Ex Parte Armoundas et al

Patent Trial and Appeal Board

Aug 8, 2017

13509390 (P.T.A.B. Aug. 8, 2017)

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.
13/509,390 08/29/2012 Antonis Armoundas 125141.00489 1900
26710 7590
QUARLES & BRADY LLP
Attn: IP Docket
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
PATTON, AMANDA K
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/10/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTONIS ARMOUNDAS and ERIC WEISS
Appeal 2016-006425
Application 13/509,390
Technology Center 3700
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
for preemptively suppressing a heart rhythm disturbance in a patient’s heart.
The Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“Arrhythmias such as ventricular tachycardia and fibrillation are often
caused by an electrical mechanism called reentry ... A major factor leading
to the genesis of ventricular fibrillation during ischemia is dispersion of
refractoriness” (Spec. | 6). “An important mechanism for enhancing
1 Appellants do not identify the Real Party in Interest.
Appeal 2016-006425
Application 13/509,390
dispersion of refractory period is alternation of the action potential from beat
to beat” (id. 17).
“Action potential altemans involves an alternating sequence in which
the shape of the action potential” “creates a situation in which a region of the
myocardium has a long refractory period on an every other beat basis” (id.
1 8). “Thus, action potential altemans, which generally occurs in diseased
tissue, can promote the development of reentry” (id.). “A reentrant
waveform can be terminated by electrical pacing that is initiated within a
specific period during reentrant excitation. This process gives rise to a new
wave whose front collides with and annihilates the reentrant wave” (id.
115). “Thus, it would be highly desirable to be able to prevent arrhythmias
from starting rather than terminating them after their initiation by
administration of an electrical shock” (id. 116).
The Claims
Claims 1—5 and 7—21 are on appeal. Claim 1 is representative and
reads as follows:
1. A method for preemptively suppressing a heart rhythm
disturbance in a patient’s heart with an implanted device
configured to generate electrical impulses, the steps of the
method comprising:
a) detecting cardiac electrical signals from the patient’s
heart;
b) measuring a beat-to-beat variability in the detected
cardiac electrical signals and estimating at least one
repolarization altemans parameter therefrom;
c) determining a severity and likelihood of an imminent
heart rhythm disturbance occurrence by comparing the at least
one repolarization altemans parameter to a dynamically
determined threshold value that is adaptively changed based on
a noise level in the detected cardiac electrical signals, wherein
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the severity and likelihood of an imminent heart rhythm
disturbance occurrence is characterized by a dynamically
changing level of repolarization altemans in the detected
cardiac electrical signals;
d) calibrating an electrical therapy plan using the
determined severity and likelihood of the imminent heart
rhythm disturbance occurrence; and
e) delivering appropriately calibrated electrical impulses
to the patient’s heart with the implanted device using the
calibrated electrical therapy plan in order to preemptively
suppress the severity and likelihood of the imminent heart
rhythm disturbance occurrence.
The Issues
A. The Examiner rejected claims 1—5 and 10-20 under 35 U.S.C.
§ 103(a) as obvious over Armoundas,2 Farazi,3 Christini,4 and
Krishnamachari5 (Ans. 2—5).
B. The Examiner rejected claims 7 and 21 under 35 U.S.C. § 103(a) as
obvious over Christini and Zhu6 (Ans. 5—7).
C. The Examiner rejected claims 8 and 9 under 35 U.S.C. § 103(a) as
obvious over Christini, Zhu, and Sharma7 (Ans. 8—9).
