activity of Doxycycline was, be- cause of this difference, unexpected (Adams Affidavit dated February 3, 1975, paragraph 12, p. 7 and para- graph 13, p. 8); but that the unexpected superiority of Doxycycline was immaterial to patentability (Adams Affidavit dated February 24, 1975 raph 13 17-18). ee F. Conclusions of Law Concerning Pfizer's False Anal- ogy Between Doxycycline and the Prior Art “Epi- mers”. 1. At page | of the specification, and in the April 25, 1962 and the March 5, 1965 amendments, Pfizer deliberately misrepresented, by falsely analogizing Doxy- cycline to prior art tetracycline “epimers” at other asymmetric positions on the tetracycline nucleus, that Doxycycline had unexpected superior antibacterial ac- tivities. . 2. Pfizer deliberately failed to state in clear, con- cise and readily understood language and further, delib- erately used confusing and unclear language in the March 5, 1965 amendment to conceal, that the absolute — = stereochemical configuration of Doxycyciine was the same as the parent natural fermentation produced tetra- cyclines at the 6-position. This language was in turn designed to conceal Pfizer’s false analogy that Doxycy- cline was comparable to the prior art tetracycline epi- mers and therefore unexpectedly superior. 3. Pfizer's deliberate misrepresentations in the speci- fication and in the April 25, 1962 and March 5, 1965 amendments falsely analogizing Doxycycline to the prior art tetracycline “epimers”, misled the Patent Office to erroneously conclude from the date of the January 19, 1965 Office Action to the date of the issuance of the Doxycycline patent that the stereo- chemistry of Doxycycline was opposite to that of the natural fermentation produced tetracyclines at the 6- position. 4. Pfizer's deliberate misrepresentations in the speci- fication and in the April 25, 1962 and March 5, 1965 amendments falsely analogizing Doxycycline to prior art tetracycline “epimers” was not material to the issue of whether or not Doxycycline was patentable under 35 U.S.C. §103. 5. Pfizer deliberately falsely analogized Doxycycline to the prior art tetracycline “epimers” in the specifica- tion and in the April 25, 1962 and March 5, 1965 amendments, and its deliberate use of misleading and unclear language in the March 5, 1965 amendment. All of which was designed to conceal the fact that Doxycycline had the same absolute stereochemical con- figuration as its parent natural fermentation produced tetracycline at the 6-position, amd which was in turn designed to conceal Pfizer’s false amalogy that Doxycy- cline was comparable to the prior art tetracycline epi- mers at the 6-position, constitutes inequitable conduct _- = which fails to satisfy an applicant’s uncompromising duty of absolute candor and full and complete disclosure of all facts which may be relevant to an issue of patentability. G. The Facts Respecting Pfizer's Misrepresentations to the Patent Office Concerning the Antibacterial Activity of Doxycycline 1. As filed, the specification of the Doxycycline application states that Doxycycline and the other claimed 6-deoxytetracycline compounds “have particu- larly good in vivo effectiveness” [in animal tests], and that these compounds “are useful by virtue of their high order of activity against a variety of micro- organisms, both in vivo and in vitro” [in test tubes] (DX 5, p. 11). 2. As filed, the specification also compares the in vitro activities of Doxycycline and the McCormick 6-deoxy compound against a number of organisms stat- ing that Doxycycline is markedly superior to the Mc- Cormick 6-deoxy compound when tested against an antibiotic resistant strain Micrococcus pyogenes var. aureus 400 (“Staph 400”), and is equivalent to the McCormick 6-deoxy compound when tested against an antibiotic susceptible strain Micrococcus pyogenes var. aureus 5 (“Staph 5”) (DX 5, p. 12). 3. On February 14, 1961 Pfizer's Dr. McBride reported the “side by side comparison of Doxycycline with tetracycline in mice infected with [Staph 5] and [Staph 400]” and concluded that Doxycycline “remains inactive against | Staph 400|” (DX 43). 4. At the time the Doxycycline application was filed, Pfizer knew that Doxycycline was active against — = Staph 400 in vitro but inactive against Staph 400 in vivo (DX 42 and 43). 5. In its rejection dated October 26, 1961 the Patent Office by Examiner Adams rejected the product claims of the Doxycycline application as obvious under 35 U.S.C. §103 (DX 5, p. 59). 6. In its first amendment dated April 26, 1962 responding to the October 26, 1961 rejection Pfizer stated that Doxycycline had outstanding antibacterial activities both in vitro and in vivo (DX 5, p. 66) and included two affidavits—one by Pfizer’s Dr. English and one by Pfizer's Dr. McBride—in support thereof (DX 5, pp. 60-64). 