Ex Parte Warren

Patent Trial and Appeal Board

Sep 27, 2012

11457891 (P.T.A.B. Sep. 27, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAY A. WARREN
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Appeal 2011-011113
Application 11/457,891
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC GRIMES, 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 cardiac
rhythm management systems and methods of applying anti-tachyarrhythmia
therapy to a heart in a patient. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
According to Appellant, the invention relates to methods and systems
for an atrial and ventricular implantable cardioverter defibrillator that can be
coupled to an implantable lead. (App. Br. 6.)
Claims 1-10 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).
Claims 1, 3, 5 and 8 are independent. Claim 1 is representative and reads as
follows:
1. A method comprising:
monitoring atrial heart activity for atrial tachyarrhythmia
activity indicative of a need for atrial anti-tachyarrhythmia therapy;
monitoring ventricular heart activity for ventricular
tachyarrhythmia activity indicative of a need for ventricular anti-
tachyarrhythmia therapy; and
in response, automatically applying, using a first
supraventricular electrode and a first ventricular electrode located on
the same intravascular lead as the first supraventricular electrode:
(1) the atrial anti-tachyarrhythmia therapy to the heart if atrial
tachyarrhythmia activity needing atrial anti-tachyarrhythmia therapy
is detected; and
(2) the ventricular anti-tachyarrhythmia therapy to the heart if
ventricular tachyarrhythmia activity needing ventricular anti-
tachyarrhythmia therapy is detected, and
in which the atrial anti-tachyarrhythmia therapy and the
ventricular anti-tachyarrhythmia therapy each include shocks,
wherein the atrial anti-tachyarrhythmia therapy shock includes
a different waveform than the ventricular anti-tachyarrhythmia
therapy shock.

The claims stand rejected as follows:
I. Claims 1-10 stand rejected under 35 U.S.C. 103(a) over Weiss (US
5,184,616, issued Feb. 9, 1993) in view of either Mirowski et al.
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(US 3,942,536, issued Mar. 9, 1976) or, alternatively, Adams (US
5,641,326, issued Jun. 24, 1997).
II. Claims 1-10 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 20-28 of U.S.
Patent 7,103,409, all claims of U.S. Patent 6,574,505, and all
claims of U.S. Patent 6,067,471.

I.
Issue
The Examiner has rejected claims 1-10 under 35 U.S.C. § 103(a) as
obvious based on the combination of Weiss and Adams.
1
The Examiner
finds that Weiss teaches “monitoring the atrium and ventricles for
tachyarrhythmia activity,” “that the cardioversion therapy can be applied
using the pacing leads 12, which extend into both atrium and ventricle of the
patient's heart,” and “that the waveforms delivered by Weiss can be
individualized for the particular patient, and that by means of appropriate
software programming, the device may automatically select the various
parameters which characterize the delivered waveforms, such as waveshape
of the waveform for antitachycardia pacing.” (Ans. 3-4.) Adams is relied
upon to “explicitly show the use of a single lead that delivers atrial and
ventricular antitachycardia therapy to the patient’s heart.” (Id. at 4, citing
Figures 2-7 of Adams.)

1
The Examiner cites Adams or Mirowski in the alternative. For the reasons
discussed below, we do not find it necessary to discuss Mirowski.
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Appellant contends that “Weiss fails to disclose automatically
applying an atrial anti-tachyarrhythmia therapy shock including a different
waveform than a ventricular anti-tachyarrhythmia therapy shock in response
to monitored atrial activity indicating an atrial tachyarrhythmia, as opposed
to monitored ventricular activity indicating a ventricular tachyarrhythmia.”
(App. Br. 14.)
The issue with respect to this rejection is: Did the Examiner error in
finding that the teachings of Weiss and Adams teach or suggest application
of different shock therapy wherein the atrial anti-tachyarrhythmia therapy
shock includes a different waveform than the ventricular anti-
tachyarrhythmia therapy shock?
Findings of Fact
FF1. The disclosure of Weiss relates to “implantable medical devices
which monitor the cardiac state of a patient by sensing the patient’s intrinsic
cardiac rhythm, particularly for the presence of tachyarrhythmias, and which
deliver therapy in the form of electrical energy to cardiac tissue in an attempt
to revert such tachyarrhythmias and restore the heart to a normal sinus
rhythm.” (Weiss, col. 1, ll. 7-13; emphasis added.)
FF2. The device in Weiss may be used to apply both atrial anti-
tachyarrhythmia therapy and ventricular anti-tachyarrhythmia therapy.
Specifically, Weiss discloses as follows:
[T]he principle of the invention applies equally to single
chamber defibrillator/pacemaker devices and dual chamber
defibrillator/pacemaker devices which incorporate in their
therapy both atrial and ventricular bradycardia and/or
antitachycardia pacing, whereby the device has the capability
of inducing fibrillation and other arrhythmias in both the atrium
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and the ventricle as well as delivering bradycardia pacing,
antitachycardia pacing, cardioversion and/or defibrillation
therapy to either the atrium and/or the ventricle of the patient’s
heart.

