Ex Parte Wurtman et al

Patent Trials and Appeals Board

Jun 27, 2019

10941025 - (D) (P.T.A.B. Jun. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/941,025 09/15/2004
49443 7590 07/01/2019
Pearl Cohen Zedek Latzer Baratz LLP
1500 Broadway
12th Floor
New York, NY 10036
FIRST NAMED INVENTOR
Richard J. Wurtman
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.
P-7105-USl 6175
EXAMINER
CRANE, LAWRENCE E
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
07/01/2019 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):
USPTO@PearlCohen.com
Arch-USPTO@PearlCohen.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD J. WURTMAN and CAROL WATKINS
Appeal2017-005364
Application 10/941,025
Technology Center 1600
Before ULRIKE W. JENKS, J. JOHN LEE, and TA WEN CHANG,
Administrative Patent Judges.
LEE, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 appeal under 35 U.S.C. § 134 from the Final Rejection of
claims 92-98, which are all the claims pending in the present Application.
We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM,
1 Appellants identify the Massachusetts Institute of Technology and Backbay
Scientific as the real parties in interest. App. Br. 1.
Appeal2017-005364
Application 10/941,025
CLAIMED SUBJECT MATTER
The present invention relates generally to a method for "improving a
cognitive function" by "administering a uridine, a uridine precursor, or a
derivative or metabolite thereof to the subject." Spec. 1. Independent claim
92 is illustrative of the claims on appeal and recites:
92. A method of improving cognitive function in a subject
comprising administering to the subject in need thereof between
about 100 mg to 0.8 g per day of uridine or uridine phosphate,
wherein the uridine is administered in an amount sufficient to
improve cognitive function.
REFERENCES
The Examiner relied on the following references:
von Borstel U.S. Patent No. 6,316,426 Bl, issued Nov. 13, 2001.
Materazzi Eur. Patent Application Pub. No. EP 0178267,
published Apr. 16, 1986.
De Bruin N.M.W.J. De Bruin et al., Combined uridine and
Choline Administration Improves Cognitive Deficits in
Spontaneously Hypertensive Rats, Neuroscience 2002
Conference of the Society for Neuroscience 1--45
(2003).
Marcus Robert Marcus & Ann M. Coulston, Water-Soluble
Vitamins, in GOODMAN & GILMAN'S THE
PHARMACOLOGICAL BASIS OF THERAPEUTICS 1541--44
(1990).
Sitaram N. Sitaram et al., Human Serial Learning:
Enhancement with Arecholine and Choline and
Impairment with Scopolamine, 201 SCIENCE 274--75
(1978).
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REJECTIONS ON APPEAL 2
Claims 92-98 stand rejected under 35 U.S.C. § 112, first paragraph. 3
Claims 92-98 stand rejected under 35 U.S.C. § 103(a) as unpatentable
in view of von Borstel, Materazzi, De Bruin, Marcus, and Sitaram.
ANALYSIS
A. Rejection Under§ 112 for Lack of Enablement
Appellants appeal the rejection of claims 92-98 under 35 U.S.C.
§ 112, first paragraph, for lack of enablement. App. Br. 4--8. As explained
below, we affirm this rejection only with respect to claims 95 and 98.
1. Claims 92-94, 96, and 97
The Examiner provided the same reasoning for the enablement
rejection for all claims on appeal except claims 95 and 98, which we address
separately below. See Final Act. 2--4. Citing In re Wands, 858 F.2d 731,
737 (Fed. Cir. 1988), the Examiner considered each of the Wands factors
and made several determinations. Id. The critical determination on appeal
is the Examiner's finding that the Specification lacks relevant working
examples because "only prospective exemplifications [were] provided." Id.
2 In addition to the rejections listed here, claims 92-98 also were rejected for
obviousness-type double patenting. Final Act. 5---6. Appellants do not
appeal this rejection, but note that they will consider submitting a terminal
disclaimer upon the indication of allowable subject matter. App. Br. 4.
3 We apply the pre-AIA version of§ 112 because the instant Application
was filed before September 16, 2012. See Leahy-Smith America Invents
Act, Pub. L. No. 112-29, §§ 4(c), (e), 125 Stat. 284,296 (2011). Similarly,
we apply the pre-AIA version of§ 103 because the instant Application was
filed before March 16, 2013. See id. §§ 3(c), (n)(l).
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at 2; see also id. at 4 (finding that insufficient direction and working
examples were provided because the relevant examples were "prospective");
Ans. 9 (stating that "the very examples necessary to provide enabling
support" are "entirely prospective").
Appellants contend that Example 13 presented in the Specification
provides the requisite working examples and direction. App. Br. 7. We
agree. Example 13 is titled "UMP-supplemented diets enhance learning and
memory in multiple species." Spec. 4 7. In this example, the Specification
reports the results of experiments conducted on multiple animal species. Id.
at 47--48. Subject animals were administered UMP (uridine-5'-
monophosphate ), and various tests were performed to study the effects on
learning and various types of memory. Id. According to the Specification,
the results show that "uridine augments cognitive function" because animals
administered a UMP-fortified diet exhibited dose-dependent improvements
in learning and memory tests. Id. at 48--49 (further concluding that "orally
administered uridine positively affects ... cognitive function"); see also id.
at Figs. 21-23A (reporting the data of the experiments). Example 13, thus,
is not prospective but instead reports the results of an actually-performed
experiment. Further, we conclude the example, including its experimental
results and reported scientific conclusions, provides sufficient enabling
disclosure to support claim 92, which recites a "method of improving
cognitive function" comprising administering uridine or uridine phosphate
"in an amount sufficient to improve cognitive function."
Therefore, we reverse the Examiner's rejection of claim 92. The
Examiner relied on the same reasoning to reject dependent claims 93, 94, 96,
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and 97. See Final Act. 2--4. Consequently, we reverse the rejection of those
claims on the same basis.
2. Claims 95 and 98
With respect to dependent claims 95 and 98, the Examiner again
relied heavily on his determination that insufficient working examples were
provided. Final Act. 2-3. With respect to these claims, however, the
Examiner specifically highlighted that they claim "administration of one or
more additional ingredients"----claim 95 recites administering one or more of
five additional substances, and claim 98 recites additionally administering a
fatty acid. See id. As explained below, Appellants have not established
reversible error in the Examiner's enablement rejection of these claims.
Appellants do not argue claims 95 and 98 separately except to state
that "[ c ]laims 93-98 recite commonly known salts or precursors to the
compounds of claims [sic] 92," and that "no undue experimentation [is]
required" to understand such compounds. App. Br. 4--8. We are not
persuaded by Appellants' arguments as they relate to claims 95 and 98. As
an initial matter, we note that claims 95 and 98 do not, in fact, recite salts or
precursors of uridine or uridine phosphate. Further, Appellants do not
address the Examiner's specific concerns regarding claims 95 and 98.
First, unlike for claim 92, Appellants do not identify any examples or
other disclosure in the Specification to rebut the Examiner's finding that
insufficient direction or working examples were provided regarding
administering the recited additional substances. In particular, Example 13
does not provide any disclosure regarding administering these additional
substances. See Spec. 47--49. Next, Appellants' arguments regarding other
Wands factors, such as the state of the prior art and the level of skill in the
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art, also do not address the limitations of claims 95 and 98 regarding
administering additional substances, focusing solely on uridine. See App.
Br. 6-7. Appellants also argue that the Examiner misconstrued the claims
(i.e., all the claims on appeal) by improperly importing limitations regarding
treating humans and particular types of diseases. Id. at 5---6. Even if true,
there is no allegation that the Examiner misconstrued the requirement of
claims 95 and 98 to administer certain additional substances, and Appellants
do not explain why any alleged error of claim construction would affect the
Examiner's determination that claims 95 and 98 are not enabled. Nor do we
find persuasive Appellants' argument that the quantity of experimentation
required is minimal, which is entirely unsupported attorney argument. See
id. at 7-8.
For the above reasons, we affirm the rejection of claims 95 and 98
under§ 112, first paragraph, for lack of enablement.
B. Rejection Under§ 103 (a) for Obviousness
The Examiner rejected claims 92-98 as obvious in view of von
Borstel, Materazzi, De Bruin, Marcus, and Sitaram. Final Act. 6-11.
Appellants argue all of these claims together and do not address them
individually. See App. Br. 8-28. Thus, we select claim 92 as representative
of the rejected claims, and we decide the appeal of the rejection of all of
those claims on the basis of claim 92. See 37 C.F.R. § 4I.37(c)(l)(iv). As
explained below, we are not persuaded the Examiner erred.
