Ex Parte Worrell et al

Board of Patent Appeals and Interferences

Apr 28, 2010

11256860 (B.P.A.I. Apr. 28, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte CORTNEY L. WORRELL, HARSH M. TRIVEDI,
KIMBERLEE PANALIGAN, and TAO XU
____________

Appeal 2009-011431
Application 11/256,860
Technology Center 1600
____________

Decided: April 28, 2010
____________

Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 by the Patent
Applicant from the Patent Examiner’s rejections of claims 1, 5-8, 10-17, and
24. The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b). We
affirm.

Appeal 2009-011431
Application 11/256,860

STATEMENT OF THE CASE
The claims are directed to an oral composition, such as a toothpaste or
mouthwash, comprising a Camellia extract. The compositions are used to
treat oral inflammations, such as gingivitis or periodontitis (Spec. 1: ¶ 1).
Claims 1, 5-8, 10-17, and 24 are pending and stand rejected by the
Examiner under 35 U.S.C. § 103(a) as obvious over the combination of
Maeda (WO 03/094878 A1, published Nov. 20, 2003 “with US Pat. Pub.
No. 2006/0134286 providing the English translation”), Scherl (Scherl et al.,
U.S. Pat. No. 6,500,409 B1, Dec. 31, 2002), and Yamane (Yamane et al.,
U.S. Pat. No. 6,149,894, Nov. 21, 2000) (Ans. 4).
Claim 1 is the only independent claim on appeal. Claim 1 reads as follows:
1. An oral composition for the treatment, inhibition or reduction of an
oral inflammatory condition comprising:
about 0.001% to about 20% by weight of a Camellia extract, said
extract including at least about 30% epigallocatechin gallate, at least about
50% total catechins, and at least about 60% total polyphenols; a substantially
water insoluble non-cationic anti-bacterial agent; and about 0.001% to about
5% by weight of Vitamin E, wherein the Vitamin E is dl-α tocopherol.

STATEMENT OF THE ISSUES
The issues in this rejection are:
Whether, in view of the cited prior art, the claimed amounts of
epigallocatechin gallate would have been obvious to persons of ordinary
skill in the art?
Whether there was motivation with a reasonable expectation of
success to have combined an extract comprising epigallocatechin gallate
with triclosan and vitamin E to make an oral care composition?

2
Appeal 2009-011431
Application 11/256,860

FINDINGS OF FACT
Maeda1
1. Maeda describes an antibacterial composition comprising
epigallocatechin gallate (EGCG) and gallocatechin gallate (GCG) (Maeda,
1: ¶ 1).
2.
[R]esearch and development has been carried out on
antibacterial agents for inhibiting the proliferation of oral
microorganisms, for example, green tea catechins; inhibitors for
glucosyl transferase produced by oral microorganisms, for
example, polyphenols from oolong tea . . . . In recent years,
plant components, in particular, polyphenols, have attracted
public attention as cariostatic agents.

(Id. at 1: ¶ 3.)
3.
For example, leaves of tea plant (Camellia sinensis) contain
polyphenols in an amount as much as 36% on a dry weight
basis, and the major components of the polyphenols are called
green tea catechins. Catechins include (-)-epicatechin (EC), (-)-
epigallocatechin (EGC), (-)-epicatechin gallate (ECG) and (-)-
epigallocatechin gallate (EGCG). Among all, it is known that
EGCG exerts an antibacterial effect . . . Further, (+)-catechin
(C), EC, (+)-gallocatechin (GC), EGC, ECG and EGCG are
described as active ingredients of anti periodontal disease
compositions in JP-A-H9-110687.

(Id.)
4. “The term ‘green tea catechins’ as used in the present invention means
green tea polyphenol catechins known as a composition having very safe

1 All references are to U.S. Pat. Pub. No. 2006/0134286 A1.
3
Appeal 2009-011431
Application 11/256,860

cariostatic and anti periodontal disease activity based on the antibacterial
activity, and includes for example, C, EC, GC, EGC, ECG, EGCG, etc., or a
mixture thereof. It is preferable that the green tea catechins contain at least
EGCG.” (Id. at 2: ¶ 12.)
5. “The composition according to the present invention may be produced by
mixing GCG with catechins having an antibacterial effect, such as EGCG.”
(Id. at 2: ¶ 16.)
6. “Alternatively, it can be obtained using any of the tea materials
described above as a starting material, according to a conventional extraction
method.” (Id.)
7. Example 1 describes a composition in which the “mixing ratio of EGCG
and GCG (manufactured by Sigma) was varied so as to adjust the final
concentration of the sample to 1 mg/mL . . . . [T]he sample having an
EGCG:GCG ratio of 1.00:0.45 showed an activity 101.23 times higher (about
15-fold) than that of the sample containing EGCG alone.” (Id. at 4: ¶ 33.)
8. Example 2 describes an extract of oolong tea comprising EGCG and
other catechins. (Id. at 4: ¶ 34.)
9. Example 3 and 4 show toothpaste and mouthwash respectively,
comprising 0.2 parts by weight oolong tea extract. (Id. at 4: ¶ 36-37.)
Scherl
10. Scherl describes oral care products comprising Triclosan, an “antiplaque
agent,” and a magnolia extract (Scherl, col. 2, ll. 18-37; col. 3, ll. 33-35).
11. Extracts of magnolia “are known to have antibacterial efficacy” in
dental caries (id. at col. 1, ll. 47-54).
12. Scherl teaches that “[v]arious other materials may be incorporated in
oral compositions,” and includes “vitamins” in its list (id. at col. 4, ll. 8-10).
4
Appeal 2009-011431
Application 11/256,860

