BOSTON SCIENTIFIC SCIMED, INC.

Patent Trials and Appeals Board

Dec 15, 2021

2021003357 (P.T.A.B. Dec. 15, 2021)

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.
15/683,467 08/22/2017 Jai SHETAKE 10121/29702(160198US01) 1918
104919 7590 12/15/2021
Fay Kaplun & Marcin, LLP -- BSC
150 Broadway, suite 702
New York, NY 10038
EXAMINER
GIULIANI, THOMAS ANTHONY
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
12/15/2021 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):
lmorev@fkmiplaw.com
okaplun@fkmiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte JAI SHETAKE, BRYAN ALLEN CLARK,
STEPHEN B. RUBLE, TIMOTHY PAUL HARRAH,
and DAVID J. TERNES
____________

Appeal 2021-003357
Application 15/683,467
Technology Center 3700
____________

Before JENNIFER D. BAHR, DANIEL S. SONG, and
WILLIAM A. CAPP, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 16–30. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Boston Scientific Scimed, Inc., as the
Applicant and real party in interest. Appeal Br. 2.
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THE INVENTION
Appellant’s invention is a medical device used primarily for the
treatment of endometriosis. Spec. ¶¶ 1–1. Claim 16, reproduced below, is
illustrative of the subject matter on appeal.
16. A catheter system, comprising:
an elongated catheter body extending between a proximal
end and a distal end;
an electrode assembly coupled to the distal end of the
elongated catheter body, the electrode assembly comprising a
plurality of arms, each of the arms including a plurality of
electrodes;
a processor configured to receive signals associated with
intrinsic tissue activity sensed by the plurality of electrodes, the
processor determining a location of a target tissue to be treated
based on the sensed intrinsic tissue activity; and
a stimulator coupled to the plurality of electrodes to deliver
energy to the target tissue.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Swanson US 5,876,336 Mar. 2, 1999
Koblish US 2002/0087208 A1 July 4, 2002
Mathur US 2013/0165916 A1 June 27, 2013
Masson US 2015/0039058 A1 Feb. 5, 2015
The following rejections are before us for review:
1. Claims 16–19, 21, 22, and 24 are rejected under 35 U.S.C.
§ 102(a)(1) as anticipated by Mathur.
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2. Claim 20 is rejected under 35 U.S.C. § 103 as unpatentable over
Mathur and Swanson.
3. Claim 23 is rejected under 35 U.S.C. § 103 as unpatentable over
Mathur and Koblish.
4. Claims 25, 26, and 28–30 are rejected under 35 U.S.C. § 103 as
unpatentable over Mathur and Masson.
5. Claim 27 is rejected under 35 U.S.C. § 103 as unpatentable over
Mathur, Masson, and Swanson.
OPINION
Anticipation of Claims 16–19, 21, 22, and 24
by Mathur
Appellant argues claims 16–19, 21, 22, and 24 as a group. Appeal
Br. 3–7. Claim 16 is representative. See 37 C.F.R. § 41.37(c)(1)(iv).
A prior art reference anticipates a claim if it discloses all of the
limitations of the claim arranged or combined in the same way as in the
claim. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed.
Cir. 2008). The Examiner finds that Mathur discloses each limitation of
claim 16. Final Act. 2. In particular, the Examiner finds that Mathur
discloses a processor that is configured in accordance with the claim. Id.
Appellant argues that Mathur fails to disclose a processor that
determines the location of target tissue to be treated based on sensed
intrinsic tissue activity. Appeal Br. 3–7. Appellant argues that Mathur’s
device treats high blood pressure by applying electrical energy to nerves
surrounding the renal artery. Id. at 4. According to Appellant, the nerves
surrounding the renal artery have already been identified as the target tissue
before the device is inserted and energy is applied to the tissue surrounding
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the artery. Id. Appellant argues that Mathur’s device is inserted to a
location adjacent to pre-identified tissue and the electrode pairs of the device
evenly heat all the adjacent tissue. Id. Appellant argues that there is nothing
in Mathur that shows that its electrodes operate in a way to provide
information for determining the location of target tissue or making a
determination based on any information from the electrodes. Id.
Furthermore, argues that Mathur fails to disclose any sensing of intrinsic
tissue activity within the meaning of claim 16. Appeal Br. 5–6.
In response to Appellant’s arguments concerning location of a target
tissue to be treated, the Examiner finds that, although Mathur relies on nerve
activity feedback to determine the efficacy of a procedure, such nerve
activity feedback is also used to determine which areas require further
treatment. Ans. 3 (citing Mathur ¶ 302). According to the Examiner, since
the sensed nerve activity indicates target areas that require further treatment,
such sensed nerve activity “determines a location of a target tissue.” Id. In
response to Appellant’s arguments concerning sensing intrinsic tissue
activity, the Examiner directs our attention to paragraph 222 as supporting a
finding that the claim limitation is met. Id.
In reply, Appellant argues that Mathur’s feedback is limited to the
temperature of tissue surrounding the electrodes. Reply Br. 3. Appellant
denies that Mathur’s device includes sensors that detect intrinsic tissue
activity. Id. According to Appellant, nothing in Mathur indicates that any
feedback is produced by the device to indicate which electrodes should be
energized much less that such a determination is made based on sensed
“intrinsic tissue activity,” as claimed. Id. at 3–4.
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Particularly with respect to the passages of Mathur cited by the
Examiner in the Answer, Appellant argues that paragraph 302 merely
indicates that treatment is assessed “by measurements” without specifying
that the measurements are actually made by Mathur’s device. Reply Br. 4.
Appellant further argues that paragraph 222 does not indicate locating tissue
to be treated based on detected activity. Reply Br. 5. Appellant argues that
Mathur’s assessment determines whether treatment has been effective or if
more treatment is needed, but does so without locating the tissue that needs
to be treated. Id. (citing Mathur ¶ 431).
Mathur discloses a device for treating tissue near a body passageway,
such as the renal artery, using a catheter that has a plurality of electrodes and
a radio-frequency (RF) energy generator. Mathur, Abstract, ¶ 3. Mathur’s
device couples electrodes with a wall of the renal artery and drives energy
between the electrodes so as to therapeutically alter nerves surrounding the
renal artery. Id. The passage relied on by the Examiner as disclosing the
sensing of intrinsic tissue activity states:
An example renal-denervation treatment method may include
delivering an RF energy treatment to a tissue proximate a renal
artery using a catheter assembly of a renal denervation catheter
system. The denervation system may include an RF energy
generator coupled with the catheter assembly by a controller.
The method may also include applying neural activity
stimulation to the tissue proximate the renal artery using the
catheter assembly; assessing stimulated neural activity
response of the tissue using the catheter assembly; and
determining a parameter of the RF energy treatment based on
the assessed neural activity.
Mathur ¶ 222 (emphasis added). Although neither Appellant nor the
Examiner provides an explicit construction of the limitation “sensed intrinsic
tissue activity,” it is clear to us from the arguments and findings that the
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Examiner considers Mathur’s disclosure of “assessing stimulated neural
activity” as satisfying the claim language. Ans. 3. It is equally clear that
Appellant contends to the contrary. Reply Br. 4–5 (“this paragraph does not
indicate any location of tissue to be treated based on any detected activity”).
According to Appellant, Mathur’s device only provides feedback with
respect to temperature of tissue that is adjacent to the electrodes. Id. at 3.
Thus, the dispute between Appellant and the Examiner largely
revolves around the meaning of “sensed intrinsic activity.” During
examination of a patent application, pending claims are given their broadest
reasonable construction consistent with the specification. In re Am. Acad. of
Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under this standard,
claim terms are given their ordinary and customary meaning as would be
understood by one of ordinary skill in the art in the context of the entire
disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed.
Cir. 2007). Thus, the PTO is required to consult the specification during
examination in order to determine the permissible scope of the claim. In re
Morris, 127 F.3d 1048, 1055 (Fed. Cir. 1997). When Appellant provides an
explicit definition for a claim term in the specification, such definition
controls. See Renishaw PLC v. Marposs Societa’ Per Azioni, 158
F.3d 1243, 1249 (Fed. Cir. 1998). However, even when Appellant does not
provide guidance in explicit definitional format, it may define claim terms
implicitly such that the meaning may be ascertained from reading the
Application. See Irdeto Access, Inc. v. Echostar Satellite Corp., 383
F.3d 1295, 1300 (Fed. Cir. 2004).
Appellant uses the term “intrinsic” in relation to tissue repeatedly
throughout the Specification. Spec. ¶ 2, 11, 17, 25, 26, 32, 33. Appellant
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discloses that electrodes 114 measure electrical impulses that are intrinsic to
physiological activity of the anatomical structure they contact. Id. ¶¶ 24, 32.
Using signals received from electrodes 114, the processing/guiding
system 116 maps irregular contracting activity within the uterus and
identifies regions to which therapy is to be delivered to disrupt such irregular
