Ex Parte Lerdahl et al

Patent Trial and Appeal Board

Sep 1, 2016

11869941 (P.T.A.B. Sep. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/869,941 10/10/2007
69683 7590 09/06/2016
C. R. Bard, Inc.
Bard Peripheral Vascular, Inc.
Intellectual Property Department
1415 W. 3rd St
Tempe, AZ 85280-1740
FIRST NAMED INVENTOR
Robert G. Lerdahl
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.
289-PDD-06-88-US-[64P] 3959
EXAMINER
EVERAGE, KEVIN D
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/06/2016 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):
BPVIP.Docket@crbard.com
Charles.Runyan@crbard.com
PTOL-90A (Rev. 04/07)
U-NITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT G. LERDAHL,
CHANDRASHEKHAR P. PATHAK, and
R. MICHAEL CASANOVA
Appeal2014-009009
Application 11/869 ,941
Technology Center 3700
Before NEALE. ABRAMS, JEFFREY A. STEPHENS, and
ERIC C. JESCHKE, Administrative Patent Judges.
STEPHENS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 seek our review under 35 U.S.C. § 134(a) from the
Examiner's Final Office Action ("Final Act.") rejecting claims 1, 2, 5, 6,
12-14, 20, 21, 31-33, 43--45, and 47-51, which are all the claims pending in
the application. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm in part.
1 The real party in interest is identified as C.R. Bard, Inc. (App. Br. 3.)
Appeal2014-009009
Application 11/869 ,941
Claimed Subject Matter
The claimed invention generally relates to a kink-resistant stent graft.
(Title.) Claim 1, reproduced below, is illustrative:
1. A stent graft, comprising:
a stent, including a plurality of struts arranged to establish
a plurality of rings along a longitudinal axis of the stent graft,
wherein adjacent rings are directly connected; and
a graft engaged with the stent, wherein the graft includes
an inner surface and an outer surface and wherein at least one of
the inner surf ace and the outer surface includes a plurality of
protrusions as viewed in cross section extending through the
longitudinal axis, wherein the protrusions form a plurality of
closed loops, the directly connected adjacent rings bisected by at
least one closed loop.
Rejection2
Claims 1, 2, 5, 6, 12-14, 20, 21, 31-33, 43--45, and 47-51 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Bebb et al. 3 and
Gianotti. 4 (Final Act. 3---6.5)
ANALYSIS
We have reviewed the Examiner's rejections in light of Appellants'
arguments (App. Br. 7-16; Reply Br. 4--11). We are not persuaded by
Appellants' arguments, except as to claim 21, discussed further below. For
2 The rejection of claim 50 under 35 U.S.C. § 112, second paragraph, is
withdrawn in the Answer. (Ans. 2-3.)
3 US 2009/0030499 Al, published Jan. 29, 2009.
4 US 6,652,577 B2, issued Nov. 25, 2003.
5 The omission of claims 49-51 from the summary of the rejection (Final
Act. 3) appears to have been inadvertent.
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Application 11/869 ,941
all other claims, we adopt as our own the findings and reasons set forth by
the Examiner in the action from which this appeal is taken and set forth in
the Answer (see Ans. 7-11). We highlight and address specific arguments
and findings for emphasis as follows.
Claims 1, 2, 5, 6, 14, 31-33, 43--45, 47, 49, and 51
Appellants argue that Gianotti only describes a stent and, therefore,
cannot be found to teach a graft or graft layer with protrusions, as recited in
independent claims 1 and 45, or a corrugation, as recited in independent
claim 31. (App. Br. 8.) Appellants also contend the Examiner has not even
alleged that one of ordinary skill in the art would add protrusions or a
corrugation to a graft or graft layer based on Gianotti. (Id. at 9.)
The Examiner relies on the combined teachings of Bebb and Gianotti
(Final Act. 3--4; Ans. 7), however, and we find altering the shape of Bebb's
stent to include Gianotti' s annular elevations would result in altering the
shape of the graft surrounding the stent. In addition, we agree with the
Examiner that Bebb teaches the claimed protrusions or corrugation in the
graft. (Ans. 7-8.) As the Examiner finds (Ans. 7), Bebb teaches:
To facilitate the capability of the device 10 to articulate, bend
and/or flex without kinking, the sleeve 20 preferably includes a
microfold, expansion portion or fold 22 that permits the sleeve to
elongate and contract in the longitudinal direction in response to
the articulation, bending and/or flexing of the tubular body 12.
