Ex Parte Mercenier et al

Patent Trial and Appeal Board

Feb 24, 2017

13882695 (P.T.A.B. Feb. 24, 2017)

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.
13/882,695 04/30/2013 Annick Mercenier 3712036-01834 1453
29157 7590 02/28/2017
K&T Oates T T .P-Phiraan
EXAMINER
P.O. Box 1135
CHICAGO, IL 60690
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
02/28/2017 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 ANNICK MERCENIER, GUENOLEE PRIOULT,
and SOPHIE NUTTEN
Appeal 2016-000786
Application 13/882,6951
Technology Center 1600
Before ERIC B. GRIMES, ELIZABETH A. LaVIER and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
powdered cereal based composition. The Examiner rejected the claims on
appeal as obvious under 35 U.S.C. § 103(a).
We affirm.
1 According to Appellants, the real party in interest is Nestec S.A. App. Br.
2.
Appeal 2016-000786
Application 13/882,695
STATEMENT OF THE CASE
Claims 1—9, 11, and 13—23 are on appeal. Claim 1, the only
independent claim, is illustrative and reads as follows:
1. A powdered cereal based composition designed to
be reconstituted in water, milk, or infant formula
comprising: at least 25 weight-% cereal, having an energy
density of at least 0.8 kcal/g and comprising after
reconstitution at least 2g/100kcal protein, less than
4.5g/100kcal fat, and less than 7.5g/100kcal added
sweetening agents with less than 3.75g/100kcal fructose,
the powdered cereal based composition comprising non­
replicating probiotic micro-organisms that have been
rendered non-replicating by a heat treatment at 120 °C to
140 °C for 1-30 seconds.
App. Br. 26.
The claims stand rejected as follows:
Claims 1—5, 13—15, 17—19 and 23 under 35 U.S.C. § 103(a) as
unpatentable over Lov2 as evidenced by CalorieKing,3 NutritionData,4
Breton,5 and Datta6 (“the First Ground of Rejection”);
2 Lov et al., WO 00/65930, published Nov. 9, 2000 (“Lov”).
3 CalorieKing, Nutrition, Carbohydrate and Calorie Counter, Calories in
Oat Bran, Raw, http://www.calorieking.com/foods/calories-in-breakfast-
cereals-to-be-cooked-oat-bran-raw, accessed Nov. 5, 2014 (“CalorieKing”).
4 SELF NutritionData, Oat Bran, Raw, http://nutritiondata.self.com/facts/
cereal-grains-and-pasta/5703/2, accessed Nov. 5, 2014 (“NutritionData”).
5 Breton et al., US Patent No. 7,651,680 B2, issued Jan. 26, 2010 (“Breton”).
6 Datta et al, Ultra-High-Temperature (UHT) Treatment of Milk:
Comparison of Direct and Indirect Modes of Heating, 57(3) The
Australian Journal of Dairy Technology 211-227, published Oct.
2002 (“Datta”).
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Claims 8 and 9 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Lov and Mateus7 as evidenced by CalorieKing,
NutritionData, Breton, Datta and Zink8 (“the Second Ground of Rejection”);
Claims 8 and 11 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Lov and Chou9 as evidenced by CalorieKing, NutritionData,
Breton, and Datta (“the Third Ground of Rejection”);
Claim 20 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Lov and Arulampalam10 as evidenced by CalorieKing,
NutritionData, Breton, Datta, and Holvoet* 11 (“the Fourth Ground of
Rejection”);
Claim 21 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Lov and Chou as evidenced by CalorieKing, NutritionData,
Breton, and Datta (“the Fifth Ground of Rejection”);
Claims 1—3, 6, 7, 13, 14, and 16—18 under 35 U.S.C. § 103(a) as
unpatentable over Hougee12 as evidenced by Datta (“the Sixth Ground of
Rejection”);
Claims 15, 19, and 22 under 35 U.S.C. § 103(a) as unpatentable over
the combination of Hougee and Arigoni13 as evidenced by Datta (“the
Seventh Ground of Rejection”).
7 Mateus et al., WO 2010/043415 A2, published Apr. 22, 2010 (“Mateus”).
8 Zink et al., US Patent No. 7,189,390 B2, issued Mar. 13, 2007 (“Zink”).
9 Chou et al., WO 2009/024429 A2, published Feb. 26, 2009 (“Chou”).
10 Arulampalam et al., US Patent Publication No. 2010/0254956 Al,
published Oct. 7, 2010 (“Arulampalam”).
11 Holvoet et al., US Patent Publication No. 2012/0164109 Al, published
Jun. 28, 2012 (“Holvoet”).
12 Hougee et al., WO 2008/153391 A2, published Dec. 18, 2008 (“Hougee”).
13 Arigoni et al., WO 2010/069737 Al, published June 24, 2010 (“Arigoni”).
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THE FIRST GROUND OF REJECTION
Claims 1—5, 13, 14, and 17
Appellants argue claims 1—5, 13, 14, and 17 together as a group. App.
Br. 10. We designate claim 1 as representative for the group.
The Examiner found that Lov disclosed a cereal emulsion including
all of the elements recited in claims 1—5, 13, 14, and 17. Ans. 3—5. The
Examiner concluded that “the only difference between Lov and the instant
claims is that Lov does not teach the disclosed composition with sufficient
specificity to be anticipatory.” Id. at 5. With respect to the claim
requirement that the composition comprise “probiotic micro-organisms that
have been rendered non-replicating by a heat treatment at 120 °C to 140 °C
for 1—30 seconds,” the Examiner found:
Although Lov does not specifically exemplify
fermentation of the cereal emulsion, followed by UHT
[Ultra High Temperature] heat treatment, the
combination is suggested by Lov since the UHT
treatment guarantees a long shelf-life and probiotic
bacteria have health promoting properties.
Therefore, a person of ordinary skill at the time the
invention was made would have been motivated to
subject the cereal emulsion to fermentation with probiotic
bacteria, followed by UHT treatment, with a reasonable
expectation of success since Lov teaches that probiotic
bacteria provide beneficial health effects and UHT
treatment extends the shelf-life of the nutritional product.
Id.
Appellants do not dispute that Lov discloses all of the elements
recited in claim 1. Instead, Appellants argue that unexpected results derived
from subjecting probiotic organisms to heat treatment show the claimed
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cereal composition to be non-obvious. Appellants assert that they
discovered that:
[H]eat treatment of probiotic micro-organisms modified
the levels of cytokines produced by human Peripheral
Blood Mononuclear Cells (PBMCs) in a temperature
dependent manner. UHT-like treated strains (140 °C,
15 seconds) induced less pro-inflammatory cytokines
while maintaining or inducing additional IL-10
production as compared to live counterpart, resulting in
resulting lower IL-12p40/IL-10 ratios compared to live
cells (FIGS. 1, 2, 3 and 4). In contrast, bacteria heat
treated at 85 °C for 20 minutes induced more pro-
inflammatory cytokines and less IL-10 than live cells,
resulting in higher IL-12p40/IL-10 ratios (FIG. 7). See
specification, page 25, line 6-page 26, line 8.
App. Br. 6. Appellants contend that these results are surprising and
unexpected. Id. at 6—7. We are not persuaded.
Lov teaches that fermenting its cereal emulsion increases shelf life
and improves the aroma and color of the emulsion. Lov p. 5,11. 31—36. In
addition Lov teaches that many of the bacterial strains used in fermentation
have “scientifically studied, health promoting, probiotic properties.” Id. at p.
6,11. 2—3. Lov also teaches that “[i]n order to guarantee long shelf-life it is
preferable to pasteurize or treat the emulsion by UHT after the
fermentation.” Id. atp. 6,11. 11—13. These teachings provide strong
motivation to ferment Lov’s cereal emulsion and then subject it to UHT
treatment after fermentation. Datta evidences that subjecting Lov’s cereal
emulsion to UHT would meet the requirement of claim 1 that the probiotic
organisms be rendered non-replicating by “a heat treatment at 120 °C to 140
°C for 1—30 seconds.” Datta 211 (“The time-temperature combinations used
in UHT systems are determined by the need to inactivate heat-resistant
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bacterial endospores .... Commonly, temperatures in the range 137—145°C
with holding times of 8—2 s [sic] are used for sterilization of milk and dairy
products”).
In sum, Lov provides good reason to ferment a cereal emulsion using
probiotic bacteria and then to subject the emulsion to UHT treatment. That
the reason for subjecting the emulsion to UHT treatment may be different
from the benefit discovered by the Appellants is irrelevant. Cross Med.
Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323 (Fed.
Cir. 2005) (“One of ordinary skill in the art need not see the identical
problem addressed in a prior art reference to be motivated to apply its
teachings.”).
