Ex Parte Alt

Patent Trial and Appeal Board

Jan 31, 2013

10622184 (P.T.A.B. Jan. 31, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte ECKHARD ALT
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Appeal 2012-002089
Application 10/622,184
Technology Center 3700
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Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of early detection and monitoring of congestive heart failure. The Examiner
has rejected the claims as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.

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Application 10/622,184

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STATEMENT OF THE CASE
Appellant’s invention relates to body-implantable devices
adapted to detect and monitor congestive heart failure in a
patient, and includes a circuit module coupled to plural surface
electrodes of the device arranged and adapted, when the device
is implanted, for contacting tissue in a portion of the patient's
body generally occupied by the lungs, to monitor changes in
local impedance of said body portion, and to detect the patient's
EKG.
(Spec., Abst.)
Claims 31 and 33 – 36 are on appeal. The claims have not been
argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Independent claim 31 reads as follows:
31. An implantable device-implemented method of early
detection and monitoring of congestive heart failure in a patient,
which comprises the steps of:
measuring local impedance of a portion of the patient’s
body generally occupied by the lungs solely through surface
mounted electrodes on the device with the device implanted
subcutaneously in the patient's body,
determining when the local impedance measurements are
indicative of a condition of congestive heart failure based on
factors other than the existence of edema,
detecting the patient’s heart rate/activity pattern through
said electrodes while concurrently monitoring said local
impedance measurements to evaluate cardiopulmonary status of
the patient, and
evaluating a trend of the heart rate/activity pattern and
said concurrent local impedance measurements against one
another over a selected period of time, as an additional indicia
of congestive heart failure.

The claims stand rejected as follows:
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I. Claims 31 and 33-36 under 35 U.S.C. § 102(b) as being anticipated
by Riff (US 5,876,353, issued Mar. 2, 1999).
II. Claims 31 and 33-36 under 35 U.S.C. § 102(b) as being anticipated
by Combs et al (US 5,957,861, issued Sep. 28, 1999).
I.
Issue
The Examiner has rejected claims 31 and 33-36 under 35 U.S.C. §
102(b) as being anticipated by Riff. The Examiner finds that Riff teaches a
device having all elements of claim 31. (Ans. 4-5 and 6-9.)
Appellant contends that Riff “does not show, disclose or suggest
multiple elements of claim[] 31.” (App. Br. 11.) Specifically, Appellant
contends that Riff fails to disclose:
 “means for determining congestive heart failure on the basis of
factors other than the existence of edema” (id.);
 “detecting the patient’s heart rate/activity pattern and evaluating
the trend of the heart rate/activity pattern and lung impedance measurements
against one another over a selected period of time as an indicia of congestive
heart failure” (id.);
 “surface-mounted electrodes on a subcutaneous device that both
measure local impedance and detect the patient's heart rate/activity pattern”
(id.).
The issue presented is:
Does the evidence of record support the Examiner’s findings that Riff
anticipates claim 31?
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Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. Riff discloses “[a]n impedance monitor for discerning edema
through evaluation of respiratory rate” (Riff, Abst.), where edema is a sign
of heart failure (see e.g., Riff col. 1, ll. 44-60).
FF2. The devices of Riff are implantable in the chest (see e.g., id. at
col. 1, ll. 44-60, and col. 8, ll. 26-28).
FF3. Riff discloses
an implantable apparatus for production of impedance
measurement in a subcutaneous region of the living body
having at least two electrically isolated electrodes, preferably
but not necessarily on the outer surface of its housing and
having within the housing an energy pulse delivery mechanism
to deliver electrical pulses to living body and means for
receiving electrical impulses on the surface of the housing so as
to determine the impedance of the body between the two
preferred or less preferred pair of electrodes

(see e.g., id. at col. 3, ll. 16-25) (emphasis added).
FF4. The devices of Riff may “use the respiratory rate as an indicator
of edema or lung water,” which “can be monitored long term like the DC
impedance signal, but instead of filtering out the respiration signals as noise,
we would for these devices use the respiration varied impedance measures
to determine breath rate.” (Id. at col. 13, ll. 59-64.) (Emphasis added.)
FF5. Riff discloses that the
the electrode configuration for impedance measurement may
include a cardiac electrode tip in the heart and an electrode on
the surface of a pacemaker housing for one measure of
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impedance and an additional pair of electrodes both located on
the housing would enable the use of two different measures of
impedance and facilitate the use of comparisons between the
resultant signals to refine the signal and provide additional
information.
(Id. at col. 3, ll. 40-48.)
FF6. Riff discloses “[r]ecording of Long Term Average and Short
Term Average values for secondary edema measure based on DC signal
level.” (Id. at Abst.; see also id. at col. 1, ll. 6-10, col. 2, ll. 38-51, col. 3, ll.
51-57, col. 14, ll. 53-55, and col. 17, ll. 23-25.)
FF7. Riff discloses
[i]t is already known in the art to have and use implantable
sensors to monitor and record data including activity sensed,
heart rate, heart rate variability, respiration, minute ventilation
and variability of, arrhythmia frequency and duration, averages
of these values over long term, pressure at various sensor
locations, O2 saturation at various sensor locations, time
located patient activated data records for holding various pieces
of these data sets around a temporal marker set by a patient
activated signaling device (which could be incorporated into a
device such as WD, or some other convenient unit) for
diagnosing patient symptoms, and so on. However, the use of
an impedance sensor dedicated to generate data specific to
edema conditions and history has not heretofore been seen.
Combining these edema measurements with any of these other
signal data provides an enhanced diagnostic and patient
management efficacy to all the devices.
(Riff, col. 13, ll. 9-25) (emphasis added).
FF8. Riff discloses
For additional beneficial data generation purposes other
sensors may be included in the implanted device and data
therefrom temporally matched with edema data to provide
additionally beneficial diagnostic data. Each sensor can be
thought of as a system for providing an indication of patient
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condition, either when it’s output is taken alone or combined in
manners known to those in the art to determine patient
condition. Such included sensor systems or subsystems could
include, for example, diurnal cycle indicators, position or
posture indicators, resting indicators, heart beat cycle
indicators, breathing indicators, movement indicators, and so
forth, each providing a signal value that could be stored or
used to trigger an activity of the implanted device.
(Riff, col. 5, ll. 32-45).
Principles of Law
Anticipation requires that every element and limitation of the claimed
invention must be found in a single prior art reference, arranged as in the
claim. Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001).
Analysis
We find that the preponderance of evidence on this record supports
the Examiner’s findings that Riff anticipates claim 31. As noted by the
Examiner, the “current claim language does not explicitly limit the exact
same surface mounted electrodes to perform both the impedance
measurement and the heart rate/activity measurement” (Ans. 8; see also
App. Br. 12-13).
Riff discloses an implantable device for use in the monitoring of
edema, a sign of congestive heart failure (FF1). The device may be
implanted subcutaneously in the patient’s body (FF2) and includes surface
mounted electrodes (FF3). The device of Riff involves using respiration
varied impedance measures to determine breath rate, which may be
indicative of congestive heart failure (FF4). Riff also discloses detecting the
patient’s heart rate or activity pattern (FF7). Riff discloses evaluating a
trend of impedance measurements (FF4, FF6 and FF7) and also the heart
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rate or activity pattern (FF7), which are compared to provide diagnostic and
patient management efficacy (FF8). We are therefore not persuaded by
Appellant’s arguments that these elements are not disclosed by Riff. (See
e.g., App. Br. 11 and Reply Br. 6.)
We are also not persuaded by Appellant’s arguments that using
respiratory rate as a surrogate marker for edema for assessing congestive
heart failure, as disclosed by Riff, is different from a means for “determining
congestive heart failure on the basis of factors other than the existence of
edema,” as required by claim 31. The Specification describes such a means
as measuring a patient’s ventilation, “represented by the measured changes
in local impedance” (Spec. 5, ll. 3-5), where ventilation is the “product of
tidal volume and respiratory rate” (Spec. 3, l. 8). Thus, we find that the
“respiratory rate” disclosed by Riff to be encompassed by the claim element
“factors other than the existence of edema.”
Conclusion of Law
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that Riff discloses each limitation of
claim 31. Claims 33-36 fall with claim 31. 37 C.F.R. § 41.37(c)(1)(vii).
II.
As explained by the Examiner, “Combs et al share the same
specification with that of Riff.” (Ans. 9.) The facts and analysis of the
Examiner’s rejection over Comb is substantially the same as the Examiner’s
rejection over Riff, discussed in Section I above. (Id. at 5-6.) Appellant’s
arguments with respect to Comb are substantially identical to Appellant’s
arguments made with respect to Riff. (App. Br. 14-16.) We thus affirm the
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Examiner’s rejection under 35 U.S.C. § 102(b) over Comb for reasons
explained above with regard to Riff.

SUMMARY
We affirm all rejections on appeal for the reasons of record.

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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