Ex Parte Gunderson et al

Patent Trial and Appeal Board

Aug 19, 2014

11096851 (P.T.A.B. Aug. 19, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BRUCE D. GUNDERSON, AMISHA S. PATEL, and
CHAD A. BOUNDS
____________

Appeal 2011-009913
Application 11/096,851
Technology Center 3700
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
ERIC B. GRIMES, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1, 2, 5, 7, 15, 17,
22–26, and 29–36 (App. Br. 3).2 Examiner entered rejections under the
written description provision of 35 U.S.C. § 112, first paragraph, 35 U.S.C.
§ 102(b), and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b).
We reverse.

1 The Real Party in Interest is Medtronic, Inc. (App. Br. 3).
2 Pending “[c]laims 20 and 28 stand objected to as being dependent upon a
rejected base claim” (App. Br. 3).
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STATEMENT OF THE CASE
The claims are directed to an implantable medical device and a
method of controlling ventricular tachycardia (VT) and ventricular
fibrillation (VF) detection in an implantable medical device. Claims 1 and
17 are representative and are reproduced in the Claims Appendix of
Appellants’ Brief.
Claims 5, 7, 15, 25, 26, 33, 34, and 36 stand rejected under the written
description provision of 35 U.S.C. § 112, first paragraph.
Claims 1, 2, 5, 15, 17, 29, and 35 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Gunderson.3
Claims 22–25 and 30–33 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Gunderson.
Claim 36 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Gunderson and Palreddy.4

Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellants’ Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose that
To monitor ventricular tachyarrhythmia, the ICD
[(implantable cardioverter defibrillator)5] senses ventricular

3 Gunderson, US 2004/0015197 A1, published Jan. 22, 2004.
4 Palreddy et al., US 2006/0116595 A1, published June 1, 2006.
5 Spec. 1: ¶ [0002].
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depolarizations or -R-waves-. For accurate tachyarrhythmia
detection, only one event (the R-wave) should be sensed during
each normal sinus cardiac cycle. Oversensing of events other
than the R-wave can result from sensing cardiac events such as
ventricular repolarizations (T-waves) and far field R-waves,
from double counting R-waves, and from sensing non-cardiac
signals such as myopotentials from surrounding muscle tissue,
noise from electromagnetic interference (EMI) external to the
patient, or noise produced by a lead failure due to failed
insulation, broken conductors or a poor connection to the ICD.
(Spec. 1–2: ¶ [0004].)
FF 2. Appellants disclose that “[i]f the VT or VF NID [number of intervals
detected6] value has been met, the microprocessor . . . checks the flag to see
whether at least two of the three count thresholds have been met . . . . If the
answer is yes, this is evidence of T-wave oversensing” (Spec. 11: ¶ [0058]).
FF 3. Appellants disclose that “[d]etection is withheld if the combination
of the three counts indicates T-wave oversensing is present, or if one of the
counts strongly indicates the presence of T-wave oversensing” (id. at 12:
¶ [0061] (emphasis added)).
ANALYSIS
The method of Appellants’ claim 5 requires, inter alia, detection of a
VT or VF is withheld in response to the third count and one of the first count
or second count indicating the presence of oversensed T-waves among the
sensed R-waves (see, e.g., Appellants’ claim 5; see also Appellants’ claim
25 (“withholding detection of the VT or VF in response to two of the first
count, the second count, and the third count exceeding the respective first
count threshold, the second count threshold and the third count threshold”)).

6 Spec. 7: ¶ [0032].
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The method of Appellants’ Claim 7 requires, inter alia, that detection be
withheld in response to one of the first count and the second count reaching
a value strongly indicating T-wave oversensing, even if the other count does
not indicate T-wave oversensing (see Appellants’ claim 7).
Examiner finds that Appellants’ Specification fails to provide written
descriptive support for the phrases “the third count and one of the first count
and second count” (see Appellants’ claim 5) or “two of the first count, the
second count, and the third count” (see, e.g., Appellants’ claim 25). We are
not persuaded. As Appellants explain, their
[S]pecification supports withholding detection if at least two of
any of the three counts indicate oversensing. One of ordinary
skill in the art would reasonable conclude that this means that
Appellant’s [sic] specification describes withholding detection
if Count 1 and Count 2 indicate oversensing, withholding
detection if Count 1 and Count 3 indicate oversensing,
withholding detection if Count 2 and Count 3 indicate
oversensing, or withholding detection if all of Count 1, Count 2,
and Count 3 indicate oversensing.
(App. Br. 10–11; see generally FF 1 and 2.) We agree with Appellants.
Examiner finds that Appellants’ Specification fails to provide written
descriptive support for the phrase “withholding detection in response to the
other one of the first and the second count reaching a value [that] ‘strongly’
indicat[es] T-wave oversensing” (see Appellants’ claim 7). We are not
persuaded. As Appellants explain, “[o]ne of ordinary skill in the art would
reasonably conclude that since any of the counts may strongly indicate
oversensing that Count 1 or Count 2 may strongly indicate oversensing”
(App. Br. 11; see generally FF 3). We agree with Appellants.
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CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Appellants’ Specification fails to provide written
descriptive support for the claimed invention. The rejection of claims 5, 7,
15, 25, 26, 33, 34, and 36 under the written description provision of
35 U.S.C. § 112, first paragraph is reversed.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Gunderson teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 4. Gunderson teaches that
One method for evaluating the interval regularity in order to
differentiate a VF detection due to a high rate VT from a VF
detection due to oversensing is to calculate a sum of successive
interval differences. For example, the difference between each
consecutive pair of intervals for a given number of the most
recent intervals leading up to VF detection may be summed. If
the sum of these consecutive interval differences is less than a
predetermined maximum, the intervals are considered regular.
For example, a criterion for detecting interval regularity may
require that the sum of 12 consecutive interval differences be
less than 150 milliseconds.
(Gunderson 8: ¶ [0073].)
ANALYSIS
The method of Appellants’ independent claim 1 requires, inter alia,
“maintaining a first count to track a number of occurrences of large
successive interval differences” (Appellants’ claim 1; see also Appellants’
only other independent claim, claim 17 (an implantable medical device
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comprising a processor that “maintain[s] a first count of T-wave oversensing
characteristics to track a number of occurrences of large successive interval
differences”)). Therefore, we are not persuaded by Examiner’s assertion
that Appellants’ “claims do not require . . . a count to track the number of
occurrences of large successive interval differences” (Ans. 8 (emphasis
removed)).
Thus, we are not persuaded by Examiner’s assertion that Gunderson’s
teaching of a method for evaluating “interval regularity in order to
differentiate a VF detection due to a high rate VT from a VF detection due to
oversensing” by “calculat[ing] a sum of successive interval differences”
reads on Appellants’ claimed invention (see Ans. 4; Cf. FF 4; App. Br. 7–9;
Reply Br. 2–3).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Gunderson teaches Appellants’ claimed invention.
The rejection of claims 1, 2, 5, 15, 17, 29, and 35 under 35 U.S.C. § 102(b)
as being anticipated by Gunderson is reversed.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
The rejection over Gunderson:
Claims 22–25 and 30–33 depend directly or indirectly from
Appellants’ claim 1.
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Examiner finds that “Gunderson does not disclose that the first count
is incremented in response to the current interval and the immediately
preceding interval” (Ans. 6). Nevertheless, Examiner concludes that, at the
time Appellants’ invention was made, it would have been prima facie
obvious to “increment the first count (per [Gunderson] par. 0073) in
response to the current and immediately preceding interval (as disclosed for
the ‘second count’ in [Gunderson] par. 0076) to provide the predictable
results of determining regularity with the most current cardiac data” (Ans.
6). We are not persuaded. Examiner failed to establish that Gunderson
makes obvious a method that comprises “maintaining a first count to track a
number of occurrences of large successive interval differences” (Appellants’
claim 1).

The rejection over the combination of Gunderson and Palreddy:
Examiner finds that Gunderson fails to suggest the detection of
“morphology variation by comparing to a template and classifying based on
a percentage match with the template” and relies on Palreddy to make up for
this deficiency in Gunderson (Ans. 7). Based on the combination of
Gunderson and Palreddy, Examiner concludes that, at the time Appellants’
invention was made, it would have been prima facie obvious “to modify
Gunderson by detecting the morphology variation by comparing to a
template and classifying based on a percentage match with the template to
provide the predictable results of effectively determining abnormal cardiac
complexes with a robust system” (id.). Examiner, however, fails to establish
that Palreddy makes up for the foregoing deficiency in Gunderson.
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CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 22–25 and 30–33 under 35 U.S.C. § 103(a) as
unpatentable over Gunderson is reversed.
The rejection of claim 36 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Gunderson and Palreddy is reversed.

REVERSED

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