10131916 (B.P.A.I. Jan. 20, 2011)

Ex Parte Kuczynski et al

Board of Patent Appeals and InterferencesJan 20, 2011

10131916 (B.P.A.I. Jan. 20, 2011)

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. 10/131,916 04/25/2002 Anthony L. Kuczynski ALZA-0005 2081 7590 01/20/2011 Joseph Lucci Woodcock Washburn LLP One Liberty Place 46th Floor Philadelphia, PA 19103 EXAMINER HAGHIGHATIAN, MINA ART UNIT PAPER NUMBER 1616 MAIL DATE DELIVERY MODE 01/20/2011 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 ANTHONY L. KUCZYNSKI, ATUL D. AYER, and PATRICK S.L. WONG __________ Appeal 2010-003055 Application 10/131,916 Patent 6,361,795 B1 Technology Center 1600 __________ Before ERIC GRIMES, JEFFREY N. FREDMAN, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING1 Appellants request rehearing of the decision entered Sept. 22, 2010 (“Decision”). Appellants argue that we misapprehended the evidentiary 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 2010-003055 Application 10/131,916 2 value of the Lebovitz Declaration in discounting it on the basis that researchers at Pfizer developed a sustained-release glipizide formulation despite Dr. Lebovitz’s concerns that such a formulation could cause hypoglycemia (Req. Rhg. 2-4). Appellants argue that “for the Board’s reasoning to have any relevance, it must be assumed that Pfizer independently developed its sustained release glipizide formulation without knowledge of the present invention” (id. at 3) and that Pfizer’s Glucotrol® XL product was in fact “developed by Alza Corporation, the assignee of the instant patent application” (id.). We are not persuaded that the Decision misapprehended or overlooked relevant facts. We will assume for present purposes that Glucotrol® XL was developed through a joint effort of Pfizer and Alza, as stated in the Request for Rehearing. Even assuming that to be the case, however, it does not cast doubt on the conclusion reached in the Decision. The evidence of record does not show that Pfizer’s researchers made their decision to develop sustained-release glipizide formulation based on any information that was not available to a person of ordinary skill in the art. Even if researchers at Pfizer might have collaborated during the development process with researchers at Alza, who might have been aware of the present invention, this possibility does not undercut our conclusion that Pfizer’s decision provides evidence that those of ordinary skill in the field would not have reasonably doubted the likelihood of success for a sustained-release dosage form of glipizide. We also note that the Curatolo patent, which is assigned to Pfizer (Curatolo, front page), supports our conclusion. Curatolo discloses that its Appeal 2010-003055 Application 10/131,916 3 products can be used for oral administration of drugs, including “hypoglycemics” such as glipizide (Decision, FF 2). Curatolo discloses glipizide formulations that release glipizide for up to 23 hours (id. at FF 8). Thus, Curatolo itself provides evidence that those of ordinary skill in the art would have expected sustained-release glipizide products to be effective for controlling blood sugar levels. And, since Curatolo is the reference relied on by the Examiner, its evidence in support of a reasonable expectation of success is especially significant. SUMMARY We adhere to our conclusion (Decision 9) that the evidence provided by Dr. Lebovitz, when weighed together with the evidence provided by Curatolo, does not establish the nonobviousness of the claimed method. The Request for Rehearing is denied. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). REHEARING DENIED lp Appeal 2010-003055 Application 10/131,916 4 JOSEPH LUCCI WOODCOCK WASHBURN LLP ONE LIBERTY PLACE 46th FLOOR PHILADELPHIA PA 19103