Derek C. Sutermeister et al.

Patent Trials and Appeals Board

Jul 23, 2019

14689363 - (D) (P.T.A.B. Jul. 23, 2019)

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.
14/689,363 04/17/2015 DEREK C. SUTERMEISTER 8150BSC0457 8772
121974 7590 07/23/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
EXAMINER
CAREY, MICHAEL JAMES
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
07/23/2019 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 DEREK C. SUTERMEISTER,
PATRICK A. HAVERKOST,
TIMOTHY A. OSTROOT,
CASS ALEXANDER HANSON,
JEFFREY S. LINDQUIST,
JOSEPH ALAN KRONSTEDT,
JAN WEBER,
JAMES M. ANDERSON, and
MARTIN R. WILLARD1
__________

Appeal 2019-000115
Application 14/689,363
Technology Center 3700
__________

Before MICHAEL L. HOELTER, LISA M. GUIJT, and
LEE L. STEPINA, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
This is an Appeal, under 35 U.S.C. § 134(a), from the Examiner’s
final rejection of claims 1–20. Final Act 1 (Office Action Summary). We

1 “The real party in interest in this Appeal is Boston Scientific Scimed, Inc.”
App. Br. 3. We refer to the appealing party as “Appellant.”
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have jurisdiction under 35 U.S.C. § 6(b). For the reasons explained below,
we affirm the Examiner’s rejection of independent claims 1–12, 19, and 20
as being indefinite, and we reverse the Examiner’s rejection of claims 13–18
as being obvious over Mathur and Uchida.
CLAIMED SUBJECT MATTER
The disclosed subject matter “pertains to medical devices, systems,
and methods for delivery of heat (e.g., therapeutic treatment using heat). In
one or more embodiments, the present disclosure pertains to heat treatment
for medical applications (e.g., nerve modulation or ablation, etc.).” Spec.
1:18–21. Claims 1, 13, and 19 are independent. Claim 1 is illustrative of the
claims on appeal, and is reproduced below.
1. A medical device for nerve modulation, the
medical device comprising:
an elongate shaft having a proximal end region and a
distal end region;
an expandable device positioned adjacent to the distal
end region of the elongate shaft; and
at least one thermistor array disposed on an outer surface
of the expandable device, the at least one thermistor array
comprising at least two thermistors and being operatively
engaged with a source of electric current, each of the at least
two thermistors having a resistance that varies with
temperature,
wherein the medical device is configured and arranged to
transfer heat to medical device surroundings,
wherein the at least two thermistors are configured and
arranged to increase in temperature to a treatment temperature
upon delivery of an electric current thereto, and
wherein at least 50 percent of the heat transferred from
the medical device to the medical device surroundings is
generated by resistance heating of the at least two thermistors.
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REFERENCES
Uchida et al. US 5,428,206 June 27, 1995
Mathur et al. US 2013/0165916 A1 June 27, 2013

THE REJECTIONS ON APPEAL
Claims 1 and 19 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C.
§ 112 (pre-AIA), second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter which the
inventor or a joint inventor, or for pre-AIA the applicant regards as the
invention.
Claims 1 and 19 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C.
§ 112 (pre-AIA), first paragraph, as failing to comply with the enablement
requirement.2
Claims 1–20 are rejected under 35 U.S.C. § 103 as unpatentable over
Mathur and Uchida.
ANALYSIS
The rejection of claims 1 and 19 as being indefinite.
The Examiner addresses the limitation found in both of these
independent claims (but not in independent claim 13) that “at least 50
percent of the heat transferred from the medical device to the medical device

2 This “enablement” rejection was first raised in the Examiner’s Answer.
See Ans. 3. The Examiner acknowledged that the “answer contains a new
ground of rejection” and accordingly, provided Appellant with two options,
either re-open prosecution or maintain the appeal. See Ans. 11. We
understand Appellant elected to maintain the appeal because this is
accomplished, as explained by the Examiner, “by filing a reply brief” (Ans.
11), and Appellant filed a Reply Brief.
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surroundings is generated by resistance heating of the . . . thermistors.3 The
Examiner finds this limitation indefinite because Appellant has not provided
a way for a skilled person “to avoid infringing on this claim” because
Appellant has not explained “how that at least 50 percent is measured to
have come from the thermistors.” Final Act. 3. MPEP § 2173 states, “[t]he
primary purpose of this requirement of definiteness of claim language is to
ensure that the scope of the claims is clear so the public is informed of the
boundaries of what constitutes infringement of the patent.”
Appellant disagrees with the Examiner’s assessment stating that a
skilled person “could readily determine” such a value “by using
relationships (e.g., Ohms law, etc.) that are known in the art for each heat
generating component.” App. Br. 7; see also Reply Br. 6, 7. Appellant
clarifies this stating, “with the understanding that such generated heat would
be released into the medical device surroundings.” Reply Br. 6, 7. The
Examiner, on the other hand, states that Appellant has not provided “a
definitive explanation for how heat transferred from the thermistors is
distinguishable from the heat generated by the medical device and
environmental heating sources,” such heat also be transferred to the medical
device surroundings as recited. Ans. 7. In other words, Appellant addresses
equations pertaining to heat generation (and makes an assumption with
respect thereto) whereas the Examiner is addressing the claim language of
“heat transferred.”4 It would appear that heat which is transferred is

