Ex Parte Roberge et al

Patent Trial and Appeal Board

Dec 11, 2012

11037560 (P.T.A.B. Dec. 11, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte REBECCA LYNN ROBERGE and ANDREW LEE WONG
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Appeal 2012-002384
Application 11/037,560
Technology Center 1600
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Before STEPHEN WALSH, ERICA A. FRANKLIN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to an oral care mouthwash composition. The Patent
Examiner rejected the claims for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 1-5, 7, and 8 are on appeal. Claim 1 is representative and
reads as follows:
1. An oral care mouthrinse composition comprising:
(a) from about 324 ppm or greater than 324 ppm bioavailable
amount of one or a mixture of quaternary ammonium agents as essential
antimicrobial active and
(b) a pharmaceutically-acceptable liquid carrier comprising a major
proportion of water, from about 5% to about 30% by weight of the
composition of glycerin as humectant, and from about 0.01% to about 10%
of a sweetening agent selected from sucrose, glucose, saccharin, dextrose,
levulose, lactose, mannitol, sorbitol, fructose, maltose, thaumatin, aspartame,
D-tryptophan, dihydrochalcones, acesulfame, cyclamate and salts thereof,
wherein the composition is essentially free of excipients having a
negative effect on bioavailability of the quaternary ammonium agents
including anionic, nonionic or amphoteric surfactants, glycol solvents and
anti-staining additives, and
wherein the composition has from about 65% or higher than 65%
bioavailability as determined by a Disk Retention Assay to deliver a
bioavailable level of quaternary ammonium antimicrobial agent required for
efficacy, has no more than 5% ethyl alcohol for improved taste and
suitability for safe use by consumers, and has an aesthetically acceptable
clear appearance.

The Examiner rejected claims 1-5, 7, and 8 under 35 U.S.C. § 103(a)
as unpatentable over Forward et al. (WO 94/12150, June 9, 1994).

OBVIOUSNESS
The Issue
The Examiner‟s found that Forward described mouthcare
compositions comprising the ingredients in Appellants‟ mouthrinse. (Ans.
5-6.) Forward included quaternary ammonium compounds, preferably
cetylpyridinium chloride, at “0.005 to 10%, preferably 0.005 to 5%, more
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preferably 0.005 to 2.5% by weight.” (Id. at 5.) Forward differed “insofar
as it does not disclose the particular endpoints of the recited range of
sweetening agents or discuss the bioavailability.” (Id. at 6.) According to
the Examiner, “[s]weetening agents affect the taste and determine[] the
sweetness of the composition. It would have taken no more than the relative
skill of one of ordinary skill in the art to have adjusted the amount of
sweetener to the recited range of 0.01 to 10% in the mouthwash
compositions in order to achieve the desired taste.” (Id. at 7.) Noting that
Appellants‟ dependent claims 3 and 4 define percentages of cetylpyridinium
chloride that overlap Forward‟s, the Examiner pointed out that an overlap in
range establishes a prima facie case of obviousness. (Id. at 8.)
Appellants contend there are additional differences the Examiner did
not find between the compositions, specifically:
(1) a level of at least about 324 ppm bioavailable quaternary
ammonium agent as the essential antimicrobial agent to provide
efficacy and
(2) at least a 65% bioavailability of the quaternary ammonium agent
in order to provide the required 324 ppm level without having to start
with high levels of active.

(App. Br. 5, emphasis omitted.)
The Examiner responds that Forward disclosed compositions having
no surfactants, and without surfactant to interfere with bioavailability, the
quaternary ammonium agent in those compositions should have a
bioavailability of at least 65%. (Ans. 9.)
The issue is whether the evidence supports finding that Forward
suggested a non-surfactant composition comprising cetylpyridinium chloride
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that was 65% bioavailable, to provide at least about 324 ppm cetyl
pyridinium chloride.

Findings of Fact
1. We adopt the Examiner‟s findings concerning the scope and content
of the prior art.
2. Dependent claims 2, 3 and 4 read:
2. A mouthrinse composition according to Claim 1, wherein the
quaternary ammonium antimicrobial agent is selected from the
group consisting of cetylpyridinium chloride . . . .
3. A mouthrinse composition according to Claim 2 wherein the
composition comprises at least about 0.035% cetylpyridinium
chloride by weight of the composition.
4. A mouthrinse composition according to Claim 3 wherein the
composition comprises from about 0.045% to about 1% of
cetylpyridinium chloride by weight of the composition.

