Ex Parte Rioux et al

Patent Trial and Appeal Board

Mar 8, 2013

11316501 (P.T.A.B. Mar. 8, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/316,501 12/21/2005 Robert Rioux 05-0328 (US01) 9793
23410 7590 03/08/2013
Vista IP Law Group LLP
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
SCHMIDT, EMILY LOUISE
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
03/08/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ROBERT RIOUX and DAVID J. SAUVAGEAU
__________

Appeal 2011-006255
Application 11/316,501
Technology Center 3700
__________

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

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 33-45 and 47-55, directed to an echogenic apparatus for use in
performing medical procedures. The claims have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
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STATEMENT OF THE CASE
Claims 33-45 and 47-55 are pending and on appeal; claims 1-32 and
46 have been canceled (App. Br. 2).
The Specification discloses “a vessel occlusion apparatus [which]
includes an elongate shaft with an expandable member [e.g., a balloon]
carried on a distal end portion of the shaft” (Spec. ¶ 6), wherein the wall of
the expandable member contains a plurality of fluid pockets (id. at ¶¶ 6, 22,
23). In addition, the Specification discloses an elongate tubular delivery
member, wherein the wall of the tubular member contains a plurality of fluid
pockets (id. at ¶ 26). In either case, the pockets are filled with an echogenic
gas or a radiopaque liquid which allows the wall of the balloon or tubular
member to be ultrasonically or fluoroscopically imaged during a medical
procedure (id. at ¶¶ 33, 37).
Figure 4 of the Specification, reproduced below, depicts fluid pockets
in the wall of a balloon:

Figure 4 depicts fluid pockets which extend along a length of a balloon wall
100. In this particular embodiment, the fluid pockets are “created by
securing a first sheet 110 of material to a second sheet 112 of material using
an adhesive 114 at selected locations” (id. at ¶ 23).

