Ex Parte Wurtman et al

Patent Trials and Appeals Board

Feb 26, 2019

12162759 - (D) (P.T.A.B. Feb. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/162,759 11/17/2008
49443 7590 02/28/2019
Pearl Cohen Zedek Latzer Baratz LLP
1500 Broadway
12th Floor
New York, NY 10036
FIRST NAMED INVENTOR
Dick 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-US8 4478
EXAMINER
CRANE, LAWRENCE E
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
02/28/2019 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 DICK WURTMAN and LISA A. TEATHER
Appeal2017-004446
Application 12/162,759
Technology Center 1600
Before DONALD E. ADAMS, DEBORAH KATZ, and DAVID COTTA,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-004446
Application 12/162,759
Appellants 1 seek our review, under 35 U.S.C. § I34(a), of the
Examiner's decision to reject claims 53---63. 2 (Appeal Brief filed July 26,
2016 ("App. Br.") 1.) We have jurisdiction under 35 U.S.C. § 6(b ). We
AFFIRM.
Appellants' specification is directed to methods for treating and
ameliorating different types of memory disorders and brain dysfunction by
administering compositions of uridine, an acyl derivative of uridine, or a
uridine phosphate. (Specification ("Spec.") 1 :4---6.)
Appellants' claim 53, the only independent claim on appeal, recites:
A method of improving hippocampal-dependent memory
comprising administering to a subject in need thereof a
composition having uridine, an acyl derivative thereof, or a
uridine phosphate and choline in a therapeutically effective
amount to improve hippocampal-dependent memory.
(App. Br. 31, Claims App'x.)
The Examiner made the following rejections, each regarding claims
53-63: as being indefinite under 35 U.S.C. § 112, second paragraph
(Examiner's Answer issued December 15, 2016 ("Ans.") 3), as being
obvious under the doctrine of obviousness-type double-patenting over
claims 1-3, 23, 28-32, and 34 of U.S. Patent Application 11/224,311 (id. at
4), and as being obvious under 35 U.S.C. § I03(a) over von Borstel, 3
1 Appellants report that the real parties-in-interest are Massachusetts Institute
of Technology and Backbay Scientific. (App. Br. 1.)
2 Appellants report that claims 1-35, 40-47, and 52 were canceled and
claims 36-39 and 48-51 were withdrawn. (See App. Br. 1.) The Examiner
states that claims 92-98 are on appeal, but this appears to be an error. (See
Ans. 2.)
3 von Borstel et al., U.S. Patent 6,316,426 Bl, issued November 13, 2001.
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Materazzi, 4 De Bruin, 5 Marcus, 6 and Sitaram 7 (id. at 5-7). Appellants do
not argue for the separate patentability of any of the claims recited in these
rejections. We focus on claim 53 in our analyses. (See 37 C.F.R.
§ 4I.37(c)(l)(iv).)
35 USC§ 112, second paragraph
The Examiner rejected Appellants' claims as being indefinite, finding
that the term "choline" is medicinally and nutritionally inappropriate
because the substance, which the Examiner finds is actually "choline
hydroxide," is a strong alkaline substance and is not appropriate for human
consumption. (See Ans. 3.) The Examiner cites to the Merck Index as
evidence that those of ordinary skill in the art would understand that the term
"choline" refers to a cation, which is distinguished from "choline
hydroxide." (See Final Act. 3; Ans. 7.)
Appellants argue that the Examiner erred in making this rejection
because one of ordinary skill in the art would have understood the claim
term "choline" to refer to various quaternary ammonium salts of choline.
(See App. Br. 6-7.) Appellants argue that references cited by the Examiner
4 Materazzi et al., European Patent Application Publication O 178 267,
published April 16, 1986.
5 De Bruin et al., "Combined uridine and choline administration improves
cognitive deficits in spontaneously hypertensive rats," NEUROBIOLOGY OF
LEARNING AND MEMORY, 80:63-79 (2003).
6 Marcus & Coulston, "Water Soluble Vitamins," Chapter 63, pages 150 and
1542-1544, Goodman & Gilman's: The Pharmacological Basis of
Therapuetics, 8th ed. Pergamon Press, Elmsford, NY (1990).
