Covidien LPDownload PDFPatent Trials and Appeals BoardDec 1, 20212021002352 (P.T.A.B. Dec. 1, 2021) 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. 15/980,465 05/15/2018 Charles Senness H-KN-02959.USC4 5363 77218 7590 12/01/2021 Medtronic Vascular - APV Division c/o IP Legal Department 3576 Unocal Place Santa Rosa, CA 95403 EXAMINER TON, MARTIN TRUYEN ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 12/01/2021 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): rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHARLES SENNESS, JOHN WHITE, and WANDA DENT Appeal 2021-002352 Application 15/980,465 Technology Center 3700 Before JOHN C. KERINS, CHARLES N. GREENHUT, and BRANDON J. WARNER, Administrative Patent Judges. GREENHUT, 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 1–6, 10–16, and 19–21. See Final Act. 1; Ans. 7.2 We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Covidien LP. Appeal Br. 3. 2 The Examiner corrected the status of claims 7–9, 17, and 18 in the Answer to indicate these claims were not rejected and “should instead be objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form.” Ans. 7; Appeal Br 21. Appeal 2021-002352 Application 15/980,465 2 We AFFIRM IN PART. CLAIMED SUBJECT MATTER The claims are directed to a stent delivery system. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A medical device delivery system comprising: a handle defining a channel; an elongate catheter extending from the handle, the elongate catheter comprising: an inner member; and an outer member mounted about the inner member and configured for longitudinal movement, relative to the inner member, from an extended position to a retracted position; a medical device mounted about the inner member; a thumbwheel mounted to the handle, the thumbwheel being configured for rotational movement to cause corresponding movement of the outer member from the extended position to the retracted position; and a clip connected to the outer member, the clip comprising an anti-rotation wing configured to be received within the channel, traverse the channel in response to rotation of the thumbwheel, and prevent rotational movement of the outer member relative to the handle. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Truckai US 5,397,304 Mar. 14, 1995 Wu US 2005/0060016 A1 Mar. 17, 2005 Matsuoka US 2006/0259124 A1 Nov. 16, 2006 Shumer US 2009/0210046 A1 Aug. 20, 2009 Melsheimer US 2013/0013049 A1 Jan. 10, 2013 Appeal 2021-002352 Application 15/980,465 3 REJECTIONS Claims 1–4, 6, 10, 12–14, 16, and 19–213 are rejected under 35 U.S.C. § 103 as being unpatentable over Shumer, Wu, and Melsheimer. Final Act. 4. Claims 5 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Shumer, Wu, Melsheimer, and Matsuoka. Final Act. 10. Claim 11 is rejected under 35 U.S.C. § 103 as being unpatentable over Shumer, Wu, Melsheimer, and Truckai. Final Act. 11. OPINION Claims 1–6, 10, 12–16, 19, and 20 Appellant argues claims 1, 3, 4, 6, 10, 12, 14, 16, 19, and 20 as a group for which claim 1 is representative under 37 C.F.R. § 41.37(c)(1)(iv). Appeal Br. 7–14. Appellant’s arguments concerning claims 2 and 13 are essentially an extension of those advanced regarding claim 1. Separate arguments are not set forth regarding claims 5 and 15. The Examiner found Shumer to disclose the basic delivery system of claim 1. Final Act. 4–5. The Examiner cited Wu regarding aspects of the recited catheter (Final Act. 6) and Appellant does not raise any issues with respect to the Examiner’s reliance on Wu. The Examiner cited Melsheimer for teaching “anti-rotation wing[s]” “received within [a] channel” to “prevent rotational movement of the [catheter] outer member relative to the handle.” Final Act. 6 (citing Melsheimer Fig. 34 and para. 74). The Examiner proposed to incorporate Melsheimer’s anti-rotation lateral 3 Claim 21 appears to have been inadvertently omitted from the Examiner’s statement of the claims rejected. See Final Act. 9–10. Appeal 2021-002352 Application 15/980,465 4 projections 160 into Shumer “to provide lateral stability to prevent the outer member from rotating in the housing of the handle and to ensure the outer member moves smoothly within the handle.” Final Act. 6. Appellant does not argue that lateral stability or preventing rotation, per se, would not provide a suitable motivation for the Examiner’s proposed modification. Rather, Appellant first argues that Shumer’s sheath 78 would already have been prohibited from rotating, therefore there would be no reason to incorporate Melsheimer’s anti-rotation projections because they would be redundant. Appeal Br. 8–11. Appellant bases this argument on the fact that Shumer’s sheath 78 is attached to Shumer’s shuttle 36 (para. 30, 33) which is, in turn, attached to Shumer’s trigger sub-assembly 32 (para. 39), which includes, or is connected to, a generally rectangular trigger slider 50 sized and shaped to move longitudinally along a trigger retainer assembly 44 that is also generally rectangular in shape and has a central cavity 46 (paras. 