NESTEC S.A

Patent Trials and Appeals Board

Jul 28, 2021

2020006317 (P.T.A.B. Jul. 28, 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.
15/100,407 05/31/2016 Delphine Egli 3712036-02628 8883
29157 7590 07/28/2021
K&L Gates LLP-Nestec S.A.
P.O. Box 1135
Chicago, IL 60690
EXAMINER
CHANG, KYUNG SOOK
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
07/28/2021 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 DELPHINE EGLI, FERDINAND HASCHKE,
KARL-JOSEF HUBER HAAG, PHILIPPE STEENHOUT,
and SZE TAN
__________

Appeal 2020-006317
Application 15/100,407
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and RYAN H. FLAX,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to reducing
the risk of developing a disorder by administering a nutritional composition
to an infant. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the Real Party-in-Interest as
SOCIÉTÉ DES PRODUITS NESTLÉ S.A. (see App. Br. 2). We refer to the
Specification of May 31, 2016 (“Spec.”); Final Action of Dec. 4, 2019
(“Final Act.”); Appeal Brief of May 27, 2020 (“Appeal Br.”); Examiner’s
Answer of July 10, 2020 (“Ans.”); and Reply Brief of Sept. 9, 2020 (“Reply
Br.”).
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Statement of the Case
Background
“Mother’s milk is recommended for all infants up to the age of 4-6
months. However, in some cases breast feeding is inadequate or
unsuccessful or inadvisable for medical reasons, or the mother chooses not
to breast feed” (Spec. 1:16–18). “Infant formulas have been developed for
these situations” (id. 1:19–20). However, “infants fed with infant formula
obtain a higher weight gain than breast fed infants. Infant formula fed
infants may therefore be more prone to become overweight or obese later in
life” (id. 2:12–14). “Hence, there is an unmet need for a nutritional
composition to be used for administration to infants of non-obese and non-
overweight mothers to reduce the risk of developing overweight, obesity,
diabetes and metabolic syndrome later in life” (id. 2:16–19).
The Claims
Claims 1, 6, 7, 9–15, and 49 are pending. Independent claim 1 is
representative and reads as follows:
1. A method for reducing the risk of developing a disorder
selected from the group consisting of metabolic syndrome,
increased weight gain, increased fat deposition, overweight,
obesity, insulin resistance, glucose intolerance, diabetes
mellitus, and combinations thereof later in an infant’s life, the
method comprising administering a nutritional composition
comprising a protein source, a lipid source, and a carbohydrate
source to the infant in the first year of life of the infant, wherein
the nutritional composition comprises 1.4 to 1.7 g of the protein
source / 100 kcal of the nutritional composition and has an
energy density from 600 to 680 kcal/litre, and the infant was
born to a non-obese and non-overweight mother.

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The Issue
The Examiner rejected claims 1, 6, 7, 9–15, and 49 under 35 U.S.C.
§ 103(a) as obvious over Koletzko,2 Mace,3 Van Goudoever,4 and Haschke5
(Final Act. 3–12).
The Examiner finds “Koletzko teaches a method for reducing
overweight of in[f]ant [sic] from non-obese mother by administering a
nutritional composition” and Van Goudoever teaches “lowering protein
content in the infant formula preventing obesity, reducing increased risk of
diabetes and overweight [sic]” (Final Act. 9). The Examiner finds it obvious
“to optimize or adjust the ranges of protein content, energy density, and the
ratio of casein to whey with the ranges of” Van Goudoever” (id. 9–10). The
Examiner also finds it obvious to “add probiotics of Haschke to the
nutritional composition of Koletzko in order to enhance intestinal flora
balance, promotion of good digestion and boosting immune function, and
increase resistance to infection” (id. 11).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Koletzko,
Van Goudoever, Mace, and Haschke render the claims obvious?
Findings of Fact
1. Koletzko teaches “[r]apid weight gain in infancy is associated
with an increased risk of later obesity in a large number of observational

