Ex Parte Whitehurst et al

Board of Patent Appeals and Interferences

May 10, 2012

10178011 (B.P.A.I. May. 10, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/178,011 06/20/2002 Todd K. Whitehurst 05-00706-01 5027
71422 7590 05/11/2012
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
DIETRICH, JOSEPH M
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
05/11/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TODD K. WHITEHURST, RAFAEL CARBUNARU,
KERRY BRADLEY, JAMES P. MCGIVERN, MATTHEW I. HALLER,
TOM XIAOHAI HE, and JANUSZ A. KUZMA
__________

Appeal 2011-001433
Application 10/178,011
Technology Center 3700
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1, 3-9, 11-15, 17, 18, 20-24, 26-32, 34-37,
39, and 46-50. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as follows
(emphasis added):
1. A microstimulator, comprising:
an elongate casing;
programmably configurable electrodes disposed on an exterior surface
of the elongated casing, the electrodes for applying steerable electric fields,
at least some of the electrodes being partitioned into separately activated
electrodes located at different positions along arc extending along an outer
extent of the elongate casing;
electrical circuitry contained within the elongate casing, the electrical
circuitry electrically connected to the electrodes, wherein the electrical
circuitry generates stimulation pulses applied by the electrodes;
programmable memory contained within the elongate casing, the
programmable memory connected to the electrical circuitry and storing
stimulation parameters that at least in part determine an operational
configuration for the electrodes and the stimulation pulses; and
a power source contained within the elongate casing, the power source
operatively connected to the electrical circuitry and providing power to the
electrical circuitry.

The following grounds of rejection are before us for review:
I. Claims 1, 3-8, 12-15, 17, 31, 34-37, 39, and 46-49 stand rejected
under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Schulman
1
and Hill
2
(Ans. 4). As Appellants do
not argue the claims separately, we focus our analysis on claim 1,
and claims 3-8, 12-15, 17, 31, 34-37, 39, and 46-49 stand or fall
with that claim. 37 C.F.R. § 41.37(c)(1)(vii).

1
Schulman et al., US 6,185,452 B1, issued Feb. 6, 2001.
2
Hill et al., US 6,266,564 B1, issued Jul. 24, 2001.
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II. Claims 9, 11, and 32 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Schulman and Hill
as further combined with Barreras
3
(Ans. 6).
III. Claims 18, 22-24, 26-30, and 50 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of
Schulman and Hill as further combined with Ungar
4
(Ans. 7).
IV. Claims 20 and 21 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Schulman and Hill as
further combined with Ungar and Schulman ‟514
5
(Ans. 8).

We affirm.

ANALYSIS
We adopt the Examiner‟s findings and conclusions as our own. In
summary, the Examiner finds that Schulman teaches all of the elements of
claim 1 except for teaching “that the electrodes are partitioned into
separately activated electrodes located at different positions along an arc
extending along an outer extent of the casing” (Ans. 4). The Examiner finds
that “Hill teaches it is known to use electrodes that are partitioned into
separately activated electrodes located at different positions along an arc
extending along an outer extent of an elongated casing (e.g. Figures 9-12)”
(id. at 4-5). The Examiner concludes that it would have been obvious to the

3
Barreras, Sr. et al., US 5,895,416, issued Apr. 20, 1999.
4
Ungar et al., US 4,649,936, issued Mar. 17, 1987.
5
Schulman et al. (Schulman ‟514), US 5,358,514, issued Oct. 25, 1994.
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ordinary artisan “to modify the electrodes as taught by Schulman with the
separately activated electrodes as taught by Hill, since such a modification
would provide the predictable results of allowing an electric field to be
steered to an exact target location, thus optimizing therapy” (id. at 5).
Appellants argue that “there is nothing predictable about using
multiple partitioned electrodes along an arc of an elongated case to
electrically position a microstimulator based merely from the fact that Hill
uses multiple electrodes along a catheter to stimulate nerves controlling
heart functions” (App. Br. 6). Appellants assert that Hill teaches that the
electrodes may be connected to a catheter, and that it is a misapplication of
Hill to extrapolate from its teachings that it would have been obvious to
place multiple electrodes partitioned on the arc of a microstimulator (id. at 6-
7).
According to Appellants, Hill does not teach an elongated cylindrical
casing, as the catheter of Hill is not a casing as it does not contain electronic
circuitry, and the ordinary artisan “would never characterize a catheter as a
casing unless he or she was forcibly attempting to analogize a catheter with a
microstimulator casing” (id. at 7). Appellants assert that the Examiner has
engaged in improper hindsight to combine the references to arrive at the
claimed invention (id. at 10-11). Specifically, Appellants assert there is no
“connection between the single electrode stimulator in Schulman ‟452 and
the multiple electrode catheter to stimulate nerves and muscles in Hill that
would cause one of ordinary skill in the art to partition reprogrammable
multiple electrodes along the exterior surface of a microstimulator to steer
electric current” except the instant Specification (id. at 11).
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Appellants‟ arguments have been carefully considered, but are not
convincing. As found by the Examiner, Schulman teaches a microstimulator
for stimulating a nerve or muscle that produces small electric currents
between spaced electrodes (Schulman, col. 1, ll. 8-25).
Hill teaches an electrostimulation device that may be external or
implantable (Hill, col. 2, ll. 27, 62-63). Hill teaches that the leads “carry an
array of electrodes from which pairs of electrodes can be chosen in order to
direct the electrical field appropriately with respect to the desired nerve
fibers” (id. at col. 2, l. 66-col. 3, l. 2). According to Hill, the ability to select
from various pairs of electrodes allows steering of the electrical field, and
has been used on electrode pads for spinal cord stimulation (id. at col 2, ll.
10-19). Hill teaches that the electrodes may be “connected to an intravenous
catheter for transvenous stimulation/destimulation of the heartbeat” (id. at
col. 2, ll. 39-41), but a more “permanent nerve stimulation arrangement is
possible by fixing electrodes onto the inside of a vessel adjacent to the nerve
to be stimulated,” reducing the invasiveness of the placement of the
electrodes and the potential for direct nerve damage (id. at col. 8, ll. 52-64).
The Supreme Court has emphasized that “the [obviousness] 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.” KSR
Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary skill
can implement a predictable variation, § 103 likely bars its patentability.”
Id. at 417. Under the correct obviousness analysis, “any need or problem
known in the field of endeavor at the time of invention and addressed by the
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patent can provide a reason for combining the elements in the manner
claimed.” Id. at 420.
In determining whether obviousness is established by combining the
teachings of the prior art, “the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981). In addition, a reference disclosure
is not limited only to its preferred embodiments, but is available for all that it
discloses and suggests to one of ordinary skill in the art. In re Lamberti, 545
F.2d 747, 750 (CCPA 1976).
We agree with the Examiner that the combination of Schulman and
Hill renders obvious the microstimulator of claim 1. While Hill is drawn to
a catheter which is implanted in a vein, Hill teaches that partitioning the
electrodes into separately activated electrodes allows for steering of the
electric field. Thus, we do not agree with Appellants that the Examiner
relied on improper hindsight, as both Schulman and Hill are drawn to using
electrodes to stimulate a nerve or muscle, and are also both drawn to an
implantable device.
Appellants further assert that the elements of the combination do not
only perform the function of each element separately, as the microstimulator
as claimed allows reprogramming of the electrodes if the implanted
microstimulator migrates within the tissue (App. Br. 8-9 (citing Spec. ¶76
and MPEP § 2141.V)). According to Appellants, the “fact that the modified
Hill microstimulator can perform the function reprogramming of the
electrodes if the implanted microstimulator migrates within the tissue is
completely irrelevant to the determination of whether the claimed
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combination merely performs the function of the elements separately
disclosed in Schulman ‟452 and Hill” (App. Br. 10).
Again, Appellants‟ arguments are not convincing. First, to the extent
that Appellants are asserting unexpected results or long felt need, there is no
persuasive evidence of such in the record. As to Appellants‟ assertion that
“the elements in combination do not merely perform the function that each
element performs separately” (MPEP § 2141(V)), we reproduce Paragraph
76 of the Specification, upon which Appellants rely, below:
Steering of the electric field (a.k.a., electrically
positioning the stimulator) can be achieved by programming the
stimulation parameters to activate different electrodes and
program each activated electrode as a cathode, an anode, or an
open circuit, as well as by controlling the current flowing from
each electrode that is activated. Such steering capability allows
the electric field to be located more precisely to target desired
neurons, minimizing stimulation thresholds needed to capture
the desired neural targets, thus minimizing power consumption
of the stimulator. Also, if microstimulator 100 or lead 112
happens to rotate or migrate, some designs allow the electric
field to be reprogrammed by adjusting the stimulation
parameters, thus allowing the microstimulator to be electrically
positioned without having to physically manipulate and
reposition the microstimulator or electrodes.

Thus, as taught by the above paragraph, it is the steering of the
electric field that allows for reprogramming of the electrodes if the
implanted microstimulator migrates within the tissue, and Hill specifically
teaches steering of the electric field.
As to Rejections II and IV, Appellants argue that neither Barreras nor
Schulman ‟514 remedy the deficiencies of the combination of Schulman and
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Hill (App. Br. 12 and 14). That argument is not found to be convincing for
the reasons with respect to claim 1 set forth above.
As to the rejection of claims 18 and 22 by Rejection III, Appellants
argue that Ungar does not remedy the deficiencies of the combination of
Schulman and Hill (id. at 13). That argument is not found to be convincing
for the reasons with respect to claim 1 set forth above.
As to the rejection of claims 23, 24, 26-30, and 50 by Rejection III,
Appellants assert that neither “Schulman („452) nor Hill discloses electrodes
that are asymmetrically placed with respect to the cuff or fixation device so
as to generate unidirectional propagation of action potentials” (id.).
Appellants further argue that there is no suggestion in any of Schulman, Hill,
or Ungar to combine the elements, and that the only thing that connects the
teachings of the three references is the instant Specification (id. at 14).
Appellants‟ arguments are not convincing. Ungar, like Schulman and
Hill, is drawn to a method of electrostimulating a nerve, and thus we agree
with the Examiner that it would have been obvious to combine the
references to arrive at the claimed invention.

SUMMARY
All of the rejections on appeal are affirmed.

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Application 10/178,011

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TIME PERIOD FOR RESPONSE
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

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