Ex Parte Fritz et alDownload PDFPatent Trials and Appeals BoardFeb 26, 201914313270 - (D) (P.T.A.B. Feb. 26, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/313,270 06/24/2014 Bryan P. Fritz 89554 7590 02/28/2019 Christopher & Weisberg, P.A. 1232 N. University Drive Plantation, FL 33322 UNITED ST A TES OF AMERICA 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 21819J-2043U-C00016896.US 2695 EXAMINER ALTER MORSCHAUSER, ALYSSA MARGO ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 02/28/2019 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): ptomail@cwiplaw.com rs.patents.five@medtronic.com cwdocketing@cardinal-ip. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Exparte BRYANP. FRITZ, ROBERT C. FARNAN, ANDREW J. DUSBABEK, OLIVER MARSEILLE, MURAT CAMKIRAN, GRANT THOMPSON, and SCOTT A. OLSON Appeal2018-003492 Application 14/313,270 Technology Center 3700 Before STEFAN STAICOVICI, EDWARD A. BROWN, and RICHARD H. MARSCHALL, Administrative Patent Judges. MARSCHALL, Administrative Patent Judge. DECISION ON APPEAL Appellant1 seeks our review under 35 U.S.C. § 134(a) of the Examiner's rejection of claims 1-14, 16-20, and 22--42. 2 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant is the Applicant, CircuLite, Inc. The Appeal Brief identifies Medtronic plc. as the real party in interest and notes that CircuLite, Inc., is wholly owned by Heartware International, Inc., a wholly owned subsidiary of Medtronic plc. Appeal Br. 1. 2 Claims 15 and 21 were cancelled. Appeal Br. 16, 18 (Claims App.). Appeal2018-003492 Application 14/313,270 THE CLAIMED SUBJECT MATTER The claimed subject matter "relates to blood pumps and ancillary devices for connecting the blood pump to associated cannulae." Spec. ,r 2. Claims 1, 17, and 18 are independent. Claim 1 is reproduced below. 1. A system for facilitating fluid connection between a blood pump and a circulatory system of a patient, comprising: a cannula having proximal and distal ends, the distal end of the cannula adapted to be in fluid communication with the circulatory system, the proximal end of the cannula configured to couple to an inlet of the blood pump; and a tunneling device configured to be inserted into a body of a patient to direct the proximal end of the cannula adjacent to the inlet for connection thereto; wherein the cannula further comprises a first connecting structure; and the tunneling device further comprises a second connecting structure, the first and second connecting structures being selectively engageable to allow in situ connection and disconnection between the cannula and tunneling device. Appeal Br. 14 (Claims App.). THE REJECTIONS Appellant appeals from the following rejections: 1. Claims 1-14, 16-20, and 22--42 under 35 U.S.C. § 112(b) as indefinite. 2. Claims 1-9, 16-19, 22-26, 41, and 42 under 35 U.S.C. § I02(a)(l) as anticipated by Marseille '975. 3 3 U.S. Patent Publication No. 2009/0023975 Al, published January 22, 2009 ("Marseille '975"). 2 Appeal2018-003492 Application 14/313,270 3. Claims 27-32 under 35 U.S.C. § 103 as unpatentable over Marseille '975. 4. Claims 10-14 and 20 under 35 U.S.C. § 103 as unpatentable over Marseille '97 5 and Marseille ' 18 8. 4 ANALYSIS Re} ections Under 3 5 US. C. § 112 (b) The Examiner found the "selectively engaging" language in each of the independent claims indefinite under 35 U.S.C. § 112(b). Final Act. 3. The Examiner found that "[i]t is unclear whether the Applicant intends for the components to be engag[e]able/engaging to allow a connection or not." Id. In the Answer, the Examiner further found that "it is unclear if once the connection is broken (i.e. disconnected) if there is intention to be able to reconnect the components." Ans. 3. As to claim 34, the Examiner found the language "selectively engaging the connecting structures further includes removing a detachable tip" indefinite because "[i]t is unclear how removing an attachment meets the limitation of 'selectively engaging the connection structures."' Final Act. 4. Appellant argues that the remainder of the claim language adequately describes the type of engagement required-"to allow in situ connection and disconnection between the cannula and tunneling device." Reply Br. 2. Appellant also argues that the specification adequately describes the connecting structure allowing for the selective engagement. Id. (citing Spec. ,r,r 43, 51 ). As to claim 34, Appellant argues that the claim clearly specifies 4 U.S. Patent Publication No. 2009/0182188 Al, published July 16, 2009 ("Marseille '188"). 