Appellants argue that the Examiner erred in rejecting claim 92 by
allegedly "introducing many additional limitations" into the claim. App. Br.
10-13. Specifically, Appellants allege the Examiner improperly construed
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the claim to require "treatment of symptoms and conditions associated with
the degradation of mental performance," and treatment of symptoms
associated with particular diseases affecting memory and learning in
particular. Id. at 11-13. To the extent Appellants accurately characterize
the Examiner's claim construction, we conclude any error is harmless.
Claim 92 recites administering uridine or uridine phosphate "in an amount
sufficient to improve cognitive function." Appellants are correct that the
recited improvement in cognitive function does not reference cognitive
deficits or disease symptoms----e.g., the claim also encompasses improving
cognitive function in subjects without disease or any cognitive deficits-but
the alleged erroneous construction is wholly contained within the broader
scope argued by Appellants. Generally, a showing that a narrower subset of
a claim is taught or suggested by the prior art also establishes that the
broader claim is taught by the prior art, and Appellants do not explain, or
even address, why that would not be the case here.
Next, Appellants argue the Examiner erred by improperly conflating
the treatment of symptoms with the treatment of a disease. App. Br. 14--17.
According to Appellants, the Examiner erroneously determined the claims
on appeal are obvious on the basis that von Borstel teaches the treatment of
certain diseases. Id. at 14--15, 17 (citing, e.g., Rapoport v. Dement, 254 F.3d
1053 (Fed. Cir. 2001)). This argument is unpersuasive, however, because
Appellants address von Borstel individually rather than addressing the
Examiner's combination of von Borstel with other references.
In discussing von Borstel, the Examiner found that von Borstel is
directed to the treatment of certain diseases, including certain dementias that
were known to involve deterioration of cognitive skills. Final Act. 7. The
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Examiner then proceeded to discuss the teachings of Materazzi and De
Bruin, finding that both references teach improved mental performance due
to uridine administration. See id. at 8. In particular, the Examiner relied on
De Bruin as teaching that uridine administration (along with a choline
source) improves cognitive performance in mammals, and providing a
motivation to combine the teachings of the asserted references, including
von Borstel. Id. at 8-9. For example, De Bruin discloses that "combined
supplementation with the amine choline and the nucleotide uridine has
positive effects on cognition." De Bruin 28 ( emphasis added). Thus, the
Examiner did not reach a conclusion of obviousness solely by inferring that
von Borstel teaches improvement of cognitive function because it teaches
treating diseases for which cognitive deficits is a symptom. The case law
cited by Appellants is inapposite as a result.
Appellants' argument that the Examiner erred under In re Kubin,
561 F.3d 1351 (Fed. Cir. 2009), is unpersuasive for similar reasons. Again,
Appellants focus on the Examiner's consideration of von Borstel
individually, rather than addressing the Examiner's asserted combination of
references. According to Appellants, the Examiner applied an erroneous
"obvious-to-try" theory because he speculatively "extrapolate[d]" that
improving cognitive function is obvious in light of von Borstel's teaching of
treating dementias. App. Br. 17-21. As discussed above, however, the
Examiner also relied on De Bruin, which expressly teaches improving
"cognition" by administering uridine. See De Bruin 28; Final Act. 8-9.
Although Appellants eventually address other references cited by the
Examiner in separate arguments, these arguments continue to address each
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reference individually, rather than in combination. See App. Br. 21-22
( arguments relating to Marcus, 4 Sitaram, and Materazzi).
With respect to De Bruin, Appellants assert that it was "published
after the priority date of the application and hence is not available as prior
art." Id. at 22. This conclusory statement is insufficient to demonstrate
error. A claim in a continuation-in-part application is entitled to claim
priority from the filing date of the parent application only if the claim is
directed solely to subject matter adequately disclosed in the parent
application. Applied Materials, Inc. v. Advanced Semiconductor Materials
America, Inc., 98 F.3d 1563, 1575 (Fed. Cir. 1996). Furthermore, Appellant
has the burden of showing that the claims are entitled to an earlier priority
date. Natural Alternatives Int'!, Inc. v. Iancu, 904 F.3d 1375 (Fed. Cir.
2018) ( explaining that "claims in a patent or patent application are not
entitled to priority under§ 120 at least until the patent owner proves
entitlement to the PTO, the Board, or a federal court"). The Examiner
determined that the present application "only has adequate priority support
back to 2004," and found that De Bruin was published in July 2003. Final
Act. 8, 11. Appellants present no facts, evidence, or argument explaining
why these determinations are erroneous.
4 Appellants argue that Marcus "refutes" the Examiner's finding that the
references teach choline sources are a "necessary and normal part of the
human diet." App. Br. 21. To the extent this can be construed as an
argument that Marcus teaches away from the claimed invention, we note that
none of the claims on appeal require choline to be a necessary part of a
human diet. Moreover, we note that Marcus states that choline, particularly
in the form of lecithin, is a common part of human diets. See Marcus 1544.
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Appellants further argue that "De Bruin misunderstood their results"
based on purported discussions with one of the inventors of the present
application, Richard Wurtman. App. Br. 22-23. Although Appellants cite
certain references purportedly supporting Wurtman's view, Appellants did
not provide the required oath or sworn declaration-these materials,
therefore, cannot constitute evidence in this proceeding. See 3 7 C.F .R.
§ 1.132 ("[ A ]ny evidence submitted to traverse the rejection or objection on
a basis not otherwise provided for must be by way of an oath or declaration
under this section."); see also 37 C.F.R. § 1.68 (explaining requirements for
written declarations, including ( 1) warning against willful false statements,
and (2) requiring a positive statement that "all statements made of the
declarant's own knowledge are true and that all statements made on
information and belief are believed to be true"). As a result, no record
evidence exists that supports these purported discussions or conclusions of
inventor Wurtman. As a result, we are not persuaded of error on that basis.
Additionally, Appellants argue that a person of ordinary skill would
have interpreted De Bruin as teaching that the experimental results (i.e.,
improved cognition) were applicable to the SHR (spontaneously
hypertensive rat) subjects in the study, but were "not transferable" to the SD
(Sprague Dawley) rats used as controls. App. Br. 24--27. As an initial
matter, claim 92 is not limited to any particular type of subject, much less
SD rats or even rats generally. Thus, improving cognitive functions with
uridine administration in SHR subjects meets the requirements of the claim.
Further, Appellants select certain statements in De Bruin and present their
own scientific conclusions about them. Id. De Bruin itself, however,
concludes, "[t]aken together, the data with uridine/choline from the present
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study indicate that combined supplementation with the amine choline and
the nucleotide uridine has positive effects on cognition." De Bruin 28. We
conclude the Examiner's finding that De Bruin teaches or suggests,
"administration of the combination of uridine and choline to mammals was
observed to cause improved mental performance," is supported by the
disclosures of De Bruin. See Final Act. 8. Moreover, we note that the
Examiner relied on De Bruin as one reference in combination with other
references. As with von Borstel, Appellants address De Bruin individually
rather than in combination with the other asserted references.
Appellants' argument that a skilled artisan would not have had a
reasonable expectation of success also is unpersuasive. See App. Br. 27-28.
According to Appellants, "the cited references fail to mention which
parameters are critical or provide any direction to guide the skilled artisan to
the recited subject matter." Id. at 28. But rather than relying on merely "a
general suggestion to experiment" (id. at 27), the Examiner set forth
persuasive reasoning based on De Bruin explaining why a person of ordinary
skill would have been motivated to combine the asserted references and
reasonable expect success when doing so ( e.g., because De Bruin discloses
improvements to cognition due to uridine administration). Final Act. 8-9.
Appellants do not identify or explain what "parameters" of claim 92 were
not taught by the asserted prior art, or for which a skilled artisan would not
have reasonably expected success.
Finally, Appellants argue that the Examiner erred by making the same
obviousness rejection in two other applications (12/162,759 and
11/224,311 ), which allegedly indicates that the rejection fails to address the
present claims with sufficient specificity. See App. Br. 8-10. This
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argument also does not persuade us of error. We evaluate each rejection on
its own merits, and, moreover, we conclude in the present case that the
Examiner's obviousness rejection of the present claims was not erroneous,
as explained above.
DECISION
We REVERSE the Examiner's rejection of claims 92-94, 96, and 97
under 35 U.S.C. § 112, first paragraph.
We AFFIRM the Examiner's rejection of claims 95 and 98 under
35 U.S.C. § 112, first paragraph.
We AFFIRM the Examiner's rejection of claims 92-98 under
35 U.S.C. § 103(a).
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)(l )(iv).
AFFIRMED
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