Ex Parte Huynh et al

Board of Patent Appeals and Interferences

Jul 10, 2012

10802314 (B.P.A.I. Jul. 10, 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.
10/802,314 03/17/2004 Van Le Huynh ECV-5539CON 3894
7590 07/10/2012
EDWARDS LIFESCIENCES LLC
One Edwards Way
Irvine, CA 92614
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
07/10/2012 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 VAN LE HUYNH, MICHAEL J. SCOTT, and
DERRICK JOHNSON
__________

Appeal 2011-005910
Application 10/802,314
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a sewing
ring attached to a periphery of a prosthetic heart valve. The Examiner
rejected the claims as anticipated and obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.

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Statement of the Case
Background
“Prosthetic heart valves are used to replace damaged or diseased heart
valves” (Spec. 1, l. 15). In “prosthetic valves, a biocompatible fabric-
covered suture or sewing ring or cuff on the valve body (mechanical) or
stent (tissue-type) provides a platform for attaching the valve to the annulus
of the particular valve being replaced” (Spec. 1, ll. 27-29).
The Claims
Claims 1-21 are on appeal. Claims 1 is representative and reads as
follows:
1. A sewing ring attached to a generally annular
periphery of a prosthetic heart valve having an inflow
end and an outflow end, comprising:
a suture-permeable ring attached to the heart valve
periphery and configured to pivot from a first position
extending generally toward the outflow end of the valve
to a second position extending generally toward the
inflow end of the valve, wherein first and second
positions are stable such that the sewing ring is bi-stable.

The issues

A. The Examiner rejected claims 1-8 and 11-19 under 35 U.S.C. § 102(b)
as anticipated by Totten
1
(Ans. 3-4).
B. The Examiner rejected claims 9 and 20 under 35 U.S.C. § 103(a) as
obvious over Totten and Huynh
2
(Ans. 4).

1
Totten et al., US 4,477,930, issued Oct. 23, 1984.
2
Huynh et al., US 5,928,281, issued Jul. 27, 1999.
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C. The Examiner rejected claims 10 and 21 under 35 U.S.C. § 103(a) as
obvious over Totten and Reichart
3
(Ans. 4-5).
A. 35 U.S.C. § 102(b) over Totten
The Examiner finds that Totten teaches “a tubular fabric with a stent
frame and a ring insert” (Ans. 3). The Examiner finds that “the Totten
suture ring is configured to pivot or move between two positions since it is
made of an elastomer . . . which illustrates that the sewing ring can pivot
about the edge” (Ans. 4). The Examiner finds that “Totten discloses the
sewing ring to be pliable or suture permeable (col. 4, line 16), thus it can be
interpreted to be bi-stable because of its flexibility and placement at a seam
or edge as seen in Fig. 8 and since it will not deform permanently, it is stable
when it moves” (Ans. 4).
Appellants “maintain that Totten does not disclose or suggest a
sewing ring, or valve having a sewing ring that is configured to pivot or
move between bi-stable first and second positions, respectively, toward the
inflow end and the outflow end of the valve. Note that bi-stable means that
the element moves between two stable positions” (App. Br. 4).
Appellants contend that
Totten clearly states that the sewing ring is encouraged to lie
smoothly when the skirt portions are pulled over it so as to
be angled somewhat upwardly toward the post (outflow) end
of the stent. This obviously means that the fabric skirt is
pulled tight to maintain the illustrated angle of the sewing
ring. While the pliability of the sewing ring of Totten will
permit it to flex outward from the angled position shown,
there is simply no basis for asserting that it can pivot or

3
Reichart et al., US 4,626,255, issued Dec. 2, 1986.
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move into another stable position angled in the opposite
direction (toward the inflow end)

(App. Br. 5).
Appellants contend that “even if the Examiner considers the claim
terms at issue to be functional, they must still be considered to carry
patentable weight. The question of whether the sewing ring in Totten, et al.
inherently pivots or moves to different positions has already been addressed
in prior amendments, and the conclusion was that it doesn't” (App. Br. 8).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the sewing ring in Totten is bi-stable
as required by claim 1?
Findings of Fact
1. The Specification teaches that:
Because of the novel connection between the sewing ring
152 and stent 154, the two positions shown in Figures
11A/13A and 11C/13B are bi-stable. Specifically, the band
172 of the insert 160 creates a generally frustoconical
sewing ring 152 that can be inverted between orientations
extending toward the outflow end and the inflow end. The
resiliency of the insert 160 means that the outer circular
edge 164 is stretched and placed in tension as it passes
between the two positions, thus biasing the insert one way or
the other.

(Spec. 16, ll. 13-18).

