Ex Parte Pan

Patent Trial and Appeal Board

Mar 26, 2018

12734013 (P.T.A.B. Mar. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121734,013 04/01/2010
69099 7590 03/28/2018
Nestle Purina Petcare Global Resources, Inc
Checkerboard Square
Intellectual Property Patents
ST. LOUIS, MO 63164
FIRST NAMED INVENTOR
Yuanlong Pan
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.
8602/US/PCT 1422
EXAMINER
DA VIS, DEBORAH A
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
03/28/2018 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):
purinapatentmail@purina.nestle.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YUANLONG P AN 1
Appeal2017-005540
Application 12/734,013
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and TA WEN CHANG,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for enhancing cognitive function in a healthy aging animal, which
have been rejected as anticipated and/or obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, "[t]he invention relates generally to
compositions and methods for enhancing cognitive function and particularly
1 Appellants identify the Real Party in Interest as Nestec, S.A. (Appeal Br.
3.)
Appeal2017-005540
Application 12/734,013
to compositions comprising unsaturated fatty acids and nitric oxide release
compounds and their use for enhancing cognitive function in animals."
(Spec. if 2.)
Claims 26, 30, 32, 36, 45, 46, 49, 196-198, and 201-210 are on
appeal. Claim 26 is illustrative and reproduced below:
26. A method for enhancing cognitive function in a healthy
aging animal comprising:
a) identifying a healthy aging animal in which
enhancement of cognitive function is desired; and
b) administering a composition comprising effective
amounts of one or more unsaturated fatty acids (UFA) and
one or more nitric oxide releasing compounds (NORC) to
the animal on an extended regular basis, wherein the
administration of the composition on an extended regular
basis results in enhanced cognitive function in the animal
as compared with an equivalent animal not administered
the composition for the equivalent period.
(Appeal Br. 23 (Claims App.).)
The Examiner rejects claims 26, 30, 32, 36, 45, 46, 49, 196-198, and
201-210 under pre-AIA 35 U.S.C. § 102(b) as being unpatentable over
McCleary. 2 (Ans. 2.)
The Examiner rejects claims 26, 30, 32, 36, 45, 46, 49, 196-198, and
201-210 under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over
McCleary. (Id. at 4.)
I.
Issue
The Examiner rejects claims 26, 30, 32, 36, 45, 46, 49, 196-198, and
201-210 as anticipated by McCleary. The Examiner finds that McCleary
2 McCleary, US 2006/0014773 Al, published Jan. 19, 2006.
2
Appeal2017-005540
Application 12/734,013
teaches administering a "mental agility composition," comprising "B 12,
docosahexanoic [acid] (DHA), GLA, which reads on unsaturated fatty acids
(UFA), L-Arginine (NORC) and Gingko Biloba and Vinopocetine (cognitive
drug) as active ingredients." (Ans. 2.) The Examiner finds that McCleary
teaches daily administration of "the mental agility composition ... to a
human having impaired or deteriorating neurological function" and finds
that this teaching meets the limitations of administering the composition on
an "extended regular basis" to "a healthy aging animal," because
"deteriorating neurological function will happen to normal healthy animals
and humans as they age." (Id.) The Examiner finds that McCleary teaches
that its mental agility composition has been found to be "very effective in
enhancing mental agility (i.e. enhancing cognitive function)." (Id. at 2-3.)
Appellant contends that McCleary does not teach treating "healthy
aging animals" and does not teach the step of "identifying a healthy aging
animal in which enhancement of cognitive function is desired." (Appeal Br.
11.)
The issue with respect to this rejection is whether McCleary teaches a
method for enhancing cognitive function in a "healthy aging animal"
comprising administering the composition recited in the claims, including
"identifying a healthy aging animal in which enhancement of cognitive
function is desired."
Findings of Fact
1. The Specification defines "aging" as "being of advanced age
such that the animal has exceeded 50% of the average lifespan for its
particular species and/or breed within a species." (Spec. i-f 24.)
3
Appeal2017-005540
Application 12/734,013
2. The Specification defines "healthy aging animals" as "those
with no known diseases, particularly diseases relating to loss of cognitive
impairment [sic] such as might confound the results." (Id.; see also id. i-f 23
("non-diseased animals (e.g., 'healthy aging animals"')).)
