Ex Parte Wariar

Board of Patent Appeals and Interferences

Mar 29, 2012

11345702 (B.P.A.I. Mar. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAMESH WARIAR
__________

Appeal 2010-009432
Application 11/345,702
Technology Center 3700
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
and systems for providing renal therapy, which the Examiner has rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses that “chronic heart failure leads to a
vicious cycle (termed the cardiorenal syndrome), where heart failure
advances renal disease, which in turn further worsens heart failure” (Spec.
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1:30 to 2:1). The Specification discloses that cardiac rhythm management
devices such as pacemakers can include sensors to monitor a patient during
dialysis or ultrafiltration therapies (id. at 4:20-21).
Claims 1, 5-12, and 14-30 are on appeal.1 Claim 1 is representative:
1. An integrated cardiorenal disease therapy management system,
comprising:
a. a renal therapy device including at least one of an external dialysis
device or an external ultrafiltration device configured to provide renal
therapy to a subject;
b. an implantable cardiac rhythm management device including:
a sensor for measuring data representative of a patient
physiological parameter; and
a cardiac rhythm management therapy circuit configured to
provide cardiac rhythm management therapy to the subject; and
c. a control system coupled to the renal therapy device and configured
to receive the data representative of the patient physiological parameter,
wherein the control system directs therapy provided by the renal
therapy device using information from the data representative of the patient
physiological parameter received from the implantable cardiac rhythm
management device when the implantable cardiac rhythm management
device has been implanted in the subject.

Issue
The Examiner has rejected claims 1, 5-12, 15-17, and 19-30 under 35
U.S.C. § 103 as being obvious in view of Gelfand,2 Mickle,3 and Basson.4

1 Claim 13 was also appealed (Appeal Br. 4), but the Examiner has
withdrawn the rejection of claim 13 (Answer 3).
2 Gelfand et al., Patent Application Publication US 2004/0176813 A1, Sept.
9, 2004
3 Mickle et al., Patent Application Publication US 2003/0032993 A1, Feb.
13, 2003
4 Basson et al., Patent Application Publication US 2007/0241915 A1, Oct.
18, 2007
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The Examiner has also rejected claims 14 and 18 under 35 U.S.C. § 103 as
being obvious in view of Gelfand, Mickle, Basson and Bosetto.5 The same
issue is dispositive for both rejections.
The Examiner finds that Gelfand discloses a system and method for
preventing hypotension during ultrafiltration (Answer 4). The Examiner
finds that Gelfand’s system comprises a renal therapy device, a sensor
device that “senses the physiological parameters of venous blood” as it
leaves the body, and a control system that receives data from the sensor and
controls “the rate of blood flow through the renal therapy device in response
to the sensed … blood parameters” (id.).
The Examiner finds that Mickle discloses a remote sensing system
that may be used in medical applications (id. at 5). “[T]he sensors may be
used as internal cardiac monitors, pulse monitors, and oxygen monitors for
systems such as … renal dialysis devices…. The sensors transfer sensed data
to an external source (i.e. the control system of the machine) to affect the
treatment.” (Id.) The Examiner finds that Basson discloses that a
pacemaker’s sensor may also be used to “send a signal to a CPU in the
patient’s automobile … to eliminate the hazardous driving conditions that
can result from occurrence of a life threatening medical situation” (id. at 6).
The Examiner concludes that it would have been obvious to modify
Gelfand’s system and method with Mickle’s sensing means “in order to
provide an alternate means for accurate sensing … of physiological
parameters … for monitoring the heart” (id. at 5-6). The Examiner also
concludes that it “would have been obvious to modify the renal therapy

5 Bosetto et al., US 5,938,938, Aug. 17, 1999
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device of Gelfand and Mickle with the use of sensors from a previously
implanted pacemaker, as taught by Basson, because doing so would provide
additional use for the pacemaker’s sensor data and prevent the need for
additional sensor means” (id. at 6).
Appellant contends that “Basson’s implanted device merely
communicates with a vehicle control system, not a medical device,” and one
of ordinary skill in the art would not have understood Basson as providing a
reason to use pacemaker-derived data to control a renal therapy device
(Appeal Br. 16).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that the use of pacemaker-derived data to control a
renal therapy device would have been obvious in view of the cited
references?
Findings of Fact
1. Gelfand discloses a system “for removing fluid from a fluid
overloaded patient at a maximum safe rate.… The system senses oxygen
saturation in … venous blood as being indicative of conditions that cause
hypotension” (Gelfand 3, ¶ 0025).
2. Gelfand discloses that “[b]y monitoring oxygen saturation, the
system detects the decrease of cardiac output that precedes the onset of
hypotension and maintains a safe filtration rate by reducing or periodically
turning off ultrafiltration” (id.).
3. Gelfand discloses that the “saturation of oxygen in the blood can
be measured by a non-invasive means of oximetry since, during the
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ultrafiltration, venous blood is passed through the extracorporeal circuit” (id.
at 5, ¶ 0058).
4. Mickle discloses a system that obtains and transmits data about an
object of interest (Mickle 1, 0003).
5. Mickle discloses that the object of interest has sensors associated
with it, and the sensors transmit readings to a remote station, which
transmits data through space to a base station (id. at 2, ¶ 0052)
6. Mickle discloses that the “remote station, for example, could be
implanted in a patient” (Id. at 3, ¶ 0053.)
7. Mickle discloses that
medical applications … such as cardiac monitors, brain
monitors, pulse monitors, blood pressure monitors, oxygen
monitors, as well as monitors which monitor the performance
of patient support equipment, such as ventilators, intravenous
delivery systems, renal dialysis machines, oxygen
supplementing devices and heart bypass devices may
beneficially employ the invention.

(Id. at 4, ¶ 0064.)
8. Basson discloses “a method for facilitating operation of a vehicle
by a driver with a potential[ly] debilitating condition in which … operation
of the vehicle by the driver is monitored based on … sensor data” (Basson 1,
¶ 0009).
9. Basson discloses that “[s]ome drivers use implanted devices such
as pace makers. These devices can include sensors for detecting life
threatening situations for the patient drivers. Such situations could be
detection of a heart attack for prior heart attack victims, loss of control due
to medical conditions such as diabetes, epilepsy, etc.” (Id. at 1, ¶ 0007.)
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10. Basson discloses that “data from devices implanted within the
driver … allows [the] vehicle control system … to alert other drivers or
other vehicles of the existence of a condition which may impair the vehicle
operator’s ability to control the vehicle” (id. at 2, ¶ 0026).
11. Basson discloses that the implant device can be a “pace maker,
biometric sensor, etc.… Implant device 34 includes a sensor … providing
sensor data used to detect a crisis situation, such as a heart attack, possibility
of heart attack, epileptic event, and the like.” (Id.)
12. Basson discloses that “[u]pon detection of such a condition,
vehicle control system 10 interacts with warning system 38 to alert other
vehicles 40 and/or other drivers 42 of the … crisis situation” (id.).
Analysis
Claim 1 is directed to a system comprising a renal therapy device, an
implantable cardiac rhythm management device (e.g., a pacemaker) that
includes a sensor for measuring patient physiological parameter data, and a
control system coupled to the renal therapy device and configured to receive
the data from the sensor.
Gelfand suggests the use of non-invasive oximetry measurements to
control a renal therapy device, and Mickle suggests the use of remote
sensors to provide data to medical devices, including monitoring the
performance of renal dialysis machines. The Examiner relies on Basson for
providing the suggestion that pacemakers can be used to provide data; e.g.,
to signal an emergency situation to a vehicle control system.
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Appellant argues that Basson’s disclosure of a pacemaker that
provides data to a vehicle control system would not have suggested using
pacemaker-derived data to control a renal therapy device (Appeal Br. 16).
We agree with Appellant that the Examiner has not adequately shown
that the system of claim 1 would have been obvious in view of the cited
references. “In rejecting claims under 35 U.S.C. § 103, the examiner bears
the initial burden of presenting a prima facie case of obviousness.” In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). “The Patent Office has the
initial duty of supplying the factual basis for its rejection. It may not …
resort to speculation, unfounded assumptions or hindsight reconstruction to
supply deficiencies” in the cited references. In re Warner, 379 F.2d 1011,
1017 (CCPA 1967).
Here, the Examiner has not provided evidence to show that, based on
the cited references, a person of ordinary skill in the art would have
considered it obvious to use data obtained from a pacemaker in controlling a
renal therapy device. The only reference cited by the Examiner that
discloses a pacemaker that provides data is Basson, and those data are
described as “for detecting life threatening situations” (Basson 1, ¶ 0007) or
“[p]otentially debilitating condition data” (id. at 1, ¶ 0009) such as a heart
attack or epileptic seizure. The Examiner has not provided evidence that
such data would be relevant to managing a renal therapy device, or evidence
of a prior art cardiac rhythm management device that senses data relevant to
the claimed system. The Examiner therefore has not carried the initial
burden of showing that the integrated cardiorenal disease therapy
management system of claim 1 would have been prima facie obvious.
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Independent claims 9 and 16 also require using data obtained from a
sensor of a cardiac rhythm management device to control a renal therapy
device, and thus the above-stated reasoning also applies to these claims. We
therefore reverse the rejection of independent claims 1, 9 and 16 and
dependent claims 5-8, 10-12, 15, 17, 19-30.
In the rejection of claims 14 and 18, the Examiner relies on the same
findings and reasoning with regard to Gelfand, Mickle, and Basson, as
discussed above, and thus we also reverse this rejection.
SUMMARY
We reverse the rejection of claims 1, 5-12, and 14-30 under 35 U.S.C.
§ 103.

REVERSED

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