Ex Parte Hargrove et al

Patent Trial and Appeal Board

May 23, 2018

13942246 (P.T.A.B. May. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/942,246 07/15/2013 Jeffrey B. Hargrove
23399 7590 05/25/2018
REISING ETHINGTON P.C.
755 W. Big Beaver Road
Suite 1850
TROY, MI 48084
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.
7841.3003.012 7538
EXAMINER
BERHANU, ETSUB D
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
05/25/2018 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):
docketing@reising.com
USPTOmail@reising.com
USPTOmail@gmx.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY B. HARGROVE, ROBERT M. FORD, and
BUCKLEY D. BERANEK
Appeal2017-004100
Application 13/942,246
Technology Center 3700
Before ULRIKE W. JENKS, DEVON ZASTROW NEWMAN, and
DAVID COTTA, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from the
Examiner's decision to reject claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Claims 1-14 and 17-21 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1 Appellant is the Applicant, Cerephex Corporation, which, according to the
Brief, is the real party in interest. Appeal Br. 2.
Appeal2017-004100
Application 13/942,246
1. A method for treating brain-related chronic pain disorders,
the method including the steps of:
assessing the brain function of a subject suffering from
chronic pain;
determining a pain-related abnormal brain condition by
obtaining a quantitative assessment of the subject's brain
function and making a statistical comparison between the
subject's quantitative assessment and a database of quantitative
assessments of individuals suffering from the pain-related
abnormal brain condition;
locating at least one area of abnormal brain activity
associated with the abnormal brain condition;
detecting at least one statistically significant difference
between the subject's quantitative assessment and a database of
quantitative assessments of healthy normal individuals; and
mitigating the abnormal brain condition by generating
and applying an electrical stimulation signal to tissues
corresponding to the at least one area of abnormal brain
activity, the electrical stimulation signal comprising a carrier
signal component and a neuromodulation signal component
having at least one parameter that is configured to cause the
electrical stimulation signal to modulate at least one abnormal
brain activity aspect that corresponds to the at least one
statistically significant difference between the subject's
quantitative assessment and the database of quantitative
assessments of healthy normal individuals.
Suppl. Resp. 2 3, Claims Appendix (emphasis added).
Appellant requests review of the Examiner's rejection of claims 1-14
and 17-21 under pre-AIA 35 U.S.C. § 103(a) over Hargrove3 in view of
2 Appellant's Supplemental Response to Notice of Non-Compliant Appeal
Brief filed May 2, 2016. ("Suppl. Resp.").
3 Hargrove et al., US 2004/0002635 Al, publ. Jan. 1, 2004 ("Hargrove").
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Application 13/942,246
Rhodes, 4 further in view of John '401, 5 and further in view of John '190. 6
Appeal Br. 7 8.
Obviousness
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of references teaches a
statistical comparison between a patient's derived EEG data and data from
similarly situated patient population as well as data from a normal
population?
Findings of Fact
Hargrove
FPL Hargrove teaches "administration of an anti-neurological dysfunction
therapy to the subject." Hargrove i-f 20; see also id. i-f 70. Hargrove
teaches using "[a] computing device-controlled system ... for the
generation of amplitude-modulated pulse-width modulation
(AMPWM) signals for use in treating neurological dysfunction via
cranial neurostimulation." Hargrove, Abstract; see also id. i-fi-122, 24.
"The neurostimulation signal is intended to 'normalize' or adjust the
brainwave frequency of the regions of the subject's brain that possess
irregular activity." Id. i-f 54.
FF2. "The normalization of the EEG signals from the regions of the
subject's brain that possess irregular activity results in an alleviation
4 Rhodes, US 2007/0156183 Al, publ. July 5, 2007 ("Rhodes").
5 John, US 2007/0043401 Al, publ. Feb. 22, 2007 ("John '401").
6 John, US 4,846,190, issued July 11, 1989 ("John '190").
7 Appeal Brief filed Dec. 21, 2015 ("Appeal Br.").
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Application 13/942,246
of the symptoms of the neurological disorders." Id. i-f 72; see also id.
,-r 84.
FF3. Hargrove teaches assessing a subject by "obtain[ing] EEG results and
evaluating the EEG results to determine whether any region of the
subject's brain possesses irregular activity as compared to other
regions of the subject's brain." Id. i-f 20; see also id. i-f 83. "The term
'irregular activity' is intended to define the EEG frequency of a[]
region of the subject's brain which does not match the predetermined
EEG activity of the remaining regions of the subject's brain." Id.
,-r 52.
Rhodes
FF4. Rhodes teaches that "it is known in the art to treat pain or other
symptoms by the application of energy in the form of alternating
current electricity, magnetism and other forms of electromagnetic
energy." Rhodes i-f 3.
FF5. Rhodes teaches diagnosing an ailment (id. i-f 5), and treating the
patient by application of electromagnetic energy (id. i-f 7). "Broadly,
electrodes are attached to the patient's extremities adjacent nerve
endings and low frequency electrical current is passed through the
electrodes." Id. i-f 5; see also id. i-f 17 ("treatment ... is effective for
chronic pain").
John '401
FF6. John '401 teaches using neurostimulators "to treat a wide variety of
medical conditions including ... pain." John '401i-f4.
FF7. John '401 teaches that "neuromodulation parameters for treatment
may be chosen either based upon the knowledge gained from the
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patient or from population data." Id. i-f 80. "[T]he activity of one
region of a network is used to guide the neurostimulation of at least a
second region of the network." Id. i-f 108. "A comparison of a model
of the patient's brain networks to models of networks of prior patients
for whom treatment was successful can assist in designing the
therapy, including selecting treatment sites for sensing and stimulation
according to the similarity of a patient's profile with profiles of past
patients." Id. i-f 80.
FF8. John '401 teaches that the use of quantitative EEG (QEEG) "imaging
provides the advantage of confirmed normative data for regional brain
electrical activity which is not yet available for other neuroimaging
methods." Id. i-f 82. "Both implantation and subsequent treatment
protocols can be based upon the classification of the features of the
individual's brain networks with respect to the subtypes of the
database." Id. ,-r 110.
John '190
FF9. John ' 190 teaches statistically evaluating EEG data.
The statistical evaluation relating to the selected
reference data and the color-coded visual display provide
an immediate and apparent indication as to whether the
current brain wave segments in any derivation are
significantly different from the patient's own on-going
prior set of brain wave EEG segments or from the
normative data observed in the patient in some prior
reference state, in the "normal outcome" group under the
same conditions, or in some other reference group.
John '190, 1:49--58. John '190 teaches color coding and visually
displaying the recording for each individual electrode. Id. at 1: 59--69.
Green means no meaningful change, amber is displayed when the
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change is different P