Ex Parte Weiner et al

Patent Trial and Appeal BoardJan 17, 2013

10168694 (P.T.A.B. Jan. 17, 2013)

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. 10/168,694 12/09/2002 David B. Weiner 130694.07501 9718 34137 7590 01/17/2013 Pepper Hamilton LLP 400 Berwyn Park 899 Cassatt Road Berwyn, PA 19312-1183 EXAMINER PARAS JR, PETER ART UNIT PAPER NUMBER 1632 MAIL DATE DELIVERY MODE 01/17/2013 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 DAVID B. WEINER, JEONG-IM SIN, and DONGHUI ZHANG __________ Appeal 2011-012069 Application 10/168,694 Technology Center 1600 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and MELANIE L. McCOLLUM, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of inducing an immune response. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 85-88 are pending and on appeal (App. Br. 4). We will focus on claim 85, the only independent claim on appeal, which reads as follows: 85. A method of inducing a humoral and cellular immune response in an individual against Herpes Simplex Virus-1 antigens encoded by nucleotides 5938-44597 of Herpes Simplex Virus-1 genome comprising the step of administering to said individual a cosmid that comprises nucleotides Appeal 2011-012069 Application 10/168,694 2 5938-44597 of Herpes Simplex Virus-1 genome, wherein said cosmid is taken up by cells in said individual, said coding nucleotide sequences are expressed and a cellular immune response and a humoral immune response- against antigens encoded by the coding nucleotide sequences are induced in said individual. Claims 85-88 stand rejected under 35 U.S.C. § 103(a) as obvious over Webb1 in view of Barry,2 Cunningham,3 Malone,4 and Weiner5 (Ans. 4-5). The Examiner relies on Webb for teaching “that polyclonal antibodies can be used to detect a protein involved in disease” and that, “[t]o produce high levels of antibodies to the protein, the purified protein is introduced into the bloodstream of the mammal together with the immunostimulating adjuvant” (id. at 5). The Examiner relies on Barry for teaching “that genetic immunization can be practiced to produce humoral immune responses to antigens of interest, wherein the antigen is introduced via an expression construct” (id.). The Examiner relies on Cunningham for teaching “that clone cos24 comprises sequences 5938-44597 of the HSV-1 genome” (id. at 6). The Examiner concludes that it would have been obvious “to introduce an expression construct comprising nucleotides 5938-44597 of the HSV-1 genome to a mammal in order to arrive at a mammal that produced polyclonal antibodies to the various proteins encoded by nucleotides 5938- 44597 of the HSV-1 genome” (id.). 1 Webb et al., US 4,746,539, May 24, 1988. 2 Barry & Johnston, Biological features of genetic immunization, 15 VACCINE 788-791 (1997). 3 Cunningham & Davison, A Cosmid-Based System for Constructing Mutants of Herpes Simplex Virus Type 1, 197 VIROLOGY 116-124 (1993). 4 Malone et al., WO 97/44446 A1, Nov. 27, 1997. 5 Weiner et al., US 6,468,982 B1, Oct. 22, 2002. Appeal 2011-012069 Application 10/168,694 3 The Examiner relies on Malone and Weiner for teaching features of dependent claims (id. at 6-7). ANALYSIS Appellants argue “that the Example set forth in the specification . . . on pages 22 and 23 and the data in Figure 3 rebut the alleged prima facie obviousness rejection” (App. Br. 8). In particular, Appellants argue: [T]he data in Figure 3 demonstrate that the immune response induced using the construct referred to in the claims has advantageous properties which were completely unexpected and could not have been predicted by those skilled in the art prior to Appellants’ disclosure. Specifically, the data show that the immune responses induced by the construct used in the claimed methods are protective against lethal infection in an accepted animal model. . . . The data demonstrates that the use of the cosmid that comprises HSV nucleotides 5938-44597 protects against viral challenge while the use of cosmid that compris[es] other HSV nucleotides do not. Thus, one skilled in the art would recognize that the induction of humoral and cellular immune responses using the cosmid that comprises HSV nucleotides 5938-44597 provides surprising an[d] unexpected results in that the humoral and cellular immune responses induced have surprising and unexpected properties. The nature of the immune responses, i.e. that they protect against viral challenge, is a surprising result that would lead one skilled in the art to conclude the invention is not obvious. (Id.) We conclude that the Examiner has not adequately addressed this argument. First, we agree with Appellants that the failure of claims to specifically recite an alleged unexpected property does not render evidence of that property irrelevant. Instead, the question is whether the evidence is commensurate in scope with the claims. In the present case, the Examiner Appeal 2011-012069 Application 10/168,694 4 has not provided sufficient basis to believe that the evidence is not commensurate in scope with the claims. Second, we agree with Appellants that the Examiner has not adequately explained why their data is not persuasive. The Examiner finds that it was known in the art “that genetic immunization stimulates humoral and cellular immunity” and that “prior HSV-1 infection ameliorates the frequency and severity of subsequent HSV-2 disease” (Ans. 8). However, this does not address Appellants’ position that it was unexpected “that the use of the cosmid that comprises HSV nucleotides 5938-44597 protects against viral challenge while the use of cosmid that compris[es] other HSV nucleotides do[es] not” (App. Br. 8). In view of the foregoing, the Examiner failed to explain why, at the time of Appellants’ claimed invention, a person of ordinary skill in this art would have reasonably expected that the specific portion of the HSV genome required by Appellants’ claimed invention would have performed as Appellants established and therefore selected this specific portion of the HSV genome from other portions suggested by the prior art. CONCLUSION The Examiner has not adequately explained why Appellants’ evidence fails to rebut the prima facie case of obviousness. We therefore reverse the obviousness rejection. REVERSED dm