2 Koletzko et al., Lower protein in infant formula is associated with lower
weight up to age 2 y: a randomized clinical trial, 89 Am. J. Clin. Nutr.
1836–45 (2009).
3 Mace et al., WO 2013/057233 A1, published Apr. 25, 2013.
4 Van Goudoever et al., US 2013/0079276 A1, published Mar. 28, 2013.
5 Haschke et al., US 2011/0195144 A1, published Aug. 11, 2011.
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studies” and that, “[c]ompared with breastfed infants, formula-fed term
infants have greater body weight gains in infancy” (Koletzko 1836, col. 1).
2. Koletzko teaches “[l]imiting the protein content of infant and
follow-on formula and, more generally, the dietary protein intake during
infancy, might constitute a potentially important approach to reducing the
risk of childhood overweight and obesity” (Koletzko 1844, col. 1).
3. Koletzko teaches, in Table 1, a lower protein infant formula
composed of 1.77 g/100 kcal protein and 69.9 g/100 ml (see Koletzko 1838,
Table 1).
4. Koletzko teaches, in Table 2, that in both low protein and high
protein intervention groups, the mean BMI for mothers was 23.7 ± 4.6 while
in the observational breast feeding group, the mean BMI for mothers was
22.4 ± 3.6 (see Koletzko 1841, Table 2).
5. Koletzko teaches the “protein intake provided by the lower-
protein formula was still higher than that of the breastfed children or than
that recommended for infants” (Koletzko 1841, col. 2).
6. Van Goudoever teaches
High early weight gain in the first 1-2 year of life is associated
with later adverse health outcomes, such as increased blood
pressure, increased overweight and body fat deposition, and
increased risk of diabetes. The higher protein intake in infants
fed infant formula compared to breastfed children, may play a
role since formula-fed children reach a higher body weight and
weight for length at one year of age. Lowering the protein
content of infant food might be one strategy that could
contribute to decreasing these adverse effects.
(Van Goudoever ¶ 14).
7. Van Goudoever teaches “a preferred energy content of between
60 and 70 kcal per 100 ml” (Van Goudoever ¶ 7). The Examiner calculates
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that “60 and 70 kcal per 100ml . . . corresponds to between 600 and 700
kcal/liter” (Final Act. 6; emphasis omitted).
8. Van Goudoever teaches “the total protein content in infant
formula is preferably between 1.3 and 1.9 g protein/100 kcal, even more
preferably between 1.3 and 1.8 g protein/100 kcal, resulting in an infant
formula comprising between 5.2 and 7.6% protein based on the total calories
of the composition” (Van Goudoever ¶ 19).
9. Example 4 of Goudoever teaches an infant formula with 1.4 g
protein per 100 kcal (see Goudoever ¶ 61).
10. Haschke teaches the “infant formulas may also comprise at
least one probiotic bacterial strain. A probiotic is a microbial cell
preparation or components of microbial cells with a beneficial effect on the
health or well-being of the host” (Haschke ¶ 21).
11. Haschke teaches a formula with “a protein content between 1.7
and 2.1 g protein/100 kcal” (Haschke ¶ 8).
12. Haschke teaches, in claim 1, that “the protein content of each
formula is selected to be in the range from 1.5 to 3 .0 g protein/ 100 kcal and
decreases according to the age of the infant” (Haschke 5, claim 1).
13. Mace teaches “a nutritional composition for infants comprising
whey protein micelles” (Mace 1:9–11).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
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claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Regarding this first rejection, we adopt the Examiner’s findings of
fact and conclusion of law (see Final Act. 3–12, FF 1–13) and agree that the
combination of Koletzko, Mace, Van Goudoever, and Haschke renders the
claims obvious. We address Appellant’s arguments below.
Appellant contends “Haschke is entirely directed to children of obese
and overweight mothers (for example, page 5, line 30-page 6, line 2),
contrary to the present claims . . . . To the contrary, the mothers tested in
Koletzko all have a BMI less than 30” (Appeal Br. 6). Appellant contends
“the skilled artisan would not have combined these references to arrive at the
claimed recipient in view of these conflicting teachings of the mothers” (id.).
Appellant asserts: “It was very surprising to the inventors of the present
invention to see this decrease in weight gain of infants in the test group
compared to infants in the control group in relation to a decrease in
BMI of the infant’s mother” (id. at 7).
We find this argument unpersuasive for several reasons. First, we do
not find the citation referring to “obese and overweight” provided by
Appellant in Haschke. Instead, it appears in Mace at 5:30 to 6:2, in the
context of using “a nutritional composition for infants comprising whey
protein micelles” (FF 11).
Second, neither Haschke nor Mace directly conflict with Koletzko’s
teaching to limit the protein content of formula in order to reduce the risk of
childhood overweight and obesity (see FF 2). Indeed, while Koletzko’s data
appears to show that feeding using lower protein content formula was
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performed for infants born to non-obese and non-overweight mothers (FF 4),
Appellant does not identify a teaching in Koletzko or other prior art
suggesting that the benefits identified by Koletzko for lower protein content
formula would not also be expected to apply to any formula-fed infant,
regardless of the mother’s weight status.
Third, we do not agree that the result was surprising based on the
teachings of the prior art. Van Goudoever teaches:
High early weight gain in the first 1-2 year of life is associated
with . . . increased blood pressure, increased overweight and
body fat deposition, and increased risk of diabetes. . . .
Lowering the protein content of infant food might be one
strategy that could contribute to decreasing these adverse
effects.
(FF 6). Similarly, Koletzko teaches that “[l]imiting the protein content of
infant and follow-on formula and, more generally, the dietary protein intake
during infancy, might constitute a potentially important approach to
reducing the risk of childhood overweight and obesity” (FF 2). Thus, rather
than surprising, based on the prior art it would have been expected that
reducing protein content in formula would result in decreased weight gain.
Fourth, as to the Example and Table 3, we note that no information
regarding the number of subjects or any statistical evidence was presented
that showed the differences in data were meaningful in any way. It is
unclear if there were three infants studied or three thousand. See McNeil-
PPC, Inc. v. L. Perrigo Co., 337 F.3d 1362, 1370 (Fed. Cir. 2003) (finding
evidence unpersuasive that “was based on the results of a study involving
only nine participants and thus did not rise to the level of statistical
significance” and finding the studies were “not shown to be reproducible”).
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Lastly, we have considered the Turini6 Declaration, but find the
opinion of Dr. Turini unpersuasive because the opinion is not based on
specific facts, but rather opinion. The Board is entitled to weigh
declarations expressing opinions as to fact and conclude that the lack of
factual corroboration warrants discounting the opinions expressed in the
declarations. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1368 (Fed.
Cir. 2004). Moreover, as an employee of the real party-in-interest, Dr.
Turini is not a disinterested person. See Ferring B.V. v. Barr Labs., Inc.,
437 F.3d 1181, 1188 (Fed. Cir. 2006) (“A witness’s interest is always
pertinent to his credibility and to the weight to be given to his testimony.”)
As we weigh the Declaration with the Examiner’s prima facie case of
obviousness, we find Dr. Turini does not provide a persuasive factual
underpinning for his legal conclusion that “the combination of Koletzko,
Mace, and Haschke proposed by the Patent Office would not have been
obvious to the skilled person without hindsight” (Turini Decl. ¶ 7).
Appellant contends “the skilled artisan would not have combined the
cited references to arrive at a nutritional composition that comprises 1.4 to
1.7 g of the protein source / 100 kcal of the nutritional composition”
(Appeal Br. 7). Appellant contends “Koletzko discloses protein contents of
1.77, 2.2, 2.9, and 4.4g/100 kcal (e.g., abstract); and Van Goudoever
discloses a lower protein content of l.3-l.9g/100 kcal,” but “the Examiner
also modifies Koletzko with Haschke, which discloses a higher protein
content of l.7-3g/100 kcal” (id. at 8). Appellant contends “these references
at best would have led the skilled artisan to arrive at an overlapping range of