contraction activity. Id. ¶ 33. Based on the output generated by the
processing/guidance system 116, a clinician may reposition electrode
structure 106 within the uterus. Id. Once therapy has been delivered to
electrodes 114, the intrinsic physiological activity of the uterus may be
mapped again by electrode structure 106 to confirm efficacy of the
treatment. Id. Appellant’s Specification differentiates between locating
target tissue using intrinsic electrical activity in the uterine wall and “other
known methods in the art” such as measuring temperature. Id. at 26.
Having reviewed Appellant’s claim language in light of the
Specification, we construe “determining a location” of target tissue based on
“sensed intrinsic tissue activity” narrowly so as to include measuring
electrical impulses that are intrinsic to tissue contacted by the electrode
assembly and so as to exclude “other” methods such as measuring
temperature. Thus, the issue before us is whether Mathur’s electrode
measures electrical impulses that are intrinsic to adjacent tissue or merely
measures temperature as argued by Appellant.
Figure 13A of Mathur depicts a block diagram of a method of
delivering RF ablation therapy. Mathur ¶ 451, Fig. 13A. Step 1313 in the
method queries whether “nerve activity reduction [has] been reached.” Id.
If the answer to this query is “no” and the answer to the subsequent query is
yes, step 1316 directs the device to “fire electrodes meeting criteria.” Id.
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¶ 428, Fig. 13A. According to Mathur, control loop step 1313 evaluates
whether a nerve signal reduction threshold has been met. Id. ¶ 451,
Fig. 13A. Mathur generates a nerve stimulation signal and then monitors for
a response. Id. ¶ 436. Neural activity is assessed by measuring the
amplitude or speed of the nerve signal in response to stimulation. Id. ¶ 438.
Mathur provides low stimulation signals in the vicinity of renal nerves to
access their activity pre and post renal denervation treatment. Id. ¶ 440.
The measurement technique employs electric stimulation over the path of a
nerve to evoke the generation of an action potential that spreads along the
excited nerve fibers. Id. ¶ 442. Such action potential is then recorded at
another point. Id. The distance between electrodes and the time required for
impulses to travel between electrodes are used to calculate nerve conduction
velocity. Id. Decreased speed of transmission indicates nerve damage. Id.
Velocity, amplitude, and shape of the response following electrical
stimulation of renal nerves is measured to determine conduction slowing,
blockage, lack of response, or lower amplitude response. Id. ¶ 443.
In Mathur, nerve signal stimulation and measurement may occur
before, during, and/or after the energy treatment. Id. ¶ 448. Regardless of
whether the nerve activity assessment is conducted pre and post treatment,
periodically between each treatment cycle, or periodically after a certain
number of treatment cycles, data from the neural activity assessments may
be used to establish or adjust parameters for the denervation treatment. Id.
¶ 450. Feedback from nerve signal assessment is used to vary parameters of
the denervation treatment. Id. Measuring nerve signals is integrated into the
energy delivery and control methods. Id. As candidate electrodes are
selected and energized in accordance with the control algorithm, nerve
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signal measuring is integrated into the control algorithm such that the control
factor of nerve response increases the precision with which energy is
delivered and a therapeutic response is achieved while avoiding the delivery
of excess energy. Id. At step 1313, if a nerve is determined to have reached
the signal reduction threshold, then the electrode may be deselected as a
candidate electrode to be energized. Id.
In view of the foregoing, Appellant’s statement that “[n]othing in
Mathur indicates that any feedback is produced by the device to indicate
which electrodes should be energized” is directly contradicted by the
evidence of record before us. Reply Br. 3. Appellant’s statement that the
“only” feedback in Mathur is based on temperature measurements is
similarly contradicted by the record. Id. at 4. Appellant’s statement that
nothing in paragraph 302 of Mathur indicates that denervation assessment is
made by “the device,” is also contrary to the evidence before us. Id. at 4.
Finally, Appellant’s argument that paragraph 222 does not indicate the
location of tissue to be treated based on detected activity is also contrary to
the record. Id. at 5.
Mathur receives signals associated with tissue activity that is sensed
by a plurality of electrodes. Mathur ¶¶ 428–51.2 Mathur features a
processor that is configured to receive signals and determine the location of
target tissue. Id. ¶¶ 168, 171, 174, 183. “The processor may be configured

