Ex Parte Wurtman et al

Patent Trial and Appeal Board

Jan 19, 2018

11224311 (P.T.A.B. Jan. 19, 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.
11/224,311 09/13/2005 Dick Wurtman P-7105-US4 8775
49443 7590 01/23/2018
Pearl Cohen Zedek Latzer Baratz LLP
1500 Broadway
12th Floor
New York, NY 10036
EXAMINER
CRANE, LAWRENCE E
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
01/23/2018 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):
US PTO @ 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 CAROL WATKINS1
Appeal 2017-000388
Application 11/224,311
Technology Center 1600
Before JOHN G. NEW, RYAN H. FLAX, and DAVID COTTA,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Massachusetts Institute of
Technology. App. Br. 1.
Appeal 2017-000388
Application 11/224,311
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1—3, 23, 28—32, and 34 as unpatentable
under 35 U.S.C. § 103(a) as being obvious over the combination of von
Borstel et al. (US 6,316,426 Bl, November 13, 2001) (“von Borstel”),
Materazzi et al. (EP 178267 Al, October 2, 1985) (“Materazzi”), N.M.W.J.
De Bruin et al., Combined Uridine and Choline Administration Improves
Cognitive Deficits in Spontaneously Hypertensive Rats, 80 Neurobiology
of Learning and Memory, 63-79 (2003) (“De Bruin”), R. Marcus et al.,
The Vitamin B Complex and Ascorbic Acid, in N. Ellison (ed.) Goodman &
Gilman’s The Pharmacological Basis Of Therapeutics (Tenth Ed.)
1766—70 (2001) (“Marcus”); R.S. Porter etal., Approach to the Neurologic
Patient: Delirium and Dementia in The Merck Manual of Diagnosis and
Therapy, 19th Ed., 1586—88 and 1669-80 (2011) (“Porter”) andN. Sitaram
et al., Human Serial Learning: Enhancement with Arecholine and Choline
and Impairment with Scopolamine, 201 Science, 274—76 (1978)
(“Sitaram”).
Claims 1—3 and 28—32 and 342 stand provisionally rejected as
unpatentable under the judicially-created doctrine of obviousness—type
2 Appellant states the Examiner has rejected claims 1—3 and 28—34 on this
ground. See App. Br. 3. However, claim 33 is canceled and we do not
consider it. See App. Br. 26.
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double patenting over claims 92—98 of U.S. App. Ser. No. 10/941,025 (the
“’025 application”).3,4
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to methods of improving cognitive
and neurological functions and increasing synthesis and release of
neurotransmitters and membrane synthesis by neural cells and brain cells, by
administering a composition comprising a uridine and a choline. Abstract.
3 The Examiner also rejected claims 1—3, 23, 28—32, and 34 as unpatentable
under the judicially-created doctrine of obviousness—type double patenting
over claims 53—63 of U.S. App. Ser. No. 12/162,759 (the “’759
application”). Appellants have agreed, if their claims are sustained, to file
a terminal disclaimer, and we therefore do not reach this ground of
rejection. See App. Br. 4—5.
4 The Examiner has also rejected claims 1—3, 23, and 28—32 and 34 as
unpatentable under 37 C.F.R. § 1.78(b) as being in conflict with claims
56—63 of the ’759 application and claims 5, 6, 10—12, and 41 of the ’025
patent. See Final Act. 3. The Examiner states that 37 CFR § 1.78(b)
“provides that where two or more applications filed by the same applicant
contain conflicting claims, elimination of such claims from all but one
application may be required in the absence of good and sufficient reason
for their retention during pendency in more than one application.” Final
Act. 5 (also citing MPEP § 822) (Examiner’s emphasis). We do not
recognize this as a proper ground for appeal. However, because we affirm
the Examiner’s rejection on the latter grounds over claim 95 of the ’025
application, the issue is moot.
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REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of improving memory or learning in a subject in
need thereof, comprising administering to the subject a
composition comprising: (i) about 0.1 to 0.8 g per day of uridine,
a uridine phosphate, or a pharmaceutically acceptable salt of the
uridine or uridine phosphate; and (ii) about 0.1 to 0.8 g per day
of choline, wherein the choline is a choline ester, a choline
phosphate, or a choline salt, and wherein the composition is
administered in a therapeutically effective amount to improve the
memory or learning in the subject.
