CARDIAC PACEMAKERS, INC.

Patent Trials and Appeals Board

Dec 14, 2020

2020003567 (P.T.A.B. Dec. 14, 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.
15/951,982 04/12/2018 Michael J. Kane 1001.3556102 1033
11050 7590 12/14/2020
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
12/14/2020 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):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL J. KANE,
JEFFREY E. STAHMANN, and KEITH R. MAILE
__________

Appeal 2020-003567
Application 15/951,982
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

HOELTER, 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 1–20. Final Act. 1 (Office Action
Summary). We have jurisdiction under 35 U.S.C. § 6(b). For the reasons
explained below, we AFFIRM the Examiner’s rejections of these claims.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Cardiac
Pacemakers, Inc.” Appeal Br. 3.
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Application 15/951,982

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CLAIMED SUBJECT MATTER
The disclosed subject matter “generally relates to systems, devices,
and methods for delivering pacing pulses to a heart and, more specifically to
systems, devices, and methods for performing rate responsive pacing with a
Leadless Cardiac Pacemaker (LCP).” Spec. 1:12–14. Method claim 1 and
system claims 13 and 18 are independent. Appeal Br. 3–5. Claim 1 is
illustrative of the claims on appeal and is reproduced below.
1. A method for providing rate responsive pacing therapy to
a heart of a patient, the method comprising:
sensing cardiac electrical data with a leadless cardiac
pacemaker (LCP) implanted within and directly coupled to a wall
of the heart of the patient such that the LCP moves with the wall
of the heart of the patient;
providing pacing therapy to the heart of the patient with
the LCP based at least in part on the sensed cardiac electrical
data, the pacing therapy including a pacing rate;
sensing patient activity of the patient using an
accelerometer that is housed in a remote device that is separate
from the LCP and not directly coupled to the heart of the patient,
and determining a patient activity data signal based at least in
part upon the patient activity sensed by the accelerometer;
wirelessly communicating the patient activity data signal
from the remote device to the LCP; and
the LCP adjusting the pacing rate of the provided pacing
therapy based at least in part on the received patient activity data
signal.
REFERENCES

Name Reference Date
Condie et al. (“Condie”) US 7,031,772 B2 Apr. 18, 2006
Kroll et al. (“Kroll”) US 7,634,313 B1 Dec. 15, 2009
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Greenhut et al.
(“Greenhut”)2
US 8,744,572 B2 June 3, 2014
Kane et al. (“Kane”) US 9,962,550 B2 May 8, 2018
Demmer et al.
(“Demmer”)
US 2015/0173655 A1 June 25, 2015

THE REJECTIONS ON APPEAL
Claim 10 is rejected under 35 U.S.C. § 112(b) as indefinite. Final
Act. 6.
Claims 1, 3, 4, 6–13, and 15–20 are rejected under 35 U.S.C. § 103 as
unpatentable over Demmer and Kroll. Final Act. 6.
Claims 2, 5, and 14 are rejected under 35 U.S.C. § 103 as
unpatentable over Demmer, Kroll, and Greenhut. Final Act. 9.
Claims 1–12 are rejected on the ground of non-statutory double
patenting as unpatentable over claims 9–19 of Kane. Final Act. 11.
ANALYSIS
The rejection of claim 10
as being indefinite
Claim 10, which indirectly depends from claim 1, recites “further
comprising determining a measure related to a respiratory rate of the patient
based, at least in part, on a difference in an amplitude of the patient activity
data signal communicated by the remote device and an amplitude of the
patient activity data signal received at the LCP.” Appeal Br. 15 (Claims
App., emphasis added). The Examiner determines that this limitation “is
unclear because there is no step of sensing/determining patient activity at the
LCP.” Final Act. 6; emphasis added. In the Answer, the Examiner states

2 No known relation to Administrative Patent Judge Greenhut.
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that “there is no indication that the LCP, as claimed, identifies this variable
amplitude (the amplitude of the remote device) or that the LCP measures the
amplitude of the patient activity signal to determine the respiratory rate of
the patient based on the difference of amplitude.” Ans. 4.
We first note that this “at the LCP” language is recited as identifying
one of the two amplitude values being contrasted. Claim 10 does not recite
that the determining step is undertaken “at the LCP.” Further, parent claim 1
merely requires the step of determining an amplitude difference, and it is the
Examiner that presupposes this determining step occurs “at the LCP.”3 Final
Act. 6. Hence, as per the Examiner, because “there is no indication that the
LCP, as claimed, identifies this variable amplitude” (Ans. 4), the Examiner
finds claim 10 to be “unclear because there is no step of sensing/determining
patient activity at the LCP.” Final Act. 6. The Examiner’s imposition of an
unclaimed limitation (i.e., “at the LCP”), and then rendering a rejection
based thereon, is not indicative that claim 10 is, in fact, “unclear,” and thus
indefinite. Final Act. 6.
Furthermore, and presuming this determining step indeed occurs “at
the LCP” as expressed by the Examiner (which Appellant concurs (see
Appeal Br. 6)), we note that parent claim 1 recites “wirelessly
communicating the patient activity data signal from the remote device to the
LCP,” which thereafter employs this signal to adjust the pacing rate. Appeal
Br. 14 (Claims App., emphasis added). Thus, if the patient activity data
signal is communicated to the LCP and thereafter acted upon, then the LCP

3 Appellant also indicates that this determining step occurs at the LCP as
well. See Appeal Br. 6. Claim 10, however, is not so expressive on this
point.
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would also, it appears, be likewise in receipt of the amplitude of that signal.
The Examiner does not explain how this received signal is unable to be
compared “at the LCP” to the originating or sent signal, or how such
comparison, even “at the LCP,” is unclear. The manner by which such a
situation may occur is expressly discussed in Appellant’s Specification. See
Spec. 24:5–20; see also Appeal Br. 6. Accordingly, we reverse the
Examiner’s rejection of claim 10 as being indefinite.
The rejection of claims 1, 3, 4, 6–13, and 15–20
as obvious over Demmer and Kroll
Appellant argues claims 1, 3, 4, and 6–12 together. See Appeal Br. 6–
10. Appellant also argues claims 13 and 15–17 together. See Appeal Br.
10–11. Finally, Appellant argues claims 18–20 together. See Appeal Br.
11–12. We select claims 1, 13, and 18 for review, with the remaining claims
standing or falling with their respectively grouped claim. See 37 C.F.R.
§ 41.37(c)(1)(iv)(2019).
Claim 1
Claim 1 recites sensing patient activity “using an accelerometer that is
housed in a remote device that is separate from the LCP.” The Examiner
relies on Demmer for such teachings.4 Final Act. 7.
Appellant disagrees stating, “in Demmer, the IMD 16 [i.e., the
implantable medical device, or pacemaker] itself includes the accelerometer
94 (see Figure 3 of Demmer),” and as such, it is not “remote” as recited.

4 The Examiner relies on Kroll for teaching that it would have been obvious
to “wirelessly” communicate patient activity data from the remote
accelerometer to the LCP, as recited. Final Act. 7.
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Appeal Br. 7; see also Reply Br. 4. Indeed, Figure 3 of Demmer illustrates
Demmer’s accelerometer as part of Demmer’s LCP, and not as a remote
device. However, the Examiner also references Paragraph 32 of Demmer as
support, which addresses Demmer’s accelerometer and states, “[c]ontrol of
rate responsive pacing using an activity sensor is generally disclosed in
commonly-assigned U.S. Pat. No. 7,031,772 (Condie, et al.), hereby
incorporated herein by reference in its entirety.” Demmer ¶ 32; emphases
added. It is Condie’s incorporated teachings the Examiner specifically relies
upon for disclosing a separate accelerometer, not Demmer’s Figure 3 as
presumed by Appellant. See Final Act. 7 (referencing Condie 7:1–14, Fig.
4). Condie states, “data from an external sensor (e.g. an accelerometer
attached onto a patient’s body 105) is acquired by the external data
processing unit 420” of Condie’s implantable medical device (i.e.,
pacemaker). Condie 7:12–14.
Thus, paragraph 32 of Demmer, via its incorporation of the teachings
of Condie discussed above, discloses use of a remote device (i.e., an
accelerometer) that is separate from a pacemaker or other implantable
medical device. See Condie 1:18–19. Consequently, Demmer discloses a
remote device that is not directly coupled to the heart of the patient, as
recited. Furthermore, the Examiner alternatively indicates that Demmer
itself (i.e., no reliance on Condie) teaches a situation when “the
accelerometer is positioned outside the heart, such as in a pectoral,
abdominal or peripheral site.” See Ans. 4 (referencing Demmer ¶ 64).
Regardless, Appellant replies that “what the Examiner appears to be
ignoring is [] why would one of skill in the art rely upon accelerometer data
communicated from a remote device when the device in the heart already
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has an accelerometer itself.” Reply Br. 5. Thus, as per Appellant, “[t]he
Examiner’s assertions regarding Condie et al. are little more than
reconstructive hindsight.” Reply Br. 5; see also Appeal Br. 9. However,
this “hindsight” argument is not persuasive because Demmer itself, whether
via paragraph 32 or paragraph 64, expressly teaches the use of a remote
accelerometer. Thus, no such teaching can be said to be gleaned only from
Appellant’s disclosure as a result of improper hindsight since Demmer
already and expressly discloses this feature. As a result, Appellant’s
argument concerning improper hindsight reconstruction is unpersuasive.
Concerning Appellant’s intimation that Demmer does not disclose a
patient activity data signal that is “subsequently wirelessly communicated
to” an LCP (see Appeal Br. 7, 9; see also Reply Br. 4), the Examiner relies
on Kroll, rather than Demmer, for this “wirelessly” limitation. Final Act. 7.
Appellant argues that Kroll does not disclose that which Appellant contends
is missing from Demmer. See Appeal Br. 9; Reply Br. 5–6. However, this
argument is not persuasive because it is not apparent that Demmer is
deficient or otherwise fails to disclose the teachings it was relied upon for.
Accordingly, we sustain the Examiner’s rejection of claims 1, 3, 4,
and 6–12 as being unpatentable over the combination of Demmer and Kroll.
Claim 13
Appellant repeats the above argument that Demmer in view of Kroll
fails to teach the recited “remote device.” Appeal Br. 11; Reply Br. 8. For
similar reasons as already discussed, Appellant’s contention is not
persuasive. We sustain the Examiner’s rejection of claims 13 and 15–17.
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Claim 18
As above, Appellant repeats the argument that Demmer in view of
Kroll fails to teach an implantable device “configured to be implantable at a
location and remote from and not directly coupled to the heart of the
patient.” Appeal Br. 12; Reply Br. 8. This argument is not persuasive of
Examiner error for the reasons already discussed. We sustain the
Examiner’s rejection of claims 18–20 as being unpatentable over Demmer
and Kroll.
The rejection of claims 2, 5, and 14
as obvious over Demmer, Kroll, and Greenhut
With respect to these claims, Appellant relies on the same arguments
presented above regarding independent claim 1. See Appeal Br. 12–13.
Consequently, we likewise sustain the Examiner’s rejection of claims 2, 5,
and 14 as being unpatentable over Demmer, Kroll, and Greenhut.
Obviousness-Type Double Patenting
Regarding this rejection, Appellant states that “[w]hile not conceding
to the correctness of this double patenting rejection, Applicants will consider
filing an appropriate Terminal Disclaimer once the claims are otherwise
indicated as being in condition for allowance.” Appeal Br. 13. Thus,
Appellant does not present arguments directed to the rejection, and has
waived or forfeited any such arguments. Accordingly, this rejection is
summarily affirmed.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
10 112(b) Indefiniteness 10
1, 3, 4, 6–
13, 15–20
103 Demmer, Kroll 1, 3, 4, 6–
13, 15–20

2, 5, 14 103 Demmer, Kroll,
Greenhut
2, 5, 14
1–12 Non-
statutory
Double
Patenting
Kane 1–12
Overall
Outcome5
1–20
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED

5 37 C.F.R. § 41.50(a)(1) states: “The affirmance of the rejection of a claim
on any of the grounds specified constitutes a general affirmance of the
decision of the examiner on that claim.”