Ex Parte CHOUDARY et al - Page 10


                   Appeal No. 2004-2134                                                               Page 10                      
                   Application No. 09/425,075                                                                                      

                   knowledge, there are no reports of proteins greater than 117 kDa being                                          
                   expressed in P. pastoris.’”  Id. at 12 (emphasis in original) (quoting Pinnell, page                            
                   601).  Appellants assert that statement teaches away from the claimed invention,                                
                   as antibodies are generally larger than 117 kDa.  See id.                                                       
                          Second, appellants rely upon Holliger for teaching that: “‘Because                                       
                   bicistronic expression works only poorly in Pichia (unlike E. coli), it is preferable                           
                   to use single-chain Ab formats.  Two chain Ab formats require that the two chains                               
                   be cloned and transformed separately.’”  Appeal Brief, page 13 (emphasis in                                     
                   original) (quoting Hollinger, page 351).  Dr. Trager also reviewed Pinnell and                                  
                   Hollinger, and appellants cite paragraph 22 of his declaration to support their                                 
                   proposition that the references would lead the ordinary artisan away from the                                   
                   claimed invention.                                                                                              
                          Again, we do not find appellants arguments to be convincing.  With                                       
                   respect to the statement of Pinnell that “[t]he size of the protein to be expressed                             
                   may also be limiting because to our knowledge, there are no reports of proteins                                 
                   greater than 117 kDa being expressed in P. pastoris,” as noted by the examiner,                                 
                   the Invitrogen catalog teaches the expression of a wide variety of proteins that                                
                   have been expressed in Pichia, such as GP-120, see Examiner’s Answer, page                                      
                   9, which appellants do not dispute is larger than 117 kDa.                                                      
                          With respect to the statement of Hollinger, appellants cannot rely on                                    
                   post-filing art references to show what one skilled in the art would know at the                                
                   time of filing.  The state of the art at the filing date of the application is used to                          
                   determine whether a particular disclosure is enabling as of the filing date.                                    





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