Opinion ID: 780687
Heading Depth: 2
Heading Rank: 3

Heading: Written Description and Enablement

Text: 43 Whether a specification supports a claim corresponding to a count, and thus satisfies the written description requirement of 35 U.S.C. § 112, ¶ 1, is a question of fact, Vas-Cath v. Mahurkar, 935 F.2d 1555, 1562, 19 USPQ2d 1111, 1116 (Fed.Cir.1991), and is, in appeals from the United States Patent and Trademark Office, reviewed under the substantial evidence standard. In re Gartside, 203 F.3d at 1315, 53 USPQ2d at 1775. Singh argues that the Board erred in concluding that Brake is entitled to the benefit of the Brake 1 application. First, Singh contends that Brake did not provide an adequate written description of the invention of the count in the Brake 1 application, and should not be entitled to its benefit. According to Singh, Brake 1 disclosed a large genus, allegedly encompassing over 9000 species 5 (n is 0 or 1 to 4), of which the count is directed to only two ( i.e., those where n = 0). Secondly, Singh asserts that Brake 1 does not provide an enabling disclosure with respect to the invention of the count, arguing that Brake 1 does not disclose how to make and use the n = 0 embodiment, and that the techniques which were available to Brake at the time of filing the Brake 1 Application were not sufficient to obtain the DNA constructs of the Count. Singh also argues that Brake 1 is replete with passages which guide one of ordinary skill in the art to constructs wherein n > 0, which constructs are not encompassed by the Count. Finally, Singh argues that during prosecution of the Brake 2 Application, Brake argued that the results obtained with the n = 0 construct were unexpected, because those of ordinary skill in the art believed that the Glu-Ala sequences were required. 44 Singh's arguments are not persuasive. First, we disagree with Singh's argument that the invention of the count represents just two of 9000+ species disclosed in Brake 1. Singh's calculation of 341 permutations for (GAXYCX) n is apparently based on an unwarranted assumption that each iteration of the parenthetical sequence is independently chosen. However, as Brake pointed out, because the variable `n' is outside the parentheses, (GAXYCX) n can code for either no amino acids ( i.e., when n = 0), or 1 to 4 copies of one of four different amino acid sequences ( i.e., Asp-Pro, Asp-Ala, Glu-Pro, or Glu-Ala). Brake, Paper No. 199 at 20-21 n. 13. Thus, there are at most only seventeen ( i.e., 4 0 + 4 1 + 4 1 + 4 1 + 4 1 ) permutations of that sequence. Even among those seventeen, however, we agree with Brake that there are only two meaningful embodiments: one in which a dipeptidylaminopeptidase A (DPAP) signal is present ( i.e., n = 1 to 4), and one in which it is not ( i.e., n = 0). 45 Moreover, Singh's calculation of twenty-eight possibilities for the Lys/Arg sequences is artificially inflated because it ignores the disclosure of claim 5 of Brake 1: 46 5. A DNA construct comprising a sequence of the following formula: L-(R-S-(GAXYCX) n -Gene) y 47 wherein: 48 L is a leader sequence recognized by yeast for secretion; 49 R and S are codons coding for arginine and lysine; 50 X is any nucleotide; 51 Y is guanosine or cytosine; 52 y is an integer of from about 1 to 10; Gene is a gene foreign to yeast; and 53 n is 0 or 1 to 4. 54 U.S. Application 06/457,325 at 16, ll. 20-32. 55 In claim 5, spacer R-S encodes four possible sequences ( i.e., Lys-Arg, Arg-Arg, Arg-Lys, or Lys-Lys), not 28. Of these four, two permutations, Lys-Arg and Arg-Arg, are within the scope of the count. 56 Singh cites Fujikawa v. Wattanasin, 93 F.3d 1559, 39 USPQ2d 1895 (Fed.Cir. 1996), for the proposition that an application disclosing a generic chemical formula must provide adequate direction to those of ordinary skill in the art to lead them to a subgenus of the proposed count. We find Singh's reliance on Fujikawa to be unsound. In Fujikawa, we held that disclosure of a generic quinoline structure with four variable groups, each of which could be independently chosen from a list of functional groups, provided insufficient written description support for a count directed to a subgeneric structure having a single combination of the four groups. Id. at 1569-71, 39 USPQ2d at 1904-05. However, Brake 1's formula does not present the same issue as did the quinoline in Fujikawa. First, replacing a functional group on a chemical compound can often have highly unpredictable results. We noted in Fujikawa that even a change as seemingly trivial as replacing an isopropyl group with the isosteric cyclopropyl group at issue in that case could result in either a significant improvement or reduction in the activity of the compound against a particular biological target. Id. In the present case, on the other hand, as mentioned above, there are only two subgenera that are biologically relevant: one in which a DPAP signal is present ( i.e., n = 1 to 4), and one in which it is not ( i.e., n = 0), a simpler case than in Fujikawa. Here, moreover, claim 5 of Brake 1 discloses that n is 0 or 1 to 4, which is a clear blaze mark providing in ipsis verbis support for n = 0 in the count. In re Ruschig, 54 C.C.P.A. 1551, 379 F.2d 990, 994-95, 154 USPQ 118, 122 (CCPA 1967). 57 The Supreme Court has explained that the possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency's finding from being supported by substantial evidence. In re Gartside, 203 F.3d at 1312, 53 USPQ2d at 1773 (citing Consolo v. Federal Maritime Comm'n, 383 U.S. 607, 620, 86 S.Ct. 1018, 16 L.Ed.2d 131 (1966)). In Fujikawa, we said that [w]hile Fujikawa's arguments are not without merit, we cannot say, on this record, that the Board's decision was clearly erroneous. 