Ex Parte Giuffrida et al

Patent Trial and Appeal Board

May 19, 2016

13153063 (P.T.A.B. May. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/153,063 06/03/2011
14783 7590 05/20/2016
Great Lakes NeuroTechnologies Inc.
4415 Euclid Ave. Ste. 500
Cleveland, OH 44103
FIRST NAMED INVENTOR
Joseph P. Giuffrida
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.
GLN-002 8223
EXAMINER
SOREY, ROBERT A
ART UNIT PAPER NUMBER
3626
MAILDATE DELIVERY MODE
05/20/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH P. GIUFFRIDA, DUSTIN A. HELDMAN,
and THOMAS 0. MERA1
Appeal2014-005677
Application 13/153,063
Technology Center 3600
Before JOSEPH A. FISCHETTI, ROBERT L. KINDER, and
CARLL. SILVERMAN, Administrative Patent Judges.
KINDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner's Final Rejection of claims 1-20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 The Appellants identify Great Lakes NeuroTechnologies Inc. as the real
party in interest. App. Br. 2.
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Application 13/153,063
Appellants' Invention
Appellants' invention generally relates to an apparatus and method for
using neural stimulation to alleviate the symptoms of movement disorders.
Spec. 1, 11. 16-21. "The present invention relates to methods for
automatically and semi-automatically adjusting treatment parameters in
therapy systems." Id. 5, 11. 15-16. In one embodiment, "[ o ]bjective
quantification of a subject's movement disorder symptoms" occurs by first
taking a "measurement of the movement" using "any [] parameter that could
give a quantitative indication of motion" and then processing this
"movement data" to develop "suggested changes to the therapy system
parameter settings based on the result of the symptom quantification
algorithm and known or predicted current therapy system parameter
settings." Id. 5, 1. 26-7, 1. 30.
Claims on Appeal
Claims 1, 8, and 13 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the subject matter on appeal:
1. A method for adjusting brain stimulation electrodes m a
subject for treating a subject's movement disorder comprising
the steps of:
applying at least one sensor having a signal to measure at least
one motor symptom of a subject's movement disorder, the
sensor having an implanted brain stimulation device for
treatment of a movement disorder;
quantifying at least one motor symptom of the subject's
movement disorder with the signal from the at least one sensor
usmg a processor;
outputting the quantification of the at least one motor symptom
to a display; and
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adjusting the implanted brain stimulation device for treatment
of the movement disorder based at least in part on the outputted
quantification of the at least one motor symptom to alleviate in
part the at least one motor symptom.
App. Br. 53 (Claims App'x).
Examiner's Rejections
I. Claims 1--4, 6-8, 10-13, 16-18 and 20 are rejected under 35
U.S.C. § 102(b) by Firlik (US 2007 /0179534 Al, pub. Aug. 2, 2007).
II. Claim 5 is rejected under 35 U.S.C. § 103(a) over Firlik and
Klapper (US 2005/0234309 Al, pub. Oct. 20, 2005).
III. Claims 9 and 19 are rejected under 35 U.S.C. § 103(a) over
Firlik and Sun (US 2008/0195166 Al, pub. Aug. 14, 2008).
IV. Claims 14 and 15 are rejected under 35 U.S.C. § 103(a) over
Firlik and Giftakis (US 2009/0083070 Al, pub. Mar. 26, 2009).
ANALYSIS
Rejection I Anticipation by Firlik
Claim 1
The citations and explanations provided by the Examiner adequately
demonstrate where each limitation of claim 1 is disclosed by Firlik. See
Final Act. 3--4; see also Ans. 2-6. We adopt these as our own and add the
following for emphasis.
Appellants first contend that Firlik fails to disclose applying at least
one sensor having a signal to measure at least one motor symptom. App. Br.
6; see also Reply Br. 2-3. Appellants concede Firlik discloses measuring
"patient performance," but Appellants contend this measurement is related
to the patient's functionality, and not motor symptoms. App. Br. 6.
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According to Appellants "[t]he measurement of motor symptoms of a
subject's movement disorder requires a differentiation between the subject's
normal movement and the disordered or symptomatic movement. Merely
measuring movement, as the Examiner suggested, does not necessarily
provide the differentiated measurement of symptoms, as is claimed, even
when symptoms are present." Reply Br. 3.
Claim 1 does not, however, require a differentiation between the
subject's normal movement and the disordered or symptomatic movement.
