Ex Parte Wu et al

Patent Trial and Appeal Board

Aug 28, 2017

13446801 (P.T.A.B. Aug. 28, 2017)

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.
13/446,801 04/13/2012 Jianping Wu P0034178.USU1 1967
71996 7590 08/30/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
EDWARDS, PHILIP CHARLES
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/30/2017 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, STEVEN L. JENSEN, and
DWIGHT E. NELSON
Appeal 2015-006966
Application 13/446,801
Technology Center 3700
Before BRETT C. MARTIN, ANNETTE R. REIMERS, and
BRENT M. DOUGAL, Administrative Patent Judges.
MARTIN, Administrative Patent Judge.
DECISION ON APPEAL
Appeal 2015-006966
Application 13/446,801
STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
rejection of claims 1—28. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
THE INVENTION
Appellants’ claims are directed “to medical devices that deliver
electrical stimulation therapy” and methods of using the same. Spec. 1,11.
8—9. Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A method comprising:
delivering the electrical stimulation from a medical device at
a first frequency to a brain of a patient when bioelectrical brain
signals of the patient oscillate at a second frequency, wherein the
second frequency corresponds to pathological brain signals of
the patient, and wherein the electrical stimulation is selected to
entrain the bioelectrical brain signals of the patient; and
adjusting the delivered electrical stimulation from the first
frequency to a third frequency while the bioelectrical brain
signals are entrained by the electrical stimulation, wherein
adjusting the delivered electrical stimulation changes the
bioelectrical brain signal oscillations to a fourth frequency
different from the second frequency.
REFERENCE
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
John US 2007/0142874 A1 June 21,2007
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Application 13/446,801
REJECTIONS
The Examiner made the following rejections:
Claims 1—28 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by John. Ans. 3.
ANALYSIS
As the Examiner states, “[t]he only limitation being argued is the
newly introduced limitation in the 5/23/2014 claim amendment ‘while the
bioelectrical brain signals are entrained by the electrical stimulation.’” Ans.
3. The Examiner goes on to assert that “[sjupport for this amendment is in
[0082] and only [0082] of the applicant’s specification.” Id. The Examiner
is simply wrong regarding this assertion and it appears to color the entire
argument of the rejection. As Appellants point out, the “originally-filed
specification includes numerous instances in which the entrainment of
bioelectrical brain signals by electrical simulation is described beyond
paragraph [0082].” Reply Br. 7. Appellants go on to point out how
entrainment is clearly described at, for example, paragraph [0026] as
follows:
To modulate the bioelectrical brain signals, when
bioelectrical brain signals are oscillating at a pathological
frequency (which may refer to a frequency associated with the
manifestation of one or more symptoms of a patient disorder),
electrical stimulation therapy may be generated and delivered to
the brain of a patient to entrain the bioelectrical brain signals.
The bioelectrical brain signals may be characterized as being
entrained by the delivered electrical stimulation when the
bioelectrical brain signals ... may be pulled, drawn, or otherwise
follow changes in the frequency of the delivered electrical
stimulation. Entrainment may be the “following” of period
and/or phase changes to delivered electrical stimulation for a
period of time and may include instances in which the changes
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Appeal 2015-006966
Application 13/446,801
of the bioelectrical brain signals are substantially the same as that
of the changes to the delivered stimulation and instance in which
the changes are not substantially the same but follow to some
degree with the changes to the electrical stimulation. In some
examples, entrainment of bioelectrical brain signals by the
delivered electrical stimulation may be evidenced by an
oscillation frequency of the brain signals that matches the
frequency of the electrical stimulation and a constant phase
relationship between the brain signal oscillations and the
delivered electrical stimulation.
Thus, at the outset of the Examiner’s argument, we are presented with
a glaring error in fact regarding the Examiner’s characterization of the
record. Furthermore, the Examiner appears to base nearly the entirety of the
argument on the erroneous assertion that paragraph [0082] is the only
description of entrainment and that this description is lacking. Given the
above-noted discussion of entrainment, we disagree with the Examiner’s
characterization and find that entrainment is more than adequately explained
in the Specification.
Additionally, despite this assertion that “[ejntrainment is a term
without a standard definition in the electrical stimulation art” and that
“[0082] does not clarify how the applicant is defining entrainment” (Ans. 3—
4), “at no point has the Examiner asserted that Appellant’s [sic] independent
claim 1 fails to satisfy the requirements of 35 U.S.C. § 112, second
paragraph as indefinite.” Reply Br. 9. Furthermore, we find it curious that
while the Examiner seems to claim no idea what entrainment clearly is, the
Examiner has no problem finding entrainment in John.
The Examiner goes on to state that “the applicant is mortgaging the
entire patentability of this case over the prior art on one limitation that does
not have a clear, detailed definition in the specification” and “attempting to
make the nuanced argument that there is some sort of an initial entrainment
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Appeal 2015-006966
Application 13/446,801
achieved prior to the influencing.” Ans. 4. First, without necessarily
agreeing that it is the case in the instant application, we note that it is not at
all uncommon for the patentability of an entire case to hinge upon one
limitation. Further, having already shown above that the Examiner has
incorrectly characterized the extent of discussion of the term “entrainment”
in the Specification and that such discussion sufficiently explains the term at
issue, we also note that Appellants’ supposed “nuanced argument” is fully
grounded in the claim language and appears not to have been given proper
weight by the Examiner.
The Examiner asserts that “there are no details of this initial
entrainment” (Ans. 4), but the claims themselves clearly describe an “initial
entrainment” before further therapeutic stimulation is applied. Claim 1 first
recites delivering electrical stimulation “wherein the electrical stimulation is
selected to entrain the bioelectrical brain signals of the patient.” This is not
the end goal in the claims, but is merely a precursor to moving on to the next
steps of the claims, thus it is an initial entrainment. Only after achieving this
initial entrainment do the claims then require “adjusting the delivered
electrical stimulation from the first frequency to a third frequency while the
bioelectrical brains signals are entrained by the electrical stimulation.'1'’
Emphasis added. The Examiner appears to use the phrase “nuanced
argument” as some sort of pejorative to describe Appellants’ attempts to
distinguish the literal requirements of the claim from what is taught in John.
Nuanced argument or not, Appellants are correct that the Examiner has
failed to show how all of the steps of the claim are found in John.
We agree with Appellants that John at best describes iteratively
increasing stimulation “until the entrainment of the natural rhythm by the
electrical stimulation occurs” and that this appears to be the end goal of
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Application 13/446,801
John, not an initial entrainment as claimed. App. Br. 9. As further
explained by Appellants, “John appears to describe stopping the iterative
process once the natural rhythm is entrained by the electrical stimulation.”
Id. Accordingly, “the cited portions of John fail to describe adjusting the
delivered electrical stimulation from a first frequency to a third frequency
while the bioelectrical brain signals are entrained by the electrical
stimulation.” Id. This is so because it appears the goal of John is to achieve
entrainment and stop, not to achieve entrainment as a means to further
additional therapeutic goals, as found in the claims.
We, therefore, disagree both with the Examiner’s characterization of
the lack of support for the term “entrainment” in the Specification, as well as
the Examiner’s assertion that John’s teaches all elements of claim 1, namely
that further therapy is performed after and while entrainment is initially
achieved. Accordingly, we do not sustain the Examiner’s rejection of claim
1. The same or similar language appears in all of the independent claims at
issue, and so, we therefore also do not sustain the Examiner’s rejection of
claims 2—28.
DECISION
For the above reasons, we REVERSE the Examiner’s decision to
reject claims 1—28.
REVERSED
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