BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Jan 10, 2022

2021000316 (P.T.A.B. Jan. 10, 2022)

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. 15/351,957 11/15/2016 Anthony F. Tassoni JR. 1001.3881101 5911 11050 7590 01/10/2022 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 EXAMINER HERBERMANN, ERICH G. ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 01/10/2022 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 ANTHONY F. TASSONI JR., MAHFUZA AHMED, and NICHOLAS L. TASSONI ____________ Appeal 2021-000316 Application 15/351,957 Technology Center 3700 ____________ Before KENNETH G. SCHOPFER, AMEE A. SHAH, and ROBERT J. SILVERMAN, Administrative Patent Judges. SHAH, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the Examiner’s final decision to reject claims 1-12 and 16-20, which constitute all the claims pending in this application.2 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real party in interest as Boston Scientific SciMed, Inc. Appeal Br. 3. 2 Claims 13-15 have been withdrawn. Appeal 2021-000316 Application 15/351,957 2 CLAIMED SUBJECT MATTER The Appellant’s invention “pertains to medical devices and methods for making and using medical devices. More particularly, the present invention pertains to stent delivery systems.” Spec. 1. Claims 1 and 16 are the independent claims on appeal. Claim 1 is illustrative of the subject matter on appeal and is reproduced below (with added bracketed notations for reference): 1. A stent delivery system, comprising: [(a)] an inner member; [(b)] a deployment sheath disposed about the inner member, wherein at least a distal region of the deployment sheath is translucent; [(c)] a stent disposed between the inner member and the deployment sheath; and [(d)] a translucent reinforcing member disposed within the translucent distal region of the deployment sheath, wherein the translucent reinforcing member and the translucent distal region of the deployment sheath allow for visualization of the stent during stent deployment. Appeal Br. 8 (Claims App.). REFERENCES The prior art references relied upon by the Examiner are: Name Reference Date Schaible et al. (“Schaible”) US 2003/0139759 A1 July 24, 2003 Gunderson et al. (“Gunderson”) US 2008/0125752 A1 May 29, 2008 Shumer et al. (“Shumer”) US 2014/0276412 A1 Sept. 18, 2014 Appeal 2021-000316 Application 15/351,957 3 REJECTIONS Claims 1-3, 5-12, and 16-20 stand rejected under 35 U.S.C. § 103 as being unpatentable over Shumer and Schaible. Claim 4 stands rejected under 35 U.S.C. § 103 as being unpatentable over Shumer, Schaible, and Gunderson. OPINION We agree with the Appellant that the Examiner does not adequately explain how the combination of Shumer and Schaible teaches the translucent reinforcing member recited in limitation (d) of independent claim 1 and similarly recited in independent claim 16. See Appeal Br. 5-6, 8, 9; Reply Br. 2-3. The Examiner finds, in relevant part, that Shumer teaches a reinforcing member disposed within the distal region of the deployment sheath, but does not directly teach wherein the reinforcing member is translucent. Final Act. 2, 7-8. The Examiner notes that Shumer discloses “individual features of one embodiment can be combined with one or more features of another embodiment or features from a plurality of embodiments,” that “the outer tubular member 120 can be made or an assembly of components that are made of a suitable material such as PEEK,” and that “the outer tubular member can be made of an assembly of components that consist of an inner layer, an outer layer and a reinforcing member placed between/in them.” Id. at 3, 8 (citing Shumer ¶¶ 70, 78, 79); see also Ans. 4. Thus, “the examiner is taking the position that since the outer tubular member and all of its assembly of components (the inner layer, outer layer and reinforcing member) can be made of PEEK material, . . . all Appeal 2021-000316 Application 15/351,957 4 three layers can be made of PEEK material.” Final Act. 3, 8; see also Ans. 4-5. We find the Examiner’s position to be inadequately supported. Shumer discloses the outer tubular member can be an assembly of components and can be