Ex Parte SongDownload PDFBoard of Patent Appeals and InterferencesJun 1, 201110638920 (B.P.A.I. Jun. 1, 2011) 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. 10/638,920 08/11/2003 Young-Ho Song 02-428 (4010/43) 5977 27774 7590 06/02/2011 MAYER & WILLIAMS PC 251 NORTH AVENUE WEST Suite 201 WESTFIELD, NJ 07090 EXAMINER VU, JAKE MINH ART UNIT PAPER NUMBER 1618 MAIL DATE DELIVERY MODE 06/02/2011 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 YOUNG-HO SONG __________ Appeal 2010-012224 Application 10/638,920 Technology Center 1600 __________ Before ERIC GRIMES, MELANIE L. McCOLLUM, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a medical device. The Examiner has rejected the claims for obviousness and, provisionally, for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification discloses that “[i]mplantable or insertable medical devices are frequently used for delivery of one or more therapeutic agents” Appeal 2010-012224 Application 10/638,920 2 (Spec. 1, ¶ 0002). “Many therapeutic agents, however, are oxidation- sensitive. This characteristic can adversely impact the shelf life and efficacy of medical devices containing such therapeutic agents” (id. at 1, ¶ 0003). Claims 1-4, 6, 8-11, 15-17, 19-22, 26, and 27 are on appeal. Claims 1, 8, and 10 are representative and read as follows: 1. A medical device comprising a medical device substrate and a therapeutic-agent containing region over said substrate, wherein said therapeutic-agent-containing region comprises trans-retinoic acid and an antioxidant in an amount chosen so that the amount of the therapeutic agent that is present in unoxidized form in the medical device after three weeks of atmospheric exposure at 25°C is at least 10 times greater than the amount of the therapeutic agent that is present in unoxidized form in the medical device after three weeks of atmospheric exposure at 25°C in the absence of said antioxidant. 8. The medical device of claim 1, wherein said therapeutic-agent containing region further comprises a polymer. 10. The medical device of claim 8, wherein said polymer is a polystyrene-polyisobutylene-polystyrene triblock copolymer. The claims stand rejected as follows: • Claims 1-4, 6, 8, 16, 19-22, 26, and 27 under 35 U.S.C. § 103(a) as being obvious over Carlyle1 in view of Herdeg2 and/or Ishii;3 1 Carlyle et al., US 2003/0204239, Oct. 30, 2003 2 Christian Herdeg et al., Effects of local all-trans-retinoic acid delivery on experimental atherosclerosis in the rabbit carotid artery, 57 CARDIO- VASCULAR RESEARCH 544-553 (2003) 3 Ishii et al., US 6,833,004, Dec. 21, 2004 Appeal 2010-012224 Application 10/638,920 3 • Claims 1-4, 6, 8-11, 15-17, 19-22, 26, and 27 under 35 U.S.C. § 103(a) as being obvious in view of Carlyle, Herdeg, Ishii, Davila4 and Bales.5 • Claims 1-4, 6, 8-11, 15-17, 19-22, and 26-27 (provisionally) for obviousness-type double patenting based on Application No. 10/955,368, Carlyle, and Herdeg. I. Issue The Examiner has rejected claims 1-4, 6, 8, 16, 19-22, 26, and 27 under 35 U.S.C. § 103(a) as being obvious over Carlyle in view of Herdeg and/or Ishii. Claims 2-4, 6, 8, 16, 19-22, 26, and 27 have not been argued separately and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner finds that Carlyle discloses a stent comprising “a therapeutic agent, such as rapamycin to reduce restenosis (see [0034]) ; [and] antioxidants, such as butylated hydroxytoluene … to prevent the stabilized drug from degrading” (Answer 6-7). The Examiner finds that Herdeg and Ishii both disclose trans-retinoic acid to inhibit vascular restenosis (id. at 7). The Examiner concludes that it “would have been obvious to the person of ordinary skill in the art … to incorporate trans- retinoic acid into CARLYLE’s stent composition … because CARLYLE disclosed using a therapeutic agent that inhibits restenosis and … trans- retinoic acid is well-known to inhibit restenosis” (id.). The Examiner 4 Davila et al., US 2002/0111590, Aug. 15, 2002 5 Bales et al., US 6,527,938, Mar. 4, 2003 Appeal 2010-012224 Application 10/638,920 4 reasons that although the references do not explicitly disclose the amount of antioxidant recited in claim 1, the amount of an ingredient “in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize” (id. at 7-8). Appellant contends that one of skill in the art would not have been motivated combine the trans retinoic acid of either Herdeg or Ishii with the stent of Carlyle (Appeal Br. 5-6) and that the cited references do not suggest the claimed amount of antioxidant (id. at 7). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusions that it would have been obvious to combine the trans retinoic acid of Herdeg or Ishii with the stent of Carlyle and that the claimed amount of antioxidant does not distinguish the claimed device from the prior art? Findings of Fact 1. Carlyle discloses “catheter-deployed endovascular stents with polymeric coatings including one or more drugs with desired timed-release properties and a preservative containing at least one antioxidant” (Carlyle 2, ¶ 0021). 2. Carlyle discloses “the use of an effective amount of preservatives in either the drug or polymer of a drug coated stent … to reduce or prevent drug and polymer degradation” (id. at 2, ¶ 0023). 3. Carlyle discloses that “[e]xamples of preservatives that may be used include antioxidants such as butylated hydroxytoluene (BHT) or vitamins A through E” (id.). Appeal 2010-012224 Application 10/638,920 5 4. Carlyle discloses that the drug or “bioactive agent may be selected to inhibit vascular restenosis” (id. at 3, ¶ 0032). 5. Carlyle discloses that the “bioactive agent may include … rapamycin…. Rapamycin or sirolimus is a medication that may interfere with the normal cell growth cycle and may be used to reduce restenosis.” (Id. at 3, ¶ 0034.) 6. Herdeg discloses that “[a]ll-trans retinoic acid (atRA) is known to inhibit smooth muscle cell growth and thus is supposed to have favorable effects on the incidence of restenosis after percutaneous coronary interventions” (Herdeg, abstract). 7. Herdeg discloses that “[i]n order to avoid systemic side effects, local delivery of atRA is preferable” (id.). 8. Herdeg discloses that “[l]ocal delivery of atRA led to limitation of restenosis formation in [an] animal model. The concept of … local atRA therapy might be a promising way to exploit the potential of atRA for vascular indications.” (Id.) 9. Ishii discloses a stent that provides “sustained release of [a] biologically/physiologically active substance, namely, slow, gradual release of the biologically/physiologically active substance for a prolonged period” (Ishii, col. 3, ll. 21-25). 10. Ishii discloses that “[e]xemplary biologically/physiologically active substances include … retinoid” (id. at col. 7, ll. 54-59). 11. Ishii discloses that “[e]xemplary preferred retinoids include all- trans retinoic acid” (id. at col. 8, ll. 29-30). Appeal 2010-012224 Application 10/638,920 6 Analysis Carlyle discloses endovascular stents with polymeric coatings including a drug and an antioxidant to inhibit oxidative degradation of the drug or polymeric coating. Carlyle discloses that the drug may be one that inhibits restenosis. Herdeg discloses that local delivery of all-trans retinoic acid (atRA) inhibited restenosis formation in an animal model and might be promising for vascular indications. Ishii discloses a stent that provides sustained-release delivery of drugs, including all-trans retinoic acid. In view of these disclosures, it would have been obvious to one of ordinary skill in the art to modify Carlyle’s stent to include all-trans retinoic acid, because Herdeg and Ishii disclose that atRA inhibits restenosis and can be included in a stent for sustained release. Appellant argues that those of skill in the art would not have been motivated to combine Herdeg’s trans-retinoic acid with Carlyle’s stent because the atRA of Herdeg “is delivered via a double balloon catheter and not with any type of coated stent” (Appeal Br. 5). This argument is not persuasive. Although Herdeg uses an animal model to investigate the anti-restenosis effects of atRA, one of skill in the art would have considered it obvious to combine Herdeg’s atRA with the Carlyle’s stent in view of Herdeg’s disclosure that atRA is effective as an anti-restenosis agent and Carlyle’s express suggestion of stents that contain anti-restenosis agents. Appellant also argues that Ishii is not combinable with Carlyle or Herdeg because Ishii’s stent requires the use of a polymer layer that releases drugs when it swells and cracks (Appeal Br. 5-6). This argument is also Appeal 2010-012224 Application 10/638,920 7 unpersuasive because the Examiner’s rejection is not based on combining the stents of Carlyle and Ishii, but only on the obviousness of substituting all-trans retinoic acid, a known anti-restenosis agent (Herdeg) that had been used in stents (Ishii), for the anti-restenosis agent rapamycin suggested by Carlyle for use in its stent. Appellant also argues that the cited references do not suggest the claimed amount of antioxidant and that the Examiner was in error in reasoning that claimed amount of antioxidant would be a result-effective variable that would be routinely optimized because Carlyle discloses competing goals of inhibiting corrosion of metallic stents or degradation of polymeric stents (Appeal Br. 7). This argument is not persuasive. Claim 1 simply requires a sufficient level of antioxidant to maintain the drug in unoxidized form for a given period of time under specified conditions. Appellants have provided no evidence to show that amount of antioxidant required to achieve this level would have been outside the range of amounts that would have been used routinely, or that the amount would have been incompatible with maintaining the integrity of metallic or polymeric stents. Conclusion of Law The evidence of record supports the Examiner’s conclusions that it would have been obvious to combine Herdeg’s trans-retinoic acid with Carlyle’s stent and that the claimed amount of antioxidant does not distinguish the claimed device from the prior art. Appeal 2010-012224 Application 10/638,920 8 II. Issue The Examiner has rejected claims 1-4, 6, 8-11, 15-17, 19-22, 26, and 27 under 35 U.S.C. § 103(a) as being obvious in view of Carlyle, Herdeg, Ishii, Davila and Bales. Since we have affirmed the rejection of claim 1 in view of Carlyle, Herdeg and Ishii as discussed above, we also affirm the rejection of claim 1 in view of Carlyle, Herdeg, Ishii, Davila and Bales. Claims 2-4, 6, 8, 11, 15-17, 19-22, 26 and 27 fall with claim 1. Appellants have argued claims 9 and 10, as a group, separately. The Examiner relies on Carlyle, Herdeg, and Ishii, as discussed above. The Examiner finds that Bales discloses “that in the field [of] stents, stable biocompatible copolymers, such as polystyrene-polyisobutylene-polystyrene polymers (SIBS) are used to coat the stent” (Answer 10). The Examiner concludes that it “would have been obvious to the person of ordinary skill in the art … to incorporate a copolymer, such as polystyrene-polyisobutylene- polystyrene polymers, into CARLYLE’s stent composition … because BALES teaches that in the field [of] stents, stable biocompatible copolymers, such as polystyrene-polyisobutylene-polystyrene polymers (SIBS) are commonly used to coat the stent” (id.). Appellant contends that Bales teaches away from using “polymeric binding materials … [because] BALES is directed to methods of forming alternative coatings that can be loaded with biological or chemical agents without resorting to the use of such polymeric binders” (Appeal Br. 8). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that one of ordinary skill in the art Appeal 2010-012224 Application 10/638,920 9 would have considered it obvious to combine Bale’s polystyrene- polyisobutylene-polystyrene copolymer with the stent suggested by the combination of Carlyle and Herdeg? Additional Findings of Fact 12. Bales discloses a process to “create a fine microporous structure on the surface of an implant article that would allow a biological or chemical agent to be infiltrated into the surface of the article without the need for binding agents” (Bales, col. 3, ll. 19-21). 13. Bales discloses that others have coated stents … with biological agents … or chemical agents … to reduce problems associated with hyper- plasia or inflammation. In order to attach these biological or chemical agents to the surface of a metallic stent, the agents have been mixed with binders such as elastomers or bio- resorbable polymers. These binders can also create problems in that they can cause inflammation, and they can cause the surface of the stent to have more friction, which reduces the ease of stent delivery. (Id. at col. 1, ll. 36-47.) 14. Bales discloses that [i]n the field of arterial stents, coatings have been applied to stainless steel and titanium alloys (e.g., TiNi alloys) to retard tissue reactions such as thrombosis, inflammation, and hyperplasia. Such coatings have been based upon stable bio- compatible polymers (such as styrene-isobutylene-styrene (SIBS)).