7. The English Affidavit (DX 5, pp. 61-62) set forth the same in vitro data incorporated in the original application with respect to the activity of Doxycycline against Staph 5 and Staph 400. The McBride Affidavit (DX 5, pp. 63-64) stated that Doxycycline was effective in vivo against Staph 5 when administered orally and by injection. 8. Pfizer did not, in its April 26, 1962 amendment, or at any other time during the prosecution of the Doxycycline application disclose to the Patent Office its knowledge that Doxycycline was inactive in vivo against Staph 400. 9. In the McBride Affidavit Pfizer indicated that Doxycycline was about 36 times as effective as the McCormick 6-deoxy compound against Staph 5 in vivo when administered orally and possessed high activity against Staph 5 when administered by injection (DX 5, pp. 63-64). 10. In the second Office Action on October 30, 1962 th: Patent Office, by Examiner Berg, stated —EE —— - —_— = that “applicants have submitted two affidavits under Rule 132 which have been carefully considered and are deemed persuasive in overcoming the rejection. . . and are deemed sufficient to overcome the rejection. ” 11. On June 20, 1964 Pfizer scientists English and Blackwood, among others, knew that further in vivo tests of Doxycycline against Staph 5 showed that it was less than one-half as effective as reported in the McBride affidavit when administered orally, and only about one-fifth as effective as reported in the McBride affidavit when administered by injection (DX 44; English Affidavit dated March 27, 1975, paragraph 2). 12. On January 19, 1965, the Patent Office by Examiner Adams entered a final rejection of the Doxy- cycline application on the ground that Doxycycline was obvious under 35 U.S.C. §103 (DX 5, pp. 94- 95). 13. In its fifth amendment dated March 5, 1965, in response to the final rejection of January i8, 1965, Pfizer stated that Doxycycline was about 36 times as effective as the McCormick 6-deoxy compound against Staph 5 when administered orally, and that such difference was evidence that Doxycycline was not obvious (DX 5, p. 104). 14. Pfizer did not, in its March 5, 1965 amendment or at any other time prior to the grant of the Doxy- cycline patent in August 1965, disclose to the Patent Office its June 20, 1964 knowledge that its most recent in vivo tests of Doxycycline against Staph 5 showed that Doxycycline was less than one-half as effective as reported in the McBride Affidavit when administered orally, and only one-fifth as effective as aiitiiin reported in the McBride Affidavit when administered by injection. 15. During the prosecution of the Doxycycline ap- plication Examiner Adams would have been interested in; and considered material, any evidence in Pfizer’s possession inconsistent with the data presented in the English and McBride Affidavits, incluaing evidence of inconsistencies between the actual in vivo antibac- terial activities of Doxycycline and the in vitro activities of Doxycycline (Adams Affidavit dated February 3, 1975, pp. 5-6), even though he knew during the prosecution of the Doxycycline application that an anti- biotic displaying in vitro activity against a particular organism is not necessarily active in vivo against the same organism (PX 9, paragraph 10, pp. 11-12). H. Conclusions of Law Concerning Pfizer’s Misrep- resentations to the Patent Office Regarding the Antibacterial Activity of Doxycycline 1. Pfizer deliberately disclosed only the favorable in vitro and in vivo activity data and deliberately withheld the unfavorable in vivo activity data from the Patent Office at all times during the prosecution of the Doxycycline application. Pfizer did this by delib- erately concealing the fact that Doxycycline was inactive against Staph 400 in vivo, and by deliberately with- holding from the Patent Office from June 20, 1964 and thereafter throughout the prosecution of the Doxy- cycline application, its June 20, 1964 knowledge that Doxycycline was less effective against Staph 5 in vivo than it had reported in the April 25, 1962 amendment and by representing in the March 5, 1965 amendment that Staph 5 was as effective in vivo as it had earlier reported. —_— = 2. Pfizer’s deliberate concealment of the fact that Doxycycline was inactive against Staph 400 in vivo and Pfizer’s deliberate withholding of, and misrepresen- tation of its June 20, 1964 knowledge that Doxycycline was less effective in vivo against Staph 5 than it had earlier reported was material to the issue of whether or not Doxycycline was obvious under 35 U.S.C. §103. 3. Pfizer’s deliberate concealment of the fact that Doxycycline was inactive against Staph 400 in vivo, and its deliberate withholding of and misrepresentation of its June 20, 1964 knowledge that Doxycycline was less effective against Staph 5 in vivo than it had earlier reported, constitutes inequitable conduct which fails to satisfy an applicant’s uncompromising duty of absolute candor and full and complete disclosure of all facts which may be relevant to an issue of patentability. I. The Facts Respecting Pfizer’s Misrepresentations to the Patent Office Concerning the Prior Inherent Coproductior of Doxycycline 1. In the late 1950's, prior to the filing of the Doxycycline application, scientists at both Pfizer and Cyanamid had hydrogenated oxytetracycline and pro- duced the McCormick 6-deoxy compound. This work was disclosed in Pfizer’s Stephens et al. paper in the Journal of the American Chemical Society, Vol. 80, pp. 5324-25 (1958) (JACS reference) and U.S. Patent No. 3,019,260 and Belgian Patent No. 565,025 (cited references), and in the Belgian Patent, all of which were cited during the prosecution of the Doxycycline application. None of the cited references state or indicate that in following the processes stated, Doxy- cycline is inherently coproduced. ein 2. Prior to filing the Doxycycline application, Pfizer knew that the hydrogenation of oxytetracycline to pro- duce the McCormick 6-deoxy compound had been de- scribed in the prior art including the cited references and the Belgian Patent (DX 1; DX 2; Tr. March 17, 1975, p. 23). 3. In 1958 and 1959 (DX 47, 48), Pfizer filed two patent applications in the names of Stephens and Conover (Stephens applications), disclosing the pro- duction of the 6-deoxytetracyclines, including the Mc- Cormick 6-deoxy compound, by the hydrogenation of the corresponding tetracyclines, e.g., oxytetracycline. In the Stephens applications Pfizer disclosed that in prior experimental work involving the hydrogenation of oxytetracycline (Stephens’ prior work) they had produced a “trace” of an “additional active entity”, which Stephens believed was Doxycycline, and stated that the “additional active entity” “may be the C- 6 epimer of 6-deoxy-5-oxytetracycline . . .” (doxycy- cline )(DX 47, pp. 8, 11), and “. . . is thought to be the C-6 epimer of 6-deoxy-5-oxytetracycline .. .” (doxycycline) (DX 48, pp. 10, 14). 4. Prior to the filing of the Doxycycline application, Pfizer contemplated relying on the disclosures in the Stephens applications and filing a continuation-in-part application claiming Doxycycline as the invention of Stephens and Conover (DX 2). However, on Oglesby’s advice Pfizer filed the Doxycycline application in the names of Messrs. Blackwood, Beereboom, Rennhard and Stephens (DX 20; DX 5, pp. 55-56). 5. When Stephens executed the oath for the Doxycy- cline application with Blackwood, Beereboom and Renn- hard as one group of inventors he swore that he ee ee eee _ did not know and did not believe that Doxycycline was ever known or used by any other group of inventors, e.g., Stephens and Conover, prior to the Blackwood, Beereboom, Rennhard and Stephens invention (DX 5, pp. 55-56). 6. At the time of the filing of the Doxycycline application and continuously until June, 1964 Stephens believed that Doxycycline was inherently coproduced in Stephens’ prior work and in following the process of one example of the Stephens applications (Stephens belief). Stephens further believed that if Doxycycline was inherently coproduced in accordance with the proc- ess described in the Stephens’ applications it was also inherently coproduced in following the processes of the cited references and the Belgian Patent (Stephens’ further belief) (DX 21, pp. 3, 12, 49 and 74; and Stephens’ Affidavit dated March 27, 1975, paragraph 18, p. 3). 7. When Pfizer filed the Doxycycline application it did not disclose to the Patent Office the evidence (the Stephens evidence) obtained in Stephens’ prior work and described in an example of each of the Stephens’ applications (DX 47, pp. 10-11; DX 48, pp. 13-14) which indicated that Doxycycline had in fact been inherently coproduced. 8. When Pfizer filed the Doxycycline application it did not advise the Patent Office of Stephens’ belief or Stephens’ further belief. 9. In the October 30, 1962 Official Action, the Patent Office by Examiner Berg rejected the pertinent product claims for Doxycycline and other claimed com- pounds as anticipated under 35 U.S.C. §102 by the — = Belgian Patent and U.S. Patent No. 3,019,260 and Belgian Patent No. 565,025 (DX 5, p. 68). 10. In its second amendment dated April 30, 1963, in response to the October 30, 1962 rejection, Pfizer represented to the Patent Office that Doxycycline was not in fact inherently coproduced by the Belgian Patent or by U.S. Patent No. 3,019,260 or by Belgian Patent No. 565,025, and that these references produced only the previously known 6-deoxytetracycline compounds, i.e., the McCormick 6-deoxy compounds (DX 5, p. 70). 