Ex Parte Moffitt et al

Patent Trial and Appeal Board

Oct 22, 2012

12204136 (P.T.A.B. Oct. 22, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/204,136 09/04/2008 Michael Moffitt 08-00264-01 4447
71422 7590 10/22/2012
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
GETZOW, SCOTT M
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
10/22/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL MOFFITT, DONGCHUL LEE,
KERRY BRADLEY, and DAVID K. L. PETERSON
__________

Appeal 2011-013601
Application 12/204,136
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a therapy
system and method. The Examiner has rejected two of the claims for
anticipation and the rest of the claims for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm the anticipation rejection and reverse the
obviousness rejection.
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STATEMENT OF THE CASE
“Spinal cord stimulation (SCS) is a well-accepted clinical method for
reducing pain in certain populations of patients” (Spec. 1, ¶ 3). The
Specification states that SCS optimally stimulates nerve fibers of the dorsal
column (DC nerve fibers) without stimulating nerve fibers in the dorsal root
(DR nerve fibers) (id. at 4, ¶ 10). “In order to stimulate the DC nerve fibers,
while guarding against the stimulation of the DR nerve fibers, SCS systems
may activate anodes that flank a single cathode in a medial-lateral electrical
field” (id.). The “electrical energy originating from the cathode(s) stimulates
the DC fibers, while the anode(s) ‘push’ the electrical stimulation away from
the DR fibers” (id. at 36, ¶ 95).
Claims 1-6, 13-19, and 22-24 are on appeal. Claims 1 and 19 are
representative and read as follows:
1. A method of providing therapy to a patient, comprising:
disposing at least four electrodes adjacent spinal cord tissue of the
patient in a medial-lateral electrode arrangement, wherein the at least four
electrodes has two inner electrodes and two outer electrodes flanking the two
inner electrodes;
configuring the inner electrodes as cathodes, and the outer electrodes
as anodes;
conveying electrical energy between the cathodes and the anodes to
create a medial-lateral electrical field that stimulates the spinal cord tissue;
and
incrementally shifting cathodic current between the cathodes to modify
the medial-lateral electrical field.
19. A neurostimulation system for providing therapy to a patient,
comprising:
a neurostimulation paddle lead carrying a plurality of electrodes
comprising at least four columns of electrodes extending along a longitudinal
axis of the paddle lead, wherein the at least four electrode columns has two
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inner electrode columns and two outer electrode columns flanking the two
inner electrode columns; and
a neurostimulator for configuring at least two electrodes of the inner
electrode columns as cathodes, and at least one electrode of each of the outer
electrode columns as anodes, conveying electrical energy between the
cathodes and the anodes to create an electrical field that stimulates tissue of
the patient, and incrementally shifting cathodic current between the cathodes
to modify the electrical field, wherein the cathodes are longitudinally offset
from each other, such that incremental shifting of the cathodic current
between the cathodes expands the electrical field along the longitudinal axis.
The claims stand rejected as follows:
• Claims 19 and 24 under 35 U.S.C. § 102(b) as anticipated by Feler1
(Answer 4) and
• Claims 1-6, 13-18, 22, and 23 under 35 U.S.C. § 103(a) as obvious
based on Feler (Answer 5).
I.
Issue
The Examiner has rejected system claims 19 and 24 as anticipated by
Feler (Answer 4). Claim 24 has not been argued separately and therefore
stands or falls with claim 19. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Feler discloses a system including a
neurostimulation paddle that includes electrodes that are longitudinally offset
from each other and can be set as cathodes by a neurostimulator (id.). The
Examiner also finds that Feler discloses that the stimulation pattern and
amplitude can be varied using its system (id. at 4-5), and therefore Feler’s
system meets all of the structural limitations of Appellants’ claims (id. at 5).