The device 10 can include multiple expansion folds 22 spaced
along and radially disposed about the central axis A-A to provide
flexibility to the body 12 bent to a radius of curvature.
(Bebb i-f 31.)
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Application 11/869 ,941
Appellants contend that "[a] fold alone cannot properly be interpreted
as a protrusion or corrugation" because "a fold does not protrude from the
surface, but instead is the surface itself." (Reply Br. 5.) Appellants also
argue the folded material remains the same thickness, so nothing is
protruding from the surface in Bebb, and argue the Specification "makes it
clear that the protrusions contemplated make the graft thicker at the location
of the protrusion," unlike a fold. (Id.)
Despite Appellants' arguments, a preponderance of the evidence
supports the Examiner's finding that Bebb teaches the claimed protrusions
or corrugation in a surface of the graft. Appellants do not cite any specific
portion of the Specification that limits the protrusions or corrugation claimed
in claims 1, 31, and 45 to protrusions that make the graft thicker at the
location of the protrusion. (See Reply Br. 5.) We note that dependent claim
50 recites that the graft at and including the protrusion is thicker than the
graft outside of the plurality of protrusions, supporting a broader
construction of the protrusions in claim 1. In addition, claims 1 and 45
recite that the graft surface includes a plurality of protrusions as viewed in
cross section extending through the longitudinal axis. Thus, the claims
recite a specific view in which the protrusions can be seen to protrude, and
Bebb's folds 22 protrude in this view as seen in Figure 5A, which is
reproduced below:
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Application 11/869,941
FIG. SA
14
Figure 5A of Bebb is a cross-sectional view of a stent
graft device showing expansion fold 22. (Bebb i-fi-120, 31.)
The Examiner's interpretation of the protrusions as viewed in cross section,
as recited in claims 1 and 45, is also consistent with the term corrugation,
recited in independent claim 31, which is generally understood to consist of
folds and is not argued by Appellants separately from the term protrusions.
Appellants also argue Gianotti does not teach the protrusions form a
plurality of closed loops, as recited in claim 1, because Gianotti' s crimped
elevations are only folded segments of wires. (App. Br. 10.) We agree with
the Examiner, however, that Gianotti's annular outwardly formed elevations
form closed loops as claimed. (Final Act. 4; Ans. 8.) The shaping of the
individual wires forming the stent changes the overall shape of the stent to
form protrusions that extend all around the circumference of the stent to
form closed loops, as taught by Figure 3 and its description in Gianotti. In
addition, we agree with the Examiner that Bebb teaches or suggests the
protrusions forming closed loops because the expansion folds 22 are "spaced
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Application 11/869 ,941
along and radially disposed about the central axis A-A" (Ans. 8 (quoting
Bebb i-f 31 )), similar to Gianotti.
Appellants next contend Bebb and Gianotti do not teach the directly
connected adjacent rings of the stent are bisected by at least one closed loop,
as recited in claim 1. (App. Br. 11.) Appellants argue "the Examiner has
not cited a closed loop and does not explain how the available parts could
even be rearranged to come up with a closed loop protrusion/corrugation
without drastically redesigning the stents of Bebb and Gianotti." (Id.) As
discussed above, we agree with the Examiner that Bebb and Gianotti teach
the claimed closed loops. (Ans. 8.) We also agree with the Examiner that
Figure 5A of Bebb shows expansion fold 22 bisecting two adjacent rings of
the stent. (Ans. 8.) Appellants' repeated contention that folds are not
protrusions from a surface (Reply Br. 7) does not apprise us of error, for the
reasons discussed above.
Appellants further argue one of ordinary skill in the art at the time of
the invention would not have modified Bebb based on Gianotti to form the
claimed invention because: (1) there was no known problem identified in
Bebb that would justify modifying Bebb based on Gianotti, and (2) Gianotti
does not involve a graft, so it does not provide any reason to modify a graft.
(App. Br. 11.) Appellants contend that a substantial purpose of Bebb is to
maintain the cross-sectional area of the stent frame during bending (i.e.,
reduce kinking), and that no further benefit is achieved by the inclusion of
the Gianotti elevations onto the Bebb stent frame because Bebb already
achieves the stated benefit obtained by the Gianotti elevations (i.e., radial
deformation). (App. Br. 12.) In our view, Bebb's inclusion of some features
to address a problem would not discourage one of ordinary skill in the art
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from looking to Gianotti to include additional features to further address the
problem and, in this regard, we agree with the Examiner that one of ordinary
skill in the art would have recognized that Gianotti' s protrusions would have
provided Bebb's stent with increased stability. (Ans. 4.) We also agree with
the Examiner's conclusion of obviousness based on these findings. In
addition, our agreement with the Examiner's findings that Bebb teaches the
disputed limitations of independent claims 1, 31, and 45, as discussed above,
is sufficient to sustain the rejections of these claims.
Accordingly, for the reasons discussed above and by the Examiner,
we are not persuaded the Examiner errs in rejecting claims 1, 31, and 45
under 35 U.S.C. § 103(a) as unpatentable over Bebb and Gianotti. Thus, we
sustain the rejection of claims 1, 31, and 45, and, for the same reasons, the
rejection of claims 2, 5, 6, 14, 32, 33, 43, 44, 47, 49, and 51, which are not
argued separately.6
Claims 12 and 13
Appellants argue the Examiner has not cited any teaching in the prior
art that the stent graft comprises at least forty corrugations per inch length
of the stent graft, as recited in dependent claim 12, or that the stent graft
comprises at least one hundred corrugations per inch length of the stent
graft, as recited in dependent claim 13. (App. Br. 14.) Appellants contend:
Stents and stent grafts are relatively small devices and come in
many different configurations specifically designed and suited to
particular applications; accordingly, the particular structure of a
6 Appellants' arguments directed to claim 49 refer to the arguments made for
claim 1. (See App. Br. 16.) Accordingly, Appellants do not provide
separate arguments specific to claim 49.
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(Id.)
stent or stent graft has a large impact on the effectiveness and
value of the stent. The Examiner cannot merely gloss over
structural limitations in this way when the structure is so
important for individual stents.
As the Examiner finds (Ans. 9), Bebb teaches the use of "multiple
expansion folds 22 spaced along and radially disposed about the central axis
A-A to provide flexibility to the body 12 bent to a radius of curvature"
(Bebb i-f 31 ). We agree with the Examiner (Ans. 9) that it would have been
obvious to adjust the number of corrugations per unit length based on the
curvature of the vessel, and that discovering the optimum or workable
ranges would have involved only routine skill in the art.
Accordingly, for the reasons discussed above and by the Examiner,
we are not persuaded the Examiner errs in rejecting claims 12 and 13 under
35 U.S.C. § 103(a) as unpatentable over Bebb and Gianotti. Thus, we
sustain the rejection of claims 12 and 13.
Claim 20
Appellants argue the cited portions of Gianotti do not teach the
plurality of protrusions are formed by at least one bead wound around a
graft layer, as recited in dependent claim 20, because the cited portions of
Gianotti do not mention a bead at all. (App. Br. 15.) Appellants further
contend a fold in a wire is not a bead or beading.
The Examiner relies on a dictionary definition of bead as "a projecting
rim, band, or molding." (Ans. 10 (citing Merriam-Webster online
dictionary).) Under this broadest reasonable construction of the term
"bead," we agree with the Examiner's finding that the protrusions in Bebb
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and Gianotti are beads because they surround the stent/graft and project from
it like a rim or band around the surface. Appellants argue the Examiner's
interpretation is not consistent with the Specification because the
Specification describes beads that constitute added material. (Reply Br. 8-9
(citing Spec. Figs. 10, 14, i1i121, 22, 48, 58).) The Specification provides
specific examples of how to form a bead by adding material to the graft.
