Ex Parte Huser et al

Patent Trial and Appeal Board

Sep 25, 2017

13208793 (P.T.A.B. Sep. 25, 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.
13/208,793 08/12/2011 Matthew S. Huser 12730-730 (PA-6834-RFB) 8739
48003 7590 09/25/2017
BGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
EASTWOOD, DAVID C
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
09/25/2017 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 MATTHEW S. HUSER and BLAYNE A. ROEDER1
__________________

Appeal 2015-006433
Application 13/208,793
Technology Center 3700
____________________

Before JAMES P. CALVE, JILL D. HILL, and ERIC C. JESCHKE,
Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Final Action
rejecting claims 1–5 and 7–12. Appeal Br. 5. Claims 6 and 13–21 are
withdrawn. Id. We have jurisdiction under 35 U.S.C. § 6(b). Appellants’
representative appeared for oral hearing on September 12, 2017.
We REVERSE.

1 Appellants identify the real party in interest as Cook Medical Technologies
LLC. Appeal Br. 3.
Appeal 2015-006433
Application 13/208,793

2
CLAIMED SUBJECT MATTER
Appellants disclose devices for delivering and deploying endoluminal
devices such as prostheses at or near an intersecting branch vessel, where the
devices are provided with fenestrations to overlap the branch vessels without
blocking flow to the vessels and guide wires to facilitate the delivery of the
catheters through a cannulated fenestration to a target vessel. See Spec. ¶¶ 2,
3, 5, 6.
Claim 1, the sole independent claim, is reproduced below.
1. A device for delivering and deploying an
endoluminal prosthesis, the device comprising:
a delivery catheter having at least one axial lumen; and
an endoluminal prosthesis disposed at a distal end portion
of the delivery catheter and comprising a tubular graft having a
first opening at a first end, a second opening at a second end,
and at least one fenestration in the graft between the first and
second ends; and
a wire comprising first and second ends, each disposed at
a proximal end portion of the delivery catheter, and a body
portion disposed between the first and second ends of the wire;
where the wire extends distally from the first wire end through
an axial lumen of the delivery catheter and the prosthesis, and
through the fenestration in the graft; and
where the wire extends proximally through a lumen of
the prosthesis and through an axial lumen of the delivery
catheter towards the second wire end.

REJECTION
Claims 1–5 and 7–12 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hartley (US 2007/0299499 A1, pub. Dec. 27, 2007) and
Muzslay (US 2011/0270385 A1, pub. Nov. 3, 2011).

Appeal 2015-006433
Application 13/208,793

3
ANALYSIS
The Examiner found that Hartley discloses a device with guide wires
36, 38 with ends and a body portion that extends distally through an axial
lumen of the catheter, the prosthesis, and a fenestration in the graft, but does
not disclose that wires 36, 38 are a single wire, as claimed. Final Act. 5–6.
The Examiner found that Muzslay teaches single tether 144 having first and
second ends 146, 148 that are used to restrain opposing openings of a graft.
Id. at 6. The Examiner determined it would have been obvious to modify
the wires of Hartley as a single wire like the single tether of Muzslay to help
stabilize the dilators during delivery, and as a simple substitution of one
known element for another for predictable results. Id. at 6–7; Ans. 6–8.
Appellants argue that the Examiner’s modification is clearly improper
hindsight lacking a rational underpinning as to why a skilled artisan would
modify Hartley. Appeal Br. 18–19. Appellants argue that Hartley does not
teach a single wire system and is not concerned with keeping branches of a
prosthesis from popping out, and Muzslay does not teach a single wire that
extends through a fenestration, a prosthesis, and a catheter as claimed, so it
makes no sense to substitute the single wire tether 144 of Muzslay for the
two-wire system of Hartley. Id. at 17; Reply Br. 3–4. We agree.
The Examiner’s determination that it would have been obvious to
make the two guide wires 36, 38 of Hartley into a single wire like the single
tether 144 of Muzslay as a simple substitution or to enhance the stability of
Hartley’s device is not supported by rational underpinnings. The Examiner
has not explained with sufficient evidence or technical reasoning why such a
modification would have enhanced stability, or why it would have been a
simple substitution of one element for another for predictable results.
Appeal 2015-006433
Application 13/208,793

4
The Examiner is correct that Hartley teaches that guide wires 36, 38
provide stability for access sheaths 28, 30 and dilators 32, 34, when these
latter elements are deployed through stent graft 16 and its fenestrations 22,
because indwelling guide wires 36, 38 support these elements as they move
into side vessels. Hartley ¶¶ 83–85, 89, Figs. 2, 2a; Ans. 6–7. However, the
Examiner has not explained sufficiently how making Hartley’s guide wires
36, 38 a single element like Muzslay’s tether 144 would have improved the
stability of Hartley’s device. In particular, Hartley teaches that each guide
wire 36, 38 exits stent graft 16 through a separate fenestration 22 aligned
with a separate side vessel. This configuration allows one access sheath 28
and dilator 32 to deploy over one guide wire 36 through one fenestration 22
into one side vessel while the other access sheath 30 and dilator 34 deploy
over another guide wire 38 through the other fenestration 22 into the other
side vessel. Hartley ¶ 89. Prior to deployment, the end of each guide wire
36, 38 is secured in nose cone dilator 8 until released to support deployment
of each access sheath and dilator into each side vessel. Id. at Figs. 2, 2A–
2C. The end of each guide wire 36, 38 must be withdrawn from nose cone
dilator 8 to access a side vessel. Id. ¶¶ 89–95, Fig. 2. Alternatively, the end
of each guide wire can be stabilized using retention system 53. Id. ¶ 101,
Fig. 2B. In both embodiments, however, the end of each guide wire 36, 38
is released when it is time to deploy access sheaths 28, 30 and dilators 32, 34
into side vessels. Id. ¶¶ 89, 104. Thus, even if Muzslay’s single wire tether
144 improved stability of Hartley’s guide wires 36, 38 before deployment,
Hartley teaches that the ends of each guide wire must be released to deploy
the access sheaths and dilators into side vessels. The proposed modification
undermines Hartley’s ability to accomplish this task. See Appeal Br. 17–19.
Appeal 2015-006433
Application 13/208,793

5
Appellants disclose how to manipulate a single wire having wire body
31C and wire ends 31A, 31B by having the operator pull or push wire ends
31A, 31B, alternately, to control the position of wire 31 with respect to each
fenestration 27, 27A. See Spec. ¶¶ 44, 46, Figs. 2, 3. However, any reliance
on this disclosure by the Examiner would be impermissible hindsight. The
Examiner has not explained sufficiently how any enhanced stability of guide
wires 36, 38 that may occur before deployment by using a single guide wire
based on the teachings of Muzslay would have motivated a skilled artisan to
make that modification when Hartley teaches that individual guide wires 36,
38 are used to stabilize each access sheath and dilator that is deployed into
each side vessel through a fenestration. The stabilizing effect of fixing the
end of each guide wire 36, 38 in nose cone dilator 8 and retention system 53
appears to provide adequate stability for the guide wires prior to deployment
of the access sheaths and dilators. See Hartley ¶¶ 89–95, 101–105.
We find no teaching or suggestion to support the Examiner’s proposed
modification in Muzslay, which uses tether 144 to secure separate pop up
branch structures 124, 126 and their fenestrations 128, 130 before they are
positioned at branch vessels 120, 122. Muzslay ¶¶ 35–39, Fig. 2. Muzslay
teaches that a single wire 144 can anchor or tether pop up branches 124, 126
while guide wires 250, 252 and catheters 254, 256 are deployed in branch
vessels as shown in Figure 2. Id. ¶¶ 43–46. Thus, both Hartley and Muzslay
use separate guide wires in branch vessels (i.e., a single guide wire in each
branch vessel). Each individual guide wire acts as a stabilizer for a catheter
that is positioned in each branch vessel. In Hartley, each guide wire 36, 38
can act as a stabilizer for an additional guide wire that is advanced into each
side vessel. Hartley ¶ 89.
Appeal 2015-006433
Application 13/208,793

6
We find no teaching or suggestion in either reference to use a single
guide wire to stabilize or guide catheters, sheaths or other elements used to
access side or branch vessels. Although Muzslay uses a single wire 144 to
anchor two pop up branches 124, 126, Muzslay, like Hartley, teaches the use
of separate guide wires to guide or stabilize elements inserted into each
branch or side vessel through each fenestration of the graft. As a result, we
are not persuaded that the proposed modification would have been a simple
substitution of one known element for another with predictable results as the
Examiner determined. Ans. 6–8. The Examiner based this determination on
a finding that “the two wires of Hartley are used for the same purpose as the
single wire of Muzslay” so a substitution would have been obvious. Id. at
7–8. We agree with Appellants that Hartley’s separate guide wires have a
different function and purpose than Muzslay’s single tether; thus, a skilled
artisan would not have been motivated to substitute such a single tether of
Muzslay for the dual guide wires of Hartley as a simple substitution for
predictable results or as a way of improving the stability of Hartley’s device.
Reply Br. 3–5; Appeal Br. 17–19. Thus, we do not sustain the rejection of
claims 1–5 and 7–12.
DECISION
We reverse the rejection of claims 1–5 and 7–12.

REVERSED