Ex Parte Lee

Patent Trial and Appeal BoardApr 10, 2013

10850072 (P.T.A.B. Apr. 10, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte FRANCIS Y.F. LEE __________ Appeal 2011-002616 Application 10/850,072 Technology Center 1600 __________ Before DEMETRA J. MILLS, ERIC GRIMES, and MELANIE L. McCOLLUM, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating cancer, which the Examiner rejected for obviousness and obviousness-type double patenting. In a previous decision, we reversed the rejection for obviousness but affirmed the double-patenting rejection. This application returns to us following a remand from the U.S. Court of Appeals for the Federal Circuit, so that we can consider the effect of Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012). In light of that decision, we reverse the rejection for obviousness-type double patenting. Appeal 2011-002616 Application 10/850,072 2 STATEMENT OF THE CASE Claims 121-127 and 141-143 are on appeal. The Examiner rejected the claims under 35 U.S.C. § 103(a) as obvious based on Danishefsky1 and Chen,2 or based on Vite3 and Chen. The Examiner also rejected the claims for obviousness-type double patenting based on the claims of Lee4 in view of Chen. In our previous decision, mailed Dec. 16, 2011 (“Decision”), we reversed the rejections under 35 U.S.C. § 103(a) because, even though the cited references supported a prima facie case of obviousness (Decision at 4- 5), Appellant had provided evidence of unexpectedly superior results that was sufficient to outweigh the evidence supporting a conclusion of obviousness (id. at 8-9). However, we affirmed the rejection for obviousness-type double patenting, on the basis that evidence of unexpected results could not be relied on to overcome that type of rejection (id. at 12). We rested our conclusion on the following statement in Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378 n.1 (Fed. Cir. 2003): “The distinctions between obviousness under 35 U.S.C. § 103 and nonstatutory double patenting include: . . . Obviousness requires inquiry into objective criteria suggesting non-obviousness; nonstatutory double patenting does not.” (Decision 12.) 1 Danishefsky et al., US 6,867,305 B2, Mar. 15, 2005. 2 Chen et al., US 2002/0147198 A1, Oct. 10, 2002. 3 Vite et al., WO 99/02514, Jan. 21, 1999. 4 Lee, U.S. RE41,393 E, reissued June 22, 2010. Appeal 2011-002616 Application 10/850,072 3 Subsequent to our decision, the Federal Circuit decided the case of Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012); the Otsuka decision casts doubt on the reading of the case law that we relied on in the Decision. In Otsuka, the accused infringers asserted that the patented claims were invalid for obviousness and obviousness-type double patenting. 678 F.3d at 1287. The district court concluded that the defendants had not shown that the claims were invalid based on either obviousness or obviousness-type double patenting. Id. at 1289-1290. The Federal Circuit affirmed those rulings. With regard to obviousness-type double patenting, the court noted that the “Defendants rely on Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377 n. 1 (Fed. Cir. 2003), which states in a footnote that ‘[o]bviousness requires inquiry into a motivation to modify the prior art; nonstatutory double patenting does not.’” Id. at 1297. The court held that Geneva was distinguishable, however, because it “involved nonstatutory double patenting based on anticipation, not obviousness. . . . For anticipation, of course, motivation in the prior art is unimportant.” Id. The Otsuka court held that the repetition of Geneva’s statement in Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009), was dictum, and that “neither Geneva nor Procter & Gamble stands for the proposition that, in considering whether one compound is an obvious variant of another for purposes of nonstatutory double patenting, analyzing the compound of the prior claim for a reason or motivation to modify is irrelevant.” 678 F.3d at 1298. The Otsuka court held that, like an analysis under § 103, “an analysis of nonstatutory Appeal 2011-002616 Application 10/850,072 4 obviousness-type double patenting . . . entails determining, inter alia, whether one of ordinary skill in the art would have had reason or motivation to modify the earlier claimed compound to make the compound of the asserted claim with a reasonable expectation of success.” Id. Although the above discussion in Otsuka specifically concerned Geneva’s statement regarding motivation to combine, the court stated with regard to secondary considerations that “[b]ecause we agree with the district court that the prior art would not have provided one of ordinary skill with a reason or motivation to make aripiprazole from the unsubstituted butoxy compound, we need not examine Otsuka’s evidence of secondary considerations of nonobviousness.” Id. at 1299. The clear implication of this statement, of course, is that if the evidence had provided a reason to make the claimed compound, the court would have gone on to consider whether the evidence of secondary considerations showed that the claimed compound would have been nonobvious as a matter of law. Based on the Otsuka decision, therefore, we conclude that the statements in Geneva and Procter & Gamble should not be taken at face value, and should be understood to apply only to instances where the rejection for obviousness-type double patenting is based on anticipation; e.g., a broader claim to a genus being anticipated by an earlier claim to a species within the genus. That is not the case here, because the Examiner’s rejection relies on “the same reasoning as set forth in the 103(a) rejection” (Office action mailed July 8, 2009, page 3). Thus, under Otsuka, the evidence of unexpected results should be considered with regard to the obviousness-type Appeal 2011-002616 Application 10/850,072 5 double patenting rejection. For the reasons thoroughly discussed in the Decision (pages 5-9), Appellant’s “evidence of unexpected results . . . outweighs the evidence supporting the prima facie case of obviousness.” Id. at 10. For the same reason, the evidence of secondary considerations also outweighs the evidence supporting the obviousness-type double patenting rejection. SUMMARY We reverse the rejection of claims 121-127 and 141-143 for obviousness-type double patenting. The rejection of claims 121-127 and 141-143 under 35 U.S.C. § 103(a) remains reversed for the reasons discussed in our decision of Dec. 16, 2011. REVERSED lp