11. In its April 30, 1963 amendment Pfizer did not disclose the Stephens’ evidence or Stephens’ belief or Stephens’ further belief. 12. On March 20, 1964 Oglesby stated in a mem- orandum to his files that Stephens believed that the amount of Doxycycline inherently coproduced in Steph- ens’ prior work and in following the process of the Stephens’ applications was “. . . of the same order of magnitude as tetracycline is produced in Duggar 2209 aureomycin fermentations” (DX 10). 13. On March 20, 1964 Pfizer knew that, if there was a basis for Stephens’ belief and Stephens’ further belief then the denial of inherent coproduction in its April 30, 1963 amendment was false (DX 10). 14. On April 14, 1964 Pfizer knew that it was still Stephens’ belief that Doxycycline was inherently coproduced in his prior work and in the process de- scribed in the Stephens’ applications. Pfizer also knew that it was still Stephens’ further belief that Doxycy- cline was inherently coproduced in following the proc- esses of the cited references and the Belgian Patent (DX 12). _— 15. During the Spring of 1964, at Oglesby’s sugges- tion, Pfizer’s Dr. Murai repeated Stephens’ prior work (the Murai 1964 investigation), on which Stephens’ belief and further belief were based, and obtained chromatographic evidence tending to indicate that Steph- ens’ “additional active entity” was Doxycycline and ultraviolet spectral evidence indicating that the “addi- tional active entity’ was not Doxycycline (DX 35 and DX 52). During the Spring of 1964, Pfizer’s Beereboom believed that chromatographic data was “much more effective” than ultraviolet spectral data in identifying Doxycycline (Beereboom deposition, DX 54, p. 310). 16. In June 1964, at the conclusion of the Murai 1964 investigation, Stephens was satisfied that the inher- ent coproduction of Doxycycline in his prior work had not been demonstrated and concluded that no detectable Doxycycline was inherently coproduced there- in. (Stephens’ Affidavit dated March 18, 1975, para- graph 18, p. 3). 17. In June 1964, at the conclusion of the Murai 1964 investigation, Pfizer concluded that it could not State unequivocally that the “additional active entity” previously produced in Stephens’ prior work was not Doxycycline, but could state that it believed that it was not (Oglesby Affidavit dated March 18, 1975, paragraph 65, p. 9). 18. On July 9, 1964 Oglesby interviewed Examiner Modance (the July 1964 interview), and disclosed that Stephens’ prior work might possibly have inherently coproduced Doxycycline. He also identified the Ste- phens’ applications, disclosed that part of the conclusion of the Murai 1964 investigation which showed by ultra- onitine violet data that there was no inherent coproduction, and offered to apprise the Examiner of any further information he might request. Examiner Modance stated that the Patent Office could not consider the question of inherent coproduction since it was not suggested by any prior art and declined Pfizer’s offer to make the facts respecting inherent coproduction of record (Oglesby Affidavit dated March 18, 1975, paragraphs 57 and 72, p. 10). 19. In its third amendment dated July 23, 1964 Pfizer made the fact of the July 1964 interview of record, but did not mention in that amendment any of Oglesby’s discussion with Examiner Modance on July 9, 1964 (DX 5, pp. 89-90). 20. On February 23, 1965 Oglesby interviewed Examiner Adams (the February 1965 interview) and disclosed that Stephens’ prior work might possibly have inherently coproduced Doxycycline, identified the Ste- phens’ applications, again disclosed that part of the results of the Murai 1964 investigation, which showed by ultraviolet data that there was no inherent coproduc- tion, and offered to apprise him of any further in- formation he might request. Examiner Adams, like Examiner Modance, stated that the Patent Office could not consider the question of inherent coproduction since it was not suggested by any prior art and declined Pfizer’s offer to make the facts respecting inherent coproduction of record (Oglesby Affidavit dated March 18, 1974, paragraph 72, p. 10). 21. Inthe July 1964 and February 1965 interviews, Oglesby did not disclose Stephens’ belief or Stephens’ further belief. ‘ 22. In its fifth amendment dated March 5, 1965, responsive to the final rejection of January 19, 1965, _ (DX 5, pp. 98-108) Pfizer made the February 1965 interview of record (DX 5, pp. 99, 106-107) stating that Pfizer could not state unequivocally that the “ad- ditional active entity” identified in the Stephens’ prior work was not Doxycycline but that based on the Murai 1964 investigation it had concluded from the differences in ultraviolet spectra, that the “additional active entity” was not Doxycycline (DX 5, pp. 106-107). In that amendment Pfizer also offered to prc vide the Patent Office, upon request, with additional information re- specting the experimental techniques used in the Murai 1964 investigaticn (DX 5, p. 107). The Patent Office did not request any further information. In that amendment Pfizer did not state that it had identified the Stephens’ applications at the July 1964 and February 1965 interviews and did not disclose Stephens’ belief or Stephens’ further belief. 