Medtronic, Inc.

Patent Trials and Appeals Board

Oct 2, 2020

2019006832 (P.T.A.B. Oct. 2, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/064,801 10/28/2013 Scott R. Stanslaski C00003291.USU1 1022
87562 7590 10/02/2020
Medtronic - WK
P.O. Box 2049
McDonough, GA 30253
EXAMINER
TOWA, RENE T
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
10/02/2020 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):
jeramie@witherskeys.com
rs.patents.five@medtronic.com
tina@witherskeys.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte SCOTT R. STANSLASKI, PENG CONG, WESLEY A. SANTA,
and TIMOTHY J. DENISON
____________________

Appeal 2019-0068321
Application 14/064,801
Technology Center 3700
____________________

Before PHILLIP J. KAUFFMAN, TARA L. HUTCHINGS, and
ALYSSA A. FINAMORE, Administrative Patent Judges.

FINAMORE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 11, 12, and 15–20. We have
jurisdiction under § 6(b). We REVERSE.

1 The citations herein refer to the Specification filed October 28, 2013
(“Spec.”), Final Office Action mailed August 2, 2018 (“Final Act.”), Appeal
Brief filed January 22, 2019 (“Appeal Br.”), Examiner’s Answer mailed
July 22, 2019 (“Ans.”), and Reply Brief filed September 19, 2019 (“Reply
Br.”).
2 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies Medtronic, Inc., a subsidiary of Medtronic plc, as the real party in
interest. Appeal Br. 4.
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Application 14/064,801

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SUBJECT MATTER ON APPEAL
The invention relates to “devices and methods for sensing
physiological signals while stimulation therapy is being conducted in
proximity to the location where the physiological signals are being sensed.”
Spec. ¶ 1. Claims 11 and 18 are independent. Independent claim 11 is
illustrative of the subject matter on appeal, and reproduced below with
italics to emphasize the limitation at issue.
11. A device for sensing a physiological signal while
stimulation therapy is being provided, comprising:
a sensing electrode;
a blanking switch;
a first electrically conductive pathway connected between
the sensing electrode and the blanking switch;
a sensing amplifier;
a second electrically conductive pathway connected
between the sensing amplifier and the blanking switch; and
a controller that maintains the blanking switch in a
non-conducting state during at least a portion of the recharge
phase and a next stimulation phase of a stimulation signal that
follows the recharge phase and that maintains the blanking
switch in a conducting state for a period of time after the next
stimulation phase that follows the recharge phase and prior to a
next recharge phase that follows the next stimulation phase, the
next recharge phase occurring prior to any stimulation phase that
occurs after the next stimulation phase, the period of time that
the controller maintains the blanking switch in the conducting
state being longer than an amount of time between an end of the
recharge phase and a beginning of the next stimulation phase that
follows the recharge phase.
Appeal Br., Claims App. (emphasis added).
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Application 14/064,801

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REJECTIONS3
Claim(s) Rejected 35 U.S.C. § References/Basis
11, 15–18 103 Zhu,4 Bardy5
12 103 Zhu, Bardy, Hemming6
19, 20 103 Zhu, Bardy, Wanasek7

ANALYSIS
Independent claim 11 recites, in pertinent part, a controller that
maintains the blanking switch in a non-conducting state during
at least a portion of the recharge phase and a next stimulation
phase of a stimulation signal that follows the recharge phase and
that maintains the blanking switch in a conducting state for a
period of time after the next stimulation phase that follows the
recharge phase and prior to a next recharge phase that follows
the next stimulation phase.
Appeal Br., Claims App. Independent claim 11 thus requires a controller for
providing a blanking scheme that blanks, i.e., maintains the blanking switch
in a non-conducting state, during a recharge phase and a subsequent
stimulation phase, and does not blank, i.e., maintains the blanking switch in
a conducting state, during the time period after the subsequent stimulation
phase and before a subsequent recharge phase.
In regard to the recited blanking scheme, the Examiner finds Zhu’s
controller 32 enables blanking during a pace pulse, i.e., stimulation, and a

3 The Examiner has withdrawn rejections of claims 11 and 15–18 under 35
U.S.C. § 103 over Zhu and Stancer, claim 12 under 35 U.S.C. § 103 over
Zhu, Stancer, and Hemming, and claims 19 and 20 under 35 U.S.C. § 103
over Zhu, Stancer, and Wanasek. Ans. 3.
4 Zhu et al., US 6,044,296, issued Mar. 28, 2000.
5 Bardy et al., US 2002/0049476 A1, published Apr. 25, 2002.
6 Hemming et al., US 5,871,512, issued Feb. 16, 1999.
7 Wanasek, US 2010/0324618 A1, published Dec. 23, 2010.
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Application 14/064,801

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recharge phase, as shown in Figure 5, reproduced below. Final Act. 13–14
(citing Zhu 8:62–67, 9:1–23, Fig. 5); Zhu 7:30–37.

Figure 5 shows resulting pacing waveform 152 comprising a pace pulse and
recharge time 164 that occur during blanking period 160. Zhu 6:13–16,
8:62–9:19.
The Examiner acknowledges Zhu does not disclose the recited
blanking scheme that blanks during a recharge phase and a subsequent
stimulation phase following the recharge phase. Final Act. 14. The
Examiner further finds Bardy teaches biphasic pacing waveform 1902
having positive portion 1904, i.e., recharge phase, followed by negative
portion 1906, i.e, stimulation phase, as shown in Figure 19, reproduced
below. Id. at 15 (citing Bardy ¶¶ 34–35, 68–71, Fig. 19).
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Figure 19 shows biphasic pacing waveform 1902 for anti-bradycardia pacing
plotted as a function of time versus instantaneous voltage. Bardy ¶¶ 33, 68.
The Examiner determines it would have been obvious to modify
Zhu’s controller by substituting Zhu’s waveform having a stimulation phase
proceeded by a recharge phase with Bardy’s waveform comprising a
recharge phase followed by a stimulation phase to result in a controller
providing the recited blanking scheme that blanks during a recharge phase
and a subsequent stimulation phase and does not blank during the time
period after the subsequent stimulation phase and before a subsequent
recharge phase. Final Act. 15; Ans. 10–11. According to the Examiner, the
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proposed modification would have been a simple substitution of one
waveform for another to yield the predictable result of adequate pacing of
the heart because Bardy teaches the polarities of the pacing waveform can be
reversed so that positive can precede the negative and vice versa. Final
Act. 15 (citing Bardy ¶¶ 67, 69); Ans. 10–11 (citing same).
Appellant argues it is not reasonable to combine the teachings of Zhu
and Bardy as the Examiner proposes because the proposed combination
would have rendered Zhu ineffective for its intended purpose of sensing the
heart’s response to the stimulation pulse, i.e., capture verification. Appeal
Br. 11; Reply Br. 2–4. According to Appellant, a person of ordinary skill in
the art would not have modified Zhu’s controller to include Bardy’s
waveform having a recharge phase followed by a stimulation phase because
“[t]he whole point of Zhu is to adequately remove the afterpotentials via the
accelerated passive recharge before the evoked response occurs at the 20ms
mark after the stimulation pulse.” Reply Br. 2. For the reasons that follow,
Appellant’s argument is persuasive.
The Examiner acknowledges that the goal of Zhu’s pacing system is
to facilitate capture verification by quickly attenuating polarization voltages
or “afterpotentials” that mask the evoked response of the heart (Ans. 11–12
(citing Zhu 8:9–18)), but disagrees that replacing Zhu’s waveform with
Bardy’s biphasic waveform would thwart Zhu’s capture verification (id.
at 13). According to the Examiner, Zhu discloses a blanking period of
12 milliseconds, which encompasses a stimulation phase of 2 milliseconds
and a recharge phase of 10 milliseconds, and Bardy teaches a biphasic
waveform having a pulse width from approximately 2 milliseconds to
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40 milliseconds. Id. (citing Zhu 9:51–56, 10:46–67, 11:1–6, Figs. 5, 7;
Bardy ¶ 71). The Examiner determines:
[A] skilled artisan would know that incorporating the teachings
of Bardy into Zhu would entail substituting the waveform of Zhu
with the biphasic waveform shown at fig. 19 of Bardy having a
reversed polarity from the waveform of Zhu and a pulse width
consistent with that required by Zhu, such as 12 milliseconds, for
example, such that the evoked response is easily distinguishable
with a stimulus waveform having a blanking period of
12 milliseconds to achieve capture verification as explained in
Zhu. In other words, a skilled artisan would know to shape the
biphasic waveform to achieve a desired active recharge, i.e. by
providing a biphasic waveform having a pulse width that
achieves capture verification.
Id. at 13–14 (emphasis added).
Even if the Examiner’s proposed combination of Zhu and Bardy
would result in waveform having a pulse width that enables recharging and
stimulation to occur before the evoked response, Zhu does not associate the
ability to sense capture with the pulse width of the waveform. Rather, as
Appellant argues, Zhu discloses that the attenuation of afterpotentials, and
thus the facilitation of capture verification, is tied to the recharge cycle.
Reply Br. 2–3 (citing Zhu 10:29–67). According to Zhu, during the recharge
cycle, first coupling capacitor 94 and second coupling capacitor 96 are
connected in series, which causes the overall capacitance to approximate a
lower capacitance, resulting in a quicker attenuation of afterpotentials
resulting from a stimulation pulse. Zhu 10:29–66, Fig. 3.
Modifying Zhu’s controller to substitute Zhu’s waveform with that of
Bardy, as the Examiner proposes, would result in a blanking period that
encompasses a recharge phase a subsequent stimulation phase, and thus
encompasses the attenuation that occurs during the recharge phase and
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before the subsequent stimulation phase. The proposed modification would
also result in sensing capture after the stimulation phase of the blanking
period and before the subsequent recharge phase of the next blanking period
such that sensing capture would occur without the afterpotential attenuation
associated with the recharge phase. Regardless of the pulse width, the
Examiner’s proposed combination of Zhu and Bardy would result in a
controller that blanks during attenuation of the afterpotentials where sensing
would be enhanced, and senses without attenuating the afterpotentials, thus
yielding a controller that is completely contrary to Zhu’s aim of facilitating
capture verification by attenuating afterpotentials.
In view of the foregoing, the Examiner has not demonstrated
sufficiently that a person of ordinary skill in the art would have combined
the teachings of Zhu and Bardy to result in a controller enabling the blanking
scheme recited in independent claim 11. We, therefore, do not sustain the
rejection of independent claim 11 and claims 15–17 depending therefrom.
Independent claim 18 recites a controller for providing a blanking
scheme similar to that of independent claim 11. Appeal Br., Claims App.
The Examiner’s rejection of independent claim 18 is similar to the rejection
of independent claim 11. Compare Final Act. 18–20, with id. at 12–16. We
do not sustain the rejection of independent claim 18 for the same reasons as
independent claim 11.
Claim 12 depends from independent claim 11, and claims 19 and 20
depend from independent claim 18. Appeal Br., Claims App. The Examiner
does not rely on Hemming or Wanasek in any manner that would remedy the
deficiency in the combination of Zhu and Bardy with respect to the
independent claims. Final Act. 20–23. For the same reasons as the
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independent claims, we do not sustain the rejections of claims 12, 19,
and 20.

CONCLUSION
We do not sustain the rejections of claims 11, 12, and 15–20. We,
therefore, reverse the Examiner’s decision to reject claims 11, 12,
and 15–20.

DECISION SUMMARY
Claim(s)
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
11, 15–18 103 Zhu, Bardy 11, 15–18
12 103 Zhu, Bardy, Hemming 12
19, 20 103 Zhu, Bardy, Wanasek 19, 20
Overall
Outcome
11, 12,
15–20

REVERSED