Ex Parte Leyde et al

Patent Trial and Appeal Board

Sep 19, 2017

11616793 (P.T.A.B. Sep. 19, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/616,793 12/27/2006 Kent Leyde 104292-1111 3118
137985 7590 09/21/2017
FOT FY Rr T ARDNFR T T P
EXAMINER
3000 K STREET N.W. WESTON, TIFFANY C
SUITE 600
WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
09/21/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENT LEYDE and JOHN HARRIS
Appeal 2016-006648
Application 11/616,79s1
Technology Center 3700
Before ULRIKE W. JENKS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of sensing an epileptic event with a processor having
programmed power usage settings. The Examiner rejects the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the Real Party in Interest is Cyberonics, Inc.
Appeal Br. 3.
Appeal 2016-006648
Application 11/616,793
STATEMENT OF THE CASE
The Specification explains that “[computational processing demands,
especially in the case of substantially continuous or repeated monitoring of
the subject, can cause energy drains and may have a negative impact on
battery life.” Spec. 117. In medical devices, “implanted batteries,
supplying the energy required to meet the computational demands can
severely limit power source life. In some applications, physiological signals
may be measured and analyzed continuously or often over long periods of
time and the need to conserve energy may be particularly acute.” Id. at 135.
Claims 1, 8, 29-31, 33, 34, 36 and 40-42 on appeal,2 and can be
found in the Claims Appendix of the Appeal Brief. Claim 1 is representative
of the claims on appeal, and reads as follows (emphasis added):
1. A method of operating a medical device system, the method
comprising:
receiving heart rate signals from a subject using a sensor
coupled to the subject so as to detect the heart rate signals from
the subject;
processing the heart rate signals received by the sensor
using a programmed computer processing unit to detect at least
one pre-onset characteristic of an epileptic_event and determine
a likelihood of the epileptic event based at least in part on the
detected at least one pre-onset characteristic, wherein said
processing the heart rate signals comprises performing a high-
power processing of a first set of the heart rate signals received
by the sensor, and
when the detected at least one pre-onset characteristic
2 Claims 1—5, 8—13, 34, 35, and 40-42 were previously rejected under
35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA), first paragraph, (see Final
Action mailed Apr. 2, 2015 (“Final Act.”)), but an amendment dated Sept. 2,
2015 was entered by the Office and this rejection was indicated as being
overcome. Advisory Act. (Sept. 22, 2015). Currently, claims 2—5, 9-13, 32,
35, and 37 are objected-to, but are not otherwise rejected. See id.
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Application 11/616,793
subsequently indicates a low likelihood of the epileptic event,
performing a low-power processing of a second set of the heart
rate signals received by the sensor subsequent to the first set of
the heart rate signals.
Appeal Br. 13, Claims Appendix.
Appellants request review of the following grounds of rejection:
I. claims 1, 29, 34, 36, and 40-42 under 35 U.S.C. § 103(a) as
unpatentable over Osorio3 in view of Piccone;4 and
II. claims 8, 30, 31, and 33 under 35 U.S.C. § 103(a) as
unpatentable over Osorio in view of Piccone and further in view of
Echauz.5
Obviousness over Osorio and Piccone
Since both of these rejections rely upon the teaching of Osorio and
Piccone regarding different power levels utilized during signal processing,
the same issue is dispositive for both of these rejections, so we consider the
rejections together.
The issue is: Does the evidence of record support the Examiner’s
conclusion that the combined teachings of Osorio and Piccone change the
power level of the processing based on the type signal information as
claimed?
3 Osorio et al., US 2007/0213785 Al, published Sept. 13, 2007 (“Osorio”).
4 Piccone et al., US 4,566,464, issued Jan. 28, 1986 (“Piccone”).
5 Echauz et al., US 2002/0103512 Al, Aug. 1, 2002 (“Echauz”).
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Application 11/616,793
Findings of Fact
FF1. Osorio teaches measuring and analyzing biological signals, for
example:
[T]he biological signals that may selected, stored and/or
reported . . . may include any number of sensed signals.
Such biological signals can include, for example,
electrical signals (such as EEG, ECoG and/or EKG),. . .
heart rate signals,.... Such biological signals may be
recorded using one or more monitoring elements such as
monitoring electrodes or sensors. ... In addition, various
types of physiologic activities may be sensed including,
for example, brain, heart and/or respiration.
Osorio 136.
FF2. Osorio teaches “techniques that estimate probability distribution
functions or cumulative distribution functions, ‘built’ relying on
representative historical profiles, comprising information in short
and/or long timescales obtained at times that may be intermittent or
temporally discontinuous from each other or from other events of
interest.” Osorio 126.
FF3. Osorio teaches that power consumption can be decreased by using less
continuous monitoring. See Osorio 130.
FF4. Osorio teaches that when assessing for Sudden Unexpected Death in
Epilepsy Patients (SUDEP) periods of prolonged ECG recordings may
be necessary to calculate the probability estimates for these patients.
Data is gathered and stored in an implanted device. Further, Osorio
states:
Th[is] data may be used to build probability estimates as
a function of time, state (asleep or in seizure) and
activities (exercising) to enable therapies at times of high
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Application 11/616,793
risk to prevent an event or, in the case of SUDEP, a fatal
outcome.
Osorio 139.
FF5. Osorio teaches that, depending on the calculated probability estimates,
a change in the patient warning may be necessary. Osorio states,
“[t]he type of therapy and parameters/dose used when the seizure
probability is 40% may be different that when it is 80% or when the
subject changes activity from a low to a high risk for injury.” Osorio
182.
FF6. The Examiner finds that “Osorio does not explicitly teach the power
consumption related to the operating changes.” Final Act. 5; see also
Ans. 3 (“Osorio does not teach a change in operation linked to power
consumption”).
FF7. Piccone teaches a “monitor 20 [that] comprises a plurality of sensing
electrodes 12, filter 14, an analytic-recognition unit (ARU) 13, power
supply 16, radio-frequency transmitter 18, radio-frequency receiver 19
and antenna 17.” Piccone 4:24—27. Piccone teaches “[w]hen the
ARU 13 determines from analysis of brainwave forms detected
through electrodes 12 that a seizure is imminent,” the ARU sends a
signal to the receiver to sound a warning alarm. Piccone 4:65—67.
Further, Piccone states, “[t]he monitor 20 generally consumes very
low power except during periods of transmission.'" Piccone 5:36—38
(emphasis added).
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Principle of Law
“[OJbviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Inti Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Analysis
Appellants contend that the Examiner has not met the burden of
presenting prima facie case of obviousness because the Examiner has not
explained how “Piccone’ s teaching of increasing power for transmissions
would teach or suggest ‘performing a low-power processing of a second set
of the heart rate signals’ as recited in claim 1.” Reply Br. 6; see also Appeal
Br. 9. (“Piccone’s change in power consumption is based on periods of
transmission and thus fails to teach or suggest power changes relating to the
processing of ‘heart rate signals’ or ‘electrical signals received by the heart
rate sensor’, or changes based on a probability of seizure”). The high and
low power use in Piccone is not identified as related to processing, but,
rather, is due to power consumption based on transmission. Appeal Br. 9—
10.
We find Appellants have the better position. Osorio teaches
calculating a probability estimate that determines if a patient will
imminently experience an epileptic event and providing a warning signal to
the patient. See FF1—FF5. The Examiner finds that Osorio does not address
changes in power consumption based on changes in operational aspects.
FF6. We agree with the Examiner’s finding that Osorio is silent with respect
to discussing changes in the computational power consumption based on
operational changes. Id.
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Piccone teaches analyzing biological signals, specifically brain wave
signals, and determining, based on the received signal, if a seizure is
imminent. See FF7. Piccone’s system includes a “monitor 20 comprises a
plurality of sensing electrodes 12, filter 14, an analytic-recognition unit
(ARU) 13, power supply 16, radio-frequency transmitter 18.” FF7. If the
analysis unit (ARU) determines a seizure is imminent, this necessitates
communication with the patient or caregiver, which requires transmission of
the information. See FF7. Piccone teaches that, during periods of
transmission, the power usage is high in the system. FF7.
We agree with the Examiner that the power usage of the system is
reduced when there is no need for transmission, i.e. when a seizure is not
imminent. See Final Act. 5 (“the device operates under low power, such as
when there is a low likelihood of seizure”). Piccone, however, is silent with
respect to power demands of the processing unit (the ARU) based on
calculating the likelihood of an epileptic event occurring. The Examiner has
not explained why the communication of an imminent epileptic event
through the transceiver would necessarily also require higher energy demand
on Piccone’s processing unit (the ARU).
The claims require that “said processing the heart rate signals [by the
programmed computer processing unit] comprises performing a high-power
processing” of the signals under one condition and a low-power processing
under another condition. We agree with Appellants’ position that the
evidence supports that the differential power usage in Piccone is due to the
systems power usage based on data transmission by the transmitter, and not
necessarily due to different power consumption of the ARU based on a
calculation processes.
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In view of the above, the preponderance of evidence on this record
fails to support Examiner’s conclusion that the combination of Osorio and
Piccone teaches different computational power usage during different signal
processing.
SUMMARY
We reverse the rejection of claims 1, 29, 34, 36, and 40-42 under
35 U.S.C. § 103(a) over Osorio and Piccone.
We reverse the rejection of claims 8, 30, 31, and 33 under 35 U.S.C.
§ 103(a) over Osorio, Piccone, and Echauz.
REVERSED
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