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Rug 01 02 09:46p 



Dorene Price 



631-744-3594 



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Attorney Docket No,: 00.22US PATENT 
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE 

In re Application of: Maes, et aL 
Serial No.: 09/773,351 Group Art Unit: 1619 j^S^ 

Filed: January 31, 2001 Examiner: Willis, M. ^ ^ 

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

RESPONSE PURSUANT TO 37 CFR 1.111 

The Assistant Commissioner of Patents and Trademarks 
Washington, D.C. 20231 
Dear Sir: 

In response to the Examiner's Final Action dated May 1, 2002, please consider the following 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. 

REMARKS 

Hie Examiner maintains a rejection of claim 19 under section 112, first paragraph for foiling to 
describe subject matter such that one of ordinary skill in the art would be enabled to make and/or use the 
present invention. Applicants have previously argued that the term "preventing" as used in claim 19 in 
connection with the description provided in the present specification, as well as in light of the explanation of 
the mechanism of the skin barrier function provided in Applicants' Responses of March 12, 2002 and of April 
12, 2002, demonstrates that this torn is sufficient to enable one of ordinary skill in the art to make and/or use 
the present invention. In response, the Examiner finds that there is no data in the specification to allow a 
prediction of certain types of damage to the skin. However, it is not necessary for a specification to disclose 
what is already known in the art Further, Applicants did not qualify the degree of accuracy with which a 
prediction is made, as this is not necessary. Anyone knows that damage is caused to the skin by the sun or by 
natural aging. Applicants merely provided this information, both in the specification as well as in the 
responses, to support the feet that preventing damage to the skin is predictably associated with a reduction or 
loss of the skin barrier function. 

Applicants provide the only data necessary to enable the present invention. In Example 1, at pages 8 
to 10, the present specification demonstrates an 88 percent barrier repair over a placebo. The barrier repair 
was measured by the recovery of the skin on the stripped and treated side of the fece in comparison with the 

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Received from < 631 744 3594 > at 8/1/02 9:44:08 PM [Eastern Daylight Time] 



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631-744-3594 



stripped and untreated side of the face. Hi Examiner also notes that broad correlations may exist between the 
loss or reduction of skin barrier function, and various trends in the pathology of the skin. However, the 
Examiner goes on to say, that the prediction of the exact amount of skin pathology is beyond the current state 
of the art. Applicants do not aim to make any predictions about the skin pathology of any particular 
individual. The claims of the present invention to meet the enablement requirement do not require such a 
prediction. Rather what is required is that the term preventing" as used in Claim 19 read in view of the 
present specification be sufficient to enable one of ordinary skill in the art to make and/or use the present 
invention. Applying this standard, Applicants have demonstrated that one of ordinary skill in the art would be 
enabled to make and/or use the present invention. 

The Examiner finds that it incorrect that to reduce a condition that exists inherently prevents that 
condition. However, it is not incorrect, as the Examiner believes, because the reduction of the condition is not 
the separate situation of a vaccination example presented by the Examiner, When a symptom exists and it is 
reduced by treatment, it is this very same treatment that keeps the condition from occurring further. This is the 
vety same definition that was taken from the dictionary in Applicants Response of April 12, 2002, and 
therefore, Applicants' argument is fully supported by what is known to one of ordinary skill in the art. Thus, 
the present specification folly enables one of ordinary skill in the art to prevent damage to the skin as described 
in claim 19, and Applicants respectfully request that the Examiner's rejections based on lack of enablement 
under 35 U.S.C. §112, first paragraph be withdrawn. 

The Examiner maintains in the final office that Ribier et al. (U.S. Patent No. 5,650,166; "the 4 166 
reference") in view of Subbiah (U.S. Patent No. 6,150,381; "the '381 referaice") renders claims 1 to 20 of the 
present invention obvious under 35 U.S.C. § 103(a) because a mixture includes random solutions and ordered 
compositions. However, there is no support provided to indicate why or how one of ordinary skill in the art 
would understand that a mixture of the present invention is taught or suggested by a lipid vesicle described in 
the 4 166 reference. There is no teaching, suggestion or motivation in the art or the knowledge of one of 
ordinary skill in the art to support the assertion that mixing components is equivalent to or includes 
encapsulating Coinponents. Any instruction to mix ingredients is not understood by one of ordinary skill in the 
art to arrange the ingredients in an orderly feshkm. This is contrary to the logic of anyone, let alone one of 
ordinary skill in die art. As previously discussed in the Response of April 12, 2002, specific processing steps 
to make a lipid vesicle of a certain order are taught and/or suggested at column 7, line 42 of the 1 1 66 reference, 
"A) Production of lipid vesicles containing ASL" to column 8, line 4 "B) Production of the cosmetic 
composition." If a mixture was a lipid vesicle, the authors of the c 166 reference would not have to go into 
such detail with respect to the processing steps. All they would have needed to do is state "mix the 
ingrediarts" A mixture of the ingredients that it takes to make a hpid vesicle certainly does not make a lipid 

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vesicle. A mixture of cholesterol sulphate and an exfbliant as is the subject of the present invention is not 
taught or suggested by the combination of the '381 reference and the '166 reference fells to teach or suggest 
the present invention, and a prima fecie case of obviousness has not been made. 

Finally, even if, a prima facie case could be made, it would be rebutted by the surprising results of the 
present invention. As noted in the present specification at page 4, lines 1 to 12, it is unexpected to find that 
two opposing components would not cancel each other out when combined as a mixture in a composition. The 
exfoliating components have an activity that is opposite that of the cholesterol sulfate which thickens and 
strengthens the protective barrier of the skin. When combined as a mixture in the compositions of the present 
invention, barrier repair is achieved. This is a surprising and unexpected result that is not taught or suggested 
by the cited references. 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 §103 
be withdrawn. 

CONCLUSION 

In view of the arguments presented above in the present submission, the claims are believed to be in 
condition for allowance, and issuance of a Notice of Allowance is respectfully solicited. 

Respectfully submitted, 



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



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