Ex Parte Rioux et al

Board of Patent Appeals and Interferences

Sep 6, 2012

10828032 (B.P.A.I. Sep. 6, 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.
10/828,032 04/20/2004 Robert F. Rioux 03-316 US 3815
23410 7590 09/07/2012
Vista IP Law Group LLP
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
HENDERSON, RYAN N
ART UNIT PAPER NUMBER
3779
MAIL DATE DELIVERY MODE
09/07/2012 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 ROBERT F. RIOUX, PAUL DICARLO and
STEVE ANDERSON
________________

Appeal 2010-004803
Application 10/828,032
Technology Center 3700
________________

Before STEVEN D.A. McCARTHY, GAY ANN SPAHN and
MICHAEL L. HOELTER, Administrative Patent Judges.

Opinion for the Board filed by McCARTHY, Administrative Patent Judge.

Opinion Dissenting filed by HOELTER, Administrative Patent Judge.

McCARTHY, Administrative Patent Judge

DECISION ON APPEAL
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STATEMENT OF THE CASE 1
At least one of the Appellants’ claims being twice rejected, the 2
Appellants1 appeal under 35 U.S.C. § 134 from the Examiner’s decision 3
finally rejecting claims 1-20. The Examiner rejects claims 1-3, 6-13 and 15-4
20 under 35 U.S.C. § 102(a) as being anticipated by Wood (US 5
2003/0093007 A1, publ. May 15, 2003); claim 4 under 35 U.S.C. § 103(a) 6
as being unpatentable over Wood and Cosman (US 2003/0040743 A1, publ. 7
Feb. 27, 2003); claim 5 under § 103(a) as being unpatentable over Wood and 8
Dietz (US 6,840,954 B2, issued Jan. 11, 2005); and claim 14 under § 103(a) 9
as being unpatentable over Wood and Fitz (US 2005/0059964 A1, publ. 10
Mar. 27, 2005). Claims 21-41 are cancelled. We have jurisdiction under 35 11
U.S.C. § 6(b). 12
We REVERSE. 13
14
The Rejection of Claims 1-3, 6-13 and 15-20 15
Claims 1 and 15 are independent. Each recites a medical probe kit 16
including a delivery cannula and an ablation probe configured to be 17
removably disposed within the cannula lumen. Each also recites a first 18
ablation electrode disposed on a distal end of the cannula shaft and a second 19
ablation electrode disposed on a distal end of the probe shaft. The first and 20
second ablation electrodes are “arranged in a bipolar configuration.” 21
Claim 1 in its entirety recites: 22
1. A medical probe kit, comprising: 23
a delivery cannula having a shaft, a lumen 24
extending through the cannula shaft, and a first 25

