Ex Parte Rao et al

Patent Trial and Appeal Board

Sep 12, 2017

14200702 (P.T.A.B. Sep. 12, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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P.O.Box 1450
Alexandria, Virginia 22313-1450
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/200,702 03/07/2014 Prakash Rao 6279.128US1 9735
45458 7590 09/14/2017
smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER
PO BOX 2938 GETZOW, SCOTT M
MINNEAPOLIS, MN 55402
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/14/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PRAKASH RAO and SRIDHAR KOTHANDARAMAN
Appeal 2016-0076621
Application 14/200,702
Technology Center 3700
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to devices for
externally controlling arrays of implanted electrodes that deliver electrical
stimulation energy to tissue. The Examiner rejected the claims as
anticipated, and for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 17—22, under 35 U.S.C. § 102(b), as anticipated by Goetz
(Final Action 2);
1 Appellants state that the real party in interest “is the assignee, Boston
Scientific Neuromodulation Corporation.” Appeal Br. 2.
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Application 14/200,702
(2) Claims 25 and 26, under 35 U.S.C. § 103(a), for obviousness over
Goetz and Davis2 3 (Final Action 2—3);
(3) Claims 1—10, 15, and 16, under 35 U.S.C. § 103(a), for
obviousness over Goetz and Kothandaraman4 (Final Action 3);
(4) Claims 12—14, under 35 U.S.C. § 103(a), for obviousness over
Goetz, Kothandaraman, and Davis (Final Action 3 4);
(5) Claim 11, under 35 U.S.C. § 103(a), for obviousness over Goetz,
Kothandaraman, and Kim5 (Final Action 4);
(6) Claims 23 and 24, under 35 U.S.C. § 103(a), for obviousness over
Goetz (Final Action 4);
(7) Claims 1—10 and 12—26, under 35 U.S.C. § 103(a), for
obviousness over Kothandaraman and Davis (Final Action 5—6); and
(8) Claim 11, under 35 U.S.C. § 103(a), for obviousness over
Kothandaraman, Davis, and Kim (Final Action 6).
Claims 1 and 17, the independent claims on appeal, read as follows
(Appeal Br. 28, 30-31):
1. An external control device for use with a two-
dimensional array of electrodes implanted within tissue and a
neurostimulator capable of delivering electrical stimulation
energy to the electrodes to create a volume of activation,
comprising:
a user interface including a current steering initiation
control element and a current steering direction control element
capable of being rotated about an axis;
2 US 2008/0163097 A1 (published July 3, 2008).
3 US 2011/0270358 A1 (published Nov. 3, 2011).
4 US 2010/0121409 A1 (published May 13, 2010).
5 US 2012/0041518 A1 (published Feb. 16, 2012).
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a controller/processor configured for, in response to
actuation of the initiation control element, generating a series of
different combinations of the electrodes in a manner that the
volume of activation gradually translates in a specific direction
when the electrical stimulation energy is delivered to the
different electrode combinations, the controller/processor
further configured for, in response to rotation of the direction
control element about the axis, defining the specific direction in
which the volume of activation is translated;
and output circuitry configured for transmitting the
different electrode combinations to the neurostimulator.
17. A neurostimulation system, comprising:
at least one neurostimulation lead configured for being
implanted within tissue, the at least one neurostimulation lead
carrying a plurality of electrodes capable of being arranged in a
two-dimensional pattern;
a neurostimulator configured for delivering electrical
stimulation energy to the electrodes to create a volume of
activation; and
an external control device including a current steering
direction control element capable of being rotated about an axis,
the external control device configured for prompting the
neurostimulator to deliver the electrical stimulation energy to
the electrodes in a manner that gradually translates the volume
of activation in a specific direction, and for defining the specific
direction in which the volume of activation is translated in
response to rotation of the direction control element about the
axis.
ANTICIPATION—GOETZ
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
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In the present case, Appellants persuade us that a preponderance of
the evidence does not support the Examiner’s finding that Goetz describes a
neurostimulation system having all of the features of independent claim 17.
As seen above, claim 17 requires the claimed neurostimulation system
to have an external control device that includes a current steering direction
control element capable of being rotated about an axis. Appeal Br. 31.
