Ex Parte Vonk et al

Patent Trial and Appeal Board

Jan 30, 2014

11459469 (P.T.A.B. Jan. 30, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte BENARDUS F. M. VONK, GUSTAAF A. P. STOOP,
and VOLKERT ZEIJLEMAKER
__________

Appeal 2011-011915
Application 11/459,469
Technology Center 3700
__________

Before TONI R. SCHEINER, LORA M. GREEN, and ULRIKE W. JENKS,
Administrative Patent Judges.

PER CURIAM.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1, 7, 10, and 13-19. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.

1 Appellants identify Medtronic, Inc. as the real party in interest (App. Br.
2).
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STATEMENT OF THE CASE
The Specification discloses “an implantable medical device system
designed to stabilize pacemaker electrode polarization signal drift” (Spec. 4,
¶ 15). The Specification discloses “[a]fter long periods of inhibition, i.e.,
long periods in which no stimulation is applied, the drift is often substantial,
and the electrode-tissue interface is unstable” (id. at 5, ¶ 16), and
“[s]ignificant drift can lead to high pace polarization artifacts, which
interfere with detection of [evoked] responses and thus hinder capture” of
the heart (id. at 5, ¶ 18). “By counteracting drift after long periods of
inhibition, the invention reduces pace polarization artifacts and enhances
capture” (id.).
Representative claims 1 and 16 read as follows:
1. A method for countering pacemaker post pace polarization artifact,
comprising:
sensing intrinsic electrical activity of the heart;
waiting for a plurality of unpaced consecutive cycles having intrinsic
activity to stabilize a lead and tissue interface; and
delivering a polarization stabilization stimulation responsive to the
occurrence of the plurality of unpaced consecutive cycles, the stimulation
being coordinated with the sensed intrinsic activity.
16. A method for countering pacemaker post pace polarization
artifact, comprising:
sensing intrinsic electrical activity of the heart;
waiting for a predetermined period of pacemaker inhibition extending
over multiple cardiac cycles due to intrinsic cardiac activity; and
delivering a polarization stabilization stimulation responsive to the
occurrence of the predetermined period of pacemaker inhibition.

