Ex Parte Aricò et al

Patent Trials and Appeals BoardApr 17, 2019

13806743 - (D) (P.T.A.B. Apr. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/806,743 03/05/2013 20462 7590 04/19/2019 GlaxoSmithKline Global Patents UP4110 1250 South Collegeville Road Collegeville, PA 19426 FIRST NAMED INVENTOR Maria Arico 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 ATTORNEY DOCKET NO. CONFIRMATION NO. VN54179US 3259 EXAMINER OGUNBIYI, OLUW ATOSIN A ART UNIT PAPER NUMBER 1645 NOTIFICATION DATE DELIVERY MODE 04/19/2019 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): US_cipkop@gsk.com laura.m.mccullen@gsk.com eofficeaction@appcoll.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARIA ARICO, BRUNELLA BRUNELLI, MAURIZIO COMANDUCCI, MARIAGRAZIA PIZZA, SILVANA SA VINO, and MARIA SCARSELLI Appeal2017-009471 Application 13/806,743 1 Technology Center 1600 Before TA WEN CHANG, DEVON ZASTROW NEWMAN and DAVID COTTA, Administrative Patent Judges. COTT A, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to an immunogenic composition. The Examiner rejected the claims on appeal under 35 U.S.C. Â§ 102(b) as anticipated. We reverse. 1 According to Appellants, the real party in interest is GlaxoSmithKline Biologicals SA. Appeal2017-009471 Application 13/806,743 STATEMENT OF THE CASE The Specification discloses that "Neisseria meningitidis (meningococcus) is a Gram-negative spherical bacterium" and that while there are vaccines based on capsular saccharides for serogroups A, C, W135, and Y, "[t]here is currently no useful vaccine authorised for general use against serogroup B ('MenB')." Spec. 1. "One antigen which has been proposed for use in immunising against MenB is the factor H binding protein ('fHbp')" which has been "well studied." Id. The Specification discloses that "[c]ompositions of the invention include at least two different meningococcal factor H binding proteins ( fHbp) to generate distinct immune responses which are not fully cross-reactive and which provide a broader spectrum of strain coverage against meningococci that the single fHbps alone." Id. at 2. Claims 1-9, and 14 are on appeal. 2 Claims 1 and 2, the only independent claims, are illustrative and read as follows: 1. An immunogenic composition which comprises an immunologically effective amount of an adjuvant, an immunologically effective amount of a first isolated factor H binding protein (fHbp) antigen and an immunologically effective amount of a second isolated fHbp antigen, wherein: the first isolated fHbp antigen comprises a first amino acid sequence which has at least 7 5% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ ID NO: 23, when aligned using the same algorithm and parameters; and the second isolated fHbp antigen comprises a second amino acid sequence which has at least 7 5% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the 2 Appellants cancelled claims 10-13 and 15-20 in an after-final amendment. The Examiner entered this amendment in a June 16, 2016, Advisory Office Action. Accordingly, these claims are no longer part of this appeal. 2 Appeal2017-009471 Application 13/806,743 second amino acid sequence has a higher sequence identity to SEQ ID NO: 23 than to SEQ ID NO: 1, when aligned using the same algorithm and parameters. 2. An immunogenic composition which comprises an immunologically effective amount of an adjuvant, an immunologically effective amount of a first isolated ffibp antigen and an immunologically effective amount of a second isolated ffibp antigen, wherein: the first isolated ffibp antigen comprises a first amino acid sequence which has at least 7 5% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ ID NO: 23, when aligned using the same algorithm and parameters; and the second isolated ffibp antigen comprises a second amino acid sequence (i) having at least 94% sequence identity to SEQ ID NO: 25 and/or (ii) consisting of a fragment of at least 50 contiguous amino acids from SEQ ID NO: 25. App. Br. 14 (Claim App.). The Examiner rejected claims 1-9, and 14 under 35 U.S.C. Â§ 102(b) as anticipated by Zlotnick. 3, 4 ANALYSIS Zlotnick discloses "proteins that can be isolated from native neisserial strains, including strains of Neisseria meningitidis (serogroups A, B, C, D, W-135, X, Y, Zand 29E), Neisseria gonorrhoeae, and Neisseria lactamica." Zlotnick 4. Zlotnick also discloses 329 amino and nucleic acid sequences relating to such proteins. Id. at 7-30. The Examiner found that several of 3 Zlotnick et al., WO 03/063766 A2, published Aug. 7, 2003 ("Zlotnick"). 4 In the Examiner's Answer, the Examiner withdrew the rejection of claims 1-10, 13, 17, and 18 under 35 U.S.C. 101 Â§ as directed to patent ineligible subject matter and the rejection of claims 1-20 under 35 U.S.C. 103(a) as obvious over the combination of Zlotnick and Comanducci (WO 04/048404 A2). Ans. 12. These rejections are thus not a part of this appeal. 3 Appeal2017-009471 Application 13/806,743 the sequences disclosed in Zlotnick were 100% identical to sequences recited in the pending claims. Ans. 4. This correspondence between Zlotnick' s sequences and the sequences of the present application is summarized in the below table. Id. SEQ ID NO: 198 SEQIDNO: 1 SEQ ID NO: 248 SEQ ID NO: 23 SEQ ID NO: 56 SEQ ID NO: 25 Claims 1, 6, and 7 of Zlotnick are reproduced below. 1. A composition comprising: (a) at least one protein encoded by an open reading frame of Neisseria species (ORF2086), said open reading frame encoding a crossreactive immunogenic antigen, and said crossreactive immunogenic antigen providing immunogenicity against infection by Neisseria meningitidis serogroup Bin a subject; or (b) at least one immunogenic portion of at least one protein described in (a); or ( c) at least one biological equivalent of at least one protein described in (a) or immunogenic fragment described in (b). 