Ex Parte Jain et al

Patent Trial and Appeal BoardNov 13, 2012

11311220 (P.T.A.B. Nov. 13, 2012)

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. 11/311,220 12/20/2005 Rajesh Jain 01975.0088 1451 22852 7590 11/13/2012 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER LOVE, TREVOR M ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 11/13/2012 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 PATENT TRIAL AND APPEAL BOARD __________ Ex parte RAJESH JAIN, SUKHJEET SINGH, ROHIT KUMAR, and MARIUS L. DE WINTER __________ Appeal 2011-013081 Application 11/311,220 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC GRIMES, 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 rejection of claims directed to an oral immediate release formulation of benzazepine-1- acetic acid derivatives and a method preparing the formulation. The Patent Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-013081 Application 11/311,220 2 STATEMENT OF THE CASE Claims 18-20 and 23-35 are on appeal. Claim 18 is representative and reads as follows: 18. An oral immediate release formulation comprising (a) at least one compound of formula (I) in an amount of up to 65% by weight, based on the total weight of the formulation: (I) wherein R1 is a [sic] chosen from: - a (C1-C6)alkoxy(C1-C6)alkyl group which may be substituted by a (C1-C6)alkoxy group, a phenyl-(C1-C6)-alkyl group and a phenyloxy- (C1-C6)-alkyl group wherein the phenyl group is optionally substituted with at least one substituent chosen from a (C1-C6)alkyl group, a (C1-C6)alkoxy group, a halogen atom, and a napthyl-(C1-C6)-alkyl group, R2 and R3, which may be identical or different, are each independently chosen from a hydrogen atoms or a halogen atoms, R4 is chosen from a biolabile ester forming group, M is chosen from a hydrogen atom and a metal ion, n is a number chosen from 1, 2 and 3; b) at least one alkaline compound in amount of at least 10% by weight, based on the total weight of the formulation; c) at least one surfactant in an amount ranging from 0.1 to 10% by weight, based on the total weight of the formulation, and d) optionally comprising auxiliary materials in an amount ranging from 1 % to 45% by weight based on the total weight of the formulation. The Examiner rejected claims 18-20 and 23-35 under 35 U.S.C. § 103(a) as unpatentable over Waldeck et al. (US 5,677,297 (Oct. 14, 1997)) and Sims et al. (US 5,288,507 (Feb. 22, 1994)). Appeal 2011-013081 Application 11/311,220 3 DISCUSSION We adopt the Examiner’s findings concerning the scope and content of the Waldeck and Sims patents. (See Ans. 4-6.) We also agree with the Examiner’s discussion of the evidence and responses to Appellants’ points. (See Ans. 7-12.) Based on the record as a whole, we conclude the Examiner properly rejected the claims for obviousness, and we adopt the Examiner’s reasoning as our own. We provide the following summary for emphasis. Briefly, Appellants contend that a person of ordinary skill in the art would have required more guidance than Waldeck and Sims provide to choose a calcium salt, sodium carbonate, and docusate sodium. Not one of the appealed claims is limited to that combination, although claims 26, 33, and 34 specify a calcium salt. More importantly, the Examiner’s evidence and discussion make clear that Waldeck and Sims made a variety of the claimed combinations obvious. If a particular composition of drug and excipients would have been obvious, it would not have been any less obvious from the point of view of a person of ordinary skill in the pharmaceutical art merely because there were a number of other obvious compositions. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that the prior art’s disclosure of a multitude of combinations failed to render any particular formulation less obvious). For example, Appellants argue that “Sims discloses a laundry list of possible pharmaceutically acceptable diluents—twenty-three acceptable diluents in all,” and contend “one of ordinary skill in the art could just as easily pick one of the other equally preferable diluents disclosed in Sims.” (App. Br. 16.) This only means that at least twenty-three choices of diluent would have been obvious. Appellants provide no evidence that any one of those Appeal 2011-013081 Application 11/311,220 4 twenty-three would have had some unexpected result. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1363 (Fed. Cir. 2007) (characterizing genus of 53 FDA-approved anions as “small,” and finding that “one of ordinary skill in the art would have favorably considered benzene sulphonate because of its known acid strength, solubility, and other known chemical characteristics”). As in the Pfizer case, so also in this case: one of ordinary skill in the art would have considered calcium salts, sodium bicarbonate, and docusate sodium favorably because Waldeck or Sims recommended them. We also agree that the Examiner weighed Appellants’ comparative evidence properly. The comparison was between a drug with a surfactant and a drug without surfactant. (Spec. 13, comparing formulations D and F, and Figure 3.) The Examiner properly found that Formulation F does not represent the closest prior art (Ans. 10), because Waldeck had disclosed a composition with a surfactant (magnesium stearate). Appellants’ Brief includes an attorney argument that magnesium stearate is not a surfactant, or would not be used in an oral formulation, but that argument is unpersuasive because the Examiner rebutted it with evidence. (Ans. 10-11.) The Examiner’s decision to accord Appellants’ comparison little weight was therefore reasonable. “[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). CONCLUSION OF LAW The totality of evidence in the record supports a conclusion of obviousness. Appeal 2011-013081 Application 11/311,220 5 SUMMARY We affirm the rejection of claims 18-20 and 23-35 under 35 U.S.C. § 103(a) as unpatentable over Waldeck et al. and Sims et al. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED lp