Ex Parte Underwood

Patent Trial and Appeal Board

Mar 1, 2019

14431383 (P.T.A.B. Mar. 1, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/431,383 03/26/2015
23598 7590 03/05/2019
BOYLE FREDRICKSON S.C.
840 North Plankinton A venue
MILWAUKEE, WI 53203
FIRST NAMED INVENTOR
Mark Y. Underwood
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
3155.133 5252
EXAMINER
ULM,JOHND
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
03/05/2019 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
Appeal2018-001945
Application 14/431,383 1
Technology Center 1600
Before JEFFREY N. FRED MAN, ERICA A. FRANKLIN, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant seeks review of the
Examiner's rejection of claims 1-11, 15, and 16. We have jurisdiction under
35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification relates to the use of apoaequorin-containing
compositions to alleviate symptoms associated with multiple sclerosis (MS).
Spec. ,r 1. Claim 1 is illustrative:
1 Appellant identifies the real party in interest as Quincy Bioscience, LLC.
Br. 3.
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Application 14/431,3 83
1. A method for alleviating a symptom associated with
Multiple Sclerosis, comprising administering to a subject in
need of such treatment an effective amount of apoaequorin.
Br. 20 (Claims Appendix).
REJECTION MAINTAINED ON APPEAL
Claims 1-11, 15, and 16 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over Underwood '562 2 and Stauderman. 3 Ans. 2; Final Action
2.
DISCUSSION
The Examiner relies on Underwood '562 as "expressly t[eaching] the
administration of apoaequorin-containing compositions to individuals for the
purpose of treating symptoms or disorders associated with calcium
imbalance ... including but not limited to sleep quality, energy quality,
mood quality, pain and memory quality." Non-Final Action 54 (citing
Underwood '562 ,r,r 3, 10, 11). As the Examiner points out, Underwood
'562 does not expressly identify MS as a disease with symptoms associated
with calcium imbalance. See id. As such, the Examiner turns to
Stauderman, which discloses MS as a disease treatable by the administration
of compounds that can modulate intracellular calcium levels. See id. at 5---6
(citing Stauderman ,r,r 134, 137). The Examiner finds it would have been
obvious to administer an apoaequorin-containing composition of Underwood
'562 to an individual afflicted with MS as described in Stauderman, "with at
2 Underwood, US 2011/0124562 Al, published May 26, 2011.
3 Stauderman et al., US 2008/0293092 Al, published Nov. 27, 2008.
4 Non-Final Action dated Oct. 21, 2015.
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Application 14/431,3 83
least the expectation that such administration would result in an
improvement in the sleep quality, energy quality, mood quality, pain and
memory quality of that individual, and a 'general improvement of a subject's
mental and physical health' relative to an untreated individual." Id. at 6
(quoting Underwood '562 ,r 14).
Before addressing Appellant's specific arguments, we first consider
Appellant's reliance on the Underwood Declaration. 5 We accord the
statements therein no persuasive weight in our analysis, for two reasons.
First, as the Examiner points out, the Underwood Declaration "contains no
evidence that declarant is an expert in the art of neurobiology or in the
treatment of neurodegenerative disease and, in particular, MS." Ans. 3.
Second, the Underwood Declaration cites no extrinsic support for the
assertions and conclusions posited by the declarant. Accordingly, it is
argumentative, not evidentiary. See In re Am. Acad. of Sci. Tech. Ctr., 367
F.3d 1359, 1368 (Fed. Cir. 2004) ("[T]he Board is entitled to weigh the
declarations and conclude that the lack of factual corroborations warrants
discounting the opinions expressed in the declarations.").
Appellant presents three interrelated arguments in support of claim 1 :
treating MS is highly unpredictable; Stauderman is speculative and not
specific to MS; and there would have been no reasonable expectation of
success. See generally Br. 13-18. These arguments do not persuade us of
any reversible error by the Examiner. Obviousness does not require absolute
5 Declaration under Rule 1.132 of Mark Y. Underwood, dated Nov. 16,
2016.
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Application 14/431,3 83
predictability, only a reasonable expectation that the beneficial result will be
achieved. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
As discussed above, Underwood '562 already teaches the
administration of apoaequorin-containing compositions for the treatment of
symptoms related to sleep quality, energy quality, mood quality, pain and
memory quality. These are precisely the goals recited in some of the present
dependent claims. See Br. 20 (Claims Appendix), claims 2 (sleep quality), 3
( energy quality), 4 (mood quality), 5 (pain), 6 (memory quality). And as the
Examiner points out, Appellant "has provided absolutely no evidence to
support a position that one skilled in this art would expect a subject afflicted
with MS to respond to general therapeutics .... in a manner that is distinct
from responses observed in the general population. Ans. 2. Thus we agree
with the Examiner that, from Underwood '562 alone, "one had more than a
reasonable expectation that a subject afflicted with MS would enjoy the
same or similar benefits from apoaequorin treatment as those subjects
employed in Examples 1 to 3 of [Underwood '562]." Id. at 2-3.
Stauderman "merely provides additional motivation to specifically apply the
method described in [Underwood '562] to individuals afflicted with MS in
particular." Id. Put differently, the gap between Underwood '562 and claim
1 is small, and filling it (as motivated by Stauderman) would have only
required the ordinary artisan to treat MS patients experiencing the recited
symptoms with the same compound used to treat patients with calcium
imbalance generally. Cf KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421
(2007) ("A person of ordinary skill is also a person of ordinary creativity,
not an automaton.").
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Application 14/431,3 83
Appellant points out that MS is one among many conditions listed in
Stauderman, and that Stauderman's examples do not involve animal models
of MS. See Br. 14--16. But the prior art must be considered for all of its
teachings, including non-preferred embodiments. See Merck & Co. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (citation omitted).
As discussed above, the Examiner relies on Stauderman for a very limited
purpose: the motivation to treat calcium imbalance-related disorders already
comes from Underwood '562, and Stauderman simply provides a set of
calcium imbalance-related disorders (including MS). The Examiner is not
relying on Stauderman for the mechanism 6 or course of treatment. Hence
Appellant's attempt to distinguish Stauderman from Underwood '562 (or the
present application) based on the alleged mechanism of action (see Br. 17-
18) is not persuasive. See In re Keller, 642 F.2d 413,426 (CCPA 1981)
("But one cannot show non-obviousness by attacking references individually
where, as here, the rejections are based on combinations of references.").
Furthermore, although Appellant cites to paragraph 36 of the Specification
for the proposition that "apoaequorin appears to modulate calcium levels by
binding to calcium ions already present in the surrounding solution" (id. at
6 Hence Appellant's attempt to distinguish Stauderman from Underwood
'562 (or the present application) based on the alleged mechanism of action
(see Br. 17-18) is not persuasive. Furthermore, although Appellant cites to
paragraph 3 6 of the Specification for the proposition that "apoaequorin
appears to modulate calcium levels by binding to calcium ions already
present in the surrounding solution" (id. at 17 (citing Spec. ,r 36)) in an
attempt to draw a contrast with Stauderman's inhibition of calcium channel
activity, this paragraph of the Specification is not so specific. The
Underwood Declaration makes the same claim, but cites no evidence apart
from paragraph 3 6 of the Specification.
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Application 14/431,3 83
17 (citing Spec. ,r 36)) in an attempt to draw a contrast with Stauderman's
inhibition of calcium channel activity, this paragraph of the Specification is
not so specific. Paragraph 36 of the Specification provides in full:
Apoaequorin is classified as a "calcium-binding protein" which
is necessary for the process of calcium regulation in nerve cells.
Apoaequorin has proven neuroprotective capabilities, protecting
cells from the damage of calcium overload. Calcium is a
critical part of cell communication. Without calcium providing
the "electricity" to the cell, we wouldn't be able to think, move,
or experience emotion. Excess calcium can cause
overstimulation of the cell and trigger other mechanisms, which
lead to a break down in cell function. Research on the effects of
apoaequorin on the brain and body have shown promise for
enhancing and improving memory, improving sleep quality,
increasing brain cell survival and improving cognitive function.
Spec. ,r 36. The Underwood Declaration makes the same claim (see
Underwood Deel. ,r 17), but cites no evidence apart from paragraph 36 of the
Specification.
Having considered Appellant's arguments in favor of the patentability
of claim 1, we are not persuaded of any reversible error by the Examiner in
rejecting claim 1. Accordingly, for the reasons described herein and those
already of record, we sustain the Examiner's rejection of claim 1. Claims 2-
8, 11, 15, and 16 are not argued separately, and fall with claim 1. See 37
C.F .R. § 41.3 7 ( c )(1 )(iv).
In regard to claims 9 and 10, which require a subject diagnosed with a
particular form (and, as to claim 10, a relapsed state) of MS (see Br. 21
(Claims Appendix)), Appellant argues:
Underwood and Stauderman do not recognize the improved
effect of apoaequorin in individuals who had been diagnosed
with either Relapsing Remitting Multiple Sclerosis or
Secondary Progressive Multiple Sclerosis or were in a relapse
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Application 14/431,3 83
status prior to beginning apoaequorin. Mere speculation that
apoaequorin could be used to treat multiple sclerosis would not
make predictable the greater success in the specific populations
recited in the claims.
Br. 18-19. This argument is not persuasive. For the reasons discussed
above with respect to claim 1, the Examiner's rejection is not speculative;
this applies equally to MS-related symptoms generally and to the specific
conditions of claims 9 and 10. Appellant points to paragraph 51 of the
Specification as evidence of the "greatest overall effect" seen in relapsed
patients (Br. 18 ( citing Spec. ,r 51) ), but fails to establish that this effect is
unexpected or otherwise not obvious in view of the prior art. Accordingly,
we discern no reversible error in the Examiner's rejection of claims 9 and
10, and we sustain the rejection of these claims.
CONCLUSION
The rejection of claims 1-11, 15, and 16 under§ 103(a) is sustained.
No time period for taking any subsequent action in connection with this
appeal may be extended under 3 7 C.F .R. § 1.13 6( a)( 1 )(iv).
AFFIRMED
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