Ex Parte Watkins et al - Page 4

               Appeal 2007-2523                                                                           
               Application 10/370,749                                                                     

               Table 6), D280N (asparagine substituted for aspartic acid, Table 8) and                    
               D280S (serine substituted for aspartic acid, Table 8)” (id.)                               
                     Specifically, Appellants argue that, “[e]ven though Column 12 of                     
               [Presta] lists the twenty amino acids known to be naturally occurring, the                 
               patent clearly states that ‘amino acid substitution’ includes natural and non-             
               natural amino acids.  Therefore, [Presta] identifies ‘amino acid substitution’             
               as the smallest preferred embodiment within the ‘amino acid modification’                  
               genus, yet this subgenus is quite large indeed!”  (Br. 11.)  “Presta never                 
               states that natural amino acids are a preferred subgenus of this immense                   
               genus” (Reply Br. 2).  Thus, Appellants argue, “the genus that was identified              
               - - amino acid substitutions - - is too large for one of skill in the field to             
               envisage each member” (Br. 11).                                                            
                     We reverse the rejection.  Presta refers to “a variant of a parent                   
               polypeptide comprising an Fc region, which variant mediates antibody-                      
               dependent cell-mediated cytotoxicity (ADCC) in the presence of human                       
               effector cells more effectively or binds an Fc gamma receptor (FcγR) with                  
               better affinity, than the parent polypeptide and comprises at least one amino              
               acid modification in the Fc region” (Presta, col. 4, ll. 30-36).  Presta states            
               that, “[b]y introducing the appropriate amino acid sequence modifications in               
               a parent Fc region, one can generate a variant Fc region which (a) mediates                
               antibody-dependent cell-mediated cytotoxicity (ADCC) in the presence of                    
               human effector cells more effectively and/or (b) binds an Fc gamma receptor                
               (FcγR) with better affinity than the parent polypeptide” (id. at col. 21, ll. 60-          
               66 (emphasis added)).  Presta states that, “[g]enerally, the modification                  
               entails one or more amino acid substitutions” (id. at col. 19, ll. 47-48).                 


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