Opinion ID: 784018
Heading Depth: 2
Heading Rank: 3

Heading: Reduction to Practice or Conception Plus Diligence

Text: 44 For Chen to prevail in this interference as the junior party, he would have had to have established by a preponderance of the evidence either that he actually reduced to practice the subject matter of the counts before Bouchard's effective filing date or that he had conceived the subject matter of the counts before Bouchard's effective filing date, and followed up with reasonable diligence from just prior to Bouchard's effective filing date up to his own constructive or actual reduction to practice. 45 Chen contends that the Board erred in concluding that he did not meet his burden of showing that he had conceived any compounds within the counts prior to the critical date. According to Chen, evidence was adduced showing that BMS-183582 and BMS-183821, which were recognized from the start to be cyclopropataxols of Counts 3A and 4, were actually reduced to practice from 7- epi  starting materials before the critical date, even though those syntheses were first disclosed in the '819 application. Chen argues that the identity of those compounds was confirmed by NMR, MS, and x-ray crystallographic analysis by non-inventors prior to the critical date, and that the Board applied an incorrect legal standard of corroboration in making its determination that Chen failed to prove actual reduction to practice. Chen contends that confirmation tests need not be definitive; reasonable certainty is the standard. According to Chen, the Board also erred by holding that structure-confirmation tests by non-inventors are disqualified from serving as corroborating evidence if, as here, the inventor told the non-inventors what he thought the test would show. 46 Bouchard responds that Chen has provided no corroborating evidence of conception or diligence in reduction to practice. According to Bouchard, cyclopropataxols were unexpected reaction products with a high potential for misidentification during analysis. Bouchard also contends that NMR and MS are unreliable for identifying previously unknown complex molecules, especially when those compounds are in mixtures, and no non-inventor witnesses contemporaneously interpreted the key spectra relied on by Chen. Bouchard points out that Chen's witness Qi Gao, a Senior Research Investigator at Bristol-Myers Squibb, testified that she solved the crystal structure of a cyclopropataxol given to her by Chen prior to the critical date, but did not explain how the x-ray data were obtained or how they demonstrate a cyclopropataxol structure. Like NMR spectra, x-ray diffraction data are capable of multiple interpretations and are not self-proving, according to Bouchard. 47 It is well established that when a party seeks to prove conception via the oral testimony of a putative inventor, the party must proffer evidence corroborating that testimony. See Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed.Cir.1996); Price v. Symsek, 988 F.2d 1187, 1194 (Fed.Cir.1993). That rule addresses the concern that a party claiming inventorship might be tempted to describe his actions in an unjustifiably self-serving manner in order to obtain a patent or to maintain an existing patent. See Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 60, 43 S.Ct. 322, 67 L.Ed. 523 (1923); Kridl v. McCormick, 105 F.3d 1446, 1450 (Fed.Cir.1997) (The tribunal must also bear in mind the purpose of corroboration, which is to prevent fraud, by providing independent confirmation of the inventor's testimony.); Price, 988 F.2d at 1194-95. There is no particular formula that an inventor must follow in providing corroboration of his testimony of conception. See Kridl, 105 F.3d at 1450. Rather, whether a putative inventor's testimony has been sufficiently corroborated is determined by a rule of reason analysis, in which an evaluation of all pertinent evidence must be made so that a sound determination of the credibility of the inventor's story may be reached. Price, 988 F.2d at 1195. However, that rule of reason analysis does not alter the requirement of corroboration of an inventor's testimony. Brown v. Barbacid, 276 F.3d 1327, 1335 (Fed.Cir.2002). Evidence of the inventive facts must not rest alone on the testimony of the inventor himself. Cooper v. Goldfarb, 154 F.3d 1321, 1330 (Fed.Cir.1998). 48 As an initial matter, we agree with Chen that the Board erred by setting forth an incorrect standard for evaluating corroborating evidence. The Board stated that 49 Chen et al.'s evidence does establish that samples of compounds prepared by Dr. Chen were forwarded to the analytical section of Bristol-Myers Squibb's laboratory in Wallington, Connecticut, by Dr. Chen for analysis. But in each instance Dr. Chen provided the analytical section with a structural formula of the compound he believed he had prepared. 50 Dr. Chen did not give the analytical section an unknown sample and request a determination of its structure by the analytical section. Thus, the analytical section's alleged confirmation of the structure provided to them by Chen cannot establish, independently of Dr. Chen's proposed formula, what was the identity of the compound produced because Dr. Chen provided them with the structure he believed the compound possessed in advance. Frilette v. Kimberlin, 56 C.C.P.A. 1242, 412 F.2d 1390, 1398, 162 USPQ 148, 155 (1969). 51 Chen, slip op. at 74-75. The Board further stated that 52 Ms. Huang's conclusion that the spectra she obtained were consistent with Dr. Chen's proposed structure and Dr. Kingston's after the fact conclusion that the spectra obtained were consistent with Dr. Chen's proposed structure are not independent analysis or even knowledge independent of Dr. Chen because each relied on Dr. Chen's proposed structure for purposes of their analysis. Frilette v. Kimberlin, supra. 53 Id. at 97-98. Finally, the Board noted that, 54 rather than analyze the samples Dr. Chen gave to the analytical group to determine without the benefit of any prior suggestion of what the compound tested actually was, the analytical group was merely running NMR analyses on the samples and reviewing the samples for evidence that Dr. Chen's proposed structure for the compounds was consistent with the NMR spectra. 