Ex Parte Hahn et al

Patent Trial and Appeal Board

Sep 13, 2017

13306745 (P.T.A.B. Sep. 13, 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.
13/306,745 11/29/2011 Stephen J. Hahn 279.I90US1 1083
45458 7590 09/15/2017
smwfPtMan t t tndrf.ro & wofnnnfr/rnf EXAMINER
PO BOX 2938 LEE, ERICA SHENGKAI
MINNEAPOLIS, MN 55402
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
09/15/2017 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):
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 STEPHEN J. HAHN,
JASON J. HAMANN, and DAVID J. TERNES
Appeal 2016-006014
Application 13/306,7451
Technology Center 3700
Before DONALD E. ADAMS, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 1—11 and 23—31
(Final Act.2 1). Examiner entered rejections under 35 U.S.C. § 112, second
paragraph, the written description provision of 35 U.S.C. § 112, first
paragraph, and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the real party in interest as “Cardiac Pacemakers, Inc.”
(App. Br. 2.)
2 Examiner’s May 1, 2015 Office Action.
Appeal 2016-006014
Application 13/306,745
STATEMENT OF THE CASE
Appellants’ disclosure “relates generally to medical devices and, more
particularly, to systems, devices and methods for setting a dose of a neural
stimulation therapy” (Spec. 12). Independent claims 1 and 31 are
representative and reproduced below:
1. An implantable neural stimulator for implantation in a
patient, comprising:
controller circuitry;
neural stimulation output circuitry configured to deliver
neural stimulation, wherein the controller circuitry is configured
to control an intensity of the neural stimulation delivered by the
neural stimulation output circuitry;
an input configured to receive a patient-controlled
trigger, wherein the controller circuitry is configured to detect
the patient-controlled trigger;
a memory with instructions operable on by the controller
circuitry, wherein the instructions include:
instructions for delivering neural stimulation using
the neural stimulation output circuitry;
instructions for implementing an up-titration
routine to automatically increase the intensity
of the neural stimulation from a lower intensity
level to a higher intensity level; and
instructions for automatically decreasing the
intensity of the neural stimulation from the
higher intensity level to the lower intensity
level in response to receiving the patient-
controlled trigger, wherein the automatically
increased intensity is maintained if the trigger
from the patient is not received,
wherein the neural stimulator is configured to detect a
specific condition, and the neural stimulator is configured to
allow the up-titration routine, implemented by the controller
circuitry operating on the instructions in the memory, to
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increase the intensity only when the specific condition is
detected.
(App. Br. 30.)
31. An implantable neural stimulator for implantation in a
patient, comprising:
controller circuitry;
neural stimulation output circuitry configured to deliver
neural stimulation, wherein the controller circuitry is configured
to control an intensity of the neural stimulation delivered by the
neural stimulation output circuitry;
an input configured to receive a patient-controlled
trigger, wherein the controller circuitry is configured to detect
the patient-controlled trigger;
a memory with instructions operable on by the controller
circuitry, wherein the instructions include:
instructions for delivering neural stimulation using
the neural stimulation output circuitry;
instructions for implementing an up-titration
routine to automatically increase the intensity
of the neural stimulation from a lower intensity
level to a higher intensity level; and
instructions for automatically decreasing the
intensity of the neural stimulation from the
higher intensity level to the lower intensity
level in response to receiving the patient-
controlled trigger, wherein the automatically
increased intensity is maintained if the trigger
from the patient is not received;
an activity detector configured to detect a specific
condition, the specific condition being a period of rest or a
period of activity,
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wherein the neural stimulator is configured to use
detection of the specific condition to enable the automatic
increase in the intensity by the up-titration routine.
(Id at 33-34.)
The claims stand rejected as follows:
Claims 26—30 stand rejected under 35U.S.C. § 112, second
paragraph, as indefinite and for omitting essential steps.
Claims 26—30 stand rejected under the written description provision of
35 U.S.C. § 112, first paragraph.
Claims 1—11, 23, 25, and 31 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Maniak3 and Torgerson.4
Claim 24 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Maniak, Torgerson, and Libbus.5
Claims 1, 26, 27, 29, and 30 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Maniak and Shafer.6
Claims 1 and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Maniak and Shuros.7
Definiteness & Omission of Essential Steps'.
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that Appellants’ claims 26—30 are indefinite and omit essential steps?
3 Maniak et al., US 2010/0168820 Al, published July 1, 2010.
4 Torgerson, US 2010/0274320 Al, published Oct. 28, 2010.
5 Libbus et al., US 2007/0142864 Al, published June 21, 2007.
6 Shafer, US 2005/0075702 Al, published Apr. 7, 2005.
7 Shuros et al., US 2010/0228310 Al, published Sept. 9, 2010.
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FACTUAL FINDINGS (FF)
FF 1. Appellants disclose:
Some system embodiments are configured to allow the
dose to increment only when specified conditions are met. For
example, an activity sensor may be used to detect periods of
rest or periods of activity, and the device may be programmed
to enable increments only during periods of rest or to enable
increments only during periods of activity. Additional
conditions may be required as well, such as a time of day, or
particular levels for cardiac demand, respiration activity, blood
pressure, heart rate, and the like.
(Spec. 140 (emphasis added); see Ans. 19; see also Ans. 11.)
FF 2. Examiner finds that “particular levels for cardiac demand, respiration
activity, blood pressure, heart rate, and the like” are disclosed by Appellants
to represent conditions that may be required to be met in addition to meeting
“specified conditions” (see Ans. 12—13; see also id. at 11 and 19—20; cf.
Spec. 140).
FF 3. Examiner finds that Appellants’ claim 1 requires an implantable
neural stimulator that “is configured to detect a specific condition, and ... to
increase the intensity [of the neural stimulation delivered by the neural
stimulation output circuitry] only when the specific condition is detected'1'’
(Ans. 12 (emphasis added); see App. Br. 30).
FF 4. Appellants’ claims 26—30 depend from Appellants’ claim 1 (see
App. Br. 30 and 33).
FF 5. Examiner finds the phrases “cardiac demand (elm 26, 27),
respiratory activity (elm 28), blood pressure (elm 29) or heart rate (elm 30)”
indefinite, because Appellants’ claims 26—30 fail to make clear whether the
phrases are intended to represent “a specific condition” or an “additional
condition” (see Ans. 12; see also App. Br. 33; Spec. 140).
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FF 6. Examiner finds that if the phrases “cardiac demand,” “respiratory
activity,” “blood pressure,” and “heart rate,” of Appellants’ claims 26—30,
are interpreted as something other than “specific conditions” then
Appellants’ claims 26—30 are “incomplete for omitting essential steps
[establishing a linking relationship between the cardiac demand, respiratory
activity, blood pressure or heart rate and the “specific condition” of
Appellants’ claim 1]. . . amounting to a gap between the steps” (Ans. 13;
see id. at 19).
FF 7. Appellants’ Specification discloses that “some embodiments [of
Appellants’ disclosure] automatically create a schedule (such as a schedule
reflecting a patient’s circadian rhythm) for switching intensity levels” (Spec.
132).
ANALYSIS
Definiteness'.
Examiner finds Appellants’ claims 26—30 indefinite (see FF 5).
Appellants contend that
one of ordinary skill in the art would understand that the first
sentence of paragraph [0040] introduces the feature that some
system embodiments are configured to allow the [doses] to
increment only when specific conditions are met, and that the
following sentences provide examples of the specific condition.
“For example,” in [0040] clearly indicates that the Appellant is
providing examples of the specific condition.
(App. Br. 27 (alteration original); see Reply Br. 10.) We are not persuaded
(see FF 1—2; see also Ans. 20 (Paragraph 40 of Appellants’ Specification
does not support Appellants’ arguments)).
We are not persuaded by Appellants’ contention that paragraph 32 of
their Specification “provides an example of the use of circadian rhythm
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(‘time of day’) without an activity sensor” (Reply Br. 10). Paragraph 32 of
Appellants’ Specification relates to the creation of “a schedule for switching
intensity levels,” wherein the schedule “reflect[s] a patient’s circadian
rhythm” (FF 7). Appellants fail to provide an evidentiary basis on this
record to support a finding that the creation of “a schedule” that reflects a
patient’s circadian rhythm provides written descriptive support for the
detection of: (a) a specific condition and (b) “cardiac demand,” “respiratory
activity,” “blood pressure,” or “heart rate”; wherein “the intensity [of the
neural stimulation delivered by the neural stimulation output circuitry
increases] only when the specific condition is detected” (see FF 7; cf. FF 1—
3). Further, Appellants fail to provide an evidentiary basis on this record to
support a finding that their disclosure of switching intensity levels according
to a schedule that may reflect a patient’s circadian rhythm provides written
descriptive support for defining a “specific condition” as “cardiac demand,”
“respiratory activity,” “blood pressure,” or “heart rate” (cf. Reply Br. 10).
Omission of Essential Steps'.
Examiner finds that Appellants’ claims 26—30 are “incomplete for
omitting essential steps [establishing a linking relationship between the
cardiac demand, respiratory activity, blood pressure or heart rate and the
“specific condition” of Appellants’ claim 1]. . . amounting to a gap between
the steps” (FF 6).
Appellants contend that for the reasons provided with regard to the
indefmiteness rejection, “one o[f] ordinary skill in the art, particularly when
enlightened by [Appellants’] [Specification, would understand that claims
26-30 are providing examples of the specific condition for increasing the
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dose” (App. Br. 27; see Reply Br. 10). For the reasons discussed above, we
are not persuaded.
Appellants contend that Examiner did not enter Appellants’ After-
Final Claim Amendments and request the entry of these amendments (App.
Br. 27—28). “[Ejxaminer’s refusal to enter an amendment... is a
petitionable matter that is not subject to review by the Board ...” (Manual
of Patent Examining Procedure § 1204.04).
CONCLUSION OF LAW
The preponderance of evidence supports Examiner’s conclusion that
Appellants’ claims 26—30 are indefinite and omit essential steps. Therefore,
the rejection of claims 26—30 under 35U.S.C. § 112, second paragraph as
indefinite and for omitting essential steps is affirmed.
Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellants’ Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 8. Examiner finds that paragraph 40 of Appellants’ Specification does
not provide written descriptive support for an interpretation of Appellants’
claims 26—30 that: (a) permits a neural stimulator to increase the intensity of
neural stimulation delivered by the neural stimulation output circuity based
solely on the detection of particular levels of: cardiac demand, respiration
activity, blood pressure, or heart rate or (b) allows for the “specific
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condition” to represent: cardiac demand, respiration activity, blood
pressure, or heart rate (Ans. 11; cf. Spec. 140).
ANALYSIS
Examiner finds that Appellants’ Specification fails to provide written
descriptive support for Appellants’ claims 26—30 (see FF 8). We are not
persuaded by Appellants’ contention that “[o]ne of ordinary skill in the art
would appreciate [that the terms] ‘for example’ and ‘may’[, as set forth in
paragraph 40 of Appellants’ Specification,] indicate] that [] Appellants’]
[are] providing examples of the specific condition” (App. Br. 26; see Reply
Br. 10). As discussed above, Appellants fail to provide an evidentiary basis
on this record to support a finding that their disclosure of switching intensity
levels according to a schedule that may reflect a patient’s circadian rhythm
provides written descriptive support for defining a “specific condition” as
“cardiac demand,” “respiratory activity,” “blood pressure,” or “heart rate”
{cf. Reply Br. 10). Further, as Examiner explains, “[d]etails are not provided
[in Appellants’ Specification] for [the phrases] cardiac demand, respiration
activity, blood pressure, or heart rate, except for stating that these parameters
are considered ‘[additional conditions [that] maybe required . . .’” in
addition to specific conditions (Ans. 11; see FF 8; cf. FF 1^4).
CONCFUSION OF FAW
The preponderance of evidence on this record supports Examiner’s
finding that Appellants’ Specification fails to provide written descriptive
support for the claimed invention. Therefore, the rejection of claims 26—30
under the written description provision of 35 U.S.C. § 112, first paragraph is
affirmed.
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Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 9. Appellants disclose that the term “[tjitration . . . refers to the process
of adjusting the dose of [] stimulation, ultimately to a level that is
therapeutically or prophylactically effective” (Spec. 136).
FF 10. Appellants disclose that “an up-titration routine . . . automatically
increase [s] the intensity of the neural stimulation from a lower intensity level
to a higher intensity lever (Spec. 14 (emphasis added)).
FF 11. Maniak “relates to [the use of] patient feedback to optimize
neuromodulation of the sympathetic nervous system” (Maniak 12).
FF 12. Maniak discloses that
[w]hen peripheral nerves are electrically stimulated for the
purpose of driving a therapeutic effect it is common that
stimulation intensity is ramped up over a period of days or
weeks in order to optimize therapeutic effect while minimizing
patient discomfort. . . .
This ramping process[, however,] is very burdensome in
its own right in that it requires multiple visits to the clinic for
the patient along with additional clinician time.
(Maniak || 3 4.)
FF 13. Maniak discloses “a system ... in which a chronically implanted
pulse generator . . . autonomously proceed[es] through an intensity ramping
profile over a programmable period of days or weeks” to attain an optimal
level of stimulation intensity for a patient (Maniak | 5).
FF 14. Maniak’s “implanted pulse generator . . . is [] capable of receiving
patient input from a patient programmer, or magnet, sound activated sensor,
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or tactile activated sensor (collectively . . . referred [to] as a ‘patient
intervention device,’ or PID) that indicates patient discomfort at a particular
level of stimulation” (id.; see id. (Maniak’s “system . . . incorporate[s]
patient feedback from the PID to customize the maximum stimulation
intensity for the individual patient without clinical interaction”)).
FF 15. Maniak discloses that
[w]hen [an] optimal level of stimulation intensity is determined
(i.e., maximum tolerable stimulation intensity) the implanted
pulse generator may autonomously transition to a sequence of
programmed therapeutic algorithms (stimulation patterns) in
which th[e] optimal intensity level is then utilized as the upper
bound of intensity for these algorithms such that therapeutic
effect is optimized while minimizing discomfort.
(id.)
FF 16. Examiner finds that Maniak discloses Appellants’ claimed invention,
with the exception of: (A) a “neural stimulator [] configured to detect[:]” (i)
“a specific condition, and . . . configured to allow the up-titration routine,
implemented by the controller circuitry operating on the instructions in the
memory, to increase the intensity only when the specific condition is
detected”; (ii) ‘ ‘'cardiac demand, blood pressure, or heart rate, and . . .
configured to allow the up-titration routine, implemented by the controller
circuitry operating on the instructions in the memory, to increase the
intensity only for particular levels of cardiac demand, blood pressure, or
heart rate”; or (iii) “respiratory activity, and the neural stimulator is
configured to allow the up-titration routine, implemented by the controller
circuitry operating on the instructions in the memory, to increase the
intensity only for particular levels of respiratory activity”; and (B)
“instructions within the memory, wherein the instructions include:
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instructions for implementing the up-titration of stimulation intensity and the
decrease in stimulation intensity based on the trigger from the patient” (Ans.
3—10 (emphasis added) (citing Maniak || 62, 93, 98, 105, 106 and Figures 8,
11, and 13)).
FF 17. Torgerson “relates to medical systems and, more particularly,
medical systems that deliver electrical stimulation therapy” (Torgerson 11).
FF 18. Torgerson discloses that
a user may program [an implantable medical device (IMD)] . . .
to automatically select different functions at different times of
day or in response to a sensor signal, such as an accelerometer,
indicating different levels o[f] activity or different postures,
e.g., a more aggressive function during the day or during high
activity, and a less aggressive function at night or during low
activity.
(Torgerson | 63 (reference number omitted); see Ans. 3 4.)
FF 19. Examiner finds that the combination of Maniak and Torgerson fails
to suggest an “activity detector [] configured to detect a period of rest, [as]
the specific condition” and relies on Libbus to “teach[] providing and
increasing stimulation when it is detected that the patient is at rest” (Ans. 6
(citing Libbus 1114)).
