Zihua Ao et al.

Patent Trials and Appeals Board

Feb 12, 2020

13775202 - (D) (P.T.A.B. Feb. 12, 2020)

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.
13/775,202 02/24/2013 Zihua Ao MJN15230 8764
6980 7590 02/12/2020
TROUTMAN SANDERS LLP
600 Peachtree St., NE, Suite 3000
Atlanta, GA 30308
EXAMINER
GWARTNEY, ELIZABETH A
ART UNIT PAPER NUMBER
1791
NOTIFICATION DATE DELIVERY MODE
02/12/2020 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):
jim.schutz@troutmansanders.com
patents@troutmansanders.com
ryan.schneider@troutmansanders.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ZIHUA AO, JOHN D. ALVEY,
JUAN M. GONZALEZ, and JENNIFER VILLEGAS
____________

Appeal 2019-002130
Application 13/775,202
Technology Center 1700
____________

Before LINDA M. GAUDETTE, MERRELL C. CASHION, JR., and
SHELDON M. McGEE, Administrative Patent Judges.

CASHION, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 21–38, 40, and 41. Appeal Br. 3.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 Mead
Johnson Nutrition Company. Appeal Br. 3.
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The invention is generally directed to “nutritional compositions
comprising an emulsion system comprising a waxy starch or a waxy starch
and citric acid esters of mono- and di-glycerides.” Spec. ¶ 1. The invention
also includes hypoallergenic nutritional compositions. Spec. ¶ 3; Appeal Br.
11; Ans. 15. According to the Specification, hypoallergenic compositions
contain hydrolyzed protein, extensively hydrolyzed protein, or free amino
acids. Spec. ¶ 3. Claim 21 illustrates the invention (formatting added):
21. A powdered nutritional composition comprising:
a protein equivalent source comprising a hydrolyzed
protein and free amino acids, wherein the hydrolyzed protein
comprises a degree of hydrolysis of at least 50%, further
wherein the protein equivalent source in present in an amount
of from about 1 g/100 kcal to about 7 g/100 kcal,
a fat source,
a carbohydrate source, wherein the carbohydrate source
is present in an amount of from about 5 g/100 kcal to about 25
g/100 kcal, and
an emulsifier system comprising a waxy potato starch
and citric acid esters of mono- and di-glycerides, wherein the
waxy potato starch is present in an amount of 6% to 15% of the
total weight of the nutritional composition, and wherein the
citric acid esters of mono- and di-glycerides are present in an
amount of between 0.1% and 2% by weight of the total weight
of the nutritional composition.
Independent claim 41 is directed to a specific nutritional composition
having additional components not recited in claim 21.
Appellant requests review of the following rejections maintained by
the Examiner:
I. Claims 21–25, 27, 30–35, 38, and 40 rejected under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Martinez (US 6,099,871, issued
August 8, 2000), Vurma (WO 2013/101400 A1, published July 4, 2013),
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Donnet-Hughes (WO 2006/108824 A1, published October 19, 2006), and
Euber (US 6,436,464 B1, issued August 20, 2002).

II. Claim 26 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Martinez, Vurma, Donnet-Hughes, Euber, and Duarte
(MX 2011010299 A, published March 29, 2013, and relying on an English
translation of the Abstract only, dated December 4, 2014).

III. Claim 28 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Martinez, Vurma, Donnet-Hughes, Euber, and Mower
(US 2006/0210697 A1, published September 21, 2006).

IV. Claim 29 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Martinez, Vurma, Donnet-Hughes, Euber, and Wittke (US
2011/0293784 A1, published December 1, 2011).

V. Claims 36 and 37 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Martinez, Vurma, Donnet-Hughes, Euber, and Russell
(US 2010/0074871 A1, published March 25, 2010).

VI. Claim 41 rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Martinez, Vurma, Donnet-Hughes, Euber, and Weizman
(Weizman, Z. et al., Effect of a probiotic infant formula on infections in
child care centers: comparison of two probiotic agents, 115(1) Pediatrics
(January 2005) (Abstract only)).

Appellant relies on the same line of arguments to address the separate
rejections of independent claims 21 and 41 (Appeal Br. 18–19). Appellant
presents separate arguments for claims 22 and 23 (id.). Appellant also
contends that the Examiner does not address the specific limitations of
claims 24–29 and 35–37 (id. at 19). We note that the Examiner rejected
claims 24, 25, 27, 30–35, 38, and 40 in Rejection I while claims 26, 28, 29,
36, and 37 were rejected separately (Rejections II–V). Appellant’s argument
for claims 24–29 and 35–37 is tantamount to “merely point[ing] out what
[the] claim[s] recite[ and] will not be considered an argument for separate
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patentability of the claim[s].” 37 C.F.R. § 41.37(c)(1)(iv) (2017).
Accordingly, we consider the patentability of the claims subject to grounds
of Rejections I–VI based on the arguments made in support of patentability
of claim 21 as representative of the subject matter claimed. We address the
arguments for claims 22 and 23 separately.
OPINION
After review of the respective positions the Appellant provides in the
Appeal and Reply Briefs and the Examiner provides in the Final Action and
the Answer, we affirm the Examiner’s prior art rejections of claims 21–38,
40, and 41 based on the fact-finding and the reasons the Examiner provides.
We add the following for emphasis.
Independent claim 21
The Examiner finds that Martinez suggests a powdered nutritional
composition (an infant formulation) comprising native and pre-gelatinized
starch and emulsifiers that differs from the subject matter of claim 21 in that
Martinez does not disclose an emulsifier system comprising (1) the use of a
waxy potato starch, (2) the use of citric acid esters of mono- and di-
glycerides, and (3) the claimed amount of emulsifier. Final Act. 3–6.
Regarding difference (1), the Examiner finds that Vurma teaches that
it was known to use waxy potato starch as a starch source for a stabilizing
material in nutritional compositions, including infant formulations. Final
Act. 5; Vurma ¶¶ 8–10, 54. The Examiner determines that it would have
been obvious to one of ordinary skill in the art to use a waxy potato starch as
the waxy starch in Martinez’s infant formulation because both references are
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directed to nutritional infant formulations.2 Final Act. 5.
Regarding difference (2), the Examiner finds that Martinez discloses
the use of soy lecithin as an emulsifier for infant formulations. Final Act. 5;
Martinez col. 4, ll. 61–66. The Examiner finds that Donnet-Hughes teaches
an infant nutritional composition can comprise emulsifiers such as soy
lecithin, citric acid esters of mono- and diglycerides, and the like. Final Act.
5; Donnet-Hughes 7. The Examiner determines that it would have been
obvious for one skilled in the art to modify Martinez’s nutritional
composition by using Donnet-Hughes’s citric acid esters of mono- and di-
glycerides in place of Martinez’s soy lecithin because both references are
directed to infant nutritional compositions and such substitution would have
amounted to nothing more than the use of a known emulsifier for its
intended use in a known environment to accomplish an entirely expected
result. Final Act. 5.
Regarding difference (3), the Examiner finds that Martinez discloses
an infant formulation that is shelf stable (i.e. remains in a single
homogenous phase and does not separate into more than one phase) after
reconstitution. Final Act. 5–6; Martinez col. 5, ll. 15–25. The Examiner
determines that it would have been obvious to one of ordinary skill in the art
to adjust the amount of emulsifier, through routine experimentation, to arrive
at the desired emulsion stability in view of Martinez’s teachings. Final Act.
6.

2 We note that Martinez discloses using potato starch in the disclosed
invention but does not expressly disclose using waxy potato starch.
Martinez col. 1, l. 8.
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The Examiner also finds that Martinez does not disclose (4) a protein
source including free amino acids. Final Act. 3–4, 5–6.
Regarding difference (4), the Examiner finds that Euber teaches an
infant nutritional composition comprising a protein source selected from any
appropriate nitrogen source including free amino acids and an emulsifier
system comprising octenyl succinic anhydride (OSA) modified starch and an
acetylated monoglyceride. Final Act. 6; Euber Abstr., col. 4, ll. 23–27, 56–
59. The Examiner determines that it would have been obvious to one of
ordinary skill in the art to have used free amino acids as an added protein
source in Martinez’s infant formulation to make a formulation compatible
for babies with protein allergies because both references are directed to
infant nutritional compositions and Euber teaches that free amino acids were
known to be used as a protein and/or nitrogen source for infant formulations
to make a hypoallergenic formulation for babies. Final Act. 6; Euber col. 1,
ll. 32–34.
Appellant argues that the combined teachings of the cited art do not
recognize that a combination of waxy potato starch and citric acid esters of
mono- and di-glycerides is a particularly useful emulsifier system for
hypoallergenic nutritional formulations comprising hydrolyzed protein and
free amino acids because waxy potato starch contains only trace amounts of
protein. Appeal Br. 11; Spec. ¶¶ 35–41.
Appellant’s argument does not identify error in the Examiner’s
determination of obviousness for the reasons the Examiner presents. Final
Act. 6; see Ans. 16. Moreover, while Appellant argues that part of the
discovery is the use of a waxy potato starch containing only trace amounts of
protein (Appeal Br. 11 (citing Spec. ¶¶ 35–41)), claim 21 does not recite that
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the waxy potato starch must be one that has only trace amounts of protein.
Appellant argues that the Examiner is benefitting from impermissible
hindsight because Martinez, while disclosing the inclusion of hydrolyzed
proteins, puts equal or more focus on intact proteins as the protein source in
providing an anti-regurgitation infant formulation to address postprandial
gastroesophageal reflux (“GER”) in infants and not a hypoallergenic
formulation. Appeal Br. 12; Martinez col. 3, ll. 61–66. In support of this
argument, Appellant contends that Martinez includes examples of
formulations with intact proteins (Examples 1–3), an example of a
formulation with hydrolyzed protein (Example 4), and examples with both
(Examples 5 and 6), as well as a comparative example utilizing intact protein
formulations (Example 7). Id. Thus, Appellant asserts that Martinez’s focus
is not a hypoallergenic formulation because the concerns surrounding
emulsification of a hypoallergenic formulation without adding intact protein
do not arise in the Martinez arena. Id.
These arguments also lack persuasive merit.
As the Examiner explains, Martinez discloses an infant formulation
comprising a protein component made up of entirely hydrolyzed protein.
Ans. 16; Martinez col. 3, ll. 61–64, col. 7, ll. 15–25 (Example 4). In fact,
Appellant’s acknowledgement that Martinez’s disclosure includes examples
of nutritional compositions comprising hydrolyzed proteins is an
acknowledgement that Martinez’s disclosure encompasses hypoallergenic
nutritional compositions. See Spec. ¶ 3.
While Appellant’s claimed invention aims to provide hypoallergenic
properties in addition to providing desirable anti-regurgitation properties (as
Martinez’s does (Appeal Br. 12; Spec. ¶ 39; Ans. 17)), it is well settled that
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a chemical composition and its properties are inseparable. In re Spada, 911
F.2d 705, 709 (Fed. Cir. 1990) (“Products of identical chemical composition
can not have mutually exclusive properties.”). Appellant has not directed us
to objective evidence showing that Martinez’s nutritional compositions
comprising hydrolyzed proteins do not possess hypoallergenic properties.
Nor has Appellant explained adequately why Martinez’s nutritional
compositions comprising hydrolyzed proteins would not also be
hypoallergenic.
Appellant asserts that Martinez is not focused on hypoallergenic
nutritional compositions because Martinez prefers nutritional compositions
that contain intact proteins and not hydrolyzed proteins. Appeal Br. 12.
As we note above, Appellant acknowledges that Martinez’s disclosure
encompasses hypoallergenic nutritional compositions comprising
hydrolyzed proteins.
Further, it is well settled that a reference may be relied upon for all
that it discloses and not merely the preferred embodiments as suggested by
Appellant. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (“[A]ll disclosures of the prior art, including unpreferred
embodiments, must be considered.” (quoting In re Lamberti, 545 F.2d 747,
750 (CCPA 1976))). Appellant has not explained adequately why
Martinez’s examples of nutritional formulations comprising intact proteins
limits Martinez’s broader disclosure that expressly includes nutritional
compositions comprising hydrolyzed proteins.
Appellant argues that, contrary to the Examiner’s assertions, Martinez
does not teach including an amount of waxy starch based on the total dry
weight of the composition. Appeal Br. 13. Appellant contends that nothing
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in Martinez provides enough information to suggest including waxy potato
starch in an amount of 6% to 15% of the total weight of the nutritional
composition because Martinez does not address emulsifying a protein-free
formulation. Id. Appellant asserts that, while Martinez teaches adjusting for
viscosity, Martinez does not address emulsification of a protein free
composition or provide a teaching which would lead the artisan to the
amount of starch needed for emulsifying a hypoallergenic formulation. Id.
This argument fails to identify reversible error in the Examiner’s
determination of obviousness for the reasons the Examiner presents. Ans.
17. The Examiner’s position is that Martinez, like Appellant, describes
nutritional compositions comprising hydrolyzed proteins that have desirable
anti-regurgitating properties. Ans. 17; Appeal Br. 12; Spec. ¶ 39; Martinez
col. 1, ll. 48–52. Appellant discloses that the total amount of waxy starch
used can be advantageously adjusted based on desired viscosity and that the
total amount of starch contributes to desirable anti-regurgitation properties
of the nutritional composition. Ans. 17; Spec. ¶ 39; Martinez col. 3, ll. 26–
32. Similarly, Martinez discloses that the use of waxy starches achieves
anti-regurgitation effects and the need to control viscosity of infant formula
so that it is sufficiently high to be effective in treating regurgitation, but not
so high as to inhibit pourability. Martinez col. 3, ll. 20–23, 26–32. Thus,
there is a reasonable basis to support the Examiner’s assertion that the
functionality of the starch in the claimed invention and in Martinez is to
serve as a component of an emulsifying system and as a thickener. Ans. 17.
Therefore, we agree with the Examiner that Martinez provides sufficient
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guidance to one skilled in the art to arrive at the claimed amount of waxy
potato starch based on the total weight of the nutritional composition.
Appellant’s argument that adjusting for viscosity does not address
emulsification of a protein free composition is not persuasive because, as we
note above, Martinez’s disclosure encompasses nutritional compositions
comprising hydrolyzed proteins. Appeal Br. 13. Appellant has not
explained adequately why Martinez fails to address emulsification of
nutritional compositions containing hydrolyzed proteins.
Appellant argues that the Examiner does not provide any reference
that supports the contention that the artisan would undertake “routine
experimentation” to determine the amount of emulsifier and, instead, merely
states that one of skill in the art would have been motivated to adjust the
amount of emulsifier. Appeal Br. 16. Appellant further argues that, absent
impermissible hindsight, the Examiner has not shown or explained that the
amount of emulsifier is recognized by the art as a result effective variable.
Id.
As the Examiner explains, Martinez discloses the need to produce an
infant formulation that is shelf stable after reconstitution. Ans. 19; Martinez
col. 5, ll. 15–25. Indeed, Martinez discloses that the formulation is in a form
ready to consume in a single homogenous phase (i.e., does not separate into
more than one phase upon visual inspection) or that the thickener does not
settle out as a sediment upon visual inspection after storage overnight in the
refrigerator. Martinez col. 5, ll. 16–21. Martinez also discloses that its
formulation has the advantage of remaining fluid. Id. at col. 5, ll. 21–25.
Thus, Martinez’s disclosure provides sufficient guidance for one skilled in
the art to determine the amount of emulsifier needed for a suitable
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formulation. Given this disclosure, Appellant has not adequately explained
why one skilled in the art, using no more than ordinary creativity, would not
have been capable of determining the appropriate amount of emulsifier to
obtain a desirable nutritional composition from Martinez’s teachings. See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”); see
also In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (presuming skill on the
part of one of ordinary skill in the art).
Appellant argues that Martinez does not teach the inclusion of free
amino acids (or extensively hydrolyzed casein protein3) in the protein
source. Appeal Br. 17. Appellant further argues that the Examiner’s
reliance on Euber for the missing element is misplaced because Euber does
not teach the claimed waxy potato starch. Appeal Br. 17; Euber col. 1, ll. 9–
10. Thus, one skilled in the art would not have been able to combine Euber
with Martinez and just include the extensively hydrolyzed proteins and free
amino acids without also including the unique emulsifying system Euber
teaches. Appeal Br. 17. That is, Appellant contends that the skilled artisan
would have been led to utilize an acetylated monoglyceride in combination
with a starch for a nutritional composition having such a protein component,

