Ex Parte Pugliese - Page 19



          Appeal No. 2005-0545                                                         
          Application No. 09/989,019                                                   

          cosmetic condition in women called cellulite according to the                
          protocol indicated on page 12 of the specification entailing                 
          ultrasound measurements on thigh diameters (Paper No. 5, p. 1, para.         
          3-4).  Pugliese’s specification describes the Formula #1 Emulsion,           
          the Formula #2 Microencasulation and the Formula #3 Emulsion as              
          comprising the following active components (Spec., pp. 10-11):               
                                   Formula #1 Emulsion                                 
               Fisetin                        .001 to 5.0 wt.%    oil phase            
               Genistein                      0.1 to 2 wt.%       oil phase            
               Theophylline acetate           .001 to 4.0 wt.%    water phase          
               Coleus forskohlii extract      .001 to 2.0 wt.%    water phase          
               L-carnitine                    .001 to 2.0 wt.%    oil phase            
                              Formula #2 Microencapsulation                            
               Quercetin                      .001 to 5.0 wt.%                         
               Genistein                      .001 to 5.0 wt.%                         
               Theophylline acetate           .001 to 4.0 wt.%                         
               Coleus forskohlii extract      .001 to 2.0 wt.%                         
               L-carnitine                    .001 to 1.5 wt.%                         
                                   Formula #3 Emulsion                                 
               Quercetin                      .001 to 5.0 wt.%    oil phase            
               Genistein                      .001 to 5.0 wt.%    oil phase            
               Theophylline acetate           .001 to 4.0 wt.%    water phase          
               Coleus forskohlii extract      .001 to 2.0 wt.%    water phase          
               Acetyl L-carnitine             .001 to 1.5 wt.%    oil phase            
               Dr. Pugliese declares (Paper No. 5, para. 5-11):                        
                    5.   Genistein was first evaluated for its potential               
               effects on the fat reduction of female thighs, as to be                 
               determined by ultrasound measurements, which measurements               
               are presented graphically in the tricolor bar charts depicted           

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