Withdrawal of S102 and $103 Rejections Based on Ribier 466, Ribier ^364, Sebag. Subbiah.
In the December 27, 2006 Office Action, the Examiner withdrew the previously raised §102
and §103 rejections against claims 1 and 3-20 based on U.S. Patent No. 5,650,166 (Ribier '166), U.S.
Patent No. 5,925,364 (Ribier '364), U.S. Patent No. 5,41 1,742 (Sebag), U.S. Patent No. 6,150,381
(Subbiah), and U.S. Patent No. 5,702,691 (Ichinose), in light of the arguments presented by
AppUcants in the October 10, 2006 Appeal Brief Specifically, the Examiner expressly
• Ribier '166 fails to disclose a composition containing cholesterol sulfate and an
exfoliant in the amounts claimed by claims 1 and 3-9;
• Ribier '364 and Sebag fail to provide adequate motivation to combine an exfoliant as
taught by Sebag (i.e., sahcylic acid) into the composition disclosed by Ribier '364
and therefore do not render claims 1, 3-4, 6-9, 1 1 and 1 8 obvious; and
• Ribier ' 1 66 fails to specifically teach or render obvious a composition having the
cholesterol sulfate and amino sugar exfoliant in the amounts claimed by claims 13-
Applicants hereby thank the Examiner for her consideration of Applicants' arguments and
her withdrawal of the previously raised §102 and §103 rejections.
Response to the §112 Rejections
In the outstanding Office Action, the Examiner rejected then pending claims 1 and 3-20
under 35 U.S.C. §112, first paragraph, as allegedly failing to comply with the written description
requirement. Specifically, the Examiner asserted that the specification as originally filed does not
provide adequate support for "an integral mixture '' of cholesterol sulfate and exfoliant/amino sugar.
In response. Applicants have hereby amended independent claims 1, 13, 16, and 19, fi:om
which claims 3-12, 14-15, 17-18, and 20 depend by deleting the term "integral." The claim
rejections under §112, first paragraph are therefore overcome.
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Response to $103 RejectioDS Based on Abe ^911, Shimada, Abe ^314, Bernstein, Kitada, and
Claims 1, 3, 5, 13, and 16-19 were rejected under 35 U.S.C. §103(a) as allegedly obvious
over the English Abstract of Japanese Patent Application No. 60-16191 1 to Abe et al. (hereinafter
"Abe '911") in view of the English Abstract of Japanese Patent Application No. 59-013708 to
Shimada et al. (hereinafter "Shimada").
Abe '91 1 discloses a cosmetic composition containing 0.01-5 wt% of cholesterol sulfate or
salts thereof for improving dried skin, preventing aging of skin, providing skin with wetting
characteristics, softness and luster by promoting water retention fimction of skin. However, nothing
in Abe '911 teaches or suggests the use of an exfoliant or amino sugar, as positively recited by the
claims of the present application . In the outstanding Office Action, the Examiner expressly conceded
the deficiency of Abe '911 (see Office Action, page 7, lines 1-2), but attempted to remedy it by citing
Shimada, which discloses a cosmetic composition containing 0.1-5 wt% of an amino sugar, such as
N-acetyl-D-glycosamine, N-acetyl-D-galactosamine, D-glucosamine, D-galactosamine, and
hydrochlorides and sulfates thereof, for moistening, emoUiating, and activating the skin and giving
smooth feeling, springiness and luster to the skin. Referring to In re Kerkhoven , 205 USPQ 1069
(CCPA 1980), which held that it is prima facie obvious to combine two compositions known to be
usefiil for the same pxirpose to form a third composition to be used for the very same purpose, the
Examiner asserted that because Abe '911 teaches use of cholesterol sulfate-containing composition
for improving dry skin and wetting skin to promote softness and luster of skin, and because Shimada
teaches use of N-acetylamino sugars for giving smoothness and moistness to skin and improving the
feeling and luster of skin, it would have been obvious for one of ordinary skill in the art to provide
the amino sugars disclosed by Shimada in the cholesterol sulfate-containing composition disclosed
by Abe '911, with the expectation to provide an ingredient suitable for moisturizing and improving
the luster of skin (see Office Action, page 7, lines 13-20 and page 8, lines 1-8).