(Weiss, col. 17, ll. 52-62; emphasis added.)
FF3. Weiss discloses that
In accordance with another aspect of the invention, an
implantable device for providing therapy to a patient's
inadequately functioning heart comprises a cardioversion
electrode lead system, means for detecting arrhythmias of the
heart, circuit means including charge storing means for
applying cardioversion therapy to the heart via the electrode
lead system, means responsive to the detection of an arrhythmia
condition for charging the charge storing means to an
appropriate energy level for delivering cardioversion therapy to
the patient's heart, and means coupled to the circuit means for
selectively providing to the cardioversion electrode lead system
pulses having any one of a plurality of different cardioversion
waveforms.

(Weiss, col. 6, ll. 52-65; emphasis added.)
FF4. Weiss discloses that “any of the waveforms shown in FIG. 8 can
be generated by pulse generator.” (Weiss, col. 14, ll. 49-50.)
FF5. Weiss discloses that the device may be programmed to
“automatically select . . . the most effective value of each parameter in order
to achieve the most appropriate stimulus,” where the parameters include: 1)
“the shape of the cardioversion or defibrillation shock waveform;” 2)
“whether pacing, micro-shock, cardioversion and defibrillation waveforms
are to be delivered to the patient's heart simultaneously, in succession or
singly;” 3) “whether the shape of the pacing, micro-shock, cardioversion or
defibrillation waveforms delivered in succession are the same or different;”
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and 4) “what type of waveform is delivered to the patient's heart each time a
waveform is delivered in a succession, where the waveforms of choice are
pacing, micro-shock, cardioversion and defibrillation.” (Weiss, col. 16, l. 45
to col. 17, l. 23; emphasis added.)
FF6. The Examiner finds that 1) “Weiss is capable of delivering
different waveforms to the patient to treat arrhythmia of the atrium and
ventricle” (Ans. 4), 2) the waveforms of Weiss each have a different shape
(Ans. 4-5, citing Fig. 8 of Weiss), and 3) “[t]he device of Weiss is
considered to be able to distinguish between a sensed atrial tachyarrhythmia
and a sensed ventricular tachyarrhythmia” because it would be “non-
sensical” otherwise (Ans. 5).
FF7. The Examiner finds that Weiss is “ambiguous as to exactly how
may leads are used to deliver both the atrial and ventricular therapy.” (Id. at
4.)
FF8. The Examiner finds that Adams discloses “the use of a single
lead that delivers atrial and ventricular antitachycardia therapy to the
patient’s heart.” (Id., citing Figures 2-7 of Adams.)
FF9. Adams discloses:
A catheter 9 bearing proximal electrode 11 and distal electrode
13 is positioned in a typical intravascular placement. Proximal
electrode I [sic] is in the superior vena cava 36 and distal
electrode is within the right ventricle 40.
(Adams, col. 5, ll. 29-34.)
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Principles of Law
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.

After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“[A] patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007).
However, a prima facie conclusion of obviousness may be supported by a
showing that a combination of familiar elements according to known
methods yields no more than predictable results. See KSR, 550 U.S. at 401;
citing United States v. Adams, 383 U.S. 39, 50-52 (1966).
The Court in KSR also emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418.
An attorney argument is not evidence unless it is an admission,
because “[a]n assertion of what seems to follow from common experience is
just attorney argument and not the kind of factual evidence that is required to
rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997) (citations omitted).
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Analysis
Claims 1-10 stand or fall together. We focus our analysis on
independent claim 1 since Appellant’s arguments are focused on the
limitations of claim 1. (App. Br. 13-18.)
Weiss discloses a medical treatment device for monitoring both atrial
heart activity and ventricular heart activity. (FF1.) The device may contain a
supraventricular electrode and a first ventricular electrode. (FF2.) The
device administers anti-tachyarrhythmia therapy via an electrode lead
system. (FF3.) The therapy may be delivered automatically in the form of
shocks (FF5) and may use different waveforms (FF3; FF4). The Examiner
finds that the device of Weiss is able to distinguish between a
tachyarrhythmia sensed from the atrium and a tachyarrhythmia sensed from
the ventricle. (FF6.)
Appellant argues that Weiss fails to establish “automatically applying
a different waveform in response to the information about the location of a
detected tachyarrhythmia.” (App. Br. 14; emphasis in original.) Appellant
contends that “Weiss’s shifting through a succession of waveforms is not the
same as automatically applying a different waveform in response to the
location of a monitored arrhythmia, as recited or incorporated in the present
claims, with both the atrium and the ventricle being monitored” and that
there is a meaningful difference “between shifting through a series of
waveforms in succession and automatically applying different waveforms in
response to information about the location of a monitored arrhythmia.” (Id.
at 15; emphasis in original.)
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We find that the Examiner has set forth a prima facie case of
obviousness that has not been adequately rebutted by Appellant. Weiss
discloses that its system “may automatically select . . . the most effective
value of each parameter in order to achieve the most appropriate stimulus”
from parameters that include “the shape of the pacing pulse waveform for
. . . antitachycardia pacing” (Weiss, col. 16, ll. 46-52; FF5; see also FF2 and
6). We agree with the Examiner that automatically applying shocks with
different waveforms for atrial or ventricular anti-tachyarrhythmia therapy
would have been obvious based on Weiss’ disclosure.
Appellant has not provided any objective evidence, such as expert
testimony, to explain his position of how a skilled worker would understand
the contents of Weiss or why it would not have been obvious based on
Weiss to automatically deliver the pacing, micro-shock, cardioversion and
defibrillation waveforms disclosed by Weiss in response to certain heart
activity. Appellant’s arguments supporting such positions cannot take the
place of evidence, In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974), and
are entitled to little, if any, weight. See, e.g., In re Payne, 606 F.2d 303, 315
(CCPA 1979); In re Lindner, 457 F.2d 506, 508 (CCPA 1972).
Appellant further contends that Adams “fail to disclose, teach, or even
suggest the claimed application of different shock therapy waveforms in
response to the location of a monitored arrhythmia, with both the atrium and
the ventricle being monitored.” (App. Br. 15.) However, the Examiner does
not rely on Adams for this teaching. Rather, Adams is relied on to establish
that use of a single lead to treat both atrial tachyarrhythmia and ventricular
tachyarrhythmia was known. (FF7.) Appellant does not dispute this
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finding. (App. Br. 13-18.) We therefore affirm the Examiner’s conclusion of
obviousness.
Conclusion of Law
The Examiner established that the teachings Weiss and Adams are
properly combinable in each of the grounds of rejection under 35 U.S.C. §
103(a).

II.
Claims 1-10 stand rejected under the judicially created doctrine of
obviousness-type double patenting. (Ans. 6.) Appellant presents no
arguments against the Examiner's rejection based on the judicially created
doctrine of obviousness-type double patenting. (App. Br. 18.) We therefore
summarily affirm it. See MANUAL OF PATENT EXAMINING PROCEDURE §
1205.02 (“If a ground of rejection stated by the examiner is not addressed in
the appellant’s brief, that ground of rejection will be summarily sustained by
the Board.”).

SUMMARY
We affirm the rejection of claims 1-10 under 35 U.S.C. 103(a) over
the combination of Weiss and Adams.
We affirm the rejection of claims 1-10 on the ground of nonstatutory
obviousness-type double patenting.
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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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