Robert Davis et al.Download PDFPatent Trials and Appeals BoardMay 21, 20212020002946 (P.T.A.B. May. 21, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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. 13/203,365 08/25/2011 Robert Davis IT-44-US 6759 50446 7590 05/21/2021 HOXIE & ASSOCIATES LLC 75 MAIN STREET SUITE 203 MILLBURN, NJ 07041 EXAMINER HUANG, GIGI GEORGIANA ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 05/21/2021 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): HoxiePatentMail@gmail.com HoxiePatentMail@hoxpat.com file@hoxpat.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte ROBERT DAVIS and ALLEN FIENBERG ____________________ Appeal 2020-002946 Application 13/203,365 Technology Center 1600 ____________________ Before DEBORAH KATZ, JON M. JURGOVAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. JURGOVAN, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks review under 35 U.S.C. § 134(a) from a Final Rejection of claims 2, 7, and 56–58, constituting all of the claims pending in the application.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.3 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. According to Appellant, the real party in interest is Intra- Cellular Therapies, Inc. Appeal Br. 2. 2 Claims 1, 5, 6, 8–26, and 29–55 were canceled, and claims 3–4, 27–28, and 59–60 were withdrawn following a restriction requirement. These claims are thus not before us in this appeal. 3 Our Decision refers to the Specification (“Spec.”) filed August 25, 2011; the Final Office Action (“Final Act.”) mailed April 22, 2019; the Appeal Brief (“Appeal Br.”) filed September 26 2019; the Examiner’s Answer Appeal 2020-002946 Application 13/203,365 2 CLAIMED INVENTION The claims recite a method of treatment of glaucoma or elevated intraocular pressure by administering an effective amount of phosphodiesterase (PDE) 1. Spec. Abstract. The PDE 1 may be administered as a monotherapy or in combination with one or more additional intraocular pressure-lowering agents. Id. Claim 2 is independent, and claims 7 and 56–58 are dependent therefrom. Claim 2, reproduced below, is representative of the claimed subject matter. 2. A method of treatment of glaucoma or elevated intraocular pressure comprising administering an effective amount of a PDE 1 inhibitor, or a combination of a PDE 1 inhibitor and an intraocular pressure-lowering agent, to a patient in need thereof wherein the PDE 1 inhibitor is a compound of the formula (IV): Formula IV (“Ans.”) mailed January 10, 2020; and the Reply Brief (“Reply Br.”) filed March 10, 2020. Appeal 2020-002946 Application 13/203,365 3 wherein R2 is H and R3 and R4 together form a tri- or tetra- methylene bridge; or at least one of R2 and R3 is methyl, isopropyl or arylalkoxy and R4 is H; or R2 and R3 are H and R4 is a C1-4 alkyl; R6 is phenylamino or benzylamino; R10 is phenyl, pyridyl, or thiadiazolyl; wherein phenyl is optionally substituted with C1-4 alkyl, halogen, haloC1-4 alkyl, hydroxyl, C1-4carboxy or an additional aryl or heteroaryl; or pyridyl or thiadiazolyl is optionally substituted with C1-4alkyl, halogen, haloC1-4alkyl, hydroxyl or C1-4carboxy; in free, salt or prodrug form. Appeal Br. 12 (Claims App.). REJECTIONS Claims 2 and 7 stand rejected under pre-AIA 35 U.S.C. § 103 as unpatentable over Li (WO 2006/133261 A2, published December 14, 2006) and Gupta (N. Gupta et al., Glaucoma as a neurodegenerative disease, 18(2) CURRENT OPIN. OPTHALMOL., 110–114 (2007), http://www.ncbi.nlm.nih.gov/pubmed/17301611 (12/1/2014)). Final Act. 6– 9. Claims 56–58 stand rejected under pre-AIA 35 U.S.C. § 103 as unpatentable over Li, Gupta, and Orzalesi (N. Orzalesi, Comparison of the effects of latanoprost, travoprost, and bimatoprost on circadian intraocular pressure in patients with glaucoma or ocular hypertension, 113(2) OPTHALMOLOGY, 239–46 (2006) , https://www.ncbi.nlm.nih.gov/ pubmed/16458092 (4/16/2019)). Final Act. 9–10. Appeal 2020-002946 Application 13/203,365 4 Claims 2 and 7 stand rejected under pre-AIA 35 U.S.C. § 103 as unpatentable over Li and Bell (US 6,235,742 B1, issued May 22, 2001). Final Act. 11–14. Claims 56–58 stand rejected under pre-AIA 35 U.S.C. § 103 as unpatentable over Li, Bell, and Orzalesi. Final Act. 14–16. Claims 2 and 7 stand rejected under pre-AIA 35 U.S.C. § 103 as unpatentable over Li and Bhushan (US 2004/0137068 A1, published July 15, 2004). Final Act. 16–21. Claims 56–58 stand rejected under pre-AIA 35 U.S.C. § 103 as unpatentable over Li, Bhushan, and Orzalesi. Final Act. 21–22. Claims 2 and 7 stand rejected for nonstatutory double patenting over claims 6 and 9–10 of Hendrick ’132 (US 9,849,132 B2, issued Dec. 26, 2017). Final Act. 22–23. Claims 56–58 stand rejected for nonstatutory double patenting over claims 6 and 9–10 of Hendrick ’132 in view of Orzalesi. Final Act. 23–24. ANALYSIS Standard of Review We undertake a limited de novo review of the appealed rejection for error based upon the issues identified by Appellant, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential). 1. Obviousness Legal Principles Title 35, section 103, provides A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically Appeal 2020-002946 Application 13/203,365 5 disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) where present, objective evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966). Independent Claim 2 The Examiner finds that Li teaches PDE 1 inhibitors including the elected species of Cis-(6aR*,10aS*)-2-(4-(Pyridin-2yl)benzyl)-5,6a,7,8,9,10,10a- heptahydro-5-methyl-3-(phenylamino)cyclohex[4,5] imidazo[l,2-a]pyrazolo[4,3-e]pyrimidin-4(2H)-one Li’s Example 8, shown above, depicts the chemical formula for a PDE 1 inhibitor for treatment of neurodegenerative diseases. for the treatment and prophylaxis of PDE 1 related disorders, including neurodegenerative diseases like Alzheimer’s and Parkinson’s. Final Act. 6 (citing Li ¶¶ 61, 65, 68, 96–Example 8). The Examiner acknowledges that Appeal 2020-002946 Application 13/203,365 6 Li does not teach treatment of glaucoma, but finds that Gupta “teaches that glaucoma is a neurodegenerative disease and that there are numerous similarities between glaucoma and other neurodegenerative diseases like Alzheimer’s and Parkinson’s.” Id. at 7. The Examiner finds it prima facie obvious that one would use Li’s compounds to treat glaucoma with a reasonable expectation of success absent evidence of criticality for the elected compound considering Gupta’s teaching that glaucoma has “numerous similarities” with the neurodegenerative diseases, Alzheimer’s and Parkinson’s, which are described in Li as treatable using Li’s compound. Id. Appellant disagrees with the Examiner’s rejection. Appeal Br. 4–5. Appellant argues that “Gupta does not mention the effectiveness of a PDE inhibitor to treat glaucoma” and that the Examiner has “not demonstrated that the Gupta abstract teaches or suggests that treatment for diseases such as Alzheimer’s or Parkinson’s could be similarly applied to glaucoma.” Id.; see also Reply Br. 2. However, the Examiner did not rely on Gupta alone to teach this feature, but on the combination of Li and Gupta. As the Examiner notes, Appellant’s argument attacks Gupta individually and does not consider what a person of ordinary skill in the art would have understood from the combination of Li and Gupta. Final Act. 8. This is an improper approach to the obviousness inquiry. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981)) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”). Also, Appellant’s argument against Gupta alone does not address the Examiner’s rejection as applied. See 37 C.F.R. Appeal 2020-002946 Application 13/203,365 7 § 41.37(c)(1)(iv) (“The arguments shall explain why the examiner erred as to each ground of rejection contested by appellant.”) (Emphasis added). Appellant argues that “Gupta also does not draw any inference whatsoever as to the role of PDE 1 in any of Parkinson’s Disease, Alzheimer’s Disease or glaucoma.” Appeal Br. 4. Appellant does not explain why Gupta must teach the role of PDE 1 in order to support the rejection. In any case, Li describes the role of PDE 1 as a selective inhibitor in treatment of neurodegenerative diseases. Li ¶¶ 1, 61. Appellant further argues that “Gupta only names a few symptoms common to Parkinson’s Disease, Alzheimer’s Disease or glaucoma.” Appeal Br. 4. Appellant’s argument overlooks that the Examiner relies on Gupta’s teaching that “[n]umerous similarities exist between glaucoma and neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases.” Gupta 1 (emphasis added); Final Act. 7. Gupta provides the specific examples of selective loss of neuron populations, transsynaptic degeneration, and common mechanisms of cell injury and death, but a person of ordinary skill would have understood that Gupta’s “numerous similarities” implies more than just a few similarities, which would have led one to consider using treatments known to be effective for neurodegenerative diseases on glaucoma. Id. Accordingly, we do not find Appellant’s argument persuasive. Appellant next asserts that “Gupta’s failure to acknowledge PDE1 inhibitors in any way would lead one to assume that glaucoma should be treated with any of the normal avenues of treatment on the market.” Appeal Br. 5. This argument again attacks Gupta individually and does not consider Appeal 2020-002946 Application 13/203,365 8 what a person or ordinary skill in the art would have understood from the combined teachings of Li and Gupta. See Merck, supra. Appellant argues that Example 10 of Appellant’s application WO 201849417 A1 shows that PDE1 inhibitory compound substantially increased survival of retinal ganglion cells in mice. Appeal Br. 9. Appellant emphasizes that treatment of glaucoma through increasing survival of optic neurons or through axonal regeneration were not known mechanisms in the art, and that this result was highly unexpected. Reply Br. 4. But using Li’s PDE 1 inhibitor compound to treat glaucoma, as suggested by Li and Gupta, would achieve the same results, even if one would not have recognized from their teachings the specific mechanisms by which the combination of Li and Gupta is effective. Appellant further argues that data submitted in the Appeal Brief, taken together with the Declaration submitted September 5, 2017 (Appeal Br. 9– 10, Appendix B), shows that the claimed compounds, applied topically to rabbits, achieve the unexpected result of penetrating ocular tissue and treating glaucoma. Appeal Br. 9–10. We agree with the Examiner that the Appellant’s data and Declaration are not commensurate in scope with the claim. Ans. 4–6. Specifically, the claim is not restricted to topical application of the claimed PDE 1 inhibitor compound. For the foregoing reasons, we sustain the Examiner’s rejection of claim 2 for obviousness over the combination of Li and Gupta. Dependent Claims 7 and 56–58 Appellant presents no separate arguments for claim 7, which falls for the reasons stated for claim 2. See 37 C.F.R. § 41.37(c)(1)(iv) (“[T]he failure of appellant to separately argue claims which appellant has grouped Appeal 2020-002946 Application 13/203,365 9 together shall constitute a waiver of any argument that the Board must consider the patentability of any grouped claim separately.”). For claims 56–58, Appellant contends that Orzalesi fails to provide a rationale that would guide one to treat glaucoma with the claimed compounds, or account for the unexpected results obtained by Appellant, or account for the alleged deficiencies of Li, Gupta, Bell, and Bhushan. Appeal Br. 10–11. The Examiner explained how one would be guided to use Li’s compound to treat glaucoma based on Li’s and Gupta’s teachings. Final Act. 9–10. Appellant does not explain why the result of using Li’s PDE 1 inhibitor compound to treat glaucoma, as suggested by Li and Gupta, would not achieve the same result of optic neuron survival and axonal regeneration observed in Appellant’s testing of its compound. Furthermore, Appellant has not identified any deficiencies in the combination of Li and Gupta that Orzalesi was needed to cover. Consequently, the dependent claims fall for the same reasons as independent claim 2. Remaining Obviousness Rejections As we sustain the Examiner’s rejections of claims 2 and 7 over Li and Gupta, and of claims 56–58 over the combination of Li, Gupta, and Orzalesi, we do not reach the remaining obviousness rejections. 2. Obviousness-Type Double Patenting Legal Principles The doctrine of double patenting seeks to prevent the unjustified extension of patent exclusivity beyond the term of a patent. In re Zickendraht, 319 F.2d 225, 232 (CCPA 1963); In re Van Ornum, 686 F.2d 937 (CCPA 1982). In obviousness-type double patenting, the examiner Appeal 2020-002946 Application 13/203,365 10 normally applies the one-way test, which requires a showing that an application’s claims are obvious in view of a patent’s. MPEP § 806. In unusual circumstances, such as when an application for an improvement issues before a basic invention through no fault of the applicant, the examiner applies a two-way test, which requires, in addition, a showing that the patent’s claims are obvious in view of the application’s. In re Janssen Biotech, Inc., 880 F.3d 1315 (Fed. Cir. 2018); In re Berg, 140 F.3d 1428 (Fed. Cir. 1998). Claims 2, 7, and 56–58 The Examiner applies the one-way test for obviousness-type double patenting, finding that, although not identical, claims 2 and 7 for a PDE 1 inhibitor are not patentability distinct from claims 6, 9, and 10 of Hendrik ’132 for the combination of a PDE 1 inhibitor and a PDE 2 inhibitor. Final Act. 22–23. Appellant argues that it “would not have been obvious to treat glaucoma or elevated intraocular pressure with a PDE1 inhibitor as presently claimed in light of the ’132 patent’s combination of a PDE1 and PDE2 inhibitor.” Appeal Br. 11. We find the Examiner’s analysis to be conclusory. It does not explain why one would have used a PDE 1 inhibitor alone to treat glaucoma when Hendrik ’132 teaches that the combination of PDE 1 and PDE 2 inhibitors has “more than an additive effect” on the nitric oxide signaling in the brain, thereby increasing cGMP levels. Hendrik ’132 3:18–22. In other words, one would have understood Hendrik ’132 to teach that the PDE1 and PDE2 Appeal 2020-002946 Application 13/203,365 11 inhibitors should be used together. The Examiner has not shown why one would seek to use the PDE 1 inhibitor alone from Hendrik ’132’s teachings. Accordingly, we do not sustain the obviousness-type double patenting rejection of claims 2, 7, and 56–58. CONCLUSION We affirm the Examiner’s rejections of claims 2 and 7 over Li and Gupta, and of claims 56–58 over Li, Gupta, and Orzalesi, for obviousness under 35 U.S.C. § 103. We do not reach the remaining obviousness rejections. We reverse the rejections of claims 2, 7, and 56–58 for obviousness- type double patenting over Hendrik. In summary: Claim(s) Rejected 35 U.S.C. §4 Reference(s)/Basis Affirmed Reversed 2, 7 103 Li, Gupta 2, 7 56–58 103 Li, Gupta, Orzalesi 56–58 2, 7 103 Li, Bell 56–58 103 Li, Bell, Orzalesi 2, 7 103 Li, Bhushan 56–58 103 Li, Bhushan, Orzalesi 2, 7 Nonstatutory Double Patenting 2, 7 56–58 Nonstatutory Double Patenting 56–58 Overall Outcome 2, 7, 56– 58 4 Since we affirm the obviousness rejections of claims 2 and 7 based on Li and Gupta, and of claims 56–58 based on Li, Gupta, and Orzalesi, we do not reach the remaining obviousness rejections. Appeal 2020-002946 Application 13/203,365 12 Because we have affirmed at least one ground of rejection with respect to each claim on appeal, the Examiner’s decision is affirmed. See 37 C.F.R. § 41.50(a)(1). 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)(1)(iv). See 37 C.F.R. § 41.50(f) (2019). AFFIRMED Copy with citationCopy as parenthetical citation