Ex Parte Wu et al

Patent Trial and Appeal Board

Oct 26, 2016

12616513 (P.T.A.B. Oct. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/616,513 1111112009
71996 7590 10/28/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
JianpingWu
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.
1023-884USOl/P0034127.00 2680
EXAMINER
BERTRAM, ERIC D
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
10/28/2016 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
medtronic _neuro _ docketing@cardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JIANPING WU, DWIGHT E. NELSON,
XIN SU, and GREGORY F. MOLNAR
Appeal2015-001048
Application 12/616,513
Technology Center 3700
Before JAMES P. CALVE, LEE L. STEPINA, and
FREDERICK C. LANEY, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-28. Appeal Br. 6. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Appeal2015-001048
Application 12/616,513
CLAIMED SUBJECT MATTER
Claims 1, 13, 24, and 26 are independent. Claim 1 is reproduced
below.
1. A method comprising, with one or more processors:
determining a sleep stage of a patient;
controlling an electrical stimulation device to deliver
electrical stimulation to a substantia nigra of a brain of the
patient based on the determined sleep stage; and
controlling the electrical stimulation device to deliver
electrical stimulation to a subthalamic nucleus of the brain of
the patient based on the determined sleep stage of the patient,
wherein delivery of electrical stimulation to the
substantia nigra and delivery of electrical stimulation to the
subthalamic nucleus are independently controlled by the one or
more processors.
REJECTION
Claims 1-28 are rejected under 35 U.S.C. § 102(a, e) as anticipated
by, or in the alternative, under 35 U.S.C. § 103(a) as unpatentable over, Wu
(US 2009/0192556 Al, pub. July 30, 2009).
ANALYSIS
The Examiner found that Wu discloses a system and method of claims
1, 13, 24, and 26, that determines a patient's sleep stage using brain signals
and controls electrical stimulation device 16 to deliver electrical stimulation
independently to one or more target tissues that include the substantia nigra
and subthalamic nucleus based on a sleep stage of the patent. Final Act. 5.
Alternatively, the Examiner determined that it would have been obvious to
deliver stimulation to the substantia nigra and subthalamic nucleus because
Wu discloses a finite number of target locations including these regions and
discloses that leads can be implanted at multiple target tissue sites. Id.
2
Appeal2015-001048
Application 12/616,513
Appellants argue that Wu discloses therapy is delivered to a patient
based on the determined sleep state of the patient, but Wu does not disclose
that delivery of electrical stimulation to two different locations in the brain is
independently controlled based on the determined sleep stage. Appeal Br. 8.
Appellants also argue that Wu does not disclose independently controlling
the delivery of electrical stimulation to the particular combination of target
tissue sites of the substantia nigra and the subthalamic nucleus. Id. at 8, 17,
20-21. Appellants further argue that delivering separate stimulation pulses
with different leads does not necessarily require independent control of the
delivery of electrical stimulation to the different tissue sites based on a
determined sleep stage. Id. at 9. Appellants assert that their Specification
discloses the independent control of stimulation as stimulation delivered to
the subthalamic nucleus at different times based on different parameters,
such as different sleep stages or brain signals, than the stimulation to the
substantia nigra. Id. at 9-10. We agree.
The Examiner has not established by a preponderance of evidence that
Wu teaches or suggests independently controlling the delivery of electrical
stimulation to the substantia nigra and subthalamic nucleus by one or more
processors based on a determined sleep stage as recited in the independent
claims 1, 13, 24, and 26. Appellants disclose independent control of therapy
as allowing electrical stimulation to be delivered to the subthalamic nucleus
at a different time based on different parameters (different sleep stages or
brain signals) than to the substantia nigra. Spec. i-f 23. Stimulation may be
delivered to the substantia nigra and the subthalamic nucleus via different
electrodes of a single lead or via different electrodes of two or more leads so
the electrodes independently stimulate those regions. Id. i-f 25, Figs. 5A, 5B.
3
Appeal2015-001048
Application 12/616,513
The Examiner's determination that Wu's delivery of stimulations to
separate leads inherently or obviously requires different control parameters
to be used to generate a pulse and direct it to the proper lead is not supported
by a preponderance of evidence. See Ans. 4--5. Wu's disclosure of delivery
of electrical stimulation to multiple regions of the brain via two leads does
not necessarily indicate that Wu's system independently controls delivery of
that electrical stimulation to the substantia nigra independent of control of an
electrical stimulation to the subthalamic nucleus. Wu discloses that multiple
leads 20 may be positioned in different locations of the brain that include the
substantia nigra and subthalamic nucleus (Wu i-f 66), but the Examiner has
not explained how this disclosure necessarily requires electrical stimulation
via lead 20A to be controlled independently of electrical stimulation via lead
20B at two different sites based on determined sleep stages. Nor has the
Examiner offered persuasive reasoning with rational underpinning to explain
why it would have been obvious to modify Wu's system to independently
control of electrical stimulation to the substantia nigra and the subthalamic
nucleus as claimed. 1
1 Wu discloses that stimulation therapy may be delivered to the subthalamic
nucleus to treat movement disorders such as Parkinson's disease but other
aspects of a patient's sleep may remain unimproved and require delivery of
dynamic therapy configured to address particular sleep disorder symptoms
based on the patient's sleep stage. Wu i-f 55. Wu also discloses that therapy
programs may be delivered by DBS system 10, which includes a processor,
during detected sleep stages and may be decreased or deactivated upon the
detection of particular sleep stages. i-fi-1 46, 49-51. Wu further discloses that
therapy delivery sites for therapy delivery during one or more sleep stages of
a patient may be the same as or different from the therapy delivery sites used
to deliver therapy to a patient to manage the patient's other conditions such
as a neurological disorder during a sleep stage. Id. i-f 59. Thus, where a
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Appeal2015-001048
Application 12/616,513
Moreover, we are not persuaded that selection of the substantia nigra
and subthalamic nucleus as sites for the claimed electrical stimulation would
have been obvious to try from a finite number of locations as the Examiner
found. Final Act. 5. Wu discloses "[e]xample locations" for leads that
include the claimed regions of the brain and many other locations without
any indication of the predictability or likelihood of success of one site versus
another in treating any particular disorder. See Wu i-f 66. Therefore, it is not
clear that the claimed regions are part of a finite number of regions or that
the selection of a particular region yields a predictable solution for
stimulation therapy or any particular therapy.2
Thus, we do not sustain the rejection of claims 1-28.
DECISION
We REVERSE the rejection of claims 1-28.
REVERSED
therapy program group includes two or more therapy programs, stimulation
therapy may be delivered simultaneously or on a time-interleaved basis,
either in an overlapping or non-overlapping manner. Id. i-f 64. Wu discloses
that leads may be positioned to manage a patient's symptoms associated
with sleep impairment together with a neurological disorder of the patient
such as a movement disorder. Id. i-f 66.
2 Wu does disclose that delivery of stimulation therapy to the subthalamic
nucleus may be an effective treatment for movement disorders such as
Parkinson's disease, but other aspects of a patient's sleep may require more
treatment. Wu i-f 55. This teaching might motivate a skilled artisan to try the
other sites identified in paragraph 66 of Wu to treat a sleep disorder and thus
to arrive at the claimed combination of substantia nigra and subthalamic
nucleus as sites for treating a movement disorder and separate sleep disorder
of a patient.
5