10762873 (B.P.A.I. Nov. 17, 2011)

Ex Parte Valiante

Board of Patent Appeals and InterferencesNov 17, 2011

10762873 (B.P.A.I. Nov. 17, 2011)

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. 10/762,873 01/21/2004 Nicholas M. Valiante PAT051923-US-NP 5927 27476 7590 11/17/2011 NOVARTIS VACCINES AND DIAGNOSTICS INC. INTELLECTUAL PROPERTY- X100B P.O. BOX 8097 Emeryville, CA 94662-8097 EXAMINER CHONG, YONG SOO ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 11/17/2011 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 BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte NICOLAS M. VALIANTE __________ Appeal 2010-009847 Application 10/762,873 Technology Center 1600 __________ Before ERIC GRIMES, MELANIE L. McCOLLUM, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an immunogenic composition, which the Examiner has rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 12-17 and 19 are on appeal. Claim 12 is the only independent claim and reads as follows: 12. An immunogenic pharmaceutical composition comprising an antigen and a tryptanthrin compound adjuvant in an amount effective to Appeal 2010-009847 Application 10/762,873 2 provide an enhanced immune response to the antigen relative to the response provided without the tryptanthrin compound adjuvant. “Tryptanthrin (indolo-[2,1-b]quinazolin-6,12-dione) is a material that is produced naturally in some plant species, and has been produced synthetically . . . . Tryptanthrin and some of its analogs have been shown to exhibit some antimicrobial activity.” (Spec. 2, ¶ 9.) The Examiner has rejected claims 12-17 and 19 under 35 U.S.C. § 103(a) as obvious based on Baker1 and Colston2 (Answer 3). The Examiner finds that Baker discloses an antimicrobial composition comprising a tryptanthrin compound that can be combined with other agents used to treat pathogenic mycobacterial infections (id. at 3-4) but does not teach combining the tryptanthrin compound with an antigen (id. at 5). The Examiner finds that Colston discloses recA mutant mycobacteria that can be used as an antigen delivery system in treating diseases, such as pathogenic infection (id. at 5-6). The Examiner concludes that it would have been obvious to combine Baker’s tryptanthrin compound with a composition comprising antigens associated with tetanus or diphtheria because Baker teaches that its tryptanthrin compound can be combined with another agent for treating pathogenic mycobacterial infections and Colston teaches that its mutant mycobacteria can be used as an antigen delivery system for delivering antigens such as tetanus toxin and diphtheria toxin (id. at 6-7). 1 Baker et al., US 5,441,955, Aug. 15, 1995 2 Colston et al., US 7,122,195 B2, Oct. 17, 2006 Appeal 2010-009847 Application 10/762,873 3 Appellant argues that Baker and Colston are fundamentally incompatible because Baker discloses that its tryptanthrin compound kills mycobacteria, while Colston’s vaccine compositions require live mycobacteria to be effective (Appeal Br. 7-8, Reply Br. 3). We agree with Appellant that the Examiner has not shown that it would have been obvious to combine Baker’s tryptanthrin compound with Colston’s antigen-expressing mycobacteria. Baker discloses tryptanthrin compounds (Baker, col. 2, l. 61 to col. 3, l. 2; col. 20, ll. 22-33) that inhibit the growth of pathogenic mycobacteria and can be used to treat myco- bacterial infections (id. at col. 3, ll. 16-22; col. 46, l. 57 to col. 48, l. 40). Colston discloses a “cell of a mycobacterium which is a member of the M. tuberculosis complex and which has an inactivated recA function” (Colston, col. 3, ll. 40-42). Colston discloses that such a cell “persists in a host immunized therewith” and “is able to persist in tissue without causing progressive infection” (id. at col. 3, ll. 49-53). Colston discloses that an “M. tuberculosis complex cell of the present invention may further comprise a gene encoding a polypeptide which is a non-mycobacterial or foreign antigen. Expression of such an antigen . . . allows the generation of an immune response in a vaccinated individual.” (Id. at col. 4, ll. 51-56.) Colston discloses that its cells “may therefore be used as an antigen delivery system in the treatment of any disease, such as a pathogenic infection, which is ameliorated by an immune response against a particular antigen” (id. at col. 4, ll. 57-60). Thus, as Appellant has pointed out, Colston discloses that its mycobacteria function as an antigen-delivery system by persisting in a Appeal 2010-009847 Application 10/762,873 4 vaccinated individual and expressing an antigen to generate an immune response, while Baker discloses that its tryptanthrin derivatives can be used to treat mycobacterial infections by inhibiting the growth of mycobacteria. We agree with Appellant that it would not have been obvious to combine the disclosures of Baker and Colston because Baker’s tryptanthrin compound would be expected to kill or at least inhibit the growth of Colston’s mycobacterial antigen-delivery system. We also agree with Appellant (Reply Br. 2-3) that the Examiner’s argument to the contrary – that Appellant is “arguing against their own claimed invention” (Answer 7) – is inapplicable because the claims do not require the antigen to be expressed by a live mycobacterial cell. SUMMARY We reverse the rejection of claims 12-17 and 19 as obvious based on Baker and Colston. REVERSED lp