Ex Parte Eberhardt et al

Patent Trials and Appeals Board

Feb 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. § 134(a) of the
Examiner's Decision rejecting claims 1---6, 9--11, 21-25, 28, and 29 under 35
U.S.C. § 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. § 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
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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.
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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
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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
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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.
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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
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