Jeffrey Welch et al.

Patent Trials and Appeals BoardDec 10, 2021

2021003653 (P.T.A.B. Dec. 10, 2021)

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. 15/224,323 07/29/2016 Jeffrey M. Welch 3028.018US1 4283 140274 7590 12/10/2021 Schwegman Lundberg & Woessner / SurModics P.O. Box 2938 Minneapolis, MN 55402 EXAMINER OSINSKI, BRADLEY JAMES ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 12/10/2021 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): slw@blackhillsip.com uspto@slwip.com PTOL-90A (Rev. 04/07) 1 UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JEFFREY M. WELCH and GREGG SUTTON ____________ Appeal 2021-003653 Application 15/224,323 Technology Center 3700 ____________ Before HUBERT C. LORIN, BIBHU R. MOHANTY, and MICHAEL C. ASTORINO, Administrative Patent Judges. MOHANTY, 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 1–26. We have jurisdiction under 35 U.S.C. § 6(b). SUMMARY OF THE DECISION We AFFIRM. 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 Surmodics MD, LLC. (Appeal Br. 2). Appeal 2021-003653 Application 15/224,323 2 CLAIMED SUBJECT MATTER The Appellants’ claimed invention relates to a coronary guide catheter (Spec. 1, line 9). Claim 1, reproduced below, is representative of the subject matter on appeal. 1. An interventional guide catheter for introducing interventional catheters into the vasculature, comprising: a main tubular shaft with a distal tip and proximal end; the main tubular shaft comprising: a main inner structural layer comprising a metallic helically wound multi-filar wire extending from a proximal tube termination to a distal end, the multi-filar wire having a wall thickness of 0.0015 to 0.010 inches, and individual strands of the multi-filar wire are engaged with adjacent strands of the multi-filar wire in a close-fitting wire matrix, a braided wire layer covering the main inner structural layer that extends from the proximal tube termination to the distal end, the braided wire layer having a thickness of 0.0005 to 0.010 inches, an outer layer of polymer jacketing covering and fixedly attached to the main inner structural layer and braided wire layer with wall thickness of 0.001 to 0.005 inches, an inner layer of polymer jacketing covering and fixedly attached to the main inner structural layer with wall thickness of 0.0005 to 0.007 inches, a distal tip made of layers of polymer, the distal tip being 0.05 to 0.20 inches in length, a distal end curve shape for anatomical conformance, the distal end curve shape imparted by the main inner structural layer. Appeal 2021-003653 Application 15/224,323 3 THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: Nobuyoshi US 5,106,363 Apr. 21, 1992 Sutton US 5,472,435 Dec. 5, 1995 Henke US 5,558,652 Sept. 24, 1996 Berg US 5,846,229 Dec. 8, 1998 Beisel US 5,947,940 Sept. 7, 1999 McGuckin, Jr. et al. US 2002/0068899 A1 June 6, 2002 Winters US 2002/0095102 A1 July 18, 2002 Hartley et al. US 2006/0095050 A1 May 4, 2006 Macnamara et al. US 2007/0233040 A1 Oct. 4, 2007 The following rejections are before us for review: 1. Claims 1–3, 5–7, 9, 11, 13, 21, 22, 25, and 26 are rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, and Berg. 2. Claim 4 is rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Nobuyoshi 3. Claim 8 is rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Winters. 4. Claims 10, 12, 14–16, and 20 is rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and McGuckin, Jr. 5. Claim 17 is rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Macnamara. 6. Claims 18 and 19 are rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Henke. Appeal 2021-003653 Application 15/224,323 4 7. Claims 23 and 24 are rejected under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Sutton. FINDINGS OF FACT We have determined that the findings of fact in the Analysis section below are supported at least by a preponderance of the evidence2. ANALYSIS The Appellant argues that the rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, and Berg is improper: 1) because the proposed combination makes Hartley unsatisfactory for its intended purpose; 2) because the references teach away from the proposed combination; 3) and because certain claimed recitations are not suggested (Appeal Br. 6–17, Reply Br. 2–8). In contrast, the Examiner has determined that cited rejection is proper (Final Act. 2–4, 11, 12, Ans. 3–7). We agree with and adopt the Examiner’s rationale for the rejection of record. Hartley discloses an implantable medical sheath in Fig. 2 with a main inner structural layer (23) comprising a helically wound wire with a thickness of 0.0015-0.010 inches (see para. 48), a braided wire layer (25) with a thickness of 0.001 to 0.006 inch covering the structural layer (see paras. 18, 49), an outer layer (27), an inner layer (22), and a proximal tip region. Beisel discloses a catheter with a helical core in Figs. 6 and 7. 2 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Patent Office). Appeal 2021-003653 Application 15/224,323 5 Beisel also discloses that winding reinforcement coils at a long pitch leaves gaps which decreases kink resistance, but that using multifilar (multiple lead) coils of a long pitch would restore kink resistance (col. 10, lines 50– 65). Beisel at Fig. 6 shows helical reinforcing members (14a, 14b, 14c) engaged with each other side by side. Berg at Fig. 1 discloses a catheter with a distal curve shape which provides for a gentle curvature for a device passing through the catheter (see also col. 2, lines 4–16). In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court rejected the Federal Circuit’s rigid application of its teaching, suggestion, motivation test in favor of an expansive and flexible approach. Id., 550 U.S. at 415. The Supreme Court noted that often, it will be necessary “to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id., 550 U.S. at 418. In KSR, the Court stated that when considering obviousness that “the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 418. When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill. See KSR at 421. Appeal 2021-003653 Application 15/224,323 6 Here, one of ordinary skill in the art would have seen the advantage of modifying the device of Hartley to include using multifilar coils as taught by Beisel, and to include a curved distal end as taught by Berg for the advantages of increasing kink resistance and to provide a gentle curvature for the device to pass through. Here, one of ordinary skill in the art would have understood that the some applications may require a catheter with more stiffness, while some may require one with less stiffness, and that Hartley’s device could be modified in the cited combination if less stiffness was desired. With regards to the specific dimensions claimed for the outer and inner layer thicknesses and size of the distal tip, one of ordinary skill in the art could have readily determined the claimed thicknesses and sized based on the desired durability and flexibility for the device. Accordingly, for these above reasons, the rejection of claim 1 is sustained. The Appellant has not provided specific arguments for dependent claims 2–26 and the rejection of these claims is affirmed as not argued. CONCLUSIONS OF LAW We conclude that Appellant not shown that the Examiner erred in rejecting claims 1–3, 5–7, 9, 11, 13, 21, 22, 25, and 26 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, and Berg. We conclude that Appellant not shown that the Examiner erred in rejecting claim 4 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Nobuyoshi. Appeal 2021-003653 Application 15/224,323 7 We conclude that Appellant not shown that the Examiner erred in rejecting claim 8 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Winters. We conclude that Appellant not shown that the Examiner erred in rejecting claims 10, 12, 14–16, and 20 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and McGuckin, Jr. We conclude that Appellant not shown that the Examiner erred in rejecting claim 17 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Macnamara. We conclude that Appellant not shown that the Examiner erred in rejecting claims 18 and 19 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Henke. We conclude that Appellant not shown that the Examiner erred in rejecting claims 23 and 24 under 35 U.S.C. § 103 as unpatentable over Hartley, Beisel, Berg, and Sutton. Appeal 2021-003653 Application 15/224,323 8 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5–7, 9, 11, 13, 21, 22, 25, 26 103 Hartley, Beisel, Berg 1–3, 5–7, 9, 11, 13, 21, 22, 25, 26 4 103 Hartley, Beisel, Berg, Nobuyoshi 4 8 103 Hartley, Beisel, Berg, Winters 8 10, 12, 14– 16, 20 103 Hartley, Beisel, Berg, McGuckin, Jr. 10, 12, 14– 16, 20 17 103 Hartley, Beisel, Berg, Macnamara 17 18, 19 103 Hartley, Beisel, Berg, Henke 18, 19 23, 24 103 Hartley, Beisel, Berg, Sutton 23, 24 Overall Outcome 1–26 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED