Ex Parte Vansickle et al

Patent Trial and Appeal Board

Dec 12, 2018

14214752 (P.T.A.B. Dec. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/214,752 03/15/2014 Dennis Allen Vansickle
45458 7590 12/14/2018
SCHWEGMAN LUNDBERG & WOESSNER/BSC
POBOX2938
MINNEAPOLIS, MN 55402
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.
6279.015US 1 4727
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
12/14/2018 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):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DENNIS ALLEN VANSICKLE, DONGCHUL LEE,
SRIDHAR KOTHANDARAMAN, QUE T. DOAN, CHANGF ANG ZHU,
JORDI P ARRAMON, JUSTIN HOLLEY, BRADLEY L. HERSHEY,
CHRISTOPHERE. GILLESPIE, RAFAEL CARBUNARU, and
NAZIM WAHAB 1
Appeal 2017-011305
Application 14/214,752
Technology Center 3700
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify Boston Scientific Neuromodulation Corporation as the
real party-in-interest. App. Br. 2.
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SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner'sFinalRejectionofclaims 1-5, 7, 9-12, 14, 16, 17, and25I-265.
Specifically, claims 1, 5, 7, 9-12, 16, 17, 251-258, and 261-263 stand
rejected as unpatentable under 35 U.S.C. § I02(e)(pre-AIA) as anticipated
by Wacnik (US 2013/0282078 Al, published October 24, 2013) ("Wacnik").
Claims 2--4 stand rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Wacnik and Moffitt et al. (US
2010/0057162 Al, published March 4, 2010) ("Moffitt' 162").
Claim 14 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Wacnik and Moffitt (US
2011/0106215 Al, published May 5, 2011) ("Moffitt '215").
Claims 259 and 264 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Wacnik and
Kothandaraman et al. (US 2010/0121409 Al, published May 13, 2010)
("Kothandaraman '409").
Claims 260 and 265 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Wacnik and Thacker et
al. (US 2010/0010566 Al, published January 14, 2010) or Wacnik and
Kothandaraman et al. (US 2013/0158628 Al, published June 20, 2013)
("Kothandaraman '628").
Claims 1, 7, 9-12, 16, 17,251,252, 255-258, and 261-263 also stand
rejected as unpatentable under 35 U.S.C. § I02(b) as anticipated by Lee (US
2012/0041511 Al, published February 16, 2012) or under 35 U.S.C.
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§ I03(a) as obvious over the combination of Lee and Mukherjee et al. (US
2011/0264156 Al, published October 27, 2011) ("Mukherjee")
Claims 2--4 also stand rejected under 35 U.S.C. § I03(a) as obvious
over the combination of Lee, Mukherjee, and Moffitt '162.
Claims 5,253, and 254 also stand rejected under 35 U.S.C. § I03(a)
as obvious over the combination of Lee, Mukherjee, and Fang et al. (US
2009/0204173 Al, published August 13, 2009) ("Fang").
Claim 14 also stands rejected under 35 U.S.C. § I03(a) as obvious
over the combination of Lee, Mukherjee, and Moffitt '215.
Claims 259 and 264 also stand rejected under 35 U.S.C. § I03(a) as
obvious over the combination of Lee, Mukherjee, and Kothandaraman '409.
Claims 260 and 265 also stand rejected under 35 U.S.C. § I03(a) as
obvious over the combination of Lee, Mukherjee, and Thacker, or the
combination of Lee, Mukherjee, and Kothandaraman '628.
We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE and enter NEW GROUNDS OF REJECTION.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to an external control device for
programming modulation parameters in an implantable neuromodulator that
provides a super-threshold neuromodulation programming mode and a sub-
threshold neuromodulation programming mode. See Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
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1. An external control device for programming modulation
parameters in an implantable neuromodulator configured to be
coupled to an electrode array, the modulation parameters
including a programmable modulation parameter capable of
being programmed with super-threshold values to provide
super-threshold neuromodulation and capable of being
programmed with sub[-]threshold values to provide sub-
threshold neuromodulation, the external control device
compnsmg:
control/processor circuitry configured to use a first
programming mode to program the neuromodulator to provide
super-threshold neuromodulation and configured to use a
second programming mode to program the neuromodulator to
provide sub-threshold neuromodulation, both the first
programming mode and the second programming mode being
semi-automated programming modes configured to control the
neuromodulator to move a locus of an electric field along the
electrode array by semi-automatically transitioning between
electrode configurations, the first programming mode having a
first limit on the programmable modulation parameter and the
second programming mode having a second limit on the
programmable modulation parameter, the first limit to limit the
programmable modulation parameter to super-threshold values
that provide super-threshold neuromodulation, and the second
limit to limit the programmable modulation parameter to
subthreshold values that provide sub-threshold
neuromodulation;
a user interface including a steering control to steer
movement of the locus of the electric field along the electrode
array and a programming selection control element configured
for allowing a user to select a programming mode from a group
of programming modes that includes at least the first
programming mode to program the neuromodulator to provide
the super-threshold neuromodulation and the second
programming mode to program the neuromodulator to provide
the sub-threshold neuromodulation; and
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the control/processor circuitry is further configured for
programming the neuromodulator in the first programming
mode in response to selection of the first programming mode
using the programming selection control element, and
programming the neuromodulator in the second programming
mode in response to selection of the second programming mode
using the programming selection control element.
ISSUES AND ANALYSIS
We decline to adopt the Examiner's findings of fact, reasoning, and
conclusion that the appealed claims are primafacie anticipated and/or
obvious by the cited prior art, and we enter new grounds of rejection. We
address the arguments raised by Appellants below.
Issue 1
Appellants argue that the Examiner erred in concluding that Wacnik
discloses Appellants' claimed control device. App. Br. 18.
Analysis
The Examiner finds that Wacnik discloses an external control device
for programming modulation parameters including processor circuitry
configured to use a first programming mode to program super-threshold
neuromodulation and a second programming mode to program sub-threshold
neuromodulation. Final Act. 7 ( citing Wacnik ,r,r 9, 32, 34, 60, 62---63, 117).
The Examiner further finds that Wacnik discloses a first limit on a
programmable parameter to program super-threshold modulation and a
second limit on a programmable parameter to program sub-threshold
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modulation. Id. The Examiner finds that Wacnik discloses a user interface
including a steering control to steer movement of the locus of the electric
field along the electrode by semi-automatically transitioning between
electrode configurations, and a programming selection control element
configured for allowing a user to select a programming mode from a group
of modes for super-threshold and sub-threshold modulation. Final Act. 7
(citing Wacnik Fig. 4, ,r,r 13, 30, 32, 62, 109) and Ans. 3 (citing Wacnik
Figs. 6A-6D, ,r,r 23, 30, 129-131). Figure 6A ofWacnik is reproduced
below.
flG. 6A
Figure 6A of Wacnik depicts a user interface screen presented
to a user by an external programmer to allow the user to input a
pain region and/or volume of effect of a stimulation therapy.
Appellants argue that Wacnik' s "therapy mode does not appear to
involve moving a locus of an electrode field along the electrode array by
semi-automatically transitioning between electrode configurations." App.
Br. 18. Appellants point to their Specification for disclosing
a semi-automated programming mode [that] semi-automatically
transitions between different electrode configurations to
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electrically "steer" the current along the implanted leads in real-
time (e.g. using a joystick or joystick-like controls) in a
systematic manner [to] allow the clinician to determine the
most efficacious modulation parameter sets.
Reply Br. 3 (citing Spec. ,r,r 15-16). According to Appellants, "[t]he
steering mode is used to control direction, and the semi-automated
programming modes control the transitions between the electrode
configurations as the current is steered along the implanted leads." Reply
Br. 4. Appellants argue that Wacnik refers to stimulating different areas by
using different sets of electrodes, rather than a user interface that steers
current using a semi-automated mode to control the transitions between
electrode configurations. Reply Br. 6 ( citing Wacnik ,r 30).
