Ex Parte Morsi

Patent Trial and Appeal Board

Mar 12, 2018

13154265 (P.T.A.B. Mar. 12, 2018)

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.
13/154,265 06/06/2011 Hesham Morsi MORS.P0002US 1665
26271 7590 03/14/2018
NORTON ROSE FULBRIGHT US LLP
1301 MCKINNEY
SUITE 5100
HOUSTON, TX 77010-3095
EXAMINER
LYNCH, ROBERT A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/14/2018 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):
hoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HESHAM MORSI1
Appeal 2017-004989
Application 13/154,265
Technology Center 3700
Before ERIC B. GRIMES, RYAN H. FLAX, and DAVID COTTA,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for healing an aneurysm, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states that some “known techniques used in treating
aneurysms are performed endovascularly,” such as depositing an embolic
material (e.g., detachable coils or liquid polymer) into the sac of the
1 Appellant identifies the Real Party in Interest as Hesham Morsi. (Appeal
Br. 4.)
Appeal 2017-004989
Application 13/154,265
aneurysm. Spec. ^ 5. The Specification states that such techniques have
disadvantages, including migration of the embolic material out of the sac of
the aneurysm, which could occlude a blood vessel. Id. 5-6.
The Specification discloses “an endovascular device for treating a
defect in the vascular wall such as aneurysm by deploying a self expandable
barrier around the aneurysm neck to block the blood flow to the aneurysm.”
Id. 10. Figure 3 is reproduced below:
Figure 3 shows a side view of an embodiment of the disclosed device
in a collapsed state. Id. ^[ 30. The device comprises
distal self-expanding disc 302 [which] includes a lattice and
proximal self-expanding disc 304 [which] includes only
reinforcing wire 310 and frame 308. The frame 308 of the
proximal self-expanding disc 304 slightly presses against frame
308 of distal self-expanding disc 302 to anchor clip 300 to the
neck of an aneurysm.
Id. H 58.
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Application 13/154,265
Claims 20-30, 39, and 62 are on appeal.2 Claim 20 is the only
independent claim and reads as follows:
20. An aneurysm occlusion and healing device comprising:
(a) a distal member in an original configuration, comprised of a
frame-less two-dimensional mesh of intersecting and interposed
wires configured to be placed inside an aneurysm and extend
across an aneurysm junction with the blood vessel to form a
barrier to blood flow into the aneurysm;
(b) the mesh of the distal member is configured to adhere to
inner lining of the aneurysm junction with the blood vessel,
where intersected and interposed wires of the distal member
form a scaffold to allow endothelium to grow on a surface of
the distal member for sealing and healing of the aneurysm;
(c) a mesh-less proximal member, comprised of one or more
support wires radially configured to be placed outside the
aneurysm extending across an aneurysm neck and vessel wall
and to press against the opposing surface of the distal member
and adjacent vessel walls to maintain the tight adherence of the
distal member against the neck of the aneurysm;
(d) where each of the distal and proximal members have an
original configuration and a deformed configuration;
(e) wherein said deformed configurations are configured to
change to said original configurations by an activating
mechanism; and
(f) wherein a portion of each of said distal and proximal
members are attached to a joint component.
2 The Claims Appendix of the Appeal Brief also includes claim 41 but that
claim was cancelled in an amendment filed Dec. 18, 2015.
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Application 13/154,265
The claims stand rejected as follows:
Claims 20, 28, 29, 39, and 62 under 35 U.S.C. § 103(a) as obvious
based on Yang3 and Koike4 (Final Action5 3);
Claims 21 and 22 under 35 U.S.C. § 103(a) as obvious based on
Yang, Koike, and Wallace6 (Final Action 7);
Claims 23-27 under 35 U.S.C. § 103(a) as obvious based on Yang,
Koike, and Lenker7 (Final Action 8); and
Claim 30 under 35 U.S.C. § 103(a) as obvious based on Yang, Koike,
and Eskuri8 (Final Action 9).
DISCUSSION
The Examiner has rejected all of the claims on appeal as obvious
based on Yang and Koike, by themselves or further combined with one of
Wallace, Lenker, or Eskuri. The same issue is dispositive for all of the
rejections.
The Examiner finds that Yang discloses a vascular closure device that
includes a distal member and a proximal member that are capable of being
placed inside and outside of an aneurysm, as well as a joint component. The
Examiner concludes that Yang’s device meets all of the structural limitations
of claim 20 “except for the proximal member being mesh-less and
comprising one or more radial support wires.” Ans. 4-6. The Examiner
3 Yang et al., US 2003/0055455 Al, published Mar. 20, 2003.
4 Koike et al., US 6,342,064 Bl, issued Jan. 29, 2002.
5 Office Action mailed Jan. 21, 2016.
6 Wallace et al., US 2007/0106311 Al, published May 10, 2007.
7 Lenker, US 6,878,161 B2, issued Apr. 12, 2005.
8 Eskuri et al., US 2007/0179527 Al, published, Aug. 2, 2007.
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Application 13/154,265
finds that Koike discloses “a closure device (C) comprising a proximal
member (2) being mesh-less (as shown in Figs. 1-8) and comprising one or
more radial support wires (radial support arms 22 of fixing member 2).” Id.
at 6. The Examiner concludes that it would have been obvious
to modify the device of Yang to have the proximal member
being mesh-less and comprising one or more radial support
wires in order to provide an equivalent closure device
configuration to clamshell closure devices that provides a
transcatheter closure device that is beneficially simple in shape,
easy to operate, capable of closing a small hole safely and
infallibly, easy to withdraw and less likely to cause adhesion of
a thrombus, as taught by Koike.
Id. at 6-7.
Appellant argues, among other things, that “[t]he patch system of
Yang requires a first catheter and a second catheter. The first and second
catheters are steered to opposite sides of a septal defect.” Appeal Br. 5.
Appellant argues that Yang’s “patch system may only be used for defects
that are approachable from opposite sides, such as congenital heart defects.
Yang does not teach or suggest that the dual-catheter patch system may be
employed for treatment of aneurysms. . . . [A]n aneurysm contains a single
opening.” Id. at 6. Appellant argues that “[t]he Examiner’s proposed
modification of making the device of Yang a clamshell device modifies the
dual-component, dual-path approach principles of the device . . . [and]
would change the principle of operation of the prior art invention.” Id. at 7.
We agree with Appellant that the Examiner has not persuasively
shown that it would have been obvious to modify Yang’s system based on
Koike’s disclosure. Yang discloses devices for placing a patch across a
septal defect, which is an abnormal opening in “a thin wall of tissue that
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Application 13/154,265
divides two or more areas within the body, for example heart chambers.”
Yang ^ 2, 6.
The patch system includes two catheters and a bridge member that can
extend between them. Id. ^[6. “The first catheter and the second catheter
may be steered to opposite sides of a septal defect. . . [and] the bridge
member may be extended so as to pass from a first lumen of the first
catheter, through the septal defect, and into a second lumen of the second
catheter.” Id. 7. Patches can then be urged from each of the two catheters,
along the bridge member, to the septal defect, and connected. Id. ^[8.
Yang’s Figures 5 and 6 are reproduced below:
Fis- 5 Fig. 6
Figure 5 shows “two catheters connected by a bridge member and
having two patches sealing a septal defect.” Id. 15. Figure 6 shows “two
catheters withdrawing from a repaired septal defect.” Id. 16. Yang’s
system therefore relies on two catheters approaching a septal defect from
opposite sides and together applying a patch on each side of the defect in
order to repair it.
