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10/06/2093 18:28 



631 




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ESTEE LAUDER 



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06/12 



Attorney Docket No.: 00.22US 



PATENT 



In te Application of: Maes, et al 



Serial No.: 09/773,351 



IN THE UNITED STATES PATENT AND TRADEMARK OFFICE 



Group Art Unit 1617 




Filed: January 31,2001 



Examiner Jiang, Shaojia A, 



For: Cholesterol Sulfate and Amino Sugar Compositions for Enhancement of Stratum Comeum Function 



Assistant Commissioner of Patents and Trademarks 
Washington, D.C 2023 1 
Dear Sir; 

In response to the Examiner's Final Action dated May 6, 2003, please consider the 
accompanying remarks which are believed to place the application in condition for allowance or in better 
condition for appeal in the event the final rejection is maintained. T wo months extension o f time i s 
requested under 37 CFR 1.136. 

aaJPatcnt No. 5,650,166 ("the '166 Ribier referenced 

In the present action, the Examiner finds that the ' 166 Ribier reference renders the present claims 
obvious because it teaches a composition comprising cholesterol sulfate, see column 3, lines 66 - 67, and 
N-acetylglucosamine (NADG), see column 5, line 67. Applicant's previous argument is summarized by 
the Examiner as being that there is no separation or vehicle taught in the '166 Ribier reference for the 
combination of NADG and cholesterol sulfate, and therefore, the '166 Ribier reference fails to teach or 
suggest a feature of the present invention. In response to this, the Examiner notes that it is irrelevant 
whether the '166 Ribier reference teaches or suggest this feature because it is well within the skill of the 
artisan to incorporate this routine skill in the art. Applicants note that the summary of their argument is 
not complete. The missing feature pointed out between the '166 Ribier reference and the present 
invention is the presence of the combination of the NADG and cholesterol sulfated the" r 166 Ribier 
reference in discretcj^ers of a lipid vesicle/ Because' these two ingredients are used to form discrete 
layers of a lipid vesicle they are not "mixed" as they are in the present invention. 



RESPONSE PURSUANT TO 37 CFR 1.113 AND 1.1 16 



REMARKS 



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The claims of the present invention have been previously amended such that the mixture of 
cholesterol sulfate and exfoliant, N-acctyl glucosamine is added to a pharmaceutical or cosmetically 
acceptable vehicle. The addition of the two ingredients at issue with respect to the * 166 Ribier reference 
is worthy of note because this where the difference between the ' 166 Ribier reference and the present 
invention lies. The '166 reference only discloses the use of these two ingredients to form lipid vesicles, 
where the discrete layers are formed and the ingredients are separate by virtue of their being present m 
separate and discrete layers of the lipid vesicle. The cholesterol sulphate is taught at column 3, lines 57 
to 67, of the '166 Ribier reference as being an additive to the lipid membrane of the vesicle. Further, one 
of the actives contained within the lipid vesicle with deep down acti on arc taught at column 5, lines 59 to 
67, to include inter alia, NADG. Thus, there is no mixing of these ingredients as they are in the present 
invention by adding them in combination to a vehicle. Unlike the present invention, the 1 166 Ribier 
vesicles contain these two ingredients in separate and distinct layers and the vehicle containing them in 
separate layers is added to a medium as taught at column 8, lines 32 to 35. This is in contrast to adding 
the ingredients themselves directly to a vehicle. This is especially the case for N-acetylglucosamine 
(NADG) as the ' 166 reference fails to teach or suggest adding the NADG directly to a vehicle because it 
teaches that the NADG is contained within the lipid vesicle. Therefore, even though the vesicle is added 
to a vehicle, because the NADG is inside the vesicle, there is no teaching in the '166 Ribier reference 
where NADG, per se, is added directly to the vehicle. 

