OTSUKA PHARMACEUTICAL CO., LTD.

Patent Trials and Appeals Board

Oct 15, 2020

2020002304 (P.T.A.B. Oct. 15, 2020)

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.
14/383,010 09/04/2014 Masahiko Tanaka 04676.0320 4110
22852 7590 10/15/2020
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
BARHAM, BETHANY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
10/15/2020 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte MASAHIKO TANAKA, MIYOKO OGIHARA,
and JUNKO KAKO

_________________

Appeal 2020-002304
Application 14/383,010
Technology Center 1600
_________________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
DAVID COTTA, Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

Appellant1 seeks our review, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 1, 2, 5, 10 and 17.2 We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word “Appellant” as defined in 37 C.F.R. § 1.42. Appellant
identifies Otsuka Pharmaceutical Co., Ltd. as the real party in interest.
(Appeal Br. 3.)
2 We consider the Final Office Action mailed January 14, 2019 (“Final
Act.”); the Appeal Brief filed August 15, 2019 (“Appeal Br.”); the
Examiner’s Answer mailed on November 29, 2019 (“Ans.”); the Reply Brief
filed January 28, 2020 (“Reply Br.”); and the oral argument held on October
1, 2020, in reaching our decision.
Appeal 2020-002304
Application 14/383,010

2
The Examiner rejected claims 1, 2, 5, 10, and 17 under 35 U.S.C.
§ 103(a) as being obvious over Liu,3 Caetano,4 and optionally Shinohara5 or
Hüttinger.6 (Final Act. 4–8.)
Appellant’s Specification is directed to sunscreen compositions.
(Spec. ¶ 1.)
Appellant’s claim 1, with bracketed numbers added for clarity, recites:
A sunscreen composition free from a metal oxide
comprising [1] three or more oil-soluble ultraviolet absorbers,
[2] composite silicone particles having an average particle
diameter of 10 μm or less, and [3] an electrolyte,
wherein:
[1] the oil-soluble ultraviolet absorbers are at least three
members selected from the group consisting of ethylhexyl
methoxycinnamate, octocrylene, diethylamino hydroxybenzoyl
hexyl benzoate, and polysilicone-15,
[2] the composite silicone particles are composite
silicone particles in which silicone rubber is coated with a
silicone resin, and
[3] the electrolyte is at least one electrolyte selected from
the group consisting of sodium chloride, magnesium chloride,
calcium chloride, adenosine phosphate and salts thereof,
ascorbic acid and salts thereof, glucoside ascorbate and salts
thereof, and sodium ascorbyl phosphate,
[1] the oil-soluble ultraviolet absorbers are contained in
an amount of 10 to 25 wt.%,
[2] the composite silicone particles are contained in an
amount of 4 to 20 wt.%,

3 Liu et al., U.S. Patent Application Publication 2007/0173599 A1, published
July 26, 2007.
4 Caetano et al., International Patent Application Publication WO
2009/067095 A1, published May 28, 2009.
5 Shinohara et al., International Patent Application Publication WO
2010/147238 A1, published December 23, 2010.
6 Huttinger et al., U.S. Patent 4,698,178, issued October 6, 1987.
Appeal 2020-002304
Application 14/383,010

3
[3] the electrolyte is contained in an amount of 0.5 to 5
wt.%,
the sunscreen composition is in the form of a water-in-oil
type (W/O) emulsion, and
the sunscreen composition is in a reversible separation
state which is separated into two layers when allowed to stand
and returns to a homogeneous single-layer emulsion form by
shaking.

(Appeal Br. 20.) Thus, Appellant’s claim 1 recites a sunscreen composition
free from a metal oxide and including three ingredients present within
recited ranges.
The Examiner finds, and we agree, that Liu teaches water-in-oil
emulsions comprising particle silicone elastomers and oil soluble UV
protection agents, both in concentrations encompassing or overlapping with
the ranges recited in claim 1. (See Final Act. 4; see Liu Abstract, ¶¶ 14, 35,
38, 53, 56, p. 8.) We also agree that Liu teaches including electrolytes
recited in claim 1, such as ascorbic acid, specifically sodium ascorbyl
phosphate, in the composition at concentrations from about 0.001% to about
30%. (See Final Act. 4; see Liu ¶¶ 74, 76, 77.) We agree, further, that
Caetano teaches using one or more sunscreens in compositions for the skin,
including suncreens recited in claim 1. (See Caetano ¶ 78; see Final Act. 5.)
Thus, Liu and Caetano together teach each of the separate components of the
claimed sunscreen composition.
In addition, Liu teaches:
It has been surprisingly found that the emulsifying
silicone elastomer, when combined with the alkyl-substituted
silicone emulsifier hereinafter described, provides a water-in-oil
emulsion having improved stability and enhanced UV
protection benefit.
Appeal 2020-002304
Application 14/383,010

4
Herein, stability of the composition relates to stability of
emulsion and stability of color/shade of the composition.
Stability of emulsion means absence of phase separation and
significant change in viscosity/rheology.

(Liu ¶¶ 21–22; see Appeal Br. 8.) Appellant argues that one of ordinary skill
in the art would not have considered that “disclosure like that of Liu, which
teaches compositions having an ‘absence of phase separation’ (Liu at
¶¶ [0021]-[0022]), could be relied upon to productively advance efforts
toward a composition as claimed, which is ‘separated into two layers when
allowed to stand.’” (See Appeal Br. 8–9.)
Although we disagree with Appellant that Liu necessarily teaches a
composition with the absence of phase separation, we agree that Liu teaches
less phase separation is preferable. As the Examiner states: “It appears
more likely that Liu would be desiring the absence of an irreversible phase
separation (a composition that would not be able to return to a homogeneous
emulsion form even by shaking) within its emulsion rather than teaching
away from a composition with a reversible separation state.” (Ans. 4.)
Thus, the Examiner seems to acknowledge that the goal of Liu, to decrease
separation, is not the same as the goal of Appellant’s claimed composition,
to achieve a “reversible separation state which is separated into two layers
when allowed to stand and returns to a homogeneous single-layer emulsion
form by shaking.”
The Examiner finds that the properties of the sunscreen composition
recited in claim 1 would naturally flow from the teachings of the prior art
because all of the ingredients and structural features of the recited in
formulation are taught and including an electrolyte as claimed would cause
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Application 14/383,010

5
the composition to exhibit a reversible separation state. (See Final Act. 7–8,
citing Spec. ¶ 107 (Table 8).) Even if, though, Liu teaches each of the
components, it does not exemplify a composition that includes each of them
in concentration within the ranges recited in claim 1. Instead, to arrive at the
claimed composition one would have to choose an electrolyte “in an amount
of 0.5 to 5 wt.%” from the range of 0.001 – 10% taught in Liu. (See Liu
¶ 74.)
Although such choosing is normally acceptable under a rejection for
obviousness under 35 U.S.C. § 103, Liu teaches that “[t]he type and amount
of skin active agents are selected so that the inclusion of a specific agent
does not affect the stability of the composition.” (Liu ¶ 75.) Thus, even
though the teachings of individual ingredients in a sunscreen composition
encompass the individual ingredients recited in claim 1, Liu teaches to not
choose an ingredient that would affect the stability, that is, the phase
separation, of the composition. (See id. at ¶ 22.)
The Examiner cites Wakamatsu to show that it was known at the time
of filing that electrolytes can cause the separation of the water phase from
the oil phase and thus affect phase separation. (See Final Act. 9, citing
Wakamatsu ¶ 2.) In light of this finding, we are not persuaded that one of
ordinary skill in the art would have chosen a concentration of sodium
ascorbyl phosphate or any other electrolyte to achieve a sunscreen
composition “in a reversible separation state which is separated into two
layers when allowed to stand and returns to a homogeneous single-layer
emulsion form by shaking” as claimed because Liu teaches that more stable
compositions are preferable. (See Liu ¶¶ 21, 22, 75.) We are persuaded that
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Application 14/383,010

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if one were to follow the teachings of Liu, there would be no reason to
choose an electrolyte as recited in claim 1.
The Examiner cites Shinohara for its teaching to include purine
nucleic acids, including adenosine phosphates, in skin compositions to
prevent water loss. (See Final Act. 5–6, citing Shinohara 7:26–29, 8:22–32,
10:16–18.) Similarly, the Examiner cites to Hüttinger for its teaching to
include sodium chloride as an electrolyte at 2 weight % in water-in-oil
emulsions for cosmetics. (See Final Act. 6, citing Hüttinger 1:10–13, 2:40–
48, 4:56–60.) We agree with the Examiner that both Shinohara and
Hüttinger provide reasons to include electrolytes in a composition for the
skin other than to affect the stability of the emulsion. But we are not
persuaded that one of ordinary skill in the art would have modified the
composition taught in Liu to include these electrolytes because it was known
that such electrolytes would also alter the stability of the emulsion and Liu
expressly states that skin active agents should be selected so that they do not
affect the stability of the composition.
Accordingly, we disagree with the Examiner that one of ordinary skill
in the art would have considered the claimed sunscreen composition to be
obvious over either Liu or the combination of Liu and either Shinohara or
Hüttinger.
Appeal 2020-002304
Application 14/383,010

7
Conclusion
Upon consideration of the record and for the reasons given, we
reverse the Examiner’s rejection.
In summary:

Claims
Rejected
35 U.S.C. § Basis/Reference(s) Affirmed Reversed
1, 2, 5, 10,
17
103(a) Liu, Caetano,
optionally
Shinohara or
Hüttinger
1, 2, 5, 10,
17

REVERSED