Ex Parte Kim et al

Board of Patent Appeals and Interferences

Mar 30, 2012

11668627 (B.P.A.I. Mar. 30, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JAEHO KIM, JOSEPH M. BOCEK,
and DAN LI
__________

Appeal 2011-000581
Application 11/668,627
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-27, directed to a cardiac rhythm management device (CRM),
specifically, an implantable cardioverter/defibrillator (ICD). The claims
have been rejected as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b).
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BACKGROUND
Tachyarrhythmias are abnormal heart rhythms characterized by a
rapid heart rate, and generally include ventricular tachyarrhythmia and
supraventricular tachyarrhythmia (Spec. 1: 11-13). Supraventricular
tachyarrhythmias (SVTs) “are arrhythmias which either originate from the
upper chambers of the heart (atria) or involve electrical pathways that
connect the upper and lower chambers of the heart.”
1
In other words, SVTs
are non-ventricular in origin.
“Ventricular cardioversion and defibrillation are used to terminate
most ventricular tachyarrhythmias” (id. at 1: 30-31), but “ventricular anti-
tachycardia pacing therapy is generally ineffective in terminating an atrial
tachyarrhythmia” (id. at 2:11-13). “Additionally, the delivery of each
cardioversion/defibrillation pulse consumes a considerable amount of power
and results in patient discomfort owing to the high voltage of the shock
pulses” (id. at. 2: 13-15).
The Specification discloses:
[A]n ICD that delivers atrial pacing prior to delivering
ventricular anti- tachyarrhythmia if atrial arrhythmia is
indicated after a tachyarrhythmia is detected when a ventricular
electrogram indicates a fast ventricular rate. A tachyarrhythmia
is detected, for example, when the ventricular rate falls within a
predetermined rate zone defined by one or more
tachyarrhythmia detection thresholds [e.g., the VT zone or the
VF zone]. During and/or following the detection, the
tachyarrhythmia is classified to determine the necessity and
type of a therapy. Because ventricular tachyarrhythmia can be
fatal without immediate treatment, the classification process
helps ensure that a necessary ventricular therapy is not

1
http://www.heartbeatmd.com/svt.htm (accessed March 26, 2012).
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inappropriately delayed or withheld. On the other hand,
because a ventricular therapy such as ventricular defibrillation
causes significant pain in the patient and shortens the life
expectancy of the ICD, it is also desirable to avoid ineffective
and/or unnecessary delivery of the ventricular therapy. For
example, it has been observed that after a tachyarrhythmia is
detected based on ventricular rate and classified as an atrial
tachyarrhythmia such as atrial fibrillation (AF) or atrial flutter
(AFL), rhythm and waveform characteristics known to be
associated with VT may be temporarily present in the
ventricular electrocardiogram, leading to an inaccurate VT
classification. A subsequent ventricular therapy would be
neither necessary nor effective in treating the atrial
tachyarrhythmia. The present implantable CRM device delivers
atrial pacing after a tachyarrhythmia is detected to avoid such
unnecessary, ineffective, and painful ventricular therapy if one
or more indications for an atrial tachyarrhythmia are present.
(Id. at 5: 29 - 6: l. 19.)