6 Declaration of Dr. Marco Turini, dated Apr. 8, 2019.
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all the protein contents disclosed in these references, namely, 1.77 to 1.9
g/100 kcal” (id. at 8–9).
We find these arguments unpersuasive because they fail to recognize
the express teachings of Koletzko, Van Goudoever, and Haschke suggesting
to reduce protein amounts in formula. The references teach: “[l]imiting the
protein content of infant and follow-on formula . . . might constitute a
potentially important approach to reducing the risk of childhood overweight
and obesity” (FF 2); “[l]owering the protein content of infant food might be
one strategy that could contribute to decreasing” “increased blood pressure,
increased overweight and body fat deposition, and increased risk of
diabetes” (FF 6); and “the protein content of each formula is selected to be
in the range from 1.5 to 3.0 g protein/ 100 kcal and decreases according to
the age of the infant” (FF 12).
As to the specific range of 1.4 to 1.7 g of protein / 100 Kcal of
nutritional composition, Koletzko teaches an exemplary lower protein infant
formula composed of 1.77 g/100 kcal protein (FF 3). Van Goudoever
teaches “the total protein content in infant formula is preferably between 1.3
and 1.9 g protein/100 kcal” (FF 8). Moreover, Example 4 of Goudoever
teaches an infant formula with 1.4 g protein per 100 kcal (FF 9). Lastly,
Haschke claims “the protein content of each formula is selected to be in the
range from 1.5 to 3 .0 g protein/ 100 kcal and decreases according to the age
of the infant” (FF 12).
In “cases involving overlapping ranges, [courts] have consistently
held that even a slight overlap in range establishes a prima facie case of
obviousness.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Here,
two of the references, Goudoever and Haschke, teach protein ranges that
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overlap the claimed range, Koletzko teaches a range adjacent to the claimed
range (FF 3, 8, 9, 12). All three references suggest the desirability of
lowering the protein range (FF 2, 6, 12). See In re Brandt, 886 F.3d 1171,
1177 (Fed. Cir. 2018) (“[P]rima facie rejections may be appropriate ‘where
there is a teaching in the prior art that the end points of the prior art range are
approximate, or can be flexibly applied.’”)
We, therefore, find that the facts do not support Appellant’s position
because the disclosures in the prior art would have led to the specific
desirable ranges disclosed, and, because all three references suggest
lowering protein amount, would reasonably suggest the lower ends of the
disclosed ranges (FF 2, 3, 6, 8, 9, 12). Further, Appellant does not identify
any evidence showing unexpected results relative to the ranges disclosed by
Goudoever and Haschke (FF 3, 12).
Appellant contends, based on In re Stepan Co., 868 F.3d 1342 (Fed.
Cir. 2017), “[t]he Examiner must include ‘an explanation as to why it would
have been routine optimization to arrive at the claimed invention. [Stepan,
868 F.3d. at 1346]” (Appeal Br. 9). Appellant contends the “Examiner has
failed to articulate any explanation as to why one of skill in the art would
have reduced the protein content of 1.77 g/100kcal to 1.7 g/100kcal” (id.).
We are not persuaded. The Examiner specifically points out that
Koletzko and Van Goudoever “focus on lowering protein content . . . to
prevent or reduce obesity/overweight/diabetes in infants” (Final Act. 9).
Unlike the factual scenario in Stepan, the references in this case all suggest a
need to lower protein content to prevent or reduce sequelae such as obesity.
There is thus a specific reason, supported by all three references as already
discussed, that supports a finding that it would have been obvious to
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optimize the disclosed protein ranges by reducing the amount of protein in
the infant formula (FF 2, 6, 12). Also unlike the situation in Stepan, both
Koletzko and Haschke suggest overlapping ranges of protein amounts,
providing a prima facie case of obviousness as per Peterson. Appellant does
not rebut this finding of overlapping ranges but simply attempts to diminish
these express teachings in the prior art. Appellant does not persuasively
explaining why an artisan would not consider the totality of the art, and
optimize the express overlapping ranges based on the express evinced desire
to reduce protein content (FF 2, 3, 6, 8, 9, 12).
Appellant contends:
The Examiner fails to explain how the skilled artisan, when
combining all these references together, would have reconciled
the differences between (i) the energy density of about 690
kcal/liter from the proposed combination of Koletzko and Van
Goudoever and (ii) the energy density of less than 650 kcal/liter
or 620-640 kcal/liter of Haschke, which do not overlap with
each other.
(Appeal Br. 11).
We find this argument unpersuasive because Van Goudoever teaches
“a preferred energy content of between 60 and 70 kcal per 100 ml”
corresponding to values of 600 to 700 kcal per liter (FF 7). And no
“reconciliation” is necessary as all of the disclosed ranges fall within the
range recited in claim 1 (and also overlap the ranges of claim 6, 7, and 49 as
discussed below). Brandt explains that “it is important for the examiner to
have a few procedural tools to aid her efforts to issue as patents only those
claims that meet the requirements of the Patent Act . . . . One of these
procedural tools is the prima facie case, an evidentiary burden-shifting
device available to the examiner.” Brandt, 886 F.3d at 1176. As applied
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here, the Examiner has provided a reasonable prima facie case of
obviousness for selection of energy content values within the range
disclosed by Van Goudoever. Appellant provides no evidence to shift the
burden back to the Examiner. We find the arguments relying upon Stepan
unpersuasive for the same reasons as given above regarding the protein
content.
We have considered, but found unpersuasive, Appellant’s argument
that “[t]here is no evidence whatsoever that even suggests that one skilled in
the art would have expected a nutritional composition with an energy density
of to about 690 kcal/liter to provide the same properties as the claimed
nutritional composition with an energy density of from 600 to 680 kcal/litre”
(Appeal Br. 12). There is express evidence in the form of the overlapping
600 to 700 kcal per liter range disclosed by Van Goudoever (FF 7). This
range demonstrates that an ordinary artisan expected values within this range
to be satisfactory for infant formula. By contrast, however, Appellant
provides no evidence for the contrary position. And it is clear that rebuttal
does require evidence because “attorney argument [is] not the kind of factual
evidence that is required to rebut a prima facie case of obviousness.” In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Claims 6, 7, and 49
Appellant contends, for each of these claims, that “the skilled artisan
would not have modified Koletzko (as evidenced by Mace) with Van
Goudoever and Haschke to arrive at the claimed energy density from 620 to
650 kcal/litre, as recited in dependent Claim 6”; “energy density from 650 to
680 kcal/litre, as recited in dependent Claim 7”; and “energy density of
about 670 kcal/litre, as recited in dependent Claim 49” (Appeal Br 12–14).
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We remain unpersuaded for the reasons given above. Briefly, Van
Goudoever teaches an overlapping range of 600 and 700 kcal/liter (FF 7).
This reasonably supports a finding of prima facie obviousness of any value
within the range absent any rebuttal evidence. Peterson, 315 F.3d at 1329.
Appellant provides no such rebuttal evidence, only attorney argument which
is unpersuasive as it lacks any factual support. Brandt, 886 F.3d at 1176;
Geisler, 116 F.3d at 1470.
Claim 12
Appellant contends
Claim 12 recites free phenylalanine in an amount of up to 2.2%,
free isoleucine in an amount of up to 0.92%, free tryptophan in
an amount of up to 0.34% and free histidine in an amount of up
to 0.19% by weight of a total protein content. None of these
recited ranges overlap with the alleged percentages in Van
Goudoever, namely, 4.5%, 7.3%, 1.7%, 3.8%.
(Appeal Br. 14).
The Examiner responds
although Van Goudoever discloses certain amounts of
phenylalanine, tryptophan, and histidine higher than instant
ranges, the prior art ranges would be optimized to obtain the
instant ranges, in the absence of criticality evidence, because all
the infant formula contains such amino acids and their amounts
vary depending on the intended purpose, age and nutritional
balance of instant composition, relationship with other
ingredients, and thus adjusting or optimizing the prior ranges of
amino acids with the instant range would not require undue
experimentation and inventive skill.
(Ans. 15–16).
Regarding claim 12, we agree with Appellant because the Examiner
does not establish either overlapping ranges of the amino acids nor any
reason to modify the amount of amino acid to values that fall within the
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range of claim 12. The Examiner provides neither calculations showing the
cited prior has overlapping ranges of amino acids, evidence showing the
claimed amino acid values were inherent in whey protein, or other evidence
showing overlapping ranges of these amino acids in infant formula. We
therefore agree with Appellant that “[m]issing from the . . . analysis is an
explanation as to why it would have been routine optimization to arrive at
the claimed invention.” Stepan, 868 F.3d at 1346. This is a situation where
the Examiner has not established by evidence that the amino acid
concentrations that he suggests could be optimized were known result-
effective variables and, therefore, were reasonably subject to routine
optimization. See In re Antonie, 559 F.2d 618, 620 (CCPA 1977).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
conclusion that Koletzko, Van Goudoever, Mace, and Haschke render
claims 1, 6, 7, and 49 obvious.
A preponderance of the evidence of record does not support the
Examiner’s conclusion that Koletzko, Van Goudoever, Mace, and Haschke
render claim 12 obvious.

DECISION SUMMARY
In summary:
Claims
Rejected 35 U.S.C. § Basis Affirmed Reversed
1, 6, 7, 9–15,
49
103(a) Koletzko, Mace,
Van Goudoever,
Haschke
1, 6, 7, 9–11,
13–15, 49
12

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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-IN-PART