Dante Duarte Lanna et al.

Patent Trials and Appeals Board

Mar 18, 2021

2020002396 (P.T.A.B. Mar. 18, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/175,716 07/18/2008 Dante Pazzanese Duarte Lanna NEHM-01DV 1092
26875 7590 03/18/2021
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI, OH 45202
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/18/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte MARK A. MCGUIRE,
SERGIO RAPOSO DE MEDEIROS,
DIMAS ESTRASULAS DE OLIVEIRA, and
LUIS JANUARIO AROEIRA1
________________

Appeal 2020-002396
Application 12/175,716
Technology Center 1600
________________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the term “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies Fundacao de Amparo a Pesquisa
do Estado de Sao Paulo as the real party-in-interest. App. Br. 1.
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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 22 and 24–31 as unpatentable under 35
U.S.C. § 103 as being obvious over the combination of C.R. Staples et al.,
Influence of Supplemental Fats on Reproductive Tissues and Performance of
Lactating Cows, 81 J. DAIRY SCI. 856–71 (1998) (“Staples”) and O’Quinn et
al. (US 6,020,377, February 1, 2000) (“O’Quinn”).
Claims 22 and 24–31 also stand rejected as unpatentable under 35
U.S.C. § 103 as being obvious over G. Bee, Dietary Conjugated Linoleic
Acids Alter Adipose Tissue and Milk Lipids of Pregnant and Lactating Sows,
130 J. NUTR. 2292–98, (2000) (”Bee”).
Claims 22 and 24–31 stand further rejected as unpatentable under 35
U.S.C. § 103 as being obvious over S.F. Chin et al., Conjugated Linoleic
Acid Is a Growth Factor for Rats as Shown by Enhanced Weight Gain and
Improved Feed Efficiency, 124 J. NUTR. 2344–49 (1994) (“Chin”).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to a process for improving
reproductive performance using a mixture of fatty acids with or without
additional proteins to be used in agriculture and animal nutrition. Spec. ¶ 2.

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REPRESENTATIVE CLAIM
Independent claim 22 is representative of the claims on appeal
and recites:
22. A method of improving reproductive performance
in a ruminant mammal, comprising:

administering to a healthy, female, ruminant mammal a
composition including at least one conjugated linoleic acid
chosen from C18:2 cis 9, trans 11; C18:2 trans 10, cis 12; C18:2
cis 8, trans 10; C18:2 trans 9, cis 11; and mixtures thereof;

wherein the composition is administered in an amount
such that the ruminant mammal absorbs 1g to 95g of the at least
one conjugated linoleic acid per day;

wherein improvement in reproductive performance of the
healthy, female, ruminant mammal is measured by the
percentage of pregnant females in a first plurality of healthy,
female ruminant mammals having been administered said
composition as compared to the percentage of pregnant females
in a second plurality of healthy, female mammals that have not
been administered said composition.

App. Br. 34.

ISSUES AND ANALYSES
We decline to adopt the Examiner’s findings, reasoning, and
conclusion that the claims on appeal are prima facie obvious over the
combined cited prior art. We address the arguments raised by Appellant
below.

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1. Rejection of claims 22 and 24–31 over Staples and O’Quinn
Issue 1

Appellant argues that the Examiner erred because a person of ordinary
skill in the art would have had no reason to combine the teachings of Staples
and O’Quinn to arrive at the claimed invention. App. Br. 8–29.

Analysis
The Examiner finds that Staples teaches that dietary fat improves
reproductive performance. Final Act. 8. The Examiner finds that Staples
teaches that dairy cows, post-insemination and fed with fishmeal, partially
hydrogenated tallow, soybeans, whole cottonseed, and other supplements
including calcium soaps of fats influence the reproductive status of the cows.
Id. (citing Staples Abstr., Table 2, 857). The Examiner finds that Staples
also teaches that cis-linoleic acid (C 18:2), is commonly found in natural
fat sources: the major fatty acid in most seed lipids (e.g., corn and soybean
meal) is linoleic acid (C18:2). Id.
The Examiner also finds that Staples teaches that linoleic acid (C18:3)
predominates in most forage lipid. Final Act. 8. The Examiner finds that
Staples teaches that linoleic acid and eicosapentaenoic acid (found in fish
meal) are proven inhibitors of cyclooxygenase in endometrial tissue of dairy
cows, and that many of the naturally occurring, unprocessed plant oils
contain a large proportion of long-chain, polyunsaturated fatty acids, such as
linoleic acid. Id. The Examiner finds that Staples teaches the amounts of
linoleic acid delivered to the small intestine by supplemental fat sources
ranges from approximately 2 to 120 g/d per cow. Id. (citing Staples Table
1).
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The Examiner finds, however, that although Staples teaches linoleic
acid, it does not teach conjugated linoleic acid. Final Act. 8. However, the
Examiner finds that O’Quinn teaches that feeds can include other
components such as soybean meal, vitamin premix, limestone (calcium
carbonate) and, monocalcium phosphate. Final Act. 9. The Examiner finds
that O’Quinn also teaches the addition of conjugated linoleic acid, which
comprises C18:2; cis 9, trans 11; trans 10, cis 12; and trans 9, cis 11. Id.
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to use other components such as soybean meal,
vitamin premix, limestone (calcium carbonate) and, monocalcium phosphate
in feeds. Final Act. 9. The Examiner concludes that a skilled artisan would
have been motivated by the teachings of O’Quinn that a feed can include
soybean meal, vitamin premix, limestone (calcium carbonate) and,
monocalcium phosphate. Id. Consequently, the Examiner concludes, a
skilled artisan would have had a reasonable expectation of successfully
producing a feed with soybean meal, vitamin premix, limestone (calcium
carbonate) and, monocalcium phosphate. The Examiner additionally
concludes that the isomer/enantiomer of a racemate is prima facie obvious.
Id. (citing In re Adamson, 275 F.2d 952, 955 (C.C.P.A. 1960)).
Appellant argues that, as an initial matter, “linoleic acid,” as taught by
Staples, does not encompasses conjugated linoleic acids (“CLAs”), or that
CLAs would be obvious in view of Staples’ teaching of “linoleic acid.”
App. Br. 8.
Appellant points to several prior art references that purport to teach
that one skilled in the art, comparing CLA versus linoleic acid, would
consider the results discussed and claimed in the present application with
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CLA to be unexpected. Id. Appellant first points to M.W. Pariza et al., The
Biologically Active Isomers of Conjugated Linoleic Acid, 40 PROG. LIPID
RES. 283–98 (2001) (“Pariza”). Id. at 9. According to Appellant, Pariza
teaches that: “Emerging evidence indicates that the cis-9, trans-11 and trans-
10, cis-12 CLA isomers produce different effects. Today we know that
these effects can be actually opposite. Given the structural differences
between these isomers, it is most unlikely that a single biochemical
mechanism underlies these effects.” Id. (quoting Pariza 285). Appellant
argues that Pariza thus teaches that that different CLA isomers can exhibit
different activities, such that the activity of one compound cannot be
predicted from another, and, specifically, that the activity of CLA cannot be
predicted from linoeic acid generally. Id.
Appellant next points to L.H. Baumgard, Identification of the
Conjugated Linoleic Acid Isomer that Inhibits Milk Fat Synthesis, 278 AM.
J. PHYSIOL.: REG. INTEGR. COMP. PHYSIOL., R179–84 (2000) (“Baumgard”).
App. Br. 10. According to Appellant, Baumgard teaches that, when
compared with the linoleic acid (cis-9, cis 12)-containing (control), and CLA
cis 9, trans 11 abomasal infusions, abomasal infusion of CLA trans 10, cis
12 significantly decreased milk fat values. Id. at 11–12 (citing Baumgard
Fig. 1).
Appellant argues from these, and other cited prior art references that
the state of the art at the time of the invention was such that the bioactivities
of linoleic acid and CLAs were so varied that a skilled artisan could not have
predicted the metabolic properties of a given CLA isomer of linoleic acid.
App. Br. 14.
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We agree with Appellant that the Examiner has failed to establish a
prima facie case of obviousness over the teachings of Staples and O’Quinn.
Staples teaches:
Protection of dehulled cottonseeds with protein-aldehyde
complexes (Protected Lipid; Rumentek Industries, Australia)
delivered approximately 175 g/d of linoleic acid to the lower gut
of lactating Hereford cows. Overall pregnancy rates were
improved from 63 to 79%…. The advantages of diets that are
high in linoleic acid on reproductive performance may be greater
during periods of heat stress because PGF2α synthesis is
increased during that time.
….

Growing evidence indicates that the design and delivery of
supplemental fatty acids to the lower gut may target reproductive
tissues to improve reproductive function and fertility.…
Improvement in embryo survival may be associated with the
suppression of uterine prostaglandin secretion via linoleic acid or
other longer chain unsaturated fatty acids.

Staples, 868–69 (internal references omitted). Staples thus teaches that
lineolic acid (in which the alkene groups at carbons 9 and 12 are both cis),
administered at approximately twice claimed dosage, demonstrated
“improvement in reproductive performance of the healthy, female,
ruminant mammal[s],” as “measured by the percentage of pregnant females
in a first plurality … having been administered said composition as
compared to the percentage of pregnant females in a second plurality … that
have not been administered said composition” as required by claim 22.
However, and as the Examiner acknowledges, Staples is silent with
respect to CLAs, including those recited in the claims. See Final Act. 8. To
cure this deficiency, the Examiner cites O’Quinn. O’Quinn teaches:
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The present invention overcomes the problems outlined above by
providing an improved and economical supplemented animal
feed and method for increasing the average daily gain (ADG) of
pigs at all growth intervals (from farrow to finish). The invention
is predicated on the fact that Modified Tail Oil (MTO), having a
desirable unsaturated fatty acid profile can be added in small
amounts to the pig[’]s normal diet, increasing the ADG and thus
decreasing the number of days necessary to attain market weight.
The addition of MTO also improves the carcass characteristics
of the pig when compared with non-supplemented pig diets.

O’Quinn col. 2, ll. 10–20. O’Quinn teaches that its MTO contains CLAs,
including: (1) cis and trans 9, 11 mix; (2) trans 9, trans 11; (3) cis 10, cis
12; and (4) trans 10, cis 12, and mixtures thereof. Id. at Table A. CLAs (1)
(both isomers) and (3) are recited in claim 12.
However, O’Quinn is not directed to improving reproductive
performance in ruminants; rather, it is directed to increasing the average
daily gain (i.e., of weight) of domestic pigs (which are not ruminants)
throughout the lifespan of the animal. The Examiner does not point to, nor
can we discern, any teaching or suggestion of O’Quinn relating to the
administration of CLAs to ruminants, or to the effect of such administration
upon reproductive performance. As such, we do not see how the combined
references directly teach or suggest the limitations of the claims reciting
administration of CLAs to ruminants or the effect of such administration
upon reproductive performance as defined in the claims.
Nor are we persuaded by the Examiner’s reasoning that, because
Staples teaches that administration of large doses of lineolic acid is related to
increases in bovine pregnancies, a person of ordinary skill in the art would
have found it obvious to substitute the CLAs taught by O’Quinn with a
reasonable expectation of success. O’Quinn teaches that:
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Conjugated Linoleic Acid (CLA). CLA is a collective term used
to describe several forms of linoleic configuration. Conjugated
linoleic acid has either the cis or trans acid, or both, located on
carbons 9 and 11, 10 and 12, or 11 and 13. It is thought that the
cis 9, trans 11 form of CLA is the biologically active form which
can be incorporated into phospholipids in the body.

