Pacestter, Inc.

Patent Trials and Appeals Board

Nov 10, 2021

2021000219 (P.T.A.B. Nov. 10, 2021)

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.
15/015,031 02/03/2016 Brian Wisnoskey A16P1002USO
(013-0240US1)
1917
152583 7590 11/10/2021
Pacesetter, Inc.
The Small Patent Law Group, LLC
1423 Strassner Dr.
Suite 100
Brentwood, MO 63144
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
11/10/2021 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):
ASJM_Patents@abbott.com
docket@splglaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BRIAN WISNOSKEY

____________

Appeal 2021-000219
Application 15/015,031
Technology Center 3700
____________

Before DANIEL S. SONG, STEFAN STAICOVICI, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE.
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision in the Final Office Action (dated June 27, 2019, hereinafter “Final

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Lenovo (Singapore) Pte. Ltd. was identified as the real party
in interest in Appellant’s Appeal Brief (filed Nov. 5, 2019, hereinafter
“Appeal Br.”). Appeal Br. 3. However, Appellant’s Supplemental Appeal
Brief (filed Dec. 18, 2019) identifies Pacesetter, Inc., as the real party
interest.
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Act.”) rejecting claims 1–13 and 21–25.2 We have jurisdiction over this
appeal under 35 U.S.C. § 6(b).

SUMMARY OF DECISION
We REVERSE.

INVENTION
Appellant’s invention is directed to a method “for automatic, adaptive,
and programmable bi-ventricular fusion pacing.” Spec. para. 1.
Claim 1, the sole independent claim, is representative of the claimed
invention and reads as follows:
1. A method for a rate adaptive bi-ventricular (BiV) fusion
pacing, comprising:
delivering a first pulse at a left ventricular (LV) lead and
a second pulse at a right ventricular (RV) lead based on a paced
atria-ventricular (AV) delay, wherein the first pulse is timed to
be delivered concurrently with a patient’s right bundle intrinsic
ventricular conduction;
repeating the delivery of the first pulse and the second
pulse for a predetermined number of cycles;
measuring an intrinsic AV conduction interval; and
adjusting the paced AV delay based on the intrinsic AV
conduction interval and a negative hysteresis delta.

Suppl. Appeal Br. 3 (Claims App).

2 Claims 14 and 15 are withdrawn and claims 16–20 are canceled.
Supplemental Appeal Brief (filed Jan. 22, 2020, hereinafter “Suppl. Appeal
Br.”).
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REJECTIONS
I. The Examiner rejects claims 1–13 and 21–25 under 35 U.S.C.
§ 112(a) as failing to comply with the written description
requirement.
II. The Examiner rejects claims 1–13 and 21–25 under 35 U.S.C.
§ 112(a) as failing to comply with the enablement requirement.
III. The Examiner rejects claims 1, 5–10, 12, 13, and 21–25 under
35 U.S.C. § 102(a)(1) as being anticipated by Ding.3
IV. The Examiner rejects claims 2 and 3 under 35 U.S.C. § 103 as
being unpatentable over Ding.
V. The Examiner rejects claims 4 and 11 under 35 U.S.C. § 103 as
being unpatentable over Ding and Min.4

ANALYSIS
Rejection I
The Examiner finds that the limitation “delivered concurrently with a
patient’s right bundle intrinsic ventricular conduction” is not supported by
the originally filed disclosure. Final Act. 3–4. According to the Examiner,
although “Appellant’s disclosure briefly mentions timing the BiV pacing
pulse to arrive coincident with a patient’s intrinsic right bundle conduction,”
nonetheless, “the language throughout the specification relies upon the
conduction of the ventricle(s).” Examiner’s Answer 3 (dated May 22, 2020,
hereinafter “Ans.”) 3 (emphasis added).

3 Ding et al., US 2004/0147966 Al, published July 29, 2004.
4 Min et al., US 2010/0145405 Al, published June 10, 2010.
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Appellant notes that paragraph 6 of Appellant’s Specification states
that “‘BiV fusion pacing corresponds to timing the BiV pacing pulse to
arrive coincident with a patient’s intrinsic right bundle conduction.’”
Appeal Br. 11. Thus, Appellant contends that the disputed claim limitation
“literally quotes language from paragraph 6 of the present application.” Id.
(emphasis omitted).
We appreciate that the Specification’s paragraph 6 does not employ
the phrase “delivered concurrently” when referring to “timing the BiV
pacing pulse to arrive coincident with a patient’s intrinsic right bundle
conduction.” However, “[i]n order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.” Purdue Pharma
L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless,
the disclosure must convey with reasonable clarity to those skilled in the art
that the inventor was in possession of the invention. See id. In this case, a
signal that is timed to be “delivered concurrently” with an event A will
likewise “arrive coincident” with said event A. The Examiner does not
adequately explain why a pulse that is timed to be “delivered concurrently
with a patient’s right bundle intrinsic ventricular conduction” would not also
“arrive coincident with . . . [the] patient’s intrinsic right bundle conduction.”
As such, the phrase “timing the BiV pacing pulse to arrive coincident
with a patient’s intrinsic right bundle conduction” in paragraph 6 of the
Specification adequately supports the limitation “delivered concurrently with
a patient’s right bundle intrinsic ventricular conduction.” Accordingly, we
do not sustain the rejection under 35 U.S.C. § 112(a) of claims 1–13 and 21–
25 as failing to comply with the written description requirement.
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Rejection II
The Examiner finds that “[t]here is no discussion in the disclosure
about the measuring of a patient’s right bundle intrinsic ventricular
conduction and timing a first pulse at a left ventricular lead to be delivered
concurrently.” Final Act. 4. According to the Examiner, “there is no
sensing, detection, or measuring of . . . [the right bundle conduction value]
and using the right bundle conduction in a step of applying a pacing signal.”
Ans. 3. The Examiner explains that “[t]here is no language in the disclosure
where the right bundle conduction is tied into the language found in the step
by step description of the therapy as presented in the detailed description of
the invention.” Id. at 3–4.
“The test of enablement is whether one reasonably skilled in the art
could make or use the invention from the disclosure in the patent coupled
with information known in the art without undue experimentation.” United
States vs. Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988). In this
case, Appellant is correct that “[i]t is not necessary to measure intrinsic
conduction at the right bundle branch in order to achieve biventricular fusion
pacing.” Appeal Br. 15. Rather, an intrinsic conduction time 314 is
measured, a first paced AV delay 316 is defined based in part on a negative
hysteresis delta configured to adjust the time BiV is delivered such that the
left ventricle is stimulated concurrently/simultaneously with the intrinsic
conduction of the right ventricle, and BiV fusion pacing 318 is delivered.
See Spec. paras. 54–62, Figs. 3, 4. We further agree with Appellant that
because the intrinsic ventricular conduction can vary based on various
patient physiology and medication parameters, after a preset number of
cycles, a second intrinsic conduction time is measured, and the first paced
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AV delay 316 is adjusted to a second paced AV delay based on the negative
hysteresis delta. Appeal Br. 15; see also Spec. paras. 63–66, Figs. 3, 4. As
such, Appellant’s Specification adequately describes the claimed bi-
ventricular (BiV) fusion pacing process such that a skilled artisan could
make or use the invention without undue experimentation. The Examiner
does not set forth the requisite findings and analysis to show that a person of
ordinary skill in the art would not have been able to perform the claimed
adaptive bi-ventricular (BiV) fusion pacing method without undue
experimentation.
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 112(a) of claims 1–13 and 21–25 as failing to
comply with the enablement requirement.

Rejection III
The Examiner finds Ding discloses all the limitations of independent
claim 1. See Final Act. 5–7. In particular, the Examiner finds Ding
discloses a method for rate adaptive bi-ventricular fusion pacing including
delivering first and second pulses at the left and right ventricles,
respectively, of a patient, such that “the first pulse is timed to be delivered
concurrently with an intrinsic ventricular conduction.” Id. at 5 (citing Ding,
paras. 41). The Examiner explains that Ding’s “pre-excitation timing of the
biventricular pacing is delivered concurrently with the intrinsic ventricular
conduction of the left ventricle in order [to] pre-excite and time the right
ventricular pacing appropriately.” Id. (citing Ding, para. 21).
In response, Appellant argues that “Ding does not teach or suggest the
claimed limitation ‘wherein the first pulse [at the LV lead] is timed to be
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delivered concurrently with a patient’s right bundle intrinsic ventricular
conduction.’” Appeal Br. 21. According to Appellant, “[t]iming a paced
event in the LV ‘pre-excited’ relative to intrinsic conduction in the LV,” as
per Ding, “is not fusion pacing and has absolutely nothing to do with
intrinsic conduction in the RV.” Id.
We agree with Appellant that Ding does not disclose the limitation in
question. Ding discloses cardiac resynchronization therapy for patients in
which “the left ventricle or parts of the left ventricle contract later than
normal during systole which thereby impairs pumping efficiency.” Ding,
para. 21. Ding further discloses that resynchronization of ventricular
contractions in such patients requires ventricular pacing therapy such that
“the left ventricle is pre-excited relative to when it would become
depolarized in an intrinsic contraction.” Id. According to Ding, pre-
excitation of the left ventricle is achieved with biventricular pacing where
the left and right ventricles are paced simultaneously based on a timing
parameter, namely, the atrio-ventricular pacing delay (AVD). Id. at paras.
21, 22, Fig. 2. Ding explains that the atrio-ventricular pacing delay
determines the “amount of pre-excitation delivered” to the patient. Id. at
pars. 22, 26.
As such, even though in Ding the left and right ventricles are paced
simultaneously (concurrently), that does not mean that the pulse to the left
ventricle is timed to “be delivered concurrently with a patient’s right bundle
intrinsic ventricular conduction.” We could not find any portion of Ding,
and the Examiner has not pointed to any portion of Ding, that discloses
stimulating the left ventricle based on a patient’s right bundle intrinsic
(ventricle) conduction. We appreciate that Ding’s atrio-ventricular pacing
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delay AVD takes into consideration “the right intrinsic atrio-ventricular
delay,” the “left intrinsic atrio-ventricular delay,” and the time “interval
from the start of left ventricular depolarization to the end of left ventricular
depolarization.” Ding, paras. 27, 28. However, none of the parameters
noted constitutes the claimed “right bundle intrinsic ventricular conduction.”
As such, even though Ding discloses simultaneous pacing of the left and
right ventricles based on an optimum atrio-ventricular pacing delay (AVD),
the pacing in Ding is not such that the signal to the left ventricle is
“delivered concurrently” with the intrinsic conduction of the right ventricle,
i.e., “right bundle intrinsic ventricular conduction.” At most, in Ding, the
left and right ventricles are paced simultaneously according to an optimum
atrio-ventricular pacing delay time interval, which is determined by the
“amount of pre-excitation” required to be delivered to the patient.
In conclusion, for the foregoing reasons, we do not agree with the
Examiner’s finding “that the stimulation described in Ding is the same
stimulation” as in Appellant’s claimed invention. Ans. 5. In particular,
Ding fails to disclose “delivering a first pulse at a left ventricular (LV) lead .
. . wherein the first pulse is timed to be delivered concurrently with a
patient’s right bundle intrinsic ventricular conduction,” as recited by
independent claim 1. Suppl. Appeal Br. 3 (Claims App) (emphasis added).
Therefore, we do not sustain the rejection under 35 U.S.C. § 102(a)(1) of
independent claim 1, and its dependent claims 5–10, 12, 13, and 21–25, as
anticipated by Ding.

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Rejections IV and V
The Examiner’s modification of Ding and use of the Min disclosure
does not remedy the deficiency of Ding discussed supra. See Final Act. 8–9.
Therefore, for the same reasons discussed above in Rejection III, we also do
not sustain the rejections under 35 U.S.C. § 103 of claims 2 and 3 as
unpatentable over Ding and of claims 4 and 11 as unpatentable over Ding
and Min.

CONCLUSION

Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/
Basis
Affirmed Reversed
1–13,
21–25
112(a) Written
description
1–13,
21–25
1–13,
21–25
112(a) Enablement 1–13,
21–25
1, 5–10,
12, 13,
21–25
102(a)(1) Ding 1, 5–10, 12,
13, 21–25
2, 3 103 Ding 2, 3
4, 11 103 Ding, Min 4, 11
Overall
Outcome
1–13,
21–25

REVERSED