We acknowledge Appellants’ argument that the cytokine-related and
anti-inflammatory properties resulting from heat treatment of probiotic
microorganisms were unexpected. We are not persuaded, however, that
these properties were, in fact, unexpected, given Lov’s teaching that
probiotic bacteria have “health promoting, probiotic properties” and that it is
“preferable” to subject the bacteria to UHT. Lov p. 6,11. 2—13. This
teaching suggests that UHT treatment does not vitiate the health promoting,
probiotic properties of the bacteria. Moreover, even if we were to accept
that the cytokine-related and anti-inflammatory properties identified by
Appellants go beyond the “health promoting, probiotic properties” taught by
Lov, and were unexpected, this showing would still be insufficient to
overcome the strong showing of obviousness in this case. See Leapfrog
Enters., Inc. v. Fisher-Price Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007)
(finding no error in conclusion that “given the strength of the prima
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facie obviousness showing, the evidence on secondary considerations was
inadequate to overcome a final conclusion” of obviousness).
Appellants also assert that they discovered that “anti-inflammatory
profiles can be generated from non-anti-inflammatory live micro-organisms
by UHT-like and HTST-like heat treatments.” Id. at 9. Claim 1, however, is
not limited to non-anti-inflammatory live micro-organisms. The anti­
inflammatory profiles generated from non-anti-inflammatory live-organisms
thus cannot support the non-obviousness of the composition of claim 1. In
re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“Evidence of
secondary considerations must be reasonably commensurate with the scope
of the claims.”).14
Accordingly, we affirm the Examiner’s decision to reject claim 1 as
obvious over Lov. Because they were not argued separately, claims 2—5, 13,
14, and 17 fall with claim 1.
Claim 15
Claim 15 depends from claim 1 and adds the requirement that the
probiotic micro-organisms be selected from a group consisting of a number
of specifically identified bacterial strains. The Examiner found that Lov
disclosed Bifidobacterium lactis 2818 (a.k.a. Bifidobacterium lactis as
evidenced by Breton), one of the strains identified in claim 15. Ans. 8.
Appellants argue that the Specification “explicitly discloses that this
strain (as well as other tested strains) exhibited enhanced anti­
inflammatory profiles” and therefore “the experimental evidence . . .
14 Claims 8, 9 and 11 are limited to organisms that Appellants assert do not,
when live, exhibit anti-inflammatory properties. We address Appellants’
unexpected results arguments with respect to those claims infra.
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clearly demonstrates unexpected results over the cited references. App. Br.
10-11. We are not persuaded.
In connection with our analysis of the Examiner’s rejection of claims
1—5, 13, 14, and 17 we found that the alleged unexpected results with respect
to generic “probiotic micro-organisms” did establish the non-obviousness of
the claimed composition. Appellants’ recitation of a sub-genera of probiotic
micro-organisms that exemplify the unexpected results alleged with respect
to the genus does not materially alter our opinion. Accordingly, we affirm
the Examiner’s rejection of claim 15 for the reasons discussed in connection
with claims 1—5, 13, 14, and 17 as obvious over Lov.
Claim 18
Claim 18 depends from claim 1 and adds the requirement that “the
heat treatment is performed at 120 °C to 140 °C for 5—15 seconds.” The
Examiner relied upon Datta as evidencing that UHT, as disclosed in Lov,
would be conducted at temperatures and for times that overlap with the
claimed ranges. Ans. 23. Appellants argue that Datta teaches that
temperatures around 135 °C require “excessively long holding times,” and
thus, “the UHT holding times disclosed by Datta for use with temperatures
of 140-150 °C would not be applicable to the claimed temperature range of
120 °C to 140 °C.” App. Br. 11. We are not persuaded.
Datta discloses that “UHT processing of milk denotes a continuous
heating process at temperatures higher than 130°C (usually 140-150°C) for
a holding period of a few seconds (usually 2—10 s).” Datta p. 211. Datta
further discloses:
The time-temperature combinations used in UHT systems are
determined by the need to inactivate heat-resistant bacterial
endospores . . . Commonly, temperatures in the range 137—
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145°C with holding times of 8—2 s [sic] are used for
sterilization of milk and dairy products.
Id. The temperatures and holding times disclosed in Datta overlap with
those recited in Claim 18, creating a prima facie case of obviousness that
Appellants have not persuasively rebutted. See In re Peterson, 315 F.3d
1325, 1329 (Fed. Cir. 2003) (“In cases involving overlapping ranges, we and
our predecessor court have consistently held that even a slight overlap in
range establishes a prima facie case of obviousness.”). Accordingly, we
affirm the Examiner’s rejection of claim 18 as obvious over Lov.