… In the work known to date, the active chemical or biological agent is mixed with the polymeric coating material, and the agent then elutes from the coating once the implant is placed in the body. (Id. at col. 2, ll. 24-32.) Appeal 2010-012224 Application 10/638,920 10 Principles of Law “A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. ” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “[I]n a section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.’” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Analysis Claim 10 depends from claim 1 and requires that the therapeutic-agent containing region further comprises a polystyrene-polyisobutylene- polystyrene triblock copolymer. As discussed above, the combination of Carlyle, Herdeg, and Ishii suggests polymer-coated stents that comprise an antioxidant and trans- retinoic acid as an active agent. Bales discloses that polymers are used as binders for therapeutic agents and that coatings based upon polymers such as styrene-isobutylene-styrene (SIBS) have been applied to stainless steel and titanium alloy stents to inhibit tissue reactions. In view of these disclosures, it would have been obvious to use the styrene-isobutylene-styrene polymers of Bales in the stent made obvious by Carlyle, Herdeg, and Ishii to act as a binder for trans retinoic acid and to inhibit tissue reactions. Appellant argues that Bales teaches away from polymeric binding materials in general because Bales is directed to alternative stent coatings Appeal 2010-012224 Application 10/638,920 11 that can be loaded with biological or chemical agents without the use of polymeric binders (Appeal Br. 8). Appellant also argues that Bales teaches that binders have been known to cause problems such as inflammation and friction during delivery (id. at 9). These arguments are not persuasive. Bales discloses that styrene- isobutylene-styrene polymers are stable biocompatible polymers known in the art for coating stents and binding active agents. The fact that Bales teaches advantages for microporous surfaces as binding surfaces for active agents and teaches that polymers generally, although not styrene- isobutylene-styrene polymers specifically, have been known to be associated with problems does not lead one of skill in the art away from the use of styrene-isobutylene-styrene polymers because these specific polymers are described as being stable, biocompatible, and well known for their use in stents. Conclusion of Law The evidence of record supports the Examiner’s conclusion that one of ordinary skill in the art would have considered it obvious to combine Bale’s polystyrene-polyisobutylene-polystyrene triblock copolymer with the stent suggested by the combination of Carlyle and Herdeg. III. The Examiner has provisionally rejected claims 1-4, 6, 8-11, 15-17, 19-22 and 26-27 in view of copending Application No. 10/955,368, Carlyle, and Herdeg. Claims 2-4, 6, 8-11, 15-17, 19-22 and 26-27 have not been Appeal 2010-012224 Application 10/638,920 12 argued separately and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner relies on Carlyle and Herdeg as discussed above. The Examiner finds that the ‘368 application claims a stent comprising a polymeric region and phenolic compound, wherein the phenolic compound is butylated hydroxytoluene (Answer 5). The Examiner concludes that it “would have been obvious to the person of ordinary skill in the art … to incorporate … trans-retinoic acid into the copending application … because trans-retinoic acid inhibits vascular restenosis, which commonly occurs with stent insertion into the vasculature vessels” (id.). We agree with and adopt the Examiner’s findings and conclusion. Appellant contends that the “rejection is … in error, based on the deficiencies in CARLYLE and HERDEG” (Appeal Br. 3). This argument is unpersuasive for the reasons discussed above with respect to obviousness. SUMMARY We affirm the rejection of claims 1-4, 6, 8-11, 15-17, 19-22, 26, 27 under 35 U.S.C. § 103(a). We also affirm the provisional obviousness-type double patenting rejection of claims 1-4, 6, 8-11, 15-17, 19-22, 26, 27 in view of copending Application No. 10/955,368, Carlyle, and Herdeg. Appeal 2010-012224 Application 10/638,920 13 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). AFFIRMED lp Copy with citationCopy as parenthetical citation