Ex Parte Eberhardt et al

Patent Trials and Appeals BoardFeb 5, 2019

13757380 - (D) (P.T.A.B. Feb. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/757,380 02/01/2013 Carol Eberhardt 28390 7590 02/07/2019 MEDTRONIC VASCULAR, INC. IP LEGAL DEPARTMENT 3576 UNOCAL PLACE SANTA ROSA, CA 95403 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. P41527.USU1 2220 EXAMINER SCHALL, MATTHEW WAYNE ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 02/07/2019 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): rs.vasciplegal@medtronic.com 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 CAROL EBERHARDT, GOPIKRISHNAN SOUNDARARAJAN, KENNY DANG, HUSSAIN RANGW ALA, MARK TORRIANNI, ERIC RICHARDSON, and KSHITIJA GARDE Appeal2018-003983 Application 13/757,380 Technology Center 3700 Before BRETT C. MARTIN, JEREMY M. PLENZLER, and RICHARD H. MARSCHALL, Administrative Patent Judges. PLENZLER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. Â§ 134(a) of the Examiner's Decision rejecting claims 1---6, 9--11, 21-25, 28, and 29 under 35 U.S.C. Â§ 103(a) as unpatentable over Chau (US 2011/0137397 Al, published June 9, 2011) and Braido (US 2011/0098802 Al, published Apr. 28, 2011). We have jurisdiction under 35 U.S.C. Â§ 6(b). We REVERSE. 1 Appellant is the Applicant, Medtronic CV Luxembourg S.A.R.L., which, according to the Appeal Brief, is the real party in interest. Appeal Br. 2. Appeal2018-003983 Application 13/757,380 CLAIMED SUBJECT MATTER Claims 1, 11, and 21 are independent, with claims 2---6, 9, 10, 22-25, 28, and 29 depending from claim 1, 11, or 21. Claim 1 is reproduced below: 1. A transcatheter valve prosthesis comprising: a tubular stent having a radially compressed configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the tubular stent including a support frame of struts and openings defined between the struts; a prosthetic valve component disposed within and secured to the stent; and an anti-paravalvular leakage component coupled to and circumferentially surrounding an outer surface of the tubular stent, the anti-paravalvular leakage component including a radially-compressible annular scaffold and a membrane of impermeable material extending over an outer surface of the annular scaffold, wherein the annular scaffold is a sinusoidal patterned ring of self-expanding material that defines a plurality of peaks, a plurality of valleys, and a plurality of segments with each segment of the plurality of segments being formed to extend between a respective peak and valley of the pluralities of peaks and valleys, the anti-paravalvular leakage component having an expanded configuration in which the segments of the annular scaffold are bowed outward relative to the outer surface of the tubular stent to form a curved, convex profile with the peaks and valleys being disposed adjacent to the outer surface of the tubular stent. OPINION Claims 1, 11, and 21 each recite a "tubular stent including a support frame" and "an anti-paravalvular leakage component coupled to and circumferentially surrounding an outer surface of the tubular stent" that includes "a radially-compressible annular scaffold ... having an expanded 2 Appeal2018-003983 Application 13/757,380 configuration in which the segments of the annular scaffold are bowed outward relative to the outer surface of the tubular stent to form a curved, convex profile." The Examiner finds that Chau discloses in figures 5-10 a valve prosthesis comprising a stent with support frame and openings (102), a prosthetic valve (106), an anti-para valvular leakage component circumferentially surrounding the stent and comprising a compressible wire scaffold of peaks and valleys ((124) or ( 126)) and a membrane of impermeable polyester material ((142) or (144) and paragraph [0100]). Final Act. 3. The Examiner acknowledges that "Chua does not specifically disclose the segments of the annular scaffold are bowed outward relative to the outer surface of the stent to form a curved, convex profile," and cites Braido as teaching that feature. Id. at 3--4. The Examiner reasons that "[i]t would have been obvious ... to modify the segments of Chau with the segments Braido in order to properly secure and seal the device in place as described in Braido." Id. at 4. Appellant provides a number of arguments in response to the rejection. Appellant disputes, for example, the Examiner's proposed modification to Chau's atrial sealing member 124 when atrial sealing member 124 is considered the "annular scaffold" recited in claims 1, 11, and 21. Appeal Br. 8-11; Reply Br. 4--8. Appellant also disputes the Examiner's alternative finding that Chau's ventricular anchors 126 correspond to the recited "annular scaffold." Appeal Br. 11; Reply Br. 3--4. Chau's Figures 5 and 8 are reproduced below for purposes of discussion. 3 Appeal2018-003983 Application 13/757,380 Figure 5 is a side view of Chau's prosthetic valve and Figure 8 shows the frame of the prosthetic valve from Figure 5. Chau ,r,r 21, 24. Chau's Figure 23 illustrates the frame positioned in a heart, and is reproduced below. Figure 23 is a section view of a heart including Chau's prosthetic valve frame. Chau ,r 27. Chau describes frame 102 having "a tubular main body 122, one or more ventricular anchors 126 extending from a ventricular end 130 of the main body and optionally an atrial sealing member 124 extending radially outward from an atrial end 132 of the main body." Chau ,r 90. Chau explains that [ w ]hen the frame 102 is implanted in the native mitral valve region of the heart, as shown in FIG. 23, the main body 122 is 4 Appeal2018-003983 Application 13/757,380 Id. positioned within the native mitral valve annulus 8 with the ventricular end 130 of the main body 122 being a lower outlet end, the atrial end 132 of the main body 132 being an upper inlet end, the ventricular anchors 126 being located in the left ventricle 6, and the atrial sealing member 124 being located in the left atrium 4. With respect to Chau's atrial sealing member 124, Appellant contends that the Examiner has failed to explain sufficiently why one skilled in the art would have modified atrial sealing member 124 to have the recited "curved, convex profile." See, e.g., Appeal Br. 11 (explaining that "one of ordinary skill in the art would not ... modify the configuration of the atrial sealing member ( 124) of Chau" as proposed by the Examiner "because the atrial sealing member ( 124) would then not be shaped to contact the atrial side of the mitral annulus and tissue of the left atrium when implanted, but instead the atrial sealing member (124) would curve back towards the frame (102) and be disposed adjacent to anterior and posterior leaflets (10, 12) of the mitral valve (2)"). The Examiner responds that "Chau discloses in paragraphs [0091] and [0096] the desire to alter the shape of the component as needed and does not teach away from a curved, convex profile." Ans. 2. Appellant has the better position. Paragraph 91 of Chau explains that "[ t ]he wire mesh can include metal wires or struts arranged in a lattice pattern, such as the sawtooth or zig-zag pattern shown in FIGS. 8-10 for example, but other patterns may also be used." Paragraph 96 of Chau explains that "[ a ]n outer rim 140 of the atrial sealing member 124 can be sized and shaped to contact the atrial side of the mitral annulus and tissue of the left atrium 8 when the frame 102 is implanted, as shown in FIG. 23." The Examiner fails to provide any, let 5 Appeal2018-003983 Application 13/757,380 alone persuasive, explanation as to why one skilled in the art would have modified Chau's atrial sealing member 124 to have the recited "curved, convex profile with the peaks and valleys being disposed adjacent to the outer surface of the tubular stent." The Examiner's explanation that one skilled in the art would have "modif[ied] the segments of Chau with the segments Braido in order to properly secure and seal the device in place as described in Braido in paragraph [0075]" (Final Act. 4) does not provide the requisite rationale, as it provides no reason why one skilled in the art would have modified Chau's atrial sealing member 124. As for Chau's ventricular anchors 126, Appellant explains that claims 1, 11, and 21 each recite that the "anti-paravalvular leakage component circumferentially surrounds ['Jan outer surface of the tubular stent' and recites that the annular scaffold [of the anti-paravalvular leakage component] is 'a sinusoidal patterned ring of self-expanding material."' Reply Br. 3. Appellant contends that "ventricular anchors (126) are positioned at opposite sides of the frame (102), i.e., are diametrically opposed, so that they 'can function to secure the frame 102 to the anterior and posterior mitral leaflets 10, 12, respectively, when the frame 102 is implanted in the mitral valve region"' and "are not an annular component that is a ring and do not circumferentially surround an outer surface of the frame (102)." Id. at 4 ( citing Chau ,r 101 ). Appellant has the better position. Appellant's characterization of Chau is accurate, as seen in the Figures reproduced above. The Examiner offers no explanation, nor do we see, how Chau's ventricular anchors form an "annular scaffold [that] is a sinusoidal patterned ring" as required by the claims. 6 Appeal2018-003983 Application 13/757,380 Because the Examiner has failed to establish sufficiently that Chau's atrial sealing member 124 would have been modified to have "a curved, convex profile ... disposed adjacent to the outer surface of the tubular stent" or that ventricular anchors 126 are an "annular scaffold [that] is a sinusoidal patterned ring," we do not sustain the Examiner's decision to reject claims 1, 11, and 21, or claims 2-6, 9, 10, 22-25, 28, and 29, which depend therefrom. DECISION We REVERSE the Examiner's decision to reject claims 1---6, 9-11, 21-25, 28, and 29. REVERSED 7