PACESETTER, INC.

Patent Trials and Appeals Board

Feb 1, 2021

2020004422 (P.T.A.B. Feb. 1, 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.
15/653,357 07/18/2017 Julie Prillinger A17P1011USO
(013-0371US1)
1969
152583 7590 02/01/2021
Pacesetter, Inc.
The Small Patent Law Group, LLC
225 S. Meramec, Ste. 725T
St. Louis, MO 63105
EXAMINER
WU, TONG E
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
02/01/2021 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
jleclair@splglaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JULIE PRILLINGER, GENE A. BORNZIN, STUART
ROSENBERG, ADITYA GOIL, WENWEN LI, PRITIKA TOUTAM,
DIDIER THERET, and FUJIAN QU
____________

Appeal 2020-004422
Application 15/653,357
Technology Center 3700
____________

Before MURRIEL E. CRAWFORD, HUBERT C. LORIN, and BIBHU R.
MOHANTY, Administrative Patent Judges.

MOHANTY, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–11 and 17–26. We have jurisdiction
under 35 U.S.C. § 6(b).

SUMMARY OF THE DECISION
We AFFIRM-IN-PART.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Pacesetter, Inc.
(Appeal Br. 3).
Appeal 2020-004422
Application 15/653,357

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CLAIMED SUBJECT MATTER
The Appellant’s claimed invention relates to a cardiac stimulation
device that includes a lead for His bundle pacing (Spec., para. 1). Claim 1,
reproduced below, is representative of the subject matter on appeal.

1. A method of pacing a His bundle of a patient heart using a
stimulation system, the stimulation system having a memory, a pulse
generator, a stimulating electrode disposed in proximity to the His
bundle, and at least one sensing electrode adapted to sense
electrical activity of the patient heart, the method comprising:

applying, using the pulse generator, a plurality of impulses
through the stimulating electrode to induce a plurality of responses
from the patient heart, the plurality of impulses having different
impulse energies corresponding to a respective output setting of the
stimulation system;

measuring, using the sensing electrode, response characteristics
for the plurality of responses;

assigning corresponding classifications to the plurality of
responses based on whether the respective response characteristics
indicate capture of one or both of the His bundle and a ventricle
of the patient heart, the response characteristics including an evoked
response delay, the assigning based at least in part on the evoked
response delay; and

for each impulse, storing each of the output setting and the
classification associated with the impulse in the memory.

THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
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Application 15/653,357

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Name Reference Date
Horth US 3,524,442 Aug. 18, 1970
Bowers US 3,920,024 Nov. 18, 1975
Sholder US 4,686,988 Aug. 18, 1987
Dong et al. US 2011/0264158 A1 Oct. 27, 2011
F. Cantù et al., Validation of Criteria for Selective His Bundle and Para-
Hisian Permanent Pacing, 29 PACE 1326 (2006).

The following rejections are before us for review:
1. Claims 2 and 3 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement as
failing to show, at the time the application was filed, possession of the
invention.
2. Claims 2, 3, 22, and 25 are rejected under 35 U.S.C. § 112(b)
second paragraph as being indefinite.
3. Claims 1, 2, 4–9, and 17–22 are rejected under 35 U.S.C.
§ 102(a) as unpatentable over Dong.
4. Claim 3 is rejected under 35 U.S.C. § 103 as unpatentable over
Dong and Horth.
5. Claim 10 is rejected under 35 U.S.C. § 103 as unpatentable
over Dong and Sholder.
6. Claim 11 is rejected under 35 U.S.C. § 103 as unpatentable
over Dong and Bowers.
7. Claim 23–26 are rejected under 35 U.S.C. § 103 as
unpatentable over Dong and Cantù.

Appeal 2020-004422
Application 15/653,357

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FINDINGS OF FACT
We have determined that the findings of fact in the Analysis section
below are supported at least by a preponderance of the evidence2.

ANALYSIS
Rejection under 35 U.S.C. § 112, first paragraph
The Examiner has determined that claim 2 fails to provide support for
“discerning selective His bundle capture from non-selective His bundle
capture on the basis that the non-selective His bundle capture has a wider
QRS than the selective His bundle capture QRS” (Final Act. 3).
In contrast, the Appellant argues that support for the cited claim
language in the rejection is provided by the Specification at paragraphs 38,
39, and 111 (App. Br. 10–14).
We agree with the Appellant. Here, the Specification at paragraphs
38 and 39 provides support for the portion of claim identified in the
rejection. Paragraphs 38 and 39 of the Specification disclose for instance
both “selective” and “non-selective” His bundle pacing (HBP), different
QRS durations, and capture of “selective” or “non-selective” HBP based on
QRS durations. Accordingly, this rejection is not sustained.

