Ex Parte Breton et al

Board of Patent Appeals and Interferences

Sep 9, 2010

10505305 (B.P.A.I. Sep. 9, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
___________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte LIONEL BRETON, ISABELLE BUREAU-FRANZ,
and
CHANTAL FANCHON,
Appellants1
____________________

Appeal 2010-000353
Application 10/505,305
Technology Center 1600
____________________

Before ERIC GRIMES, CAROL A. SPIEGEL, and
MELANIE L. MCCOLLUM, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL2

1 The real party in interest is NESTEC S.A. (Appellants' Appeal Brief filed 3
March 2009 ("App. Br.") at 2). This decision also cites to the Examiner's
Answer mailed 28 May 2009 ("Ans."), Appellants' Reply Brief filed 23 July
2009 ("Reply Br."), and the Specification of the '305 Application ("Spec.").
2 The two-month period for filing an appeal or commencing a civil action, as
recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited
in 37 C.F.R. § 41.52, begins to run from the "MAIL DATE" (paper delivery
mode) or the "NOTIFICATION DATE" (electronic delivery mode) shown
on the PTOL-90A cover letter attached to this decision.
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Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of claims 1-10 and 25-30. Claims 11-24, the only other pending
claims, stand withdrawn from consideration as directed to a non-elected
invention. (App. Br. 4; Ans. 2.) We have jurisdiction under 35 U.S.C. §
134. We AFFIRM.
I. Statement of the Case
The subject matter on appeal is directed to an orally administrable
composition containing a photoprotecting effective amount of at least one
probiotic lactic acid bacterium, from 10-12 to 20 % by weight of at least one
carotenoid, a yeast extract, and an orally acceptable carrier.
According to the '305 Specification, "photoprotection" describes an
"attempt to block or reduce the adverse clinical, histological and
immunological effects of solar radiation exposure on the skin" (Spec. 3:14-
16), such as erythema, inflammation, sun burn, barrier function,
photoageing, and alteration of the immune system (id. at 2:24-29).
According to the '305 Specification, the probiotic lactic acid bacteria is
present in an amount of at least 105 cfu/g carrier, preferably from about 105
to 1015 cfu/g carrier (id. at 5:11-15).
Claim 1 is illustrative and reads (App. Br. i):
1. An orally administrable composition for the
photoprotection of the skin comprising a
photoprotecting effective amount of at least one
probiotic lactic acid bacterium, and at least one
carotenoid, wherein the at least one carotenoid is
present in the composition in an amount from
10-12 % to 20% by weight, included in an orally
acceptable carrier, the composition further
comprising a yeast extract.

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The probiotic lactic acid bacterium of claim 1 may be selected from
Lactobacilli and Bifidiobacteria (claim 2), e.g., Lactobacillus johnsonii
(CNCM I-1225), Lactobacillus paracasei (CNCM I-2116), Bifidobacterium
adolescentis (CNCM I-2168), or Bifidobacterium longum (CNCM I-2170)
(claim 4). The carotenoid of claim 1 may be α-carotene, ß-carotene, γ-
carotene, lycopene, zeaxanthine, and/or luteine (claim 26). The carrier of
claim 1 may be a food (claim 7), a drinkable solution (claim 9), a
pharmaceutical carrier (claim 27), or an oral nutritional supplement (claim
29).
The Examiner rejected claims 1-10 and 25-30 as unpatentable under
35 U.S.C. § 103(a) over the combined teachings of Cavaliere Vesely,3
Runge,4 Berggren,5 Brassart,6 and Reddy7 (Ans. 3-5).8
The Examiner found that Cavaliere Vesely, Runge, and Berggren
teach an orally administrable composition comprising at least one probiotic

3 European Patent Application EP 1 020 123 A1, Beverages containing live
lactic bacteria, published 19 July 2000, by Cavaliere Vesely et al.
("Cavaliere Vesely").
4 US Patent 7,037,708 B1, Dried Microogranism Cultures and Method for
Producing Same, issued 2 May 2006, to Runge et al., based on application
09/673,136, filed 29 April 1999 ("Runge").
5 International Patent Publication WO 00/70972 A1, New Composition,
published 30 November 2000, by Berggren et al. ("Berggren").
6 US Patent 5,603,930, Lactobacillus Johnsonii CNCM I-1225, issued 18
February 1997, to Brassart et al. ("Brassart").
7 US Patent 4,806,368, Shelf Life and Subsequent Growth of Lactobacillus
Acidophilus, Propionibacterium Shermanii and Leuoconostoc Citrovorum in
Dietary Fiber Based Supplement Preparation, issued 21 February 1989, to
Malireddy S. Reddy ("Reddy").
8 The Examiner withdrew US Patent 6,156,355, issued to Shields, Jr. et al.,
from the final rejection because she deemed it a duplicative reference (see
the Office communication mailed 9 October 2009).
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lactic acid bacterium, a carotenoid, and an ingestible carrier (id. at 3). The
Examiner found that Brassart teaches that Lactobacillus johnsonii CNCM I-
1225 is a known, orally administrable probiotic lactic acid bacterium (id. at
4). The Examiner found that Reddy teaches that adding yeast extract to
Lactobacillus compositions is known for its viability enhancement and
provision of vitamin B (id. at 6). The Examiner found that the
concentrations of components discussed in the references appear to be
substantially the same as claimed (id. at 4). If not, the Examiner concluded
that the claimed concentrations would have been a matter of routine
optimization of results effective variables (id.). The Examiner further
concluded that it would have been obvious to modify the compositions of
Cavaliere Vesely, Runge, and Berggren by including known probiotic
strains, e.g., Lactobacillus johnsonii CNCM I-1225, as taught by Brassart,
and yeast extract, as taught by Reddy, to provide "a healthful composition
comprising a probiotic strain in a photoprotecting amount known to have
favorable effects against disease and … carotenoids such as ß-carotene as
well as yeast extract, materials known to have at least antioxidant effects and
containing vitamin B, respectively" (id. at 4-5).
Appellants argue that (1) the cited references, alone or in combination,
fail to teach or suggest all elements of the claimed invention, and that (2) a
skilled artisan would have had no reason to combine the cited references,
none of which are directed to skin photoprotection, (3) absent hindsight
reconstruction (App. Br. 9-16; Reply Br. 2). Appellants further argue that
the provided Affidavit9 demonstrates that the claimed composition provides

9 Affidavit Under 37 C.F.R. § 1.132 by Isabelle Bureau-Franz, dated 8 April
2008, with attached Exhibit B ("Affidavit").
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unexpected synergistic photoprotective effects (App. Br. 11-15; Reply Br. 2-
5).
Appellants have not separately argued the patentability of any of the
dependent claims on appeal (see e.g., App. Br. 10-11). Therefore, we decide
this appeal on the basis of claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
At issue is whether the evidence of record supports a prima facie
conclusion that it would have been obvious to modify the compositions of
Cavaliere Vesely, Runge, and Berggren by adding a yeast extract thereto;
and, if so, whether Appellants have provided evidence that, when weighed
with the evidence of obviousness, is sufficient to overcome the prima facie
conclusion of obviousness.
II. Findings of Fact
The following findings of fact ("FF") are supported by a
preponderance of the evidence of record.
A. Cavaliere Vesely
[1] Cavaliere Vesely discloses non-milk beverages containing probiotic
lactic acid bacteria (Cavaliere Vesely ¶¶ 1, 8, 10, 21, 26, 45).
[2] The probiotic bacteria provide a number of beneficial effects,
including stimulating the immune system and synthesizing some B
vitamins (id. at ¶¶ 9-10).
[3] Examples 1-3 of Cavaliere Vesely describe the preparation of an
energy drink, an antioxidant beverage, and a multivitamin drink,
respectively, containing a mixture of probiotic bacteria and
carotenoids (id. at ¶¶ 64-71).
[4] In multivitamin drink Example 3, 0.1 g of a mixture of probiotic lactic
acid bacteria is added to 500 ml of a mineral water matrix of water
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70% orange juice 15%, carrot juice 5%, lemon juice 4%, vitamins (C,
niacin, provitamin A, E, pantothenic acid, B6, B2, folacin, biotin, and
B12 at an overall concentration of 75 mg/500 ml), sugars 5.85%, and
flavors 0.15% (id. at ¶¶ 69-71).
[5] According to Cavaliere Vesely, bacterial cultures containing high
concentrations of bacteria in the "thousand million CFU/g", i.e., 109
cfu/g, are preferred (id. at ¶ 33).
B. Runge
[6] Runge discloses powdered concentrates of lactic acid bacterial
cultures, preferably comprising about 5 x 108 to 1 x 1012 cfu/g, for
preparing foodstuffs and feedstuffs (Runge 1: 4-7; 4:19-28; 6:19-43;
claim 18).
[7] Example S2 teaches preparing a powdered bacterial concentrate
containing water, maltodextrin, lactose, NaCl, citric acid, ascorbic
acid, K5 bacterial ferment, 5% ß carotene, and 2% α-tocopherol (id. at
16:8-41).
C. Berggren
[8] Berggren discloses a sports drink containing viable lactobacilli, e.g.,
Lactobacillus johnsonii Lji, mixed with micronutrients, including
carotenoids and B vitamins, carbohydrates, salts, and proteins,
designed to increase energy and fluid levels and to relieve stress
(Berggren p. 2, ¶ 5, to p. 3, ¶ 2; p. 4, ¶ 1; p. 6, ¶ 7).
[9] Example 1 discloses a sports drink prepared from whey proteins,
sugars, micronutrients, including ß-carotene, fruit juice concentrate,
water, and oatbase containing Lactobacillus in an amount of 1-2 x 109
cfu/ml (id. at p. 10, ¶ 3, to p. 11, ¶ 4).
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[10] Example 3 discloses a tablet containing Lactobacillus, inulin, and
micronutrients which can be taken together with about 1/2 liter fluid
(id. at 12, ¶ 2).
D. Brassart
[11] Brassart teaches that Lactobacillus johnsonii CNCM I-1225 is a lactic
acid bacterium with a capacity for immunomodulation and/or
reduction of fecal enzymatic activity and that the bacterium may be
administered in an ingestible carrier, such as yogurt or a milk-based
powder formulation, in a concentration of 108 to 1010 cfu/g for liquid
or frozen forms (Brassart 1:36-59).
E. Reddy
[12] Reddy teaches mixing lyophilized probiotic lactic acid bacteria,
reducing compounds, vitamins, minerals, lecithin, milk derived
nutrients, autolyzed yeast extract, and apple fiber into a nutritional
supplement tablet (Reddy (1:11-16; 2:11-13, 35-39; 3:9-35).
[13] According to Reddy, the yeast extract stimulates bacterial growth in
the gastrointestinal tract, provides a B vitamin supplement, supplies
most of the major and minor trace minerals (id. at 2:52-57), and has "a
pronounced effect on the growth of L. acidophilius in the presence of
bile salts" (id. at 7:62-64).
F. The rebuttal Affidavit
[14] Coinventor Isabelle Bureau-Franz, PharmD, PhD, testified that
the admixture of a photoprotecting effective
amount of at least one probiotic lactic acid
bacterium, at least one carotenoid, and a yeast
extract elicits an enhanced synergistic effect or
response with respect to the photoprotection of the
skin. The composition has been found to be
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effective … for preventing inflammation or
irritation of the skin after exposure to ultraviolet
radiation, … [and] to provide complete
prophylactic protection against the
immunosuppressive effects of ultraviolet radiation.

(Affidavit ¶¶ 1, 2, 6).
[15] Dr. Bureau-Franz identified attached Exhibit B ("Exh. B") as a
summary of a contact hypersensitivity ("CHS") reaction test study
demonstrating the efficacy of the claimed composition with respect to
photoprotection of the skin (id. at ¶ 7).
[16] In the study, mice were divided into four groups -- a control group
with no UV exposure, a control group exposed to UV, a sensitized
group exposed to the contact allergen 2,4-dinitrofluorobenzene
("DNFB") with no UV exposure, and a sensitized group exposed to
DNFB and to UV (id.).
[17] Each of four groups were fed (a) food without additional supplements,
(b) food with maltodextrin, (c) food with "matrix," i.e., ß-carotene,
lycopene, inactivated yeast extract, magnesium stearate, corn starch,
and silicon dioxide, (d) food with carotenoids, i.e., matrix without the
yeast extract, and (e) food with matrix plus 108 cfu/d La1 (Affidavit ¶
8; Exh. B, Table I).
[18] "It has been independently determined by the Examiner that 'La1', is,
in fact, Lactobacillus johnsonii CNCM I-1225" (Ans. 8).
[19] Dr. Bureau-Franz testified that sensitization occurred about 5 or 6
days after UV exposure by painting either DNFB or acetone on the
abdomen of the mouse, followed by a challenge on day 12 after UV
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exposure by painting DNFB on right ear of the mouse and acetone on
the left ear of the mouse (Affidavit ¶ 9).
[20] Dr. Bureau-Franz testified that Exhibit B, Figure 2, demonstrates the
results of the challenge, expressed as the difference in swelling
between the right and left ears (id.). Figure 2 is reproduced below.

{Figure 2 of Affidavit Exhibit B demonstrates the results of the DNFB
challenge.}

[21] According to Dr. Bureau-Franz, comparing column 3 (invention) to
column 2 (control without UV exposure) shows "the skin reacted
readily to the presence of the allergen on the right ear because the
animal did not experience local immunosuppression due to the
exposure to UVR" (id. at ¶ 10).
[22] Further according to Dr. Bureau-Franz, "the formulas corresponding
with the data of columns 1 and 4-5 proved unsuccessful in preventing
local immunosuppression resulting from UVR exposure" (id. at ¶ 11).
III. Discussion
A. Legal principles
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"[T]he test [for obviousness] is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
Keller, 642 F.2d 413, 425 (CCPA 1981). A rejection under 35 U.S.C. §
103(a) is based on the following factual determinations: (1) the scope and
content of the prior art; (2) the level of ordinary skill in the art; (3) the
differences between the claimed invention and the prior art; and (4) any
objective indicia of non-obviousness. KSR Int'l Co. v. Teleflex Inc., 550
U.S. 398, 399 (2007) (citing Graham v. John Deere Co., 383 U.S. 1, 17
(1966)).
In KSR, the Court also reaffirmed that evidence of unexpected results
may rebut an examiner’s prima facie case of obviousness. 550 U.S. at 416.
However, to establish that claimed subject matter yields an unexpected
result, the claimed subject matter must be compared to the closest prior art.
In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.").
Moreover, "objective evidence of nonobviousness must be commensurate in
scope with the claims." In re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990)
(quoting In re Lindner, 457 F.2d 506, 508 (CCPA 1972)); see also In re
Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("[A]pplicant’s showing of
unexpected results must be commensurate in scope with the claimed
range.").
B. Analysis
Claim 1 broadly recites an orally administrable composition
containing a photoprotecting effective amount of at least one probiotic lactic
acid bacterium, from 10-12 to 20 % by weight of at least one carotenoid, a
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yeast extract, and an orally acceptable carrier. Cavaliere Vesely discloses
orally administrable compositions, i.e., non-milk beverages, containing at
least one probiotic lactic acid bacterium and at least one carotenoid in an
orally acceptable carrier (FF 1-4). Appellants do not dispute the Examiner's
finding that the bacterium and the carotenoid are present in the claimed
amounts (Ans. 4) (also compare FF 4-5 and Spec. 5:11-15 (the probiotic
lactic acid bacteria is present in an amount of at least 105 cfu/g carrier)).
Reddy discloses mixing probiotic bacteria with yeast extract (FF 12) and
teaches that the yeast extract stimulates bacterial growth, provides a B
vitamin supplement, and supplies most of the major and minor trace
minerals (FF 13). Therefore, it would have been prima facie obvious to one
of ordinary skill in the art to add a yeast extract to the probiotic bacteria-
containing beverages of Cavaliere Vesely to stimulate bacterial growth and
supply B vitamin and trace minerals as taught by Reddy.
Runge and Berggren likewise disclose orally administrable
compositions containing at least one probiotic lactic acid bacterium and at
least one carotenoid in an orally acceptable carrier in undisputedly the
claimed amounts (FF 6-10). Therefore, it would have been likewise prima
facie obvious to one of ordinary skill in the art to add a yeast extract to the
probiotic bacteria-containing compositions of Runge and Berggren to
stimulate bacterial growth and supply B vitamin and trace minerals as taught
by Reddy.
To overcome a prima facie case of obviousness, a showing of
unexpected results must be based on a comparison with the closest prior art.
Baxter Travenol Labs., 952 F.2d at 392. Here, the closest prior art, the
compositions of Cavaliere Vesely, Runge, or Berggren, contain both at least
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one probiotic bacterium and at least one carotenoid in an orally acceptable
carrier (FF 4-9). Thus, Appellants' comparison to compositions that do not
contain at least one probiotic bacterium and at least one carotenoid, is not a
comparison to the closest prior art which teaches combining at least one
probiotic bacterium with at least one carotenoid.
Second, a showing of unexpected results must be commensurate in
scope with the claimed subject matter. Kulling, 897 F.2d at 1149. Here, the
single composition shown by Appellants, food with matrix plus 108 cfu/d
Lactobacillus johnsonii CNCM I-1225 (FF 17-18), is not commensurate in
scope with the claimed subject matter. There are multiple genera of
probiotic lactic acid bacteria (see e.g., claim 2), each of which contain a
number of species (see e.g., claim 3). Furthermore, there may be multiple
strains of each bacterial species (see e.g., claim 4). Appellants' showing is
limited to a single strain of a single species of a single genus of probiotic
lactic acid bacteria, i.e., Lactobacillus johnsonii CNCM I-1225. Appellants'
showing also uses two carotenoids, ß-carotene and lycopene, whereas the
claimed subject matter recites "at least one carotenoid." In addition, but for
the amount of probiotic bacteria in the food, the showing does not state the
amounts of the other food components, e.g., ß-carotene or lycopene.
Similarly, while the claimed subject matter broadly recites "a
photoprotecting effective amount" of at least one probiotic lactic acid
bacterium, the showing is limited to a single concentration of bacterium.
Therefore, Appellants' showing is not commensurate in scope with the
claimed subject matter.
Third, Appellants contend that the claimed subject matter "elicits an
enhanced synergistic effect or response with respect to the photoprotection
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of the skin" (FF 14) based upon their showing of a lack of local
immunosuppression in mice fed food with matrix plus 108 cfu/d
Lactobacillus johnsonii CNCM I-1225. However, Brassart explicitly
teaches that Lactobacillus johnsonii CNCM I-1225 has a capacity for
immunomodulation (FF 11). Thus, it may well be that the lack of local
immunosuppression shown in mice fed food with matrix plus 108 cfu/d
Lactobacillus johnsonii CNCM I-1225 is a function of the specific strain of
Lactobacillus johnsonii used. Therefore, Appellants' showing fails to
establish even a synergistic effect or response with respect to the
photoprotection of the skin.
C. Conclusion
We will sustain the rejection of claims 1-10 and 25-30 under 35
U.S.C. § 103(a) over Cavaliere Vesely, Runge, Berggren, Brassart, and
Reddy. The evidence of record supports a prima facie conclusion that it
would have been obvious to modify the compositions of Cavaliere Vesely,
Runge, and Berggren by adding a yeast extract thereto; and, Appellants have
not provided evidence that, when weighed with the evidence of obviousness,
is sufficient to overcome the prima facie conclusion of obviousness.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claims 1-10
and 25-30 as unpatentable under 35 U.S.C. § 103(a) over the combined
teachings of Cavaliere Vesely, Runge, Berggren, Brassart, and Reddy is
AFFIRMED; and,
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FURTHER ORDERED that 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)(vi).
AFFIRMED

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