Ex Parte Wegener et al

Board of Patent Appeals and Interferences

Jan 20, 2010

10974253 (B.P.A.I. Jan. 20, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL T. WEGENER and YUKIHIKO HARA
__________

Appeal 2009-006630
Application 10/974,253
Technology Center 1600
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Decided: January 20, 2010
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness and indefiniteness. We have jurisdiction under 35
U.S.C. § 6(b).
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STATEMENT OF CASE
The following claim is representative.

1. A method of treating a patient suffering from bacterial
vaginosis comprising providing a composition in liquid form, wherein the
composition in suppository or liquid form includes a dissolved plant
polyphenol prepared from a green tea extract to provide a polyphenol dose
of at least 50 mg, wherein the green tea extract comprises at least one
polyphenol selected from the group consisting of (-)-epigallocatechin
gallate, (-)- epicatechin gallate, (-)-epigallocatechin, and (-)-epicatechin, and
further providing an instruction to administer the composition in an amount
effective to treat the bacterial vaginosis.

Cited References
Neurath US 6,462,030 B1 Oct. 08, 2002
Reid US 2003/0118571 A1 Jun. 26, 2003
Lee KR 2002/069388 A Sep. 04, 2002

Grounds of Rejection
1. Claims 1-8 and 11-13 are rejected under 35 U.S.C. § 103(a) as being
anticipated by Lee in view of Neurath.
2. Claims 9 and 10 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Lee in view of Neurath and Reid.
3. Claims 1 and 3-13 are rejected under 35 U.S.C. § 112, second paragraph
for claim indefiniteness.
FINDINGS OF FACT
1. The Examiner finds that Lee discloses sanitary napkins comprising an
absorptive cotton with a least one plant extract, one of which is green tea
extract. The tampon is used to facilitate healing of bacterial vaginosis (BV).
The green tea extract is excellent in the anticancer effect, the skin anti-aging
effect and has an excellent deodorization effect. (Ans. 3-4.)
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2. According to the Examiner, Lee teaches that the polyphenol component
of the green tea extract has antibacterial and antivirus effects (page 7, ll. 11-
14). (Ans. 4.)
3. The Examiner notes that Lee differs from the instant claims insofar as it
does not teach using the compositions formulated as liquids or suppositories
and topically applied as creams, ointments and oral compositions. (Ans. 4.)
4. The Examiner finds that Neurath teaches compositions to treat bacterial
vaginosis. The compositions come in pharmaceutical formulations suitable
for vaginal or topical administration. (Ans. 4.)
5. The Examiner further finds that Neurath discloses that formulations
suitable for vaginal administration may be presented as pessaries, tampons,
creams, gels, pastes, jelly, foams or sprays or aqueous or oily suspensions,
solutions or emulsions (liquid formulations). In addition to the active
ingredient, carriers known in the art to be appropriate are incorporated into
the compositions. The form of delivery preferred in the reference is a
suppository. (Ans. 4.)
6. According to the Examiner, Neurath discloses that the suppositories may
be conveniently formed by admixture of the active compound with the
softened or melted carrier or carriers followed by chilling and shaping in
molds that can be configured as vaginal suppositories (col. 11, ll. 26-48).
This would reduce costs and avoid possible disposal problems. Such
suppositories can be inserted into the vagina intact, whereby the shell of the
capsule will soften and rupture upon interaction with moisture within the
vagina, thus releasing the active ingredient (col. 12, ll. 30-39). (Ans. 4.)
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7. The Examiner further notes that Neurath differs from the instant claims
insofar as it does not teach using the green tea polyphenols in the
formulations. (Ans. 4-5.)
8. The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to have formulated suppositories out of the
compositions of Lee motivated by the desire to reduce cost and avoid
possible disposal problems, as taught by the Neurath. (Ans. 5.)
9. The Examiner further concludes that it would also have been obvious to
formulate the compositions of the primary reference into creams, gels,
pastes, jelly, foams or sprays or aqueous or oily suspensions, solutions or
emulsions because they are suitable for vaginal administration, as taught by
the secondary reference. (Ans. 5.)
10. The Examiner notes that the combination of Lee and Neurath differs
from the subject matter of claims 9 and 10 in that the combination does not
teach an oral composition. (Ans. 5.)
11. The Examiner cites Reid et al. for teaching oral compositions for
treating vaginal and cervical infections. (Ans. 5.)
12. According to the Examiner, Reid teaches that the oral compositions are
used to improve gastrointestinal and urogenital health. Organisms, e.g.
urogenital pathogens, which cause many urogenital infections, such as
bacterial vaginosis and urinary tract infections, originate predominantly in
the gastrointestinal tract. (Ans. 5.)
13. Reid teaches that its compositions may also contain compatible
substances used in pharmaceutical formulations such as vitamin C and
estrogen, which both may be phytochemicals. (Reid, page 5, paragraph
0046.)
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14. The Examiner notes that Reid differs from the instant claims insofar as
it does not teach compositions comprising green tea polyphenols. (Ans. 5.)
15. The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to have made oral compositions out of the
compositions of the primary reference and used them in conjunction with the
compositions of the teachings of the combined primary and secondary
references motivated by the desire to treat the disease at the point of
infection and where the cause of the disease originates in gastrointestinal
tract, as taught by the secondary reference. (Ans. 6.)

