Ex Parte Pugliese - Page 20



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

          in Exhibit A, titled “Density Measurements of Ultrasound                     
          Scans”;                                                                      

                    6.   Such measurements were made at 1 (blue bar),                  
               28 (purple bar), and 56 (yellow bar) day intervals starting             
               from initial topical application of Formula No. 3, assess               
               average epidermis density, average papillary dermis density,            
               and average reticular dermis density, respectively;                     



                    7.   Papillary dermis density is an indicator of                   
               connective tissue cell replacement, while reticular dermis              
               density is an indicator of reduction in fat cell size and/or            
               number;                                                                 
                    8.   As a medically licensed physician and clinician,              
               it is my professional opinion that the exemplary isoflavone,            
               genistein, shows a measurable increase (c. 5 units) in                  
               epidermis density at 28 days, followed by a slight dip at               
               day 56; a progressive increase in papillary dermis density              
               from c. 27 units at day one to c. 48 units at day 56; and,              
               a progressive increase in reticular dermis density from                 
               c. 35 units at day 1 to c. 66 units at day 56;                          
                    9.   Five women with clinically determined moderate                
               cellulite were treated with an emulsion like Formula #3, but            
               having active components, save genistein being omitted, and             
               the emulsifiers and emollients being retained, with twice               
               daily applications to both thighs; the degree of cellulite              
               was determined by measuring visual ratio of connective                  
               tissue to fat infiltration into connective tissue;                      
                    10. Based on ultrasound measurements, made at both                 
               four and eight weeks, the amount of fatty tissue decreased,             
               while the amount of connective tissue increased by about 8%             
               at four weeks, and by 19% at eight weeks, respectively                  
               (Exs. B & C).                                                           
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