Ex Parte Cavazza et alDownload PDFBoard of Patent Appeals and InterferencesSep 12, 201112320430 (B.P.A.I. Sep. 12, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte CLAUDIO CAVAZZA, CLAUDIO PISANO, and LOREDANA VESCI __________ Appeal 2011-007991 Application 12/320,430 Technology Center 1600 __________ Before TONI R. SCHEINER, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of treating peripheral neuropathies induced by the administration of oxaliplatin. The Patent Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-007991 Application 12/320,430 2 STATEMENT OF THE CASE Claims 28-40 and 43-45 are on appeal. Claim 28 is representative and reads as follows: 28. A method of treating peripheral neuropathies induced by the administration of oxaliplatin comprising administering to a subject acetyl L-carnitine or a pharmaceutically acceptable salt thereof and said oxaliplatin. The Examiner rejected the claims as follows: • claims 28-32, 34, 37-40 and 43-45 under 35 U.S.C. § 103(a) as unpatentable over Calvani1 and Machover;2 • claim 33 under 35 U.S.C. § 103(a) as unpatentable over Calvani, Machover, and Moretti;3 and • claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over Calvani, Machover, and Colvin.4 1 US Patent No. 4,751,242 issued to Menotti Calvani et al., Jun. 14, 1988. 2 D. Machover et al., Two consecutive phase II studies of oxaliplatin (ʟ- OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines, ANNALS OF ONCOLOGY, no. 7, 95-98 (1996). 3 Int’l Publication No. WO 1997/34596 by Sonia Moretti et al., published Sep. 25, 1997. 4 US Patent No. 4,936,823 issued to David P. Colvin et al., Jun. 26, 1990. Appeal 2011-007991 Application 12/320,430 3 Claims 29-40 and 43-45 have not been argued separately and therefore stand or fall with claim 28. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS The Issue The Examiner’s position is that Calvani taught a method of treating drug induced peripheral neuropathies comprising administering acetyl-L- carnitine or a pharmaceutically acceptable salt in a pharmaceutically acceptable carrier. (Ans. 5.) However, the Examiner found that Calvani did not specifically teach that oxaliplatin may induce peripheral neuropathy. (Id.) The Examiner found that Machover taught that oxaliplatin was useful in treating cancer but may induce peripheral neuropathy as a side effect. (Id.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to administer acetyl-L-carnitine with oxaliplatin with a reasonable expectation of success because oxaliplatin was known to induce peripheral neuropathy and acetyl- L-carnitine was known to treat drug-induced peripheral neuropathy. (Id.) Appellants contend that “Calvani only discloses three drugs capable of inducing neurotoxicity[:] isoniazide, nitrofurantoin and adriamicine.” (App. Br. 10.) Appellants assert that the mechanism of oxaliplatin is very different from the mechanisms of these drugs, including adriamicine, an anti-cancer agent. (Id. at 10-11.) Therefore, according to Appellants, “broad generalization about the administration of acetyl-L-carnitine with any of these three drugs cannot be used to extrapolate and predict the effectiveness of acetyl-L-carnitine with oxaliplatin.” (Id. at 11.) Appeal 2011-007991 Application 12/320,430 4 Moreover, Appellants assert that a skilled artisan would not have been motivated to combine the teachings of Calvani and Machover because Machover did not suggest treating oxaliplatin-induced peripheral neuropathies “since Machover disclose[d] that the neuropathies have a favorable course.” (Id.) The issue is whether the record supports the Examiner’s conclusion that the combination of Calvani and Machover would have made it obvious to treat peripheral neuropathies induced by oxaliplatin by administering acetyl-L-carnitine with the oxaliplatin. Findings of Fact 1. We agree with the Examiner’s explicit findings regarding the scope and content of the prior art references. (See Ans. 5-7.) 2. Machover disclosed that “severe neuropathy had a favorable course after discontinuation of oxaliplatin….” (Machover p. 98.) 3. Machover disclosed that “[t]he dose limiting toxic effect of oxaliplatin was sensory peripheral neuropathy, which occurred in almost all of the patients.” (Id. at p. 97.) Principles of Law Motivation to combine prior art teachings can be found in the knowledge of those skilled in the art at the time of the invention, and by the nature of the problem to be solved. Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d 1332, 1339 (Fed. Cir. 2005); accord DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006)(“the ‘evidence’ of motive will likely consist of an explanation of the well-known principle or problem-solving strategy to be applied”). Appeal 2011-007991 Application 12/320,430 5 Analysis After considering all the evidence and arguments, we conclude that the record supports a conclusion of prima facie obviousness. We are not persuaded of nonobviousness by Appellants’ assertion that a skilled artisan could not predict the effectiveness of acetyl-L-carnitine with oxaliplatin because the mechanism of action of oxaliplatin is very different from the mechanism of action of the drugs disclosed in Calvani. (See App. Br. 10- 11.) This is merely attorney argument, unsupported by factual evidence. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Further, Appellants consider Calvani too narrowly. Calvani disclosed isoniazide, nitrofurantoin and adriamicine as three examples of drugs known to induce peripheral neuropathies. Calvani did not limit its teaching to use acetyl-L-carnitine to treat peripheral neuropathies to neuropathies induced by these three drugs, or even to drug-induced toxicity. Rather, as the Examiner explained, Calvani’s teaching is directed to treating peripheral neuropathies, no matter what the actual etiological cause is, e.g., secondary to viral infections, metabolic disturbances, mechanical stresses, radiations, genetic factors, pathologies of the immune system, or drug-induced toxicity. (See Ans. 8.) Therefore, contrary to Appellants’ assertion (App. Br. 11) Calvani would have provided an artisan a reasonable expectation of successfully treating oxaliplatin-induced peripheral neuropathy with acetyl-L-carnitine because “the nature of the problem called for exactly the solutions in the prior art.” Princeton Biochemicals, Inc. v. Beckman Coulter, Inc., 411 F.3d at 1339 (affirming obviousness where motivation was found in the knowledge of those skilled in the art at the time, and where the nature of the Appeal 2011-007991 Application 12/320,430 6 problem also supplied a motivation); accord, DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d at 1366. Appellants also contend that a skilled artisan would not have been motivated to treat oxaliplatin-induced peripheral neuropathies because Machover disclosed that the neuropathies induced by oxaliplatin have a favorable course. (App. Br. 11.) We disagree with Appellants. Machover explained that the neuropathy had a favorable course after discontinuation of oxaliplatin. (FF-2.) Additionally, Machover disclosed taught that the peripheral neuropathy was a dose-limiting toxic effect of oxaliplatin. (FF- 3.) Thus, an artisan would have been motivated to avoid such a need to discontinue or limit the dose of oxaliplatin by instead treating the peripheral neuropathy that it induced. Moreover, in the combination, Calvani expressly provided motivation for treating drug-induced peripheral neuropathy. (See Ans. 5.) Accordingly, we affirm the Examiner’s obviousness rejections. CONCLUSION OF LAW The combination of Calvani and Machover would have made it obvious to treat peripheral neuropathies induced by oxaliplatin by administering acetyl-L-carnitine with the oxaliplatin. SUMMARY We affirm the rejection of claims 28-32, 34, 37-40 and 43-45 under 35 U.S.C. § 103(a) as unpatentable over Calvani and Machover; Appeal 2011-007991 Application 12/320,430 7 we affirm the rejection of claim 33 under 35 U.S.C. § 103(a) as unpatentable over Calvani, Machover, and Moretti; and we affirm the rejection of claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over Calvani, Machover, and Colvin. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED lp Copy with citationCopy as parenthetical citation