Ex Parte Ghanem et al

Patent Trial and Appeal Board

Sep 1, 2016

11554346 (P.T.A.B. Sep. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111554,346 10/30/2006
27581 7590 09/06/2016
Medtronic, Inc. (CRDM)
710 MEDTRONIC PARKWAY NE
MS: LC340 Legal Patents
MINNEAPOLIS, MN 55432-9924
FIRST NAMED INVENTOR
Raja N. Ghanem
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.
P0027 43 7 .00/LGl 0126 5281
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
09/06/2016 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):
medtronic_crdm_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAJAN. GHANEM, ROBERT W. STADLER,
and XUSHENG ZHANG
Appeal2014-008789
Application 11/554,346
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134(a) from the
Examiner's rejection of claims 7-15, 18-26, 28-32, 34, and 35. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The Specification discloses "an implantable medical device system,
and ... a method and apparatus for detecting arrhythmias in a subcutaneous
medical device" (Spec. 1 i-f 1 ).
1 Appellants identify the Real Party in Interest as Medtronic, Inc. (App.
Br. 3.)
Appeal2014-008789
Application 11/554,346
Claims 7-15, 18-26, 28-32, 34, and 35 are reproduced in the Claims
Appendix of the Appeal Brief. Claim 7 is representative of the claims on
appeal and reads as follows (emphasis added):
7. A method of treating a shockable event of a heart
generating a cardiac signal representative of a plurality of
depolarizations and repolarizations of the heart,
the treating of the shockable event being conducted by a
medical device having a plurality of electrodes being
configured to deliver an output from an energy storage device,
compnsmg:
sensing the cardiac signal with the plurality of electrodes,
the plurality of electrodes forming a first sensing vector and a
second sensing vector;
identifying the shockable event based, at least in part, on
the cardiac signal; then
charging the energy storage device during a charging
period in response to identifying the cardiac event; then
conditionally terminating the charging step, prior to a
completion of the charging step, based, at least in part, on a
morphology of the cardiac signal sensed by each of the first
sensing vector and the second sensing vector in a plurality of
sensing windows not being indicative of the shockable event;
and
delivering the output based, at least in part, on the
completion of the charging step.
(App. Br. 14, Claims Appendix.)
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Appeal2014-008789
Application 11/554,346
Issue
The Examiner has rejected claims 7-15, 18-26, 28-32, 34, and 35
under 35 U.S.C. § 103(a) as obvious in view of Gilli,2 Ostroff,3 and Stadler4
(Ans. 2; Final Rejection (hereinafter Final Rej.) 2---6). 5
The issue presented is: Does a preponderance of the evidence of
record support the Examiner's conclusion that the combination of Gilli,
Ostroff, and Stadler would have made obvious a method of treating a
shockable event in a heart rhythm that comprises, among other steps,
charging the energy storage device and terminating the charging step when
plurality of sensing windows indicate no shockable event has occurred as
required by claim 7?
Findings of Fact
FF 1. Gilli discloses an "implantable defibrillator [that] contains a
high energy shock system to revert VT /VF' s [sic] [ventricular
tachycardia/ventricular fibrillations] to normal sinus rhythm" (Gilli,
Abstract). "When the apparatus is in an automatic shock sequence, there are
two points of reconfirmation: at the programmed minimum time to shock
2 Norma L. Gilli et al., US 5,191,884, issued Mar. 9, 1993 ("Gilli").
3 Alan H. Ostroff, US 2004/0254613 Al, published Dec. 16, 2004.
4 Robert W. Stadler et al., US 7,103,404 B2, issued Sept. 5, 2006 ("Stadler").
5 Office Action mailed Oct. 23, 2013. The Examiner appears to have
inadvertently omitted claims 34 and 35 in the statement of the rejection in
this Office Action, however, the claims are indicated as rejected on the
accompanying form PTOL-326 included with that communication.
Appellants in their Appeal Brief recognize that claims 34 and 35 are
encompassed by the rejection (see App. Br. 8), accordingly, we have
included these claims with the rejection in the opinion.
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Appeal2014-008789
Application 11/554,346
and after the full charge has been reached, or at thirty seconds, whichever
comes first" (id.). "Reconfirmation involves testing the tachycardia
detection output (TDO). If the TDO is high, reconfirmation occurs. If the
TDO is low, reconfirmation will not occur and the device will subsequently
dump the discharge" (id.). "Two reconfirmations must occur before a shock
is delivered to the patient. If the TDO is low at either reconfirmation, the
charge will be dumped" (id.)
FF2. Figure 5 of Gilli is shown below:
7.XCJ{YC.A~~"':-~.~
-DJ.~~~f"f;~~li.J.f.-Qg.}._ .. _._.._.._..._.._.._ ... .._.._.._._.._._.._.._.._.._.._J ·1 _._._._._ • ._._ • ._._d ........................................ .._.._._._._._._._._._._.._._._._._.._._._ .. ,,_._._._ ..... .._ .................. l.:!..!.__
~;;:~~ ! i ih~~l~.t'j l '>HI fl '; i I H 11 H nm I rn fl I 111 i I I
~'C0 ,•c\-.._._,-,.+._A\~/i/;\t,/1W/•h\.!"lvW,,'/vVv'NvL;:"_",°'1'·-"'~·
' ' t~ itt
(S) (~}
Figure 5 illustrates "reconfirmation in the initial shock sequence" (Gilli, col.
3, 11. 49-50). "Initially the TDO is low due to appropriate sensing of sinus
rhythm. , .. At 7, . , . six out of seven intervals fall within the TDW
[tachycardia detection vvindowJ, The TDO is then set high, and.,. [the
system] starts charging the capacitors'' (id. at col. 12, lL 37-43). "At 8; the
first reconfinnation (RC) point .. , the TDO is still high and VT/VF is
confin11ed'; (icL at coL 12, 1L 43---45). "At 9, the second reconfirmation
point, (at full charge or at thirty seconds, whichever comes first), T'DO is
still high and VT!VF is therefore reconfirmed. At l (L a defibrillation shock
~ ,
is delivered to the patienf~ (id. at 12, lL 45----49 ).
FF3. Figure 5A of Gilli is shown below:
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Appeal2014-008789
Application 11/554,346
Figure 5A illustrates "spontaneous reversion before a first reconfirmation"
(id. at col. 3, 11. 51-52).
Initially the TDO is low due to sensing of sinus rhythm .... At
7, six out of seven 1nterva1s are inside the 'TDVV. 'I'he 'fDO is
then set high and ... [the system] starts charging. At 8-9, two
interva1s longer than the TDI [(tachycardia detection interval)]
are sensed due to the spontaneous reversion to NSR. At 1 O~ the
TDO resets to low as there are no longer six out of seven
1nterva1s inside the 'fD\V. i\ t 11, the first reconfirmation
occurs at six seconds after detection. As the TDO is low,
VT /VF is not confirmed, so although the discharge is "flagged''
to dump, charging continues to the programmed voltage. At 12,
the second reconfirrnatfon point (at fu11 charge or thirty
seconds, whichever comes first), TDO is low and VT!VF is not
reconfirmed. The apparatus dumps the energy internally ...
[and] retun1s to the defib standby condition
(id. at col. 12, L 55-col. LL L 2).
FF4. Ostroff discloses "a method and means for discriminating
between cardiac rhythms appropriate for therapy using an implantable
cardioverter defibrillator" (Ostroff i-f 2).
FF5. Ostroff discloses the use of "multiple templates and multiple
vector views to compare specific attributes of the sensed cardiac complex in
order to discriminate between rhythms. In particular embodiments, the
present invention may capture different sensing or vector views and compare
the sensed cardiac complex to its corresponding stored template" (id.
i-f 11 ).
FF6. Ostroff discloses that, "by having the ability to switch between
views, a vector view may be chosen that possesses the best signal to noise
ratio for R wave detection, and has the best sensitivity to observe particular
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Appeal2014-008789
Application 11/554,346
attributes the detection architecture may use for discriminating between
arrhythmias" (id. i-f 54).
FF7. Stadler discloses an implanted medical device that can be
"configured to obtain both a tachyarrhythmia rate and a morphology of a
cardiac waveform" (Stadler, col. 1, 11. 48-50). The device "uses the
obtained tachyarrhythmia rate and morphology to determine whether the
heart beat indicates termination of the identified tachyarrhythmia episode"
(icL at col. 1, 11. 50-54).
FF8. Stadler discloses that the "[i]mplanted medical device 10
determines whether the tachyarrhythmia episode has terminated during a
charging period of capacitors 88 and 90" (id. at coL 9, 1L 39-43). Stadler
discloses that,
if the implanted medical device is programmed to deliver a
cardioversion shock in the case of ventricular tachycardia, the
processor may determine whether the identified
tachyarrhythmia episode has terminated during a period of
charging of capacitors or a confirmation period and, if so,
forego the cardioversion shock. This feature can conserve
battery resources and avoid painful, unnecessary therapies
(id. at col. 2- 11. 3 l-33)-
FF9. The Specification explains that a window is simply
referencing a period of time during which ECG data is gathered and
analyzed, such as in 3 second increments (see Spec. i-f 74 ("other times
periods for the processing time [can be] utilized ... , but should preferably
be within a range of 0.5 to 10 seconds)).
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Appeal2014-008789
Application 11/554,346
Analysis
The Examiner finds that Gilli discloses "a method and apparatus of
treating a shockable event of a heart by generating a cardiac signal ... [and]
treating the shockable event ... [with] a medical device having a plurality of
electrodes delivering output from an energy storage device" (Final Rej. 2-3;
FF1-FF3). The Examiner finds that Gilli discloses "terminating charging
[based] on a morphology of the cardiac signal in a plurality of sensing
windows not being indicative of the shockable event" (Final Rej. 3; Ans. 3;
FF3). The Examiner finds that Gilli does not disclose a "plurality of
electrodes form[ing] a first sensing vector and second sensing vector, and
terminating the charging prior to the completion of the charge" (Final Rej.
3). The Examiner looks to Ostroff and Stadler for these teachings (FF4-
Error! Reference source not found.).
The Examiner finds that Ostroff discloses that "it is known to use
multiple sensing vectors, sensing cardiac events, during sensing windows"
(Final Rej. 4; FF4-FF6; FF9). The Examiner finds that Stadler discloses
termination of "charging prior to completion ... [after] detections of a non-
shockable rhythm ... for providing the predictable results of conserving
battery resources and avoiding delivery of unnecessary painful therapy"
(Final Rej. 4; FF7 and Error! Reference source not found.). The
Examiner concludes that it would have been obvious to one of ordinary skill
in the art to modify Gilli's system "with the teachings of Ostroff and
Stadler" (Final Rej. 4 ). The Examiner reasons that "such a modification
would provide the predictable results of efficient detections of shockable
rhythms or non-shockable rhythms by determining different 'views' of the
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Appeal2014-008789
Application 11/554,346
heart in time for efficient therapy and reconfirmation thereof' (id,). The
Examiner reasons that termination of "charging prior to completion if there
is repeated, at least two, detections of a non-shockable rhythm would
provide the predictable results of conserving battery resources and avoiding
delivery of unnecessary painful therapy" (id.).
Appellants argue that Gilli discloses an implantable defibrillator that
requires "two points of confirmation ... before continuing with the shocking
sequence, namely at the programmed minimum time ... and after the full
charge has been reached" (App. Br. 8). Claim 7 requires terminating the
charging step "based ... on a morphology of the cardiac signal sensed ... in
a plurality of sensing windows not being indicative of the shockable event."
(id.)
Appellants argue that Gilli "teaches away from the express
requirements" of claim 7 because Gilli "requires two confirmations of a
shockable event in order to continue to proceed to shock" (id.) Appellants
argue that when "an event occurs that has one confirmation to shock but one
confirmation not to shock ... Gilli ... would not shock since two
confirmations to shock were not received" (id. at 9). Appellants argue that,
in the same situation, the invention of claim 7 "would continue to shock
since two confirmations NOT to shock ... were not received. In this case,
the devices achieve completely different results" (id.).
Appellants argue that the difference between Gilli and the method of
claim 7 can be appreciated when "there is one confirmation to shock and one
confirmation not to shock" (id,). Appellants argue that Stadler does not cure
the deficiencies of Gilli because Stadler discloses not shocking if
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Appeal2014-008789
Application 11/554,346
tachyarrhythmia has terminated during a period of charging or during a
confirmation period (id. at 10). Appellants argue that Ostroff "is cited only
for the disclosure of the use of two vectors and does not otherwise enter into
this discussion ... [and] is not relevant on this issue" (id. at 12).
We are not persuaded by Appellants' argument. Claim 7 requires
termination of charging upon the condition that a first cardiac signal in a first
window and a second cardiac signal in a second window are both not
indicative of a shockable event. As indicated by the Examiner, Gilli
discloses that when a first cardiac signal in a first window and a second
cardiac signal in a second window are both not indicative of a shockable
event, the energy in the apparatus is dumped internally (see FF3; Final. Rej.
6; see also Ans. 3 ("Fig. 5A does indeed show a plurality of windows of
morphology data not being indicative of a shockable event which terminates
the charging step")). The Examiner identified one scenario in Gilli's
example 5A that shows two consecutive nonshockable signals, so no shock
is given (FF3). Just because Gilli discloses other scenarios that also dump
the defibrillator charge if only one of the two signals says not to shock does
not distinguish Gilli's teaching in example 5A from claim 7, because claim 7
reads on the situation where Gilli gets two signals that say not to shock.
Thus, we affirm the rejection of independent claim 7 under 35 U.S.C.
§ 103(a) as being obvious in view of Gilli, Ostroff, and Stadler for the
reasons set forth by the Examiner. Claims 8-15, 18-26, 28-32, 34, and 35
have not been argued separately and therefore fall with independent claim 7.
See 37 C.F.R. § 41.37(c)(l)(iv).
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Appeal2014-008789
Application 11/554,346
Conclusion of Law
A preponderance of the evidence supports the Examiner's conclusion
that the combination of Gilli, Ostroff, and Stadler would have made obvious
a method of treating a shockable event of a heart that comprises, among
other steps,
conditionally terminating the charging step, prior to a completion
of the charging step, based, at least in part, on a morphology of
the cardiac signal sensed by each of the first sensing vector and
the second sensing vector in a plurality of sensing windows not
being indicative of the shockable event
as required by claim 7.
SUMMARY
We affirm the rejection of claim 7 under 35 U.S.C. § 103(a). Claims
8-15, 18-26, 28-32, 34, and 35 have not been argued separately and fall
with claim 7.
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
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