Ex Parte Carpentier

Patent Trial and Appeal Board

Aug 1, 2017

13600040 (P.T.A.B. Aug. 1, 2017)

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.
13/600,040 08/30/2012 Alain Carpentier HVT-5782C 8840
30452 7590 08/01/2017
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
EXAMINER
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
08/01/2017 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 ALAIN CARPENTIER
Appeal 2016-001369
Application 13/600,0401
Technology Center 3700
Before ULRIKE W. JENKS, JOHN G. NEW, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a prosthetic
tricuspid annuloplasty ring. The Examiner entered final rejections for
anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
STATEMENT OF THE CASE
Background
Heart valve disease is a widespread condition in which one
or more of the valves of the heart fails to function properly. . . .
1 Appellant identifies the real party in interest as Edwards Lifesciences
Corporation of Irvine, California. App. Br. 1.
Appeal 2016-001369
Application 13/600,040
Valve disease can be severely debilitating and even fatal if left
untreated.
Various surgical techniques may be used to repair a
diseased or damaged valve. In a valve replacement operation,
the damaged leaflets are excised and the annulus sculpted to
receive a replacement valve. Another less drastic method for
treating defective valves is through repair or reconstruction,
which is typically used on minimally calcified valves. One repair
technique that has been shown to be effective in treating [blood
flow] incompetence is annuloplasty, in which the deformed valve
annulus is reshaped by attaching a prosthetic annuloplasty repair
segment or ring to the valve annulus. The annuloplasty ring is
designed to support the functional changes that occur during the
cardiac cycle: maintaining coaptation and valve integrity to
prevent reverse flow while permitting good hemodynamics
during forward flow.
The present application has particular relevance to the repair of
the tricuspid valve, which regulates blood flow between the right
atrium and right ventricle.
Spec. 114, 5, 8.
The present invention provides an improved tricuspid
annuloplasty ring that better conforms to the native annulus and
is shaped to protect certain features of the surrounding anatomy.
. . . Additionally, the present ring is contoured to better
approximate the three-dimensional shape of the tricuspid
annulus; specifically, the ring is substantially planar but includes
a bulge in the inflow direction at the location of the bulge created
by the adjacent aorta. The bulge helps reduce stress between the
ring and surrounding tissue, and thus the potential for tearing or
ring dehiscence.
Id. 135.
2
Appeal 2016-001369
Application 13/600,040
The Claims
Claims 1—22 are pending. Claims 1, 2, 4—7, and 9-22 are on appeal.2
Claims 1 and 12 are illustrative and read as follows (with claim terms at
issue italicized for reference):
1. A prosthetic tricuspid annuloplasty ring for implant at a
tricuspid annulus having the following anatomical landmarks as
seen in series in a clockwise direction: an antero-septal
commissure, an anterior leaflet with an aortic part and a
remaining part, a postero septal commissure, a septal leaflet, the
ring comprising:
a ring body surrounding a central open area and having a
plan view shape lying partially in a plane and having an inflow
side and an outflow side, wherein the plan view as seen looking
at the inflow side has an asymmetric ovoid shape that includes
the following elements connected in series in a clockwise
direction when implanted at the tricuspid annulus:
a first free end located adjacent the antero-septal
commissure, a first segment corresponding to the aortic part of
the anterior leaflet, a second segment corresponding to the
remaining part of the anterior leaflet and ending at the postero
septal commissure, a third segment from the postero septal
commissure to part way along the septal leaflet, and a fourth
segment that terminates in a second free end at a septal point on
the tricuspid annulus, the second and third segments extending
around a large end of the ovoid shape, and the ring body being
discontinuous so that the first free end and the second free end
are separated across a gap,
wherein the second segment lies in the plane while a
majority of the other segments are out of the plane,
wherein the ring body has at least one arcuate bulge out of
the plane toward the inflow side defining a path that rises up and
down, and
2 The Examiner notes that claims 3 and 8 are objected to in form only.
Ans. 12.
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Application 13/600,040
wherein the first and secondfree ends are bent in an inflow
direction, each bend commencing in close proximity with an
extreme tip of the respective free end.
Appeal Brief (Claims Appendix, emphasis added)
12. A prosthetic tricuspid annuloplasty ring for implant at
a tricuspid annulus having the following anatomical landmarks
as seen in series in a clockwise direction: an antero-septal
commissure, an anterior leaflet with an aortic part and a
remaining part, a postero septal commissure, and a septal leaflet,
the ring comprising:
a ring body having a plan view shape lying partially in a
plane relative to an axis in an inflow-outflow direction
circumscribed by the ring body such that the ring body has an
upper, inflow side and a lower, outflow side,
wherein the plan view shape as seen looking at the inflow
side is an asymmetric ovoid that includes the following elements
connected in series in a clockwise direction when implanted at
the tricuspid annulus, a first free end located adjacent the antero-
septal commissure, a first segment, a second segment which is
larger than the first segment, a third segment which is smaller
than the first segment, and a fourth segment which is smaller than
the first segment and terminates in a second free end located at a
septal point on the tricuspid annulus, the second and third
segments extending around a large end of the ovoid shape, and
the ring body being discontinuous so that the first free end and
the second free end are separated across a gap,
wherein the second segment lies in the plane while a
majority of the other segments are out of the plane,
wherein the ring body has an upward saddle-shaped aortic
arcuate bulge in the first segment out of the plane toward the
inflow side to accommodate an anatomical bulge of the aorta into
the tricuspid annulus, and
wherein the first free end is bent upward in an inflow
direction commencing in close proximity with an extreme tip of
the first free end with a downward bend located between the first
free end and the aortic arcuate bulge.
Id. at 19-20, emphasis added.
4
Appeal 2016-001369
Application 13/600,040
The Issues
The following rejections are before us to review:
Claims 1, 2, 6, 12, 13, 16, and 19 are rejected under pre-AIA 35
U.S.C. § 102(e) as being anticipated by Redmond.3 Ans. 2.
Claims 4, 5, 14, and 15 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Redmond and McCarthy.4 Id. at 8.
Claims 7, 17, and 18 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Redmond as is applied above. Id. at 9.
Claims 9—11 and 20—22 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Redmond and Carpentier.5 Id. at 11.
ANTICIPATION
The Examiner has rejected claims 1,2, 6, 12, 13, 16, and 19 as
anticipated by Redmond. The Examiner finds that Redmond discloses all of
the claim limitations, including “wherein the first and second free ends are
bent in an inflow direction.” Ans. 4, emphasis omitted. In so doing, the
Examiner provides the following Annotated Figure 3:
3 US 2009/0036979 Al, published Feb. 5. 2009 (“Redmond”).
4 US 2003/0208264 Al, published Nov. 6, 2003 (“McCarthy”).
5 US 4,917,698, issued Apr. 17, 1990 (“Carpentier”).
5
Appeal 2016-001369
Application 13/600,040
5CJ
Annotated Figure 3 is an annotated version of Figure 3 of Redmond, which
is an isometric view of an exemplary annuloplasty band. Redmond 120.
The Examiner also provides Annotated Figure 4, copied below:
Annotated Figure 4 is an annotated version of Figure 4 of Redmond, which
is a side view of an exemplary annuloplasty band. Redmond 121.
Appellant argues, among other points, that “Redmond does not have
the two free ends of the stiffening element of the annuloplasty ring turned
upward.” App. Br. 9. In support, Appellant points to Figures 2, 4, and 5 of
Redmond, shown below.
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Appeal 2016-001369
Application 13/600,040
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Fig. 3
Figure 2 of Redmond is a top view of an exemplary annuloplasty band.
Redmond 119. Figure 4 of Redmond is a side view of an exemplary
annuloplasty band. Redmond 121. Figure 5 of Redmond is a view from the
anterior portion end of an exemplary annuloplasty band. Redmond 122.
According to Appellant,
The first free end 51 appears to show a slight downward bend,
although any implication of a sudden bend is nullified by the top
plan view in Figure 2, wherein the first free and 51 merely curls
inward toward the second free end 52. The second free end 52
in Figure 4 appears to be angled slightly upward, though any
“bend” which creates this shape is gradual and not “in close
proximity with the tip.”
App. Br. 9.
The Examiner responds that:
the claim language is simply too broad for Appellant to argue
that the upward bends of both ends are not “in close proximity
with an extreme tip” of each free end. The Examiner maintains
that the specification has no examples or specific distances that
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Appeal 2016-001369
Application 13/600,040
would limit the Examiner to agreeing that the ring of Redmond
does not meet the very broad claim limitation.
Ans. 17.
With regard to claim 12, Appellant argues Redmond does not
teach the claim limitation “downward bend located between the first
free end and the aortic arcuate bulge.” App. Br. 12. Appellant argues
“[t]he left side of Figs. 4 and 5 in Redmond shows a gentle upward
curve which is downwardly concave. This is a single curvature, and
does not anticipate an upward bulge, a downward bend, and then an
upward bend near the tip of the free end.” Id.
The Examiner responds that “[Annotated Figure 4] does indeed
depict a gentle upward curve. Examiner points out that the angles and
severity of said bend is not a part of the claim language however, and
so appears to be a moot point.” Ans. 17.
We agree with Appellant that the evidence does not support the
Examiner’s finding that Redmond teaches all of the limitations of claims 1
and 12.
With regard to claim 1, we agree with Appellant that the Figures cited
above support that the free ends of Redmond do not meet the limitation
“wherein the first and second free ends are bent in an inflow direction, each
bend commencing in close proximity with an extreme tip of the respective
free end” because at least one free end does not point “in an inflow
direction.” In reaching this conclusion, we find Figure 7, shown below,
helpful to clarify the location of each portion of the ring:
8
Appeal 2016-001369
Application 13/600,040
111
Fig. 7
Figure 7 is a schematic view of a stiffening element of an exemplary
annuloplasty band that has been opened and laid out providing a 2D view of
the circumferential side view of the stiffening element, showing maximum
and minimum positions and range between them. Redmond 25, 45.
Redmond discloses that Figure 7 shows the “[t]he maximum positions
111 and minimum positions 112 can occur at desired positions along the
perimeter of the device and correspond to desired positions along the
annulus in order to preferably mimic the natural anatomical shape of the
annulus.” Id. 145. Accordingly, Figure 7 shows the elevation increases and
decreases of the respective portions of the annulus, proceeding from the first
free end on the left along the annulus to the second free end at the terminus
of the annulus on the right. If, as the Examiner suggests, both free ends
were “bent in an inflow direction, each bend commencing in close proximity
with an extreme tip of the respective free end,” both ends shown in Figure 7
would be pointed toward the same (inflow) direction. Thus, Figure 7
clarifies that the free ends of the ring do not both “point in an inflow
direction.”
9
Appeal 2016-001369
Application 13/600,040
With regard to claim 12, we likewise find Figure 7 clarifies that
Redmond does not teach a ring with a “downward bend located between the
first free end and the aortic arcuate bulge.”
To begin, we construe this term to clarity where the claim requires
the downward bend must be located. The Specification provides the
following:
a prosthetic tricuspid annuloplasty ring comprises an asymmetric
generally ovoid ring body generally arranged in a plane and
about an axis along an inflow-outflow direction with a first free
end located adjacent an antero-septal commissure when
implanted and a second free end located at a septal point. The
ring body extends in a clockwise direction as seen looking at an
inflow side from the first free end around a first segment, a
second segment, a third segment, and a fourth segment that
terminates in the second free end.
Spec. 121.
As seen in Figs. 7B and 7C, the exemplary ring 50 also includes
an upward arcuate bow or bulge 64 in the first segment 60a, and
another upward bulge 65 in the fourth segment 60d. The “aortic”
bulge 64 accommodates a similar contour of the tricuspid
annulus due to the external presence of the aorta and desirably
extends from near the first free end 56a along first segment 60a
to a location that corresponds to the end of the aortic part of the
anterior leaflet.
Id. 147.
10
Appeal 2016-001369
Application 13/600,040
Figures 7A—7C of the Specification are shown below:
Phi 7C Fig. 7A
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Fig. 7B
Figures 7A—C are plan, septal and anterior elevational views, respectively, of
an exemplary tricuspid annuloplasty ring illustrating its free ends bent
toward the inflow side and an aortic bulge and a septal bulge. Spec. 131.
Thus, according to the Specification portions above, the “downward
bend” at issue in claim 12 is marked at 62a with 64 being the aortic arcuate
bulge and 65 being the septal bulge. Spec. H 21, 47.
Figure 7 is copied below again for reference:
ill
Fig. 7
Figure 7 is a schematic view of a stiffening element of an exemplary
annuloplasty band that has been opened and laid out providing a 2D view of
11
Appeal 2016-001369
Application 13/600,040
the circumferential side view of the stiffening element, showing maximum
and minimum positions and range between them. Redmond 25, 45.
Figure 7, which shows elevation changes along the length of the ring
as discussed above, clarifies that the ring of Redmond lacks a “downward
bulge” between the free end on the left (corresponding to 56a in Figure 7A
above, from the Specification) and the anterior arcuate bulge (corresponding
to 62a in Figure 7C above, from the Specification).
The Examiner has not pointed to other disclosures in Redmond that
teach this limitation. “Anticipation requires that all of the claim elements
and their limitations are shown in a single prior art reference.” In re
Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). Because the Examiner has
not provided evidence sufficient to support a prima facie case of
anticipation, we reverse the rejection of claims 1 and 12 as anticipated by
Redmond. Because claims 2, 6, 13, 16, and 19 depend from claims 1 or 12,
we likewise reverse the rejections of these claims.
OBVIOUSNESS
The Examiner has rejected claims 4, 5, 14, and 15 as obvious over
Redmond and McCarthy; claims 7, 17, and 18 as obvious over Redmond; and
claims 9-11 and 20—22 as obvious over Redmond and Carpentier. Ans. 8—11.
As discussed above, however, the Examiner has not shown that Redmond
teaches all of the limitations of the independent claims. Because all of the
obviousness rejections depend on the Examiner’s findings regarding Redmond
with respect to claims 1 and 12, we therefore reverse the rejections.
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Appeal 2016-001369
Application 13/600,040
SUMMARY
We reverse the rejection of all claims.
REVERSED
13