55 Id. at 108. 56 To the extent that the Board's statements quoted above suggest that an analytical chemist must be kept in the dark as to what an inventor believes a submitted compound's structure is in order for that chemist's later testimony to have corroborative value, the Board is mistaken. Neither the Frilette decision cited by the Board nor any other decision of this court or our predecessor courts requires as much. In the relevant part of Frilette, that decision simply held that: 57 [T]he designation of the material involved in the ... tests in [appellant's witness] Lago's records as Linde Molecular Sieve 13X calcined ammonium exchange cannot establish identification since that designation was merely copied by Lago from the label on the bottle in which the sample was given to him by Frilette and was not based on either knowledge or analysis by Lago. 58 412 F.2d at 1398. The dispositive fact in that case, as we understand it, was not that Lago obtained the molecular sieves from a labeled bottle, but rather that Lago's only information regarding the material was the writing on the label that was apparently affixed to the bottle by Frilette, the very person whose statements required corroboration by Lago. There is no suggestion in that decision that Lago's records would not have been adequate to establish identification if Lago had actually analyzed the material or otherwise confirmed its identity, irrespective of whether the bottle was labeled. Thus, the question here is not whether the analytical chemist knew beforehand what Chen thought he had obtained, but whether the chemist herself conducted tests to prove the identity of what Chen obtained. 59 Nonetheless, the Board's error here was harmless in any event because Chen failed to prove his case. Chen alleged before the Board that he actually reduced to practice six compounds within the counts prior to December 9, 1992. Chen, slip op. at 59. The Board found, however, that Chen utterly failed to explain in his brief how the evidence on which he relies as evidence of an actual reduction to practice of the subject matter of the counts `reads on' the specific limitations required by each of the counts. Id. at 64. Moreover, the Board found that Chen did not produce any evidence establishing how Chen identified any compounds within the counts in the reaction mixtures he prepared, or even that he ever resolved any such mixtures into their component parts. Id. 60 The record does not indicate how, if at all, the analytical data obtained by the analytical chemists to whom Chen sent his compounds for analysis confirm Chen's suggested structures, containing instead only attorney arguments and conclusory proclamations that the data are consistent with Chen's suggestions. Id. at 69. The Board found, in particular, that it cannot be determined from the chemists' conclusions what formed the underlying basis for their belief that the tested samples were consistent with the structures proposed by Chen. Indeed, as Bouchard points out, to establish adequate identification of the epi -route compounds, Chen relies on the same analytical techniques, namely NMR and MS, that resulted, as of July 1, 1992, in a firm (but incorrect) conclusion that a mixture of fluorotaxols had been obtained. As found by the Board, the NMR and MS spectra that Chen apparently relies on to confirm the structure of the compounds as compounds within the counts are capable of more than one reasonable interpretation. Id. at 75. 61 Finally, the Board found that [t]here is neither evidence contemporaneous in time with Dr. Chen's notebook entries nor evidence independent of any of the inventors (Chen and Farina) which corroborates Dr. Chen's testimony concerning the alleged actual reductions to practice. Id. at 74. As noted by the Board, no witness who signed any of Dr. Chen's or any other involved researchers' notebooks testified in this proceeding, and all of the information within those notebooks therefore remains uncorroborated. Id. at 77. 62 As to Chen's alternative theory of conception coupled with diligence toward reduction to practice, the Board found an even greater paucity of detail with respect to the underlying facts. Id. at 81. The Board found, in particular, that [t]he section of Chen et al.'s brief devoted to the `reasonable diligence' aspect of their priority case is little more than various conclusions made without regard to any underlying facts which support the conclusions made by Chen et al. Id. at 82. The Board identified the critical period for diligence as running from December 8, 1992 to March 13, 1993, and found that Chen had provided absolutely no evidence of who worked on what applications on which days for any day in the critical period. Id. at 83-84. With regard to compounds BMS-183582 and BMS-183821, the Board found the corresponding data to be unreliable, some having been replotted years later, others having inconsistent dates, some prior to the critical date and others later. Id. at 95-97, 99-103. The Board concluded that, while Chen was undoubtedly actively engaged in synthesizing derivatives of taxol in the critical time period, his proofs do not allow for identification of exactly what was prepared, and [c]ompounding this problem is the absence of adequate evidence establishing how Dr. Chen and the other researchers separated the compounds allegedly produced and subsequently tested the compounds for structural determination and utility. Id. at 104. 63 On the basis of these and the numerous other findings of the Board, we hold that substantial evidence supports the Board's conclusion that Chen did not establish by preponderant evidence either that he actually reduced to practice the subject matter of the counts before Bouchard's effective filing date or that he conceived the subject matter of the counts before Bouchard's effective filing date and then was reasonably diligent in constructively or actually reducing the subject matter of the counts to practice in a period beginning just prior to Bouchard's effective filing date. Accordingly, we affirm the Board's decision.