3 The limitation of “or extensively hydrolyzed casein protein” is not recited
by independent claim 21 (or independent claim 41). It is recited in
dependent claim 27, which Appellant has not specifically argued. See
generally Appeal Br. To the extent that Appellant argues this limitation, our
discussion with respect to the addition of free amino acids is applicable to
the addition of this component given that the Examiner relies on Euber to
address both, the free amino acids and the extensively hydrolyzed casein
protein. Final Act. 6.
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but not the waxy potato starch and citric acid esters of mono- and di-
glycerides claimed herein. Id.
These arguments also lack persuasive merit.
As the Examiner explains, the language in claim 21 is drafted with the
open transitional language of “comprising” that does not exclude additional
unrecited components including the components of the emulsifying system
of Euber. Ans. 19. In fact, Appellant acknowledges that Euber’s octenyl
succinic anhydride modified starch, can be an additional element of the
claimed emulsification system. Appeal Br. 17. Thus, Appellant has not
explained adequately why one skilled in the art would not have used an
acetylated monoglyceride in combination with a starch for nutritional
composition having such a hydrolyzed protein component such as the waxy
potato starch and citric acid esters of mono- and di-glycerides claimed.
We have also considered Appellant’s arguments that Vurma is not
directed to a hypoallergenic composition and its combination with Martinez
does not teach or suggest the claimed weight percentages of waxy potato
starch claimed herein. Appeal Br. 15. We find these arguments
unpersuasive for the reasons the Examiner presents, which we adopt as our
own. Ans. 17–18.
Dependent claims 22 and 23
Claim 22 recites that the waxy potato starch comprises a combination
of native and pre-gelatinized potato starches.4 Claim 23 recites that the
weight ratio of native to pre-gelatinized waxy starch is from 0.1:1 to 2:1.

4 We understand that Appellant’s arguments for claim 22 are also directed to
independent claim 41. Appeal Br. 18. Accordingly, our discussion of claim
22 is equally applicable to independent claim 41.
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Regarding claim 22, the Examiner finds that Martinez discloses that
the waxy starch can be used in its native state or with additional pre-
treatments such as pre-gelatinization. Final Act. 11; Martinez col. 2, l. 11.
Appellant argues that, while Martinez teaches the use of either of the
native and pre-gelatinized starches, Martinez does not teach the combined
use of these starches. Appeal Br. 14.
We are unpersuaded by this argument for the reasons the Examiner
presents. Ans. 17. “It is prima facie obvious to combine two compositions
each of which is taught by the prior art to be useful for the same purpose, in
order to form a third composition which is to be used for the very same
purpose.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Appellant has
pointed to no objective evidence showing criticality resulting from the use of
a starch blend of native and pre-gelatinized starches.
Regarding claim 23, the Examiner asserts that, while Martinez
discloses that either of the native and pre-gelatinized starches can be used in
nutritional compositions, Martinez does not necessarily teach away or
discourage the combination. Final Act. 4; Ans. 17. The Examiner also
asserts that Appellant has not provided evidence that the claimed ratio of
native and pre-gelatinized starch is critical. Ans. 17.
Appellant argues that there is nothing in any of the cited references
that teaches the claimed ratio of native to pre-gelatinized starches, even if
waxy potato starch was substituted for Martinez’s starches, and a
combination of native and pre-gelatinized starches was used. Appeal Br. 14.
Appellant’s argument fails to identify reversible error in the
Examiner’s determination of obviousness for the reasons presented by the
Examiner. Ans. 17.
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Moreover, Appellant’s invention contemplates using a combination of
the same starch in native and pre-gelatinized forms. See Spec. ¶ 83
(Example 2). The Specification does not describe any advantage in using a
native versus a pre-gelatinized form of the same starch. See id. ¶ 34. Nor
does Appellant directs us to any evidence of the criticality of the claimed
ratio range. Thus, absent a showing that the claimed weight ratio of native
to pre-gelatinized waxy starch is critical, one skilled in the art would not
expect a combination of the native and pre-gelatinized starches, particularly
native and pre-gelatinized forms of the same starch, to perform any
differently that when used individually.
Arguments not specifically addressed are deemed not persuasive for
the reasons the Examiner presents.
Accordingly, we affirm the Examiner’s prior art rejections of claims
21–38, 40, and 41 for the reasons the Examiner presents and we give above.

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CONCLUSION
In summary:

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
21–25, 27,
30–35, 38,
40
103(a) Martinez, Vurma,
Donnet-Hughes,
Euber
21–25, 27,
30–35, 38,
40

26 103(a) Martinez, Vurma,
Donnet-Hughes,
Euber, Duarte
26
28 103(a) Martinez, Vurma,
Donnet-Hughes,
Euber, Mower
28
29 103(a) Martinez, Vurma,
Donnet-Hughes,
Euber, Wittke
29
36, 37 103(a) Martinez, Vurma,
Donnet-Hughes,
Euber, Russell
36, 37
41 103(a) Martinez, Vurma,
Donnet-Hughes,
Euber, Weizman
41
Overall
Outcome
21–38, 40,
41

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

AFFIRMED