NESTEC S.A.

Patent Trials and Appeals Board

Oct 19, 2021

2020004921 (P.T.A.B. Oct. 19, 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.
15/104,013 06/13/2016 Carlos Antonio De Castro 3712036-02659 4119
29157 7590 10/19/2021
K&L Gates LLP-Nestec S.A.
P.O. Box 1135
Chicago, IL 60690
EXAMINER
TRAN, LIEN THUY
ART UNIT PAPER NUMBER
1793
NOTIFICATION DATE DELIVERY MODE
10/19/2021 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 CARLOS ANTONIO DE CASTRO, CRISTINA CRUZ-
HERNANDEZ, FREDERIC DESTILLATS, FRANCESCA GIUFFRIDA,
RAJAT MUKHERJEE, and SAGAR THAKKAR
____________

Appeal 2020-004921
Application 15/104,013
Technology Center 1700
____________

Before JEFFREY B. ROBERTSON, BRIAN D. RANGE, and
JANE E. INGLESE, Administrative Patent Judges.

INGLESE, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 requests review under 35 U.S.C. § 134(a) of the
Examiner’s final rejection of claims 10, 13, 15, 16, and 20–24.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42.
Appellant identifies SOCIÉTÉ DES PRODUITS NESTLÉ S.A. as the real
party in interest. Appeal Brief filed February 25, 2020 (“Appeal Br.”), 2.
2 Final Office Action entered August 30, 2019 (“Final Act.”), 1.
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Application 15/104,013

2
CLAIMED SUBJECT MATTER
Appellant claims a method for promoting a healthy establishment of
cognitive function in an infant younger than three months old. Appeal Br. 3.
Claim 10, the sole pending independent claim, illustrates the subject matter
on appeal, and reads as follows:
10. A method for promoting a healthy establishment of
cognitive function in an infant younger than three months old,
the method comprising administering to the infant younger than
three months old a synthetic nutritional composition
comprising:
13.8–17 mg/100ml of n-6 eicosatrienoic acid;
0.2–0.25 mg/100ml of disialoganglioside-3 (GD-3); and
0.2–0.25 mg/100ml of monosialoganglioside-3 (GM-3);
the GM-3 and the GD-3 in a GM-3:GD-3 ratio of 1.2 to
1.35.

Appeal Br. 15 (Claims Appendix) (emphasis added).
REJECTION
The Examiner maintains the rejection of claims 10, 13, 15, 16, and
20–24 under 35 U.S.C. § 103 as unpatentable over Rueda (US
2008/0003330 A1, published January 3, 2008) in view of Carlson (US
2004/0265462 A1, published December 30, 2004) in the Examiner’s Answer
entered April 17, 2020 (“Ans.”).
FACTUAL FINDINGS AND ANALYSIS
Upon consideration of the evidence relied upon in this appeal and
each of Appellant’s contentions, we reverse the Examiner’s rejection of
claims 10, 13, 15, 16, and 20–24 under 35 U.S.C. § 103, for reasons set forth
in the Appeal and Reply Briefs, and below.
Appeal 2020-004921
Application 15/104,013

3
We need address independent claim 10 only, which requires the
recited method for promoting a healthy establishment of cognitive function
in an infant younger than three months old to comprise administering to the
infant a synthetic nutritional composition comprising, in part, 0.2–0.25
mg/100ml of disialoganglioside-3 (GD-3) and 0.2–0.25 mg/100ml of
monosialoganglioside-3 (GM-3), where the ratio of GM-3 to GD-3 is 1.2 to
1.35.
The Examiner finds that Rueda discloses a method of accelerating
cognitive development in an infant during the first 2 to 4 months of life that
involves administering a formula to the infant containing, in part, about 5
mg/L (0.5 mg/100ml) of gangliosides, such as GD-3 and GM-3. Final Act.
2. The Examiner finds that Rueda does not disclose “the individual amount
of GD-3, GM-3, and ratio” of GM-3 to GD-3 recited in claim 10. Id. The
Examiner determines, however, that it would have been obvious to one
skilled in the art “to determine the individual amounts of ganglioside, [and]
ratio . . . within the ranges disclosed in Rueda through routine
experimentation depending on the nutritional profile targeted.” Final Act. 3.
The Examiner adds that a “difference in concentration does not amount to
patentability in absence of showing of criticality or unexpected result.”
Final Act. 3 (citing In re Aller, 220 F.2d 454 (CCPA 1955).
Appellant argues that Rueda discloses that one or more, more
typically all, of the gangliosides GD-3, O-Acetyl-GD-3, and GM-3 may be
included in Rueda’s formula, and Rueda discloses the total concentration of
gangliosides in the formula, but Rueda does not disclose or suggest that
“individual amounts of the particular gangliosides are significant or that the
ratio of particular gangliosides is significant.” Appeal Br. 6.
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Application 15/104,013

4
Appellant’s arguments identify reversible error in the Examiner’s
rejection, for reasons that follow.
Rueda discloses that “[t]he infant formulas of the present invention
comprise at least about 5 mg/L of gangliosides, including from about 7 mg/L
to 50 mg/L, also including from about 10 to about 30 mg/L.” Rueda ¶ 46.
Rueda discloses that “gangliosides for use in” Rueda’s infant formula
“typically comprise one or more, more typically all, of the gangliosides
GD-3, O-Acetly-GD-3 and GM-3.” Id.
Rueda thus discloses the total amount of all gangliosides included in
Rueda’s infant formula, and Rueda indicates that such gangliosides may be
one or more of GD-3, O-Acetyl-GD-3, and GM-3. At no point does Rueda
disclose amounts of individual gangliosides that may be included in Rueda’s
infant formula, much less disclose individual amounts of each of GD-3 and
GM-3. Rather, Rueda discloses ranges of total ganglioside content, two of
which do not encompass the maximum value of the combined amounts of
GD-3 and GM-3 that could be included in the composition recited in claim
10 when present at a ratio of GM-3 to GD-3 of 1.2 to 1.35 (0.25 mg/100ml
GM-3 + 0..208 mg/100ml GD-3 = 0.458 mg/100ml GM-3 + GD-3).
Specifically, neither about 7 mg/L (0.7 mg/100ml) to about 50 mg/L (5
mg/100ml), nor about 10 mg/L (1.0 mg/100ml) to about 30 mg/L (3.0
mg/100ml), encompasses 0.458 mg/100ml (0.208 mg/100ml GD-3 + 0.25
mg/100ml GM-3). And the third total ganglioside content range Rueda
discloses—at least about 5 mg/L (0.5 mg/100ml)—is vast due to its lack of
an upper boundary.
Given the breadth of the third range, and taking into account that the
range is directed to total ganglioside content rather than individual amounts
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Application 15/104,013

5
of each of GD-3 and GM-3, and also considering that Rueda’s narrower
ranges do not encompass the maximum value of the combined amounts of
GD-3 and GM-3 that could be included in the composition recited in claim
10, the Examiner’s reliance on a per se rule of obviousness is not sufficient
to establish that in view of Rueda’s disclosures, one of ordinary skill would
have arrived at individual contents of GD-3 and GM-3 required by claim 10
through nothing more than routine experimentation. In re Peterson, 315
F.3d 1325, 1330 n. 1 (Fed. Cir. 2003) (discussing a situation in which “the
disclosed range is so broad as to encompass a very large number of possible
distinct compositions . . . [which] might present a situation analogous to our
cases involving the failure of a very broad disclosed genus of substances to
render prima facie obvious specific substances within its scope”) (citing In
re Baird, 16 F.3d 380 (Fed. Cir. 1994); In re Jones, 958 F.2d 347 (Fed. Cir.
1992)); see also In re Harris, 409 F.3d 1339, 1342–1343 (Fed. Cir. 2005)
(“Peterson discussed that a disclosed range might become too broad to teach
a subset range.”).
The present case is not simply a situation of overlap between a prior
art range and a claimed range. Rather, Rueda does not disclose suitable
amounts of each of GD-3 and GM-3 to include in Rueda’s infant formula.
Nor does Rueda provide any indication of relative amounts of GD-3 and
GM-3 to include in the formula. As Appellant argues (Appeal Br. 6–7), the
Examiner does not identify any disclosure in Rueda, or provide any other
evidence, establishing that the ratio of GM-3 to GD-3 in an infant formula is
a result-effective variable. The Examiner’s reliance on Aller to establish the
prima facie obviousness of the ratio recited in claim 10, therefore, is
unfounded. In re Antonie, 559 F.2d 618, 620 (CCPA 1977) (explaining that
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Application 15/104,013

6
in Aller “the court set out the rule that the discovery of an optimum value of
a variable in a known process is normally obvious. We have found
exceptions to this rule in cases . . . in which the parameter optimized was not
recognized to be a result-effective variable.”).
On the record before us, the Examiner does not provide a persuasive,
reasoned explanation supported by objective evidence establishing that
Rueda’s disclosures would have led one of ordinary skill in the art seeking to
produce an infant formula to include GD-3 and GM-3 in such formula in
amounts as recited in claim 10, and in a ratio of GM-3 to GD-3 as recited in
the claim. We, accordingly, do not sustain the Examiner’s rejection of claim
10, and claims 13, 15, 16, and 20–24, which each depend from claim 10,
under 35 U.S.C. § 103.

DECISION SUMMARY

Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
10, 13, 15,
16, 20–24
103 Rueda, Carlson 10, 13, 15,
16, 20–24

REVERSED