QUINCY BIOSCIENCE, LLC

Patent Trials and Appeals Board

Sep 4, 2020

14358274 - (D) (P.T.A.B. Sep. 4, 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.
14/358,274 05/15/2014 Mark Y. Underwood 3155.118 5942
23598 7590 09/04/2020
BOYLE FREDRICKSON S.C.
840 NORTH PLANKINTON AVENUE
MILWAUKEE, WI 53203
EXAMINER
CHERNYSHEV, OLGA N
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
09/04/2020 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):
docketing@boylefred.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_____________

Ex parte MARK Y. UNDERWOOD and JAMES R. MOYER1
_____________

Appeal 2020-000685
Application 14/358,274
Technology Center 1600
______________

Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and
JOHN A. EVANS, Administrative Patent Judges.

EVANS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) from the
Examiner’s Non-Final Rejection of Claims 1–4 and 6. Appeal Br. 4. We
have jurisdiction over the pending claims under 35 U.S.C. § 6(b).
We AFFIRM.

INVENTION
The claims relate to apoaequorin-based compositions and methods for
preconditioning neurons in a subject to reduce neuronal injury due to brain

1 We use the word “Appellant” to refer to “Applicants” as defined in
37 C.F.R. § 1.42(a). The Appeal Brief identifies Quincy Bioscience, LLC as
the real party in interest. Appeal Br. 3.
Appeal 2020-000685
Application 14/358,274
2

ischemia. See Abstract. Claim 1, the sole independent claim, is reproduced
below with some formatting added.
1. A method of preconditioning neurons to reduce
neuronal injury when brain ischemia occurs in a subject,
comprising preventatively administering apoaequorin to
neurons in a subject, whereby the apoaequorin initiates a
change in cytokine expression levels resulting in a reduction in
neuronal injury when brain ischemia occurs in the subject at
least 48 hours thereafter, as compared to neurons not
administered the apoaequorin when brain ischemia occurs in the
subject at least 48 hours thereafter.

PRIOR ART
Name2 Reference Date
Underwood WO 2009/114597 A1 Sept. 17, 2009

REJECTIONS3 AT ISSUE4
1. Claims 1–4 and 6 stand rejected under 35 U.S.C. § 112, second
paragraph, as indefinite. Final Act. 2–4.
2. Claims 1–4 and 6 stand rejected under 35 U.S.C. § 112, first
paragraph, as lacking enablement. Final Act. 4–6.

2 All citations herein to the reference are by reference to the first named
inventor/author only.
3 The present application was examined under the pre-AIA first to invent
provisions. Final Act. 2.
4 Throughout this Decision, we refer to the Appeal Brief (“Appeal Br.”) filed
April 30, 2019, the Reply Brief (“Reply Br.”) (none filed), the Final Office
Action (“Final Act.”) mailed May 4, 2018, the Examiner’s Answer mailed
August 5, 2019, and the Specification (“Spec.”) filed May 15, 2014.
Appeal 2020-000685
Application 14/358,274
3

3. Claims 1–4 and 6 stand rejected under 35 U.S.C. §102(b) as
anticipated by Underwood. Final Act. 6–7.

ANALYSIS
We have reviewed the rejections of Claims 1–4 and 6 in light of
Appellant’s arguments that the Examiner erred. We have considered in this
decision only those arguments Appellant actually raised in the Briefs. Any
other arguments which Appellant could have made but chose not to make in
the Briefs are deemed to be waived. See 37 C.F.R. § 41.37(c)(1)(iv). We
adopt as our own the findings and reasons set forth in the rejection from
which this appeal is taken and in the Examiner’s Answer, to the extent
consistent with our analysis below. We provide the following explanation to
highlight and address specific arguments and findings primarily for
emphasis.

CLAIMS 1–4 AND 6: INDEFINITENESS.
Claim 1, the sole independent claim, recites, inter alia,
“preventatively administering apoaequorin to neurons in a subject, whereby
the apoaequorin initiates a change in cytokine expression levels resulting in
a reduction in neuronal injury when brain ischemia occurs in the subject at
least 48 hours thereafter.”
The Examiner finds the Specification fails to inform one of skill in the
art how to determine when a stroke may happen such that the claimed
apoaequorin may be administered “at least” (Claim 1), or “exactly” (Claim
6) 48 hours prior thereto. Final Act. 3. The Examiner repeats this finding in
the Answer. Ans. 9.
Appeal 2020-000685
Application 14/358,274
4

Appellant contends the term “preventatively,” as recited in the claims,
is definite because it refers to “administering apoaequorin”
prior to the occurrence of brain ischemia to prevent brain
ischemia. Any alleged ambiguity in the claim term
“preventatively” is resolved by the Applicant’s quantitative
metric that limits the nature of the administration of
apoaequorin – “whereby the apoaequorin initiates a change in
cytokine expression levels resulting in a reduction in neuronal
injury when brain ischemia occurs in the subject at least 48
hours thereafter” – and therefore, provides a clear cut indication
of the scope of the subject matter covered by the claim.
Appeal Br. 11. Appellant does not file a Reply Brief.
We find a person of ordinary skill in the medical arts would
understand the clause “preventatively administering apoaequorin to neurons
in a subject,” as recited in Claim 1. The USPTO assesses indefiniteness
pursuant to the Federal Circuit’s guidance in In re Packard, 751 F.3d 1307,
1310 (Fed. Cir. 2014). See Ex parte McAward, Appeal 2015-006416 (PTAB
Aug. 25, 2017) (precedential) (“[a] claim is indefinite when it contains
words or phrases whose meaning is unclear”).
In Claim 1, the “whereby” clause states the intended result of
“administering apoaequorin.” “A ‘whereby’ clause that merely states the
result of the limitations in the claim adds nothing to the patentability or
substance of the claim.” Texas Instruments Inc. v. Int’l Trade Comm’n, 988
F.2d 1165, 1172 (Fed. Cir. 1993).
In view of the foregoing, we decline to sustain the rejection of Claims
1–4 and 6 as indefinite.
CLAIMS 1–4 AND 6: ENABLEMENT.
The Examiner makes substantially similar findings as discussed
above. See Final Act. 4–6.
Appeal 2020-000685
Application 14/358,274
5

Appellant proffers similar contentions and further argues Examples 1
and 2, as set forth in the Specification, satisfy the enablement requirement.
Appeal Br. 13.
The Examiner finds the disclosure of Examples 1 and 2 relate to
controlled, experimental settings where the timing of ischemia may be
defined. Final Act. 11. The Examiner finds in real life, the timing of
ischemic stroke is uncontrolled.5 Id.
Similarly as discussed above, we find a person of ordinary skill in the
medical arts, upon reading the Specification would understand how to
effectuate the clause “preventatively administering apoaequorin to neurons
in a subject,” as recited in Claim 1. And similarly, we find the recited
“whereby” clause of Claim 1 does not affect the patentability of the claims
and does not render the claims indefinite.
In view of the foregoing, we decline to sustain the rejection of Claims
1–4 and 6 as lacking enablement.

CLAIMS 1–4 AND 6: ANTICIPATION BY UNDERWOOD.
Claim 1, the sole independent claim, recites, inter alia,
“preventatively administering apoaequorin to neurons in a subject, whereby
the apoaequorin initiates a change in cytokine expression levels resulting in
a reduction in neuronal injury when brain ischemia occurs in the subject at
least 48 hours thereafter.”

5 In regards to the Examiner’s expressed concern, as relating to scheduled
surgery, or perhaps a scheduled prize fight, the timing of an ischemic insult
may be determined with relative certainty.
Appeal 2020-000685
Application 14/358,274
6

Appellant contends Underwood fails to disclose administering
apoaequorin prior to an ischemic event. Appeal Br. 14.
The Examiner finds that “[u]nder the principles of inherency, if the
prior art necessarily functions in accordance with, or includes, the claimed
limitations, it anticipates. Ans. 14. (citing In re King, 801 F.2d 1324, 1326,
(Fed. Cir. 1986)). The Examiner further finds Underwood “essentially
discloses the same method, administering the same drug, apoaequorin, for
the same duration, daily, which meets the limitation for ‘at least 48 hours,’
to the same patient population.” Id., citing Underwood ¶¶ 26, 27.
We agree with the Examiner that Underwood fully anticipates
“preventatively administering apoaequorin to neurons in a subject,” as
recited in Claim 1 because administration of apoaequorin-containing
compositions to a subject in order to correct or maintain the calcium balance
in that subject, as taught in paragraph 26 of Underwood, will include
administration to subjects who will suffer from brain ischemia at least 48
hours later. As discussed above, we find the recited “whereby” clause of
Claim 1 does not affect the patentability of the claims.
In view of the foregoing, we sustain the rejection of Claims 1–4 and 6
under 35 U.S.C. § 102(b).

CONCLUSION

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 6 112,
second
paragraph
Indefiniteness 1–4, 6
1–4, 6 112, first
paragraph
Enablement 1–4, 6
Appeal 2020-000685
Application 14/358,274
7

1–4, 6 102(b) Underwood 1–4, 6
Overall
Outcome

1–4, 6

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED