Ex Parte Atanasoska et alDownload PDFPatent Trial and Appeal BoardFeb 10, 201511094638 (P.T.A.B. Feb. 10, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte LILIANA ATANASOSKA, SCOTT SCHEWE, and ROBERT WARNER1 __________ Appeal 2012-006351 Application 11/094,638 Technology Center 1600 __________ Before LORA M. GREEN, MELANIE L. McCOLLUM, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. McCOLLUM, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a medical balloon and to a guide wire. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1, 3, 6, 7, 10–14, 30, 31, and 33–51 are pending and on appeal (App. Br. 5). Claims 1, 34, 47, and 50 are independent and read as follows: 1 Appellants identify the real party in interest as Boston Scientific Scimed, Inc. (App. Br. 3). Appeal 2012-006351 Application 11/094,638 2 1. A medical balloon comprising a composite region, said composite region comprising an organic polymer and a sol-gel derived ceramic in separate phases or bi-continuous phases, or both. 34. A medical balloon having an abrasion resistant coating on a substrate, the substrate comprising a substrate polymer and the coating comprising an organic polymer and a sol-gel derived ceramic in separate phases or bi-continuous phases, or both. 47. A medical balloon comprising a nylon or polyether-block- polyamide substrate, a coating on the substrate, the coating comprising an organic polymer and a sol-gel derived ceramic in separate phases or bi- continuous phases, or both, and wherein said organic polymer in said coating is a polyether-block-polyamide. 50. A guide wire comprising a composite coating, said composite coating comprising an organic polymer and a sol-gel derived ceramic in separate phases or bi-continuous phases, or both. Claims 1, 3, 6,2 10–14, 30, 31, 33, 41–44, 46–48, 50, and 51 stand rejected under 35 U.S.C. § 103(a) as obvious over Bates3 as evidenced by de Toledo4 and in view of Hatcher5 (Ans. 5). Claims 7 and 34–39 stand rejected under 35 U.S.C. § 103(a) as obvious over Bates as evidenced by de Toledo and in view of Hatcher and Kickelbick6 (Ans. 7). 2 We note that claim 6 depends from claim 4, which was cancelled (App. Br. 5 & 24). For the purpose of this appeal, we are assuming that claim 6 depends from claim 1, which claim 4 previously depended upon (Spec. 22). 3 Bates et al., US 2006/0020331 A1, Jan. 26, 2006. 4 de Toledo, US 5,178,158, Jan. 12, 1993. 5 Hatcher et al., WO 2004/005533 A2, Jan. 15, 2004. 6 Guido Kickelbick, Concepts for the Incorporation of Inorganic Building Blocks into Organic Polymers on a Nanoscale, 28 PROG. POLYM. SCI. 83– 114 (2003). Appeal 2012-006351 Application 11/094,638 3 Claim 40 stands rejected under 35 U.S.C. § 103(a) as obvious over Bates as evidenced by de Toledo and in view of Hatcher, Kickelbick, and Rammler7 (Ans. 8). Claims 33, 40, 45, and 49 stand rejected under 35 U.S.C. § 103(a) as obvious over Bates as evidenced by de Toledo and in view of Hatcher and Rammler (Ans. 9). I The Examiner relies on Bates for disclosing “a coated medical device, i.e. implantable balloon, with a bioactive deposited or within the balloon” (Ans. 5). In particular, the Examiner finds: Bates et al. disclose the medical device, i.e. the balloon is attached to a catheter shaft which includes a guide wire as well as an inflation lumen for inflating the balloon . . . ; wherein it is known in the art that guide wires and catheters may be used interchangeably for medical applications as evidenced by de Toledo. Bates et al. further disclose the medical device is formed with a base material which itself comprises a plurality of layers . . . , i.e. PEBAX, which is defined in the instant specification . . . as polyether-block-polyamides and a bioactive material coating, i.e. anti-proliferative agent. (Id.) However, the Examiner acknowledges that Bates does “not disclose a balloon comprising a composite comprising a polymer and a sol-gel derived ceramic in separate phases or bi-continuous phases, or both” (id.). The Examiner relies on Hatcher for disclosing “a sol-gel combined with a polymer to form a composite that can