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REMARKS 

Response to §103 Rejections of Claims 1, 3, 5, 13 and 16-19 Over Abe '911 and Shimada 

In the September 14, 2007 Office Action, the Examiner finalized the previously raised 
rejections against claims 1, 3, 5, 13, and 16-19 under 35 U.S.C. §103(a) as allegedly obvious over the 
English Abstract of Japanese Patent AppUcation No. 60-16191 1 to Abe et al. (hereinafter "Abe 
'911") in view of the Enghsh Abstract of Japanese Patent AppUcation No. 59-013708 to Shimada et 
al. (hereinafter "Shimada"). 

Specifically, the Examiner asserted that Abe '911 teaches use of a cosmetic composition 
containing cholesterol sulfate and/or its salt for improving dried skin, preventing aging of skin, 
providing skin with wetting characteristics, softness and luster by promoting the water retention 
function of skin, that Shimada teaches use of a cosmetic composition containing N-acetylamino 
sugars or their salts for providing smoothness, moist, springiness and luster to the skin, and that one 
of ordinary skill in the art would have found it obvious to combine the N-acetylamino sugars 
disclosed by Shimada into the cosmetic composition disclosed by Abe '911 with the expectation of 
providing an ingredient suitable for moisturizing and improving the luster of skin. Further in support 
of the finding of obviousness, the Examiner cited In re Kerkhoven, 205 USPQ 1069 (CCPA 1980), in 
which the Court of Customs and Patent Appeals held that "[i]t is prima facie obvious to combine two 
compositions each of which is taught by the prior art to be usefiil for the same purpose, in order to 
form a third composition to be used for the very same purpose. . . [T]he idea of combining them 
flows logically firom their having been individually taught in the prior art." 

Applicants respectftiUy disagree with the Examiner's reasoning, for the following reasons: 
Obviousness is a conclusion of law based upon factual determinations. It has been well 
established that when challenge is made on the ground that the claimed invention would have been 
obvious, all evidence relevant to the obvious-nonobvious issue must be considered . In re Semaker, 
111 USPQ 1, 7 (Fed. Cir. 1983). Because virtually aU inventions are combinations of old elements 
known in the art, it is insufficient for the Examiner to merely estabUsh that the separate elements of 
the invention existed in the prior art. The Examiner must consider what the prior art as a whole 
would have suggested to one skilled in the art. Environmental Designs, Ltd. v. Union Oil Company 
of California, 218 USPQ 865, 870 (Fed. Cir. 1983), citing In re McLaughlin, 170 USPQ 209, 212 
(CCPA 1971). Specifically, the Examiner must view the beliefs of those in the field at the time. 



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Arkie Lures Inc. v. Gene Larew Tackle Inc., 43 USPQ2d 1294, 1297 (Fed. Cir. 1997). For example, 
evidence indicating that the combination of such separate elements was not viewed as technically 
feasible must be considered, since conventional wisdom teaching that a combination of known 
elements should not be made is itself evidence of non-obviousness. Id. Further, evidence of separate 
uses of such known elements for years , without combining their properties, also weighs on the side 
of unobviousness of the combination. Id. 

In the present case, although the Abe '911 and Shimada references separately disclose the 
cosmetic uses of cholesterol sulfate or a salt thereof and N-acetylamino sugars for improving skin 
appearance and feel, evidence also indicates that cholesterol sulfate and exfoliants such as N- 
acetylamino sugars are known to achieve their respective skin care benefits through opposite 
mechanisms or modes of action on the stratum comeum layer of the skin . 

On one hand, cholesterol sulfate is known to retard skin desquamation and increase 
stratum comeum layer thiclaiess , which in turn improves the water retention function of the skin 
and thereby provides skin with better wetting characteristics, softness and luster. Specifically, 
cholesterol sulfate has been shown to inhibit activities of certain enzymes (such as stratum comeum 
tryptic enzyme and chymotryptic enzyme) that have been impUcated with desmosome breakdown 
and comeocyte desquamation, and it has long been known that excess cholesterol sulfate inhibits 
desquamation, and hydrolysis of cholesterol sulfate in the stratum comeum promotes comeocyte 
desquamation . See page 234-235 of the enclosed article by Madison entitled "Barrier Function of the 
Skin: 'La Raison d'Etre' ofthe Epidermis," Epidermal BARRIER FUNCTION, Vol. 121, No. 2, pp. 
231-241 (Aug 2003), ari«g various scientific journal articles dated fi-om 1994-2001. 

On the other hand, exfoliants such as N-acetylamino sugars are icnown to promote sldn 
desquamation and reduce the stratum corneum layer thicicness . Specifically, exfoliants function 
to weaken or break the desmosome bonds that hold the comeocytes together and allow the cells to 
slough off from the skin surface, thereby resulting in a thinner stratum comeum layer that is more 
flexible and compact, reflects more light, and overall gives the skin a more youthful appearance . See 
pages 2 ofthe enclosed article by Diana L. Howard entitied "Skin Exfoliation" and pubUshed as 
"Sloughing Off in Les Nouvelles Esthetiques in September 2003 (retiieved from 
http://wvyw.dermalinstitute.com/New IDI Site/newIDIhome/txtonly NEW/skinexfohation.htm on 
October 30, 2007). 



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The two articles cited hereinabove clearly reveal prior art knowledge of the opposite 
mechanisms of action through which cholesterol sulfate and exfoliants achieve their respective skin 
care benefits. The Examiner must consider the prior art as a whole , which includes not only the Abe 
'911 and Shimada references disclosing skin care benefits achieved separately by cholesterol sulfate 
and N-acetylamino sugars, but also the knowledge of the opposite mechanisms of action by 
cholesterol sulfate and exfoliants, in determining obviousness or non-obviousness of the claimed 
invention of the present application. 

The totahty of the prior art disclosure as described hereinabove not only fails to teach or 
suggest but actually leads away fi'om. combination of cholesterol sulfate or a salt thereof and 
exfoliants such as N-acetylamino sugars . In other words, a person ordinarily skilled in the art, i.e., a 
person who would have been aware of the opposite mechanisms of action by cholesterol sulfate and 
exfoUants, would not be motivated toward, but would be motivated against, combining cholesterol 
sulfate or a salt thereof with exfoUants such as N-acetylamino sugars, due to the likelihood that the 
effects of these two ingredients would cancel each other out and thereby defeat the very purposes of 
the Abe '911 and Shimada references. 

Further, the skin care benefits of cholesterol sulfate or a salt thereof and N-acetylamino 
sugars have been known since 1984-1985, as indicated by the pubhcation dates of the Abe '911 and 
Shimada references. For over 15 years prior to the claimed invention of the present appUcation, 
these two ingredients have been used separately in cosmetic compositions, with no evidence 
indicating that they have ever been combined in a single cosmetic composition. Such separate uses 
for years without combination prior to the present invention also support the non-obviousness of 
combining cholesterol sulfate or a salt thereof with N-acetylamino sugars . 

Based on the foregoing. Applicants submit that contrary to the Examiner's assertions in the 
outstanding Office Action, it would not have been obvious for a person ordinarily skilled in the art to 
combine the cholesterol sulfate or a salt thereof disclosed by the Abe '911 reference and the N- 
acetylamino sugars disclosed by the Shimada reference. Consequently, claims 1, 3, 5, 13, and 16-19 
of the present appUcation are patentable over Abe '911 and Shimada. 

Response to §103 Rejections of Claim 4 Over Abe '911, Shimada, and Abe '314 

In the outstanding Office Action, the Examiner finaUzed the previous rejection of claim 4 
under 35 U.S.C. §103(a) as allegedly obvious over Abe '911 in view of Shimada, as appUed to 



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claims 1, 3, 5, 13, and 16-19 above, and further in view of Japanese Patent Application Publication 
No. 05-051314 to Abe et al. (hereinafter "Abe '314"). 

