11058509 (B.P.A.I. Dec. 22, 2009)

Ex Parte Gong et al

Board of Patent Appeals and InterferencesDec 22, 2009

11058509 (B.P.A.I. Dec. 22, 2009)

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. 11/058,509 02/14/2005 David K. Gong 53309-US-CNT 8984 1095 7590 12/22/2009 NOVARTIS CORPORATE INTELLECTUAL PROPERTY ONE HEALTH PLAZA 104/3 EAST HANOVER, NJ 07936-1080 EXAMINER STOICA, ELLY GERALD ART UNIT PAPER NUMBER 1647 MAIL DATE DELIVERY MODE 12/22/2009 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 DAVID K. GONG, JAYNE E. HASTEDT, and JOHN S. PATTON __________ Appeal 2009-008478 Application 11/058,509 Technology Center 1600 __________ Decided: December 22, 2009 __________ Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) from the Patent Examiner’s final rejection of Appellants’ claims. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2009-008478 Application 11/058,509 2 STATEMENT OF THE CASE Claims 1-49 and 51-62, which are all the pending claims, are on appeal. They relate to: (i) a powder comprising interleukin-13 [IL-13] antagonist (claims 1-23); (ii) a composition comprising spray-dried IL-13 antagonist (claims 24-46); (iii) a method of administering IL-13 antagonist to the lungs (claims 47-49 and 51-55); (iv) a method of treating an IL-13 related condition by “pulmonarily administering” an IL-13 antagonist powder (claims 56-59); and (v) a method of preparing IL-13 antagonist-containing powder (claims 60-62). Claims 24 and 25 are illustrative and read as follows: 24. A composition, comprising spray-dried particle comprising IL-13 antagonist. 25. The composition of claim 24, wherein the IL-13 antagonist comprises at least one IL-13 binding member selected from IL-13Rα2, fragments thereof, homologs thereof, and conjugates thereof. The Examiner rejected all the claims under 35 U.S.C. § 103(a) as unpatentable over Hastedt,1 Duez,2 Andrews,3 and Wynn.4 1 Jayne E. Hastedt et al., Storage Stable Powder Compositions of Interleukin-4 Receptor, US 2002/0176846 A1 (Nov. 28, 2002). 2 C. Duez et al., An IL-13 Inhibitor Prevents Airway Hyperresponsiveness (AHR) and Inflammation in Both Models of Primary and Established Allergic Disease, 165 AM. J. RESP. AND CRIT. CARE MED., A426. Appeal 2009-008478 Application 11/058,509 3 Appellants do not argue the claims separately. Claim 24 is the broadest claim on appeal, and Appellants’ most specific arguments concern the antagonist IL-13Rα2. Because claim 25 is the first claim dependent on claim 24 that designates IL-13Rα2 as the antagonist, we select claim 25 as representative. 37 C.F.R. § 41.37(c)(1)(vii). Claims 1-24, 26-49, and 51-62 stand or fall with claim 25. OBVIOUSNESS The Issue The Examiner’s position is that Wynn taught administration via inhalation of the IL-13 antagonist IL-13Rα2 to treat an IL-13 related condition. (Ans. 6-7.) The Examiner concluded that “motivated by a need to treat an IL-13 related disease, it would have been obvious . . . to have used the teachings of Hastedt et al. to prepare a composition” for practicing Wynn’s treatment method. (Id. at 7.) It is undisputed that Hastedt described spray-dried inhaleable powder particle compositions including a soluble form of IL-4 receptor that worked as an IL-4 antagonist. (Ans. 4; App. Br. 10.) Appellants contend that (i) the prior art fails to teach all the limitations of the claims (App. Br. 10.), (ii) the Office failed to make a prima facie case of obviousness (id.), (iii) “Duez never contemplated pulmonary delivery using a dry powder inhalation” (id. at 11), (iv) Andrews “teaches away” 3 Allison-Lynn Andrews et al., Kinetic Analysis of the Interleukin-13 Receptor Complex, 277 J. BIOL. CHEM. 46073-46078 (2002). 4 Thomas A. Wynn et al., Treatment of Fibrosis by Antagonism of IL-13 and IL-13 Receptor Chains, WO 00/64944 (Nov. 2, 2000). Appeal 2009-008478 Application 11/058,509 4 from treating IL-13 related diseases using IL-13Rα2 dry powder composition (id.), and (v) Wynn does not disclose “other” IL-13-related disease treatment (id.). According to Appellants, “none of the cited references teach, suggest, or motivate a skilled person to arrive at Appellants’ invention of spray-dried powder compositions of IL-13 antagonists.” (Id. at 12.) The issue with respect to this appeal is whether Appellants have shown the Examiner erred in concluding that a spray-dried particle composition of IL-13Rα2 would have been obvious. Findings of Fact We adopt the Examiner’s findings of fact concerning the prior art. Principles of Law A rejection for obviousness must include “articulated reasoning with some rational underpinning to support the legal conclusion.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). The proper question to ask is whether a person of ordinary skill in the art, facing the wide range of needs created by developments in the field of endeavor, would have seen a benefit to combining the prior art teachings. KSR, 550 U.S. at 424; see also In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (the desirability of the combination may arise from nature of the problem, teachings of references, or the ordinary knowledge of those skilled in the art). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. “[I]f Appeal 2009-008478 Application 11/058,509 5 a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. A prior art reference is said to teach away from an Applicant’s invention “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Analysis Although Appellants argue that the prior art fails to teach all the limitations of the claims (App. Br. 10.), they do not identify a missing limitation. This argument is not persuasive of Examiner error. We find the argument that “Duez never contemplated pulmonary delivery using a dry powder inhalation” (id. at 11), also unpersuasive of error. Considering Duez’s teachings in context with the other applied references, as we must, we agree with the Examiner that the combined references suggest the claimed invention. Appellants argue that Andrews’ IL-13Rα2 “may act as a ‘decoy’ receptor,” and may contain a putative consensus phosphorylation site “that may interact with Src homology 2-containing proteins.” (App. Br. 11.) According to Appellants, these points mean that Andrews “teaches away” from the claims. (Id.) The Examiner found the phosphorylation site argument irrelevant, and Appellants have given no explanation that persuades us the Examiner was wrong. According to the Examiner, the Appeal 2009-008478 Application 11/058,509 6 important point is that Andrews taught that IL-13 binds IL-13Rα2. (Ans. 8- 9.) Thus, the Examiner found that Andrews suggested the IL-13Rα2 “will act as an antagonist by subtracting from the pool of circulating IL-13.” (Id.) Andrews stated: “[i]t has been suggested that IL-13Rα2 may act as a decoy receptor regulating the action of IL-13. The kinetic data may give some support to this model . . . .” (Andrews at 46078, penultimate paragraph.) We do not agree with Appellants that this “decoy” teaching should be understood as discouraging the use of IL-13Rα2 as an antagonist to regulate IL-13 action. See Gurley, 27 F.3d at 553. Instead, we find the Examiner has the better argument: we agree that Andrews meant that IL-13Rα2 would act as an antagonist. Appellants argue that Wynn does not disclose IL-13-related disease treatment other than Schistosomiasis-mediated fibrosis. (App. Br. 11.) We disagree. The evidence supports the Examiner’s finding that Wynn taught “treating an IL-13 related condition,” and that Wynn listed several treatable conditions. (See Ans. 6-7, citing Wynn at 5, 17, and 32). CONCLUSION OF LAW Appellants have not shown the Examiner erred in concluding that a spray-dried particle composition of IL-13Rα2 would have been obvious. SUMMARY We affirm the rejection of claims 1-49 and 51-62 under 35 U.S.C. § 103(a) as unpatentable over Hastedt, Duez, Andrews, and Wynn. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). Appeal 2009-008478 Application 11/058,509 7 AFFIRMED lp NOVARTIS CORPORATE INTELLECTUAL PROPERTY ONE HEALTH PLAZA 104/3 EAST HANOVER NJ 07936-1080