Ex Parte Stone et al

Patent Trial and Appeal Board

Jan 28, 2019

13385555 (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/385,555 02/24/2012
121974 7590 01/30/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
Corbett W. Stone
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.
8150BSC0254Cl 5387
EXAMINER
A VIG AN, ADAM JOSEPH
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
01/30/2019 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CORBETT W. STONE, MICHAEL F. HOEY,
ARTHUR G. BLANCK, LEN BRIGGS, MIKE PERRY, and
ROLFE TYSON GUSTUS
Appeal2018-000387 1
Application 13/385,555
Technology Center 3700
Before BRETT C. MARTIN, MICHELLE R. OSINSKI, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner's
decision to reject claims 1-3 and 5-29. We have jurisdiction under 35
U.S.C. § 6(b ).
1 The Appeal Brief indicates that Vessix Vascular, Inc. is the real party in
interest. Appeal Br. 3.
Appeal2018-000387
Application 13/385,555
We REVERSE.
CLAIMED SUBJECT MATTER
The claims are directed to a catheter-based treatment for luminal
diseases, particularly for atherosclerotic plaque, vulnerable or hot plaque,
and the like, and the invention allows the remodeling of body tissue using
heat. Spec. ,r 4. Claim 22, reproduced below with emphasis added, is
illustrative of the claimed subject matter:
22. A method for inducing desirable temperature effects on a
target body tissue disposed about a body lumen of a patient, the
method comprising:
positioning a radially expandable member supported by a
distal end of a catheter body within the lumen adjacent the target
body tissue to be heated, the expandable member having a low
profile insertion configuration and a larger profile configuration;
wherein the expandable member comprises a balloon
having a plurality of flexible circuits adhesively bonded to an
outer surface thereof, each flexible circuit including a polymeric
substrate bearing a pair of electrodes, each pair of electrodes
collectively defining a plurality of electrodes, the flexible circuits
being sufficiently flexible to allow folding and inflation of the
balloon;
expanding the expandable member to the larger profile
configuration within the lumen so as to engage the plurality of
electrodes mounted on the plurality of flexible circuits against a
wall of the lumen, the plurality of electrodes defining a plurality
of remodeling zones in a tissue treatment area that extend about
a circumference of the body lumen;
energizing the plurality of electrodes to transmit a
remodeling energy to each of the plurality of remodeling zones,
with a controller having a power source electrically coupled to
the plurality of electrodes; and
heating collateral healthy tissue in at least some
remodeling zones in the tissue treatment area with the
remodeling energy without causing thermal damage, and heating
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Appeal2018-000387
Application 13/385,555
both the target body tissue and collateral healthy tissue in
remodeling zones including the target tissue so as to
efficaciously alter the target tissue while inhibiting damage to
collateral healthy tissue of the wall of the lumen.
Appeal Br. 20-21 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Kordis
Danaek
Steinke
Carmel
us 5,499,981
US 2003/0233099 Al
US 2005/0096647 Al
US 2006/0089638 Al
REJECTIONS
Mar. 19, 1996
Dec. 18, 2003
May 5, 2005
Apr. 27, 2006
I. Claims 22-28 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Steinke, Danaek, and Kordis.
II. Claims 1-3 and 5-21 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Steinke, Danaek, Kordis, and Carmel.
OPINION
Rejection L Claims 22-28
The Examiner finds that Steinke discloses many of the steps recited in
claim 22, including positioning a radially expandable member comprising a
balloon adjacent to target body tissue to be heated, the expandable member
comprising a plurality of flexible circuits attached thereto. Final Act. 2-3.
However, the Examiner finds Steinke does not disclose "the flexible circuits
being sufficiently flexible to allow folding and inflation of the balloon; and
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Appeal2018-000387
Application 13/385,555
that the flexible circuits are adhesively bonded to the expandable member."
Id. at 3 ( emphasis added). The Examiner relies on the teachings of Danaek
to remedy this deficiency. Id. at 4. Specifically, the Examiner finds Danaek
teaches an expandable balloon that has flexible circuits attached to it, and
these circuits are flexible enough to allow for inflation of the balloon. Id.
(citing Danaek ,r 23, Fig. 10). The Examiner also finds that Danaek teaches
"each flexible circuit [is] adhesively bonded to the surface of the expandable
member." Id. ( citing Danaek ,r 146).
The Examiner states, "Steinke and Danaek teach different flexible
electrode constructions disposed on the surfaces of expandable members of
intraluminal catheters" and, therefore, "it would have been obvious to one of
ordinary skill in the art at the time that the invention was made to substitute
one known flexible electrode construction for the other in order to achieve
the predictable result of a flexible electrode construction disposed on an
expandable member[] of an intraluminal catheter." Id.
As for the recited adhesive connection to the expandable member, the
Examiner reasons that it would have been obvious "to adhesively bond the
flexible electrode to the balloon member, since this attachment method is
specifically disclosed by Danaek as a means of attaching the energy delivery
device to the expandable member." Id. at 5.
Appellants contend "there does not appear to be any teaching in
Danaek of a 'flexible electrode construction' in which a flexible circuit is
adhesively bonded to an outer surface of anything, much less an outer
surface of a balloon." Appeal Br. 10. Rather, Appellants contend, "Danaek
describes a printed circuit that is situated around a leg of an expandable
basket, rather than being adhesively bonded to an outer surface of a
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Appeal2018-000387
Application 13/385,555
balloon." Id. (emphasis modified). Appellants contend that Danaek
discloses the use of an adhesive only for securing a printed circuit around a
leg of an expandable basket, not for bonding flexible circuits to the outer
surface of a balloon.
In response, the Examiner states:
the structure of Steinke already provides for electrodes on a
surface of a balloon. Danaek is only utilized to demonstrate that
flex circuit constructions were known in the art and that
substitution of this known electrode construction for other
known constructions would have yielded predictable results.
Danaek is further utilized to teach that adhesives were a known
means for attaching said electrode construction to the surface of
an expandable member. The fact that Danaek allegedly teaches
flexible circuits in the context of a basket expandable member
therefore does not impact the conclusion of obviousness.
Ans. 6.
In reply, Appellants reiterate the assertion that "there does not appear
to be any teaching [in] the cited art of a 'flexible electrode construction' in
which a flexible circuit is adhesively bonded to an outer surface of anything
( as opposed to being wrapped around and attached to itself), much less an
outer surface of a balloon, which has a shape and mechanical properties that
are remote from those of a leg of an expandable basket as described by
Danaek." Reply Br. 9. Appellants also point out that the legs of the
expandable basket disclosed by Danaek are made of stainless steel or nitinol,
unlike the materials from which an expandable balloon is made. See id. at
9-10.
Appellants have the better position. The Examiner's finding that
Danaek discloses flexible circuit constructions is supported by a
preponderance of the evidence. See Danaek ,r 23 ("Other examples of the
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Application 13/385,555
energy transfer element include a polymeric heating element, an electrically
conductive paint, or a printed flex circuit which are on a portion of the
leg."). However, we agree with Appellants that this specific teaching relates
only to the attachment of a printed flex circuit to a leg of an expandable
basket, not a balloon. The Examiner's statement of the rejection of claim
22, on page 4 of the Final Office Action, refers to an expandable member (i)
"comprising a balloon," (ii) that "includes a plurality of flexible circuits
attached thereto," (iii) "the flexible circuits being sufficiently flexible to
allow folding and inflation of the balloon," (iv) with "each flexible circuit
adhesively bonded to the surface of the expandable member." In other
words, the statement of the rejection appears to find that a single
embodiment of the expandable member satisfies criteria (i}-(iv). Such a
finding is not supported by a preponderance of the evidence. This is
illustrated by the quotation from paragraph 146 of Danaek found on page 4
of the Final Office Action, which states "In any variation of the invention
the use of adhesives or other coatings may also be used to secure the energy
transfer element." This quotation omits the words "to the basket leg 106" at
the end of the sentence. Specifically, the full sentence at issue from
paragraph 146 of Danaek states, "In any variation of the invention the use of
adhesives or other coatings may also be used to secure the energy transfer
element to the basket leg 106." Underlining added. In other words, the
language that was omitted in the Examiner's reproduced quotation limits the
use of adhesive to basket legs (in contrast to use with a balloon). The
Examiner does not adequately explain how attachment of a flexible
electrode to a basket leg by adhesive bonding renders it obvious to attach a
flexible electrode to a balloon by adhesive bonding in light of the
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Application 13/385,555
differences between basket legs and balloons identified by Appellants.
Reply Br. 9-10.
Accordingly, we do not sustain the Examiner's rejection of claim 22
and claims 23-28 depending therefrom as unpatentable over Steinke,
Danaek, and Kordis.
Rejection II; Claims 1-3 and 5-21
Independent claims 1 and 21 require "flexible circuits each adhesively
bonded to an outer surface of the balloon" and "a plurality of flex circuits
distributed about the balloon, each flex circuit including a polymeric
substrate ... the polymeric substrate being adhesively bonded to an outer
surface of the balloon," respectively. Appeal Br. 15, 19 (Claims App.). To
address these claim requirements, the Examiner relies on the same findings
of fact regarding Danaek discussed above with respect to Rejection I. Final
Act. 9, 16. Accordingly, for the same reasons discussed above regarding
Rejection I, we do not sustain the Examiner's rejection of claims 1 and 21,
and associated dependent claims 2, 3, and 5-20, as unpatentable over
Steinke, Danaek, Kordis, and Carmel.
DECISION
The Examiner's decision to reject claims 1-3 and 5-29 is reversed.
REVERSED
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