Ex Parte Makower et al

Patent Trial and Appeal Board

Jan 10, 2019

13578555 (P.T.A.B. Jan. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/578,555 10/15/2012
142169 7590 01/14/2019
Apertomed LLC
2570 W. El Camino Real
Suite 310
Mountain View, CA 94040
FIRST NAMED INVENTOR
Joshua Makower
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.
NCEPT.002A 1056
EXAMINER
IGBOKO, CHIMA U
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
01/14/2019 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):
jhanley@exploramed.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSHUA MAKOWER,
EARL A. BRIGHT II, THEODORE M. BENDER,
JOSEPH CANTANESE III, JOHNY. CHANG,
THOMAS KING, CLINTON SLONE,
THEODORE C. LAMSON, and AZIZ IMRAAN 1
Appeal2018-000568
Application 13/578,555
Technology Center 3700
Before JAMES P. CAL VE, MICHELLE R. OSINSKI, and
BRENT M. DOUGAL, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Office Action
rejecting claims 1, 2, 4, and 63---68. Appeal Br. 3. Claims 3 and 5---62 are
cancelled. Id. at 10 (Claims App.). We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 Apertomed, Inc. is identified as the real party in interest. Appeal Br. 2.
Appeal2018-000568
Application 13/578,555
CLAIMED SUBJECT MATTER
The claimed method is "for treating venous obstruction or venous
insufficiency" which also provides treatment for neurological disorders that
are associated with such venous obstructions and insufficiencies including
multiple sclerosis. Spec. ,r 2.
Claim 1, the sole independent claim, is reproduced below.
1. A method for treating chronic cerebrospinal venous
insufficiency in a human or mammalian subject, said method
comprising the steps of relieving a stenosis at a site in a vein
which drains blood from the brain in a subject exhibiting chronic
cerebrospinal venous insufficiency, and placing an endovascular
device in or near the stenotic body lumen, wherein the device
includes a valve.
Appeal Br. 10 (Claims App.).
REJECTIONS
Claim 1 is rejected under 35 U.S.C. § I02(b) as being anticipated by
Paul, Jr. (US 2009/0264991 Al, pub. Oct. 22, 2009) ("Paul") or, in the
alternative, under 35 U.S.C. § I03(a) as being unpatentable over Paul and
Zamboni (A prospective open-label study of endovascular treatment of
chronic cerebrospinal venous insufficiency, Journal of Vascular Surgery,
Vol. 50, No. 6, 1348-1358, Dec. 2009).
Claims 2, 4, and 63----67 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Paul and Zamboni.
Claim 68 is rejected under 35 U.S.C. § I03(a) as being unpatentable
over Paul, Zamboni, and Case (US 2007/0100432 Al, pub. May 3, 2007).
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Appeal2018-000568
Application 13/578,555
ANALYSIS
Claim 1 Anticipated By Paul, or
Unpatentable over Paul and Zamboni
The Examiner correctly finds that Paul teaches a method for treating
chronic cerebrospinal insufficiency in humans by placing an endovascular
device (valved stent) in or near the stenotic body lumen. Non-Final Act. 3.
The Examiner also correctly finds that Paul teaches to place a valved device
at stenotic body lumen throughout the human body including human jugular
veins and placement in the jugular vein would treat chronic cerebrospinal
venous insufficiency by allowing blood to drain from the brain. Id. at 3--4.
The Examiner correctly finds that Zamboni teaches steps of relieving
stenosis at a site in a vein to allow blood to drain from the brain in a subject
exhibiting chronic cerebrospinal venous insufficiency (CCVI). Id. at 3.
The Examiner correctly reasons that it would have been obvious to
combine these teachings to first relieve stenosis at a site in a vein that drains
blood from the brain of a patient with CCVI, as taught by Zamboni, before
placing a valved endovascular device at the remediated site, as taught by
Paul, for the predictable result of relieving CCVI thereby. Id. at 3--4.
Appellant acknowledges that Paul teaches to place an endovascular
device in a jugular vein. Appeal Br. 7. Paul teaches the use of devices to
"maintain the patency of the vessel." Paul ,r,r 3, 7, 8. Indeed, Paul describes
such devices as being rigid enough and having sufficient radial strength to
maintain vein patency and prevent collapse or fracture. Id. ,r,r 7-9, 30, 33.
A skilled artisan would understand from these teachings that Paul's
implantable, valved endovascular devices are placed in or near a stenosis to
treat venous insufficiency by providing and maintaining venous patency.
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Appeal2018-000568
Application 13/578,555
Appellant defines "stenosis" as
any full or partial blockage or restriction of flow through a body
lumen, including but not limited to full or partial blockages or
restrictions of flow caused by narrowing of the body lumen, such
as being twisted or having sharp reductions in diameter due to
malformation, or by the presence of obstructive matter within the
body lumen.
Spec. ,r 15. Because Paul uses implantable, valved devices to treat venous
valve insufficiency, Paul also uses the devices to maintain vein patency and
prevent "restenosis." Paul ,r,r 7, 70. An ordinary meaning of "patency" is
"[t]he state or quality of being open, expanded, or unblocked." Definition of
patency by The American Heritage® Medical Dictionary at https://medical-
dictionary.thefreedictionary.com/patency (viewed Jan. 4, 2019).
Appellant also acknowledges that Zamboni teaches to restore outflow
venous patency from the brain as a way to treat multiple sclerosis. Appeal
Br. 7. Nonetheless, Appellant contends that a skilled artisan would not have
been motivated to implant Paul's valve in the outflow tract of the brain to
treat CCVI because such valves used to treat venous insufficiency generally
would not be understood to play a beneficial role in more complex downhill
venous flow from the brain. Id. at 7-8. These arguments are not persuasive.
First, as discussed above, Paul teaches to implant valved devices in or
near stenotic sites to maintain venous patency, and the sites include jugular
veins, which drain blood from the brain. See Paul ,r 74.
Second, Zamboni teaches not only the use of transluminal angioplasty
to relieve stenosis in jugular veins and azygous veins to treat patients with
symptoms of multiple sclerosis, but Zamboni also teaches and suggests the
use of stents to maintain venous patency. Zamboni, 1348-50, 1353, Fig. 3B.
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Appeal2018-000568
Application 13/578,555
Zamboni uses a metallic, self-expanding stent to treat venous twisting
that cannot be resolved by percutaneous transluminal angioplasty (PTA). Id.
at 1353, 1356. Zamboni also teaches that restenosis occurs in patients after
PT A of the jugular veins has been undertaken and suggests stent insertion as
the "logical alternative" to treat this venous stenosis/restenosis. Id. at 1356.
Although Zamboni notes an apparent lack of devices on the market
for this purpose, Paul provides the relevant teaching of valved, implantable
stents used to maintain venous valve patency and prevent restenosis in veins
to include the jugular vein. Id.; Paul ,r,r 3-10, 74. Paul also teaches the use
of such devices to treat venous insufficiency diseases that impact a person's
ability to work and live a normal lifestyle. Paul ,r 5. Paul's devices include
self-expanding and balloon-expandable support frames. Id. ,r,r 64---67. Thus,
similar to Zamboni' s use of PT A to relieve steno sis, Paul uses balloons to
implant and expand stents to relieve stenosis and maintain patency.
These express teachings of Paul and Zamboni provide the rational
underpinnings and expectation of success for the Examiner's obviousness
determination. Further, contrary to Appellants' assertions of teaching away
(Appeal Br. 6), Zamboni teaches to relieve stenosis via PTA and use stents
to maintain patency and prevent restenosis. Though Zamboni notes an
apparent lack of devices on the market, he also states that their use would be
a "logical alternative." Zamboni, 1356. Paul teaches to use implantable,
valved devices for CCVI to maintain venous patency and prevent restenosis.
Indeed, Appellant acknowledges prior art teachings that stenting is the safest
way to avoid restenosis following angioplasty to treat CCVI. See Spec. ,r 10.
Thus, there is a reasonable expectation of success. Intelligent Bio-Systems,
Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016).
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Appeal2018-000568
Application 13/578,555
Appellant discloses the field of their invention as methods, systems,
and devices for treating venous obstruction or venous insufficiency and for
the treatment of disorders associated therewith. Spec. ,r 2. Paul is directed
to treating venous valve insufficiency and venous insufficiency generally to
include maintaining venous patency and preventing restenosis. Paul ,r,r 3-9.
Similarly, Zamboni treats stenosis of the principal cerebrospinal pathways
by eliminating venous strictures of the jugular and azygous veins to improve
venous drainage. Zamboni, 1348; Appeal Br. 8 (arguing that the teachings
of Paul and Zamboni are not in the same field of endeavor). The teachings
of Paul and Zamboni also are reasonably pertinent to the problem Appellant
confronted of treating venous insufficiency and stenosis. Accordingly, we
sustain the rejection of claim 1 as unpatentable over Paul and Zamboni. 2
Claims 2, 4, and 63-68
Unpatentable over Paul and Zamboni and Case
Appellants argue the patentability of claims 2, 4, and 63---68 because
they depend from claim 1. Appeal Br. 1. Because we sustain the rejection
of claim 1, this argument is not persuasive, and we also sustain the rejections
of these claims.
DECISION
We affirm the rejections of claims 1, 2, 4, and 63-68 under 35 U.S.C.
§ 103(a).
2 In view of our determination, we do not address the Examiner's alternative
determination that Paul anticipates claim 1.
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Appeal2018-000568
Application 13/578,555
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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