10147633 (B.P.A.I. Jan. 21, 2011)

Ex Parte Houck et al

Board of Patent Appeals and InterferencesJan 21, 2011

10147633 (B.P.A.I. Jan. 21, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte JOHN C. HOUCK and JAMES CLAGETT __________ Appeal 2009-015193 Application 10/147,633 Technology Center 1600 __________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2009-015193 Application 10/147,633 2 STATEMENT OF CASE The following claims are representative. 4. A method for treating cutaneous inflammation in a mammal, the method comprising administering to the mammal an anti-inflammatory effective amount of a peptide having the formula f-Met-Leu-X where X (SEQ ID NOS: 1, 2 and 3) is selected from the group consisting of Tyr, Tyr- Phe (SEQ ID NO: 1), Phe-Phe (SEQ ID NO: 2) and Phe-Tyr (SEQ ID NO: 3). 5. A method for treating cutaneous inflammation in a mammal, the method comprising administering to the mammal an anti-inflammatory effective amount of a peptide having the formula f-Met-Leu-X where X (SEQ ID NOS: 1, 2 and 3) is selected from the group consisting of Tyr, Tyr- Phe (SEQ ID NO: 1), Phe-Phe (SEQ ID NO: 2) and Phe-Tyr (SEQ ID NO: 3), wherein the cutaneous inflammation is selected from the group consisting of dermatitis, eczema, psoriasis, contact dermatitis, sunburn and aging. Cited References Kermode et al., The significance of functional receptor heterogeneity in the biological responses of the rabbit neutrophil to stimulation by chemotactic formyl peptides, 276 BIOCHEM. J. 715-723 (1991). Schubert et al., Transendothelial cell diapedesis of neutrophils in inflamed human skin, 281 ARCHIVES OF DERMATOLOGICAL RESEARCH 475-481 (1989). Bochner et al., Interleukin-1 is released at sites of human cutaneous allergic reactions, 86 J. ALLERGY AND CLINICAL IMMMUNOLOGY 830-899 (1990). Gleisner et al., Inhibition of Mast-cell Degranulation by Chemotactic Peptides, 5 INFLAMMATION 13-17 (1981). Grounds of Rejection 1. Claims 4-6 are rejected under 35 U.S.C. § 103(a) for obviousness over Kermode in view of Schubert. Appeal 2009-015193 Application 10/147,633 3 2. Claims 4-6 are rejected under 35 U.S.C. § 103(a) for obviousness over Gleisner in view of Kermode and Bochner. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 3-8. Discussion 1. Claims 4-6 are rejected under 35 U.S.C. § 103(a) for obviousness over Kermode in view of Schubert. ISSUE The Examiner concludes that It would have been prima facie obvious to one of ordinary skill in art at the time the invention was made to be motivated to treat inflammation using formyl-Met peptides described in Kermode, such as in particular f-Met-Leu-Phe-Phe and f-Met-Leu-Tyr, because the reference teaches that formyl- Met peptides possess useful biological properties as they stimulate various functions of neutrophils which constitute defense reaction to infectious microorganisms. One would expect that in vitro observations of the effect of formyl-Met peptides on neutrophils will be translated into similar in vivo effect, because Kermode teaches that the rabbit peritoneal neutrophils is an adequate in vitro model as they have proved suitable for detailed biological characterization of the biological responses of neutrophils to chemotactic peptides. Further, with respect to treatment of cutaneous inflammation in particular, neutrophils participate in anti- inflammatory response to cutaneous inflammation similarly to reaction to any other in vivo inflammation. See, for example, Shubert et al. Therefore, it would be obvious to apply formyl- Met peptides described in Kermode as stimulating neutrophil response to treat cutaneous inflammation. Appeal 2009-015193 Application 10/147,633 4 (Ans. 6.) Appellants argue that because the cited references fail to teach an anti- inflammatory effect of the f-Met peptides, it follows that they also fail to suggest the use of these peptides in “‘an anti-inflammatory effective amount,’” as claimed. (App. Br. 8.) The issue is: Does the cited prior art suggest using the claimed anti- inflammatory effective amount of f-Met peptides in the method of treating cutaneous inflammation as claimed? PRINCIPLES OF LAW “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. ANALYSIS Appellants argue that because the cited references fail to teach an anti- inflammatory effect of the f-Met peptides, it follows that they also fail to suggest the use of these peptides in “’an anti-inflammatory effective Appeal 2009-015193 Application 10/147,633 5 amount,’” as claimed. (App. Br. 8.) We are persuaded by Appellants’ argument. Kermode teaches that formyl peptides stimulate neutrophil degranulation and infiltration which is a hallmark of inflammation. (Kermode 715; App. Br. 7.) Appellants further support their position with the Declaration of Garrett Lindemann.2 Thus, we agree with Appellants that Kermode does not teach an anti-inflammatory effective amount of formyl peptides, as claimed. CONCLUSION OF LAW The cited reference does not support the Examiner’s obviousness rejection. The obviousness rejection is reversed. 2. Claims 4-6 are rejected under 35 U.S.C. § 103(a) for obviousness over Gleisner in view of Kermode and Bochner. ISSUE The Examiner argues that it would have been obvious to use structural analogues of f-Met peptides used in Gleisner as anti-inflammatory agents. (Ans. 8.) Appellants argue that “Gleisner uses peptides that are different from the claimed peptides.” (Id. at 11.) Appellants argue there is unpredictability in the structure-function relationship of the peptides. (Id. at 12-13.) 2 Declaration of Garrett Lindemann, executed June 8, 2007. Appeal 2009-015193 Application 10/147,633 6 The issue is: Does the combination of Gleisner, Kermode and Bochner suggest using the claimed peptides in a method of treating cutaneous inflammation? ANALYSIS Appellants argue that “Gleisner uses peptides that are different from the claimed peptides.” (Id. at 11.) Appellants argue there is unpredictability in the structure-function relationship of the peptides. (Id. at 12-13.) Gleisner teaches the peptide f-Met-Leu-Phe is a potent inhibitor of mast cell degranulation. (Gleisner 14.) Gleisner does not teach the peptide f-Met-Leu-Phe-Phe, as claimed. Fig. 2 of Kermode teaches that the peptide f-Met-Leu-Phe-Phe causes neutrophil degranulation which is a hallmark of inflammation. Tables 1 and 2 of Kermode evidence that differing f-Met peptides have distinct and unpredictable dissociation constants and chemotactic properties. Thus, we are persuaded by Appellants’ argument that there is unpredictability in the structure-function relationship of the peptides and for this reason the cited references do not suggest the invention as claimed. The Specification further supports this position. Page 20 of the Specification, Table 1 shows that the peptide f-Met-Leu-Phe disclosed in Gleisner inhibited degranulation by 30% whereas the peptide f-Met-Leu-Phe-Phe inhibited degranulation by 100% and the peptide f-Met-Leu-Phe-Lys did not inhibit degranulation at all. We do not find that the cited references teach an anti-inflammatory effective amount of any of the f-Met peptides recited in the claims. Appeal 2009-015193 Application 10/147,633 7 CONCLUSION OF LAW Gleisner, Kermode and Bochner do not suggest using the claimed peptides in a method of treating cutaneous inflammation. The obviousness rejection is reversed. REVERSED cdc LATHROP & GAGE LLP 4845 PEARL EAST CIRCLE SUITE 201 BOULDER, CO 80301