Ex Parte Brett et al

Patent Trial and Appeal Board

Dec 21, 2018

12637948 (P.T.A.B. Dec. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/637,948 12/15/2009
24280 7590 12/26/2018
CHOATE, HALL & STEWARTLLP
TWO INTERNATIONAL PLACE
BOSTON, MA 02110
FIRST NAMED INVENTOR
Gerard Brett
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.
2009263-0003 4243
EXAMINER
DANG, PHONG SON H
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/26/2018 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):
patentdocket@choate.com
jnease@choate.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GERARD BRETT, DAVID RONAN, LIAM MULLOY,
and STEVEN HORAN
Appeal 2018-002644
Application 12/637,948 1
Technology Center 3700
Before LINDA E. HORNER, MICHELLE R. OSINSKI, and
BRENT M. DOUGAL, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner's rejections of claims 148-152, which are all of the pending
claims. Final Office Action (March 20, 2017) ("Final Act."). We have
jurisdiction under 35 U.S.C. § 6(b ).
1 Appellants identify Vivasure Medical Limited as the real party in interest.
Appeal Brief (September 18, 2017) ("Appeal Br."), at 2.
Appeal2018-002644
Application 12/637,948
The Examiner rejected all of the claims as unpatentable under
35 U.S.C. § 103. Appellants contest the Examiner's proposed combination
of the prior art. For the reasons explained below, the Examiner did not err in
the determination of obviousness. Thus, we AFFIRM.
CLAIMED SUBJECT MATTER
Claim 148 is the sole independent claim on appeal and is reproduced
below.
148. An interventional medical closure device for
closing a single opening through a wall of an individual blood
vessel comprising a lumen, the device comprising:
a foot, sized for deployment inside a blood vessel, for
engaging, upon deployment, an internal surface of the wall of the
blood vessel, wherein the foot is sized for deployment inside a
blood vessel;
a plug for engaging, upon deployment, an external surface
of the wall of the vessel;
a biodegradable anchor for engaging, upon deployment,
the plug, wherein the anchor, upon deployment, is implanted in
the tissue and has at least one dimension that exceeds at least one
dimension of the plug; and
a delivery element comprising an elongated shaft, through
which the foot, the plug and the anchor are introduced to the
blood vessel,
wherein, upon engagement, the foot exerts a compressive
force on the internal surface of the lumen, and the plug and the
anchor exert a compressive force on the external surface of the
lumen, so that the compression of the blood vessel wall on both
sides of the single opening assists in closure of the single
openmg.
Appeal Br. 10 (Claims Appendix).
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Appeal2018-002644
Application 12/637,948
REJECTION
In the Final Office Action, the Examiner rejects claims 148-152 under
35 U.S.C. § I03(a) as unpatentable over Egnelov (US 2006/0142797 Al,
published June 29, 2006) and Kensey (US 5,531,759, issued July 2, 1996).
Final Act. 2.
ANALYSIS
The Examiner found that Egnelov discloses an interventional medical
closure device substantially as recited in independent claim 148, including a
sealing device comprised of a foot, a plug, and a biodegradable anchor.
Final Act. 2-4 (including annotated Figure 2 of Egnelov). The Examiner
found that Egnelov is "silent on the delivery device[2J for introducing the
sealing device into the tissue." Id. at 5. The Examiner found that Kensey
discloses a system for closing a puncture comprising a delivery device with
an elongated shaft for delivering a sealing device, comprising a foot, a plug,
and an anchor, into the tissue. Id. at 4-5. The Examiner determined that it
would have been obvious "to employ the delivery device as taught by
Kensey into Egnelov in order to deliver the sealing device to the punctured
tissues needed to be closed." Id. at 5.
2 Egnelov discusses a prior art sealing device disclosed in U.S. Patent
No. 6,508,828 (issued January 21, 2003) to Akerfeldt for sealing a puncture
hole in a vessel wall, where the sealing device includes an inner sealing
member, and outer sealing member, and a retaining member. Egnelov ,r 3.
Egnelov incorporates the entire contents of Akerfeldt, including the
description of the various techniques, procedures, and devices therein, into
Egnelov's disclosure. Id. ,r 4. Akerfeldt discloses a delivery device
(introducer 24) having an elongated shaft and pusher 22 used to deliver the
sealing device to the wound site in the vessel wall. Akerfeldt, Figs. 8-14
and accompany description in col. 6, 1. 9-col. 7, 1. 3.
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Appeal2018-002644
Application 12/637,948
Appellants argue that the Examiner erred in the rejection of claim 148
because the proposed modification to Egnelov to use the delivery device of
Kensey would render Egnelov unsatisfactory for its intended purpose of
sealing a puncture hole in a vessel wall. Appeal Br. 5-6 ( arguing that
