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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: 1617 



Filed: January 31, 2001 



Examiner: Jiang, Shaojia A. 



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

AMENDMENTS 

1 (currently amended): A composition for topical application to the skin comprising [[a ]] an integral 
mixture of cholesterol sulfate or salts thereof present in an amount between 0.05 to about 5.00 percent, 
integral with an exfoliant present in an amount between 0.1 to about 10.0 percent by weight of the 
composition in a cosmetically or pharmaceutically acceptable vehicle. 



3 (original): The composition of claim 1 wherein the composition contains a salt of cholesterol sulfate. 

4 (original): The composition of claim 3 wherein the salt is potassium. 

5 (original): The composition of claim 1 wherein the exfoliant is an amino sugar selected from the group 
consisting of N-acetyl-D-glucosamine, N-acetylgalactosamine, and a combination thereof. 

6 (original): The composition of claim 1 further comprising at least one fatty acid selected from the 
group consisting of butyric acid, caproic acid, octanoic acid, decanoic acid, dodecanoic acid, 
tetradecanoic acid, palmitic acid, stearic acid, linoleic acid and oleic acid. 

7 (original): The composition of claim 6 wherein said fatty acid is linoleic acid. 

8 (original): The composition of claim 1 further comprising cholesterol. 

9 (original): The composition of claim 1 further comprising both linoleic acid and cholesterol. 



2 (canceled): 



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10 (original): The composition of claim 1 further comprising sclareolide. 

1 1 (original): The composition of claim 1 further comprising a protease inhibitor selected from the group 
consisting of white birch extract, silver birch extract, Boswellia extract, bearberry extract, Centella 
asiatica extract, and Pygeum africanum extract. 

12 (previously presented): The composition of claim 1 further comprising both sclareolide and 
white birch extract. 

13 (currently amended): A cosmetic or pharmaceutical formulation for topical application of a 
composition to the skin, the formulation containing a mixtur e comprising an integral mixture of 
cholesterol sulfate or salts thereof in an amount from about 0.05 to about 5.00 percent, and from about 
0.1 to about 10.0 percent by weight of an amino sugar selected from the group consisting of N-acetyl-D- 
glucosamine, N-acetylgalactosamine, and a combination thereof by weight of the composition-beiftg 
int e gral with on e anoth e r in a cosmetically or pharmaceutically acceptable vehicle. 

14 (original): The formulation of claim 13 further comprising both cholesterol and a fatty acid selected 
from the group consisting of butyric acid, caproic acid, octanoic acid, decanoic acid, dodecanoic acid, 
tetradecanoic acid, palmitic acid, stearic acid, linoleic acid and oleic acid. 

15 (original): The formulation of claim 14 wherein the fatty acid is linoleic acid present in an amount 
less than 1 percent and the cholesterol is present in an amount less than 1 percent. 

16 (currently amended): A method for improving or maintaining a healthy skin barrier which comprises 
adding an effective amount of [[a ]] an integral mixture to a cosmetically or pharmaceutically acceptable 
vehicle wherein said integral mixture comprises cholesterol sulfate or salts thereof in an amount from 
about 0.05 to about 5.00 percent by weight of the composition, and from about 0.1 to 10.0 percent by 
weight of the composition an amino sugar selected from the group consisting of N-acetyl-D-glucosamine, 
N-acetylgalactosamine, and a combination thereof, and applying said vehicle containing said mixture to 
the skin. 

17 (original): The method of claim 16 in which the mixture comprises from about 0.1 to about 2.0 
percent cholesterol sulfate. 



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18 (previously presented): The method of claim 16 in which the composition comprises about 0.04 
to about 1.0 percent cholesterol sulfate. 



19 (currently amended): A method of treating or reducing damage to the skin, wherein the damage is 
associated with a reduction or loss of skin barrier function, which comprises adding an effective amount 
of [[a ]] an integral m ixture to a cosmetically or pharmaceutically acceptable vehicle wherein said mixture 
comprises cholesterol sulfate or salts thereof in an amount from about 0.05 to about 5.00 percent by 
weight of the composition , and about 0.1 to about 10.0 percent of an amino sugar selected from the group 
consisting of N-acetyl-D-glucosamine, N-acetylgalactosamine, and a combination thereof by weight of 
the composition, and applying said vehicle containing said mixture to the skin. 

20 (previously presented): The method of claim 19 further comprising cholesterol sulfate or salts 
thereof in an amount of about 0.1 to 2.0 percent, about 0.5 to 8.0 percent of N-acetyl-D-glucosamine, 
cholesterol in an amount of about 0.2 to 1.0 percent, linoleic acid in an amount of about 0.2 to 1.0 
percent by weight of the composition, sclareolide in an amount of about 0.001 to about 1.000 percent, 
and white birch extract in an amount of about 0.001 to about 1.000 percent. 



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