Ex Parte Marquez

Patent Trial and Appeal Board

Sep 21, 2012

10811565 (P.T.A.B. Sep. 21, 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.
10/811,565 03/29/2004 Salvador Marquez ECV-5783 1380
30452 7590 09/21/2012
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
EXAMINER
PRONE, CHRISTOPHER D
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
09/21/2012 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 PATENT TRIAL AND APPEAL BOARD
________________

Ex parte SALVADOR MARQUEZ
________________

Appeal 2010-004897
Application 10/811,565
Technology Center 3700
________________

Before JENNIFER D. BAHR, MICHAEL L. HOELTER and JOHN W.
MORRISON, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1-18 (App. Br. 2). Claims 19-23 have been cancelled
(App. Br. 2). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM and we designate the affirmance (see infra) as
containing new grounds of rejection.

THE CLAIMED SUBJECT MATTER
The claimed subject matter pertains to “an internal support frame for a
prosthetic heart valve and, more particularly, to a leaflet support frame that
separates into cusps after implantation” (Spec. ¶ [0001]). Independent claim
1 is illustrative of the claims on appeal and is reproduced below:
1. A support frame for a flexible leaflet prosthetic heart
valve, comprising:
a plurality of cusps each sized and shaped to support a
cusp of a flexible leaflet of the heart valve; and
a plurality of commissures, one each between each
adjacent pair of cusps, the commissures each having a point of
weakness designed to fracture upon repeated relative
movement of the cusps after implantation such that the cusps
move substantially independently of each other, wherein the
support frame exhibits a substantially continuous stiffness along
the cusps and commissures similar to that resulting from the
cusps and commissures being formed integrally.

REFERENCES RELIED ON BY THE EXAMINER

Klöckner WO 00/53356 A1 Sep. 14, 2000
Marquez US 6,736,845 B2 May 18, 2004

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THE REJECTION ON APPEAL
Claims 1-18 are rejected under 35 U.S.C. § 103 as being unpatentable
over Marquez and Klöckner (Ans. 4).