Obviousness
1. Claims 1-8 and 11-13 are rejected under 35 U.S.C. § 103(a) as being
anticipated by Lee in view of Neurath.
2. Claims 9-10 are rejected under 35 U.S.C. § 103(a) as being unpatentable
over Lee in view of Neurath and Reid.

ISSUE
The Examiner argues that it would have been obvious to one of
ordinary skill in the art to have formulated suppositories out of the
compositions of Lee motivated by the desire to reduce cost and avoid
possible disposal problems, as taught by the Neurath.
Appellants contend that the Examiner has failed to present a prima
facie case of obviousness because Lee fails to teach treating bacterial
vaginosis using a composition in liquid form, a composition containing
dissolved polyphenols, and the claimed amounts of polyphenols. Appellants
argue there is no motivation to combine the cited references. (App. Br. 10.)
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The issue is: Have Appellants demonstrated error in the Examiner’s
obviousness rejection or shown there is no motivation to combine the cited
references?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we considered the factors set forth
in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and
content of the prior art; (2) the differences between the prior art and the
claims at issue; (3) the level of ordinary skill in the relevant art; and (4)
objective evidence of nonobviousness, including secondary considerations
or indicia of nonobviousness, if present.
“[O]bviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
As noted by the United States Supreme Court,

If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
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technique is obvious unless its actual application is beyond his
or her skill.

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).

In KSR, the Supreme Court also addressed the “obvious to try” issue:

When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 421.
“[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).

ANALYSIS
Appellants contend that the Examiner has failed to present a prima
facie case of obviousness because Lee fails to teach treating bacterial
vaginosis using a composition in liquid form, and there is no motivation to
combine the cited references. (App. Br. 10.) Appellants further argue that
while Lee teaches a treatment of bacterial vaginosis, it discloses the use of
dry powder for treatment. (See Lee, pages 8-9). (App. Br. 10.) Appellants
argue that
Specifically, Lee teaches to use various liquid extracts
onto an absorbing sheet that dries up the liquid so it can be
dried with hot air, mixed in a binder or sprayed at high pressure
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onto a sanitary napkin. (Id.) Clearly, there is no indication in
Lee’s publication that such combination would be
unsatisfactory for its purpose. On the contrary, Lee’s
combination of dried catechins on a cloth is taught to be the
essential ingredient to Lee’s invention. Thus, Lee in fact
teaches away from a method of liquid since the purpose of Lee
is to provide a dried pad.
Neurath, on the other hand, teaches the treatment of
bacterial vaginosis using a liquid extract. However, Neurath’s
liquid extract is not derived from green tea or any other plant
material for that matter. Neurath specifically teaches specific
cellulose acetate derivatives, such as phthalic acid-modified
acetates which are deemed critical for antimicrobial activity.
(See Neurath, col. 3, l. 3). Neurath’s cellulose acetate
derivatives are insoluble in aqueous solvents and were therefore
micronized and suspended in the carrier as described in his
examples. Clearly, the liquid carrier in Neurath is dictated by
the specific cellulose acetate derivatives. Thus, Neurath fails to
disclose or suggest a liquid comprising a dissolved plant
polyphenol prepared from a green tea extract to provide a
polyphenol dose of at least 50 mg.

(App. Br. 10.)