The Examiner finds that the addition of a mixture of NADG and cholesterol sulfate to a vehicle 
is considered to be well within the ski)) of the ordinary artisan. However, the addition of many mixtures 
to a vehicle have been found patentable because as it pertains to obviousness, an inventive concept is 
patentable if it is not taught or suggested by a cited prior art reference or known generally. Thus, while 
Applicants refrain from comment regarding the general task of adding a mixture to a vehicle, what is at 
issue with respect to the present inventive concept is whether one of ordinary skill in the art would was in 
possession of the addition of a mixture of NADG and cholesterol sulfate to a vehicle. Applicants assert 
that the cited prior art demonstrates that the addition of the specific combination of NADG and 
cholesterol sulfate to a vehicle was not in the possession of one of ordinary skill in the art as it merely 
suggests that the cholesterol sulfate is useful in the lipid bilayer of a vesicle holding NADG inside of it, 
None of the cited prior art references teach or suggest adding a combination of NADG and cholesterol 
sulfate as a mixture directly to a vehicle. In particular, the 4 166 Ribier reference fails to teach an amino 
sugar added directly to the vehicle, and therefore, there is no teaching or suggestion of the mixture of 
cholesterol sulfate and an amino sugar added to the vehicle by the ' 166 reference. 



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U.S. Patent Nos._5j550J66. 6.159.381, and 5,702.69) ("the three references") 

The Examiner finds that Claims 10-12 and 20 arc not patentable over the combination of the 
three references (individually referred to as the '166, the '381, and the '691 references") for reasons of 
record stated in the Office Action of November 5, 2002. Further, the Examiner claims that the 
motivation to make the combination of the three references is provided sufficiently in the Office Action 
of November 5, 2002. However, in Applicants' previous response it was pointed out that neither of the 
additional references remedied the defect of the 1 166 Ribier reference in that it failed to teach or suggest 
the addition of the NADG directly to a vehicle because the * 166 Ribier reference merely taught how to 
incorporate NADG inside of a lipid vesicle, and then subsequently the incorporation of the vesicle 
containing NADG inside into a vehicle. However, Applicants comment herein on the motivation 
presented in the Office Action of November 5, 2002. As noted by the Examiner in the Office Action of 
November 5, 2002, the motivation stems from the benefit of anti-inflammatory properties as those taught 
in the *691 reference and the anti-acne properties as taught m the '381 reference in a cosmetic 
formulation. The missing ingredients have art recognized suitability in cosmetic formulations. 
Therefore, the selection of known materials based on their suitability for their intended uses is 
determined to be prima facie obvious. However, the uses of the materials in the ' 1 66 Ribier reference is 
different than the use in the present invention, and therefore, the '166 Ribier reference fails to teach or 
suggest the present invention, and the *381 and the '691 references fail to remedy this defect. 

As discussed above the cholesterol sulfate of the '166 Ribier reference is taught as part of the 
membrane of the lipid vesicle that holds the deep down active agent, NADG, contained within the 
vesicle. This is different than a simple mixture of NADG with cholesterol sulfate like that of the present 
invention. Thus, the uses of NADG in the '166 Ribier reference as an active encapsulated in a lipid 
vesicle is different than the mixture of NADG with cholesterol sulfate for two reasons. First, the '166 
Ribier reference fails to place in possession of one of ordinary skill in the art the direct mixture of NADG 
and cholesterol sulfate. While the cholesterol sulfate is part of the membrane of the lipid vesicle it is not 
mixed with NADG as it remains a separate entity inside of the membrane layers of the lipid vesicle. 
Second, while the NADG is encapsulated inside of the m embrane I ayers i t i s n ot d irectly a dded t o a 
vehicle because the NADG remains protected from the vehicle by virtue of its presence inside of the 
membrane layers. 



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As found by the US Supreme Court tn United States v. Adams et al^ 148 USPQ 479, 482-84 (US 
SupCt 1966), the case of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 
(1945) is inapposite in a situation where the subject matter of the prior art is a completely different 
design type. In Adams, magnesium in place of zinc and copper as a substitute for silver were found not 
to be mere equivalent substitutions in batteries the design of which between that of the prior art and the 
invention at issue were of a completely different type. Adams, at 483. As in Adams, the design and use 
of cholesterol sulfate in a membrane layer of a lipid vesicle encapsulating NADG is completely different 
than the type of design, and use of the present invention whereby cholesterol sulfate is simply combined 
with NADG and as a mixture are added directly to a vehicle. Thus, because the mixture of cholesterol 
sulfate and NADG is not taught or suggested by the e 166 Ribier reference, the 4 166 Ribicr reference fails 
to render the present invention obvious. Further, the *381 and the '691 references fail to teach or suggest 
the direct addition of a mixture of NADG and cholesterol sulfate to a vehicle because the Examiner in the 
Office Action of November 5 ? 2002 notes that the '381 reference teaches the use of sclareolide in topical 
formulations particularly for acne, and the *691 reference teaches that white birch extract is a known 
anti-inflammatory agent. The teachings of the '381 and the '691 references fail to remedy the defect of 
the 1 166 Ribier reference, and therefore, the combination of the cited references fail to establish a prima 
facie case of obviousness. 

U.S. Patent Nos, 5.925.364 and 5.411.742 ("the two references 11 ! 

The third obviousness rejection is based on the two references (individually referred to as the 
'3G4 Ribier and the *742 referenceO- 

The Examiner rejects Claims 1, 3 - 4, 6 - 9, 11 and 18 under 35 ILS.C. 103(a) as being 
unpatentable over the *364 Ribicr reference in view of the l 742 reference. Applicants assert that the 
argument applied to the '364 Ribier reference previously in their Response of February 5, 2003 applies 
herein because of the reference to the disclosure of oily globules coated with a lamellar liquid crystal 
coating and the similarity with the 1 ipid vesicles of the * 166 Ribier reference. S pecifically, the * 364 
Ribier reference discloses an emulsion composition that has oily globules with a lamellar liquid crystal 
coating dispersed in an aqueous phase. Like that of the '166 Ribier reference, the composition as 
described in the claims can include materials such as alkali metal salts of cholesteryl sulphate as the ionic 
amphophilic lipid as one of the layers coating an active (i.e., similar to the membrane layers of the '166 
Ribier vesicles). Therefore, the oily globules of the '364 Ribier reference, like that of the '166 Ribier 
reference, fails to teach or suggest the mixture of NADG and cholesterol sulfate in the present invention. 



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The '364 Ribier compositions can contain as a fatty substance a keratolytic agent. One of the 
many keratolytic agents listed is retinol and salicylic acid which the Examiner notes are known 
exfoliants. Therefore, according to the Examiner, the '364 Ribier reference in combination with the '742 
reference is obvious to one of ordinary skill in the art. Motivation is, according to the Examiner, based in 
using the fatty acid and cholesterol of the '364 Ribier reference since fatty acids are known, to be used in 
cosmetic compositions for treating skin. Further, the Examiner notes that cholesterol is a well know 
ingredient in a cosmetic. Therefore, one of ordinary skill in the art would have reasonably expected that 
a combination of the '364 Ribier compositions with the 742 compositions would be useful for the same 
purpose, treating skin, and would improve the therapeutic effect of treating the skin. Applicants assert 
that the basts of motivation to combine the references is misplaced because the combination of the '364 
Ribier and the '742 references does not render the present invention. 

Both the '364 Ribier reference and the ' 742 reference disclose lipid vesicle/lamellar systems. 
Thus, neither reference alone or in combination teaches or suggests the mixture of NADG and 
cholesterol sulfate like that of the present invention for the reasons presented above with respect to the 
' 1 66 Ribier reference. Basically, the lipid vesicles/lamellar systems separate the NADG (exfoliant) from 
the cholesterol sulfate because the cholesterol sulfate i s p art o f the m embrane 1 ayer o f the vesicle or 
lamellar system. As it is noted by the Examiner in the present action both the '364 Ribier reference and 
the '742 reference disclose metal salts of cholesterol sulphate. There is a basic reason why both 
references make such a disclosure - namely both references disclose lipid vesicle/lamellar systems 
whereby the layers of the vesicle or lamellar system contains cholesterol sulfate. The capsule formed by 
the membrane holds within it an active which can include an exfoliant. However, one of ordinary skill in 
the art would not find a disclosure of encapsulating an exfoliant within a lipid vesicle to be a teaching of 
a mixture of the exfoliant with cholesterol sulfate found in the membrane layer of the vesicle. Thus, 
Applicants assert that the scope of the '364 Ribier and the '742 references is to be interpreted in view of 
how one of ordinary skill in the art would make such an interpretation. Evidence of this interpretation is 
found in the cited references wherein it is disclosed that the cholesterol sulfate is part of the membrane 
forming the vesicle and the exfoliant is an active encapsulated therein. 

See column 4, lines 42 - 50, of the '364 Ribier reference ^[wjhen the compositions 
according to the invention are used for cosmetic treatment ... the active agent 
contained in the oily phase is . . . keratolytic agents. The oily phase of the *364 
Ribier reference is coated with a lamellar liquid crystal coating that can contain 
cholesterol sulfate derivatives. See column 3, line 36 to column 4, line 15, of the 
'364 Ribier reference "[tjhe coating ... of the oily globules preferably requires the 



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use of a total amount of hydrophilic surface-active agent, of lipophilic surface-active 
agent and of ionic amphiphilic lipid ..." and " [t]he ionic amphiphilic lipid used 
within the context of the present invention is . . . metal salts of cholesteryl sulphate. . 



In the same fashion, sec column 3, line 64 to column 6, line 20, of the '742 reference 
"the constituent lipid phase of the membranes of the vesicles of the dispersion 
comprises, in a known manner, at least one amphiphilic lipid . . . cholesterol sulphate. 
. . " And, see column 3, lines 1 to 8, "[t)he subject of the invention is therefore a 
composition for the treatment of acne by topical application containing . . . vesicles of 
amphiphilic lipid(s) consisting of a lipid phase membrane encapsulating an aqueous 
phase E, the lipid phase containing as additive a charged lipid . . . [containing] at least 
one salicylic acid derivative of formula: ..." 

Clearly, it can be seen from, the inventions described by both the ' 364 Ribier r efcrcncc and t he 4 742 
reference that these arc both inventions related to lipid vesicles/ lamellar systems like that of the * 166 
Ribier reference. Therefore, the combination of these references for reasons stated above, fail to teach or 
suggest a mixture of NADG and cholesterol sulfate as in the present invention, 

Finally, even if the interpretation of one of ordinary skill in the art were that a lipid vesicle 
containing cholesterol sulfate in the membrane layer and NADG encapsulated therein was equivalent to 
the mixture of the present invention, Applicants assert that it would be rebutted by the surprising results 
of the present invention. The Examiner notes in the present action that the Example m the present 
Specification does not provide clear and convincing evidence of non obviousness or unexpected results 
over the cited prior art because there is no direct comparison of the same. However, as Applicants have 
pointed out in the present response, the two systems arc not the same and there was no reason to believe 
that the mixture of the ingredients of the present invention directly in a vehicle would necessitate a 
comparison with a lipid vesicle as these are two completely different systems. The present invention 
focuses on the finding that two ingredients, the cholesterol sulfate and the amino sugar, although they 
have opposing activities , when added as a mixture to a pharmaceutical or cosmetic vehicle, do not 
neutralize one another's activities, but rather their activity occurs in tandem, and can improve or maintain 
a healthy skin barrier. This benefit cannot even be addressed with the cited references because these two 
materials are not in fact mixed. Rather, they are separated such that one, the cholesterol sulfate, is part of 
a protective membrane that encases the other, the NADG. The whole point of the lipid vesicles/lamellar 
systems of the cited references is to protect and prevent the active inside from interacting with anything 
else. Thus, a comparison of this kind would be futile. 



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CONCLUSION 

Because none of the cited references alone nor in combination would lead one of ordinary skill in 
the art to the compositions and methods of the present invention, a prima facie case of obviousness has 
not been established Applicants request therefore, that the Examiner's rejection under ยง103 be 
withdrawn. In view of the arguments presented above in the present submission, the claims are believed 
to be jn condition for allowance, and issuance of a Notice of Allowance is respectfully solicited. 

Respectfully submitted/ 



Date C< *?**>3 



Dorcnc M. Price (Reg, No. 43,018) 
Estee Lauder Companies 
125 Pinelawn Road 
Melville, NY 11747 
(631) 531-1194 



received 

OCT 0 7 2003 



OFFI 



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