To the extent "one motor symptom" could be interpreted to require this
differentiation, Firlik discloses use of "diagnostic session information" for
first time users (or others) to determine various parameters for establishing
what Appellants argue would be normal movement. Firlik i-fi-1 88, 89.
Appellants' Specification recognizes that measurement of motor
symptoms must begin with measurement of body movement. The
Specification states that "quantification of a subject's movement disorder
symptoms" includes, "as a first step, measurement of the movement." Spec.
5, 11. 26-23. The Specification notes that numerous measurement
parameters may be used, including any "parameter that could give a
quantitative indication of motion." Id. Indeed, the Specification describes
"movement data" as including any signal corresponding to movement of any
part of the body, which may be continuously measured or measured for a
short period of time. See Spec. 6, 11. 7-16.
We agree with the Examiner that Firlik discloses measurement of
motor symptoms through measurement of body motion. See Ans. 3--4
("Firlik's sensors measure patient movement, whether or not the movement
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is disordered; hence, they measure motor symptoms assuming said patient
presents said symptoms."); see, e.g., Firlik i-fi-1 63, 89.
One of the purposes of Firlik is the treatment of movement disorders
related to Parkinson's disease. Firlik discloses use of prior patient
performance to manage or direct neural stimulation. See, e.g., id. i1 90 ("The
[therapy management computer] TMC 800 may further manage or direct the
application of neural stimulation to the patient 10 in an anticipatory or
approximately anticipatory manner based upon expected and/or prior patient
movements."). Firlik describes the purpose of this neural stimulation is for
"providing, maintaining, or prolonging symptomatic relief from neurologic
dysfunction." Id. i133. Likewise, Firlik makes clear that stimulation sites
are selected to treat movement disorders related to Parkinson's disease. See
id. i132 (incorporating by reference US patent applications that describe
determining stimulation sites for treating movement disorders related to
Parkinson's Disease). The numerous sensors disclosed in Firlik detect
patient performance, which includes motor symptoms, so that stimulation
can be provided for treatment of the symptoms. Thus, we disagree with
Appellants' contentions that Firlik fails to disclose applying sensors to
measure motor symptoms.
Appellants also contend "that Firlik does not teach or disclose of
quantifying a motor symptom of the subject's movement disorder, and
actually fails to explicitly point out quantifying symptoms or anything else
related to movement disorders." App. Br. 7. Although Firlik discloses a
"score," Appellants contend "[i]t is unclear how evaluating or scoring
'patient performance' information, as Firlik calls it, is equivalent to
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quantifying at least one symptom of a movement disorder." Id. at 8; see also
Reply Br. 2-5. We disagree.
Firlik discloses numerous examples of using sensors to obtain
movement data used for analysis of movement disorders and to provide
patient interactive neural stimulation for treatment and therapy based on the
information obtained through the sensors. See Firlik, Abstract; see also Ans.
4 ("Firlik teaches an assessment unit (P AU) processing/analyzing/
evaluating/scoring patient information to determine patient performance.").
Firlik describes acquiring and characterizing diagnostic session information,
as well as scoring patient performance information associated with patient
performance tests. See id. i-fi-189, 63. Firlik also discloses analyzing and
scoring performance evaluation tests for later use in treatment. See id. A
skilled medical professional, or the TMC, may use the characterization or
scoring information to define or adjust therapy or treatment session
parameters. Id.; see also Ans. 4--5 ("a therapy management computer
(TMC) assessing and monitoring patient motion ... and processing or
analyzing signals to determine a level of patient performance"). Firlik
discloses use of measured sensor signals, and then analyzing or
characterizing those signals to establish or adjust neural stimulation
parameters based upon present or historical patient performance. Firlik i195.
Both the characterization and scoring of session information related to
patient testing corresponds to the claimed "quantifying at least one motor
symptom of the subject's movement disorder with the signal from the at
least one sensor using a processor." App. Br. 26, Claims App'x. The fact
that Firlik describes adjusting neural stimulation based on historical patient
performance to provide symptomatic relief also demonstrates the
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quantification of the motor symptom may be stored for later use by either a
skilled clinician or the TMC for treatment.
Because Appellants have offered no persuasive argument as to
Examiner error for the rejection of claim 1, we sustain the Examiner's
rejection of claim 1 under 35 U.S.C. § 102(b) based on Firlik.
Claim 2
Appellants' contentions with respect to claim 2 incorporate the
arguments of claim 1, which we find unpersuasive, but otherwise fail to
explain why the Examiner erred. See 37 CPR§ 41.37(c)(l)(iv) ("The
arguments shall explain why the examiner erred as to each ground of
rejection contested by appellant. ... [A]ny arguments or authorities not
included in the appeal brief will be refused consideration by the Board for
purposes of the present appeal.") (emphasis added). Regardless, the
Examiner cites several portions of Firlik that disclose the sensors as both an
accelerometer and a gyroscope as required by claim 2. See Ans. 7.
Claims 4, 6, and 7
Claim 4 requires "wherein the quantification of at least one motor
symptom of the subject's movement disorder is based at least in part on
historical data." Claim 6 requires "the adjustment made to the implanted
brain stimulation device is based at least in part on historical data." Claim 7,
dependent from claim 6, further requires "wherein the historical data
comprises recorded adjustments made to brain stimulation devices implanted
in movement disorder patients, said recorded adjustments made by at least
one expert clinician." For the reasons set forth above for claim 1, and for the
reasons provided by the Examiner, we sustain the Examiner's rejection of
claims 4, 6, and 7 based on Firlik. See Final Act. 5---6; see also Ans. 7-8.
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We add for emphasis that Firlik discloses storing and retrieving diagnostic
session information. Based on an analysis of the diagnostic session
information (or scores) by a clinician, Firlik discloses defining or adjusting
treatment session parameters. Firlik i-f 89; see also Ans. 8 (citing Firlik
i-f 89). The stored diagnostic session information would include recorded
adjustments made to brain stimulation devices. See, e.g., Firlik i-f 88 ("TMC
800 may direct the NSS 100 to apply neural stimulation signals and/or
activate implanted monitoring devices during one or more portions of a
diagnostic session"); see also Fig. 12 (historical data would correspond to
the recorded adjustments made in the disclosed feedback loop).
Claim 8
The citations and explanations provided by the Examiner adequately
demonstrate where each limitation of claim 8 is disclosed by Firlik. See
Final Act. 6-8; see also Ans. 9-10. We adopt these as our own and add the
following for emphasis.
Independent claim 8 is similar in scope to claim 1, but has additional
limitations argued by Appellants. In pertinent part, claim 8 requires:
estimating or calculating a level of adjustment to be
applied to the selected at least one parameter of the therapeutic
medical device using a processor, the estimation or calculation
being based at least in part on the measurement of the at least
one motor symptom and at least in part on recorded data
representing the judgment of one or more expert clinicians;
presenting the estimated or calculated level of adjustment
for the selected at least one parameter of the therapeutic
medical device to a medical professional and/or the subject;
App. Br. 54--55 (Claims App'x). Appellants contend Firlik fails to disclose
these limitations. App. Br. 18; see also Reply Br. 11 ("one of ordinary skill
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in the art would readily and clearly understand that patient performance
feedback in no way teaches or even suggests adjustments of a parameter of a
therapy device"). Appellants argue claim 8 "requires that the estimated or
calculated adjustments are made based in part on recorded data representing
the judgment of one or more expert clinicians," and "the adjustments are
estimated or calculated based in part on past clinician judgment, not that the
clinicians use past patient performance to determine adjustments." App. Br.
19.
Appellants also contend that Firlik fails to disclose "the step of
presenting the estimated or calculated level of adjustment for the selected at
least one parameter of the therapeutic medical device to a medical
professional and/or the subject." App. Br. 19.
The Examiner finds Firlik discloses a "performance assessment unit
(PAU) processing/analyzing/ evaluating/scoring patient information to
determine patient performance" as well as "a therapy management computer
(TMC) assessing and monitoring patient motion" and "processing or
analyzing signals to determine a level of patient performance." App. Br. 7.
The Examiner finds the recorded data representing the judgment of one or
more expert clinicians "is met by adjusting stimulation, a function of a
patient performance analysis, based on prior/historical patient performance,"
which can be reviewed, included, and used at the discretion of clinicians or
physicians thereby representing their judgment. Id. The Examiner finds
"[f]eedback information according to Firlik is utilized in directing neural
stimulation based upon signals generated by the sensors," and "Firlik's
patient performance feedback information is sufficient to meet broad 'level
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of adjustment' information and such information is displayed by Firlik."
Ans. 9-10.
Regarding the "presenting the estimated or calculated level of
adjustment" limitation, the Examiner cites several portions of Firlik that
disclose presenting information to the patient or a professional through a
display device. See Final Act. 8. The Examiner finds Firlik's presentation
of patient performance feedback information on a display would satisfy the
challenged limitation. Id.
We first note that the claimed "recorded data representing the
judgment of one or more expert clinicians" is not claiming the judgment of
the clinicians themselves, but instead claiming data that is representative of
that judgment. See Spec. 9. Further, a broad, but reasonable, interpretation
of "judgment" would include data derived from prior adjustment of
treatment session parameters performed by a clinician. Thus, and as
explained below, we agree with the Examiner that use of patient
performance data would represent the judgment of a clinician.
Firlik discloses that patient performance information may comprise
signals, video images, scores associated with performance evaluation tests,
or other information. Firlik i-f 63. Each of these forms of information are
recorded data that may be defined and analyzed at the direction of a medical
professional. Id. Figure 12, cited by the Examiner (Ans. 9), depicts a
continual feedback loop where neural stimulation is adjusted and the patient
responses from these adjustments are monitored (measured motor symptom)
to determine impact. The loop (Figure 12) then repeats with additional
neural stimulation adjustments, which may be based on prior recorded data
representing clinician input or judgment. We therefore agree with the
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Examiner that Firlik discloses adjusting neural stimulation based on clinician
analysis andjudgment. See id. i-fi-f 172, 174; see also id. i163 ("PAU 860
may analyze such information on a regular or periodic basis, and/or in
response to a request received from a medical professional."). Firlik
explains that "a medical professional ... may select, define, or adjust
therapy period or treatment session parameters." Id. i189. Each loop
(Figure 12) occurring after the first adjustment would be based on past
recorded data representing the clinician's prior judgment, as well as
continued measurement of the motor symptom. Thus, we agree with the
Examiner that Firlik discloses the disputed "estimating or calculating"
limitation as required by Claim 8.
We also agree with the Examiner that Firlik discloses the "presenting
the estimated or calculated level of adjustment" limitation. Ans. 9. Firlik
discloses that "a medical professional ... may select, define, or adjust
therapy period or treatment session parameters." Id. i189. Treatment
session parameters would include the level of adjustment. See, e.g., id. i133
("parameters may be varied in one or more manners to enhance a likelihood
of providing, maintaining, or prolonging symptomatic relief from neurologic
dysfunction"), i-f 80, i-f 86 ("Such parameters may correspond to
... sensory stimuli, neural stimulation parameters."). To select a treatment
session parameter, or level of neural stimulation, it is presented to a
professional for selection as depicted in the "process for interactive neural
stimulation" of Figure 12. Id. i122. Firlik discloses that such information
may be presented to the professional or patient via a display device. See
Final Act. 8; see also Firlik i-fi-1 82, 145, 171 ("monitoring various types of
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patient performance related signals, patient responses, and/or biological
signals or markers associated with neural stimulation").
For the reasons set forth above, and for the reasons provided by the
Examiner, we sustain the Examiner's rejection of claim 8 under 35 U.S.C.
§ 102(b) based on Firlik.
Claims 10-12
Each of claims 10-12 depend directly from claim 8. For the reasons
set forth above for claim 8, and for the reasons provided by the Examiner,
we disagree with Appellants' contention and sustain the Examiner's
rejection of claims 10-12 based on Firlik. See Final Act. 8-9. For claims 10
and 11, Appellants' contentions fail to explain why the Examiner erred and
are therefore unpersuasive. See App. Br. 20.
As to claim 12, Appellants contend Firlik fails to disclose "wherein
the step of adjusting the at least one parameter of the therapeutic medical
device is executed upon the manual or vocal confirmation of the presented
estimated or calculated level of adjustment, the confirmation being made by
a medical professional or the subject." Id. According to Appellants Firlik
"never teaches or discloses that a clinician can approve or confirm estimated
or calculated levels of any adjustment." Id. at 21.
We add for emphasis that Firlik's Figure 12 depicts "a process for
interactive neural stimulation." Firlik i-f 22. The interactive nature of Figure
12 discloses adjusting neural stimulation (blocks 3220 and 3230) by a
professional based on continued monitoring of patient motor symptoms
(block 3050). See id. i-f 174 ("Process portion 3220 can include determining
whether to adjust neural stimulation."). As discussed above, the
embodiment relied on by the Examiner allows "a medical professional" to
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"select, define, or adjust therapy period or treatment session parameters."
Id. i-f 89. Thus, the medical professional' s adjustment of the treatment
session parameters in Firlik corresponds to the claimed manual confirmation
of the presented estimated or calculated level of adjustment.
Claim 13
Independent claim 13 recites subject matter similar to claims 1 and 8.
Appellants largely repeat many of the arguments discussed above for claims
1 and 8, which we determined to be unpersuasive. See App. Br. 21-23.
Appellants challenge whether or not Firlik discloses the following
limitations of claim 13:
a command module for receiving the analog signal
acquired by the sensor unit, the electronic module comprising a
memory and an analog-to-digital converter for converting the
analog signal into a digital signal corresponding to the at least
one quantified motor symptom; and
a clinician unit for receiving the digital signal and for
processing the signal acquired by the sensor unit, for rece1vmg
an input related to the subject's deep brain stimulation
implant's parameter settings during measurement of the analog
signal with the sensor unit, and to produce an output comprising
computed adjustments for one or more of the adjustable
parameters of the deep brain stimulation implant, the output
being based at least in part on the signal acquired by the sensor
and at least in part on the input related to the subject's deep
brain stimulation implant's parameter settings; and a display for
receiving the output.
App. Br. 56 (Claim App'x); see id. at 23-24. Appellants contend "Firlik
fails to teach or disclose any such [clinician] unit that receives both an input
from the sensor unit and an input relating to the stimulation implant's
parameter settings during measurement of the analog signal." Id. at 24.
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According to Appellants "[a]t best, Firlik's therapy management computer
(TMC), may be construed to receive a signal from the sensors to produce an
output that might comprise adjustments, but there is no indication in Firlik
that the TMC receives an input related to the stimulation implant's
parameter settings used during measurement of the analog signal with the
sensors." Id.
We agree with the Examiner that Firlik discloses the claimed
"command module" and the "clinician unit" limitations. See Final Act. 10-
11. As cited by the Examiner, Figure 12 and corresponding text, describe a
feedback loop where the input from the sensors (at block 3050) and the input
relating to the adjustment of the neural stimulation (from blocks 3220 and
3230) are both received at monitoring block (3050). The output of this
monitoring block (3050) is based on the received sensor signals as well as
feedback of patient performance from the neural stimulation. See Final Act.
10-11. As explained by the Examiner, Firlik thus allows a "determin[ation]
to adjust neural stimulation based on monitored signals and patient
performance." Id. at 11. We have considered Appellants remaining
arguments but find them unpersuasive.
Claim 16
Appellants argue the Examiner's rejections of claim 16 is erroneous
for reasons similar to those that Appellants argue the rejection of claim 13 is
erroneous. See App. Br. 24--25. Inasmuch as we are not persuaded by any
of Appellants' argument regarding claim 13, we sustain the rejection of
claim 16. Appellants' additional contention fails to explain why the
Examiner erred, and is therefore unpersuasive. Id.
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Claims 3, 17, 18, and 20
Claim 3, dependent from claim 1, requires "the enclosure and sensors
altogether having a volume of no more than or about 12 cubic centimeters
and a mass of no more than or about 12 grams." The Examiner finds that the
language "no more than or about" is broad and one of ordinary skill in the
art at the time of the invention would recognize Firlik's sensors meet the
broad limitation. Ans. 7. The cited portions of Firlik do not, however,
provide any indication of volume or mass of the claimed sensors as required
by claim 3. See App. Br. 13. Likewise, the volume and mass of the
disclosed sensors are not necessarily inherent from Firlik's disclosure, the
only reference before us for consideration.
Claims 17, 18, and 20 depend from claim 13. Claim 17 requires "the
sensor unit comprises at least one accelerometer and at least one gyroscope
and has a volume of no more than or about 12 cubic centimeters and a mass
of no more than or about 12 grams." The Examiner cites Firlik Figure 4 and
paragraph 110 as disclosing these limitations. The cited portions of Firlik do
not, however, provide any indication of volume or mass of the claimed
sensors as required by claim 17. See App. Br. 25.
Claim 18 requires "the command module has a mass of no more than
or about 85 grams." The Examiner again cites Firlik Figure 4 and paragraph
110 (Final Act. 12), but these portions of Firlik lack any disclosure of
volume or mass of the claimed command module. See App. Br. 25.
Claim 20 requires "the sensor unit and command module are
integrated into the same enclosure having a volume of no more than or []
about 82 cubic centimeters and a mass of no more than or about 97 grams."
The Examiner cites Firlik Figure 4 and paragraphs 110, 111, and 117. The
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cited portions of Firlik fail to disclose an enclosure with a mass of no more
than about 97 grams.
Accordingly, based on the record before us, we do not sustain the
Examiner's anticipation rejection of claims 3, 17, 18, and 20 based on Firlik.
Rejection II Obviousness Over Firlik and Klapper
Claim 5
Claim 5 depends from claim 4 and further requires "the historical data
comprises scores based on the Unified Parkinson's Disease Rating Scale
(UPDRS) assigned to movement disorder patients by at least one expert
clinician."
The Examiner finds that this limitation is taught by Klapper, which
describes use of a UPDRS motor score and creating an algorithm capable of
predicting the movement states of a current Parkinson's patient based upon
information collected from prior patients. Final Act. 13. The Examiner
finds "[t]he limitation gives no guidance as to how the assignment is
performed/made or what the aspect of the UPDRS is utilized to determine
the historical score." Ans. 10. Regardless, the Examiner finds "Klapper
teaches the UPDRS motor score and creating an algorithm capable of
predicting the movement states of a current Parkinson's patient based upon
information collected from prior patients." Id. at 10-11. Further, the
Examiner finds that Firlik and Klapper could be "combined according to
known methods to yield predictable results" and the use of the combination
would be predictable because the "second sensor is used to collect
movement data as expected." Id. at 11.
Appellants contend "Klapper does not provide a score given by a
skilled clinician using the UPDRS and recorded into historical data, and in
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fact teaches away from doing so." App. Br. 32. Appellants offer various
theories as to why Klapper teaches away from the use of a UPDRS or
UPDRS-like system. Id. at 33. For example, Appellants contend Klapper
creates its own score with a scoring system that may be similar in range but
in no other way related to or correlated with the UPDRS. Id. Instead,
according to Appellants, "Klapper's scores are based on sensor data
measured during ambulatory monitoring, self-assessment scores provided by
the prior users, and/ or a combination thereof - not scores provided by a
clinician using the UPDRS." Id. Appellants also contend the Examiner's
motivation for combining Firlik and Klapper is flawed. Id. at 33-36.
We have considered, and rejected, similar arguments related to
Klapper made by Appellants in a related appeal-Appeal No. 2012-006524
- involving Application Serial No. 12/250,792. In our Decision on Request
for Rehearing, we determined:
Klapper also suggests that one type of predictive algorithm for
use in this apparatus and method is a predictive algorithm based
on the UPDRS scale. Klapper i-fi-129-30. Klapper states that
UPDRS scale is a "more general assessment[] of Parkinsonism"
and that the assessment "could be of value simply as a means to
demonstrate how severely the patients were affected and
whether the experience with them generalizes to other patient
populations." Id. i129. Klapper explains that the general
assessments "serve as a means of stratifying patients so that
different prediction algorithms could be constructed for
different subgroups of patients. These general assessments of
Parkinsonism include: ... The UPDRS scale. Id. i-fi-129-30.
Appeal No. 2012-006524, Decision on Request for Rehearing, 7 (Apr. 13,
2015) ("Dec."); see also id. at 8 ("Paragraph 114 of Klapper provides
support for using a predictive algorithm that would have an output
substantially predictive of a UPDRS."). Thus, we agree with the Examiner's
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finding that Klapper creates an algorithm creating scores based on the
UPDRS.
The Examiner has persuasively established that integrating Klapper' s
use of a historical data, or scores, based on the UPDRS would have been
combining known elements according to known methods to yield predictable
results. See Ans. 11-12. We further agree that integrating this aspect of
Klapper into Firlik would achieve the predictable result of using a "second
sensor ... to collect movement data as expected." Ans. 11.
Rejection III Obviousness Over Firlik and Sun
Claims 9 and 19
The Examiner rejects claims 9 and 19 as obvious based on a
combination of Firlik and Sun. Final Act. 14.
Appellants contend that Sun is non-analogous art and therefore
improper for use in the combination. App. Br. 37. Appellants contend "Sun
is directed to 'implantable devices and methods for monitoring physiological
information relating to sleep"' and that "[ s ]leep stage detection is not the
same field of endeavor as the present claim which is directed to a method for
adjusting treatment parameters to alleviate motor symptoms of a movement
disorder." Id. at 38 Appellants also argue "detecting sleep stage and altering
therapy to improve sleep is not reasonably pertinent to the problem of
adjusting stimulation parameters to alleviate movement disorder motor
symptoms." Id.
The Examiner has persuasively established Sun is in the same field of
endeavor as the claimed invention. Appellants' invention relates to an
apparatus and method for using neural stimulation to alleviate the symptoms
of movement disorders. Sun relates generally to sleep monitoring, however,
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its application is broader. Sun discloses its invention "may also be used to
treat various medical conditions," and specifically, "it may be used to treat
neurological ... conditions ... such as Parkinson's disease." Sun i-f 149; see
also Sun claims 25 ("treating a condition"), 27 ("a movement disorder"), and
28 ("Parkinson's disease"). Thus, Sun is both in the same field of endeavor,
as well as reasonably pertinent to the same problem faced by the inventors of
the current application. Appellants' contentions to the contrary are
unpersuasive. These same disclosures in Sun provide sufficient motivation
to one of ordinary skill in the art to combine the teachings of Sun into the
system of Firlik to address the same problem in a predictable manner. See
Final Act. 14 (explaining reasons for combining Sun and Firlik).
We have considered Appellants' remaining arguments related to
claims 9 and 19 but find them unpersuasive for the reasons set forth by the
Examiner. As such, we sustain the Examiner's rejection of claims 9 and 19
based on Firlik and Sun.
Rejection IV Obviousness Over Firlik and Giftakis
Claims 14 and 15
Appellants contend "Firlik and Giftakis fail to teach or disclose
wherein the clinician unit additionally comprises electronic components for
wirelessly transmitting the output to the deep brain stimulation implant via
Bluetooth, as is claimed." App. Br. 46. Further, Appellants contend
even though Giftakis may disclose the use of Bluetooth for its
patient programmer to communicate with an IMD, it fails to
teach or disclose transmitting an output comprising computed
adjustments for one or more of the adjustable parameters of the
deep brain stimulation implant, the output being based at least
in part on the signal acquired by the sensor and at least in part
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on the input related to the subject's deep brain stimulation
implant's parameter settings, as is claimed.
Id. Appellants also contend there is no basis for combining the references as
proposed by the Examiner. Id. at 47--48.
We have considered Appellants' contentions but find them
unpersuasive for the reasons set forth by the Examiner. Initially, we note
that Appellants argue the Examiner's rejections of claims 14 and 15 are
improper for reasons similar to those that Appellants argue the rejections of
claims 1 and 13 are improper. Next, we find unpersuasive Appellants'
arguments that are premised on Giftakis failing to teach limitations that the
Examiner does not rely on it to teach. See App. Br. 46--47; see also Ans. 15
("Giftakis was not relied upon to teach the elements met by Firlik as
suggested in Appellants' argument."). The Examiner relies on Giftakis to
teach integrating Bluetooth protocol into the invention of Firlik, which
already teaches wireless communication with the implant. See Ans. 15; see
also Firlik i-f 160. We find the reasons for the combination supported and
agree with the Examiner that the combination teaches the elements as
claimed.
We have considered Appellants' remaining arguments related to
claims 14 and 15 but find them unpersuasive for the reasons set forth by the
Examiner. As such, we sustain the Examiner's rejection of claims 14 and 15
based on Firlik and Giftakis.
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Application 13/153,063
CONCLUSION
The rejection of claims 1, 2, 4, 6-8, 10-13, and 16 under 35 U.S.C.
§ 102(b) as anticipated by Firlik is affirmed. The rejection of claims 3, 17,
18, and 20 under 35 U.S.C. § 102(b) as anticipated by Firlik is reversed.
The rejection of claim 5 under 35 U.S.C. § 103(a) as unpatentable
over Firlik and Klapper is affirmed.
The rejection of claims 9 and 19 under 35 U.S.C. § 103(a) as
unpatentable over Firlik and Sun is affirmed.
The rejection of claims 14 and 15 under 35 U.S.C. § 103(a) as
unpatentable over Firlik and Sun is affirmed.
DECISION
We affirm the Examiner's Final Rejection of claims 1, 2, 4--16, and
19.
We reverse the Examiner's Final Rejection of claims 3, 17, 18, and
20.
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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