West Affum Holdings Corp.

Patent Trials and Appeals Board

May 19, 2020

14485594 - (D) (P.T.A.B. May. 19, 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.
14/485,594 09/12/2014 Joseph L. Sullivan WAHC169400 1056
153490 7590 05/19/2020
COJK - Kestra Medical
1201 Third Avenue
Suite 3600
Seattle, WA 98101
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
05/19/2020 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):
efiling@cojk.com
eofficeactions@appcoll.com
larry.lycke@kestramedical.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOSEPH L. SULLIVAN, ROBERT P. MARX, and
ZHONG QUN LU
____________

Appeal 2019-005878
Application 14/485,594
Technology Center 3700
____________

Before JOHN C. KERINS, STEFAN STAICOVICI, and
LISA M. GUIJT, 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 July 19, 2018, hereinafter “Final
Act.”) rejecting claims 106 and 107.2 We have jurisdiction over this appeal
under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. West Affum Holdings Corp. is identified as the real party
in interest in Appellant’s Appeal Brief (filed Feb. 28, 2019, hereinafter
“Appeal Br.”). Appeal Br. 3.
2 Claims 1–100 and 108–118 are canceled, and claims 101–105 are
withdrawn. Appeal Br. 46–48, 50, Appendix E.
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SUMMARY OF DECISION
We REVERSE and enter a NEW GROUND of REJECTION pursuant
to our authority under 37 C.F.R. § 41.50(b).

INVENTION
Appellant’s invention relates to a wearable cardiac defibrillator. Spec.
para. 4.3
Claims 106 and 107 are independent. Claim 106 is representative of
the claimed invention and reads as follows:
106. A non-transitory computer-readable storage medium
storing one or more programs which, when executed by at least
one processor of a wearable cardiac defibrillator (WCD) system
that includes a support structure configured to be worn by a
patient, an energy storage module configured to store an
electrical charge, a discharge circuit coupled to the energy
storage module, and a measurement circuit configured to render
a physiological input from a patient Electrocardiogram (ECG)
signal, the WCD system cooperating with a motion detector,
result in:
receiving the physiological input;
performing an ECG rhythm analysis based on the
physiological input;
generating a shock advice parameter from the ECG
rhythm analysis;
determining whether or not the motion detector detected
a motion event by a motion detection input from the motion
detector or an absence of such a motion detection input; and
responsive to it being determined that no motion event
has been detected, determining whether or not the shock advice
parameter has a numerical value greater than a first threshold

3 Like Appellant and the Examiner, we refer to the Specification filed Sept.
12, 2014.
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and, responsive to so determining cause the discharge circuit to
discharge the stored electrical charge through the patient, else
responsive to it being determined that a motion event has
been detected, determining whether or not the shock advice
parameter has a numerical value greater than a second threshold
different from the first threshold and, responsive to so
determining cause the discharge circuit to discharge the stored
electrical charge through the patient.

REJECTIONS4
I. The Examiner rejects claims 106 and 107 under 35 U.S.C.
§ 112(a) as failing to comply with the written description
requirement.
II. The Examiner rejects claims 106 and 107 under 35 U.S.C.
§ 112(a) as failing to comply with the enablement requirement.
III. The Examiner rejects claims 106 and 107 under 35 U.S.C.
§ 102(a)(1) as being anticipated by Volpe.5,6

ANALYSIS
Rejection I
The Examiner finds that Appellant’s original disclosure does not
support the limitations “performing an ECG rhythm analysis” and
“generating a shock advice parameter from the ECG rhythm analysis,” as

