Ex Parte Hamann et al

Patent Trial and Appeal Board

May 19, 2017

13472988 (P.T.A.B. May. 19, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/472,988 05/16/2012 Jason J. Hamann 279.J22US1 5874
45458 7590 05/23/2017
SCHWEGMAN LUNDBERG & WOESSNER/BSC
PO BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
VOORHEES, CATHERINE M
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/23/2017 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):
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SLW @blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JASON J. HAMANN, DAVID J. TERNES, STEPHEN RUBLE,
and JUAN GABRIEL HINCAPIE ORDONEZ
Appeal 2015-001989
Application 13/472,988
Technology Center 3700
Before LISA M. GUIJT, BRETT C. MARTIN, and ERIC C. JESCHKE,
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
decision rejecting claims 1-15 and 17—21. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
Claims 1,3, and 11 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal, with
disputed limitations italicized for emphasis.
Appeal 2015-001989
Application 13/472,988
1. An implantable medical device, comprising:
a stimulation output circuit configured to deliver
neurostimulation during therapy sessions;
a storage device configured to store values of a plurality
of stimulation parameters including one or more primary
parameters each having a value selected for efficacy of the
neurostimulation and one or more secondary parameters each
having a value adjustable for preventing neural accommodation
while maintaining the efficacy of the neurostimulation, the
values including a plurality of value sets for the one or more
secondary parameters, the value sets each being a set of one or
more values each given to one of the one or more secondary
parameters;
a control circuit configured to control the delivery of the
neurostimulation using the plurality of stimulation parameters
including a dosing parameter of the one or more primary
parameters, the dosing parameter specifying a measure of total
doses of the neurostimulation for a therapy session and
representing a number of electrical pulses delivered during the
therapy session, the control circuit including a parameter adjuster
configured to adjust one or more parameters of the plurality of
stimulation parameters, the parameter adjuster including a
secondary parameter adjuster configured to select a subset of one
or more value sets from the stored plurality of value sets for the
one or more secondary parameters for each session of the therapy
sessions and adjust the one or more secondary parameters using
the selected subset of the one or more value sets during the each
[sic] session, the subsets of the one or more value sets selected
for the therapy sessions to allow the secondary parameter
adjuster to adjust the one or more secondary parameters
randomly through the therapy sessions; and
an implantable housing encapsulating the stimulation
output circuit the storage device, and the control circuit.
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Application 13/472,988
REJECTIONS
I. Claims 1—7, 9—15, 17, and 19-21 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Stypulkowski (US 2003/0135248 Al;
pub. July 17, 2003) and Bioinduction (WO 2005/115536 Al; pub. Dec. 8,
2005).
II. Claims 8 and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Stypulkowski, Bioinduction, and Pless (US 7,174,213 B2;
pub. Feb. 6, 2007).
ANALYSIS
Rejection I
Independent claims 1 and 11, and dependent claims 2, 4, 5, 7, 9, 10, 12—15,
17, and 19—20
Regarding independent claim 1, the Examiner finds, inter alia, that
Stypulkowski discloses an implantable medical device comprising a
stimulation output circuit configured to deliver neurostimulation during
therapy sessions, and a storage device configured to store values of
parameters, including (i) primary parameters having values selected for
efficacy of the neurostimulation and (ii) secondary parameters having values
adjustable for preventing neural accommodation while maintaining the
efficacy of the neurostimulation. Final Act. 3^4 (citing Stypulkowski,
Abstract, || 27, 29—39, 42, Fig. 5). The Examiner also finds that
Stypulkowski discloses a control circuit configured to control the delivery of
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Application 13/472,988
the neurostimulation using the parameters. Id. at 4 (citing Stypulkowski,
Fig. 5).
The Examiner determines that Stypulkowski “does not expressly state
that the one or more primary parameters include a dosing parameter . . .
representing a number of electrical pulses delivered during the therapy
session.” Final Act. 6. The Examiner relies on Bioinduction for teaching
“that the ‘limitation of charge to a patient is a key consideration in the safety
of the apparatus,’” and also “how to calculate the charge to the patient (e.g.,
a measure of the dose[)].” Id. (citing Bioinduction 54:1—2, 11—15). The
Examiner reasons that
one of ordinary skill in the art would have recognized the benefits
of including a dosing parameter or threshold limitation to the one
or more primary parameters, which dosing parameter represents
a number of electrical pulses delivered during the therapy session
for safety as taught by Bioinduction. It is for this reason that one
of ordinary skill in the art would have modified the apparatus and
method of Stypulkowski to include a primary parameter that is a
dosing parameter that specifies a measure of total dose of
neurostimulation for a therapy session in view of the teachings
of Bioinduction and because the combination would have
yielded predictable results.
Id. at 6—7. The Examiner makes similar findings and applies similar
reasoning with respect to independent claim 11. Final Act. 5—7.
Appellants argue that neither Stypulkowski nor Bioinduction teaches
or suggests a dosing parameter representing a number of electrical pulses
delivered during a therapy session, as recited in claims 1 and 11. Appeal Br.
9. Appellants argue that the Examiner’s consideration of Bioinduction’s
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Application 13/472,988
charge limitation as the claimed dosing parameter is unreasonable and that
the Examiner failed to consider that the claims require the dosing parameter
to represent a number of electrical pulses delivered during the therapy
session. Id. at 9—11. Appellants submit that Bioinduction’s charge
limitation does not represent the number of electrical pulses delivered during
the therapy session, because
charge is a function of the current (pulse amplitude), the number
of electrical pulses, and the pulse width of the electrical pulses,
as known in the art. The same amount of charge could result
from fewer pulses each having a longer pulse width, or more
pulses each having a shorter pulse width, for example. Thus, the
limitation of charge as taught by Bioinduction cannot represent
the number of electrical pulses.
Id. at 11 (emphasis added).
The Examiner responds, inter alia, that during patent examination,
claims are to be given their broadest reasonable interpretation consistent
with the specification, with claim language being read in light of the
specification as it would be interpreted by one of ordinary skill in the art (see
In re Am. Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)),
and that Appellants’ Specification describes the claim term “dosing
parameter” “as ‘representative of the dose of the neurostimulation for the
therapy session measured by the number of electrical pulses delivered during
the therapy session.’” Ans. 3 (citing Spec. 16:20—22, 18:23—28). Appellants
reply that “one does not know the number of electrical pulses simply based
on charge.” Reply Br. 2.
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Application 13/472,988
The Specification discloses that
[w]hen the neurostimulation is delivered as electrical pulses with
a specified duration of the therapy session and a specified pulse
frequency, this measure of total dose of the neurostimulation is
expressed as a duty cycle or a total stimulation duration and
represents the total number of the electrical pulses delivered
during the therapy session.
Spec. 19:29-20:3 (emphasis added). The Specification also discloses that
[w]hen the neurostimulation is delivered as electrical pulses with
a specified duration of the therapy session and a specified pulse
frequency, the duty cycle is a dosing parameter representative of
the dose of the neurostimulation for the therapy session measured
by the number of electrical pulses delivered during the therapy
session.
Spec. 16:18—22 (emphasis added). Specification further discloses that
[w]hen the neurostimulation is delivered as electrical pulses with
a specified duration of the therapy session and a specified pulse
frequency, the specified dose (as a duration) is a dosing
parameter representative of the dose of the neurostimulation for
the therapy session measured by the number of the electrical
pulses delivered during the therapy session.
Spec. 18:24—28 (emphasis added).
Thus, according to the Specification, although the duty cycle or total
stimulation duration is not the number of the electrical pulses delivered
during the therapy session, the duty cycle or total stimulation duration
represents the total number of electrical pulses delivered during the therapy
session. Moreover, one does not know the number of electrical pulses
simply based on the duty cycle (or dosing parameter), as Appellants contend
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Application 13/472,988
is a requirement of claim 1. Rather, the duration of therapy and pulse
frequency must also be specified, in addition to the duty cycle, to determine
the number of electrical pulses delivered during the therapy session
according to the Specification as quoted supra.
Bioinduction discloses that (i) “[t]he term ‘pulse’ refers to either the
positive or negative (forward or reverse) element of the biphasic waveform,”
wherein “the pulse frequency is the number of forward and reverse pulses
per second, counting both” and (ii) “[a] cycle consists of both a forward and
reverse pulse,” such that “the number of forward and reverse pulses per
second (the pulse frequency) will be equal to twice the cycle frequency.”
Bioinduction 4:33—5:11. Bioinduction discloses that “limitation of charge
delivered to the patient” should not exceed a certain limit, wherein “[t]he
charge delivered to the patient is calculated by adding the charge transferred
in positive and negative cycles and the continuous output of the boost
converter during the pulse time.” Id. at 54:1—15. Thus, Bioinduction’s
limitation of charge describes a dosage of electrotherapy, and is, therefore,
reasonably interpreted as a dosing parameter. Moreover, similar to the duty
cycle dosing parameter disclosed in the Specification, which is not itself a
number of electrical pulses but representative of the total number of electric
pulses delivered during the therapy session when other parameters are
known (i.e., duration of therapy and pulse frequency), a preponderance of
the evidence supports the Examiner’s finding that Bioinduction’s limitation
of charge is representative of the total number of electric pulses delivered
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Application 13/472,988
during the therapy session, for example, when other parameters are known
(i.e., charge transferred in positive and negative cycles, factoring in the boost
converter).
