Ex Parte Lesch et al

Patent Trial and Appeal BoardOct 19, 2017

12522646 (P.T.A.B. Oct. 19, 2017)

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. 12/522,646 07/09/2009 Hanna P. Lesch GB07/02695.8 2023 22925 7590 10/23/2017 PHARMACEUTICAL PATENT ATTORNEYS, LLC 55 MADISON AVENUE 4THFLOOR MORRISTOWN, NJ 07960-7397 EXAMINER NGUYEN, QUANG ART UNIT PAPER NUMBER 1633 NOTIFICATION DATE DELIVERY MODE 10/23/2017 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): docket @ LicensingLaw. net administration @LicensingLaw.net PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HANNA P. LESCH, KARI J. AIRENNE, and SEPPO YLA-HERTTUALA Appeal 2015-003488 Application 12/522,646 Technology Center 1600 Before DEMETRA J. MILLS, ERIC B. GRIMES, and JOHN E. SCHNEIDER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellants request rehearing of the decision entered July 27, 2017 (“Decision”), and argue that the Decision failed to consider all of the evidence. The request for rehearing is denied. First, Appellants argue that the Decision erred in affirming the rejection of claim 10 for lack of adequate descriptive support. (Req. Reh’g 1.) Appellants argue that the Decision overlooked Appellants’ declaratory evidence showing that “the claimed method produces cells that survive for at least 144 hours.” (Id. at 2.) This argument is unpersuasive because, as stated in the Decision, “in any case ‘[t]he written description requirement requires possession as shown Appeal 2015-003488 Application 12/522,646 in the specification, not as shown by prior experimental work.’ Allergan, Inc. v. SandozInc., 796 F.3d 1293, 1309 (Fed. Cir. 2015).” (Decision 5.) Appellants argue that, “[alternatively, the Decision at 5 cites Allergan, Inc. v. Sandoz Inc., 796 F.3d 1309 at 11(a) (Fed. Cir. 2015).” (Req. Reh’g 2.) Appellants argue that Allergan supports the patentability of claim 10 because “the Specification adequately describes how to make the cell culture of Claim 10. . . . This cell culture inherently produces the claimed 144 hour lifespan. The Specification therefore need not describe the claimed 144 hour lifespan expressly. See Allergan.” (Id. at 3.) We are not persuaded. As Appellants point out, in Allergan, “[t]he court summarized, ‘A claim that recites a property that is necessarily inherent in a formulation that is adequately described is not invalid as lacking written description merely because the property itself is not explicitly described.’” (Req. Reh’g 3.) Here, however, claim 10 is not directed to a composition having a certain property that may be inherent in that composition. Claim 10 is directed to a method that requires an active step of “culturing said producer cell for at least about 144 hours post transduction.” (Appeal Br. 27 (Claims App’x).) An active step in a method is not an inherent property of that method. In this case, that step requires continuing to culture the cells for at least about 144 hours, while the Specification describes culturing cells for no longer than 48 hours. Second, Appellants argue that they “compiled two scientific declarations . . . explaining in detail exactly why Leblois-Prehaud failed to enable.” (Req. Reh’g 4.) Those declarations, however, were not part of the record of this application when the rejections of record were appealed. They 2 Appeal 2015-003488 Application 12/522,646 therefore cannot be evidence that we overlooked or misapprehended. See 37 C.F.R. § 41.52(a)(1) (“The request for rehearing must state with particularity the points believed to have been misapprehended or overlooked by the Board.”). 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 3