Ex Parte Nagarathnam et alDownload PDFPatent Trial and Appeal BoardSep 20, 201312726660 (P.T.A.B. Sep. 20, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DHANAPALAN NAGARATHNAM and CHUNGUANG WANG ____________ Appeal 2012-006098 Application 12/726,660 Technology Center 1622 ____________ Before DONALD E. ADAMS, LORA M. GREEN, and ULRIKE W. JENKS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims 8-12 (App. Br. 1).2 Examiner entered rejections under 35 U.S.C. § 112, second paragraph and the enablement provision of 35 U.S.C. § 112, first paragraph.3 We have jurisdiction under 35 U.S.C. § 6(b). 1 The Real Party in Interest is Bayer Healthcare LLC (App. Br. 1). 2 Examiner’s objection to pending claims 2, 4, 5, and 7 is not presented for review (App. Br. 1; Cf. October 21, 2010 Office Action 39). We also recognize Examiner’s objection to claims 3 and 12, which is a petitionable rather than appealable issue (id.). 3 Office Records identify Application Nos. 11/354,977 and 12/698,386 as abandoned. Therefore, Examiner’s provisional rejections under the judicially created doctrine of obviousness-type double patenting over Applications 11/354,977 and 12/698,386 are moot. Therefore, claims 1, 3, Appeal 2012-006098 Application 12/726,660 2 We affirm. STATEMENT OF THE CASE The claims are directed to a method of treatment and method of preparing a compound. Claims 8, 9, and 12 are representative and are reproduced in the Claims Appendix of Appellants’ Brief.4 Claims 8, 10, and 12 stand rejected under 35 U.S.C. § 112, second paragraph. Claims 8-11 stand rejected under the enablement provision of 35 U.S.C. § 112, first paragraph. Definiteness: ISSUE Does the preponderance of evidence on this record support Examiner’s conclusion that: (a) The phrase “[a] method of treating an indication mediated by Rho- kinase,” as it appears in Appellants’ claim 8 indefinite; and (b) The structural formula for formula (4), as it appears in Appellants’ claim 12, indefinite for failing to recite “or NHAr2”? FACTUAL FINDINGS (FF) FF 1. Examiner finds that the scope of Appellants’ claim 8 is broad (Ans. 4-12). FF 2. Examiner recognizes that Appellants’ claim 8 “embrace[s] all indications which are mediated by a RHO-kinase” (id. at 10). and 6, which stand rejected only under the judicially created doctrine of obviousness-type double patenting, were not included in our deliberations. 4 We recognize Examiner’s identification of error in Appellants’ Claim Appendix, specifically the “of record” version of: (1) claim 1 does not recite the formula for “formula II”; and (2) claim 12 does not recite “or NHAR2” in the structural formula for “formula (4)” (Ans. 3-4). Appeal 2012-006098 Application 12/726,660 3 FF 3. Examiner finds that “the correct [(of record)] version of” claim 12 fails to recited NHAr2 as an alternative to the “NHR3” substituent in formula (4) (see generally id. at 12; Claim 12). ANALYSIS Claims 8 and 10: Examiner asserts that “the problem [with claim 85] is not so much that it is broad, but that one cannot … determine what disorders it actually covers and does not cover” (Ans. 10; Cf. FF 1). We are not persuaded. As Examiner recognizes Appellants’ claim 8 “embrace[s] all indications which are mediated by a RHO-kinase” (FF 2). As Examiner appreciates “[t]he fact that the claim is broad, without more, does not rise to the level of indefiniteness” (Ans. 10; see also App. Br. 4). In re Miller, 441 F.2d 689, 693 (CCPA 1971) (“breadth is not to be equated with indefiniteness”). Claim 12: Examiner finds that “[a]ccording to the reagent list[,set forth in Appellants’ claim 12,] R3 or Ar2 could be attached to the N atom. But the structure (4) has only the R3 in the correct version of the claim. Thus, either the structure is wrong (should have either R3 or Ar2) or the reagent list is wrong (should only have the reagent with R3)” (Ans. 12). Therefore, Examiner reasons that “[o]ne cannot be sure which it is, but in either case, the claim is wrongly written” (id.). Appellants contend that “an amendment is provided herewith making the obvious typographical correction” (App. Br. 4). As Examiner correctly notes, however, “no amendment was tendered” (Ans. 12). 