Ex Parte Sih et al

Board of Patent Appeals and Interferences

Feb 26, 2009

10377257 (B.P.A.I. Feb. 26, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HARIS J. SIH, SCOTT A. MEYER,
and PAUL A. HAEFNER
__________

Appeal 2008-21211
Application 10/377,257
Technology Center 3700
__________

Decided:2 February 26, 2009
__________

Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL

1 The real party in interest is Cardiac Pacemakers, Inc.
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2008-2121
Application 10/377,257

This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-41, 59, and 60. We have jurisdiction under 35 U.S.C. § 6(b).

BACKGROUND
Tachyarrhythmia is an abnormally fast heart rate originating in the
atria or the ventricles. “Tachycardia is a term generally used to describe
cardiac rhythms that are rapid, but relatively organized. Conversely,
fibrillation is characterized by rapid, chaotic, and disorganized heart
rhythms.” (Spec. 1: 16-20).
“Cardiac rhythm management systems may include both a pacemaker
and . . . [a]n implantable cardioverter/defibrillator (ICD) . . . [which]
monitors cardiac activity and delivers high energy electrical stimulation to
the heart to interrupt a tachycardia or fibrillation condition . . . [and]
terminate the diagnosed arrhythmia” (id. at 2: 10-18).
“[I]t is desirable to reduce the energy of the electrical stimulation for
treating arrhythmias, particularly chronic atrial arrhythmias” (id. at 2: 26-
27), because “the patient is typically conscious and can feel the electrical
stimulation applied to the heart” (id. at 2: 25-26). “Using lower energy
stimulation to terminate the arrhythmia may be more comfortable for the
patient and [may also] extend the battery life of the ICD” (id. at 15: 5-6).
According to the Specification, “[p]acing an arrhythmic heart
chamber prior to the delivery of cardioversion/defibrillation shock . . . can be
used to organize the electrical cardiac activity so that lower . . . energy may
be used to terminate the tachyarrhythmia” (id. at 6: 10-14).
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The present invention is directed to “a method for providing cardiac
therapy to the heart. Pace pulses are delivered to an atrium during a
tachyarrhythmic episode. Capture of the atrium . . . is detected[,] [and]
[c]ardioversion/defibrillation stimulation is delivered to the atrium
responsive to the detection of capture” (id. at 3: 7-12).
STATEMENT OF THE CASE
Claims 1-41, 59, and 60 are pending and on appeal. Claims 1, 19, and
21 are representative of the subject matter on appeal:
1. A method for providing cardiac therapy, comprising:
delivering pace pulses to an atrium of a heart during a tachyarrhythmia
episode:
detecting capture of the atrium associated with at least one of the pace
pulses; and
delivering cardioversion/defibrillation stimulation to the atrium
responsive to the detection of capture.

19. A method for providing tachyarrhythmia therapy to a heart, comprising:
delivering pace pulses to the heart during a tachyarrhythmia episode:
detecting capture of the heart associated with at least one of the pace
pulses; and
delivering cardioversion/defibrillation stimulation responsive to the
detection of capture.

21. The method of claim 19, wherein:
delivering the pace pulses to the heart comprises delivering the pace
pulses to a ventricle; and
delivering the cardioversion/defibrillation stimulation to the ventricle.

The Examiner relies on the following evidence:
Pendekanti et al. US 6,085,116 Jul. 4, 2000
Pendekanti et al. US 6,154,672 Nov. 28, 2000

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The Examiner rejected the claims as follows:
I. Claims 1-20, 22-41, 59, and 60 under 35 U.S.C. § 102(b) as
anticipated by Pendekanti '116.

