Cardiac Pacemakers, Inc.

Patent Trials and Appeals Board

Jan 3, 2020

14884417 - (D) (P.T.A.B. Jan. 3, 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.
14/884,417 10/15/2015 Qi An 279.L96US1 2268
45458 7590 01/03/2020
SCHWEGMAN LUNDBERG & WOESSNER/BSC
PO BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
WU, TONG E
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
01/03/2020 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):
SLW@blackhillsip.com
uspto@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte QI AN, PRAMODSINGH HIRASINGH THAKUR, and
YINGHONG YU
Appeal 2019-004006
Application 14/884,417
Technology Center 3700
Before JENNIFER D. BAHR, STEFAN STAICOVICI, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
MARSCHALL, Administrative Patent Judge.
DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant,1 appeals from the
Examiner’s decision to reject claims 1–20. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

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 Cardiac
Pacemakers, Inc. Appeal Br. 2.
Appeal 2019-004006
Application 14/884,417

2
CLAIMED SUBJECT MATTER
The invention relates to devices “for stimulating excitable tissue and
evaluating resultant physiologic response.” Spec. ¶ 2. Claims 1 and 15 are
independent. Claim 1 is reproduced below.
1. A system for evaluating electrostimulation of a heart,
comprising:
an electrostimulation circuit, configured to deliver multi-
site electrostimulation to two or more sites of a chamber of the
heart;
a heart sound (HS) sensor circuit, configured to sense a
HS signal during the multi-site electrostimulation delivered to
the two or more sites; and
a pacing analyzer circuit, in communication with the HS
sensor circuit, configured to determine a capture status
indication associated with the multi-site electrostimulation
using a comparison of a morphology of the HS signal sensed
during the multi-site electrostimulation to HS morphologies
corresponding to electrostimulation at each of the two or more
sites of the heart,
wherein the capture status indication includes one or
more of a full capture indication indicating the multi-site
electrostimulation captures each of the two or more sites, or a
partial capture indication indicating the multi-site
electrostimulation captures at least one of the two or more sites
and fails to capture at least another one of the two or more sites.
Appeal Br. 19 (Claims App.).
Appeal 2019-004006
Application 14/884,417

3
REJECTIONS ON APPEAL
1. Claims 4 and 18 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement. Final Act. 5–6;
Ans. 3–4.2
2. Claims 1–4, 8–10, and 12–19 are rejected under 35 U.S.C. § 103 as
being unpatentable over Yonce,3 Anderson,4 and Lekholm.5 Final
Act. 7.
3. Claims 5, 6, 11, and 20 are rejected under 35 U.S.C. § 103 as being
unpatentable over Yonce, Anderson, Lekholm, and Patangay.6
Final Act. 9.
4. Claims 7 and 20 are rejected under 35 U.S.C. § 103 as being
unpatentable over Yonce, Anderson, Lekholm, and Zhang.7 Final
Act. 10.
5. Claims 1–20 are rejected on the ground of nonstatutory double
patenting as unpatentable over claims 1, 3, 5, 6, 10–13, 15, and 17
of U.S. Patent No. 9,616,239 and Yonce. Final Act. 12.

2 The Examiner initially rejected claims 1–20 under § 112(a), but withdrew
the rejection with the exception of the rejection of claims 4 and 18 as failing
to comply with the written description requirement. See Final Act. 5–6;
Ans. 3–4.
3 US 2005/0137638 A1, published June 23, 2005 (“Yonce”).
4 US 2009/0030334 A1, published Jan. 29, 2009 (“Anderson”).
5 US 4,763,646, issued Aug. 16, 1988 (“Lekholm”).
6 US 7,853,327 B2, issued Dec. 14, 2010 (“Patangay”).
7 US 2013/0030484 A1, published Jan. 31, 2013 (“Zhang”).
Appeal 2019-004006
Application 14/884,417

