Ex Parte AlbaniDownload PDFPatent Trial and Appeal BoardJun 9, 201612302685 (P.T.A.B. Jun. 9, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/302,685 08/19/2009 Salvatore Albani 28213 7590 06/13/2016 DLA PIPER LLP (US) 4365 EXECUTIVE DRIVE SUITE 1100 SAN DIEGO, CA 92121-2133 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 ATTORNEY DOCKET NO. CONFIRMATION NO. UCSD1940-l 9260 EXAMINER EWOLDT, GERALD R ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 06/13/2016 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): gtdocket@dlapiper.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SALVATORE ALBANI Appeal2014-000739 Application 12/302,685 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and RICHARD J. SMITH, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. § 134(a) involves claims 1, 2, 4, 27, and 28 (App. Br. 3). 2 Examiner entered a rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 Appellant identifies the Real Party in Interest as "The Regents of the University of California" (App. Br. 3). 2 "Claims 5, 8-10, 13-15, and 17-25 [stand] withdrawn" from consideration (App. Br. 3). Appeal2014-000739 Application 12/302,685 STATEMENT OF THE CASE Claim 1 is representative and reproduced below: 1. A composition comprising a peptide selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 56 and SEQ ID NO: 57 and a chloroquine molecule. App. Br. 21 (Claims Appendix). Examiner finds, and Appellant does not dispute, that Appellant's "[ c ]laim 1 ... encompass[ es] a composition comprising a peptide of any of SEQ ID NOs: 1-57 and a chloroquine molecule." (Ans. 3). Claims 1, 2, 4, 27, and 28 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of 0 'Dell, 3 Weinblatt, 4 Hsiao, 5 Albani, 6 and Koffeman. 7 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 3 O'Dell et al., Treatment of Rheumatoid Arthritis With Methotrexate and Hydroxychloroquine, Methotrexate and Sulfasalazine, or a Combination of the Three Medications, 46(5) AM. COLL. RHEUM. 1164--1170 (2002). 4 M. E. Weinblatt, METHOTREXATE IN RHEUMATOID ARTHRITIS: TOXICITY ISSUES, 35(5) BRIT. J. RHEUM. 403--406 (1996). 5 Hsiao et al., Evaluation for synergistic suppression of T cell responses to minor histocompatibility antigens by chloroquine in combination with tacrolimus and a rapamycin derivative, SDZ-RAD, 30 BONE MARROW TRANSPLANTATION 905-913 (2002). 6 Albani, WO 03/026579 A2, published April 3, 2003. 7 Koffeman et al., Epitope-Specific Immunotherapy of Rheumatoid Arthritis 60(11) AM. COLL. RHEUM. 3207-16 (2009). 2 Appeal2014-000739 Application 12/302,685 FACTUAL FINDINGS (FF) FF 1. Examiner finds that O'Dell discloses an "immunosuppressive combination composition of methotrexate (MTX) and hydroxychloroquine (HCQ) for the treatment of rheumatoid arthritis (RA)" (Ans. 3). FF 2. Examiner finds that O'Dell fails to disclose a composition comprising a peptide having any of SEQ ID NOs: 1-57 (id.). FF 3. W einblatt discloses that MTX "is hepatotoxic" (Weinblatt 403; Ans. 4). FF 4. Hsiao discloses that "hydroxychloroquine[ is a] lysosomotrophic amine[ s] that inhibit[ s] processing and presentation of MHC class II antigens to CD4+ T cells in vitro ... and unlike most current immunosuppressive agents, hydroxychloroquine has little renal or hepatic toxicity" (Hsiao 905- 906; see generally Ans. 4 ). FF 5. Albani discloses a method "for the combination of epitope-specific and cytokine/anticytokine therapy to achieve effective control of immune mediated disease processes," which "include, but are not limited to, rheumatoid arthritis" (Albani i-f 11 ). FF 6. Examiner finds that Albani discloses antigen-specific epitopes that include "the peptides of SEQ ID Nos:l-57'' (Ans. 4; see e.g., Appellant's SEQ ID Nos: 1-3; cf Albani 9: Table 1, SEQ ID Nos: 21-23) FF 7. Albani defines the term cytokine as encompassing "chemokines, interleukins, lymphokines, monokines, colony stimulating factors, and receptor associated proteins, and functional fragments thereof. As used herein, the term "functional fragment" refers to a polypeptide which possesses biological function or activity that is identified through a defined functional assay" (Albani i-f 36). 3 Appeal2014-000739 Application 12/302,685 ANALYSIS Based on the combination of O'Dell, Weinblatt, Hsiao, Albani, and Koffeman, Examiner concludes that, at the time Appellant's invention was made, it would have been prima facie obvious to combine "HCQ and the epitope-specific peptides of [Albani] for the treatment of RA" (Ans. 4). In this regard, Examiner asserts that Albani suggests "replac[ing] MTX with the epitope-specific peptides of [Albani] to both reduce toxicity and create a more specific composition for the treatment of RA with reduced side effects" (id.). We are not persuaded. As Appellant explains, "Albani describes methods for generally treating immune mediated diseases with combinations of antigen-specific epitopes and cytokines or agents that affect cytokine activity or expression" (App. Br. 11; FF 5-7). Albani does not "describe or suggest combinations of chloroquine molecules, [as suggested by 0 'Dell, Weinblatt, and Hsiao], much less [the combination of chloroquine molecules] with an immune tolerance agent (e.g., a peptide selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 56 and SEQ ID NO: 57)" (App. Br. 12; see FF 1--4; cf FF 5 and 7). On this record, Examiner failed to establish an evidentiary basis to support a conclusion that MTX and/or HCQ are functionally equivalent to Albani' s cytokines or agents that affect cytokine activity or expression (see FF 5-7; cf FF 1--4). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1, 2, 4, 27, and 4 Appeal2014-000739 Application 12/302,685 28 under 35 U.S.C. § 103(a) as unpatentable over the combination of O'Dell, Weinblatt, Hsiao, Albani, and Koffeman is reversed. REVERSED 5 Copy with citationCopy as parenthetical citation