O’Quinn col. 1, ll. 44–51 (emphasis added). Bee (cited by the Examiner in
one of the accompanying rejections) teaches: “Conjugated linoleic acids
(CLA), a naturally occurring group of dienoic derivatives of linoleic acid,
have been shown to have a variety of effects in animal models,” but does not
teach improved reproductive performance in ruminants. Bee 2292 (internal
reference omitted).
Similarly, Baumgard (cited by Appellant), teaches:
Conjugated Linoleic Acids (CLA) are octadecadienoic acids that
are found predominately in food products derived from ruminant
animals. They have been implicated in a wide range of beneficial
effects, including anticarcinogenic. antidiabetic, and immune
stimulation. CLA have also been shown to reduce body fat and
alter nutrient partitioning in growing animals, including mice and
pigs. However, all of these biological effects have been observed
using dietary supplements that contain a variety of CLA isomers,
and effects of specific isomers are unknown.

Baumgard, R179 (emphasis added, internal references omitted). Baumgard
further teaches that: “CLA administration also affects lipid synthesis in
lactating cows, resulting in marked reductions in milk fat secretion.” Id.
(internal references omitted).
What emerges from the diverse teachings of these references is that
the metabolic effects of the administration of CLAs are generally unknown
and, therefore, unpredictable, and may even adversely affect aspects of
reproductive physiology in ruminants (viz., decreased milk fat secretion).
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The Examiner, relying upon Adamson, reasons that because CLAs are
isomers of lineolic acid, they are therefore prima facie obvious. See Final
Act. 9. We are not persuaded. The claim at issue in Adamson was a
composition claim, and not a method of administering a composition to
achieve a certain end. 275 F.2d at 952 (finding that claim 1 recited “[a]
laevo-isomer of a compound selected from the class consisting of 1-
cyclohexyl-1-phenyl-3-piperidinopropan-1-ol and 1-cyclohexyl-1-phenyl-3-
pyrrolidinopropan-1-ol and their acid addition salts and quaternary
ammonium salts substantially separated from the dextro-isomer”). The
predecessor to our reviewing court found that the prior art taught that the
claimed composition was one of a pair of isomers disclosed as being a
racemate (i.e., an optically neutral composition of opposing stereoisomers).
275 F.2d at 954. In concluding that the laevo-isomer was obvious over the
racemate, the court held that: “It is our opinion that the Karrer teachings
would suggest to one skilled in the art that the racemates of the Adamson
references may be resolved into their laevo- and dextroisomers, and
appellants in following the teachings of the cited prior art have done no more
than the obvious.” Id. at 955.
Such is not the case in the appeal presently before us. Appellant does
not attempt to claim CLAs as compositions that are patentably structurally
distinct from linoleic acid based upon the fact that they are isomers. Rather,
Appellant claims a method of administering certain CLAs, and mixtures
thereof, as a means of improving reproductive performance in ruminants.
We find that the Examiner has not established, based upon the teachings of
Staples and O’Quinn, why a skilled artisan would have been motivated to
combine the teachings of the references to arrive at the claimed invention.
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We are therefore not persuaded, for the reasons we have explained, that the
Examiner has established a prima facie case that the claims in appeal are
obvious over the combined teachings and suggestions of the prior art
references. We consequently reverse the Examiner’s rejection upon this
ground.

2. Rejection of claims 22 and 24–31 over Bee
The Examiner finds that Bee teaches treatment of pregnant sows (i.e.,
female pigs) with dietary conjugated linoliec acid. Final Act. 10. The
Examiner finds that Bee teaches that the administered CLAs were (in order
of magnitude) (1) cis 9, trans 11; (2) trans 10, cis 12; (3) cis 9, cis 11; (4) a
trans 9, trans 11/trans 10, trans 12 mix; and (5) cis 10, cis 12 administered
in the amounts to 58.9 g/100 g fat. Id. The Examiner finds that, because of
the many similarities between pigs and humans, the results of dietary
supplementation with CLA in sows may serve as a model for the effects of
CLA supplementation on human milk composition. Id. The Examiner also
notes that Bee teaches that, in dairy cows, infusion of CLA into the
abomasum altered milk fatty acid composition and markedly depressed the
total content and yield of milk fat. Id.
The Examiner acknowledges that Bee fails to otherwise teach the
treatment of ruminants with CLAs. Final Act. 10. Nevertheless, the
Examiner concludes that it would have been obvious to one of ordinary skill
in the art to interchange the use of CLA in sows, as taught by Bee, and cows.
Id. The Examiner concludes that a person of ordinary skill in the art would
have been motivated to do so, because Bee teaches that cows and sows have
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both been treated with CLAs, and that a skilled artisan would therefore have
had a reasonable expectation of success. Id. at 10–11.
We are not persuaded that the Examiner has established a prima facie
case of obviousness. Bee summarizes its teachings thus:
In conclusion, the data show that feeding sows a CLA-enriched
diet during gestation and lactation can increase the concentration
of CLA and markedly affect the fatty acid composition of backfat
tissue, colostrum and mature milk lipids. The effect on the lipid
composition was similar for adipose tissue and milk. Compared
with the [linoleic acid-enriched oil] group, significantly more
[saturated fatty acids] and less [monounsaturated fatly acids]
were deposited in the tissue and excreted [sic] in the milk,
whereas changes in the [polyunsaturated fatty acid] content were
minimal, except for a significant decrease in the arachidonic acid
level.

Bee 2297. Bee does not teach or suggest that administration of the CLAs
recited in the claims on appeal increases the reproductive performance, as
expressly defined in the claims, of ruminants, or even of sows. Indeed, Bee
even teaches that the administration of CLAs in pigs has the opposite effect
of administration in dairy cows, depressing the total content and yield of
milk fat in the latter. Compare id. at 2297 with 2292. Because Bee fails to
teach or suggest the limitations of the claims, we reverse the Examiner’s
rejection of the claims upon this ground.

3. Rejection of claims 22 and 24–31 over Chin
The Examiner finds that Chin teaches supplementally feeding the
CLA cis 9, trans 11 isomer to Fischer rats during gestation and lactation
significantly improved the postnatal body weight gain of pups, as measured
on day 10 of lactation. Final Act. 11. The Examiner finds that Chin teaches
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that pups that continued to receive the CLA-supplemented diet after weaning
had significantly greater body weight gain and improved feed efficiency
relative to control animals. CLA isomers are i.e. cis-9, trans-11. Id.
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to “interchange the use of CLA in cows and rats.”
Id. at 12. The Examiner reasons that a skilled artisan would have been
motivated to do from the teaching that cow and rats both have been treated
with CLA, and would therefore have had a reasonable expectation of
successful. Id.
We are again not persuaded that the Examiner has established a prima
facie case of obviousness. Chin does not expressly teach administration of
CLAs to ruminants, but notes only that CLAs may be an inherent component
of cow’s milk. See Chin 2344, 2348. Chin does not teach or suggest that
administration of CLAs to rats (or ruminants) increases reproductive
performance, as expressly defined by the claims, rather the references
teaches significantly improved postnatal body weight gain in the rat pups.
See Chin Abstr. The mere fact that CLAs have, in separate studies, been
administered to rats and cows is insufficient, by itself, to have given a skilled
artisan a reasonable expectation of success of improving the reproductive
performance of ruminants, as measured by “the percentage of pregnant
females in a first plurality of healthy, female ruminant mammals having
been administered [the recited CLAs] as compared to the percentage of
pregnant females in a second plurality of healthy, female mammals that have
not been administered [the recited CLAs],” and as recited in claim 22.
We consequently reverse the Examiner’s rejection of the claims upon
this ground.
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CONCLUSION
The Examiner’s rejection of claims 22 and 24–31 under 35 U.S.C.
§ 103 is reversed.
REVERSED

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
22, 24–31 103 Staples,
O’Quinn

22, 24–31
22, 24–31 103 Bee 22, 24–31
22, 24–31 103 Chin 22, 24–31
Overall
Outcome
22, 24–31