AMGEN K-A, INCDownload PDFPatent Trials and Appeals BoardDec 17, 20202020002001 (P.T.A.B. Dec. 17, 2020) 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. 15/513,132 03/21/2017 Hidemi NAKAGAWA MEDIM-36323.251 4706 72960 7590 12/17/2020 Casimir Jones, S.C. 2275 Deming Way Ste 310 Middleton, WI 53562 EXAMINER LI, RUIXIANG ART UNIT PAPER NUMBER 1646 NOTIFICATION DATE DELIVERY MODE 12/17/2020 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): docketing@casimirjones.com pto.correspondence@casimirjones.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte HIDEMI NAKAGAWA and HIROKI MATSUDO ____________ Appeal 2020-002001 Application 15/513,132 Technology Center 1600 ____________ Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks our review,2 under 35 U.S.C. § 134(a), of the Examiner’s decision to reject claims 15, 16, and 18–23 (Appeal Br. 1–2.) We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Amgen K-A, Inc. (See Appeal Br. 1.) 2 We consider the Specification dated March 21, 2017 (“Spec.”), Final Office Action issued February 25, 2019 (“Final Act.”), the Appeal Brief filed October 14, 2019 (“Appeal Br.”), and the Examiner’s Answer issued November 8, 2019 (“Ans.”). Appeal 2020-002001 Application 15/513,132 2 INTRODUCTION Appellant’s Specification describes Interleukin (“IL”)-17RA as a type I transmembrane receptor that binds with proinflammatory cytokines, including IL-17A, IL-17F, and IL-17A/F. (Spec. ¶¶ 3, 5.) The Specification explains that blocking Interleukin-17RA “represents a novel mechanism to inhibit the inflammation and clinical symptoms associated with autoimmune and inflammatory diseases including” psoriasis. (Id. ¶ 5.) The Specification describes AM-14 as a specific monoclonal antibody that binds to human IL- 17RA and blocks the biological activities of IL-17A, IL17F, and IL17A/F heterodimer. (Id. ¶ 6.) The Specification further describes treating psoriasis patients who have been previously treated or cannot be treated with anti-tumor necrosis factor-alpha (“TNF-alpha”) antibodies. (Id. ¶ 31.) For example, the Specification describes psoriasis patients who cannot be treated with an anti- TNF-alpha antibody as patients who exhibit primary or secondary failure to anti-TNF-alpha antibody treatment. (Id. ¶ 41.) Appellant’s claim 15 recites: A method for the treatment of pustular psoriasis or psoriatic erythroderma, comprising administering an anti-IL-17RA monoclonal antibody to a psoriasis patient who has failed treatment with an anti-TNF- alpha antibody, wherein each of the CDR1, CDR2, and CDR3 of the heavy chain variable region (VH) of the anti-IL-17RA monoclonal antibody comprises the amino acid sequence of SEQ ID NOs: 1, 2, and 3, respectively, and each of the CDR1, CDR2, and CDR3 of the light chain variable region (VL) of the anti-IL-17RA monoclonal antibody Appeal 2020-002001 Application 15/513,132 3 comprises the amino acid sequence of SEQ ID NOs: 4, 5, and 6, respectively. (Appeal Br. 9.) ANALYSIS The Examiner rejects claims 15, 16, and 18–233 under 35 U.S.C. § 103 as unpatentable over Guettner4 and Martin.5 (See Final Act. 3–5.) Appellant does not argue for the separate patentability of any of the rejected claims in the Appeal Brief. Accordingly, we focus on claim 15 in our review. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds Guettner teaches a method of treating a patient with pustular psoriasis or psoriatic erythroderma by administering an IL-17 receptor antibody. (Final Act. 3, citing Guettner abstract, 3–4, 12, 14, 15.) Guettner teaches that the patient “may be an anti-TNF alpha psoriasis treatment non-responder, partial responder, . . . relapser or rebounder.” (Guettner 60; see Final Act. 3.) The Examiner finds that Guettner does not teach the specific anti-IL-17RA monoclonal antibody recited by claim 15, comprising amino acid sequences of SEQ ID Nos: 1–6. (See Final Act. 3– 4.) The Examiner finds that Martin teaches the monoclonal anti-IL-17RA antibody of claim 15, comprising amino acid sequences of SEQ ID Nos: 1– 6. (See Final Act. 4, citing sequence alignment in Office Action issued November 2, 2018.) The Examiner finds that Martin teaches administering 3 Claims 1–14 are withdrawn. Claims 17 and 24–34 are cancelled. 4 Guettner et al., WO 2012/045848 A1, published April 12, 2012 (referred to as the ’848 PCT by Appellant). 5 Martin et al., WO 2011/046958 A1, published April 21, 2011 (referred to as the ’958 PCT by Appellant). Appeal 2020-002001 Application 15/513,132 4 anti-IL-17RA antibodies to treat various diseases including pustular psoriasis and erythrodermic psoriasis. (See Final Act. 4, citing Martin 99.) The Examiner finds that it would have been obvious to administer Martin’s anti-IL-17RA antibody to treat pustular psoriasis or psoriatic erythroderma because Guettner teaches administering anti-IL-17 receptor antibodies to treat the conditions in patient who have failed anti-TNF-alpha antibody treatment. (See Final Act. 4.) Appellant argues Guettner teaches treating psoriasis using anti-IL-17 monoclonal antibodies, e.g., secukinumab, rather than an anti-IL-17 receptor antibody. (Appeal Br. 3.) Appellant argues that treating psoriasis with an IL-17 binding antibody does not automatically suggest treating psoriasis with an IL-17 receptor binding antibody. (Id.) We are not persuaded by Appellant’s argument because Guettner teaches administering an anti-IL-17 receptor antibody. For example, Guettner teaches treating psoriasis by administering an IL-17 antagonist. (Guettner 3:25–4:2.) Guettner teaches “examples of IL-17 antagonists include IL-17 binding molecules and IL-17 receptor binding molecules.” (Id. at 12:13–18.) Guettner teaches IL-17 receptor binding molecules include “antibodies to the IL-17 receptor.” (Id. at 13:3–13.) Finally, Guettner teaches administering a therapeutically effective amount of an IL- 17 antagonist, “e.g., an IL-17 receptor antibody.” (Id. at 20:3–6.) Although Guettner teaches working examples of administering secukinumab to treat psoriasis (see Examples 2 and 3), all disclosures of the prior art including the unpreferred embodiments must be considered. See Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Appeal 2020-002001 Application 15/513,132 5 Appellant further argues that the Examiner has not provided a reason to combine and modify the prior art teachings to arrive at the claimed invention. (Appeal Br. 4.) Appellant argues that the rejection takes the position that “one of ordinary skill in the art could have carried out the claimed method,” not that a person of ordinary skill in the art would have had a reason to do so. (Id.) We are not persuaded by Appellant’s argument because the Examiner provides articulated reasoning with some rational underpinning to support the legal conclusion of obviousness. (See Final Act. 4.) The Examiner finds that a person of ordinary skill in the art would have been motivated to administer Martin’s anti-IL-17RA monoclonal antibody, which is useful for treating psoriasis, in Guettner’s method for treating psoriasis in patients who have failed anti-TNF-alpha antibody treatment with an anti-IL-17 receptor monoclonal antibody. (See id.) Combining Guettner’s treatment method with Martin’s specific antibody is no more than the combination of familiar elements according to known methods yielding predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Finally, Appellant argues that the Examiner impermissibly engaged in hindsight reconstruction of the claimed invention using Appellant’s invention as a roadmap. (Appeal Br. 5.) We are not persuaded by Appellant’s argument as the Examiner has shown that the prior art: (1) teaches the claimed elements and limitations and (2) provides a reason to combine the references with a reasonable expectation of success in the combination. Accordingly, the Examiner’s rejection properly takes into account only knowledge that was within the level of ordinary skill at the time the claimed invention was made and does Appeal 2020-002001 Application 15/513,132 6 not include knowledge gleaned only from applicant’s disclosure. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Appellant fails to present any argument persuading us that the Examiner erred. CONCLUSION Upon consideration of the record and for the reasons given, we affirm the Examiner’s rejection. In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 15, 16, 18–23 103 Guettner, Martin 15, 16, 18–23 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136. AFFIRMED Copy with citationCopy as parenthetical citation