(See, e.g., Spec. i1 58 ("[T]he beaded stent graft 800 can include a plurality
of protrusions, e.g., formed by a bead 818 wound around the graft 804. In a
particular embodiment, the bead 818 can be a generally flat, fiber, ribbon,
tape or filament.").) We do not find these examples' use of the terms "bead"
or "beading" to be inconsistent with the Examiner's broader construction of
the term, merely because they show particular ways of forming the bead that
involve adding material. The Specification does not define "bead" to be
more limited than its ordinary meaning identified by the Examiner, and we
decline to import the limitation of added material from these examples into
the claims when applying the broadest reasonable construction standard.
We also are not persuaded by Appellants' argument that claim 20's
recitation of at least one bead wound around the recited graft layers requires
the bead to be a separate element capable of being wound around the graft
layer (Reply Br. 9). Structurally, the folded rims that form the protrusions in
Bebb and Gianotti are wound around the stent/graft because they are formed
by a folded portion that encircles (i.e., winds around) the stent/graft.
Accordingly, for the reasons discussed above and by the Examiner,
we are not persuaded the Examiner errs in rejecting claim 20 under
35 U.S.C. § 103(a) as unpatentable over Bebb and Gianotti. Thus, we
sustain the rejection of claim 20.
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Claim 21
Claim 21, which depends from claim 20, recites that the at least one
bead is sintered to the inner graft layer, the outer graft layer, or a
combination thereof Here, we agree with Appellants' argument (App. Br.
15) that the Examiner has not shown the sintering recited by the claim would
form a structure that is the same as the folds in Bebb or Gianotti. The
sintering recited in claim 21 indicates that a separate bead is added to the
graft, and would create a thicker graft at those portions due to the added
material. Accordingly, we do not sustain the rejection of claim 21 under
35 U.S.C. § 103(a) as unpatentable over Bebb and Gianotti.
Claim 48
Appellants argue that adding Gianotti' s elevations to the stent frame
of Bebb would not result in a stent that is generally cylindrical with uniform
diameter, as recited in claim 48, which depends from claim 1. (App. Br.
15.) The Examiner finds the elevations taught by Bebb are in the graft
portion, and that the stent remains uniform in diameter. (Ans. 10.) In reply,
Appellants argue Figure 5A of Bebb shows a stent with flared ends, so it
does not have a uniform diameter. (Reply Br. 10.) One of ordinary skill in
the art would understand the stent in Figure 5A ofBebb to have a uniform
diameter like that of the stents shown in Bebb's Figures 1 and 3, despite the
expansion of the stent shown at the edges where there appears to be no graft
material. Appellants' stent can also expand (see Spec. i-f 36), and local
expansion of one portion of the stent more than another would not change
the fact that the stent materials as constructed have a uniform diameter.
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Accordingly, for the reasons discussed above and by the Examiner,
we are not persuaded the Examiner errs in rejecting claim 48 under
35 U.S.C. § 103(a) as unpatentable over Bebb and Gianotti. Thus, we
sustain the rejection of claim 48.
Claim 50
Appellants argue that the wires in Gianotti maintain the same
thickness, even when folded or bent outwardly, and, therefore, Gianotti does
not teach that the graft at and including the protrusion is thicker than the
graft outside of the plurality of protrusions, as recited in claim 50. (App. Br.
16.) Appellants also argue that modifying the stent of Bebb with the
teachings of Gianotti would have no impact on the thickness of the graft of
Bebb, i.e., it would remain the same thickness throughout. (App. Br. 16.)
The Examiner finds Gianotti teaches protrusions may be formed inwardly
and outwardly, and that these protrusions in combination with Bebb's inner
and outer graft sleeves would provide thicker protrusions in the graft. (Ans.
11.) We agree with the Examiner's findings, and Appellants' arguments do
not apprise us of error. Although a fold in a single graft layer may not alter
the thickness of that layer, having two graft layers with opposite folds
increases the thickness of the graft at the outward protrusions.
Accordingly, for the reasons discussed above and by the Examiner,
we are not persuaded the Examiner errs in rejecting claim 50 under
35 U.S.C. § 103(a) as unpatentable over Bebb and Gianotti. Thus, we
sustain the rejection of claim 50.
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Application 11/869 ,941
DECISION
We affirm the Examiner's decision to reject claims 1, 2, 5, 6, 12-14,
20, 31-33, 43--45, and 47-51. We reverse the Examiner's decision to reject
claim 21.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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