Jonathan Walter. Krueger et al.

Patent Trials and Appeals Board

May 13, 2020

2018007569 (P.T.A.B. May. 13, 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.
14/825,669 08/13/2015 Jonathan Walter Krueger 279.L83US1 1897
45458 7590 05/13/2020
SCHWEGMAN LUNDBERG & WOESSNER/BSC
PO BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
WU, TONG E
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
05/13/2020 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 JONATHAN WALTER KRUEGER,
DEEPA MAHAJAN, and DAVID L. PERSCHBACHER
____________________

Appeal 2018-007569
Application 14/825,669
Technology Center 3700
____________________

Before JENNIFER D. BAHR, BENJAMIN D. M. WOOD, and
ANNETTE R. REIMERS, Administrative Patent Judges.

WOOD, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 appeals under 35 U.S.C. § 134 from a Non-Final Action
entered June 23, 2017 rejecting claims 1–20. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42.
Appellant identifies the real party in interest as Cardiac Pacemakers, Inc.
Appeal Br. 2.
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THE CLAIMED SUBJECT MATTER
The claims are directed to atrial fibrillation detection using ventricular
rate variability. Claim 11, reproduced below, is illustrative of the claimed
subject matter:
11. A method of detecting atrial fibrillation, the method
comprising:
receiving, at a processor circuit, indications of pairs of
first and second ventricular rate changes of three temporally
adjacent ventricular heart beats;
determining, using the processor circuit, a first court of
instances of the pairs in which a combined rate change
magnitude characteristic in units of beats per minute (bpm) is
less than at least one first criterion having a unit of bpm;
determining, using the processor circuit, a second count
of instances of the pairs in which both of the first and second
ventricular rate changes are negative; and
determining, using the processor circuit, atrial fibrillation
information using the first and second counts.
REFERENCES