Claim 17 requires the external control device to be configured to prompt the
neurostimulator to deliver electrical stimulation energy to tissue-implantable
electrodes “in a manner that gradually translates the volume of activation [of
the electrodes in the tissue] in a specific direction, and for defining the
specific direction in which the volume of activation is translated in response
to rotation of the direction control element about the axis.” Id.
Consistent with Appellants’ Specification, “translating] the volume
of activation in a specific direction” as required by claim 17 {id.) means that
the external control device causes the electrodes in the treated volume of
tissue to deliver electrical stimulation to the treated region of tissue in a
serial and directional fashion controlled by the rotatable steering device. See
Spec. ]]16 (describing external control device as “generating a series of
different combinations of the electrodes (e.g., fractionalized electrode
combinations) in a manner that the volume of activation gradually translates
in a specific direction”) (emphasis added); see also id. at 144 (describing
“pulse generation circuitry that delivers electrical stimulation energy in the
form of a pulsed electrical waveform (i.e., a temporal series of electrical
pulses to the electrodes 26 in an electrode array”) (emphasis added).
The Examiner contends that, because Goetz describes a rotatable knob
that changes the shape of the field of tissue that is stimulated by electrodes,
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Goetz’s device provides the controlled directional stimulation required by
claim 17. See Ans. 2—3 (“When the field shape gets larger, the direction the
field changes, or translates, is in the outward direction, and when the field
shape gets smaller, the field is considered to translate in the inward
direction.”) (citing Goetz 1170).
We acknowledge Goetz’s disclosure that a trackball, scroll wheel, or
joystick may be used to perform the manipulations of electrode stimulation
described in that reference. See Goetz | 81. Nonetheless, we are not
persuaded that the Examiner has explained with adequate specificity how
simply changing the size of the field of stimulated tissue equates to the
delivery of electrical stimulation to the treated region of tissue in a serial and
directional fashion, controlled by a rotatable steering element, as claim 17
requires. Because Appellants persuade us, therefore, that the Examiner has
not shown that Goetz describes a system having all of the elements required
by claim 17, we reverse the Examiner’s rejection of that claim, and its
dependent claims 18—22, as anticipated by Goetz.
OBVIOUSNESS—GOETZ AND DAVIS
In rejecting claims 25 and 26, both of which depend from claim 17
discussed above, over Goetz and Davis, the Examiner cited “paragraphs 93-
97 of Davis which teach adjusting the sensitivity of the wheel, and thus the
speed of changing the volume of activation, and using an inertia parameter
that will continue changing the field of activation for a set period of time
after manipulation of the wheel.” Final Action 2—3.
The Examiner concluded that, “[t]o use such features with the device
of Goetz would have been obvious since they would merely produce
predictable results.” Id. at 3.
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As is evident, the Examiner does not identify teachings in Davis that
remedy the deficiencies of Goetz as to claim 17, discussed above, from
which claims 25 and 26 depend. Appellants persuade us, therefore, that the
Examiner has not shown that the combination of Goetz and Davis teaches or
suggests a device having all of the elements required by claims 25 and 26.
We, therefore, reverse the Examiner’s rejection of those claims over those
references.
OBVIOUSNESS—
GOETZ AND KOTHANDARAMAN
In rejecting claims 1—10, 15, and 16 over Goetz and Kothandaraman,
the Examiner concluded that it would have been obvious to use the initiation
control element 106 shown in Figure 6 of Kothandaraman with Goetz’s
device, “since it would merely yield the predictable result of allowing the
programming ability to start or stop.” Final Action 3. Alternatively, the
Examiner reasoned, “the on/off button of the programmer of Goetz can also
be considered to be an initiation control element in that it functions in the
same manner, namely to turn on or off the ability to program the device.”
Id.
Claim 1, like claim 17 discussed above, recites an external control
device that includes a current steering direction control element capable of
being rotated about an axis. Appeal Br. 28.
Claim 1, like claim 17, requires the external control device to be
configured to deliver electrical stimulation to a treated region of tissue in a
serial and directional fashion, controlled by the rotatable steering element.
See id. (claim 1 reciting a controller/processor configured for “generating a
series of different combinations of the electrodes in a manner that the
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volume of activation gradually translates in a specific direction when the
electrical stimulation energy is delivered to the different electrode
combinations” wherein the controller/processor is “further configured for, in
response to rotation of the direction control element about the axis, defining
the specific direction in which the volume of activation is translated”).