2 Armoundas et al., US 2007/0191890 Al, published Aug. 16, 2007.
3 Farazi, US 7,756,571 Bl, issued July 13, 2010.
4 Christini et al., US 6,915,156, issued July 5, 2005.
5 Krishnamachari, US 6,453,191 B2, issued Sept. 17, 2002.
6 Zhu et al., US 7,245,970 B2, issued July 17, 2007.
7 Sharma et al., US 2011/0105929 Al, published May 5, 2011.
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A. 35 U.S.C. § 103(a) over Armoundas, Farazi, Christini, and
Krishnamachari
The Examiner finds:
Armoundas discloses a method for preemptively suppressing a
heart rhythm disturbance in a patient’s heart with an implanted
device configured to generate electrical impulses, the steps of
the method comprising: a) detecting cardiac electrical signals
from the patient’s heart; b) measuring a beat-to-beat variability
in the detected cardiac electrical signals; c) determining a
severity and likelihood of an imminent heart rhythm
disturbance occurrence by comparing the measured beat-to-beat
variability to a threshold value; d) calibrating an electrical
therapy plan using the determined severity and likelihood of the
imminent heart rhythm disturbance occurrence; and e)
delivering appropriately calibrated electrical impulses to the
patient’s heart with the implanted device using the calibrated
electrical therapy plan in order to preemptively suppress the
severity and likelihood of the imminent heart rhythm
disturbance occurrence.
(Ans. 2—3). The Examiner finds “Farazi discloses a degree of altemans
utilized as an index for impending ventricular arrhythmia and a dynamic
threshold for said index . . . Christini discloses dynamic thresholds in
general” {id. at 3). The Examiner finds it obvious to “modify Armoundas to
include an alteman index and dynamic thresholding associated with t[he]
index, as taught by Christini and Farazi, in order to assess the level of risk
for an impending ventricular arrhythmia” (id.).
The Examiner acknowledges “Armoundas fails to explicitly disclose
the dynamically determined threshold value is adaptively changed based on
a noise level in the detected cardiac electrical signals” (id.).
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Application 13/509,390
The Examiner finds Krishnamachari teaches
a similar method for detecting altemans which incorporates a
dynamic threshold dependent on random noise with a noise
threshold. Further, it is disclosed that the voltage threshold is
1.8 microvolts and the noise threshold is 1.9 microvolts with
application of a scale factor to the altemans noise value for a
more effective voltage threshold value.
(Ans. 3^4; emphasis omitted).
The Examiner finds it obvious “to modify Armoundas to explicitly
include a scaling factor incorporating compensation for a noise threshold, as
taught by Krishnamachari, in order to effectively set the dynamic voltage
threshold for alteman detection by adaptively taking into account noise in
the cardiac electrical signals” {id. at 4; emphasis omitted).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the prior art suggests
“comparing the at least one repolarization altemans parameter to a
dynamically determined threshold value that is adaptively changed based on
a noise level in the detected cardiac electrical signals” as required by claim
1?
Findings of Fact
1. The Specification teaches:
Because the amplitude of random noise has a significant
effect on the altemans voltage, noise, and K-score estimation,
the altemans voltage, noise, and K-score threshold values are
considered as functions of random noise levels. This allows for
a more accurate assessment of repolarization altemans in the
presence of significant random noise.
(Spec. 1 88).
2. The Specification teaches an example where
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a new altemans voltage threshold can be formed as a function
of altemans noise for any value of random noise using an
adapted version of Eqn. (3). For example, for random noise
values of five microvolts, and for altemans noise of 1.8
microvolts, the corresponding altemans voltage threshold is
20.29 microvolts.
(Spec. 177).
3. Armoundas teaches:
In a method in accordance with the present invention, the level
of repolarization altemans can be quantified by means well
known in the art, such as measurement of the altemans voltage
and measurement of the altemans ratio in one or more
electrocardiographic leads. Threshold values of these
parameters can be established such as 1.9 microvolts for the
altemans voltage and a value of 3.0 for the altemans ratio.
When the level of repolarization altemans exceeds a threshold
value over some period of time (such as one minute) therapy is
delivered to suppress the repolarization altemans and thus
reduce the likelihood that a heart rhythm disturbance will occur.
