Ex Parte DiLorenzo

Patent Trial and Appeal Board

Apr 11, 2013

11159842 (P.T.A.B. Apr. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte DANIEL JOHN DILORENZO
__________

Appeal 2012-002829
Application 11/159,842
Technology Center 1600
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Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a patient’s neurological or psychiatric disorder. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Application 11/159,842

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Statement of the Case
Background
“The present invention relates generally to neurological disease and,
more particularly, to intracranial stimulation for optimal control of
movement disorders and other neurological disease” (Spec. 1 ¶ 0002).
The Claims
Claims 59-86 are on appeal. Claim 59 is representative and reads as
follows:
59. A method of treating a patient’s neurological or
psychiatric disorder, the method comprising:
using a control module coupled to a first electrode and a
second electrode to deliver electrical stimulation to a nervous
system component through the first electrode and the second
electrode to treat the patient’s neurological or psychiatric
disorder, said first electrode and said second electrode being
implanted in the patient’s body;
monitoring impedance between the first electrode and the
second electrode;
automatically adjusting at least one parameter of the
electrical stimulation to compensate for a monitored change of
electrode impedance between the first electrode and the second
electrode; and
delivering a subsequent electrical stimulation with the at
least one adjusted parameter to the nervous system component
through the first electrode and the second electrode to treat the
patient’s neurological or psychiatric disorder.

The issues
A. The Examiner rejected claims 59-86 under 35 U.S.C. § 103(a) as
obvious over Combs
1
and Fischell
2
(Ans. 4-10).

1
Combs et al., U.S. Patent No. 5,957,861, issued Sep. 28, 1999.
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B. The Examiner rejected claims 59-61, 63-66, 72, 73, 75, 77-80, and 86
on the ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1, 12, 17, 21, 23, and 24 of DiLorenzo
3
(Ans. 11).
C. The Examiner rejected claims 59-86 on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 49-56,
59-70, and 75-85 of U.S. Patent No. 7,209,787 (Ans. 11-12).
A. 35 U.S.C. § 103(a) over Combs and Fischell
The Examiner finds that Combs teaches “an implantable device for
measuring impedance in patients with edema and to manage the disease,
wherein the cause of said edema may be due to various diseases, such as
heart failure or myocardial infarctions” (Ans. 5). The Examiner finds that
Combs teaches
that the implantable device comprises at least two electrodes
between which the impedance will be measured and
monitored (reads on step II)) wherein the data may be output
to a physician and a means for delivering electrical impulses
to a living body. The control module is able to deliver
electrical impulses to the living body between the two
electrodes

(id.). The Examiner finds that Combs teaches “the device will give a
stimulus if required wherein the measurements are made and stored in
memory and acted upon a program stored in memory, wherein the program
can initiate routines to change the behavior of an implanted device based on
the stored values, such as calibration” (id. at 6).

2
Fischell et al., U.S. Patent No. 6,016,449, issued Jan. 18, 2000.
3
DiLorenzo, D., U.S. Patent No. 7,324,851 B1, issued Jan. 29,
2008.
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The Examiner finds that Fischell teaches “an implantable device
comprising electrodes, which may be implanted deep within the brain tissue
or close proximity to the brain and configured to deliver electrical
stimulation to manage a patient’s neurological disorder” (Ans. 7). The
Examiner finds it obvious to
have combined the implantable device configured to deliver
stimulation to manage a patient's neurological disorder and
deliver the electrical stimulation to the nervous system
component through a first and second electrode as taught by
Fischell et al. with the implantable device as taught by
Combs et al. This is because Combs et al., as stated above,
at col. 3, 5, and 13 describe that the invention can be used in
conjunction with traditional pacemaker systems and other
implantable devices or may be incorporated into them
wherein the device can be programmed to communicate and
be modified automatically, i.e. automatically adjusting a
parameter.

(Id. at 8.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Combs and Fischell render
claim 59 obvious?
Findings of Fact
1. Combs teaches that the importance of “long term impedance
measurement and noting changes therein is that it is an valuable clinical
indicator of the health of the living body” (Combs, col. 1, ll. 22-24).
2. Combs teaches “implantable devices including but not limited
to tissue stimulators having measurement capability for determining
impedance measurements and is particularly well suited to measure long
term edema variations within a living body” (Combs, col. 1, ll. 6-10).
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3. Combs teaches:
an implantable apparatus for production of impedance
measurement in a subcutaneous region of the living body
having at least two electrically isolated electrodes,
preferably but not necessarily on the outer surface of its
housing and having within the housing an energy pulse
delivery mechanism to deliver electrical pulses to living
body and means for receiving electrical impulses on the
surface of the housing so as to determine the impedance of
the body between the two preferred or less preferred pair of
electrodes.

(Combs, col. 3, ll. 16-25.)
4. Combs teaches that:
Additional triggers for storing data on measurements
made at the time of a trigger signal could be automatic,
based on regular measurements made by the implanted
device. For example, if a doctor believes a 10% change in
LTA over a two week period should invoke hospitalization,
he could set such a trigger in the implanted device memory.
The device then would incorporate an automatic process for
checking the data against the automatic trigger values, and
when the comparison indicated a trigger condition.

(Combs, col. 11, ll. 8-15.)
5. Combs teaches that “calibration against stored reference values
or setting up on new reference values is handled. If changes are required, say
for example in the level of stimulus required to elicit useful sensor response,
they are determined at the next step” (Combs, col. 12, ll. 32-36).
6. Combs teaches that “[a]lternative types of implantable devices
may also be used to house this invention including for example,
defibrillators, drug infusion devices, spinal cord stimulators or any other
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implantable device having the minimum external number of electrodes and
being provided with an impedance stimulation and measurement circuit”
(Combs, col. 5, ll. 20-25).
7. Fischell teaches “a multi-electrode array with sophisticated
signal processing techniques to achieve reliable detection of the onset of a
neurological event (such as an epileptic seizure or migraine headache)”
(Fischell, col. 2, ll. 42-45).
8. Fischell teaches that the “invention also provides means for
generating an ensemble of coordinated electrical stimuli designed to
terminate the neurological event immediately upon (or even prior to) its
onset. Thus, the present invention is a responsive detection and stimulation
system for the early recognition and prompt treatment of a neurological
event” (Fischell, col. 2, ll. 52-57).
9. Fischell teaches the “capability to program the functions and
parameters of the system to enhance the detection of a neurological event
and to optimize the system responses for stopping a neurological event such
as an epileptic seizure” (Fischell, col. 4, ll. 32-36).
Principles of Law
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Combs reasonably teaches the use of a control module for electrical
stimulation by monitoring impedance between two electrodes and
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automatically adjusting the electrical stimulation based on the measured
changes in impedance, and then stimulating using the electrodes (FF 1-6).
Fischell teaches treatment of epilepsy using electrical stimulation and
a programmable device (FF 7-9).
However, we agree with Appellant that there “is nothing in Fischell,
Combs, or any other reference cited by the Examiner to suggest that
electrode impedance is either a precursor of an event such as an epileptic
seizure or the epileptic seizure itself” (App. Br. 7). Without any evidence
that the prior art was aware of a relationship between impedance and a
neurological or psychiatric disorder, there is no reason to automatically
adjust “at least one parameter of the electrical stimulation to compensate for
a monitored change of electrode impedance” as required by independent
claims 59 and 73.
The Examiner finds that Fischell “teaches that his device can be used
to detect whether a neurological event such as a seizure is ABOUT TO
OCCUR (col. 7, lines 46-51), and teaches that this detection occurs through
measurement of various electrical parameters” (Ans. 14).
We are not persuaded. The Examiner’s general reliance on “electrical
parameters” does not provide any specific reason or evidence that
impedance between two electrodes was known to have any correlation or
causative relationship with any psychiatric or neurological disorder. In
particular for epilepsy, the Examiner has not established that the prior art
recognized that an impedance measurement would provide any useful
information regarding future epileptic incidents.
Conclusion of Law
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The evidence of record does not support the Examiner’s conclusion
that Combs and Fischell render claim 59 obvious.
B. & C. Double Patenting
We summarily affirm the obviousness-type double patenting
rejections. See Manual of Patent Examining Procedure § 1205.02 (“If a
ground of rejection stated by the examiner is not addressed in the appellant’s
brief, that ground of rejection will be summarily sustained by the Board.”);
See also In re Berger, 279 F.3d 975, 984 (Fed. Cir. 2002) (in which the
Board affirmed an uncontested rejection of claims under 35 U.S.C. 112,
second paragraph, and on appeal the Federal Circuit affirmed the Board's
decision and found that the appellant had waived his right to contest the
indefiniteness rejection by not presenting arguments as to error in the
rejection on appeal to the Board).
SUMMARY
In summary, we reverse the rejection of claims 59-86 under 35 U.S.C.
§ 103(a) as obvious over Combs and Fischell.
We summarily affirm the rejection of claims 59-61, 63-66, 72, 73, 75,
77-80, and 86 on the ground of nonstatutory obviousness-type double
patenting as being unpatentable over claims 1, 12, 17, 21, 23, and 24 of
DiLorenzo.
We summarily affirm the rejection of claims 59-86 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 49-56, 59-70, and 75-85 of U.S. Patent No. 7,209,787.

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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

cdc