7 Sitaram & Weingartner, "Human Serial Leaming: Enhancement with
Arecholine and Choline and Impairment with Scopolamine," SCIENCE,
201 :274--276 (1978).
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Application 12/162,759
use the term "choline" to mean a quaternary ammonium salt, as does the
Wikipedia website. (See App. Br. 6-7.)
We are persuaded that the Examiner erred in rejecting Appellants'
claims as being obvious. Appellants' Specification provides several
embodiments for the term "choline," including choline salts, choline esters,
choline phosphates, and any "choline precursor, choline metabolite, choline-
based compound." (Spec. ,r 208; see also ,r,r 205-206.)
Because Appellants' Specification provides specific embodiments that
exemplify the meaning of the term "choline," the term is not indefinite.
Accordingly, we reverse the Examiner's rejection.
Obviousness-Type Double-Patenting
The Examiner rejected Appellants' pending claims under the doctrine
of obviousness-type double-patenting over claims 1-3, 23, 28-32, and 34 of
pending U.S. application 11/224,311. (See Ans. 4.) This was a provisional
rejection because a patent had not yet been issued with the cited claims.
U.S. application 11/224,311 was abandoned on April 11, 2018, and
the recited claims will not issue in this application. Accordingly, the
rejection is moot and we do not consider its merits.
35 US.C. § 103(a)
The Examiner rejected Appellants' claims as being obvious over the
combination of von Borstel, Materazzi, De Bruin, Marcus, and Sitaram. 8
(Final Act. 5-8.)
8 Appellants argue that the Examiner has made the same obviousness
rejection in two other applications (10/941,025 and 11/224,311 ), which must
indicate that the rejection fails to address the specific claims of each
application. (See App. Br. 8-9.) This argument unpersuasive because we
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Application 12/162,759
Von Borstel is directed to uses of aceylated derivatives of uridine.
(See von Borstel abstract.) A specific use highlight in von Borstel is
treatment of a "central nervous system disorders," including cerebrovascular
dementia and senile dementia, by administering aceylate uridine prodrug.
(See von Borstel 26:49-52, claims 11 and 12; see Final Act. 6.) Von Borstel
teaches it was known in the art that uridine is useful in the treatment of a
variety of neurological disorders, including providing beneficial effects in
cerebrovascular disorders involving "mental efficiency." (von Borstel
5:37--43; Final Act. 6.)
Materazzi teaches that uridine may be used to block the decrease in
neuron activity that occurs as the brain ages or when the neurons are
deprived of the normal level of energy materials. (See Materazzi 8; see also
claim 1 ("Use of uridine for the manufacture of a medication for
counteracting decay in neuron functional activity in brain pathologies."); see
Final Act. 6.)
De Bruin teaches that administering uridine and choline to a specific
strain of rats ( spontaneously hypertensive rats or "SHR"), which have
deficits in spatial learning, normalized their performance on learning tests
evaluate each rejection on its own merits. We note that although Appellants
stated that there were no known pending appeals related to the current
appeal (see App. Br. 1 ), appeals in these applications should have been
identified. (See 37 C.F.R. § 4I.37(c)(l)(ii).) Specifically, Appeal Briefs
were filed in application 10/941,025 on July 5, 2016, and in application
11/224,311 on December 7, 2015, both prior to the filing of the current
Appeal Brief on July 26, 2016. A decision affirming the Examiner's
rejection of the claims in application 11/224,311 was issued on January 23,
2018.
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Application 12/162,759
when compared with control rats. (See id.) DeBruin concludes that "SHR
may provide an interesting model in the screening of substances with
therapeutic potential for [the] treatment of cognitive disorders" and that "[a]
combination of uridine and choline administration improved selective
attention and spatial learning in SHR." (De Bruin abstract.)
Marcus teaches that choline sources are a necessary part of a normal
diet and have been considered as treatment for certain nervous system
disorders. (See Marcus 1543--44; see Final Act. 7.)
Sitaram teaches that choline was known to significantly enhance serial
learning in normal human subjects. (See Sitaram abstract; see Final Act. 7 .)
Sitaram suggests that choline can be used as therapeutic agent in dementia.
(See Sitaram 276; see Final Act. 7.) Sitaram teaches that it was known that
acetylcholine may be involved in learning and memory mechanisms and that
choline, a dietary constituent, had recently been shown to increase whole
brain and hippocampal acetylcholine in rats. (See Sitaram 27 4; see Final
Act. 7.)
The Examiner determines that it would have been obvious to an
ordinarily skilled artisan to combine the teachings of the cited references
because von Borstel teaches beneficial effects of uridine on memory and
learning and Sitaram teaches beneficial effects of choline on memory and
learning. (See Final Act. 7.) De Bruin's teaching of the positive effects of
co-administration of uridine and choline on mental performance further
supports the obviousness of the claimed method of improving hippocampal-
dependent memory by administering uridine and choline to a subject. (See
id. 7.)
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We first take up Appellants' argument that De Bruin is not prior art
because it was published after the priority date of the current application.
(See App. Br. 23.) The first page of De Bruin indicates that it was published
in 2003. We have no reason to believe it was published later. The current
application claims priority to International application PCT/US07 /02405,
which claims priority to U.S. application 11/341,912, filed January 30, 2006.
(See Transmittal Letter to the United States Designated/Elected Office
Concerning a filing under 35 U.S.C. § 371, filed July 30, 2008; see also
Preliminary Amendment filed July 30, 2008.) Because the only evidence we
have is that De Bruin was published before the claimed priority date,
Appellants fail to persuade us that the Examiner erred in citing De Bruin.
Appellants argue that the Examiner erred by introducing limitations
into claim 53 and, thus, relied on an inappropriately broad interpretation.
(See App. Br. 9--12.) Specifically, Appellants argue that the Examiner
introduced the phrase "effective treatment of symptoms or conditions
associated with degradation of mental performance," while ignoring the
requirement to improve memory9 in claim 53. (See id.) According to
Appellants, the Examiner's overly broad interpretation includes an
expansive list of diseases not recited in the claims, such as senile dementia
and Alzheimer's disease. (See id. 10-12.)
We are not persuaded that the Examiner erred in his interpretation of
claim 5 3. Contrary to Appellants' argument, we do not consider the
9 Appellants argue that the Examiner ignores the claim phrase "a method of
improving memory or learning" in claim 53. (See App. Br. 9.) Appellants'
claim 53 does not recite "learning" and includes the phrase "improving
hippocampal-dependent memory" instead. (See App.Br. 31, Claims App'x.)
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Application 12/162,759
Examiner's explanation of the claims to introduce new limitations or to
broaden impermissibly the scope of claim 53. (See App. Br. 10-11, quoting
Final Act. 6.) For example, even though claim 53 does not include the word
"dementia," Appellants do not explain why a "method of improving
hippocampal-dependent memory ... in a subject in need thereof' would not
include treating patients with dementia or treating other symptoms or
conditions associated with degradation of mental performance. Appellants
do not distinguish "hippocampal-dependent memory" from other types of
memory. Although Appellants' claims might include methods that improve
hippocampal-dependent memory when there has been no prior degradation
of memory performance, Appellants do not persuade us that the proper
interpretation of claim 53 does not also include methods of improving
memory when there has been such degradation.
As the Examiner notes, Appellants' dependent claim 54 recites the
method according to claim 53, "wherein the subject has autism-spectrum
disorder, a brain disorder, or suffered from hippocampal-dependent memory
loss which is secondary to meningitis." (See App. Br. 31, Claims App 'x; see
Ans. 8.) "[B]rain disorders" encompasses many conditions associated with
degradation of mental performance. Thus, independent claim 53 is even
broader in scope and is properly interpreted to mean enhancing memory or
learning performance by treatment of the symptoms or conditions associated
with degradation of mental performance. Accordingly, Appellants fail to
persuade us that the Examiner erred in interpreting claim 53. See In re Am.
Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) ("During
examination, 'claims ... are to be given their broadest reasonable
interpretation consistent with the specification .... "' ( citation omitted)).
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Appellants also argue that the Examiner erred by conflating symptoms
of a disease and treating the disease. (See App. Br. 12-16.) According to
Appellants, the Examiner erred by relying on the diseases taught in
von Borstel ( cerebrovascular dementia and senile dementia) to address
symptoms of the diseases recited in claim 5 3 (improving memory), because
the treatment of a symptom is not coterminous with the treatment of a
disease. (See id.) We are not persuaded that the Examiner erred in citing
von Borstel under the facts of this case.