Repolarization altemans can be reliably estimated by analysis
of approximately 128 beats. Thus, in about a minute or so
(assuming a rate of 105-110 beats/min) the number of beats
needed in the estimation will have been detected and/or
recorded. As previously defined, repolarization altemans as
used herein includes any change in the morphology of the T-
wave or ST segment of the electrocardiogram on occurring on
an every other beat basis. In other embodiments, the beat-to-
beat variability in the cardiac electrical activity that is measured
is heart rate variability.
(Armoundas 139).
4. Armoundas teaches “a threshold value of heart variability may
be established, such as the Standard Deviation of Normal to Normal RR
intervals measure of heart rate variability being equal to 60 milliseconds”
(Armoundas 139).
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5. Farazi teaches: “It is also possible to have multiple thresholds
such that in addition to determining whether T-wave altemans are present,
changes in magnitudes of alternations can be determined. This can be used,
e.g., to determine a degree of the T-wave altemans” (Farazi 13:13—17).
6. Farazi teaches:
at least one metric is measured of T-waves in a predetermined
number of beats (e.g., 2 to 10 beats) that follow each of the
detected intrinsic premature contractions of the ventricles. The
metric measured at step 304 can be, e.g., T-wave amplitude, T-
wave slope, T-wave area, T-wave width, T-wave timing, T-
wave morphology, QT interval, evoked QT interval, T-wave
positive/negative slopes and durations, etc.
(Farazi 11:40-47).
7. Christini teaches:
If the sign is not consistent, as tested at step 160, then the
amplitude of additional beats in a series of heart beats is again
detected, as indicated by the arrow looping back to step 110.
The heart beat processing is then repeated to dynamically
define an electrical stimulus or stimuli to selectively apply
through one or more electrodes. Only if the sign is consistent,
however, is the electrical stimulus/stimuli delivered to the
patient.
(Christini 6:53—60).
8. Krishnamachari teaches:
The ECG system 1020 may obtain thirty-two signals
from the fourteen leads . . . These thirty-two signals may be
used by the ECG system 1020 to produce a set of low-noise
ECG signals (e.g., VI, V2, V3, V4, V5, and V6). The ECG
system 1020 then may use the set of low-noise ECG signals to
produce low noise vector signals (VM, X, Y, Z) using, for
example, a vector enhancement technique. In some instances,
the ECG system 1020 may produce other combinations of low-
noise ECG signals. The ECG system 1020 also may associate a
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high noise flag with the ECG signals. The ECG System 1020
may set the high noise flag if noise in the vector magnitude
ECG lead VM is greater than HlGH_NOfSE_THRESHOLD, a
value of about 1.8 pV, and if the noise level plus the altemans
level in VM is greater than NOfSE_ALT_THRESHOLD, a
value of about 2.5 pV.
The ECG system 1020 then may generate altemans
measures 1005 based on the low-noise ECG signals. For
example, the ECG system 1020 may generate altemans
measures 1005 through power spectmm (Fourier) analysis of
the signals. Alternatively, time domain analysis may be
employed, such as, for example, complex demodulation,
estimation by subtraction, least squares estimation,
autoregressive estimation, and/or auto-regressive moving
average estimation.
(Krishnamachari 5:30—54).
Principles of Law
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). A proper § 103 analysis requires “a searching comparison of the
claimed invention — including all its limitations — with the teaching of the
prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
Analysis
Appellants contend “the combination of Armoundas, Farazi, Christini,
and Krishnamachari fails to teach or suggest the dynamic thresholding
recited in claim 1” (App. Br. 3). In particular, Appellants explain
“Armoundas simply uses the level of RA as a binary trigger for whether or
not to deliver therapy”; “Farazi is limited to teaching that multiple, static
thresholds can be used to assess changes in T-wave altemans”; “Christini
reveals that no mention is made of a threshold value that is changed as a
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function of noise present in a measured signal”; and “[t]he portion of
Krishnamachari cited in the Office Action (i.e., column 5, lines 30—54) does
not teach adaptively changing a threshold for a repolarization altemans
parameter based on the noise level in detected cardiac electrical signals”
(App. Br. 3—5).
The Examiner responds:
Armoundas does disclose at least one repolarization altemans
parameter (i.e., altemans ratio) that is adaptively changed based
on a noise level in the detected cardiac electrical signal. The
altemans ratio is well known in the art to be the magnitude of
the alteman(s) divided by the noise level for at the time of the
alteman (e.g., the noise level for that segment of data
containing the alteman or the noise level determined by the
current segment and all segments preceding the current
segment).
(Ans. 9). The Examiner finds “Krishnamachari further discloses the
evaluation system 1030 modulating a determination of an alteman threshold
crossing (and subsequent determination of sustained repolarization
altemans) according to real-time ECG noise levels and/or noise levels
relative to altemans levels” (id.). The Examiner also finds “Farazi discloses
the well-known process of detecting intrinsic premature contractions of the
ventricles by T-wave metrics to determine the presence of T-wave altemans.
Thresholds are set due to actual changes in a metric of T- waves accounting
for changes due to noise and/or changes due to misalignments” (id. at 10).
We find that Appellants have the better position. Armoundas, as the
Examiner conceded in the rejection (see Ans. 3), never suggests dynamic
threshold values based on noise levels. The Examiner, in the response,
contends the “altemans ratio is well known in the art to be the magnitude of
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the alteman(s) divided by the noise level for at the time of the alteman”
(Ans. 9), and newly cites Walker8 to support this position.
We view this taking of Official Notice in the Answer, and the new
reliance on Walker in the Answer,9 as improper. See In re Hoch, 428 F.2d
1341, 1342 n.3 (CCPA 1970) (“Where a reference is relied on to support a
rejection, whether or not in a ‘minor capacity,’ there would appear to be no
excuse for not positively including the reference in the statement of the
rejection.”) Moreover, the Examiner has not established or identified a
teaching in Walker demonstrating that this ratio serves as a dynamic
threshold as required by claim 1.
We also do not find a suggestion of dynamic threshold values based
on noise levels in Farazi, Christini, or Krishnamachari in the portions relied
upon by the Examiner (FF 5—8). In particular, the Examiner relies upon
Krishnamachari for “application of a scale factor to the altemans noise value
for a more effective voltage threshold value” (Ans. 4; emphasis omitted).
However, as Appellants point out (see App. Br. 6), Krishnamachari sets a
noise flag based on two specific threshold values, 1.8 pV and 2.5 pV, and
does not dynamically adjust these thresholds based on the noise levels (FF
8).
8 Walker et al., Repolarization altemans: implications for the mechanism
and prevention of sudden cardiac death, 57 Cardiovascular Res. 599-614
(2003).
9 See MPEP § 1207.03 (III) (“If Evidence (such as a new prior art reference,
but not including a newly relied upon dictionary definition) is applied or
cited for the first time in an examiner’s answer, then 37 CFR 41.39(a)(2)
requires that the rejection be designated as a new ground of rejection.”)
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Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the prior art suggests “comparing the at least one repolarization
altemans parameter to a dynamically determined threshold value that is
adaptively changed based on a noise level in the detected cardiac electrical
signals” as required by claim 1.
B. 35 U.S.C. § 103(a) over Christini and Zhu
The Examiner finds “Christini discloses a method for preemptively
suppressing a heart rhythm disturbance in a patient’s heart with an implanted
device configured to generate electrical impulses” but “Christini fails to
explicitly disclose identifying the optimal location for detecting altemans”
(Ans. 5—6). The Examiner finds:
Zhu discloses detecting IEGM signals from multiple electrodes
within the heart and choosing the optimal electrodes for pacing
and detection of the capture based on signals from electrodes
providing the highest probability of success for capture
(Abstract; Col. 7, Line 48 - Col. 8, Line 57). To elaborate, Zhu
explicitly discloses detection of loss of capture/detected
capture, e.g., potentially due to lead dislodgement or exit block,
leading to a switch to other sensing/pacing channels found to
not employ that lead. Zhu is changing sensing/pacing
configuration to one that best achieves capture AND sensing of
said capture (i.e. by going down the list of preferred electrode
configurations).
