Ex Parte Cazares et al

Patent Trial and Appeal Board

Mar 4, 2015

12686122 (P.T.A.B. Mar. 4, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte SHELLEY CAZARES, JAEHO KIM, YAYUN LIN, and
CARLOS RICCI
____________

Appeal 2012-006758
Application 12/686,122
Technology Center 3700
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
1

This appeal under 35 U.S.C. § 134 involves claims 1–20 (App. Br. 3).
Examiner entered rejections under 35 U.S.C. § 103(a) and obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The claims are directed to a method of operating a medical device and
a medical system. Claims 1, 11, and 20 are representative and are
reproduced in the Claims Appendix of Appellants’ Brief.

1
The Real Party in Interest is Cardiac Pacemakers, Inc. (App. Br. 1.)
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Application 12/686,122

2
Claims 1–20 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Schwartz
2
and Stadler.
3

Claims 1–20 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–12
of Cazares.
4

Appellants contend that they “will file a terminal disclaimer . . . once
allowable subject matter is identified” (App. Br. 11). Because Appellants do
not present arguments against the rejection of claims 1–20 under the
judicially created doctrine of obviousness-type double patenting, the
rejection is summarily affirmed and will not be discussed further.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants’ Figures 1B and 2B are reproduced below:

2
Schwartz et al., US 2004/0093035 A1, published May 13, 2004.
3
Stadler et al., US 7,103,404 B2, issued Sept. 5, 2006.

4
Cazares et al., US 7,653,431 B2, issued Jan. 26, 2010.
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Figure 1B illustrates “a cardiac [sensed] waveform 100 representing a
particular beat morphology . . . and one or more cardiac waveform features
120. A [detected] waveform feature 120 may include a particular point of a
cardiac signal waveform 100 having [an] amplitude coordinate and a time
coordinate” (Spec. 8: 2–9: 2; see also id. at ll. 24–28 (“Figure 1B illustrates
the morphology of a cardiac beat signal waveform with identification of
amplitude and timing signal features that may be extracted for template
creation and/or for comparison with templates formed using previous beats
in accordance with embodiments of . . . [Appellants’] invention”)).
“Figure 2B illustrates rate-indexed templates in accordance with
embodiments of . . . [Appellants’] invention” (Spec. 6: 4–5; see also id. at
10: 10–12 (“As illustrated in Figure 2B, each [rate-indexed SVT] template
T0, T1, T2 is stored individually, and is indexed according to its associated
rate, r0, r1, r2. Each template may be used to represent a range of rates”);
Spec. 10: 18–20 (“To conserve device memory, the increment between rates
may be managed to prevent the total number of templates from becoming
excessively large”); Spec. 15: 17–20 (After acquisition of the rate-indexed
templates . . . the rate-indexed templates may be used for SVT/VT
discrimination”)).
FF 2. Appellants disclose that
“[i]f a tachyarrhythmia episode is detected . . ., the episode rate
is estimated. . . . An SVT template is selected . . . based on the
episode rate. The morphology of the cardiac signal detected
during the tachyarrhythmia episode is compared to the selected
SVT template. If the episode morphology is sufficiently similar
. . . to the template, the episode is classified . . . as SVT
[(supraventricular tachyarrhythmia)]. If the episode
morphology is not sufficiently similar . . . to the template, the
episode is classified . . . as VT [(ventricular tachyarrhythmia)].
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(Spec. 15: 24–30; see also id. at 2: 10 (“[v]entricular tachyarrhythmia
(VT)”); id. at 1: 31 (“supraventricular tachyarrhythmia (SVT)”).)
FF 3. Schwartz relates “to cardiac rhythm management systems and
methods using multiple templates for discriminating between rhythms”
(Schwartz ¶ 1; see generally Ans. 4).
FF 4. Schwartz suggests a device that “includes memory storage for data
associated with two or more morphological templates, such as a first
morphological template . . . and . . . a second morphological template . . .,
which are obtained from heart . . . under different conditions” and “a
correlation module . . ., which distinguishes between at least two different
rhythm states by comparing and correlating the morphology of at least one
recently received cardiac complex to at least one of the stored first and
second morphological templates” (Schwartz ¶ 25; Ans. 4).
FF 5. Examiner finds that Schwartz fails to suggest “determining the heart
rate at which the change in morphology occurs” and relies on Stadler to
make up for this deficiency in Schwartz (Ans. 5).
FF 6. Stadler suggests an “implanted medical device . . . [that] can be
configured to obtain both a tachyarrhythmia rate and a morphology of a
cardiac waveform” (Stadler, col. 1, ll. 48–50; Ans. 5 (Stadler suggests “that
it is known to monitor both the heart rate and the cardiac morphology
data”)).
FF 7. Stadler suggests “a processor [that] compares the tachyarrhythmia
rate to a relative threshold rate and compares the morphology to a template
morphology” (Stadler, col. 1, ll. 55–57; see generally Ans. 5).
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FF 8. Stadler suggests that
[w]hen the rate of the tachyarrhythmia episode decreases, [the]
implanted medical device . . . applies [a] slow redetection
criteria in attempts to redetect the tachyarrhythmia episode . . . .
The slow redetection criteria may include comparing the rate of
the tachyarrhythmia episode to a threshold tachyarrhythmia
rate, comparing the pattern of atrial and ventricular
depolarization events to known patterns of VT or SVT rhythms,
and/or also comparing a morphology of a cardiac waveform
associated with a heart beat with a template morphology.
(Stadler, col. 14, ll. 1-14; Ans. 5)
ANALYSIS
Based on the combination of Schwartz and Stadler, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious
to modify the system as taught by Schwartz with both the heart
rate and the cardiac morphology data, and further . . . monitor[]
the heart rate at which the different morphologies [occur] by
comparing the heart rate data to the corresponding morphology
template of VT or SVT, since [Stadler suggests] monitoring of
the heart rate data occurs concurrently with morphological
monitoring and VT and SVT pattern monitoring.
(Ans. 5.) In reaching this conclusion, “Examiner acknowledges [that] the
heart rate and VT and SVT patterns are not actually compared against each
other” in Stadler and that Stadler’s reference to a template “refers to . . . a
normal sinus rhythm template,” not a VT or SVT morphology template
(Ans. 8 and 9; see App. Br. 9 (Stadler only describes obtaining a normal
sinus rhythm template” and the “‘known patterns of VT or SVT rhythms’
mentioned in [Stadler’s] Col. 14[, ll. 7–8] are not morphology templates, nor
are they compared to heart rate data”); Reply Br. 4 (Stadler does not teach
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determining that a change in morphology has occurred or comparing heart
rate data with morphology data); see generally Reply Br. 3)).
Nevertheless, Examiner asserts that “since morphology refers to the
overall shape/pattern of the wave form” a “SVT pattern[] . . . meet[s] the
claimed limitation of SVT morphology” and, therefore, “the concurrent
monitoring of both . . . [heart rate data and VT or SVT patterns] would
necessarily provide [an] indication of a rate at which the change in
morphology occurs” (Ans. 8 and 9; Cf. FF 9). We are not persuaded by
Examiner’s unsupported assertion that Stadler’s careful and distinct use of
the words “pattern” and “morphology” can be disregarded as the two terms,
in Examiner’s view, have the same meaning (see FF 9 (“comparing the
pattern . . . to known patterns . . . and/or also comparing a morphology . . .
with a template morphology”); see Reply Br. 5 (“[t]he assertion that
Stadler’s SVT patterns would correspond to the claimed SVT morphology is
unsupported”)). “[R]ejections on obviousness grounds cannot be sustained
by mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
In sum, Examiner failed to establish an evidentiary basis on this
record to support a conclusion that the combination of Schwartz and Stadler
suggests the characterization of morphologies of the SVT waveform and
determining whether the morphologies of the SVT waveforms are dependent
or independent with respect to heart rate, as required by Appellants’ claimed
invention.
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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 1–20 under 35
U.S.C. § 103(a) as unpatentable over the combination of Schwartz and
Stadler is reversed.
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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