Ex Parte Bruins et al

Patent Trial and Appeal BoardMar 24, 2014

11178309 (P.T.A.B. Mar. 24, 2014)

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. 11/178,309 07/12/2005 Nico Bruins 01975.0075 3921 22852 7590 03/25/2014 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER STONE, CHRISTOPHER R ART UNIT PAPER NUMBER 1628 MAIL DATE DELIVERY MODE 03/25/2014 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 NICO BRUINS, HENDERIK W. FRIJLINK, and MICHIEL HENRICUS de VRIES __________ Appeal 2012-001122 Application 11/178,309 Technology Center 1600 __________ Before ERIC GRIMES, LORA M. GREEN, and ERICA A. FRANKLIN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 1, 6, 9, and 14-16.2 We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is Solvay Pharmaceuticals B.V. (App. Br. 4.) 2 Claims 10 and 11 are also pending, but stand withdrawn from consideration (App. Br. 6). Appeal 2012-001122 Application 11/178,309 2 STATEMENT OF THE CASE Claim 1 is the only independent claim on appeal, and reads as follows (emphasis added): 1. An extended release formulation comprising (1) from about 0.1 mg to about 2.5 mg of 3-amino- 8-(1-piperazinyl)-2H-1-benzopyran-2-one or a pharmaceutically acceptable salt thereof or a hydrate of said pharmaceutically acceptable salt thereof and (2) at least one pharmaceutically acceptable excipient chosen from: a) hydroxypropylmethyl cellulose, b) a mixture of two or morehydroxypropylmethyl celluloses, and c) a starch excipient comprising from 20 % to 80% long-chain amylase, by weight based on dry substance, wherein said long-chain amylase has a degree of polymerization of at least 100, a cold water solubility of at most 25% by weight based on dry substance, and a specific area of at least 1 m2/g; wherein said formulation releases at most 40% of the active substance within 45 minutes. The following grounds of rejection are before us for review: I. Claims 1 and 14 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of van Steen,3 Oosterbaan,4 and Green5 (Ans. 5). 3 van Steen, EP 0 650 964 A1, published Oct. 25, 1994. 4 Oosterbaan et al., US 2003/0190353 A1, published Oct. 9, 2003. 5 Green et al., US 2004/0023948 A1, published Feb. 5, 2004. Appeal 2012-001122 Application 11/178,309 3 II. Claim 6 stands rejected under 35 U.S.C. § 103(a) being rendered obvious by the combination of van Steen, Oosterbaan, and Green, as being further combined with Lui6 (id. at 7). III. Claim 9 stands rejected under 35 U.S.C. § 103(a) being rendered obvious by the combination of van Steen, Oosterbaan, and Green, as being further combined with Arends-Scholte7 (id. at 8). IV. Claims 15 and 16 stand rejected under 35 U.S.C. § 103(a) being rendered obvious by the combination of van Steen, Oosterbaan, and Green, as being further combined with Kobylecki8 (id. at 9). ANALYSIS Claims 1 and 14 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by the combination of van Steen, Oosterbaan, and Green (Ans. 6). The Examiner finds that van Steen teaches the claimed compound, but does not disclose its use in an extended release composition, nor within the claimed dosage range (id.). The Examiner relies on Oosterbaan to teach an extended release pharmaceutical composition comprising hydroxypropylmethylcellulose (HPMC) (id.). The Examiner finds that Oosterbaan teaches that such extended release compositions provide for a convenient, single daily dose, as well as a flattened drug plasma profile, thus reducing side effects (id.). The 6 Lui, US 5,009,895, issued Apr. 23, 1991. 7 Arends-Scholte et al., WO 96/09815, published Apr. 4, 1996. 8 Kobylecki et al., US 2002/0183938 A1, published Dec. 5, 2002. Appeal 2012-001122 Application 11/178,309 4 Examiner then relies on Green for teaching the dosage of the claimed compound that can be used in a pharmaceutical composition (id.). Specifically, the Examiner finds that Green teaches that “dosages of 3- amino-8-(1-piperazinyl)-2H-1-benzopyran-2-one including 0.25, 0.5 and 1 mg are appropriate for use in pharmaceutical compositions” (id.). The Examiner concluded that the ordinary artisan would have combined the references to provide an extended release formulation to produce a convenient, once daily dosage form with reduced side effects (id. at 7). The Examiner further found, with regards to the claimed formulation releasing at most 40% of the active substance within 45 minutes, that this was nothing more than functional language that does not further structurally limit the composition, and it was thus not given patentable weight (id. at 7). Appellants argue that there is no reasonable expectation of success that the amount of active ingredient used in the an immediate release formulation as taught by Green would be appropriate for use in an extended release formulation as presently claimed (App. Br. 16). Specifically, Appellants argue that Oosterbaan is directed to an extended release formulation, while Green is directed to an immediate release formulation that promotes pre-gastric absorption (id. at 15). Appellants also argue that none of the cited references teaches or suggests an extended release formulation comprising the claimed compound that would release at most 40% of the active substance within 45 minutes (id. at 17). Again, Appellants note that Green teaches that its formulation disintegrates within 1 to 60 seconds, and it would thus not meet the release profile required by claim 1 (id.). Appeal 2012-001122 Application 11/178,309 5 We agree with Appellants that the Examiner has not set forth a prima facie case of obviousness. Under 35 U.S.C. § 103, the factual inquiry into obviousness requires a determination of: (1) the scope and content of the prior art; (2) the differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17 (1966). “All words in a claim must be considered in judging the patentability of that claim against the prior art.” In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970). Green teaches a fast dispersing formulation containing the claimed active ingredient in an amount of from 0.25 to 50 mg that disintegrates within 1 to 60 seconds (App. Br. 15). The Examiner uses the amount of active ingredient in the fast dispersing formulation set forth in Green as equivalent to the amount claimed in the extended release formulation of claim 1. The Examiner has not provided evidence or scientific reasoning, however, as to why one skilled in the art would have understood that the same amount of active ingredient used in the fast dispersing formulation would be appropriate for use in an extended release. In addition, the Examiner has not provided sound reasoning as to why the recited release rate limitation does not provide a structural limitation for the claimed formulation. Moreover, the combination of references does not teach or suggest that the release rate limitation would be met. Appeal 2012-001122 Application 11/178,309 6 SUMMARY All of the rejections on appeal are reversed. REVERSED cdc