Ex Parte Barker

Patent Trial and Appeal Board

Mar 9, 2016

13021162 (P.T.A.B. Mar. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/021, 162 02/04/2011 Stephen Edward George Barker
23557 7590 03/11/2016
SALIW ANCHIK, LLOYD & EISENSCHENK
A PROFESSIONAL ASSOCIATION
PO Box 142950
GAINESVILLE, FL 32614
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.
GJE.7630Dl 3945
EXAMINER
MATHEW, SEEMA
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
03/11/2016 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):
euspto@slepatents.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN EDWARD GEORGE BARKER
Appeal2014-000805
Application 13/021, 162
Technology Center 3700
Before LYNNE H. BROWNE, THOMAS F. SMEGAL, and
MARK A. GEIER, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stephen Edward George Barker (Appellant) appeals under 35 U.S.C.
§ 134 from the Examiner's decision rejecting claims 1-13. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. An arteriovenous bypass grafting procedure, which comprises
fitting an elongate device around an external surface of a vessel
Appeal2014-000805
Application 13/021, 162
to be grafted, wherein the device is arcuate in cross-section and
self-supporting, and wherein the device comprises inner and
outer layers that are maintained in contact by their natural
elasticity or by bonding, wherein the outer layer is more rigid
than the inner layer such that it provides a structural framework
for the device, wherein the inner layer stimulates
neovascularisation and degrades faster than the outer layer, and
wherein the device is fitted around the external surface of the
vessel such that there is a space between the device and the
vessel.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Kowligi
Dubrow
Martin
US 5,152,782 Oct. 6, 1992
US 2005/0038498 Al Feb. 17, 2005
WO 98/20027 May 14, 1998
REJECTIONS
I. Claims 1-6, 8, 9, and 11-13 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Martin and Dubrow.
II. Claims 7 and 10 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Martin, Dubrow, and Kowligi.
DISCUSSION
Rejection I
The Examiner finds that Martin teaches all of the limitations of claim
1 except that "Martin et al. does not expressly disclose the outer layer is
more rigid than the inner layer." See Final Act. 2--4. We note that the
rejection does not address the limitation requiring "a space between the
2
Appeal2014-000805
Application 13/021, 162
device and the vessel." See id. In the Advisory Action, the Examiner finds
that "Martin et al. teaches the inner layer is wetted with a pharmaceutical
formulation containing the agents to be delivered (see page 25, lines 13-19),
therefore teaching that there is a space between the inner layer and the blood
vessel." Ad. Act. 2.
Appellant argues that in Martin
The inner layer is impregnated with the pharmaceutical
formulation having the active agent and, therefore, must be in
contact with the adventitial surface of the vessel along the
device's entire length. That is, the Martin embodiment discussed
at page 25, lines 10-25, has no space between the device and the
vessel, as required by the claimed invention.
Appeal Br. 4. Martin states
In the embodiments described above, the sealed reservoirs are
shown as taking the form of a radial space or clearance between
the adventitial surface of the blood-carrying vessel and the
interior of at least the first body portion, which space is at least
part-filled in use by a pharmaceutical formulation. Such a space
is not, however, essential. For example, in an alternative
embodiment, the body may have a generally impermeable
flexible outer layer and a flexible inner layer which is
impregnated with the formulation and which is arranged to be in
contact the adventitial surface in use. The outer layer may, for
example, be made of solid collagen and the inner layer made of
sponge-like collagen cross-linked thereto, the sponge-like layer
being capable of being impregnated with the pharmaceutical
formulation containing the agent to be delivered. In such a
situation, the device may be provided to the surgeon for fitment
with the formulation already impregnated therein, or it may be
wetted with the formulation after fitment, for example by being
injected as described earlier.
Martin, p. 5, 11. 6-18. Thus, Martin describes a single layer embodiment
which employs a reservoir and has a space, and a two layer embodiment
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Appeal2014-000805
Application 13/021, 162
which does not use a reservoir and has no space. 1 As the rejection relies on
the two layer embodiment, the Examiner's determination that "there is a
space between the inner layer and the blood vessel" is in error. See Ad. Act.
2.
In the Advisory Action, the Examiner alternatively concludes that "it
would have been obvious to one having ordinary skill in the art to recognize
Martin's inner layer can be spaced apart from the vessel at a distance of at
least 1 mm for the purpose of accommodating a needle and syringe that can
inject a pharmaceutical formulation." Adv. Act. 2. The Examiner fails to
provide evidence in support of this conclusion or explain why one skilled in
the art would consider it obvious to provide such a space. Accordingly, the
Examiner's alternative reasoning lacks rational underpinnings.
Dubrow does not cure the deficiencies in the Examiner's rejection of
claim 1 discussed supra. Accordingly, we do not sustain the Examiner's
decision rejecting independent claim 1, and claims 2---6, 8, 9, and 11-13
which depend therefrom.
Re} ection II
The rejection of claims 7 and 10 relies upon the same erroneous
findings and determinations as the rejection of claim 1 from which claims 7
and 10 depend. Accordingly, we do not sustain the Examiner's decision
rejecting claims 7 and 10.
1 We note that while one or more layers of material between the bioactive
agents and the wall of the blood vessel provide separation between the
bioactive agents and the wall of the blood vessel, they do not constitute a
space. See Ans. 3.
4
Appeal2014-000805
Application 13/021, 162
DECISION
The Examiner's rejection of claims 1-13 is REVERSED.
REVERSED
5