of any suitable material including but not limited to polymer materials such as PTFE and PEEK. Shumer ¶ 70; see also id. ¶ 80. One embodiment is a single piece outer tubular construction that includes a nylon braided tube with a PTFE liner or a fluoropolymer braided tube with a lubricous liner such as PTFE on the inside diameter of the tube, and where at least a portion of the outer tubular members can be constructed of an alloy or metallic material. Id. ¶ 70. Shumer also discloses an alternative embodiment of a construction with multiple outer tubular members that can “be constructed of a composite comprising a fabrication of several different materials, such as a co-extrusion of different polymers, or a fiber-reinforced composite material such as fiber reinforced resin materials or braided materials.” Id. ¶ 71. In this alternative, the outer tubular member “can include a braided tube with a PTFE liner, a Polymide middle layer with braiding and a Pebax 72D outer layer.” Id. “Exemplary constructions for the outer tubular member include a single layer of polyimide or PEEK; a trilayer material of L25, Plexar, HDPE; or a braided tube with a PTFE liner, a Polyimide middle layer braiding middle layer, and a Pebax 72D outer layer.” Id. ¶ 72. “The inner and/or outer tubular members can also be reinforced by the addition of a strengthening member, such as, for example, a wire coil.” Id. In this embodiment where the outer tubular member can include an outer layer and an inner layer, “the outer tubular member can include a reinforcing layer disposed between the outer layer and the inner Appeal 2021-000316 Application 15/351,957 5 layer, such as a braided material. For example, the reinforcing layer can be provided in the form of a braided stainless steel tube or sheet or the like.” Id. ¶¶ 78, 79. Other reinforcement “can be in the form of a tube including woven fabric or appropriately oriented filaments, such as carbon fibers encased in a polymeric matrix,” whereby the fibers can be incorporated into the layers. Id. In discussing the forming of the outer tube having inner, outer, and reinforcing layers, Shumer describes a reinforcing layer in the form of stainless steel braided material. Id. ¶ 80. Although Shumer discusses the outer tube having different layers including a reinforcing layer that can be comprised of any suitable material, we do not understand Shumer to teach that the reinforcing layer can be PEEK. Shumer teaches that the outer tubular member can be made of a single layer of PEEK, but in all discussions where the outer tubular member includes multiple layers, Shumer describes the reinforcing layer as stainless steel braided material or the like. See Shumer ¶¶ 72, 80. The Examiner points out (Final Act. 3) that Shumer generally indicates “the particular features presented herein can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter includes any suitable combination of the features disclosed herein” (Shumer ¶ 82). Even accounting for Shumer’s possibilities of combining features (see id. ¶¶ 81, 82), we agree with the Appellant that Shumer does not teach that the reinforcing member can be made of PEEK and Schaible, upon which the Examiner relies on for teaching translucent PEEK, does not cure this deficiency. See Appeal Br. 5; Reply Br. 2-3. Thus, based on the record before us, we do not sustain the Examiner’s rejection under 35 U.S.C. § 103 of independent claims 1 and 16. As the Appeal 2021-000316 Application 15/351,957 6 Examiner relies on these findings dependent claims 2, 3, 5-12, and 17-20 (see Final Act. 4-7, 9, and 10), we also do not sustain the rejection of these claims. We also do not sustain the rejection under 35 U.S.C. § 103 of dependent claim 4, as we do not understand the Examiner’s reliance on Gunderson to remedy the deficiency in the Examiner’s rejection of independent claim 1. CONCLUSION The Examiner’s decision to reject claims 1-12 and 16-20 under 35 U.S.C. § 103 is reversed. In summary: Claim(s) Rejected 35 U.S.C. § References/Basis Affirmed Reversed 1-3, 5-12, 16-20 103 Shumer, Schaible 1-3, 5-12, 16-20 4 103 Shumer, Schaible, Gunderson 4 Overall Outcome 1-12, 16-20 REVERSED