Ex Parte HASTINGS et al

Patent Trial and Appeal Board

Feb 22, 2019

14032553 (P.T.A.B. Feb. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/032,553 09/20/2013
121974 7590 02/26/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
FIRST NAMED INVENTOR
ROGER N. HASTINGS
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
8150BSC0189 4685
EXAMINER
DORNBUSCH, DIANNE
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
02/26/2019 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 ROGER N. HASTINGS and MARK L. JENSON 1
Appeal2018-000774
Application 14/032,553
Technology Center 3700
Before JAMES P. CAL VE, MICHELLE R. OSINSKI, and
ARTHUR M. PESLAK, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 8, 10, 13, 14, and 23, which are all of the pending
claims. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Boston Scientific Scimed, Inc. ("Appellant"), is the Applicant as provided
in 37 C.F.R. § 1.46 and is identified as the real party in interest. Appeal
Br. 3.
Appeal2018-000774
Application 14/032,553
THE CLAIMED SUBJECT MATTER
Claim 8, the sole independent claim, is reproduced below.
8. A method for performing intravascular nerve modulation, the
method comprising:
providing a nerve modulation system comprising:
an elongate shaft having a proximal end region and
a distal end region;
a first transducer disposed adjacent the distal end
region; and
a second transducer disposed adjacent to the first
transducer;
advancing the nerve modulation system through a lumen
such that the first transducer is adjacent to a first target region;
supplying a first current to the first transducer to generate
a first acoustic energy that is directed to the first target region
such that a temperature of the first target region is raised to a first
temperature that is sufficient to generate a thermal nerve block;
and
supplying a second current to the second transducer to
generate a second acoustic energy different from the first
acoustic energy, said second acoustic energy directed to a second
target region adjacent to the second transducer such that a
temperature of the second target region is raised to a second
temperature that is greater than the first temperature and is
sufficient to perform nerve modulation.
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Crowley
Gross
us 5,630,837
WO 2012/120495 A2
THE REJECTIONS
May 20, 1997
Sept. 13, 2012
I. Claims 8, 10, 13, 14, and 23 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite. Final Act. 2-3; Ans. 2.
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Application 14/032,553
II. Claims 8, 10, 13, 14, and 23 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Crowley and Gross. Final Act. 10-
13; Ans. 2.
OPINION
Rejection I
In determining whether a claim is definite under 35 U.S.C. § 112,
second paragraph, "[t]he USPTO, in examining an application, is obliged to
test the claims for reasonable precision." In re Packard, 751 F.3d 1307,
1313 (Fed. Cir. 2014 ). "[A] claim is indefinite when it contains words or
phrases whose meaning is unclear." Id. at 1322 (citing MPEP § 2173.05(e))
(9th ed. 2018).
The Examiner determines that the recitation of "a first temperature
that is sufficient to generate a thermal nerve block" and "a second
temperature that is . . . sufficient to perform nerve modulation" renders the
claims indefinite because "it is unclear to the [E]xaminer what the sufficient
temperature would be." Final Act. 3 ( emphasis omitted). More particularly,
the Examiner determines that "[t]he term 'sufficient' is not defined by the
claim [and] the [S]pecification does not provide a standard for ascertaining
the requisite degree." Ans. 3.
The Examiner also determines that "[a] person of ordinary skill in the
art would not understand what the temperature would be to perform nerve
modulation since it may vary depending on the patient's size and body
temperature as well as the temperature of the target region of the patient."
Id. The Examiner also points out that "the [S]pecification states a
temperature which is dependent on the body temperature of the patient." Id.
at 4.
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Application 14/032,553
Appellant responds that one of ordinary skill in the art would
understand what temperatures are sufficient to perform thermal nerve block
and nerve modulation because the "procedures are well known in the art."
Appeal Br. 6. Appellant also points to the Specification (id. at 7), which
describes a temperature increase of 5-10 QC greater than surrounding body
temperature, i.e., "approximately 40- 49 QC, depending on the body
temperature of the patient" as being suitable for a thermal nerve block.
Spec. 10:16-20; see also id. at 5:15-17, 19-23. The Specification further
contrasts the temperature sufficient to generate a thermal nerve block with
"the point at which tissue begins to denature or irreversibly change, for
example, approximately 50-60QC," which we understand would correspond
to temperatures for nerve modulation (or ablation). Id. at 10:21-24; see also
id. at 5:23-27 (describing "the application of energy at a power, frequency,
and duration to raise the temperature of a target region to at least a
temperature at which tissue begins to denature or cause irreversible tissue
changes" as "high energy" or "high intensity") and id. at 16:12-14
( describing the application of energy "at a higher intensity to perform tissue
modulation"). In view of the identified description in the Specification, we
view there to be an objective standard by which the temperatures sufficient
to generate a thermal nerve block and to perform nerve modulation can be
ascertained when reading the disclosure.
As to the remaining bases of the Examiner's rejection, Appellant
responds that "the Examiner has not provided any citation in support for the
assertion that the temperature to perform nerve modulation may vary
depending on the patient's size and body temperature." Reply Br. 7.
Appellant also responds that "body temperature is relatively constant
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Application 14/032,553
(human body temperature is generally recognized as being 37 QC and a
health care professional would presumably not perform intravascular nerve
modulation operation on a patient with a high fever), so that any variation is
very slight." Id. at 8. We agree with Appellant that there is a very small
variability in body temperature, and in light of the specific ranges of
temperature set forth in the Specification as being sufficient to generate a
thermal nerve block and to perform nerve modulation, respectively, the
claim language is definite.
For these reasons, we do not sustain the rejection of claims 8, 10, 13,
14, and 23 under 35 U.S.C. § 112, second paragraph, as being indefinite.
Rejection II
The Examiner finds that Crowley teaches:
a method for performing intravascular tissue modulation, the
method comprising: . . . supplying a first current to a first
transducer to generate a first acoustic energy that is directed to
the first target region such that the temperature of the first target
region is raised to a first temperature that is sufficient to generate
a thermal nerve block (Fig. 2-5 and col. 5, 11. 1-56)[;] and
supplying a second current to the second transducer to generate
a second acoustic energy . . . directed to a second target region
adjacent to the second transducer such that a temperature of the
second target region is raised to a second temperature that is
greater than the first temperature and is sufficient to perform
nerve modulation (Fig. 2-5 and col. 5, 11. 1-56).
Final Act. 10-11.
The Examiner finds that "Crowley discloses the invention essentially
as claimed except for performing intravascular nerve modulation[, but] does
disclose using the transducers to ablate selected tissue." Id. at 11 (citing
Crowley 4:48---67). The Examiner finds that "Gross teaches an intravascular
nerve modulation system in which treatment energy is transmitted from a
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Appeal2018-000774
Application 14/032,553
transducer in order to heat the nerve in order to inhibit or block signal
conduction through the nerve as well as in order to perform nerve
modulation, specifically nerve ablation." Id. (citing Gross 1:16-25, 26:17-
27). The Examiner concludes that it would have been obvious "to modify
the transducers of Crowley [to] be able to be configured to perform nerve
inhibition as well as nerve modulation, as taught by Gross, in order to treat
hypertension by blocking signal conduction through the nerve through
blocking or modulating the nerve." Id. at 12-13 (citing Gross 1, 26).
Appellant argues that "Crowley is directed to cardiac tissue ablation in
conjunction with cardiac arrhythmias ... and to changing the phase and
frequency applied to transducer rings in order to change the acoustic energy
radiation patterns that are produced" (Appeal Br. 9), rather than to raising
tissue to temperatures sufficient to perform thermal nerve block and nerve
modulation, specifically (id. at 9-10). Appellant argues that "Gross does not
make up for these deficiencies in Crowley" (id. at 10), and fails to disclose
or suggest a method that raises the temperatures of first and second target
regions to temperatures sufficient to generate a thermal nerve block and
perform nerve modulation, respectively (id. at 11 ).
Although Crowley teaches "applying power to different combinations
of transducers 526 [to] generate different radiation patterns" (Crowley, 5:9-
12) and Gross discloses both (i) modification of the function of nerve tissue
by heating to temperatures between 37--45 QC without causing ablation (see,
e.g., Gross 2:5-9, 3:16-20) and (ii) "partial or complete ablation" (see, e.g.,
id. at 26:24--27) including thermal energy applied in "a wide range of
temperatures, ... 45---60 C , or 60-100 C"), the Examiner has not adequately
explained what would have led one of ordinary skill in the art to modify the
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Application 14/032,553
transducers of Crowley so as to perform both nerve inhibition and nerve
modulation in connection with adjacent transducers on an elongate shaft of a
nerve modulation system. That is, Gross teaches that "for some applications
relating to treatment of renal nerve tissue, it is sufficient to heat the nerve
tissue without causing ablation" ( Gross 3: 16-17), and that "[ t ]he treatment
energy applied to the tissue typically causes heating of the tissue without
ablation (or alternatively, partial or complete ablation)" (id. at 26:24--26),
but provides no indication as to when applications causing mere heating
versus ablation would be desirable and/or that such applications resulting in
mere heating and ablation should be utilized in combination as opposed to
alternatively. Therefore, the Examiner has not adequately explained how the
teachings of Gross would have led one of ordinary skill in the art to modify
adjacent transducers on an elongate shaft of Crowley such that a first
transducer generates acoustic energy to raise a temperature of a first target
region to a first temperature sufficient to generate a thermal nerve block and
a second transducer generates acoustic energy to raise a temperature of a
second target region to a second, greater temperature that is sufficient to
perform nerve modulation.
For the foregoing reasons, Appellant apprises us of error in the
Examiner's conclusion that the combination of Crowley and Gross renders
obvious the subject matter of claim 8. We do not sustain the rejection of
claim 8, and claims 10, 13, 14, and 23 depending therefrom, under 35 U.S.C.
§ 103(a) as unpatentable over Crowley and Gross.
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Application 14/032,553
DECISION
The Examiner's decision to reject claims 8, 10, 13, 14, and 23 under
35 U.S.C. § 112, second paragraph, as being indefinite is reversed.
The Examiner's decision to reject claims 8, 10, 13, 14, and 23 under
35 U.S.C. § 103(a) as unpatentable over Crowley and Gross is reversed.
REVERSED
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