Ex Parte LawsonDownload PDFPatent Trial and Appeal BoardJan 13, 201611910612 (P.T.A.B. Jan. 13, 2016) 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. 11/910,612 10/27/2008 Alastair David Griffiths Lawson 07-957 8167 20306 7590 01/14/2016 MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP 300 S. WACKER DRIVE 32ND FLOOR CHICAGO, IL 60606 EXAMINER BRISTOL, LYNN ANNE ART UNIT PAPER NUMBER 1643 MAIL DATE DELIVERY MODE 01/14/2016 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ALASTAIR DAVID GRIFFITHS LAWSON1 ____________ Appeal 2013-005882 Application 11/910,612 Technology Center 1600 ____________ Before ERIC B. GRIMES, JACQUELINE T. HARLOW, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of obtaining at least one recombinant antibody with increased affinity for a selected antigen. (Appeal Br. 8–12.) We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellant, the real party in interest is UCB Celltech (Appeal Br. 2.) Appeal 2013-005882 Application 11/910,612 2 STATEMENT OF THE CASE The Specification states that [antibodies] are Y-shaped molecules comprising two identical heavy chains and two identical light chains. . . . Each chain consists of one variable domain that varies in sequence and is responsible for antigen binding . . . known as the VH and VL domains for the heavy and light chains respectively. . . . . . . [T]hree regions within the variable domains that are hypervariable in sequence . . . are primarily responsible for antigen recognition and are referred to as “complementarity- determining regions” (CDRs). (Spec. 1, ll. 10–20.) Claims on Appeal Claims 1–9, 11, 12, and 21–30 are on appeal.2 (Appeal Br. 8–12.) Claim 1 is illustrative and reads as follows (with emphasis added): 1. A method of obtaining at least one recombinant antibody with increased affinity for a selected antigen from a family of antibodies which bind the selected antigen comprising: a) obtaining from B cells a family of two or more antibodies which bind the same antigen and retain the in vivo generated VH and VL pairings in which the VH CDR3 amino acid sequence of each antibody in the family is 100% identical, wherein the antibodies are obtained by isolating individual B-cells which produce antigen specific antibodies and wherein each antibody obtained in step a) is isolated from 2 Claims 10 and 13–20 are withdrawn from further consideration as being drawn to a nonelected invention. (Adv. Act. 2, dated Aug. 2, 2012.) Appeal 2013-005882 Application 11/910,612 3 a single B cell, and the sequences encoding the variable regions of those antibodies are obtained; b) preparing new combinations of VH and VL regions by re-pairing the VH region of an antibody obtained in step (a) with the VL region from a different antibody obtained in step (a) to produce new recombinant antibody; and c) screening the recombinant antibody produced in step (b) and selecting said antibody if it has increased affinity for the selected antigen compared to any one of the antibodies obtained in step (a). Examiner’s Rejection Claims 1–9, 11, 12, and 21–30 stand rejected under 35 U.S.C. § 102(e) as anticipated by Burton.3 (Ans. 3.) Issue Whether the Examiner erred in finding claims 1–9, 11, 12, and 21–30 anticipated by Burton. Principles of Law Anticipation requires that a prior art reference disclose every limitation of the claimed invention, either explicitly or inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). Analysis The anticipation rejection is based, in part, on the Examiner’s findings that Burton teaches (1) “isolating antibody-producing clones from in vivo 3 US 2003/0187247 A1, published Oct. 2, 2003. Appeal 2013-005882 Application 11/910,612 4 stimulated B cells of HIV-seropositive individuals” (Ans. 4), and (2) “a family of antibodies isolated from B cells (i.e. with their natural pairings)” (id. at 6). Appellant argues that “[t]he examiner has wrongly assumed that simply because the antibodies from which the library was generated were produced in vivo, that the in vivo retention feature of the claim is satisfied.” (Reply Br. 8.) In support of this argument, Appellant references Burton’s description of phage display vectors and the preparation of antibody libraries for the contention that phage display techniques, by their very nature, “create diversity by combining different permutations of heavy and light chains, and therefore the antibodies present in the library do not retain their natural VH/VL pairings.” (Id.) Appellant also argues that “Burton does not teach a family of antibodies retaining their natural parings” and that “the clones in Burton do not retain their in vivo VH/VL pairing because they have been generated through combining heavy and light chain libraries.” (Id. at 9.) We are persuaded by Appellant’s arguments. Claims 1 and 21, the only independent claims, recite methods that require that the family of antibodies obtained from B cells “retain the in vivo generated VH and VL pairings.” (Appeal Br. 8, 10.) However, the Examiner fails to establish that this claim limitation is explicitly or inherently disclosed in Burton. In contrast, Appellant has persuasively argued that “the present method obtains antibodies to a target antigen while retaining their natural variable region pairing” whereas “the initial antibody population disclosed in Burton does not retain its in vivo VH/VL pairings.” (Reply Br. 6, 8.) Accordingly, we Appeal 2013-005882 Application 11/910,612 5 find that the Examiner erred in finding claims 1–9, 11, 12, and 21–30 anticipated by Burton. SUMMARY Because the Examiner has not shown by a preponderance of evidence that the claimed invention is anticipated by Burton, we reverse the rejection on appeal. REVERSED bar Copy with citationCopy as parenthetical citation