Ex Parte McIntyre et al

Board of Patent Appeals and Interferences

Apr 7, 2010

10832556 (B.P.A.I. Apr. 7, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte JON T. MCINTYRE,
BARRY N. GELLMAN, and JOZEF SLANDA
____________________

Appeal 2009-007178
Application 10/832,556
Technology Center 3700
____________________

Decided: April 7, 2010
____________________

Before: WILLIAM F. PATE III, JENNIFER D. BAHR, and
STEVEN D.A. MCCARTHY, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1,
4-27, and 44-48. App. Br 2. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2009-007178
Application 10/832,556

2
The claims are directed to a self anchoring radio frequency ablation
array. Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A tissue treatment device comprising:
a handle;
a shaft including a tissue abutting distal end which, when
in an operative position, abuts an outer surface of a target tissue
mass;
a tissue anchoring coil operatively connected to the
handle and deployable from the shaft, the tissue anchoring coil
penetrating and stabilizing tissue while the distal end of the
shaft abuts the outer surface of the target tissue mass, the coil
forming an electrode of a first polarity; and
a plurality of arms deplorable [sic] in proximity to the
coil, at least one of the arms comprising a second electrode of a
second polarity.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Edwards
Mulier
LeVeen
Osypka
Eggers
US 5,507,743
US 5,807,395
US 5,827,276
US 5,964,754
US 6,032,674
Apr. 16, 1996
Sep. 15, 1998
Oct. 27, 1998
Oct. 12, 1999
Mar. 7, 2000

REJECTIONS
Claims 1, 4-17, 20, 22, 24 and 44-48 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Osypka, Edwards, and LeVeen. Ans. 3.
Claims 18, 19, 21 and 25-27 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Osypka and Edwards. Ans. 3.
Appeal 2009-007178
Application 10/832,556

3
Claim 23 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Osypka, Edwards, and Mulier. Ans. 3.

ISSUES
Appellants argue claims 1, 4-17, 20, 22, 24 and 44-48 as a group.
App. Br. 6-11. While claims 9, 18 and 44 are separately mentioned,
Appellants advanced patentability based upon the same reasons as claim 1.
App. Br. 10-11; Reply Br 5-6. We select claim 1 as the representative claim,
and claims , 4-17, 20, 22, 24 and 44-48 will stand or fall with claim 1.
37 C.F.R. § 41.37(c)(1)(vii).
Regarding claim 1, Appellants contend the Examiner erred by finding
that the references would have taught the claimed “tissue anchoring coil”
“forming an electrode of a first polarity” and “at least one of [a plurality of]
arms comprising a second electrode of a second polarity.” App. Br. 6-10.
Claim 18, grouped with claims 19, 21 and 25-27, is argued based upon a
similar limitation. App. Br. 12-14; Reply Br 7-9. Claim 18 includes only an
anchoring portion comprising a first electrode and a second electrode. Claim
18 does not require a plurality of arms.
Claim 23 is argued solely based upon dependency. App. Br. 14-15.

FINDINGS OF FACT
1. Osypka discloses a device for creating perforations, borings or
channels in the heart wall. The device has a needle 6 forming at least
one electrode or pole connected to a high frequency generator so that
the created channels can be coagulated upon creation and thus remain
open. Col. 1, ll. 6-8, 50-64; col. 5, ll. 24-35; col. 7, ll. 14-36.
Appeal 2009-007178
Application 10/832,556

4
2. Osypka suggests using the device “to coagulate troublesome tissue in
the heart (ablation).” Col. 1, l. 67 – col. 2, l. 2; col. 7, ll. 36-38.
3. Osypka teaches that a bipolar coagulation needle may be provided
which has electrodes or poles spaced or insulated from each other.
Col. 2, ll. 8-14; col. 5, ll. 44-48.
4. Osypka teaches that an advantage of a bipolar arrangement is
dispensing with the external ground electrode—a common cause of
burns. Col. 2, ll. 13-15.
5. Osypka teaches a holding coil 8 in addition to the needle 6 can be
used for fixation to the patient’s tissue. Col. 6, ll. 35-43; fig. 6.
6. Osypka teaches that the holding coil 8 may be constructed as an
additional electrode and that doing so would provide the additional
benefit of creating several perforations simultaneously. Col. 3, ll. 28-
34; col. 6, ll. 44-48.
7. Osypka teaches using multiple insertions at the same location to create
multiple channels in the heart wall. Col. 6, ll. 1-14; fig. 9.
8. Osypka fails to disclose that the holding coil 8 and the needle 6 may
form first and second poles of a bipolar arrangement.
9. Edwards discloses an RF treatment apparatus for ablating tumors. The
device 10 includes an active electrode 12 and an indifferent coiled
electrode 14. Col. 3, ll. 11-20; col. 4, l. 67 – col. 5, l. 1; fig. 1A.
10. Edwards discloses that the device can be monopolar or bipolar. Col. 5,
ll. 18-20.
11. Edwards discloses that active 12 and indifferent 14 electrodes can
switch functions. Col. 5, ll. 31-35.
Appeal 2009-007178
Application 10/832,556

5
12. Edwards fails to disclose that the active and indifferent electrodes
form the first and second poles of the bipolar arrangement.
13. LeVeen discloses an improved RF system for tissue ablation wherein
multiple electrodes may be used to treat a relatively large tissue
volume and reduce the number of deployments needed for treatment.
Col. 2, l. 61 – col. 3, l. 4.
14. LeVeen teaches that the system may be bipolar, wherein RF current is
established between the at least two electrodes, or monopolar, wherein
current flows between the electrodes and a separate return electrode.
Col. 3, ll. 12-15. In the bipolar arrangement the electrodes are
connected to the two poles of the RF power supply. Col. 7, ll. 10-12.