93 F.3d at 1571, 39 USPQ2d at 1905. In view of the fact that the substantial evidence standard of review that we now use post- Zurko requires us to give decisions of the Board greater deference than we gave in cases such as Fujikawa, we likewise decline to find legal error in the Board's conclusion on the record in the present case. 58 Singh's reliance on Bigham v. Godtfredsen, 857 F.2d 1415, 8 USPQ2d 1266 (Fed. Cir.1988), is also unavailing. In Bigham, Godtfredsen's first application disclosed a compound having a substituent X, where X was defined as a halogen atom. The application provided as its only example a compound in which X was chloro. Id. at 1416, 857 F.2d 1415, 8 USPQ2d at 1267. This court ruled that that application's disclosure of halogen did not meet the requirements of § 112 as a written description of bromo or iodo species, particularly where Godtfredsen had earlier argued in the same case that bromo and iodo were patentably distinct from chloro in order to urge bifurcation of the count. Id. at 1417, 857 F.2d 1415, 8 USPQ2d at 1268. In the present case, in contrast, n = 0 was disclosed in Brake 1. If Godtfredsen had provided examples of fluoro, bromo, and iodo compounds in addition to the chloro compound, that case might have been decided differently, even in spite of Godtfredsen's patentably distinct argument. 59 Singh's arguments with respect to enablement are likewise unconvincing. Enablement is a question of law based on underlying factual determinations. In re Swartz, 232 F.3d 862, 863, 56 USPQ2d 1703, 1704 (Fed.Cir.2000). We review the Board's underlying findings of fact for substantial evidence, and review de novo its ultimate conclusion whether a disclosure is enabling. Id. Singh argues in his brief: 60 The Board takes internally inconsistent positions with respect to whether methods for obtaining a construct of the Count using Brake's starting material were available to those of ordinary skill in the art at the time the Brake 1 Application was filed. To support its finding that Brake is entitled to benefit, the Board finds that such methods existed. However, to support its finding that Singh had not conceived of the invention prior to the Brake 1 Application filing date, the Board makes the contrary finding. 61 We find no error or inconsistency in the Board's analysis. As we wrote in Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1050, 34 USPQ2d 1565, 1569 (Fed.Cir. 1995), the enablement requirement ... looks to the objective knowledge of one of ordinary skill in the art. Id. (citing Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1532, 3 USPQ2d 1737, 1742 (Fed.Cir.1987)). Thus, whereas the test for determining whether or not Singh conceived the construct of the count depended on Singh's own personal knowledge of methods for making the construct and his formulation of a definite and permanent idea therefor, whether Brake 1 enables an invention within the count does not depend on what Brake knew, but rather on whether the application enables one skilled in the art to make and use the invention, Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed.Cir.1986), at the time the patent application was filed. Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345, 56 USPQ2d 1332, 1337 (Fed.Cir.2000). The Board found that the testimony of Brake's witness, Dr. Patricia Tekamp-Olson, demonstrated that those of ordinary skill in the art had in their possession in 1982 various molecular biological methods sufficient to make and use the n = 0 construct, including site-directed mutagenesis. Brake, Paper No. 199 at 24-27. The Board also found that Singh's expert, Dr. Joseph Falkinham, mischaracterized the teachings of the Fritz article on which he relied in his attempts to discredit Tekamp-Olson's testimony. Id. at 40. 62 As further proof that Brake 1 does not provide an enabling disclosure of the invention of the Count, Singh also alleges, for example, that the Brake 1 Application actually steers the artisan to species clearly outside the Count, that during prosecution of the Brake 2 Application, Brake argued that the results obtained with the n = 0 construct were unexpected, and that Dr. Brake did not realize the disadvantages of the n > 0 constructs until well after the Brake 1 Application was filed. We are not persuaded by any of these arguments, and conclude that Singh has apparently confused the criteria for proving obviousness with those for demonstrating that a disclosure is nonenabling. Although the questions (1) whether or not a reference teaches away from a claimed invention and (2) whether or not a claimed invention provides unexpected results are relevant in determining whether or not a claimed invention would have been obvious, W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550, 220 USPQ 303, 311 (Fed.Cir.1983), they are not the primary questions bearing on enablement. The fact that the Brake patent states that n in the construct is preferably 2 or 3 is also irrelevant to the question of enablement of the n = 0 construct. 6 Similarly, the fact that the n = 0 construct might have had after-discovered advantages over the n > 0 constructs has no bearing at all on whether or not Brake 1 contained an enabling disclosure. 63 We thus conclude that substantial evidence supports the Board's finding that Brake was entitled to the benefit of the Brake 1 application. We have considered Singh's other arguments and do not find them persuasive.