Ex Parte Ellis

Patent Trial and Appeal Board

May 26, 2016

13041279 (P.T.A.B. May. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/041,279
109143 7590
DSM Services USA
6480 Dobbin Road
Columbia, MD 21045
03/04/2011
05/31/2016
FIRST NAMED INVENTOR
Lorie A. ELLIS
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.
28650-US-CNT[l] 4697
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
05/31/2016 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):
dsmna.ip@dsm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LORIE A. ELLIS 1
Appeal2014-005233
Application 13/041,279
Technology Center 1600
Before JEFFREY N. FREDMAN, JACQUELINE T. HARLOW, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of treating cognitive decline by administering DHA-containing formulations.
The Examiner rejected the claims as obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
"A decline in memory and cognitive function is considered to be a
normal consequence of aging in humans." (Spec. 1, 11. 17-18.) According
1 Appellant identifies the Real Party in Interest as DSM IP Assets B.V.,
Netherlands. (Br. 4.)
Appeal2014-005233
Application 13/041,279
to the Specification, "[a]ge-related cognitive decline is a term used to
describe objective memory decline in the elderly who have cognitive
functioning that is normal relative to their age peers . . . [yet] may indicate
the early stages of a condition such as dementia." (Id. at 1, 11. 17-21; see
also, id. at 6, 11. 10-14 ("the individual is identified as having or being
susceptible to dementia or pre-dementia by measurement of a biological
marker, a family history showing dementia, mild cognitive impairment, or
age-related cognitive decline.") "Alzheimer's disease (AD) is the most
prevalent form of dementia." (Id. at 13, 11. 6-7.)
The Specification states that "[t]he present invention generally relates
to compositions and methods for treating or preventing dementia and pre-
dementia-related conditions and/or symptoms or characteristics of such
conditions." (Id. at 1, 11. 12-14.)
Claims 64-83 and 87-89 are on appeal. Claim 64 is illustrative:
64. A method of treating a human with age-related cognitive
decline, comprising:
administering to a human in need thereof a
therapeutically effective amount of an oral dosage
formulation comprising docosahexaenoic acid (DHA)
and docosapentaenoic acid n-6 (DP An-6), wherein the
DHA and DP An-6 are in a ratio from about 1: 1 to about
10: 1.
(Br. 19 (Claims App'x).)
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The claims stand rejected as unpatentable under 35 U.S.C. § 103(a)
over Tanaka.
DISCUSSION
We determine on appeal whether the Examiner established by a
preponderance of the evidence that claims 64-83 and 87-89 would have
been obvious over Tanaka.
The Examiner finds that Tanaka teaches a food product or dietary
supplement having the claimed ingredients in the claimed ratios. For
example, Examiner states that "Tanaka et al. teach a food product
comprising at least 90% lipids containing about 40% to about 48%w/w
docosahexaenoic acid (DHA) and about 8% to about 13%w/w
docosapentaenoic acid (DPA) ... [and thus] is within the Applicant's ratio
set forth in claim 64." (Final Act. 3; see also, Tanaka claims 1 and 14.)
The Examiner further finds that Tanaka discloses the benefits of food
products containing DHA. In particular, the Examiner cites Tanaka's
teaching that "[i]n relation to the metabolic system of [the] brain, it has also
become apparent that DHA is effective in improving memory and learning,
preventing senile dementia, and treating Alzheimer's disease." (Tanaka col.
1, 37-39 (cited in Final Act. 3--4).) Moreover, the Examiner points to
Tanaka's teaching that its DHA composition can be desirably used in foods
for geriatrics. (Final Act. 4; see also, Tanaka col. 3, 11. 4-11, claim 9.)
Although the Examiner finds that Tanaka does not expressly recite
administering its DHA food/supplement to treat humans with age-related
cognitive decline ("ARCD"), the Examiner states that such a use would have
been predictable and obvious based on the teachings of the prior art.
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According to the Examiner, "Tanaka clearly reports the [] therapeutic benefit
of DHA composition including improvement of memory and learning is well
known in the art. Therefore, the usefulness in improving cognition via
administration of DHA composition was known at the time the invention
was made in view of Tanaka." (Final Act. 2.) Thus, the Examiner contends,
"[i]t would have been obvious to one of ordinary skill in the art to employ
Tanaka's lipid food product ... for treating pre-dementia in human[s]
characterized by age-related cognitive decline or mild cognitive
impairment." (Id. at 4.) Also, the Examiner finds, "[t]here is a reasonable
expectation of successfully treating such cognitive conditions with Tanaka's
food product ... because the lipid food product of Tanaka has the active
agent of DHA that is effective for the treatment of such condition for
geriatric consumption." (Id. at 5.)2
Appellant does not dispute that Tanaka discloses a formulation with
the ingredients and ratios required by the claims, nor that, assuming such a
formulation was administered to a human with ARCD, it would be
therapeutically effective. Instead, Appellant argues the Examiner erred
because "(l) the Office failed to show that Tanaka discloses or provides a
reason to use DHA for treating a human with age-related cognitive decline
(ARCD) ... [and] (2) one of ordinary skill in the art could not have
2 We adopt the Examiner's other findings that are uncontested on appeal,
which appear relevant for certain elements of the claims. For example, the
Examiner finds that Tanaka discloses that various oils may be added to its
food product. (Final Act. 4-5.)
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Application 13/041,279
reasonably expected that DHA would be effective in treating a human with
ARCD based on Tanaka." (Br. 10.)
Appellant's arguments, which hinge on drawing a near-complete
distinction between dementia and Alzheimer's disease, on the one hand, and
ARCD on the other, are unpersuasive.
The problem for Appellant is twofold. First, the line between ARCD,
dementia, and Alzheimer's disease is not as clear and well recognized as the
picture Appellant paints with its arguments. Indeed, the Specification states
that "authorities differ on whether age-related cognitive decline is in part
related to Alzheimer's disease and other forms of dementia or whether it is a
distinct entity." (Spec. 21, 11. 13-19.) And the Specification indicates the
conditions are more related than not - disclosing that the invention includes
"[ m ]ethods to determine whether an individual has or is susceptible to
dementia or pre-dementia, including Alzheimer's Disease ... [by] detection
of Age-Related Cognitive Decline." (Id. at 21, 11. 1-6; see also, id. at 6, 11.
10-14.) The Specification further states that ARCD "may indicate the early
stages of a condition such as dementia." (Id. at 1, 11. 17-21.) The
Specification also does not disclose or evidence that the formulation is
effective in treating ARCD as a distinct condition. Quite the opposite, as the
Examiner points out, the example provided in the Specification "provides
employment of DHA to modulate onset or severity of pathophysiological
symptoms of disease in a novel triple transgenic mouse model of
Alzheimer's Disease." (Ans. 7 (citing Spec. 50, Example 1 ).) In fact,
although ARCD now appears as part of the claims in this continuation
application filed in 2011, over five years after its apparent priority date,
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ARCD is discussed in the Specification more as background to what is
repeatedly described as the invention: "methods for treating or preventing
dementia and pre-dementia-related conditions." (See, e.g., Spec. 1, 11. 12-
14, Abstract.)3
The Specification, in sum, does not support the line Appellant asks us
to draw. Accordingly, the broadest reasonable interpretation of treating age-
related cognitive decline includes the treatment or prevention of dementia or
pre-dementia.4 (Ans. 2-3.)
The second problem for Appellant's arguments is the narrow reading
of the teachings of Tanaka. True, Tanaka does not use the term "age-related
3 Appellant cites DSM-IV, which Appellant says "clearly differentiate
ARCD and dementia." (Br. 11 (citing Diagnostic and Statistical Manual of
Mental Disorders, 4th Ed.) This source cannot, however, override the
relationship bet,~1een the conditions described expressly in the Specification.
In the battle of external sources, consistent with the Specification's teaching
that authorities differ on whether ARCD is distinct from dementia, the
Examiner also cited art indicating that ARCD, dementia, and Alzheimer's
disease are considered related. (Ans. 5 (citing Brann et al., U.S. 6,528,529
Bl, issued Mar. 4, 2003, col. 14, 11. (describing "diseases and disorders
characterized by cognitive impairment such as attention deficit disorder, or
neurodegenerative diseases, e.g., Alzheimer's disease, other forms of age-
related cognitive decline, e.g., senile dementia, or dementia-related
symptoms.")).)
4 The term "age-related cognitive decline" appears only in the preamble of
the claims. We interpret this term as limiting in order to provide meaning to
the remainder of the claim. See Pitney Bowes, Inc. v. Hewlett-Packard Co.,
182 F.3d 1298, 1305 (Fed. Cir. 1999) (finding a preamble may be limiting if
"necessary to give life, meaning, and vitality" to the claim.) Claim 64, for
example, recites in the body the term "a therapeutically effective amount."
If we found the preamble not limiting, the remainder of the claim would beg
the question: "a therapeutically effective amount" for what?
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cognitive decline," but identical language between the prior art and claims is
not required to sustain an obviousness rejection. In re Skoner, 517 F.2d 947,
950 (CCP A 1975) ("Any other result would permit the allowance of claims
drawn to unpatentable subject matter merely through the employment of
descriptive language not chosen by the prior art.") So too, Tanaka does not
merely disclose the use of DHA in food for treating Alzheimer's disease. To
the contrary, Tanaka teaches that "DHA is effective in improving memory
and learning, preventing senile dementia, and treating Alzheimer's disease."
(Tanaka, col. 1, 11. 37-39.) Tanaka teaches further that its DHA
compositions can be used effectively in "a geriatric food." (Id. at col. 3, 11.
4-7.) Thus, we find Tanaka discloses a broader spectrum of desirable uses
of DHA to improve cognition. And, like the Examiner, we find that a person
of ordinary skill in the art would have reason to use Tanaka's DHA
food/supplement to improve the memory and learning of aged persons and to
help prevent dementia - therefore treating ARCD as in the pending claims.
As for Appellant's argument that the skilled artisan would not have
expected DHA to be effective in treating ARCD, we disagree. That is
precisely what the person of ordinary skill would reasonably expect in view
of Tanaka. Tanaka teaches DHA improves memory and learning and would
help prevent senile dementia. So, Tanaka's DHA composition would have
been understood as suited for those susceptible to dementia or exhibiting
conditions of pre-dementia, which we find overlaps with ARCD as described
in the Specification. Appellant's citation to "Search Results" that purport to
show "at least 142 different conditions that are associated with memory
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loss" (Br. 13) does not change this outcome where the Specification
indicates a relationship between ARCD and dementia as discussed above.
Moreover, Appellant's citation to experimental results created years
after the date of invention showing that DHA helps treat ARCD fails to
persuade us that the pending claims are nonobvious. (Appeal Br. 13, 16
(discussing Yurko-Mauro et al., Beneficial effects of docosahexaenoic acid
on cognition in age-related cognitive decline, 6 ALZHEIMER'S & DEMENTIA
1-9 (2010) ("Yurko-Mauro")).) Instead the experiment reveals results
flowing predictably from the teachings of Tanaka. In re Skoner, 517 F.2d at
950 ("Expected beneficial results are evidence of obviousness of a claimed
invention.") That the exact extent of therapeutic benefit may have been
unknown at the time of the invention - but later shown by experimentation
- does not make Appellant's claims nonobvious. Pfizer, Inc. v. Apotex,
Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) ("obviousness cannot be avoided
simply by a showing of some degree of unpredictability in the art so long as
there was a reasonable probability of success ... the expectation of success
need only be reasonable, not absolute.") As discussed above, a person of
ordinary skill would have had reason to give Tanaka's DHA composition to
geriatrics and would reasonably expect improvement in memory and
learning in those susceptible to dementia.
Appellant emphasizes that the experiment described in Yurko-Mauro
showed administering DHA improved certain types of memory impairment
that is characteristic of ARCD, but not other memory impairment that is
characteristic of Alzheimer's disease ("AD"). (Br. 16-17.) This does not,
however, rebut the prima facie case of obviousness such as by providing
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persuasive evidence of unexpected results. For example, Yurko-Mauro does
not show that administering the DHA composition as claimed provides
surprisingly superior therapeutic benefits relative to administering the
composition described in the closest prior art (Tanaka). Insofar as Appellant
argues Yurko-Mauro found DHA ineffective to treating AD (different from
Tanaka), this overstates Yurko-Mauro's results. (Br. 18.) Yurko-Mauro
found that DHA supplementation "did not produce changes" in a type of
memory impaired in "later stages of AD," but expressly states that its study
"was not designed to assess long-term effects of DHA on cognitive decline
rates or conversion rates to MCI or mild AD." (Yurko-Mauro 7-8.) Yurko-
Mauro also did not assess the effects ofDHA in subjects diagnosed with AD
and states "[i]t is possible that significant changes in these other cognitive
domains [reflecting memory characteristics impaired in late-stage ADJ
would be seen with more severe cognitive impairment or longer DHA
supplementation." (Id. at 8.) And finally, Yurko-Mauro elsewhere
recognizes that DHA intake has been shown to likely benefit subjects
having, or at risk of AD. (Id. at 1 ("Higher DHA intake is inversely
correlated with relative risk of Alzheimer disease."; id. at 8 ("Previous
clinical studies with LCPUF As have demonstrated small but significant
benefits in patients with MCI or mild AD.").)
In addition to the above arguments, Appellant contends that the
Examiner failed to consider the state of the art at the time of the invention,
which would have "taught away from using DHA to treat ARCD." (Br. 14.)
More specifically, Appellant argues that "[s]everal peer reviewed articles at
the time of the filing of the present application concluded that there is no
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beneficial role of omega-3 fatty acids, such as DHA, in treating cognitive
function." (Id.)
We are not persuaded. Appellant's Specification, presumably
prepared with consideration of the state of the art at the time, teaches that
DHA "has been shown to improve cognitive performance and visual acuity
in subjects with and without dementia (Suzuki et al (2001))." (Spec. 2, 11.
20-30 (cited at Ans. 8).) Tanaka also teaches that DHA is effective at
preventing dementia and treating Alzheimer's disease as discussed above.
(Tanaka col. 1, 11. 37-39.) Appellant, however, cites various publications -
only three of which appear to have been published at the time of invention
- and argues that these publications teach away from the use of Tanaka's
DHA composition to treat ARCD. Because the experimental results
described in the Quinn,5 Yurko-Mauro, and Morris6 publications were not
available at the time of invention, those results could not have been known
to the person of ordinary skill in the art and thus cannot constitute evidence
of teaching away.
In any event, the references cited by Appellant undercut Appellant's
argument. For example, notwithstanding the existence of some pre-filing
references that found little to no cognitive benefits associated with the
5 Quinn et al., Docosahexaenoic Acid Supplementation and Cognitive
Decline in Alzheimer's Disease: A Randomized Trial, 304: 17 JOURNAL OF
THE AMERICAN MEDICAL ASSOCIATION 1903-1911 (2010) ("Quinn").
6 Morris, et al., Fish Consumption and Cognitive Decline With Age in a
Large Community Study, 62 ARCH. NEUROL. 1-5 (Dec. 2005) ("Morris").
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administration of fatty-acids, 7 references like Quinn and Morris describe the
state of the art by citing studies showing that DHA has been shown as
effective in treating cognitive disorders. Morris, which was published very
near the apparent priority date of the present application, is especially
instructive. If, as Appellant argues, it was well understood in the art that
DHA was ineffective, the fact that Morris in 2005 "hypothesized that DHA
would have the strongest association with cognitive change based on its
abundance in brain tissue and evidence from animal models demonstrating
superior learning and memory performance among DHA-fed rodents" makes
no sense. (Morris 4.) The more reasonable takeaway is that the state of the
art was that DHA was known (or at least expected) to provide benefits to
cognitive performance, and that Morris merely reached a contrary result with
its study. (Id. ("These findings are in contrast with our previous study, in
which we observed strong reductions in Alzheimer disease risk among
7 Appellant also cites the following three references: Laurin et al., Omega-3
fatty acids and risk of cognitive impairment and dementia, 5 JOURNAL OF
ALZHEIMER'S DISEASE 315-322 (2003) ("Laurin"); Kalmijn et al.,
Polyunsaturated Fatty Acids, Antioxidants, and Cognitive Function in Very
Old Men, 145: 1 AMERICAN JOURNAL OF EPIDEMIOLOGY 3 3--41 ( 1997)
("Kalmijn"); Manzato et al., Cognitive functions are not affected by dietary
fatty acids in elderly subjects in the Pro. V.A. study population, 15:1 AGING
CLIN. EXP. REs. 83-85 (2003) ("Manzato"). Although these studies were
published before the date of invention, they do not reflect a broad
understanding in the art that DHA was ineffective. To the contrary, Laurin
for example reports "[i]t has also been postulated that a high dietary intake
of DHA or n-3 PUP As could be associated with a reduced risk of dementia
or cognitive decline [23, 40]. Few studies have explored this hypothesis but
data so far suggest that fish consumption could be inversely associated with
cognitive decline and dementia [20, 21]." (Laurin 315.)
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persons with high intakes of total co-3 fatty acids, DHA, and a-linoleic
acid."); see also, Quinn 1 ("Several studies have found that consumption of
fish, the primary dietary source of omega-3 fatty acids, is associated with
reduced risk of cognitive decline or dementia . . . . Some studies have found
that consumption of DHA, but not other omega-3 fatty acids, is associated
with a reduced risk of Alzheimer disease.").)
On balance, considering all these references along with the
Specification's description of the state of the art, we disagree with
Appellant's teaching away argument. Medichem, S.A. v. Rolabo, S.L., 437
F.3d 1157, 1165 (Fed. Cir. 2006) ("Where the prior art contains apparently
conflicting teachings (i.e., where some references teach the combination and
others teaching away from it) each reference must be considered for its
power to suggest solutions to an artisan of ordinary skill ... consider[ing]
the degree to which one reference might accurately discredit another.")
(internal quotation marks omitted).
For the reasons above, we conclude that the Examiner established by a
preponderance of the evidence that claim 64 would have been obvious under
35 U.S.C. § 103(a) over Tanaka. Claims 65-83 and 87-89 have not been
argued separately and therefore fall with claim 64. See 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm rejection of claims 64-83 and 87-89 under 35 U.S.C.
§ 103(a) as obvious over Tanaka.
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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. § l.136(a).
AFFIRMED
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