Ex Parte Libbus et al

Patent Trial and Appeal Board

Feb 12, 2015

11746263 (P.T.A.B. Feb. 12, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte IMAD LIBBUS and AVRAM SCHEINER
__________

Appeal 2012-005915
Application 11/746,263
Technology Center 3700
__________

Before DEMETRA J. MILLS, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation. We have jurisdiction under 35 U.S.C. § 6(b).
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Application 11/746,263

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STATEMENT OF CASE
According to the Specification, the invention “relates generally to
medical devices and, more particularly, to systems, devices and methods for
analyzing neural stimulation systems.” Spec. ¶ 1.

The following claim is representative.
1. A device adapted to analyze an implantable neural stimulation
system that includes an implantable neural stimulation lead for an
implantable neural stimulator to be implanted into a patient, the device
comprising:
an external housing;
a pacing circuit in the housing, the pacing circuit adapted to deliver a
test neural stimulation signal;
at least one test lead cable adapted to electrically connect the pacing
circuit and the implantable neural stimulation lead to enable the test neural
stimulation signal to be delivered to a neural target through the test lead cable
and the implantable neural stimulation lead;
a sensing circuit in the housing;
at least one physiological sensor adapted to sense a physiological
response to stimulation of the neural target; and
at least one sensor cable adapted to electrically connect the sensing
circuit and the at least one physiological sensor.

8. The device of claim 1, wherein the test lead cable includes clips
adapted to connect to conductor terminals of the neural stimulation lead.

Cited References

Shafer et al. US 2004/0172075 A1 Sept. 2, 2004
(hereinafter “Shafer”)
Dingman et al. US 2006/0253155 A1 Nov. 9, 2006
(hereinafter “Dingman”)

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Grounds of Rejection
Claims 1–3, 6–13, 15, and 17–19 are rejected under 35 U.S.C.
§ 102(b) as being anticipated by Shafer.
Claims 1–19 are rejected under 35 U.S.C. § 102(e) as being
anticipated by Dingman.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
4–15.

Discussion
Anticipation by Shafer
ISSUE
The Examiner argues that Shafer teaches each element of the claimed
device. (Ans. 4–5.)
Appellants argue that, “[t]he rejection asserts that element 210 is an
implantable neural stimulation lead, and that elements 220, 221 are at least
one test cable. However, Shafer et al. identify element 210 as nerve
stimulation electrodes and elements 220 and 221 as cardiac stimulation
electrodes (Shafer at [0076]).” App. Br. 15. Appellants argue that, “[t]he
claimed implantable neural stimulation lead and the test lead cable are
separate elements.” Id. Appellants further argue that, the “cardiac
stimulation electrodes 220, 221 are not connected to the nerve stimulation
electrodes 210 to enable the test neural stimulation signal to be delivered to a
neural target through the cardiac stimulation electrodes 220, 221 and nerve
stimulation electrodes 210.” App. Br. 16.
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The issue is: Does the cited prior art support the Examiner’s finding
that the claimed subject matter is anticipated?

PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office). The Board “determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction ‘in light of the specification as
it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
The interpretation of terms in a claim is a matter of law. In re Am.
Acad. of Sci. Tech. Ctr., 367 F.3d at 1363. During prosecution before the
Office, claims are to be given their broadest reasonable interpretation
consistent with the Specification as it would be interpreted by one of
ordinary skill in the art. Id. at 1364.
To anticipate, every element and limitation of the claimed invention
must be found in a single prior art reference, arranged as in the claim.
Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001).

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ANALYSIS
Anticipation by Shafer
We do not find that the Examiner has provided evidence to support a
prima facie case of anticipation on this record.
Appellants argue that, the “rejection asserts that element 210 is an
implantable neural stimulation lead, and that elements 220, 221 are at least
one test cable. However, Shafer et al. identify element 210 as nerve
stimulation electrodes and elements 220 and 221 as cardiac stimulation
electrodes (Shafer at [0076]).” Br. 15.
Appellants argue that “the claimed implantable neural stimulation lead
and the test lead cable are separate elements.” Br. 15. Appellants further
argue that the “cardiac stimulation electrodes 220, 221 are not connected to
the nerve stimulation electrodes 210 to enable the test neural stimulation
signal to be delivered to a neural target through the cardiac stimulation
electrodes 220, 221 and nerve stimulation electrodes 210.” Br. 16.
The Examiner responds that
[E]lement 210 is a nerve electrode connected to the system via
a lead and therefore constitutes a neural lead. Further elements
220-221 are electrodes connected to the system via cables and
therefore constitute and anticipate the cited test cables. It is
noted that the claim does not define the test cable just that it
provides a test signal. In this case the stimulation signal that is
sent through the test cable connected to electrodes 220-221
anticipates the claimed test cable and test signal.

Ans. 8.

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Shafer discloses that
[T]wo electrodes for stimulation of the heart at 220 and 221.
Cardiac stimulation electrodes used to stimulate the heart may
be, for example, non-invasive, e.g., clips, or invasive, e.g.,
needles or probes. Cardiac stimulation electrodes may be
positioned through a thoracotomy, sternotomy, endoscopically
through a percutaneous port, through a stab wound or puncture,
through a small incision in the chest, placed on the chest or in
combinations thereof.

