Ex Parte Williams et al - Page 7


              Appeal No.  2005-0902                                                                    Page 7                 
              Application No. 09/529,053                                                                                      

                      Appellants argue that                                                                                   
                      McChesney shows immunosuppressive effects of leflunomide alone and                                      
                      with cyclosporine in canines with kidney allograft transplants. . . .  The                              
                      McChesney reference includes no experimental procedures for assessing                                   
                      antiviral or antibacterial effects of leflunomide.                                                      
                      Clearly, then, the combined Coghlan and McChesney references provide                                    
                      no suggestion whatsoever in their disclosures to those of ordinary skill in                             
                      the art that leflunomide products had been found to be effective in                                     
                      inhibiting viral virion assembly or might be tested for such effects with any                           
                      reasonable expectation of success.                                                                      
              Appeal Brief, page 11.                                                                                          
                      Appellants’ arguments are based on an incorrect interpretation of the claim:                            
              claim 16 does not require administering leflunomide with the expectation of obtaining an                        
              antiviral effect.  Appellants may have recognized a new benefit of administering                                
              leflunomide to patients but claim 16 as written reads on prior art processes.  See In re                        
              Woodruff, 919 F. 2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990):  “It is a                                
              general rule that merely discovering and claiming a new benefit of an old process                               
              cannot render the process again patentable.”                                                                    
              3.  Weithmann and Hammer                                                                                        
                      The examiner rejected claims 22 and 23 as obvious in view of Weithmann and                              
              Hammer.  The examiner noted that Weithmann teaches treating viral disorders,                                    
              including HIV infection, by administering leflunomide at doses of 3-50 mg daily.  See                           
              col. 2, lines 4-10 and 34-37; col. 3, lines 7-10; and claim 1.                                                  
                      Weithmann does not teach administering leflunomide in combination with another                          
              antiviral agent, but Hammer discloses several antiviral agents used to treat HIV                                
              infection.  See, in particular, Figure 2, which shows several reverse transcriptase                             
              inhibitors:  all of the compounds shown except didanosine are pyrimidine analogs.                               





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