Ex parte MATHIOWITZ - Page 7




          Appeal No. 95-2876                                                          
          Application 07/906,403                                                      


               comprising a pharmaceutically indifferent core, such                   
               as microcrystalline cellulose, and layer containing                    
               a pharmaceutical such as digoxin and a biodegradable                   
               polymer such as polyethylene glycol or hydroxy                         
               propylmethyl cellulose.  While Appelgren et al. may                    
               not specify the particle diameter of the                               
               incorporated drug such as digoxin, choice of this                      
               parameter would be within the expected skill of a                      
               worker in the art, and thus obvious.  The “particle                    
               diameter of fifty microns or less” for the                             
               incorporated substance has not been disclosed as, or                   
               shown to be, critical by applicants in the instant                     
               case.                                                                  
               Appellants do not dispute much of the examiner's findings              
          of fact and conclusions as shown above.  Appellants only argue              
          that:                                                                       
               (1) Appelgren's examples do not suggest its                            
          pharmaceutically indifferent core to be a polymer (see Brief,               
          page 14);                                                                   
               (2) Appelgren does not describe or suggest incorporating               
          a substance (drug) in the core or the coating (see Brief, page              
          19);      (3) Appelgren does not describe or suggest a uniform              
          coating layer of polymer (see Brief, page 20); and                          
               (4) Appelgren does not describe or suggest polymers                    
          having suitable phase separation properties (see Brief, pages               
          14 and 19).  We are not persuaded by any of these arguments.                


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