II. Claims 19-35, 41, and 60 under 35 U.S.C. § 102(b) as anticipated by
Pendekanti '672.

We reverse.
ANTICIPATION I
The Issue
The issue raised by this rejection is whether the Examiner has
provided an adequate factual basis to support the conclusion that Pendekanti
'116 discloses a method of providing cardiac therapy comprising delivering
cardioversion/defibrillation stimulation to an atrium of the heart in response
to detection of capture of the atrium.
Findings of Fact
FF1 The Examiner rejected claims 1-20, 22-41, 59, and 60 under 35
U.S.C. § 102(b) as anticipated by Pendekanti '116.
FF2 Appellants claim a method for providing cardiac therapy,
comprising delivering pace pulses to the atrium of the heart during a
tachyarrhythmia episode, detecting capture of the atrium, and delivering
cardioversion/defibrillation stimulation to the atrium in response to the
detection of capture.
FF3 According to the Specification, “[w]hen a pace pulse produces a
contractile response in heart tissue, the contractile response is typically
referred to as capture, and the electrical cardiac signal corresponding to
capture is denoted the evoked response” (Spec. 2: 4-9). “Detection of the
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evoked response may be used to verify . . . capture of the heart tissue” (id. at
2: 8-9). “When capture occurs consistently, the heart chamber is said to be
entrained by the pace pulses” (id. at 7: 7-8).
FF4 Pendekanti '116 describes “a method for terminating atrial
fibrillation . . . in which multisite pacing is conducted in a synchronous
manner . . . as an equal-interval train of pulses delivered at a predetermined
coupling interval” (Pendekanti '116, col. 4, ll. 16-21). “This pacing regimen
brings large regions of fibrillating atrial tissue into phase-lock . . . Once
phase-lock is obtained via such asynchronous multisite pacing, an atrial
defibrillation shock is delivered . . . to terminate atrial fibrillation” (id. at col.
4, ll. 23-27).
FF5 Pendekanti '116 describes another “method for terminating
atrial fibrillation . . . in which multisite pacing is conducted in an
asynchronous manner, whereby the pacing is delivered concurrently to
different local sites of the atrium . . . to procure local captures via localized
pacing therapies” (Pendekanti '116, col. 4, l. 67 to col. 5, l. 5). “This pacing
regimen also brings large regions of fibrillating atrial tissue into phase-lock
. . . Once phase-lock is obtained via such asynchronous multisite pacing, an
atrial defibrillation shock is delivered . . . to terminate atrial fibrillation” (id.
at col. 5, ll. 9-14). “In a further optional embodiment involving the
asynchronous pacing regimen, once local phase-lock is achieved, regional
capture methods can be performed using a synchronized pacing regimen . . .
to maximize the capture area” (id. at col. 5, ll. 23-28).
FF6 According to Pendekanti '116,
Capture: means pacing of the atria from one or more sites
where each pacing stimulus results in a repeatable activation
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pattern of the entire atrium. The wavefronts originate at the
pacing electrodes and the phase relationship between the pacing
stimulus and the activation of each section of the atrial tissue
remains constant throughout the pacing event.
* * *
Phase-locking: [means] pacing of the atrium from one or more
sites which results in wavefronts that appear to be constant in
phase with the pacing stimulus but where there does not appear
to be a cause and effect relationship. That is, the wavefronts do
not appear to originate at the pacing sites and small changes in
phase between the pacing stimulus and the activation of each
section of a region occur over time.

(Pendekanti '116, col. 5, l. 53 to col. 6, l. 12.)
FF7 Pendekanti '116 stipulates: “As a qualification, where
EGM [electrogram] data on the atrium is limited, it is often difficult to
differentiate between phase-locking and capture, as defined herein,
and, for those cases, phase-locking terminology is used herein to refer
to both capture and phase-locking” (Pendekanti '116, col. 6, ll. 12-17).
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
The Examiner’s rejections must be supported by a preponderance of
the evidence. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed.
Cir. 1988).
The Patent Office has the initial duty of supplying the factual
basis for its rejection. It may not, because it may doubt that the
invention is patentable, resort to speculation, unfounded
assumptions or hindsight reconstruction to supply deficiencies
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in its factual basis. To the extent the Patent Office rulings are
so supported, there is no basis for resolving doubts against their
correctness. Likewise, we may not resolve doubts in favor of
the Patent Office determination when there are deficiencies in
the record as to the necessary factual bases supporting its legal
conclusion . . . .

