Ex Parte Miesel et al

Patent Trial and Appeal Board

Nov 7, 2013

11691423 (P.T.A.B. Nov. 7, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KEITH A. MIESEL, KENNETH T. HERUTH,
and GREGORY F. MOLNAR1
__________

Appeal 2011-012508
Application 11/691,423
Technology Center 3700
__________

Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method,
system, and computer-readable storage medium. The Examiner has rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.

1 Appellants identify the real party in interest as Medtronic, Inc. (App.
Br. 3.)
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STATEMENT OF THE CASE
Claims 1-19, 21-24, and 31-33 are on appeal (App. Br. 3).2 Claim 1 is
illustrative and reads as follows:
1. A method comprising:
delivering to a patient, from an implantable medical device, at least
one of a movement disorder therapy, Parkinson’s disease therapy, epilepsy
therapy, tremor therapy, or deep brain stimulation;
monitoring gait of the patient based on a signal generated by an
implantable sensor that varies as a function of patient activity; and
detecting a gait freeze event based on the signal.
Claims 1-19, 21-24, and 31-33 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Nieuwboer et al. (WO 2005/020866 A1, Mar. 10,
2005) in view of Baru Fassio et al. (US 2005/0010265 A1, Jan. 13, 2005)
(Ans. 5).
The Examiner relies on Nieuwboer for disclosing
a method and system comprising delivering a therapy from a
medical device to a patient to treat a movement disorder . . . ;
monitoring gait of the patient based on a signal generated by a
sensor that varies as a function of patient activity . . . ; and
detecting a gait freeze event based on the signal with a
processor.
(Id.) The Examiner acknowledges that “Nieuwboer fails to disclose that the
movement disorder therapy is delivered from an implantable medical device
or the sensor is implantable” (id.).
The Examiner relies on Baru Fassio for teaching “a fully implantable
nerve signal sensing and stimulation device that delivers to a patient a
movement disorder therapy from an implantable medical device and

2 Claims 25-30 are also pending but have been withdrawn from
consideration (App. Br. 3).
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monitors a physiological signal from the patient via an implantable sensor”
(id.). The Examiner finds that Baru Fassio “teaches that an implantable
system is desirable in order to overcome difficulties with electrode
placement or movement, pain and discomfort associated with external skin
electrodes and frequent malfunctions associated with mechanical switches
and external cables” (id.). The Examiner concludes:
[I]t would have been obvious to one having ordinary skill in the
art at the time of the invention to modify the method of
Nieuwboer such that the movement disorder therapy and
monitoring gait of the patient are carried out by a fully
implantable device, as taught by Baru Fassio, in order to ensure
appropriate electrode placement, limit patient pain and
discomfort, and eliminate problems associated with external
cable malfunctions.
(Id.)
FINDINGS OF FACT
1. Nieuwboer discloses:
A device and method for improving the walk of people
suffering from movement disorders are described. These
disorders include freezing gait, start hesitation, festination and
some difficulties with getting up from a chair or out of bed and
are typically seen in Parkinson’s disease suffers. The device
includes a pulsed signal producing means (12) for producing
pulsed signals and a frequency controlling means (16) for
altering the frequency of the signals produced. The device also
includes more than one output means (18) for transferring the
signal to at least one sensory device (20). The method includes
providing a series of regular pulsed sensory signals which act as
a series of cues, to a person suffering from a movement
disorder, to move in response to the cues.
(Nieuwboer, Abstract.)
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2. Nieuwboer also discloses:
By providing a device from which may be selected more than
one pulsed signal, the advantage is provided that since different
users respond better to one sensory stimulation, i.e. auditory,
visual or tactile signals, a single unit can be provided which
allows the user to experiment and find which stimulation works
most effectively for them. Alternatively, it may be the case that
a user finds that under certain conditions one form of
stimulation is more effective than another, or that one form of
stimulation may be unsuitable. For example, it is clear that in a
noisy environment an audible signal may be inappropriate.
Furthermore, some users may find the use of two simultaneous
forms of stimulation provides the most effective assistance in
overcoming movement disorders.
(Id. at 3.)
3. In addition, Nieuwboer discloses that the “device may further
comprise activity monitoring means for monitoring the movement of the
person using the device” and “recording means for recording a signal from
said activity monitoring means and/or the frequency of said pulsed signal
and/or the or each sensory device used” (id. at 4-5).
4. Nieuwboer discloses that “[b]y the use of ambulatory
monitoring and by recording data such as pulse frequency and output means
selected, it is possible to analyse these data and determine what frequency
and output devices are most effective for each user” (id. at 5).
5. Nieuwboer also discloses that the tactile signal may be provided
by a vibrating device, the audio signal may be provided by an ear piece, and
the visual signal may be provided by a light emitting diode (id. at 6).
6. In particular, Nieuwboer Figures 1 and 2 depict “a device 10 for
improving the walk of a person suffering from movement disorders hav[ing]
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a pulsed signal producing means 12 which produces a pulsed signal,” “a
frequency controlling means which is operated using buttons 16a and 16b,”
“a number of outputs, 18a, 18b and 18c, from which it is possible to transfer
the signal . . . to one or more sensory devices 20a, 20b and 20c,” a switch 22
for controlling which sensory device is to be used, and a switch 28 for
turning the device on and off (id. at 7-8).
7. In addition, Nieuwboer discloses that the “device may also
include a motion sensor . . . which is able to detect the movement of the
person using the device. The data provided by the motion sensor . . . may be
transferred through data output 32 using a cable, such as that shown at 34, to
a computer for analysis.” (Id. at 8.)
8. Nieuwboer also discloses that “the signal producing means 12
may be in the form of a wrist-worn control device with the operating buttons
locating thereon. . . . The output devices could be connected to the control
device by wires but could alternatively be connected via wireless
connection.” (Id. at 9.)
9. Baru Fassio discloses:
Currently available, the FES [functional electrical stimulation]
systems for treating foot drop have been either totally external
to the body or partially implanted with certain components
implanted and other components external to the body. The
totally external stimulation systems typically consist of
stimulation electrodes that are placed on the skin over the area
below the knee where the common peroneal nerve courses quite
superficially, as well as a battery power source, a sensor . . . and
the stimulation control circuitry. Problems with totally external
stimulation systems have included . . . difficulties with
electrode placement, variable results because of electrode
movement or changes to skin conductance, [and] pain or
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discomfort caused by the skin stimulation. . . . Frequent
malfunctions and breakdowns of mechanical switches and
external cables are also common.
(Baru Fassio, ¶ [0007].)
PRINCIPLES OF LAW
A claim “composed of several elements is not proved obvious merely
by demonstrating that each of its elements was, independently, known in the
prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The
relevant question is “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue.” Id. If a
proposed modification would render the prior art being modified “inoperable
for its intended purpose,” then there is no suggestion to make the proposed
modification. In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
ANALYSIS
Nieuwboer discloses a “device and method for improving the walk of
people suffering from movement disorders . . . includ[ing] freezing gait”
(Finding of Fact (FF) 1). Nieuwboer’s “method includes providing a series
of regular pulsed sensory signals which act as a series of cues, to a person
suffering from a movement disorder, to move in response to the cues” (id.).
In addition, Nieuwboer discloses that its “device may further comprise
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activity monitoring means for monitoring the movement of the person using
the device” (FF 3; see also FF 7).
However, it is undisputed that Nieuwboer does not disclose that its
device is implantable (Ans. 5). In addition, we agree with Appellants that
the Examiner has not adequately explained why one of ordinary skill in the
art would have modified Nieuwboer’s device to make it implantable.
The Examiner concludes that it would have been obvious “to modify
the method of Nieuwboer such that the movement disorder therapy . . . [is]
carried out by a fully implantable device, as taught by Baru Fassio, in order
to ensure appropriate electrode placement, limit patient pain and discomfort,
and eliminate problems associated with external cable malfunctions” (id.).
We are not persuaded.
First, with regard to ensuring appropriate electrode placement, we
agree with Appellants that this rationale for modification of Nieuwboer is
inadequate (App. Br. 6-7). As noted by Appellants, “the device of
Nieuwboer does not include electrodes for [providing electrical]
stimulation” (id. at 6).3 Even if we interpret the term electrode to encompass
a vibratory electrode, we agree with Appellants that the Examiner has not
pointed to any teaching in Nieuwboer of a vibratory electrode (Reply Br. 8).
Instead, Nieuwboer discloses that the tactile signal may be provided by a

3 As noted by Appellants (App. Br. 8), Nieuwboer discloses that “devices
which have been used in an attempt to assist persons overcoming a freezing
gait include the use of electric stimulating pulses applied to the leg muscles
thereby stimulating the person to take a step forward” (Nieuwboer 2).
However, it is undisputed that Nieuwboer’s device does not include
electrodes for providing electrical stimulation (Ans. 8).
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vibrating device (FF 5). In addition, the Examiner has not adequately
explained why the concerns associated with the placement of electrical
stimulation electrodes, as disclosed in Baru Fassio (FF 9), would have been
applicable to a vibrating device intended to provide a tactile signal.
Moreover, even if it would have been obvious to implant Nieuwboer’s
vibrating device, which the Examiner has not shown,4 this would not explain
why it would have been obvious to use “a fully implantable device,” as
alleged by the Examiner (Ans. 5).
We also agree with Appellants that the rationale regarding limiting
patient pain and discomfort is inadequate (App. Br. 6). Baru Fassio
discloses that “[p]roblems with totally external stimulation systems have
included . . . pain or discomfort caused by the skin stimulation” (FF 9).
However, given that Nieuwboer’s device does not include electrodes for
providing electrical stimulation, we conclude that this rationale is not
applicable to Nieuwboer’s device.
The Examiner also argues that the “motivation to combine would be
application to the motion sensory electrodes disclosed by Nieuwboer, as it
would be desirable to ensure appropriate placement of the sensor at all times,
thus ensuring that the sensed motion signal is accurate” (Ans. 9). However,
this rationale does not address Appellants’ argument that the Examiner has

4 We note that the Examiner has, in the Examiner’s Answer, provided some
evidence that it was “known in the art that auditory and tactile stimulation
may be applied by implantable, and even implanted, devices” (Ans. 10-11).
However, the question before us is whether the Examiner has set forth a
prima facie case that Nieuwboer and Baru Fassio suggest the present claims.
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not set forth a prima facie case that it would have been obvious to modify
Nieuwboer’s therapy device to be implantable.
With regard to the rationale regarding eliminating problems associated
with external cable malfunctions, Appellants do not dispute that modifying a
device to be fully implantable would eliminate such problems (see App.
Br. 8-9). However, Nieuwboer discloses a device having buttons 16a and
16b for controlling the frequency at which the device is operated, a
switch 22 for controlling which sensory device is to be used, and a switch 28
for turning the device on and off (FF 6). In addition, Nieuwboer describes
why being able to adjust these features is important (FF 2). We conclude
that the Examiner has not adequately addressed Appellants’ argument that
modifying Nieuwboer’s device to be fully implantable would render the
device unsatisfactory for its intended purpose (App. Br. 9).
In response to Appellants’ argument, the Examiner notes that the
claim merely requires that the device is “implantable,” not that it is
implanted (Ans. 9-10). However, it is undisputed that one of ordinary skill
in the art would not consider a device that has buttons and switches for
adjusting various parameters to be an implantable medical device (Ans. 5;
Reply Br. 9).
In addition, the Examiner finds that, with many implantable devices,
the stimulation parameters are tested and selected prior to permanent
implantation (Ans. 10). We note initially that the Examiner has not relied on
any evidence to support this position. In addition, although Nieuwboer does
teach “allow[ing] the user to experiment and find which stimulation works
most effectively for them” (FF 2), Nieuwboer does not suggest then utilizing
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only that form and degree of stimulation. On the contrary, Nieuwboer
discloses that “it may be the case that a user finds that under certain
conditions one form of stimulation is more effective than another, or that one
form of stimulation may be unsuitable” (id.). Thus, we agree with
Appellants that the intended purpose of Nieuwboer’s device is to provide a
user suffering from movement disorders with options for cuing the user to
move and that the Examiner has not adequately explained how a fully
implantable device would be suitable for Nieuwboer’s intended purpose.
CONCLUSION
The Examiner has not set forth a prima facie case of obviousness. We
therefore reverse the obviousness rejection.

REVERSED

cdc