Ex Parte Gerber et al

Board of Patent Appeals and Interferences

Dec 14, 2011

11116963 (B.P.A.I. Dec. 14, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MARTIN T. GERBER and JOHN C. RONDONI
____________

Appeal 2010-003615
Application 11/116,963
Technology Center 3700
____________

Before KEN B. BARRETT, MICHAEL C. ASTORINO, and
JAMES P. CALVE, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
decision rejecting claims 1-11, 13-23, and 25-31 under 35 U.S.C. § 103(a) as
being unpatentable over Mann (US 6,941,171 B2; issued Sep. 6, 2005) in
view of Bauhahn (US 2004/0181262 A1; issued Sep. 16, 2004). Claims 12
and 24 have been cancelled. We have jurisdiction under 35 U.S.C. § 6.
We AFFIRM.
THE INVENTION
The claims related to a neurostimulator system and method. Claim 1,
set forth below, is illustrative of the claimed subject matter on appeal:
1. A method comprising:
receiving, in an external programmer during
application of neurostimulation therapy, information
that is provided by a patient and that relates to
efficacy of the neurostimulation therapy being
delivered to the patient by an implanted
neurostimulator to manage urinary incontinence;
sensing, via at least one sensor, information related
to efficacy of neurostimulation therapy delivered by
an implanted neurostimulator;
adjusting, in a processor, one or more stimulation
parameters associated with the neurostimulation
therapy being applied to the patient by applying a set
of adaptive logic to the received information and the
sensed information to formulate an adjustment of a
stimulation parameter based on both the sensed
information and the received information; and
inputting the adjusted parameters from the
programmer to the implanted neurostimulator.

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ISSUE
The issue presented by this appeal is:
Does the combination of Mann and Bauhahn disclose a processor that
adjusts stimulation parameters by applying adaptive logic to sensed and
patient information as called for in independent claims 1, 30, and 31?
Does the combination of Mann and Bauhahn disclose “the processor
is associated with the implanted neurostimulator” as recited in claims 20 and
26, and “at least part of the adaptive logic is stored in memory associated
with the implantable neurostimulator” as recited claim 28?
ANALYSIS
The Examiner found that Mann discloses an implantable stimulator
system and method for adaptive neurostimulation therapy as called for in
independent claims 1, 30, and 31 including adjusting stimulation parameters
adaptively in response to sensed conditions. Ans. 3-4, 7-8. The Examiner
also found that Mann suggests that patient feedback may be used to adjust
stimulation parameters in certain situations. Ans. 4, 8. The Examiner found
that Bauhahn discloses a system for neurostimulation therapy that adjusts
neurostimulation therapy in response to user input information. Ans. 4, 8.
The Examiner determined it would have been obvious to one of ordinary
skill in the art to modify Mann in view of Bauhahn to deliver and adjust
neurostimulation therapy adaptively or automatically based on information
input by a user and sensed information because Bauhahn teaches that user
input information pertaining to therapy efficacy provides a useful way to
guide adjustment and optimization of therapy parameters. Ans. 4-5, 9. The
Examiner also determined that this modification involves combining prior
art elements according to known methods and known techniques to improve
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similar devices to yield predictable results. Ans. 9. The Examiner further
found that Mann is capable of using sensed and patient information (Ans.
10) and incorporating patient received information into the control loop
program of Mann would require only routine skill in the art. Ans. 11-12.
Appellants argue that Mann teaches away from using both received
information (patient feedback) and sensed information to adjust stimulation
parameters. App. Br. 7. Appellants assert that Mann uses only one source
of efficacy information – patient feedback or sensed information – to adjust
therapy. App. Br. 7. Appellants contend that Mann suggests that patient
feedback may be used to refine parameters when a sensing function is not
necessary or desirable, and patients provide no efficacy information during
treatment modalities when sensing is used to set parameters. App. Br. 7.
We are not persuaded that Mann’s disclosure of different approaches
to adjusting stimulation parameters teaches away from using sensed and
patient information. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (“A
reference may be said to teach away when a person of ordinary skill, upon
reading the reference, would be discouraged from following the path set out
in the reference, or would be led in a direction divergent from the path that
was taken by the applicant.”); In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004) (prior art’s disclosure of alternate designs is not a teaching away from
any of the alternatives unless the reference criticizes, discredits, or
discourages a claimed solution). Mann does not criticize, discredit, or
discourage the use of both sensed and patient-input information to adjust
neurostimulation parameters. Mann discloses that stimulation parameters
can be adjusted based on information from sensors, implantable devices, or
sensors and implantable devices, and patient information can be used to
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determine and refine stimulation parameters when sensors or devices are not
included. Mann, col. 26, ll. 21-33. While this passage may not provide a
teaching to combine sensed and patient information, it does not teach away
from such a combination.
Appellants also argue that neither Mann nor Bauhahn discloses a
processor that adjusts stimulation parameters based on sensed information
and patient information about efficacy as called for in claims 1, 30, and 31.
App Br. 9. Appellants further argue that because neither reference accounts
for a processor that adjusts stimulation parameters by using both forms of
information, such an arrangement cannot be a known method or technique
under KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). App. Br. 9-10.
Appellants also assert that using adaptive logic to adjust stimulation
parameters based on patient efficacy information is above and beyond mere
automation of a manual task. App. Br. 9.
These arguments are not persuasive because Mann’s system has a
processor that runs adaptive logic to adjust stimulation parameters based on
sensed information and accepts patient feedback as a control input to adjust
the adaptive logic program of the stimulator 100 and to deliver prescribed
stimulation patterns. Mann, col. 20, ll. 58-63; col. 25, ll. 41-45; Mann, col.
26, ll. 21-33, fig. 5. Appellants disclose that patient information includes
information that is entered via a user interface to indicate a level of efficacy
achieved by neurostimulation therapy. Spec. 8, para. [0034]. Appellants’
argument that neither reference discloses a processor adjusting stimulation
parameters from both patient and sensed information is largely a piecemeal
attack on the references because the Examiner has relied on the combined
teachings of Mann and Bauhahn. The Examiner’s reason for combining
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Bauhahn with Mann to incorporate patient received information with sensed
information in an adaptive closed loop program is supported by a rational
underpinning of combining known techniques and methods to achieve
predictable results involving modifications that are within the level of
ordinary skill in the art. See KSR, 550 U.S. at 421 (“A person of ordinary
skill is also a person of ordinary creativity, not an automaton.”); see also
Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir.
2007) (where the prior art combination lacked a reader but readers were
well-known in the art at the time of the invention, it would have been
obvious to add a reader to provide a well-known benefit in a children’s toy
that simplified its use and improved its marketability absent evidence that
inclusion of the reader was beyond the level of ordinary skill in the art or an
unobvious step over the prior art). Appellants have not persuaded us that the
proposed combination of Mann and Bauhahn is beyond the level of ordinary
skill in the art or that it yields unexpected results.
Claims 20, 26, and 28
Claims 20 and 26 depend from claims 1 and 31, respectively, and
recite that “the processor is associated with the implanted neurostimulator.”
Claim 28 depends from claim 31 and recites “at least part of the adaptive
logic is stored in memory associated with the implantable neurostimulator.”
The Examiner found that Mann discloses a processor within a handheld
programming device and within an implantable microstimulator housing that
contains a programmable memory for storing adaptive logic. Ans. 6-7, 12.
Appellants define the term “associated with” in paragraph [0025] of
the Specification as follows: “associated with refers to a structure that is
either housed with or within a device, or attached to a device via a lead.”
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App. Br. 10. Appellants argue that the Office Action that finally rejected
these claims did not explain how the processor is associated with an
implantable neurostimulator or how the adaptive logic is stored in memory
associated with an implantable neurostimulator. App. Br. 10. Appellants
also argue that neither Mann nor Bauhaus discloses this subject matter.
App. Br. 10-11.
The Examiner’s findings that Mann discloses a processor and adaptive
logic stored in a memory associated with an implantable neurostimulator are
supported by a preponderance of evidence. Mann discloses an implantable
stimulator 100 that houses a processor and other electronic circuitry 12 that
generate electrical/infusion pulses that are applied to a patient via electrodes
72 in accordance with a program stored in programmable memory 18 of the
stimulator as called for in claims 20, 26, and 28. Mann, col. 20, ll. 58-63;
col. 25, ll. 37-40; fig. 5. Appellants’ argument that neither reference
discloses an implantable device with a processor and memory with adaptive
logic that adjusts stimulation parameters based on sensed and received
information is not persuasive for the reasons discussed supra for claims 1,
30, and 31.
Accordingly, we sustain the Examiner’s rejection of independent
claims 1, 30, and 31 and dependent claims 2-11, 13-23, and 25-29.
CONCLUSION
The combination of Mann and Bauhahn discloses a processor that
adjusts stimulation parameters by applying adaptive logic to sensed and
patient information as called for in independent claims 1, 30, and 31.
The combination of Mann and Bauhahn discloses “the processor is
associated with the implanted neurostimulator” as recited in claims 20 and
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26, and “at least part of the adaptive logic is stored in memory associated
with the implantable neurostimulator” as recited in claim 28.
DECISION
The Examiner’s decision to reject claims 1-11, 13-23, and 25-31 is
AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

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