In re Warner, 379 F.2d 1011, 1017 (CCPA 1967)(emphasis added). Warner
concerned the factual basis of an obviousness rejection, but its central
premise is equally appropriate here.
Analysis and Conclusion of Law
Appellants contend that Pendekanti ´116 does not disclose delivering
a defibrillation stimulation to the atrium in response to detecting capture of
the atrium, but “only teaches delivering the defibrillation stimulation ‘once
phase-lock is obtained.’” (App. Br. 8.) Appellants contend that “Pendekanti
´116 clearly teaches that phase locking and capture are different
mechanisms” (id. at 8-9), and “only uses the term phase locking to refer to
capture or phase locking when these mechanisms cannot be differentiated”
(id. at 9). Appellants contend “if capture cannot be differentiated from
phase locking, then capture cannot be detected” (id.), thus Pendekanti ´116
does not disclose “that the defibrillation stimulation is delivered responsive
to the detection of capture” (id. at 8).
The Examiner acknowledges that Pendekanti ´116 discloses
delivering a defibrillation shock “‘once local phase-lock is obtained’” (Ans.
9), but concludes that Pendekanti ´116 actually “discloses delivering
defibrillation stimulation responsive to the detection of capture” (id. at 10).
The Examiner concedes that “the definitions for capture and phase-lock
disclosed by Pendekanti ´116 differ slightly” (id. at 9), but reasons that
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Pendekanti ´116 “discloses pacing with the intention of evoking capture of
the heart” and “discloses performing regional capture measures and
coordinating pulsing regimens in neighboring captured regions of the heart
to maximize the capture area” (id. at 9), thus, “it is apparent that the terms
capture and phase-lock are used interchangeably” by Pendekanti ´116 (id.).
The Examiner’s conclusion is not supported by a preponderance of the
evidence. Pendekanti ´116 explicitly differentiates between phase-locking
and capture (FF6), and teaches that the defibrillation stimulation is delivered
“[o]nce phase-lock is obtained” (FF4, 5). It may be that Pendekanti ´116
delivers pacing pulses with the intent of evoking local capture, and it may
also be that the pacing pulses sometimes invoke capture, but there is nothing
in the reference to indicate that Pendekanti ´116 detects capture and delivers
the defibrillation stimulation in response. Indeed, Pendekanti ´116 teaches
that there may be times when capture occurs in response to the pacing
pulses, but the available EGM data is insufficient to differentiate it from
phase-lock - i.e., the data is insufficient to detect it (FF7). In such cases, the
term phase-lock is used to cover both capture and phase lock, but it does not
change the fact that the defibrillation stimulation is delivered “[o]nce phase-
lock is obtained” (FF4, 5), i.e., in response to phase-lock, not in response to
detection of capture.
The Examiner has not provided an adequate factual basis to support
the conclusion that Pendekanti '116 discloses a method of providing cardiac
therapy comprising delivering cardioversion/defibrillation stimulation to an
atrium of the heart in response to detection of capture of the atrium.
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ANTICIPATION II
The Issue
The issue raised by this rejection is whether the Examiner has
provided an adequate factual basis to support the conclusion that Pendekanti
'672 discloses a method of providing cardiac therapy comprising delivering
cardioversion/defibrillation stimulation to the heart, in response to detection
of capture of the heart tissue.
Findings of Fact
FF8 The Examiner rejected claims 19-35, 41, and 60 under 35
U.S.C. § 102(b) as anticipated by Pendekanti '672.
FF9 Appellants claim a method for providing cardiac therapy,
comprising delivering pace pulses to heart tissues, including a ventricle,
during a tachyarrhythmia episode, detecting capture of the heart tissue, and
delivering cardioversion/defibrillation stimulation to the heart in response to
the detection of capture.
FF10 Pendekanti '672 teaches that
[A] defibrillation shock has a greatly increased probability of
success if a substantial majority of the tissue in the low gradient
region is in the process of activation by fibrillatory wavefronts
or is about to be depolarized.

(Pendekanti '672, col. 5, ll. 8-18.)

