Ex Parte Williams et al - Page 6


              Appeal No.  2005-0902                                                                    Page 6                 
              Application No. 09/529,053                                                                                      

                      Thus, we construe claim 16 to be directed to a method comprising contacting                             
              cells susceptible to viral infection with, e.g., leflunomide or its active metabolite in an                     
              amount effective to inhibit virion assembly, either in vitro or in vivo.  We construe claim                     
              22 to be directed to the same method, where the cells are also contacted with another                           
              antiviral agent in addition to the leflunomide product.                                                         
              2.  Coghlan and McChesney                                                                                       
                      The examiner rejected claims 16-21, 24, and 25 as obvious in view of Coghlan                            
              and McChesney.  We conclude that McChesney anticipates claim 16, as we interpret it,                            
              so we need not address Coghlan.                                                                                 
                      McChesney describes an experiment in which dogs weighing 10-30 kg were                                  
              administered either leflunomide or its active metabolite (A77-1726).  See the paragraph                         
              bridging pages 1717 and 1718, and the first paragraph on page 1718.  The dogs treated                           
              with leflunomide received 2, 4, 8, or 16 mg/kg/day; the dogs treated with A77-1726                              
              received 2, 4, 6, or 8 mg/kg/day.  See the second full paragraph on page 1718.  The                             
              dosages described by McChesney therefore correspond to between 20 and 480 mg/day                                
              of leflunomide and 20-240 mg/day of A77-1726.1                                                                  
                      Thus, McChesney describes in vivo administration of leflunomide and its active                          
              metabolite at dosages within the range taught in the instant specification to be effective                      
              for inhibiting virion assembly.  McChesney therefore anticipates claim 16.  Anticipation                        
              is the epitome of obviousness.  See Connell v. Sears, Roebuck & Co., 722 F.2d 1542,                             
              1548, 220 USPQ 193, 198 (Fed. Cir. 1983).                                                                       

                                                                                                                              
              1 The calculated dosages correspond to the lightest dog at the lowest dose and the heaviest dog at the          
              highest dose for each drug.                                                                                     





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