Ex Parte Armstrong et al

Patent Trial and Appeal Board

Feb 27, 2013

11045602 (P.T.A.B. Feb. 27, 2013)

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.
11/045,602 01/27/2005 Randolph K. Armstrong 1000.064 2890
41332 7590 02/28/2013
CYBERONICS, INC.
LEGAL DEPARTMENT, 6TH FLOOR
100 CYBERONICS BOULEVARD
HOUSTON, TX 77058
EXAMINER
STOKLOSA, JOSEPH A
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
02/28/2013 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 RANDOLPH K. ARMSTRONG and
SCOTT A. ARMSTRONG
____________________

Appeal 2010-004665
Application 11/045,602
Technology Center 3700
____________________

Before: WILLIAM V. SAINDON, NEIL T. POWELL, and
JILL D. HILL, Administrative Patent Judges.

POWELL, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2010-004665
Application 11/045,602

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STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1
and 3-6. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
THE CLAIMED SUBJECT MATTER
Independent claim 1, reproduced below, is illustrative of the appealed
subject matter.
1. An implantable neurostimulator,
comprising:
a pulse generator that provides an electrical
pulse signal to stimulate a cranial nerve in a
patient;
a stimulation lead assembly coupled to said
pulse generator for delivering said electrical pulse
signal to said cranial nerve, said lead assembly
having a proximal end coupled to said pulse
generator and a distal end comprising a stimulation
electrode assembly adapted to be coupled to said
cranial nerve;
a plurality of sensors coupled to said pulse
generator, each said sensor being individually
selectable; and
sensor select logic that selects any two or
more of said plurality of sensors for sensing a
voltage difference between the selected sensors.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:

Pless 6,597,954 B1 Jul. 22, 2003
Lesnick 4,424,812 Jan. 10, 1984

Appeal 2010-004665
Application 11/045,602

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REJECTIONS
Appellants seek our review of the following rejections.
1. Claims 1, 3, 5, and 6 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Pless.
2. Claim 4 stands rejected under 35 U.S.C. § 103(a) as obvious over
Pless.

ANALYSIS
Anticipation Rejection
Appellants argue claims 1, 3, 5, and 6 as a group. See App. Br. 4-9.
We select independent claim 1 as representative, treating claims 3, 5, and 6
as standing or falling with representative claim 1. See 37 C.F.R.
§ 41.37(c)(1)(vii).
In support of the general finding that Pless anticipates claim 1, the
Examiner makes independent, alternative findings regarding how Pless’s
disclosure meets the claim limitations “a stimulation electrode assembly
adapted to be coupled to said cranial nerve.” Ans. 4-5. As one basis, the
Examiner finds that Pless suggests using its device to stimulate the vagus
nerve.1 Id. at 5. As the other basis, the Examiner finds that Pless discloses a
stimulation lead assembly coupled to a pulse generator, and that Pless’s
system “is capable of stimulating any nerve, including the vagus.” Id. at 4;
see also Id. at 5.

1 Apparently because claim 3 recites “wherein the cranial nerve comprises a
vagus nerve,” the Examiner and Appellants use the terms “cranial nerve”
and “vagus nerve” interchangeably in their discussion of the anticipation
rejection.
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Application 11/045,602

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Addressing the Examiner’s second basis, Appellants argue “Pless fails
to make any teaching that its electrodes, which are adapted to be coupled to
the brain, not to a cranial nerve, could stimulate a cranial nerve.” Reply Br.
6. Accordingly, Appellants contend that Pless does not anticipate claim 1
because the electrodes of Pless’s lead assembly do not constitute “a
stimulation electrode assembly adapted to be coupled to said cranial nerve.”
App. Br. 5. Elaborating on the contention that Pless discloses electrodes
adapted to be coupled only to the brain, Appellants state:
An example of an electrode assembly adapted to
be coupled to a cranial nerve is shown in
[Appellants’] Figure 1, elements 12, 14, and 15
coupled to vagus nerve 13. Simple comparison of
Pless’ Figs. 9-10 with Appellant’s Figure 1 shows
the person of ordinary skill in the art would
understand the brain electrodes taught by Pless are
not adapted to be coupled to a cranial nerve.

Id. at 7-8.
The Examiner responds that Appellants’ invitation to compare
drawings fails to identify any specific structural feature of Pless’s electrodes
that makes them not “adapted to be coupled to said cranial nerve.” Ans. 6.
The Examiner notes that “electrodes are merely pieces of conductive
material that deliver electrical signals.” Id. Given this, the Examiner finds
that one could attach Pless’s electrodes to a cranial nerve, which would
allow them to deliver electricity to the cranial nerve. Id. The Examiner also
states that the claims do not require that the device provide therapeutic
effects. Id. Accordingly, the Examiner maintains that Pless’s electrodes are
“adapted to be coupled to said cranial nerve.” Id.
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In response, Appellants argue that “the term ‘stimulation,’ as used by
the present claims, relates to the delivery of an electrical signal to a cranial
nerve sufficient to elicit a physiological response.” Reply Br. 6. In concert
with this, Appellants argue that electrodes “less adapted” to be coupled to a
cranial nerve would stimulate the cranial nerve less effectively, and
Appellants assert that a person of ordinary skill in the art would not “use an
electrode unadapted to be coupled to a cranial nerve for stimulating a cranial
nerve.” Id.
Contrary to Appellants’ suggestion that Pless lacks any indication that
its electrodes could stimulate a vagus nerve, Pless discloses that its system
“is capable of applying electrical stimulation to neurological tissue through
the electrodes 612-618.” Pless, col. 11, ll. 35-37 (emphasis added). This
suggests, absent any evidence to the contrary presented by Appellants, that
Pless’s electrodes have the capability to couple to neurological tissue,
including the vagus nerve or other cranial nerves, and to stimulate that
neurological tissue. Consistent with the Examiner’s findings, this makes
sense because electrodes are simply conductive structures that provide an
electrical connection to whatever they are attached to. See Ans. 6.
Accordingly, the Examiner has a sound basis for the finding that one could
attach Pless’s electrodes to the vagus nerve, instead of the brain, and that
Pless’s system would be capable of stimulating the vagus nerve by
conducting electricity to it via the electrodes. See Id.
Appellants’ arguments do not present evidence or reasoning that
convincingly contradicts the Examiner’s finding. If we accept Appellants’
implication that the claim language “to stimulate a cranial nerve in a patient”
has a limiting effect on the claimed “stimulation electrode assembly,” and if
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we further accept Appellants’ contention that “the term ‘stimulation,’ as
used by the present claims, relates to the delivery of an electrical signal to a
cranial nerve sufficient to elicit a physiological response” (see Reply Br. 6),
these arguments fail to apprise us of error in the Examiner’s finding because
Appellants do not identify any specific reason that Pless’s electrodes could
not elicit a physiological response in the vagus nerve by supplying electricity
to it. No such reason appears to us from Appellants’ vague invitation to
compare Pless’s drawings with Appellants’.
Appellants’ arguments that electrodes “less adapted” for use with a
cranial nerve would stimulate the nerve less effectively are not
commensurate in scope with the claim limitations. The plain language of the
claim encompasses any electrode assembly “adapted to be coupled to said
cranial nerve,” regardless of whether it is more or less adapted to serve this
function. And Appellants’ assertion about electrodes “unadapted to be
coupled to a cranial nerve” merely assumes the answer to the disputed issue.
Thus, Appellants have not apprised us of error in the Examiner’s
finding that Pless’s system is capable of stimulating any nerve, including the
vagus, and that it therefore meets the claim limitations “a stimulation
electrode assembly adapted to be coupled to said cranial nerve.”
Accordingly, we need not reach the dispute over the Examiner’s alternate
finding that Pless discloses using its system to stimulate the vagus nerve.

Obviousness Rejection
Claim 4 depends directly from claim 1 and recites that the implantable
neurostimulator further comprises “a programmable register and wherein
each sensor is selectable by writing a predetermined value to said register.”
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App. Br. 14, Cl. App. Thus, claim 4 recites no limitations related to a
stimulation electrode, but claim 4 includes the electrode limitations of claim
1. See Id. Appellants traverse the obviousness rejection by arguing that it
would not have been obvious to modify Pless’s disclosed device to include
“both a stimulation electrode to provide electrical stimulation to a cranial
nerve and a sensor.” App. Br. 11. Appellants concede that Pless discloses a
device that includes an electrode to provide electrical stimulation and a
sensor, stating that “Pless teaches a device comprising a sensor at a first
location in the brain and a stimulation electrode to provide electrical
stimulation at a second location in the brain.” Id. at 10-11. Appellants do
not clearly contend that this device fails to meet any claim limitations related
to the sensor. See Id. at 10-12; Reply Br. 11-12. Thus, the only discernible
reason for Appellants’ assertion that Pless does not teach the claimed device
is that Pless does not disclose the claim 1 limitations related to an electrode.
Accordingly, Appellants’ traversal of the obviousness rejection rests
on an assumption that Pless’s device fails to meet the electrode limitations of
claim 1: “a stimulation lead assembly . . . having a distal end comprising a
stimulation electrode assembly adapted to be coupled to said cranial nerve.”
As discussed above, Appellants’ arguments regarding the anticipation
rejection fail to apprise us of error in the Examiner’s finding that Pless’s
device meets these limitations. Appellants’ arguments regarding the
obviousness rejection do not provide any additional substantive argument or
evidence that apprises us of error in the Examiner’s finding that Pless’s
device meets the electrode limitations of claim 1. Because Appellants’
arguments regarding the obviousness rejection of claim 4 rest on a faulty
assumption that Pless’s device requires modification to meet the claim 1
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electrode limitations, Appellants have not established error in the
obviousness rejection.
DECISION
We affirm the Examiner’s decision regarding claims 1 and 3-6.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED

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