App. Br. 25.
ISSUES AND ANALYSES
We agree with the Examiner that the appealed claims are obvious over
the cited prior art, and unpatentable under the doctrine of obviousness-type
double patenting. We address the arguments raised by Appellants below.
A. Rejection of claims 1—3, 23, 28—32, and 34 under 35 U.S.C. $ 103(a)
Issue 1
Appellants argue that the Examiner erred by introducing claim
limitations into claim 1 that change the scope of the claim contrary to
applicant’s recitations. App. Br. 7—8.
Analysis
The Examiner finds that von Borstel teaches the administration of
uridine in the treatment of central nervous system disorders, including the
treatment of at least two types of dementia. Final Act. 5—6 (citing von
Borstel col. 6,11. 23—31, cols. 25—26, claims 11, 12). The Examiner further
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finds that Materazzi also teaches the administration of uridine to treat mental
decline in mammals. Id. at 6 (citing Materazzi 8). The Examiner finds
Sitaram teaches that the administration of an effective amount of a choline
source can result in “significantly enhanced serial learning in normal human
subjects.” Id. at 7 (quoting Sitaram 274, 276).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to combine the references because von Borstel,
Materazzi, and Sitaram all teach that choline or uridine can improve learning
and memory in mammals. Final Act. 7.
Claim 1 recites, in relevant part: “A method of improving memory or
learning in a subject in need thereof.” The Examiner finds that:
The instant claims are directed to a method of enhancing memory
or learning performance by the effective treatment of symptoms
or conditions associated with degradation of mental performance
in a subject in need thereof by the co-administration of ulidine,
or a uridine phosphate prodrug (e.g. UMP, etc.) and a choline
source (e.g. a choline salt, etc.). This method includes the
treatment of symptoms associated with dementias including
senile dementia and Alzheimer’s disease, a genus of
cerebrovascular diseases characterized by the occurrence of
memory deficits and learning difficulties as symptoms, the very
symptoms targeted by the instant claimed method of treatment.
The instant claims may also be read to be directed to a palliative
method of treatment wherein the noted symptoms of the noted
diseases are treated.
App. Br. 8—9 (quoting Final Act. 5) (Appellants’ emphasis). Appellants
argue that the phrase employed by the Examiner: “symptoms or conditions
associated with degradation of mental performance in a subject,” is not
found in the claims on appeal. Id. at 9. According to Appellants, the
introduction of this “limitation” is solely of the Examiner’s doing, but,
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Appellants assert, this interpretation is not supported by the record and is
legal error, specifically, the impermissible importation of limitations into the
claim from Appellants’ Specification. Id.
We are not persuaded. Claim 1 recites: “A method of improving
memory or learning in a subject in need thereof ” (Emphasis added). As an
initial matter, we note that the language of a preamble is generally not
accorded patentable weight. See Catalina Marketing Int 7, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (A preamble is
not limiting “where a patentee defines a structurally complete invention in
the claim body and uses the preamble only to state a purpose or intended use
for the invention”) (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir.
1997)). In the appeal before us, the body of the claim defines a complete
invention, viz., administering uridine and choline at the defined
concentrations in “in a therapeutically effective amount to improve the
memory or learning in the subject.” In other words, even if the language of
the preamble were stricken from the claim, a complete invention is
nevertheless still defined.
Appellants are correct in arguing that, generally,5 limitations may not
be imported from the Specification into the language of the claims;
however, even if we accord patentable weight to the language of the
preamble, the claims they are given their broadest reasonable interpretation,
in light of the Specification.
5 Absent of course, an explicit definition of the claim term in question in the
Specification. See In re Am. Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1364
(Fed. Cir. 2004). No such definition is set forth in Appellants’
Specification.
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To interpret the claim term “in a subject in need thereof’ we look to
Appellants’ Specification for instruction on any special meaning that may be
given the term. Appellants’ Specification provides, by way of example, a
condition that requires “[tjreating or ameliorating a decline in a cognitive
function.” Spec. 195. Such a decline in cognitive function can include “a
memory disorder,” comprising a “memory decline” associated with “brain
aging,” “Pick’s disease,” “Lewy Body disease,” and dementia associated
with, e.g., Huntington’s disease or AIDS dementia. Spec. 196. The
Specification also states, by way of further example, that “a person in need
thereof’ could include individuals with “cognitive dysfunction compris[ing]
age-related memory impairment” or an “emotional disorder compris[ing] a
seasonal effective disorder ... [or] a bipolar disorder,” or “endogenous
depression.” Spec. ^fl[ 98—100.
In short, in construing the claim term “in a subject in need thereof,”
the Examiner has interpreted the very broad language of the claim to include
those individuals with “symptoms or conditions associated with degradation
of mental performance in a subject,” including dementias. See Final Act. 5.
We therefore do not agree with Appellants’ contention that the Examiner is
impermissibly importing limitations into the claim from the Specification.
To the contrary, we find that the claim term “in a subject in need thereof,”
when viewed in light of the Appellants’ Specification, broadly includes
those individuals with symptoms or conditions disclosed by the
Specification itself.
Issue 2
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Appellants argue that the Examiner erred in conflating the treatment
of symptoms and diseases and contend the two have been ascribed separate
legal definitions. App. Br. 11.
Analysis
Appellants point to the Examiner’s finding that Appellants’ claimed
method of improving memory or learning is the same as “the effective
treatment of symptoms or conditions associated with degradation of mental
performance” and that “the instant claims may also be read to be directed to
a palliative method of treatment wherein the noted symptoms of the noted
diseases are treated.” App. Br. 11 (quoting Final Act. 5). According to
Appellants, their claimed method is directed to improving learning and
memory. Id. However, Appellants assert, the Examiner erroneously
expands the scope of the claims to include methods of treating a variety of
diseases or symptoms thereof. Id.
By way of illustration, Appellants point to the Examiner’s finding that
von Borstel is “directed to the treatment of ‘a central nervous system
disorder, ’ a term further defined by von Borstel as at least two dementias
(‘cerebrovascular dementia’ and ‘senile dementia’ in claims 11 and 12,
respectively).” App. Br. 11 (quoting Final Act 6). However, Appellants
contend, despite the Examiner’s findings, the treatment of symptom does not
necessarily treat the underlying disease. Id. at 12.
In support of their argument, Appellants cite our reviewing court’s
holdings in Rapoportv. Dement, 254 F.3d 1053 (Fed. Cir. 2001) and Jansen
v Rexall, 342 F.3d 1329 (Fed. Cir. 2003). App. Br. 12. Appellants contend
that, in Rapoport, the Federal Circuit held that the Appellant’s claimed
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method, which was directed to a method of treating sleep apnea, were in fact
directed only to “treatment of sleep apneas, and does not also include by its
plain terms treatment of the symptoms associated with sleep apneas.” Id.
(quoting Rapaport, 254 F.3d at 1059, internal quotations omitted).
Appellants also assert that Jansen reinforced the court’s holding in
Rapaport, stating that the court: “interpreted Rapoport] to refer to sleep
apnea per se, not just ‘symptoms associated with sleep apnea.’” Id. (quoting
Jansen, 342 F.3d at 1333). Appellants contend that these, and other cases,
support their contention that “the treatment of a symptom is not coterminous
with the treatment of a disease.” Id. at 13.
We are not persuaded by Appellants’ arguments. As we have
explained, we interpret Appellants’ claims in view of their Specification.