FF11 Pendekanti '672 discloses two different methods of treating
ventricular arrhythmias, one active and one passive. Both of the methods
“reduce ventricular defibrillation threshold (VDFT) energy requirements
and/or increase the probability of a successful outcome when the
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defibrillation shock is delivered at a given energy level” (Pendekanti '672,
col. 4, ll. 43-47).
FF12 In the active method, pace pulsing trains are delivered to a
fibrillating ventricle “to capture the tissue” (Pendekanti '672, col. 4, l. 56).
“Once capture of a substantial extent of the tissue of the low gradient region
is achieved via pacing, a high energy defibrillation shock is delivered in a
timed manner” (id. at col. 4, ll. 56-58). Specifically, the defibrillation shock
is delivered when “a substantial majority of the tissue in the low gradient
region is in the process of activation by the fibrillatory wavefronts or is
about to be depolarized” (id. at col. 5, ll. 9-11 (emphasis added)). As
Pendekanti '672 explains:
When pacing is used to achieve regional capture in the low
gradient region, . . . the timing of the defibrillation shock will be
caused to occur during either one of the above-mentioned
electrophysiological periods by delivering the shock after the
last pulse at an interval of about 80-95% of the pacing rate or
about 5-20% of the pacing rate respectively.

(Pendekanti '672, col. 5, ll. 18-24 (emphasis added).)
FF13 In the alternative, passive method, no pace pulses are delivered
at all, so the ventricle is not captured before the defibrillation shock is
delivered. As Pendekanti '672 explains:
[R]eal time sensing . . . is used to generate ventricular
electrogram (EGM) information from one or more sensing sites
in the low gradient region, and when the sensed data indicates a
substantial extent of tissue is simultaneously in the process of
activation or is about to depolarized, then the defibrillation
shock is immediately delivered. This alternative mode of therapy
involves “passive-timing” in the sense that no intervention effort
is made to disturb the natural electrophysiological state of the
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heart with external electrical stimuli until one of several
opportunistic electrophysiological states are detected as
occurring in the myocardial tissues of the low gradient region.

(Pendekanti '672, col. 5, ll. 35-47 (emphasis added).)
Analysis and Conclusion of Law
The Examiner notes that “Pendekanti '672 discloses that once capture
is achieved by . . . pacing pulses, a high energy defibrillation shock is
delivered” (Ans. 10). The Examiner asserts “[i]n order to determine[ ] if
capture is achieved, it is inherent that capture must be detected, otherwise it
is impossible to make this determination” (id.).
However, even if we assume for the sake of argument that Pendekanti
'672 actually detects capture of the ventricle, the issue here is whether the
Examiner has established that Pendekanti '672 delivers the defibrillation
shock in response to detection of capture.
Appellants contend that Pendekanti '672 times defibrillation “to
certain electrophysiological events related to the fibrillation wavefronts”
(App. Br. 13), specifically, “after the last pulse has been delivered” (id.),
“when a substantial majority of the tissue in the low gradient region is in the
process of activation by fibrillatory wave fronts or is about to be
depolarized” (id. at 13-14). Appellants contend that “[f]ibrillatory
wavefronts are intrinsic activations and are thus unrelated to capture via
pacing” (id. at 14).
Appellants’ contentions are consistent with the evidence of record.
As discussed above, Pendekanti '672 teaches that pacing pulses are not
administered in the passive method of treating ventricular fibrillation
(FF13). It follows then that capture via pacing cannot be achieved or
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detected in the passive method. Nevertheless, Pendekanti '672 teaches that
the defibrillation shock is timed to the same electrophysiological events (i.e.,
when most of the tissue is in the process of activation or is about to
depolarized) in both the passive method and the active method (FF12, 13).
Therefore, we agree with Appellants that Pendekanti '672 “does not teach
defibrillation responsive to capture detection” (App. Br. 13), as required by
the claims.
The Examiner has not provided an adequate factual basis to support
the conclusion that Pendekanti '672 discloses a method of providing cardiac
therapy comprising delivering cardioversion/defibrillation stimulation to the
heart, in response to detection of capture of the heart tissue.
SUMMARY
We reverse the rejection of claims 1-20, 22-41, 59, and 60 under 35
U.S.C. § 102(b) as anticipated by Pendekanti '116, and the rejection of
claims 19-35, 41, and 60 under 35 U.S.C. § 102(b) as anticipated by
Pendekanti '672.
REVERSED

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