Ex Parte Markou et alDownload PDFBoard of Patent Appeals and InterferencesJun 15, 201210527525 (B.P.A.I. Jun. 15, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/527,525 10/14/2005 Athina Markou TSRI 897.1 3218 26621 7590 06/15/2012 THE SCRIPPS RESEARCH INSTITUTE OFFICE OF PATENT COUNSEL, TPC-8 10550 NORTH TORREY PINES ROAD LA JOLLA, CA 92037 EXAMINER CARTER, KENDRA D ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 06/15/2012 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte ATHINA MARKOU, PAUL KENNY, NEIL PATERSON, and SVETLANA SEMENOVA __________ Appeal 2011-001816 Application 10/527,525 Technology Center 1600 __________ Before DONALD E. ADAMS, LORA M. GREEN, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a process of treating drug dependence. The Examiner entered rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1-3, 6, 7, 9, 16, 27, 28, and 32 stand rejected and appealed (App. Br. 8). Claim 1 is representative and reads as follows: 1. A method for treating drug dependence in a subject, comprising administering to a subject with drug dependence an effective amount of (a) a first antagonist which modulates Appeal 2011-001816 Application 10/527,525 2 metabotropic glutamate receptor 2 [mGluR2] and/or metabotropic glutamate receptor 3 [mGluR3], and (b) a second antagonist which modulates metabotropic glutamate receptor 5 [mGluR5], thereby treating the disorder; wherein the drug dependence is selected from the group consisting of nicotine addiction, alcohol addiction, opiate addiction, amphetamine addiction, cocaine addiction, and methamphetamine addiction. The following rejections are before us for review: (1) Claims 1-3, 6, 7, and 16, under 35 U.S.C. § 103(a) as obvious over Adam1 combined with either Corsi2 or Chiamulera3 (Ans. 4-5); and (2) Claims 9, 27, 28, and 32, under 35 U.S.C. § 103(a) as obvious over Chiamulera, Adam, and admitted prior art appearing in the Specification at pages 14 and 16 (Ans. 6-8). DISCUSSION The Examiner concluded that it would have been obvious to treat drug dependence with an mGluR2/3 antagonist as well as an mGluR5 antagonist, as recited in claim 1, based on Adam’s teaching that mGluR2/3 antagonists were useful for treating nicotine/opiate dependence, combined with the teachings in Corsi or Chiamulera that mGluR5 antagonists were similarly useful for treating drug dependence (Ans. 4-5 (citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980))). 1 U.S. Patent No. 6,407,094 B1 (issued June 18, 2002). 2 U.S. Patent App. Pub. No. 2003/0195139 A1 (published October 16, 2003). 3 Christian Chiamulera et al., Reinforcing and locomotor stimulant effects of cocaine are absent in mGluR5 null mutant mice, 4 NATURE NEUROSCIENCE 873-74 (2001). Appeal 2011-001816 Application 10/527,525 3 As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. We agree with Appellants that a preponderance of the evidence does not support the Examiner’s prima facie case of obviousness. Specifically, based on the totality of the record, we conclude that Appellants have advanced sufficient evidence to rebut the Examiner’s prima facie case of obviousness. As explained in the Markou Declaration,4 an ordinary artisan would have expected that exposing mGluR2/3 and mGluR5 receptors to their antagonists would have “opposite neurochemical and behavioral effects” (Markou Declaration ¶ 4(ii)). This is borne out by the disclosure in Mills,5 cited in the Markou Declaration, which discloses that the mGluR5 antagonist MPEP “reduced EAA [extracellular excitatory amino acid] concentrations . . . while treatment with LY 341495 [a group-II (mGluR2/3) antagonist] increased EAA levels” in a rat spinal cord injury model (Mills 835). Thus, while the references cited by the Examiner might separately disclose treating drug dependence with mGluR2/3 antagonists and mGluR5 4 Declaration of Dr. Athina Markou under 37 C.F.R. § 132 (executed September 2, 2008). Note that the first page of the Declaration inadvertently states that the declaration is made under 37 C.F.R. § 131. 5 Charles D. Mills et al., Involvement of metabotropic glutamate receptors in excitatory amino acid and GABA release following spinal cord injury in rat, 79 J. NEUROCHEM. 835-48 (2001). Appeal 2011-001816 Application 10/527,525 4 antagonists, Appellants have advanced essentially a direct side-by-side comparison from the prior art demonstrating that the two types of compounds administered in the claimed processes have opposing physiological activities. In contrast, the Examiner provides no convincing response explaining why an ordinary artisan would have used compounds with opposite physiological activities in the claimed combination therapy. We acknowledge the oft-stated directive in In re Kerkhoven that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . .[T]he idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d at 850. Here, however, unlike the situation in Kerkhoven, Appellants have advanced direct evidence that an ordinary artisan would have expected the two types of antagonists administered in the claimed processes to have opposing physiological activities. Thus, as the Examiner has not provided a clear evidence-based explanation as to why an ordinary artisan would have been prompted to use compounds having opposing physiological activities in the claimed combination therapy processes, we agree with Appellants that the preponderance of the evidence does not support the Examiner’s prima facie case. Appeal 2011-001816 Application 10/527,525 5 We therefore reverse the Examiner’s rejection of claims 1-3, 6, 7, and 16, as obvious over Adam and either Corsi or Chiamulera. As we conclude that the above analysis governs the Examiner’s rejection of claims 9, 27, 28, and 32 over Chiamulera, Adam, and admitted prior art, we also reverse that rejection. REVERSED dm Copy with citationCopy as parenthetical citation