Ex Parte Remmereit

Patent Trial and Appeal Board

Apr 6, 2018

13463964 (P.T.A.B. Apr. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
13/463,964
72960 7590
Casimir Jones, S.C.
FILING DATE
05/04/2012
04/10/2018
2275 Deming Way Ste 310
Middleton, WI 53562
FIRST NAMED INVENTOR
Jan Remmereit
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.
LSNAS-32001/US-2/0RD 4845
EXAMINER
PROSSER, ALISSA J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
04/10/2018 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):
docketing@casimirjones.com
pto .correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAN REMMEREIT
Appeal2017-005454
Application 13/463,964 1
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods of
improving a performance parameter in a horse. The Examiner entered final
rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 Appellant identifies the real party in interest as "Life Science Nutrition
AS." Br. 3.
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Application 13/463,964
STATEMENT OF THE CASE
Background
The Specification discloses that the economic industry relating to
equines has an economic impact approaching $102 billion, that "substantial
financial resources are devoted to ensuring the health and well being of
horses ... , [that] the horse racing industry has a substantial economic impact
... [and, that] there is great need for supplements which enhance the
performance of horses, as well as which improve the health and well being
of horses." Spec. 1:26-33.
The Specification discloses a "composition containing sialic acids or
precursors, and their use to improve performance-related and social
parameters in mammals, particularly humans and horses." Id. at 1 :9--11.
Claims 15, 17-25, and 28-33 are pending and on appeal. Br. 3.
Claim 15, the sole independent claim, is illustrative and reads as follows:
15. A method of improving a performance parameter in
a horse comprising:
administering to a horse in need thereof a composition
comprising an effective amount of a sialic acid composition or
sialic acid precursor composition sufficient to cause a positive
effect on said performance parameter in said horse, wherein
said performance parameter in said horse is selected from the
group consisting of reduction in injuries, increase in oxygen
uptake, reduction in lactic acid, increase in workload tolerance,
improved joint and ligament health, increase in endurance,
faster recuperation after workload, improved pulse parameters,
improved appearance, improved muscularity, improved coat
quality, and improved kidney function, and
monitoring said horse for improvement in said
performance parameter.
Br. 19--20 (Claims Appendix).
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The following rejections are before us to review:
I. Claims 15, 17-25, 28-31, and 33 are rejected under pre-AIA
35 U.S.C. § 103(a) as obvious over Remmereit, 2 Johnson, 3
Wikipedia, 4 and Sola-Penna. 5
II. Claim 32 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Remmereit, Johnson, Wikipedia, Sola-Penna, and Colarow. 6
III. Claims 15, 17, 18, 20-23, 28, 29, 31, and 32 are rejected underpre-
AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell,7
Pugliese, 8 and Wang 1. 9
IV. Claim 19 is rejected underpre-AIA 35 U.S.C. § 103(a) as obvious
over Colarow, Fretwell, Pugliese, Wang 1, and Wang 2. 10
2 U.S. 2009/0221526 Al, published September 3, 2009 ("Remmereit").
3 Philip J. Johnson et al., Medical implications of obesity in horses - lessons
for human obesity, 3(1) J. DIABETES SCIENCE AND TECHNOLOGY 163-174
(2009) ("Johnson").
4 Wikipedia entry for "Horse," http://en.wikipedia.org/wiki/Horse, last
modified February 4, 2015 ("Wikipedia").
5 Mauro Sola-Penna, Metabolic regulation by lactate, 60(9) LIFE 605-608,
(2008) ("Sola-Penna").
6 WO 2010/052324 Al, published May 14, 2010 ("Colarow").
7 WO 2007 /031725 Al, published March 22, 2007 ("Fretwell").
8 Marco Pugliese et al., Severe cognitive impairment correlates with higher
cerebrospinal fluid levels of lactate and pyruvate in a canine model of senile
dementia, 29 PROGRESS INNEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL
PSYCHIATRY 603---610 (2005) ("Pugliese").
9 Bing Wang et al., Dietary sialic acid supplementation improves learning
and memory in piglets, 85 AMERICAN JOURNAL OF CLINICAL NUTRITION
561-569 (2007) ("Wang l").
10 B. Wang and J. Brand-Miller, The role and potential of sialic acid in
human nutrition, 57 EUROPEAN J. OF CLINICAL NUTRITION 1351-1369
(2003) ("Wang 2").
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V. Claim 24 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Colarow, Fretwell, Pugliese, Wang 1, and Jensen. 11
VI. Claim 25 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Colarow, Fretwell, Pugliese, Wang 1, and McMahon. 12
VII. Claims 30 and 33 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wassenaar. 13
Appellant has waived arguments based on Wang 2 for rejection IV,
Jensen for rejection V, McMahon for rejection VI, and Wassenaar for
rejection VII. Br. 15-17. See 37 C.F.R. § 41.37(c)(l)(iv) (Appeal Brief
must contain "[ t ]he arguments of appellant with respect to each ground of
rejection."); Hyatt v. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008) ("When
the appellant fails to contest a ground of rejection to the Board, ... the
Board may treat any argument with respect to that ground of rejection as
waived."). Accordingly, the issues that are dispositive for rejection III are
dispositive for rejections IV-VII.
I
The Examiner finds that Remmereit teaches "nutraceutical NGNA (n-
glycolylneuraminic acid) compositions" (e.g., "a composition comprising an
effective amount of a sialic acid composition or sialic acid precursor
composition"), that NGNA "induces physiological responses such as
alleviating (monitoring is implicit to alleviating) the symptoms of viral-
induced obesity, alleviating the symptoms of colds, preventing the onset of
11 U.S. 5,064,675, issued November 12, 1991 ("Jensen").
12 U.S. 2005/0096295 Al, published May 5, 2005 ("McMahon").
13 U.S. 2007/0048354 Al, published March 1, 2007 ("Wassenaar").
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colds, increasing energy and increasing the feeling of well-being in
subjects," and that Remmereit includes "any animal, such as a mammal like
a dog, cat, bird, livestock, and preferably a human" in its definition of a
subject. Final Act. 3--4. The Examiner finds Remmereit describes
monitoring subjects administered NGNA prior to exercise. Id. at 4. The
Examiner further finds that NGNA can be isolated from a natural source, the
sea cucumber (Holothuroidea Echinodermata), can be purchased from
commercial sources, or can be synthesized at up to 99% purity. Id. The
Examiner concludes that because the product is not 100% pure, at least some
of the parent mannosamine compound would be present in the NGNA final
synthesized product. Id. The Examiner further finds that Remmereit
discloses ranges ofNGNA for use as a dietary supplement, which renders
the claimed range obvious by overlap, and that the product may be
administered in multiple forms, with inert ingredients and other
supplements, and as a food product itself or included in animal feed. Id. at
5.
The Examiner finds Remmereit does not teach "administering to a
horse in need thereof and monitoring said horse for improvement in said
performance parameter which is a reduction in lactic acid." Id. However,
the Examiner finds that Johnson teaches that "obesity is common to many
domestic animal species, including horses," and that"[ e ]quine health
consequences of obesity include for example exercise intolerance (reduced
athleticism)." Id. at 6. The Examiner finds Johnson teaches that study of the
insulin resistance of a subject is used to characterize "the adverse medical
consequences of obesity." Id.
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The Examiner finds that the Wikipedia entry for "horse" discloses that
the range of horse weights can vary between 380 to 1000 kg. Id. The
Examiner finds that Sola-Penna teaches that "lactate levels are chronically
elevated in obese individuals, suggesting that elevated lactate decreases both
insulin section and responsiveness to insulin (insulin resistance)." Id.
The Examiner finds that, based on the teachings cited above, the
skilled artisan would have found it obvious to
administer the dietary supplement of Remmereit comprising
NGNA (a sialic acid or sialic acid precursor) which induces
physiological responses such as alleviating the symptoms of
viral-induced obesity, alleviating the symptoms of colds,
preventing the onset of colds, increasing energy and increasing
the feeling of well-being in subjects specifically to horses
because Johnson teach [sic] obesity is common to many
domestic animal species, inclusive of horses, and the health
consequences of equine obesity include for example exercise
intolerance.
