Ex Parte Kornet et al

Patent Trial and Appeal Board

Jan 30, 2017

12608855 (P.T.A.B. Jan. 30, 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.
12/608,855 10/29/2009 Lilian Kornet P0027512.00/1111-174US01 7259
27581 7590
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
EXAMINER
MORALES, JON ERIC C
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/01/2017 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):
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LILIAN KORNET and RAPHAEL SCHNEIDER
Appeal 2015-000856
Application 12/608,855
Technology Center 3700
Before MICHAEL L. HOELTER, JILL D. HILL, and GORDON D.
KINDER, Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Lilian Komet and Raphael Schneider (“Appellants”) appeal under 35
U.S.C. § 134(a) from the Examiner’s decision to reject claims 1, 4—11, 14,
15, 17—24, and 27—36. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal 2015-000856
Application 12/608,855
CLAIMED SUBJECT MATTER
Independent claims 1, 4, 5, 11, 14, and 15 are pending. Claim 1,
reproduced below, illustrates the claimed subject matter.
1. A method comprising:
sensing a parameter indicative of heart rate turbulence;
measuring heart rate turbulence based on the sensed
parameter; and
predicting an occurrence of an arrhythmia based on the
measured heart rate turbulence; and
wherein the sensed parameter comprises cardiac
contractility, the method further comprising deriving a plurality
of values of an interval between cardiac contractions from the
sensed parameter, and wherein measuring heart rate turbulence
comprises calculating heart rate turbulence based on the interval
values.
REJECTION
I. Claims 1, 4—11, 14, 15, 17—24, and 27—36 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Farazi (US 7,580,747 Bl; iss. Aug.
25, 2009) and Dalai (US 2008/0004672 Al; pub. Jan. 3, 2008). Final Act. 2.
ANALYSIS
Claim 1 recites: (1) sensing cardiac contractility; (2) deriving a
plurality of values of an interval between cardiac contractions from the
sensed cardiac contractility; (3) measuring heart rate turbulence based on the
cardiac contraction interval values; and (4) predicting an occurrence of an
arrhythmia based on the measured heart rate turbulence.
Regarding independent claims 1 and 11, the Examiner finds that
Farazi senses “a parameter indicative of heart rate turbulence,” “measures
heart rate turbulence based on the sensed parameter 406,” and “predicts an
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occurrence of an arrhythmia based on the measured heart rate turbulence.”
Final Act. 2. The Examiner finds that Farazi does not disclose the sensed
parameter being cardiac contractility, and therefore does not disclose (1)
deriving cardiac contraction interval values from cardiac contractility, and
(2) calculating heart rate turbulence based on the cardiac contraction interval
values. Id. at 2—3. The Examiner finds, however, that Dalai discloses the
cardiac contractility limitations missing from Farazi. Id. at 3. The
Examiner concludes that it would have been obvious to modify Farazi to
derive cardiac contraction interval values to measure heart rate turbulence as
taught by Dalai “to facilitate proper [] detection of heart rate turbulence and
sensing of arrhythmia.” Id.
Regarding independent claims 4 and 14, the Examiner again finds that
Farazi senses “a parameter indicative of heart rate turbulence,” “measures
heart rate turbulence based on the sensed parameter 406,” and “predicts an
occurrence of an arrhythmia based on the measured heart rate turbulence.”
Id. The Examiner also finds that Farazi discloses “charging a therapy
delivery circuit in response to predicting the occurrence of the arrhythmia.”
Id. (citing Farazi 7:7—32). The Examiner makes no findings regarding the
disclosure of Dalai, and does not propose combining Farazi and Dalai. Id.
Regarding independent claims 5 and 15, the Examiner again finds that
Farazi senses “a parameter indicative of heart rate turbulence,” “measures
heart rate turbulence based on the sensed parameter 406,” and “predicts an
occurrence of an arrhythmia based on the measured heart rate turbulence.”
Id. at 3^4. The Examiner also finds that Farazi discloses “identifying an
abnormal heartbeat, [and] measuring heart rate turbulence resulting from the
abnormal heartbeat.” Id. at 4—5 (citing Farazi 7:34-45). The Examiner
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makes no findings regarding the disclosure of Dalai, and does not propose
combining Farazi and Dalai. Id. at 5.
Claims 1 and 28
Appellants argue claims 1 and 28 as a group. We select claim 1 as
representative, and claim 28 stands or falls with claim 1.
Cardiac Contractility
Regarding independent claim 1, Appellants argue that the Examiner
failed to indicate what parameter, sensed by Dalai, measures “cardiac
contractility.” Appeal Br. 8. Appellants contend that Dalai fails to disclose
any sensing of cardiac contractility. Id.
Regarding sensing of “cardiac contractility,” the Examiner appears to
define “cardiac contractility” as cardiac contractions. The term is only used
twice in Appellants’ original disclosure, and is never defined. See Spec. 26
(original claim 9) and Spec. 27 (original claim 19). The Examiner’s
definition of “cardiac contractility” is consistent with Appellants’
Specification, and Appellants have not offered an alternative definition.
Spec 125 (disclosing the use of “sensors capable of sensing mechanical
cardiac contractions” and R-R intervals, and explaining that “R-R interval
values may be used to calculate a heart rate turbulence related parameter.”).
We thus find no error in the Examiner’s definition of “cardiac contractility”
as “cardiac contractions.”
Farazi discloses using heart rate turbulence to predict sudden cardiac
death, and appreciates that arrhythmia is an event that can cause sudden
cardiac death — thus Farazi uses heart rate turbulence to predict arrhythmia.
See Farazi Background, 14:52—62. Regarding sensing of cardiac
contractions, Farazi discloses two sensors 82, 84 to predict arrhythmia by
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classifying time intervals between sensed events via comparison of the
intervals to “rate zone limit[s].” Farazi 6:52—7:6, 7:19—32. One skilled in
the art would understand that Farazi senses cardiac contractions to derive the
intervals therebetween. Farazi discloses in its step 404, recording R-R
intervals following a premature contraction, which Farazi also refers to as
“measuring one or more degrees of heart rate turbulence.” Farazi 13:42-45,
13:48—50. Similar to disclosure found in the discussion of Appellants’
Figure 9, Farazi’s measured heart rate turbulence parameters can include
turbulence onset and slope. The measured degree of heart rate turbulence is
used to classify the risk of sudden cardiac death (e.g., arrhythmia). Farazi
13:45—48.
Farazi therefore discloses sensing cardiac contractions, recording
intervals between cardiac contractions, measuring heart rate turbulence
based on the recorded intervals, and predicting arrhythmia based on the
measured heart rate turbulence.
Dalai discloses diabetic therapy that includes anti-arrhythmia therapy
(Dalai 15), wherein sensors measure cardiac contraction intervals (Dalai H
34—35 (such as R-R intervals)), which are used to quantifying heart rate
turbulence (Dalai 136). One skilled in the art would understand that Dalai
senses cardiac contractions to derive the intervals therebetween. Dalai
provides a more detailed explanation of how heart rate turbulence is
measured from R-R intervals. Dalai 136.
Given the Examiner’s definition of “cardiac contractility” as “cardiac
contractions,” we discern no error in the Examiner’s finding that Dalai
discloses sensing cardiac contractility.
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Predicting Arrhythmia
Appellants also argue that neither Farazi nor Dalai discloses
predicting an occurrence of an arrhythmia based on []measured heart rate
turbulence,” because Farazi is directed to sudden cardiac death (SCD) and
Dalai discloses using heart rate turbulence to determine Heart failure (HF),
and predicting SCD and HF are different than predicting an arrhythmia.
Appeal Br. 8—9.
We are not persuaded by this argument because, as explained above,
Farazi recognizes that arrhythmia is a cause of SCD, and Dalai recognizes
that arrhythmia is a cause of HF.
Reasoning
Appellants next argue that the Examiner’s proposed reason for
combining Farazi and Dalai lacks a rational basis, because neither Farazi nor
Dalai discloses mechanical sensing of cardiac contractions, “let alone that
mechanical sensing of cardiac contractions either facilitates proper detection
of [heart rate turbulence] or aids in the sensing of arrhythmia.” Appeal Br.
9.
“Mechanical” sensing is not recited in claim 1. Further, as explained
above, both Farazi and Dalai disclose sensing cardiac contractions to
ascertain intervals therebetween to measure heart rate turbulence and predict
arrhythmia. We therefore are not persuaded by Appellants’ argument.
Claim 27
Claim 27 depends from claim 1, and recites various sensor types to
sense cardiac contractility. The Examiner finds that Farazi discloses this
limitation. Final Act. 5. Appellants argue that the Examiner’s finding is
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necessarily erroneous, because the Examiner acknowledges, in rejecting
claim 1, that Farazi does not disclose “the ‘sensed parameter’ being cardiac
contractility.” Appeal Br. 10; Final Act. 2.
We are not persuaded by this argument because, for the reasons set
forth above regarding claim 1, we determined that Farazi senses R-R
intervals, and one skilled in the art would understand that Farazi senses
cardiac contractions to derive the intervals therebetween.
Appellants also argue that Farazi only discloses a physiological sensor
108 detecting “changes in cardiac performance or changes in a physiological
condition of the heart,” and an activity sensor 116 determining the activity
and posture of the patient, none of these sensed parameters being cardiac
contractility. Appeal Br. 10; Reply Br. 3^4.
The Examiner clarifies that it is Dalai that discloses sensing
“intracardiac or intravascular pressure, an accelerometer or other sensor
capable of detecting heart or blood sounds, vibrations, or motion, an intra­
cardiac or intra-arterial impedance, [etc.].” Ans. 6 (citing Dalai 134
(sensing and analyzing parameters such as “heart rate variability (HRV),
heart rate turbulence (HRT), heart sounds, electrogram features, activity,
respiration and pulmonary artery pressure”) and 140 (respiration detection)).
We are not persuaded that the Examiner’s finding regarding Dalai is
in error.
Claims 4, 33, and 34
Appellants argue claims 4, 33, and 34 as a group. We select
independent claim 4 as representative. Claims 33 and 34 stand or falls with
claim 4. The Examiner finds that Farazi discloses the limitations of claim 4.
Final Act. 3.
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Regarding independent claim 4, Appellants argue that “the portions of
Farazi relied upon as disclosing charging a therapy delivery circuit in
response to predicting the occurrence of the arrhythmia, make no mention
of’ using heart rate turbulence to predict arrhythmia. Appeal Br. 11.
According to Appellants, Farazi detects arrhythmia, rather than predicting
the occurrence thereof. Id. at 12. Further, there is no suggestion that
Farazi’s arrhythmia detector 75 utilizes heart rate turbulence to detect
arrhythmias. Id. Thus, although Farazi discloses charging a therapy
delivery circuit, Appellants contend that such charging “cannot reasonably
be considered to be in response to predicting the occurrence of an
arrhythmia based on heart rate turbulence” as claimed. Id.
For the reasons set forth above regarding claim 1, we agree with the
Examiner that Farazi uses the intervals between cardiac contractions to
measure heart rate turbulence, which is then used to predict the occurrence
of arrhythmia. We therefore are not persuaded by this argument.
Claims 5—8 and 31
Appellants argue claims 5—8 and 31 as a group. We select
independent claim 5 as representative. Claims 6—8 and 31 stand or fall with
claim 5. The Examiner finds that Farazi discloses the limitations of
independent claim 5, including “measuring heart rate turbulence resulting
from the abnormal heartbeat.” Final Act 3^4 (citing Farazi 7:34-45).
Regarding independent claim 5, Appellants argue that Farazi fails to
disclose “measuring heart rate turbulence resulting from an abnormal heart
beat.” Appeal Br. 13.
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The Examiner finds that Farazi’s “ventricular premature beat” (or
premature ventricular contraction) is an abnormal heart beat. Ans. 7.
Appellants do not refute this finding, and we are not persuaded that it is in
error.
Claim 9
Claim 9 depends from claim 5, and recites that the sensed parameter
comprises cardiac contractility, deriving a plurality of values of an interval
between cardiac contractions from the sensed parameter, and calculating
heart rate turbulence based on the interval values. The Examiner relies on
Dalai for this disclosure. Final Act 4.
Appellants argue that “the Examiner has failed to provide any
explanation as to why one of ordinary skill in the art would have found it
obvious to modify Farazi to include the relied upon disclosure of Dalai.”
Appeal Br. 14.
Although the Examiner does not restate a reason for combining Farazi
and Dalai in addressing independent claim 5 or dependent claim 9 (Final Act
3—4), the Examiner’s reasoning is set forth in the analysis of claim 1 (id. at
3) and, as explained above regarding claim 1, we are not persuaded that the
Examiner’s reasoning lacks a rational basis.
Claim 10
Claim 10 depends from claim 5 and recites “comparing the measured
heart rate turbulence to a threshold value” and predicting arrhythmia “based
on the comparison.” The Examiner finds this disclosure in Farazi. Final
Act. 4—5 (citing Farazi 13:42—50 (measuring heart rate turbulence and
assessing risk of sudden cardiac death based thereon), 18:5—23 (measuring
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heart rate turbulence, and comparing heart rate turbulence to a threshold to
assess autonomic tone)).
Appellants argue that the cited portions of Farazi do not disclose using
heart rate turbulence to predict an occurrence of arrhythmia. Appeal Br. 14.
As set forth above regarding claim 1, Farazi discloses using heart rate
turbulence to predict arrhythmia. We therefore are not persuaded by this
argument.
Claims 11 and 30
Appellants reiterate the arguments set forth regarding claim 1. Appeal
Br. 15. For the reasons set forth above, we are not persuaded by these
arguments.
Claim 29
Appellants reiterate the arguments set forth regarding claims 1 and 27.
Appeal Br 15—16. For the reasons set forth above, we are not persuaded by
these arguments.
Claims 14, 35, and 36
Appellants reiterate the arguments set forth regarding claim 4. Appeal
Br. 16—17. For the reasons set forth above, we are not persuaded by these
arguments.
Claims 15—18, and 33
Appellants reiterate the arguments set forth regarding claim 5. Appeal
Br. 17. For the reasons set forth above, we are not persuaded by these
arguments.
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Claim 19
Appellants reiterate the arguments set forth regarding claim 9. Appeal
Br. 17—18. For the reasons set forth above, we are not persuaded by these
arguments.
Claim 20
Appellants reiterate the arguments set forth regarding claims 5 and 10.
Appel Br. 18. For the reasons set forth above, we are not persuaded by these
arguments.
DECISION
We AFFIRM the rejection claims 1, 4—11, 14, 15, 17—24, and 27—36
under 35 U.S.C. § 103(a) as unpatentable over Farazi and Dalai.
AFFIRM
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