Ex Parte Gerber et al

Board of Patent Appeals and Interferences

Jul 19, 2012

10977336 (B.P.A.I. Jul. 19, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MARTIN T. GERBER and WILLIAM D. WEIMER
____________

Appeal 2009-015343
Application 10/977,336
Technology Center 3700
____________

Before LINDA E. HORNER, MICHAEL L. HOELTER, and
MICHELLE R. OSINSKI, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Martin T. Gerber and William D. Weimer (Appellants) seek our
review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1,
2, 7-11, 14, 19-21, 27-32, 37-40, 43, 48-50, 55, and 56 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement, and under 35 U.S.C. § 103(a) as unpatentable over Tanagho
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(US 4,771,779, iss. Sep. 20, 1988) and Whitehurst (US 7,054,689 B1, iss.
May 30, 2006). We have jurisdiction under 35 U.S.C. § 6(b). We reverse
the written description rejection and affirm the obviousness rejection.
THE INVENTION
Appellants’ claimed invention relates to “medical devices for delivery
of neurostimulation therapy.” Spec. 1, para. [0002]. Claim 1, reproduced
below, is representative of the subject matter on appeal.
1. A method for delivering neurostimulation
therapy, the method comprising:
applying first neurostimulation therapy to a
patient via a first set of one or more implanted
stimulators to support a first phase of urinary
activity;
applying second neurostimulation therapy to
the patient via a second set of one or more
implanted stimulators to support a second phase of
urinary activity;
sensing one or more physiological
conditions within the patient via one or more
sensors implanted within the patient; and
deactivating application of the first
neurostimulation therapy and activating
application of the second neurostimulation therapy
in response to the one or more sensed
physiological conditions,
wherein at least some of the stimulators in
the first set are positioned at sites that are different
from sites at which at least some of the stimulators
in the second set are positioned.

ISSUES
The issues presented by this appeal are:
Does Appellants’ original disclosure reasonably convey to those
skilled in the art that Appellants, as of the filing date, had possession of
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deactivating application of a first neurostimulation therapy used to support a
first phase of urinary activity and activating application of a second
neurostimulation therapy used to support a second phase of urinary activity
in response to one or more sensed physiological conditions, as called for in
independent claims 1 and 31, and wherein the first phase includes urinary
retention and the second phase includes urinary voiding, as called for in
dependent claims 7 and 37?
Would one of ordinary skill in the art have been led by the combined
teachings of Tanagho and Whitehurst to a method for delivering
neurostimulation therapy that includes deactivating application of a first
neurostimulation therapy and activating application of a second
neurostimulation therapy in response to one or more physiological
conditions sensed via one or more sensors implanted within a patient?
FINDINGS OF FACT
We find that the following enumerated findings are supported by at
least a preponderance of the evidence.
1. The Specification discloses that “[v]arious embodiments of the
present invention provide solutions to one or more problems existing
in the prior art with respect to prior art systems for neurostimulation
. . . includ[ing] difficulties associated with effectively treating
different phases or components of a physiological activity, such as
sexual activity or urinary activity.” Spec., para. [0008].
2. The Specification discloses that “[u]rinary activity involves retention
and voiding phases.” Spec, para. [0008].
3. The Specification discloses that “the invention may produce a
composite neurostimulation therapy that targets different nerve sites,
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simultaneously or at different times, with the aid of an array of
distributed stimluators” and “the invention may provide a more
orderly transition between distinct phases of physiological activity,
and more effective restoration and support of the distinct phases.”
Spec., para. [0012] (emphasis added).
4. The Specification discloses with reference to an implantable
neurostimulation system 10 of Figure 1 that a “[m]aster controller 16
may use information received from sensing devices 18 as a triggering
event for adjustment of neurostimulation” and that “[a]djustment may
include selective activation or deactivation of different sets of
neurostimulators 14[.]” Spec., para. [0029] (emphasis added).
5. The Specification discloses that system 10 may be applied to deliver
therapies formulated for urinary incontinence. Spec., para. [0032].
6. The Specification discloses that for urinary incontinence applications:
In a first phase of urinary activity, master controller 16 may
activate a first set of stimulators 14 to cause bladder
contraction and urinary voiding, and then activate a second
set of stimulators 14 to cause bladder relaxation for retention
of urine. Alternatively, a first set of stimulators 14 may
cause urinary sphincter contraction to retain urine, while a
second set of stimulators 14 causes sphincter relaxation to
permit urine flow. In either case, sensing devices 18 may
provide feedback to master controller 16 for maintenance of,
or transition between, such phases of urinary activity.
Spec., para. [0067] (emphasis added).
7. The Specification discloses that system 10 is responsive to an explicit
indication by patient 12 that he or she is ready for “progression to the
second phase of activity” and that for transition from the first phase to
the second phase “the first set of stimulators 14 may be deactivated
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upon or shortly following activation of the second set of stimulators.”
Spec., para. [0073] (emphasis added).
8. Tanagho teaches “placement of one or more electrodes at strategical
[sic] anatomical locations on critical nerves of [a] patient to control
one or more functions of a bladder.” Col. 1, ll. 16-18.
9. Tanagho discloses a first implanted stimulation system having
electrodes positioned on nerves controlling external sphincter
functions and a second implanted stimulation system having
electrodes positioned on nerves controlling bladder functions, and an
electronic control system to generate and send stimulation pulses to
the first stimulation system. Col. 2, ll. 3-9.
10. Tanagho discloses:
When it is desired to evacuate the bladder, a switch is closed
causing the electronic control system to discontinue the
external sphincter stimulation and, after a predetermined
delay, to generate and transmit electrical bladder stimulation
pulses to the second stimulation system. After a
predetermined time, the bladder stimulation is automatically
stopped. After another predetermined delay, the electronic
control system resumes the generation and transmission of
sphincter stimulation pulses to the first stimulation system.
Col. 2, ll. 9-19. See also col. 10, ll. 3-8, 40-55 and col. 11, ll. 19-31
(describing a detailed embodiment in which a patient or attendant
momentarily closes a switch when it is desired to evacuate the
bladder, and as a consequence, stimulation of the urethral sphincter
closure is disabled and activation of stimulation of the bladder is
initiated, and at the end of a selected time period, the output
automatically reverses).
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11. Whitehurst discloses an implantable stimulator system utilizing one or
more implantable microstimulators for treating urinary and/or bowel
dysfunction. Col. 1, ll. 16-18,
12. Whitehurst teaches that “[i]n order to help determine the strength of
electrical stimulation required to produce the desired therapeutic
effect, in one preferred embodiment, a patient’s response to and/or
need for treatment is sensed, such as changes in bladder condition.”
Col. 7, ll. 62-66.
13. Whitehurst discloses, for example, that an electroneurograph built into
the microstimulator would sense relatively low-frequency activity
when the bladder is empty and relatively high-frequency activity
when the bladder is full. Col. 8, ll. 3-7.
14. Whitehurst teaches that in operation, the patient turns the implantable
stimulator on and off using a handheld controller. Col. 8, ll. 21-23.
15. Whitehurst discloses controlling one or more microstimulators via
closed-loop operation by using a need for and/or response to
stimulation that is sensed via the microstimulators to automatically
adjust the stimulation parameters used by the microstimulators “to
provide stimulation tailored to the response to stimulation.” Col. 10,
ll. 9-20. “For example, amplitude of stimulation may be increased in
response to increased bladder pressure.” Col. 10, ll. 28-29.
PRINCIPLES OF LAW
To satisfy the written description requirement, “the [original]
specification must describe an invention understandable to that skilled
artisan and show that the inventor actually invented the invention claimed.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
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(en banc). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. (citations omitted).
ANALYSIS
Written Description
Independent claims 1 and 31
Independent claims 1 and 31 call for deactivating application of a first
neurostimulation therapy used to support a first phase of urinary activity and
activating application of a second neurostimulation therapy used to support a
second phase of urinary activity in response to one or more sensed
physiological conditions. The Specification describes generally that the
invention is applicable to treating different phases of urinary activity and
that the invention can produce a combination therapy that targets different
nerve sites at different times to provide an orderly transition between distinct
phases (Facts 1, 3). The Specification also describes that the implantable
neurostimulation system of the invention, which can be used to deliver
therapies for urinary incontinence, can selectively activate or deactivate
different sets of neurostimulators (Facts 4, 5). With regard to the specific
urinary incontinence embodiment, the Specification describes that sensing
devices may provide feedback to a master controller to cause transition
between a first phase of urinary activity, in which stimulators cause bladder
contraction and urinary voiding, and a second phase of urinary activity, in
which stimulators cause bladder relaxation for retention of urine (Fact 6).
The Specification describes, with regard to the method of the invention, that
for transition from the first phase to the second phase “the first set of
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stimulators 14 may be deactivated upon or shortly following activation of
the second set of stimulators” (Fact 7). Considering the entirety of the
original disclosure, we find that it reasonably conveys to those skilled in the
art that Appellants had possession of the claimed neurostimulation method
and system for treating urinary activity that includes deactivating delivery of
a first neurostimulation therapy to support a first phase of urinary activity
and activating delivery of a second neurostimulation therapy to support a
second phase of urinary activity in response to one or more sensed
physiological conditions, as called for in independent claims 1 and 31.
Dependent claims 7 and 37
Dependent claims 7 and 37 call for deactivating application of a first
neurostimulation therapy used to support urinary retention and activating
application of a second neurostimulation therapy used to support urinary
voiding in response to one or more sensed physiological conditions. The
Specification describes that the invention can be used to treat the retention
and voiding phases or urinary activity (Fact 2). The Specification further
describes that sensing devices may provide feedback to a master controller
to cause transition between a first phase of urinary activity, in which
stimluators cause urinary sphincter contraction to retain urine, and a second
phase of urinary activity, in which stimulators cause sphincter relaxation to
permit urine flow (Fact 6). This disclosure in the Specification reasonably
conveys to persons skilled in the art that Appellants had possession of the
claimed neurostimulation method and system called for in dependent claims
7 and 37. Accordingly, we cannot sustain the rejection of claims 1, 2, 7-11,
14, 19-21, 27-32, 37-40, 43, 48-50, 55, and 56 under 35 U.S.C. § 112, first
paragraph.
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Obviousness
Appellants argue all the claims subject to this rejection as a group.
App. Br. 10-13. We select claim 1 as representative, and the remaining
claims stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
Claim 1 calls for sensing one or more physiological conditions and
deactivating and activating certain therapy “in response to the one or more
sensed physiological conditions.” Tanagho discloses a system of implanted
stimulators for controlling bladder functions, including a first set for sending
stimulation pulses to the nerves controlling sphincter functions and a second
set for sending stimulation pulses to the nerves controlling bladder functions
(Facts 8, 9). Tanagho discloses that for treatment of urinary incontinence,
the control system sends stimulation pulses to the first set of stimulators to
cause urine retention, and then when a patient closes a switch to indicate a
desire to evacuate the bladder, the sphincter stimulation is discontinued and
stimulation pulses are sent to the second set of stimulators for a
predetermined time to cause voiding of the bladder, after which
predetermined time period the system automatically reverses the output to
discontinue stimulation pulses to the bladder and resume stimulation pulses
to the sphincter (Fact 10). As such, Tanagho discloses a control system that
activates stimulation pulses to a first set of stimulators to support urinary
retention, then in response to patient input, deactivates stimulation pulses to
the first set of stimulators and activates stimulation pulses to a second set of
stimulators to support urinary voiding, and thereafter in response to a timer,
deactivates stimulation pulses to the second set of stimulators and activates
stimulation pulses to the first set of stimulations to resume urinary retention.
Tanagho does not disclose sensing one or more physiological conditions
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within the patient via one or more sensors implanted within the patient and
does not disclose that the deactivating and activating of the stimulation
pulses are “in response to the one or more sensed physiological conditions”
as called for in the claims.
Whitehurst discloses a similar system of implanted stimulators for
controlling bladder functions, including allowing a patient to initiate bladder
voiding via the stimulators, but teaches that the stimulators could also be
used for sensing one or more physiological conditions within the patient,
such as the degree to which the bladder is full (Facts 11-14). Such data
could be used for closed-loop feedback control of the stimulators, for
example, to adjust the amplitude of stimulation in response to sensed bladder
pressure (Fact 15). As such, Whitehurst discloses an improvement to the
stimulation system of Tanagho in that it uses the stimulators to sense
physiological conditions so as to provide better treatment via the stimulation
pulses in response to the sensed needs of the patient.
We agree with the Examiner that the use of Whitehurst’s sensors and
closed-loop feedback in the system of Tanagho would improve Tanagho by
eliminating the need for the timing element so that the improved system
would use the feedback from the sensors to ensure that the patient’s bladder
is empty before discontinuing the stimulation pulses that cause voiding of
the bladder. Ans. 6-7, 9-10. While both Whitehurst and Tanagho disclose
that bladder voiding is initiated by patient input, Tanagho discloses that the
end of the bladder voiding phase and the resumption of the bladder retention
phase occur automatically upon expiration of a selected time period. It
would have been obvious to one of ordinary skill to use the feedback from
Whitehurst’s sensors, which are capable of sensing when the bladder is
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empty (Fact 13), to improve Tanagho’s system by continuing the bladder
voiding phase until the sensors indicate that bladder is empty. This is an
improvement of Tanagho in that the feedback from Whitehurst’s sensors
would ensure that the bladder is completely voided and would further ensure
that stimulation of the bladder does not continue unnecessarily after the
bladder is empty. This improvement is nothing more than a predictable use
of prior art elements according to their established functions. KSR Int’l Co.
v. Teleflex, Inc., 550 U.S. 398, 417 (2007).
Appellants argue that Whitehurst primarily describes using sensors to
determine the strength of electrical stimulation parameters and not to
deactivate a first set of stimulators based on a sensed physiological
condition. Reply Br. 10. While we agree that the main focus of Whitehurst
is to use the sensors to modify the strength of the stimulation parameters,1
we disagree with Appellants that one of ordinary skill in the art, applying the
sensors and feedback loop of Whitehurst to the system of Tanagho, would
not have found it obvious to use the feedback to determine when the bladder
is empty so as to discontinue the bladder voiding phase in Tanagho. “[T]he
analysis need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
Id. at 418. Accordingly, we sustain the Examiner’s rejection of claim 1, and
the remaining claims which fall with claim 1, as unpatentable under
35 U.S.C. § 103.

1 We note that Whitehurst suggests that the sensors “may be used to
orchestrate first the activation of microstimulator(s) targeting nerves that
inhibit voiding, and then, when appropriate, the microstimulator(s) targeting
nerves that cause voiding.” Col. 12, l. 66 – col. 13, l. 3.
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CONCLUSIONS
Appellants’ original disclosure reasonably conveys to those skilled in
the art that Appellants, as of the filing date, had possession of the subject
matter of independent claims 1 and 31 and dependent claims 7 and 37.
One of ordinary skill in the art would have been led by the combined
teachings of Tanagho and Whitehurst to a method for delivering
neurostimulation therapy that includes deactivating application of a first
neurostimulation therapy and activating application of a second
neurostimulation therapy in response to one or more sensed physiological
conditions sensed via one or more sensors implanted within a patient.
DECISION
The decision of the Examiner to reject claims 1, 2, 7-11, 14, 19-21,
27-32, 37-40, 43, 48-50, 55, and 56 under 35 U.S.C. § 112, first paragraph,
is REVERSED, and under 35 U.S.C. § 103(a) as unpatentable over Tanagho
and Whitehurst 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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

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