We agree with Appellants that Wacnik does not disclose processor
circuitry and a user interface including "a steering control to steer movement
of the locus of the electric field along the electrode array" "by semi-
automatically transitioning between electrode configurations" as recited by
Appellants' independent claims 1,251, and 261. Although Wacnik discloses
a system configured to map (program) a volume of effect, which includes a
locus of an electric field, and generate therapy programs by specifying
electrode configurations, which changes the locus of the electric field,
Wacnik lacks a steering control as claimed. Without a steering control,
Wacnik does not disclose semi-automatically transitioning between
electrode configurations.
Because, we find that because Wacnik does not disclose the claimed
elements, the prior art rejections of the remaining dependent claims on
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appeal that incorporate Wacnik fall with the rejection of the independent
claims.
Issue 2
Appellants argue that the Examiner erred in concluding that Lee
alone, or in combination with Mukherjee, teaches Appellants' claimed
control device. App. Br. 28.
Analysis
The Examiner finds that Lee teaches an external control device for
programing modulation parameters in an implantable neuromodulator
including processor circuitry for programming peripheral nerve field
stimulation ("PNFS") and a peripheral nerve stimulation ("PNS"). Final
Act. 22 (citing Lee Fig. 7, ,r,r 8, 9, 47, 50). The Examiner finds that Lee
teaches upper and lower limits on programmable modulation parameters,
including pulse width and pulse rate, when the user selects either the PNFS
or PNS programming modes. Id. ( citing Lee, Fig. 7, ,r,r 8, 9). The Examiner
further finds that Figure 7 of Lee depicts a user interface including steering
control 122 to steer movement of the locus of the electric field along the
electrode array and programming selection control element 124 configured
for allowing a user to select PNFS or PNS programming modes. Id. at 22-
23 ( citing Lee, Figs. 1, 6, 7, ,r 4 7).
The Examiner finds that Mukherjee teaches a device that limits
modulation parameters to values that provide super-threshold and sub-
threshold modulation as desired. Final Act. 23 ( citing Mukherjee ,r,r 35, 43,
45). The Examiner concludes "[i]t would have been obvious to ... modify
the system as taught by Lee, with the first limit to limit the modulation
parameter to values that provide super-threshold modulation, and the second
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limit to limit the modulation parameter to values that provide sub-threshold
modulation as taught by Mukherjee." Id.
Appellants argue that the "begin value" and "end value" of Lee would
not limit the modulation parameters to values that provide super-threshold
modulation and sub-threshold modulation, respectively. App. Br. 28.
Appellants further argue that Mukherjee refers to myocardial stimulation not
neuromodulation. App. Br. 29. Therefore, the "sub-threshold" stimulation
of Mukherjee refers to stimulus inadequate to produce an electrical pacing
response in a subject's heart. Id. (citing Mukherjee ,r 28). Because
Mukherjee teaches myocardial stimulation, Appellants argue that Mukherjee
does not show or suggest super-threshold neuromodulation. Id.
We agree with Appellants that Lee does not appear to teach processor
circuitry configured with programming modes having a first super-threshold
parameter limit and a second sub-threshold limit on a programmable
modulation parameter. Rather, both the PNFS programming mode and the
PNS programming mode appear to include modulation parameters to
generate paresthesia and thus super-threshold neuromodulation. See Lee ,r 6.
We further agree with Appellants that Mukherjee does not remedy Lee's
deficiencies, because the sub-threshold limits of Mukherjee refer to
myocardial stimulation and not neuromodulation.
Because we find that neither Lee alone, nor in combination with
Mukherjee, teaches the claimed elements, the prior art rejections of the
remaining dependent claims on appeal fall with the rejection of the
independent claims.
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NEW GROUND OF REJECTION
We here enter a New Ground of Rejection. Independent claims 1,
251, and 261 are rejected as unpatentable under 35 U.S.C. § 103(a) as being
obvious over Wacnik and Lee.
