Ex Parte Pugliese - Page 21



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

                    11. From the foregoing graphic presentations of my                 
               clinical observations, I am able to conclude that genistein,            
               in combination with afore-described active components, or               
               even if used alone in an emulsion, is capable of inhibiting             
               the undesirable destructive effects of estrogen on connective           
               tissue, like collagen, and it thus provides a positive effect           
               on treating cellulite, as indicated by measuring their visual           
               ratios as recited above.                                                
               We have carefully considered Pugliese’s declaration, especially         
          the procedure, the visual observations, the objective results                
          reported in the attached exhibits, and the conclusions Dr. Pugliese          
          has drawn therefrom.  We are somewhat confused by the lot.                   
               Even if we presume to understand precisely what the components          
          and component proportions of the formulations with and without               
          genistein that Pugliese tested on the thighs of women exhibiting             
          cellulite, precisely how the measurements were taken and recorded,           
          and the individual and comparative reliability of the observations           
          and data recorded for each formulation with and without genistein,           
          Pugliese concludes at best that genistein alone, or genistein in             
          combination with other known active agents, provides a positive              
          effect on treating cellulite.  Pugliese’s declaration that the               
          claimed subject matter is patentable is less persuasive and carries          
          less weight than the combined teachings of the applied prior art             
          that the claimed subject matter would have been obvious to persons           
          having ordinary skill in the art for treating cellulite with                 

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