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Claims 33 and 35 are representative of the subject matter on appeal:
33. A vessel occlusion apparatus, comprising:
an elongate shaft having a fluid delivery lumen; and
an expandable member carried on a distal end portion of the shaft, the
expandable member comprising a body defining an interior region, the
interior region in communication with the fluid delivery lumen, the body
formed of a first sheet of material secured to a second sheet of material using
an adhesive at selected locations, thereby creating a plurality of fluid pockets
between the first sheet and the second sheet,
wherein the fluid pockets are fluidically isolated from any fluid
lumens.
35. An apparatus for use in a medical procedure, comprising:
an elongate tubular delivery member having a proximal portion, a
distal portion, and a lumen extending between the proximal and distal
portions, wherein the distal portion of the tubular member is formed of a
first sheet of material secured to a second sheet of material using an adhesive
at selected locations, thereby creating a plurality of fluid pockets between
the first sheet and the second sheet,
wherein the fluid pockets are fluidically isolated from any fluid
lumens.
The Examiner relies on the following evidence:
Bosley US 5,289,831 Mar. 1, 1994
O’Boyle US 5,609,606 Mar. 11, 1997
Green et al. US 5,807,327 Sep. 15, 1998
Zappala US 6,364,855 B1 Apr. 2, 2002
Schroeder et al. US 2005/0075723 A1 Apr. 7, 2005
Lim et al. US 6,946,173 B2 Sep. 20, 2005
The claims stand rejected as follows:
I. Claims 33, 34, 36, 37, 40, 41, and 43 under 35 U.S.C. § 103(a)
as unpatentable over Lim, Bosley, and Zappala (Ans. 4-5);
II. Claims 38 and 39 under 35 U.S.C. § 103(a) as unpatentable
over Lim, Bosley, Zappala, and Schroder (Ans. 7).
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III. Claim 42 under 35 U.S.C. § 103(a) as unpatentable over Lim,
Bosley, Zappala, and O’Boyle (Ans. 7-8).
IV. Claim 44 under 35 U.S.C. § 103(a) as unpatentable over Lim,
Bosley, Zappala, and Green (Ans. 8).
V. Claims 35, 47, 48, 51, and 52 under 35 U.S.C. § 103(a) as
unpatentable over Bosley and Zappala (Ans. 5-6).
VI. Claims 49 and 50 under 35 U.S.C. § 103(a) as unpatentable
over Bosley, Zappala, and Schroeder (Ans. 8-9).
VII. Claims 53-55 under 35 U.S.C. § 103(a) as unpatentable over
Bosley, Zappala, and Green (Ans. 9).
FINDINGS OF FACT
1. Lim discloses a catheter balloon comprising “a first layer [33]
formed of a polymeric material such as ePTFE coated or impregnated with a
bondable material [35] . . . positioned against a second layer [34] and . . .
heated to fusion bond together” (Lim, col. 6, ll. 8-13; col. 8, ll. 1-13).
2. Bosley discloses an “echogenic device to be sonically imaged”
(Bosley, col. 7, ll. 38), e.g., “catheters, devices made from catheters, stents,
pacing leads, introducers, pacemakers, ultrasonic rulers, . . . pumps, [and]
balloons” (id. at col. 7, ll. 41-44).
3. Bosley’s echogenic device is partially made up of a composite
material comprising sound reflective particles, e.g., glass particles,
embedded in a formable, pliable plastic matrix material which can be
molded or extruded into a variety of shapes (id. at col. 7, ll. 49-63).
Alternatively, the glass particles can be attached to the surface of the
echogenic device using a medical grade adhesive, and coated with a layer of
plastic material to provide a smooth outer surface (id. at col. 11, ll. 31-43).
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4. Zappala discloses a urethral catheter which “features an
inflatable balloon at the distal/bladder end and a central lumen containing a
semisolid masma comprising a plurality of hypoechoic, gas filled
microspheres” (Zappala, col. 2, ll. 54-57).
REJECTIONS I-IV
Rejections I-IV are based, in whole or in part, on the Examiner’s
proposed combination of Lim, Bosley, and Zappala. As the same issue is
dispositive for all four rejections, we will discuss them together.
Independent claim 33 is directed, in relevant part, to an occlusion
apparatus with an elongate shaft having a fluid delivery lumen and an
expandable member “formed of a first sheet of material secured to a second
sheet of material using an adhesive at selected locations, thereby creating a
plurality of fluid pockets between the first sheet and the second sheet,
wherein the fluid pockets are fluidically isolated from any fluid lumens.”
The Examiner finds that Lim discloses a vessel occlusion apparatus
with an expandable member, i.e., a balloon, “defining an interior region . . .
in communication with [a] fluid delivery lumen” (Ans. 4), wherein the
balloon is “formed of a first sheet of material secured to a second sheet of
material using an adhesive” (id.). The Examiner acknowledges that Lim’s
balloon does not include “a plurality of fluidically isolated [fluid] pockets”
(id.). However, the Examiner finds that Bosley “teaches a catheter in which
particles . . . can alternatively be attached to a surface with adhesive or
embedded in its material . . . which can be placed between two layers . . . to
allow the catheter to be sonically imaged” (id.). In addition, the Examiner
finds that Zappala “teaches gas filled microspheres which are used to
acoustically image a catheter” (id.).
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The Examiner concludes that it would have been obvious for one of
ordinary skill in the art “to use microspheres between the layers of the
balloon of Lim et al. as in Bosley and to further use the gas filled
microspheres of Zappala because Bosley and Zappala teach this to allow the
catheter device to be sonically imaged” (id. at 4).
Appellants contend, in relevant part, that “even if . . . one of ordinary
skill in the art would have been motivated to include the spheres of Bosley