2 See Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988)
(explaining the general evidentiary standard for proceedings before the
Patent Office).
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Application 15/653,357

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Rejection under 35 U.S.C. § 112, second paragraph
The Appellant has not argued the rejections of record under 35 U.S.C.
§ 112(b) second paragraph as being indefinite. Accordingly, this rejection is
sustained.

Rejection under 35 U.S.C. § 102(a)
The Appellant argues that the rejection of claim 1 is improper because
the cited prior art fails to disclose the claim limitation for:
assigning corresponding classifications to the plurality of responses
based on whether the respective response characteristics indicate
capture of one or both of the His bundle and a ventricle of the patient
heart, the response characteristics including an evoked response delay,
the assigning based at least in part on the evoked response delay

(App. Br. 15, 17).
In contrast, the Examiner has determined that the argued cited claim
limitation is shown by Dong at paragraphs 78–93 (Ans. 16, 17).
We agree with the Appellant. Here the citations to Dong at
paragraphs 78–93 fail to disclose the argued claim limitation. For example,
Dong at paragraphs 87 and 93 do disclose classification of a cardiac cycle
based on a characteristic including His-bundle capture, partial capture, or
non-capture, there is no disclosure of an evoked response delay in the
manner claimed. Accordingly, the rejection of claim 1 and its dependent
claims is not sustained. Claim 17 contains a similar limitation and the
rejection of this claim and its dependent claims is not sustained.

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Application 15/653,357

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Rejections under 35 U.S.C. § 103
The Appellant argues that the each of the respective rejections of
claims 3, 10, 11, 23, and 24 made under 35 U.S.C. § 103 is defective
because they fail to disclose the limitation identified as missing from claim 1
in the rejection addressed above (App. Br. 30–33).
The Examiner relies on the same rationale for claim limitation
addressed with regard to claim 1 as described above (Ans. 18, first two lines
of section C).
We agree with the Appellant as the cited prior art fails to disclose the
argued claim limitation identified in the discussion of claim 1 made above.
Accordingly, the rejections of claims 3, 10, and 11 is not sustained.
The Appellant argues that the prior art fails to disclose the limitations
of claim 23 which require:
wherein the assigning further comprises assigning the classification of
selective HIS bundle capture when the response characteristic has a
first evoked response delay and assigning the classification of non-
selective HIS bundle capture when the response characteristic has a
second evoked response delay that is shorter than the first evoked
response delay.

(App. Br. 34, 35).
In contrast, the Examiner cites to Cantù at the Introduction, at page
1328, col. 1, item 2, and at page 1328, col. 2, item 2 as disclosing the cited
claim limitation (Final Act. 9, Ans. 19–21).
We agree with the Appellant in this regard. Here, the citation to
Cantù fail to disclose the claim limitation. For example, which the
Introduction does disclose His Bundle pacing that portion does not relate to
evoked response delays or duration. While the portions of page 1328
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referenced (item 2, in each column) do reference ventricular intervals these
are not specifically shown to relate to the His bundle in the manner claimed
for classification. Accordingly, the rejections of 23 and 24 are not sustained.
Claim 25 has a claim limitation similar to claim 23 discussed above
and the rejection of this claim, and its dependent claim 26, is not sustained
for the same reasons given above.

CONCLUSIONS OF LAW
We conclude that Appellant has shown that the Examiner erred in
rejecting the claims 2 and 3 under 35 U.S.C. § 112, first paragraph.
We conclude that Appellant has not shown that the Examiner erred in
rejecting the claims 2, 3, 22, and 25 under 35 U.S.C. § 112(b) second
paragraph.
We conclude that Appellant has shown that the Examiner erred in
rejecting the claims 1, 2, 4-9, and 17-22 under 35 U.S.C. § 102(a) as
unpatentable over Dong.
We conclude that Appellant has shown that the Examiner erred in
rejecting the claim 3 under 35 U.S.C. § 103 as unpatentable over Dong and
Horth.
We conclude that Appellant has shown that the Examiner erred in
rejecting the claim 10 under 35 U.S.C. § 103 as unpatentable over Dong and
Sholder.
We conclude that Appellant has shown that the Examiner erred in
rejecting the claim 11 under 35 U.S.C. § 103 as unpatentable over Dong and
Bowers.
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We conclude that Appellant has shown that the Examiner erred in
rejecting the claim 23–26 under 35 U.S.C. § 103 as unpatentable over Dong
and Cantù.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
2, 3 112, first
paragraph
Written
Description
2, 3
2, 3, 22,
25
112, second
paragraph
Indefiniteness 2, 3, 22,
25

1, 2, 4–9,
17–22
102 Dong 1, 2, 4–9,
17–22
3 103 Dong, Horth 3
10 103 Dong, Sholder 10
11 103 Dong, Bowers 11
23–26 103 Dong, Cantù 23–26
Overall
Outcome
2, 3, 22,
25
1, 4–11,
17–21, 23,
24, 26
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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART