West Affum Holdings Corp.

Patent Trials and Appeals Board

Oct 20, 2020

14485594 - (R) (P.T.A.B. Oct. 20, 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 10/20/2020
COJK - Kestra Medical
1201 Third Avenue
Suite 3600
Seattle, WA 98101
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
10/20/2020 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 SULLIVAN, ROBERT P. JR. MARX, and
ZHONG QUN LU
____________

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

Before: JOHN C. KERINS, STEFAN STAICOVICI, and
BRETT C. MARTIN, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
In response to our decision, on Appeal dated May 19, 2020 (hereinafter
“Decision”), reversing the Examiner’s rejections of claims 106 and 107 under 35
U.S.C. §§ 112(a) and 102(a)(1), but entering a new ground of rejection of claims
106 and 107 under 35 U.S.C. § 112(a) as failing to comply with the enablement
requirement, Appellant filed a Response Under 37 C.F.R. § 41.50(b) on July 20,
2020 (hereinafter “Response”) arguing that the Board’s new ground of rejection
was erroneous.1 As Appellant’s Response does not include an appropriate

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.
Appeal 2019-005878
Application 14/485,594

2

amendment or new evidence related to the new ground of rejection, the Examiner
appropriately treats Appellant’s Response “as a request for rehearing per 37 C.F.R.
§ 41.50(b)(2).” See generally Miscellanous Communication to Applicant, dated
Aug. 27, 2020, hereinafter “Misc. Comm.”).

DISCUSSION
In our Decision we determined that “[a]lthough 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.”2 Decision 10.
Appellant responds “that the Board erred in its conclusion that the
specification fails to enable the step of ‘generating a shock advice parameter
from the ECG rhythm analysis.’” Response 6. According to Appellant,
generating a single shock advice parameter from an ECG
rhythm analysis has been known in the art since at least as early
2013 as is evidence by U.S. Patent Publication No. US
2014/0107541 filed on March 15, 2013 by Sullivan et al.
entitled System and Method for Electrocardiogram Analysis
and Optimization of Cardiopulmonary Resuscitation and
Therapy Delivery.

Id. at 6–7 (citing Sullivan, para. 163). Appellant explains that Sullivan,
discloses “computing an ‘Index’ based upon an ECG rhythm analysis and
making a shock/no-shock recommendation if the Index exceeds a threshold.”
Id. at 7. Thus, Appellant contends that in a similar manner, Appellant’s

2 As noted in our Decision, we refer to the Specification filed Sept. 12,
2014. See Decision 2, n. 3.
Appeal 2019-005878
Application 14/485,594

3

Specification describes generating a shock advice parameter from a rhythm
analysis and making a shock determination if a “still shock criterion” is
greater than 5 when no motion is detected, or if a “moving shock criterion”
is greater than 7, when a motion event is detected. Id. at 8–9 (citing Spec.
paras. 101–104). As such, Appellant concludes that “the disclosure of the
Specification coupled with the knowledge of those of ordinary skill in the art
at the time of the invention provides sufficient detail that embodiments of
Appellant’s disclosure may be implemented without undue
experimentation.” Id. at 9 (citing In re Wands, 858 F.2d 731, 737 (Fed. Cir.
1988)).3
Sullivan discloses a rhythm analysis algorithm for making a shock/no-
shock decision as a patient undergoes CPR chest compressions. Sullivan,
paras. 16, 162. In particular, Sullivan discloses measuring parameters X and
Y (such as ECG amplitude, frequency, impedance, etc.), generating an
“Index” calculated using equation A*X+B*Y+C (where A, B, and C are
constants), and making a shock recommendation if the Index exceeds a
threshold or a no-shock recommendation if it does not. Id. paras. 163, 164,
and Fig. 17.
In contrast, Appellant’s Specification describes a shock advice
parameter as merely being “a number from zero to 10” that is compared to

3 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.
Appeal 2019-005878
Application 14/485,594

4

first and second threshold values. Spec. para. 101. Although Appellant’s
shock advice parameter is also generated from a patient’s rhythm analysis,
as noted in our Decision, the Specification “provides no information or
guidance as to how one skilled in the art would arrive” at such a number.
Decision 10.
In particular, we appreciate that Sullivan’s equation noted above
constitutes one manner of generating a shock advice parameter, i.e., Index,
from an ECG rhythm analysis. However, Sullivan’s Index is suited for
making a shock/no-shock decision during CPR chest compressions, whereas
Appellant’s shock advice parameter is suited for making a shock decision
based on a patient’s movement. Compare Sullivan, para. 16, with Spec. 101.
Appellant fails to explain in a persuasive manner how a person of ordinary
skill would relate Sullivan’s rhythm analysis algorithm to Appellant’s shock
advice parameter. Just because Sullivan discloses a rhythm analysis
algorithm for making a shock/no-shock decision during CPR chest
compressions is not persuasive that a person of ordinary skill would know
how to generate Appellant’s shock advice parameter for making a shock
decision based on a patient’s movement.
Thus, as Sullivan’s Index and Appellant’s shock advice parameter are
suited for different purposes, and the Specification’s only description of the
shock advice parameter is “a number from zero to 10,” absent undue
experimentation, a person of ordinary skill in the art would not know how to
generate Appellant’s shock advice parameter. Specifically, Appellant’s
Specification fails to provide any direction as to how a skilled artisan would
determine Appellant’s shock advice parameter from a rhythm analysis of a
patient’s physiological data. See e.g., n.3, (factors (6), and (8)).
Appeal 2019-005878
Application 14/485,594

5

Furthermore, although we appreciate Appellant’s position that the
Specification describes threshold values (see Response 9 (citing Spec. para.
101)), nonetheless, the Specification does not describe any working
examples of a rhythm analysis algorithm for generating Appellant’s shock
advice parameter for making a shock decision based on a patient’s
movement. See e.g., n.3, (factor (7)).
In conclusion, for the foregoing reasons, Appellant’s Request for
Rehearing is denied.

CONCLUSION
We have granted Appellant’s Request for Rehearing to the extent that
we have considered our Decision in light of the points raised therein, but
have denied the Request for Rehearing with respect to any modification to
the Decision.
Outcome of Decision on Rehearing:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Denied Granted
106, 107 112(a) Enablement 106, 107

Final Outcome of Appeal after Rehearing:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
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

Appeal 2019-005878
Application 14/485,594

6

DENIED