Claims 1, 7, 10, and 13-19 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Nappholz et al. (US 5,184,615, issued February 9, 1993).
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ISSUES
The issues presented are:
Does the evidence of record support the Examiner’s finding that the
term “unpaced consecutive cycles having intrinsic activity” in independent
claims 1 and 13 includes cycles in which a pacemaker delivers a stimulus?
Does the evidence of record support the Examiner’s finding that the
term “period of pacemaker inhibition extending over multiple cardiac cycles
due to intrinsic cardiac activity” in independent claim 16 includes cycles in
which a pacemaker delivers a stimulus?
FINDINGS OF FACT
FF1. The Specification discloses “an implantable medical device
system designed to stabilize pacemaker electrode polarization signal drift”
(Spec. 4, ¶ 15).
FF2. The Specification discloses that “[i]n cases where pacing pulses
are applied on a frequent basis, the voltage at the electrode-tissue interface
remains comparatively constant or stable, with comparatively little drift” (id.
at 4, ¶ 16).
FF3. The Specification discloses that “[a]fter long periods of
inhibition, i.e., long periods in which no stimulation is applied, the drift is
often substantial, and the electrode-tissue interface is unstable” (id. at 5, ¶
16).
FF4. The Specification discloses that “[b]y counteracting drift after
long periods of inhibition, the invention reduces pace polarization artifacts”
(id. at 5, ¶ 18).
FF5. The Specification discloses that “Figure 6 is a flow chart
illustrating one embodiment of a process in which [the] IMD [implantable
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medical device] may be programmably configured to stabilize polarization
signal drift” (id. at 18, ¶ 66).
FF6. The Specification discloses that “IMD 10 operates to deliver
electrical pulses to heart 8 only when such pulses are needed. If no
stimulation is required, IMD 10 will enter an inhibition period 82 . . . [in
which] IMD 10 inhibits the production of stimulating pulses, and
polarization signal drift may occur” (id.).
FF7. The Specification discloses that the “more extensive the
inhibition period, the more drift is likely, and the larger the resulting pace
polarization artifact when stimulation resumes” (id.).
FF8. The Specification discloses that “[o]ne process for counteracting
drift . . . is to apply one or more pulses following a predetermined period of
inhibition. By altering the level of stored charge, the pulses stabilize the
electrode-tissue interface” (id. at 18-19, ¶ 67).
FF9. The Specification discloses “[o]ne embodiment of the invention
counts the number of cardiac cycles occurring with inhibition, i.e., without a
pacemaker-supplied pacing stimulus, and provides a pulse 86 on the Nth
cycle” (id. at 19, ¶ 68).
FF10. The Specification discloses that “[d]uring inhibition period 82,
IMD 10 determines 84 whether N inhibitions have occurred, i.e., whether N
cardiac cycles have taken place without stimulation . . . . If N cycles have
occurred, one or more pulses are applied and the counter resets 86” (id.).
FF11. Nappholz discloses an “antiarrhythmia pacemaker [that]
generates a stimulating pulse to a patient’s heart, [and] then measures and
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processes cardiac potential signals evoked by the stimulating pulse”
(Nappholz, col. 3, ll. 51-55).
FF12. Nappholz discloses that the ability to “reduce stimulation
polarization artifacts is desirable in a system which analyzes the evoked
potential because, in addition to generating a cardiac response, an electrical
stimulus gives rise to a form of noise called the stimulation polarization
artifact” (id. at col. 5, ll. 4-8).
FF13. Nappholz discloses that, in order to minimize “polarization
artifact at the pacing electrode, the pacemaker of the present invention
generates stimulating pulses using a technique known as charge balancing”
(id. at col. 5, ll. 22-26).
FF14. Nappholz discloses that “[p]acemaker 17 initiates the
polarization artifact reduction procedure . . . in the event of failure of three
consecutive generated pulses to evoke a cardiac response” (id. at col. 11, ll.
61-66).
PRINCIPLES OF LAW
During examination, the USPTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant's
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).