or the gas-filled spheres of Zappala in between the layers 33 and 34 taught
by Lim . . . such a construction does not render obvious the claimed
apparatus” (Reply Br. 2), at least because the applied prior art references do
not teach or otherwise suggest “creating fluid pockets between first and
second sheets of . . . [an expandable member] by using an adhesive at
selected locations” (id.; see also App. Br. 8), as required by independent
claim 33.
We agree with Appellants. All the claims subject to Rejections I-IV
require “a first sheet of material secured to a second sheet of material using
an adhesive at selected locations, thereby creating a plurality of fluid pockets
between the first sheet and the second sheet” (see claim 33). As discussed
above, Lim discloses a bi-layer balloon with no fluid pockets (FF1); Bosley
discloses echogenic glass particles that are either embedded in a moldable
matrix material or attached to the surface of a device using an adhesive, and
then coated with a layer of plastic material to provide a smooth outer surface
(FFs 2, 3); and Zappala discloses gas-filled microspheres suspended in a
“masma” (FF4). Thus, the Examiner has not established that any of the cited
references (or the secondary references Schroeder, O’Boyle, or Green)
discloses the structure required by the claims, in a balloon or otherwise, nor
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has the Examiner explained why one of ordinary skill in the art would have
had a reason to modify any of the devices of the cited art to include such a
structure.
On this record, the Examiner has not established that it would have
been obvious to form fluid pockets between the layers of Lim’s bi-layer
balloon by using an adhesive only at selected locations of the balloon, as
required by the claims. Accordingly, Rejections I-IV are reversed.
REJECTIONS V-VII
Rejections V-VII are based, in whole or in part, on the Examiner’s
proposed combination of Bosley and Zappala. As the same issue is
dispositive for all three rejections, we will discuss them together.
Independent claim 35 is directed, in relevant part, to an apparatus with
an elongate tubular delivery member with a lumen, wherein the distal
portion of the tubular member is “formed of a first sheet of material secured
to a second sheet of material using an adhesive at selected locations, thereby
creating a plurality of fluid pockets between the first sheet and the second
sheet, wherein the fluid pockets are fluidically isolated from any fluid
lumens.”
The Examiner finds that Bosley discloses “an elongate tubular
delivery member having a proximal portion, a distal portion, and a lumen . . .
wherein the distal portion of the tubular member is formed of a first sheet of
material secured to a second sheet of material using an adhesive at selected
locations, thereby creating a plurality of pockets” which the Examiner
concedes do not contain fluid (Ans. 5). Again, the Examiner finds that
Zappala “teaches gas filled microspheres which are used to acoustically
image a catheter” (id.).
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The Examiner concludes that it would have been obvious for one of
ordinary skill in the art “to use the micro spheres of Zappala in the device of
Bosley because the particles of Bosley allow the catheter to be sonically
imaged and Zappala teach[es] gas filled micro spheres to equivalently allow
the catheter device to be sonically imaged” (id. at 6).
Appellants contend that neither reference discloses or suggests a distal
portion of a tubular member “that is formed of a first sheet of material
secured to a second sheet of material using adhesive at selected locations.
Nor does either reference disclose or otherwise suggest creating a plurality
of fluid pockets between the two sheets by using adhesive at selected
locations” (App. Br. 10), as required by claim 35.
Again, we agree with Appellants. All the claims subject to Rejections
V-VII require “a first sheet of material secured to a second sheet of material
using an adhesive at selected locations, thereby creating a plurality of fluid
pockets between the first sheet and the second sheet” (see claim 35). As
discussed above, Bosley discloses echogenic glass particles that are either
embedded in a moldable matrix material or attached to the surface of a
device using an adhesive, and then coated with a layer of plastic material to
provide a smooth outer surface (FFs 2, 3), while Zappala discloses gas-filled
microspheres suspended in a “masma” (FF4). Thus, the Examiner has not
established that either of the cited references (or secondary references
Schroeder or Green) discloses the structure required by the claims, nor has
the Examiner explained why one of ordinary skill in the art would have had
a reason to modify any of the devices of the cited art to include such a
structure. Accordingly, Rejections I-IV are reversed.
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SUMMARY
I. The rejection of claims 33, 34, 36, 37, 40, 41, and 43 as
unpatentable over Lim, Bosley, and Zappala is reversed.
II. The rejection of claims 38 and 39 as unpatentable over Lim,
Bosley, Zappala, and Schroder is reversed.
III. The rejection of claim 42 as unpatentable over Lim, Bosley,
Zappala, and O’Boyle is reversed.
IV. The rejection of claim 44 as unpatentable over Lim, Bosley,
Zappala, and Green is reversed.
V. The rejection of claims 35, 47, 48, 51, and 52 as unpatentable
over Bosley and Zappala is reversed.
VI. The rejection of claims 49 and 50 as unpatentable over Bosley,
Zappala, and Schroeder is reversed.
VII. The rejection of claims 53-55 as unpatentable over Bosley,
Zappala, and Green is reversed.

REVERSED

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