Ex Parte KnappDownload PDFBoard of Patent Appeals and InterferencesOct 12, 201011598903 (B.P.A.I. Oct. 12, 2010) Copy Citation 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. 11/598,903 11/14/2006 David Knapp 00-0118US2 1654 27774 7590 10/12/2010 MAYER & WILLIAMS PC 251 NORTH AVENUE WEST 2ND FLOOR WESTFIELD, NJ 07090 EXAMINER CHANNAVAJJALA, LAKSHMI SARADA ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 10/12/2010 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 DAVID KNAPP __________ Appeal 2010-006674 Application 11/598,903 Technology Center 1600 __________ Before ERIC GRIMES, DEMETRA J. MILLS, and LORA M. GREEN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134 involving claims to a medical article that releases a therapeutic agent. The Examiner has rejected the 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 2010-006674 Application 11/598,903 2 claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1-7, 14, 15, and 22-33 are on appeal. Claim 1 is the only independent claim and reads as follows: 1. A therapeutic medical article comprising: a medical article; a precursor compound; and an activator compound, wherein said medical article is adapted, upon placement at an administration site within the body of a patient, to release said precursor compound and said activator compound such that said activator compound interacts with said precursor compound and converts said precursor compound into activated form that is a therapeutic agent for local delivery within the body of said patient. Issue The Examiner has rejected claims 1-7, 14, 15, and 22-33 under 35 U.S.C. § 103(a) as being obvious in view of Papandreou.2 The Examiner finds that Papandreou discloses a medical device “that is loaded with an agent comprising a sulfhydryl group (thiol group) (precursor compound) and further treated with a nitric oxide (NO) carrier (activator compound)” (Answer 4), and that interaction of the sulfhydryl groups with the NO carrier results “in the release of nitric oxide directly at the target site” (id.). The Examiner concludes that “it would have been obvious for one of an ordinary skill in the art … to coat [the] medical stents of [Papandreou] with a thiol group containing agent and further with an NO donor containing compound because [Papandreou] teaches that the liberation 2 Papandreou et al., US 6,171,232 B1, Jan. 9, 2001. Appeal 2010-006674 Application 11/598,903 3 of nitric oxide from vasodilators, particularly NO donors, is potentiated by the thiol donors” (id. at 5). Appellant contends that Papandreou provides “no teaching or suggestion to release a precursor compound (e.g., thiol) and an activator compound (e.g., nitric oxide donor) such that the activator compound interacts with the precursor compound and converts said precursor compound into activated form” (Appeal Br. 4-5). The issue presented is: Does the evidence of record support the Examiner’s conclusion that Papandreou suggests a medical device that is adapted to release both a precursor compound and an activator compound? Findings of Fact 1. Papandreou discloses “coated medical devices…. More particularly, a thiol group containing agent is loaded onto a medical device for in vivo interaction with a nitric oxide donor” (Papandreou, col. 1, ll. 5-9). 2. Papandreou discloses that, in a “preferred embodiment, protected sulfur containing compounds are covalently attached onto medical device surfaces of polymer-coated metals, polymers and the like. These thus immobilized compounds … are useful for enhancing local release of nitric oxide in vivo” (id. at col. 1, ll. 9-14). 3. Papandreou discloses that a “further object of the present invention is to provide medical devices having sulfhydryl groups on their working or engagement surfaces to provide the favorable property of accelerating release of nitric oxide locally when patients within which the medical devices are implanted are administered nitrovasodilators such as nitroglycerin” (id. at col. 2, ll. 47-52). Appeal 2010-006674 Application 11/598,903 4 4. Papandreou discloses that “the nitric oxide donor or provider is delivered to the treatment location by any of several different approaches. These include oral ingestion, … and loading onto the medical device prior to its implantation or insertion” (id. at col. 5, ll. 7-13). 5. Papandreou illustrates the covalent attachment of the sulfhydryl containing compounds to a polymer deposited on a medical device (id. at col. 5, l. 15-col. 6, l. 33, Fig. 1 and Fig. 2). Principles of Law “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). Analysis Claim 1 is directed to a therapeutic medical article that is adapted to release a precursor compound and an activator compound such that the activator compound converts the precursor compound into an activated, therapeutic form, when the article is placed in a patient’s body. Appellant argues that Papandreou does not suggest devices that release both a precursor compound and an activator compound (Appeal Br. 4-5, Reply Br. 4). Appellant’s argument is persuasive. Although Papandreou’s device can be loaded with both a sulfhydryl group-containing compound and a NO- donor compound, Papandreou discloses that the sulfhydryl-containing Appeal 2010-006674 Application 11/598,903 5 compounds are preferably covalently attached to the medical device and describes them as “immobilized compounds” (FF 2). The Examiner has not pointed to any passage in Papandreou that describes the sulfhydryl- containing compounds as being released from the medical device. The Examiner finds that “a skilled artisan would have expected the release of the two (precursor and activator) compounds from the article of [Papandreou] (see column 2, lines 47-52)” (Answer 8-9). We do not agree that this passage supports the Examiner’s position. This passage (quoted above in FF 3) describes Papandreou’s devices as “having sulfhydryl groups on their working or engagement surfaces” (FF 3), not releasing sulfhydryl groups from those surfaces. Thus, we are compelled to conclude that the Examiner has not adequately explained how Papandreou suggests a medical device that releases both a precursor compound and an activator compound. The rejection of claim 1, and dependent claims 2-7, 14-15 and 22-33, is reversed. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Papandreou suggests a medical device which is adapted to release both a precursor compound and an activator compound. SUMMARY We reverse the rejection of claims 1-7, 14-15 and 22-33 under 35 U.S.C. § 103(a). REVERSED Appeal 2010-006674 Application 11/598,903 6 cdc MAYER & WILLIAMS PC 251 NORTH AVENUE WEST 2ND FLOOR WESTFIELD, NJ 07090 Copy with citationCopy as parenthetical citation