Ex parte ANHAUSER et al. - Page 4




          Appeal No. 1998-0244                                                        
          Application No. 08/531,890                                                  

          of a pharmaceutical.  The patch includes a pressure sensitive               
          adhesive layer 1, an impermeable backing layer 2, a matrix                  
          layer 3 containing the pharmaceutical and an inert protective               
          layer 4,                                                                    
          these components being arranged as shown in the drawing                     
          figure.  Of the process by which the plaster is made, Seth                  
          states only that                                                            
               [t]he [matrix] composition is applied at a                             
               temperature of about 45E-50E C. to the backing layer                   
               in a thickness which is calculated on the basis of                     
               the amount of active substance which is to be                          
               released per unit area and time (for example cm  and2                       
               hour).  The composition is then allowed to cool and                    
               solidify to result in a solid coated body.  The                        
               coated body is then cut to the desired dimensions,                     
               and the cut pieces are provided with the pressure-                     
               sensitive adhesive layer on the side of the backing                    
               layer, and with the inert protective layer on the                      
               side of the matrix layer [column 4, lines 18 through                   
               28].                                                                   
               As conceded by the examiner, the process disclosed by                  
          Seth fails to respond to the limitations in independent claim               
          3, and the corresponding limitations in independent claim 4,                
          (1) requiring “pressure-sensitive adhesive” drug-reservoir-                 
          sections and (2) setting forth the particular manipulative                  
          steps by which the transdermal therapeutic patches are                      
          continuously produced.  In essence, the examiner relies on                  

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