Ex Parte Kangas et alDownload PDFPatent Trial and Appeal BoardMay 18, 201812815138 (P.T.A.B. May. 18, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/815,138 06/14/2010 11050 7590 05/22/2018 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 FIRST NAMED INVENTOR Steve Kangas 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 2001.1351101 1757 EXAMINER PARAD, DENNIS J ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 05/22/2018 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEVE KANGAS, MICHAEL SEAN OWENS, JON PATTERSON, DA VE EKBERG, ERIK HAUN, ERIC HENDERSON, AARON FOSS, AND YEN-LANE CHEN Appeal2017-005994 Application 12/815, 13 81 Technology Center 1600 Before DONALD E. ADAMS, RYAN H. FLAX, and DAVID COTTA, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 1-3, 6-11, 14-- 17, 19, 31, 32, and 54 (Final Act. 2 1). 3 Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants identify the real party in interest as "Boston Scientific Scimed, Inc." (App. Br. 3). 2 Office Action mailed December 31, 2015. 3 Appellants' claim 20 stands withdrawn from consideration (Final Act. 1 ). Appeal2017-005994 Application 12/815, 138 STATEMENT OF THE CASE Appellants disclose "a method of making a drug delivery balloon having a coating thereon comprising a drug, wherein the drug has characteristic amorphous and crystalline forms" (Spec. 2). Claim 1 is representative and reproduced below: 1. A method of making a drug delivery balloon having a coating thereon comprising a drug, the balloon made of a balloon material, the drug selected from the group consisting of paclitaxel, paclitaxel analogs and paclitaxel derivatives, wherein the drug has a characteristic amorphous form and a crystalline form comprising: a) applying a coating of the drug in the amorphous form to the balloon material, and, subsequent to applying the coating, b) annealing with a solvent vapor the coating which has been applied in step a), the solvent vapor comprising an alcohol, to produce the crystalline form of the drug on the balloon, wherein in the applying step a) the drug coating is applied to a balloon surface that has been nucleated by blooming of a component in the balloon material to the surface thereof, the component crystallizing at the surface of the balloon material as a result of the blooming to induce formation of drug crystals in the annealing step. (Claims App'x. 4 2 (emphasis added).) 54. A method of making a drug delivery balloon having a coating thereon comprising a drug, the balloon made of a balloon material, the drug selected from the group consisting of paclitaxel, paclitaxel analogs and paclitaxel derivatives, wherein the drug has a characteristic amorphous form and a crystalline form comprising: 4 Appellants September 2, 2016 Response to Notification ofNon-Compliant Appeal Brief. 2 Appeal2017-005994 Application 12/815, 138 a) applying a coating of the drug in the amorphous form to the balloon material, and, subsequent to applying the coating, b) annealing with a solvent vapor the coating which has been applied in step a), the solvent vapor comprising an alcohol, to produce the crystalline form of the drug on the balloon, wherein in the applying step the drug coating is applied to a balloon surface that has been nucleated by treating the balloon material so as to cause a component from within the balloon material to migrate to the swface of the balloon material, the component crystallizing at the surface of the balloon material and inducing formation of drug crystals in the annealing step. (Claims App'x 4 ( emphasis added).) The claims stand rejected as follows: Claims 1-3, 6, 7, 9-11, 14, 19, 31, 32, and 54 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Reyes5 and Hossainy. 6 Claim 8 stands rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Reyes, Hossainy, and Amey. 7 Claims 15-17 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Reyes, Hossainy, and Parsonage. 8 5 Reyes et al., US 2008/0020013 Al, published Jan. 24, 2008. 6 Hossainy et al., US 2005/0186248 Al, published Aug. 25, 2005. 7 Amey et al., US 2007/0178136 Al, published Aug. 2, 2007. 8 Parsonage et al., US 2006/0088566 Al, published Apr. 27, 2006. 3 Appeal2017-005994 Application 12/815, 138 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Reyes "relates to releasable taxane therapeutic agent coatings for endolumenal medical devices, including stents" (Reyes ,r 2). FF 2. Reyes "coatings include[] a taxane therapeutic agent in a layer that is free of a polymer that alters the release rate of the therapeutic agent" (Reyes ,r 23; see also id. ,r 60). FF 3. Reyes discloses "methods of manufacturing and treating therapeutic taxane coatings on medical devices," wherein "the methods comprise a conditioning step ... that converts a portion of paclitaxel from an amorphous solid form to a hydrated solid form that is slower-eluting than the amorphous solid form" (Reyes ,r 17; see id. ,r 18 ("[t]he post-deposition treatment of a medical device coating comprising a taxane therapeutic agent, or 'conditioning' of the coating, is performed to alter the solid form composition of taxane therapeutic agent in the coating") ( emphasis added)); id. ,r 59 (Reyes' "[m]ethods preferably comprise the steps of depositing or providing a taxane therapeutic agent on a medical device in a first solid form in a coating, followed by conditioning the coating to provide a coating comprising a second solid form having desirable solubility and durability properties")). FF 4. Reyes discloses: The recitation of "conditioning of a coating" refers to subjecting a coating to physical conditions effective to change the durability and/or solubility of the coating in an elution 4 Appeal2017-005994 Application 12/815, 138 medium. The physical conditions of conditioning may include maintaining the coating at a specified temperature and/ or humidity for a specified period of time. Alternatively, conditioning may include contacting the coating with a fluid, such as water or steam. The conditioning of a coating preferably provides a desired modification of physical properties, such as durability or elution rate, suitable for an intended use. For example, a coating comprising a paclitaxel taxane therapeutic agent as an amorphous paclitaxel solid form may be conditioned by maintaining the coating at a temperature and a relative humidity for a time period effective to provide a dehydrate paclitaxel solid form within the coating. (Reyes ,r 68; see generally id. ,r,r 98-108; see also id. ,r 122 ("[b]ulk samples of anhydrous taxane therapeutic agent can be prepared by dissolving a taxane therapeutic agent such as paclitaxel in any suitable alcohol-based solvent, followed by evaporation of the solvent to leave a[] crystalline solid"); id. ,r 143 ("ultrasonic spray coating is preferably performed at an ambient temperature of about 85-8Q F[] and in a coating chamber at a pressure of less than about 0.05 psi," wherein "[t]he temperature during ultrasonic spray coating should be high enough to rapidly evaporate the methanol in the spray solution before contacting the stent").) FF 5. Hossainy discloses: Local administration of therapeutic agents via stents has shown some favorable results in reducing restenosis. However, the properties of stent coatings can be improved. For example, when the outermost layer of the coating comprises a blend of hydrophobic and hydrophilic polymers, the hydrophobic polymers tend to bloom to coating-air interface. Yet, in many applications it is highly desirable to have hydrophilic polymers evolve at the coating-air interface to provide the stent coating with better blood compatibility, biological activity and non- fouling properties. Accordingly, the present invention discloses 5 Appeal2017-005994 Application 12/815, 138 such improved stent coatings and methods for fabricating thereof. (Hossainy ,r 9; see also id. ,r,r 20, 33-35, 40 (discussing the post-coating treatment of a coated stent resulting in the blooming of the hydrophilic polymer component of the coating to the coating-air interface).) ANALYSIS Based on the combination of Reyes and Hossainy, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to modify Reyes coating method to include Hossainy' s polymer drug coating, such that after, or post-coating, the polymer drug coated device is treated such that a hydrophilic component of the polymer drug coating blooms to the coating-air interface (see Ans. 5). We are not persuaded. Examiner has, at best, established that the combination of Reyes and Hossainy suggest a method wherein after a polymer drug coating is applied to a medical device, the polymer drug coating may be treated to cause the blooming of a component of a polymer drug coating to the coating air interface (see FF 1-5; Ans. 5). This is, however, not what Appellants' have claimed. To the contrary, Appellants' independent claim require, inter alia, blooming of a component in the balloon material, i.e. blooming of a component of the device, to the surface of the balloon material prior to application of the drug coating (see Claims App 'x. 2 ("the drug coating is applied to a balloon surface that has been nucleated by blooming of a component in the balloon material to the surface thereof') ( emphasis added); id. at 4 ("the drug coating is applied to a balloon surface that has been nucleated by treating the balloon material so as to cause a component from 6 Appeal2017-005994 Application 12/815, 138 within the balloon material to migrate to the surface of the balloon material") ( emphasis added)). For the reasons set forth above, we are not persuaded by Examiner's assertion that Appellants' "claims do not recite blooming of the balloon material component and nucleation of that component of the balloon material before application of the amorphous drug" or that Appellants' "'balloon material' may broadly include any coatings to the surface thereof' (Ans. 10, 14; cf App. Br. 8-9, 10, 13-14; Reply Br. 3, 9). Examiner further failed to establish an evidentiary basis on this record to support a conclusion that Amey or Parsonage make up for the foregoing deficiency in the combination of Reyes and Hossainy (see Ans. 6-9; cf App. Br. 19-20; Reply Br. 17-18). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1-3, 6, 7, 9-11, 14, 19, 31, 32, and 54 under 35 U.S.C. § 103(a) as unpatentable over the combination of Reyes and Hossainy is reversed. The rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable over the combination of Reyes, Hossainy, and Amey is reversed. The rejection of claims 15-17 under 35 U.S.C. § 103(a) as unpatentable over the combination of Reyes, Hossainy, and Parsonage is reversed. REVERSED 7 Copy with citationCopy as parenthetical citation