Ex Parte Snell et al

Patent Trial and Appeal Board

Sep 6, 2017

13622919 (P.T.A.B. Sep. 6, 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.
13/622,919 09/19/2012 Jay Snell A12P1040 7723
36802 7590 09/08/2017
PACESETTER, INC.
15900 VALLEY VIEW COURT
SYLMAR, CA 91392-9221
EXAMINER
PATTON, AMANDA K
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/08/2017 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):
Patent.CRMDSylmar@sjm.com
lcancino-zepeda@sjm.com
epineiro @ sj m. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAY SNELL, CAROL HUDGINS, and
KATHLEEN KRESGE
Appeal 2016-001396
Application 13/622,9191
Technology Center 3700
Before FRANCISCO C. PRATS, RACHEL H. TOWNSEND, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method for
discriminating the morphology of the ST segment of a heartbeat. The
Examiner entered final rejections for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM.
STATEMENT OF THE CASE
Background
The Specification discloses:
1 Appellants identify the Real Party in Interest as Pacesetter, Inc., dba St.
Jude Medical, Cardiac Rhythm Management Division. Br. 3.
Appeal 2016-001396
Application 13/622,919
The ST segment represents the portion of the cardiac signal
between ventricular depolarization and ventricular repolarization
.... Deviation of the ST segment during an ST episode from a
baseline is a result of injury to cardiac muscle, variations in the
synchronization of ventricular muscle depolarization, drug or
electrolyte influences, or the like. Various morphology
discrimination techniques have been proposed that utilize ST
segment shifts to identify ST episodes.
Spec. 14.
“However, conventional morphology discrimination techniques
declare an unduly false positive ST episode.” Id. 1 5. A need remains for an
ST monitoring method and system able to reduce or prevent false positive
ST episode detections caused by rate dependent bundle branch blocks,
posture-related axis changes of the EGM signal and other non-ST segment
related physiologic behavior. Id. 1 6.
The disclosure of the Specification relates to “morphology
discrimination, and more particularly to methods and systems that utilize
reference morphology templates to validate ST morphology discrimination.”
Id.^l. “Embodiments are described herein for an ST morphology
discrimination (MD) system and method that are utilized to help distinguish
a normally conducted intrinsic ventricular beat from one with delayed
conduction.” Id. 126.
The Claims
Claims 1—18 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A method for ST morphology discrimination,
comprising:
sensing cardiac signals of a heart;
2
Appeal 2016-001396
Application 13/622,919
obtaining a reference morphology template based on at
least one baseline cardiac signal associated with a normal
physiology waveform;
identifying a potential ST segment shift from the cardiac
signals;
comparing the cardiac signals to the reference morphology
template to derive a morphology indicator representing a degree
to which the cardiac signals match the reference morphology
template in response to the identification of a potential ST
segment shift; and
declaring the potential ST segment shift to be an actual ST
segment shift based on the morphology indicator.
Br. 12 (Appendix of Claims).
Appellants seek our review of the Examiner’s rejection of claims 1—18
under pre-AIA 35 U.S.C. § 103(a) as obvious over Snell,2 Kroll,3 Zhang,4
Dong,5 6 7and Gilkerson.6 7
OBVIOUSNESS
In rejecting the claims, the Examiner finds that Kroll discloses a
“method for us[ing] ST morphology discrimination comprising: sensing
cardiac signals of the heart (i.e. [,] ventricular intracardiac electrogram
(IEGM) signal) and identifying ST segments within the ventricular IEGM
2 US 2011/0245699 Al, published October 6, 2011 (“Snell”).
3 US 6,865,420 Bl, issued March 8, 2005 (“Kroll”).
4 US 2008/0177194 Al, issued July 24, 2008 (“Zhang”).
5 US 2012/0035489 Al, published February 9, 2012 (“Dong”).
6 US 6,493,579 Bl, issued December 10, 2002 (“Gilkerson”).
7 We note that, while Dong and Gilkerson are not formally included in the
Examiner’s statement of rejection, the Examiner cited the teachings of Dong
and Gilkerson in the Final Office Action (mailed October 27, 2014). See
Final Act. 4. Accordingly, we treat them as part of the rejection herein.
3
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Application 13/622,919
signal; and analyzing the ST segments to detect an indication of a possible
cardiac ischemic event within the patient.” Ans. 2 (citation omitted). The
Examiner finds Kroll applies the method to confirm the existence of
myocardial ischemia in order to recommend a treatment or continue
monitoring where no ischemia is detected. Id. at 2—3.
The Examiner finds Snell discloses a method of identifying the ST
segments with a ventricular IEGM signal that is detected by an implanted
medical device, and analyzing the ST segments to detect “an indication of a
possible cardiac ischemic event within the patient.” Id. at 3. The Examiner
finds Snell discloses that stability of the ST segment can be used to
characterize heart defects including arrhythmia and ischemia and to
recommend types of therapy. Id. The Examiner finds Snell discloses
“obtaining baseline ST segment morphology data based on at least one
baseline (i.e. [,] non-shifted ST segment(s)) associated with a normal
physiology waveform” and using identified shifted ST-segments for
comparison with the baseline data in the method. Id.
The Examiner finds Zhang discloses
utilizing a ischemia trigger event detector to detect an indication
of possible ischemia (ST deviation) based on a first condition and
an ischemia detector to detect a second condition (R-R interval
stability) to confirm or reject a determination of ischemia based
on ST deviation by whether R-R interval stability is also
detected.
Id.
The Examiner finds that none of Kroll, Snell, or Zhang discloses
“obtaining a reference morphology template based on at least on[e] baseline
cardiac signal associated with a normal physiology waveform, wherein the
reference morphology template is utilized to derive a morphology indicator
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Application 13/622,919
representing a degree to which the cardiac signals match the reference
morphology template in response to the identification of a potential segment
shift.” Id. at 3^4. Accordingly, the Examiner turns to Dong and Gilkerson,
for additional information regarding the prior art.
The Examiner finds Dong discloses using “morphology template
comparisons” to “determine stability of rhythms during detected cardiac
episodes and alters therapy depending upon the additional stability
measure.” Ans. 4. The Examiner finds Gilkerson also discloses “use of
stability measures to inhibit therapy depending on [whether] ventricular
rhythms are found to be stable or unstable during initial detection of
problematic cardiac rhythms.” Id.
The Examiner concludes that the ordinarily skilled artisan would have
found it obvious at the time of the invention
to modify Kroll to explicitly provide stimulation therapy for
ischemia where ischemia is detected based on both ST segment
deviations and verified through stability measurement
determination utilizing morphology template comparisons, as
taught by Snell, Zhang, Dong and Gilkerson, in order to detect
ischemia through ST segment deviations by verifying said
deviations are likely attributed to ischemia rather than other
factors (e.g.[,] variations in patient activity).
Id.
ISSUE
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that Snell, Kroll, and
Zhang as informed by Dong and Gilkerson suggest the claimed subject
matter. We select claim 1 as representative of the claims subject to this
ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv).
ANALYSIS
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Application 13/622,919
Appellants raise several arguments in support of their position that the
Examiner erred in rejecting the claims over the cited prior art. Br. 6—10.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992):
[T]he examiner bears the initial burden ... of presenting a prima
facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, Appellants do not persuade us that a
preponderance of the evidence fails to support the Examiner’s conclusion
that the method for discriminating the morphology of the ST segment of a
heartbeat of claim 1 would have been obvious to an ordinary artisan.
As required by claim 1, Kroll discloses a method of detecting
differences in ST morphology “by identifying changes in the ST-segment of
the intracardiac electrogram (EGM) sensed using large sensing electrode
surfaces created by electrically coupling one or more cardiac electrodes or
by using larger surface area shocking coils.” Kroll Abstract. The Kroll
method is summarized in Figures 5 and 6, reproduced below:
6
Appeal 2016-001396
Application 13/622,919
.m ifia
420 .
V DETECT
{ ftlYOCAflDlAt.
\ ISCHEMIA?
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DEMAND? ,
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Figure 5 is “a flow chart illustrating a method of performing myocardial
ischemia detection.” Id. at 3:46-48. Figure 6 is “a flow chart illustrating a
method of monitoring myocardial ischemia and providing a stimulation
response aimed at alleviating the ischemia.” Id. at 3:49—51. As the
Examiner found, Kroll discloses detecting ST morphology by analyzing the
sensed ST segment deviations and using the morphology as a predictor of
ischemia as well as a treatment guide. Kroll 10:21—53 (e.g., “The three
EGM signals received from ischemia sensing circuit 150 are therefore
processed in any combination to confirm the presence or absence of
ischemia based on the predetermined criteria defining expected deviations of
the ST-segmenf’). Figures 5 and 6 show the detection method and the
therapy monitoring procedure.
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Appeal 2016-001396
Application 13/622,919
As the Examiner notes (Ans. 3), Kroll does not specifically disclose
using a “reference morphology template based on at least one baseline
cardiac signal associated with a normal physiology waveform” despite that
the steps of “analyze EGM signals for ST-segment deviation” and “ST-
segment deviation detected?” suggest that the method disclosed by Kroll
includes comparing ST-segments against a baseline to confirm whether a
deviation is detected.
As the Examiner found, though, and we agree, Dong discloses using
“morphology template comparisons” to “determine stability of rhythms
during detected cardiac episodes and alters therapy depending upon the
additional stability measure.” Ans. 4. Dong discloses the use of templates
in discriminating heart rhythms, including tachycardia. Dong, || 90-98.
Dong discloses a method for obtaining a reference morphology template as
follows:
a template can be generated from a snapshot representative of
one of the patient’s normal supra-ventricular conducted beats.
Cardiac signals are sensed from pacing leads (rate channel) and
shock leads (shock channel). A fiducial point is determined from
the signals sensed on the rate channels and is used to align signals
sensed on the shock channels. A template for a patient is
generated using the aligned shock channel signals. The template
is representative of one of the patient’s normal supra-ventricular
conducted beats. Subsequently detected beats are then used to
confirm that the generated template is representative of one of
the patient’s normal supra-ventricular conducted beats.
Dong 192.
Furthermore, as the Examiner found, Gilkerson discloses analyzing
the stability of ventricular rhythms “to distinguish unstable (irregular)
ventricular rhythms from stable (regular) ventricular rhythms [by] measuring
the degree of variability of the tachycardia R-R intervals.” Gilkerson 7:40—
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Appeal 2016-001396
Application 13/622,919
43. Once variability is calculated, the treating physician decides whether to
inhibit therapy for atrial fibrillation, or to use stability analysis to determine
the therapy to be delivered, such as applying shock to an unstable patient.
Id. at 7:50—54.
We agree with the Examiner (Ans. 4) that, in light of the teachings of
Kroll, Dong, and Gilkerson, the skilled artisan would have found it obvious
to determine ST morphology by comparing sensed cardiac signals to a
predetermined reference morphology template and measuring any detected
shift in the ST segment. Although not required by claim 1, we further agree
with the Examiner that these references would have guided the skilled
artisan to modify Kroll to provide stimulation therapy for ischemia where ST
segment stability analysis indicated the subject was experiencing ischemia.
Id. We further find that Kroll, Dong, and Gilkerson alone provide sufficient
teaching to support the Examiner’s conclusion of obviousness. See In re
May, 574 F.2d 1082, 1090 (CCPA 1978) (the Board may rely upon fewer
than all the references cited by the Examiner). Nevertheless, we agree with,
and adopt as our own, the Examiner’s findings and conclusions regarding
the teachings of Snell and Zhang. Ans. 4. These findings further support the
Examiner’s conclusion of obviousness as they evidence that ordinarily
skilled artisans at the time of the invention would have known that cardiac
ST segments should be analyzed for stability to detect arrhythmia or
ischemia and in assessing the necessary type of therapy. See Snell H 13, 35,
43, 49-59, 68—78, and 88—101, and Zhang || 5—15.
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Application 13/622,919
Appellants argue that none of the cited references perform all steps of
the claimed method. Appellants argue:
neither Kroll nor Snell disclose or suggest comparing a cardiac
signal to a reference morphology template to derive a
morphology indicator representing a degree to which the cardiac
signals match the reference morphology template in response to
the identification of a potential ST segment shift and declaring
the potential ST segment shift to be an actual ST segment shift
based on the morphology indicator as recited in the claimed
invention.
Br. 8. See also Br. 7 regarding Kroll alone. Appellants further argue that
Zhang “does not disclose comparing a cardiac signal to a reference
morphology template as recited in the claimed invention.” Id. at 9.
These arguments are not persuasive as the Examiner’s rejection is
based on the combined teachings of Kroll, Snell, Zhang, Dong, and
Gilkerson. See Ans. 4. Nonobviousness cannot be established by attacking
the references individually when the rejection is predicated upon a
combination of prior art disclosures. In re Merck & Co. Inc., 800 F.2d 1091,
1097 (Fed. Cir. 1986); see also In re Keller, 642 F.2d 413, 426 (CCPA
1981) (finding “one cannot show nonobviousness by attacking references
individually where, as here, the rejections are based on combinations of
references” (citations omitted)). Thus, whether any of the references
individually fails to teach determining ST morphology by comparing sensed
cardiac signals to a predetermined reference morphology template and
measuring any detected shift in the ST segment is not dispositive as to
whether the combination of teachings of the references renders the claimed
invention obvious. As stated by the Examiner, Dong, and Gilkerson provide
motivation for the skilled artisan to apply the ST morphology discrimination
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Application 13/622,919
methods disclosed in Kroll (along with Snell and Zhang, which further
illustrate the knowledge in the art), and Gilkerson provides motivation to
modify Kroll to use a template for comparison of the detected ST segment to
a normal baseline template. Ans. 4. The Examiner sufficiently establishes
that an ordinary artisan reading Kroll, Snell, Zhang, Dong, and Gilkerson
would have reasonably expected that the templates disclosed in Dong and
Gilkerson could be used to assess ST-segment morphology in the methods
disclosed by Kroll, Snell, and Zhang.
We are further unpersuaded by Appellants’ argument that “Dong and
Gilkerson, like Kroll, disclose the use of morphology as an arrhythmia
discriminator and provide no teaching or indication that morphology may be
useful in verifying the presence of an ischemic event” or that none of the
references “disclose or suggest comparing the morphology of a current
cardiac signal within a shifted set of cardiac signals to a stored morphology
template as recited in the claimed invention to confirm the detection of
ischemia as indicated by ST segment deviations.” Br. 10. Although we find
Kroll teaches ischemic prediction as discussed above, claim 1 does not
require either a stored morphology template or verification of the presence
of an ischemic event. See Super Guide Corp. v. DirecTV Enters., Inc., 358
F.3d 870, 875 (Fed. Cir. 2004). (“Though understanding the claim language
may be aided by the explanations contained in the written description, it is
important not to import into a claim limitations that are not a part of the
claim.”). Claim 1 recites discrimination of ST morphology through use of a
reference morphology template to assess the shift, which we find is obvious
in light of the cited references.
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Claims 2—18 have not been argued separately8 and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1—18 under pre-AIA 35 U.S.C. §
103(a) as obvious over Snell, Kroll, Zhang, Dong, and Gilkerson.
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)(l)(iv).
AFFIRMED
8 Appellants argue independent claims 1 and 10 together and do not raise
arguments specific to claim 10. Br. 6—10. Likewise, Appellants do not raise
arguments with respect to the dependent claims, but rely on arguments
raised with respect to the independent claims. Id. at 10.
12