Ex Parte Hess et al

Board of Patent Appeals and Interferences

Jul 24, 2012

11115597 (B.P.A.I. Jul. 24, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL F. HESS and EDUARDO N. WARMAN
__________

Appeal 2011-008780
Application 11/115,597
Technology Center 3700
__________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and ERICA A.
FRANKLIN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a pacing
therapy device and method. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
Claims 4, 5, 18, 19, and 21-28 are pending and on appeal (App. Br. 2).
Claim 4 is illustrative and reads as follows:
4. A device for providing pacing therapy, the device comprising:
an atrial lead for sensing electrical activity in an atrium;
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a ventricular lead for sensing electrical activity in a ventricle and for
delivering electrical pulses to the ventricle;
sensing circuitry connected to the atrial and ventricular leads for
sensing depolarizations in the atrium and ventricle, respectively;
pulse generation circuitry connected to the ventricular lead for
delivering pacing pulses to the ventricle, respectively; and
control circuitry responsive to sensed atrial depolarizations, for
detecting atrial arrhythmias and for controlling the pulse generation circuitry
in a mode in which the pulse generation circuitry delivers an atrial
synchronized pulse to the ventricular lead in response to each atrial
depolarization and causing the pulse generation circuitry, in response to a
detected atrial arrhythmia, to deliver atrial synchronized pacing pulses to the
ventricular lead in response only to selected atrial depolarizations, wherein
the control circuitry determines a desired ratio of atrial depolarizations to
ventricular paced pulses based on a beat rate of the atrial arrhythmia and a
preferred ventricular beat rate and causes the pulse generation circuitry to
deliver atrial synchronized pulses to the ventricular lead in response to
detection of a number of atrial depolarizations corresponding to the desired
ratio.
Claims 4, 5, 18, 19, 21, 22, and 24-28 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Kleckner et al. (US 2004/0210264 A1, Oct. 21,
2004) in view of Kramer (US 2004/0210266 A1, Oct. 21, 2004) (Ans. 4).
Claim 23 stands rejected under 35 U.S.C. § 103(a) as obvious over
Kleckner in view of Kramer and Peterson et al. (US 5,893,882, Apr. 13,
1999) (Ans. 5).
The Examiner relies on Kleckner for disclosing
a method and device for providing pacing therapy . . .
comprising: atrial and ventricular leads . . . , sensing circuitry
and pulse generation circuitry connected to said leads . . . ; and
control circuitry responsive to said sensed atrial depolarizations
for detecting arrhythmias and for controlling the pulse
generation circuitry in either a first and/or a second mode, in
which said second mode is based on a reduced proportion of
sensed atrial depolarizations as compared to the first mode, so
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that said circuitry delivers an atrial synchronized pulse in
response to each atrial depolarization and when said
arrhythmias are detected, to deliver atrial synchronized pulse[s]
in response only to selected atrial depolarization . . . ; wherein
the device further includes a physiologic parameter sensor . . .
in which said control circuitry determines a sensor-based pacing
rate and said second mode delivers atrial synchronized pulses at
a proportion dependent upon said sensor-based pacing rate.
(Ans. 4.) The Examiner finds that Kleckner “discloses the claimed invention
. . . except wherein control circuitry determines a desired ratio of atrial
depolarizations to ventricular paced pulse[s] based on a beat rate of an atrial
arrhythmia” (id. at 4-5).
The Examiner relies on Kramer for teaching
that it is known to use a device and a method for treating a
patient’s heart by way of a device that is controlled to pace the
ventricle synchronous with the intrinsic atrial rate, i.e. the
device is programmed based on the analysis of an intrinsic
atrial rate in relation to a paced ventricular output, in which the
relation between the two is further defined as a ratio of the atrial
rate and ventricular pacing pulses.
(Id. at 5.) The Examiner concludes:
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify the method
and device as taught by Kleckner et al. with the use [of]
ventricular therapy defined by the number of occurrences of
atrial depolarizations, i.e. atrial rate tracking as taught by
Kramer, since such a modification would provide the a method
and device for providing pacing therapy via utilizing control
circuitry, wherein said control circuitry determines a desired
ratio of atrial depolarizations to ventricular paced pulse[s] based
on a beat rate of an atrial arrhythmia for providing the
predictable results pertaining to providing atrial synchronized
ventricular pacing that controls stimulation to a preselected
ventricle in accordance with a timing sequence which is
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dependent upon tracked atrial events so as to selectively control
ventricular stimulation to the heart that is used to treat cardiac
heart failure.
(Id.)
Appellants argue that none of the applied references disclose that the
“control circuitry determines a desired ratio of atrial depolarizations to
ventricular paced pulse[s] based on a beat rate of an atrial arrhythmia . . .
and delivering pacing pulses according to the ratio” (App. Br. 10).
ANALYSIS
For a patient having a complete block of all intrinsic conduction,
Kramer discloses:
As the sinus rate increases, [a conventional atrial tracking]
pacemaker’s pacing rate tracks the atrial rate until the pacing
rate reaches a preprogrammed atrial maximum tracking rate
(AMTR). . . . At this point, as the atrial rate continues to
increase, there is a fall-off in the ventricular pacing rate
attributable to a pacemaker mediated atrial Wenckebach
behavior. . . . During this period, some of the pacemaker’s
ventricular pacing pulses are inhibited by the pacemaker to
prevent pacing the ventricle at a rate above the AMTR. As the
sinus rate . . . continues to increase above the AMTR, the
average ventricular pacing rate slowly decreases until a 2:1
ratio between the atrial rate and ventricular pacing occurs.
(Kramer ¶ [0058].) Thus, Kramer discloses a 2:1 ratio between the atrial
rate and ventricular pacing. However, we agree with Appellants that the
Examiner has not adequately explained how Kramer (or Kleckner) teaches
or suggests control circuitry that
determines a desired ratio of atrial depolarizations to ventricular
paced pulses based on a beat rate of the atrial arrhythmia and a
preferred ventricular beat rate and causes the pulse generation
circuitry to deliver atrial synchronized pulses to the ventricular
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lead in response to detection of a number of atrial
depolarizations corresponding to the desired ratio,
as required by claim 4, as well as claim 18. We therefore reverse the
obviousness rejection of claims 4 and 18 and of claims 5 and 19, which
depend from claims 4 and 18, respectively.
That being said, neither of claims 21 or 25 recites this limitation.
Instead, claim 21 recites control circuitry for “controlling the pulse
generation circuitry in a second mode to deliver atrial synchronized pacing
pulses to the ventricular lead in response to a reduced proportion of sensed
atrial depolarizations as compared to the first mode.” Similarly, method
claim 25 recites “delivering atrial synchronized ventricular pulses in a
second mode, comprising delivering atrial synchronized pacing pulses to the
ventricular lead in a reduced proportion as compared to the first mode.”
Appellants have not adequately explained why Kleckner and Kramer fail to
suggest such a second mode. We therefore affirm the obviousness rejection
of claims 21 and 25. Claims 22, 24, and 26-28 are not separately argued and
therefore fall with claims 21 and 25. 37 C.F.R. § 41.37(c)(1)(vii).
With regard to claim 23, which depends from claim 21, the Examiner
additionally relies on Peterson (Ans. 5). However, Appellants do not point
to any defect in the Examiner’s reliance on Peterson for the feature of
claim 23 and instead traverse this rejection because it “expressly depends
upon the erroneous rejection discussed above” (App. Br. 15). As discussed
above, Appellants have not adequately explained why the rejection of
claim 21 is erroneous. We therefore also affirm the obviousness rejection of
claim 23.
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SUMMARY
We reverse the obviousness rejection of claims 4, 5, 18, and 19.
However, we affirm the obviousness rejections of claims 21-28.
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-IN-PART

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