FF 20. Shafer “relates to medical devices and methods for modulating
neurons and modulating an immune response” (Shafer 12; see also id. 19
(Shafer discloses “a device capable of stimulating a sympathetic nervous
system of a subject”)).
FF 21. Shafer discloses a “sensor . . . coupled to [a] device to modify
parameters of the device such that the device increases stimulation or
decreases stimulation of a sympathetic neuron,” when a sensed signal falls
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below or rises above a predetermined threshold (Shafer || 109 and 119
(reference numbers omitted)).
FF 22. Shafer’s
[sjensor may detect biochemical parameters, physiological
parameters, and combinations thereof. Biological parameters
include pH, a chemical, an ion, a biological molecule, a gas,
spectral indicators thereof, and combinations thereof.
Physiological parameters such as body temperature, heart rate,
blood pressure, cardiac output, electrical activity of a neuron,
and the like, or combinations thereof.
(Shafer 1110 (reference number omitted).)
FF 23. Shuros “relates generally to medical devices and, more particularly,
to systems, devices and methods for modulating the autonomic nervous
system” (Shuros 12; see generally Ans. 9).
FF 24. Shuros discloses the use of a “respiration sensor ... to guide the
neural stimulation to block sympathetic activity during the inspiratory phase
when sympathetic activity is intrinsically high, and to stimulate the vagus
nerve during an expiratory phase to enhance the parasympathetic activity”
(Shuros 125; see id. 1 59; Ans. 9).
ANALYSIS
The combination ofManiakand Torgerson, with or without Libbus:
Based on the combination of Maniak and Torgerson, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to modify Maniak [] to include a sensor such as
an accelerometer for detecting periods of high activity and increasing the
intensity of stimulation as taught by Torgerson in order to accommodate
stimulation levels according to the patient’s needs” (Ans. 4). We are not
persuaded.
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Appellants’ independent claims require, inter alia, that an implantable
neural stimulator comprises controller circuitry that detects a specific
condition prior to an increase in stimulation intensity during an up-titration
routine (see App. Br. 30 and 33—34).
We recognize that: Maniak discloses a system comprising an
implanted pulse generator that autonomously executes an intensity ramping
profile, or up-titration routine, to determine the optimal level of stimulation
intensity for the patient (FF 13); Maniak’s system further comprises a PID,
wherein patient feedback from the PID is incorporated into intensity
ramping profile to customize the maximum stimulation intensity for the
patient (FF 14); and, when Maniak’s system determines an optimal level of
stimulation intensity, Maniak’s implanted pulse generator autonomously
transitions into a sequence of programmed therapeutic algorithms
(stimulation patterns) in which the optimal intensity level determined by
Maniak’s system is utilized as the upper bound of intensity for the
algorithms (FF 15). Thus, Maniak discloses a system that is divided into
two phases, wherein the implanted pulse generator operates to either: (1)
determine an optimal therapeutic stimulation intensity through performance
of an up-titration routine or (2) deliver stimulation therapy through
programmed therapeutic algorithms, wherein the upper bound of intensity
for the therapy is the optimal therapeutic stimulation intensity determined in
phase (1).
Examiner finds that Maniak fails to disclose a neural stimulator
configured to allow the up-titration routine to increase the intensity only
when a specific condition is detected (FF 16). At best, Maniak’s system
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makes use of a PID during an up-titration routine, wherein the PID
“indicates patient discomfort at a particular level of stimulation” (FF 14).
Torgerson discloses “medical systems that deliver electrical
stimulation therapy,” i.e., phase (2) of Maniak’s system (FF 17). A user of
Torgerson’s system may program an IMD “to automatically select different
functions at different times of day or in response to a sensor signal, such as
an accelerometer, indicating different levels of activity or different postures”
(FF 18). Thus, Torgerson would modify phase (2) of Maniak’s system, such
that Torgerson’s sensor is combined with Maniak’s implanted pulse
generator to provide Maniak’s device the added benefit of delivering
stimulation therapy in response to a sensor signal (see id.). Examiner failed
to explain or otherwise establish an evidentiary basis to support a conclusion
that Torgerson’s sensor could be combined with Maniak’s device in such a
way as to affect the up-titration phase, phase (1), of Maniak’s system (see
generally App. Br. 15 (“Torgerson does not disclose ... [a] neural
stimulator [Jconfigured to allow [an] up-titration routine, implemented by
the controller circuitry operating on the instructions in the memory, to
increase the intensity only when [a] specific condition is detected”); see also
Reply Br. 3—5).
