Ex Parte RuaneDownload PDFPatent Trial and Appeal BoardDec 8, 201713926515 (P.T.A.B. Dec. 8, 2017) 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. 13/926,515 06/25/2013 Patrick H. Ruane 2209-4 7742 31554 7590 12/12/2017 CARTER, DELUCA, FARRELL & SCHMIDT, LLP 445 BROAD HOLLOW ROAD SUITE 420 MELVILLE, NY 11747 EXAMINER BOWMAN, ANDREW J ART UNIT PAPER NUMBER 1717 NOTIFICATION DATE DELIVERY MODE 12/12/2017 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 @ cdfslaw. com tgiordano@cdfslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PATRICK H. RUANE Appeal 2017-004847 Application 13/926,515 Technology Center 1700 Before CHUNG K. PAK, JAMES C. HOUSEL, and JANE E. INGLESE, Administrative Patent Judges. INGLESE, Administrative Patent Judge. DECISION ON APPEAL Appellant1 requests our review under 35 U.S.C. § 134(a) of a final rejection of claims 1, 2, and 4—222. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant is the Applicant, The Spectranetics Corporation, which, according to the Appeal Brief filed April 5, 2016 (“App. Br.”), is the real party in interest. App. Br. 1. 2 Appellant cancelled claim 3 in an amendment filed December 7, 2015, and the Examiner confirmed entry of the amendment in an Advisory Action issued January 8, 2016. Appeal 2017-004847 Application 13/926,515 STATEMENT OF THE CASE Appellant claims a method of forming a coated medical device. App. Br. 2—3. Claim 1 illustrates the subject matter on appeal and is reproduced below: 1. A method of forming a coated medical device comprising: applying a coating to an outer surface of a medical device, the coating including a therapeutic agent dispersed in a matrix of a polymer or oligomer excipient; post-processing the medical device by immersion in a solvent or solution, thereby selectively removing a substantial portion of the polymer or oligomer excipient from the matrix in which the therapeutic agent is dispersed; and sterilizing the post-processed medical device, wherein the coating comprises less than 50% by weight of the therapeutic agent prior to post-processing, and the coating comprises greater than 50% by weight of the therapeutic agent after post-processing. App. Br. 10 (Claims Appendix) (emphasis added). The Examiner sets forth the following rejections in the Answer entered December 2, 2016 (“Ans.”)3: I. Claims 1, 2, 4—10, and 16—22 under 35 U.S.C. § 103(a) as unpatentable over Tuch (US 2008/0051871 Al, published February 28, 2008)4; 3 The Examiner indicates that the grounds of rejection set forth in the Answer are not new grounds of rejection, but are modified relative to the grounds of rejection set forth in the Final Office Action entered October 7, 2015 (“Final Act.”) in response to Appellant’s cancellation of claim 3 in the amendment filed December 7, 2015. Ans. 2, 7. 4 Although the Examiner states that this rejection is under § 102(b), we interpret this rejection as an obviousness rejection under § 103(a) rather than an anticipation rejection under § 102(b), in light of the Examiner’s 2 Appeal 2017-004847 Application 13/926,515 II. Claims 11—14 under 35 U.S.C. § 103(a) as unpatentable over Tuch in view of Lavelle (US 2007/0078446 Al, published April 5, 2017) as evidenced by El https://en.wikipedia.org/wiki/Polyethelyene glycol; and III. Claim 15 under 35 U.S.C. § 103(a) as unpatentable over Tuch in view of Lavelle and Zhao (US 2010/0233236 Al, published September 16, 2010) as evidenced by El. DISCUSSION Upon consideration of the evidence relied upon in this appeal and each of Appellant’s contentions, we reverse the Examiner’s rejections of claims 1, 2, and 4—22 under 35 U.S.C. § 103(a) for the reasons set forth in the Appeal Brief and below. Rejection I We need only consider claim 1 because the remaining claims on appeal include all the limitations of claim 1. As set forth above, claim 1 requires the recited method of forming a coated medical device to comprise, inter alia, applying to an outer surface of a medical device a coating that includes a therapeutic agent dispersed in a matrix of a polymer or oligomer excipient, and selectively removing a substantial portion of the polymer or oligomer excipient from the matrix in which the therapeutic agent is dispersed by immersing the medical device in a solvent or solution. Appellant’s Specification explains that this “post-processing” procedure of immersing the coated medical device controls selective removal of the placement of this rejection under the heading “Claim Rejections — 35 USC § 103” and the Examiner’s explicit indication that “there are no longer any 102 rejections remaining in the current application.” Ans. 2—3, 7. 3 Appeal 2017-004847 Application 13/926,515 coating matrix excipient relative to the therapeutic agent, and allows a significantly higher amount of the coating matrix excipient than the therapeutic agent to be removed from the coating. Spec. 125. The Examiner finds that Tuch discloses applying to the exterior of a medical device a coating that “may contain a polymer, and a drug applied at the same time as the polymer (examples), and a pore-forming agent.” Ans. 3 (citing Tuch || 37—39, examples). The Examiner finds that because Tuch discloses that the ratio of the pore-forming agent to the polymer may be 9:1, the pore-forming agent reasonably functions as a matrix material. Ans. 3 (citing Tuch 143). The Examiner finds that Tuch discloses removing the pore-forming agent. Ans. 3. The Examiner further finds that paragraph 62 of Tuch “makes clear” that “the starting solution for their entire invention” includes a solvent, a polymer dissolved in the solvent, and a therapeutic agent dispersed in the solvent. Ans. 8. The Examiner finds that all embodiments of Tuch are not required to be porous, but if a pore-forming agent is utilized, “it seems implied that it is to be part of this” starting solution described in paragraph 62. Id. However, Tuch’s disclosure as a whole describe two main aspects of Tuch’s invention. The first aspect relates to a medical device coated with a porous material that includes a therapeutic agent. Tuch || 15—17, 34; Fig. 2. Tuch discloses that the porous material can be in the form of a sheet. Tuch 137. Tuch discloses forming such a porous sheet by dissolving a polymer, such as polyether urethane, in an organic solvent, adding a particulate material to the solution that is insoluble in the organic solvent, such as sodium chloride or sucrose, casting the solution including the particulate material into a thin film, and applying a second solvent, such as water, to 4 Appeal 2017-004847 Application 13/926,515 dissolve and remove the particulate material. Tuch 140. Tuch discloses loading the porous polymeric sheet material thus formed with a therapeutic agent by immersing the material in a solution or dispersion of the therapeutic agent in a solvent, allowing the solution or dispersion to fill the pores, and evaporating the solvent, which results in dispersion of the therapeutic agent within at least a portion of the pores. Tuch | 52. Tuch exemplifies this aspect of his invention in Example 1. Tuch || 68—70. As Appellant points out, this first aspect of Tuch’s invention does not involve applying to an outer surface of a medical device a coating that includes a therapeutic agent dispersed in a matrix of a polymer or oligomer excipient, and selectively removing a substantial portion of the polymer or oligomer excipient from the matrix in which the therapeutic agent is dispersed, as require by claim 1. App. Br. 4—5. Although the Examiner finds that Tuch discloses removing the pore-forming agent from the polymeric material, Tuch discloses removing the pore-forming agent before loading the therapeutic agent into the polymeric material in order to create pores in the material that will contain the subsequently loaded therapeutic agent. Tuch || 40, 52. The second aspect of Tuch’s invention relates to a method of coating an intravascular stent with a therapeutic substance that involves applying to the body of a stent a solution including a solvent, a polymer dissolved in the solvent, and a therapeutic substance dispersed in the solvent, and evaporating the solvent, to form a coating of the polymer and therapeutic substance on the surface of the stent. Tuch || 23, 62—63. Tuch exemplifies this aspect of his invention in Examples 4—8. Tuch H 73—77. As Appellant correctly argues, Tuch does not disclose including a 5 Appeal 2017-004847 Application 13/926,515 pore-forming agent in the stent coating of this second aspect of Tuch’s invention. Reply Br. 4. Although as discussed above the Examiner asserts that Tuch implies that a pore-forming agent could be included in the stent coating solution, the Examiner does not point to any disclosures in Tuch, other than paragraph 62, to support this assertion. We find no disclosure in paragraph 62 implying that a pore-forming agent could be used in the stent coating described in this paragraph. Nor do we find any such disclosure in the remaining portions of Tuch. In view of Tuch’s separate discussion and exemplification of first and second aspects of Tuch’s invention (described above), and lack of any disclosure indicating that the pore-forming agent of the first aspect could be used in the coating solution of the second aspect, one of ordinary skill in the art reasonably would have interpreted Tuch’s disclosures as a whole to indicate that the first and second aspects of Tuch’s invention are independent. The Examiner fails to provide a persuasive explanation supported by evidence of why one of ordinary skill in the art would have understood otherwise. Therefore, the Examiner fails to establish that Tuch would have suggested applying to an outer surface of a medical device a coating that includes a therapeutic agent dispersed in a matrix of a polymer or oligomer excipient, and selectively removing a substantial portion of the polymer or oligomer excipient from the matrix in which the therapeutic agent is dispersed, as require by claim 1. We accordingly do not sustain the Examiner’s rejection of claims 1, 2, 4—10, and 16—22 under 35 U.S.C. § 103(a) as unpatentable over Tuch. Rejections II and III We do not sustain these rejections because the Examiner does not rely 6 Appeal 2017-004847 Application 13/926,515 on Lavelle, Zhao, and/or El for any disclosure that remedies the deficiencies of Tuch. DECISION We reverse the Examiner’s rejections of claims 1, 2, and 4—22 under 35 U.S.C. § 103(a). REVERSED 7 Copy with citationCopy as parenthetical citation