Ex Parte Williams et al - Page 4


              Appeal No.  2005-0902                                                                    Page 4                 
              Application No. 09/529,053                                                                                      

              thereof that retain all or part of the anti-viral activity of leflunomide.”  Page 18, lines                     
              12-18.  Regarding effective doses of leflunomide, the specification states:                                     
                      Anti-viral therapeutically effective amounts of leflunomide product include                             
                      amounts effective for inhibiting viral growth, i.e., replication, or inhibiting                         
                      virion assembly.  The leflunomide product can be administered to humans                                 
                      at doses ranging from about 0.1 to 80 mg daily, varying in children and                                 
                      adults, or more preferably at doses ranging from about 15 to 25 mg daily                                
                      for adults.  Most preferable are doses calculated to provide a circulating                              
                      blood level of about 40 to 60 µM.                                                                       
              Page 16, lines 17-23.                                                                                           
                      Reading the claims in light of the specification, therefore, we construe claim 16 to                    
              require administration of leflunomide, its active metabolite, related derivatives, or anti-                     
              virally active metabolites thereof, in an amount that is effective to inhibit viral growth or                   
              viral assembly; such amounts can vary from 0.1 mg/day to 80 mg/day for a human.                                 
                      We do not interpret claim 16 to require administering leflunomide to a patient;                         
              i.e., in vivo administration.  Claim 16 requires only contacting a cell that is susceptible to                  
              viral infection with a leflunomide product.  It does not require administering a                                
              leflunomide product to a patient or a human or an animal.  During examination, claims                           
              are given their broadest reasonable interpretation.  See In re Morris, 127 F.3d 1048,                           
              1053-54, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997).  Since claim 16 is not expressly                                
              limited to an in vivo method, the broadest reasonable interpretation of the claim is that it                    
              also reads on in vitro methods.                                                                                 
                      We also do not interpret claim 16 to be limited to a method of treating cells that                      
              are already infected by viruses.  Claim 25 adds to claim 16 the limitation that the “cells                      
              are virally infected.”  Since a dependent claim must further limit the claim from which it                      







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