5 Claim 10 depends from claim 8. Appeal 2012-006098 Application 12/726,660 4 CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner’s conclusion that the phrase phrase “[a] method of treating an indication mediated by Rho-kinase,” as it appears in Appellants’ claim 8 indefinite. This rejection of claims 8 and 10 under 35 U.S.C. § 112, second paragraph is reversed. The preponderance of evidence on this record supports Examiner’s conclusion that claim 12 is indefinite. The rejection of claim 12 under 35 U.S.C. § 112, second paragraph is affirmed. Enablement: ISSUE Does the evidence of record support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention? FACTUAL FINDINGS (FF) FF 4. Examiner finds that Appellants’ Specification fails to provide an enabling disclosure for the treatment of “cancers, neuronal degeneration, spinal cord injury, restenosis, and thrombotic disorders” (Ans. 13). FF 5. Examiner highlights the scope of the diseases encompassed by Appellants’ claims (id. at 16-32; see also id. at 33-35). FF 6. Examiner finds that Appellants’ Specification fails to provide direction or guidance for the treatment of the different disorders encompassed by Appellants’ claims (id. at 32). FF 7. Examiner finds that “no benzopyrazolyl (or indolyl) quinazolinyl compounds (amines or otherwise) of any kind have been used for the treatment of” the diseases encompassed by Appellants’ claims (id.; see also Appeal 2012-006098 Application 12/726,660 5 id. at 33-35; and id. at 37 (“Appellants have … been invited to make … literature [identifying which diseases are treatable with the compounds required by Appellants’ claims] but have not done so, and the [E]xaminer is not aware of any such article”)). FF 8. Examiner finds that Appellants’ Specification fails to provide “working examples of any kind to any disease” (id.). FF 9. Examiner finds, inter alia, that: (a) Appellants’ claim 8 “presupposes that all ‘indications’ mediated by rho-kinas arise from too much rho-kinase and hence can be treated by inhibitors of rho-kinase, which these compounds are alleged to be. However, indications mediated by rho-kinase can also arise from too little rho-kinase” (Ans. 36 (citing, as examples supporting Examiner’s reasoning, rho-kinase’s involvement in actomyosin regulation, segregation of GFAP into daughter cells, leukocyte transendothelial migration, and cytokinesis)). (b) Appellants’ claims “presuppose[] that nothing else does what rho- kinase does, so that if rho-kinase is suppressed, the activity is suppressed. But this ignores the fact that the body has many redundancies, and if rho-kinase activation is suppressed, another [kinase] can easily take its place, so that such suppression may have no net effect” (id. (citing, as examples supporting Examiner’s reasoning, CPI-17’s phosphorylation by rho-kinase and, inter alia, integrin-linked kinase (ILK), Mysoin RLC phosphorylation by rho- kinase and p21-activated kinase, and MYPT1 phosphorylation at the T654 site by rho-kinase and DMPK)). ANALYSIS Weighing the evidence of record in light of the factors set forth in In re Wands, 858 F.2d 731, 735, 736-37 (Fed. Cir. 1988), Examiner concludes that Appellants’ Specification fails to provide an enabling disclosure for the treatment of “cancers, neuronal degeneration, spinal cord injury, restenosis, and thrombotic disorders” (FF 4; see also FF 5-9). Appeal 2012-006098 Application 12/726,660 6 We are not persuaded by Appellants’ contention that “[t]he fact that many indications may be mediated by RHO-linase (or may not) is immaterial, inasmuch as one of ordinary skill in the art can readily determine, for example by perusing the literature cited in the present specification, which indications are so treatable” (App. Br. 5; Cf. FF 7). We are not persuaded by Appellants’ contention that Examiner failed to provide “reasons or evidence to doubt the ability of any of the six compounds to treat the listed diseases exists” (id.; Cf. FF 5-9). CONCLUSION OF LAW The evidence of record support Examiner’s conclusion that undue experimentation would be required to practice the claimed invention. The rejection of claims 8 and 9 under the enablement provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims 10 and 11 are not separately argued and fall with claims 8 and 9 respectively. TIME PERIOD FOR RESPONSE 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 dm Copy with citationCopy as parenthetical citation