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ANALYSIS
Independent claims 1 and 13
Claim 1 is directed to a method comprising the steps of “sensing
intrinsic electrical activity of the heart; waiting for a plurality of unpaced
consecutive cycles having intrinsic activity . . . and delivering a polarization
stabilization stimulation responsive to the occurrence of the plurality of
unpaced consecutive cycles” (emphasis added).
The Examiner finds that “Nappholz discloses sensing intrinsic
electrical activity of the heart” (Ans. 3). The Examiner finds that “Nappholz
discloses that artifact reduction sub-procedures 151 and 155 may be initiated
following the detection of three consecutive cardiac cycles without an
evoked cardiac response” (id.). The Examiner finds that “[e]ven though a
[pacing] stimulus was provided, the cycles are ‘unpaced’ since capture was
never attained, and as such, the detected cardiac activity is inherently only
intrinsic in nature since the delivered pulse had no affect whatsoever on the
rhythm of the heart” (id. at 3-4). The Examiner finds that “Nappholz
discloses that these three cycles could be normal rhythm, fibrillation, or
tachycardia, all of which are intrinsic activity” (id. at 4). The Examiner
finds that “[a]s seen in figure 5 [of Nappholz], after this wait state 158, the
system initiates artifact reduction sub-procedures 151 and 155, which
coordinates the delivery . . . of a triphasic stimulus waveform designed to
eliminate or reduce the polarization artifact” (id. at 4).
Appellants argue, in relevant part, that the Examiner incorrectly
asserts that “‘waiting for a plurality of unpaced consecutive cycles as
required by the claims can be read on three successive cycles in which
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pacing pulses are delivered” (Reply Br. 5). Appellants argue that this is “an
instance of the Examiner creating a definition contrary to that well known in
the relevant art” (id.).
The Examiner responds that “the definition of ‘pacing’ is ‘to set the
rate of activity for.’ If the pacing pulses did not capture the heart, then the
heart is not being artificially paced, and, by ordinary definition, is unpaced”
(Ans. 5).
We agree with Appellants that the Examiner’s interpretation of the
term “unpaced consecutive cycles” as encompassing cycles in which pacing
pulses are generated, but capture of the heart is not detected, is not consistent
with the way one of ordinary skill would understand the term when read in
light of Appellants’ Specification. As discussed above, claim terms are
given their broadest reasonable meaning in view of any enlightenment
provided by the Specification. See Morris, 127 F.3d at 1054. The present
Specification does not expressly define the term “unpaced consecutive
cycles,” but discloses a procedure to stabilize pacemaker electrode
polarization signal drift that occurs after a period of inhibition - where
inhibition is equated with a period of time in which no stimulation is applied
by the pacemaker (FFs 3, 6). For example, the Specification discloses that
the pacemaker “counts the number of cardiac cycles occurring with
inhibition, i.e., without a pacemaker-supplied pacing stimulus, and provides
a pulse 86 on the Nth cycle” (FF 9). Given this disclosure, one of skill in the
art would not reasonably interpret the term “plurality of unpaced consecutive
cycles having intrinsic activity” to include a plurality of consecutive cycles
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in which pacemaker-generated pulses are delivered, whether or not capture
of the heart is detected.
Accordingly, the rejection of independent claim 1 and dependent
claims 7 and 10 as anticipated by Nappholz is reversed.
Independent claim 13 is similar to claim 1 and requires, among other
steps, “waiting for an occurrence of a defined number of unpaced
consecutive cycles having intrinsic activity . . . and delivering a polarization
stabilization stimulation responsive to the occurrence of the defined number
of unpaced consecutive cycles.” The Examiner relies on Nappholz for
disclosing these steps based on the same rationale as above, and we reverse
the rejection of independent claim 13 for the same reason discussed above.
Accordingly, the rejection of independent claim 13 and dependent
claims 14, and 15 as anticipated by Nappholz is reversed.
Independent Claim 16
Claim 16 is directed to a method comprising, among other steps,
“waiting for a predetermined period of pacemaker inhibition extending over
multiple cardiac cycles due to intrinsic cardiac activity; and delivering a
polarization stabilization stimulation responsive to the occurrence of the
predetermined period of pacemaker inhibition.”
The Examiner finds that Nappholz’s “pacemaker is inhibited from
delivering a polarization stabilization stimulation” (Ans. 6) “during the ‘a
failure of three consecutive generated pulses to evoke a cardiac response’”
(id.), and “the period during which the three unpaced cycles occurs is also
the ‘period of pacemaker inhibition.’” (Id.)
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Appellants contend that claim 16 requires “waiting for a
predetermined period of pacemaker inhibition extending over multiple
cardiac cycles due to intrinsic cardiac activity . . . [which] requires a
plurality of cycles during which pacing pulses are not delivered” (App. Br.
8). Appellants argue that the Examiner’s “argument with regard to
‘unpaced’ . . . is simply inapplicable to claims 16-19, if the term ‘inhibition’
means that pacing pulses are not delivered . . . [which] is exactly what it
does mean” (id.).
Again, the present Specification discloses that a “period of inhibition”
is a period in which no stimulation is applied by the pacemaker (FFs 3, 6).
That being the case, we agree with Appellants that the Examiner’s
interpretation of the term “period of pacemaker inhibition” as including a
period in which the pacemaker generates pulses is not consistent with the
way one of ordinary skill would understand the term when read in light of
Appellants’ Specification.
Accordingly, we reverse the rejection of independent claim 16 and
dependent claims 17-19 as being anticipated by Nappholz.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
the terms “unpaced consecutive cycles having intrinsic activity” and “period
of pacemaker inhibition extending over multiple cardiac cycles due to
intrinsic cardiac activity” encompass cycles in which a pacemaker-generated
stimulus is applied. Therefore, the evidence of record does not support the
Examiner’s finding that Nappholz anticipates the claimed invention.
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SUMMARY
The rejection of claims 1, 7, 10, and 13-19 under 35 U.S.C. § 102(b)
as anticipated by Nappholz is reversed.

REVERSED

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