Jackson, Brad et al.Download PDFPatent Trials and Appeals BoardNov 16, 202014725221 - (D) (P.T.A.B. Nov. 16, 2020) 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. 14/725,221 05/29/2015 Brad Jackson 356080US01/1213-025US01 5538 137834 7590 11/16/2020 MDT_RTGNV/Shumaker & Sieffert P.A. Attn: IP Legal Department 826 Coal Creek Circle Louisville, CO 80027 EXAMINER ROLDAN-RAMOS, CHRISTIAN ART UNIT PAPER NUMBER 1723 NOTIFICATION DATE DELIVERY MODE 11/16/2020 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): pairdocketing@ssiplaw.com rs.patents.two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRAD JACKSON, RICK WILLIAMS, ANTHONY HUYNH, and JOHN NGUYEN Appeal 2019-001804 Application 14/725,221 Technology Center 1700 Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. HILL, Administrative Patent Judge. Appeal 2019-001804 Application 14/725,221 2 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 1–10 and 12–222. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. BACKGROUND Sole independent claim 1, reproduced below with certain limitations italicized for emphasis, represents the claimed invention. 1. A method of forming a catheter, the method comprising: positioning an inner liner over a first portion, a second portion, and a third portion of a mandrel, the first portion having a first diameter, the second portion having a second diameter less than the first diameter, and the third portion having a tapering diameter that tapers from the first diameter to the second diameter, the third portion being located between the first and second portions; applying a thermoset adhesive to an outer surface of the inner liner; positioning a structural support member over the inner liner after applying the thermoset adhesive to the outer surface, wherein an inner diameter of the structural support member, prior to being positioned over the inner liner, tapers along at least a portion of a length of the structural support member; 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Medtronic plc of Dublin, Ireland, which is the ultimate parent entity of the assignee of record, Covidien LP. Appeal Br. 3. 2 The claims were amended after the final Office Action to cancel claim 11 and add the subject matter of claim 11 to claim 1. Appeal 2019-001804 Application 14/725,221 3 curing the thermoset adhesive to adhere the structural support member to the inner liner; and positioning an outer jacket over the structural support member after curing the thermoset adhesive. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Samson US 5,702,373 Dec. 30, 1997 Myers US 2010/0049167 A1 Feb. 25, 2010 Dinh US 2013/0253417 A1 Sept. 26, 2013 REJECTIONS3 I. Claims 1–10, 12, 13, 15, 17, 18, 21, 21, and 22 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Myers and Samson. II. Claims 14, 16, 19, and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Myers, Samson, and Dinh. OPINION Rejection I – Claims 1–10, 12, 13, 15, 17, 18, 21, 21, and 22 Regarding claim 1 as amended to include the subject matter of claim 11, the Examiner finds that Myers discloses a method of forming a catheter, comprising: positioning an inner liner 30 over first, second, and third portions of a mandrel 50, the first portion 50A having a first diameter, the 3 A rejection under 35 U.S.C. § 102(a) was withdrawn by the Examiner after claim 1 was amended to include the subject matter of dependent claim 11. Ans. 14. We understand the rejection of claims 1–6, 8, 17–18, 21, and 22, which were previously rejected under 35 U.S.C. § 102(a) as anticipated by Myers, to now be rejected under 35 U.S.C. § 103(a) as unpatentable over Myers and Samson. Id. at 15–16; Reply Br. 3–4. Appeal 2019-001804 Application 14/725,221 4 second portion 50B having a second diameter less than the first diameter, and the third portion 50C having a diameter tapering from the first diameter to the second diameter and extending between the first and second mandrel portions. Final Act. 2–3. The Examiner also finds that Myers discloses positioning a structural support member 40 over the inner liner 30, an inner diameter of the structural support member 40, prior to being positioned over the inner liner 30, tapering along at least a portion 40C of its length. Id. at 3. The Examiner finds that Myers further discloses positioning an outer jacket 12 over the structural support member 40. Id. The Examiner then finds that, although Myers does not disclose any adhesive applied to an outer surface of its inner liner 30, Samson discloses “an adhesive such as epoxy, a polyamide or a polyester applied to an outer surface” of its inner liner 214 and a structural support member 206 positioned on top of the inner liner 214 and adhesive “to facilitate bonding.” Final Act. 8. The Examiner reasons that it would have been obvious to have utilized adhesive, as disclosed by Samson, “to predictably facilitate bonding between the layers according to known methods in the catheter art.” Id. Regarding the claimed adhesive being a thermoset, the Examiner appears to admit that neither Myers nor Samson disclose a thermoset adhesive, but contends that (1) “epoxies, polyesters, and polyimides only come in two varieties. Those that cure at room temperature and those that require heat,” and that (2) given such a finite number of adhesive possibilities (two), it “would have been reasonable to try each.” Id. at 8–9 (citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421 (2007)). The Examiner reasons that “the particular nature of the adhesive employed, its composition, and/or physical properties would have been obvious to one Appeal 2019-001804 Application 14/725,221 5 having ordinary skill in the art based on considerations of cost, availability, bond strength, mode of application or environmental preference,” and selection of a suitable adhesive could “be achieved in the course of routine experimentation, by reference to standard technical literature (e.g., Adhesive Age trade magazine, Adhesive Handbook), or through consultation with industrial or specialty adhesive suppliers (e.g. Dupont, Dura, Loctite, Lord, etc.).” Id. The Examiner also reasons that, although Samson fails to teach curing the adhesive before applying the outer layer, such structure and step would have been obvious, because “failing to cure the adhesive prior to applying the jacket would have predictably caused the coil to shift along the inner layer when applying the jacket and such would have negated the purpose of securing it in the first place.” Id. at 8–9. The Examiner contends that “a particular selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Id. at 9 (citing In re Burhans, 154 F.2d 690 (CCPA 1946)). Appellant contends that Samson discloses only that “an adhesive may be coated onto the inner liner tubing. Polyesters and polyimides, in particular, are useful as adhesives.” Appeal Br. 8 (citing Samson 10:33–35). 35. Appellant argues that, given Samson’s limited discussion of adhesives, the Examiner’s reasoning lacks a rational underpinning. Id. More specifically, Appellant argues that the combination of Myers and Samson fails to disclose at least positioning an outer jacket over an inner liner and a support member after curing a thermoset adhesive. Id. Appellant further contends that the Examiner’s proposed reason for modifying Myers –– “to ... achieve that specific process or bonding of the structural support member Appeal 2019-001804 Application 14/725,221 6 [described by Samson ]” is merely an end result of the modification, rather than a reason to make the modification. Appeal Br. 10 (citing Advisory Act. 3). Indeed, Appellant argues, the Examiner’s reasoning appears to come only from an improper reliance on Appellant’s own disclosure and hindsight reasoning. Id. Appellant argues that the combination of Myers and Samson also fails to disclose the order of the steps recited in claim 1. Appeal Br. 11. According to Appellant, for various reasons, the Examiner’s reason why the claimed sequence of steps would have been obvious lacks a rational basis. See id. at 11–13. According to Appellant, because “Samson describes using the adhesive in the context of connecting the outer member 202 and the inner member 204 to each other, not in the context of connecting the braid member 206 to the inner member 204,” the prior art’s failure “to cure the adhesive prior to applying the jacket ... would have negated the purpose of securing [the coil to the inner liner] in the first place,” such that the Examiner’s reasoning regarding the claimed order of steps that includes curing “finds no support in Samson.” Id. at 12. Further, Appellant argues, “the Examiner failed to provide any objective evidence or technical reasoning to establish that the proposed modification to Myers’ method . . . would include curing Samson’s adhesive prior to applying Myers’ outer jacket 12 over the coil member 40 and the inner member 30.” Id. at 13. Regarding the Examiner’s reliance on Burhans, Appellant argues that, unlike the facts of Burhans, “the order of the steps recited in Appellant’s claim 1 produces new results not described by Myers and Samson,” for example, applying “a thermoset polymer between member 20 and inner liner 18 may help eliminate an adhesive layer between member 20 and outer Appeal 2019-001804 Application 14/725,221 7 jacket 24, which may help reduce the wall thickness T . . . of catheter body 12 and, therefore, increase the inner diameter of catheter body 12 for a given outer diameter.” Appeal Br. 14–15 (quoting Spec. ¶ 230 (emphasis added)). This increased inner diameter allows “more effective aspiration of thrombi, for accommodation of a larger range of medical devices or easier manipulation of medical devices within inner lumen 26, or both.” Id. at 15 (citing Spec. ¶ 232). The Examiner responds that Myers uses fusion bonding to attach its layers and Samson uses adhesive bonding or heating to attach its layers, suggesting that both adhesive and heating are known in the art. Ans. 16. Thus, the Examiner reasons, “Samson discloses adhesive bonding as a suitable alternative to fusion bonding,” which supports the Examiner’s “position of swapping out one known bonding method for another” in addition to Samson’s teaching of “adhesive bonding as a suitable means for bonding the inner liner in the catheter art.” Id. at 17. According to the Examiner, under the exemplary rationales set forth in KSR “(combining prior art elements according to known methods to yield predictable results, simple substitution of one known element for another to yield a predictable result, use of a known technique to improve a similar device in the same way, etc.”), it would have been obvious to “have swapped out one known catheter inner liner bonding method (fusion bonding) for another known method (adhesive bonding),” predictably resulting in “a bonded catheter.” Id. The Examiner asserts that Samson’s disclosure of an adhesive coating on its inner layer 204 renders use of the claimed “thermoset adhesive” obvious. Ans. 18–19. The Examiner then reasons, inter alia, that “a skilled artisan would appreciate using an adhesive to bond the inner liner and the Appeal 2019-001804 Application 14/725,221 8 structural support member and select a desired material for the outer jacket that tack to the other layers upon heating,” making it “obvious to use [an] adhesive that does not melt upon heating of the outer jacket so that the already secured structural support member and inner liner do not slide or so that heating have no effect in the layers configuration.” Id. at 19. Appellant has the better argument. The only explicit disclosure of a thermoset adhesive is in Dinh (at ¶ 90), upon which the Examiner does not rely in the rejection of claim 1. Likewise, only Dinh discloses curing an adhesive (at ¶ 36, 44). However, even Dinh does not disclose applying thermoset adhesive on an outer surface of an inner liner, positioning a structural support member on the thermoset adhesive after application thereof, and then curing the thermoset adhesive before positioning an outer jacket on the inner layer and the adhered structural support member. Samson’s disclosure of using a polyester/polyimide adhesive to adhere its inner liner 204 and its outer covering 204 (Samson, 10:12–35) is simply not enough evidence to support the Examiner’s conclusion that it would have been obvious to apply, specifically, a thermoset polymer to Myers’ inner liner 30 before positioning its structural support member 40 thereon, and then cure the thermoset material before positioning Myers’ outer jacket 12 over its structural support member 40. We are simply not persuaded that the claimed steps not disclosed in Myers and Samson can be rendered obvious without evidence establishing that Samson’s polyester/polyimide adhesives include a thermoset adhesive, or that a thermoset adhesive is a known alternative to polyester/polyimide adhesives. Further lacking is any reason, having a rational basis other than Appellant’s own disclosure, that a skilled artisan would have cured the thermoset adhesive after positioning Myers’ Appeal 2019-001804 Application 14/725,221 9 structural support member 40 on its inner liner 30 and before positioning Myers’ outer jacket 12 thereon. For these reasons, the Examiner’s reasoning lacks a rational basis, and we do not sustain the rejection of independent claim 1. Claims 2–13, 15, 17, 18, 21, 21, and 22 depend directly or indirectly from claim 1 and are similarly rejected over Myers and Samson. We, therefore, do not sustain the rejection of dependent claims 2–13, 15, 17, 18, 21, 21, and 22. Rejection II – Claims 14, 16, 19, and 20 Claims 14, 16, 19, and 20 depend from claim 1. Claim 14 recites the thermoset adhesive comprising a urethane adhesive. Claim 16 recites a thickness of the thermoset adhesive. Claim 19 recites a marker band, and claim 20 depends from claim 19 and additionally recites an outer jacket positioned distal to the marker band and the structural support member. The Examiner additionally rejects dependent claims 14, 16, 19, and 20 over Dinh. In addition to the findings set forth above for Myers and Samson, the Examiner finds that “Samson discloses a thermoset adhesive,”4 and Dinh discloses a catheter having an inner liner 202, an outer jacket 206, and a structural support member 208 positioned therebetween. Final Act. 11. The Examiner also finds that an elastomeric adhesive 210 is applied between Dinh’s inner liner 202, structural support member 208, and outer jacket 206. Id. The Examiner further finds that Dinh discloses “the adhesive can comprise materials such as urethane adhesives (paragraph 4 In contradiction to this statement, the initial rejection of claim 11, which now applies to amended claim 1, explicitly stated that Samson “fails to teach the adhesive is specifically a thermoset and fails to specifically teach curing the adhesive before applying the outer layer.” Final Act. 8. Appeal 2019-001804 Application 14/725,221 10 [0077]),” and “[b]ased on the teachings of Dinh it would have been obvious to an ordinary skilled artisan before the effective filing date of the application that urethane adhesives were suitable in catheter construction . . . to predictably produce a product suitable for its intended medical use.” Id. The Examiner has not provided evidence to support the finding that “Samson discloses a thermoset adhesive” (Final Act. 11). However, Dinh discloses a thermoset adhesive (at ¶ 90), and curing an adhesive (at ¶ 36, 44). However, the Examiner makes no finding that Dinh discloses or suggests applying thermoset adhesive on an outer surface of an inner liner, positioning a structural support member on the thermoset adhesive after application thereof, and then curing the thermoset adhesive before positioning an outer jacket on the inner layer and the adhered structural support member. The Examiner further fails to explain how or why a skilled artisan would combine Dinh, Myers, and Samson to achieve the claimed steps of positioning a structural support member on the thermoset adhesive after application thereof, and then curing the thermoset adhesive before positioning an outer jacket on the inner layer and the adhered structural support member. These limitations are recited in claim 1, upon which claims 14, 16, 19, and 20 depend. For this reason, we do not sustain Rejection II. CONCLUSION We do not sustain the pending obviousness rejections. Appeal 2019-001804 Application 14/725,221 11 DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–13, 15, 17, 18, 21, 21, 22 103(a) Myers, Samson 1–10, 12, 13, 15, 17, 18, 21, 21, 22 14, 16, 19, 20 103(a) Myers, Samson, Dinh 14, 16, 19, 20 Overall Outcome 1–10, 12– 22 REVERSED Copy with citationCopy as parenthetical citation