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2. Figures 11A and 11C of the Specification are reproduced
below:

“Figures 11A-11C are elevational views of a stent/sewing ring subassembly
of an exemplary aortic or pulmonic heart valve of the present invention
illustrating conversion of the sewing ring between two bi-stable positions”
(Spec. 6, ll. 9-11).
3. Figures 13A and 13B of the Specification are reproduced
below:

“Figures 13A and 13B are cross-sectional views through the stent/sewing
ring subassembly of Figures 11A-11C illustrating in more detail the sewing
ring in the bi-stable positions” (Spec. 6, ll. 14-16).
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4. Figure 6 of Totten is reproduced below:

“FIG. 6 is a view illustrating the first step in the anchoring of the sewing
ring to the base of the stent” (Totten, col. 3, ll. 20-21).
5. Totten teaches that a “sewing ring 28 is positioned in outer
surrounding relation to the base of the stent and in a manner to be described
is integrated into the valve by the fabric covering so as to serve as a secure
means of implantation” (Totten, col. 4, ll. 8-11).
6. Totten teaches that the “ring 28 may be composed of cloth, e.g.,
felt or a compliant elastomer, e.g., silicone elastomer which, upon grafting
or implantation, will together with the covering 14, form a suitable base for
fibrous ingrowth” (Totten, col. 4, ll. 12-15).
7. Totten teaches that the “the ring is sufficiently pliable as to
conform to irregular openings but will assure a snug fit and seal with the
wall of the annulus to which it is secured” (Totten, col. 4, ll. 16-18).
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8. Totten teaches that
to encourage the ring to lay smoothly when the skirt portions
are pulled over it in a manner to be described and so as to be
angled somewhat upwardly toward the post end of the stent,
a corner 42 is trimmed off of the inner edge so as to form a
beveled edge along the upper corner of the flat surface
portion 40.

(Totten, col. 5, ll. 47-53).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
“Inherency ... may not be established by probabilities or possibilities.
The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999).
Analysis
The dispute centers on whether the sewing ring of Totten inherently
satisfies the functional requirement of claim 1 for a bi-stable sewing ring.
We begin with claim interpretation of the term “bi-stable”. The
Specification specifically discusses the term “bi-stable” explaining that the
two positions shown in figures 11A or 13A are represent one stable position
and that the positions show in figures 11C and 13B represent an alternate
stable position for the sewing ring (FF 1-3). The Specification explains that
a “bi-stable” sewing ring can be “inverted between orientations extending
toward the outflow end and the inflow end” (Spec. 16, ll. 15-16; FF 1).
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We conclude that the term “bi-stable” is reasonably interpreted in
light of the Specification as requiring the sewing ring to be invertable
between two orientations, toward the outflow or inflow ends, where the ring
will remain in the selected orientation unless altered by the artisan (FF 1-3).
Totten teaches a sewing ring which is attached to the generally
annular periphery of a prosthetic heart valve and which has an inflow end
and an outflow end (FF 4-8). Totten teaches that the “ring 28 may be
composed of cloth, e.g., felt or a compliant elastomer, e.g., silicone
elastomer which, upon grafting or implantation, will together with the
covering 14, form a suitable base for fibrous ingrowth” (Totten, col. 4, ll.
12-15; FF 6).
The Examiner finds that “because of the structural design of Totten’s
sewing ring being placed at an edge and is pliable or flexible it is fully
capable of moving between two positions about the edge. As a result this
would be bi-stable according to Appellant's definition of bi-stable” (Ans. 5).
We are not persuaded. As we interpret the term “bi-stable”, the term
requires more than the ability to temporarily move between two positions,
which is a feature of any elastomeric material. Instead, as read in light of the
Specification, “bi-stable” also requires that the ring will remain in a selected
position until inverted or changed by the artisan as already discussed above.
In order to properly invoke the inherency doctrine, the Examiner must
provide evidence or reasoning to suggest that the product being claimed is
necessarily identical to the product of the prior art, and that the products are
identical insofar as shown by the available evidence. MEHL, 192 F.3d at
1365. Here, the Examiner has failed to provide any evidentiary basis or
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scientific reasoning which would demonstrate the sewing ring of Totten is
capable of being placed into a first stable position and then, upon action by
the artisan to alter or invert the sewing ring, also remain stable in a second,
different, position.
The evidence of record in Totten does not suggest that the sewing ring
of Totten is capable of being placed into two alternate, different, stable
positions. (FF 4-8).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the sewing ring in Totten is bi-stable as required by claim 1.
B. 35 U.S.C. § 103(a) over Totten and Huynh
This rejection relies upon the underlying anticipation rejection over
Totten which we reversed above. Having reversed the anticipation rejection
over Totten for a failure to teach “that the sewing ring is bi-stable” as
required by claim 1, we necessarily reverse this obviousness rejection further
including Hunyh as Hunyh also does not teach a “bi-stable” sewing ring.
C. 35 U.S.C. § 103(a) over Totten and Reichart
This rejection relies upon the underlying anticipation rejection over
Totten which we reversed above. Having reversed the anticipation rejection
over Totten for a failure to teach “that the sewing ring is bi-stable” as
required by claim 1, we necessarily reverse this obviousness rejection further
including Reichart as Reichart also does not teach a “bi-stable” sewing ring.

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SUMMARY
In summary, we reverse the rejection of claims 1-8 and 11-19 under
35 U.S.C. § 102(b) as anticipated by Totten.
We reverse the rejection of claims 9 and 20 under 35 U.S.C. § 103(a)
as obvious over Totten and Huynh.
We reverse the rejection of claims 10 and 21 under 35 U.S.C. § 103(a)
as obvious over Totten and Reichart.

REVERSED

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