10204048 (B.P.A.I. Nov. 22, 2010)

Ex Parte Hedner et al

Board of Patent Appeals and InterferencesNov 22, 2010

10204048 (B.P.A.I. Nov. 22, 2010)

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. 10/204,048 12/12/2003 Jan Hedner C2432.0048/0US0 6008 32172 7590 11/22/2010 DICKSTEIN SHAPIRO LLP 1633 Broadway NEW YORK, NY 10019 EXAMINER GHALI, ISIS A D ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 11/22/2010 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 JAN HEDNER, KARS SJÖSTRÖM, KAJ STENLÖF, and LUDGER GROTE __________ Appeal 2010-007039 Application 10/204,048 Technology Center 1600 __________ Before ERIC GRIMES, FRANCISCO C. PRATS, and MELANIE L. McCOLLUM, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims to a method of treating sleep disordered breathing. The Examiner rejected the claims as obvious. 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 2010-007039 Application 10/204,048 2 We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1-5, 7-10, and 20 are pending and on appeal (App. Br. 3).2 Claim 1, the only independent claim, is representative and reads as follows: 1. A method for treating sleep disordered breathing consisting of peroral administration to a patient a therapeutically effective dose of an active agent consisting of topiramate. The only rejection before us for review is the Examiner’s rejection of claims 1-5, 7-10, and 20 under 35 U.S.C. § 103(a) as obvious over Najarian3 (Ans. 4-5). OBVIOUSNESS The Examiner finds that, based on Najarian, an ordinary artisan would have considered it obvious to treat sleep apnea, a disorder encompassed by claim 1, by orally administering topiramate (id.). Appellants contend that Najarian would not have rendered claim 1 obvious because claim 1 requires the active agent used in the claimed treatment to “consist[] of” topiramate, which excludes any additional active agents in the treatment (App. Br. 5). Thus, Appellants argue, because Najarian teaches that its treatment regimen is a combination therapy that uses topiramate alongside another therapeutic agent, Najarian does not suggest practicing the method as claimed (id. at 10). 2 Appeal Brief filed September 21, 2009. 3 U.S. Patent No. 7,056,890 B2 (filed June 3, 2003). Appeal 2010-007039 Application 10/204,048 3 We agree with Appellants that the Examiner has not made a prima facie case of obviousness. Claim 1 recites a method for treating sleep disordered breathing, which undisputedly encompasses treating sleep apnea. Claim 1 requires the method to “consist[] of” orally administering a therapeutically effective dose of an active agent that “consist[s] of topiramate.” As Appellants note, “‘closed’ transition phrases such as ‘consisting of’ are understood to exclude any elements, steps, or ingredients not specified in the claim.” AFG Indus., Inc. v. Cardinal IG Co., Inc., 239 F.3d 1239, 1245 (Fed. Cir. 2001). Thus, claim 1 excludes the use of active agents other than topiramate from the treatment regimen. Najarian discloses regimens for effecting weight loss in patients suffering from Syndrome X, a complex of medical problems associated with obesity, and also discloses that its treatments alleviate side effects that accompany obesity, including sleep apnea (Najarian, col. 15, l. 37, through col. 16, l. 37). Unlike the requirements of claim 1, however, Najarian consistently states that its regimen “involves treating a subject with a sympathomimetic agent (e.g., phentermine or a phentermine-like drug) in combination with an anticonvulsant sulfamate derivative (e.g., topiramate) such that the subject experiences weight loss. The combination methods of the present invention also are effective against symptoms associated with Syndrome X” (id., abstract (emphasis added); see also, e.g., col. 3, ll. 25 (“[T]he combination methods of the present invention have been shown to have beneficial side effects, such as ameliorating sleep apnea”)(emphasis added)). Given these teachings, we do not agree with the Examiner that Najarian would have Appeal 2010-007039 Application 10/204,048 4 prompted a person of ordinary skill in the art to treat obesity, and any attendant sleep apnea, with only topiramate. The Examiner argues that when the claims are given their broadest reasonable interpretation, the “consisting of” language “limits the active agent to topiramate of the ‘therapeutic effective dose’ and does not limit the administration to topiramate only. This broader interpretation is supported by claim 7 which recites that the ‘therapeutically active dose is released from a composition for controlled release’” (Ans. 6-7). Thus, the Examiner reasons, “the therapeutically effective dose is in the form of a composition that contains an active agent consisting of topiramate” (id. at 7). We are not persuaded. Claim 1 requires the practitioner to administer to a patient a therapeutically effective dose of an active agent that “consist[s] of topiramate.” Because “consisting of” excludes from the described feature any additional elements or ingredients not specified by the claim (see AFG Indus. v. Cardinal IG Co., 239 F.3d at 1245), we do not agree with the Examiner that it is reasonable to interpret claim 1 as encompassing treatment methods, such as Najarian’s, that use active agents in addition to topiramate. The fact that claim 7 incorporates the topiramate into a controlled release formulation does not, in our view, allow the practitioner to administer any active agents other than topiramate, given the constraints of claim 1. The Examiner also argues that the phrase “consisting of peroral administration” does not limit the administered drug to topiramate, but instead only limits the drug administration route to peroral; “[i]t has been held that ‘[w]hen the phrase ‘consists of’ appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the Appeal 2010-007039 Application 10/204,048 5 claim as a whole’” (Ans. 7 (citing Mannesmann Demag Corp. v. Engineered Metal Products Co., 793 F.2d 1279 (Fed. Cir. 1986); also In re Crish, 393 F.3d 1253 (Fed. Cir. 2004)). We are not persuaded. In the instant case, claim 1 contains two “consisting of” recitations, one in the preamble, limiting the method steps, and one in the claim body, limiting the active agent to topiramate. We therefore do not agree that it was reasonable to interpret claim 1 as encompassing methods of treating sleep apnea in which any active agent other than topiramate is administered. We acknowledge, as the Examiner argues, that Najarian describes methods in which the sympathomimetic agent and anticonvulsant sulfamate derivative (i.e., topiramate) are administered at different times of day (Najarian, col. 11, ll. 13-26), with topiramate being “best given later in the day because the drug can be sedating” (id. at col. 13, ll. 41-42). Absent some clear teaching beyond these disclosures, however, we are not persuaded that an ordinary artisan would have been prompted to use topiramate by itself to treat sleep apnea. To the contrary, Najarian at best would have suggested to an ordinary artisan that a combination therapy of a sympathomimetic agent and topiramate, administered separately, would be useful in treating obesity, and would also ameliorate the sleep apnea side effect of the obesity. However, as discussed above, claim 1 does not encompasses treatment methods that include administration of any active agent other than topiramate. In sum, claim 1 requires the practitioner to treat sleep apnea by administering topiramate as the only active agent. For the reasons discussed, we are not persuaded that Najarian would have prompted an ordinary artisan Appeal 2010-007039 Application 10/204,048 6 to treat apnea with only topiramate. Accordingly, we agree with Appellants that the Examiner has not made a prima facie case of obviousness with respect to claim 1, and therefore reverse the Examiner’s rejection of that claim, and its dependents, as obvious over Najarian. REVERSED alw DICKSTEIN SHAPIRO LLP 1633 BROADWAY NEW YORK ,NY 10019