Marie Thomas et al.

Patent Trials and Appeals Board

Aug 14, 2019

13264704 - (D) (P.T.A.B. Aug. 14, 2019)

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.
13/264,704 03/05/2012 Marie Thomas 069818-4850 1313
22428 7590 08/14/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
PYLA, PAUL D
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
08/14/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARIE THOMAS, FRANCIS LECROIX,
EVAN ABRAHAMSE, and HOUKJE BOURITIUS
____________

Appeal 2018-005227
Application 13/264,704
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants1 seek review of the
Examiner’s rejections of claims directed to a method of reducing
regurgitation or reflux by administering a nutritional composition. We have
jurisdiction under 35 U.S.C. § 6(b).
For the reasons set forth below, we REVERSE.

1 Appellants identify the Real Party in Interest as N.V. Nutricia. Appeal
Br. 3. We have considered, and herein refer to, the Specification of October
14, 2011 (“Spec.”); Non-Final Office Action of March 24, 2017 (“Non-Final
Act.”); Appeal Brief of October 19, 2017 (“Appeal Br.”); Examiner’s
Answer of March 1, 2018 (“Answer”); Reply Brief of April 23, 2018
(“Reply Br.”); and the transcript of the Oral Hearing held July 2, 2019
(“Tr.”).
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Application 13/264,704

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STATEMENT OF THE CASE
Claims 17–20, 23, and 25–29 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 17, the sole independent
claim, is representative of the claims on appeal, and reads as follows:
17. A method for reducing regurgitation or reflux of a
nutritional composition, comprising administering to a patient
suffering from gastro-esophageal reflux and/or disease a
nutritional composition comprising:
(a) whey protein and/ or casein;
(b) locust bean gum in an amount less than 4 g per
100 g dry weight; and
(c) a fermented milk-derived product,
wherein the composition as a liquid has a viscosity of
(i) 80 mPa.s or higher at a pH of about 5.0 at 37°C and a shear
rate of 10 s-1 or (ii) between 30 and 80 mPa.s at neutral pH at
37°C and a shear rate of 10 s-1, and
wherein the composition comprises less than 1.5 g protein
per 100 ml liquid product.
The following grounds of rejection are before us for review:
I. claims 17–20, 23, and 25–28 are under 35 U.S.C. § 103(a) as
unpatentable over Miyazawa,2 Singhal,3 and Garcia-Rodenas;4 and
II. claim 29 under 35 U.S.C. § 103(a) as unpatentable over
Miyazawa, Singhal, Garcia-Rodenas, and Blareau.5

2 Miyazawa et al., Effect of Locust Bean Gum in Anti-regurgitant Milk on the
Regurgitation in Uncomplicated Gastroesophageal Reflux, 38 J. Ped.
Gastro. & Nutrition 479–483 (2004)(“Miyazawa”).
3 Singhal et al., US 2007 /0254062 Al, publ. Nov. 1, 2007 (“Singhal”).
4 Garcia-Rodenas et al., US 2007/0104700 Al, publ. May 10, 2007 (“Garcia-
Rodenas”).
5 Blareau et al., WO 1996006924A1, publ. Mar. 7, 1996 (“Blareau”)
(translation of record).
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Since both rejections rely upon the teaching of Miyazawa, Singhal,
and Garcia-Rodenas regarding the method of reducing regurgitation using a
composition containing a fermented milk product and locust bean gum, the
same issue is dispositive for both of these rejections, so we will consider the
rejections together.
Appellants’ concede the prima facie case. Tr. 3:7–10 (“[A]s the briefs
indicate Appellants are not arguing the prima facie case on whether there
may have been some motivation to combine Locust Bean Gum LBG and
milk ferment into a composition”). Accordingly, we only address
Appellants’ arguments directed to unexpected results.
At oral hearing, as well as in the Briefs, Appellants contend that the
claims are directed to a method of reducing gastro-esophageal reflux by
administering the composition that contains protein, locust beam gum, and a
fermented milk derived product. See Tr. 2–9; Appeal Br. 4–9. Appellants
explain that the surprising aspect is the behavior of the nutritional
composition when in a neutral pH environment versus when in an acidic
environment, such as for example the environment found in the stomach.
See Tr. 4–6; Appeal Br. 6. Claim 17, the sole independent claim, recites
“wherein the composition as a liquid has a viscosity of (i) 80 mPa.s or higher
at a pH of about 5.0 at 37°C and a shear rate of 10 s-1 or (ii) between 30 and
80 mPa.s at neutral pH at 37°C and a shear rate of 10 s-1.” Thus, the claim
requires that the viscosity of the nutritional composition differs when held at
neutral pH as compared to a more acidic pH environment found in the
stomach.
Appellants direct our attention to Table 4 of the Specification, which
shows that the viscosity of the composition initially increases when first
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exposed to an acidic environment. Appeal Br. 6, fn. 5. Table 4, reproduced
below, shows the relative viscosity of infant milk formula comparing:
fermented milk product and locust beam gum (LBG), locust beam gum only,
or starch only.

The table shows that when infant milk formula is combined with locust
beam gum and a fermented milk product under acidic conditions, such as
those found in the stomach, the relative viscosity of the fermented milk
product and locust bean gum composition increases in the first 15 to 30
minutes and maintains this relative increase until well past 60 minutes.
Spec. 15:6–15; Appeal Br. 6. As explained in the Specification, “the period
60 minutes [after ingestion], more particular the first 30 minutes are the most
important, since the majority of reflux happening during this time.” Spec.
15:10–12; see also Tr. 5:6–13.
The Specification also measures the viscosity of the various infant
milk formulas in the bottle. See Spec. 13–14 (Example 6). The goal for
reflux treatment using the nutritional composition is that while the formula is
in the bottle it maintains a relative low viscosity thereby making it easier for
the infant to drink the formula from the bottle, but once the formula hits the
stomach environment it immediately begins to thicken in order to reduce
reflux. Tr. 5:18–6:8; see also Spec. 14 (“a low viscosity in the bottle makes
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it easier to drink and pass the hole in the teat.”). Table 3 of the
Specification, reproduced below, shows the viscosity measurements of the
infant formula in a bottle environment over time.

The table shows that when the infant milk formula is formulated with the
fermented milk product and locust beam gum the viscosity of the product
does not change much after 15 minutes, the same is true for the infant milk
formula formulated with starch only. Spec. 14. While the infant formula
formulated with locust beam gum only continues to thicken over time.6
Spec. 14:9–12 (“From Table 3 it can be deduced that compared to the old
AR formula with LBG and without ferment, less viscosity is developed in
the bottle. This is advantageous, since a low viscosity in the bottle makes it
easier to drink and pass [through] the hole in the teat.”); see also Appeal Br.
6 (the infant milk formula (IMF) “with fermented [milk] product and LBG
(in accordance with claimed composition) thickens slower and has a lower

6 We recognize that the amount of locust beam gum between the fermented
milk product containing composition (0.42 g LBG per 100 ml (Spec. 13:21))
and the locust bean gum only composition (0.47 g LBG per 100 ml (id. at
14:2)), is slightly different in table 3, but we do not think that this slight
difference accounts for the significant viscosity increases with the locust
beam gum only formulation.
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relative viscosity in the bottle at all times compared to IMF with LBG
only.”).
Table 2 of the Specification, reproduced below, shows the effect of
fermented milk product on the viscosity of a locust bean gum formulation.

The table shows that increasing the amounts of fermented milk product in a
composition containing locust bean gum increases the viscosity of the
composition. Spec. 12–13. Here, the test maintains the locust bean gum
concentration steady at 3% by weight while changing the amount of
fermented milk product in the composition. Id. at 13:3. Of note, the
viscosity of the fermented milk product by itself is negligible. Id. at 12:25–
13:3 (see table 1, line 1 showing the viscosity with Lactofidus mPa.s
(fermented milk product) without locust bean gum). Thus, the Specification
provides evidence that fermented milk product by itself does not contribute
significantly to the viscosity of an infant milk formulation. It is only when
the fermented milk product is combined with locust bean gum that there is
some interaction between the locust beam gum and the fermented milk
product that results in the observed increased viscosity in the formulation
once it is ingested. See Tr. 7:17–21 (“[T]he inventors aren’t sure what’s
going on here but the effect is reproducible and the only true difference
between the stomach and the bottle is the difference in PH so it’s probably
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on account of the PH but what the underlying mechanism is going on is still
up in the air.”).
Examiner’s position is that Appellants’ unexpected results are not
persuasive because they are not commensurate in scope with the recitation in
the claims. See Ans. 21–24. Specifically, Examiner contends that the tables
and graphs provided do not establish that the results show statistical and
practical significance in order to find that they are unexpected. Ans. 24.
We have reviewed Examiner’s arguments in light of the arguments
presented by Appellants and evidence provided in the Specification showing
an unexpected interaction between the fermented milk product and the locust
beam gum that results in the increased viscosity of the composition once the
composition is exposed to a more acidic environment. Examiner’s position
is that the experimental protocols could be improved with more and better
statistical information. We recognize that generally any experimental
protocol can be fine-tuned and improved. However, the question before us
is whether the evidence provided is sufficient to overcome the prima facie
case of obviousness presented by Examiner, and on this record we find that
it does.
Here, the Specification shows that the fermented milk product by
itself does not significantly contribute to the viscosity of an infant milk
formulation, less than 2 mPa.s. Spec. 12 (table 1 line 1, column 3
(“Viscosity with Lactofidus mPa.s”). It is only when the fermented milk
product is combined with locust beam gum that viscosity of the product
increases far more than would be expected when formulated with locust
beam gum or fermented milk product only. Compare Spec. 12 (table 1 line
1, column 3 (“Viscosity with Lactofidus mPa.s”) with Spec. 13 (table 2,
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column 2). Thus, we find that this evidence is sufficient to establish that
there is some unexpected interaction between locust beam gum and the
fermented milk product that contributes to the increased viscosity when the
locust bean gum is mixed with fermented milk product. Additionally,
Appellants show that the effect of this interaction between locust beam gum
in the fermented milk product is even more pronounced when the
formulation is exposed to an acidic environment. Id. at 14 (table 3). Based
on these disclosures in the Specification, we conclude that the balance of the
evidence favors Appellants. Accordingly, we reverse the obviousness
rejection.

SUMMARY
We reverse the rejection of all claims.

REVERSED