3 Appeal2018-003492 Application 14/313,270 removal of the tip before engaging the connecting structures, and the specification describes this procedure. Id. at 9. We agree with Appellant that the claim term "selectively engageable," when read in light of the specification, does not render any of the claims indefinite. As Appellant points out, the claim language itself specifies that the engagement allows "connection and disconnection between the cannula and tunneling device," undermining the Examiner's finding that it is unclear whether the claims allow for connection or not. See Final Act. 3. Similarly, in light of the "connection and disconnection" claim language and the structures described in the specification, it is apparent that the claims require the ability to reconnect the structures after they are disconnected, if desired. See Ans. 3 (finding lack of clarity regarding the ability to reconnect components). Finally, we do not view the similar language in claim 34 as introducing indefiniteness issues because it includes the step of "removing a detachable tip of the tunneling device" "before selectively engaging the connecting structures." See Appeal Br. 22 (Claims App.); Final Act. 4. The order of the steps are made clear by the claim language itself, and, as discussed above, the "selectively engaging" language alone does not introduce ambiguity. Based on the foregoing, we do not sustain the rejection of claims 1- 14, 16-20, and 22--42 under 35 U.S.C. § 112(b) as indefinite. Rejections Under 35 US.C. §§ 102(a)(l) and 103 Claims 1 and 1 7 require a cannula and tunneling device with respective connecting structures that are "selectively engageable to allow in situ connection and disconnection." Appeal Br. 14 (Claims App.). Similarly, method claim 18 requires the step of "selectively engaging a first 4 Appeal2018-003492 Application 14/313,270 connecting structure of the cannula in situ with a second connecting structure of the tunneling device." Id. at 17. Claim 1 also requires a "proximal end of the cannula configured to couple to an inlet of the blood pump" and "a tunneling device configured ... to direct the proximal end of the cannula adjacent to the inlet" of the blood pump. Id. at 14 (Claims App.). The Examiner found that Marseille '975 discloses a cannula (10) having a proximal end configured to couple to an inlet of a blood pump ( 15). Final Act. 4--5. The Examiner also found that Marseille '975 discloses distal tip portions (92, 122) on one end of the cannula (10), which satisfies the "tunneling device" limitation. Id. at 5; Ans. 4. As to the connecting structures, the Examiner referred to Figures 5A, 5B, 6A, and 6B and the "integral connection" between the cannula and tunneling device in Marseille '975. Final Act. 5; Ans. 4. As to selective engagement, the Examiner found the following regarding Marseille '975: In the exemplary embodiment of FIGS. 5A-5B, the rigid flared tip portion 92 includes a cylindrical portion 102 embedded within a segment of the main portion 100 of the elongate body 111 of the cannula 90. Ans. 4. Appellant argues that the tips 92, 122 the Examiner relies upon as tunneling devices are not selectively engageable to allow for in situ connection and disconnection relative to the respective cannulae 90, 120. Appeal Br. 1 O; Reply Br 3--4. Appellant also argues, with respect to claim 1, that even if tip portions 92, 122 constitutes a tunneling device, it is not "configured to direct the proximal end of the cannula to a pump inlet." Appeal Br. 10. 5 Appeal2018-003492 Application 14/313,270 We agree with Appellant that the Examiner has not supported adequately the finding that Marseille '975 discloses connecting structures on the cannula and tunneling device that are "selectively engageable to allow in situ connection and disconnection between the cannula and tunneling device," or a tunneling device configured to direct the proximal end of the cannula to the pump inlet. The Examiner does not offer an explicit construction of the "selectively engageable" limitation, and as discussed above the Examiner found the limitation indefinite. It appears that the Examiner reads the limitation broadly enough that it covers "integral engagement between the walls" of the cannula and tip. Ans. 4. We disagree. As noted above in the context of our discussion regarding indefiniteness, the claim language itself requires selective engagement that allows for connection and disconnection of the cannula and tunneling device connecting structures in situ. An integral connection between the cannula and tunneling device does not allow for this selective connection and disconnection, and the Examiner's findings do not even address the in situ nature of the required selective engagement. See id.; Marseille '975 ,r 44 ( describing coupling of the two components using "adhesives, mechanical fasteners, fittings, integral formation, and the like," but not suggesting any in situ connection or disconnection). As to the tunneling device limitation, tip portions 92, 122 of Marseille '975 (the alleged tunneling devices) are at the distal end of the cannula that connects to wall 40 of heart 14, and therefore do not "direct the proximal end of the cannula to a pump inlet" as the claim requires. See Marseille '975 Fig. 5B (depicting tip portion 92 inserted into incision into heart chamber 14a); Appeal Br. 10. 6 Appeal2018-003492 Application 14/313,270 Based on the foregoing, we do not sustain the anticipation rejection of independent claims 1, 17, and 18, or claims 2-9, 16, 19, 22-26, 41, and 42 that ultimately depend from those claims. The Examiner's obviousness rejections of dependent claims 10-14, 20, and 27-32 do not remedy the deficiencies noted above in the anticipation rejections, and we therefore do not sustain the obviousness rejections for the same reasons discussed above. See Final Act. 6-7. DECISION We reverse the decision of the Examiner to reject claims 1-14, 16-20, and 22--42. REVERSED 7 Copy with citationCopy as parenthetical citation