1 The Appellants identify the real party in interest as Boston Scientific
Scimed, Inc.
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ablation electrode disposed on a distal end of the 1
cannula shaft; 2
an ablation probe configured to be 3
removably disposed within the cannula lumen via 4
a proximal end of the cannula shaft, the ablation 5
probe having a shaft and a second ablation 6
electrode disposed on a distal end of the probe 7
shaft, wherein the first and second ablation 8
electrodes are arranged in a bipolar configuration; 9
and 10
an elongated medical device configured to 11
be removably disposed within the cannula lumen 12
via the proximal end of the cannula shaft, such that 13
the ablation probe and medical device can be 14
exchanged. 15
Wood describes a coaxial biopsy apparatus for cauterizing the biopsy 16
track on withdrawal of the apparatus from the body of a subject. (Wood, 17
para. 0018). The biopsy apparatus includes an elongated needle or stylet 16 18
slidably received within a lumen 38 in a cannula 18. (Wood, paras. 0024 19
and 0025). The cannula 18 can be made from either electrically conductive 20
material or electrically non-conductive material. If the cannula 18 is made 21
from electrically conductive material, an electrically insulative layer 20 22
surrounds a major portion of its length, exposing only an electrically 23
conductive distal end portion 32. A radio frequency (“RF”) conduit 36 such 24
as a wire connects an RF generator with the distal end portion 32. (Wood, 25
paras. 0021, 0030 and 0031). If the cannula 18 instead is made from an 26
electrically non-conductive material, it may include an exposed metal foil 27
band around its distal end. In this embodiment, a wire connects the RF 28
generator with the metal foil band. (Wood, para. 0030). In one 29
embodiment, the stylet 16 is electrically coupled to the RF generator, either 30
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through the electrical conduit 36 or through a separate electrical conduit. 1
Wood teaches that this embodiment “provide[s] added length to the 2
cauterization electrode 32 for cauterizing tissue deeper in the subject’s 3
body.” (Wood, para. 0046). 4
This appeal turns on whether Wood describes a medical probe kit 5
“wherein the first and second ablation electrodes are arranged in a bipolar 6
configuration.” The Appellants do not point to any formal definition of the 7
term “bipolar configuration” in the Specification. 8
The term “bipolar electrode” appears to be a term of art in the medical 9
field. The ordinary usage of the term “bipolar electrode” is sufficiently 10
broad to encompass an “electrode whereby two active electrodes are 11
attached to a single support and hav[e] a structure that allows high frequency 12
electric currents to pass through these two electrodes when electrified.” 13
(UroSource, Bipolar Transurethral Resection of the Prostate: A Valid 14
Innovation, http://www.urosource.com/diseases/neurogenic-luts/view/article 15
/bipolar-transurethral-resection-of-the-prostate-a-valid-innovation/?tx_ 16
ttnews%5BbackPid%5D=191&cHash=e6fcaf906d2044a848b090d6e577e6f17
7 (last visited August 27, 2012)(citing International Electrotechnical 18
Comm’n 1998)). This definition is consistent with the Specification, which 19
mentions an arrangement in which high frequency (that is, RF) electric 20
current “is delivered to two electrodes in a bipolar fashion, which means that 21
current will pass between ‘positive’ and ‘negative’ electrodes in close 22
proximity to each other, e.g., two electrodes on the same probe or array.” 23
(Spec. 3, ll. 8-11). 24
A quick survey of Internet sites advertising “bipolar electrodes” 25
suggests that the term “bipolar configuration” does not encompass one 26
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single spatial arrangement of two electrode components. For example, the 1
electrode components of a bipolar electrode may be either adjacent or 2
concentric (that is, coaxial). What appears to distinguish electrodes in 3
bipolar configurations as used in medical applications is their functional 4
relationship, that is, the capacity of one electrode to act as a ”ground” for the 5
other electrode. When the electrodes are energized, current passing between 6
the electrodes is localized within a small region of surrounding tissue. Once 7
again, this understanding appears consistent with the usage of the term 8
“bipolar” in the Specification. (See Spec. 3, ll. 11-14 (“Bipolar 9
arrangements, which require the RF energy to traverse through a relatively 10
small amount of tissue between the tightly spaced electrodes, are more 11
efficient than monopolar arrangements, which require the RF energy to 12
traverse through the thickness of the patient’s body.”)). In this sense, the 13
limitation “wherein the first and second ablation electrodes are arranged in a 14
bipolar configuration” is functional. 15
That said, functional recitations limit the structure defined by an 16
apparatus claim. Structure must be capable of performing the recited 17
function in order to satisfy the function limitation. For example, in Re 18
Schreiber, 128 F.3d 1473 (Fed. Cir. 1997), the Board found that a spout 19
useful for purposes such as dispensing oil from an oil can anticipated a claim 20
reciting a “dispensing top for passing only several kernels of a popped 21
popcorn at a time from an open-ended container filled with popcorn.” Id at 22
1475. The Court held that, 23
where the Patent [& Trademark] Office has reason 24
to believe that a functional limitation asserted to be 25
critical for establishing novelty in the claimed 26
subject matter may, in fact, be an inherent 27
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characteristic of the prior art, it possesses the 1
authority to require the applicant to prove that the 2
subject matter shown to be in the prior art does not 3
possess the characteristic relied on. 4
Id. at 1478 (quoting In re Swinehart, 439 F.2d 210, 212 (CCPA 1971)). Our 5
reviewing court agreed with the Board that the Examiner had articulated a 6
reason to believe that the prior art spout inherently possessed the dimensions 7
necessary to perform the function of “passing only several kernels of a 8
popped popcorn at a time from an open-ended container filled with 9
popcorn.” Id at 1478. Alternatively, the court agreed with the Board’s fact 10
finding that the prior art spout was “capable of functioning to dispense 11
kernels of popped corn in the manner set forth in claim 1.” Id. On these 12
alternative bases, our reviewing court affirmed the rejection. 13
Wood itself teaches that the cauterization electrodes illustrated in 14
Wood are monopolar. (Wood, para. 0019). While Wood suggests how 15
Wood’s apparatus might be redesigned so as to form the cauterization 16
electrodes into bipolar electrodes (see id.), the Examiner does not appear to 17
find that the redesigned apparatus suggested by Wood would satisfy the 18
limitations of claim 1 or claim 15. Nevertheless, the Examiner cites 19
paragraph 0046 of Wood as support for the Examiner’s finding that Wood’s 20
apparatus has a second ablation electrode disposed at a distal end of the 21
probe shaft; and Figure 3B of Wood as support for the Examiner’s finding 22
that Wood’s apparatus has first and second ablation electrodes arranged in 23
bipolar configuration. (Ans. 3). Paragraph 0046 of Wood does not describe 24
any separation or insulation between the outer surface of the proximal end of 25
the stylet 16 and the inner surface of the lumen 38 of the cannula 18, 26
however. 27
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On the one hand, close proximity between the two electrodes may 1
promote the localization of current between the two. On the other hand, 2
contact between the two electrodes would imply that the two would assume 3
the same RF voltage and act as a single pole. The former case might 4
represent an arrangement of electrodes in a bipolar configuration where the 5
latter case could not. Here, the Examiner finds nothing in the disclosure of 6
Wood which might imply that the stylet 16 is separated or insulated from the 7
cannula 18 in the particular embodiment described in paragraph 0046 of 8
Wood. Were the stylet 16 and the exposed distal end 32 of the cannula 18 9
connected to RF generators, the two necessarily would act as a single pole. 10
Therefore, assuming for purposes of this appeal only that paragraph 0046 11
and Figure 3B of Wood describe a single embodiment, that embodiment 12
would not include, expressly or inherently, first and second ablation 13
electrodes “arranged in a bipolar configuration.” 14
Wood does not describe an embodiment including first and second 15
ablation electrodes capable of satisfying the limitation “wherein the first and 16
second ablation electrodes are arranged in a bipolar configuration.” We do 17
not sustain the rejection of claims 1-3, 6-13 and 15-20 under § 102(a) as 18
being anticipated by Wood. 19
20
The Rejection of Claim 4 21
Cosman describes a set or kit of tools for performing a biopsy and 22
then ablating a bone tumor. The kit includes a cannula 142; a stylet 160 and 23
an RF electrode or ablation probe 202. (Cosman, para. 0043). The RF 24
electrode 202 is surrounded by an insulative portion 203 along a major 25
portion of its length so as to expose only a distal portion 204. (Cosman, 26
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para. 0046 and fig. 3). The RF electrode 202 includes a hub structure 210 1
for electric connection with an external RF generator. (Id.) Cosman teaches 2
cooling the exposed distal portion 204 (Cosman, para. 0047), presumably to 3
achieve a larger RF ablation volume (Cosman, para. 0029). 4
In use, the cannula 142 with the stylet 160 may be pushed through soft 5
tissues and drilled into bone to access the bone tumor. The stylet 160 may 6
then be removed. The exposed distal portion 204 of the RF electrode 202 7
may then be advanced through a lumen 148 the cannula 142 into 8
engagement with the tumor. (Cosman, para. 0048). Once the RF generator 9
begins energizing the RF electrode 202, the exposed distal portion 204 will 10
begin heating the bone and ablating the tumor. (Cosman, para. 0049). 11
Cosman teaches varying the exposed length of the distal portion 204 12
depending on the size of the tumor. To this end, the insulative portion 203 13
may consist of a cannula or sheath having an insulation portion. The sheath 14
can be moved back and forth over a metal electrode inserted into the sheath 15
to achieve various lengths of the exposed distal portion 204. (See Cosman, 16
para. 0039). 17
The Examiner concludes that it would have been obvious “to modify 18
the [stylet 16] as taught by Wood with an insulative portion as taught by 19
Cosman such that the length of the conductive, exposed portion could be 20
adapted to accommodate the dimension of the area being treated.” (Ans. 6). 21
Wood does not appear to teach the use of Wood’s apparatus for ablation 22
treatment, however. Instead, Wood teaches the use of the apparatus for 23
cauterizing a biopsy track on withdrawal of the apparatus from the body of 24
the subject. (Wood, para. 0016). Wood teaches energizing the stylet 16 25
only for the purpose of “provid[ing] added length to the cauterization 26
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electrode 32 for cauterizing tissue deeper in the subject’s body.” (Wood, 1
para. 0046). This added length may be adjusted by moving the stylet 16 2
back and forth in the partially insulated cannula 18. Adding another cannula 3
or sheath around the stylet 16 would be redundant, at best, and may create 4
uncertainty as to the amount of cauterizing energy transferred to tissues 5
along the biopsy track, at worst. (See App. Br. 11; Reply Br. 4-5). The 6
Examiner has not articulated a persuasive reason why one of ordinary skill 7
in the art might have combined Cosman’s cannula 142 and ablation probe 8
202 with Wood’s improvement in the particular manner proposed by the 9
Examiner. We do not sustain the rejection of claim 4 under § 103(a) as 10
being unpatentable over Wood and Cosman. 11
12
The Rejections of Claims 5 and 14 13
The Examiner cites Dietz as teaching a bipolar ablation probe having 14
electrodes with thermoelectric cooling. (Ans. 6). This teaching does not 15
remedy the deficiencies in the description of Wood. (See App. Br. 11-12). 16
We do not sustain the rejection of claim 5 under § 103(a) as being 17
unpatentable over Wood and Dietz. 18
The Examiner cites Fitz as teaching a cannula having multiple 19
channels for deploying a plurality of ablation probes. (Ans. 7). This 20
teaching does not remedy the deficiencies in the description of Wood, either. 21
(See App. Br. 12). We do not sustain the rejection of claim 14 under 22
§ 103(a) as being unpatentable over Wood and Fitz. 23
24
DECISION 25
We REVERSE the Examiner’s decision rejecting claims 1-20. 26
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1
REVERSED 2
3
4
5
6
7
8
mls 9
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HOELTER, Administrative Patent Judge, dissenting. 1
Claims 1 and 15 are independent claims and each recites a medical 2
probe kit having a delivery cannula with a first ablation electrode disposed 3
on a distal end of the cannula shaft. Each claim also recites an ablation 4
probe removably disposed within the cannula and with a second ablation 5
electrode disposed on the distal end of the probe shaft. Claims 1 and 15 6
require that “the first and second ablation electrodes are arranged in a 7
bipolar configuration.” I would affirm based on the Examiner’s finding that 8
Wood’s ablation electrodes are “arranged in a bipolar configuration” (Ans. 9
3). 10
I agree that Appellants do not point to any formal definition of the 11
term “bipolar configuration” in the Specification; however, Appellants’ 12
Specification provides guidance as to such an arrangement (see also Reply 13
Br. 2). Appellants’ Specification indicates that “current is delivered to two 14
electrodes in a bipolar fashion, which means that current will pass between 15
‘positive’ and ‘negative’ electrodes in close proximity to each other, e.g., 16
two electrodes on the same probe or array” (Spec. 3:9-11). Appellants’ 17
Specification further emphasizes the efficiency of energy that traverses 18
“between the tightly spaced electrodes” as contrasted with “monopolar 19
arrangements, which require the RF energy to traverse through the thickness 20
of the patient’s body” (Spec. 3:11-14). Appellants’ description is not 21
contrary to how a bipolar configuration is understood in the medical field 22
(see supra). Appellants thus describe electrodes in a bipolar configuration 23
as being arranged “in close proximity to each other,” or “tightly spaced,” 24
and “on the same probe or array.” 25
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Appellants do not dispute the close proximity or arrangement of 1
Wood’s electrodes and the Examiner references Wood’s Figure 3B as an 2
example of such a close arrangement (Ans. 3). Further, Wood’s paragraph 3
[0019] teaches that the “outer and inner needles can be coaxial” and that the 4
outer cannula “can be a monopolar electrode (as illustrated), or can be 5
formed into a bipolar electrode.” Wood’s paragraph [0020] further discusses 6
the “coaxial” arrangement of the electrodes. 7
Instead, Appellants contend that Wood does not disclose electrodes 8
that can function as bipolar electrodes2 (App. Br. 6, 7, Reply Br. 2). The 9
patentability of a claim “depends on the claimed structure, not on the use or 10
purpose of that structure” (Catalina Marketing Int’l., Inc. v. 11
Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). See also 12
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. 13
Cir. 1990) (“apparatus claims cover what a device is, not what a device 14
does.” (italics in original))). Accordingly, I am not persuaded the 15
Examiner’s finding that Wood’s electrodes are “arranged in a bipolar 16
configuration” is in error. 17
Regarding whether Wood teaches that stylet 16 and cannula 18 are 18
electrically isolated, attention is directed to Appellants’ acknowledgement 19
that “Wood appears to suggest an alternative embodiment of a bipolar 20
arrangement where the electrodes are coaxial with an insulative layer 21
disposed concentrically therebetween, but does not teach or suggest a bipolar 22
arrangement between the electrode (32) and the stylet (16)” (App. Br. 8). 23

