JIMRO CO., LTD.Download PDFPatent Trials and Appeals BoardJul 29, 20212021001017 (P.T.A.B. Jul. 29, 2021) 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. 15/522,406 04/27/2017 Matsuya MANABE Q232899 5196 23373 7590 07/29/2021 SUGHRUE MION, PLLC 2000 PENNSYLVANIA AVENUE, N.W. SUITE 9000 WASHINGTON, DC 20006 EXAMINER LOPEZ, LESLIE ANN ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 07/29/2021 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): PPROCESSING@SUGHRUE.COM USPTO@sughrue.com sughrue@sughrue.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MATSUYA MANABE Appeal 2021-001017 Application 15/522,406 Technology Center 3700 Before JOHN C. KERINS, JILL D. HILL, and CYNTHIA L. MURPHY, Administrative Patent Judges. HILL, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 13, 15, and 17–202, which constitute all the claims pending in this application. We have jurisdiction under 35 U.S.C. § 6(b). A video oral hearing was conducted on July 15, 2021. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as JIMRO CO., LTD. Appeal Br. 3. 2 Claims 1–12 are canceled. Claims 13–24 are pending. Claims 14, 16, and 21–24 are withdrawn. Final Act. 2. Appeal 2021-001017 Application 15/522,406 2 We REVERSE. BACKGROUND Sole independent claim 13, reproduced below, represents the claimed subject matter: 13. A drug-eluting stent having a net-like main body which is made of a metal or a polymeric material and has flection sections, wherein a surface of the main body is coated with a mixture comprising cilostazol and a bioabsorbable polymer, wherein the bioabsorbable polymer comprises (a) a polymer comprising DL lactide and glycolide in a weight ratio of 7:3 - 9:1, whose molecular weight is 40,000 - 400,000, (b) a polymer comprising DL lactide whose molecular weight is 50,000 - 100,000, (c) a polymer comprising L lactide and DL lactide in a weight ratio of 6:4 - 8:2, whose molecular weight is 300,000 - 600,000, (d) a polymer comprising L lactide whose molecular weight is 50,000 - 150,000, or (e) a polymer comprising L lactide and caprolactone in a weight ratio of 6:4 - 8:2, whose molecular weight is 150,000 - 400,000. REJECTIONS I. Claims 13, 15, and 18 stand rejected under 35 U.S.C. § 103 as unpatentable over Rypacek, Pohjonen, and Iguchi. Final Act. 8. II. Claim 17 stands rejected under 35 U.S.C. § 103 as unpatentable over Rypacek, Iguchi, and Tartaglia. Final Act. 10. III. Claims 19 and 20 stand rejected under 35 U.S.C. § 103 as unpatentable over Rypacek, Pohjonen, Iguchi, and Sirhan. Final Act. 11. Appeal 2021-001017 Application 15/522,406 3 ANALYSIS Rejection I Claim 13 recites a drug-eluting stent coated with a mixture comprising the antiplatelet drug cilostazol and a bioabsorbable polymer, the bioabsorbable polymer having a specific combination of weight ratios and ranges of molecular weights of DL lactide polymer, L lactide polymer, and a polymer combination of DL lactide and L lactide polymers. See Appeal Br. 27 (Claims App.). The Examiner finds that Rypacek discloses, inter alia, a drug-eluting stent “coated with a mixture comprising [an antiplatelet] drug and a bioabsorbable polymer . . . whose molecular weight is 300,000 - 600,000.” Final Act. 8 (citing Rypacek ¶¶ 83, 271–273, 334). The Examiner also finds that Rypacek’s bioabsorbable polymer comprises L lactide and DL lactide in a weight ratio of 1:1. Id. (citing Rypacek ¶ 335). The Examiner admits that Rypacek does not disclose the bioabsorbable polymer comprising L lactide and DL lactide in the claimed weight ratio of 6:4 - 8:2, but finds that Pohjonen discloses this L lactide and DL lactide weight ratio of 6:4 - 8:2 for use with implants. Id. at 8–9 (citing Pohjonen 3:19–53, 1:6–18). The Examiner reasons that, because Pohjonen and Rypacek are concerned with the same field of endeavor, namely implants coated with polymers comprising L lactide and DL lactide, it would have been obvious to “modify Rypacek such that the polymer comprises L lactide and DL lactide in a weight ratio of 6:4 - 8:2 as taught by Pohjonen as it is a simple substitution of one known element for another to obtain predictable results. Id. at 9 (citing MPEP § 2143). Appeal 2021-001017 Application 15/522,406 4 The Examiner then admits that the combination of Rypacek and Pohjonen does not disclose the drug being cilostazol, but finds that Rypacek discloses the concentration of its antiplatelet drug encompassing 50% by weight, and lguchi discloses a stent with a drug-polymer coating “where the drug is cilostazol at 50% by weight.” Final Act. 9 (citing Iguchi 13:15–35, Rypacek ¶ 26). The Examiner reasons that lguchi, Rypacek, and Pohjonen “are concerned with the same field of endeavor, namely polymer coatings for stents,” so that it would have been obvious to “modify the combination of Rypacek and Pohjonen such that the drug is cilostazol as taught by lguchi . . . to inhibit thrombogenesis at the stent surface and to inhibit endothelial cell proliferation of the blood vessel. Id. (citing Iguchi 7: 18–30). Appellant initially notes: In cases involving the chemical arts––such as the presently claimed invention––the Federal Circuit has held that it is particularly necessary to articulate some reason that would have led a person of ordinary skill in the art to modify a known composition in a particular manner to obtain a predictable outcome. See, e.g., Eisai Co. Ltd v. Dr. Reddy's Laboratories, Ltd, 533 F.3d 1353, 1359 (Fed. Cir. 2008). This is because the chemical arts are unpredictable and thus potential solutions are less likely to be genuinely predictable. See id. Appeal Br. 8. Appellant argues, inter alia, that “the cited prior art does not address the unpredictability and difficulties in developing a matrix for delivering a poorly-soluble drug like cilostazol from a DES.” Appeal Br. 12. Appellant also argues that a skilled artisan “would not have had a reasonable expectation of success.” Id. Appellant contends that “small changes in the repeating units and/or [molecular weight] of the polymer can produce very different results,” as Appeal 2021-001017 Application 15/522,406 5 evidenced by Figure 5 of their Specification, which shows “wide variation in dissolution at the same [molecular weight].” Appeal Br. 16. Appellant argues that “Pohjonen does not overcome this unpredictability in the art” and a skilled artisan “would not have had any reason to think that Pohjonen's polymer is suitable for delivering a poorly-soluble drug like cilostazol.” Id. The Examiner responds that solubility is not recited in the claims. Ans. 4. The Examiner also disagrees that Appellant’s Figure 5 establishes poor solubility of cilostazol. Id. at 7. The Examiner does not, however, discuss the predictability of the art and its effect on whether it would have been obvious to change the weight ratio of L lactide and DL lactide, or substitute cilostazol for Rypacek’s antiplatelet drug. Appellant has the better argument, given the Federal Circuit’s guidance that the chemical arts are unpredictable, making potential solutions less likely to be genuinely predictable. This unpredictability makes it particularly necessary to articulate a reason why a skilled artisan would modify a known composition in a particular manner to obtain a predictable outcome. See Eisai, 533 F.3d at 1359. Here, Appellant’s Specification discusses the poor solubility of cilostazol, and the resulting difficulty in creating a nanoparticle therewith for coating a stent. Spec. ¶¶ 7–8, 12, 14, and 32. The Examiner’s reasoning is conclusory in stating that it would have been obvious to “modify Rypacek such that the polymer comprises L lactide and DL lactide in a weight ratio of 6:4 - 8:2 as taught by Pohjonen as it is a simple substitution of one known element for another to obtain predictable results.” Final Act. 9. Merely alleging predictable results in an unpredictable art falls short of providing a rational basis. Further, the Examiner concludes that replacing Rypacek’s antiplatelet drug with Iguchi’s Appeal 2021-001017 Application 15/522,406 6 antiplatelet drug would have been obvious “to inhibit thrombogenesis at the stent surface and to inhibit endothelial cell proliferation of the blood vessel.” Id. Since Rypacek already includes an antiplatelet drug, the Examiner’s reasoning, again, seems to be substitution of one known element –– an antiplatelet drug –– for another to obtain predictable results, which is insufficient in an unpredictable art. None of Sirhan, Dave, or Turnell, noted by the Examiner as teaching cilostazol with a lactic acid polymer (Final Act. 3), remedies the Examiner’s lack of a reasoning with rational basis. First, the teachings of these references are not incorporated into the pending rejections. The Examiner contends that, because these references “teach the same type of polymer as the combination of Rypacek and Pohjonen, it is clear that one of ordinary skill in the art . . . would understand cilostazol to be easily used with the polymer of Rypacek.” Final Act. 3. Lacking an explanation of why the specific combinations of Sirhan, Dave, and Turnell establish that combining cilostazol with L lactide and DL lactide in a certain weight ratio is predictable, the Examiner has not establish the predictability alleged in the stated reason for combining Rypacek, Pohjonen, and Iguchi. For these reasons, we do not sustain the rejection of independent claim 13 as obvious over Rypacek, Pohjonen, and Iguchi. Claims 15 and 18 depend from claim 13. We do not sustain Rejection I. Claims 17, 19, and 20 also depend from claim 13, and none of the remaining references or Examiner analyses cure this deficiency, and thus we do not sustain Rejections II or III for the same reasons. CONCLUSION The Examiner’s rejections are not sustained Appeal 2021-001017 Application 15/522,406 7 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 13, 15, 18 103 Rypacek, Pohjonen, Iguchi 13, 15, 18 17 103 Rypacek, Iguchi, Tartaglia 17 19, 20 103 Rypacek, Pohjonen, Iguchi, Sirhan 19, 20 REVERSED Copy with citationCopy as parenthetical citation