2 Although ¶¶ 428–51 are not cited in the Final Action or Answer, it is not a
new ground of rejection to cite additional portions of the same reference
relied upon by the examiner. In re Meinhardt, 392 F.2d 273, 280
(CCPA 1968). We consider a reference in its entirety for what it fairly
suggests to one skilled in the art, and pointing to other portions of the same
reference used by the examiner is not viewed as being a new ground of
rejection. In re Hedges, 783 F.2d 1038 1039 (Fed. Cir. 1986).
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to control the delivery of energy to regulate one or more parameters of the
energy treatment based on monitoring feedback from at least some of the
electrical circuits.” Id. ¶ 183.
The only open question remaining for us to consider is whether the
electrical tissue activity that is sensed by Mathur is properly considered to be
“intrinsic.” Appellant’s Specification does not distinguish between
“intrinsic” and “extrinsic” tissue activity when it comes to receiving tissue
activity signals from electrodes. See generally Spec. In Mathur, electric
stimulation is introduced at a first electrode and then such signal is received
at a second electrode that is spaced apart from the first electrode. Mathur
¶ 442. The time required for the electrical impulse to travel between
electrodes is used to calculate nerve conduction velocity. Id. Such electrical
signal may be considered “intrinsic” in the sense that the signal passes
through the nerve. Appellant never argues that an electrical signal is
“extrinsic” if it originates from an electrode that is external to the nerve. See
generally Appeal Br. Appellant never offers a construction that
differentiates between “intrinsic” and “extrinsic” tissue activity that is
sensed by electrodes. Id. Consequently, we construe sensed “intrinsic”
tissue activity in a reasonable, but broad, manner to encompass the nerve
conduction activity described in paragraph 442 of Mathur. Am. Acad. of
Sci., 367 F.3d at 364 (explaining that construing claims broadly during
prosecution is not unfair, because Appellant has the opportunity to amend
claims to obtain more precise coverage).
The Examiner’s findings of fact are supported by a preponderance of
the evidence. In view thereof, we sustain the Examiner’s rejection of
claims 16–19, 21, 22, and 24 as anticipated by Mathur.
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Unpatentability of Claims 20, 23, and 25–30
over Combinations Based on Mathur
Claim 25 is an independent claim and claims 26–30 depend
therefrom. Claims App. Claims 20 and 23 depend, directly or indirectly,
from claim from claim 16. Id.
These claims are not separately argued apart from relying on
arguments advanced with respect to claim 16 which we have previously
considered and found unpersuasive. Appeal Br. 7–10. We recognize that
the Examiner’s ground of rejection for claim 16 is anticipation under 35
U.S.C. § 102 whereas the ground of rejection of this claims is obviousness
under 35 U.S.C. § 103. See Cohesive Tech., Inc., v. Waters Corp., 543
F.3d 1351, 1364 (Fed. Cir. 2008) (explaining that, although prior art
references that anticipate a claim will usually render that claim obvious, the
tests for anticipation and obviousness are different). Nevertheless, we
determine that Appellant has failed to demonstrate error with respect to the
Examiner’s Section 103 grounds of rejection. 37 C.F.R. § 41.37(c)(1)(iv)
(the Appeal Brief “shall explain why the examiner erred as to each ground of
rejection contested by appellant.”); see also In re Jung, 637 F.3d 1356, 1365
(Fed. Cir. 2011) (noting the Board’s long-standing practice under its rules to
require an applicant to identify the alleged error in an examiner’s rejections);
Halliburton Energy Services, Inc. v. M-I LLC, 514 F.3d 1244, 1250 n.2 (Fed.
Cir. 2008) (explaining that the Board will not, as a general matter, advocate
for appellants by scouring the record to see if it can identify some flaw in the
Examiner’s findings of fact, articulated reasoning, or legal conclusions).
We sustain the Examiner’s unpatentability rejections of claims 20, 23,
and 25–30.
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CONCLUSION
Claims
Rejected
35
U.S.C. §
References Affirmed Rev’d
16-19, 21,
22, 24
102 Mathur 16-19, 21,
22, 24

20 103 Mathur, Swanson 20
23 103 Mathur, Masson 23
25, 26, 28-30 103 Mathur, Masson 25, 26, 28-30
27 103 Mathur, Masson, Swanson 27
Overall
Outcome
16-30

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED