Ex Parte Makous et al

Patent Trial and Appeal Board

Sep 22, 2016

12976764 (P.T.A.B. Sep. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/976,764 12/22/2010 James C. Makous
42074 7590 09/26/2016
Faegre Baker Daniels LLP
PATENT DOCKETING - INTELLECTUAL PROPERTY (32469)
2200 WELLS FARGO CENTER
90 SOUTH SEVENTH STREET
MINNEAPOLIS, MN 55402-3901
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.
09-00177US02 8059
EXAMINER
OROPEZA,FRANCESP
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
09/26/2016 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):
PatentDocketing@FaegreBD.com
e-OfficeActionBSC@FaegreBD.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES C. MAKOUS, COURTNEY LANE, KRISTEN JAAX,
and ANDREW DIGIORE
Appeal2014-008582
Application 12/97 6, 7 64
Technology Center 3700
Before EDWARD A. BROWN, LEE L. STEPINA, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
James C. Makous et al. (Appellants) 1 appeal under 35 U.S.C. § 134
from the Examiner's decision rejecting claims 1-3 and 8-13. 2 We have
jurisdiction over this appeal under 35 U.S.C. § 6(b).
SUMMARY OF DECISION
We AFFIRM.
1 According to Appellants, the real party in interest is Boston Scientific
Neuromodulation Corporation. App. Br. 2.
2 Claims 4--7 are withdrawn. Id.
Appeal2014-008582
Application 12/976,764
SUMMARY OF INVENTION
Appellants disclose "methods for treating disorders via brain
stimulation." Spec. i-f 2. Claim 1, reproduced below from page 9 (Claims
Appendix) of the Appeal Brief, is the sole independent claim and is
representative of the claimed subject matter:
1. A method for treating a patient having a dysfunction
using a stimulation lead implanted within the brain of the
patient, the implanted stimulation lead carrying a plurality of
electrodes located adjacent a respective plurality of regions of
the brain, the method comprising:
generating a plurality of pulsed electrical waveforms,
each pulsed electrical waveform having a different set of
stimulation parameters; and
concurrently delivering the plurality of pulsed electrical
waveforms respectively to the plurality of electrodes, thereby
stimulating the plurality of brain regions to treat the
dysfunction.
REJECTION
Claims 1-3 and 8-13 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Jaax (US 2007/0100389 Al, pub. May 3, 2007) and Okun
(US 2008/0103547 Al, pub. May 1, 2008).
ANALYSIS
Claims 1, 2, and 8-13
Regarding independent claim 1, the Examiner finds that Jaax discloses
the invention substantially as claimed, but does not disclose "the waveforms
being delivered concurrently." Final Act. 2-3 (citing Jaax, i-fi-111, 12, 15,
75-77, 128, 150; Abstract; and Figs. 4, 9). The Examiner finds that Okun
teaches stimulation of a plurality of brain regions "for the purpose of treating
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Application 12/976,764
movement disorders, specifically Parkinson's Disease" and "concurrent
neural stimulation in deep brain stimulation therapy for the purpose of
providing effective treatment to the patient," and reasons that it would have
been obvious to a skilled artisan to provide concurrent neural stimulation to
the brain regions taught by Okun with the system disclosed by Jaax "in order
to utilize a proven location and proven treatment protocol so effective
treatment can be provided to the patient, the treatment providing long-term
benefit to the patient as symptoms of Parkinson's Disease are ameliorated or
eliminated." Final Act. 3--4 (citing Okun, i-fi-15, 10, 36, 37, 52); see also Ans.
11. In the Answer, the Examiner finds Jaax to also disclose concurrent
delivery of pulsed electrical waveforms (Ans. 7-9 (citing Jaax, i136)), and
clarifies that "Okun is included in the rejection of record to teach locations
in the brain to be stimulated to treat patients with Parkinson's Disease" (id.
at 13).
Appellants disagree, arguing that "Jaax does not disclose ...
concurrently delivering a plurality of pulsed electrical waveforms from
electrodes of a single stimulation lead that are implanted adjacent a
respective plurality of brain regions." App. Br. 5. Continuing, Appellants
argue "there is no disclosure in Jaax that [the disclosed] waveforms are
actually delivered from the electrodes of a single lead that are adjacent
different brain regions" and that "the Examiner has not shown that different
waveforms are concurrently delivered to the electrodes of a single lead that
are adjacent different brain regions." Id. at 6; see also Reply Br. 1-5.
We are not persuaded by Appellants' arguments. As noted by the
Examiner (Final Act. 2; see also Ans. 5---6), Jaax illustrates a single lead
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Application 12/976,764
having a plurality of electrodes in Figure 4. Appellants argue that Jaax only
discloses using multiple leads, referencing Jaax Figure 5. App. Br. 4. Jaax,
however, discloses inclusion of only a single lead in this embodiment, and
furthermore that such lead is the only means of stimulation:
As seen in the embodiments depicted in FIG. 5, one or more
electrode leads 170 and/or catheters 180 attached to SCU 160
run subcutaneously, for instance, in a surgically-created shallow
groove( s) in the skull, to an opening( s) in the skull, and pass
through the opening( s) into or onto the brain parenchyma and
surrounding tissue.
Jaax i-f 92 (emphasis added). We interpret this language as disclosing
embodiments having only one electrode lead and no catheters attached to the
system control unit (SCU). Jaax further discloses that this sole lead includes
a plurality of electrodes: "Each lead includes at least two electrodes 172,
and may include as many as sixteen or more electrodes 172." Id. i-f 96.
Thus, Jaax discloses a single lead having a plurality of electrodes, and
Appellants' arguments to the contrary are unpersuasive.
The Examiner finds that Jaax further discloses that the plurality of
electrodes are located adjacent a respective plurality of brain regions. Final
Act. 2 (citing Jaax, i-fi-112, 15); Ans. 6-7 (citing Jaax, i-fi-111, 13, 23, 36, 55,
71 ). J aax discloses "applying electrical stimulation to one or more areas of
the brain" (Jaax i-f 11 (emphasis added)) and that "the electrodes ... are
implanted in or adjacent to one or more language areas of the aphasia
patient's brain" (id. i-fl2 (emphasis added)). Thus, Jaax discloses placing the
electrodes, such as the multiple electrodes of a single lead (discussed above),
adjacent a plurality of regions of the brain, and Appellants' arguments to the
contrary are unpersuasive.
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The Examiner also finds that Jaax discloses delivering a plurality of
different waveforms. Final Act. 2 (citing Jaax i-fi-175, 128); Ans. 6 (citing
Jaax i-fi-f 15, 75). Jaax discloses that "the SCU may provide a multiplicity of
stimulation channels, wherein each stimulation channel is independently
programmable with different stimulation parameters including one or more
of: pulsewidth, stimulation amplitude, repetition rate or pulses per second
(pps ), and an electrode configuration that may be either monopolar or
bipolar." Jaax i-f 15 (emphasis added). Thus, Jaax discloses generating and
delivering a plurality of waveforms, each waveform having a different set of
stimulation parameters, and Appellants' arguments to the contrary are
unpersuasive.
Finally, the Examiner finds that Jaax discloses concurrent delivering
waveforms to individual ones of the electrodes. Ans. 6-7 (citing Jaax i136).
Jaax discloses that the SCU "activates one or more electrodes ... implanted
in or on the brain of the patient to deliver a stimulus to one or more areas of
the brain active in communication." Jaax i136 (emphasis added); see also
id. i-f 15 (discussing different stimulation channels having different
stimulation parameters). Thus, Jaax discloses, or at least suggest,
concurrently delivering waveforms to individual ones of the plurality of
electrodes, and Appellants' arguments to the contrary are unpersuasive.
Accordingly, for the foregoing reasons, we sustain the Examiner's
rejection of independent claim 1, as well as dependent claims 2 and 8-13, as
being unpatentable over Jaax and Okun.
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Brief:
Claim 3
Claim 3 is reproduced below from the Claims Appendix of the Appeal
3. The method of claim 2, wherein the plurality of brain
regions comprises a ventralis intermedius of the thalamus and a
subthalamic nucleus.
The Examiner relies on Jaax as discussed above with respect to claim 1, and
relies on Okun to teach "stimulation of the ventralis intermedius of the
thalamus and the subthalamic nucleus for the purpose of treating movement
disorders, specifically Parkinson's Disease," reasoning that it would have
been obvious to a skilled artisan to use the device and methodology of Jaax
to treat the brain regions taught by Okun "in order to utilize a proven
location and proven treatment protocol so effective treatment can be
provided to the patient, the treatment providing long-term benefit to the
patient as symptoms of Parkinson's Disease are ameliorated or eliminated."
Final Act. 2--4; see also Ans. 9--11.
Appellants disagree, arguing that "[t]here is no disclosure in Jaax or
Okun that a single stimulation lead be implanted within the brain of a
patient, such that electrodes are adjacent both the ventralis intermedius of
the thalamus and the subthalamic nucleus, and that different waveforms be
delivered to these electrodes." App. Br. 7-8.
We find Appellants' arguments to be unpersuasive. The structure and
methodology of Jaax is discussed above. As noted by the Examiner, Jaax
discloses that its device and methodology can be used for the treatment of
Parkinson's disease. Final Act. 2 (citing Jaax i-f 94). As further noted by the
Examiner, Okun teaches the electrical stimulation of the ventralis
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intennedius of the thalamus and subthalamic nucleus for the treatment of
Parkinson's disease. Final Act. 3--4 (citing Okun i-fi-15, 10, 36, 37, 52); Ans.
11 (citing Okun i-fi-13-5, 16). Appellants' conclusory arguments fail to
apprise us of error in the Examiner's findings or reasoning. Accordingly, we
sustain the Examiner's rejection of claim 3 as being unpatentable over Jaax
and Okun.
DECISION
The Examiner's decision to reject claims 1-3 and 8-13 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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