Ex Parte Rooney et al

Patent Trial and Appeal Board

Jun 17, 2013

11450133 (P.T.A.B. Jun. 17, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte ETHAN A. ROONEY, CARL D. WAHLSTRAND,
GARY W. KING, THOMAS E. CROSS JR.,
JEFFREY S. EVANSON, KENNETH T. HERUTH, and
PAUL W. WACNIK
____________________

Appeal 2011-002936
Application 11/450,133
Technology Center 3700
____________________

Before: STEFAN STAICOVICI, BENJAMIN D. M. WOOD, and
HYUN J. JUNG, Administrative Patent Judges.

WOOD, Administrative Patent Judge.

DECISION ON APPEAL

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Application 11/450,133

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STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
3, 5, 6, 8, 9, 11, 13-16, 18, 19, 21, 23, 25-27, 29, 31-39, 42, and 44. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
THE INVENTION
The claims are directed to methods and systems for treating pain by
administering “peripheral nerve field stimulation” in combination with
another form of therapy. Spec., paras. [0002], [0013]. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A method for treating pain of a patient comprising:
delivering peripheral nerve field stimulation to a
region of a body of the patient in which a patient
experiences pain via at least one electrode implanted
in the region; and
delivering spinal cord stimulation to the patient via
at least one electrode implanted in an epidural space
of the patient in combination with the peripheral nerve
field stimulation.
REFERENCES
Borkan
Adams
Tadlock
US 4,379,462
US 5,792,187
US 6,978,180 B2
Apr. 12, 1983
Aug. 11, 1998
Dec. 20, 2005
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REJECTIONS1
Claims 1, 3, 5, 6, 8, 9, 13-15, 18, 19, 21, 25-27, 31-39, and 44 stand
rejected under 35 U.S.C §102(e) as anticipated by Tadlock. Ans. 3-4.
Claims 1-3, 11, 15, 16, 18, 19, 23, 27, 29, 33, 36-39, and 42 stand
rejected under 35 U.S.C §103(a) as unpatentable over Adams and Borkan.
Ans. 6-7.
ANALYSIS
Claims 1, 3, 5, 6, 8, 9, 13-15, 18, 19, 21, 25-27, 31-39, and 44 – Anticipation
– Tadlock
Independent claim 1 is drawn to a method of treating pain comprising
delivering “peripheral nerve field stimulation” (“PNFS”) to a region of the
body of a patient in which the patient experiences pain, in combination with
delivering spinal cord stimulation (“SCS”) to the patient via at least one
electrode implanted in an epidural space of the patient. App. Br. 23.
Independent claims 15, 27, and 36 are drawn to systems that deliver PNFS
and SCS as set forth in claim 1. Id. at 25, 27, 29. Independent claims 13, 25
and 44 are drawn to a method (claim 13) or systems (claims 25 and 44) that
deliver PNFS to a region of a patient experiencing pain, in combination with
delivering at least one therapeutic agent to the patient intrathecally. Id. at

1 In addition to the prior-are rejections, the Examiner also provisionally
rejected claims 1, 7, 10, 2, 3, 5, 6, 8, 9, 11, 27, 28, 29, 31-35, 36, 38, 40, 41,
37, 39, and 42 on the ground of nonstatutory obviousness-type double
patenting over claims 1-5, 7-9, 15, 22, 17-21, 28-30, and 34, respectively, of
copending Appl. No. 11/450,144. Ans. 9-10. Because we reverse the
pending prior-art rejections, it is premature for the Board to address the
Examiner’s provisional rejection. We therefore do not reach this rejection.
See Ex Parte Moncla, 95 USPQ2d 1884, 2010 WL 2543659 (BPAI 2010)
(precedential).
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25, 27, 30. Thus, each of the independent claims requires the delivery of
PNFS in combination with another form of therapy.
The Examiner found that Tadlock discloses a method for treating pain
involving delivering electrical stimulation to a patient’s brain stem. Ans. 3-4
According to the Examiner, “the stimulation applied to the brain stem may
in fact be applied to peripheral nerves which emanate from the brain stem,”
(id. (citing Tadlock, col. 4, ll. 29-47; col. 11, ll. 19-25; col. 13, ll. 38-43;
col. 16, ll. 50-53; figs. 9A-9E)) and, in particular, “stimulation of the brain
stem provides a site for stimulation of the nerves of the head and face as a
pain relief strategy” (id. at 11 (citing Tadlock, col. 4, ll. 43-47)). Thus,
according to the Examiner, “Tadlock discloses delivering peripheral nerve
field stimulation to a region of the body, the head and face, in which a
patient experiences pain.” Id. at 11-12.
In contrast, Appellants argue, inter alia, that “Tadlock does not
disclose, or even contemplate delivering PNFS to a region of the body in
which a patient experiences pain.” App. Br. 11.
The Examiner has not shown by a preponderance of the evidence that
Tadlock discloses delivering PNFS. The Specification defines PNFS as
electrical stimulation delivered via one or more electrodes implanted in the
patient’s tissue within the region where the patient experiences pain, with
the PNFS current generally spreading parallel to the skin surface. Spec.,
paras. [0014], [0016]. PNFS does not deliberately stimulate specific
peripheral nerves, which might stimulate smaller fibers in the peripheral
nerves and thus cause the patient to experience “unpleasant sensations.” Id.
at para. [0016]. The Specification distinguishes PNFS from “peripheral
nerve stimulation” (“PNS”), which does involve the delivery of electrical
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stimulation to a specific peripheral nerve responsible for the pain sensation.
Id. at para. [0017]. According to the Specification, PNS electrodes are
implanted near the peripheral nerve “upstream” from the region where the
patient experiences pain, i.e., closer to the spinal cord than the region of
pain. Id. at para. [0018].
Tadlock discloses electrically stimulating the brain stem “to treat
various neurological disorders such as pain.” Tadlock, col. 4, ll. 29-31.
Tadlock teaches that the brain stem “connects the brain with the spinal
cord,” and thus serves as the “main router for the central nervous system.”
Id. at col. 4, ll. 34-36. According to Tadlock, “brain stem stimulation allows
the entire body or a substantial portion of it to be stimulated from one
location.” Id. at col. 4, ll. 51-52. Thus, “[s]timulation of the brain stem
provides a site for stimulation and hence pain relief for various parts of the
body, notably areas such as the head and face, the meninges, and the
intracranial vessels and associated nerve innervation that would otherwise be
difficult to access for stimulation.” Id. at col. 4, ll. 43-47.
The Examiner apparently infers that stimulation of a patient’s brain
stem to relieve head and face pain constitutes the claimed “stimulat[ing] a
region of a body where the patient experiences pain,” because the brain
stem, head and face are all in the same general region. Assuming, arguendo,
that the “region in which a patient experiences pain,” can be interpreted this
broadly, the Examiner has not adequately explained why this method
constitutes PNFS as opposed to PNS (or some other therapy). For example,
Tadlock teaches stimulating “target nerve tissue” in the brain stem to relieve
pain, which, according to the Specification’s definition of the two therapies,
suggests PNS rather than PNFS. Because we are not persuaded that Tadlock
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teaches administering PNFS, as required by all of the independent claims,
we do not sustain the Examiner’s rejection of those claims, as well as their
dependent claims, as anticipated by Tadlock.
Claims 1-3, 11, 15, 16, 18, 19, 23, 27, 29, 33, 36-39, and 42 – obviousness –
Adams and Borkan
Independent claims 1, 15, and 27 require the delivery of PNFS via at
least one electrode “implanted” in the region where the patient is
experiencing pain. App. Br. 23, 25, 27. The Examiner found that Adams
teaches administering “peripheral nerve stimulation” via “electrode patch
100 implanted in the region of a patient’s back to electrically stimulate the
dorsal ganglia 76, which are part of the peripheral nervous system, to
alleviate pain [in] the thorax.” Ans. 6-7, 16 (citing Adams, col. 3, ll. 50-58,
col. 5, ll. 58-67, col. 6, ll. 31-34, fig. 3). But, as Appellants point out,
Adams fails to teach delivering peripheral nerve field stimulation (PNFS)
via an electrode implanted in the region and delivering spinal cord
stimulation (SCS) via an electrode implanted in an epidural space, as
required by claims 1, 15, and 27. See App. Br. 20. Although the Examiner
found that Borkan teaches delivering SCS via at least one electrode
implanted in the epidural space, the Examiner does not explain how the
proposed combination of Adams and Borkan teaches or suggests
administering PNFS via an implanted electrode, given that electrode patch
100, which the Examiner finds administers peripheral nerve stimulation, is
not “implanted,” but rather placed on the surface of the patient’s skin.
Adams, col. 6, ll. 31-34 (“external cutaneous patch electrode 100 [lies]
parallel the axis of the spine”); id., fig. 4 (showing electrode 100 on skin
surface). The Examiner does not cite Borkan to cure this deficiency. See
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Ans. 7. Because the proposed combination does not teach or suggest all of
the limitations of independent claims 1, 15, and 27, we do not sustain the
Examiner’s rejection of these claims, as well as their dependent claims, as
obvious over Adams and Borkan.
Independent claim 36 is drawn to a system in which the medical
device that delivers PNFS is “implantable.” Id. at 29-30. The Examiner did
not make separate findings with respect to claim 36, apparently relying on
the finding that electrode 100 is implanted to satisfy claim 36’s requirement
that the electrode be implantable. See Ans. 8, 16. Because the Examiner has
not shown by a preponderance of the evidence that electrode 100 is
implanted, and given that there is no separate finding that electrode 100 is
implantable, we do not sustain the Examiner’s rejection of claim 36, and its
dependent claims, as obvious over Adams and Borkan.
DECISION
For the above reasons, the Examiner’s rejection of claims 1-3, 5, 6, 8,
9, 11, 13-16, 18, 19, 21, 23, 25-27, 29, 31-39, 42, and 44 is reversed.
REVERSED

JRG