Ex Parte Krause

Patent Trial and Appeal Board

Jun 22, 2016

11380307 (P.T.A.B. Jun. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111380,307 0412612006
27581 7590 06/24/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Paul G. Krause
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
P002346 l.OO/LG10126 2354
EXAMINER
PATEL, NIKETA I
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
06/24/2016 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):
medtronic_crdm_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte PAUL G. KRAUSE
Appeal2013-003181
Application 11/380,307 1
Technology Center 3700
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
MELANIE L. McCOLLUM, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an implantable medical device
programmed to identify the presence of at least one of a plurality of risk
stratification measurement triggers. Appellant appeals from the Examiner's
rejections of claims 1, 7-11, 13, and 16-18 as anticipated or obvious under
35 U.S.C. § 103. We have jurisdiction under 35 U.S.C. § 134(a). The
rejections are affirmed.
STATEMENT OF CASE
Claims 1, 7-11, 13, and 16-18 are pending. The claims stand finally
rejected by the Examiner as follows:
1 "The '307 Application."
Appeal2013-003181
Application 11/380,307
1. Claim 1under35 U.S.C. § 102(e) (pre-AIA) as anticipated by
Farazi (U.S. Pat. No. 7,702,391 Bl, issued April 20, 2010, continuation of
application filed Feb. 17, 2005). Final Rejection ("Final Rej." dated May
10, 2012) 2.
2. Claims 7-11, 13, and 16-18 under 35 U.S.C. § 103(a) (pre-AIA) as
obvious in view of Farazi and Rueter (U.S. Pat. No. 5,944,745, issued Aug.
31, 1999). Final Rej. 4 and 5.
Claim 1 is representative and is reproduced below:
1. An implantable medical device comprising a sensor, a
hermetically sealed enclosure, and memory disposed within the
hermetically sealed enclosure, wherein the device is
programmed to identify the presence of at least one of a
plurality of risk stratification measurement triggers and to store
a physiological signal sensed by the sensor in response to
identification of the at least one risk stratification measurement
trigger, wherein the risk stratification measurement triggers
include at least one trigger selected from the group consisting
of a resting sinus rhythm trigger, a moderate exercise sinus
rhythm trigger, a heavy exercise sinus rhythm trigger, and a
PVC trigger and wherein the physiological signal stored in
response to the resting sinus rhythm trigger includes an
electrocardiogram signal suitable for a risk stratification
measurement selected from the group consisting of T-wave
altemans, ischemia detection via ST segment analysis, signal-
averaged QRS complex, QT dynamicity, QT wave morphology
analysis, and T-wave morphology analysis.
Appeal Br. 13 (Claims Appendix).
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Application 11/380,307
1. ANTICIPATION BY FARAZI
Claim 1
Claim 1 is directed to an implantable device comprising: 1) a sensor,
2) a hermetically sealed enclosure, and 3) a memory in the enclosure. The
device is programmed to identify the presence of at least one of a plurality of
risk stratification measurement triggers and to store a physiological signal
sensed by the sensor in response to identification of the at least one risk
stratification measurement trigger. The claim has two principal
requirements of the response to the risk stratification measurement trigger.
First, "a physiological signal sensed by the sensor" must be stored in
response to a least one trigger "selected from the group consisting of a
resting sinus rhythm trigger, a moderate exercise sinus rhythm trigger, a
heavy exercise sinus rhythm trigger, and a PVC trigger." A PVC is a
premature ventricular contraction. See '307 Appl. i-f 16. The claim does not
specify the type of physiological signal which must be stored, except in
response to a resting sinus rhythm trigger. The Specification describes
specific examples of a physiological signal, but it does not limit the claim to
these disclosed signals. ("Further, although the physiological signal is
primarily referred to as an ECG [electrocardiogram], is [sic, it] should be
understood that other physiological signals are included within the scope of
the invention, such as electrograms." Id. at 4, i-f 12.)
Second, when the risk stratification measurement trigger is a "resting
sinus rhythm," the physiological signal is "selected from the group
consisting of T-wave altemans, ischemia detection via ST segment analysis,
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Appeal2013-003181
Application 11/380,307
signal-averaged QRS complex, QT dynamicity, QT wave morphology
analysis, and T-wave morphology analysis."
Rejection
The Examiner found that Farazi describes an implantable device with
all of the limitations of claim 1, anticipating it. Specifically, the Examiner
found that the device in Farazi has all three structural requirements of the
device recited in the claim. Final Rej. 2. As to the functional programmed
requirements, the Examiner found that the device is programmed "to identify
the presence of a PVC trigger ([Farazi,] column 10, lines 18-24)" and to
store a physiological signal in response to it (citing Farazi at col. 21, 11. 31-
45). Final Rej. 2. The Examiner found that PR intervals were measured and
stored after base line data and PVC triggers, corresponding to the first
requirement of the claim. Id. at 3--4. A PR interval is a specific interval in
an ECG. Farazi, col. 10, 11. 10-11. The Examiner also found that the signal
stored in response to the resting sinus rhythm trigger includes ischemia
detection via ST segment analysis (citing Farazi at col. 19, 1. 66 to col. 20, 1.
3), corresponding to the second requirement of the claim. Final Rej. 3--4.
Appellant contends that for claim 1 to be anticipated by Farazi, "the
occurrence of PVC's would accordingly have to trigger storage of a
physiological signal comprising an electrocardiogram signal." Br. 9.
Appellant contends that PR intervals are "not recordings of the amplitudes of
the electrical activity signal of the heart over time, as would be required to
be considered stored electrocardiograms." Id. Appellant also argues that
"detections of P and R-waves are not described as requiring signal storage in
Farazi" and that storage of the ST signals is not "responsive to" the detected
PR intervals. Id. at 10.
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Application 11/380,307
Discussion
1. Store a physiological signal in response in response to a PVC
trigger
The first part of the claim requires a program to store a physiological
signal in response to a risk stratification measurement trigger such as a PVC
trigger. As found by the Examiner, Farazi describes detecting PR intervals
in an ECG that follow a PVC trigger. Final Rej. 2. The following findings
of fact ("FF") support the Examiner's determination.
FFl
In accordance with an embodiment of the present
invention, microcontroller 60 includes an ischemia detector
202, which as described in more detail below, can detect
ischemic events based on monitored short-term fluctuations in
cardiac intervals (e.g., PR intervals) that follow premature
contractions of the ventricles.
Farazi, col. 10, 11. 30-35.
FF2
Step 402 involves monitoring short-term fluctuations in
PR intervals that follow a premature contraction of the
ventricles. Any fluctuations (or lack thereof) in PR intervals
that occur following a premature contraction of the ventricles
will typically be recognizable only during the first 25 beats
following the contraction.
Id. at col. 14, 11. 19-24.
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Application 11/380,307
FF3 Farazi also describe storing the signals so they can be later processed
and/or sent by telemetry to external device:
Cardiac signals are also applied to the inputs of an analog to-
digital (AID) data acquisition system 90. Data acquisition
system 90 is configured to acquire intracardiac electrogram
signals, convert the raw analog data into a digital signal, and
store the digital signals for later processing and/or telemetric
transmission to an external device 102.
Id. at col. 7, 11. 53-58.
FF4
... information related to a risk of SCD [sudden cardiac death]
can be stored for later retrieval and/ or transmission to a
physician or other clinician. This can include, for example,
storing the PR intervals, a degree of fluctuations in the PR
intervals and/ or a degree of risk of SCD.
Id. at col. 16, 11. 34--37.
FF5
At step 506, one or more response can be triggered based on the
assessed autonomic tone. In accordance with an embodiment of
the present invention, information related to autonomic tone can
be stored for later retrieval and/or transmission to a physician or
other clinician. This can include, for example, storing the PR
intervals, a degree of fluctuations in the PR intervals and/or a
degree of autonomic tone.
Id. at col. 18, 11. 4--10.
Appellant contends that PR intervals do not meet the claimed
limitation of a physiological signal because the signal must be an
electrocardiogram signal with amplitudes. Br. 9.
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Application 11/380,307
This argument is not persuasive because the claims do not require the
signal to be an ECG. As discussed above, while an ECG is an example of a
physiological signal (Spec. i-f 12), the claims are not limited to an ECG
signal. Appellant appears to be reading a limitation that does not appear in
the claim. Thus, a portion of an ECG, such as a PR interval, meets the claim
limitation. Farazi discloses storing the PR interval as required by the claim
1 (FF4 and FF5), as well as storing an electrogram signal (FF3). Appellant
is therefore incorrect that Farazi does not disclose storing a physiological
signal.
2. resting sinus rhythm trigger and the physiological signal is ST
segment analysis
The second part of the claim requires that when the trigger is a resting
sinus rhythm, the physiological signal is selected from a specific group of
recited physiological signals. The Examiner cited disclosure in Farazi for its
teaching of detecting and storing ST segments in response to a resting or
baseline rhythm. The following findings of fact are pertinent:
FF6
Additionally, or alternatively, other techniques for detecting
ischemic events can be used together with techniques described
herein which related to monitoring short term fluctuations in PR
intervals that follow premature contraction of the ventricles. For
example, the above described embodiments can be used to
supplement (e.g., to increase the confidence level of) the
detection of an ischemic event using some other technique.
Alternatively, some other technique can be used to supplement
the detection of an ischemic event that was detected using one
of the above described embodiments of the present invention.
For a more specific example, in U.S. Pat. No. 6,609,023
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Application 11/380,307
(Fis[c]hell et al.), which is incorporated herein by reference, ST
segments are analyzed for the purpose of detecting myocardial
infarctions and/or myocardial ischemia. More specifically, the
'023 patent discloses that ischemia can be detected by
comparing ST segment shifts to an appropriate threshold, where
an "ST shift" is the difference between the ST deviation of any
single beat in a recently collected electrogram segment and f!
baseline average ST deviation extracted from a baseline
electro gram segment. This is just one example of a technique
that can be used together with the embodiments of the present
invention that detect ischemic events based on monitored short-
term fluctuations in PR intervals that follow premature
contractions of the ventricles.
Farazi, col. 21, 11. 31-55 (emphasis added).
As indicated by the above-quoted passage, particularly the underlined
portions, Farazi teaches that a baseline electrogram segment is obtained, and
in response to this baseline trigger, "a baseline average ST deviation [is]
extracted" which is utilized to determine ST segment shifts in subsequent
measurement. The latter steps meet the claimed requirement of a
"physiological signal stored in response to the resting sinus rhythm trigger,"
where the signal "includes an electrocardiogram signal suitable for a risk
stratification measurement" which is "ST segment analysis." In other
words, Farazi describes measuring a "resting sinus rhythm," namely, the
baseline electrogram segment, and then storing this signal and subsequently
collecting signals ("comparing ST segment shifts to an appropriate
threshold, where an 'ST shift' is the difference between the ST deviation of
any single beat in a recently collected electrogram segment and a baseline
average ST deviation") which constitute "an electrocardiogram signal
suitable for a risk stratification measurement" as recited in the claim.
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Application 11/380,307
Appellant, in arguing that the Examiner erred, states that the
"occurrence of short PR intervals is not a precondition to storing the ST
segments." Br. 10. There is no language in the second part of the claim that
requires the ST segment analysis to be responsive to the PR interval
collection. The claim separately requires the ST segment analysis to be a
response to a resting sinus rhythm trigger. The Examiner's statement that
"any subsequent measurement of the ST interval to confirm the PR interval
would be taken when the patient is at rest" was made in the context that the
ST segment analysis was responsive to a resting rhythm, confirming the data
collected for the PR intervals. Final Rej. 4.
In sum, Appellant has not demonstrated error in the anticipation
rejection of claim 1 by Farazi.
OBVIOUSNESS REJECTION BASED ON F ARAZI
The Examiner found that Farazi discloses the claimed invention
except for a prioritization scheme as recited in dependent claims 7-11. Final
Rej. 4--5. The Examiner also found the limitations in claims 13 and 16-18
met by Rueter. Id. at 5---6. For independent claim 13, the Examiner also
found that Farazi lacks a disclosure of a prioritization scheme, but provided
a fact-based rationale as to why Rueter's scheme would have been applied to
Farazi by one of ordinary skill in the art. Id. at 5---6.
Appellant makes the same arguments for claim 13 as for the claim 1.
Specifically, Appellant contends that Farazi does not disclose storage of an
electrogram signal "whatsoever." Br. 11.
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Application 11/380,307
Appellant's contention is not supported by a preponderance of the
evidence. Findings of Fact 3, 4, and 5 provide express evidence that signals
are stored. The claims do not require storage of a complete ECG.
In sum, Appellant has not demonstrated error in the obviousness
rejection of claim 13. Consequently, we affirm the rejection of claim 13.
Separate arguments were not provided for clams Claims 7-11 and 16-18.
These claims therefore fall with claims 7 and 13. 37 C.F.R. §
41.37(c)(l)(iv).
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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