Ex Parte McDermott

Patent Trial and Appeal Board

Jul 10, 2017

12441085 (P.T.A.B. Jul. 10, 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.
12/441,085 03/12/2009 John D. McDermott 289-PDD-05-71-US 8956
69683 7590
C. R. Bard, Inc.
Bard Peripheral Vascular, Inc.
Intellectual Property Department
1415 W. 3rd St
Tempe, AZ 85280-1740
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
07/12/2017 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)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN D. McDERMOTT
Appeal 2016-004832
Application 12/441,0851
Technology Center 3700
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1—7, 11, 16, 17,
and 57—62 (App. Br. 2; Reply Br. 2). Examiner entered rejections under 35
U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies the real party in interest as “C. R. Bard, Inc.” (App. Br.
2).
Appeal 2016-004832
Application 12/441,085
STATEMENT OF THE CASE
The claims are directed to a stent graft. Claims 1 and 61 are
representative and reproduced below:
1. A stent-graft, comprising:
a generally tubular vascular graft of biocompatible material
having luminal and abluminal surfaces; and
a plurality of discrete bioresorbable annular members attached
to the vascular graft and spaced apart along a longitudinal axis
of the vascular graft
wherein each annular member has a closed-ended undulating
arrangement of struts that form a first set of apices directed
toward a first end of the stent-graft and a second set of apices
directed toward an opposite end of the stent-graft with an equal
number of first and second apices, with the annular members
being spaced apart along the axis far enough apart as to prevent
interference between adjacent annular members upon radial
compression of the stent-graft.
(App. Br. 13.)
61. The stent-graft of Claim 1, wherein the first set of apices
are circumferentially offset from the second set of apices.
(Id. at 15.)
The claims stand rejected as follows:
Claims 1,2, 16, 17, and 57—62 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Cully2 and Haindl.3
Claims 3, 6, and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Cully, Haindl, and Burnside.4
2 Cully et al., US 2005/0131515 Al, published June 16, 2005.
3 Haindl, DE 102 23 399 Al, published Dec. 11, 2003 (English Translation
10223399-Desc-en, Aug. 11, 2014 relied upon).
4Burnside et al., US 2004/0098095 Al, published May 20, 2004.
2
Appeal 2016-004832
Application 12/441,085
Claims 4 and 5 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Cully and Haindl, Burnside and
Banas.5
Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Cully, Haindl, White6 and Hess.7
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellant’s Figure 1 is reproduced below:
Appellant’s FIG. 1 illustrates:
A stent-graft 10... over an inflatable member 2 on a distal end
of a catheter, such as a balloon catheter. The stent-graft 10
includes a generally tubular vascular graft 12 and discrete
annular members 14 spaced apart along a longitudinal axis of
the graft 12, the graft 12 providing a base member or substrate
for the annular members 14.
(Spec. 129.)
5 Banas et al., US 6,124,523, issued Sept. 26, 2000.
6 White et al., US 5,782,904, issued July 21, 1998.
7Hess et al., US 2001/0053931 Al, published Dec. 20, 2001.
3
Appeal 2016-004832
Application 12/441,085
FF 2. Appellant’s Figure 2 is reproduced below:
Appellant’s FIG. 2 illustrates:
Annular member 20 [, which] includes struts 22 arranged in an
undulating configuration that is preferably closed ended. The
struts 22 intersect at an apex to form a first set of apices 24 and
a second set of apices 26 offset therefrom, such that annular
member 20 includes an equal number of first and second apices
24, 26. Each apex includes a peak P and a trough T.
(Spec. 131.)
FF 3. Cully “relates to the field of removable stent-grafts” (Cully 11).
FF 4. Cully’s “[djevices . . . comprise a structural support, such as a stent
component, provided with a covering of a graft material,” wherein “[t]he
graft material that covers the stent component... is preferably . . . expanded
polytetrafluoroethylene (ePTFE)” and “[t]he graft material covering the stent
component may be provided on the exterior surface of the stent component,
the luminal surface of the stent component, or may cover both the exterior
and luminal surfaces” (Cully H 16, 18, 25; Ans. 3 4).
FF 5. Cully’s “stent-graft is cohesively removable (i.e., is cohesively
disassembled), meaning that it is removed in its entirety, without loss of
pieces or the formation of separate remnants during the removal (e.g., the
unraveling) process” (Cully 120).
4
Appeal 2016-004832
Application 12/441,085
FF 6. Cully’s:
[DJevice ... is removable by gripping an end of the helically-
wound structural support with a retrieval device and applying
tension to the structural support in the direction in which it is
intended to be withdrawn from the site of implantation. The
design of the device is such that the structural support (e.g.,
stent component) is extended axially while the adjacent portion
of the graft separates between windings of the structural
support. For a stent-graft, for example, the axial extension of
the stent component, with adjacent portions of the graft still
joined to the stent component, allows the device to be
“unraveled” (or “unwound”) and removed through a catheter of
diameter adequately small to be inserted into the body cavity
that contained the previously-deployed stent-graft.
(Cully 119.)
FF 7. Cully discloses “another embodiment, [wherein,] the stent-graft of
[Cully’s] invention may be delivered and deployed at a site, with
permanently attached but separate stent components also deployed and
intended to be left implanted permanently at, for example, the ends of the
stent-graft” (Cully 123; see id. 124 (Cully’s “stent-graft or the stent
component thereof may be made to be removable in lengthwise sections or
segments”); Ans. 3).
FF 8. Examiner finds that Cully fails to disclose “annular ring members
along the axis of the graft being discrete closed ended annular members”
(Ans. 3).
5
Appeal 2016-004832
Application 12/441,085
FF 9. Haindl’s Figure 4 is reproduced below:
4
Haindl’s FIG. 4 illustrates a stent-graft, wherein “support members . . . rings
14 . . . consist of a sequence of closed expansion elements 16 which are
connected circumferentially to one another by connecting webs 18” (Haindl
3; Ans. 3).
FF 10. Haindl’s Figure 3 is reproduced below:
Haindl’s “FIG. 3 [illustrates a stent graft, wherein] supporting elements 10
are enclosed in plastic material of a tube-shaped film 12 of resorbable
material and held” (Haindl 3; Ans. 3).
FF 11. Examiner finds that Haindl discloses “that stent-grafts can be
constructed with the support structure as one piece along the length (Fig. 4)
or alternatively as a plurality of discrete closed-ended annular members 10
spaced apart along the length of the graft, Fig. 3” (Ans. 3).
r,j 5
6
Appeal 2016-004832
Application 12/441,085
FF 12. Haindl’s Figure 5 is reproduced below:
Haindl’s “FIG. 5 [illustrates a stent-graft,] wherein the support elements are
formed by wave-shaped rings 22 in the circumferential direction, which
consist of plastically deformable material” (Haindl 3; Ans. 3).
FF 13. Examiner finds that Haindl’s FIG. 5 illustrates:
[AJnnular members [22] defined as undulating arrangements of
struts formed with first and second sets of apices with equal
numbers of first and second apices and one set of apices
directed toward a first end of a graft while the second set of
apices are directed to a second end of the graft (these are offset
from one another since they extend alternatively about the
circumference).
(Ans. 3—4.)
7
Appeal 2016-004832
Application 12/441,085
FF 14. Haindl’s Figure 6 is reproduced below:
stretching” (Haindl 3; Ans. 8—9).
FF 15. Examiner finds that the combination of Cully and Haindl “fail to
disclose . . . annular members including a coating of polyurethane that
covers at least a portion of the annular members” (Ans. 4).
FF 16. Burnside “relates to a self-expanding stent-graft having a
bioabsorbable structure such as a stent and a permanent graft bonded
together with an adhesive” (Burnside 1 6; see also id. 1 84 (“A variety of. . .
adhesives . . . may be used for bonding the graft ... to the bioabsorbable
structural support” and while Burnside exemplifies a, poly-L-lactide, “PLLA
material. . . other bioabsorbable materials may be used”)).
FF 17. Burnside’s “graft may ... be made of film, sheet, or tube such as an
ePTFE . . . material” (Burnside 1 6; see id. 115 (Burnside discloses that
“[t]he structural support and the permanent graft may be bonded by adhesive
means and the adhesive means may be bioabsorbable,” wherein “[t]he
8
Appeal 2016-004832
Application 12/441,085
bioabsorbable structural support may be made of at least one of. . . PLLA
[and] . . . ePTFE”).
FF 18. Examiner finds that Burnside discloses the use of a polyurethane
adhesive” (Ans. 4—5, citing Burnside ^fl[ 85, 109, 113).
FF 19. Examiner finds that the combination of Cully, Haindl, and Burnside
“fail[s] to disclose the specific adhesive layer being tetrafluoroethylene to
cover the annular members” and relies on Banas to make up for this
deficiency in the combination of Cully, Haindl, and Burnside (Ans. 5, citing
Banas 5: 21, 22, and 28—31 and 9: 20-22 and 26 (Banas discloses stent
materials made of ePTFE)).
FF 20. Examiner finds that the combination of Cully and Haindl “failed to
disclose the annular stent members being woven into the graft and attached
with bio-resorbable sutures” and relies on White to disclose “stent annular
members . . . woven .. . into the tubular graft” and Hess to disclose “that
bio-resorbable sutures can be used to attach the stent annular members to a
vascular graft” (Ans. 6, citing White 3:1—5 and Hess ^fl[ 40, 48).
ANALYSIS
The rejection over the combination of Cully and Haindl:
Based on the combination of Cully and Haindl, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to “provide the bio-resorbable support structure of the stent-
graft[, disclosed by Cully,] with discrete closed ended annular members
having . . . undulating arrangements as [disclosed] by Haindl [to] provide[]
more flexibility” to Cully’s stent-graft (Ans. 4). In this regard, Cully’s
helical stent component is limited in its longitudinal flexibility
per the wire structure. However common sense in the art
suggests that the individual closed ended undulating annular
9
Appeal 2016-004832
Application 12/441,085
members provides more flexibility in that they are not attached
to one another and thus the flexible graft is permitted to have
more ability to be stretched since the annular members are not
directly attached to one another other than [through] the flexible
graft material.
(Ans. 8.)
Claim 1:
Appellant contends that Examiner’s “proposed modification of Cully
with the discrete annular structures of Haindl renders Cully inoperable for its
intended purpose,” because
The entire objective of the Cully configuration is to permit the
cohesive removal of the stent-graft. In order to achieve the
stated purpose of the Cully stent-graft, it must comprise a
helically wound wire configuration that can be removed after
implantation. As such, the proposed substitution of the annular
members of Haindl is not prima facie supported as such a
substitution would render the Cully device inoperable as being
a removable implant.
(App. Br. 7—8; see Reply Br. 3.) Appellant’s contention fails to account for
Cully’s full disclosure and is, therefore, not persuasive. Notwithstanding,
Appellant’s contention to the contrary, Cully discloses a stent-graft that is
“delivered and deployed at a site, with permanently attached but separate
stent components also deployed and intended to be left implanted
permanently at, for example, the ends of the stent-graft” (FF 7). Thus, while
a portion of Cully’s stent-graft may comprise a helically wound segment to
facilitate removal of the stent-graft that comprises the helically wound
segment, Cully clearly discloses that portions of the stent-graft may be left in
place (App. Br. 7—8; see generally Reply Br. 3—5; cf. FF 7).
10
Appeal 2016-004832
Application 12/441,085
We recognize Appellant’s contention that “Cully does not suggest any
configuration for the[] members” intended to remain permanently in place
after removal of the removable stent-graft portion that is helically wound
(App. Br. 9). Haindl, however, makes up for this deficiency in Cully (FF
10—13). As Appellant recognizes, “the Haindl components would merely be
implanted separately or with the assistance of the Cully device” (App. Br. 9).
Thus, Appellant failed to provide an evidentiary basis to support Appellant’s
contention that “the proposed combination does not lead to the claimed
configuration,” (see id.', see generally Reply Br. 3—6). In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997) (Argument by counsel cannot take the
place of evidence).
For the reasons articulated by Examiner, we are not persuaded by
Appellant’s contention that Haindl fails to suggest a stent-graft that has
improved flexibility (Ans. 8; cf. App. Br. 9; see also App. Br. id. at 10). The
obviousness inquiry “not only permits, but requires, consideration of
common knowledge and common sense.” DyStar Textilfarben GmbH & Co.
v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006); see KSR Inti Co.
v. Teleflex Inc., 550 U.S. 398, 421 (2007) (eschewing “[rjigid preventative
rules that deny factfinders recourse to common sense”).
Appellant’s recognize that HaindFs configuration “may be a flexible
construction,” but assert that Examiner failed to distinguish “the relative
flexibility between the [Cully and Haindl] designs such that a conclusion to
support a selection of one over the other” can be made (Reply Br. 7). We
are not persuaded. As discussed above, Cully and Haindl suggest stent-
grafts of differing configurations. Cully discloses both permanent and
removable stent-grafts and Haindl discloses permanent stent-grafts. Thus,
11
Appeal 2016-004832
Application 12/441,085
we find no error in Examiner’s combination of Cully and Haindl, wherein
different design elements may be combined to achieve the expected result of
obtaining a stent-graft comprising permanent and removable portions.
Claim 61:
Appellant contends that Examiner “never addresses the specific
configurations of claims 61 and 62 including the specifically claimed
configurations of the apices” and, therefore, “failed to support [Examiner’s]
prima facie burden of showing how the cited references render the claimed
configuration obvious” (App. Br. 10). We are not persuaded. As Examiner
explains, Haindl’s Figures 5 and 6 illustrate the specific configurations
required by Appellant’s claims 61 and 62 (Ans. 8—9; FF 12—14; see, e.g.,
Non-Final Act. 4 (directing attention to Haindl’s Fig. 5)).
According to Appellant’s claimed invention, each annular ring
comprises first and second sets of apices (see App. Br. 15 (Claims 60-62)).
We find no requirement in Appellant’s claimed invention that relates the
first and/or second apices on one annular ring to the respective first and/or
second apices on a second annular ring (id. ). Therefore, notwithstanding
Appellant’s contention to the contrary, Haindl’s Figures 5 and 6 illustrate a
plurality of annular rings, wherein the “‘first set of apices [on each
individual annular ring are] circumferentially offset from the second set of
apices’” and the first and second sets of apices on each individual annular
ring are longitudinally aligned, e.g., the first and second apices on an
individual annular ring have the same longitudinal length (FF 12—14; cf.
Reply Br. 7—8).
12
Appeal 2016-004832
Application 12/441,085
The rejection over the combination of Cully, Haindl, and Burnside'.
Appellant’s claim 3 depends ultimately from and further limits the
annular members of Appellant’s claim 1 to include a coating of polyurethane
that covers at least a portion of the annular members in contact with ePTFE
(see App. Br. 13).
The combination of Cully and Haindl suggest stent components that
are “preferably . . . expanded polytetrafluoroethylene (ePTFE)” (FF 4; see
generally FF 1—3 and 5—14). Burnside discloses stent components made of
ePTFE, which “may be bonded by [a variety of] adhesive means,” including
a polyurethane adhesive (FF 16—18).
Based on the combination of Cully, Haindl, and Burnside, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to use polyurethane coatings on stent members as
taught by Burnside . . . applied to the annular members of the stent-graft of
Cully ... as modified with Haindl such that it enhances the bonding of the
graft with the stent” (Ans. 4—5).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Burnside fails to disclose a support structure made of the
same material suggested by the combination of Cully and Haindl or an
adhesive that may be used with the material suggested by the combination of
Cully and Haindl (App. Br. 10-11; cf FF 4 and 16—18). For the same
reasons, we are not persuaded by Appellant’s contentions regarding Cully’s
citation of Hayes or Appellant’s contentions regarding Hayes (Reply Br. 8).
13
Appeal 2016-004832
Application 12/441,085
The rejection over the combination of Cully and Haindl, Burnside and
Banas:
Appellant’s claim 4 depends from and further limits the stent-graft of
Appellant’s claim 3 to further comprise a layer of amorphous fluoropolymer
including tetrafluoroethylene (TEF) and 4,5-difluoro-2,2-
bis(trifhioromethyl)-l,3-dioxole, or a perfluoroelastomer, covering the
annular members (App. Br. 13).
Based on the combination of Cully and Haindl, Burnside and Banas,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious “to use an adjoining layer as taught by
Banas . . . with the stent-graft of Cully . . . modified with Haindl and
Burnside ... to ensure that the components stay together when implanted in
the patient” (Ans. 5; see FF 1—19).
The combination of Cully, Haindl, and Burnside suggests the use of
ePTFE stent materials (FF 4 and 16—18). Banas also discloses the use of
ePTFE stent materials (FF 19). Therefore, we are not persuaded by
Appellant’s contention that “Banas is using an adhesive layer to join
different materials than that of any of Cully, Haindl, and Burnside” and,
therefore, “the benefit of the Banas layer is unknown” (App. Br. 11). For
the foregoing reasons, Appellant fails to explain why a person of ordinary
skill in this art would not have had a reasonable expectation of success in
utilizing Banas’ method of adhering components of a stent-graft to construct
the stent-graft suggested by the combination of Cully, Haindl, and Burnside
(see id.', Reply Br. 9). In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988)
(“Obviousness does not require absolute predictability of success ... all that
is required is a reasonable expectation of success”); In re Geisler, 116 F.3d
14
Appeal 2016-004832
Application 12/441,085
1465, 1471 (Fed. Cir. 1997) (argument by counsel cannot take the place of
evidence).
The rejection over the combination of Cully, Haindl, White and Hess'.
Appellant’s claim 11 depends from and further limits Appellant’s
claim 1 to require that “the annular members are woven into a tubular base
and attached thereto with bio-resorbable sutures” (App. Br. 14).
Based on the combination of Cully, Haindl, White, and Hess,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious “to weave the annular members into
the graft as taught by White . . . with the stent graft of Cully ... as modified
by Haindl such that it prevents longitudinal separation” or, in the alternative,
“use bio-resorbable sutures to secure the stent annular members to the graft
as [disclosed] by Hess . . . with the stent graft of Cully . . . modified with
Haindl and White . . . since such a modification enhances the apparatus and
prevents separation of the elements when being deployed” (Ans. 6).
Having found no deficiency in the combination of Cully and Haindl,
we are not persuaded by Appellant’s contention that the combination of
White and Hess fails to overcome Appellant’s asserted deficiency in the
combination of Cully and Haindl (see App. Br. 11—12 (“Neither White or
Hess overcome the deficiencies identified above with respect to modifying
the Cully stent structure”); see also Reply Br. 9).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
15
Appeal 2016-004832
Application 12/441,085
The rejection of claims 1 and 61 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Cully and Haindl is affirmed. Claims
2, 16, 17, and 57—60 are not separately argued and fall with claim 1. Claim
62 is not separately argued and falls with claim 61.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Cully, Haindl, and Burnside is affirmed. Claims 6
and 7 are not separately argued and fall with claim 3.
The rejection of claim 4 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Cully and Haindl, Burnside and Banas is affirmed.
Claim 5 is not separately argued and falls with claim 4.
The rejection of claim 11 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Cully, Haindl, White, and Hess is affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
16