In rebuttal, the Examiner finds that Lee first formulates the green tea
extract into a liquid or powder form. (Lee, 4-5.) The liquid or powder is
delivered by using a sanitary unit, and that although the liquid is dried on the
sanitary unit, the active agent is still used specifically to treat BV as recited
in the instant claims. (Ans. 7.)
The Examiner argues that Neurath is used to disclose that BV is
treated with different types of formulations of an active agent other than a
sanitary unit (a tampon). The formulations are suitable for vaginal
administration and may be presented as tampons as in the case of Lee as
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well as in the case of the instant claim 8, creams, gels, foams, spray or
aqueous administration as in the case of the instant claims. (Ans. 7.)
The Examiner concludes that it would have been reasonable to one of
ordinary skill in the art to have made other types of formulations of the
compositions of Lee not only for their suitability for vaginal delivery but
also because not every individual is comfortable with one form of
administration, specifically a tampon, as well as the possibility of toxic
shock syndrome associated with the use of tampons. (Ans. 7.)
We find that Examiner has the better argument. Lee teaches that
green tea can be made in liquid form and that green tea, including green tea
polyphenols, is a known agent in the treatment of bacterial vaginosis. (FF 1,
2.) Neurath teaches that it is known in the art to treat vaginosis by aqueous
administration of active agents, or using a suppository (FF5). Appellants
have presented no rebuttal evidence that green tea may not be administered
as an aqueous extract to treat BV. Appellants have presented no evidence of
secondary considerations or unexpected results.
Appellants argue that the claims expressly require dissolved
polyphenols. (App. Br. 11.) Appellants argue that the dried green tea in the
tampon of Lee does not include a dissolved polyphenol as evidenced by the
Declaration of Shimamura which discloses that green tea, when applied to
cellulosic material, may polymerize upon drying (Shimamura Declaration,
pages 1-2).
We are not persuaded. Lee teaches the preparation of green tea in
liquid form and its use as an active agent for the treatment of bacterial
vaginosis. (FF 1, 2.) Appellants have not established on the record before
us, that the liquid form of green tea (before it is dried) disclosed in Lee does
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not contain dissolved polyphenols, or that it would not have been obvious to
one of ordinary skill in the art to use green tea in the liquid form as disclosed
in Lee in liquid formulations or other known formulations to treat BV as
described in Neurath.
Finally, Appellants argue that Lee does not disclose the claimed
polyphenol dose. (App. Br. 10.) Lee discloses generally the treatment of
BV with green tea, including green tea polyphenols. (FF 1, 2.) “[W]here the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation.” In
re Aller, 220 F.2d 454, 456 (CCPA 1955). It would have been obvious for
one of ordinary skill in the art, reviewing the disclosure of Lee, to determine
the optimum effective dose by routine experimentation.

CONCLUSION OF LAW
Appellants have not demonstrated error in the Examiner’s
obviousness rejection and have not shown that there is no motivation to
combine the cited references. The obviousness rejection is affirmed.

2. Claims 9-10 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Lee in view of Neurath and Reid.
Appellants present similar argument in response to this rejection as to
the rejection over Lee in view of Neurath and argue that Reid does not
overcome the deficiencies of Lee and Neurath. (App. Br. 12.)
Appellants further argue that Reid discloses oral administration of
probiotics to treat vaginosis and that green tea is a phytochemical and not a
probiotic, and that one of ordinary skill in the art would not assume that
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polyphenols would act the same way as probiotics and could also be
ingested to treat bacterial vaginosis. (App. Br. 12. )
However, the probiotic compositions of Reid may also contain
compatible substances used in pharmaceutical formulations such as vitamin
C and estrogen, which both may be phytochemicals. (FF13.) It is further
well known that pharmaceutical chemicals and phytochemicals may be
administered orally, and that green tea may be administered orally, as a
“tea”. Appellants have provided no evidence that one of ordinary skill in the
art at the time of the invention would not have considered green tea effective
when administered orally for the treatment of BV. Therefore, we are not
convinced by Appellants’ argument.
For the reasons discussed herein, we affirm this rejection.

3. Claims 1 and 3-13 are rejected under 35 U.S.C. § 112, second
paragraph for claim indefiniteness.
Appellants do not contest this rejection and therefore it is summarily
affirmed. (App. Br. 3-4.)

CONCLUSION OF LAW
Appellants have not demonstrated error in the Examiner’s
obviousness rejection.
All rejections are affirmed.

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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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