Ex Parte Wheeler et al

Patent Trial and Appeal BoardOct 25, 2012

10181684 (P.T.A.B. Oct. 25, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ALAN W. WHEELER, GARY ELLIOTT, and CHRISTOPHER CLUFF ____________ Appeal 2011-010822 Application 10/181,684 Technology Center 1600 ____________ Before TONI R. SCHEINER, DONALD E. ADAMS, and STEPHEN WALSH, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims 1, 4-6, 13, 37, and 42 (App. Br. 3). 1 We have jurisdiction under 35 U.S.C. § 6(b). STATEMENT OF THE CASE The claims are directed to a method for producing a (1) mucosal and systemic (claims 1, 5, 6, and 13) or (2) IgA (claims 4, 37, and 42) immune 1 Pending claims 8, 11, 34-36, 38, 41, and 43-45 stand withdrawn from consideration (App. Br. 3 and 14; Fin. Rej. 2: ¶ 1). Appeal 2011-010822 Application 10/181,684 2 response in a human or animal. Claim 1 is representative and is reproduced in the Claims Appendix of Appellants’ Brief. Claims 1, 4-6, 13, 37, and 42 stand rejected under 35 U.S.C. § 102(b) as being anticipated by Blaser. 2 Claims 1, 4-6, 13, 37, and 42 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Blaser and Hauser. 3 We reverse. Anticipation: ISSUE Does the preponderance of evidence on this record support Examiner’s finding that Blaser teaches Appellants’ claimed invention? FACTUAL FINDINGS (FF) FF 1. Blaser teaches “a vaccine composition comprising a polypeptide antigen PEB1A from Campylobacter jejuni” (Ans. 4; Blaser 24: 1-4). FF 2. Blaser teaches that “[a]n adjuvant can … be a part of the carrier of the vaccine, in which case it can be selected by standard criteria based on the antigen used, the mode of administration and the subject” (Blaser 24: 20-23; see generally Ans. 4). FF 3. Blaser identifies six groups and a variety of sub-groups of “preferred” adjuvants, including (2) oil-in-water emulsion formulations (with or without other specific immunostimulating agents such as … bacterial cell wall components), such as for example … (c) Ribi TM adjuvant system (RAS) … containing 2% Squalene, 0.2% Tween 80, and 2 Blaser et al., WO 95/05850, published March 2, 1995. 3 Hauser et al., US 5,776,468, issued July 7, 1998. Appeal 2011-010822 Application 10/181,684 3 one or more bacterial cell wall components from the group consisting of[, inter alia,] monophosphorylipid A (MPL). (Blaser 25: 17 - 26: 3; see Ans. 4 and 8.) FF 4. Appellants’ disclose that “MPL adjuvant is [a] TH-1 inducing adjuvant” (Ans. 5; see Spec. 8: 10-12). FF 5. Blaser teaches that “administration can be by oral or sublingual means, or by injection, depending on the particular vaccine used and the subject to whom it is administered” (Blaser 24: 24-26; see Ans. 4 and 5). ANALYSIS Based on Blaser, Examiner finds that Appellants’ “claimed composition and the referenced composition are identical and both compositions are being administered to the identical population, inducing an IgA mucosal response and a serum IgG systemic response and induction of IgA response distal from [the] sublingual site are inherently achieved” (Ans. 5). Examiner also finds that Blaser “teaches a small genus (6 species for adjuvants and 3 species for route of administration)” (Ans. 8). We are not persuaded. Notwithstanding Examiner’s contention to the contrary, Blaser teaches more than 6 species of adjuvant (FF 3; App. Br. 7; Reply Br. 2). Further, as Appellants point out, Blaser teaches “that the choice of adjuvant for the PEB1A vaccine depends not only on the antigen, but also on the mode of administration of the vaccine” (App. Br. 7; Reply Br. 2; FF 2). Therefore, while Examiner is correct in that Blaser mentions the words adjuvant, MPL, and sublingual, Examiner failed to establish an evidentiary basis on this record to support a finding that a person of ordinary skill in this art would have reasonably selected MPL as a component of a vaccine that is Appeal 2011-010822 Application 10/181,684 4 administered sublingually as required by Appellants’ claimed invention (see, e.g., claim 1; Cf. FF 2; App. Br. 7; Reply Br. 2). In re Wilder, 429 F.2d 447, 450 (CCPA 1970) (“[I]n an ex parte proceeding to obtain a patent, ... the Patent Office has the initial burden of coming forward with some sort of evidence tending to disprove novelty.”). CONCLUSION OF LAW The preponderance of evidence on this record fails to support Examiner’s finding that Blaser teaches Appellants’ claimed invention. The rejection of claims 1, 4-6, 13, 37, and 42 under 35 U.S.C. § 102(b) as being anticipated by Blaser is reversed. Obviousness: ISSUE Does the preponderance of evidence on this record support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 6. Examiner relies on Blaser as discussed above (see Ans. 5). FF 7. Examiner finds that Blaser fails to suggest “antigens that are derived from virus, prion, neoplasm, autoantigen, animal, or plant” (id. at 6). FF 8. Examiner relies on Hauser to suggest a “vaccine composition comprising a MPL and an antigen from various sources including bacteria, virus, tumor, animal pathogen, or fungus” (id.). FF 9. Appellants’ Evidence Appendix contains a number of references relied upon by Appellants to establish that: (1) MPL is a glycolipid adjuvant that contains ester and amidic bonds and (2) the buccal mucosa and saliva Appeal 2011-010822 Application 10/181,684 5 contain enzymes that degrade compounds comprising ester and amidic bonds (App. Br. 9-10). ANALYSIS Based on the combination of Blaser and Hauser, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious to “substitute and/or add other antigenic materials,” as suggested by Hauser, in Blaser’s composition and method of using the composition (Ans. 6). Appellants contend that Hauser fails to suggest the sublingual administration of a composition comprising MPL and therefore fails to make up for the deficiency in Blaser (see generally App. Br. 8). The weight of the evidence falls in favor of Appellants. Examiner failed to establish an evidentiary basis on this record to support a conclusion that a person of ordinary skill in this art would have reasonably selected MPL as a component of a vaccine that is administered sublingually as required by Appellants’ claimed invention. In this regard, we recognize Appellants’ contention that the state of the art at the time of their invention suggested that enzymes present in the buccal mucosa and saliva would have degraded a MPL adjuvant administered sublingually; therefore, a person of ordinary skill in this art would not have had a reasonable expectation “that the antigen/glycolipid adjuvant combination could be delivered to the blood stream and produce the systemic IgG and mucosal IgA-mediated response of the claimed invention” when administered sublingually (App. Br. 9-11; see also Reply Br. 3-4 (“based upon what was known in the art at the time of the invention, one of skill in the art would not be led to apply MPL sublingually because Appeal 2011-010822 Application 10/181,684 6 they would appreciate that salivary enzymes would disrupt the ester-amidic bonds of the MPL molecule”)). Absent an evidentiary basis to support a conclusion that differs from Appellants’ contentions, we are not persuaded by Examiner’s assertion that “none of the references [relied upon by Appellants] specifically teach that the sublingual route is not suitable for MPL” (Ans. 9). For the same reasons, we are not persuaded by Examiner’s assertion that “[j]ust because the MPL has esters, it does not mean that the esterases would digest MPL” (id. at 10). Lastly, Examiner’s rejection is based on the combination of Blaser and Hauser, therefore we are not persuaded by Examiner’s assertion that other prior art, not relied upon, “suggests the way to overcome the problems associated with [administration via an] oral route” (Ans. 10). 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). CONCLUSION OF LAW The preponderance of evidence on this record fails to support a conclusion of obviousness. The rejection of claims 1, 4-6, 13, 37, and 42 under 35 U.S.C. § 103(a) as unpatentable over the combination of Blaser and Hauser is reversed. Appeal 2011-010822 Application 10/181,684 7 REVERSED alw