Ex Parte RUBIN - Page 11




               The examiner's prima facie case of obviousness is supported              
          by substantial evidence in the form of Dempski and Conte.                     
               Dempski tells us that one having ordinary skill in the art               
          knew that levodopa and carbidopa could be administered                        
          simultaneously for the purpose of treating Parkinson's disease.               
          It turns out, however, that a single dose of both compounds had               
          problems.  Accordingly, Dempski determined that the compounds                 
          should be administered in the form of a controlled slow release               
          mechanism.  Indeed, applicant concedes that "[t]he examiner                   
          correctly states *** that 'the combination of levodopa and                    
          carbidopa in a sustained release formulation is well known in the             
          art.'"  Supplemental Appeal Brief, page 2.  The Dempski slow                  
          release mechanism is a "single" layer.                                        
               Dempski differs from the subject matter of claim 1 in that               
          claim 1 calls for a two-layer release mechanism, one layer being              
          an immediate release layer and the other layer being a sustained              
          release layer (Finding 21).                                                   
               Conte, while directed to the administration of drugs in                  
          general, including mixtures of levodopa and carbidopa, describes              
          a device containing first and second drug layers in which the                 
          first layer involves immediate or controlled release of a drug                
          and the second layer involves slow release of the same or a                   
          different drug.  The Conte device is said to overcome problems                
          (col. 2, line 42 through col. 3, line 3)  with devices which                  
          release drugs at a constant rate (col. 3, lines 8-9).  Applicant              
          concedes that the examiner correctly determined that "the prior               

                                        - 11 -                                          





Page:  Previous  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  Next 

Last modified: November 3, 2007