Ex Parte Lambert et al

Patent Trial and Appeal Board

Sep 26, 2016

12138647 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/138,647 06/13/2008
23909 7590 09/28/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Pierre Lambert
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
8534-00-0C 9832
EXAMINER
PARAD, DENNIS J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
09/28/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
Patent_Mail@colpal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PIERRE LAMBERT and CLAUDE BLANV ALET 1
Appeal2014-004246
Application 12/138,647
Technology Center 1600
Before ULRIKE W. JENKS, JACQUELINE T. HARLOW, and
TA WEN CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
single-compartment dual phase mouth wash composition and a method
comprising applying such composition, which have been rejected as lacking
in written description and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We REVERSE.
1 Appellants identify the Real Party in Interest as Colgate-Palmolive
Company. (Appeal Br. 2.)
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Application 12/138,647
STATEMENT OF THE CASE
According to the Specification, dual phase mouth wash compositions
are known in the art. (Spec. i-f 1.) The Specification states that "[o]ne of the
benefits of a dual phase mouth wash composition is that the hydrophobic
phase generally resides above the hydrophilic phase," and such "separation
of the hydrophobic phase on top of the hydrophilic phase" inhibits the
degradation by oxidation of actives in the hydrophilic phase. (Id. at i-f 2.)
The Specification also states that, "in compositions where the hydrophobic
and hydrophilic phases do not completely separate, e.g., emulsion remains
after allowing the composition to remain at rest, the actives in the
hydrophilic phase are subject to degradation by oxidation." (Id.) Thus, the
Specification asserts that "there is a need to develop oral care compositions
comprising a hydrophilic and hydrophobic phase which separates into two
distinct phases, and does not contain a microemulsion created by mixing the
phases together." (Id.) Further according to the Specification,
[ t ]he present invention is directed in part to mouth wash having at
least two phases, e.g., a hydrophilic phase and a hydrophobic phase.
The hydrophilic and hydrophobic phases remain separated while at
rest; however, upon shaking [there is] generate[d] a dispersion of the
hydrophobic phase in the hydrophilic phase, e.g., an oil-in[-]water
emulsion. The dispersion is stable long enough to enable a dosage of
the mouth wash to be dispensed, e.g., to the user, and the dispersion
returns to the original state ... when left at rest.
(Id. at i-f 4.)
Claims 1, 3, 5-8, 11-20, 22, and 23 are on appeal. 2 Claim 1, the only
independent claim, is representative and reproduced below:
2 Claims 9 and 10 have been withdrawn from consideration as being drawn
to a nonelected species. (Final Act. 2; Appeal Br. 17 (Claims App.).)
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Application 12/138,647
1. A single-compartment dual phase mouth wash
composition comprising:
a hydrophobic phase;
a hydrophilic phase comprising a fluoride ion source and
an antibacterial agent; and
a hydrotrope component,
wherein hydrophobic and hydrophilic phases separate
following mixing of the phases and does not contain an
emulsion one hour following mixing,
wherein the composition contains up to about 0.01 % by
weight of a surfactant.
(Br. 16 (Claims App.).)
The Examiner rejects claims 1, 3, 5-8, 11-20, 22, and 23 under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement. (Ans. 2)
The Examiner also rejects claims 1, 3, 5-8, 11-2 0, 22, and 2 3 under
35 U.S.C. § 103(a) as being unpatentable over Yukl, 3 Gaffar, 4 and Weiss. 5
(Id. at 4.)
I.
Issue
The Examiner has rejected claims 1, 3, 5-8, 11-20, 22, and 23 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement. The Examiner finds that the Specification lacks
"any written description support for the requirement that the mouth wash is
3 Yukl et al., US 2005/0002876 Al, published Jan. 6, 2005.
4 Gaffar et al., US 5,496,540, issued Mar. 5, 1996.
5 Weiss et al., US 4,525,342, issued Jun. 25, 1985.
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Application 12/138,647
limited to a 'single-compartment."' (Ans. 2-3.) Appellants argue among
other things that the Specification "describe[s] Appellants' mouth wash as
having at least two phases that, when shaken, create a dispersion that, after
use and rest, returns to its separate-phase state. Thus, the materials must be
in physical contact before, during, and after use." (Appeal Br. 5.)
Appellants argue that "such continuous physical contact [of the materials]
would only be achieved if all of the components of the claimed mouthwash
were present within the same compartment" and that the Specification thus
"reasonably conveys to those of skill in the art that Appellants were in [full]
possession of the presently-claimed invention." (Id.)
The issue with respect to this rejection is whether the evidence of
record supports the Examiner's conclusion that the claims fail to comply
with the written description requirement with respect to the "single-
compartment" limitation.
Principles of Law
"[T]he test for sufficiency [of written description] is whether the
disclosure of the application relied upon reasonably conveys to those skilled
in the art that the inventor had possession of the claimed subject matter as of
the filing date." Ariad Phann., Inc. v. Eli Lil~y and Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010). "Such description need not recite the claimed
invention in haec verba but must do more than merely disclose that which
would render the claimed invention obvious." JC',U ll!fed., Inc. v. Alaris lvled.
S'.ys., Inc., 558 F.3d 1368, 1377 (Fed. Cir. 2009).
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Application 12/138,647
Analysis
The Specification discloses that "the invention is directed in part to
mouth wash having ... a hydrophilic phase and a hydrophobic phase,"
where the phases remain separated while at rest but "generates a dispersion
of the hydrophobic phase in the hydrophilic phase, e.g., an oil-in[-]water
emulsion" upon shaking. (Spec. i-f 4.) The Specification also discloses that
"[t]he dispersion is stable long enough to enable a dosage of the mouth wash
to be dispensed, e.g., to the user, and the dispersion returns to the original
state within two minutes when left at rest." (Id.) The Specification further
supplies an example in which claimed and comparative mouth wash
compositions are "shaken by hand for 30 seconds to form an emulsion, and
are allowed to rest for various amounts of time," whereby "[ n Jo emulsion
will be observed between the [hydrophilic and hydrophobic] phases in [the
claimed compositions] 10 seconds at rest, while a[ n] emulsion will be
observed in [the comparative compositions] after one hour at rest." (Id. at i-f
31.)
We agree with Appellants that the Specification reasonably conveys
to those skilled in the art that Appellants had possession of the claimed
"sing1e--compartmenf' dual phase mouth wash. In pmiicufar, the
Specification's description of the claimed mouth wash as having two
separate phases that generates an emulsion upon shaking before returning to
their original separated state upon being left at rest reasonably conveys to a
skilled artisan that the two phases of the mouth wash are in contact with
each other and thus in a single compartment
The Exam in er argues that "[ n Jo where in the Specification ... is there
any mention of compartments, let alone the number of compartments, for
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Application 12/138,647
containing the claimed composition" and further argues that "nothing in the
Specification implicitly even suggests compartmentalizing the composition."
(Ans. 11.) We disagree. The written description requirement does not
demand that the Specification includes the exact phrase "single-
compartment." ICU lvied., 558 F.3d at 1377. As discussed above, the
Specification discloses shaking the claimed mouth wash composition to
generate an emulsion and leaving it at rest to return the two phases of the
composition to a separated state. Such a description reasonably conveys to a
skilled artisan that the claimed mouth wash composition is in a container and
that the two phases of the composition are in contact with one another and
thus in a single compartment.
The Examiner argues that a single compartment isn't necessary to
achieve "the purpose of having at least two phases that, when shaken, create
a dispersion that, after use and rest, return[] to [a] separated phase state" and
further argues that a single compartment is also "not the only possibility for
the phases to be in physical contact" (Ans. 13.) In particular, the Examiner
suggests that "one could design a plurality of containers or a plurality of
compartments in a single container and combine the phases at the time of
use." (Id.)
\Ve are not convinced. In the design envisioned by the Examiner, the
two phases of the mouth wash composition are in physical contact only at
the time of use. However, the description of the invention in the
Specification, in which the two phases generate an emulsion upon shaking
before re-separating into two distinct phases when left at rest, reasonably
conveys to a skined artisan that the phases of the clairned mouth wash are
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Application 12/138,647
also in physical contact before and after the time of use, i.e., are in a single
compartment.
Accordingly, we reverse the Examiner's rejection of claims 1, 3, 5-8,
11-20, 22, and 23 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement.
II.
Issue
The Examiner has rejected claims 1, 3, 5-8, 11-20, 22, and 23 under
35 U.S.C. § 103(a) as being unpatentable over Yukl, Gaffar, and Weiss.
(Ans. 4.) The Examiner finds that Yukl teaches a mouthwash composition
and a method of treating an inflammatory disease such as gingivitis using
such composition. (Id.) The Examiner finds that Yukl teaches that its
mouthwash composition "may comprise a plurality of phases ... wherein
the phases may be ... encapsulated in a single container (i.e., in a single
compartment) such that the phases are combined at the time of use for
stability and compatibility." (Id. at 5.) The Examiner finds that Yukl
teaches its mouthwash composition "preferably includes a surfactant (i.e.,
the addition of a surfactant is optional)" and further teaches
(Id.)
an exemplary embodiment ... comprising 0% to about 80% of a
humectant, from about 0.01 % to about 7% of a surfactant, from about
0.03% to about 2% of a flavoring agent, from about 0.005% to about
3% of a sweetening agent, from about 0.001 % to about 0.5% of a
coloring agent, with the balance being water.
The Examiner finds that Yukl teaches that the humectant of its
mouthwash composition can comprise glycerol, sorbital, and propylene
glycol, which are hydrotropes, and further teaches that the mouthwash
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Application 12/138,647
composition may comprise flavoring and numbing agents, which include
"essential oils" and compounds that Appellants have defined as "herbal
extract antibacterial agents." (Id at 5, 17 (citations omitted).) The
Examiner further finds that Yukl teaches that its mouthwash composition
may comprise antibacterial agents and a fluoride ion. (Id. at 6.)
The Examiner finds that Gaffar teaches "a mouthwash composition
(Abstract) comprising a fluorine-providing compound" and also teaches that
"it will often be desirable to use anionic surfactants in oral compositions
(i.e., the addition of a surfactant is optional)." (Id. at 6-7 .) The Examiner
finds that Gaffar teaches an exemplary embodiment comprising
glycerol (i.e. glycerin; 10% by weight), propylene glycol (7% by
weight) (i.e. glycerin and propylene glycol are in a weight ratio of
about 1.43: 1 ), sorbitol, triclosan, polyvinylmethylether/maleic
anhydride copolymer, and sodium fluoride ... and that the
mouthwash composition advantageously possesses anti-tartar, anti-
calculus, tooth hardening, anti-caries, and stabilizing properties ....
(Id. at 7)
Finally, the Examiner finds that Weiss teaches a mouth wash
composition that is "detergent (i.e., surfactant) free" and further teaches that
"the use of detergents/ surfactants in the oral cavity has adverse effects such
as gum recession, circulatory impairments, hyperhydration of the exposed
tissue, edema, and allergic reactions." (Id.) The Examiner further finds that
Weiss teaches a mouth wash composition comprising two phases: "an
oily/hydrophobic phase (having hydrocarbons and/or fats and/or oils) and a
hydrophilic/aqueous phase (having essential oil with antibacterial activity,
sweetener, cosmetic additives, preservative, food color, and fluoride
additive) that are mixed just prior to their use." (Id. at 8.)
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The Examiner concludes that it would have been prima facie obvious
to a skilled artisan to modify Yukl' s single-compartment mouth wash
composition having a plurality of phases "such that the mouthwash
composition is a surfactant-free two-phase mouthwash having a hydrophilic
phase and a hydrophobic phase as taught by [Weiss] wherein the hydrophilic
phase comprises glycerin and propylene glycol ... , sorbital, triclosan,
polyvinylmethylether I maleic anhydride copolymer, and sodium fluoride as
taught by Gaffar" (id. at 8), because
[Yukl] teach[ es] that [its] composition can comprise of glycerin,
propylene glycol, sorbitol, triclosan, polyvinylmethylether/maleic
anhydride copolymer, sodium fluoride, and mineral oil, and that
encapsulating the phases in a single container (i.e. a single
compartment) is useful for maintaining stability and compatibility[;]
[ Gaffar] teach[ es] that the particular combination of glycerin,
propylene glycol, sorbitol, triclosan, polyvinylmethylether/maleic
anhydride copolymer, [and] sodium fluoride advantageously
possesses anti-tartar, anticalculus, tooth hardening, anti-caries, and
stabilizing properties[;] and [Weiss] teach[ es] two-phase mouthwash
compositions having a mineral oil/edible oil hydrophobic phase and a
hydrophilic phase [that] are effective in removing dental plaque,
removing a large percentage of adhering microorganisms, and
reducing the effect of halitosis without needing a surfactant because
the use of surfactants in the oral cavity has adverse effects such as
gum recession, circulatory impairments, hyperhydration of the
exposed tissue, edema, and allergic reactions.
(Id. at 9.)
The Examiner further concludes that,
[ s ]ince the composition of the above ... prior art combination and
claim 1 appear to be the same (i.e. the composition comprises a
hydrophobic phase, a hydrophilic phase comprising a fluoride ion
source and an antibacterial agent, and a hydrotrope component), the
hydrophobic and hydrophilic phases would also separate following
mixing of the phases and not contain an emulsion one hour following
mixmg.
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Application 12/138,647
(Id.)
Appellants contend among other things that the prior art does not
teach the limitation "wherein the hydrophobic and hydrophilic phases
separate following mixing of the phases and does not contain an emulsion
one hour following mixing," which appears in independent claim 1 and thus
is a limitation in all of the claims on appeal. (Appeal Br. 7.) Appellants
further argue that the Examiner has not shown that the prior art composition
inherently meets this limitation. (Id. at 7-8.)
The issue with respect to this rejection is whether the evidence of
record supports the Examiner's conclusion that the cited references suggest a
mouth wash composition comprising a hydrophilic phase and a hydrophobic
phase "wherein hydrophobic and hydrophilic phases separate following
mixing of the phases and does not contain an emulsion one hour following
mixing."
Analysis
As discussed above, Appellants contend that the prior art does not
teach, explicitly or inherently, a dual-phase mouth wash composition
"wherein hydrophobic and hydrophilic phases separate following mixing of
the phases and does not contain an emulsion one hour following mixing."
(Appeal Br. 7-8.) The Examiner counters that the Examiner "has shown
that the claimed composition and the ... prior art is predicated on combining
components which are well known and are all found in the ... formulation
of [Yukl]." (Ans. 14--15.) The Examiner contends that "[ w ]here the
claimed and prior art products are identical or substantially identical in
structure or composition, or are produced by identical or substantially
identical processes, a prima facie case of either anticipation or obviousness
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has been established," and further points out that "when the PTO shows a
sound basis for believing that [Appellants'] products ... and the prior art are
the same, [Appellants] ha[ ve] the burden of showing that they are not." (Id.
at 15 (citations and quotation marks omitted).)
We find that Appellants have the better argument. The parties do not
dispute the prior art references do not explicitly disclose the limitation at
issue (i.e., that the hydrophilic and hydrophobic phases of the mouth wash
"separate following mixing of the phases and does not contain an emulsion
one hour following mixing"). The question is thus whether the composition
suggested by the prior art references inherently meets this limitation and
whether the Examiner has properly shifted the burden to Appellants to show
a difference between the claimed and the prior art products.
We find that the Examiner has not shown that the composition
allegedly suggested by the prior art references inherently possesses the
characteristics of having hydrophilic and hydrophobic phases that separate
following mixing such that the composition does not contain an emulsion
one hour following mixing. In particular, assuming that the Examiner is
correct that the prior art suggests a composition comprising all of the
claimed ingredients, the Examiner has not shown that the particular relative
ratios of ingredients suggested by the prior art references, if any, necessarily
results in hydrophilic and hydrophobic phases that will behave in the
claimed manner. Par Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186,
1195-1196 (explaining that to rely on inherency in an obviousness analysis
"the limitation at issue necessarily must be present, or the natural result of
the combination of elements explicitly disclosed by the prior art").
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Likewise, the Examiner's attempt to shift the burden of proof to
Appellants is premature. The Examiner must show a "sound basis" for
concluding that the prior art products meets the claim limitations before
Appellants can be put to the burden of showing a difference. See In re
Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Here, the Examiner has at most
argued that the prior art references suggest a composition containing the
claimed ingredients, without, for instance, pointing to evidence in the record
or providing sound technical reasoning that the relative ratios of the
ingredients suggested by the prior art, if any, are substantially similar to a
claimed composition (i.e., a composition in which the phases separate
following mixing and do not form an emulsion one hour following mixing).
Accordingly, we reverse the Examiner's rejection of claims 1, 3, 5-8,
11-20, 22, and 23 under 35 U.S.C. § 103(a) as being unpatentable over
Yukl, Gaffar, and Weiss.
survnvIARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 1, 3, 5-8, 11-20, 22, and 23.
REVERSED
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