Ex Parte Walker et al

Board of Patent Appeals and Interferences

Jun 25, 2012

12015125 (B.P.A.I. Jun. 25, 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.
12/015,125 01/16/2008 Blair D. Walker 1156-36.CON 1797
24955 7590 06/26/2012
ROGITZ & ASSOCIATES
750 B STREET
SUITE 3120
SAN DIEGO, CA 92101
EXAMINER
EISENBERG, REBECCA E
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
06/26/2012 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 BLAIR D. WALKER, SCOTT M. EVANS,
DAVID P. BAIDING, and PETER BARKER
____________

Appeal 2010-005575
Application 12/015,125
Technology Center 3700
____________

Before JOHN C. KERINS, WILLIAM V. SAINDON, and
JAMES P. CALVE, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the rejection of claims
38-41. App. Br. 2.1 Claims 1-37 have been canceled. We have jurisdiction
under 35 U.S.C. § 6.
We REVERSE.

1 Refers to Appeal Brief filed Nov. 20, 2009.
Appeal 2010-005575
Application 12/015,125

2
CLAIMED SUBJECT MATTER
Claim 38 is representative of the claimed subject matter on appeal:
38. An apparatus for delivery of thermal treatment and
medication to a selected area in the vascular system of a
patient, comprising:
an elongated flexible catheter assembly;
at least two heat transfer elements on a distal
portion of said catheter assembly insertable to said
selected area in said vascular system;
a temperature control lumen within said catheter
assembly, said temperature control lumen being in fluid
flow communication with said heat transfer elements, to
supply a temperature controlled fluid to said heat transfer
elements;
a medicament delivery lumen within said catheter
assembly, said medicament delivery lumen being in fluid
flow communication with said distal portion of said
catheter assembly, to deliver a medicament to said distal
portion of said catheter assembly;
a return lumen in said catheter assembly, said
return lumen being in fluid flow communication with
said heat transfer elements, to receive said temperature
controlled fluid from said heat transfer elements; and
an exit port in said distal portion of said catheter
assembly, said exit port being in fluid flow
communication with said medicament delivery lumen to
allow said medicament to exit said catheter assembly in
the proximity of said heat transfer elements.

REJECTIONS
Claims 38 and 39 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Williams (US 4,941,475; iss. Jul. 17, 1990) and Uecker
(US 3,937,224; iss. Feb. 10, 1976).
Appeal 2010-005575
Application 12/015,125

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Claims 40 and 41 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Williams, Uecker, and Bierman (US 5,192,274; iss. Mar.
9, 1993).
ANALYSIS
Claims 38 and 39 as unpatentable over Williams and Uecker
The Examiner found that Williams discloses an apparatus for delivery
of thermal treatment and medication to a selected area in the vascular system
of a patient comprising an elongated flexible catheter assembly 101 and a
heat transfer element 201 on a distal portion of the assembly, but fails to
teach two heat transfer elements as called for in claim 38. Ans. 3-4. The
Examiner found that Uecker teaches two balloons with a common lumen
(abstract) where each balloon serves as a heat transfer element. Ans. 4. The
Examiner also found that Uecker illustrates the use of multiple balloons in a
device with a common lumen where when heated fluid is infused into one
balloon, the second balloon is heated and thereby teaches that it is known to
use multiple balloons to distribute heat. Ans. 5. The Examiner determined
that it would have been obvious to include the two balloons with a common
lumen to increase the heat transfer efficiency, heat a larger area or multiple
areas by having the balloons spread out, and have more control over the
areas being heated. Ans. 4, 6. The Examiner also found that Williams
teaches that the balloon length can be increased so that heat can be removed
from (and added to) the bloodstream over a considerable part of the catheter
length and therefore does not teach away from the claimed use of multiple
balloons as heat transfer elements. Ans. 6.
Appellants argue that Uecker teaches the use of balloons for blocking
colonic branches but nowhere teaches the use of these balloons for the
Appeal 2010-005575
Application 12/015,125

4
irrelevant task (to Uecker) of heat transfer. App. Br. 4-5. Appellant also
argues that Uecker teaches that the balloons are inflated with air, saline
solution, or water but does not disclose the temperature of these elements or
the concept of distributing heat from the balloons, which are used only for
blocking colonic passages. Reply Br. 1. We agree. Uecker teaches that the
balloons 9, 10 are inflated to provide a seal between the balloon surface 20
and tissue walls 21. Col. 3, ll. 53-57; fig. 2. The Examiner has not pointed
to anything in Uecker that teaches the use of the sealing balloons 9, 10 as
heat transfer elements. See Ans. 4, 5. Therefore, the Examiner’s reliance on
Uecker to teach the use of two balloons as heat transfer elements with a
common lumen lacks a rational underpinning.
Appellants further argue that the Examiner’s reason for combining
Uecker’s teaching with Williams is flawed because the Examiner has not
established any basis for finding that two balloons heat more efficiently or
permit heating of a larger area than a single balloon. App. Br. 5. Appellants
also argue that the Examiner’s finding that using two balloons yields more
control over the area being heated is just conjecture and lacks support in
evidence or technical reasoning. App. Br. 5. We agree. As Appellants
point out, Williams is directed to measuring cardiac output using localized
thermodilution which involves measuring the amount of blood flow based
on the amount of heat that is transferred from the flowing blood to cooling
fluid in a heat transfer balloon. Col. 1, ll. 9-12; col. 2, l. 65 to col. 3, l. 6;
App. Br. 4. Therefore, even if using two balloons improves efficiency of
heating of a larger area with more control as the Examiner asserts, the
Examiner has not adequately explained why a skilled artisan would modify
Williams for these reasons when Williams measures blood flow based on the
Appeal 2010-005575
Application 12/015,125

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amount of heat that is removed from the blood during a relatively short time.
To the extent the Examiner found that two balloons improves heat transfer
generally as compared to one balloon, the Examiner has not explained how
using a second balloon would increase efficiency and control in Williams’
thermodilution system when Williams teaches that heat transfer efficiency is
optimized by removing heat for a very short time in a narrowly defined
region using a relatively high temperature differential so that the signal-to-
noise ratio is optimized. Col. 3, ll. 61-68; col. 15, ll. 23-28; App. Br. 5
(citing col. 5, ll. 23-25 and 32-34); Reply Br. 2.
Williams also teaches that heat can be removed from (and added to)
the bloodstream over a longer portion of the catheter length (col. 15, ll. 27-
31) by providing a longer balloon and this arrangement has the advantage of
providing a relatively large heat-exchange area without using a balloon with
a relatively large diameter so that a normal slender diameter catheter can be
used along the entire length (col. 15, ll. 35-40). However, the Examiner has
not adequately explained why this teaching would have led a skilled artisan
to add a second balloon heating element to Williams when Williams teaches
that the advantages are provided by a single, longer, thinner balloon heating
element and when Williams is not concerned with thermally treating a blood
supply but instead measures blood flow based on the amount of heat that is
removed from blood flowing in a relatively discrete region in a short period
of time. See App. Br. 5. As such, we cannot sustain the rejection of claim
38 or its dependent claim 39 based on Williams and Uecker.
Claims 40 and 41 as unpatentable over Williams, Uecker, and Bierman
The Examiner found that Williams and Uecker fail to teach a patient
anchor for affixing the catheter assembly to a patient’s skin as called for in
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Application 12/015,125

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claims 40 and 41, which depend from claim 38. Ans. 5. The Examiner
found that Bierman teaches a patient anchor. Ans. 5. However, Bierman
does not overcome the deficiencies of Williams and Uecker as to claim 38.
Accordingly, we cannot sustain the rejection of claims 40 and 41.
DECISION
The rejections of claims 38-41 are REVERSED.

REVERSED

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