Id. at 6-7. The Examiner finds the artisan would have reasonably expected
that administration ofNGNA "would alleviate the symptoms of obesity and
restore exercise tolerance," thereby improving the horse's performance
parameters, including reducing lactic acid, because "the method of
Remmereit in view of Johnson administers the same active (NGNA) in the
same dose as required by the dependent claims to the same patient
population (horses)." Id. at 7. The Examiner further concludes that because
Sola-Penna teaches that lactate levels are chronically elevated in obese
individuals, it would have been obvious to "specifically monitor the lactate
levels for a reduction thereof' and that the artisan would have known to
adjust dosing upwards as necessary for obese horses with respect to average
horses. Id. at 7-8.
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Appellant contends that the claimed invention is not obvious because
"the combined references do not teach each element of the claims, there is
no reasonable expectation of success, and the combination is improper and
not supported." Br. 9.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that Remmereit, Johnson,
Wikipedia, and Sola-Penna suggest the claimed method of improving a
performance parameter in a horse. We select claim 15 as representative of
the claims subject to this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv).
As stated in Jn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a prima
facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Here, Appellant does not persuade us that a preponderance of the
evidence fails to support the Examiner's conclusion that the claimed method
of improving a performance parameter in a horse would have been obvious
to an ordinary artisan.
Unless otherwise indicated herein, we adopt the Examiner's findings
of fact, reasoning on scope and content of the claims and prior art, and
conclusions set out in the Final Action and Answer. Final Act. 14 3-21; Ans.
2-10. Only those arguments made by Appellant in the Appeal Brief have
been considered in this Decision. Arguments not presented in the Brief are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
14 Examiner's Final Action, mailed December 16, 2015 ("Final Act.").
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We agree with the Examiner (see Final Act. 3-8; Ans. 6-8) that the
skilled artisan would have found it obvious to combine the teachings of
Remmereit, Johnson, Wikipedia, and Sola-Penna to practice the claimed
method of improving a performance parameter in a horse. As found by the
Examiner, Remmereit teaches administering nutraceutical NGNA
compositions to mammals because of its ability to alleviate the symptoms of
viral-induced obesity, treat and prevent colds, and increase the energy and
feeling of well-being in subjects. Remmereit Abstract, i-fi-12, 7, 39, 46. The
skilled artisan would also have learned that a mammal that was administered
NGNA compositions, or a precursor composition, could be monitored for an
increase of its performance based on the exercise study described by
Remmereit. Id. i-fi-173-79, Figures 2a-f. The skilled artisan would also have
learned from Remmereit the dose ranges, potential cofactors, and methods of
administration for mammals given NGNA as a dietary product, and how to
obtain NGNA from commercial and other sources. Id. i-fi-19, 42, 50-55, 57-
60, 63, 69, 71.
We further agree with the Examiner that the skilled artisan would
have learned by reading Johnson that horses are known to have obesity
issues, that obese horses are less able to exercise, and that monitoring insulin
resistance is a method used to characterize obesity in animals. Johnson 163,
166. The skilled artisan would have been informed by the Wikipedia entry
(Wikipedia 1) of a general range of weights for horses and have been able to
apply that information, along with the dosing information learned from
Remmereit, to determine a dose range to administer to an obese horse. The
skilled artisan would further have learned from Sola-Penna that obesity
correlates to elevated lactate levels, and that insulin secretion and
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responsiveness to insulin both decrease in obese individual. Sola-Penna
606-7.
We agree with the Examiner that the skilled artisan would have had a
reasonable expectation of success in practicing the claimed method using the
teachings of the cited references, in that the artisan would have been able to
administer a sufficient dose ofNGNA to a horse to reduce its lactic acid
and/ or increase its endurance and/ or improve its appearance and would have
known to monitor the horse's reduction in lactic acid, which comprises
measuring a parameter using a factor correlated to the performance aspect.
It is obvious to those skilled in the art to substitute one known equivalent for
another, as the Examiner has suggested here. See In re Omeprazole Patent
Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) ("[T]his court finds no ...
error in [the] conclusion that it would have been obvious to one skilled in the
art to substitute one ARC [alkaline reactive compound] for another.").
We conclude the combined teachings of the references as a whole
would have suggested the claimed invention to the ordinarily skilled artisan.
In re Keller, 642 F.2d 413, 425 (CCPA 1981) (The test for obviousness is
what the combined teachings of the references, as a whole would have
suggested to those of ordinary skill in the art). KSR Int 'l Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007).
We have considered Appellant's arguments but do not find them
persuasive.
Appellant argues that"[ n ]one of [the claimed] uses [i.e., performance
parameters] are directed or related to treatment of obesity or colds, or indeed
increased energy or well-being" and that "the combined references do not
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teach the claims element of a reduction in lactate following the
administration of the identified compounds." Br. 9.
We begin with claim construction, to determine the meaning of
"performance parameter" to apply in our analysis. The Specification does
not define "performance parameter." With regard to the use of sialic acid
compositions to improve performance parameters, the Specification provides
Examples 14 and 15. Spec. 22: 14--34. Both examples state that subjects
(Group A) were administered "the sialic acid formulation" and a control
group (Group B) administered a placebo. Id. The participants "maintain[ed]
existing workout and exercise patterns." In both examples, the Specification
states:
At the end of the trial, Group A reports improvements, as
compared to control Group B, in combinations of the following
parameters: reduction in injuries, reduction in infectious
disease, increase in lean muscle mass, increase in oxygen
uptake, reduction in lactic acid, increase in workload tolerance,
improved joint and ligament health, increase in endurance,
faster recuperation after exercise, faster recuperation from
disease, improved pulse parameters, improved gastric health,
improved food utilization, improved appearance, improved
muscularity, and improved kidney function.
Id. Thus, the Specification does not state any of the metrics by which an
ordinarily skilled artisan would "monitor" the claimed performance
parameters. Accordingly, we apply the broadest reasonable construction in
light of the Specification. See Phillips v. AWH Corp., 415 F.3d 1303, 1316
(Fed. Cir. 2005) (en bane) ("The Patent and Trademark Office ('PTO')
determines the scope of claims in patent applications not solely on the basis
of the claim language, but upon giving claims their broadest reasonable
construction 'in light of the specification as it would be interpreted by one of
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ordinary skill in the art."' (quoting In re Am. A cad. of Sci. Tech Ctr., 3 67
F.3d 1359, 1364 (Fed. Cir. 2004))).
With specific regard to the claimed performance parameters
"reduction in injuries, increase in oxygen uptake, reduction in lactic acid,
increase in workload tolerance, improved joint and ligament health, increase
in endurance, faster recuperation after workload, improved pulse parameters,
improved appearance, improved muscularity, improved coat quality, and
improved kidney function," we find that these are characteristics of a horse
that may improve or decline and that can be functionally measured by
observation or testing. We further find that the skilled artisan would have
understood that each of these parameters is subject to measurement, and that
the measurement is objective in some cases (e.g., reduction in lactic acid)
and subjective in others (e.g., improved appearance). For each parameter,
we find the ordinarily skilled artisan would have found it reasonable to
measure - and thereby monitor- the respective improvement in any given
parameter using metrics customarily and reasonably associated with or
applied to each parameter. For instance, "reduction in lactic acid" could be
measured by chemical assessment of samples and "faster recuperation after
workload" could reasonably be interpreted as shortening the time after
which the horse is able to return to a subsequent task, whether improved by
minutes, hours or days.
We further find that a skilled artisan would reasonably have believed
that a horse having "increased energy or well being" or having received
treatment for a cold would be expected to recuperate more quickly after
work; as such, the skilled artisan would reasonably have correlated
"increased energy or well being" to either the "faster recuperation after
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workload" parameter or to "increase in workload tolerance." We further
find that the skilled artisan would reasonably have believed that an obese
horse would have a slimmer appearance and that "improved appearance" or
"improved muscularity" could reasonably result from reducing the horse's
obesity. Accordingly, we agree with the Examiner that treating obesity,
providing increased energy, and increasing the well-being of a subject, each
of which can be accomplished through administration ofNGNA, are each
methods "to improve a performance parameter in a horse" as recited in claim
15 based on application of the broadest reasonable construction of those
terms in light of the Specification.
Appellant next argues that the Examiner's reasoning behind the prima
facie case is flawed. Br. 11. According to Appellant, Remmereit does not
teach that AD-36, which Remmereit indicates causes viral obesity in
humans, "infects or causes obesity in horses or animals other than humans
and no indication that administration ofNGNA reduces lactic acid in any
animal, much less horses," "Johnson does not provide a nexus between
reduced lactate in horses and treatment of obesity in horses," and Sola-Penna
teaches "that lactate levels are increased in diabetic obese individuals, and
contain[ s] no statement about non-diabetic, obese individuals in general."
Id. Appellant argues that the Examiner's rationale is "clearly based on
hindsight and is in error" and a 'jump from a teaching regarding obesity
related to AD-36 infection in humans as taught in Remmereit, to conditions
associated with obese diabetic humans as taught in Sola-Penna, [then tied] to
obesity in horses." Id.
The Examiner responds that Remmereit's teachings of use ofNGNA
"include, but are not limited to, individuals suffering from viral obesity ...
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symptoms of viral-induced obesity include weight gain, weight loss and
obesity." Ans. 7. The Examiner notes that Remmereit claims "alleviating
symptoms and ... the administration of an antiviral" and "does not identify
whether the test subjects were infected with AD-36." Id.
We are not persuaded that the Examiner's rationale is error. We agree
with the Examiner that Remmereit's teachings are not constrained to viral
obesity caused by AD-36. Rather, Remmereit shows that NGNA can be
used to address obesity as well as cold symptoms and to generally increase
the well-being of subjects. Remmereit Abstract, i-fi-12, 7, 39, 46. "It is well
settled that a prior art reference is relevant for all that it teaches to those of
ordinary skill in the art." In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992).
Because, as discussed above, treating obesity, treating colds, providing
increased energy, and increasing the well-being of a subject are each
methods "to improve a performance parameter in a horse," we agree with the
Examiner that Remmereit teaches this limitation of claim 15.
Sola-Penna discloses that "lactate levels are chronically elevated in
diabetic obese individuals" and that the elevation "is sustained by the
augmented lactate production by adipocytes from obese subjects (29), can be
found prior to diabetes onset (28), and may participate on this process.
Lactate production by adipocytes is proportional to the volume of these cells
(30) and thus to the degree of obesity." Sola-Penna 606 (emphasis in
original). Accordingly, we find Sola-Penna's teachings correlate lactate
production to general obesity and are not observations restricted to
individuals having diabetes. The Examiner relied on Johnson for its
teachings that horses are known to have obesity issues, that obese horses are
less able to exercise, and that monitoring insulin resistance is a method used
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to characterize obesity in animals. Johnson 163, 166. Appellant's argument
regarding the lack of demonstrated nexus is thus unpersuasive as the test for
obviousness is what the combined teachings of the references, as a whole
would have suggested to those of ordinary skill in the art. Keller, 642 F.2d
at 425. The law does not require that the teachings of the reference be
combined for the reason or advantage contemplated by the inventor, as long
as some suggestion to combine the elements is provided by the prior art as a
whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976). As discussed above, we find the
suggestion to combine exists here and we discern no error in the Examiner's
reasonable interpretation that, e.g., the performance parameter of "improved
appearance" could have been achieved by the skilled artisan through
targeting obesity, as taught by the references.
We also acknowledge, but are unpersuaded by, Appellant's argument
regarding "hindsight." Br. 11. Appellant points to no evidence that any of
the Examiner's findings were beyond the level of ordinary skill at the time
of the invention or could have been taken only from Appellant's
Specification. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
Conclusion of Law
A preponderance of the evidence supports the Examiner's conclusion
that Remmereit, Johnson, Wikipedia, and Sola-Penna suggest the claimed
method of improving a performance parameter in a horse. Claims 17-25,
28-31, and 33 have not been argued separately and therefore fall with claim
15. 37 C.F.R. § 41.37(c)(l)(iv).
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II
Claim 3 1 depends from independent claim 31 and recites that the
"sialic acid or sialic acid precursor are derived from a natural source." Br.
21 (Claims App.) Claim 32 depends from claim 31 and recites that the
"natural source is a non-animal or non-mammalian source." Id.
The Examiner finds that Remmereit, Johnson, Wikipedia, and Sola-
Penna do not teach "wherein the natural source is a non-animal or non-
mammalian source" but finds that "Colarow teach sialic acid can be easily
provided from bacterial sources (natural source, non-animal)." Final Act. 8-
9. The Examiner finds that "Remmereit and Colarow are analogous
inventions in nutritional supplementation comprising sialic acids" and that
the skilled artisan would have found it obvious to "use sialic acids provided
from bacterial sources (non-animal natural source) as taught by Colarow in
the NGNA compositions of Remmereit because simple substitution of
functionally equivalent elements yields predictable results, absent evidence
to the contrary." Id. at 9.
We agree with the Examiner that, absent evidence to the contrary,
substitution of sialic acid from a non-animal or non-mammalian source
would be expected to be equivalent and would be obvious to the skilled
artisan. "Express suggestion to substitute one equivalent for another need
not be present to render such substitution obvious." In re Fout, 675 F.2d
297, 301, (CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed.
Cir. 1997) ("Because the applicants merely substituted one element known
in the art for a known equivalent, this court affirms [the rejection for
obviousness].").
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Appellant argues that Colarow "does not cure the defects noted for the
combination of Remmereit, Johnson, Wikipedia, and Sola-Penna noted
above." Br. 12. Appellant argues that "Colarow teaches the following uses:
treatment or prevention of neurodegeneration, improvement of cognitive
performance, improvement of brain development, support of the immune
system, boosting immunity and improving gut function," which Appellant
argues are not the claimed uses (performance parameters). Id.
We are not persuaded. As discussed with respect to the first rejection,
Remmereit, Johnson, Wikipedia, and Sola-Penna suggest the claimed
method of improving a performance parameter in a horse. The Examiner
relies on Colarow for the teaching that sialic acid can be obtained from
bacterial sources. Final Act. 9. Appellant has provided no evidence or
persuasive argument why the ordinarily skilled artisan would not have
successfully used Colarow's teachings to obtain sialic acid from bacterial
sources. Attorney arguments and conclusory statements that are
unsupported by factual evidence are entitled to little probative value. See In
re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). We affirm the rejection of
claim 32.
III
The Examiner has rejected claims 15, 17, 18, 20-23, 28, 29, 31, and
32 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell,
Pugliese, and Wang 1. The Examiner finds that Colarow teaches that
"[ s ]ialic acids are a family of charged nine carbon mono saccharides derived
from neuraminic acid" that can be used as "sialic acid enriched food
products (oral administration) intended for humans or animals, in particular
companion animals, pets, and/or livestock." Final Act. 10. The Examiner
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finds that food enriched with sialic acid can "promote healthy growth and
aging and improve cognitive functioning, reduce low grade inflammations,
[and] improve the gut barrier." Id. The Examiner finds that by virtue of
teaching improving the gut barrier and reducing inflammation, that Colarow
teaches monitoring the subject for the effect of the administration. Id. The
Examiner finds that Colarow teaches N-acetylneuraminic acid as a preferred
embodiment, along with natural sources of sialic acids, use of sialic acids to
fortify foodstuffs, and ranges for sialic acid amounts in food products along
with organic and inorganic carriers, vitamins, minerals, and
protein/carbohydrate/lipid sources that can accompany sialic acid in
foodstuffs. Id. at 10-11.
The Examiner finds Colarow does not teach "administering
specifically to animals that are horses in need thereof and monitoring said
horse for improvement in said performance parameter which is a reduction
in lactic acid as required by claim 15 and the elected embodiment thereof."
Id. at 11.
The Examiner finds Fretwell teaches "a food supplement and a
method for improving the cognitive ability (functioning) of a companion
animal including domestic animals such as cats, dogs and horses comprising
the administration of leucine, isoleucine and valine." Id. The Examiner
further finds Fretwell teaches that "[t]he ability of an animal to carry out a
vital or required function depends on the cognitive ability and/or function of
an animal" and that "improvement in cognitive ability results in an
improvement in physical performance." Id. at 11-12.
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The Examiner finds Pugliese teaches that in a dog model "there is a
parallel increase of lactate, pyruvate and potassium concentrations in
[instances of] severe cognitive deficit." Id. at 12.
The Examiner finds Wang teaches that "in animal models an
exogenous source of sialic acid increased learning performance" and
provided dose ranges for varying animals by weight. Id.
The Examiner finds that, based on the teachings cited above, the
skilled artisan would have found it obvious
to administer the sialic acid enriched food products of Colarow
intended for humans or animals, in particular companion
animals, pets, and/or livestock for promoting healthy growth
and aging, improving cognitive functioning, reducing low grade
inflammations and improving the gut barrier to horses because
Fretwell teach companion animals including domestic animals
such as horses are in need of a food supplement for improving
cognitive ability.
Id. at 13. The Examiner further concludes the skilled artisan would have
been motivated to combine the teachings of Colarow and Fretwell "because
the ability of an animal to carry out a vital or required function depends on
the cognitive ability and/or function of the animal and the improvement in
cognitive ability results in an improvement in physical performance" and
that the artisan would have had a reasonable expectation of success because
"Colarow contemplate the administration of the sialic acid enriched food
product in particular to companion animals, pets and/or livestock and
Fretwell explicitly contemplate administration to companion animals
including domestic animals such as horses." Id. The Examiner finds that
Colarow' s teaching of improvement of certain parameters "implies the
monitoring of said parameters." Id. Because Pugliese teaches that cognitive
impairment correlates with higher levels of lactate in a dog model, the
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Examiner finds the skilled artisan would have further found it obvious "to
specifically monitor the lactate levels for a reduction thereof." Id. The
Examiner further finds that Wang would have provided the artisan with
information necessary "to administer a daily dosage of the sialic acid
enriched food product of Colarow such that the food is fortified" because
Wang provides guidance on "the sialic acid content of a commercially
available pig milk replacer and the maximum daily dosage of Wang is
comparable to the amount of sialic acid naturally present in sow milk and the
results of Wang show sialic supplementation enhances learning." Id. at 14.
The Examiner finds the overlap in the claimed ranges of the rejected claims
supports that the method would have been obvious. Id.
Appellant argues "the references do not teach each element of the
claims, do not provide a reasonable expectation of success, and are not
properly combinable." Br. 13. Appellant argues that Colarow does not
teach the claimed uses for improving performance parameters in a horse, but
rather teaches the use of sialic acid to improve cognitive function. Br. 13.
Appellant further argues that because "Fretwell, Pugliese and Wang likewise
teach uses related to cognitive function" the combined references do not
teach the claimed uses or support a prima facie case of obviousness because
the references lack a "teaching or suggestion ... that administration sialic
acid decreases lactate accumulation in horses (or any of the other claimed
uses)." Id. at 13-14. Rather, Appellant argues, the Examiner has "jumped
from use for treating cognitive impairment to use for reducing lactate
accumulation while providing no scientifically sound support for that jump."
Id. at 14. According to Appellant, Pugliese's "teach[ings] that cognitive
impairment in dogs is associated with high levels of lactate is completely
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irrelevant to whether administration of sialic acid to a horse with reduce
lactate accumulation" and that regardless of the mechanism "for the
increased lactate in dogs observed by Pugliese, there is no evidence that that
[sic] mechanism is any way related to lactate accumulation in horses." Id. at
15. Appellant contends the skilled artisan would not have combined the
references as suggested, or, in doing so, have believed a reasonable
expectation of success in practicing the claimed method. Id.