Appellants also argue that “the dosing parameter is one of the ‘one or
more primary parameters each having a value selected for efficacy of the
neurostimulation,’” and that “Bioinduction’s ‘limitation of charge to a
patient is a key consideration in the safety of the apparatus,” not efficacy.
Appeal Br. 11 (emphasis added). Appellants contend that “[i]t is known in
the art that the safety and efficacy thresholds for a dosing parameter are not
necessarily the same and must be separately evaluated,” and that “[o]ne of
ordinary skill in the art would not set the dosage parameter to its safety
threshold for the purpose of efficacy.” Id.
The Examiner relies on Stypulkowski for disclosing primary
parameters with values selected for neurostimulation efficacy, as set forth
supra. See Stypulkowski, Abstract (“Techniques for varying stimulus
parameters used in neural stimulation to improve therapy efficacy.”) The
Examiner proposes modifying Stypulkowski’s to include Bioinduction’s
limitation of charge dosing parameter as a primary parameter, to improve the
safety of Stypulkowski’s device, as set forth supra. We understand
Appellants’ argument to be that such a modification would not result in the
claimed subject matter, because Stypulkowski’s modified primary
parameter, namely, Bioinduction’s limitation of charge dosing parameter,
does not have a value selected for efficacy, as required by claims 1 and 11.
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Application 13/472,988
An ordinary meaning of the claim term “efficacy” in light of the
Specification is “the power to produce an effect.” Webster’s Third New
Int’l Dictionary 725 (1993). Thus, claim 1 requires the primary
parameter to have a value selected for having the power to produce an effect
of the neurostimulation. According to the Examiner’s proposed
modification, the value of the primary parameter (i.e., limitation of charge)
would be selected for having the power to produce an effect of the
neurostimulation: to deliver neurostimulation without harming the patient.
Thus, we are not persuaded by Appellants’ argument.
Accordingly, we sustain the Examiner’s rejection of independent
claims 1 and 11. Appellants chose not to present separate arguments for the
patentability of claims 2, 4, 5, 7, 9, 10, 12—15, 17, and 19-20, which depend
from claims 1 and 11, and therefore, we also sustain the Examiner’s
rejection of claims 2, 4, 5, 7, 9, 10, 12—15, 17, and 19—20. See Appeal Br.
8—14; Reply Br. 2—5.
Independent claim 3 and dependent claims 6 and 21
Regarding independent claim 3, the Examiner finds, inter alia, that
Stypulkowski discloses a sensing circuit and a feedback sensor
corresponding to the claimed control circuit including a secondary parameter
adjuster, wherein the secondary parameter adjuster is configured to adjust
secondary parameters in response to a detection of the indication of neural
accommodation, as claimed. Final Act. 7 (citing Stypulkowski || 5, 6).
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Application 13/472,988
Appellants argue that “the Examiner [fails] to indicate or clarity what
provides the limitation ‘in response to a detection of the indication of neural
accommodation,’” as required by claim 3. Appeal Br. 12. The Examiner
responds, inter alia, that Figure 6 of Stypulkowski teaches varying the
primary and secondary parameters in response to a detection of the
indication of neural accommodation. Ans. 5.1
With reference to Rise (US 5,683,422), Stypulkowski discloses that it
is known to use “a closed loop feedback control algorithm for both blocking
and facilitating neural activity at a stimulation site,” wherein “if the
feedback sensor values indicate too much activity, the stimulation frequency
is increased up to a preset maximum value,” and “[i]f the frequency
parameter is at the maximum value, the algorithm next increases the pulse
width up to a present maximum value.” Stypulkowski 15. Stypulkowski
acknowledges that Rise addresses reducing effects of neurodegenerative
disorders, rather than “the problem of development of a physiological
tolerance to the stimulation.” Id. 1 8. However, a reference “may be used as
evidence of obviousness under [35 U.S.C.] § 103 for all it fairly suggests to
one of ordinary skill in the art.” In re Wiggins, 488 F.2d 538, 543 (CCPA
1973). Here, Stypulkowski suggests that feedback sensor values could
1 To the extent the Examiner relies on the clinician to perform the function
of the claimed secondary parameter adjuster, Appellants correctly argue that
“[a] control circuit does not include a clinician.” Reply Br. 4.
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Application 13/472,988
indicate (or detect) neural accommodation, as claimed, and automatically
adjust (by algorithm as opposed to by a clinician) parameters accordingly.
Accordingly, we sustain the Examiner’s rejection of independent
claim 3. Regarding claims 6 and 21, which depend from claim 3, Appellants
rely on their arguments presented supra for claims 1 and 11. Appeal Br. 13.
