Ex Parte Shelchuk et al

Patent Trial and Appeal Board

Feb 17, 2017

11737650 (P.T.A.B. Feb. 17, 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.
11/737,650 04/19/2007 Anne M. Shelchuk A07P1072 6022
36802 7590
PACESETTER, INC.
15900 VALLEY VIEW COURT
SYLMAR, CA 91392-9221
EXAMINER
HELLER, TAMMIE K
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/22/2017 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 ANNE M. SHELCHUK and DAN E. GUTFINGER
Appeal 2015-004096
Application 11/737,650
Technology Center 3700
Before JENNIFER D. BAHR, LINDA E. HORNER, and
BRANDON J. WARNER, Administrative Patent Judges.
WARNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Anne M. Shelchuk and Dan E. Gutfmger (“Appellants”)1 appeal under
35 U.S.C. § 134(a) from the Examiner’s decision rejecting claims 1—3, 6,
and 8. Br. 3. Claim 9 has been canceled, and claims 4, 5, 7, and 10—20 have
been withdrawn. See Final Act. 1 (Office Action Summary). We have
jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is Pacesetter, Inc.,
dba St. Jude Medical, Implantable Electronic Systems Division. Br. 3.
Appeal 2015-004096
Application 11/737,650
CLAIMED SUBJECT MATTER
Appellants’ disclosed invention relates to “measuring pressure to
generate an indication of ischemia.” Spec. 12. Claim 1, reproduced below,
is the sole independent claim and is representative of the subject matter on
appeal.
1. A method of generating an indication of ischemia
associated with a heart of a patient, comprising:
detecting one or more electrical depolarizations;
determining a change in one or more ischemia related
parameters in the electrical depolarizations;
detecting an indication of an ischemic condition as a
function of the change in the one or more ischemia related
parameters;
determining an electrical depolarization to mechanical
contraction delay for a ventricle of a heart;
determining whether the delay is more than an expected
delay;
corroborating the indication of an ischemic condition in
accordance with a determination that the delay is more than the
expected delay; and
modifying cardiac therapy in response to the
corroboration of an indication of an ischemic condition.
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Patangay US 2008/0177191 A1 July 24,2008
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Application 11/737,650
REJECTION
The following rejection is before us for review: Claims 1—3, 6, and 8
stand rejected under 35 U.S.C. § 102(e) as anticipated by Patangay. Final
Act. 2-4.
ANALYSIS
Appellants argue against the rejection of claims 1—3, 6, and 8 as a
group. See Br. 5—9. We select claim 1 as representative of the issues that
Appellants present in the appeal of this rejection, with claims 2, 3, 6, and 8
standing or falling therewith. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner found that Patangay discloses a method of generating
an indication of ischemia in a heart, where the method includes all of the
limitations as recited in independent claim 1. See Final Act. 2—3. In
particular, the Examiner found that Patangay discloses detecting electrical
depolarizations, and detecting an indication of ischemia based on a change
in ischemia-related parameters in the electrical depolarizations. See id.
(citing Patangay, Figs. 7, 9-13,137). The Examiner also found that
Patangay discloses “determining an electrical depolarization (Q or R wave)
to mechanical contraction (SI heart sound) delay for a ventricle of a heart”
{id. at 3 (citing Patangay, Fig. 7, Tflf 63—64)), and determining whether the
delay is greater than an expected delay in order to corroborate an indication
of ischemia (see id. (citing Patangay 1 65)).
Appellants argue that Patangay “do[es] not disclose or in any way
suggest determining a change in one or more ischemia[-]related parameters
in detected electrical depolarization to detect an indication of an ischemic
event.” Br. 7. In particular, Appellants assert that Patangay “discloses a
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Application 11/737,650
method that detects ischemia based upon changes in an interval between
detected physiologic cardiovascular events wherein at least one of the events
is a heart sound event” and “activating an alarm or some other user
detectable indication that an ischemic event has occurred.” Id. at 8 (citing
Patangay 137). In response to Appellants’ argument, the Examiner clarifies
that “Patangay discloses . . . that an ECG signal is obtained in combination
with a heart sound signal and ischemia related parameters associated with
the ECG and the heart sound signal are utilized to determine ischemia,
specifically determining a change in these parameters from a baseline.”
Ans. 2—3 (citing Patangay H 49—53).
We are not persuaded by Appellants’ argument. The Examiner’s
findings regarding Patangay’s disclosure, particularly as clarified in the
Answer, are supported by a preponderance of the evidence. Specifically,
Patangay discloses that “cardiac signal sensing circuit 640 senses electrical
cardiac signals associated with the action potential signals of a heart.”
Patangay 151; see also id. (disclosing that “[ejxamples of signal sensing
circuits 640 include, without limitation, a subcutaneous electrocardiogram
(ECG) sensing circuit, an intracardiac electrogram (EGM) sensing circuit,
and a wireless ECG sensing circuit”). Patangay discloses that “IMD 605
declares that an ischemic event occurred using ... a measured change in the
cardiac signal from an established baseline cardiac signal.” Id. 1 53.2 Thus,
2 For example, Patangay discloses that “signal analyzer circuit 630
declares that an ischemic event has occurred using a specified measured
minimum change from the corresponding baseline heart sound signal and a
sensed cardiac signal having an S-wave to T-wave (‘ST’) interval that
deviates by at least a specified amount from an ST interval of a baseline
cardiac signal.'” Patangay 1 53 (emphasis added).
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Application 11/737,650
Appellants’ argument does not apprise us of error in the Examiner’s findings
(Final Act. 2—3; Ans. 2—3) that Patangay discloses detecting electrical
depolarizations, and detecting an ischemic event based on a determined
change in ischemia-related parameters in the depolarizations.
Appellants argue that paragraphs 63 and 64 of Patangay “do[] not
disclose or suggest determining an electrical depolarization to mechanical
contraction delay for a ventricle of a heart[,] nor does this section of
Patangay . . . corroborate an indication of an ischemic condition in
accordance with a determination that the delay is more than an expected
delay.” Br. 8. According to Appellants, “Patangay . . . attempts to
determine the PEP [(pre-ejection period)] by monitoring the interval
between the Q-wave and the S1 heart sound and is in no way related to the
detection of ischemia.” Id.
Appellants’ argument is not convincing. Patangay discloses that,
“[a]s the result of an ischemic event, contractility of the heart may change,”
and “[t]he pre-ejection period (PEP) may also rise.” Patangay 1 62; see also
id. 1 63 (disclosing that “[sjurrogate measurements for intervals such as PEP
can be used to monitor cardiac output”). Patangay discloses that “[a]n
indication of an increase in PEP can be detected from a measured increase in
a time interval from the Q-wave to the SI heart sound (Q-Sl).” Id. | 64. In
this regard, the Examiner explains that “the R-Sl interval and Q-Sl intervals
are both intervals between an electrical depolarization, the R or Q wave, and
a mechanical contraction, indicated by the SI heart sound.” Ans. 3. We do
not discern a significant distinction between the “electrical depolarization to
mechanical contraction delay for a ventricle of a heart,” as recited in claim 1,
and the interval between a Q-wave and S1 heart sound identified by the
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Application 11/737,650
Examiner in the cited portions of Patangay. Additionally, Patangay
discloses “declaring] that an ischemic event occurred using both a measured
change in the cardiac signal from an established baseline cardiac signal and
a measured change in the heart sound signal from an established
corresponding baseline heart sound signal,” and “[u]sing both signals to
conclude that an ischemic event occurred increases the confidence of
specificity in the conclusion.” Patangay 1 53. Thus, Appellants do not
apprise us of error in the Examiner’s finding (Final Act. 3; Ans. 3 4) that
Patangay discloses corroborating an indication of ischemia using an
electrical depolarization to mechanical contraction delay, which is supported
by a preponderance of the evidence.
Appellants also argue that Patangay does not disclose “a method for
detecting ischemia that first detects an indication of an ischemic condition
from parameters determined from electrical depolarizations and then
corroborates the indication of an ischemic condition as a function of the
delay between electrical depolarization and mechanical contraction.”
Br. 7—8. We do not find this argument persuasive of error because it is not
commensurate in scope with claim 1. Namely, claim 1 does not require that
the parameter-based ischemia determination necessarily occur “first” or
before the electrical depolarization to mechanical contraction delay-based
ischemia determination. Further, we do not understand “corroborating” as
requiring any particular order; rather, we construe “corroborating” as simply
requiring the use of both determinations to make the diagnosis more certain.3
3 An ordinary meaning of “corroborate” is “to support with evidence or
authority” or “make more certain,” which is consistent with the use of this
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As stated by our reviewing court in In re Hiniker Co., 150 F.3d 1362, 1369
(Fed. Cir. 1998), “the name of the game is the claim.” It is well established
that limitations not appearing in the claim cannot be relied upon for
patentability. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982).
Accordingly, for the foregoing reasons, we sustain the rejection of
independent claim 1, and of claims 2, 3, 6, and 8 falling therewith, under
35 U.S.C. § 102(e) as anticipated by Patangay.
DECISION
We AFFIRM the Examiner’s decision rejecting claims 1—3, 6, and 8
under 35 U.S.C. § 102(e) as anticipated by Patangay.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
term within Appellants’ Specification. See Merriam-Webster’s Collegiate
Dictionary (11th ed. 2003); see also Spec. 14, 41, 44, 48.
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