Ex Parte Stadler et al

Patent Trial and Appeal Board

Feb 5, 2015

11687094 (P.T.A.B. Feb. 5, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ROBERT W. STADLER, RAJA N. GHANEM, and
XUSHENG ZHANG
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Appeal 2012-005894
Application 11/687,094
Technology Center 3700
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Before DEMETRA J. MILLS, JEFFREY N. FREDMAN and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for anticipation and obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
Appeal 2012-005894
Application 11/687,094
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STATEMENT OF CASE
According to the Specification, the invention generally relates to an
implantable medical device system, and more particularly to a method and
apparatus for detecting arrhythmias in a subcutaneous medical device. (Spec.
1.) In the Summary of the Invention in the Brief (page 7) Appellants notes
that such
therapy has, in the past, been delivered when physiological
characteristics of the patient exceed a threshold. In a simplified
example, a cardioverter/defibrillator may deliver a shock to the
patient's heart in the event the patient's heart rate exceeds 180
beats per minute, a common threshold for tachycardia.
However, such approaches may not necessarily result in
appropriate therapy delivery all of the time; for instance, if
cardioversion therapy were delivered any time a patient's heart
rate rose above 180 beats per minute, patients may be shocked
when the patient's heart is desirably beating fast, for instance if
the patient is exercising vigorously or experiencing great stress.

(App. Br. 7).

The following claim is representative (emphasis added):
1. A method of detecting a cardiac event with a medical
device comprising a processor and a plurality of
electrodes, comprising the steps of:
sensing cardiac signals from the plurality of electrodes
during a predetermined sensing window;
determining a relationship between a plurality of
characteristics associated with a morphology of the cardiac
signals;
generating a threshold in response to the relationship
between the plurality of characteristics associated with the
morphology of the cardiac signals;
comparing a first characteristic of the plurality of
characteristics with the threshold to obtain a comparison
indicative of an association of the cardiac signals with the
cardiac event; and

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delivering a therapeutic output based, at least in part, on
the comparison indicative of an association of the cardiac
signals with the cardiac event.

Cited References

Stadler et al., US 6,397,100 B2 issued May 28, 2002
(hereinafter “Stadler”)
Grounds of Rejection
1. Claims 1–4, 8–11 and 15–18 are rejected under 35 U.S.C. 102(b) as
being anticipated by Stadler.
2. Claims 5–7, 12–14 and 19–21 are rejected under 35 U.S.C. 103(a) as
being unpatentable over Stadler.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
5–9. The following facts are highlighted.
1. Figure 5 of the Specification is reproduced below.

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FIG. 5 is a schematic diagram of a rectifier and auto-
threshold unit in a subcutaneous device according to an
embodiment of the present invention. Waveform 402
depicts a typical subcutaneous ECG waveform and
waveform 404 depicts the same waveform after filtering
and rectification. A time dependant threshold 406 allows
a more sensitive sensing threshold temporally with
respect to the previous sensed R-wave. Sensed events
408 indicate when the rectified EGG signal 404 exceeds
the auto-adjusting threshold and a sensed event has
occurred.

(Spec. 17–18.)

2. Stadler, col. 6, ll. 44–55, discloses that

For an implanted device, the amplitudes of the ECG or
EGM are quite different than surface ECG amplitudes.
Rather than calibrate each patient's device to absolute
voltage units, and derive some new significance
threshold for ST changes in an implanted device, our
approach has been to prefer normalization of the ST
change by the R-wave amplitude makes common
thresholds (i.e., 10%) applicable to all patients. (This has
a multidimensional aspect as well, as the R-wave
amplitude and ST deviation can be vectors, and the
vector deviation of the ST segment form the isoelectric
baseline can be normalized by the magnitude of the R-
wave).

(Emphasis added.)

3. According to the Specification, page 17, ¶ 0057, “an auto-adjusting
threshold is generated as described in the ʼ824 [US 5,117,824] patent
or ʼ350 [US Publication No. 2004/0260350] publication.”

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Discussion
ISSUE
The issue is: Does the cited prior art support the Examiner’s finding
that the claimed subject matter is anticipated or obvious?

PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office). The Board “determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction ‘in light of the specification as
it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.

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“[O]bviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).

ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness.
Claim 1 requires a step of “generating a threshold in response to the
relationship between the plurality of characteristics associated with the
morphology of the cardiac signals.”
Figure 14 of Stadler is reproduced below.

Figure 14 shows the ischemia parameter is calculated in S234, then
compared against the programmed ischemia parameter threshold in S236,
and thereafter flags are set (S238) or cleared (S240) based on the
relationship to the parameter. The ischemia parameter threshold is

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programmed and has no causal or dependent relationship to the calculation
of the ischemia parameter. (Col. 24, ll. 61-63.)
The Examiner argues that:
In step 235, the ischemia parameter threshold, which is a
dedicated threshold as indicated in col. 14 line 65 to col. 15 line
25, is generated/“caused to come about or arise” /“brought
forth”, wherein, as indicated in the figures, columns and lines
above, each characteristic is compared to the dedicated
threshold to determine an association of whether ischemia
exists or not.

(Ans. 10.)

Appellants contend that:
As shown in Figure 14, Stadler et al ʼ100 does not show,
disclose or suggest any causal or dependent condition between
the threshold in S235 and the calculation of the ischemia
parameter. No arrow enters S235, thus the threshold has
nothing to do with anything else in the flowchart, and certainly
nothing to do with the calculation of the ischemia parameter in
S234. Stadler et al ʼ100 recites that the threshold is
programmed, which is neither here nor there with respect to a
relationship between the characteristics.

(Reply Br. 8.)

We do not find that the Examiner has provided sufficient evidence or
sufficiently explained how Stadler discloses a step of “generating a threshold
in response to the relationship between the plurality of characteristics
associated with the morphology of the cardiac signals.”
Stadler states that,
“Rather than calibrate each patient’s device to absolute
voltage units, and derive some new significance threshold for
ST changes in an implanted device, our approach has been to
prefer normalization of the ST change by the R-wave amplitude

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makes common thresholds (i.e., 10%) applicable to all
patients.”

(FF 2.)
Thus, Stadler appears to disclose that their method and device use a
normalization process instead of deriving a new significance threshold in
response to the relationship between a plurality of characteristics associated
with the morphology of the cardiac signals.
For this reason, the anticipation and obviousness rejections over
Stadler are reversed.

CONCLUSION OF LAW
The cited reference does not support the Examiner’s anticipation and
obviousness rejections, which are reversed.

REVERSED

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