Ex Parte Wurtman et al

Patent Trial and Appeal Board

Feb 12, 2018

11920915 (P.T.A.B. Feb. 12, 2018)

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.
11/920,915 08/13/2009 Richard J. Wurtman P-7906-US1 1231
49443 7590 02/14/2018
Pearl Cohen Zedek Latzer Baratz LLP
1500 Broadway
12th Floor
New York, NY 10036
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
02/14/2018 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):
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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 INGRID RICHARDSON1
Appeal 2016-003785
Application 11/920,915
Technology Center 1600
Before ERIC B. GRIMES, DEBORAH KATZ, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to methods
of improving cognitive function or improving intelligence in a subject,
which have been rejected for obviousness and obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Claims 74—77, 80, 81, 85—93, 95, and 96 are on appeal. Claim 74 is
illustrative and read as follows:
1 Appellants identify the Real Parties in Interest as the Massachusetts
Institute of Technology and Backbay Scientific. (Br. 1.)
Appeal 2016-003785
Application 11/920,915
74. A method of improving a cognitive function in a subject
in need thereof comprising administering to said subject a
composition comprising:
(a) an omega-3 fatty acid, an omega-6 fatty acid, or a
combination thereof, (b) uridine, an acyl derivative thereof, a
uridine phosphate or a CDP-choline, and (c) a choline salt,
wherein the composition has about 200 mg to 800 mg of
uridine, an acyl derivative thereof, a uridine phosphate or a CDP-
choline and about 200 mg to 800 mg of the choline salt and the
composition is administered in a therapeutically effective
amount to improve cognitive function in the subject and the
subject has no cognitive impairment or memory disorder.
The claims stand rejected as follows:
Claims 74, 75, 81, 85, 87, 88, 91-93, 95, and 96 under 35 U.S.C.
§ 103(a) as obvious based on Wurtman2 (Ans. 2);
Claims 76, 77, 80, 86, 89, and 90 under 35 U.S.C. § 103(a) as obvious
based on Wurtman and Masor3 (Ans. 3);
Claims 74—77, 80, 81, 85—93, 95, and 96, provisionally, for
obviousness-type double patenting based on claims 1—3, 5, 6, 9-24, 37—39,
41—47, 49—51, 53, 54, 87, and 91 of application 10/941,025 (Ans. 5);
Claims 74—77, 80, 81, 85—93, 95, and 96, provisionally, for
obviousness-type double patenting based on claim 1 of application
11/510,737 and Masor (Ans. 6); and
Claims 74—77, 80, 81, 85—93, 95, and 96 for obviousness-type double
patenting based on claims 1—14 of U.S. 8,551,452 B2 (Ans. 7).
2 Wurtman et al., US 2003/0114415 Al; publ. June 19, 2005.
3 Masor et al., US 5,492,899; iss. Feb. 20, 1996.
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Application 11/920,915
I
The Examiner has rejected claims 74, 75, 81, 85, 87, 88, 91—93, 95,
and 96 as obvious based on Wurtman. The Examiner finds that Wurtman
teaches “a treatment regimen to prevent or reduce memory impairment and
improve cognitive function” by administering effective amounts of choline,
cytidine, and uridine, or a pharmaceutically acceptable salt of those
compounds. (Ans. 2.) The Examiner finds that Wurtman also teaches
linoleic acid or linolenic acid as part of its treatment regimen. (Id.)
We agree with the Examiner that the method of claim 74 would have
been obvious based on Wurtman, which discloses “compositions and
methods for preventing and treating memory impairment, particularly
memory impairment caused by any of a number of disorders, such as stroke,
brain injury, mild cognitive impairment (MCI), Alzheimer’s Disease (AD),
cerebrovascular disease, and other disorders which cause cognitive
disturbances.” (Wurtman 127, emphasis added.)
“The compositions according to this invention include citicoline, or its
metabolism products, choline, cytidine, and/or uridine, and optionally one or
more fatty acids such as linoleic acid and linolenic acid, and their active
metabolites, e.g., arachidonic acid and docosohexenoic acid.” (Id.)
“Citicoline monosodium is an exogenous form of cytidine-5'-
diphosphocholine (CDP-choline).” (Id. 124.) Linoleic acid is an omega-6
fatty acid; a-linolenic acid is an omega-3 fatty acid that is metabolized to
docosahexaenoic acid. (See Spec. Tflf 62, 70.) Wurtman states that “where
any combination of choline, cytidine, and uridine is used, it is also preferably
administered orally as a pharmaceutically-acceptable salt.” (Id. 1 53.)
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Application 11/920,915
Wurtman discloses that
[a] variety of dosage ranges are suitable. The citicoline
dosage under the invention may be from about 10 mg to about
1000 mg from one to about 4 times per day. . . . When choline
and cytidine and/or uridine are used, the dose is preferably
sufficient to provide these compounds in amounts that are
commensurate with the amounts of choline, cytidine and/or
uridine released when citicoline is metabolized.
(Id. 1 57.)
Wurtman states that “[treatment under the invention is preferably
begun prior to the onset of cognitive impairment symptoms, such as memory
loss, e.g., in people who have had a stroke or brain injury, or shortly after
such symptoms are first exhibited.” {Id. | 54.) Similarly, Wurtman states
that “citicoline, or the choline, cytidine, uridine combinations, may be
administered as a preventative measure to patients at risk for developing
disorders that cause cognitive impairment. It is beneficial to co-administer
these compositions with essential fatty acids . . . such as linoleic acid or
linolenic acid.” {Id. 156.)
Based on these disclosures, it would have been obvious to administer
a composition comprising an omega-3 or omega-6 fatty acid (such as
linoleic acid or a-linolenic acid), uridine, and a choline salt in order to
improve cognitive function. Wurtman expressly suggests administering its
composition to a subject before any symptoms of cognitive impairment, such
as memory loss, have been exhibited, and therefore makes obvious
practicing its method on a subject with no cognitive impairment or memory
disorder.
In addition, Wurtman identifies the dosage of citicoline, or a
combination of choline and uridine, as a result-effective variable, and thus
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Application 11/920,915
would have made obvious optimizing the amount of choline and uracil in its
composition. “[T]he discovery of an optimum value of a variable in a
known process is normally obvious,” unless the results of optimizing a
variable were unexpectedly good or the parameter optimized was not
recognized in the prior art as one that would affect the results. In re Antonie,
559 F.2d 618, 620 (CCPA 1977).
Appellants argue that Wurtman “continuously focuses the drug
administration to the treatment of those who have suffered an injury.” (Br.
11.) Appellants argue that “[e]ven preventive administration of the
composition is premised on the expectation of the onset of cognitive
impairment caused by stroke, brain injury, or ‘shortly after’ such
symptoms.” (Id.) Appellants argue that “[t]he patient population of the
reference is completely opposite that of the claims, injured versus healthy
subjects.” (Id. at 12.) Based on the same reasoning, Appellants argue that
Wurtman teaches away from the claimed method. (Id. at 13—15.) Similarly,
Appellants argue that one of skill in the art would not “abandon the explicit
teachings of the ‘415 publication (to administer a composition to a subject
that is cognitively impaired) and, contrary to this, administer the
composition to a healthy subject.” (Id. at 16.)
These arguments are unpersuasive, because claim 74 limits the treated
subjects to those “ha[ving] no cognitive impairment or memory disorder.”
(Claim 74.) The claim language says nothing about injured versus healthy
patients; it only distinguishes between those who already have a cognitive
impairment or memory disorder, and those who do not. As discussed above,
Wurtman states that “[treatment under the invention is preferably begun
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Application 11/920,915
prior to the onset of cognitive impairment symptoms, such as memory loss,
e.g., in people who have had a stroke or brain injury, or shortly after such
symptoms are first exhibited.” (Wurtman | 54, emphasis added.) Thus,
although the patients discussed in Wurtman might be at risk of developing a
cognitive impairment, such as memory loss, Wurtman expressly suggests
treating patients who do not have a cognitive impairment or memory
disorder.
We affirm the rejection of claim 74 under 35 U.S.C. § 103(a) based on
Wurtman. Claims 75, 81, 85, 87, 88, 91—93, 95, and 96 have not been
argued separately and therefore fall with claim 74. 37 C.F.R.
§ 41.37(c)(l)(iv).
II
The Examiner has rejected claims 76, 77, 80, 86, 89, and 90 as
obvious based on Wurtman and Masor. The Examiner finds that “Wurtman
et al. fails to teach the uridine monophosphate and choline chloride, and
further administration to an infant,” but “Masor et al. teaches a nutritional
infant formula comprising uridine monophosphate and choline chloride.”
