Ex Parte Kitson et al - Page 7


                Appeal No. 2004-0902                                                   Page 7                  
                Application No. 09/780,060                                                                     

                required by claim 3.  While the declaration states that both compositions 26 and               
                27 of Kawada contain cholesteryl sodium sulfate, which, according to their                     
                research does not crystallize to the same extent as cholesterol, cholesteryl                   
                sodium sulfate is the component that is present in the smallest amount in those                
                compositions.  With respect to the presence of the cholesteryl sodium sulfate as               
                well as the use of 2-oleoylaminooctadecane-1,3-diol as the ceramide, as set                    
                forth by the specification, a crystalline phase formulation is defined where 70%               
                or more of lipids by mass are in a crystalline phase, and therefore complete                   
                crystallization is not required.  Moreover, the declaration does not present                   
                evidence demonstrating that when applied to the skin, the compositions of                      
                Kawada do not achieve the property of adopting a crystalline lamellar phase to                 
                that extent.  Finally, the specification teaches that several changes occur when               
                the composition is applied to the skin, such as drying, pH changes, etc., all of               
                which may affect the hydration state of the composition.  Appellants have not                  
                supplied any data demonstrating that compositions 26 and 27 of Kawada would                    
                not adopt a crystalline lamellar phase and that the amount of hydration of the                 
                composition is a critical factor.                                                              
                      Appellants argue further that Kawada provides data at column 14, lines                   
                18-19, and column 13, lines 51-58, to show that the reference’s liquid crystals do             
                not crystallize.  See Appeal Brief, page 5.  Appellants conclude that “the                     
                compositions of Kawada are lamellar liquid crystals that do not crystallize,                   
                whereas the claimed invention is directed to non-crystalline phase lamellar lipid              







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