Claim 19
Claim 19 depends from claim 1 and adds the requirement that the heat
treatment is performed “at a temperature exceeding 135 °C for 5—15
seconds.” Claim 19 also adds the requirement that the probiotic micro­
organisms be selected from a group consisting of a number of specifically
identified bacterial strains.
Appellants argue that the Specification “explicitly discloses that this
strain (as well as other tested strains) exhibited enhanced anti­
inflammatory profiles” and therefore “the experimental evidence . . .
clearly demonstrates unexpected results over the cited references.” App. Br.
12. We are not persuaded.
As discussed with respect to Claim 15, Appellants’ recitation of a sub­
genus of probiotic micro-organisms that exemplify the unexpected results
alleged with respect to the genus does not materially alter our opinion. As
discussed with respect to claim 18, the temperatures and holding times
disclosed in Datta overlap with those recited, creating a prima facie case of
obviousness that Appellants have not persuasively rebutted. Accordingly,
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we affirm the Examiner’s rejection of Claim 19 as obvious over Lov for the
reasons discussed in connection with claims 15 and 18.
Claim 23
Claim 23 depends from claim 19 and adds the requirement that the
probiotic micro-organisms comprise Bifidobacterium lactis NCC 2818.
Appellants argue that the Specification “explicitly discloses that this strain
(as well as other tested strains) exhibited enhanced anti-inflammatory
profiles” and therefore “the experimental evidence . . . clearly demonstrates
unexpected results over the cited references.” App. Br. 13. We are not
persuaded. As discussed with respect to Claim 15, Appellant’s recitation of
a specific probiotic micro-organism that exemplifies the unexpected results
alleged with respect to the genus does not materially alter our opinion.
Accordingly, we affirm the Examiner’s rejection of Claim 23 as obvious
over Lov for the reasons discussed in connection with claim 15.
SECOND GROUND OF REJECTION
Claim 8
Claim 8 depends from claim 1 and adds the requirement that “the heat
treatment is performed at a temperature exceeding 135 °C for 5—15
seconds.” Claim 8 also adds the requirement that the probiotic micro­
organisms be “selected from the group consisting of Lactobacillus paracasei
NCC 2461, Lactobacillus rhamnosus NCC 4007, and combinations thereof.”
The Examiner found that Lov disclosed Lactobacillus paracasei, but
acknowledged that Lov did not identify the Lactobacillus paracasei as strain
NCC 2461. Ans. 9. The Examiner found that this element was supplied by
Mateus (as evidenced by Zink). Id. The Examiner concluded that it would
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have been obvious to substitute the known probiotic bacterial strain
disclosed in Mateus for the known strain disclosed in Lov. Id.
Appellants argue that unexpected results demonstrate the non­
obviousness of the claimed composition. Appellants contend that they
discovered that Lactobacillus paracasei NCC 2461 and Lactobacillus
rhamnosus NCC 4007 exhibit anti-inflammatory properties after being
subjected to UHT or HTST treatment even though live bacteria of the same
strains do not exhibit anti-inflammatory properties. App. Br. 14. Appellants
argue that it was surprising and unexpected that anti-inflammatory properties
could be generated by heat treating a strain of bacteria that, when live, did
not exhibit anti-inflammatory properties. Id. We are not persuaded.
As discussed with respect to claim 1, Lov provides good reason to
ferment a cereal emulsion using probiotic bacteria and then to subject the
emulsion to UHT treatment. Mateus teaches that probiotic bacteria “are
preferably microorganisms (alive, including semi-viable or weakened,
and/or non-replicating). . . that could confer health benefits on the host
when administered in adequate amounts, more specifically, that beneficially
affect a host by improving its intestinal microbial balance, leading to effects
on the health or well-being of the host.” Mateus also identifies
Lactobacillus paracasei NCC 2461 as an example of probiotic bacteria.
Mateus 1102 (emphasis added).
The teaching in Mateus that non-replicating probiotic bacteria confer
health benefits and the identification of Lactobacillus paracasei NCC 2461
suggest that it was not unexpected that the claimed composition would
confer health benefits. As discussed with respect to claim 1, we are not
persuaded that the anti-inflammatory properties of Lactobacillus paracasei
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NCC 2461 exceed the expected health benefits that Lov teaches are
conferred by probiotic bacteria. But even if we were to accept that the anti­
inflammatory properties were unexpected, this would still be insufficient to
demonstrate the non-obviousness of the claimed composition. Given the
strong suggestion in Mateus that Lactobacillus paracasei NCC 2461 is
probiotic and provides health benefits, and the strong teaching in Lov to
subject probiotic organisms to heat treatment, we find that the
preponderance of the evidence supports the Examiner’s finding that claim 8
would have been obvious to the person of ordinary skill in the art. See
Leapfrog, 485 F.3d at 1162. Accordingly, we affirm the Examiner’s
rejection of Claim 8 as obvious over Lov and Mateus.
Claim 9
Claim 9 depends from claim 8 and adds the requirement that “the
probiotic micro-organisms that have been rendered non-replicating comprise
Lactobacillus paracasei NCC 2461.” Appellants’ arguments with respect to
claim 9 are substantially the same as their arguments with respect to claims 1
and 8. App. Br. 15. Accordingly, we affirm the Examiner’s rejection of
Claim 9 as obvious over Lov and Mateus for the reasons discussed in
connection with claims 1 and 8.
THIRD GROUND OF REJECTION
Claim 8
Claim 8 depends from claim 1 and adds the requirement that “the heat
treatment is performed at a temperature exceeding 135 °C for 5—15
seconds.” Claim 8 also adds the requirement that the probiotic micro-
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organisms be “selected from the group consisting of Lactobacillus paracasei
NCC 2461, Lactobacillus rhamnosus NCC 4007, and combinations thereof.”
The Examiner found that Lov disclosed Lactobacillus rhamnosus, but
acknowledged that Lov did not identify the Lactobacillus rhamnosus as
strain NCC 4007. Ans. 11. The Examiner found that this element was
supplied by Chou. Id. The Examiner concluded that it would have been
obvious to substitute the known probiotic bacterial strain disclosed in Chou
the known strain disclosed in Lov. Id.
As with the Second Ground of Rejection, Appellants argue that
unexpected results demonstrate the non-obviousness of the claimed
composition. Appellants contend that they discovered that strains of
Lactobacillus paracasei NCC 2461 and Lactobacillus rhamnosus NCC 4007
exhibit anti-inflammatory properties after being subjected to UHT or HTST
treatment even though live bacteria of the same strains do not exhibit anti­
inflammatory properties. App. Br. 16. Appellants argue that it was
surprising and unexpected that anti-inflammatory properties could be
generated by heat treating a strain of bacteria that, when live, did not exhibit
anti-inflammatory properties. We are not persuaded.
As discussed with respect to claim 1, Lov provides good reason to
ferment a cereal emulsion using probiotic bacteria and then to subject the
emulsion to UHT treatment. Chou discloses nutritional products for
“supporting weight management.... [and] preventing and/or treating
metabolic disorders by modulating, in particular reducing the amount of
proteobacteria and/or deferribacteres in the gut.” Chou p. 1,11. 3—6. The
nutritional products are taught to include probiotic bacterial strains,
including Lactobacillus rhamnosus NCC 4007. Id. at p. 10,1. 29. Chou
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further teaches that the benefits of probiotic bacteria are “generally known to
those skilled in the art and may include managing lactose intolerance,
prevention of colon cancer, lowering cholesterol, lowering blood pressure,
improving immune function and preventing infections, reducing
inflammation and/or improving mineral absorption.” Id. at p. 11,11. 3—5
(emphasis added). Finally, Chou discloses that providing probiotic bacteria
in non-replicating form is beneficial:
Importantly, for the effectiveness of the agent capable of
reducing the amount of enterobacteria in the gut it is not
necessarily required that the probiotic bacteria are alive
in the composition. The probiotics might also be
effective, e.g., by means of their metabolites that they
have produced. Using inactive probiotics has the
advantage that the amount of active agent can be exactly
determined. Furthermore, inactive probiotics are usually
very storage stable and easy to incorporate in products.
Id. at p. 12,11. 16-21.
Based on the teachings of Lov and Chou, it appears that the anti­
inflammatory properties of inactivated Lactobacillus rhamnosus NCC 4007
were not unexpected. But even if the anti-inflammatory properties were
unexpected, this would still be insufficient to demonstrate the non­
obviousness of the claimed composition. Given the teaching in Chou that
Lactobacillus rhamnosus NCC 4007 is probiotic and provides health
benefits (including reducing inflammation), the further teaching in Chou that
inactive bacteria provides advantages over active bacteria, and the teaching
in Lov to subject probiotic organisms to heat treatment, we find that the
preponderance of the evidence supports the Examiner’s finding that claim 8
would have been obvious to the person of ordinary skill in the art. See
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Leapfrog, 485 F.3d at 1162. Accordingly, we affirm the Examiner’s
rejection of claim 8 as obvious over Lov and Chou.
