10480793 (B.P.A.I. May. 31, 2011)

Ex Parte Ertl et al

Board of Patent Appeals and InterferencesMay 31, 2011

10480793 (B.P.A.I. May. 31, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte HILDEGHUND C. J. ERTL and JAMES M. WILSON __________ Appeal 2010-008817 Application 10/480,793 Technology Center 1600 __________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and JEFFREY N. FREDMAN, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2010-008817 Application 10/480,793 2 STATEMENT OF CASE The following claim is representative. 3. A method of preferentially inducing a CD8+ T cell response to an immunogen in a subject, said method comprising the step of delivering to the subject a recombinant simian adenovirus comprising a nucleic acid molecule encoding an immunogen under the control of expression control of regulatory sequences which direct expression of the immunogen in the subject. Cited References Wilson et al. WO 98/10087 Mar. 12, 1998 Pavlakis et al. US 5,972,596 Oct. 26, 1999 Wilson et al. US 6,083,716 Jul. 4, 2000 Schneider et al, Inactivation of the Human Immunodeficiency Virus Type 1 Inhibitory Elements Allows Rev-Independent Expression of Gag and Gag/Protease and Particle Formation, 71 J. VIROL. 4892-4903 (1997). Fitzgerald et al., A Simian Replication-Defective Adenoviral Recombinant Vaccine to HIV-1 Gag, 170 J. IMMUNOLOGY 1416-1422 (2003). Grounds of Rejection 1. Claims 3 and 4 are rejected under 35 U.S.C. § 102(b) for anticipation over Wilson as evidenced by Fitzgerald. 2. Claims 3 and 4 are rejected under 35 U.S.C. § 102(e) for anticipation over Wilson ‘716 as evidenced by Fitzgerald. 3. Claims 3, 10, 16-19, 23 and 25 are rejected under 35 U.S.C. § 103(a) for obviousness over Wilson in further view of Schneider, Pavlakis and Fitzgerald. Appeal 2010-008817 Application 10/480,793 3 FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 3-7. Discussion ISSUE The Examiner concludes that either Wilson document as evidenced by Fitzgerald teaches each element claimed. Appellants argue that neither Wilson nor Wilson ‘716 describes a method for preferentially inducing a CD8+ T cell response. The issue is: Does Wilson or Wilson ‘716 describe a method for preferentially inducing a CD8+ T cell response, as claimed? PRINCIPLES OF LAW In order for a prior art reference to serve as an anticipatory reference, it must disclose every limitation of the claimed invention, either explicitly or inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. Appeal 2010-008817 Application 10/480,793 4 “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Where . . . the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product…. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). We note, however, as set forth in In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)): Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient. ANALYSIS We agree with the Examiner’s fact finding, statement of the rejection and responses to Appellants’ arguments as set forth in the Answer. We affirm the anticipation and obviousness rejections for the reasons of record. We provide the following additional comment. Appeal 2010-008817 Application 10/480,793 5 We conclude that the Examiner has established a prima facie case of anticipation and obviousness on the evidence before us. The Examiner has established that both Wilson references teach the claimed method step and that the preferential induction of a CD8+ T cell response to an immunogen in a subject is an inherent property of the C68 adenovirus vector when used in Wilson’s method. (Answer 3-4, Fitzgerald, abstract, page 1418 col. 2, first full paragraph.) Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed.Cir.2001) (“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by Kris. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent”). Under these circumstances Appellants have the burden of proving that the prior art does not necessarily or inherently possess the claimed characteristics. Best, 562 F.2d at 1255. Appellants have provided no evidence to rebut the Examiner’s prima facie case of anticipation and obviousness or show that the use of a C68 adenovirus vector as in either Wilson document does not result in preferentially induced or superior CD8+ responses. CONCLUSION OF LAW The cited references support the Examiner’s anticipation and obviousness rejections. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Appeal 2010-008817 Application 10/480,793 6 DJM JNF DEA cdc