Applicants respectfiilly disagree with the Examiner's assertions of obviousness, for the
It has been well established that a prima facie case of obviousness can be rebutted by a
"showing of facts supporting the opposite conclusion," which dissipates the prima facie holding
and requires the examiner to "consider all of the evidence anew." In re Piasecki , 745 F.2d 1468,
1472 (Fed. Cir. 1984); and In re Rinehart . 531 F.2d 1048, 1052 (CCPA 1976). Rebuttal evidence
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may show, for example, that the prior art teaches away from the claimed invention, In re Geisler ,
116 F3d 1465, 1471 (Fed. Cir. 1997); that the claimed invention achieved unexpected results
relative to the prior art. Id., at 1469-70; that objective evidence (e.g., commercial success)
supports the conclusion that the invention would not have been obvious to a skilled artisan,
Piasecki, 745 F.2d at 1475; or that the prior art did not enable one skilled in the art to produce the
now-claimed invention, In re Payne, 606 F.2d 303, 314-15 (CCPA 1979).
Abe '911 expressly teaches that skin wetting agent and skin softener conventionally used in
cosmetic compositions may cause inhibition of normal physiological functions of skin . One of the
advantages of the cholesterol sulfate-containing cosmetic disclosed by Abe '91 1 lies in its capability
of promoting water retention function of skin through normalizing functions between stratum
comeum cells and through making structure of such cells dense, so that this cosmetic does not
require a large amount of the conventional skin wetting agent and skin softener, and there is therefore
no fear that it may inhibit normal physiological functions of skin (see the English Abstract of Abe
*91 1). In contrast, Shimada teaches that amino sugars, such as N-acetyl-D-glucosamine and salts
thereof, function to moisturize and soften the skin and thereby impart good gloss and tension to the
skin (see the English Title and Abstract of Shimada provided by Derwent Patent Index). Therefore,
the amino sugars disclosed by Shimada can be considered skin wetting agents or skin softeners , the
use of which is expressly taught away by Abe '911, due to concerns described hereinabove.
Therefore, a person ordinarily skilled in the art, after reading Abe '91 1 and Shimada, would not have
been motivated to use the skin-moisturizing/softening amino sugars disclosed by Shimada in the
cholesterol sulfate-containing composition disclosed by Abe '91 1, in light of the express teaching-
awayby Abe '911.
Further, the present invention, by combining cholesterol sulfate and an exfoliant, such as an
amino sugar, achieves an unexpected and surprising result . As explained by the instant
specification, cholesterol sulfate retards desquamation by enhancing the cohesion of the stratum
comeum and thereby results in increased stratum comeum layer thickness , while the exfoliant, or
more specifically, the amino sugar, acts in exactly the opposite manner by desquamating the skin and
thinning or reducing the thickness of the stratum comeum layer . A person ordinarily skilled in the art
would expect the impacts of these two components of opposite functions to cancel each other out
when they are combined. However, surprisingly and unexpectedly, the combination of these two
components of opposite functions in the cosmetic composition of the present invention achieves a
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balanced result in nurturing the skin and improving/protecting the barrier of the stratum comeum.
Such an unexpected and surprising result further rebuts the prima facie case of obviousness.
Consequently, the combinatioii of Abe ^911 and Shimada. as proposed by the Examiner,
is not obvious and cannot be used to support rejections of claims of the present application .
Claim 4, which depends from claim 3, was rejected under 35 U.S.C. §103(a) as allegedly
obvious over Abe ' 9 11 in view of Shimada, and further in view of Japanese Patent Application
Publication No. 05-051314 to Abe et al. (hereinafter "Abe '314").
As mentioned hereinabove, the combiaation of Abe '911 and Shimada as proposed by the
Examiner is not obvious and cannot be used to support rejections of claims of the present application.
Abe '314 was filed after Abe '91 1 by the same applicant (i.e., Kanebo Ltd.) who filed Abe '91 1 .
Specifically, Abe '314 discloses use of specific cholesterol sulfate salts, such as calcium, magnesium,
sodium, and potassium salts, for promoting the water retention function of skin consistent with the
teachings of Abe '91 1 (see the English translation of Abe '314, paragraph ). Nothing in Abe
'314 teaches or suggests use of the cholesterol sulfate salts in a manner different from that taught by
Abe '911. More specifically, nothing in Abe '314 contradicts or modifies the teaching-away by Abe
'911 from using skin wetting agents or skin softeners in the cholesterol sulfate-containing cosmetic
composition. Therefore, Abe ^314 cannot remedy the deficiency of Abe ^911 and Shimada, and
thus cannot support the rejection against claim 4 of the present application .
Claims 6-12, 14-15, and 20, which depend from claims 1, 13, and 19 respectively, were
rejected under 35 U.S.C. §103(a) as allegedly obvious over Abe '91 1 in view of Shimada, and
fiirfher in view of International Patent Application Publication No. 90/01323 to Bemstein (hereinafter
"Bemstein"), Japanese Patent Application Publication No. 10-017458 to Kitada et al. (hereinafter
"Kitada"), and/or Japanese Patent Application Publication No. 06-263627 to Takahashi et al
As mentioned hereinabove, the combination of the primary references Abe '911 and Shimada
as proposed by the Examiner is not obvious and cannot be used to support rejections of claims of the
present application. The secondary references, i.e., Bemstein, Kitada, and Takahashi, were cited by
the Examiner for their respective disclosure of fatty acids, cholesterol, sclareolide, and protease
inhibitors. Therefore, the applied disclosure of Bemstein, Kitada. and Talcahashi references
cannot remedy the above-explained deficiency of Abe ^911 and Shimada, and thus cannot
support the rejections against claims 6-12, 14-15, and 20 of the present application .
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Based on the foregoing. Applicants hereby request the Examiner to reconsider, and upon
reconsideration to withdraw, the §103 rejections of claims 1 and 3-20 of the present application.
Response to the Obviottsness-Tvpe Double Patenting Rejection
In the outstanding Office Action, the Examiner imposed a provisional obviousness-type
double patenting rejection against claims 1 and 3-20 of the present application based on claims 1-21
of co-pending U.S. Patent Application No. 10/424,616 (hereinafter "the '616 Application").
Specifically, the Examiner asserted that claims 1 and 3-20 of the present application and claims 1-21
of the '616 Application are both drawn to "a skin/cosmetic composition containing cholesterol
sulfate, fatty acids, and a sterol (such as cholesterol) and methods employing the compositions" and
are therefore "not patentably distinct fi-om each other" (see Office Action, page 26, lines 1-6).
Applicants respectfiiUy disagree. Claims 1 and 3-20 of the present application are drawn to a
composition comprising a mixture of (1) cholesterol sulfate or salts thereof and (2) an exfoliant or an
amino sugar and methods of using the same. In contrast, claims 1-21 of the '616 Application are
drawn to a composition comprising: (1) cholesterol sulfate and (2) optionally, a sunscreen, a self-
tanning agent or a combination of a fatty acid, a ceramide, and a sterol and methods of using the
same. Therefore, the Examiner's assertion that claims 1 and 3-20 of the present application and
claims 1-21 of the '616 Application are both drawn to a skin/cosmetic composition containing
cholesterol sulfate, fatty acids, and a sterol (such as cholesterol) and methods employing the
compositions is incorrect. Instead, claims 1 and 3-20 of the present application clearly and
unequivocally recite an exfoliant or amino sugar , which are entirely absent fi"om claims 1-21 of the
'616 Application. In other words, claims l-21ofthe'616 Application fail to provide any basis,
either express or implicit, for the exfoliant or amino sugar positively recited by claims 1 and 3-20 of
the present application.
Correspondingly, Applicants request the Examiner to reconsider, and upon reconsideration to
withdraw, the provisional obviousness-type double patenting rejection against claims 1 and 3-20 of
the present application.
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Estee Lauder Companies
155 Pinelawn Road
Suite 345 South
Melville, NY 11747
Telephone No.: 631-414-6089
Facsimile No.: 631-531-1340
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