Colgate-Palmolive Company

Patent Trials and Appeals Board

Dec 2, 2021

2020006263 (P.T.A.B. Dec. 2, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/840,046 12/13/2017 Mahmoud Hassan T11205-00-US-01-OC 1090
23909 7590 12/02/2021
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/02/2021 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 MAHMOUD HASSAN, XIANG CHEN, SHYAMALA PILLAI,
GUOFENG XU, LATONYA KILPATRICK-LIVERMAN,
SUMAN CHOPRA, ROBERT DICOSIMO, and MARK S. PAYNE
__________

Appeal 2020-006263
Application 15/840,046
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a two-
phase oral care whitening composition. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Colgate-
Palmolive Company (see Appeal Br. 2). We have considered the
Specification of Dec. 13, 2017 (“Spec.”); Non-Final Office Action of Nov.
26, 2019 (“Non-Final Action”); Appeal Brief of Apr. 27, 2020 (“Appeal
Br.”); Examiner’s Answer of July 2, 2020 (“Ans.”); and Reply Brief of Sept.
2, 2020 (“Reply Br.”).
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Application 15/840,046

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Statement of the Case
Background
“While oral care whitening gels including hydrogen peroxide have
proven to be effective for oral care whitening teeth, different chromophores
on the surfaces are often oxidized at varying rates and/or via varying
mechanisms” (Spec. ¶ 2). “Accordingly, oral care whitening gels including
a single oral care whitening agent (e.g., hydrogen peroxide) may require
relatively longer periods of treatment to appreciably whiten the teeth” (id.).
“While the oral care products incorporating a variety of oral care whitening
agents have demonstrated increased efficacy in oral care whitening teeth,”
these may be unstable so “the oral care products are often provided as a two-
component oral care whitening system, which may be maintained separate
from one another until the time of use, where they may be mixed with one
another to generate the oral care whitening agents” (id. ¶ 3).
The Claims
Claims 1, 7–20, and 22 are on appeal. Claim 1 is an independent
claim, is representative and reads as follows:
1. A two-phase oral care whitening composition,
comprising:
a hydrophobic phase comprising a source of hydrogen
peroxide; a nonionic surfactant; and an acyl donor; and
a hydrophilic phase comprising an amphoteric surfactant;
an enzyme that catalyzes the generation of peracetic acid
between the source of hydrogen peroxide and the acyl donor,
and
wherein when the hydrophobic phase and the hydrophilic
phase are combined the resulting oral care product has a
viscosity of from about 75,000 cP to about 200,000 cP.

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The Rejection2
The Examiner rejected claims 1, 7–10, 12–20, and 22 under 35 U.S.C.
§ 103(a) as obvious over Wieland,3 Butterick,4 and Zaidel5 (Non-Final Act.
3–9).
The issue with respect to this rejection is: Does a preponderance of the
evidence of record support the Examiner’s conclusion that the prior art
suggests the composition of claim 1?
Findings of Fact
1. Butterick teaches “oral care compositions and methods are
provided that use a CE-7 perhydrolase to enzymatically produce a peracid
benefit agent for use in oral care applications such as oral cavity surface
bleaching, teeth whitening” (Butterick ¶ 20).
2. Butterick teaches “certain personal care applications may
benefit from the ability to target/focus the peracid benefit agent to the
desired body surface by localizing peracid production on or near the desired
target body surface” (Butterick ¶ 8).
3. Butterick teaches:
the terms “tooth whitening” and “tooth bleaching” are used
interchangeably, to refer to improving the brightness (e.g.,
whitening) of a tooth or teeth. It is intended that the term
encompass any method suitable for whitening teeth, including

2 We note that the Examiner withdrew the rejection of claim 11 in the
Examiner’s Answer (Ans. 3) and that a terminal disclaimer was filed in
copending US 15/840,050, mooting the provisional double patenting
rejection.
3 Wieland et al., US 2005/0281773 A1, published Dec. 22, 2005.
4 Butterick et al., US 2012/0328534 A1, published Dec. 27, 2012.
5 Zaidel et al., US 2006/0045854 A1, published Mar. 2, 2006.
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the present invention, as well as chemical treatment, mild acid
treatment, abrasive tooth whitening, and laser tooth whitening.
In particularly preferred embodiments, the present invention
provides a perhydrolase and perhydrolase-containing
compositions suitable for whitening teeth.
(Butterick ¶ 313).
4. Butterick teaches the “personal care product formulation will be
comprised of at least two components that remain separated until use.
Mixing of the components rapidly forms an aqueous peracid solution. Each
component is designed so that the resulting aqueous peracid solution
comprises an efficacious peracid concentration” (Butterick ¶ 385).
5. Butterick teaches:
The type and amount of the various ingredients used within two
component formulation should to be carefully selected and
balanced to provide (1) storage stability of each component,
especially the perhydrolysis activity of the enzyme catalyst and
(2) physical characteristics that enhance solubility and/or the
ability to effectively form the desired aqueous peroxycarboxylic
acid solution (e.g., ingredients that enhance the solubility of the
ester substrate in the aqueous reaction mixture and/or
ingredients that modify the viscosity and/concentration of at
least one of the liquid components . . . ).
(Butterick ¶ 387).
6. Butterick teaches “[o]ne requirement for long term storage
stability of the enzyme in triacetin is that there is not a significant reaction of
the triacetin with any water that might be present” and the excipient “must
provide stability of the enzyme in the organic substrate for the enzyme under
conditions where acetic acid might be generated due to the presence of low
concentrations of water in the formulation” (Butterick ¶ 405).
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7. Butterick teaches the “dried enzyme powder may be stored as a
formulation in the organic compound that is a substrate for the at least one
enzyme” (Butterick ¶ 405).
8. Butterick teaches a two-step application in Example 16 where:
A solution of 10 μM of each enzyme in 10 mM phosphate
buffer, pH 7.2 was prepared and 500 μL of solution was
incubated with each enamel substrate for 60 min. The enzyme
solution was removed and each well was rinsed three times
with an additional 500 μL of buffer. The enamel blocks were
placed in a fresh well for the whitening process. A solution
with a final concentration of 40 mM triacetin, 100 mM H202 in
50 mM phosphate pH 7.2 buffer was freshly prepared and 500
μL of solution was added to each enamel block. Over the
course of 1 hr the enamel blocks were removed and a color
measurement was obtained and then each was returned to the
solution in the well plate.
(Butterick ¶ 556).
9. Wieland teaches “mouth, teeth and denture care products” that
comprise “perhydrolases, a hydrogen peroxide source and a substrate for the
perhydrolase” (Wieland ¶¶ 90, 93).
10. Wieland teaches “perhydrolases are combined in the agent
according to the invention with one or several of the following ingredients:
nonionic, anionic or cationic surfactants” (Wieland ¶ 115) as well as
“zwitterionic surfactants can be used as emulsifiers” (Wieland ¶ 256).
11. Wieland teaches, in the context of dental care products, that
“materials suitable to control viscosity include layered silicates, for example
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montinorillonite, colloidal swelling silicas, e.g. aerogel silicas or pyrogenic
silicas” (Wieland ¶ 347).
12. Wieland teaches that “[h]ydrophobic bases are particularly
suitable as additives for paste and liquid products” (Wieland ¶ 366).
13. Zaidel teaches “oral care compositions comprising: (a) a
peroxide complex . . . (b) whitening agent; and . . . (c) an orally acceptable
non-aqueous carrier . . . Nonaqueous hydrophilic polymers useful in the
practice of the present invention preferably provide a viscosity for the
composition in the range between about 10,000 cps to 600,000 cps” (Zaidel
¶¶ 46–49).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003), and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellant contends “simply because Wieland may teach that
‘hydrophobic bases are particularly suitable additives for paste and liquid
products’ . . . this does not motivate one skilled in the art to invent an oral
care composition comprising two-phases, one hydrophilic and one
hydrophobic” (Appeal Br. 3). Appellant also contends “Butterick may
report the use of a multi-component system and that the perhydrolytic
enzyme may be stored in an aqueous solution . . . However, Butterick fails to
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teach a two-phase system comprising a hydrophobic and hydrophilic phase”
(id.).
The Examiner responds:
Since Weiland et al. teaches “[h]ydrophobic bases” (p. 28, para.
[0366]) as suitable additives, and Butterick et al. teaches that
the perhydrolytic enzyme is stable in aqueous solution (p. 14,
para. [0323]), one would have reasonably inferred a
hydrophobic phase and hydrophilic phase to be suitable as
storage media in the two-phase system for the perhydrolase
enzyme and hydrogen peroxide source.
(Ans. 4).
We find Appellant has the better position. Not only does the
Examiner lack a teaching or example of any hydrophobic phase, much less
in a two-phase whitening or dentrifice composition, but the Examiner’s
reason is not persuasive. The Examiner presumes that a second phase for an
aqueous phase perhydrolytic enzyme in Butterick would be a hydrophobic
phase, but the two examples in Butterick were both combinations of
liquid/solid phases (Butterick ¶¶ 389–390). When Butterick discusses
“multiple active fluids (liquid-liquid) systems [that] typically use multi-
chamber dispenser bottles or two-phase systems” (Butterick ¶ 381), the
Examiner does not identify any disclosure in Butterick or prior art cited
therein that uses or directly suggests a hydrophobic phase, much less in a
dentrifice. And when Wieland discusses “hydrophobic bases”, Wieland is
generally discussing additives to pastes and liquids (FF 12), but does not
suggest that the phase in entirety is hydrophobic, nor does Wieland teach or
suggest a two-phase system with hydrophobic and hydrophilic phases.
We therefore agree with Appellant that this rejection relies on
hindsight. “We must still be careful not to allow hindsight reconstruction of
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references to reach the claimed invention without any explanation as to how
or why the references would be combined to produce the claimed
invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3
(Fed. Cir. 2008).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that the prior art suggests the composition of claim 1.

DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 7–10,
12–20, 22
103 Wieland, Butterick,
Zaidel
1, 7–10,
12–20, 22

REVERSED