MEDTRONIC, INC.

Patent Trials and Appeals Board

Jun 2, 2021

2020005418 (P.T.A.B. Jun. 2, 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.
13/749,237 01/24/2013 Jamu Alford C00004225.USU2/
LG10137L33
1910
71996 7590 06/02/2021
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
MEHL, PATRICK M
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
06/02/2021 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMU ALFORD, STEVEN M. GEOTZ,
LOTHAR KRINKE, MARK S. LENT,
ERIK R. SCOTT, XUAN K. WEI, and
JOHN D. WELTER1
Appeal 2020-005418
Application 13/749,237
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FREDMAN and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims relating
to planning and delivery of neuromodulation therapy, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as Medtronic, Inc. Appeal
Br. 3. We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42.
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Application 13/749,237

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STATEMENT OF THE CASE
“The disclosure relates generally to a medical diagnostic and therapy
management system, and, more specifically, a medical diagnostic and
therapy management system that uses ultrasound waveforms focused on
neural targets.” Spec. 1.
The Specification states that
[b]ecause the ultrasonic stimulation can be used to activate or
inhibit or block neural activity, ultrasound waveforms may be
focused at dual or multi-site locations to simulate the effects of
cathodes and anodes. Therefore, focusing of ultrasound energy
at multiple sites (one or more sites to stimulate the tissue and
one or more other sites to inhibit stimulation) can be used to
determine effective electrode combinations and the types of
leads that should be used for delivering or steering electrical
stimulation with implanted electrodes.
Id. at 35.
Claims 1–15, 17–40, and 50–54 are on appeal. Claim 50, reproduced
below, is illustrative (emphasis added):
50: A method comprising:
identifying, using a neuromodulation therapy planning
system that includes an ultrasound transducer array externally
positioned relative to a patient, one or more therapy parameters,
wherein identifying the one or more therapy parameters
comprises causing, at a first time, the ultrasound transducer
array to deliver ultrasound waveforms for causing
neuromodulation of neural tissue in the patient that simulates
neuromodulation of the neural tissue that would be caused by
electrical stimulation via an implantable electrical stimulation
system; and
causing, at a second time that is after than the first time,
the implantable electrical stimulation system implanted in the
patient to deliver neuromodulation therapy to the patient using
the identified one or more therapy parameters.

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Application 13/749,237

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Claims 1 and 21 are the other independent claims and are directed to a
system and method, respectively. Both claim 1 and claim 21 recite “delivery
of [or delivering] ultrasound waveforms for causing neuromodulation of
neural tissue in a patient that simulates neuromodulation of the neural tissue
that would be caused by electrical stimulation via an implantable electrical
stimulation system.”
The claims stand rejected as follows:
Claims 50–54 under 35 U.S.C. § 103(a) as obvious based on Wagner2
and Dilorenzo3 (Final Action4 14);
Claims 1–12, 15, 17–32, and 35–40 under 35 U.S.C. § 103(a) as
obvious based on Wagner, Macé,5 and Dilorenzo (Final Action 3);
Claims 13 and 33 under 35 U.S.C. § 103(a) as obvious based on
Wagner, Macé, Dilorenzo, and Ishibashi6 (Final Action 12); and
Claims 14 and 34 under 35 U.S.C. § 103(a) as obvious based on
Wagner, Macé, Dilorenzo, and Cupples7 (Final Action 13).
OPINION
Claims 50–54
Claims 50–54 stand rejected as obvious based on Wagner and
Dilorenzo. The Examiner finds that Wagner discloses almost all of the
limitations of claim 50, including

2 US 2011/0245734 A1, pub. Oct. 6, 2011.
3 US 2007/0150025 A1, pub. June 28, 2007.
4 Office Action mailed August 28, 2019.
5 Emilie Macé et al. Functional ultrasound imaging of the brain, NATURE
METHODS 8:662–664 (2011).
6 US 6,267,734 B1, iss. July 31, 2001.
7 US 6,675,038 B2, iss. Jan. 6, 2004.
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Application 13/749,237

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causing, at a first time, the ultrasound transducer array to
deliver ultrasound waveforms for causing neuromodulation
of neural tissue in the patient (determining/identifying one or
more parameters to apply ultrasonic stimulation or electrical
stimulation application to a targeted region of interest [0067]-
[0069] the determination being made either pre, during or post
stimulation, wherein the determination/identification of the one
or more therapy parameters before the application to the cause
the neuromodulation of the neural tissue in the patient is a
matter of choice of engineering design as taught by Wagner for
the purpose of applying the right stimulation to the right
location with the right amplitude as suggested by Wagner
([0080] for causing the ultrasound transducer array to deliver
ultrasound waveforms for causing neuromodulation of neural
tissue in the patient), ]) that simulates neuromodulation of
the neural tissue that would be caused by electrical
stimulation via an implantable electrical stimulation system
of the neuromodulation therapy delivery system ([0073]
implanted Deep Brain Stimulation DBS and Ultrasound
stimulation both being used for neurostimulation wherein both
are directed to the similar region of interest as in Figs.1 and 2
and wherein the computer/processor can calculated the
stimulation characteristics for the different modes of
stimulation, as in [0067]-[0069], therefore the neurostimulation
performed using the ultrasound can be correlated and translated
into neurostimulation performed using the implanted DBS
reading therefore on the ultrasound causing neuromodulation
that simulates neuromodulation of the neural tissue that would
be caused by electrical stimulation via an implantable electrical
stimulation system of the neuromodulation therapy delivery
system as claimed).
Final Action 15–16.
“Appellant respectfully disagrees with the position advanced by the
Examiner.” Appeal Br. 7. Appellant argues that “Wagner describes ‘methods
for treating osteoarthritis,’” in which “a ‘mechanical source such as an
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Application 13/749,237

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ultrasound source 16 is applied on the scalp and provides concentrated
acoustic energy 18.’” Id.
Appellant argues that
Wagner further provides that “the targeted region can be
imaged with any imaging modality that provides anatomical
information about the region.” Wagner states that the “image
could then be used to determine the placement of the
stimulation source.” According to Wagner, “with an
electrosonic (electrical source and mechanical (i.e.,
sonic/ultrasound) . . . ) approach one would determine
placement of the electrical source and the ultrasound source to
target the desired regions. . . .”
Id. at 8 (footnote omitted, alteration in original). Appellant concludes that
Wagner fails to disclose or suggest anything even remotely
similar to “simulat[ing] neuromodulation of the neural tissue
that would be caused by electrical stimulation via an
implantable electrical stimulation system,” as recited by claim
50. In particular, Wagner makes absolutely no mention of any
simulation of neuromodulation, much less using ultrasonic
waveforms to simulate neuromodulation “that would be caused
by electrical stimulation via an implantable electrical
stimulation system,” as claimed.
Id. (alteration in original).
Appellant reasons that, “[a]s such, even taking the Examiner’s
unsupported statement that ‘the neurostimulation performed using the
ultrasound can be correlated and translated into neurostimulation performed
using the implanted DBS’ as true, Wagner provides no disclosure or
suggestion of performing such a correlation and translation.” Id. at 9.
Finally, Appellant argues that “Dilorenzo fails to cure this deficiency of
Wagner.” Id.
We agree with Appellant that the Examiner has not persuasively
shown that the disputed limitation—“deliver[ing] ultrasound waveforms for
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causing neuromodulation of neural tissue in the patient that simulates
neuromodulation of the neural tissue that would be caused by electrical
stimulation via an implantable electrical stimulation system”—would have
been obvious based on Wagner.8
Wagner states that its invention “relates to methods for treating
osteoarthritis.” Wagner ¶ 5. Specifically, the methods “focus stimulation in
select regions of the central nervous system (e.g., brain and/or spinal cord) to
block processing of pain signals received by the brain from an injured joint.”
Id.
With regard to providing ultrasound that “simulates neuromodulation
of the neural tissue that would be caused by electrical stimulation via an
implantable electrical stimulation system,” as recited in all of the
independent claims, the Examiner cites Wagner’s disclosure of “implanted
Deep Brain Stimulation DBS and Ultrasound stimulation both being used for
neurostimulation” (Final Action 15, citing Wagner ¶ 73), “wherein both are
directed to the similar region of interest as in Figs.1 and 2 and wherein the
computer/processor can calculate[] the stimulation characteristics for the
different modes of stimulation” (id. at 15–16, citing Wagner’s ¶¶ 67–69).
See also Final Action 4 (citing the same disclosures with respect to the
analogous limitations in independent claims 1 and 21).

8 The Examiner relies on Dilorenzo only for the claim limitation requiring
“causing, at a second time that is after than the first time, the implantable
electrical stimulation system implanted in the patient to deliver
neuromodulation therapy to the patient using the identified one or more
therapy parameters.” Final Action 17. Therefore, we will not further discuss
Dilorenzo.
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We have reviewed the cited passages but do not find any description
in them of “deliver[ing] ultrasound waveforms for causing neuromodulation
. . . that simulates neuromodulation . . . that would be caused by electrical
stimulation via an implantable electrical stimulation system,” as recited in all
of the independent claims.
The Examiner’s explanation also does not persuade us that Wagner
discloses the disputed limitation. Claim 50 does not recite “implanted Deep
Brain Stimulation DBS and Ultrasound stimulation both being used for
neurostimulation.” Final Action 15. It recites first delivering ultrasound
waveforms that cause neurostimulation that simulates the neurostimulation
that would be caused by an implantable electrical system, and then
delivering neurostimulation by the implantable electrical system. The
Examiner’s explanation does not account for either the “simulating” or
sequential administration required by the claim.
The Examiner’s reasoning that both the DBS and ultrasound “are
directed to the similar region of interest” and “the computer/processor can
calculate[] the stimulation characteristics for the different modes of
stimulation” (Final Action 15–16) also does not persuade us that Wagner
discloses delivering ultrasound waveforms that cause neurostimulation that
simulates the neurostimulation that would be caused by an implantable
electrical system, as required by claim 50. Nor does the Examiner’s
reasoning persuade us that the disputed limitation would have been obvious
to a person of ordinary skill in the art, despite not being expressly disclosed.
And, as noted above (footnote 8), the Examiner does not point to any
disclosure of this limitation in Dilorenzo.
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Application 13/749,237

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We conclude that the Examiner has not shown, by a preponderance of
the evidence, that a method meeting all of the limitations of claim 50 would
have been obvious based on Wagner and Dilorenzo. We therefore reverse
the rejection of claim 50 under 35 U.S.C. § 103(a), as well as the rejection of
dependent claims 51–54.
Claims 1–15 and 17–40
Claims 1–15 and 17–40 stand rejected as obvious based on Wagner
and Dilorenzo, combined with other references, as follows: (a) claims 1–12,
15, 17–32, and 35–40 based on Wagner, Macé, and Dilorenzo; (b) claims 13
and 33 based on Wagner, Macé, Dilorenzo, and Ishibashi; and (c) claims 14
and 34 based on Wagner, Macé, Dilorenzo, and Cupples.
As noted above, independent claims 1 and 21 also require “delivery of
[or delivering] ultrasound waveforms for causing neuromodulation of neural
tissue in a patient that simulates neuromodulation of the neural tissue that
would be caused by electrical stimulation via an implantable electrical
stimulation system.” The Examiner relies on the same paragraphs in Wagner
with respect to this limitation for claims 1 and 21 as for claim 50. Final
Action 4. The Examiner does not point to any disclosure of this limitation in
Dilorenzo or Macé. See Final Action 5, 6. The Examiner relies on Ishibashi
and Cupples only for limitations of dependent claims. Id. at 13, 14.
For the reasons explained above with respect to claim 50, neither the
Examiner’s explanation nor Wagner’s disclosure persuade us that Wagner
discloses “delivery of [or delivering] ultrasound waveforms for causing
neuromodulation . . . that simulates neuromodulation . . . that would be
caused by electrical stimulation via an implantable electrical stimulation
system,” as required by independent claims 1 and 21.
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We therefore reverse the rejection of claims 1 and 21 under 35 U.S.C.
§ 103(a), as well as the rejection of dependent claims 2–15, 17–20, and 22–
40.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/
Basis
Affirmed Reversed
50–54 103(a) Wagner,
Dilorenzo
50–54
1–12, 15,
17–32, 35–
40
103(a) Wagner,
Macé,
Dilorenzo
1–12, 15, 17–
32, 35–40
13, 33 103(a) Wagner,
Macé,
Dilorenzo,
Ishibashi
13, 33
14, 34 103(a) Wagner,
Macé,
Dilorenzo,
Cupples
14, 34
Overall
Outcome
1–15, 17–40,
50–54

REVERSED