28–29). Although not expressly discussed by Shumer, it is reasonable based on Shumer’s description and figures for Appellant to conclude that the generally rectangular trigger slider 50 cannot rotate within the generally rectangular trigger retainer assembly cavity 44, 46. Appeal Br. 8–9. However, Appellant’s reasoning does not hold true when considering the connection between the Shumer’s shuttle 36 and Shumer’s trigger sub- assembly 32. The mechanism for effectuating motion of the Shumer’s shuttle 36 via the trigger is described in paragraph 39 of Shumer: Here, as the trigger is moved proximally, the trigger slider 50 travels proximally along the trigger retainer assembly 44 (See FIGS. 4 and 5). By way of a fixed connection, the trigger slider 50 brings the pulley proximally thereby reconfiguring the pattern Appeal 2021-002352 Application 15/980,465 5 through which the belt 56 must travel from its connection to the shuttle assembly 36. Since this path reconfiguration is essentially an attempt to lengthen an otherwise fixed length belt 56, the shuttle assembly 32 is caused to move proximally. Thus, as Appellant seems to recognize (Appeal Br. 7, 9; Reply Br. 6), Shumer’s belt 564 is what serves to connect Shumer’s trigger sub-assembly 32 to Shumer’s shuttle 36. Although there may be some point at which a belt may begin to resist twisting and there may even be some resistance to initial twisting, belts would generally not be considered by a skilled artisan to amount to a rigid connection and would not generally be regarded by a skilled artisan as inhibiting their own twisting. Thus we cannot agree with Appellant that the skilled artisan would regard Shumer’s arrangement, including, among other things, the trigger sub-assembly 32 coupled to the shuttle 36 via belt 56, as inhibiting rotation of Shumer’s shuttle, and therefore Shumer’s sheath 78, to any meaningful degree. We recognize that the specific makeup and nature of Shumer’s belt is not disclosed. To the extent Shumer’s arrangement could possibly be regarded as potentially limiting rotation of Shumer’s shuttle 36 and sheath 78, like the Examiner we see no reason why one skilled in the art would regard it as doing so nearly as well as Melsheimer’s projections particularly designed for that specific purpose. Final Act. 3. Acknowledging the differences between Melsheimer’s trigger slider and Shumer’s, as Appellant urges we must (Reply Br. 5–6), we still agree with the Examiner that Melsheimer’s use of both slider 162 and anti-rotation projections 160 (Fig. 34) weighs in favor of the Examiner’s position that 4 Undisputedly regarded by the Examiner as falling within the scope of the recited term “cable” for purposes of claims 10–12. Appeal 2021-002352 Application 15/980,465 6 these are not, as Appellant would have us believe, mutually exclusive arrangements. Ans. 3–4. Melsheimer employs a deployment knob 14 cooperating with a slot 16 in a manner similar to the trigger slider 50 and trigger retainer 44 of Shumer. Melsheimer para. 57. Although we recognize the arrangements are not identical, Appellant has not apprised us as to why they differ in any meaningful way with regard to the rather limited reason for which the Examiner mentions this—to demonstrate sliders with triggers or knobs that do not appear to be subject to rotation may, contrary to Appellant’s assertion, still benefit from the inclusion of structure for the specific purpose of preventing rotation of a shuttle and attached components of a catheter. This point is not critical to the Examiner’s rejection, but the Examiner has provided some evidence regarding this point and Appellant has provided only unsupported attorney argument. Thus, we agree that the evidence here weighs in favor of the Examiner’s position. Appellant next argues that, even if one desired to incorporate Melsheimer’s lateral projections 162 into Shumer, such an incorporation would be impossible because there is no space for them due to the presence of Shumer’s belt 56 and trigger retainer 44. Appeal Br. 11–13; Reply Br 7– 8. Appellant expounds on this point further with respect to claim 2, which requires additional anti-rotation structure: “diametrically opposed anti- rotation wings” and “a pair of channels.” Appeal Br. 15. This is the only point argued with respect to claim 2 (representative of claims 2 and 13). The Examiner’s premise on this point is correct, in that one need not use the precise locations taught in Melsheimer (Ans. 4–5; Final Act. 3–4) because “[i]t is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical Appeal 2021-002352 Application 15/980,465 7 substitution of elements.” In re Mouttet, 686 F. 3d 1322, 1332 (Fed. Cir. 2012). As the Examiner points out, Melsheimer’s projections could be incorporated into Shumer’s shuttle so as to cooperate with rails or grooves in Shumer’s already existing cavity 46 or could be disposed at essentially any other circumferential positions about Shumer’s shuttle without detracting from their capacity to prevent rotation. Neither claim 1 nor claim 2 contains any language precluding such an arrangement. For the foregoing reasons we affirm the Examiner’s rejection of claims 1 and 2, and the rejections of those claims argued therewith. Claim 21 In rejecting claim 21, as with claim 1 from which claim 21 depends, the Examiner relied upon the embodiment depicted in Figure 34 of Melsheimer. In particular, the Examiner has consistently referred to Melsheimer’s slide’s main body 162 as contributing teachings relevant to the recited “clip,” which the Examiner regards as shuttle 36 in Shumer. Final Act. 4–5. The Examiner asserts that Melsheimer’s teaching to put the anti- rotation lateral projections 160 along the entire length of the main body 162 would suggest doing the same for Shumer’s shuttle 36. Final Act. 9–10. Appellant does not dispute that such a modification would yield an “anti- rotation wing [that] is positioned at a proximal end of the clip” as required of claim 21 because, according to the Examiner, the wing would span the entire clip and claim 21 does not preclude the anti-rotation wing from being positioned at other portions of the clip in addition to the proximal end so long as it is also positioned at the proximal end. Ans. 6. Appeal 2021-002352 Application 15/980,465 8 The sole point of contention raised by Appellant with regard to claim 21 is that “Melsheimer, however, does not describe anti-rotation wing extending along the entire length of a clip.” Appeal Br. 17–18; Reply Br. 8– 9. In making this assertion, Appellant reproduces and discusses the embodiment of Melsheimer depicted in Figure 26. Id. This embodiment is distinct from the one cited by the Examiner. Melsheimer para. 66. Although a version of slide 38 is depicted, Figure 26 in Melsheimer does not depict the main body 162 of the slide or the anti-rotation projections 160 of the cited Figure 34 embodiment. It is recognized that there are some similarities between the embodiments, in that body 104 may be similar to main body 162, and, although not expressly discussed, the slide 38 of the Figure 34 embodiment might also include a distal threaded portion 102 for retaining flared sheath end 98 in nut 100 (Melsheimer Fig. 25). In addition, indicator tab 114 appears to have some similarities to the anti-rotation projections 160 but those are distinct structures so it is not clear how Appellant is deducing anything about anti-rotation projections 160 based on Figure 26 of Melsheimer. Appellant does not expressly argue, but as best as we can understand it, Appellant’s position appears to presume that, in order for the Examiner’s assertion regarding Melsheimer’s teachings to be valid, anti-rotation projections 160 must extend over the entire length of slide 38 as opposed to over the entire length of main body 162. Appellant’s argument fails, firstly, because it does not address the Examiner’s rejection. Secondly, as discussed above, “a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.” In re Mouttet, 686 F. 3d at 1332. The relevant inquiry is whether in light of Appeal 2021-002352 Application 15/980,465 9 Melsheimer’s teaching of the projection positions it would have been obvious to the skilled artisan to place anti-rotation elements along the entire length of, and therefore at least at the proximal end of, Shumer’s shuttle. This issue is not addressed by Appellant and, as noted above, Appellant does not dispute that the modification proposed by the Examiner would yield the subject matter of claim 21. Appellant’s arguments ultimately fail here for not addressing the grounds of rejection set forth by the Examiner. 37 C.F.R. § 41.37(c)(i)(iv). Claim 11 It is well-settled that “there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int’l. Co. v. Teleflex, 550 U.S. 398, 418 (2007). With regard to claim 11, according to the Examiner, it would have been obvious “to have the pull cable of the Shumer reference include the ball segment of the [Truckai] reference and to have the ball segment engage with the outer clip to retain the intermediate section of the pull cable within the opening to provide a strong pivotal connection between the pull cable and the outer clip.” Final Act 11 (citing Truckai col. 6, ll. 51–57). According to the Examiner, this modification “would additionally impart the advantage of being pivotal in nature.” Ans. 7. Appellant correctly argues “the Examiner has not shown that a person of ordinary skill in the art would have understood there to have been a reason to provide a pivotal connection between Shumer’s belt 56 (the ‘pull wire’ according to the Examiner) and shuttle assembly 36 (a ‘clip’ according Appeal 2021-002352 Application 15/980,465 10 to the Examiner)” (Appeal Br. 20 (footnotes and emphasis omitted)) and “[t]he Examiner, however, failed to establish that the applied art indicates a pivotal attachment mechanism is an advantage” (Reply Br. 10 (emphasis omitted)). For the reasons articulated by Appellant we do not sustain the Examiner’s rejection of claim 11. CONCLUSION The Examiner’s rejection of claim 11 is REVERSED. The Examiner’s other rejections are AFFIRMED. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 6, 10, 12–14, 16, 19–21 103 Shumer, Wu, Melsheimer 1–4, 6, 10, 12–14, 16, 19–21 5, 15 103 Shumer, Wu, Melsheimer, Matsuoka 5, 15 11 103 Shumer, Wu, Melsheimer, Truckai 11 Overall Outcome 1–6, 10, 12– 16, 19–21 11 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 IN PART Copy with citationCopy as parenthetical citation