Analysis
On balance, we find Appellant to have the better argument. To
anticipate "it is not enough that the prior art reference discloses part of the
claimed invention, which an ordinary artisan might supplement to make the
whole, or that it includes multiple, distinct teachings that the artisan might
somehow combine to achieve the claimed invention." Net MoneyIN, Inc. v.
VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Instead, anticipation
requires that "a prior art reference discloses within the four comers of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the claim."
Id.
Moreover, while a prior art reference may anticipate without
disclosing a claim limitation if such limitation is inherently present in the
reference, inherent anticipation requires that "a claim limitation that is not
expressly disclosed 'is necessarily present ... in the ... anticipating
reference,"' In re Montgomery, 677 F.3d 1375, 1379--80 (Fed. Cir. 2012)
(citations omitted and emphasis added). That is, "[t]he inherent result must
inevitably result from the disclosed steps; '[i]nherency ... may not be
established by probabilities or possibilities."' Id. (citations omitted, first
alteration added).
The Examiner finds that McCleary teaches administering its
composition to a "healthy aging animal," because it teaches administration
4
Appeal2017-005540
Application 12/734,013
of the composition to "a human having impaired or deteriorating
neurological function" and "deteriorating neurological function will happen
to normal healthy animals and humans as they age." (Ans. 2.) In response
to Appellant's arguments, the Examiner also contends that
McCleary teaches methods for enhancing mental agility
(cognitive function), which include impaired or deteriorating
neurological functions. Non-limiting conditions [causing]
impaired or deteriorating neurological functions include ADD
and ADHD, difficulty functioning under pressure[,] emotional or
mood problems. These non-limiting conditions are in healthy
animals and non-healthy animals having such conditions.
McCleary do not indicate that animals with ADD, ADHD,
emotional or mood problems are unhealthy animals. All
populations of animals are aging naturally. All populations of
animals with ADD, ADHD, emotional or mood problems are not
unhealthy or healthy. Therefore, the treatment of mental agility
taught by McCleary would be for healthy and unhealthy animals
identified.
(Id. at 6.)
While we understand the Examiner's position, we are not persuaded
that the Examiner has established a prima facie case of anticipation. As an
initial matter, the Examiner does not appear to contend that McCleary
explicitly disclose administering its composition to a healthy aging animal.
Rather, the Examiner first contends administration of the composition to a
human having impaired or deteriorating neurological function inherently
discloses administration of the composition to a healthy aging animal,
because neurological function naturally deteriorates in normal healthy
animals and humans as they age. (Ans. 2.) However, an inherent result
must "inevitably result from the disclosed steps" and not be based on
probabilities or possibilities. In re Montgomery, 677 F.3d at 1379--80. In
this case, the Examiner has not established that a human having impaired or
5
Appeal2017-005540
Application 12/734,013
deteriorating neurological function is necessarily a "healthy aging animal" as
that phrase is defined in the Specification, i.e., an animal that has "exceeded
50% of the average lifespan for its particular species and/or breed within a
species" with "no known diseases, particularly diseases relating to loss of
cognitive impairment [sic]." 3 (FFl, FF2.)
Neither are we persuaded by the Examiner's similar contention that
McCleary teaches enhancing cognitive function in healthy aging animals
because (1) all animals are aging naturally; and (2) McCleary teaches that
conditions resulting in impaired or deteriorating neurological functions
include, e.g., ADD, ADHD, difficulty functioning under pressure, and
emotional or mood problems, and these conditions are found in healthy and
non-healthy animals alike. (Ans. 6.) As defined in the Specification,
"aging" requires that an animal exceeds 50% of the average lifespan for its
particular species. (FFl .) Thus, the Examiner has not established on this
record that all animals are inherently "aging" as that term is used in claim
26. Likewise, the Examiner has not established that an aging human
diagnosed with a condition such as ADD would be considered a "healthy
aging human" in light of the definition in the Specification that "a healthy
aging animal" be one with no known diseases, particularly diseases relating
to loss of cognitive impairment [sic] such as might confound the results."
(FF2.)
3 We note that disclosure of a small genus that allows a skilled artisan to "at
once envisage" each member of the genus may anticipate claims directed to
any single member of the genus. In re Petering, 301F.2d676, 681-82
(CCPA 1962). However, the Examiner has not made findings that "a human
having impaired or deteriorating neurological function" and "healthy aging
[human]" satisfies such a genus/species relationship.
6
Appeal2017-005540
Application 12/734,013
Accordingly, we reverse the Examiner's rejection of claim 26 as
anticipated by McCleary. The anticipation rejection based on McCleary of
claims 30, 32, 36, 45, 46, 49, 196-198, and 201-210, which depend directly
or indirectly from claim 26, are reversed for the same reasons.
II.
Issue
The Examiner has also rejected claims 26, 30, 32, 36, 45, 46, 49, 196-
198, and 201-210 as obvious over McCleary. The Examiner concludes that,
in light of McCleary's disclosures discussed above with respect to the
anticipation rejection,
[i]t would have been obvious to one of ordinary skill in the art at the
time the invention was made to administer a composition comprising
... one or more unsaturated fatty acids (UFA) a nitric oxide releasing
compound (NORC) and other active ingredients. One skilled in the art
would have been motivated because it is effective for mental agility by
improving impaired or deteriorating neurological function in human
animals. From the teachings of the reference, it is apparent that one of
ordinary skill in the art would have had a reasonable expectation of
success in producing the claimed invention.
(Ans. 5.)
Appellant contends that McCleary does not teach "'a method for
enhancing cognitive function in a healthy aging animal' including the step of
'a) identifying a healthy aging animal' but is directed to 'normalizing
impaired or deteriorating neurological function in the body of a human
having impaired or deteriorating neurological function."' (Appeal Br. 17.)
Appellant contends that the claimed composition of UFA and NORC is "not
taught by McCleary as necessary to enhance cognitive function" because
McCleary "specifically lists L-arginine [(a NORC)] as optional and requires
6 other components to enhance cognitive function." (Id. at 18.) For the
7
Appeal2017-005540
Application 12/734,013
same reason, Appellant contends that McCleary teaches away from the
claimed invention. (Id. at 18-19.) Appellant further contends that the
claimed method also exhibits unexpected results over McCleary for this
reason and because "the claims do not require 5 core components that are
required under McCleary but ... still provides the function of enhancing
cognition." (Id. at 19-21.)
The issues with respect to this rejection are (1) whether McCleary
suggests a method for enhancing cognitive function in a "healthy aging
animal," including "identifying a healthy aging animal in which
enhancement of cognitive function is desired"; (2) whether McCleary
teaches away from the claimed methods; and (3) whether Appellant has
provided evidence of unexpected results that, when considered together with
evidence of obviousness, shows the claimed methods to be non-obvious.
Findings of Fact
3. The Specification defines "enhancing cognitive function" as
"one or more of increasing cognitive, motor, or behavioral function in an
animal or preventing, reducing, or delaying a decline in cognitive, motor, or
behavioral function in an animal." (Spec. i-f 15.) "Cognitive function" refers
to "the special, normal, or proper physiologic activity of the brain, including
one or more of the following: mental stability, memory/recall abilities,
problem solving abilities, reasoning abilities, thinking abilities, judging
abilities, ability to discriminate or make choices, capacity for learning, ease
of learning, perception, intuition, attention, and awareness." (Id. i-f 20.) The
Specification states that "[p ]revention, reduction, or delay of 'decline' is
frequently a more useful comparative basis when working with non-diseased
aging animals (e.g., 'healthy aging animals')." (Id. i-f 23.)
8
Appeal2017-005540
Application 12/734,013
4. The Specification defines "unsaturated fatty acids" or "UFA" as
"polyunsaturated fatty acids or monosaturated fatty acids, including
monocarboxylic acids having at least one double bond." (Id. i-f 16.) The
Specification states that UFAs include linoleic acid (LA) and
docosahexaenoic acid (DHA). (Id.)
5. The Specification defines "nitric oxide releasing compounds"
or "NORC" as "any compound or compounds that cause or can result in the
release of nitric oxide in an animal." (Id. i-f 18.) The Specification states that
examples ofNORC include "L-arginine, L-arginine-containing peptides and
proteins, and analogs or derivatives thereof that are known or determined to
release nitric oxide." (Id.)
6. The Specification defines "effective amounts" as "an amount
... that is effective to achieve a particular biological result." (Id. i-f 19.) The
Specification states that, "[i]n various embodiments, 'effective amount'
refers to an amount suitable to prevent a decline ... , or, in certain
embodiments, to improve any one or more of the [qualities such as]
cognitive function or performance, learning rate or ability, problem solving
ability, attention span and ability to focus on a task or problem, motor
function or performance, social behavior, and the like." (Id.) "Effective
amount" may also be an amount "suitable to reduce either the extent or rate
of decline in an animal's cognitive skills or functioning, and/or ... delay the
onset of such decline." (Id.)
7. The Specification defines "long-term administration" as
"periods of repeated administration or consumption in excess of one month .
. . . Sometimes this is referred to as consumption for 'extended' periods."
(Id. i-f 28.)
9
Appeal2017-005540
Application 12/734,013
8. The Specification defines "regular basis" as "at least monthly
dosing with the compositions or consumption of the compositions, more
preferably weekly dosing." (Id. i-f 29.)
9. McCleary teaches that its invention relates to "compositions
and methods for enhancing human mental agility, i.e., for supporting and
promoting healthy human nerve or brain function, for preventing human
nerve or brain dysfunction, or for treatment of human nerve or brain
dysfunction." (McCleary i-f 3; see also id. i-f 21.)
10. McCleary teaches that a "clinical study showed that a
supplement including the composition according to [its] invention resulted in
enhanced memory, concentration, focus, cognitive functioning, learning, and
mood, and reduced depression and anxiety." (Id. i-f 21; see also id. i-f 189.)
11. McCleary teaches that therapeutic interventions in the prior art
"have been used to address individual aspects of impaired neurological
functions" but that its invention is directed towards "using multiple
simultaneous avenues of intervention designed to generate maximal
synergistic activity." (Id. i-f 23 .)
12. McCleary teaches "a mental agility composition" comprising
at least one agent which promotes synthesis of ATP and/or
creatine phosphate in the body; at least one antioxidant for
scavenging free radicals in at least one pathway in the body; at
least one agent for normalizing or maintaining membrane
function and structure in the body; at least one agent for
normalizing or maintaining normal neurotransmitter function in
the body; at least one agent for down-regulating cortisol action;
and at least one agent for suppressing activation of apoptotic
pathways in the body. The composition may further contain one
or more of at least one agent for suppressing inflammation in the
body; at least one agent for normalizing or maintaining vascular
wall function and structure in the body; at least one agent for
10
Appeal2017-005540
Application 12/734,013
normalizing or maintaining function of nerve growth factors
and/or neurotropic factors in the body; at least one agent for
suppressing toxic metal ionic effects; at least one agent for
normalizing or maintaining methyl metabolism in the body; at
least one agent for normalizing or maintaining metabolism of
insulin and glucose in the body; and at least one agent for
upregulating activity of heat shock proteins in the body.
(Id. at Abstract.)
13. McCleary teaches that preferred agents for "normalizing or
maintaining membrane function and structure in the body" include one or
more of the following:
gamma linolenic acid (GLA); highly polyunsaturated long chain
fatty acids such as docosahexanoic acid (DHA), phosphatidyl
serine (PS), phosphatidyl choline (PC), phosphatidyl
ethanolamine (PE), and phosphatidyl inositol (PI); CDP-choline;
methyl donors; S-adenosyl methionine; antioxidants. . . ; and
sphingosine.
(Id. ii 136.)
14. McCleary teaches that
[t]he ability of blood vessels to dilate and contract in response to
metabolic needs and to retain a smooth, non-adherent, non-
occlusive vascular lumen is required for normal brain function.
This depends critically upon adequate function of nitric oxide
pathways within the endothelial cells and their interactions with
platelets and plasma proteins.
(Id. ii 66.)
15. McCleary teaches that, preferably, an agent for normalizing or
maintaining vascular wall function and structure in the body is "selected
from the group consisting of: magnesium, L-arginine, L-taurine,
antioxidants, insulin-sensitivity enhancers, long chain polyunsaturated fatty
acids, vinpocetine, choline, betaine, vitamin B6, vitamin B12, folic acid, and
11
Appeal2017-005540
Application 12/734,013
supplemental potassium." (Id. i-f 161; see also id. i-f 132 (preferred
antioxidants include the amino acids "arginine, taurine, and cysteine").)
16. McCleary teaches that "L-arginine drives the constitutive nitric
oxide pathway, which further dilates blood vessels and helps to maintain
proper endothelial function" and that "[a]ntioxidants play a key role in this
regard by preventing inactivation of nitric oxide." (Id. i-f 162.) McCleary
further teaches that "[ s ]upplementation with long chain polyunsaturated fatty
acids or vinpocetine enhances red blood cell deformability with subsequent
improvements in nutrient delivery through the smallest caliber vascular
channels." (Id.)
17. McCleary teaches a preferred embodiment having the following
daily dosages for the following active ingredients, among others: 10 mg-
500 mg (effective range) or 25 mg-2000 mg (preferred range) DHA; 100
mg-9000 mg (effective range) or 200 mg-8,000 mg (preferred range) L-
Arginine; and 5mg-500 mg (effective range) or 50 mg-200 mg (preferred
range) GLA. (Id. i-f 182.)
18. McCleary teaches a method involving
the steps of administering (preferably daily) for a therapeutically
effective period of time to a human having impaired or
deteriorating neurological function an effective amount of the
composition of this invention. The composition is administered
orally or parenterally, preferably orally.
The term "therapeutically effective period of time" with
respect to the administration of the composition in the method of
this invention means that period of time sufficient to normalize
impaired or deteriorating neurological function in a human.
Preferably, the composition of this invention is administered on
a daily basis for a period of at least three weeks, more preferably
at least six weeks.
12
Appeal2017-005540
Application 12/734,013
(Id. ifif 184, 186.)
19. McCleary defines "effective amount" as "amount of [a]
component which, when used in combination with the other components in
the composition, will provide the composition with the capability of
normalizing impaired neurological function in humans." (Id. if 115.)
20. McCleary teaches that aging is associated with
neurodegenerative changes. (See, e.g., id. if 10 (discussing prior art
treatment for nervous system deterioration associated with aging and
Alzheimer's disease); if 11 (discussing prior art treatment for "memory and
learning disorders such as, e.g., Alzheimer's diease, myasthenia gravis, and
other age-related memory impairments"); if 17 (discussing prior art
treatment for Alzheimer's disease and age-related neuron degeneration);
if 67 (stating that "[t]here is evidence that many of the neurodegenerative
changes associated with brain aging may be caused, in part, by a decline in
the activity of ... 'Nerve Growth Factors' (NGF)"; if 73 (stating that
"[ fJactors which compromise methyl metabolism ... play key roles in the
development of various neurological diseases" and that "[ m ]ethylation
deficiency is also important in the basic process of aging").)
21. The Specification states:
Aged or aging animals frequently suffer some degree of
cognitive impairment. Changes, including decline in cognitive
function that progresses with age, and age-related changes in
brain morphology and cerebrovascular function are commonly
observed, e.g., brain aging. Age-related or age-associated
cognitive impairment may manifest itself in many ways, e.g.,
short-term memory loss, diminished capacity to learn,
diminished rate of learning, diminished attention, diminished
motor performance, and/ or dementia, among other indicia. In
some cases, a specific etiology of such cognitive decline is
13
Appeal2017-005540
Application 12/734,013
unknown. In other cases, cognitive impairment results from the
onset or progression of recognized diseases, disorders, or
syndromes, for example, Alzheimer's disease (AD). It is known
that age-associated cognitive decline is distinct from and can
occur independently of AD.
(Spec. if 3.)
Analysis
Appellant does not separately argue the claims. Thus, we limit our
analysis to claim 26 as representative. 37 C.F.R. § 41.37(c)(l)(iv).
We agree with the Examiner that claim 26 is obvious over McCleary.
McCleary teaches a preferred composition of its invention comprising one or
more unsaturated fatty acids (i.e., GLA and DHA) and a nitric oxide
releasing compound (i.e., L-Arginine). (FF4, FF5, FF12, FF13, FF15-
FF 17.) McCleary teaches that use of its composition resulted in "enhanced
memory, concentration, focus, cognitive functioning, learning, and mood,
and reduced depression and anxiety." (FFlO; see also FF18-FF19 (teaching
administration of "effective amount" of its composition where an effective
amount is an amount that has the capability of normalizing impaired
neurological function in humans.) McCleary teaches that the composition is
preferably administered on a daily basis for a period of at least three weeks
and more preferably at least six weeks (i.e., on an extended regular basis as
that phrase is defined in the Specification). (FF7, FF8, FF18.)
McCleary does not explicitly mention administering its composition
to a healthy aging animal as defined in the Specification, e.g., a human who
has exceeded 50% of the average lifespan for humans and who has no
known disease. (FF 1, FF2.) However, we find that McCleary suggests
administering its composition to a healthy aging animal. In particular,
14
Appeal2017-005540
Application 12/734,013
McCleary teaches that its invention relates to "supporting and promoting
healthy human nerve or brain function" and preventing dysfunction, as well
as treating dysfunction. (FF9 (emphasis added).) Likewise, McCleary (as
well as the Specification) shows that it is known in the prior art that aging is
associated with neurodegenerative changes and cognitive impairment.
(FF20, FF21.) Accordingly, we find that a skilled artisan would have reason
to identify a healthy aging human in whom enhancement of cognitive
function is desired and to administer McCleary's composition to the person
in the manner described above in order to support or promote healthy nerve
or brain function and/or prevent dysfunction, with a reasonable expectation
of success.
We have considered Appellant's arguments but do not find them
persuasive. Appellant first contends that "McCleary does not teach 'a
method for enhancing cognitive function in a healthy aging animal'
including the step of 'a) identifying a healthy aging animal' but is directed to
'normalizing impaired or deteriorating neurological function in the body of a
human having impaired or deteriorating neurological function' and uses
cognitive drugs for its treatments." (Appeal Br. 17.) We are not persuaded
for the reasons discussed immediately above: McCleary does not only teach
using its composition to treat existing dysfunction but also teaches using the
composition to support or promote healthy brain function and/or prevent
dysfunction, and it is known that aging is associated with neurodegenerative
changes and cognitive impairment. (FF20, FF21.) This combination of
teachings provides a reason for a skilled artisan to use the composition to
treat a healthy aging human in order to, e.g., prevent cognitive impairment to
which an aging human is susceptible.
15
Appeal2017-005540
Application 12/734,013
Appellant next argue that McCleary teaches nitric oxide releasing
compounds (NORC) such as L-arginine as optional for its composition and
also teaches components other than unsaturated fatty acids (UFA) and
NORC. (Appeal Br. 17-18.) Appellant argues that,
[a]s such, Appellant['s] recited composition of UFA and NORC
is not taught by McCleary as necessary to enhance cognitive
function. Rather, McCleary specifically lists L-arginine as
optional and requires 6 other components to enhance cognitive
function. As such, the Appellants [sic] note that McCleary
teaches away from the present composition that enhances
cognitive function using UFA and NORC.
(Id. at 18; see also Reply Br. 7.)
We are not persuaded. To render claim 26 obvious, it is not
required that the prior art teaches UFA and NORC to be indispensable
to enhancing cognitive function, merely that a skilled artisan would
have reason to combine UFA and NORC in a composition for use in a
method for enhancing cognitive function in a healthy aging animal. In
this case, as discussed above, McCleary supplies such a reason by
suggesting that NORC such as L-arginine contributes to normal brain
function (FF 14--FF 16), that L-arginine be included with a UFA in a
composition for enhancing mental agility, including in a preferred
embodiment (FF12, FF13, FF15, FFl 7),4 and that the composition of
4 Appellant appears to argue that McCleary' s inclusion of L-arginine in a
preferred embodiment that also contains an UFA does not render claim 26
obvious because the preferred embodiment "was not used for treating
healthy aging animals and ... the inclusion of arginine does not refute
McCleary's direct teaching that arginine is optional and is not responsible
for McCleary's cognition benefit." (Reply Br. 7.) These arguments are not
persuasive. As discussed above, McCleary teaches that its compositions
may be used to support or promote healthy brain and nerve function and to
16
Appeal2017-005540
Application 12/734,013
its invention is useful for supporting and promoting healthy nerve or
brain function and preventing nerve or brain dysfunction (FF9).
Likewise, the fact that McCleary teaches a composition
containing active ingredients in addition to UFA and NORC does not
render claim 26 non-obvious. As an initial matter, claim 26 uses the
open transitional phrase "comprising." Thus, McCleary' s
composition reads on the composition recited in claim 26 regardless
of whether McCleary's composition requires additional active
ingredients. 5 Crystal Semiconductor Corp. v. Tri Tech
Microelectronics Intern., Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001)
(explaining that "the transition 'comprising' creates a presumption ...
that the claim does not exclude additional unrecited elements").
Furthermore, McCleary does not suggest all of the active
ingredients in its composition must be present in order for the
composition to enhance cognitive function. Indeed, McCleary
suggests the opposite by teaching that different therapeutic
interventions "have been used to address individual aspects of
prevent dysfunction, which would suggest using such compositions to treat
healthy aging animals. Furthermore, contrary to Appellant's argument, a
teaching of arginine as optional is not a teaching that arginine does not
confer a cognition benefit. Indeed, McCleary teaches that L-arginine helps
maintain normal brain function by normalizing or maintaining vascular wall
function and structure because it drives the constitutive nitric oxide pathway.
(FF14-FF16.)
5 In the Reply Brief, Appellant contends in conclusory fashion that the use of
the transitional phrase "comprising" "does not refute the arguments
discussed ... including that McCleary does not teach each step of the
presently claimed method, the present method provides unexpected results
over the art, and McCleary teaches away from the present invention."
(Reply Br. 9.) We are not persuaded for the reasons discussed herein.
17
Appeal2017-005540
Application 12/734,013
impaired neurological function" but that its invention is intended to
provide "multiple simultaneous avenues of intervention designed to
generate maximal synergistic activity." (FFl 1.) In short, McCleary
suggests that individual components of its composition address
different aspects of impaired neurological function (i.e., can enhance
cognitive function in a particular way); its composition is merely more
comprehensive in combining multiple avenues of intervention. (Id.)
Finally, we note but are not persuaded by Appellant's argument
that McCleary teaches away from the claimed invention. "[I]n
general, a reference will teach away if it suggests that the line of
development flowing from the reference's disclosure is unlikely to be
productive of the result sought by the applicant." In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994). Nothing in McCleary suggests that a
composition containing UFA and NORC should not be administered
to healthy aging animals to enhance cognitive function-in fact quite
the opposite as discussed above.
Appellant argues that, "since McCleary specifically teaches that
its enhancing compositions require 6 core components while
Appellants [sic] have used 2 components, one of which is taught by
McCleary as optional," McCleary in fact suggests that the
composition recited in claim 26 is unlikely to be productive "because
it does not require 5 core components used by McCleary." (Appeal
Br. 19.) Appellant further argues based on the above that the subject
matter of the invention exhibits unexpected results, especially because
"omission of an element and retention of its function is an indicia of
18
Appeal2017-005540
Application 12/734,013
unobviousness." (Id. at 20 (internal quotation marks and citation
omitted); see also generally id. at 19--21; Reply Br. 8-9.)
We are not persuaded for many of the same reasons already
discussed. In particular, McCleary suggests each of its individual
active ingredients, including L-arginine, is useful in treating some
aspect of cognitive impairment. (McCleary i-f 23; FF14-FF16.) Thus,
it is not unexpected that a combination of two of the active ingredients
disclosed in McCleary would enhance cognitive function. Neither has
Appellant shown that the combination of UFA and NORC results in
unexpectedly superior enhancement of cognitive function when
compared to McCleary's compositions.
Likewise, unexpected results must be shown to be
commensurate with the scope of the claim. In re Lindner, 457 F.2d
506, 508 (CCP A 1972). Claim 26 encompasses a composition
containing the other active ingredients described in McCleary so long
as such a composition also contains UFA and NORC. Thus, assuming
arguendo that Appellant has shown it is unexpected that a
combination of UFA and NORC would enhance cognitive function-
which Appellant has not-Appellant has not shown such unexpected
results commensurate with the scope of claim 26.
Accordingly, we affirm the Examiner's rejection of claim 26 as
obvious over McCleary. Claims 30, 32, 36, 45, 46, 49, 196-198, and 201-
210, which were not separately argued, fall with claim 26. 37 C.F.R.
§ 41.37(c)(l)(iv).
19
Appeal2017-005540
Application 12/734,013
SUMMARY
For the reasons above, we reverse the Examiner's rejection of claims
26, 30, 32, 36, 45, 46, 49, 196-198, and 201-210 as anticipated by
McCleary but affirm the rejection of claims 26, 30, 32, 36, 45, 46, 49, 196-
198, and 201-210 as obvious over McCleary.
AFFIRMED
20