Ex Parte Brod

Patent Trial and Appeal BoardMar 19, 2015

11570221 (P.T.A.B. Mar. 19, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte STALEY A. BROD 1 __________ Appeal 2012-008787 Application 11/570,221 Technology Center 1600 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of immunotherapy, which have been rejected based on a lack of adequate written description in the Specification. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellant, the Real Party in Interest is Research Development Foundation. (Appeal Br. 2.) Appeal 2012-008787 Application 11/570,221 2 STATEMENT OF THE CASE The Specification discloses “uses of soluble immune response suppressor (SIRS) in the treatment of multiple sclerosis or other autoimmune diseases.” (Spec. 1:7–8.) “Three biologically active species of soluble immune response suppressor (SIRS) have been isolated at pH7, pH6, and pH5, SIRS-a7, SIRS-a6, and SIRS-a5, respectively.” (Id. at 3:8–9.) “Although the complete sequence of soluble immune response suppressor protein is not known, a putative N-terminal 21 amino acid sequence has been obtained for one of the less hydrophobic isoforms, soluble immune response suppressor-a7 (SIRS-a7).” (Id. at 3:16–18.) Claims 2–17, 20–22, 30–46, 48–50, and 53–57 are on appeal. Claim 14 is illustrative and reads as follows 2 (emphasis added): 14. A method of immunotherapy in an individual comprising orally administering to the individual a therapeutically effective amount of a polypeptide comprising the amino acid sequence (SEQ ID NO:4): X1-X2-X3-X3-X4-X4-X4-X4-X4-X4-Pro-X5-X2-X2-X6-X4-X4-X7-X7-X3-X4 wherein X1 is Met, Val, Leu or Cys; 2 Claim 14 is reproduced above as it reads in the Claims Appendix of the Appeal Brief. We note that, following the non-final Office Action mailed Nov. 17, 2011, Appellant filed an amendment to the claims (Feb. 13, 2012) that amended claims 14 and 33 to refer to SEQ ID NO: 5 rather than SEQ ID NO: 4. On Feb. 14, 2012, Appellant filed a Substitute Sequence Listing. According to USPTO records, however, SEQ ID NO: 5 of the Substitute Sequence Listing is a DNA sequence, not an amino acid sequence as required by claims 14 and 33. We have therefore considered the issue on appeal assuming the claims were intended to refer to the amino acid sequence of SEQ ID NO: 4. We leave it to the Examiner and Appellant to address any ambiguity in the prosecution history after this application is returned to the examining corps. Appeal 2012-008787 Application 11/570,221 3 X2 is Thr, Ala or Gly; X3 is Glu, Arg, Asp or Lys; X4 is Gln, Ser, Asn or Gly; X5 is Glu, Arg, Asp or Lys; X6 is Ile, Leu, Val, Met or Thr, and; X7 is Ala, Cys, Thr or Gly, and wherein said polypeptide is not SIRS-a7, SIRS-a6 or SIRS-a5. Claim 33, the only other independent claim, also includes the proviso that said polypeptide is not SIRS-a7, SIRS-a6 or SIRS-a5. DISCUSSION The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 112, first paragraph, on the basis that “Applicant’s amendment of Claims 14 and 33, ‘ ... wherein said polypeptide is not SIRS-a7, SIRS-a6, or SIRS- a5’ is not supported by the specification.” (Office Action mailed Nov. 17, 2011, page 3). The Examiner finds that “Applicant is now claiming a method employing all possible fragments of SIRS-a7, -a5, and -a6, excluding only full length SIRS proteins. Said method employing this subgenus of SIRS polypeptides is not disclosed in the instant specification.” (Id.) Appellant argues that the claim limitation at issue exclude[s] from the scope of the claims three naturally occurring SIRS proteins, designated SIRS-a7, SIRS-a6 and SIRS-a5. These prior art proteins are discussed in the specification at page 3, lines 8-15. The claim amendment introducing the negative limitation was intended simply to exclude these prior art proteins from the scope of the claims. Appeal 2012-008787 Application 11/570,221 4 (Appeal Br. 4.) Appellant argues that the Specification’s discussion of the SIRS proteins as prior art can be understood to “teach that these three proteins are not intended to be part of the invention, in which case a negative limitation cannot be new matter.” (Id.) Appellant argues that, alternatively, the Specification’s discussion could be read as meaning that SIRS-a7, SIRS- a6 and SIRS-a5 were disclosed as species that could be used in the claimed method, in which case they are positively recited species that can therefore be excluded from the scope of the claims. (Id. at 4–5, citing MPEP § 2173.05(i)). We agree with Appellant that the Examiner has not shown that the Specification fails to provide a descriptive basis for excluding use of SIRS- a7, SIRS-a6, and SIRS-a5 from the scope of the claimed method. The Specification identifies SIRS-a7, SIRS-a6, and SIRS-a5 as previously known proteins. (Spec. 3:8–10.) The Specification also states that “the prior art is deficient in methods of using soluble immune response suppressor or the N-terminal peptide or any variant thereof as a therapeutic immunomodulator of multiple sclerosis or other autoimmune diseases. The present invention fulfills this long-standing need and desire in the art.” (Id. at 3:28–31.) The most logical interpretation of these statements is that the disclosed invention includes “using soluble immune response suppressor or the N-terminal peptide or any variant thereof as a therapeutic immuno- modulator” (id. at 3:29–30), including the known SIRS proteins SIRS-a7, SIRS-a6, and SIRS-a5. As Appellant has pointed out, the identification of SIRS-a7, SIRS-a6, and SIRS-a5 as species that are useful in the disclosed Appeal 2012-008787 Application 11/570,221 5 method provides a descriptive basis for excluding those species from the scope of the claims. “If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims.” MPEP § 2173.05(i) (citing In re Johnson, 558 F.2d 1008, 1019 (CCPA 1977)). On the other hand, however, if page 3 of the Specification would not be read to disclose SIRS-a7, SIRS-a6, and SIRS-a5 as species that are useful in the disclosed method, then it must be read to disclose them merely as SIRS proteins that were known in the art, not as part of Appellant’s invention. We agree with Appellant that, under this reading, the Specification would not be understood to disclose use of SIRS-a7, SIRS-a6, or SIRS-a5 in the disclosed method, and therefore expressly excluding them is supported by the Specification under this reading as well. We agree with Appellant that the facts of this case are similar to those of In re Johnson, 558 F.2d 1008 (CCPA 1977). In that case, the applicant excluded two species from the scope of its claims after losing an interference. Id. at 1013. The claims were denied an earlier filing date on the basis that the amended claims lacked adequate support in the applicant’s specification. Id. at 1014. The court held, however, that “appellants are merely excising the invention of another, to which they are not entitled, and are not creating an ‘artificial subgenus’ or claiming ‘new matter.’” Id. at 1019. Similarly here, Appellants have merely excised from their claims three species that are admitted in the Specification to be known in the prior art. As stated by the Johnson court, The notion that one who fully discloses, and teaches those skilled in the art how to make and use, a genus and numerous Appeal 2012-008787 Application 11/570,221 6 species therewithin, has somehow failed to disclose, and teach those skilled in the art how to make and use, that genus minus two of those species, and has thus failed to satisfy the requirements of § 112, first paragraph, appears to result from a hypertechnical application of legalistic prose relating to that provision of the statute. All that has happened here is that appellants narrowed their claims to avoid having them read on [the prior art]. Id. In summary, the Specification describes SIRS-a7, SIRS-a6, and SIRS-a5 as proteins known in the prior art, and regardless of whether it would be read to describe them as species useful in the method that is disclosed and claimed, it provides adequate descriptive support to exclude those known species from the scope of the claims. SUMMARY We reverse the rejection of claims 2–17, 20–22, 30–46, 48–50, and 53–57 under 35 U.S.C. § 112, first paragraph. REVERSED dm