4
ANALYSIS
Written Description Rejection
Dependent claims 4 and 18 require receiving “a first threshold value
based on a statistical distribution of multiple measurements of the first HS8
feature vector, and a second threshold value based on a statistical
distribution of multiple measurements of the second HS feature vector.”
Appeal Br. 20, 23 (Claims App.). In support of the written description
rejection, the Examiner finds that the “specification does not disclose a
threshold value based on a statistical distribution of multiple measurements
of a feature vector, or how to otherwise determine any threshold values.”
Ans. 4; see also Adv. Act. 2 (mailed Aug. 9, 2019) (“[I]n order to practice
the claimed invention, such thresholds must still necessarily be determined
somehow, and the specification does not disclose how to determine any
thresholds (whether by some automated process or some manual process).”).
Appellant argues that the Specification provides adequate written
description support for the limitations because Figure 5 illustrates statistical
distribution of HS feature vectors represented by circles, and that the
different radii of the circles correspond to different thresholds TH1 and TH2.
Appeal Br. 10 (citing Spec. Fig. 1, ¶¶ 77–84). According to Appellant, the
Specification “describes, at least implicitly, that TH1 and TH2 are
respectively based on the statistical distribution of the HS feature vectors.”
Id. (emphasis omitted). Appellant also argues that the claims merely require
receiving threshold values, not determining a threshold values as the
Examiner’s findings suggest. Reply Br. 2. Appellant contends that the

8 “HS” refers to heart sounds. See Claim 1 (quoted above); Spec. ¶ 9.
Appeal 2019-004006
Application 14/884,417

5
Specification teaches display of the statistical distributions and “provide
threshold values (TH1 and TH2) accordingly.” Id. at 3.
We agree with Appellant that the limitations at issue do not expressly
require determination of a threshold; they instead use the language “receive”
when referring to a “threshold value based on a statistical distribution.”
Appeal Br. 20, 23 (Claims App.). In addition, in the withdrawal of the
majority of the § 112(a) rejections, the Examiner acknowledges that the
Specification discloses “receiving threshold values.” Ans. 3; see also
Appeal Br. 9–10.
We agree with the Examiner, however, that the Specification does not
show possession of an invention where the threshold values are “based on a
statistical distribution of multiple measurements” of HS feature vectors. The
Specification describes using threshold values to help determine a capture
status. Id. ¶¶ 76–80, 87. In Figure 5, which Appellant relies on, the
threshold values are used to define the bounds of a circle centered at a
statistical distribution of HS feature vectors. Id. ¶¶ 77–78 (describing HS
feature vectors 510 and 520), 80 (describing circles 515, 525 defined by
threshold values (the radii of the circles) and statistical distributions (centers
of the circles)). Although this description may link the threshold values to
the statistical distributions in some manner, the Specification does not
describe arriving at the threshold values based on the statistical distributions,
just as the radii of circles are not necessarily based on the centers of their
respective circles. Without more guidance in the Specification as to how the
threshold values are determined, we do not agree with Appellant that the
Specification adequately describes and supports the limitations in claims 4
and 18. In addition, to the extent that Appellant argues that it would have
Appeal 2019-004006
Application 14/884,417

6
been obvious to one of ordinary skill in the art that the threshold values are
based on the statistical distribution, because it is “implicit” in the disclosure
even if not described explicitly, this argument is unavailing here. See
Appeal Br. 10. “[A] description that merely renders the invention obvious
does not satisfy the written description requirement. Idenix Pharm. LLC v.
Gilead Scis. Inc., 941 F.3d 1149, 1165 (Fed. Cir. 2019) (quoted source
omitted). Accordingly, we sustain the rejections of claims 4 and 18 as
failing to comply with the written description requirement.
Section 103 Rejections
Appellant focuses its arguments on independent claim 1, and for the
remaining claims refers back to its arguments as to claim 1. See Appeal Br.
12–17. Accordingly, we will focus our analysis on independent claim 1.
Claim 1 requires the use of “a heart sound (HS) sensor circuit” and “a pacing
analyzer circuit, in communication with the HS sensor circuit, configured to
determine a capture status indication.” Appeal Br. 19 (Claims App.).
“Capture status” refers to applying sufficient stimulation energy “to capture
the heart tissue,” i.e., cause a desired contraction in, the heart. Spec. ¶¶ 5–6;
Ans. 4.9 Claim 1 requires a “capture status indication” that includes “full
capture” at two or more sites, or a “partial capture” at one or more, but not
all, of the electrostimulation sites. Claim 15, which is the only other
independent claim, contains similar limitations. Appeal Br. 22–23 (Claims
App.).
The Examiner finds that Yonce discloses most of the limitations of
claim 1, but does not disclose using heart sounds. Final Act. 7. The