The Examiner responds that
inherency may supply a missing claim limitation in an
obviousness analysis where the limitation is the natural result of
the combination of prior art elements. Appellant's result to be
achieved of a reduction in lactate is a necessary (inherent)
consequence of the administration of sialic acid or a precursor
thereof to a horse.
Ans. 9. The Examiner further responds that the rejection provides a
rationale for administering an amount within the claimed range of a sialic
acid composition to a horse, and the reason for doing so, rendering the
claimed method obvious. Id. The Examiner further responds that Pugliese
is relied upon for its teachings that "cognitive impairment correlates with
higher levels of lactate in a dog model," which would have taught the
ordinary artisan that monitoring lactate levels for a reduction of lactate
would be a means to measure cognitive impairment or fatigue associated
with high lactate. Id.
We are persuaded by Appellant's arguments that the Examiner's
rejection is not supported by the weight of evidence. Claim 15 recites the
following performance parameters subject to monitoring: "reduction in
injuries, increase in oxygen uptake, reduction in lactic acid, increase in
workload tolerance, improved joint and ligament health, increase in
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endurance, faster recuperation after workload, improved pulse parameters,
improved appearance, improved muscularity, improved coat quality, and
improved kidney function." Br. 19-20. Although we understand the
Examiner's logic that an animal's ability to perform depends on its cognitive
ability, we are mindful that the Federal Circuit has found, "obviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention." Belden Inc. v. Berk-TekLLC, 805 F.3d
1064, 1073 (Fed. Cir. 2015). Ultimately, therefore, "[i]n determining
whether obviousness is established by combining the teachings of the prior
art, 'the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art."' In re GPAC Inc., 57 F.3d
1573, 1581 (Fed. Cir. 1995) (citation omitted).
In this regard, we are not persuaded that the skilled artisan, upon
reading Colarow, Fretwell, Pugliese and Wang 1, would have been
motivated to use the demonstrated benefits of sialic acid in improving
cognition to improve the recited performance parameters in Appellant's
claim 15. We agree with Appellant that a preponderance of the evidence
does not support the Examiner's conclusion of obviousness over these
references. We reverse the rejection of claims 15, 17, 18, 20-23, 28, 29, 31,
and 32.
IV-VII
Claim 19 stands rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wang 2. Claim 24
stands rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow,
Fretwell, Pugliese, Wang 1, and Jensen. Claim 25 stands rejected under pre-
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AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang
1, and McMahon. Claims 30 and 33 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and
Wassenaar. Appellant has waived arguments based on Wang 2, Jensen,
McMahon, and Wassenaar. Br. 15-17. Each of these rejections depends on
the findings of the Examiner with regard to Colarow, Fretwell, Pugliese, and
Wang 1, and the Examiner does not advance additional findings that address
the deficiency discussed above with regard to rejection III. See Final Act.
15, and 17-19. We therefore reverse the rejection of claims 19, 24, 25, 30,
and 33 for the reasons discussed above.
SUMMARY
We affirm the rejection of claims 15, 17-25, 28-31, and 33 under pre-
AIA 35 U.S.C. § 103(a) as obvious over Remmereit, Johnson, Wikipedia,
and Sola-Penna.
We affirm the rejection of claim 32 under pre-AIA 35 U.S.C. § 103(a)
as obvious over Remmereit, Johnson, Wikipedia, Sola-Penna, and Colarow.
We reverse the rejection of claims 15, 17, 18, 20-23, 28, 29, 31, and
32 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell,
Pugliese, and Wang 1.
We reverse the rejection of claim 19 under pre-AIA 35 U.S.C. §
103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wang 2.
We reverse the rejection of claim 24 under pre-AIA 35 U.S.C. §
103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Jensen.
We reverse the rejection of claim 25 under pre-AIA 35 U.S.C. §
103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and McMahon.
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We reverse the rejection of claims 30 and 33 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and
Wassenaar.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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