(Ans. 4.) The Examiner concludes that it would have been obvious to
include uridine monophosphate (UMP) and choline chloride in Wurtman’s
composition, because “both formulations are supplements.” (Id.)
Appellants argue, among other things, that Masor does not mention
improving cognitive function and, therefore, combining its teachings with
Wurtman is merely speculation. (Br. 19.)
We agree with Appellants that the Examiner has not provided an
adequate reason for including the UMP and choline chloride of Masor’s
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Application 11/920,915
infant formula in Wurtman’s composition. Masor discloses “infant formulas
which contain ribo-nucleotide equivalents.” (Masor 1:7—8.) Ribo­
nucleotide equivalents include UMP. {Id. at 4:26—35.) Masor discloses an
exemplary formula containing choline chloride and UMP. {Id. at 10:62, 65.)
However, Masor does not disclose that its formula has any effect on
improving cognition. It discloses, rather, that its formula “enhanc[es] the
immune system of a human,” can be “use[d] to treat or prevent diarrheal
disease,” and provides “a novel antioxidant system.” {Id. at 5:43^44, 5:58,
6:34.) As discussed above, Wurtman discloses that its composition is used
to prevent or treat memory impairment or cognitive impairment such as
memory loss. The Examiner has not identified a reason, based on the cited
references or the knowledge of those skilled in the art, why a person of
ordinary skill in the art would have included components of Masor’s infant
formula in a composition intended to have a different effect in treated
subjects, such as Wurtman’s composition.
We therefore reverse the rejection of claims 76, 77, 80, 86, 89, and 90
under 35 U.S.C. § 103(a) based on Wurtman and Masor.
Ill
The Examiner has provisionally rejected claims 74—77, 80, 81, 85—93,
95, and 96 on the basis that they are not patentably distinct from claims 1—3,
5, 6, 9-24, 37—39, 41—47, 49-51, 53, 54, 87, and 91 of application
10/941,025. (Ans. 5.) At oral argument, Appellants’ counsel pointed out all
of the cited claims of the ’025 application have been cancelled. Thus, the
provisional rejection does not identify any claims in the ’025 application that
define an invention that is not patentably distinct from the claims of the
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instant application. We therefore reverse the provisional rejection based on
the ’025 application.
IV
The Examiner has provisionally rejected claims 74—77, 80, 81, 85—93,
95, and 96 for obviousness-type double patenting based on claim 1 of
application 11/510,737 and Masor.4 The Examiner finds that claim 1 of the
’737 application is directed to improving memory or cognition by
administering CDP-choline and a polyunsaturated fatty acid, whereas the
claims of the instant application are directed to improving cognitive function
by administering a uridine compound and a fatty acid. (Ans. 6—7.) The
Examiner finds that the method claimed in the ’737 application does not
include choline salts, but concludes that including them would have been
obvious based on Masor. (Id.)
Appellants argue that claim 1 of the ’737 application “is directed to a
different composition and is directed to a patient population explicitly
excluded in the present claims.” (Br. 7.) That is, “[t]he ‘737 claim[]
explicitly recites a diseased subject. ... In direct contrast, the present claim
recites: ‘wherein the subject has no cognitive impairment or memory
disorder. ’ Therefore,. . . the first claim does not overlap with the second
claim.” (Id. at 8.)
We will reverse this provisional rejection. As discussed above, the
Examiner has not persuasively shown that it would have been obvious to a
4 The Examiner also cites a variety of claims between claim 4 and claim 39
of the ’737 application, but as Appellants point out (Br. 6), all of the cited
claims except claim 1 have been cancelled.
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Application 11/920,915
person of ordinary skill in the art based on Masor’s disclosure of infant
formula, to include a choline salt in a composition intended to improve
memory or cognition.
In addition, we agree with Appellants that the Examiner has not
shown that claim 1 of the ’737 application and the instantly pending claims
are directed to methods that are not patentably distinct. Claim 1 of the ’737
application recites improving memory, learning, or cognition in a subject,
“wherein the subject has Alzheimer’s disease, age-related cognitive disorder,
age-associated memory impairment (AAMI), memory decline, Pick’s
disease, Lewy Body disease or dementia.” Claim 74 on appeal, by contrast,
recites improving a cognitive function in a “subject [who] has no cognitive
impairment or memory disorder.”
The Examiner reasons that “a specific symptom, i.e. [,] improving
memory, learning, or cognition, in a subject with a condition renders
obvious treating that specific symptom without the condition,” and gives the
example of aspirin being used to treat a headache regardless of whether the
headache is due to a migraine or to sensitivity to noise. (Ans. 9.)
Regardless of whether it would be obvious to use an analgesic to treat
pain arising from different causes, however, we do not agree that the
Examiner’s rationale justifies a rejection for obviousness-type double
patenting based on the facts here.
There are two justifications for obviousness-type double
patenting. The first is “to prevent unjustified timewise extension
of the right to exclude granted by a patent no matter how the
extension is brought about.” The second rationale is to prevent
multiple infringement suits by different assignees asserting
essentially the same patented invention.
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Application 11/920,915
In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013) (citations
omitted).
As discussed above, the claims of the instant application exclude
subjects having a memory disorder, while claim 1 of the ’737 application
requires the treated subject to have “Alzheimer’s disease, age-related
cognitive disorder, age-associated memory impairment (AAMI), memory
decline, Pick’s disease, Lewy Body disease or dementia.” The Examiner has
not shown that the subjects treated in each of the two claimed methods overlap,
and therefore has not shown that either application would provide a time-wise
extension of a specific right to exclude, or that someone practicing a specific
method would be at risk of multiple infringement suits based on the separate
patents. The Examiner therefore has not shown that a provisional rejection of
the instant claims based on claim 1 of the ’737 application is merited.
V
The Examiner has rejected claims 74—77, 80, 81, 85—93, 95, and 96
for obviousness-type double patenting based on claims 1—14 of U.S.
8,551,452 B2. The Examiner concludes that the two sets of claims are not
patentably distinct because it would have been obvious, based on the claims
of the ’452 patent, “to use the omega-3 fatty acid, uridine and choline in
treating cognitive function.” (Ans. 7—8.)
Appellants argue that
[t]he ‘452 patent is directed to a method of evaluating a
subject’s compliance with taking a uridine dietary supplemental
regimen and the present claim is directed to a method of
improving cognitive function by administering uridine. Should
both claims be allowed, there is no improper patent term
extension given the lack of subject matter overlap.
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(Br. 9.)
We agree with Appellants. Claim 1 of the ’452 patent is directed to a
“method of evaluating a subject’s compliance with a uridine dietary
supplementation regimen” that comprises administering a uridine dietary
supplement, then “determining [the] subject’s brain cytidine-containing
compound level” using a specific in vivo magnetic resonance spectroscopy
method, and using the cytidine-containing compound level to evaluate the
subject’s compliance with the dietary supplementation regimen. (’452
patent, claim 1.)
Claim 74 of the instant application merely requires administering a
composition comprising (for example) an omega-3 fatty acid, uridine, and a
choline salt. While dependent claims of the ’452 patent state that the uridine
dietary supplementation regimen can include a uridine source, an omega-3
fatty acid, or a choline salt, the method claimed in the ’452 patent still
requires the steps of determining the subject’s brain cytidine-containing
compound level using a specific in vivo magnetic resonance spectroscopy
method, and using the cytidine-containing compound level to evaluate the
subject’s compliance with the dietary supplementation regimen, neither of
which are required by the claims of the instant application.
Thus, the Examiner has not established that the instant claims would
provide a time-wise extension of the ’452 patent’s right to exclude, or that
someone practicing the instantly claimed method would be at risk of
multiple infringement suits based on the ’452 patent and a patent to the
instant claims. The Examiner therefore has not shown that a provisional
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rejection of the instant claims based on the claims of the ’452 patent is
merited.
SUMMARY
We affirm the rejection of claims 74, 75, 81, 85, 87, 88, 91—93, 95,
and 96 under 35 U.S.C. § 103(a) based on Wurtman.
We reverse the rejection of claims 76, 77, 80, 86, 89, and 90 under 35
U.S.C. § 103(a) based on Wurtman and Masor.
We reverse both of the provisional rejections for obviousness-type
double patenting.
We reverse the rejection of claims 74—77, 80, 81, 85—93, 95, and 96
for obviousness-type double patenting based on the claims of U.S. 8,551,452
B2.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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