Ex Parte Frazer

Patent Trial and Appeal BoardJan 7, 2014

10475203 (P.T.A.B. Jan. 7, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte IAN HECTOR FRAZER ____________ Appeal 2012-002760 Application 10/475,203 Technology Center 1600 ____________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and JEFFREY N. FREDMAN, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims 1-3, 5, 9-12, 16- 35, and 57-61 (App. Br. 4).2 Examiner entered rejections under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is the University of Queensland (App. Br. 2). 2 Pending “[c]laims 6-8, 13-15, 36-56, and 62-73 [stand] withdrawn from consideration” (App. Br. 4). Appeal 2012-002760 Application 10/475,203 2 STATEMENT OF THE CASE The claims are directed to a composition for eliciting a humoral and a cellular immune response against a target antigen. Claims 1 and 57 are representative and are reproduced in the Claims Appendix of Appellant’s Brief. Claims 1-3, 5, 9-12, 16-24, 30, and 57-61 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Tobery,3 Hinkula,4 and Delogu.5 Claims 25-29 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Tobery, Hinkula, Delogu, and Schiller.6 Claims 31-35 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Tobery, Hinkula, Delogu, MacInnes,7 and Dietrich.8 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 3 Timothy Tobery & Robert F. Siliciano, Cutting Edge: Induction of Enhanced CTL-Dependent Protective Immunity In Vivo by N-End Rule Targeting of a Model Tumor Antigen, 162 J. IMMUNO. 639-642 (1999). 4 Hinkula et al., Recognition of Prominent Viral Epitopes Induced by Immunization with Human Immunodeficiency Virus Type 1 Regulatory Genes, 71 J. VIROL. 5528-5539 (1997). 5 Delogu et al., DNA Vaccination against Tuberculosis: Expression of a Ubiquitin-Conjugated Tuberculosis Protein Enhances Antimycobacterial Immunity, 68 INFECTION AND IMMUNITY 3097-3102 (2000). 6 John T. Schiller & Douglas R. Lowy, Papillomavirus-Like Particle Vaccines, 28 J. NATL. CANCER INST. MONOGR. 50-54 (2000). 7 MacInnes et al., US 6,019,984, issued Feb. 1, 2000. 8 Dietrich et al., Listeriolysin-a useful cytolysin, 9 TRENDS IN MICROBIOLOGY (2001). Appeal 2012-002760 Application 10/475,203 3 FACTUAL FINDINGS (FF) FF 1. Examiner finds that Hinkula suggests “that HIV-1 nef protein induces humoral and cellular immune responses in immunized mice and that HIV-1 nef protein comprises both cytotoxic T cell and B cell (antibody) epitopes” (Ans. 6). FF 2. Examiner finds that Tobery suggests “that HIV-1 nef protein fused with ubiquitin induces enhanced stimulation of murine and human CTL responses” but, fails to suggest stimulation of “humoral immune responses” (id. at 5-6). FF 3. Examiner finds that Delogu suggests that ubiquitinated tuberculosis antigen exhibits “enhanced cell-mediated immunity in the absence of a humoral response” (id. at 6). FF 4. Examiner finds that the combination of Tobery, Hinkula, and Delogu fails to suggest “compositions comprising a viral capsid protein or compositions comprising a crystalline virus capsid protein” and relies on Schiller to make up for the foregoing deficiencies in the combination of Tobery, Hinkula, and Delogu (id. at 9 (Examiner finds that, similar to Hinkula’s non-ubiquitinated HIV-1 nef protein, Schiller suggests the “generation of humoral and cellular immune responses . . . to immunization of humans with L1 and L1/L2 papillomavirus capsid proteins incorporated into VLPs formulated in an adjuvant”)). FF 5. Examiner finds that the combination of Tobery, Hinkula, and Delogu fails to suggest “ISCOM, cytolysin or listeriolysin adjuvants” and relies on MacInnes and Dietrich to make up for the foregoing deficiencies in the combination of Tobery, Hinkula, and Delogu (id. at 10). Appeal 2012-002760 Application 10/475,203 4 ANALYSIS According to Examiner, a person of ordinary skill in this art would have been “interested in inducing not only T-cell but also B-cell immune responses in order to generate HIV-1 virus [nef protein] neutralizing antibodies in addition to cytotoxic T cells in an immunized subject” (Ans. 7; FF 2). In this regard, Examiner recognizes that Hinkula teaches that HIV-1 nef protein that is not fused with ubiquitin: (1) comprises both (i) cytotoxic T cell and (ii) B cell (antibody) epitopes and (2) induces humoral and cellular immune response in immunized mice (id.; FF 1). Nevertheless, based on the combination of Tobery, Hinkula, and Delogu, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to combine: (a) Tobery’s composition comprising retrovirus HIV-1 nef protein fused to ubiquitin, which elicits a cellular immune response (see also FF 3 (Delogu suggests that ubiquitinated tuberculosis antigen exhibits “enhanced cell-mediated immunity in the absence of a humoral response”)) with (b) Hinkula’s HIV-1 nef protein which is not fused with ubiquitin, which elicits both a cellular and humoral immune response (id.; FF 1-3). We are not persuaded. Examiner failed to explain why a person of ordinary skill in this art, interested in eliciting a cellular and humoral immune response to HIV-1 nef protein, would have done any more than what was suggested by Hinkula (see FF 2; see also App. Br. 10 (“There is insufficient motivation to combine Tobery [] with Hinkula to achieve the results that Hinkula achieves alone”) (emphasis omitted); Cf. Ans. 7-8 (“In order to elicit both the humoral and cellular immune response to the same antigen, the skilled artisan would have been motivated to provide a composition comprising both the ubiquitinated Appeal 2012-002760 Application 10/475,203 5 and non-ubiquitinated antigen”)). Simply stated, since Hinkula suggests induction of both cellular and humoral responses with a non-ubiquitinated HIV- nef protein, there would have been no reason to provide a composition comprising both ubiquitinated and non-ubiquitinated HIV-1 nef protein to induce both cellular and humoral responses (see FF 1; Cf. Ans. 7-8). Obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention. Id. at 421, 127 S.Ct. 1727. Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Examiner failed to establish an evidentiary basis on this record to support a conclusion that Schiller or the combination of MacInnes and Dietrich makes up for the foregoing deficiencies in the combination of Tobery, Hinkula, and Delogu (see FF 4-5; App. Br. 20 (“Examiner proposes to apply to Schiller the teachings of Tobery [] in order to achieve what is achieved in Schiller alone”); App. Br. 21 (“MacInnes and Dietrich fail to remedy the insufficiencies of Tobery [], Hinkula, and Delogu”)). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1-3, 5, 9-12, 16-24, 30, and 57-61 under 35 U.S.C. § 103(a) as unpatentable over the combination of Tobery, Hinkula, and Delogu is reversed. Appeal 2012-002760 Application 10/475,203 6 The rejection of claims 25-29 under 35 U.S.C. § 103(a) as unpatentable over the combination of Tobery, Hinkula, Delogu, and Schiller is reversed. The rejection of claims 31-35 under 35 U.S.C. § 103(a) as unpatentable over the combination of Tobery, Hinkula, Delogu, MacInnes, and Dietrich is reversed. REVERSED cdc