STATEMENT OF THE CASE
Claims 1-27 are pending and on appeal. Appellants do not present
separate arguments for the claims, therefore, we select claim 1 as
representative of the subject matter on appeal, as provided by 37 C.F.R. §
41.37(c)(1)(vii). Claim 1 reads as follows (emphases added):
1. An implantable cardioverter/defibrillator (ICD), comprising:
a pacing circuit to deliver atrial and ventricular pacing pulses;
a defibrillation circuit to deliver ventricular defibrillation pulses;
a cardiac sensing circuit to sense cardiac signals;
a rate detector to detect an atrial rate and a ventricular rate using the
cardiac signals;
a tachyarrhythmia detection and classification circuit coupled to the
rate detector, the tachyarrhythmia detection and classification circuit
including:
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a tachyarrhythmia detector to detect tachyarrhythmia using
the ventricular rate and one or more tachyarrhythmia threshold
rates; and
a tachyarrhythmia classifier to classify the detected
tachyarrhythmia and detect one or more indications for one or more
types of tachyarrhythmia; and
a pacing controller, coupled to the pacing circuit, defibrillation circuit,
and the tachyarrhythmia detection and classification circuit, to control the
delivery of the atrial and ventricular pacing pulses, the pacing controller
including an atrial pacing initiator adapted to initiate the delivery of the
atrial pacing pulses in a selected atrial pacing mode during the detected
tachyarrhythmia if the detected tachyarrhythmia is classified as
ventricular tachyarrhythmia and one or more indications for atrial
tachyarrhythmia are detected.
Claims 1-27 stand rejected under 35 U.S.C. § 102(b) as unpatentable
over Kim et al. (US 2005/0149125 A1, published July 7, 2005).
We affirm.
ISSUE
Does the evidence of record support the Examiner‟s finding that
Kim‟s ICD is configured to detect a tachyarrhythmia, and to classify the
detected tachyarrhythmia, and to administer atrial anti- tachyarrhythmia
pacing if the tachyarrhythmia is classified as a ventricular tachyarrhythmia,
but indicators of atrial tachyarrhythmia are also present?
FINDINGS OF FACT
Kim teaches that ventricular tachyarrhythmia (VT) “can be detected
when the ventricular rate falls within the VT zone” (Kim ¶ 5), i.e., a zone
defined by a predetermined number of beats per minute.
Kim further teaches that “[a] rapid ventricular rate in the VT zone,
however, is not necessarily due to VT but can also result from a tachycardia
that originates from „above‟ the ventricles. Such tachyarrhythmias are
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referred to as supraventricular tachycardias (SVTs) and include . . . atrial
tachyarrhythmias” (id.). “An abnormal rhythm in the atria . . . can be
transmitted ante-gradely to the ventricles . . . [and] is characterized by
elevated rates in both the atria and the ventricles” (id.), but “[e]levated rates
in both the atria and ventricles can also occur with VT as well, . . . due to
retrograde conduction of excitation from the ventricles to the atria” (id.).
According to Kim “retrograde conduction is possible in most people
and confounds the discrimination between VT and SVT based upon atrial
and ventricular rates alone when both rates are similar” (id.).
Kim teaches that:
Ventricular . . . therapy delivered to treat an SVT will not be
effective and potentially could make matters worse by
triggering a ventricular arrhythmia . . . It is thus important for
an ICD to recognize than an elevated ventricular rate is due to
an SVT rather than a VT so that ventricular . . . therapy and
specific therapy for the atrial tachyarrhythmia can be delivered
if appropriate. Conversely, because VT is generally a more
serious condition, the ICD also needs to detect VT with a high
degree of sensitivity so that therapy can be delivered promptly.
(Id.)
The Examiner‟s fact findings regarding Kim are set forth on pages 3-5
of the Answer, and we adopt them as our own, with particular emphasis on
the Examiner‟s findings regarding paragraph 28 of Kim, which we
reproduce below:
When the measured atrial and/or ventricular rates exceed
specified threshold values, the device detects an arrhythmia and
is programmed to respond with appropriate therapy. For
example, if a ventricular rate is measured which is in the VT
zone, the device decides whether VT or an SVT is present using
the rate and [ECG] morphology criteria . . . If the ventricular
rate is greater than the atrial rate, VT is detected, and the device
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may be programmed to initiate ventricular anti-tachycardia
pacing or a ventricular shock. If the atrial rate is greater than or
equal to the ventricular rate and a specified minimum number
of normally conducted beats are detected, an SVT is detected,
and, if the SVT is classified as an atrial tachyarrhythmia, the
device may be programed to deliver atrial anti-tachycardia
pacing or an atrial cardioversion shock. Rate stability,
suddenness of onset, and/or atrial rate criteria can also be used
as additional criteria to classify the arrhythmia as atrial in origin
when the ventricular rate is in the VT zone.
(Kim ¶ 28.)
DISCUSSION
Appellants contend that “claim 1 clearly distinguishes between (1)
detecting a tachyarrhythmia and (2) then classifying the „detected
tachyarrhythmia.‟ . . . [but] “the Examiner‟s . . . interpretation conflates the
two” (Reply Br. 3). Appellants contend that “Kim first detects a
tachyarrhythmia, by measuring a ventricular rate which is in the VT zone,
and only then classifies the tachyarrhythmia, that is „decides whether a VT
or SVT is present‟” (id. at 4; Cf. Appellants‟ claim 1, which requires a
“tachyarrhythmia detection and classification circuit including: a
tachyarrhythmia detector to detect tachyarrhythmia . . .; and a
tachyarrhythmia classifer to classify the detected tachyarrhythmia”).
Appellants contend that “the Examiner‟s interpretation conflating detecting
and classifying impermissibly renders the separately recited „classifying‟
meaningless” (id. at 3).
Appellants contend “the express language of claim 1 requires the
tachyarrhythmia to be separately detected by the tachyarrhythmia detector
and classified by the tachyarrhythmia classifier” (id). “Consequently, it is
improper to consider the limitation „classified as a ventricular
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tachyarrhythmia‟ . . . to require only „the identification of the ventricular rate
within the VT zone‟ at least because the tachyarrhythmia is classified by the
tachyarrhythmia classifier rather than the tachyarrhythmia detector alone”
(id. at 5).
Essentially, Appellants contend that Kim detects a ventricular
tachyarrhythmia, and subsequently classifies it as ventricular in origin, in
which case ventricular therapy is applied, or classifies it as supraventricular
in origin, in which case atrial therapy is applied, whereas the claims require
detecting a tachyarrhythmia, then classifying it, and applying atrial therapy
if the detected tachyarrhythmia is classified as ventricular, if one or more
indications for atrial tachyarrhythmia are also present.
Appellants‟ argument is not persuasive. Kim‟s ICD determines
whether a detected putative ventricular tachyarrhythmia is ventricular or
atrial in origin, based on whether indicators for atrial tachyarrhythmia are
also detected (i.e., atrial rate versus ventricular rate, morphology criteria,
etc.). For example, if the ICD detects a ventricular tachyarrhythmia, but the
atrial rate is faster than the ventricular rate, the tachyarrhythmia is, in Kim‟s
words, “classified” as atrial in origin (i.e., supraventricular or non-
ventricular in origin) - that is, it is not a true ventricular tachyarrhythmia. In
that case, Kim‟s ICD is adapted to deliver atrial anti- tachyarrhythmia
pacing or an atrial cardioversion shock, instead of the more extreme and
unnecessary ventricular anti- tachyarrhythmia pacing or ventricular
cardioversion shock.
While Kim classifies a detected ventricular tachyarrhythmia as
supraventricular (which triggers atrial therapy), we are persuaded that any
difference between the ICD as claimed and Kim‟s ICD is merely semantic.
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That is, we see no actual difference between Kim‟s triggering atrial anti-
tachyarrhythmia pacing based on detecting a putative ventricular
tachyarrhythmia, and subsequently classifying the detected ventricular
tachyarrhythmia as an SVT of atrial origin, and triggering atrial anti-
tachyarrhythmia pacing based on detecting a tachyarrhythmia and
subsequently classifying the tachyarrhythmia as a ventricular
tachyarrhythmia accompanied by “indications for atrial tachyarrhythmia,” as
required by the claims.
That is, Kim‟s classification of the detected putative ventricular
tachyarrhythmia as atrial in origin, i.e., as a supraventricular
tachyarrhythmia (one that is other than ventricular in origin) is predicated on
an underlying detection of a tachyarrhythmia with a ventricular rate in the
VT zone, coupled with an indication that the origin of the tachyarrhythmia is
not a true ventricular tachyarrhythmia, but is actually atrial in origin (e.g., if
the measured atrial rate is greater than the ventricular rate). Thus Kim does
disclose separate detection and classification steps as required by the claims,
but Kim‟s classification step takes the presence of “indications for atrial
tachyarrhythmia” into account in classifying the putative ventricular event as
an atrial SVT, i.e., not a true ventricular tachyarrhythmia.
SUMMARY
The rejection of claims 1-27 as anticipated by Kim is affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED
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