Kensey' s delivery device, which is intended for sealing a percutaneous
puncture, "is significantly larger than the device of Egnelov"). Appellants'
argument is based on bodily incorporation of Kensey's delivery device with
the sealing device of Egnelov and does not "take account of the inferences
and creative steps that a person of ordinary skill in the art would employ."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). See also In re
Keller, 642 F.2d 413,425 (CCPA 1981) (holding that the test for
obviousness does not require that features of a secondary reference may be
"bodily incorporated" into the structure of the primary reference or that the
claimed invention must be "expressly suggested" in the references). In other
words, the Examiner does not need to base a determination of obviousness
on precise teachings in Kensey of a delivery device sized for use to seal a
puncture wound in a blood vessel. See KSR, 550 U.S. at 418 ("the analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim").
We find no error in the Examiner's determination that a person having
ordinary skill in the art would understand that basic modifications, such as
change in size, may need to be considered when configuring the delivery
device of Kensey to be used with Egnelov's sealing device. Examiner's
Answer (November 22, 2017) ("Ans."), at 3. For instance, although Kensey
is focused on a device and technique to assist in the prevention of post-
laparoscopic puncture herniation, Kensey looks to related prior art that
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Appeal2018-002644
Application 12/637,948
addresses closure devices and methods for use for sealing a puncture in
blood vessels for suggestions as to devices that could be used to effect
sealing of a percutaneous puncture formed during a laparoscopic procedure
of the abdomen or an endoscopic procedure of the thoracic cavity. Kensey,
col. 2, 1. 49 - col. 4, 1. 62. This disclosure in Kensey is evidence that it was
within the skill level of one having ordinary skill in the art at the time of
Appellants' invention to adapt a closure system for sealing a smaller
puncture in a blood vessel to be used in a closure system for sealing a larger
puncture of a laparoscopic procedure. Thus, the Examiner's determination
that it would have been within the skill level of a person having ordinary
skill in the art to adapt the size of Kensey's delivery device to be used with
Egnelov's sealing device is reasonable.
Appellants further argue that the Examiner erred in the rejection of
claim 148 because the proposed modification to Egnelov to use the delivery
device of Kensey would change the principle of operation of Egnelov
because "the delivery mechanism of Kensey cannot be applied to the device
ofEgnelov." Appeal Br. 6-7. Specifically, Appellants argue that Kensey's
delivery device, which employs a tamper to push the compressed sealing
device out from the delivery device, "would likely render [Egnelov's]
sealing device inoperable." Id. at 7.
Appellants' argument has several problems. First, Appellants'
assertion that Kensey's tamper would render Egnelov's sealing device
inoperable is not supported by evidence. See In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) ("Attorney's argument in a brief cannot take the place of
evidence."). Second, Egnelov incorporates by reference Akerfeldt, which
uses a pusher, similar to Kensey's tamper, to push its sealing device out of
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Application 12/637,948
the elongated shaft of an introducer. Egnelov ,r,r 3, 4; Akerfeldt, Figs. 8-14,
col. 6, 1. 9-col. 7, 1. 3. The fact that Akerfeldt pushes a sealing device that is
similar to Egnelov's sealing device out of the elongated shaft of an
introducer belies Appellants' argument that use of a tamper would render
Egnelov's sealing device inoperable. Third, Appellants' argument is based
partly on the fact that Kensey' s tamper is used to "aid deformation of the
sealing member." Appeal Br. 7. This aspect of Appellants' argument again
is based on an improper requirement of bodily incorporation of Kensey' s
delivery device with the sealing device ofEgnelov. As discussed above, a
person having ordinary skill in the art would understand how to make any
necessary modifications to Kensey's delivery device to render it suitable for
use to deliver Egnelov's sealing device.
For these reasons, we do not discern error in the Examiner's rejection
of claim 148 as unpatentable over the combined teachings of Egnelov and
Kensey. Appellants do not present any additional arguments for the separate
patentability of dependent claims 149-152. Thus, these claims fall with
claim 148. See 37 C.F.R. § 4I.37(c)(l)(iv).
DECISION
The decision of the Examiner rejecting claims 14 8-15 2 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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