NESTEC S.A.

Patent Trials and Appeals Board

Aug 13, 2021

2020006635 (P.T.A.B. Aug. 13, 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.
16/061,121 06/11/2018 Nora Schneider 3712036-03122 7528
29157 7590 08/13/2021
K&L Gates LLP-Nestec S.A.
P.O. Box 1135
Chicago, IL 60690
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
08/13/2021 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NORA SCHNEIDER, JONAS HAUSER,
SEAN DEONI, TAMAS BARTFAI, and
JONATHAN O'REGAN
Appeal 2020-006635
Application 16/061,121
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims to a method to reduce a risk of or
mitigate sub-optimal de novo myelination trajectory in a formula fed infant
up to 12 months of age as being obvious and for obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Société des
Produits Nestlé S.A. (Appeal Br. 2).
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Application 16/061,121

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We REVERSE the obviousness rejection, but AFFIRM the
obviousness-type double patenting rejections.
STATEMENT OF THE CASE
“[B]rain structure, in particular the amount and/or spatial distribution
of myelin throughout the brain, [] affects brain connectivity e.g.[,] via what
pathway and how quickly and efficiently, messages in the form of neural
impulses are communicated within the brain and in particular between
different brain regions.” (Spec. 2.)
Infant formula is used as an alternative to mother’s milk. (Spec. 1.)
“However, studies have shown that infant formula does not always induce
identical effects on the body as mother’s milk.” (Id.) According to
Appellant’s Specification:
In a recent study it was demonstrated that the brain structure, in
particular the amount and/or temporal-spatial distribution of
myelinated matter throughout the brain, []of exclusively
breastfed infants can differ from infants fed infant formula.
(Id. at 1.) Appellant’s Specification indicates:
there is a need to find ways to promote, support or optimise de
novo myelination, in particular the de novo myelination
trajectory, and/or brain structure, in particular the amount
and/or spatial distribution of myelinated matter throughout the
brain, and/or brain connectivity in a subject, in particular a
formula fed subject.
(Id. at 2.) Appellant’s invention is directed at the use of a composition to
support de novo myelination trajectory in a formula fed infant. (Id.)
Claims 1, 6–9, 12, 19, and 27 are on appeal. Claim 1, reproduced
below, is illustrative of the claimed subject matter:
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1. A method to reduce a risk of or mitigate sub-optimal de novo
myelination trajectory in a formula fed infant up to 12 months of
age, the method comprising administering to the formula fed
infant a synthetic nutritional composition comprising
sphingomyelin in an amount greater than 300 mg/kg dry weight
of the synthetic nutritional composition.

The prior art relied upon by the Examiner is:
Name Reference Date
Rueda et al. US 2008/0003330 A1 Jan. 3, 2008
Fleith et al. US 2012/0171178 A1 July 5, 2012
James Farquharson et
al.
Effect of diet on the
fatty acid composition
of the major
phospholipids of infant
cerebral cortex, 72
Archives of Disease in
Childhood, 198–203
1995

The following rejections are before us on review:
Claims 1, 6–9, 12, 19, and 272 under 35 U.S.C. § 103 as being
unpatentable over Rueda, Fleith, and Farquharson.
Claims 1, 6–9, 12, and 19 provisionally under the judicially created
doctrine of obviousness-type double patenting over claims of the following

2 The Examiner’s rejection identifies claim 20 as being rejected. However,
prior to the final rejection, claim 20 had been canceled by amendment dated
January 10, 2020 and claim 27 was added as a new claim. We understand
the Examiner’s rejection to have inadvertently referenced claim 20, instead
of claim 27.
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copending applications in view of Rueda: 16/061,099, 16/061,063,
16/061,061, and 16/061,047.3

DISCUSSION
A. Claim 1
The Examiner found that Rueda teaches administering infant formula
that contain phospholipids to infants between 0 and 12 months promotes
brain development, accelerates neural migration and cognitive development
in the infant. (Final Action 4 (citing Rueda Abstr.).) The Examiner further
found that Rueda teaches “the preferred phospholipids include
sphingomyelin,” among others and that the “[m]ost preferred are
combinations of . . . five phospholipids[, sphingomyelin, phosphatidyl
ethanolamine, phosphatidyl choline, phosphatidyl inositol, and phosphatidyl
serine,] especially such combinations in which sphingomyelin represents at
least 20% by weight of total phospholipids.” (Id. (citing Rueda ¶ 51).) The
Examiner found, however, that Rueda does not teach the claimed
sphingomyelin concentration of an amount greater than 300 mg/kg. (Id.)
The Examiner found that Fleith “teaches a method supporting
improving cognitive [performance] in a child,” by “administering
phospholipid” which “will promote or optimize de novo myelination and/or
brain structure.” (Final Action 5 (citing Fleith ¶¶ 22, 53).) The Examiner

3 Additional provisional non-statutory obviousness rejections were made
over claims in copending applications 16/061,106 and 15/103,424 in view of
Rueda. However, those applications have been abandoned and thus the
rejections have been obviated. We further note that the Examiner did not
include claim 27 in these rejections. This would appear to be an inadvertent
error in light of the claims pending in the related applications.
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found that Fleith “teaches the composition is an infant formula or growing
up milk.” (Id. (citing Fleith ¶ 42).) The Examiner noted that, Fleith teaches
that in addition to including the vitamin, folic acid; the minerals, iron, zinc,
and calcium; and, the fatty acids, docosahexanoic acid and arachidonic acid,
the milk includes sphingomyelins at between 20 and 220 mg/100g dry
matter. (Id. (citing Fleith ¶¶ 78 (sphingomyelin).) The Examiner further
found that Fleith teaches a particular composition where sphingomyelin is
included in an amount that is higher than 300 mg/kg. (Id. (citing Fleith
Table 7).)
The Examiner determined that it would have been obvious “to include
the composition of Fleith” to “expand the teachings of Rueda” in order “to
reduce a risk of de novo myelination trajectory with a reasonable expectation
of success because Rueda recognizes that their formula promotes brain
development, accelerate[s] neural migration, and cognitive development in
the infants upon administration.” (Id. at 5–6.) The Examiner indicated that
the risk reduction would “necessarily occur” by administering the
composition because Appellant’s claimed method only requires that single
step. (Id. at 6.)4
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.” In
re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). We conclude that the
Examiner has failed to establish a prima facie case because we disagree that
there is an objective teaching from the prior art or asserted by the Examiner

4 The Examiner only relies on Farquharson for teaching that one would
compare formulation of an infant formula to human breast milk. (Final
Action 4–5.)
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to be knowledge generally available to one of ordinary skill in the art that
would lead one to feed an infant greater than 300 mg/kg dry weight of a
nutritional composition of sphingomyelin as required by the claims.
It is true that Fleith teaches a composition that “provides nutrients
useful to contribute to the development of the brain and its proper
functioning” (Fleith ¶ 41), noting that the fatty acid DHA is important in
order to develop the brain (id. ¶ 54, 55) as is iron (id. ¶ 67) and vitamin D
(id. ¶ 74) whereas sphingomyelin is noted to be important in brain
functioning (id. ¶ 78). However, as Appellant explained, Fleith teaches that
the “growing up milk” is for use with children three to six years old, not an
infant formula as the Examiner asserted. (Appeal Br. 7; see, e.g., Fleith,
Abstr. ¶¶ 22, 42.) The Examiner has provided no evidence that the
composition of an infant formula and a nutritional drink for a three to six
year old would necessarily be expected to include the same ingredients in
the same amounts. Appellant, on the other hand, has established that Fleith
does not consider the two formulations to be the same and that the
nutritional needs of infants and children are different. (See Fleith ¶¶ 2–4;
Appeal Br. 7.) Furthermore, Fleith teaches that the sphingomyelin is
“preferably provided as a natural component of milk, in particular cow’s
milk, the latter being preferably used for the preparation of the
composition.” (Fleith ¶ 78; see also id. ¶ 80 (“With respect to the nutrients
iodine, sphingomyelin and sialic acid, these nutrients are not specifically
added to the nutritional composition, but are present due to their presence in
milk components, in particular, whole milk, skimmed milk and/or
buttermilk, for example.”).) Infants are preferably not given cow’s milk.
Thus, we do not agree with the Examiner that one of ordinary skill in the art
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would have been motivated to combine the composition of table 7 of Fleith,
with its sphingomyelin amount at more than 300 mg/kg, with the infant
formula composition of Rueda.
Moreover, we do not find that there would have been motivation from
Fleith in general to include sphingomyelin at greater than 300 mg/kg in the
Rueda composition. Despite Fleith teaching that sphingomyelin is found in
myelin and its function in propagating nerve electrical signals, it does not
provide a reason that one would expect the range taught to be useful in a
nutrition formulation for a child between the ages of 3 and 6 to assist in
proper brain functioning, i.e., between 20 mg–200 mg/100 g of dry weight
of the nutritional composition (Fleith ¶ 78), to be the same amounts
necessary or useful for an infant. Nor does Fleith provide any direction to
select an amount of greater than 30 mg/100 g of dry weight of the nutritional
component from that range for use with infants.5 In fact, Fleith teaches with
respect to sphingomyelin included as a nutrient in the formulation for
children ages 3 to 6 that:
the exact amounts are subject to fluctuations, which are
dependent on the origin of the milk in terms of the animal from
which it is harvested (cow, goat, etc[.]), from the geographical
origin, and also from the season. The values given herein are

5 Although Rueda teaches that there is a need for infant formulas to contain
the natural ingredients found in human milk (Rueda ¶ 6) and is directed to
infant formulas “with select concentrations and types of those compounds
inherently found in human milk” (Id. ¶ 7), the Examiner has not established
that human breast milk is known to have at least 30 mg/100 g (i.e., 300
mg/kg) of sphingomyelin. We are aware of prior art that indicates that the
amount of sphingomyelin in postpartum human breast milk is between 4.7
and 12.8 mg/100 g. See, e.g., Francesca Giuffrida et al., Quantification of
Phospholipids Classes in Human Milk, 48 Lipids 1051–1058, 1056 (2013).
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thus approximations and may be considered as medium to long
term averages.
(Fleith ¶ 80.)
Moreover, we also disagree with the Examiner’s position that one of
ordinary skill in the art would have had a reasonable expectation that
sphingomyelin in the amounts used in Fleith would result in a reduction in a
risk of sub-optimal de novo myelination trajectory. Rueda, although
describing phospholipids generally as having a positive effect on neuroblast
migration (Rueda ¶ 11–13), does not describe any particular function of
sphingomyelin in its formulation, much less in myelination. Although Fleith
teaches that “sphingomyelin is a component of the myelin sheath” (Fleith ¶
78), it does not indicate that sphingomyelin provided in formulations for
ingestion by 3 to 6 year old children affects myelination itself. Rather,
Fleith describes the sphingomyelin as assisting in propagation of nerve
electrical signals. (Fleith ¶ 78.)
Farquharson, which teaches “[m]yelination . . . proceeds rapidly after
birth,” indicates that fatty acids from human milk or infant formula help
synthesize “the complex hydrocarbon structures necessary for the creation of
neurotransmitter membranes,” (Farquharson 198) but does not discuss
sphingomyelin or sphingolipids. Indeed, all that is provided is an analysis of
cerebral cortex phosphatidylcholine, phosphatidylethanolamine,
phosphatidylserine and the associated fatty acids of infants fed human or
formula milk in the first months of life. (Id. at 199–203.) Thus,
Farquharson does not make up for the deficiencies noted above.
Thus, for the foregoing reasons, we do not affirm the Examiner’s
rejection of claims 1, 6–9, 12, 19, and 27 as being obvious from Rueda,
Fleith, and Farquharson.
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B. Nonstatutory obviousness double patenting rejections
The Examiner provisionally rejected claims 1, 6–9, 12, and 19 under
the judicially created doctrine of obviousness-type double patenting over
claims of the following copending applications in view of Rueda:
16/061,099, 16/061,063, 16/061,061, 16/061,047.
We note that Application 16/061,099 has been allowed and thus the
rejection is no longer provisional.
Appellant does not contest the Examiner’s rejection and Appellant
also has not filed terminal disclaimers in this application to obviate the
obviousness-type double patenting rejections. Therefore, we summarily
affirm the Examiner’s obviousness-type double patenting rejections. Hyatt
v. Dudas, 551 F.3d 1307, 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.”).
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 6–9, 12,
19, 27
103 Rueda, Fleith,
Farquharson
1, 6–9, 12,
19, 27
1, 6–9, 12,
19
Nonstatutory
Double Patenting
1, 6–9, 12,
19

Overall
Outcome
1, 6–9, 12,
19,
27

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART