Ex Parte Aleles et al - Page 6



             Appeal No. 2006-2248                                                                               
             Application No. 10/158,618                                                                         

             invention are sensitive to metal ions and in particular to bi- and tri-valent actions              
             and in certain instances, appear to degrade rapidly in their presence.  The chelating              
             agent forms a complex with the metal ions thereby inactivating them and                            
             preventing them from affecting the retinoid compounds.  Chelating agents which                     
             are useful in the compositions of this invention include ethylenediamine tetraacetic               
             acid (EDTA) and derivatives and salts thereof, dihydroxyethyl glycine, citric acid,                
             tartaric acid, and mixtures thereof.  The chelating agents should be utilized in a                 
             stabilizing effective amount and may range from about 0.01 to about 2% based on                    
             the weight of the total composition, preferably from about 0.05 to about 1%                        
             (col. 6, lines 45-59).                                                                             
                          11. The pH of the compositions should be in the range of from                         
             about 4 to about 9, and preferably from about 4 to about 7.  Most preferably, the                  
             pH of the compositions should be at least 5 (col. 7, lines 5-8).                                   
                          12. Preferably, glycerin is included in the formulations of this                      
             invention as a humectant, however, it should be present in relatively low amounts.                 
             Preferably, the amount of glycerin should be less than 10% of the total                            
             composition.  More preferably, it should be less than 5% of the total composition                  
             by weight.  It is theorized that glycerin may enhance penetration of an active or                  
                                                      - 6 -                                                     




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