Ex Parte Carroll et al

Patent Trial and Appeal Board

Oct 29, 2014

10761424 (P.T.A.B. Oct. 29, 2014)

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.
10/761,424 01/22/2004 William J. Carroll MBHB 09-333-US 1421
20306 7590 10/29/2014
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP
300 S. WACKER DRIVE
32ND FLOOR
CHICAGO, IL 60606
EXAMINER
KAHELIN, MICHAEL WILLIAM
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
10/29/2014 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 WILLIAM J. CARROLL1
__________

Appeal 2012-005368
Application 10/761,424
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for stimulating the spinal cord to treat pain, which have been rejected for
obviousness and for containing new matter. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.

1 According to Appellant, the Real Party in Interest is Meagan Medical, Inc.
(Appeal Br. 1).
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STATEMENT OF THE CASE
“Electrical stimulation of the posterior spinal cord, spinal cord
stimulation (SCS), has developed into an effective therapeutic tool for
treating chronic pain conditions” (Spec. 1:15–17) but “SCS stimulates the
dorsal column in a somewhat superficial manner” (id. at 2:11). The
Specification states that
[p]roviding an interferential component to the electrode array of
the SCS allows the crossing of the two signals wherein the
resultant additive effect of the beat frequency produces deeper
penetration of the signal and a higher resultant amplitude at the
stimulation site. The interferential current would recruit larger
numbers of dorsal column fibers and provide greater levels of
pain relief and benefit to intractable pain patients.
(Id. at 2:16–21.)
Claims 1–5, 7, 8, 15–19, 21, and 22 are on appeal. Claim 1 is
illustrative and reads as follows:
1. An electrical stimulator for the treatment of intractable pain
syndromes, comprising:
an interferential current generator comprising a sine wave generator
which generates an interferential alternating current output comprising first
and second sinusoidal signals having different first and second frequencies
with a base medium frequency of at least 500Hz but no more than 20KHz;
and
at least two pairs of implantable electrodes wherein each electrode has
a first and a second end, wherein the first ends are connected to said
interferential current generator and the second ends are configured to be
implanted to a dura matter in an epidural space at predetermined locations
proximate to a subject’s spinal cord, wherein each pair of said at least two
pairs of implantable electrodes transmits one of said first and second
sinusoidal signals such that the first and second frequencies interfere with
each other to produce at least one beat frequency signal proximate to the
subject’s spinal cord, and wherein a majority of the at least one beat
frequency signal is directionally distributed and controlled, enabling the at
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least one beat frequency signal to avoid remaining in and shunting through
cerebrospinal fluid proximate to the subject’s spinal cord, thereby recruiting
dorsal column fibers.

I.
The Examiner has rejected all of the claims on appeal “under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement” (Ans. 4). The Examiner finds that the limitation of
claim 1 reciting that “a majority of the at least one beat frequency signal is
directionally distributed and controlled, enabling the at least one beat
frequency signal to avoid remaining in and shunting through cerebrospinal
fluid proximate to the subject’s spinal cord, thereby recruiting dorsal column
fibers” is not supported (id. at 4–5) because the Specification “makes no
mention of the beat frequency signal being configured to avoid remaining in
and shunting through CSF proximate to the subject’s spinal cord” (id. at 5).
Appellant argues that the disputed limitation is supported by the
Specification’s discussion of the differences between traditional SCS and
interferential SCS (at 2:11–21), by its discussion of interferential current (at
3:16–23), and by its discussion of properties of the claimed system (at 6:15–
20 and 7:14–16) (Appeal Br. 4–7). Appellant also argues that the Yearwood
Declaration2 shows that “a particular feature or limitation of a claim is
disclosed in an application based on an understanding of underlying factual
description of the Specification” (id. at 8).

2 Declaration under 37 C.F.R. § 1.132 of Thomas L. Yearwood, signed
March 7, 2011.
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We agree with Appellant that the evidence of record does not support
the Examiner’s finding that a skilled artisan would not recognize a
description of the disputed limitation in the Specification. The Examiner
acknowledges that page 3 of the Specification describes interferential
stimulation as providing “increased directional control and depth of
penetration” (Ans. 8–9). The Examiner also acknowledges that page 6 of
the Specification describes the digital signal processor and signal generating
source of the disclosed system as generating a current that “recruits larger
numbers of dorsal column fibers” (id. at 9–10). Thus, the only aspect of the
disputed limitation that the Examiner has not acknowledged to be described
appears to be that the “beat frequency signal . . . avoid[s] remaining in and
shunting through [the] cerebrospinal fluid proximate to the subject’s spinal
cord.”
However, the Specification states that, in conventional SCS, “most of
the current distribution remains in the cerebrospinal fluid (CSF) and does not
project deeply into the dorsal column” (Spec. 2:14–16), while by
“[p]roviding an interferential component . . . the resultant additive effect of
the beat frequency produces deeper penetration of the signal” (id. at 2:16–
18). This description supports Appellant’s position that the Specification
would have been recognized, by those skilled in the art, to describe the
disputed limitation. That is, because most of the current in conventional
SCS remains in the CSF, it does not project deeply into the dorsal column,
while providing an interferential component allows deeper penetration of the
signal, meaning that it does not remain in the CSF.
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Dr. Yearwood has testified that he understands the Specification to
describe the disputed limitation (Yearwood Decl. ¶ 20). Specifically, in
traditional SCS, the stimulating field spreads within the CSF as intensity of
stimulation increases, because of the highly conductive nature of the CSF
compared to that of the spinal cord tissue itself (id. at ¶ 11). By contrast,
providing an interferential component allows an additive effect that causes a
beat frequency that “produces deeper penetration of the signal and a higher
resultant amplitude at the stimulation site because only sub-threshold
signals, of minimal biological consequence, remain in or shunt through the
CSF” (id. at ¶ 13).
Dr. Yearwood’s opinion is consistent with the Specification’s
description of the claimed device and is persuasive evidence that a person of
ordinary skill in the art would recognize a description of the disputed
limitation in the Specification. The Examiner finds the Yearwood
Declaration to be “unpersuasive to overcome the evidence found against
support” (Ans. 10) but provides no evidence or sound technical reasoning to
doubt the testimony of Dr. Yearwood.
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“In reviewing the examiner’s decision on appeal, the Board must necessarily
weigh all of the evidence and argument. . . . [T]he ultimate determination of
patentability is made on the entire record.” Id. In this case, the Examiner’s
rejection of the claims based on 35 U.S.C. § 112, first paragraph, is not
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supported by a preponderance of the evidence of record and is therefore
reversed.
II.
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as obvious based on Reiss3 and Holsheimer4 (Ans. 5). The
Examiner finds that Reiss discloses an interferential SCS system meeting the
limitations of claim 1 except that Reiss’ system does not include implantable
electrodes (Ans. 5–6). The Examiner finds that
Holsheimer teaches that it is known to use electrodes implanted
to the dura matter for use in interferential spinal cord
stimulation as set forth in ABSTRACT for providing the
predictable results of decreasing power consumption by placing
the electrode on the actual stimulation site as well as
ensuring/maintaining proper placement of the electrodes in
chronic stimulation patients.
(Id. at 6.)
The Examiner concludes that it would have been obvious “to modify
the system as taught by Reiss with electrodes implanted to the dura matter
since such a modification would provide the predictable results of [ ]
ensuring/maintaining proper placement of the electrodes in chronic
stimulation patients” (id.).
Appellant argues that one of ordinary skill in the art would not
implant Reiss’ electrodes in order to ensure or maintain proper placement
(Appeal Br. 19–20, citing the Yearwood Declaration). Appellant argues that
Holsheimer and Reiss are directed to very different types of therapy and a

3 Reiss et al., US 5,512,057, patented Apr. 30, 1996.
4 Holsheimer et al., US 5,643,330, patented July 1, 1997.
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skilled artisan would not modify Reiss’ surface stimulation system based on
Holsheimer’s implantable system (id. at 20–21, citing the Yearwood
Declaration). Appellant also argues that the references do not disclose how
Reiss’ system, if modified to include implantable electrodes, could be
operated to provide effective therapy without causing pain, and that
application of interferential therapy cannot necessarily be scaled down to
provide these effects (id. at 22, citing the Yearwood Declaration).
We conclude that the Examiner has not provided adequate evidence to
support the rejection. The Examiner finds that “Holsheimer teaches that it is
known to use electrodes implanted to the dura matter for use in interferential
spinal cord stimulation as set forth in ABSTRACT” (Ans. 6). The abstract
of Holsheimer, however, does not refer to “interferential spinal cord
stimulation.” It states that the disclosed apparatus can provide “overlapping
areas of stimulation of the spinal area” (Holsheimer, abstract) but does not
state that pulses interfere with each other to produce a beat frequency signal,
as in the claimed interferential apparatus. Rather, Holsheimer states that
“[i]n the overlapping areas of stimulation, the frequency of stimulation is
double the frequency of the pulses given by the each stimulator channel
separately” (id.), which implies that the pulses are timed so as not to
interfere with each other but simply to supply more frequent stimulation in
the area of overlap.
The Examiner also finds that
Holsheimer teaches that it is known to use electrodes implanted
to the dura matter . . . as set forth in ABSTRACT for providing
the predictable results of decreasing power consumption by
placing the electrode on the actual stimulation site as well as
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ensuring/maintaining proper placement of the electrodes in
chronic stimulation patients.
(Ans. 6.) This finding, as well, is not supported by the cited evidence.
Holsheimer’s abstract does not state that implantable electrodes use less
power, nor that they are used for ensuring or maintaining proper placement
of the electrodes in chronic stimulation patients. The Examiner has not
pointed to any other evidence of record that provides a reason for modifying
Reiss’ system in the manner proposed in the rejection.
Appellant, on the other hand, has provided the Yearwood Declaration
as evidence that the proposed modification would not have been obvious to a
person of ordinary skill in the art. Dr. Yearwood has testified that “Reiss is
not used for dorsal column stimulation, and thus, implanting the electrodes
in Reiss upon the dura matter does not make sense” (Yearwood Decl. ¶ 27).
Dr. Yearwood has also testified that Reiss’ surface stimulation system
“us[es] currents having intensity values orders of magnitude larger than can
be used with dorsal column stimulation” (id. at ¶ 28); that Reiss does not
describe how its system could be operated using implantable electrodes so
that the current intensity would provide effective therapy without causing
pain (id. at ¶ 29); and that “[i]t is untrue that with any application of
interferential therapy, electrodes can simply be implanted, and the therapy
can be scaled down” so as to provide the desired effect without causing pain
(id. at ¶ 30). Dr. Yearwood concludes that “[a]s a practicing doctor, [he]
would not modify the system in Reiss to include implantable electrodes” (id.
at ¶ 35).
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.”
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Oetiker, 977 F.2d at 1445. “After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration to
persuasiveness of argument.” Id.
The Examiner’s reasons for combining the teachings of Reiss and
Holsheimer are not supported by the cited evidence. Appellant has provided
the Yearwood Declaration as evidence that a person of ordinary skill in the
art would not have combined the references as proposed by the Examiner.
The Examiner’s rejection under 35 U.S.C. § 103(a) is not supported by a
preponderance of the evidence, and therefore must be reversed.
SUMMARY
We reverse both of the rejections on appeal.

REVERSED

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