As we have explained supra, Wacnik teaches or suggests the
limitations of claim 1, except for the limitation reciting: "a steering control
to steer movement of the locus of the electric field along the electrode
array ... by semi-automatically transitioning between electrode
configurations."
Lee teaches a programming screen in Figure 7, reproduced below:
I
no
FIG.7
Figure 7 of Lee depicts a plan view of a programming screen
for programming an implantable stimulator.
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Programming screen 100 of Lee allows a user to perform automated
stimulation parameter testing and electrode combination selection functions,
including pulse width entry 102, pulse rate entry 104, pulse amplitude entry
106, electrode combination control 122, and mode selection control 124.
See Lee ,r,r 49-53, Figure 7. Lee teaches that the: "[E]lectrode combination
control 122 having arrows that can be clicked by the user to select one of
three different electrode combinations." Id. ,r 52. Lee also teaches that the
electrode combinations can be created semi-automatically "by gradually
shifting current between ... the electrodes via a directional device, such as a
joystick or mouse (e.g. shifting anodic electrical current from electrode El to
electrode E2 in 5% increments)." Id. Lee teaches further that the mode
selection control 124 "can be alternately clicked by the user to selectively
place the system 10 between a PNFS mode, in which the microstimulator 12
can be operated or programmed to perform only PNFS, and a PNS mode, in
which the microstimulator 12 can be operated or programmed to perform
only PNS." Id. ,r 53. Therefore, we find Lee teaches a user interface
including a steering control to steer movement of the locus of the electric
field along the electrode array by semi-automatically transitioning between
electrode configurations, and a programming selection control to select first
and second programming modes having first and second limits on
programmable modulation parameters. 2
2 We find that similar user interfaces including a steering control for
electrically steering current along implanted leads in real-time and a mode
selector are taught by the references previously cited by the Examiner. See
Kothandaraman '409, Figs. 11-13; and Thacker, Figs. 21-23.
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We conclude that it would have been obvious for a person of ordinary
skill in the art to modify the external control device of Wacnik with the
functionality and user interface of Lee. We further conclude that such a
person of ordinary skill would have been motivated to combine the functions
of Lee with the external device of Wacnik to include Lee's electrode
steering control and selection of programming modes, for the purpose of
improving Wacnik's mapping mode. Likewise, including two programming
(mapping) modes, each with threshold parameter limits, would have
improved the function of Wacnik to provide sub-threshold mapping with
imperceptible stimulation as preferred by some patients. See Wacnik ,r 31.
We further conclude that a person of ordinary skill in the art would have had
a reasonable expectation of success given the similarity between the systems
in applying pre-set thresholds for neuromodulation therapy. We
consequently reject independent claims 1,251, and 261 under 35 U.S.C.
§ 103(a) as being obvious over Wacnik and Lee.
We have entered new grounds for only the independent claims and
leave it to the Examiner to evaluate the patentability of the other claims in
view this combination with other newly found or previously cited references.
DECISION
The Examiner's rejections of claims 1, 5, 7, 9--12, 16, 17, 251-258,
and 261-263 as anticipated under 35 U.S.C. § 102(b) and/or (e) are reversed.
The Examiner's rejections of claims 1-5, 7, 9-12, 14, 16, 17, and
251-265 as obvious under 35 U.S.C. § 103(a) are reversed.
We have also entered a new ground of rejection for independent
claims 1,251, and 261 pursuant to 37 C.F.R. § 4I.50(b). 37 C.F.R.
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§ 41.50(b) provides that "[a] new ground of rejection ... shall not be
considered final for judicial review."
37 C.F.R. § 4I.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to the
exammer ....
(2) Request rehearing. Request that the proceeding be reheard
under § 41. 5 2 by the Board upon the same record ....
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 ). See 37 C.F.R.
§ 1.136(a)(l)(iv) (2010).
REVERSED
37 C.F.R. § 4I.50(b)
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