ANALYSIS
The subject matter of claims 1 and 18 involves no more than the
predictable use of prior art elements according to their established functions
and would have been obvious to one having ordinary skill in the art. KSR
Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416.
Initially Appellants argue that there is no teaching or suggestion to
combine the references. App. Br. 7. This argument is foreclosed by KSR Int'l
Co. v. Teleflex Inc. in which the Court rejected the rigid requirement of a
teaching or suggestion or motivation to combine known elements in order to
show obviousness. KSR Int’l Co., 550 U.S. at 415. The Court noted that an
obviousness analysis “need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ.” Id. at 401.
Appeal 2009-007178
Application 10/832,556

6
Appellants contend that using Osypka’s needle and coil as opposing
poles of a bipolar electrode for tissue ablation is not taught or suggested by
Osypka and modifying Osypka to do so would compromise the intended
function of Osypka—creating channels within the walls of the heart. App.
Br. 7; Reply Br 4-5. Appellants are correct in pointing out that Osypka lacks
an express teaching of the holding coil 8 and the needle 6 forming first and
second poles of a bipolar arrangement. Fact 8. Edwards also lacks such an
express teaching. Fact 12. Lacking an express teaching does not constitute
“teaching away” since it does not criticize, discredit, or otherwise discourage
the solution claimed. In re Fulton, 391 F.3d 1195, 1201.What a reference
teaches or suggests must be examined in the context of the knowledge, skill,
and reasoning ability of a skilled artisan. What a reference teaches a person
of ordinary skill is not limited to what a reference specifically “talks about”
or what is specifically “mentioned” or “written” in the reference. Syntex
(U.S.A.) LLC v. Apotex, Inc. 407 F.3d 1371, 1380 (Fed. Cir. 2005).
Both the needle 6 and coil 8 of Osypka can function as electrodes.
Facts 1 and 6. Both Osypka and Edwards specifically suggests a employing
a bipolar arrangement. Facts 3 and 10. While, arguably, Osypka may suggest
bipolar operation for the needle 6 itself, one of ordinary skill in the art would
recognize that there are essentially only a limited number of possibilities for
the various electrodes of a bipolar arrangement, positive, negative and
ground. Making Osypka’s coil electrode and needle electrode have opposite
polarities would have the predictable result of providing current flow
between the electrodes. One of ordinary skill in the art would recognize that
such a modification could be used to ablate tissue between the electrodes or
to dispose of the external ground electrode. See Fact 4. LeVeen further
Appeal 2009-007178
Application 10/832,556

7
evidences that one of ordinary skill in the art would understand the term
“bipolar electrode” to teach or suggest a configuration wherein current flows
locally between the two inserted electrodes instead of between those
electrodes and a separate ground electrode. Fact 14. Appellants’ argument
that such a modification to Osypka would create larger channels and thereby
render Osypka inoperable for its intended purpose of creating channels
within the heart walls is unpersuasive. Firstly, Osypka expressly suggests
using the device for the alternate purpose of ablation of troublesome tissue.
Fact 2. Edwards teaches the use of an almost identical structure for that same
purpose. Fact 9. Secondly, the size of the created channels is dependent upon
the size and position of the conducting electrode needles. One of ordinary
skill in the art would not regard Osypka’s structures as limited to any
particular size and would understand how to dimension them appropriately
to achieve the desired channel size.
Appellants contend that adding multiple electrode arms and separating
the electrodes would serve no benefit and compromise the intended function
of Osypka, creating channels within the walls of the heart. App. Br. 8-9. The
desirability of creating multiple channels simultaneously is expressly
suggested by Osypka. Fact 6. The advantages of substituting LeVeen’s
multiple arm structure to create multiple channels in place of multiple
insertions, or to ablate a larger area, are expressly described by LeVeen. See
Facts 7 and 13. Appellants’ argument is therefore unpersuasive.
For these reasons, the Examiner did not err in determining that it
would have been obvious to one having ordinary skill in the art to modify
Osypka’s coil and needle to be electrodes of a first and second polarity or to
substitute Osypka’s electrode needle with a plurality of electrode arms. It is
Appeal 2009-007178
Application 10/832,556

8
noted that LeVeen was not applied in rejecting claim 18. It is relied upon in
the discussion above pertaining to claim 18 only to the extent that it provides
a further explanation of the meaning of the term “bipolar” used by Osypka
and Edwards.

CONCLUSIONS OF LAW
The Examiner did not err by finding that the prior art references
would have rendered obvious the claimed combination including a “tissue
anchoring coil” “forming an electrode of a first polarity” and “at least one of
[a plurality of] arms comprising a second electrode of a second polarity.”

DECISION
For the above reasons, the Examiner’s rejections of claims 1-20 are
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2009).

AFFIRMED

Vsh

FAY KAPLUN & MARCIN, LLP
150 BROADWAY, SUITE 702
NEW YORK NY 10038