Therefore, for the reasons stated supra, we also sustain the Examiner’s
rejection of claims 6 and 21.
Rejection II
Claims 7 and 17 require, in relevant part, a control circuit configured
to control the delivery of the neurostimulation using a duty cycle, including
on and off-periods during which the neurostimulation is or is not delivered,
wherein the duty cycle is a primary parameter. Appeal Br. 18, 20 (Claims
App.). The Examiner relies on Bioinduction for teaching that “[a] generator
provides a biphasic waveform compris[ing] successive cycles, each
containing a positive and negative pulse (a duty cycle with [on] and off
periods).” Final Act. 9. The Examiner reasons, inter alia, that it would have
been obvious to modify Stypulkowski’s control circuit, in view of
Bioinduction, to control the delivery of the neurostimulation using a duty
cycle, as claimed, because “it is well-known to monitor the amount of
electrical pulses during a therapy session and to measure the total dose of the
neurostimulation using a duty cycle as taught by Bioinduction.” Id.
Claims 8 and 18 depend from claims 7 and 17, respectively, and
further require, in relevant part, the secondary parameter adjuster to be
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configured to adjust a duration of a ramp during which a stimulation
intensity gradually increases or decreases from zero to its specified value for
an on-period, wherein the duration of the ramp is a secondary parameter.
Appeal Br. 18, 21 (Claims App.). The Examiner finds, inter alia, that “Pless
teaches a truncated ramp waveform,” and reasons that one of ordinary skill
in the art “would have recognized the benefits of adjusting a duration of a
ramp,” as claimed and as taught by Pless, because such is “a routine
engineering program in the neural stimulator art.” Final Act. 12 (citing Pless
15:27—62). The Examiner further reasons that
[o]ne of ordinary skill in the art could have applied the known
adjustment of intensity using a ramp as taught by Pless in the
device and method of Stypulkowski in view of Bioinduction to
slowly bring the intensity of the neural stimulation to its highest
value in the same manner as taught by Pless and the combination
would have yielded predictable results.
Id.
Appellants argue that Pless’ truncated ramp waveform does not have
an intensity that gradually increases or decreases for an on-period, “when the
‘on-period’ is the alleged positive pulse of a biphasic waveform.” Appeal
Br. 14. However, as stated supra, the Examiner relies on Bioinduction, not
Pless for disclosing a generator that provides a biphasic waveform
comprising on and off periods. Thus, Appellants’ argument does not apprise
us of error in the Examiner’s findings or reasoning.
Appellants also argue that “Stypulkowski, Bioinduction, and Pless do
not teach or suggest a duration of the alleged ‘truncated ramp waveform’ of
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Pless is suitable for being [a secondary parameter],” as claimed, wherein the
truncated ramp waveform “is adjustable for preventing neural
accommodation while maintaining the efficacy of the neurostimulation,” as
recited in claims 1 and 11. Appeal Br. 14. The Examiner responds that
Stypulkowski teaches, for example, stimulation parameters
having an amplitude as the one primary parameter and a pulse
width as the one secondary parameter. . . . Pless teaches that a
truncated ramp stimulation waveform is well-known in the
stimulation art.. .. One of ordinary skill in the art. .. could have
varied the duration of the ramp as a secondary parameter, which
is based on the secondary pulse width parameter as taught by
Stypulkowski, for example, because employing a truncated ramp
waveform instead of a pulse waveform as taught by
Stypulkowski is well-known in the neural stimulation art as
taught by Pless and would be a routine engineering program in
the stimulator art.
Ans. 6—7.
We are not persuaded by Appellants’ argument that the Examiner’s
proposed combination, namely, substituting Stypulkowski’s secondary
parameter, i.e., pulse width, with Pless’ truncated ramp waveform, lacks
rational basis. Pless discloses and depicts “a truncated ramp waveform
where the rate of the ramp, the amplitude reached and the well at the
extrema are all selectable parameters,” explaining that “[t]he truncated ramp
has the advantage of ease of generation while providing the physiological
benefits of a sinusoidal or quasi-sinusoidal waveform.” Pless 15:57—62
(emphasis added), Fig. 17. Notably, Appellants do not dispute the
Examiner’s finding, as set forth supra, that Stypulkowski discloses a
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secondary parameter having a value adjustable for preventing neural
accommodation while maintaining the efficacy of the neurostimulation, or
that a truncated ramp waveform instead of a pulse waveform is well-known
in the neural stimulation art.
Accordingly, we sustain the Examiner’s rejection of claims 8 and 18.
DECISION
We affirm the Examiner’s rejection of claims 1-15 and 17—21.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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