Ex Parte Shah

Board of Patent Appeals and Interferences

Aug 17, 2010

10815282 (B.P.A.I. Aug. 17, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte TILAK M. SHAH
____________

Appeal 2009-002203
Application 10/815,282
Technology Center 1700
____________

Before EDWARD C. KIMLIN, PETER F. KRATZ, and
JEFFREY T. SMITH, Administrative Patent Judges.

KRATZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 74-108. We have jurisdiction pursuant
to 35 U.S.C. § 6.

Appeal 2009-002203
Application 10/815,282

Appellant’s claimed invention is directed to a gastric occlusive device
comprising a balloon (gas retentive device) and an inflation element. The
device provides for inflation of the balloon within a subject’s gastric cavity.
The balloon is constructed via vacuum thermoformed half sections of multi-
layer films, which half-sections are bonded to each other along peripheral
portions forming a seam. The balloon exhibits a non-pillowed, spheroidal
shape upon inflation. In this regard, pillowing is said to be contraindicated
for such a gastric occlusive device (App. Br. 6).
Claim 74 is illustrative and reproduced below:
74. A gastric occlusive device comprising:
a balloon that in an inflated state is non-pillowed and spheroidal
in shape, formed from two vacuum thermoformed half-sections of a
multilayer film comprising: (A) a layer of sealing film, having main top and
bottom surfaces; and (B) at least one layer of thermoplastic polymer film,
laminated to the layer of sealing film, on at least one of the main top and
bottom surfaces; wherein the sealing film has a composition and thickness
imparting gas barrier character to the multilayer film and wherein the at least
one layer of thermoplastic polymer film alone lacks such gas barrier
character, wherein the half-sections are processed in a vacuum
thermoforming die having a substantially non-planar surface, and the
vacuum thermoformed half-sections are bonded to one another along
peripheral portions thereof to form a peripheral seam; and
an inflation element adapted to permit inflation of the balloon
within the gastric cavity of a subject for treatment of said subject.

The Examiner relies on the following prior art reference as evidence
in rejecting the appealed claims:
Connors 6,976,950 B2 Dec. 20, 2005
Claims 74-108 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Connors.

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Appeal 2009-002203
Application 10/815,282

We reverse for substantially the reasons set forth by Appellants taken
in light of the testimony of Tilak M. Shaw as set forth in the Declaration
under 37 C.F.R. § 1.132 (Decl.) (App. Br. 5-14, Evid. Appdx.; Reply Br. 1-
6). We add the following for emphasis.
All of the appealed claims require a gastric occlusive device
comprising a balloon that includes a seam (formed from bonded vacuum
thermoformed half-sections comprising multi-layer films) with the balloon
being so constructed as to have a spheroidal and non-pillowed shape upon
inflation.
Connors is directed to an implantable device that is disclosed as being
useful in baffling or attenuating transient pressure waves in organs of the
body, such as in the human urinary bladder for treating urinary tract
disorders (col. 1, ll. 15-34 and col. 10, l. 47- col. 13, l. 28). Connors
furnishes several illustrative embodiments which are disclosed as being
related to the fields of urology and gynecology, albeit Connors notes that
embodiments of the invention may be useful in other organs of the body
(col. 6, ll. 48-62).
The Examiner generally focuses on separate embodiments depicted in
Figures 5 and 16C of Connors in maintaining the rejection (Ans. 3-4). The
Examiner relies on Figure 5 of Connors for disclosing an attenuation device
including a spherically configured inflatable container made from first and
second compartments bonded together by a seam.
Appellant urges that the attenuation device of the embodiment of
Figure 5 of Connors is pillowed as evidenced by Figure 5A of Connors, not
non-pillowed as required by the claims on appeal (App. Br. 10-11).

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Appeal 2009-002203
Application 10/815,282

The Examiner turns to Figure 16C of Connors for an alleged teaching
of a spherically-shaped balloon that is non-pillowed and to selections from
column 23 of Connors for a teaching of employing a multi-layer wall
structure comprising a gas barrier layer and a moisture barrier layer (Ans. 5).
In this regard, the Examiner maintains that “it would have been obvious to
one of ordinary skill in the art to have employed the multilayer’s in the
embodiment of Fig. 16[C] in the balloon of Fig. 5 [of Connors], for the
purpose of enhancing flexibility, moisture barrier, gas barrier, and high
impact strength” (Ans. 5).
However, Figure 16C of Connors does not show a seam as being
present as required by the appealed claims for the balloon prepared from
vacuum thermoformed half-sections as urged by Appellant (Reply Br. 3).
Appellant argues that the Examiner has not reasonably carried the burden to
establish how Figure 16C of Connors coupled with general references to a
spherical shaped attenuation device in the disclosure of Connors, among the
other disclosed shapes and embodiments therein, would have suggested a
gastric occlusive device balloon structure that is not only spherical and non-
pillowed, but also includes a seam formed from bonding separate multi-layer
film halves, as claimed by Appellant (App. Br. 7-14; Reply Br.2-6).
In this regard, Appellant has buttressed the arguments presented with
evidence in the form of a Declaration under 37 C.F.R. § 1.132 by Tilak M.
Shaw (the named inventor). Mr. Shaw opines that vacuum thermoforming is
the only method of forming a device corresponding to the claimed device
known to Mr. Shaw and Connors does not disclose vacuum thermoforming
as a method for making a multilayer film-formed balloon via separately
formed halves, which balloon includes a peripheral bonding seam joining the
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Appeal 2009-002203
Application 10/815,282

halves and is non-pillowed and spheroidal in shape in the inflated state
(Decl. 7-15; see generally App. Br. and Reply Br.). Moreover, according to
Mr. Shaw, one of ordinary skill in the art would not have looked to vacuum
thermoforming at the time of the invention for forming such a balloon (Decl.
13-14).
As argued by Appellant, the Examiner has not specifically articulated
in the Answer how Connors otherwise discloses or suggests to one of
ordinary skill in the art how to construct a balloon with all of the
characteristics required by each of the appealed claims (Reply Br. 2-6).
On this record, the Examiner’s failure to address and attempt to
discredit the 37 C.F.R. § 1.132 Declaration testimony of Tilak M. Shaw
employed in support of Appellant’s arguments in the Appeal Brief and
Reply Brief, of itself, warrants reversal of the stated rejection.
In sum and as correctly urged by Appellants, the Examiner does not
reasonably explain how the referred to Patent Specification passages of
Connors taken with the depicted embodiments represented in Figures 5 and
16C teach or suggest a balloon having all of the claimed characteristics to an
ordinary skilled artisan given the additional non-rebutted information
provided in the 37 C.F.R. § 1.132 Declaration testimony of Tilak M. Shaw
(App. Br. 7-14, Evid. Appdx.; Reply Br. 1-6).
The aforementioned failure on the part of the Examiner represents a
dispositive issue that we resolve in Appellant’s favor.

ORDER
The Examiner’s decision to reject claims 74-108 under 35 U.S.C. §
103(a) as being unpatentable over Connors is reversed.
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Appeal 2009-002203
Application 10/815,282

REVERSED

tc

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