23. Pfizer did not disclose any of the facts respect- ing the possible inherent coproduction of Doxycycline to the Patent Office until the July 1964 and the Febru- ary 1965 interviews, and Pfizer did not make any facts respecting the possible inherent coproduction of Doxycycline in Stephens’ prior work of record in the Patent Office until March 5, 1965 (DX 5, pp. 107- 108). 24. Pfizer did not, at any time during the prosecu- tion of the Doxycycline application disclose to the Patent Office Stephens’ belief or Stephens’ further belief which Stephens maintained from prior to the filing of the Doxycycline application and until June 1964. 25. Pfizer did not at any time during the prosecu- tion of the Doxycycline application disclose to the Patent Office the chromatographic evidence obtained —_ = in the Murai 1964 investigation tending to indicate that the “additional active entity” in Stephens’ prior work was Doxycycline. 26. The Patent Office knew from the March 5, 1965 amendment that Pfizer obtained chromatographic data in Stephens’ prior work indicating that Doxycycline might be inherently coproduced when following the process disclosed in the Stephens’ applications. The Patent Office did not know from that amendment or from anything else that Pfizer disclosed to the Patent Office, that chromatographic data was also obtained in the Murai 1964 investigation which tended to indicate that Doxycycline was inherently coproduced in Stephens’ prior work. 27. Examiner Adams understood the March 5, 1965 amendment to impliedly represent that there was no data resulting from the Murai 1964 investigation which tended to indicate that Doxycycline was inherently co- produced in Stephens’ prior work (Adams Affidavit dated February 3, 1975, paragraph 6, p. 3). 28. Examiner Adams understood the March 5, 1965 amendment to impliedly represent that there was no data resulting from the Murai 1964 investigation which tended to indicate that Doxycycline was inherently co- produced in following the processes disclosed in the cited references or the Belgian Patent (Adams Affidavit dated February 3, 1975, paragraphs 5, 6, pp. 3-4). 29. Examiner Adams did not avail himself of Ogles- by’s offer in the March 5, 1965 amendment to supply additional information regarding the techniques em- ployed in the Murai 1964 investigation and considered the information provided from the Murai 1964 investiga- tion sufficient to establish patentability, even if inherent = = coproduction had been in issue, because Examiner Adams did not know of the chromatographic data obtained in the Murai 1964 investigation and assumed that Oglesby had fairly represented the results obtained in the Murai 1964 investigation (Adams Affidavit dated February 3, 1975, paragraphs 5 and 6, pp. 3-4; Adams Affidavit dated February 24, 1975, paragraph 7, p. 7). 30. Examiner Adams did not know from the March 5, 1965 amendment or from anything else Pfizer dis- closed to the Patent Office during the prosecution of the Doxycycline application either Stephens’ belief or Stephens’ further belief. 31. Had Pfizer disclosed to Examiner Adams that chromatographic data, tending to indicate the inherent coproduction of Doxycycline in Stephens’ prior work and in following the process described in the Stephens’ applications, had been obtained in the Murai 1964 investigation, and had Pfizer further disclosed Stephens’ belief and Stephens’ further belief, Examiner Adams would have been interested in and considered that chromatographic data material (Adams Affidavit dated February 3, 1975, paragraph 5, p. 3). J. Conclusions of Law Concerning Pfizer’s Misrepre- sentations to the Patent Office Respecting the Prior Inherent Coproduction of Doxycycline 1. At all times during the prosecution of the Doxy- cycline application Pfizer deliberately withheld from the Patent Office Stephens’ belief that Doxycycline was inherently coproduced in Stephens’ prior work and in following the process disclosed in the Stephens’ ap- plications, and further deliberately withheld from the Patent Office Stephens’ further belief that if Doxycycline - was inherently coproduced in Stephens’ prior work and in the process described in the Stephens applications, that Doxycycline was also inherently coproduced in the processes disclosed in the cited references and the Belgian Patent, which beliefs Stephens maintained from prior to the filing of the Doxycycline application and until June, 1964. 2. Pfizer had a duty to disclose Stephens’ belief and Stephens’ further belief to the Patent Office with reasonable diligence after the filing of the Doxycycline application and at all times thereafter during the prose- cution of the Doxycycline application. 3. In the March 5, 1965 amendment reporting the results of the Murai 1964 investigation, Pfizer deliberately disclosed only the favorable ultraviolet data which indicated that inherent coproduction did not occur, which deliberately withholding the unfavorable chromatographic data obtained during the same investi- gation, which tended to indicate that inherent coproduc- tion did occur. 4. Pfizer had a duty to disclose that part of the Murai 1964 investigation which tended to indicate the inherent coproduction of Doxycycline by chromato- graphic data in the July 1964 and February 1965 interviews and in its March 5, 1965 amendment and at all times thereafter during the prosecution of the Doxycycline application. 5. The cited references and the Belgian Patent were prior art as to the Doxycycline application under 35 U.S.C. $102. 6. Stephens’ prior work and the Stephens’ applica- tions were not prior art as to the Doxycycline applica- tion under 35 U.S.C. §102. = = 7. Pfizer’s offers to apprise the Patent Office of any further information it might request concerning the Murai 1964 investigation in the July 1964 and the February 1965 interviews and in the March 5, 1965 amendment is insufficient to satisfy Pfizer’s un- compromising duty of absolute candor and full and complete disclosure. It was Pfizer’s duty to disclose that in the Murai 1964 investigation chromatographic data tended to indicate inherent coproduction, and since the reported results of the Murai 1964 investigation did not indicate any contradictory data, the Patent Office had no duty to inquire further. 8. Pfizer is estopped to assert that it disclosed to Examiners Modance and Adams in the July 1964 and the February 1965 interviews that Stephens’ prior work might possibly have inherently coproduced Doxy- cycline and that it identified the Stephens applications because Pfizer failed to state in writing and of record that it brought that information to the attention of the Patent Office in those interviews. 9. By disclosing only the possibility of inherent coproduction by chromatographic data at the time of Stephens’ prior work, and by withholding Stephens’ belief and Stephens’ further belief, and dy deliberately withholding that part of the Murai 1964 investigation which tended to indicate the inherent coproduction of Doxycycline by chromatographic data in Stephens’ prior work, Pfizer deliberately withheld from the Patent Office the facts and Stephens’ beliefs on which the Patent Office might have concluded that the cited references and the Belgian Patent were prior art which anticipated the Doxycycline application under 35 U.S.C. $102. Pfizer therefore deliberately withheld facts and beliefs which were material to the issue of whether —_ In or not Doxycycline was anticipated under 35 U.S.C. §102. 10. Pfizer's deliberate withholding of Stephens’ be- lief that Doxycycline was inherently coproduced in Stephens’ prior work and Stephens’ further belief that if Doxycycline was inherently coproduced in accordance with the process described in Stephens’ application it was also inherently coproduced in following the proc- esses of the cited references and the Belgian Patent and its deliberate withholding of that part of the Murai 1964 investigation which tended to indicate the inherent coproduction of Doxycycline by chromatographic data in Stephens’ prior work constitutes inequitable conduct which fails to satisfy an applicant’s uncompromising duty of absolute candor and full and complete disclosure to the Patent Office of all facts which may be relevant to an issue of patentability. K. The Facts Respecting Pfizer’s Withholding of Ex- perimental Data Evidencing Its Inability to Carry Out Portions of the Patented Process Use of a Ruthenium Catalyst 1. The Doxycycline patent application and patent states that Doxycycline and the further compounds claimed therein may be produced by the hydrogenation of certain other compounds in the presence of “noble metal” catalysts (DX 67, column 1, lines 21-30 and 51-65). The patent application and patent further iden- tify ruthenium as one of the preferred noble metal catalysts (DX 67, column 2, lines 26-28 and 38- 40). 2. The Doxycycline patent claims, in addition to Doxycycline and other related compounds, the process for producing such compounds by hydrogenating cer- = = tain other compounds with “a cataly [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385004_0737%3A2. Public record. Not legal advice.