Ex Parte Meyer et al

Patent Trial and Appeal Board

Jun 30, 2016

11320173 (P.T.A.B. Jun. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111320, 173 12/28/2005
21186 7590 07/05/2016
SCHWEGMAN LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS, MN 55402
Scott A. Meyer
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
279.988US1 6163
EXAMINER
HANKINS, LINDSEY G
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
07/05/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOTT A. MEYER and ALOK S. SATHA YE
Appeal2013-004228
Application 11/320, 173
Technology Center 3700
Before JOHN C. KERINS, RICHARD H. MARSCHALL, and
FREDERICK C. LANEY, Administrative Patent Judges.
KERINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Scott A. Meyer and Alok S. Sathaye (Appellants) appeal under
35 U.S.C. § 134(a) from the Examiner's final decision rejecting claims 1-30.
We have jurisdiction over this appeal under 35 U.S.C. § 6(b).
We REVERSE.
THE INVENTION
Appellants' invention relates to an implantable medical device for
providing vagal stimulation and for limiting atrial proarrhythmia. Claim 1 is
illustrative and is reproduced below:
Appeal2013-004228
Application 11/320, 173
1. An implantable medical device, comprising:
a sensor configured to sense atrial arrhythmia
vulnerability data;
a therapeutic stimulator configured to deliver an
electrical signal to provide vagal stimulation; and
means for controlling the therapeutic stimulator, the
controlling means configured to receive sensed atrial
arrhythmia vulnerability data and to control the therapeutic
stimulator to reduce the vagal stimulation to limit atrial
proarrhythmia using the sensed atrial arrhythmia vulnerability
data,
wherein the sensed atrial arrhythmia vulnerability data includes
signs or symptoms of increased atrial vulnerability including at
least one of: sensed changes in atrial arrhythmia etiology,
relative timing of atrial arrhythmia related to the introduction or
delivery of stimulation therapy; or sensed increases in
premature atrial complexes (P ACS), PAC trains or atrial flutter.
THE REJECTIONS
The Examiner has rejected claims 1-23 and 25-30 under 35 U.S.C.
103(a) as being unpatentable over Weinberg (US 2003/0078623 Al,
published Apr. 24, 2003) in view of Hettrick (US 2005/0245975 Al,
published Nov. 3, 2005); and claim 24 as being unpatentable over Weinberg
in view of Hettrick and Rahme (US 6,511,500 Bl, issued Jan. 28, 2003).
ANALYSIS
The Examiner cites to Weinberg as disclosing all limitations found in
independent claim 1, with the exception of the atrial arrhythmia vulnerability
data to be sensed being one of the claimed types, in particular, an increase in
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Application 11/320, 173
premature atrial complexes (PA Cs). Final Act. 2-3. The Examiner relies on
Hettrick as disclosing that "it is known to observe an increased frequency of
PACs to indicate onset of atrial arrhythmia." Id. at 3. The Examiner
concludes that it would have been obvious to modify the Weinberg system
and method to include
Id.
sensing an increase in PA Cs as an indication of atrial
vulnerability ... so that the vagal stimulation method, disclosed
by Weinberg, can be adjusted, since Hettrick teaches that
sensing an increase in PA Cs is an indication of onset of atrial
arrhythmia and would provide the predictable results of
preventing vagal stimulation induced AV
dissociation/arrhythmia ...
Appellants argue that "the combination of Weinberg and Hettrick,
along with the reasoning advanced by the Office, do not show the reduction
of neural stimulation to limit atrial proarrhythmia in response to signs or
symptoms of increased atrial vulnerability, where the signs or symptoms ...
include ... increases in premature atrial complexes (PACS)." Appeal Br.
15. Although we either disagree with, or are not persuaded by, various
positions advanced by Appellants, we agree that the proposed modification,
as explained by the Examiner, does not teach or render obvious the subject
matter of claim 1.
Weinberg is directed to a system that initiates vagal stimulation when
sensed cardiac activity, e.g., atrial rate, is outside (above) a preset limit, with
the vagal stimulation intended to attempt to bring the cardiac activity to
below the upper rate limit. Weinberg, Figs. 21, 23; p. 11, paras. 134, 135,
141. As part of the method, as shown in Figure 23, while vagal stimulation
is being applied, a determination is made as to whether, due to an
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Appeal2013-004228
Application 11/320, 173
excessively high intensity of stimulation, a condition referred to as A-V
dissociation1 has occurred. Id., Fig. 23, para. 141. If A-V dissociation has
occurred, a decrease in one or more parameters (amplitude, pulse width,
frequency, see para. 129) of the vagal stimulation is effected, to reduce the