3 Claim 1 recites “of the at least two thermistors” whereas claim 19 recites
“of the at least one thermistor.”
4 The Examiner states that the limitation in question “invokes that the
measured value is the heat transferred, not the heat generated.” Ans. 6.
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dependent on many factors, including distance from the heat source as well
as the thermal characteristics of the “surroundings” to which the heat is
transferred. Here, Appellant’s Specification states that “surroundings” “may
include a lumen wall (e.g., biological tissue, etc.),” and as such, a variety of
different “surroundings” (whether in the same patient, or different patients)
will have a variety of different heat absorbing characteristics affecting the
transfer of heat thereto.
We have been informed by our reviewing court that “a single claim
covering both an apparatus and a method of use of that apparatus” fails to
meet the requirements of § 112 because “it is unclear whether infringement .
. . occurs when one creates a[n infringing] system, or whether infringement
occurs when the user actually uses [the system in an infringing manner],”
e.g., attempts to transfer heat to the “surroundings.” IPXL Holdings, LLC v.
Amazon.com, Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005). In other words, “a
construction that would require empirical testing is incorrect.” Homeland
Housewares v. Whirlpool, 865 F.3d 1372, 1375 (Fed. Cir. 2017).
Accordingly, claim 1 is a claim wherein “one would be at a loss to determine
whether a particular [apparatus] is covered by [the] claim.” Ex parte
Brummer, 12 USPQ.2d 1653, 1655 (BPAI 1989).
We agree with the Examiner that the claims are not so clear that “the
public is informed of the boundaries of what constitutes infringement of the
patent.” MPEP § 2173. In other words, Appellant has not explained how
one skilled in the art would be able to ascertain (without, perhaps, empirical
testing) the measure of heat transferred from the thermistors to a patient’s
surroundings, in order to avoid infringement. Accordingly, we sustain the
Examiner’s rejection of independent claims 1 and 19, and their dependent
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claims 2–12 and 20, as being indefinite. Because we sustain the Examiner’s
rejection of these claims as being indefinite, we decline to additionally
address the Examiner’s further rejections of these same claims based on (a) a
lack of enablement and (b) being obvious over Mathur and Uchida. See 37
C.F.R. § 51.50(a)(1). Our election to not address these further rejections is
no indication that claims 1–12, 19, and 20 are, or are not, enabled and/or
obvious.
The rejection of claims 13–18
as being obvious over Mathur and Uchida
Independent claim 13 (and hence dependent claims 14–18), includes
the limitation “with the proviso that no electrode is associated with the
conductive layer.” The Examiner relies on the teachings of Mathur, and a
dictionary definition of “associated,” in finding this limitation obvious. See
Ans. 9–11. However, Mathur expressly teaches:
An electrode 222 is shown layered over a portion of the
insulating layer 206, which has a plurality of passages (e.g.,
holes) to enable the electrode 222 to couple to the elongated
electrode support 216 of the ground trace 210 (of conductive
layer 204).
Mathur ¶ 327; see also Fig. 2B. Mathur, thus, both describes and illustrates
a plurality of passages/holes that “enable the electrode 222 to couple to” a
part of “conductive layer 204.” In view of such teachings, we are not
persuaded by the Examiner’s opposite findings that, instead, in Mathur, no
electrode is associated with the conductive layer. See Ans. 10, 11. In other
words, the Examiner finds that because the different materials of Mathur’s
two components are not “in anyway combined, such as through welding”
(Ans. 10), that this renders Mathur’s two components as not being
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“associated” with each other. Such a finding is a mischaracterization of the
explicit teachings of Mathur above.
Accordingly, we reverse the Examiner’s rejection of claims 13–18 as
being obvious over Mathur and Uchida.

DECISION
The Examiner’s rejection of claims 1–12, 19, and 20 as being
indefinite is affirmed.
As indicated, we did not address the Examiner’s further rejection of
claims 1–12, 19, and 20 as lacking enablement or being obvious in view of
Mathur and Uchida.
The Examiner’s rejection of claims 13–18 as being obvious over
Mathur and Uchida is reversed.
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-IN-PART