Ex Parte Chobotov et al

Patent Trial and Appeal Board

Jul 9, 2018

12245620 (P.T.A.B. Jul. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/245,620 10/03/2008 Michael V. Chobotov
128926 7590 07/11/2018
Foley & Lardner LLP
3000 K Street N.W.
Suite 600
Washington, DC 20007-5109
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.
109167-0584 4420
EXAMINER
SHIPMON, TIFFANYP
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
07/11/2018 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL V. CHOBOTOV, ROBERT G. WHIRLEY,
and JOSEPH W. HUMPHREY1
Appeal2016-008595
Application 12/245,620
Technology Center 3700
Before TONI R. SCHEINER, ERIC B. GRIMES, and RY ANH. FLAX,
Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1-14, 29, and 39-44, directed to a modular endovascular graft
assembly. The claims have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b ).
We reverse.
BACKGROUND
Thoracic or abdominal aortic aneurysms involve expansion and
weakening of the aorta, a serious and life-threatening condition for which
intervention is generally indicated. Spec. ,r 2. Because of the risks and
1 Appellants identify the Real Party in Interest as TriVascular, Inc. Br. 3.
Appeal 2016-008595
Application 12/245,620
complexity of surgical repair of aortic aneurysms, endovascular repair has
become a widely-used alternative therapy. According to the Specification,
"[ m Jany of the existing endovascular devices and methods for treatment of
aneurysms ... use systems having relatively large transverse profiles ...
[and] have greater than desired lateral stiffness, which can complicate the
delivery process." Id. ,r 5. In addition, "the treating facility typically must
maintain a large and expensive inventory of stent grafts in order to
accommodate the varied sizes of patient vessels due to varied patient sizes
and vessel morphologies." Id. "Alternatively, intervention may be delayed
while awaiting custom size stent grafts to be manufactured and sent to the
treating facility." Id.
The Specification discloses a modular graft assembly "adaptable to a
wide range of patient anatomies ... that can be safely and reliably deployed
using a flexible low profile system." Id. In particular, the Specification
discloses a bifurcated main graft member formed from a supple graft
material with a main fluid flow lumen therein, with ipsilateral and
contralateral legs in communication with the main fluid flow lumen. Id. ,r 6.
A network of inflatable channels may be disposed anywhere on the main
graft member including the ipsilateral and contralateral legs. Id. The
network of inflatable channels is configured to accept a hardenable fill or
inflation material to provide structural rigidity to the main graft member
when the network of inflatable channels is in an inflated state. Id. An
inflatable cuff is disposed on a proximal portion of the main graft member
which is configured to seal against the inside surface of a patient's vessel. A
proximal anchor member, disposed and secured at the proximal end of the
main graft, comprises a self-expanding proximal stent portion secured to a
2
Appeal 2016-008595
Application 12/245,620
self-expanding distal stent portion with "struts having a cross sectional area
that is substantially the same as or greater than a cross sectional area of
proximal stent portions or distal stent portions adjacent the strut." Id.
Figure 1 of the Specification, reproduced below, is an elevation view
of an embodiment of a modular graft assembly.
FIG, 1
2
.14
L __ )
$7
Figure 1 of the Specification depicts an embodiment of a modular graft
assembly, showing bifurcated main graft member 12, ipsilateral and
contralateral graft extensions 14, 15, and proximal anchor member 32. Id.
,r,r 33, 34. Proximal anchor member 32 includes proximal self-expanding
stent 32A having a generally serpentine shape with four "crowns or apices"
at either end. The proximal crowns or apices of the proximal stent 32A are
coupled to alternating distal crowns or apices of distal self-expanding stent
32B. Id. ,r 34.
3
Appeal 2016-008595
Application 12/245,620
Figure IA of the Specification, reproduced below, is an elevation
view of the proximal anchor member and connector ring of the modular
graft assembly.
FIG. 1A
Figure IA is an elevation view of the proximal anchor member and
connector ring of the modular graft assembly. Proximal stent 32A is
coupled to distal stent 32B of proximal anchor member 32 with struts 71
disposed between adjacent crowns or apices of the two stents. Id. ,r 52. In
some embodiments, the cross sectional area of the material in the area of
struts 71 is greater than the cross sectional area of either proximal stent 32A
or distal stent 32B adjacent struts 71. Id. According to the Specification,
"[ s ]uch a configuration may be useful in avoiding stress and strain
concentrations at the junctions between the proximal and distal stents 32A
and 32B." Id.
4
Appeal 2016-008595
Application 12/245,620
STATEMENT OF THE CASE
Claims 1-14, 29, and 39-44 are on appeal. 2 Claims 1, 29, and 39 are
independent. Claims 1 and 39 are representative of the subject matter on
appeal and read as follows, with principal disputed limitations italicized:
1. A modular endovascular graft assembly, comprising:
a bifurcated main graft member formed from a supple
graft material including a main fluid flow lumen therein, an
ipsilateral leg with an ipsilateral fluid flow lumen in
communication with the main fluid flow lumen, a contralateral
leg with a contralateral fluid flow lumen in communication with
the main fluid flow lumen and a network of inflatable channels
disposed on the main graft member including the ipsilateral and
contralateral legs which is configured to accept a hardenable fill
material to provide structural rigidity to the main graft member
when the network of inflatable channels are in an inflated state
and which includes at least one inflatable cuff disposed on a
proximal portion of the main graft member configured to seal
against an inside surface of a patient's vessel;
a proximal anchor member which is formed from a single
piece of material, which is disposed at a proximal end of the
main graft member, which is secured to the main graft member
and which includes a self-expanding proximal stent portion, a
self-expanding distal stent portion, and struts that are disposed
between adjacent crowns of respective proximal stent portions
and distal stent portions, said struts including a cross sectional
area that is the same as or greater than a cross sectional area
of either proximal stent portions or distal stent portions
adjacent each strut and configured to avoid stress and strain
concentrations at junctions between the self-expanding distal
stent portion and the self-expanding proximal stent portion;
at least one ipsilateral graft extension including a fluid
flow lumen disposed therein with the fluid flow lumen of the
graft extension sealed to and in fluid communication with the
2 Claims 15-28, 30-38, and 45--47 have been canceled.
5
Appeal 2016-008595
Application 12/245,620
fluid flow lumen of the ipsilateral leg of the main graft member;
and
at least one contralateral graft extension including a fluid
flow lumen disposed therein with the fluid flow lumen of the
graft extension sealed to and in fluid communication with the
fluid flow lumen of the contralateral leg of the main graft
member.
3 9. A proximal anchor member for anchoring an
endovascular graft, comprising:
a monolithic structure formed from a single piece of
material;
a self-expanding proximal stent portion;
a self-expanding distal stent portion; and
one or more struts which are disposed between adjacent
crowns of respective proximal stent portions and distal stent
portions, said one or more struts including a cross sectional
area that is the same as or greater than a cross sectional area
of either proximal stent portions or distal stent portions
adjacent each strut and configured to avoid stress and strain
concentrations at junctions between the self-expanding distal
stent portion and the self-expanding proximal stent portion.
Claims 1-6, 11-14, 29, 39, and 42--44 stand rejected under pre-AIA
35 U.S.C. § I03(a) as unpatentable over Chobotov (U.S. Patent No.
6,395,019 B2, issued May 28, 2002) and Ouriel (U.S. Patent Application
Publication 2003/0120263 Al, published June 26, 2003); and
Claims 7-10, 40, and 41 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Chobotov, Ouriel, and Smith (U.S. Patent No. 6,929,709
B2, issued August 16, 2005).
THE PRIOR ART
Chobotov
Chobotov discloses a bifurcated endovascular graft with an inflatable
tubular frame structure configured to conform to the morphology of a
6
Appeal 2016-008595
Application 12/245,620
patient's vessel or vessels, e.g., the junction between the abdominal branch
of the aorta and the iliac arteries. Chobotov 2: 17-30, 5: 11-15. An
inflatable cuff is disposed on the proximal end of the frame which, when
inflated, supports and seals the graft against the interior of the vessel.
Elongated inflatable channels, configured to accept a hardenable fill
material, are disposed on the graft-including the bifurcated portions.
Chobotov 2: 17-30, 41-51. In addition, Chobotov discloses that expansion
members, which provide an anchoring function, are attached to the proximal
end of the frame structure of the graft, as well as the distal ends of the
bifurcated portions. Id. at 3:38-52, 4:36-46.
Figure 3, reproduced below in relevant part, is a longitudinal cross-
sectional view of the expansion member attached to the proximal end of
Chobotov's endovascular graft:
7
Appeal 2016-008595
Application 12/245,620
Figure 3 is a longitudinal cross-sectional view of expansion member 24
attached to proximal neck portion 23 of Chobotov's endovascular graft 10.
Expansion member 24 can be made from expandable rings 27 formed in a
zig-zag pattern connected by links 28. Id. at 7: 17-34. Links 28 "allow
articulation of the expansion member 24 to traverse curvature of a patient's
anatomy both during delivery and in situ." Id. at 7:34--37.
Ouriel
Ouriel discloses an endovascular prosthesis for "treating an aortic
aneurysm that extends close to or into branching arteries of the aorta."
Ouriel ,r 52. The prosthesis includes a trunk lumen and at least two branch
lumens extending from the trunk lumen. Id.
Figure 1, reproduced below in relevant part, is a perspective view of
the distal end of Ouriel' s endovascular prosthesis:
8
Appeal 2016-008595
Application 12/245,620
Figure 1 is a perspective view of the distal end of Ouriel's endovascular
prosthesis. Outflow limbs 14( a-d) interconnect the branches 64( a-d) with
the branch arteries of the aorta (i.e., the right and left internal iliac arteries
and the right and left external iliac arteries), and include inner graft layers,
outer graft layers, and expandable support members ( visible at the distal
ends of outflow limbs 14(a-d)). Ouriel ,r,r 101, 103.
DISCUSSION
"[R ]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007)
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). "[D]ependent
claims are nonobvious if the independent claims from which they depend are
nonobvious." In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992).
Obviousness of Claims 1-6, 11-14, 29, 39, and 42-44
over Chobotov and Ouriel
Claims 1-6, 11-14, 29, 39, and 42--44 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Chobotov and Ouriel.
The Examiner finds that Chobotov discloses a bifurcated endovascular
graft assembly ( endovascular graft 10), with ipsilateral and contralateral legs
(first and second bifurcated portions 82, 83); a network of inflatable
channels (inflatable frame structure 13) disposed on the main graft and legs,
and configured to be filled with a hardenable fluid; an inflatable cuff
(proximal inflatable cuff 16) disposed on the proximal portion of the main
graft member; and a self-expanding anchor member secured to the proximal
end of the main graft member ( expansion member 24 ). Ans. 2-3.
9
Appeal 2016-008595
Application 12/245,620
The Examiner acknowledges that Chobotov does not disclose graft
extensions in fluid communication with the ipsilateral and contralateral legs
of the graft assembly, but finds that Ouriel "teaches a stent graft with graft
extensions (14a-d) for the legs of the main graft ... for the purpose of
treating aneurysms." Ans. 3. The Examiner concludes that it would have
been obvious to modify Chobotov's graft "to have the extensions of Ouriel,
in order to effectively treat different sizes of aneurysms" (id. at 4).
In addition, the Examiner acknowledges that the proximal anchor
member of Chobotov's graft assembly is not formed from a single piece of
material, but concludes that it would have been obvious "to construct the
proximal anchor member from a single piece of material, since it has been
held that forming in one piece an article which has formerly been formed in
two pieces and put together involves only routine skill in the art." Id. at 3.
Finally, the Examiner acknowledges that Chobotov's anchor member does
not have struts with a cross-sectional area the same as or greater than the
cross-sectional area of the proximal or distal stent portions adjacent each
strut, but concludes that it would have been obvious "to modify the cross
section of the struts to be the same or greater [than] the proximal and distal
stent portions in order to fit in the endovascular region of the body." Id.
Appellants contend, in relevant part, that "Chobotov does not disclose
the claimed relative sectional areas of the struts and proximal and distal stent
portions and insufficient support to so modify the structure of Chobotov is
provided without the use of impermissible hindsight reconstruction of the
claimed limitations." Br. 8.
We agree with Appellants. As discussed above, the rejected claims
require a proximal anchor member, formed from a single piece of material,
10
Appeal 2016-008595
Application 12/245,620
which includes a self-expanding proximal stent portion, a self-expanding
distal stent portion, and struts disposed between adjacent crowns of
respective proximal stent portions and distal stent portions, where the struts
have a cross sectional area that is the same as or greater than a cross
sectional area of either proximal stent portions or distal stent portions
adjacent each strut. It is clear from the Specification and claims that the
"struts" are an integral part of the anchor member, and that the "cross
sectional area" of the struts refers to the relative cross sectional area of the
points of connection between the proximal and distal portions of the anchor
member (see, e.g., elements 71, as shown in Figure IA of the Specification),
rather than the cross sectional area of the entire anchor member. The zig-
zag rings of Chobotov's expansion member, on the other hand, are
connected by separate links of undisclosed cross sectional area (i.e.,
elements 28, as shown in Figure 3 of Chobotov), rather than integral
connections. The Examiner proposes modifying "the cross section of
[ Cho botov' s] struts to be the same or greater [than] the proximal and distal
stent portions in order to fit in the endovascular region of the body." The
Examiner has not explained how the cross sectional area of the struts ( as
opposed to the cross sectional area of the expansion member overall) would
have any impact on the ability of the anchor member to fit into a patient's
vasculature.
We agree with Appellants that the Examiner has not identified a
"logical connection between the cross section of the struts and the ability to
fit in the endovascular system" (Br. 7-8), and that the Examiner's rationale
"is unclear and insufficient for support of a prima faci[ e] case of
obviousness" (id. at 7). That is, the Examiner's rationale lacks a rational
11
Appeal 2016-008595
Application 12/245,620
underpinning to support the legal conclusion of obviousness. Accordingly,
we reverse the rejection of claims 1---6, 11-14, 29, 39, and 42--44, all of
which require that the struts include a cross sectional area that is the same as
or greater than a cross sectional area of either proximal stent portions or
distal stent portions adjacent each strut.
Obviousness of Claims 7-10, 40, and 41 over
Chobotov, Ouriel, and Smith
Claims 7-10, 40, and 41, which depend directly or indirectly from
independent claims 1 and 39, stand rejected as unpatentable over Chobotov,
Ouriel, and Smith.
As discussed above, the evidence of record does not support the
Examiner's conclusion that the subject matter of claims 1 and 39 would have
been obvious over the combined disclosures of Chobotov and Ouriel, and
merely adding Smith to the combination does not remedy the underlying
deficiencies in the Examiner's reasoning regarding the combination of
Chobotov and Ouriel. Accordingly, we reverse this rejection as well.
SUMMARY
The rejection of claims 1-6, 11-14, 29, 39, and 42--44 under
35 U.S.C. § 103(a) as unpatentable over Chobotov and Ouriel is reversed;
and the rejection of claims 7-10, 40, and 41 under 35 U.S.C. § 103(a) as
unpatentable over Chobotov, Ouriel, and Smith is reversed.
REVERSED
12