Name Reference Date
Ritscher

US 2004/0092836 A1

May 13, 2004
Sarkar US 2006/0247548 A1 Nov. 2, 2006
REJECTIONS
Claims 1–20 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement.
Claims 1–20 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement.
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Claims 1–20 are rejected under 35 U.S.C. § 101 as directed to
ineligible subject matter.
Claims 1–5, 8, and 11–15 are rejected under 35 U.S.C. § 102(a)(1) as
anticipated by Sarkar.
Claims 6, 9, 16, and 17 are rejected under 35 U.S.C. § 103 as
unpatentable over Sarkar and Ritscher.
Claims 7, 10, and 18–20 are rejected under 35 U.S.C. § 103 as
unpatentable over Sarkar.
ANALYSIS
Claims 1–20—Rejected as Failing to Comply
with the Written Description Requirement
Appellant argues claims 1–20 as a group. Appeal Br. 11–12. We
select claim 11 as representative of the group, and decide the appeal of this
rejection on the basis of claim 11 alone. 37 C.F.R. § 41.37(c)(1)(iv) (2017).
Claim 11 is directed to a method of detecting atrial fibrillation (AF)
using “first and second counts” of pairs of ventricular rate changes,
measured in beats per minute. Appeal Br. 20 (claims. app.). The
Specification defines these first and second counts—i.e., first count a and
second count b—as points on a two-dimensional scatter plot (or Lorenz
plot), the x-axis value determined by one ventricular rate change of a pair,
the y-axis value determined by the other ventricular rate change of the pair.
Spec. ¶¶ 34, 50–53, Fig. 4B. Counts falling within a region centered at the
origin of the scatter plot (region 409 depicted in Figure 4B, representing a
“magnitude” criterion) comprise first count a, and those falling within a
region in the lower left quadrant of the scatter plot (region 410 depicted in
Figure 4B, representing a “double decrement” criterion) comprise second
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count b. The Specification discloses using counts a and b to determine a
“First Indication” and “Second Indication,” respectively, of AF. Spec.
¶¶ 51–53, Fig. 5. The First Indication is determined by comparing the first
count a to the total number of instances of pairs T of ventricular rate changes
in a “window” of temporally consecutive heart beats using the equation .
Id. ¶¶ 50–51. The Second Indication is determined by comparing the second
count b to the total T of pairs of ventricular rate changes, or . Id. ¶¶ 52–53.
According to the Specification, “AF is indicated for a valid window when
the first and second indications are satisfied.” Id. ¶ 55 (emphasis added).
In rejecting the claims as failing the written-description requirement,
the Examiner finds that “[t]he specification merely states, ‘AF is indicated
for a valid window when the first and second indications are satisfied’ . . .
and completely omits what would be considered meeting or satisfying the
indications.” Non-Final Act. 4. According to the Examiner, “[t]he
specification describes a multitude of calculations culminating in a first
indication and a second indication (Paragraphs 49, 50), but fails to
explain how to interpret these two numbers to detect AF.” Id.
In response, Appellant refers us to Figures 4B and 7 as providing
“pictorial examples of heart rhythm information and corresponding scatter
plots,” and asserts that “one o[f] ordinary skill in the art, once having been
taught the elements of Appellant’s claims 1, 8 and 11, can provide
boundaries and criterion, in combination with the heart rhythm information
in FIG. 7, among other places, to ‘provide atrial fibrillation information
using the first and second counts.’” Appeal Br. 12.
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This is unpersuasive. First, it is attorney argument. Appellant does
not explain how one of ordinary skill in the art can provide the necessary
“boundaries and criterion” from Figures 7 and 4B. Nor is it self-evident
how to do so. Figure 4B explains how ventricular-rate-change pairs can be
represented as first count a and second count b, but does not explain how the
first and second indications are derived from the first and second counts. As
for Figure 7, it is unclear how to quantify first count a, second count b,
counts that would not fall into either a or b, or total count T. As the
Examiner points out, there is nothing in Figure 7 that “ties back to the first
and second indications.” Ans. 12.
Even if Appellant is correct that one of ordinary skill in the art could
have derived necessary “boundaries and criterion” from the Specification,
that would not be enough to satisfy the written-description requirement. As
Appellant states, one of ordinary skill in the art would have to “determine a
threshold for such counts that rise to the level of atrial fibrillation, or a
threshold to determine whether the first or second indications are satisfied.”
Reply Br. 5–6. A disclosure that leaves it to the reader to determine
thresholds necessary to detect AF does not adequately describe a claim
drawn to detecting AF, even if one of ordinary skill in the art would have
found it obvious from the disclosure how to do determine the thresholds.
See Tronzo v. Biomet, Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) (holding
