Ex Parte Williams et al - Page 3


              Appeal No.  2005-0902                                                                    Page 3                 
              Application No. 09/529,053                                                                                      

                                                        Background                                                            
                      Leflunomide (HWA-486) is a known product, as is its metabolite A771726.  See                            
              the specification, page 1.  “Leflunomide originated from a series of compounds that                             
              were designed as agricultural herbicides. . . . It was later found to have anti-                                
              inflammatory and immunosuppressive activity, and it has been evaluated in animal                                
              models of autoimmune disease and transplant rejection. . . . No anti-viral activity has                         
              previously been reported for leflunomide or its metabolite.”  Id., pages 1-2.                                   
                      The specification discloses that “[l]eflunomide has been discovered to inhibit viral                    
              growth in a manner different from other conventional anti-viral agents, which typically                         
              act by inhibiting viral DNA replication in the early stages of infection.  In contrast,                         
              leflunomide appears to act by inhibiting virion assembly.”  Page 13.                                            
                                                         Discussion                                                           
                      The claims subject to each rejection stand or fall together, because Appellants                         
              have not stated otherwise.  See the Appeal Brief, page 3.  We will focus on claim 16 as                         
              representative of the claims rejected over Coghlan and McChesney and claim 22 as                                
              representative of the claims rejected over Weithmann and Hammer.                                                
              1.  Claim construction                                                                                          
                      Claim 16 is directed to a “method for inhibiting viral replication in cells susceptible                 
              to viral infection” by contacting the cells with a “leflunomide product” in an amount                           
              “effective to inhibit viral virion assembly.”  Claim 22 is directed to the same method,                         
              “further comprising contacting the cells with another anti-viral agent.”                                        
                      The specification defines “leflunomide product” to mean “leflunomide . . . (HWA-                        
              486), or its active metabolite . . . (A771726), or related derivatives . . . or metabolites                     





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