Appellants cite to several Federal Circuit cases in support of their
argument, but neither Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001),
Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003), nor
Eli Lilly and Co. v. Teva Pharms. USA Inc., 619 F.3d 1329 (Fed. Cir. 2013),
is instructive in light of the facts of this case. (See App. Br. 14.) In
Rapoport, the court held that a count directed to a method of treating sleep
apnea was not a method of treating anxiety, a symptom of sleep apnea. (See
Rapoport, 254 F.3d at 1060.) In Jansen, the court held that a method of
treating macrocytic-megaloblastic anemia was not infringed by treatments
for maintaining blood homocysteine level, an aspect of that disease. (See
Jansen, 342 F.3d at 1333.) In Lilly, the court held that claims to using a
compound to treat osteoporosis were not invalidated by prior art teaching
treatment of autoimmune diseases because there was no evidence that one of
ordinary skill in the art would have considered osteoporosis and autoimmune
diseases to be related. (See Lilly, 619 F.3d at 1337-38.) In each of these
cases, the recited disease was not defined by the symptoms or aspects at
lSSUe.
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In contrast, treating dementia necessarily involves improving the
symptom of memory loss. As the Examiner found, memory loss is
commonly and notoriously associated with mental diseases such as senile
dementia and Alzheimer's disease. (See Ans. 9; see also Final Act. 6 (citing
Merck Manual (1999) at 1393, to show that demenias were well known to
include chronic deterioration of intellectual function and other cognitive
skills involved in daily living).) Appellants have not directed to us to
evidence showing otherwise.
Appellants argue that the Examiner erred in relying on von Borstel
because it is directed to "a limited set of indications which are not recited in
the claims." (App. Br. 17.) Appellants argue that von Borstel provides only
general guidance on the claimed methods. (See id.) According to
Appellants, because "improving hippocampal-dependent memory" is not
recited in von Borstel, the reference is not directed to Appellants' claimed
methods. We are not persuaded by this argument because von Borstel
specifically claims methods of treating cerebrovascular dementia and senile
dementia. (See von Borstel 26:49--52.) Because, as explained above, the
Examiner found that one of ordinary skill in the art would have understood
memory loss to be commonly and notoriously associated with dementia, and
Appellants have not persuaded us otherwise, 10 we are not persuaded that the
10 Appellants argue that treating depressed patients with antidepressants is an
example of "overreaching and broad extrapolation" that can lead to
dangerous consequences. (App. Br. 19, citing Bobo et al., "Bipolar disorder
in adults: Treating major depression with antidepressants," UpTo Date,
2013.) We are not persuaded that examples of medical practice are relevant
to patent law determinations. The evidence Appellants present does not
persuade us that claims to treating dementia are not properly relied upon in a
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teachings of von Borstel are more general than the subject matter of
Appellants' claimed methods. (See Ans. 9.)
Appellants also argue that the Examiner erred because von Borstel
does not teach the use of choline and does not teach the use of any additional
ingredient. (See App. Br. 18.) This argument is not persuasive because it
does not address the Examiner's rejection based on the combination of
references cited. The Examiner did not rely on von Borstel as teaching the
use of choline. Rather, the Examiner cited Sitaram for the use of choline to
enhance learning and memory and cited De Bruin to show that both choline
and uridine had been used together. (See Final Act. 7 .) "Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references." In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants also argue that the Examiner erred because von Borstel
teaches away from using uridine, directing the use of novel acyl derivatives
instead. (See App. Br. 18.) Appellants' claimed methods include the use of
uridine or "an acyl derivative thereof." (See App. Br. 31, Claims App'x.)
Furthermore, Appellants do not identify a teaching in von Borstel that
specifically discourages one from using uridine. Accordingly, this argument
fails. See In re Gurley, 27 F3d 551, 553 (Fed. Cir. 1994) ("A reference may
be said to teach away when a person of ordinary skill, upon reading the
reference, would be discouraged from following the path set out in the
case for the obviousness of claims directed to "improving hippocampal-
dependent memory."
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reference, or would be led in a direction divergent from the path that was
taken by the applicant.").
Appellants argue further that von Borstel "alleges that the compounds
are suitable to address a variety of disorders or conditions, but not any one in
particular." (App. Br. 18.) According to Appellants, von Borstel merely
provides "a general invitation to experiment in 'brain function' ... as
'mental efficiency."' (App. Br. 18.) We are not persuaded by this argument
because, as explained above, von Borstel provides a specific teaching in its
claims to treat dementia by administering an acyl derivative of uridine. (See
von Borstel 26:49--52.) We are not persuaded that, considering von Borstel,
or more importantly considering the combination of references cited by the
Examiner, one of ordinary skill in the art would have been provided with
only general guidance. The teachings cited by the Examiner are more than
the general guidance discussed in In re Kubin, 561 F.3d 1351 (Fed. Cir.
2009). (See App. Br. 17 .)
Appellants argue that the Examiner's reliance on De Bruin was in
error because "De Bruin misunderstood their results." (See App. Br. 23-25.)
In support, Appellants refer to alleged discussions with inventor Wurtman.
(See id.) According to Appellants, De Bruin "never improved cognition
because his model study could not distinguish whether uridine treated
ADHD or improved cognition," which is an allegedly "fundamental flaw in
his study" that lead to a misunderstanding of the results. (App. Br. 25.) We
are not persuaded by this argument because in the absence of an oath or
sworn declaration under 37 C.F.R. § 1.68 from inventor Wurtman, the report
of this discussion is hearsay. Appellants cite to several references regarding
aspects of their argument, but the conclusion of the specific results and
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conclusions presented in De Bruin are attributed only to discussions with
inventor Wurtman. "Argument of counsel cannot take the place of evidence
lacking in the record." Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA
1977).
Appellants argue that because De Bruin reports results in SHR, but
not SD or WKY rats, the Examiner's interpretation of De Bruin is flawed.
(See App. Br. 25-28.) We are not persuaded by this argument because even
if the results in one type of rat are not "transferable" to all rats (see App. Br.
28), the Examiner relied on De Bruin for what it suggests along with the
other cited references. De Bruin was not cited as an anticipation of the
claimed methods. De Bruin suggests that SHR is a model for screening
therapeutics for cognitive disorders and that administering both uridine and
choline improved selective attention and spatial learning in those rats. (See
De Bruin abstract.) Whether or not De Bruin would have actually proved to
ordinarily skilled artisans the effectiveness of uridine and choline treatment
in "subject[ s] in need thereof," it still suggests that these components could
be used to improve memory.
Appellants argue that there would not have been a reasonable
expectation of success because "the rejection is based on the premise that a
skilled artisan would vary many parameters while pursuing a promising field
of experimentation." (App. Br. 28-29.) We disagree with Appellants'
characterization of the Examiner's rejection. The rejection is based on the
teachings in von Borstel and Materazzi of the beneficial effects of uridine on
diseases of memory (dementias) and brain function in aging, a teaching in
Sitaram regarding the role of choline in memory and learning, and the
teachings in De Bruin to administer both uridine and choline to improve
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spatial learning. (See Ans. 7.) The "many parameters" to which Appellants
refer are not clear. Although von Borstel refers to several topics, such as
heart, muscles, etc., the claims to treating dementias clearly highlight the
subject matter of Appellants' claimed methods. Appellants argue that the
teachings of Materazzi, Marcus, and Sitaram do not indicate anything about
improving hippocampal-dependent memory, but because von Borstel does,
Appellants' argument does not address the Examiners' rejection in its
entirely. (See App. Br. 29.)
Appellants have not persuaded us that the Examiner erred in rejecting
the pending claims under 35 U.S.C. § 103(a), which bars patentability unless
"the improvement is more than the predictable use of prior art elements
according to their established functions." KSR Int'! Co. v. Teleflex Inc., 550
U.S. 398, 417 (2007). Accordingly, we affirm the Examiner's rejections
under 35 U.S.C. § 103(a).
Conclusion
Upon consideration of the record and for the reasons given,
the rejection of claims 53---63 under 35 U.S.C. § 112, second
paragraph, is not sustained;
the rejection of claims 53---63 under the doctrine of obviousness-type
double-patenting is moot; and
the rejection of claims 53---63 under 35 U.S.C. § 103(a) is sustained.
Therefore, we affirm the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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