Ex Parte Vidal et al

Patent Trial and Appeal Board

Jun 18, 2013

10478079 (P.T.A.B. Jun. 18, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KARINE VIDAL, ANNE DONNET-HUGUES,
DOMINIQUE-ANNE GRANATO, and IRENE CORTHESY-THEULAZ1
__________

Appeal 2012-003093
Application 10/478,079
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and ULRIKE W. JENKS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition for modulating an immune response. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellants state that the real party in interest is Nestec S.A. (Appeal Br. 2).
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STATEMENT OF THE CASE
The Specification discloses that a “composition containing
lipoteichoic acid from lactic acid bacteria can maintain immune
homeostasis, [and] prevent or decrease inflammatory processes induced by
Gram negative bacteria” (Spec. 3:18-20).
Claims 32 and 33 are on appeal. Claim 32 is representative and reads
as follows:
32. A composition for modulating an immune response induced by
bacteria, comprising lipoteichoic acid isolated from defatted lactic acid
bacteria as an active ingredient in a composition suitable for oral
administration to a human, wherein the lactic acid bacteria is selected from
the group consisting of: Lactobacillus johnsonii CNCM I-1225,
Lactobacillus acidophilus CNCM I-2332, and combinations thereof.

Issue
The Examiner has rejected claims 32 and 33 under 35 U.S.C. § 103(a)
as obvious in view of Usami2 and Brassart.3 The Examiner finds that Usami
discloses lipoteichoic acid “extracted from gram positive Lactobacillus
bacteria … [which has] immune modulating properties because of its
antitumor and therapeutic properties” (Answer 6). The Examiner finds that
Brassart discloses “an oral composition comprising [a] supernatant
component from Lactobacillus johnsonnii [sic] CNCM I-1225,” and
discloses that the strain is gram positive (id.). The Examiner concludes that
it would have been obvious to one of ordinary skill in the art “to select and
extract lipoteichoic acid from gram positive Lactobacilli, as disclosed by

2 Usami et al., EP 0 135 820, Apr. 3, 1985.
3 Brassart et al., US 5,578,302, Nov. 26, 1996.
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[Usami], and to further extract the same from the strain CNCM I-1225
disclosed by Brassart et al because lipoteichoic acid is well known to be
taken from these species” (id.).
Appellants contend that cited references do not disclose or suggest
isolating lipoteichoic acid from defatted bacteria (Appeal Br. 16-17).
Appellants also contend that “it would not have been obvious to apply the
teachings of Usami to the Lactobacilli strains of Brassart because there is a
low degree of predictability in this field … [and] one skilled in the art would
understand that the lipoteichoic acid associated with the bacterial strains of
Usami is distinguishable from the lipoteichoic acid associated with
Lactobacillus johnsonii CNCM I-1225” (id. at 18).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that the cited references would have made obvious a
composition encompassed by claim 32?
Findings of Fact
1. Usami discloses “an antitumor agent comprising lipoteichoic acids
(hereafter referred to as LTA)” (Usami 1:2-3).
2. Usami discloses that “LTA has valuable therapeutic properties,
especially an excellent antitumor activity without causing any side effects in
animals” (id. at 1:28-30).
3. Usami discloses that “[e]xamples of gram positive bacteria having
LTA are those belonging to such genera as Streptococcus, Micrococcus,
[and] Lactobacillus” (id. at 1:17-20).
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4. Usami discloses that the “structures of LTA may partially differ
among bacteria of different genera or even among different species of the
same genus” (id. at 1:20-24).
5. Usami discloses that “[p]artial structural differences of LTA do not
have serious influence on its biological activities. Thus LTA from any
species or genera of gram-positive bacteria has good possibility to serve as
an antitumor agent.” (Id. at 2:6-10.)
6. Usami discloses that bacterial strains having LTA and which may
be used in its invention include Lactobacillus plantarum, Lactobacillus
fermentum, and Lactobacillus casei (id. at 2:15-28).
7. In a working example, Usami states that “LTA from L. plantarum
… has an anti-tumor effect on solid-type Meth-A fibrosarcoma” (id. at 4:37-
38).
8. Usami discloses obtaining LTA preparations by the following
process:
Cells were collected and disrupted by a Braun cell
homogenizer. A fraction of cell envelopes was collected by
centrifugation and it was suspended in distilled water.… An
equal volume of 95% phenol was added to the suspension, and
extraction of LTA was conducted.… The water phase was
separated … [and] water was added to the remaining phenol
phase to repeat the extraction twice in the same manner. All of
the water phases were combined and after being fully dialysed
against distilled water, the combined water phase was
lyophilized to obtain a crude LTA preparation.

(Id. at 3:10-23.)
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9. Usami discloses that LTA “can be formulated by a conventional
formulation process into any desired form such as an oral agent” (id. at
2:34-36).
10. Brassart discloses that “[s]tomach ulcers are treated by
administering orally to a human in need thereof an anti-Helicobacter pylori
effective amount of a composition containing, in combination with an
ingestible support, a culture of Lactobacillus johnsonii strain CNCM I-1225
or a supernatant phase isolated from a culture of Lactobacillus johnsonii
strain CNCM I-1225” (Brassart, abstract).
11. Brassart discloses that “certain strains of lactic acid bacteria …
are capable of displacing pathogenic bacteria, such as Heliobacter (H.)
pylori for example, from the intestinal cells to which they adhere” (id. at col.
1, ll. 48-52).
12. Brassart discloses that “the strains in question have the ability to
produce an agent showing such power of displacement and, above all, to
produce it in their culture medium” (id. at col. 1, ll. 52-55).
13. The Specification describes a process for the isolation of LTA
which includes defatting harvested bacteria by mixed them with methanol
and chloroform, incubating them, and recovering defatted bacteria by
filtration (Spec. 16:9-15).
Analysis
Claim 32 is directed to an oral formulation for modulating a bacteria-
induced immune response that comprises lipoteichoic acid isolated from
defatted lactic acid bacteria – either Lactobacillus johnsonii CNCM I-1225
or L. acidophilus CNCM I-2332.
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Usami discloses an antitumor composition, which can be an oral
formulation, comprising lipoteichoic acid isolated from gram positive
bacteria, including Lactobacillus plantarum, L. fermentum, or L. casei.
Usami discloses that “LTA from any species or genera of gram-positive
bacteria has good possibility to serve as an antitumor agent” (FF 5).
Brassart discloses that stomach ulcers may be treated by orally
administering a composition containing a culture of Lactobacillus johnsonii
strain CNCM I-1225 or a supernatant isolated from such a culture. In view
of Usami’s disclosure that LTA isolated Lactobacillus plantarum has an
anti-tumor effect (FF 7), it would have been obvious to one of ordinary skill
in the art to use LTA isolated from Brassart’s Lactobacillus johnsonii strain
CNCM I-1225 in Usami’s oral anti-tumor composition because Brassart
discloses that this strain is suitable for oral administration and Usami
suggests that LTA from any gram-positive species has a good possibility to
serve as an antitumor agent.
Appellants argue that it would not have been obvious to use Brassart’s
strain in Usami’s composition “because there is a low degree of
predictability in this field … [and] one skilled in the art would understand
that the lipoteichoic acid associated with the bacterial strains of Usami is
distinguishable from the lipoteichoic acid associated with Lactobacillus
johnsonii CNCM I-1225” (Appeal Br. 18).
This argument is not persuasive. Although Usami discloses that the
LTA structures may differ among different bacterial species, Usami also
discloses any such differences do not seriously influence its biological
activity. Usami expressly suggests that LTA from any gram-positive
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bacterial species has a good possibility to serve as an antitumor agent.
Obviousness does not require absolute predictability of success, only a
reasonable expectation of success. In re O’Farrell, 853 F.2d 894, 903-04
(Fed. Cir. 1988).
Appellants also argue that the cited references do not disclose or
suggest isolating lipoteichoic acid from defatted bacteria (Appeal Br. 16-17).
Appellants argue that “the Specification teaches defatting Lactobacilli
cultures by mixing the cultures with methanol and chloroform” (id. at 17).
Appellants argue that, by contrast, “Usami discloses extracting its
lipoteichoic acid not merely by washing but rather by disruption of the cells
with a homogenizer, treatment with phenol and ammonium acetate and
subsequent purification” (id.).
The Examiner reasons, however, that Usami is “carrying out a process
of defatting the bacteria to extract the LTA, using [a] solvent extraction
technique. It is believed by the Examiner that the technique disclosed by
Usami et al provides for defatted lactic acid bacteria. Note that Usami et al
disclose … [an] LTA-fraction having only a mole ratio of 0.08 fatty acids.”
(Answer 7-8.)
We agree with the Examiner that it is reasonable to conclude that
Usami’s phenol extraction step results in defatted bacteria. The claims are
directed to a composition, not a method of making it. Thus, the “isolated
from defatted bacteria” limitation distinguishes the claimed product from
that made obvious by the prior art only if it results in a structurally different
product. See In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985) (“If the
product in a product-by-process claim is the same as or obvious from a
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product of the prior art, the claim is unpatentable even though the prior
product was made by a different process.”).
As the Examiner has pointed out, Usami discloses that its process
includes a phenol extraction step in which the water phase was removed
from the (fat-containing) organic phase and retained (Usami 3:14-23).
Usami also discloses that its process results in LTA having only 7.3%, or a
mole ratio of only 0.08, fatty acids (id. at 5, Table 1). Thus, Usami’s LTA
preparation reasonably appears to be one derived from defatted bacteria.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations
omitted):
Where …the claimed and prior art products are identical or
substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
Appellants have not pointed to evidence of record showing that Usami’s
process results in a composition that differs structurally from the
composition defined by claim 32.
Appellants also argue that Usami “fails to teach that lipoteichoic acid
has immune modulating properties and instead merely discloses that
lipoteichoic acid has not been fully studied with respect to its immuno-
pharmacological properties and can be used as an antitumor agent” (Appeal
Br. 18-19).
This argument is not persuasive. “It is well settled that the recitation
of a new intended use for an old product does not make a claim to that old
product patentable.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
See also Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,
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809 (Fed. Cir. 2002) (“[T]he patentability of apparatus or composition
claims depends on the claimed structure, not on the use or purpose of that
structure.”). Here, the LTA composition made obvious by the prior art
appears to be structurally the same as the product of claim 32. Thus, the
claimed product would have been obvious based on Usami and Brassart.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have made obvious a composition encompassed by
claim 32. Claim 33 has not been argued separately and therefore falls with
claim 32. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the rejection of claims 32 and 33 under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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