be applied to the surface or integrated within a variety of medical devices, i.e. catheters” (id. at 6). In particular, the Examiner finds: 7 Rammler, WO 94/23787 A1, Oct. 27, 1994. Appeal 2012-006351 Application 11/094,638 4 Hatcher et al. . . . disclose the composite may be a coating on a substrate made of metal or polymer materials . . . . Hatcher et al. also disclose the composite can be produced into discontinuous fibers and/or continuous filament, i.e. mats, weaves and meshes . . . . Hatcher et al. further disclose the composite may contain active agents. (Id.) The Examiner concludes: It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. . . . Therefore, it would have been obvious to one of ordinary skill in the art to have coated the balloon part of the catheter of Bates as evidenced by de Toledo with the sol-gel and polymer composite motivated by the desire to use a coating suitable for coating catheters as disclosed by Hatcher et al. . . . The shaft and balloon make up the catheter of Bates et al. and may be formed with the same material. Catheters and guide wires may be used interchangeably for medical applications; therefore it would have been obvious to one of ordinary skill to have coated the catheter and all its parts, i.e. balloon with the coating of Hatcher et al. (Id. at 6–7.) Analysis For the reasons set forth by Appellants (App. Br. 10–17 & Reply Br. 2–7), we conclude that the Examiner has not adequately explained why one of ordinary skill in the art would have coated the balloon or guide wire of Bates with the composite described in Hatcher. In response to Appellants’ arguments, the Examiner finds that Bates discloses a coating to “help facilitate the delivery of the active agent to the vessel cells” and that Hatcher discloses “sol-gel compositions that can be Appeal 2012-006351 Application 11/094,638 5 used as a vehicle for delivery of biologically active agents; wherein the active agent would be in the sol-gel and not adhered to the base material of the medical device” (Ans. 11). Therefore, the Examiner argues that “one would be motivated to use the sol-gel coating of Hatcher et al. as the coating of Bates, since both coatings are used for the delivery of active agents and can be used for coating catheters, guide wires and balloons” (id. at 11–12). We are not persuaded. Bates discloses that a “hydrophilic material, also known as a slip coating lessens the adhesion of the base material to the lipophilic bioactive material and helps facilitate a delivery of the lipophilic material to the vessel cells at the delivery site” (Bates, ¶ 14). On the other hand, Hatcher discloses that a “bioactive glass composite can be formed from the bioactive sol-gel solution, including a fibrous form,” and “[f]ibers can serve as a scaffold for cell growth and in the repair of hard or soft tissue defects” (Hatcher, Abstract). Hatcher does disclose that its composition “can be used as a vehicle for the in situ delivery of biologically active agents” (id. at 16: 20– 21). However, we agree with Appellants that the Examiner has not adequately explained how the applied references “suggest that the sol-gel derived ceramic disclosed by Hatcher et al. would be a suitable substitute for the hydrophilic coating disclosed by Bates et al., [specifically] that it would act as a slip coating in the bloodstream to facilitate transfer of the lipophilic material to the cell wall” (Reply Br. 4). Conclusion The Examiner has not set forth a prima facie case that Bates and Hatcher, as evidenced by de Toledo, suggest the products of claims 1, 3, 6, Appeal 2012-006351 Application 11/094,638 6 10–14, 30, 31, 33, 41–44, 46–48, 50, and 51. We therefore reverse the obviousness rejection of these claims over that Bates and Hatcher, as evidenced by de Toledo. II In rejecting claims 7 and 34–39, the Examiner relies on Bates, de Toledo, and Hatcher as discussed above, but finds that these references “do[] not disclose a covalent linkage between the polymer and sol-gel derived ceramic or an abrasion resistant coating” (Ans. 7). Therefore, the Examiner additional relies on Kickelbick for disclosing “a sol-gel and polymer formation with covalent links that are strong . . . and have scratch-resistance or barrier properties” (id.). However, the Examiner does not adequately explain how Kickelbick overcomes the deficiency discussed above. Therefore, we conclude that the Examiner has not set forth a prima facie case that Bates, Hatcher, and Kickelbick, as evidenced by de Toledo, suggest the balloons of claims 7 and 34–39. We therefore reverse the obviousness rejection of these claims. III Claim 40 depends from claim 34 and recites that the balloon further comprises “a therapeutic agent on the substrate and said coating extends over said therapeutic agent” (App. Br. 25). In rejecting claim 40, the Examiner relies on Bates, de Toledo, Hatcher, and Kickelbick as discussed above, but finds that these references “do[] not disclose a coating over the therapeutic agent” (Ans. 8). The Examiner additionally relies on Rammler for disclosing coating the surface of a balloon with therapeutic agents, i.e. cell proliferation inhibitors, and then using protective polymers Appeal 2012-006351 Application 11/094,638 7 which will erode with time, as to release the drug . . . ; wherein upon inflation of the balloon the therapeutic agents will be released and pressed into the vessel wall as well as exposed to the flow of blood to move the drug from the surface into contact with the vessel wall. (Id. at 8–9.) The Examiner concludes: It would have been obvious to have coated the balloon of Bates as evidenced by de Toledo in view of Hatcher and further in view of Kickelbick with an anti-proliferative drug and then further coated the balloon with the composite material motivated by the desire to release and press the therapeutic agent into the vessel wall as well as expose the agent to the flow of blood to move the drug from the surface of the balloon into contact with the vessel wall and to achieve the known properties of the anti-proliferative agent with the advantage of releasing the drug gradually as the coating erodes over time as disclosed by Rammler. (Id. at 9.) Analysis Rammler discloses “balloons for use with catheters . . . , where the balloons are shaped to provide for delivery of medicaments or other agents to a site of a lesion in a vessel” (Rammler 2: 28–31). In particular, Rammler discloses: A portion [or] substantially all of the surface of the balloon may be coated, in whole or in part, with various therapeutic agents, which may adhere to the surface of the balloon as a result of . . . use of protective polymers which will erode with time, so as to release the drug, in accordance with the time frame of the association of the balloon with the site to be treated. (Id. at 6: 23–30.) However, we conclude that the Examiner has not adequately explained why Hatcher’s coating, which “can serve as a scaffold Appeal 2012-006351 Application 11/094,638 8 for cell growth and in the repair of hard or soft tissue defects” (Hatcher, Abstract), would have been used as Rammler’s protective polymer. Conclusion The Examiner has not set forth a prima facie case that Bates, Hatcher, Kickelbick, and Rammler, as evidenced by de Toledo, suggest the balloon of claim 40. We therefore reverse the obviousness rejection of claim 40 over Bates, Hatcher, Kickelbick, and Rammler, as evidenced by de Toledo. IV In rejecting claims 33, 40, 45, and 49, which directly or indirectly depend from claims 1, 34, or 47, the Examiner relies on Bates, de Toledo, and Hatcher as discussed above, but finds that these references “do[] not disclose a coating over the therapeutic agent” (Ans. 9). Thus, the Examiner relies on Rammler as discussed above (id. at 10). However, for the reasons discussed above in sections I and III, we conclude that the Examiner has not set forth a prima facie case that Bates, Hatcher, and Rammler, as evidenced by de Toledo, suggest the balloons of claims 33, 40, 45, and 49. We therefore reverse the obviousness rejection of these claims over Bates, Hatcher, and Rammler, as evidenced by de Toledo. REVERSED cdc Copy with citationCopy as parenthetical citation