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Koike discloses “a closure device and a catheter assembly suitable for
transcatheter operations, i.e., operations for closing or repairing endocardiac
or vascular defects.” Koike 1:6-9. Koike’s device comprises
a closure membrane with a fixing means of fixing the closure
membrane to a tissue wall surrounding a defect aperture, said
fixing means exhibiting a shape memory behavior and
recovering its memorized shape when heated to the body
temperature to sandwich the tissue wall from both sides of the
defect aperture between the fixing means and the closure
membrane.
Id. at 2:47-53. Koike’s Figure 1 is reproduced below:
Figure 1 shows Koike’s closure device, which “comprises an easily
foldable closure member 1, a fixing member 2 for fixing the closure member
1 to a tissue surrounding a defect aperture, and a connecting member 3.” Id.
at 4:27-30. The fixing member 2 “is a member to be located on one side of
the tissue surrounding the defect aperture [] to sandwich the tissue between
the fixing member 2 and the closure member 1 located on the opposite side
of the tissue surrounding the defect aperture.” Id. at 5:16-21.
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In operation, the closure device is compressed into a catheter, which is
then inserted through the defect aperture; then fixing member 2 is pushed
out of the catheter, and assumes the shape shown in Figure 1. Id. at 6:64 to
7:8. The catheter is then withdrawn to the opposite side of the defect, where
the rest of the device (including closure member 1) is pushed out of the
catheter and assumes its expanded shape. Id. at 7:10-15. Closure member 1
and fixing member 2 are then pulled towards each other by connecting
member 3, closing the defect aperture. Id. at 7:21-27.
Thus, Koike’s device, like Yang’s system, is intended to insert a patch
in order to repair a defect in a tissue wall (septum). Yang’s system relies on
two patches applied from opposite sides of the defect and attached to each
other, while Koike’s device is applied from one side of the defect and
includes a single membranous member, together with a hinge-and-struts
arrangement to clamp the membrane against the defect to be repaired.
The Examiner provides the following annotated versions of Yang’s
Figures 5 and 6 to illustrate the device resulting from the proposed
combination of Yang and Koike:
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The annotated figures show Yang’s Figures 5 and 6 with one of the
patches replaced by a “second member comprising radial fixing members.”
Ans. 3. The Examiner reasons that “[a]s shown, the modified device of
Yang remains fully capable of use in its preferred manner of delivery and
usage thereby maintaining its original principle of invention.” Id.
With regard to claim 20’s requirements that the distal member be
“configured to be placed inside an aneurysm and extend across an aneurysm
junction with the blood vessel,” and that the proximal member be
“configured to be placed outside the aneurysm extending across an
aneurysm neck and vessel wall,” the Examiner reasons that “the statement of
intended use and other functional statements ... do not impose any
structural limitations on the claims distinguishable over the device of Yang
in view of Koike which is capable of being used as claimed if one so desires
to do so.” Id.
We disagree. Yang’s system, even if modified by Koike as proposed
by the Examiner, relies on two catheters approaching a septal defect from
opposite sides in order to apply separate components to each side, which are
then attached to each other. See Ans. 3 (annotated drawings). As Appellant
has pointed out, this system cannot be used to close off an aneurysm from a
blood vessel, because an aneurysm only has one opening, and therefore does
not allow a catheter to approach the aneurysm opening from inside the
aneurysm. The system proposed by the Examiner therefore does not include
a distal member configured to be placed inside an aneurysm, as required by
claim 12.
Although Koike discloses a device that is also intended for closing a
hole in tissue, we agree with Appellant that modifying Yang’s system to
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include a device like that in Koike would change the principle of operation
of Yang’s system from one in which separate patches are applied from either
side of a defect, and then attached to each other, to one in which a single
patch is applied from one side of the defect and held in place by a clamshell­
like closing mechanism. The Examiner has not persuasively shown that,
without the benefit of hindsight, such a modification would have been
considered obvious to a person of ordinary skill in the art.
The Examiner has not cited any disclosure in Wallace, Lenker, or
Eskuri that makes up for the deficiency discussed above. We therefore
reverse all of the rejections on appeal.
REVERSED
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