Ex Parte Kusleika

Board of Patent Appeals and Interferences

Jul 24, 2012

10825309 (B.P.A.I. Jul. 24, 2012)

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.
10/825,309 04/16/2004 Richard S. Kusleika 12013/48803 7747
23838 7590 07/25/2012
KENYON & KENYON LLP
1500 K STREET N.W.
SUITE 700
WASHINGTON, DC 20005
EXAMINER
VU, QUYNH-NHU HOANG
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
07/25/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RICHARD S. KUSLEIKA
__________

Appeal 2011-009358
Application 10/825,309
Technology Center 3700
__________

Before TONI R. SCHEINER, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
process for treating tissue at a treatment site with a body lumen. The Patent
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.

STATEMENT OF THE CASE
Claims 16-24, 38 and 39 are on appeal. Claim 1 is representative and
reads as follows (emphasis added):
Appeal 2011-009358
Application 10/825,309

2
1. A process for treating tissue at a treatment site within a body
lumen, comprising:
providing an elongate flexible catheter having a flexible treatment
sheath mounted to a distal end region of the catheter and a dilatation balloon
within the flexible treatment sheath, wherein the flexible treatment sheath is
formed of an elastic material and the dilatation balloon is formed of a
substantially inelastic material;
intraluminally advancing the elongate flexible catheter until the
flexible treatment sheath is adjacent a predetermined treatment site;
while maintaining the dilatation balloon in an unexpanded condition,
supplying a treatment fluid under pressure to a compartment formed by the
treatment sheath, to elastically expand the treatment sheath radially into a
substantially conforming contact with the surrounding tissue at the treatment
site, cause the treatment fluid to pass through the treatment sheath from
the compartment to the surrounding tissue, and maintain the treatment sheath
expanded into said contact; and
while maintaining the treatment sheath in said substantially
conforming contact with the surrounding tissue at the treatment site, radially
expanding the dilatation balloon within the compartment, whereby the
dilatation balloon acts radially upon the surrounding tissue through
the treatment sheath to effect a dilatation of the surrounding tissue.

The Examiner rejected claims 16-24, 38 and 39 under 35 U.S.C. §
103(a) as unpatentable over Shockey
1
and Sogard.
2

The Examiner’s position is that Shockey disclosed a process for
treating tissue at a treatment site within a body lumen, comprising providing
an elongate flexible catheter having a flexible treatment sheath formed of an
elastic material and a dilatation balloon. (Ans. 3.) The Examiner found that
Shockey did not disclose that its dilatation balloon was formed of
substantially inelastic materials. (Id.) The Examiner found that Sogard

1
US Patent No. 4,994,033 issued to Rick L. Shockey et al., Feb. 19, 1991.
2
US Patent No. 5,447,497 issued to David J. Sogard et al., Sep. 5, 1995.

Appeal 2011-009358
Application 10/825,309

3
disclosed a device having an elongate flexible catheter with a flexible
treatment (outer) sheath and a dilatation balloon made from inelastic
materials such as rigid or stiff polymeric materials. (Id.) According to the
Examiner, it would have been obvious to a person of ordinary skill in the art
at the time the invention was made to have modified Shockey’s device to
include a dilatation balloon made of an inelastic material, as taught by
Sogard, to dilate and prevent rupture of the balloon. (Id. at 4.)
Appellant contends, among other things, that Shockey’s outer
expander membrane, i.e., flexible treatment sheath, is not formed of an
elastic material, as required by independent claim 16. (App. Br. 10.)
Rather, Appellant asserts that Shockey’s sheath is substantially inelastic.
(Id.) In support of this contention, Appellant asserts that the same materials
that Shockey discloses for this outer member, i.e., polyethylene tetrathalate
(PET) and polyvinyl chloride (PVC), are among the inelastic materials
Appellant discloses in their Specification for their inelastic balloon. (Id. at
10-11)(citing Spec. [0045]).
In the Response to Argument, the Examiner states that “[i]t is very
well-known in the art that polyethylene tetrathalate [and] polyvinyl chloride
[are] soft or elastic materials.” (Ans. 5.) In support of this statement, the
Examiner notes that: (a) Sogard disclosed that examples of soft or flexible
polymeric materials include thermoplastic elastomers, polyethylene, and
PVC (id.); (b) the present Specification disclosed that the flexible treatment
sheath is formed of an elastic biocompatible polymer, e.g., latex or other
suitable materials such as polyurethane, silicon, and thermoplastic
elastomers (id.)(citing Spec [0047]); and (c) additional prior art provides
evidence that PVC is a thermoplastic elastomer (id. at 7-8).
Appeal 2011-009358
Application 10/825,309

4
Appellant replies by citing rebuttal evidence which characterizes
PET and PVC as “generally” and “relatively” inelastic material. (Reply Br.
3-4.) Appellant additionally replies with evidence indicating the modulus of
elasticity for PET and PVC is on the order of 400,000 psi, whereas the
Specification states that in the invention elastic material may have a
relatively low “modulus of elasticity in the range of about 2,000 to 80,000
psi.” (Id.)
After considering all the evidence and arguments, we conclude that
the record does not support a conclusion of prima facie obviousness.
Specifically, the Examiner relied on Shockey as disclosing a flexible
treatment sheath formed of elastic material by teaching that the material may
be PET or PVC. However, as the evidence submitted by Appellant
confirms, these materials are not inherently elastic, but may also be
generally inelastic. (See Reply Br. 3-5.) Shockey did not identify the
elasticity characteristic of its materials or otherwise disclose such
characteristic for its treatment sheath. Consequently, we find that the
Examiner has not established that Shockey’s treatment sheath was
necessarily formed of elastic material, as required by independent claim 16.
Accordingly, we reverse the obviousness rejection of claims16-24, 38 and
39.
REVERSED

alw