Ex Parte Rowe et al

Board of Patent Appeals and Interferences

Aug 31, 2012

11441406 (B.P.A.I. Aug. 31, 2012)

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.
11/441,406 05/24/2006 Stanton J. Rowe ECV-5820 9258
30452 7590 08/31/2012
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
EXAMINER
STEWART, JASON-DENNIS NEILKEN
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
08/31/2012 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STANTON J. ROWE, LARRY WOOD, HENRY BOURANG,
GEORGE BAKIS, BENJAMIN SPENSER, NETANEL BENICHOU,
YARON KEIDAR, and ASSAF BASH
__________

Appeal 2011-003909
Application 11/441,406
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
two-stage prosthetic heart valve. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
The Specification describes a prosthetic heart valve comprising an
expandable anchoring member (e.g., a stent) and a non-expandable valve
member. (Spec. [0007] – [0008]; [0054] – [0055].) Figure 1 of the
Specification shows an embodiment.

Figure 1 depicts a prosthetic valve comprising expandable stent (20) and
non-expandable valve member (30). (Id. at [0026], [0061]; see also Figures
14A and 14B and [0043].) Valve member (30) includes leaflets (36), which
are supported by commissural posts (34). (Id. at [0064].) The base of the
valve member also has a ring (32). (Id.) The stent includes three posts (26),
which may comprise malleable material so that posts (26) may be crimped
over commissural posts (34) on the valve member. (Id. at [0067].)
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Claims 40-47 and 51-67 are on appeal, with claims 40, 51, and 60
being independent.
1
Independent claim 40 is representative and reads as
follows (emphasis added):
40. A two-stage prosthetic heart valve, comprising:
an expandable anchoring member having opposed ends and an
open channel therethrough, and sized to contact a heart valve annulus
in an expanded state;
a non-expandable valve member having a suture-permeable
sewing ring on an inflow end configured for connection to the
anchoring member, the valve member having a plurality of
commissure posts extending in an outflow direction that support
flexible leaflets comprising animal tissue therebetween, the sewing
ring being sized to seat against or within a first end of the anchoring
member; and
at least one coupling member attached to the anchoring
member and extending from the first end thereof over the commissure
posts of the valve member so as to secure the valve member to the
anchoring member.
Independent claims 51 and 60 also recite a prosthetic heart valve comprising
an expandable anchoring member, a non-expandable valve, and “coupling
posts” or “coupling means,” respectively, that are “attached to the anchoring
member and extending from the first end thereof [] over [] the commissure
posts of the [valve], so as to secure the [valve] to the anchoring member.”
The claims stand rejected as follows:

1
See Amendment dated Sept. 14, 2009, for a correct listing of pending
claims. As noted therein, claims 48-50 and 68-70 are withdrawn, and claim
71 is cancelled. As stated by the Examiner (Ans. 6), claim numbering in the
Claims Appendix of the Appeal Brief incorrectly begins with 41, but should
begin with 40.
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• claims 40-43, 51-54, and 59-63 under 35 U.S.C §103(a) as obvious
over Schreck (U.S. Pat. No. 6,454,799 B1, issued Sep. 24, 2002) in view of
Campbell (U.S. Publ. No. 2006/0085060 A1, published Apr. 20, 2006).
• claims 45-47, 56-58, and 65-67 under 35 U.S.C §103(a) as obvious
over Schreck in view of Campbell, and further in view of Bailey et al. (U.S.
Publ. No. 2003/0023300 A1, published Jan. 30, 2003).
• claims 44, 55 and 64 under 35 U.S.C §103(a) as obvious over
Schreck in view of Campbell, and further in view of Berreklouw (U.S. Publ.
No. 2008/0281411 A1, published Nov. 13, 2008).
I.
Issue
Does the Examiner establish by a preponderance of the evidence that
Schreck, alone or in combination with other cited references, teaches or
suggests a heart valve comprising a coupling member, coupling posts, or
coupling means “attached to the anchoring member and extending from the
first end thereof over the commissure posts” of the valve so as to secure the
valve to the anchoring member, as recited in independent claims 40, 51, and
60?
Principles of Law
The Examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). If the Examiner fails to
establish a prima facie case of unpatentability in the first instance, the
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rejection is improper and must be reversed. Id.; In re Rijckaert, 9 F.3d 1531,
1532 (Fed. Cir. 1993).
Analysis
The Examiner states that Schreck describes the two-stage prosthetic
heart valve recited in pending independent claims, except that Schreck‟s
heart valve comprises an expandable anchoring member and an expandable
valve member, i.e., does teach the use of a non-expandable valve member.
(Ans. 4.) The Examiner finds, however, that Campbell discloses a “stock”
non-expandable valve member, and it would have been obvious to one of
skill in the art at the time of invention to modify the device of Schreck to
have the prongs and non-expandable, stock valve of Campbell. (Id.)
Appellants argue, inter alia, that neither Campbell nor Schreck
discloses coupling members that extend from a first end of an anchoring
member over each of the commissure posts of a valve member (App. Br. 7).
We agree that the Examiner fails to establish a prima facie case that any
cited reference, alone or in combination, teaches or suggests a coupling
member/posts/means “extending from the first end [of the anchoring
member] over the commissure post,” as recited in the independent claims.
Specifically, the Examiner states that Schreck “discloses coupling
members 42 that have hinges 60 and fit over the commissure posts of the
valve member (Fig. 2),” and that the “coupling members of Schreck are
formed from a malleable material and are fully capable of pivoting and
being bent to assume a second configuration” (Ans. 4). The Examiner also
states that “inserts 76 of Schreck are interpreted by the Examiner as
„commissure posts‟”, where “[c]oupling member 42 extend form the
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anchoring member over the inserts 76” (Ans. 7). (We assume the Examiner
intends to refer to “inserts 72” (versus “stitching 76”) as described in
Schreck, col. 7, ll. 52-63.) The Examiner further notes that “Schreck also
discloses another embodiment in which coupling member 146 extends over
the commissure posts of the valve (Figs. 6, 7)” (id.).
Looking at Figures 2, 6, and 7 in Schreck and descriptions of these
figures therein, however, we find that Schreck does not depict or describe a
coupling member/posts/means attached to an anchoring member “extending
from the first end thereof over the commissure posts of the valve member”
as recited in claim 40, for example.
Figures 1 and 2 in Schreck, for instance, show the following:

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Figures 1 and 2 depict an expandable heart valve comprising a support stent
(i.e., an expandable anchoring member) and a flexible tubular member (i.e.,
an expandable valve member). (Schreck, col. 4, ll. 52-56.)
The Examiner interprets “commissure post 42” in these figures as
corresponding to a coupling member attached to the anchoring member (i.e.,
“stent 24” in Figure 1) as claimed, and interprets “inserts 72” (called “insert
76” by the Examiner) as corresponding to “commissure posts” as claimed.
The Examiner does not explain, and we do not see in Figure 2 or in a
description of what is shown in Figure 2 in Schreck, however, how coupling
member “post 42” extends “from the first end [of the anchoring member]
over the commissure posts” (i.e., inserts 72 or 76 in Schreck).
Rather, Schreck depicts that “inserts 72 are used to secure the loops
70 to the exterior of the commissure posts 42” (Schreck, col. 7, ll. 52-53).
Thus, coupling member “post 42” is adjacent to “inserts 72,” but does not
extend from the first end of stent 24 over “inserts 72.” While the Examiner
points to “hinge 60” located at the bottom of coupling member “post 42” in
Figure 1 (Ans. 4), and Schreck teaches that each of “posts 42 is [] bent 180º
outward,” and Figure 1 shows “180º bend 60” (Schreck, col. 7, ll. 18-32;
Figure 1), such disclosures do not teach or indicate that “posts 42” are bent
over commissure posts, such as “inserts 72,” which are located at the other
end of the valve member.
In addition, Figures 6 and 7 of Schreck show the following:
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Figures 6 and 7 depict another embodiment of an expandable heart valve
comprising a tissue-engaging base (104) (i.e., an expandable anchoring
member) and a wireform-supported leaflet subassembly (102) (i.e., an
expandable valve). The Examiner asserts that “coupling member 146
extends over the commissure posts of the valve” in these figures (Ans. 7).
The Examiner does not indicate, however, which component in the heart
valve depicted in Figures 6 and 7 corresponds to “commissure posts” as
recited in the claims.
Schreck teaches that “the commissure posts 146 and cusp posts 148”
may be “attached to the wireform commissures 112 and cusps 114,
respectively, as part of the leaflet subassembly 102 ….” (Schreck, col. 10,
12-27). Figures 6 and 7 do not show that “posts 146” and “148” extend
“over the commissure posts of the valve member,” i.e., “commissures 112
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and cusps 114” (id.). Rather, “posts 146” and “148” are placed underneath
and within the loops of “commissures 112 and cusps 114” (see Figure 7; see
also Figure 14). The Examiner does not explain, nor point to evidence in the
record indicating, how a coupling member in a cited reference extends “from
the first end thereof over the commissure posts of the valve member” as
recited in pending claims.
Because the Examiner fails to establish by a preponderance of the
evidence that Schreck, or another cited reference, teaches or suggests a heart
valve comprising a coupling member/posts/means “extending from the first
end [of an anchoring member] over the commissure posts” of the valve so as
to secure the valve to the anchoring member, as recited in independent
claims 40, 51, and 60, the Examiner fails to establish a prima facie case that
such claims, and therefore dependent claims 41-43, 52-54, 59, and 61-63,
are obvious over Schreck in view of Campbell.
For the same reasons discussed above, the Examiner also fails to
establish by a preponderance of the evidence that claims 45-47, 56-58, and
65-67, which depend on independent claim 40, 51, or 60, are obvious over
Schreck in view of Campbell, further in view of Bailey. The Examiner does
not assert that Bailey teaches what Schreck lacks in relation to the
“extending … over the commissure posts” element recited in the
independent claims (Ans. 5).
For the same reasons discussed above, the Examiner likewise fails to
establish by a preponderance of the evidence that claims 44, 55, and 64,
which also depend on independent claim 40, 51, or 60, are obvious over
Schreck in view of Campbell, further in view of Berreklouw. The Examiner
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states that “Berreklouw discloses coupling elements 11, 12 that are made
from shape memory materials and curl into a second configuration upon
implantation in the body (paragraph 74, Fig. 9)” (Ans. 6). The Examiner‟s
statement, as well as paragraph [0074] in Berreklouw, suggest bending
“anchoring elements” in “an assembly comprising: a ring having anchoring
elements for attaching the ring in a passage surrounded by body tissue,” such
as a blood vessel (Berreklouw Abstract; [0001] – [0002]). The Examiner‟s
statement and citation to paragraph [0074], however, do not establish how
Berreklouw teaches or suggests to one skilled in the art to extend a coupling
member attached to an anchoring member (e.g., stent) “over” commissure
posts of a valve member in a heart valve, such as the heart valve described in
Schreck. Thus, the Examiner fails to establish a prima facie case of
obviousness based on Schreck in view of Campbell, further in view of
Berreklouw.
Conclusion of Law
We conclude that the Examiner fails to establish by a preponderance
of the evidence that Schreck, alone or in combination with other cited
references, teaches or suggests a heart valve comprising a coupling member,
coupling posts, or coupling means “attached to the anchoring member and
extending from the first end thereof over the commissure posts” of the valve
so as to secure the valve to the anchoring member, as recited in independent
claims 40, 51, and 60.

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11
SUMMARY
We reverse the rejection of claims 40-43, 51-54, and 59-63 as obvious
over Schreck in view of Campbell. We also reverse the rejection of claims
45-47, 56-58, and 65-67 as obvious over Schreck in view of Campbell, and
further in view of Bailey, and also reverse the rejection of claims 44, 55 and
64 as obvious over Schreck in view of Campbell, and further in view of
Berreklouw.

REVERSED

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