Claim 4 depends directly fi-om claim 3, which in turn depends from claim 1 . Therefore, 
claim 4 incorporates all the hmitations recited by claim 1, including the combination of cholesterol 
sulfate or a salt thereof and an exfohant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfohant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfohant. Abe '314 was filed after Abe '911 by the same apphcant, 
i.e., Kanebo Ltd. Specifically, Abe '314 discloses uses of specific cholesterol sulfate salts, such as 
calcium, magnesium, sodium, and potassium salts, for promoting the water retention ftmction of skin, 
consistent with the teachings of Abe '911 (see the Enghsh translation of Abe '314, paragraph 
[0007]). Nothing in Abe '314 teaches or suggests use of the cholesterol sulfate salts in a manner 
different from that taught by Abe '911. 

Therefore, Abe '314 does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejection against claim 4 of the present apphcation. 

Response to §103 Rejections of Claims 6-9 and 14-15 Over Abe '911, Shimada, and Bernstein 

Claims 6-9 and 14-15 were rejected by the Examiner in the outstanding Office Action under 
35 U.S.C. § 103(a) as allegedly obvious over Abe '911 in view of Shimada, as apphed to claims 1, 3, 
5, 13, and 16-19 above, and fiuther in view of hitemational Patent Application Pubhcation No. 
WO90/01323 to Bemstein (hereinafter "Bernstein"). 

Claims 6-9 and 14-15 depend from claims l and 13, respectively, and therefore incorporate 
all the limitations recited by claims 1 and 13, including the combination of cholesterol sulfate or a 
salt thereof with an exfohant or an amino sugar. 

As discussed in the above section pertaining to claims 1 and 13, it would not have been 
obvious for one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof 
disclosed by Abe '911 and the exfohant or amino sugar (i.e., N-acetylamino sugar) disclosed by 
Shimada, and claims 1 and 13 are therefore patentably distinguished over Abe '911 and Shimada 
by reciting a combination of cholesterol sulfate or a salt thereof and an exfohant or amino sugar. 



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Bernstein only discloses uses of fatty acids, such as arachidotiic, linoleic, linolenic, palmitic, stearic, 
oleic and docosanoic acids, and sterols, such as cholesterol and cholesterol sulfate, for improving the 
protective water barrier of the stratum comeum layer of the skin and treating dry skin. Nothing in 
Bernstein teaches or suggests combination of cholesterol sulfate or a salt thereof with an exfoliant or 
amino sugar. 

Therefore, Bernstein does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejections against claims 6-9 and 14-15 of the present 
application. 

Response to §103 Rejections of Claim 10 Over Abe '911, Shimada, and Kitada 

The Examiner rejected claim 10 under 35 U.S.C. §103(a) as allegedly obvious over Abe '911 
in view of Shimada, as applied to claims 1, 3, 5, 13, and 16-19 above, and further in view of 
Japanese Patent AppUcation Publication No. 10-017458 to Kitada (hereinafter "Kitada"). 

Claim 10 directly depends fi-om claim 1 and therefore incorporates all the Umitations recited 
by claim 1, including the combination of cholesterol sulfate or a salt thereof with an exfoliant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoUant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoUant. Kitada only discloses use of a plant extract firom Salvia 
officinalis L, which contains sclareohde, for improving the uniformity of skin and preventing skin 
darkness caused by aging. Nothing in Kitada teaches or suggests combination of cholesterol sulfate 
or a salt thereof with an exfoliant. 

Therefore, Kitada does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejection against claim 10 of the present appUcation. 

Response to §103 Rejections of Claim 11 Over Abe '911, Shimada, and Takahashi 

The Examiner further rejected claim 1 1 under 35 U.S.C. §103(a) as allegedly obvious over 
Abe '911 in view of Shimada, as applied to claims 1, 3, 5, 13, and 16-19 above, and further in view 
of Japanese Patent AppUcation PubUcation No. 06-263627 to Takahashi et al. (hereinafter 
"Takahashi"). 



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Claim 11 directly depends from claim 1 and therefore incorporates all the limitations recited 
by claun 1, including the combination of cholesterol sulfate or a salt thereof with an exfoUant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoliant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoUant. Takahashi only discloses use of a plant extract from white 
birch, which contains protease inhibitors, for preventing skin aging, improving the stratum coraeum, 
and imparting skin-beautifying effects. Nothing in Takahashi teaches or suggests combination of 
cholesterol sulfate or a salt thereof with an exfoliant. 

Therefore, Takahashi does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejection against claim 11 of the present application. 

Response to §103 Rejections of Claim 12 Over Abe '911, Shimada, Kitada, and Takahashi 

The Examiner rejected claim 12 under 35 U.S.C. §103(a) as allegedly obvious over Abe '911 
in view of Shimada, as apphed to claims 1, 3, 5, 13, and 16-19 above, and fiirther in view of Kitada 
and Takahashi. 

Claim 12 directly depends from claim 1 and therefore incorporates all the hmitations recited 
by claim 1, including the combination of cholesterol sulfate or a salt thereof with an exfohant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoUant (i.e., ISI-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distmguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoUant. 

Further, as discussed hereinabove in sections pertaining to claims 10 and 1 1 , nothing in the 
Kitada and Takahashi reference teaches or suggests combination of cholesterol sulfate or a salt 
thereof with an exfoUant. In other words, Kitada and Takahashi do not remedy the above-described 
deficiency of Abe '911 and Shimada and thus cannot support the rejection against claim 12 of the 
present appUcation. 



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Response to §103 Rejections of Claim 20 Over Abe '911, Shimada, Bernstein, Kitada and 
Takahashi 

The Examiner rejected claim 20 under 35 U.S.C. §103(a) as allegedly obvious over Abe '911 
in view of Shimada, as appUed to claims 1,3,5,13, and 16-19 above, and further in view of 
Bernstein, as applied to claims 6-9 and 14-15 above, and further in view of Kitada and Takahashi. 

Claim 20 directly depends from claim 19 and therefore incorporates all the limitations recited 
by claim 19, including the combination of cholesterol sulfate or a salt thereof with an amino sugar. 

As discussed in the above section pertaining to claim 19, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the amino sugar disclosed by Shimada, and claim 19 is thereby patentably distinguished 
over Abe '911 and Shimada by reciting a combination of cholesterol sulfate or a salt thereof and an 
amino sugar. 

Further, as discussed hereinabove in the section pertaining to claims 6-9 and 14-15 and the 
sections pertaining to claims 10 and 11, nothing in the Bernstein, Kitada, and Shimada references 
teaches or suggests combination of cholesterol sulfate or a salt thereof with an amino sugar. Li other 
words, the secondary references Bernstein, Kitada, and Shimada do not remedy the above- 
described deficiency of Abe '911 and Shimada and thus cannot support the rejection against claim 
20 of the present appUcation. 

Response to the Obviousness-Type Double Patenting Rejection 

Li the outstanding Office Action, the Examiner reiterated the previously raised provisional 
obviousness-type double patenting rejection against claims 1, 6, 8 and 9 of the present appUcation 
based on claims 7-20 of U.S. Patent AppUcation No. 10/424,616 (hereinafter "the '616 
AppUcation"). 

However, the '616 Application has been abandoned as of August 17, 2007 and is therefore 
no longer co-pending with the present appUcation. Correspondingly, the provisional obviousness- 
type double-patenting rejection against claims 1, 6, 8 and 9 of the present appUcation is moot. 

Conclusion 



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Based on the foregoing. Applicants submit that claims 1-20 as currently pending in the 
present application are in condition for allowance. Accordingly, Applicants respectfiiUy request the 
Examiner to issue a Notice of Allowance in favor of the Applicants. 



RespectfiiUy submitted. 




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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