ANALYSIS
Appellant presents separate arguments for both independent claim 1
and independent claim 11 (App. Br. 4-7). We address these claims
separately infra. No separate arguments are presented with respect to
dependent claims 2-10 and 12-18 which stand or fall with their respective
independent claim.
We affirm the Examiner’s rejection of claims 1 and 11; however,
since the basis of our rationale differs from that of the Examiner, pursuant to
our authority under 37 C.F.R. § 41.50(b), we designate this affirmance as a
new ground of rejection in order to afford Appellant a full and fair
opportunity to react to the thrust of the rejection.
The Rejection of Claim 1 as being
unpatentable over Marquez and Klöckner
The Examiner relies primarily on Marquez for disclosing the
limitations of claim 1 but relies on Klöckner for disclosing “a continuous
homogeneous metal sheet [made] with dedicated thinner weak portions as
break points” (Ans. 4). The Examiner finds that it would have been obvious
“to combine the teaching of continuous homogeneous breakable connections
as taught by Klöckner with the implant of Marquez in order to simplify
production and reduce costs” (Ans. 4).
Appellant contends that Marquez does not disclose a “frame (stent)
having a substantially continuous stiffness along the cusps” nor does
Marquez disclose commissures that are “designed to fracture upon repeated
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relative movement of the cusps after implantation” (App. Br. 5, see also
Reply Br. 2). Appellant contends that Marquez “discloses flexible
commissures,” that “[t]his is not a substantially continuous stiffness” and
that Marquez discloses that the fragile bridge 90 disclosed therein is
designed to dissolve in the body and not fracture upon repeated relative
movement (App. Br. 5, Reply Br. 2).
These contentions are not persuasive. Regarding the claim limitation
of “substantially continuous stiffness,” the Examiner finds that Marquez
employs the same material (i.e., nitinol, Ans. 4) that is preferred by
Appellant because, as Appellant indicates, the frame “must be relatively
stiff” (Spec. ¶ [0029]). Marquez also teaches that “[t]he holder includes
structure for maintaining a relatively fixed shape of the flexible prosthetic
heart valve during implantation” (Marquez 4:25-27). Further, while the
Examiner relies on Klöckner, not Marquez, for disclosing “a continuous
homogeneous metal” (Ans. 4), it is noted that Marquez also teaches that “the
stent 70 is desirably formed of a single piece (such as seen in FIG. 20D)”
(Marquez 9:10-12). In view of the teachings of Marquez and Klöckner, the
Examiner finds that “[t]he claims only require a continuous stiffness which
the combination discloses through its materials and configurations[,] not a
specific degree of stiffness” (Ans. 5).
Regarding the claim limitation of “a point of weakness designed to
fracture upon repeated relative movement,” the Examiner relies on Klöckner
for this teaching, not Marquez (see Ans. 4). Klöckner teaches a mesh “cut in
such a manner that certain webs are connected to one another only very
thinly, i.e., certain mesh nodes are constructed as designed breaking points”
(Klöckner, pg. 3). In view of these teachings of Marquez and Klöckner, we
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are not persuaded the Examiner erred in finding that “[b]y utilizing the
homogeneous frame comprising breaking points taught by Klöckner the
frame of Marquez would have a continuous stiffness that will fracture upon
movement after implantation” (Ans. 5).
Appellant also contends that designing Marquez’s “commissures to
fracture would be counter to the intent of the invention of Marquez” (App.
Br. 6). This contention is not persuasive because Marquez teaches
commissures that are designed to separate in the body (see App. Br. 5 and
Marquez 10:25-34). Appellant does not present evidence that separation of
Marquez’s device after implantation by fracturing instead of by dissolving
would affect the operation of Marquez’s device.
Appellant further contends that in view of Klöckner’s expanded
metal mesh that is cut so as to have break points, “Applicants fail to see how
such a structure ‘exhibits a substantially continuous stiffness along the cusps
and commissures’” as claimed because “the ultrathin nodes of the metal
mesh of Klöckner, et al. would seem to be substantially weaker than the
surrounding mesh, and certainly not as stiff” (Reply Br. 3). Appellant does
not explain how the claimed structure of “substantially continuous stiffness”
having “a point of weakness designed to fracture” is different from the
Examiner’s suggested combination which also teaches a structure of
“substantially continuous stiffness” and also having “a point of weakness
designed to fracture.” Accordingly, we are not persuaded by Appellant’s
contention. Appellant further argues that “[t]here is no mention [in
Klöckner] of providing break points that withstand ‘repeated relative
movement’ before fracture” or that Klöckner’s “ultrathin break points
fracture rather quickly” (Reply Br. 3). Claim 1 does not specify how many
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repeated movements are required nor does claim 1 specify how quickly the
fracture is to occur. Further, Appellant does not present evidence that
Klöckner’s break points are unable to withstand repeated relative movement.
These arguments are not persuasive.
Appellant also traverses the Examiner’s finding that Klöckner is
“in the same field of endeavor” (Reply Br. 4; Ans. 4). In addressing this
statement, the Examiner clarifies that “Klöckner is in the field of metal
fabrication which would comprise bridging three curved metal portions as
done in the current application” (Ans. 5). Appellant contends that “[t]his
characterization is overbroad,” that the “natural consequence of such a