Examiner failed to establish that Libbus makes up for the foregoing
deficiencies in the combination of Maniak and Torgerson (see App. Br. 20;
cf. FF 19; Ans. 6-7).
The combination of Maniak and Shafer.
Based on the combination of Maniak and Shafer, Examiner concludes
that, at the time Appellants’ invention was made, it would have been prima
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facie obvious “to modify Maniak [] to include a sensor for detecting cardiac
demand, blood pressure, or heart rate and increasing the intensity of
stimulation as taught by Shafer in order to accommodate stimulation levels
according to the patient’s needs” (Ans. 8). We are not persuaded.
As discussed above, Maniak discloses a system that operates in two
phases: (1) an up-titration phase and (2) a therapeutic stimulation phase (see
FF 13-15 ; see Reply Br. 7 (“the purpose of Maniak is to automatically
increase maximum stimulation,” wherein “Maniak is pushing the patient’s
tolerance of the stimulation in a ramp up process over [a] period of days or
weeks”). Like Torgerson, discussed above, Shafer discloses a “sensor . . .
coupled to [a] device to modify parameters of the device such that the device
increases stimulation or decreases stimulation of a sympathetic neuron,”
when a sensed signal falls below or rises above a predetermined threshold
(FF 21; see generally Reply Br. 7). Thus, Shafer, like Torgerson, relates to
the delivery of stimulation therapy phase, phase (2), of Maniak’s system not
the up-titration phase of Maniak’s system.
Examiner failed to explain or otherwise establish an evidentiary basis
to support a conclusion that Shafer’s sensor could be combined with
Maniak’s device in such a way as to affect the up-titration phase, phase (1),
of Maniak’s system {see generally Reply Br. 8; App. Br. 21).
The combination of Maniak and Shuros:
Based on the combination of Maniak and Shuros, Examiner concludes
that, at the time Appellants’ invention was made, it would have been prima
facie obvious “to modify Maniak [] to include a sensor for detecting
respirator activity and increasing the intensity of stimulation as taught by
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Shuros [] in order to accommodate stimulation levels according to the
patient’s needs” (Ans. 9-10). We are not persuaded.
As discussed above, Maniak discloses a system that operates in two
phases: (1) an up-titration phase and (2) a therapeutic stimulation phase (see
FF 13—15; see generally App. Br. 24). Like Torgerson and Shafer, discussed
above, Shuros discloses a sensor, specifically a “respiration sensor ... to
guide the neural stimulation to block sympathetic activity during the
inspiratory phase when sympathetic activity is intrinsically high, and to
stimulate the vagus nerve during an expiratory phase to enhance the
parasympathetic activity” (FF 24; see generally App. Br. 24—25; Reply Br.
10). Thus, Shuros, like Torgerson and Shafer, relates to the delivery of
stimulation therapy phase, phase (2), of Maniak’s system not the up-titration
phase of Maniak’s system.
Examiner failed to explain or otherwise establish an evidentiary basis
to support a conclusion that Shuros’s sensor could be combined with
Maniak’s device in such a way as to affect the up-titration phase, phase (1),
of Maniak’s system {see generally App. Br. 25; Reply Br. 10 (“the reasoning
of the rejection does not articulate the reasoning with the rational
underpinning required to support the legal conclusion of obviousness”)).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1—11, 23, 25, and 31 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Maniak and Torgerson is reversed.
The rejection of claim 24 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Maniak, Torgerson, and Libbus is reversed.
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The rejection of claims 1, 26, 27, 29, and 30 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Maniak and Shafer is reversed.
The rejection of claims 1 and 28 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Maniak and Shuros is reversed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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