6. The composition of claim 1, wherein the at least one protein comprises the amino acid sequence of any of even numbered SEQ ID NOS:2-174. 7. The composition of claim 6, additionally comprising at least one protein comprising the amino acid sequence of any of even numbered SEQ ID NOS: 176-252. Zlotnick 128. 4 Appeal2017-009471 Application 13/806,743 In finding that Zlotnick anticipates claim 1, the Examiner reasoned that the language "at least one protein" in Zlotnick' s claim 7 encompassed more than one protein selected from the recited sequences. Ans. 10. Since the amino acid sequences recited in Zlotnick's claim 7 include sequences corresponding to SEQ ID NOS:1 and 23 of pending claim 1, the Examiner concluded that Zlotnick disclosed the limitations of pending claim 1 requiring "a first amino acid sequence which has at least 7 5% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ ID NO: 23" and "a second amino acid sequence which has at least 75% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the second amino acid sequence has a higher sequence identity to SEQ ID NO: 23 than to SEQ ID NO: 1. Id. The Examiner employed similar logic in finding claim 2 anticipated, reasoning that the amino acid sequences recited in Zlotnick' s claim 7 included sequences corresponding to SEQ ID NOS:1 and 25 of pending claim 2. Id. The Examiner thus concluded that Zlotnick disclosed the limitations of pending claim 2 requiring "a first amino acid sequence which has at least 75% sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ ID NO: 23" and "a second amino acid sequence (i) having at least 94% sequence identity to SEQ ID NO: 25 and/or (ii) consisting of a fragment of at least 50 contiguous amino acids from SEQ ID NO: 25." Id. Appellants argue that claim 6 of Zlotnick recites 87 specific sequences and claim 7 of Zlotnick recites 39 specific sequences. App. Br. 4. 5 Appeal2017-009471 Application 13/806,743 According to Appellants, when claims 6 and 7 are considered together, they "recite[] 3,393 (87*39) different sequence combinations." Id. Appellants argue that the Examiner has "not cited to any section of Zlotnick et al. that teaches or suggests the specific combination of sequences as recited in the pending claims." Id. Appellants contend that Zlotnick does not anticipate the claims because it "does not teach each element arranged together as claimed without picking and choosing." Id. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): "[T]he examiner bears the initial burden ... of presenting a prima facie case ofunpatentability." Appellants have persuaded us that the Examiner has not carried the burden of establishing that the claimed invention was anticipated by Zlotnick. In order for a reference to anticipate a claim, it must: clearly and unequivocally disclose the claimed [composition] or direct those skilled in the art to the [composition] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference. Such picking and choosing may be entirely proper in the making of a 103, obviousness rejection, where the applicant must be afforded an opportunity to rebut with objective evidence any inference of obviousness which may arise from the similarity of the subject matter which he claims to the prior art, but it has no place in the making of a 102, anticipation rejection. In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972). Here, in order to have arrived at the composition of pending claim 1, based on the disclosure of Zlotnick' s claim 7, the ordinary artisan must have first selected Zlotnick's SEQ ID N0:198 from among the 39 sequences disclosed in claim 7. The ordinary artisan would then have needed to select SEQ ID N0:248 from among the 38 remaining sequence disclosed in claim 6 Appeal2017-009471 Application 13/806,743 7. Accordingly, the composition of pending claim 1 requires picking the recited combination from 1482 possible sequence combinations. 5 Similarly, in order to arrive at the composition of pending claim 2, the ordinary artisan would first have needed to select Zlotnick's SEQ ID N0:56 from among the 87 sequences recited in claim 6 and then have selected SEQ ID N0:198 from among the 39 sequences disclosed in claim 7. The composition of pending claim 2 thus requires picking from among 3,393 possible sequence combinations. We acknowledge that the claimed combination of sequences is encompassed within claim 7 of Zlotnick. However, the Examiner does not explain how or why the ordinary artisan would have known to select the combination of SEQ ID NO: 198 and SEQ ID N0:248 from among 1,482 potential combinations to arrive at the combination recited in pending claim 1. Nor does the Examiner explain how or why the combination of SEQ ID N0:56 and SEQ ID NO: 198 would have been selected from among the 3,393 possible combinations to arrive at the combination recited in pending claim 2. On this record, the general teaching of a composition that may include the recited sequences does not "unequivocally disclose" the specific combination of sequences recited in the pending claims without the need for "picking and choosing." Accordingly, we reverse the Examiner's rejection of claims 1-9 and 14 as anticipated by Zlotnick. 5 With respect to pending claim 1, we do not factor in the 87 sequences recited in Zlotnick's claim 6 because any one of those 87 sequences in combination with SEQ ID NOS 198 and 248 would anticipate claim 1. 7 Appeal2017-009471 Application 13/806,743 SUMMARY For the reasons discussed herein, we reverse the Examiner's rejection of claims 1-9 and 14 under 35 U.S.C. Â§ 102(b) as anticipated by Zlotnick. REVERSED 8