“These adjuvants, when present, are incorporated in the compositions in
amounts which do not substantially adversely affect the properties and
characteristics desired.” (Id. at col. 4, ll. 11-13.)
Yamane
13. Yamane describes toothpaste compositions that include, among a list of
“therapeutic ingredients,” triclosan and “Vitamin E analogs (dl-.alpha.-
tocopherol acetate, tocopherol succinate, tocopherol nicotinate, etc.)”
(Yamane, col. 4, ll. 10-13).
Level of ordinary skill in the art
14. Persons of ordinary skill in the art were familiar with selecting
ingredients from lists (FF12-13) to formulate oral care products and to
determine optimal amounts of such ingredients to achieve their known
effects.
ANALYSIS
The claims in this application are directed to compositions for “the
treatment, inhibition or reduction of an oral inflammatory condition.” The
composition comprises three components:
• “about 0.001% to about 20% by weight of Camellia extract, said
extract including at least about 30% epigallocatechin gallate, at least about
50% total catechins, and at least about 60% total polyphenols”;
• “a substantially water insoluble non-cationic anti-bacterial agent”;
and
• “about 0.001% to about 5% by weight of Vitamin E, wherein the
Vitamin E is dl-α tocopherol.”
The Examiner found that the prior art taught oral care compositions
with the claimed components: Maeda’s composition containing Camellia
5
Appeal 2009-011431
Application 11/256,860

extract with epigallocatechin gallate and other catechins (Ans. 4-5; FF1 & 3-
4); Scherl’s composition containing triclosan, a water insoluble non-cationic
anti-bacterial agent, and vitamins (Ans. 5; FF10); and Yamane’s with
triclosan and vitamin E (Ans. 5-6; FF13). The Examiner acknowledged that
neither reference taught all three components in the same composition and in
the claimed amounts, but determined that it would have been obvious to
have combined them as each were known ingredients in oral care
compositions (Ans. 6 & 11).
It is well known that it is prima facie obvious to combine two or
more ingredients 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 useful for the same purpose. The idea for combining
them flows logically from their having been used individually
in the prior art.

(Id. at 6.)
As to the specific amounts, the Examiner concluded that it would have
been obvious to select the claimed amounts, as each component was known
to be effective in an oral care compositions and the corresponding amounts
would therefore have been recognized to be “result effective parameter[s]”
(id.).

Claimed percentages/amounts of Camellia are not suggested or taught by
Maeda
Appellants contend that “Maeda does not disclose the EGCG,
catechin, or polyphenol content of the oolong tea extract at all.” (App. Br.
12.) Appellants acknowledged that the ratios of catechins (including EGCG)
in the extract are disclosed, but “the ECGC [sic, EGCG?] content of the
6
Appeal 2009-011431
Application 11/256,860

oolong tea extract is entirely unknown. ‘Obviousness cannot be predicated
on what is unknown.’” In re Spormann, 363 F.2d 444, 448 (CCPA 1966).”
(Id. at 13.)
Epigallocatechin gallate, and other catechins, were known in the prior
art as active ingredients of anti-periodontal disease and oral care
compositions (FF3, FF8, & FF9). It is true that Maeda did not disclose what
amounts of EGCG and the other catechins were present in certain of its
compositions. However, Maeda recognized EGCG as an effective agent in
treating dental caries and periodontal disease (FF4), and included it in oral
care products in the form of an extract (FF8). A person of ordinary skill in
the art, with the knowledge that EGCG, and other catechins, were effective
oral care ingredients, would have routinely selected the amounts necessary
to achieve the effect they were well known to produce (FF14). Appellants
have not provided any evidence to rebut the Examiner’s finding that
selecting effective amounts of EGCG was commensurate with the skill in the
art. It is not reasonable that the lack of disclosure by Maeda about the
specific amounts by weight to use of EGCG would have deterred the skilled
worker from using EGCG for exactly the purpose taught by Maeda.2
Relying on statements in the Specification, Appellants contend that
the claimed combination of Camellia extract and triclosan “acts
synergistically.” (Spec. 10: ¶ 34; Reply Br. 7.)
Unexpected results must be “commensurate in scope with the degree
of protection sought by the claimed subject matter.” In re Harris, 409 F.3d

2 Furthermore, Maeda does disclose one example (FF7) in which amounts of
EGCG in a composition are described, but in this example, an extract is not
used.
7
Appeal 2009-011431
Application 11/256,860

1339, 1344 (Fed. Cir. 2005). The Specification did not disclose what
amounts of the extract and triclosan were synergistic and whether such
synergy occurred over the entire scope of claim 1 which spans a breadth of
20,000 (“about 0.001% to about 20% by weight of a Camellia extract”).
Consequently, the statements about synergy are insufficient to rebut the
determination that the claims would have been obvious to one of ordinary
skill in the art.
Lack of motivation to combine and expectation of success
Appellants contend that “there is simply no teaching, suggestion, or
motivation to combine the teachings of Maeda, Scherl et al., and Yamane et
al. in order to practice the currently claimed invention.” (App. Br. 14-15.)
“[A]lthough the prior art discloses water insoluble non-cationic antibacterial
agents, vitamin E, dl-α-tocopherol, magnolia extracts and rosemary extracts
may be useful in dentifrice compositions, the prior art does not teach or
suggest that such compounds have the same utility or perform the same
function” (id. at 15).
The Examiner’s case is premised on the findings that each of the
claimed ingredients had been used in oral care compositions (Ans. 11). The
evidence from Scherl and Yamane establishes that persons of ordinary skill
in the art routinely selected ingredients from lists in formulating oral care
products (FF14). Triclosan and vitamin E are expressly taught as the type of
ingredient routinely utilized in oral care compositions. Appellants have not
disputed this nor explained why it would be outside the scope of the ordinary
level of skill in the art to have selected them.
Appellants distinguish the facts in this case from certain case law
cited by the Examiner (App. Br. 15-16). However, we are not persuaded
8
Appeal 2009-011431
Application 11/256,860

that the holdings in those cases militate against the Examiner’s
determination that selecting individual ingredients which had been used in
oral health care products would have been the type of routine activity that
persons of ordinary skill in this field typically carry out.
Appellants contend that “a dentrifice composition containing a
cationic antibacterial agent with an anionic surfactant would likely result in
inactivation of the antibacterial agent due to a reaction between cations and
anions, rendering the dentrifice composition ineffective in combating oral
bacteria.” (Id. at 16-17.) Appellants also contend that “there is simply no
teaching or suggestion” in the cited references that “a water insoluble non-
cationic antibacterial agent may be stable in the present of Camellia extract”
or dl-α-tocopherol (id. at 17).
Appellants have not provided any evidence to buttress the lack of
expectation of success. Arguments of counsel cannot take the place of
evidence lacking in the record. Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d
588, 595 (Fed. Cir. 1997). In addition, the claims do not require “an anionic
surfactant” and therefore argument about its incompatibility with a “cationic
antibacterial agent” is not persuasive.
Additionally, it is argued by Appellants that Maeda does not provide
guidance or motivation “to modify the EGCG concentration and/or ratios for
the purpose of preparing an anti-inflammatory composition.” (Reply Br. 7-
9.)
The claim recites that the composition is “for the treatment, inhibition
or reduction of an oral inflammatory condition.” We do not interpret the
claim preamble to require that persons of ordinary skill in the art recognize
that the composition was advantageous against oral inflammation. See
9
Appeal 2009-011431
Application 11/256,860

Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378-79 (Fed. Cir.
2005). Thus, as long as there is a reason to have modified the prior art to
make the claimed combination – as the Examiner found there was – the
claim limitations would be met. Appellants have not provided evidence that
the claimed composition, as reasonably suggested by the prior art, would not
have treated, inhibited, or reduced an oral inflammatory condition. To the
contrary, Maeda teaches using its compositions to treat periodontal disease
(FF4), which the Specification admits involves inflammation (Spec. 1: ¶ 1).

CONCLUSIONS OF LAW & SUMMARY
The claimed amounts of epigallocatechin gallate would have been
obvious to persons of ordinary skill in the art. There was motivation with a
reasonable expectation of success to have combined an extract comprising
epigallocatechin gallate with triclosan and vitamin E to make an oral care
composition. The rejection of claim 1 is affirmed. Claims 5-8, 10-17, and
24 fall with claim 1 because separate arguments for their patentability were
not provided. 37 C.F.R. § 41.37(c)(1)(vii).

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

10
Appeal 2009-011431
Application 11/256,860

cdc

COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY NJ 08855

11