9 The Examiner provides a helpful background of the relevant art and a
summary of the reasons for the rejection in the Answer. See Ans. 4–13.
Appeal 2019-004006
Application 14/884,417

7
Examiner finds that Anderson discloses “a heart sound sensor circuit
configured to sense a HS signal during delivery of electrostimulation
(Paragraphs 2, 25), in order to verify capture using heart sounds.” Id. The
Examiner determines that it would have been obvious to a person of
ordinary skill in the art
to modify Yonce as taught by Anderson to include a HS sensor
circuit as recited, in order to verify capture using heart sounds.
As heart sound signals inherently contain morphological
features, one of ordinary skill in the art would understand that
the concept of morphological comparison in Yonce can extend
to morphological features of heart sound signals.
Id. at 7–8. The Examiner, in the alternative, finds that even if Yonce does
not naturally extend to heart sound signals, Lekholm discloses “a heart
sound sensor circuit configured to sense a HS morphology during delivery of
electrostimulation . . . in order to verify capture.” Id. at 8 (citing Lekholm,
Abstract, 1:55–63, 2:15–22, 2:41–44). The Examiner determines that it
would have been obvious to a skilled artisan “to modify Yonce and
Anderson as taught by [Lekholm] to include a HS sensor circuit as recited,
in order to verify capture using heart sound morphologies.” Id.
As to distinguishing between full and partial capture, the Examiner
finds that one of ordinary skill in the art “would recognize that a full capture
and partial capture inherently have different energy signatures (i.e. full
capture has more energy than a partial capture)” and if so, “it follows that
heart sounds could be expected to distinguish between a full and partial
capture.” Ans. 16–17. The Examiner also finds that “if heart sounds can be
used to distinguish between a sick or otherwise dysfunctional heart
contraction from a healthy heart contraction [as shown in the prior art], then
it follows that heart sounds could be expected to distinguish between a
Appeal 2019-004006
Application 14/884,417

8
partial capture and full capture.” Id. at 16. The Examiner emphasizes that
the prior art “need not conclusively prove whether or not heart sounds will
actually distinguish between full and partial capture in practice,” and finds
that one would have been motivated to try, and that one “would have
reasonably expected the idea to work on some level.” Id. at 17.
Appellant argues that Yonce fails to disclose the use of heart sounds at
all, and Anderson and Lekholm fail to disclose the use of heart sounds to
verify cardiac capture as required by claim 1. Appeal Br. 12. Appellant also
argues that although Yonce uses ECG signals to determine capture status,
the differences between ECG signals and HS signals are significant, and the
cited references do not suggest extending ECG features to HS morphologies
to determine capture status. Id. at 12–13. Appellant contends that the
teachings from Anderson and Lekholm that the Examiner relies upon,
related to the ability to use HS to detect arrhythmias, hemodynamics and
other cardiac disease, do not suggest that heart sounds should be used to
distinguish between full and partial cardiac capture. Id. at 13. As to
motivation to combine, Appellant argues that the differences between ECG
morphology and HS morphology cut against the Examiner’s combination,
and that the Examiner failed to articulate a sufficient rationale for the
combination. Id. at 15. According to Appellant, although Anderson and
Lekholm may use heart sounds to verify capture or non-capture in a “binary
decision,” that “falls short of a disclosure of different HS morphologies
under a full capture or a partial capture” and “would not provide a
reasonable expectation of success.” Id. As to the Examiner’s findings on
full vs. partial capture using heart sounds, Appellant contends that it remains
unclear “what the ‘energy’ refers to[,] . . . energy is not equivalent to signal
Appeal 2019-004006
Application 14/884,417

9
morphology[, and the e]nergy signature represented by ECG is different
from energy signature represented by HS.” Reply Br. 5. In Appellant’s
view, “that the partial and full captures have different energy signatures does
not imply that any detected difference in energy signature would necessarily
be attributable to distinct capture status (e.g., a full capture versus a partial
capture).” Id. Appellant also contends that the use of heart sounds in some
applications to aid treatment does not mean that “different capture status
(e.g., partial and full captures) would result in distinguishable HS
morphologies” because those other applications do not rely on “multisite
pacing of one heart chamber.” Id. at 6.
We agree with Appellant. As to the ability to distinguish between full
and partial capture using heart sounds, the Examiner makes several key
findings that lack any citation to support in the record. For example, the
Examiner finds that one of ordinary skill in the art “would recognize” that
full vs. partial capture would have different energy signatures and that “it
follows that heart sounds could be expected to distinguish between a full and
partial capture,” but the Examiner does not point to any portion of Anderson
or Lekholm, or other authority, in support. Ans. 16–17. Similarly, the
Examiner’s finding that the usefulness of heart sounds to diagnose certain
conditions leads to the conclusion that “heart sounds could be expected to
distinguish between a partial capture and full capture” lacks any citation to
record evidence. See id. Our review of the cited portions of Anderson and
Lekholm does not reveal the missing teachings. As Appellant persuasively
argues, the use of “energy” in the Examiner’s findings is not defined, and
there is insufficient basis to assume that such allegedly different energy
levels in different heart sounds could result in the ability to distinguish
Appeal 2019-004006
Application 14/884,417

10
between full vs. partial capture. See Reply Br. 5. The successful use of
heart sounds in other contexts, including the ability to detect a capture, also
fails to establish that the same approach could distinguish between full and
partial capture in the context of “multisite pacing of one heart chamber.” Id.
at 6. Without support for these findings, the Examiner’s position requires
speculation, and, thus, there is an inadequate basis to conclude that using
heart sounds to distinguish between full and partial capture would be met
with a reasonable expectation of success.
Based on the foregoing, we do not sustain the rejection of claim 1 as
obvious. Appellant relies on the same arguments as to the remaining claims
subject to obviousness rejections. See Appeal Br. 13–14, 16–17. The
Examiner relies on the same findings in the rejections of those claims,
without relying on additional art in a manner that remedies the deficiencies
addressed above, and we therefore do not sustain the obviousness rejections
of claims 2–20 for the same reasons discussed above. See Final Act. 7–10.
Double Patenting
The Examiner finds that claims 1–20 are unpatentable over claims 1,
3, 5, 6, 10–13, 15, and 17 of U.S. Patent No. 9,616,239 and Yonce. Final
Act. 12. Appellant does not address the double patenting rejection. See
Appeal Br. 7–18. Accordingly, we summarily sustain the Examiner’s
double patenting rejection of claims 1–20.
DECISION
We affirm the Examiner’s rejections of claims 4 and 18 as failing to
comply with the written description requirement under § 112, and affirm the
Examiner’s rejection of claims 1–20 under the nonstatutory doctrine of
double patenting. We reverse the Examiner’s rejections under § 103.
Appeal 2019-004006
Application 14/884,417

11

DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
4, 18 112(a) Written Description 4, 18
1–4, 8–10,
12–19
103 Yonce, Anderson,
Lekholm
1–4, 8–10,
12–19
5, 6, 11, 20 103 Yonce, Anderson,
Lekholm, Patangay
5, 6, 11, 20
7, 20 103 Yonce, Anderson,
Lekholm, Zhang
7, 20
1–20 nonstatutory Double Patenting 1–20
Overall
Outcome
1–20
FINALITY AND 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