1 Feler et al., US 2007/0179579 A1, Aug. 2, 2007
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Appellants contend that shifting the cathodic current in the manner
recited in claim 19 provides an unpredictable result (Appeal Br. 10-11).
Appellants also contend that it would not have been obvious to shift cathodic
current between cathodes that are longitudinally, or rostral-caudally, offset
from each other in order to expand the electrical field (Reply Br. 4).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Feler discloses a system having all of the
structural elements of claim 19?
Findings of Fact
1. “Application of electrical fields to spinal nerve roots, spinal cord,
and other nerve bundles for the purpose of chronic pain control has been
actively practiced for some time” (Feler 1, ¶ 3).
2. “Percutaneous leads and laminotomy leads are the two most
common types of lead designs that provide conductors to deliver stimulation
pulses from an implantable pulse generator (IPG) to distal electrodes adjacent
to the pertinent nerve tissue” (id. at 1, ¶ 6).
3. “[C]onventional laminotomy or paddle lead 150 has a paddle
configuration and typically possesses a plurality of electrodes 151
(commonly, two, four, eight, or sixteen) arranged in columns” (id. at 1, ¶ 7).
4. “To supply suitable pain-managing electrical energy, multi-
programmable IPGs enable the pattern of electrical pulses to be varied across
the electrodes of a lead. Specifically, such systems enable electrodes of a
connected stimulation lead to be set as an anode (+), as a cathode (-), or to a
high-impendence [sic, high-impedance] state (OFF).” (Id. at 1, ¶ 8.)
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5. “[A] range of very simple to very complex electrical fields can be
created by defining different electrodes in various combinations of (+), (-),
and OFF” (id.).
6. Feler discloses
a paddle lead . . . with multiple columns and multiple rows. . . .
After implantation, an electrode combination on a first row of
electrodes can be determined that is effective for a first pain
location. . . . Then, another electrode combination on a second
row of electrodes can be determined for a second pain
location. . . . [T]he patient’s IPG can be programmed to deliver
pulses using the first and second rows according to the
determined electrode combinations.
(Id. at 1, ¶ 9.)
7. Feler discloses an embodiment in which its paddle lead comprises
five columns and four rows of electrodes (id. at 4, ¶ 40).
8. Feler discloses that a “single channel pulse generator refers to a
pulse generator that provides an equal magnitude pulse to each active
electrode at a given time. . . . Each ‘active’ electrode experiences the same
amplitude; only the polarity varies depending upon whether the electrodes are
set as cathodes or anodes.” (Id. at 4, ¶ 45.)
9. Feler discloses that “according to some embodiments, multiple
current or voltage source IPGs could alternatively be employed. . . . The
stimulation amplitudes associated with the various channels can be varied
and delivered to adjacent electrodes to ‘steer’ the stimulation.” (Id. at 6,
¶ 60.)

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Analysis
We agree with the Examiner that Feler discloses a neurostimulation
system meeting all of the structural requirements of claim 19. Claim 19
requires a neurostimulation paddle having at least four columns of electrodes;
Feler discloses a paddle lead having multiple rows and columns, including an
embodiment with five columns and four rows of electrodes (FFs 6, 7).
Claim 19 also requires a neurostimulator “for configuring” certain
electrodes as cathodes or anodes, for “conveying electrical energy,” and for
“incrementally shifting cathodic current between the cathodes.” These
limitations require that, to anticipate claim 19, the prior art system must have
a structure that provides the capability of carrying out the recited functions,
but they do not require the prior art to actually describe using its system in the
recited manner in order to anticipate the claimed system. “It is well settled
that the recitation of a new intended use for an old product does not make a
claim to that old product patentable.” In re Schreiber, 128 F.3d 1473, 1477
(Fed. Cir. 1997). See also Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
289 F.3d 801, 809 (Fed. Cir. 2002) (“[T]he patentability of apparatus or
composition claims depends on the claimed structure, not on the use or
purpose of that structure.”).
Feler discloses that its system, as well as other prior art systems using
programmable implantable pulse generators (IPGs), has the capacity to set
specific electrodes on the lead as either cathodes or anodes (FFs 4-6). Feler
also discloses that the “patient’s IPG can be programmed to deliver pulses” to
appropriately programmed electrodes (FF 6). Feler’s system therefore
includes “a neurostimulator for configuring at least two electrodes of the
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inner electrode columns as cathodes, and at least one electrode of each of the
outer electrode columns as anodes, [and] conveying electrical energy
between the cathodes and the anodes to create an electrical field that
stimulates tissue of the patient,” as recited in claim 19.
Feler also discloses activating electrodes in two different rows of its
lead simultaneously to provide pain relief to different locations in the patient
via a single paddle lead (FF 6). Because each of the activated rows includes
at least one cathode and at least one anode, Feler’s system is capable of
configuring as cathodes electrodes that are longitudinally offset from each
other, as required by claim 19.
Finally, Feler describes embodiments of its system that include a
multiple current or voltage source IPG, which provides the capability of
varying the stimulation amplitudes “delivered to adjacent electrodes to ‘steer’
the stimulation” (FF 9). These disclosed embodiments therefore have the
capability of “incrementally shifting cathodic current between the cathodes to
modify the electrical field,” as recited in claim 19. In summary, Feler
discloses a neurostimulation system having the structure required by claim
19.
Appellants argue that it would not have been obvious to shift cathodic
current between cathodes that are longitudinally offset from each other in
order to expand the electrical field (Reply Br. 4), and that doing so provides
an unpredictable result (Appeal Br. 10-11).
This argument is not persuasive. Appellants’ argument is directed to
the intended use of the claimed system but a prior art description of a product
having the same structure as a later-claimed product anticipates the later
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claim, regardless of whether the claimed product is intended to be used in a
different manner than is described in the prior art. See, e.g., Schreiber, 128
F.3d at 1477 (“Schreiber’s contention that his structure will be used to
dispense popcorn does not have patentable weight if the structure is already
known, regardless of whether it has ever been used in any way in connection
with popcorn.”).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Feler
discloses a system having all of the structural elements of claim 19.
II.
The Examiner has rejected claims 1-6, 13-18, 22, and 23 as obvious
based on Feler. Claims 1 and 13, the only independent claims among those
rejected on this basis, are directed to methods of providing therapy by
configuring electrodes as cathodes and anodes in a specific pattern, namely,
two electrodes of inner columns configured as cathodes and two electrodes of
outer columns, flanking the inner columns, configured as anodes. Both
claims also require “incrementally shifting cathodic current between the
cathodes to modify the medial-lateral electrical field.”
The Examiner finds that “to configure two inner electrodes as cathodes
and two outer electrodes as anodes is considered to be taught in paragraphs
40 and 46,47” (Answer 5). The Examiner also reasons that a skilled worker
“would understand that some electrode configurations would work better
than others for a particular patient. It should not be surprising that
adjustment to the electrical field, (whether to the size or location of the field
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or to the current strength), can and are made by the physician in order to
provide the stimulation therapy that is most beneficial to the patient.” (Id. at
7.)
Appellants argue that “Feler makes no mention of any specific
electrode combinations” (Appeal Br. 6), and that the “Examiner has not
pointed to any specific stimulation parameter modification technique that
would lead one of ordinary skill in the art to configure the inner electrodes as
cathodes, and to incrementally shifting cathodic current between the cathodes
to modify the medial-lateral electrical field” (id. at 8).
We agree with Appellants that the Examiner has not provided evidence
or sound reasoning sufficient to support a conclusion that it would a skilled
worker would have considered it obvious to configure the electrodes in
Feler’s system to provide two inner electrodes configured as cathodes flanked
by outer electrodes configured as anodes.
The Examiner points to paragraphs 40, 46, and 47 of Feler as teaching
the recited configuration of cathodes and anodes. We disagree. Feler’s
paragraph 40 describes an embodiment having five columns and four rows of
electrodes, and describes the advantages of having multiple columns of
electrodes. It does not describe configuring the electrodes as anodes or
cathodes in any specific pattern.
Paragraphs 46 and 47 describe configuring electrodes as anodes or
cathodes in specific patterns in order to either confine the electrical field to
the periphery of the paddle or to steer the stimulation in either the inward or
outward lateral direction. Each of the specified patterns of electrode
configuration, however, includes only a single electrode configured as a
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cathode, along with either one or two electrodes – on only one side of the
cathode – configured as anode(s).
Thus, the Examiner has not provided a sufficient basis for concluding
that Feler teaches or would have suggested either (a) configuring two inner
electrodes as cathodes, or (b) configuring electrodes that flank the cathode(s)
on both sides as anodes. Because the Examiner has not shown that Feler
teaches or suggests configuring two inner electrodes as cathodes, he also has
not shown that it would have been obvious to shift the cathodic current
between the cathodes. We agree with Appellants that Feler’s description of
programmable IPGs as allowing the creation of very complex electrical fields
is not adequate to suggest the specific electrode configuration and current-
shifting required by claims 1 and 13.
SUMMARY
We affirm the rejection of claim 19 as anticipated by Feler. Claim 24
falls with claim 19. 37 C.F.R. § 41.37(c)(1)(vii).
We reverse the rejection of claims 1-6, 13-18, 22, and 23 as obvious
based on Feler.
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-IN-PART

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