that “[a] disclosure in a parent application that merely renders the later-
claimed invention obvious is not sufficient to meet the written description
requirement; the disclosure must describe the claimed invention with all its
limitations”) (internal citation omitted). Accordingly, we agree with the
Examiner that the Specification does not adequately describe the claimed
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invention, and thus sustain the Examiner’s rejection of claims 1–20 for
failing the written-description requirement of 35 U.S.C. § 112(a).
Claims 1–20—Rejected as Failing to Comply
with the Enablement Requirement
The Examiner determines that Claims 1–20 are not adequately
enabled by the Specification for the same reasons that the Examiner found
the claims to fall short of the written-description requirement. Non-Final
Act. 3–4. Appellant responds, inter alia, that “the Examiner has failed to
consider the many factors necessary to determine that a claim is not enabled
under §112 as required by MPEP § 2164.01(a).” Id. at 12.
Section 112 requires a written description to enable “those skilled in
the art how to make and use the full scope of the claimed invention without
‘undue experimentation.”’ Koito Mfg. Co., Ltd. v. Turn-Key-Tech, LLC, 381
F.3d 1142, 1155 (Fed. Cir. 2004) (internal citation omitted). Whether undue
experimentation is needed is not a single, simple factual determination, but
is a conclusion reached by weighing many factual considerations. In re
Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). The Wands factors include: (a)
the quantity of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working examples, (4)
the nature of the invention, (5) the state of the prior art, (6) the relative skill
of those in the art, (7) the predictability or unpredictability of the art, and (8)
the breadth of the claims. Id. “[T]he PTO bears an initial burden of setting
forth a reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the
application.” In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993).
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The Examiner has not made any findings regarding whether undue
experimentation is required for one of ordinary skill in the art to determine
the threshold values for the first and second indications to detect AF, much
less considered any of the Wands factors. Therefore, the Examiner has not
established a prima facie case of lack of enablement, and we do not sustain
this rejection.
Claims 1–20—Rejected as Directed to Ineligible Subject Matter
To determine whether a claim falls within a judicially recognized
exception to patent eligibility under 35 U.S.C. § 101, we apply the two-step
framework set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 566 U.S. 66 (2012), and reaffirmed in Alice Corporation
Proprietary Ltd. v. CLS Bank International, 573 U.S. 208 (2014). For the
first Alice step (Step 2A of the USPTO’s Patent Subject Matter Eligibility
guidance, MPEP § 2106), we determine whether the claims at issue are
directed to a patent-ineligible concept such as an abstract idea, law of nature,
or natural phenomenon. Alice, 573 U.S. 208 (citing Mayo, 566 U.S. at 78–
79). If so, we advance to the second Alice step (Step 2B of the USPTO’s
Patent Subject Matter Eligibility guidance) where “we consider the elements
of each claim both individually and ‘as an ordered combination’ to
determine whether the additional elements ‘transform the nature of the
claim’ into a patent-eligible application” of the otherwise patent-ineligible
concept. Id. (quoting Mayo, 566 U.S. at 78–79).
We also apply the USPTO’s additional guidance on applying step 2A.
See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg.
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50 (Jan. 7, 2019) (“Revised Guidance”).2 The Revised Guidance establishes
a two-prong inquiry for determining whether a claim is directed to a judicial
exception. Id. at 54. In prong one, we determine whether the claim recites a
judicial exception, such as a law of nature, natural phenomenon, or abstract
idea. Id. If so, we look to whether the claim recites additional elements that
integrate the judicial exception into a practical application. Id. at 50. Thus,
a claim is directed to a judicial exception only if the claim recites a judicial
exception and does not integrate that exception into a practical application.
Id. At that point we look to whether the claim adds a specific limitation
beyond the judicial exception that is not well-understood, routine, and
conventional activity in the field or whether the claim simply appends well-
understood, routine, and conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception. Id.
at 56.
The Examiner determines that claims 1–20 are “directed to the
abstract idea of data mining (i.e. analyzing data in an attempt to discover
something useful).” Non-Final Act. 4. The Examiner further determines
that the claims do not include additional elements that are sufficient to
amount to significantly more than the judicial exception because “even
though a multitude of calculations are required to culminate in a first
indication and a second indication , there is no meaningful
interpretation or explanation of these first and second indication values.” Id.

2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01-
07/pdf/2018-28282.pdf.
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In response, Appellant argues, inter alia, that “the Examiner fails to
address any element of claims 1-20 with specificity.” Appeal Br. 10.
Appellant notes, in particular, that the Examiner did not address independent
claim 8’s recitation of “an ambulatory medical device for use in a patient,”
an “atrial fibrillation detection processor circuit,” etc. Id.
We assume for purposes of this decision that the Examiner correctly
determined in Step 2A that the claims are directed to an abstract idea. We
take issue, however, with the Examiner’s application of step 2B. The search
for an inventive concept “considers all claim elements, both individually and
in combination,” to be “consistent with the general rule that patent claims
‘must be considered as a whole.’” Alice, 573 U.S. at 218 n.3 (internal
citation omitted). The Examiner did not address many of the claim elements
in considering whether additional elements provided an inventive concept to
the claimed abstract idea. For example, the Examiner did not consider the
limitations in independent claim 1 reciting a processor circuit and counter
circuits; the limitations in independent claim 8 reciting an ambulatory
medical device, processor circuit, detector circuit, heart beat sensing circuit,
window determiner circuit and counter circuits; and the limitations in
independent claim 11 reciting a processor circuit. To be clear, we are not
expressing the view that any of the claims is patent eligible; rather, we
merely determine, in this particular case, that the Examiner’s analysis of
Step 2B in this case is insufficient for Appellant to respond to it or for us to
review it. Accordingly, we do not sustain the Examiner’s rejection of claims
1–20 as directed to ineligible subject matter.
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Claims 1–5, 8, and 11–15—Rejected as Anticipated by Sarkar
The Examiner finds that Sarkar discloses all of the limitations of
claims 1–5, 8, and 11–15. Non-Final Act. 5–6. The Examiner specifically
finds that Sarkar discloses the limitations in independent claim 1 requiring
counter circuits that determine counts of pairs of ventricular rate changes as
claimed, and similar limitations in independent claims 8 and 11. Non-Final
Act. 5 (citing Sarkar ¶¶ 31, 41, 45, 74, 76, Figs. 1, 6). Appellant responds,
inter alia, that Sarkar “fails to disclose or suggest using units of bpm, as
required by claims 1, 8, and 11,” but instead discloses “fixed millisecond
values.” Appeal Br. 14 (citing Sarkar ¶¶ 41, 57).
The Examiner acknowledges that Sarkar uses differences in R-R
intervals (the time interval between R-wave events) to detect AF rather than
changes in ventricular heart rate, but finds that Sarkar “meets the claim
requirements” because “heart rate data in the claim can inherently be
expressed in ‘time per beat’ or ‘beats per time.’” Ans. 14.
Appellant disputes that the claimed heart-rate limitations are
inherently found in Sarkar’s R-R interval disclosure. According to
Appellant:
Intervals and rates scale differently. Percent changes in rates
change differently than percent changes in intervals. Monitored
patients do not have a constant heart rate. Variations in heart
rate can be vast, such as when a patient is at rest (e.g., 60 bpm)
and when the patient is active (e.g., 140 bpm), etc. A two-beat
change is always 2 beats, whether at 60 bpm or at 140 bpm.
However, in ms [milliseconds], a two-beat change at 60 bpm
(from 60 to 62 bpm) is 32 ms; whereas a two-beat change at
140 bpm (from 140 to 142 bpm) is only 6 ms. The ms
difference in Sarkar is different than the rate change magnitude
characteristics required by Appellant’s claims.
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Reply Br. 7.
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “Inherency, however, may
not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient.”
In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal
quotation marks omitted). It is undisputed that Sarkar does not expressly
disclose the claimed heart rate limitations. It is also not entirely clear from
the record that these limitations can inherently be found in Sarkar’s use of R-
R intervals, particularly given Appellant’s point that a given rate change
represents a different interval change depending on the baseline heart rate.
Because we are not persuaded that Sarkar inherently discloses the heart-rate
limitations, we do not sustain the Examiner’s rejection of claims 1–5, 8, and
11–15 as anticipated by Sarkar.
Claims 6, 9, 16, and 17—Rejected as Unpatentable over Sarkar and Ritscher
The Examiner’s rejection of dependent claims 6, 9, 16, and 17 as
unpatentable over Sarkar and Ritscher relies on the erroneous finding that
Sarkar inherently discloses the limitations in the independent claims directed
to ventricular rate changes in beats per minute. Ritscher is not relied on to
cure this deficiency. Therefore, we do not sustain this rejection.
Claims 7, 10, and 18–20—Rejected as Unpatentable over Sarkar
Because the Examiner’s rejection of dependent claims 7, 10, and 18–
20 relies on the erroneous finding that Sarkar discloses the limitations in the
independent claims directed to ventricular rate changes in beats per minute,
we do not sustain this rejection.
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CONCLUSION
The following table summarizes our disposition of the rejections at
issue in this appeal:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
1–20 112(a) Written
Description
1–20
1–20 112(a) Enablement 1–20
1–20 101 Eligibility 1–20
1–5, 8, 11–15 102(a)(1) Sarkar 1–5, 8, 11–
15
6, 9, 16, 17 103 Sarkar, Ritscher 6, 9, 16, 17
7, 10, 18–20 103 Sarkar 7, 10, 18–20
Overall
Outcome
  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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED