Ex Parte Williams et al - Page 5

                Appeal 2007-1159                                                                                 
                Application 09/839,946                                                                           
                mammalian tissue by precipitation under certain dialysis conditions (Conley,                     
                       Appellants assert that the Declaration of Merry R. Sherman, Ph.D,                         
                filed under 37 CFR  1.132 and attached as Exhibit D to the Brief, supports                      
                their conclusion that “the authors of Lee would not be expected to have                          
                produced an uricase preparation in which at least about 90% of the uricase                       
                was in a tetrameric form; instead, more than 10% of the uricase would have                       
                been present in a non-tetrameric aggregated form.”  (Br. 12-13 (emphasis in                      
                original).)  Dr. Sherman at paragraph 5 of the Declaration, referencing the                      
                Specification at page 16, lines 5-8, states that “while mammalian uricases in                    
                vivo (i.e., associated with the peroxisome) exist as a tetramer, isolated                        
                purified preparations of natural and recombinant uricase, as indicated in the                    
                present specification and as disclosed by Lee, usually contain a mixture of                      
                aggregated non-tetrameric forms of the enzyme, in addition to the tetrameric                     
                       Page 16, lines 5-8 of the Specification, states:                                          
                             Purified preparations of naturally occurring and                                    
                       recombinant uricases usually contain a mixture of aggregates of                           
                       the enzyme, in addition to the tetrameric (140 kDa) form.  The                            
                       percentage of each uricase preparation that is in the tetrameric                          
                       form generally varies from approximately 20% to 90%.                                      

                       The Specification, as referenced by the Declaration of Dr. Sherman,                       
                thus states that uricase preparations containing up to 90% of uricase in the                     
                tetrameric form were known in the prior art.  Moreover, as discussed above,                      
                claim 50 encompasses uricase preprations containing only approximately                           
                90% of the uricase in tetrameric form.  Therefore, claim 50 encompasses                          


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