13286707 (P.T.A.B. Jun. 9, 2017)

Ex Parte Ghayur et al

Patent Trial and Appeal BoardJun 9, 2017

13286707 (P.T.A.B. Jun. 9, 2017)

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. 13/286,707 11/01/2011 Tariq Ghayur 12252.0066 (10117.US.O!) 7358 12278 7590 AbbVie/Finnegan 901 New York Ave., NW Washington, DC 20001 06/13/2017 EXAMINER WU, JULIE ZHEN QIN ART UNIT PAPER NUMBER 1642 NOTIFICATION DATE DELIVERY MODE 06/13/2017 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): regional-desk @ finnegan. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TARIQ GHAYUR, JUNJIAN LIU, JIJIE GU, and MARIA C. HARRIS1 Appeal 2016-001765 Application 13/286,707 Technology Center 1600 Before ULRIKE W. JENKS, TAWEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a binding protein that is capable of binding Tumor Necrosis Factor (TNF) and Prostaglandin E2 (PGE2). The Examiner rejects the claims as obvious and on the grounds of nonstatutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the Real Party in Interest is AbbVie Inc. Appeal Br. 4. Appeal 2016-001765 Application 13/286,707 STATEMENT OF THE CASE The Specification discloses the production of dual variable domain (DVD) binding proteins. See Spec. 5:19-20. Claims 116, 119, 122, 123, 126-129, 136-138, 146, and 147 are on appeal2, and can be found in the Claims Appendix of the Appeal Brief. Claim 116 is representative of the claims on appeal, and reads as follows: 116. A binding protein comprising first and second polypeptide chains, each independently comprising VD1- (Xl)n-VD2-C-(X2)n, wherein VD1 is a first variable domain; VD2 is a second variable domain; C is a constant domain; XI is a linker; X2 is an Fc region; n is 0 or 1; wherein the VD1 domains on the first and second polypeptide chains form a first functional target binding site and the VD2 domains on the first and second polypeptide chains form a second functional target binding site, and wherein the binding protein is capable of binding TNF and PGE2, and the first and second polypeptide chains of the binding protein comprise: SEQ ID NO: 178 and 179 (DVD 1074),... or SEQ ID NO: 244 and 245 (DVD 1726). Appellants seek review of the following rejections: Claims 116, 119, 122, 123, 126-129, 136-138, 146, and 147 under 35 U.S.C. § 103(a) as unpatentable over Ghayur-I,3 Paszty,4 and Ghayur-II.5 2 Claims 130-135 and 139-145 have been withdrawn. Appeal Br. 4. 3 Ghayur et al., US 2010/0074900 Al, published Mar. 25, 2010, now US 8,822,645 B2, issued Sept. 2, 2014 (“Ghayur-I”). 4 Paszty et al., US 2007/0110747 Al, published May 17, 2007 (“Paszty”). 5 Ghayur et al., US 2009/0311253 Al, published Dec. 17, 2009, now US 9,035,027 B2, issued May 19, 2015 (“Ghayur-II”). 2 Appeal 2016-001765 Application 13/286,707 Claims 116, 119, 122, 123, 126, 129, 136-138, 146, and 147 on the ground nonstatutory obviousness-type double patenting over claims in copending application 12/499,652 (Ghayur-I, nowU.S. Patent No. 8,822,645 B2, issued Sept. 2, 2014) and Paszty and Ghayur-II. Obviousness over Ghayur-I, Paszty, and Ghayur-II The issue is: Does the preponderance of the evidence of record support the Examiner’s conclusion that it would have been obvious to one of ordinary skill in the art to substitute framework region (FR) sequences found in Paszty and Ghayur-II for the FR sequences in Ghayur-I? Findings of Fact We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art as set out in the Answer and Final Action mailed Aug. 29, 2014. For emphasis only we highlight the following: FF1. Ghayur-I teaches a polypeptide chain [that] comprises VDl-(Xl)n-VD2-C- (X2)n, wherein VD1 is a first variable domain, VD2 is a second variable domain, C is a constant domain, XI represents an amino acid or polypeptide, X2 represents an Fc region and n is 0 or 1... . VD1 and VD2 are capable of binding different antigens. Ghayur-I 114. FF2. Ghayur-I teaches antibody components: In a full-length antibody, each heavy chain is comprised of a heavy chain variable region (abbreviated herein as HCVR or VH) and a heavy chain constant region. . . . Each light chain is comprised of a light chain variable region (abbreviated herein as FCVR or VF) and a light chain constant region. . . . The VH and VF regions can be further subdivided into regions of 3 Appeal 2016-001765 Application 13/286,707 hypervariability, termed complementarity determining regions (CDR), interspersed with regions that are more conserved, termed framework regions (FR). Each VH and VL is composed of three CDRs and four FRs. Ghayur-1191. FF3. Ghayur-I teaches making framework substitutions. Framework residues in the human framework regions may be substituted with the corresponding residue from the CDR [(complementarity determining region)] donor antibody to alter, e.g., improve, antigen binding. These framework substitutions are identified by methods well known in the art... . FR residues can be selected and combined from the consensus and import sequences so that the desired antibody characteristic, such as increased affinity for the target antigen(s), is achieved. In general, the CDR residues are directly and most substantially involved in influencing antigen binding. Ghayur-I 1158. FF4. Ghayur-I teaches cloning of TNFa/Anti-PGE2 DVD-Ig. six murine anti-murine TNFa/anti-PGE2 DVD-Ig molecules with no either human linker (hNL), human short linker (hSL), or human long linker (hLL) were generated .... The DNA encoding the VH of the DVD- Ig molecules was fused to human heavy chain IgGl constant region and the DNA encoding the VL of the DVD-Ig molecules was fused to human light chain k constant region, respectively. Ghayur-I 1 603. Ghayur I teaches VH and VL regions of anti-human TNF and anti-PGE2 DVD-IG with human linkers. Ghayur-I 1611 (Table 8). FF5. Ghayur-I teaches “a pharmaceutical composition comprising a binding protein, as disclosed herein .... In a further embodiment the pharmaceutical composition comprises at least one additional 4 Appeal 2016-001765 Application 13/286,707 therapeutic agent for treating a disorder. ... For example, the additional agent is selected from the group” including rapamycin. Ghayur-I | 64. FF6. The Examiner finds that Ghayur-I teaches SEQ ID NO: 118 and 119, these sequences contain “the variable domains that binds TNF[, and that] are comprised of SEQ ID N0:30 and SEQ ID N0:31, which is the same [sequence] as the variable domain for TNF of instant DVD 1074.” Ans. 5. FF7. A graphical depiction of the teachings of the references is provided by the Examiner in the Answer. Figure 1 of the Examiner’s Answer is reproduced below: Figure 1 Claimed DVD1074 TNF PGE2 jIcnIk PI }0|5Q, C