(App. Br. 19.)
3. Appellants‟ Specification states:
Mouthrinse formulations comprising from about 0.035 to about
0.1 % CPC [cetylpyridinium chloride] would pass the DRA test if
assay results show the level of bioavailable CPC to be ≥ 324 ppm. For
example, a formulation comprising 0.05% CPC at 72% bioavailability
would provide 360 ppm CPC. Testing of products containing
bioavailable levels of CPC of ≥ 324 ppm demonstrates positive
clinical (antigingivitis, antiplaque) outcomes. Determination of CPC
bioavailability in a finished product is important to product
performance as it readily defines the amount (concentration) of active
available for deposition at the site of action. Because the positively
charged (cationic) hydrophilic region is critical to antimicrobial
activity, any formulation component that diminishes the activity of
this cationic group or that competes with the group may inactivate the
product.

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(Spec. 13-14.)
4. Forward taught that cetylpyridinium chloride was a preferred cationic
antimicrobial agent, and “[t]ypically, the cationic antimicrobial agent
will be present in the range 0.005 to 10%, preferably 0.005 to 5%,
more preferably 0.005 to 2.5% by weight.”
(Forward 3-4.)

Principles of Law
“[W]here there is a range disclosed in the prior art, and the claimed
invention falls within that range, there is a presumption of obviousness. But
the presumption will be rebutted if it can be shown: (1) That the prior art
taught away from the claimed invention, In re Geisler, 116 F.3d 1465, 1471
(Fed. Cir. 1997); or (2) that there are new and unexpected results relative to
the prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).” Iron
Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir.
2004). “[A] prima facie case of obviousness exists when the claimed range
and the prior art range do not overlap but are close enough such that one
skilled in the art would have expected them to have the same properties.” In
re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). “[A] prima facie case of
obviousness arises when the ranges of a claimed composition overlap the
ranges disclosed in the prior art. . . . Even without complete overlap of the
claimed range and the prior art range, a minor difference shows a prima
facie case of obviousness.” In re Harris, 409 F.3d 1339, 1341 (Fed. Cir.
2005) (citations omitted).
“[T]he discovery of an optimum value of a variable in a known
process is usually obvious.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
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1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters
for prior art result effective variables “flows from the „normal desire of
scientists or artisans to improve upon what is already generally known.‟” Id.
(quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Where . . . claimed and prior art products are identical or
substantially identical . . . 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. . . . Whether
the rejection is based on “inherency” under 35 U.S.C. §102, on
“prima facie obviousness” under 35 U.S.C. §103, jointly or
alternatively, the burden of proof is the same.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).

Analysis
We conclude that the preponderance of evidence supports the
Examiner‟s position. Although claim 1 defines the composition in terms of
about 324 ppm or greater quaternary ammonium antimicrobial agent,
dependent claim 3 evidences that “at least about 0.035% cetylpyridinium
chloride by weight” may provide the requisite “at least 324 ppm.” (FF 2.)
Dependent claim 4 similarly evidences that “from about 0.045% to about 1%
of cetylpyridinium chloride by weight” also may meet claim 1‟s
requirement. The Examiner found these amounts to be within Forward‟s
most preferred range of cetylpyridinium chloride, and the evidence supports
that finding. (See Ans. 7; FF 4.) Given that Forward taught compositions
prepared without surfactant, the Examiner reasoned that the 65%
bioavailability requirement would necessarily satisfied by Forward‟s non-
surfactant compositions. We see no inconsistency between the Examiner‟s
reasoning and the Specification‟s explanation of bioavailability. (See FF 3.)
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We conclude the evidence is sufficient to shift the burden to Appellants to
prove that Forward‟s non-surfactant compositions comprising cetylpyridium
chloride in the amounts Forward taught, do not meet the 65% bioavailability
requirement. See Best, 562 F.2d at 1255. We find Appellants‟ additional
arguments unpersuasive in the absence of evidence supporting them.
Attorney‟s argument in a brief cannot take the place of evidence. Geisler,
116 F.3d at 1471.
Claims 2-5, 7, and 8 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

SUMMARY
We affirm the rejection of claims 1-5, 7, and 8 under 35 U.S.C.
§ 103(a) as unpatentable over Forward.
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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