4 The Examiner has withdrawn the rejection under 35 U.S.C. 112(b) of
claims 106 and 107. Examiner’s Answer 3 (dated June 5, 2019, hereinafter
“Ans.”).
5 Volpe et al., US 2008/0312709 A1, published Dec. 18, 2008.
6 We consider the inclusion of claim 100 in the heading of this rejection to
be a typographical error because claim 100 is canceled. See footnote 2.
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recited by each of independent claims 106 and 107. See Final Act. 7–9
(citing Spec. paras. 48, 101).7
With respect to the first limitation in dispute, the Examiner notes that
“[t]here are numerous manners in which ECG signals can be analyzed” and
“there are also numerous rhythms which are to be determined from ECG
analysis,” such as “Atrial Fibrillation, Ventricular Fibrillation, Atrial Flutter,
bradycardia, tachycardia, normal sinus rhythm etc.” Ans. 4–5. Thus,
according to the Examiner, “the [S]pecification does not describe in any
meaningful way how the ECG analysis is performed” because “[n]owhere is
there an algorithm, or equations, or steps which specifically provide
verification of what type of analysis is performed or what specific signals
are used to perform the rhythm analysis.” Id. at 4 (emphasis added).
In regards to the second limitation, the Examiner takes the position
that “it is unclear what an ‘advice parameter’ would be, could be or is in
relation to [the] ECG rhythm analysis.” Final Act. 7. According to the
Examiner, “there is no disclosure as to how this parameter is generated, [i.e.,
calculated,] what variable, equations, steps etc. are used to determine [such]
a parameter.” Id. (citing Spec. paras. 49, 101) (emphasis added); see also
Ans. 4. In particular, the Examiner notes, “there is no way of knowing, from
the disclosure as written, how to generate a shock advice parameter from an

7 The Examiner also finds that Appellant’s original disclosure does not
support “that an ECG rhythm analysis based on physiological input is used
in a first manner and in a second manner to determine shock or no shock
criterion.” Final Act. 9. However, as neither claim 106 nor claim 107
recites such limitations, we consider this rejection to be moot. We note that
these limitations are recited in claim 100, which is canceled. See
Appellant’s Amendment 2, filed Oct. 17, 2017.
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ECG rhythm analysis.” Final Act. 8 (emphasis added). Thus, according to
the Examiner, “the [S]pecification fails to provide adequate disclosure as to
1) what appellant intends a shock advice parameter to be, 2) what signals are
used to determine a shock advice parameter, 3) how the signal is analyzed or
4) how an ECG analysis is performed.” Ans. 6.
We appreciate the Examiner’s position that the Specification does not
explicitly describe, “how the ECG analysis is performed” (Ans. 4) or “how
to generate a shock advice parameter from an ECG rhythm analysis,” (Final
Act. 8) as it is not clear what signals are used, how they are analyzed, and
how an ECG analysis is performed. However, the lack of such descriptions
may constitute a failure to comply with the enablement requirement,
whereas the instant rejection is based on a failure to comply with the written
description requirement. The written description requirement found in 35
U.S.C. § 112 is separate and distinct from the enablement requirement of
that provision. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en banc) (citing Vas-Cath, Inc. v. Mahurkar, 935
F.2d 1555, 1562–63 (Fed. Cir. 1991)).
In particular, “[t]he test for the sufficiency of the written description
‘is whether the disclosure of the application relied upon reasonably conveys
to those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.’” Vasudevan Software, Inc. v.
MicroStrategy, Inc., 782 F.3d 671, 682 (Fed. Cir. 2015) (quoting Ariad,
598 F.3d at 1351). Here, we agree with Appellant that paragraph 85 of the
Specification provides written descriptive support for the limitation of
“performing an ECG rhythm analysis,” as recited by each of independent
claims 106 and 107. See Reply Br. 4–6. In particular, in paragraph 85,
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Appellant’s Specification describes an ECG rhythm analysis where a
physiological input is derived from an ECG signal that can be “high-pass
filtered at a first cut-off frequency” or “high-pass filtered at a second cut-off
frequency different from the first cut-off frequency.” Moreover, as the
Examiner specifically states that “ECG rhythm analysis is known in the art”
(see Ans. 4), Appellant is correct that “one skilled in the art would not need
every detail of the ECG rhythm analysis explained in order to understand
that the Applicant(s) had possession of the invention and be informed of the
invention sought to be patented.” Reply Br. 6. As such, Appellant’s original
disclosure supports the limitation “performing an ECG rhythm analysis,” as
recited by each of independent claims 106 and 107.
As to the second disputed limitation noted above, we agree with
Appellant that paragraph 101 of the Specification supports the limitation of
“generating a shock advice parameter from the ECG rhythm analysis,” as
recited by each of independent claims 106 and 107. See Appeal Br. 22. In
particular, paragraph 101 describes performing a rhythm analysis from a
physiological input and then generating a shock advice parameter from the
rhythm analysis, wherein the shock advice parameter has a numerical value
from zero to 10. As such, Appellant’s original disclosure supports the
limitation “generating a shock advice parameter from the ECG rhythm
analysis,” as recited by each of independent claims 106 and 107.
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 112(a) of claims 106 and 107 as failing to
comply with the written description requirement.

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Rejection II
The Examiner finds that “the [S]pecification, while being enabling for
ventricular fibrillation, does not reasonably provide enablement for all types
of ECG rhythm analysis,” such as “atrial fibrillation, atrial flutter,
ventricular flutter, heart failure, long-QT syndrome etc.” Final Act. 10
(emphasis added).
Insofar as the enablement requirement is concerned, the dispositive
issue is whether Appellant’s disclosure, considering the level of ordinary
skill in the art as of the date of Appellant’s application, would have enabled
a person of such skill to make and use applicant’s invention without undue
experimentation. See In re Strahilevitz, 668 F.2d 1229, 1232 (CCPA 1982).
In calling into question the enablement of Appellant’s disclosure, the
Examiner has the initial burden of advancing acceptable reasoning
inconsistent with enablement so as to shift the burden to Appellant to show
that one of ordinary skill in the art could have practiced the claimed
invention without undue experimentation. See id. Determining whether any
necessary experimentation is undue involves consideration of many relevant
factors including, but not limited to: (1) the breadth of the claims; (2) the
nature of the invention; (3) the state of the prior art; (4) the level of one of
ordinary skill; (5) the level of predictability in the art (6) the amount of
direction provided by the inventor; (7) the existence of working examples;
and (8) the quantity of experimentation needed to make or use the invention
based on the content of the disclosure. In re Wands, 858 F.2d 731, 737 (Fed.
Cir. 1988).
In this case, the Examiner has not discussed any of these factors in
establishing that Appellant’s disclosure is non-enabling with respect to other types
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of ECG rhythm analysis besides ventricular fibrillation and ventricular tachycardia.
See Spec. para. 48. In other words, the Examiner does not set forth the requisite
findings and analysis to show that a person of ordinary skill in the art could not
make or use the invention without undue experimentation.
Nonetheless, we note that “a single embodiment provides broad enablement
in the sense that, once imagined, other embodiments can be made without
difficulty and their performance characteristics predicted by resort to known
scientific laws.” In re Fischer, 427 F.2d 833, 839 (CCPA 1970). Here, because
“ECG rhythm analysis is known in the art” (see Ans. 4), the enabled embodiments
of using ECG signals to detect ventricular fibrillation or ventricular tachycardia
provide broad enablement in the sense that a person of ordinary skill in the art
would know how to make and use other types of ECG rhythm analysis for other
cardiovascular conditions without undue experimentation. See Reply Br. 11.
Accordingly, for the foregoing reasons, we do not sustain the rejection
under 35 U.S.C. § 112(a) of claims 106 and 107 as failing to comply with
the enablement requirement.

Rejection III
Each of claims 106 and 107 requires, inter alia, “generating a shock
advice parameter from the ECG analysis” and comparing it to first and
second thresholds. Appeal Br. 39–40, Appendix A.
The Examiner finds that Volpe discloses a processor 54 “configured
to . . . perform rhythm analysis based on the physiological input in a first
manner if no motion is detected, perform rhythm analysis in a second
manner different from the first if motion is detected . . . determine whether a
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shock is necessary and discharge a shock to the patient.” Final Act. 12–13
(citing Volpe, 69–73, Fig. 5).
Appellant argues that Volpe fails to disclose comparing the numerical
value of the claimed “shock advice parameter” to different thresholds.
Appeal Br. 36.
In response, the Examiner takes the position that because Volpe’s
“algorithm analyzes the data and determines if a shock is necessary” Volpe
discloses “a shock advice parameter from the ECG data.” Ans. 9.
According to the Examiner, “[i]f the shock is delivered then there would
inherently be some type of threshold to determine if the shock is, in fact,
necessary” and “if there is not enough evidence that a shock is necessary this
would be below the threshold and no shock would be given.” Id.
Volpe discloses an arrhythmia detection algorithm in which patient
motion detected in conjunction with detection of a treatable arrhythmia
determines whether a shock is delivered. Volpe, para. 72, Fig. 5. In
particular, Volpe discloses that if the patient becomes motionless when the
treatable arrhythmia is detected, it is more probable that the arrhythmia
diagnosis is correct, and, thus, a shock is delivered. Id. However, if patient
motion is detected after the treatable arrhythmia is detected, the probability
that that the arrhythmia diagnosis is correct is lower, and, thus, delivery of
the shock is delayed. Id. As such, Appellant is correct that only a single
threshold comparison is made in Volpe, namely, when the treatable
arrhythmia is detected, i.e., step V51 in Appellant’s amended Figure 5 of
Volpe. See Reply Br. 15. After the treatable arrhythmia is detected in
Volpe, the shock is either administered immediately, or is merely delayed.
See Volpe, Fig. 5.
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Thus, we agree with Appellant that because in Volpe “[t]he decision
to shock the patient is made singularly at V51,” “there are not multiple
thresholds to which a number is compared.” Reply Br. 16. Hence, “Volpe .
. . does not disclose ‘generating a shock advice parameter from the ECG
rhythm analysis’, and compare its numerical value to different thresholds, as
recited in both claims 106 and 107.” Id. at 17 (emphasis omitted).
Accordingly, we do not sustain the rejection under 35 U.S.C. § 102(a)(1) of
claims 106 and 107 as anticipated by Volpe.

NEW GROUND OF REJECTION
Claims 106 and 107 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the enablement requirement.
The original disclosure does not provide enabling support for the
limitation “generating a shock advice parameter from the ECG rhythm
analysis,” as recited by each of independent claims 106 and 107. Although
the Specification describes a shock advice parameter as a numerical value
from zero to 10 (see Spec. para. 101), the Specification does not describe
how the shock advice parameter is determined from a rhythm analysis, that
is, what variables, equations, and/or algorithms are used to determine it. The
Specification additionally provides no information or guidance as to how
one skilled in the art would arrive at a value of from zero to 10 for the shock
advice parameter. Hence, the disclosure, as filed, is not sufficiently
complete to enable one of ordinary skill in the art to make and use the
claimed invention without undue experimentation. Most notably, as per In
re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), because the original
disclosure does not set forth prior art that discloses a shock advice
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parameter, fails to provide any direction as to how a skilled artisan would
determine the shock advice parameter from a rhythm analysis, and does not
disclose any working examples, the necessary experimentation to
determine the shock advice parameter is undue.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/
Basis
Affirmed Reversed New
Ground
106, 107 112(a) Written
description
106, 107
106, 107 112(a) Enablement 106, 107
106, 107 102(a)(1) Volpe 106, 107
106, 107 112(a) Enablement 106, 107
Overall
Outcome
106, 107 106, 107

This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
Section 41.50(b) also provides (emphasis added):
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:

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(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new Evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
[E]xaminer, in which event the prosecution will be remanded to
the [E]xaminer. The new ground of rejection is binding upon
the examiner unless an amendment or new Evidence not
previously of Record is made which, in the opinion of the
[E]xaminer, overcomes the new ground of rejection designated
in the decision. Should the [E]xaminer reject the claims,
appellant may again appeal to the Board pursuant to this
subpart.

(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same Record. The request
for rehearing must address any new ground of rejection and
state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01 (9th ed.
2018).
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).

REVERSED
37 C.F.R. § 41.50(b)