Shafer 8 ¶ 75. The Examiner has not indicated where Shafer specifically
shows that the two electrodes 220 and 221 are used as test cables. Thus, we
do not find that the Examiner has shown each element claimed in the prior
art and the anticipation rejection over Shafer is reversed.

Anticipation by Dingman
Claims 1–19 are rejected under 35 U.S.C. § 102(e) as being
anticipated by Dingman.
The Examiner contends that Dingman teaches each element claimed.
The Examiner particularly argues with regard to “neural stimulation” as
claimed, that cardiac tissue contains both cardiac muscle and nerves and
meets both limitations. (Ans. 12.) The Examiner argues that Dingman
discloses neural stimulation lead 210. Ans. 6.
Appellants contend that, “Dingman does not address neural
stimulation.” Br. 27.
The issue is: Does the Examiner’s cited evidence support a prima
facie case of anticipation?

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ANALYSIS
We find the Examiner has provided sufficient evidence to support a
prima facie case of anticipation.
Appellants argue that Dingman does not address neural stimulation.
Br. 27. Dingman discloses an atrial pacing lead 210 which includes a ring
electrode and a tip electrode. Dingman ¶ 27. The electrode can deliver
pacing pulses to the right atria. (Id.) The Examiner finds that cardiac tissue
comprises innervated muscle and that when the pacing lead provides pacing
pulses to the heart, cardiac nerves are stimulated, resulting in neural
stimulation. Ans. 12. Appellants have failed to provide evidence to rebut
this finding of the Examiner.

Claims 4–7, 9–11, 13, 14, and 16
We acknowledge that Appellants have separately argued the above
dependent claims (Br. 28–33). We have carefully considered each of
Appellants’ arguments; however, for the reasons set forth by the Examiner
in the Answer, we affirm the rejection of these dependent claims.

Claim 8
We specifically address Appellants’ arguments with respect to claim
8.
The Examiner finds that “Dingman discloses that the leads [sic]
contains clips to connect the test lead (e.g. 141, 142, 143, 144).” Ans. 7.
Appellants argue that “[t]he rejection does not explain how the lead
includes clips adapted to connect to conductor terminals of the neural
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stimulation lead. Dingman does not use the work [sic] clip. Elements 141,
142, 143 and 144 are identified as ‘connectors’, and not clips.” Br. 30–31.
We begin with claim interpretation. Claim 8 requires that “the test
lead cable includes clips1 adapted to connect to conductor terminals of the
neural stimulation lead.” According to the Specification, page 4, ¶ 14, in an
embodiment,
[T]he lead test cable terminates in alligator clips, which can be
used to attach the bipolar test cable to the bipolar implantable
neural stimulation lead. Other connectors or clamps adapted to
quickly make and break an electrical and mechanical
connection between the lead test cable and the implantable
neural stimulation cable can be used. An embodiment of the
sensor cable is a multipolar cable that terminates in two or more
ECG button connectors to be placed on the patient’s skin.

We note that the claim does not use the language “directly connect”
and that “[o]ther connectors or clamps adapted to quickly make and break an
electrical and mechanical connection between the lead test cable and the
implantable neural stimulation cable can be used.” Id. Nor is the claim
limited to alligator clips.

1 The term “clip” means :
1. Any of various devices for gripping or holding things together; a clasp or
fastener.” http://www.thefreedictionary.com/clip (see clip2).
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Dingman, Figure 2, is reproduced below.

Dingman, Fig. 2 shows
The electrodes of leads 110, 120, and 130 and electrode 108 are
electrically connected to PSA [pacing system analyzer] 150
using a cable 140 with connectors 141, 142, 143, and 144.
Connectors 141, 142, 143, and 144 are each configured for a
temporary connection between cable 140 to one of leads 110,
120, 130, and 106. PSA 150 performs a test including pacing
and measurements to ensure that leads 110, 120, and 130 are
properly positioned and to find a set of suitable pacing
parameters. When the test is completed, cable 140 is
disconnected from the leads, and lead 106 (with reference
electrode 108) is removed from body 102. An implantable
pacemaker is connected to leads 110, 120, and 130 and is
implanted in body 102 in approximately the location where
electrode 108 was placed.

Dingman 2 ¶ 24 (emphasis added.) Lead 220 (an RV sensing lead) includes
tip electrode 222 with distal end 221. PSA further includes a surface ECG
sensing circuit to sense one or more surface ECG signals through surface
ECG electrodes attached to the skin. Id. at 4 ¶ 37. “The PSA provides for
testing during operation.” Id. at 2 ¶ 23.
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In view of the above, we agree with the Examiner that the connectors
of Dingman function in a similar manner as an alligator clip on an ECG, and
provide a temporary connection. In other words, Dingman discloses the test
lead cable 220 includes clips or connectors 141–144 adapted to connect to
conductor terminals 221–222 of the neural stimulation lead.
In view of the above, the anticipation rejection of claim 8 is affirmed
and the anticipation rejection as a whole, over Dingman is affirmed.

CONCLUSION OF LAW
The Dingman supports the Examiner’s anticipation rejection which is
affirmed. The anticipation rejection over Shafer is reversed.
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).

AFFIRMED

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