Claim 11
Claim 11 depends from claim 8 and adds the requirement that “the
probiotic micro-organisms that have been rendered non-replicating comprise
Lactobacillus rhamnosus NCC 4007.” Appellants’ arguments with respect
to claim 11 are substantially the same as their arguments with respect to
claims 1 and 8. App. Br. 17. Accordingly, we affirm the Examiner’s
rejection of Claim 11 as obvious over Lov and Chou for the reasons
discussed in connection with claims 1 and 8.
FOURTH GROUND OF REJECTION
Claim 20
Claim 20 depends from claim 19 and adds the requirement that “the
probiotic micro-organisms that have been rendered non-replicating comprise
Bifidobacterium longum NCC 3001.”
The Examiner found that Lov disclosed Bifidobacterium longum, but
acknowledged that Lov did not identify the Bifidobacterium longum as strain
NCC 3001. Ans. 12. The Examiner found that this element was supplied by
Arulampalam. Id. at 12—13. The Examiner concluded that it would have
been obvious to substitute the known probiotic bacterial strain disclosed in
Arulampalam for the known strain disclosed in Lov. Id. at 13.
Appellants argue that the Specification “explicitly discloses that this
strain (as well as other tested strains) exhibited enhanced anti­
inflammatory profiles” and therefore “the experimental evidence . . .
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clearly demonstrates unexpected results over the cited references.” App. Br.
19—20. We are not persuaded.
In connection with our analysis of the Examiner’s rejection of claims
1—5, 13, 14, and 17 in the First Ground of Rejection, we found that the
alleged unexpected results with respect to generic “probiotic micro­
organisms” did establish the non-obviousness of the claimed composition.
Appellants’ recitation of a specific species of probiotic micro-organism that
exemplifies the unexpected results alleged with respect to the genus does not
materially alter our opinion. Accordingly, we affirm the Examiner’s
rejection of claim 20 as obvious over Fov and Arulampalam for the reasons
discussed in connection with claims 1—5, 13, 14, and 17 for the First Ground
of Rejection.
FIFTH GROUND OF REJECTION
Claim 21
Claim 21 depends from claim 8 and adds the requirement that “the
probiotic micro-organisms that have been rendered non-replicating comprise
Bifidobacterium longum NCC 2705.”
The Examiner found that Fov disclosed Bifidobacterium longum, but
acknowledged that Fov did not identify the Bifidobacterium longum as strain
NCC 2705. Ans. 14. The Examiner found that this element was supplied by
Chou. Id. The Examiner concluded that it would have been obvious to
substitute the known probiotic bacterial strain disclosed in Chou for the
known strain disclosed in Fov. Id.
Appellants argue that the Specification “explicitly discloses that this
strain (as well as other tested strains) exhibited enhanced anti­
inflammatory profiles” and therefore “the experimental evidence . . .
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clearly demonstrates unexpected results over the cited references.” App. Br.
18. We are not persuaded.
In connection with our analysis of the Examiner’s rejection of claims
1—5, 13, 14, and 17 in the First Ground of Rejection, we found that the
alleged unexpected results with respect to generic “probiotic micro­
organisms” did establish the non-obviousness of the claimed composition.
Appellants’ recitation of a specific species of probiotic micro-organism that
exemplifies the unexpected results alleged with respect to the genus does not
materially alter our opinion. Accordingly, we affirm the Examiner’s
rejection of claim 20 as obvious over Lov and Chou for the reasons
discussed in connection with claims 1—5, 13, 14, and 17 for the First Ground
of Rejection.
SIXTH GROUND OF REJECTION
Claims 1—3, 6, 7, 13, 14, 16, and 17
Appellants argue claims 1—3, 6, 7, 13, 14, 16, and 17 together as a
group. We designate claim 1 as representative for the group.
Hougee discloses a infant/toddler nutrition product. Hougee Abstract.
The Examiner found that Hougee taught that “supplementation with non-
viable (i.e. non-replicating) Bifidobacterium breve imparts a preventative/
curative effect on food allergy, asthma and infection” and that
Bifidobacterium breve can be rendered non-replicating by “known methods
including heat treatment steps such as UHT treatment.” Ans. 15. The
Examiner further found that Hougee taught that, “[t]he presence of the non-
viable B. breve prevents and/or treats a variety of disorders such as
infections, diarrhea, constipation, food allergy and asthma, while providing
increased shelf-life, a reduced incidence of bacterial contamination,
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decreased post-acidification of the product, improved dosage control and
improved convenience of reconstitution.” Id. at 16. Based on these
disclosures, the Examiner concluded that the claimed composition was
obvious over Hougee. Id. at 17.
Appellants argue that obviousness is rebutted by evidence of “new
and unexpected results.” App. Br. 20. The unexpected results identified by
Appellants are the same as discussed in connection with the First Ground of
Rejection. Id. Appellants contend:
None of the cited references even suggest that the skilled
artisan would have expected these experimental results.
Instead, the primary reference Hougee teaches that the
effect of non-viable B. breve cells was “slightly smaller
than that of living B. breve. ” Emphasis added; Hougee,
paragraph [0012]; see also Tables 1 and 2. Regarding the
evidentiary reference Datta, this reference merely teaches
UHT processing of milk such that all microorganisms are
“destroyed.” This evidentiary reference is completely
silent regarding probiotics, let alone that UHT treatment
of probiotics generates or enhances anti-inflammatory
profiles thereof.
App. Br. 21. We are not persuaded.
Hougee teaches that “[a] microbiota rich in bifidobacteria is beneficial
since it has a preventive effect on infections, diarrhea, constipation, gastro­
intestinal inflammation, intestinal maturation, allergy, in particular food
allergy, atopic diseases including atopic dermatitis, and asthma and it has a
beneficial effect on the immune system.” Hougee 1. Like Appellants,
Hougee discloses the “surprising” finding that non-viable bacteria confer
health benefits. Id. at 2 (“The inventors have surprisingly found that infant
and/or toddler nutrition comprising nondigestible oligosaccharides can be
advantageously supplemented with non-viable Bifidobacterium breve cells
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to have a preventive and/or curative effect on food allergy and/or other
atopic diseases.”). Hougee teaches that using non-viable bacteria is
preferable to using viable probiotic bacteria and provides multiple
advantages. Id. (listing advantages including easier storage with reduced
costs, absence of post-acidification, ability to pasteurize thus reducing the
chance of contamination, enabling use of liquid ready-to-use formula that
can be stored at room temperature, enabling a powdered product, and
providing a more easily controlled dose of bacterial cells). Finally, Hougee
teaches bacteria can be rendered non-viable by UHT treatment. Id. at 6.
In sum, Hougee provides good reason to include probiotic bacteria in
a nutritional product and good reason to render the bacteria non-replicating
by UHT treatment. That the reason for subjecting the bacteria to UHT
treatment may be different from the benefit discovered by the Appellants is
irrelevant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424
F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in the art need not
see the identical problem addressed in a prior art reference to be motivated
to apply its teachings.”).
We acknowledge Appellants’ argument that the Hougee teaches the
health benefit of non-viable Bifidobacterium breve to be “slightly smaller
than that of living B. breve” (App. Br. 21), but are not persuaded. Given
Hougee’s teaching that the use of non-viable bacteria is preferred, the
alleged enhanced anti-inflammatory properties of non-viable bacteria are
insufficient to overcome the strong showing of obviousness in this case. See
Leapfrog, 485 F.3d at 1162.
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Accordingly, we affirm the Examiner’s decision to reject claim 1 as
obvious over Hougee. Because they were not argued separately, claims 2, 3,
6, 7, 13, 14, 16, and 17 fall with claim 1.
Claim 18
Claim 18 depends from claim 1 and adds the requirement that “the
heat treatment is performed at 120 °C to 140 °C for 5—15 seconds.” The
Examiner relied upon Datta as evidencing that UHT, as disclosed in Hougee,
would be conducted at temperatures and for times that overlap with the
claimed ranges. Ans. 18. Appellants argue that Datta teaches that
temperatures around 135 °C require “excessively long holding times,” and
thus, the UHT holding times disclosed by Datta for use with temperatures of
140-150 °C would not be applicable to the claimed temperature range of 120
°C to 140 °C.” App. Br. 22. We are not persuaded.
Datta discloses that “UHT processing of milk denotes a continuous
heating process at temperatures higher than 130°C (usually 140-150°C) for
a holding period of a few seconds (usually 2-10 s).” Datta p. 211. Datta
further discloses:
The time-temperature combinations used in UHT
systems are determined by the need to inactivate heat-
resistant bacterial endospores . . . Commonly,
temperatures in the range 137-145°C with holding times
of 8-2 s [sic] are used for sterilization of milk and dairy
products.
Id. The temperatures and holding times disclosed in Datta overlap with
those recited in Claim 18, creating a prima facie case of obviousness that
Appellants have not persuasively rebutted. See In re Peterson, 315 F.3d
1325, 1329 (Fed. Cir. 2003) (“In cases involving overlapping ranges, we and
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our predecessor court have consistently held that even a slight overlap in
range establishes aprima facie case of obviousness.”) Accordingly, we
affirm the Examiner’s rejection of claim 18 as obvious over Hougee.
SEVENTH GROUND OF REJECTION
Claim 15
Claim 15 depends from claim 1 and adds the requirement that the
probiotic micro-organisms be selected from a group consisting of a number
of specifically identified bacterial strains, including Bifidobacterium breve
NCC 2950. The Examiner found that Arigoni disclosed Bifidobacterium
breve NCC 2950, and taught it to be “useful for treating rotavirus diarrhea in
infants and small children . . . even when rendered non-replicating.” Ans.
19—20. The Examiner thus concluded that it would have been obvious to use
Bifidobacterium breve NCC 2950, as taught by Arigoni, as the non­
replicating probiotic in the composition of Hougee. Id. at 20.
Appellants argue:
Arigoni does not remedy the deficiencies of Hougee as
evidenced by Datta regarding the unexpected results
achieved by independent Claim 1 from which Claim 15
depends. Arigoni merely teaches that anti-diarrhea
activity was retained after heat treatment at 90 °C for 30
minutes. Sqq Arigoni, Example 3, Table 3 and Fig. 2.
This reference does not even suggest that anti­
inflammatory profiles of probiotics can be generated or
enhanced by UHT treatment.
Therefore, the unexpected results rebut the alleged prima
facie obviousness of independent Claim 1 over Hougee
and Arigoni as evidenced by Datta.
App. Br. 22.
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We are not persuaded by Appellants’ arguments for the reasons
discussed in connection with the Sixth Ground of Rejection. While not
necessary to our decision given Hougee’s teaching of UHT, we note that
Arigoni’s teaching is not limited to heat treatments at 90 °C for 30 minutes.
Arigoni also discloses, inter alia, reducing bacterial load by “rapidly heating
the liquid mixture to a temperature in the range of about 80°C to about
150°C for about 5 seconds to about 5 minutes.” Arigoni p. 8,11. 4—6.
Accordingly we affirm the Examiner’s rejection of claim 15 for the reasons
discussed in connection with the Sixth Ground of Rejection.
Claim 19
Claim 19 depends from claim 1 and adds the requirement that “the
heat treatment is performed at a temperatures exceeding 135 °C for 5—15
seconds.” Claim 19 also adds the requirement that the probiotic micro­
organisms be selected from a group consisting of a number of specifically
identified bacterial strains.
Appellants argue that the Specification “explicitly discloses that this
strain (as well as other tested strains) exhibited enhanced anti­
inflammatory profiles” and therefore “the experimental evidence . . .
clearly demonstrates unexpected results over the cited references.” App. Br.
23. We are not persuaded.
In connection with our analysis of the Examiner’s rejection of claims
1—3, 6, 7, 13, 14, 16, and 17 in the Sixth Ground of Rejection we found that
the alleged unexpected results with respect to generic “probiotic micro­
organisms” did not establish the non-obviousness of the claimed
composition. Appellants’ recitation of a sub-genus of probiotic micro­
organisms that exemplify the unexpected results alleged with respect to the
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genus does not materially alter our opinion. Accordingly, we affirm the
Examiner’s rejection of claim 19 for the reasons discussed in connection
with claims 1—3, 6, 7, 13, 14, 16, and 17 in the Sixth Ground of Rejection.
Claim 22
Claim 22 depends from claim 19 and adds the requirement that “the
probiotic micro-organisms that have been rendered non-replicating comprise
NCC 2905.” Appellants argue that the Specification “explicitly discloses
that this strain (as well as other tested strains) exhibited enhanced anti­
inflammatory profiles” and therefore “the experimental evidence . . .
clearly demonstrates unexpected results over the cited references.” App. Br.
24. We are not persuaded. As discussed with respect to Claim 19,
Appellants’ recitation of a specific probiotic micro-organism that
exemplifies the unexpected results alleged with respect to the genus does not
materially alter our opinion. Accordingly, we affirm the Examiner’s
rejection of Claim 22 as obvious over Hougee and Arigoni for the reasons
discussed in connection with claim 19.
SUMMARY
For these reasons and those set forth in the Examiner's Answer, and
the Final Office Action, the Examiner's decision to reject claims 1—9, 11,
and 13—23 is affirmed.
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).
AFFIRMED
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