Claim 1 is directed broadly to “A method of improving memory or learning
in a subject in need thereof.” The claim language is thus much broader than
that of the claim in Rapaport, which was directed to: “A method for
treatment of sleep apneas.” 254 F.3d at 1055. In holding that the claimed
method did not also treat anxiety, which may be secondarily associated with
sleep apnea, our reviewing court found that the claim term referred
unambiguously to the “treatment of sleep apneas,” narrowly defined, and did
not also include by its plain terms “treatment of symptoms associated with
sleep apneas.” Id. at 1059. Furthermore, the Specification of the senior
party to the Rapoport interference expressly disclosed that: “the written
description of the ... application actually confirms the Board’s
interpretation, and explicitly defines ‘sleep apneas’” as meaning: “In the
context of this invention, sleep apneas comprise all the sub-categories such
as those caused by upper airway obstruction; those whose origins arise in the
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central nervous system; and those of a mixed type with contribution from
both components.” Id. The court therefore held that the claim term
“treatment of sleep apneas” was limited to treatment of the underlying sleep
apnea disorder, i.e., reducing the frequency and severity of the apnea
episodes during sleep and not to the secondarily associated anxiety. Id. at
1060.
In contrast, Appellants’ claim term does not recite a method of
treating such a specific condition, but is directed to a method “of improving
memory or learning in a subject in need thereof.” The language of the claim
is not limited to a single condition and does not distinguish between
treatment of the symptoms or of the direct underlying cause of those
symptoms. Furthermore, Appellants do not attempt to argue that the
symptoms to be treated (i.e., symptoms exhibited by those in need of
memory and learning improvement) is in any way secondary to the
underlying cause. Indeed, Appellants’ Specification embraces both
symptoms and their underlying causes as being directly related to the need
for memory and learning improvement.
For example, the Specification discloses that their method is directed
to improving “cognitive function in a subject.” Spec. 138. Such cognitive
functions include “memory,” “learning,” “intelligence,” and “mental
fitness.” Spec. Tflf 39-43. All of these are generally measured externally by
testing and are therefore necessarily symptomatic in nature.
On the other hand, Appellants’ methods are also directed to
ameliorating or decreasing the underlying causes of such symptoms: i.e., “a
memory disorder,” comprising “a memory decline” associated with “brain
aging,” “Pick’s disease,” “Lewy Body disease,” and dementia associated
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with, e.g., Huntington’s disease or AIDS dementia. Spec. 196.
Furthermore, the Specification discloses how the method may improve the
underlying decrease in neural function; i.e., by increasing production of
phospholipids produced by neurons, improving synaptic transmission,
improving neurite outgrowth, stimulating dendritic branching, increasing the
amount of neuronal membrane, etc. Spec. Tflf 52—59.
In short, the scope of Appellants’ claimed method embraces a wide
range of both symptoms and their underlying causes. This is distinguishable
from Rapaport, in which the claim was directed much more narrowly to a
specific condition, sleep apnea, and its direct underlying causes; i.e., apneas
caused by “caused by upper airway obstructions, sleep apneas whose origins
arise in the central nervous system, and sleep apneas of a mixed type,” i.e.,
“the underlying respiratory disorder” and not those symptoms secondarily
associated with the condition, such as anxiety, which can also have other,
non-apnea-related causes. Rapaport, 254 F.3d at 1059-60.
We consequently are not persuaded by Appellants’ argument that the
Examiner’s interpretation of the claims somehow exceeds the scope of the
claim by conflating symptom and underlying cause.
Issue 3
Appellants next argue that the Examiner erred by determining the
claimed invention was “obvious-to-try,” contrary to the Federal Circuit’s
holding in In reKubin, 561 F.3d 1351 (Fed. Cir. 2009). App. Br. 14.
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Analysis
Appellants argue that the Examiner’s rejection is based upon an
“obvious to try” analysis that is impermissible under the Federal Circuit’s
jurisprudence. App. Br. 14. Appellants argue that the Examiner gathers
individual elements taught by the prior art and assembles them by proposing
general research and varying numerous parameters or possible choices until
one combination arrived at a successful result. Id. Appellants acknowledge
that von Borstel suggests a general approach to a promising field, however,
Appellants contend, it fails to offer the specific guidance or detailed
enabling methodology for practicing the claimed invention. Id.
Appellants point first to the Examiner’s finding that von Borstel is
“directed to the treatment of ‘a central nervous system disorder,’ a term
further defined as at least two dementias.” App. Br. 14 (quoting Final Act.
6). Appellants note that the Examiner finds that two of the dependent claims
of von Borstel patent are directed to specific dementias (i.e., cerebrovascular
dementia (claim 11) and senile dementia (claim 12)) and finds that these two
dementias are encompassed in “central nervous system disorders.” Id.
Appellants allege the Examiner, therefore concluded that a method for
treating dementia is coterminous or overlapping with a method of improving
memory or learning because of “the beneficial effects of the administration
of an effective dosage of uridine or a uridine prodrug on various organ
functions including “brain function.” Id. at 15. Appellants argue that this
allegedly overreaching analysis is too speculative and therefore constitutes a
fundamental flaw in the rejection. Id. Specifically, Appellants assert that
the suggestion that treating a nervous system disorder or brain function is
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enough to suggest the recited subject matter is simply unsupported by the
technology. Id.
Appellants contend further that the Examiner selectively chose one
category of seven different systemic types of conditions taught by von
Borstel. App. Br. 15—16. Appellants acknowledge that the Examiner’s
findings further focus on a subcategory, “nervous system disorders].” Id. at
16. Appellants assert that focusing on a single subtopic, “nervous system
disorder,” from the larger list of conditions taught by von Borstel is still too
general because it represents a field with numerous subtopics of wide scope.
Id. Appellants point to Kubin as holding that such a generalization cannot
form the basis of a prima facie case of obviousness. Id.
Furthermore, Appellants contend that, because “memory” and
“learning,” as recited in the claims, are absent in von Borstel, the Examiner
impermissibly finds that a skilled artisan would have known to work back
from claims 11 and 12 directed to cerebrovascular dementia and senile
dementia. App. Br. 16. Appellants also contend that the teachings of Merck
are too generalized too cure these alleged deficiencies of von Borstel. Id. at
16-17.
We do not find Appellants’ arguments persuasive. As we have
explained, Appellants’ claims are read in view of the disclosures of the
Specification. See SanDisk Corp. v. Kingston Technology Co., Inc., 695
F.3d 1348, 1353 (Fed. Cir. 2012). As we have also explained supra, we
construe the phrase “improving memory or learning in a subject in need
thereof,” as broadly embracing a wide range of symptoms, conditions, and
their underlying causes, as disclosed in the Specification, specifically
including dementias. Spec. 196.
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The Examiner finds that von Borstel teaches administration of uridine
compounds can be used to treat, inter alia, dementias. See Final Act. 5—6.
Appellants do not dispute this finding of fact. Appellants’ Specification
discloses that dementias are examples of a “decline in cognitive function”
that can be treated by Appellants’ claimed invention to improve memory and
learning.
Moreover, Appellants reliance upon Kubin is inapposite. The Federal
Circuit held in Kubin that “[wjhere what was ‘obvious to try’ was to explore
a new technology or general approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance as to the
particular form of the claimed invention or how to achieve it,” such an
analysis is not probative of obviousness. Kubin, 561 F.3d at 1359.
However, in Kubin, the Federal Circuit also observed that the Supreme
Court, in KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), affirmed
the logical inverse of this statement by stating that 35 U.S.C. § 103 bars
patentability unless “the improvement is more than the predictable use of
prior art elements according to their established functions.” Id. (citing KSR,
550 U.S. at 417).
The test of obviousness “is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). In this instance, von Borstel
expressly teaches co-administration of uridine and choline is useful in the
treatment of dementias and other “central nervous system disorders.” See
von Borstel, col. 10,11. 24—29. We agree with the Examiner that the
teachings of von Borstel thus directly teach or suggest Appellants’ claimed
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invention of “improving memory or learning in a subject in need thereof,”
when that phrase is viewed in light of Appellants’ Specification. Ans. 8.
Issue 4
Appellants argue that the Examiner’s reliance on the remaining
references —i.e. Materazzi, DeBruin, Marcus, Sitaram, and Porter — provide
evidence that the Examiner’s prima facie conclusion of obviousness
impermissibly relied upon hindsight analysis. App. Br. 18—22.
Analysis
With respect to the teachings of Materazzi, Appellants argue that,
contrary to the Examiner’s findings, Materazzi does not disclose the
administration of uridine to treat mental decline in mammals (at page 8).
App. Br. 18. Appellants contend that the reference teaches that “uridine may
be used to block the decrease in neuron activity which occurs as the brain
ages, and in any case in which the neurons are deprived of the normal level
of energy materials (hypoxemia, ischemia, hypoglycemia).” Id. (quoting
Materazzi 8). Therefore, Appellants argue, Materazzi is not relevant to the
analysis.
With respect to De Bruin, Appellants contend that the reference was
published after the priority date of the application and is therefore not
available as prior art. App. Br. 18. Appellants also argue that one of the
inventors named in the appeal, Dr. Dick Wurtman, has informed Appellants’
counsel that, in his opinion, the authors of De Bruin have misinterpreted the
data taught by that reference. Id.
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According to Appellants, Dr. Wurtman is of the opinion that what De
Bruin teaches is the treatment of Attention Deficit/Hyperactivity Disorder
(ADHD) and its related symptoms. App. Br. 19. Appellants relate that Dr.
Wurtman explained that “Spontaneously Hypertensive rats” (“SH rats”) are
generally used to study the effects of ADHD since SH rats exhibit the
impulsiveness, hyperactivity, and inattentiveness associated with ADHD.
Id. Appellants contend that Professor Wurtman suggested that the De Bruin
reference misinterpreted the results presented therein, because the study
treated ADHD, and did not improve cognition; consequently, Appellants
state, Dr. Wurtman has indicated the analysis is both simplistic and
straightforward. Id.
With respect to Marcus, Appellants contend that the actual teachings
of Marcus refute the Examiner’s findings. App. Br. 21. Appellants point to
the Examiner’s finding that Marcus “discloses choline sources to be a
necessary and normal part of the human diet.” Id. (quoting Final Act. 7).
Appellants contend that this reading overstates Marcus, which teaches that
“[although choline is not a vitamin as defined above, sufficient ambiguity
exists concerning a possible dietary requirement for this substance that it is
customarily considered in discussions of water-soluble vitamins.” Id.
(quoting Marcus, 1542). Appellants argue that the phrase “sufficient
ambiguity exists concerning a possible dietary requirement” cannot be
reasonably understood to mean “choline sources to be a necessary and
normal part of the human diet,” as the Examiner found. Id. Appellants also
point to Marcus’ teaching that “[bjecause of the lack of evidence of a
choline deficiency syndrome in human subjects, choline cannot be
considered an essential dietary constituent for man,” which, Appellants
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maintain, refutes the Examiner’s findings. Id. (citing Marcus 1544).
Appellants therefore argue that, contra the Examiner’s findings, Marcus
does not stand for the proposition that choline is a necessary and normal part
of human diet. Id.
Appellants next argue that the Examiner relies upon Sitaram and
Porter as teaching only a single element of the claims. App. Br. 21.
Appellants assert that the Examiner relies upon Sitaram as teaching that
administration of an effective amount of a choline source has the effect of
“significantly enhanced serial learning in normal human subjects.” Id.
(quoting Final Act. 7). Appellants argue that there is nothing in Sitaram that
suggests to combine choline with uridine or to use the recited amounts. Id.
With respect to Porter, Appellants argue that Porter is relied on as
teaching that: “symptoms of dementia include loss of memory and loss of
learning capability.” App. Br. 22 (quoting Final Act. 7). Appellants argue
that Porter is not discussed in the Examiner’s reasoning, and allege that it
was included as an “afterthought” by the Examiner. Id.
We are not persuaded by Appellants’ arguments.
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill in
the art.
Keller, 642 F.2d at 425.
We are not persuaded by Appellants’ arguments regarding Materazzi.
With respect to Materazzi, the reference teaches the administration of
uridine to treat mental decline in mammals. Final Act. 6. The Examiner
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includes Materazzi to reinforce the teachings of the other references, and in
particular von Borstel, that administration of uridine can be used to treat
decreases in mental function. See, e.g., von Borstel col. 10,11. 24—35.
We are not persuaded by Appellants’ arguments regarding De Bruin.
With respect to De Bruin, the record indicates that De Bruin was published
in 2003, but the precise date of publication is uncertain. Appellants’
application claims the benefit of US App. Ser. No. 60/095,002, with a
priority date of July 31, 1998. As such, we agree with Appellants that De
Bruin does not quality as prior art to Appellants’ application. However, we
conclude that disallowing De Bruin as prior art does not fatally undermine
the Examiner’s prima facie case of obviousness. The Examiner relies upon
De Bruin as teaching that the administration of the combination of uridine
and choline to mammals was observed to cause improved mental
performance. Final Act. 6. As such, we find that the Examiner has relied
upon De Bruin as reinforcing the teachings of von Borstel, which, as we
have explained supra, also teaches the administration of choline and uridine
to improve mental function. Id.
With respect to the alleged statements of Dr. Wurtman, Appellants
adduce no affidavit or declaration submitted under 37 C.F.R. § 1.68, or any
other direct evidence provided by Dr. Wurtman, or otherwise, in support of
Appellants’ argument or that evidences Dr. Wurtman held the alleged
opinions or made the alleged statements. As such, Appellants’ argument is
no more than hearsay and mere attorney argument, to which we accord little
probative value. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
With respect to Marcus, whatever the merits of Appellants’ argument,
we do not see the relevance of this reference to Appellants’ claims, which do
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not recite or require that choline be a necessary portion of human dietary
requirements. We do not see how this reference fits into the Examiner’s
conclusion ofprima facie obviousness or that it is necessary, and we
consequently need not consider it in our analysis of the Examiner’s prima
facie case.
Finally, with respect to Sitaram and Porter, again, the Examiner relies
upon these references to further buttress the Examiner’s prima facie
conclusion of obviousness, as both further reinforce the teachings of von
Borstel. Appellants do not argue that the Examiner relies on either reference
exclusively as teaching a necessary limitation of the claims, rather, we see
them as indicative of the Examiner’s “belt-and-suspenders” approach in
reaching the conclusion of obviousness.
The gravamen of this portion of Appellants’ argument is that the
Examiner, by relying piecemeal on a number of references, has
impermissibly used hindsight (i.e., “ex post facto”) analysis to reach a
conclusion of obviousness. We do not agree, as the teachings of most of the
references cited by the Examiner are mutually supportive of the Examiner’s
finding of fact that choline and/or uridine can improve mental function,
including learning and/or memory. Furthermore:
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). In the appeal
before us, Appellants point to no evidence that the Examiner relied upon
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Application 11/224,311
knowledge that could have been derived solely from the disclosures of
Appellants’ Specification. We do not, therefore, find persuasive Appellants’
argument that the Examiner improperly relied upon hindsight analysis.
Issue 5
Appellants argue that the Examiner erred by failing to consider
objective evidence of non-obviousness. App. Br. 22.
Analysis
Appellants contend that their Specification discloses synergistic
effects of the combination of uridine and choline in the recited quantities.
App. Br. 22. Appellants point to Example 13, which they allege
demonstrate the enhanced effect on learning and memory of UMP-
supplemented diets, and to Examples 14 and 15, which Appellants contend
demonstrate the synergistic effect of the combination of uridine and choline
in neurotransmitter release, which they contend can be extrapolated to
learning and memory. Id.
Appellants particularly emphasize Example 15, which they argue
demonstrates that the amount of neurotransmitter release decreased with
each successive stimulation period; however, Appellants assert, this decrease
was significantly less in the presence of uridine or choline. App. Br. 24.
Appellants contend that this effect was enhanced by the presence of both
uridine and choline. Id. Appellants therefore argue that, based on the results
of Example 13, a person of ordinary skill would reasonably expect that the
synergistic effect would also be seen for learning and memory. Id.
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We are not persuaded. Example 13 demonstrates that rats
administered a uridine dietary supplement demonstrated reduced working
and reference memory errors in a water maze test. Spec. 1215—17.
Example 14 demonstrates that the ability of neurons in hippocampal slice
preparations to synthesize new phospholipids, and thus repeatedly release
neurotransmitters, is increased in an additive or synergistic fashion by
addition of uridine together with choline. Spec. 1223. Example 15, also
conducted with hippocampal slice preparations, discloses that the amount of
neurotransmitter release decreases with successive slice stimulation periods;
however, this decrease is significantly less in the presence of either uridine
or choline and the effect is enhanced by the presence of both uridine and
choline. Spec. 1224.
We are not persuaded that the results disclosed in Examples 13—15 of
Appellants’ Specification would have been unexpected by the skilled artisan
(as compared to the closest prior art) so as to overcome the Examiner’s
conclusion ofprima facie obviousness. Appellants’ Specification discloses
no quantitative or statistical analysis to demonstrate that the combination of
uridine and choline are synergistic rather than merely additive.
As an initial matter, if Appellants’ argument is that the alleged
objective evidence of synergy disclosed in their Specification is probative of
unexpected results, Appellants’ failure to compare their results with the
closest related prior art confounds any such argument. See In re Baxter
TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.”). Furthermore, even if
Appellants’ Specification does demonstrate a synergistic effect of the
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combined administration of choline and uridine (a conclusion of which we
are very skeptical), synergism, in and of itself, is not conclusive evidence of
non-obviousness in all instances. See In re Kollman, 595 F.2d 48, 55 n.6
(CCPA 1979). It is Appellants’ burden to show that any such synergy would
have been unexpected to a person of ordinary skill in the art, via a
comparison with the teachings of the prior art. We conclude that Appellants
have not met that burden, and we consequently affirm the Examiner’s
rejection of the claims.
B. Rejection of claims 1—3, 23, 28—34 under the doctrine of obviousness-
type double patenting
Analysis
Appellants argue that their claims on appeal are directed to a method
of improving memory or learning by administering a composition of uridine
and choline. App. Br. 6. In contrast, argue Appellants, claims 92—98 of the
’025 application are directed to improving cognitive function by the
administration of uridine only. Id. Appellants assert that there is no choline
present in the independent or dependent claims 92—98. Id.
The Examiner points to claim 95 of the ’025 application, which lists
five additional ingredients, two of which (acylglycerophosphocholine,
lysolecithin, glycerophosphatidylcholine) are choline-based compounds.
Ans. 7. The Examiner finds that it was well-known in the art that such
choline-based compounds are rapidly hydrolyzed to produce choline and,
therefore, choline is inherently included as an active ingredient. Id. (citing
von Borstel cols. 5—6,11. 66—7).
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Claims 92—94 and 96—98 of the ’025 application are all directed to
administration of uridine or uridine derivatives in amounts sufficient to
increase neurotransmitter release. See ’025 application, Amend. Claims,
filed September 15, 2004. None of these claims recite choline. Claim 95
recites: “[t]he method according to claim 92 further comprising
administering sphingomyelin, acylglycerophosphocholine, lysolecithin,
glycerophosphatidylcholine, fatty acid, or a combination thereof to the
subject.” Acylglycerophosphocholine and glycerophosphatidylcholine are
both choline-based compounds.
The von Borstel reference teaches:
Examination of the fate of CDP-choline [cytidine-
diphosphocholine] following its administration to animals or
humans indicates that this compound is very rapidly degraded,
yielding cytidine, choline, and phosphate. After oral
administration, no intact CDP-choline enters the circulation,
although plasma cytidine and choline concentrations rise. After
intravenous injection, breakdown to cytidine and choline occurs
within about 10 seconds.
von Borstel cols. 5—6,11. 66—7. Although the Examiner recites that it was
well known in the art that acylglycerophosphocholine and
glycerophosphatidylcholine are similarly rapidly hydrolyzed in vivo, we do
not find any teaching of von Borstel that supports that finding of fact.
Nevertheless, Appellants’ claim 1 recites: “wherein the choline is a choline
ester, a choline phosphate, or a choline salt” and both
acylglycerophosphocholine and glycerophosphatidylcholine, as recited in
claim 95, are choline phosphates. We consequently affirm the Examiner’s
rejection of the claims as obvious over claim 95 of the ’025 application.
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DECISION
The Examiner’s rejection of claims 1—3, 23, 28—32, and 34 as
unpatentable under 35 U.S.C. § 103(a) is affirmed.
The Examiner’s rejection of claims 1—3, 23, 28—32 and 34 as
unpatentable under the judicially-created doctrine of obviousness-type
double patenting is affirmed.
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)(l)(iv).
AFFIRMED
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