In setting forth the prima facie case of obviousness, the Examiner did
not identify where either Kothandaraman or Goetz describes a device that
includes the functionality of controllably delivering electrical stimulation to
the treated region of tissue in a serial and directional fashion, in the manner
required by claim 1. See Final Action 3.
In response to Appellants’ arguments in that regard, the Examiner
contends that Goetz shows that “the field shapes [of electrically stimulated
tissue] can be stretched or shrunk, etc. (par. 73). Thus, the field shape can
be translated in the direction the clinician desires. Further, the manipulation
tools the clinician uses to change the field shapes can be selection media
such as scroll wheels.” Ans. 3.
As discussed above, however, we are not persuaded that the Examiner
has explained with adequate specificity how simply changing the size of the
field of stimulated tissue equates to the delivery of electrical stimulation to
the treated region of tissue in a serial and directional fashion, controlled by a
rotatable steering element, as claim 1 requires. Because Appellants persuade
us, therefore, that the Examiner has not shown that the combination of Goetz
and Kothandaraman teaches or suggests a system having all of the elements
required by claim 1, we reverse the Examiner’s rejection of that claim, and
its dependent claims 2—10, 15, and 16, for obviousness over those
references.
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OBVIOUSNESS—
GOETZ, KOTHANDARAMAN, AND DAVIS
In rejecting claims 12—14 over Goetz, Kothandaraman, and Davis, the
Examiner cited “paragraphs 93-97 of Davis which teach[] controlling the
speed of the scroll wheel, and thus the manner in which the electrode
combinations are generated, as well as an inertia element which continues
the changing of the field for a certain time after the wheel has ceased
turning.” Final Action 4. The Examiner concluded that “[t]o use such
features with the device of Goetz would have been obvious since they would
merely produce predictable results.” Id.
As is evident, the Examiner does not identify teachings in Davis that
remedy the deficiencies of Goetz and Kothandaraman as to claim 1,
discussed above, from which claims 12—14 depend. Appellants persuade us,
therefore, that the Examiner has not shown that the combination of Goetz,
Kothandaraman, and Davis teaches or suggests a device having all of the
elements required by claims 12—14. We, therefore, reverse the Examiner’s
rejection of those claims over those references.
OBVIOUSNESS—
GOETZ, KOTHANDARAMAN, AND KIM
In rejecting claim 11 over Goetz, Kothandaraman, and Kim, the
Examiner stated only that, regarding “the subject matter of claim 11, see
office action of 3/30/15.” Final Action 4.
Our review of the Non-Final Action entered March 30, 2015 does not
show a rejection over the combination of Goetz, Kothandaraman, and Kim.
See Non-Final Act., generally. Rather, the only two rejections included in
the Non-Final Action are (1) an obviousness rejection of claims 1—10 and
12—26 over the combination of Kothandaraman and Davis (Non-Final Act.
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2—3), and (2) an obviousness rejection of claim 11 over Kothandaraman,
Davis, and Kim {id. at 3). Thus, the obviousness rationale advanced in the
Final Action does not explain why the combination of Goetz,
Kothandaraman, and Kim, asserted as demonstrating the obviousness of
claim 11, teaches or suggests all of the claimed elements.
In any event, as to the Kim reference, the Non-Final Action states that
“Kim teaches using an ideal multipole, par. 59. To use such with the device
of Kothandaraman and Davis would have been obvious since such would be
a combination of prior art elements yielding a predictable result.” Non-Final
Act. 3.
As is evident, the Examiner does not identify teachings in Kim that
remedy the deficiencies of Goetz and Kothandaraman as to claim 1,
discussed above, from which claim 11 depends. Appellants persuade us,
therefore, that the Examiner has not shown that the combination of Goetz,
Kothandaraman, and Kim teaches or suggests a device having all of the
elements required by claim 11. We, therefore, reverse the Examiner’s
rejection of that claim over those references.
OBVIOUSNESS—GOETZ
In rejecting claims 23 and 24, both of which depend from claim 17
discussed above, over Goetz, the Examiner found that “the field shapes, and
thus the electrode combinations, of Goetz can be stored for later use, and
thus are considered to be defined prior to prompting the neurostimulator to
deliver electrical stimulation energy to the electrodes.” Final Action 4.
The Examiner concluded, therefore, that, “[ejither way, no unexpected
result would occur from defining a specific direction prior to the generation
of different electrode combinations or prompting as opposed to defining the
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direction while the device is delivering neurostimulation.” Id.
As is evident, the Examiner does not identify additional teachings in
Goetz that remedy the deficiencies of Goetz as to claim 17, discussed above,
from which claims 23 and 24 depend. Appellants persuade us, therefore,
that the Examiner has not shown that Goetz teaches or suggests a device
having all of the elements required by claims 23 and 24. We, therefore,
reverse the Examiner’s rejection of those claims over Goetz.
OBVIOUSNESS—
KOTHANDARAMAN AND DAVIS
The Examiner’s rationale for rejecting claims 1—10 and 12—26 over
Kothandaraman and Davis is set forth in the Non-Final Action entered
March 30, 2015. See Final Action 5 (stating “[s]ee office action of
3/30/15”).
The Examiner cited Kothandaraman as teaching “user interface (figs.
6-14), and a controller/processor 80 which is capable [of] programming
different combinations of electrodes and shifts the current automatically,
including fractionalized currents, from electrode to electrode, pars. 33, and
106-120.” Non-Final Act. 2.
The Examiner cited Davis as teaching “a directional control element
in the form of a scroll wheel 122, 162 which can control the direction of the
volume of activation 102.” Id. The Examiner concluded that “[t]o use such
with the device of Kothandaraman would have been obvious in that it would
be a combination of prior art elements yielding a predictable result.” Id.
As the Supreme Court has explained, “rejections on obviousness
grounds cannot be sustained by mere conclusory statements; instead, there
must be some articulated reasoning with some rational underpinning to
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support the legal conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 418 (2007). We agree with Appellants that, because the
Examiner did not explain with any specificity why an ordinary artisan would
have combined the prior art elements in the posited manner, the Examiner’s
rejection lacks the articulated reasoning, as well as the rationale
underpinning, required to sustain an obviousness rejection.
We have carefully reviewed the Examiner’s arguments, both in the
Final Action (see Final Act. 5—6), and in the Answer (Ans. 4—6), as well as
the multiple portions of the references cited therein. Nonetheless, in the
absence of a reasoned, specific, evidence-based explanation as to why the
particular cited portions of the references would have led an ordinary artisan
to the precise combination of elements recited in the claims, we are not
persuaded that merely providing a list of multiple teachings alleged as
corresponding to claim elements is sufficient to establish that the claimed
devices would have been obvious. See Unigene Laboratories, Inc. v.
Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). (“Obviousness requires
more than a mere showing that the prior art includes separate references
covering each separate limitation in a claim under examination.”).
Moreover, similar to the situation in the rejections discussed above,
we are not persuaded that the Examiner has explained with adequate
specificity why the cited combination of Kothandaraman and Davis teaches
or suggests a device having the functionality of delivering electrical
stimulation to a treated region of tissue in a serial and directional fashion,
controlled by a rotatable steering element, in the manner required by both
claims 1 and 17.
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In sum, for the reasons discussed, we reverse the Examiner’s rejection
of claims 1—10 and 12—26 for obviousness over Kothandaraman and Davis.
OBVIOUSNESS—
KOTHANDARAMAN, DAVIS, AND KIM
The Examiner’s rationale for rejecting claim 11 over Kothandaraman,
Davis, and Kim is set forth in the Non-Final Action entered March 30, 2015.
See Final Action 6 (stating “[s]ee office action of 3/30/15”).
The Non-Final Action states that “Kim teaches using an ideal
multipole, par. 59. To use such with the device of Kothandaraman and
Davis would have been obvious since such would be a combination of prior
art elements yielding a predictable result.” Non-Final Act. 3.
As is evident, the Examiner does not identify teachings in Kim that
remedy the deficiencies of Kothandaraman and Davis as to claim 1,
discussed above, from which claim 11 depends. Appellants persuade us,
therefore, that the Examiner has not shown that the combination of
Kothandaraman, Davis, and Kim teaches or suggests a device having all of
the elements required by claim 11. We, therefore, reverse the Examiner’s
rejection of that claim over those references.
SUMMARY
For the reasons discussed, we reverse each of the Examiner’s
rejections.
REVERSED
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