2We note that Appellants contend that the “bipolar configuration” claim
limitation is structural language, not functional language (Reply Br. 2).
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In view of the record presented, I respectfully dissent regarding the 1
interpretation of “arranged in a bipolar configuration” and instead, agree 2
with the Examiner that “the structure of the invention as disclosed by Wood 3
meets the claim limitations” (Ans. 8). I would sustain the Examiner’s 4
rejection of claims 1, 2, 6-12, 15, 16 and 18-20. 5
Regarding dependent claims 3 and 17, I agree with the Examiner’s 6
analysis (see Ans. 3, 5, 8) and regarding claim 13, Appellants rely on 7
arguments directed to claims 1 and 15 (App. Br. 9, Reply Br. 4) and do not 8
dispute the Examiner’s additional reason for rejecting the additional 9
limitation recited (Ans. 4). 10
Regarding claim 4, it is noted that the Examiner did not rely on 11
Cosman for teaching a probe that is removably disposed within a cannula 12
(Ans. 3, 6) and I further agree with the Examiner that “one cannot show 13
nonobviousness by attacking references individually where the rejections are 14
based on combinations of references” (Ans. 9). See In re Merck & Co., 800 15
F.2d 1091, 1097 (Fed. Cir. 1986); In re Keller, 642 F.2d 413, 426 (CCPA 16
1981). Accordingly, I would sustain the rejection of claim 4 as I am not 17
persuaded that this rejection is in error. 18
I further would sustain the rejection of claims 5 and 14 as Appellants 19
do not appear to have presented a separate, persuasive argument for their 20
patentability. 21