broad field is that any metal-working technique may be imputed” and
that “Applicants do not believe that such a broad collection of prior art is
warranted” (Reply Br. 4).
We note that Appellant’s stated Field of the Invention is a “support
frame for a prosthetic heart valve” (Spec. ¶ [0001]). We agree with
Appellant that the Examiner’s characterization of Klöckner being in the field
of metal fabrication is not the same as being in the field of heart valve
fabrication. However, the Examiner appears to have identified a common
problem addressed by both Klöckner and Appellant, such common problem
being the bridging of multiple portions (Ans. 5). Our reviewing court has
provided instruction that a reference is analogous art if it either is in the field
of the applicant’s endeavor or is reasonably pertinent to the particular
problem with which the inventor was concerned. In re Kahn, 441 F.3d 977,
987 (Fed. Cir. 2006). The Examiner’s rejection is based on Klöckner being
in the field of Appellant’s endeavor but we believe, more correctly, that
Klöckner is appropriate art for consideration because Klöckner is reasonably
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pertinent to the particular problem with which the inventor was concerned
(i.e. bridging multiple portions). Our reviewing court has also provided
instruction that “[m]ere reliance by the Board on the same type of rejection
or the same prior art references relied upon by the examiner, alone, is
insufficient to avoid a new ground of rejection where it propounds new facts
and rationales to advance a rejection-none of which were previously raised
by the Examiner.” In re Stepan, 2010-1261 (Fed. Cir. Oct. 5, 2011). In
view of these instructions and to ensure Appellant has a full and fair
opportunity to react to the thrust of the rejection, we designate Klöckner
being analogous art as a new ground of rejection.
Appellant further contends that “[s]ince Marquez, et al. do[es] not
teach points of weakness, there is no motivation to look to any secondary
reference to find one” (Reply Br. 5). Regarding the assertion that Marquez
does not teach points of weakness, this contention is not persuasive as
Marquez does indeed disclose attachment 90 that is designed to dissolve
(Marquez 10:25-34, see also App. Br. 5). Furthermore, whether Marquez
teaches a point of weakness or not, Appellant acknowledges that a person
skilled in heart valve fabrication “would likely already be aware of the
concept of frangible break points, even without the ‘help’ of Klöckner, et
al.” (Reply Br. 5). Regarding the assertion that there is no motivation to
look to a secondary reference, we note the Examiner finds motivation to
combine Marquez and Klöckner based on the desire “to simplify production
and reduce costs” (Ans. 4). There is no indication by Appellant that the
Examiner’s stated motivation to combine these references is unreasonable.
Accordingly, we are not persuaded by Appellant’s contention.
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In view of the record presented, we sustain the rejection of claims 1-
10 but designate a new ground of rejection to the effect that Klöckner is
analogous art.
The Rejection of Claim 11 as being
unpatentable over Marquez and Klöckner
Appellant’s arguments with respect to claim 11 mirror those discussed
supra with respect to claim 1 and our analysis is similar. However, claim 11
requires the commissures and cusps be “formed integrally of a homogeneous
material” and Appellant contends that Marquez “does not disclose a support
frame of a continuous homogeneous material” (App. Br. 6). We note the
Examiner relied on Klöckner for disclosing a continuous homogeneous
material, not Marquez (Ans. 4) even though Marquez also teaches a single
piece frame (see Marquez 9:10-12). Appellant’s contention is not
persuasive. Appellant further reiterates the contention that Klöckner is not
in the same field of endeavor “as heart valve fabrication” (App. Br. 7). For
the reasons stated supra, we find that Klöckner is analogous art but
designate this a new ground of rejection because the rationale relied upon
was not previously raised by the Examiner.
In view of the record presented, we sustain the rejection of claims 11-
18 but designate a new ground of rejection to the effect that Klöckner is
analogous art.

DECISION
The rejection of claims 1-18 under 35 U.S.C. § 103(a) are affirmed.
However, since our rationale relies on findings additional to those made
by the Examiner, pursuant to our authority under 37 C.F.R. § 41.50(b),
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we designate this affirmance as containing new grounds of rejection in order
to afford Appellant a fair opportunity to respond. 37 C.F.R. § 41.50(b)
provides “[a] new ground of rejection pursuant to this paragraph shall not be
considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides
that Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE
DECISION, must exercise one of the following two options with respect
to the new grounds of rejection to avoid termination of the appeal as to the
rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the [E]xaminer, in which
event the proceeding will be remanded to the [E]xaminer. . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record . . .
Should Appellant elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If Appellant elects prosecution before the Examiner and this does not
result in allowance of the application, abandonment or a second appeal, this
case should be returned to the Patent Trial and Appeal Board for final action
on the affirmed rejection, including any timely request for rehearing thereof.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
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AFFIRMED; 37 C.F.R. § 41.50(b)

JRG