level of stimulation "back to a level that did not cause A-V dissociation."2
Id., para. 141. The method eventually disables the vagal stimulation once a
determination is made that the cardiac activity or atrial rate is back below the
upper rate limit for a desired period of time. Id., para. 134, 141, Fig. 23.
Claim 1 requires the presence of a sensor configured to sense atrial
arrhythmia vulnerability data, with the data including "at least one of: sensed
changes in atrial arrhythmia etiology, relative timing of atrial arrhythmia
related to the introduction or delivery of stimulation therapy; or sensed
increases in premature atrial complexes (P ACS), PAC trains or atrial
flutter." Appeal Br., Claims Appendix. The Examiner, in apparent
recognition that Weinberg does not explicitly disclose what type of data is
analyzed to determine whether A-V dissociation has occurred, turns to
Hettrick for its disclosure of sensing an increase in P ACs as an indication of
onset of atrial arrhythmia. Final Act. 3; Adv. Act. 4. The Examiner thus
concludes that it would have been obvious to employ, in Weinberg, a sensor
1 Atrial-Ventricular (A-V) dissociation is described in paragraph 104 of
Weinberg as being a partial or total interruption of conduction from the atria
to the ventricle.
2 We note, in this regard, that a preponderance of the evidence, i.e., the
paragraphs cited from Weinberg, as well as paragraph 8 and Figures 21-23,
leads us to find unpersuasive Appellants' attorney argument that a
"reduction in the parameter is not a reduction in neural stimulation as
claimed." Appeal Br. 13.
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Application 11/320, 173
that is configured to sense data in the form of increase in PA Cs as indicating
onset of atrial arrhythmia.
From our review, it appears that Weinberg senses the onset of atrial
arrhythmia at step 1508 in the method illustrated in Figure 23, which data is
used in step 1512 to decide whether to commence vagal stimulation at step
1516, or to stop (or not start, if already stopped) vagal stimulation at step
1514. Weinberg, Fig. 23, para. 141. Thus, even ifthe data sensed were
increases in PACs, as taught by Hettrick, the modified system would not
include the claimed means for controlling the therapeutic stimulator to
reduce vagal stimulation using the sensed data.
The Examiner instead appears to be proposing employing a sensor
configured to sense increases in P ACs at step 1526 in the Weinberg Figure
23 method, as an indication that A-V dissociation has occurred, and, if so,
employing that sensed data to adjust (decrease) the vagal stimulation
parameters to decrease the amplitude or intensity of the stimulation itself. In
this regard, the Examiner posits that "AV dissociation refers to an atrial-
ventricular conduction block ... and therefore any arrhythmia relating to the
atria is considered an atrial arrhythmia." Ans. 5.
Even accepting the Examiner's position that A-V dissociation is
properly regarded as being an atrial arrhythmia, 3 the Examiner has not
established, either by citation to evidence, or using sound technical
reasoning, that data in the form of increases in PA Cs as taught by Hettrick,
can predictably be used to determine whether the particular condition of
3 Appellants counter, without citing to any evidence in support, that "AV
dissociation refers to a ventricular arrhythmia, not an atrial arrhythmia."
Appeal Br. 13; Reply Br. 2.
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Application 11/320, 173
interest in Weinberg, i.e., A-V dissociation, has occurred. Indeed, at least
one passage in Weinberg suggests that sensing both atrial and ventricular
conditions is necessary to monitor A-V dissociation. Weinberg, para. 104.
As such, the Examiner has not adequately explained how a modification of
this type would predictably allow for control (reduction) of vagal stimulation
upon determining that A-V dissociation has occurred, as provided for in
Weinberg.
The rejection of claim 1 as being unpatentable over Weinberg and
Hettrick is therefore not sustained. Independent claims 13, 18, 25, and 28
include essentially the same limitations discussed above with respect to
claim 1, and the rejection of those claims is also not sustained for the same
reasons. Claims 2-12, 14--17, 19-23, 26, 27, 29, and 30 each depends from
one of the independent claims, and the rejection of these claims is also not
sustained.
Claim 24, which depends indirectly from independent claim 18 is
rejected over the combination of Weinberg and Hettrick, and further in view
of Rahme. The Examiner does not rely on Rahme in any manner that
overcomes the basic deficiencies in the combination of Weinberg and
Hettrick. Accordingly, the rejection of claim 24 is not sustained.
DECISION
The decision of the Examiner to reject claims 1-30 under 35 U.S.C.
§ 103(a) is reversed.
REVERSED
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