(Ans. 6—7; emphasis omitted).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the prior art suggests
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“identifying optimal locations in a patient’s heart” for pacing electrodes as
required by claim 21?
Findings of Fact
9. Zhu teaches: “Clinical testing of the patient while the device is
operating is commonly employed to select a particular pacing configuration
and mode that is optimum for that particular patient” (Zhu 7:59-62).
10. Zhu teaches: “Capture verification can be performed by
delivering a pacing pulse and attempting to sense an evoked response ... In
this test, it is determined whether or not a sensing/pacing channel is
achieving capture with the pacing pulses delivered by the channel’s
electrode” (Zhu 6:53—63).
11. Zhu teaches: “Upon detection of a loss of capture in a
sensing/pacing channel making up the selected pacing configuration, the
controller is programmed to switch from the selected pacing configuration
and associated pacing mode to a next pacing configuration and associated
pacing mode contained in the ordered list” (Zhu 8:34-40).
Analysis
Appellants contend “Zhu does not teach or suggest the optimal
placement of electrodes at locations where RA measurements can be
maximized. Rather, Zhu is concerned with selecting the desired pacing
mode for delivering treatment” (App. Br. 8).
The Examiner responds
Zhu teaches multiple electrodes located at a variety of
pacing/sensing locations within the heart for pacing and
sensing. Each electrode can be utilized for pacing or sensing
and are connected to a switching circuit 70 (Fig. 1). The input
of the evoked response sensing channel is preferably switched
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to an electrode of another sensing/pacing channel for sensing
(rather than utilizing the same electrode for sensing and
pacing). Capture verification testing involves selecting (via the
switching circuit 70) the particular electrode(s) utilized for
evoked response detection in accordance with which electrode
is placed in a location where an evoked response can be most
easily sensed (Col. 6, Line 53 - Col. 7, Line 47).
(Ans. 10).
We find that Appellants have the better position. At no point in the
Examiner’s response does the Examiner establish that Zhu or Christini teach
“identifying optimal locations in a patient’s heart” followed by placing leads
“at the identified optimal locations” as required by claim 21. Instead,
Christini teaches placing leads in the heart (FF 7) and Zhu appears to teach
optimizing the configuration of leads that have already been implanted (FF
9-11).
To the extent that the Examiner relies upon Zhou10 as evidentiary, the
Examiner does not identify a teaching in Zhou for either “identifying
optimal locations in a patient’s heart” or for placing leads “at the identified
optimal locations” in the Answer (see Ans. 10—11).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the prior art suggests “identifying optimal locations in a patient’s heart”
for placing electrodes as required by claim 21.
C. 35 U.S.C. § 103(a) over Christini, Zhu and Sharma
This rejection relies upon the underlying obviousness rejection over
Christini and Zhu. Having reversed the Christini and Zhu rejection for the
10 Zhou et al., US 2006/0116596 Al, published June 1, 2006.
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reasons given above, we necessarily reverse the obviousness rejection
further including Sharma, since the Examiner does not rely upon Sharma to
address the “identifying optimal locations in a patient’s heart” limitation.
SUMMARY
In summary, we reverse the rejection of claims 1—5 and 10—20 under
35 U.S.C. § 103(a) as obvious over Armoundas, Farazi, Christini, and
Krishnamachari.
We reverse the rejection of claims 7 and 21 under 35 U.S.C. § 103(a)
as obvious over Christini and Zhu.
We reverse the rejection of claims 8 and 9 under 35 U.S.C. § 103(a)
as obvious over Christini, Zhu, and Sharma.
REVERSED
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