Ex Parte USMAN et al - Page 3


                  Appeal No. 2002-1251                                                              Page 3                     
                  Application No. 08/459,340                                                                                   

                          The specification defines “catalytically critical sites” to “include sites which,                    
                  if altered from a ribonucleotide or a NAA to a deoxyribonucleotide, substantially                            
                  reduces or even eliminates catalytic activity.”  Page 13.  A “substantial” reduction                         
                  in catalytic activity in turn is defined as a “reduction which limits the usefulness of                      
                  the nucleozyme as a catalyst in vitro or in vivo.”  Id.  The specification describes                         
                  how to identify catalytically critical sites in a given nucleozyme and discloses that,                       
                  for example, “[t]he hammerhead nucleozyme has four catalytically critical sites                              
                  which are the G9, G12, A13 and A29 positions” shown in the application’s Figure                              
                  1.  Specification, page 14.                                                                                  
                          Finally, the specification discloses that nucleozymes also “may be used as                           
                  therapeutic agents introduced in vivo due to their resistance to chemical and                                
                  enzymatic degradation.”  Page 6.  Thus, “[a] nucleozyme may be provided in a                                 
                  pharmaceutical composition.  The pharmaceutical composition would include at                                 
                  least one nucleozyme and a pharmaceutically acceptable carrier.”  Id.                                        
                                                         Discussion                                                            
                  1.  Written description                                                                                      
                          The examiner rejected all of the claims on the basis that the specification                          
                  did not adequately describe the claimed “pharmaceutical composition.”  The                                   
                  examiner reasoned that                                                                                       
                          The specification as filed fails to teach any compositions which                                     
                          would provide for the in vivo (whole organism) delivery of                                           
                          ribozymes such that the ribozyme can find its target and cleave the                                  
                          target in vivo.  The specification is wholly prophetic in this regard                                
                          and fails to teach any compositions per se which would function as                                   
                          claimed.                                                                                             






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