Ex Parte Kjellstrom et al

Patent Trial and Appeal Board

May 17, 2013

11045571 (P.T.A.B. May. 17, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte BARBRO M. KJELLSTROM and TOMMY D. BENNETT
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Appeal 2011-005509
Application 11/045,571
Technology Center 3700
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Before TONI R. SCHEINER, DONALD E. ADAMS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1, 2, 7-13, 17-20, and 22-27, directed to a device and method for
monitoring heart failure in a patient. The claims have been rejected on the
grounds of anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
According to the Specification, “[t]he present invention is based upon
the discovery that a ventricular pressure index for a ventricular contraction,
which is based upon pressures in the ventricle, is a predictor of worsening
heart failure” (Spec. ¶ 5). Pressures within the ventricle (typically the right
ventricle) are measured by sensors located inside the patient‟s heart (id. at ¶¶
14, 27; Fig. 2).
Claims 1, 2, 7-13, 17-20, and 22-27 are pending and on appeal.
Claims 3-6, 14-16, and 21 have been cancelled (App. Br. 2). Claims 1, 2, 11
and 12 are representative of the subject matter on appeal:
1. A medical device for monitoring heart failure in a patient, the medical
device comprising:
an input circuit that receives a pressure signal representative of
pressures sensed within a ventricle as a function of time; and
a processor that derives from the pressure signal a ventricular pressure
index for a ventricular contraction based upon pressures in the ventricle and
provides an output based upon the ventricular pressure index, wherein said
ventricular pressure index corresponds to one of: a heart failure status or a
changing heart failure status;
wherein, for the ventricular contraction, the processor determines
from the pressure signal a diastolic pressure in the ventricle and a systolic
pressure in the ventricle and a diastolic pressure in a vessel into which the
ventricle pumps blood; and
wherein the processor determines the ventricular pressure index for a
ventricular contraction as a function of the systolic pressure in the ventricle,
the diastolic pressure in the ventricle, and the diastolic pressure in the blood
vessel.
2. The medical device of claim 1 and further comprising a blood
pressure sensor locatable in the ventricle for providing the pressure signal to
the input circuit.
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11. A method for predicting worsening heart failure, the method
comprising:
for a ventricular contraction, sensing blood pressures within a
ventricle of a patient's heart as a function of time;
deriving from the sensed blood pressures a ventricular pressure index
based upon blood pressures in the ventricle; and
providing an output based upon the ventricular pressure index,
wherein said ventricular pressure index corresponds to one of: a heart failure
status or a changing heart failure status, and further comprising;
determining from the sensed blood pressures a diastolic pressure in
the ventricle and a systolic pressure in the ventricle; and a diastolic pressure
in a blood vessel into which the ventricle pumps blood; and
wherein determining a ventricular pressure index comprises
determining the ventricular pressure index as a function of the systolic
pressure in the ventricle, the diastolic pressure in the ventricle, and the
diastolic pressure in the blood vessel.
12. The method of claim 11 wherein the blood pressure is sensed by a
blood pressure sensor located in the ventricle of the heart.
The Examiner relies on the following evidence:
Carney US 5,368,040 Nov. 29, 1994
Nikolic US 5,758,652 Jun. 2, 1998
Chio et al. US 2002/0120201 A1 Aug. 29, 2002
The claims stand rejected as follows:
Claims 1, 7-11, 17-20, 22, and 25-27 under 35 U.S.C. § 102(b) as
anticipated by Chio (Ans. 3-4).
Claims 2, 12, 13, 23, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Chio and Nikolic (Ans. 5); and
Claims 1, 2, 11-13, and 22-24 under 35 U.S.C. § 102(b) as anticipated
by Carney (Ans. 4-5).
We reverse.
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ANTICIPATION BY CHIO
Chio discloses “a method for remotely monitoring the cardiovascular
condition of a patient . . . using a data acquisition device at a patient site to
non-invasively acquire cardiovascular condition information” (Chio ¶ 13).
Chio teaches that:
The patient's personal data acquisition device 20 not only
records and derives traditional hemodynamic parameter
numbers such as systolic pressure, diastolic blood pressure,
mean arterial pressure and heart rate, but also records the
continuous waveforms from the patient via the pressure cuff 16.
The waveform can be used to determine systolic, mean arterial,
and diastolic pressures as well as to determine information
about arterial compliance and functional properties of the
arteries.
(Chio ¶ 28.)
The Examiner finds that Chio “determines a ventricular pressure
index” (Ans. 4), based on “diastolic and systolic pressures in the ventricle
and a diastolic pressure in a vessel” (id.).
There is no dispute that Chio measures “systolic, diastolic and mean
arterial pressure . . . from a standard pressure cuff or from pressure sensors
located in arteries” (Ans. 6; App. Br. 7; Chio ¶ 28). However, Appellants
contend that these “are measurements of peripheral blood pressure
parameters, not measurements of the pressures in the ventricle” (App. Br. 7),
which are “pressures measured on the opposite side of a closed valve from
those measured peripherally” (id.).
The Examiner‟s position is that “the claims do not require that the
pressure measurements be made within the ventricle, but rather tha[t] a
received pressure signal be „representative of pressures sensed within a
ventricle as a function of time[]‟” and “[b]lood pressure measured via a
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standard pressure cuff or arterial pressure sensors would be representative of
such pressures, as the pressure within the ventricle influences such
measurements” (Ans. 6).
We agree with Appellants that the evidence of record does not support
the Examiner‟s finding that Chio “determines a ventricular pressure index”
(id. at 4), based on “diastolic and systolic pressures in the ventricle and a
diastolic pressure in a vessel” (id.). First, the Examiner has not established
that pressures measured outside the ventricle (i.e., on the other side of a
closed valve) are representative of pressures within the ventricle. Nor has
the Examiner established that Chio derives ventricular pressures from its
standard blood pressure measurements, much less a “ventricular pressure
index” based on “the systolic pressure in the ventricle, the diastolic pressure
in the ventricle, and the diastolic pressure in the blood vessel” as required by
all the claims subject to this rejection.
Accordingly, we will reverse the rejection of claims 1, 7-11, 17-20,
22, and 25-27 as anticipated by Chio.
OBVIOUSNESS OVER CHIO & CARNEY
Claims 2, 12, 13, 23, and 24 stand rejected as obvious over Chio and
Nikolic.
The Examiner acknowledges that Chio “fails to disclose that the blood
pressure is measured via a blood pressure sensor located in the right
ventricle” (id. at 5), and cites column 4, lines 39-52 of Nikolic as disclosing
a method of evaluating the condition of a heart wherein blood pressure is
measured via a sensor implanted in the right ventricle or by a blood pressure
cuff (id.). The Examiner concludes that it would have been obvious for one
of ordinary skill in the art “to utilize a blood pressure sensor implanted in the
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right ventricle, as taught by Nikolic, in the invention of Chio as it has been
held that to choose from a finite number of identified, predictable solutions
with a reasonable expectation of success requires only routine skill in the
art” (id.).
Appellants contend that “[t]he addition of Nikolic is not argued to
make up for the deficiencies in teaching of Chio . . . and does no[t] do so”
(App. Br. 12).
As the Examiner has not explained how Nikolic cures Chio‟s failure
to determine a ventricular pressure index based on the diastolic and systolic
pressures in the ventricle and the diastolic pressure in a vessel, we are
constrained to reverse this rejection as well.
ANTICIPATION BY CARNEY
Claims 1, 2, 11-13, and 22-24 stand rejected as anticipated by Carney.
Carney discloses “a method and apparatus to determine the
hemodynamic status of a patient from measurements of pulmonary pressure
and right atrial pressure obtained from a single absolute pressure sensor
implanted in the right ventricle” (Carney, col. 1, ll. 61-65). Carney teaches
that “[b]oth of these values have been shown to correlate with the degree of
cardiac failure of a patient” (id. at col. 1, ll. 65-67).
Carney‟s technique involves:
[C]ontinual monitoring of the right ventricular pressure using
an absolute pressure sensor and marking the right ventricular
pressure at the moment of specific events.
When the pulmonary valve is open during right
ventricular systole, the pressure in the right ventricle is nearly
identical to the pulmonary arterial pressure. Therefore,
pulmonary artery systolic pressure equals right ventricle
systolic pressure.
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(Carney, col. 1, l. 68 - col. 2, l. 7.)
Carney also teaches that “numerous pressure readings other than those
described hereinbefore, can be obtained . . . . For example, the present
invention can be used to obtain right ventricular systolic and diastolic
maximum dP/dt, etc.” (Id. at col. 5, ll. 2-6.)
The Examiner finds that Carney “derives from the pressure signal
diastolic and systolic pressures in the ventricle and a diastolic pressure in a
vessel” (Ans. 4), and further derives a “ventricular pressure index, which
corresponds to a heart failure status, based on the derived pressures” (id. at
5).
Appellants contend that the claims require a single index value
computed as a function of three pressures: the diastolic pressure in the
ventricle, the systolic pressure in the ventricle, and the diastolic pressure in a
blood vessel into which the ventricle pumps blood (App. Br. 8). Appellants
“do not dispute that Carney mentions all three measurements” (id.), but
contend that “Carney simply does not use all three of measured or
determined ventricular diastolic, ventricular systolic and arterial diastolic
pressures to determine a ventricular pressure index” (id.); nor does Carney
“disclose any mechanism for deriving an index from all three” (id.), and
moreover, “[t]he two values disclosed as used to determine the index in
Carney are not even measured during ventricular diastole” (id.).
We note, as does the Examiner, that Carney‟s device is capable of
measuring both the diastolic and systolic pressures in the right ventricle, and
the diastolic pressure in the pulmonary artery (i.e., a blood vessel into which
the ventricle pumps blood), but we are compelled to agree with Appellants
that the Examiner has not explained where or how Carney‟s device or
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method determines a ventricular pressure index based on these three
measurements. On this record, the Examiner has not established a prima
facie case of anticipation.
Accordingly, we are constrained to reverse the rejection of claims 1,
2, 11-13, and 22-24 as anticipated by Carney.
SUMMARY
The rejection of claims 1, 7-11, 17-20, 22, and 25-27 under 35 U.S.C.
§ 102(b) as anticipated by Chio is reversed.
The rejection of claims 2, 12, 13, 23, and 24 under 35 U.S.C. § 103(a)
as unpatentable over Chio and Nikolic is reversed.
The rejection of claims 1, 2, 11-13, and 22-24 under 35 U.S.C. §
102(b) as anticipated by Carney is reversed.

REVERSED

cdc