Ex Parte SANTOLI et al - Page 6


                  Appeal No. 2001-2411                                                                                         
                  Application No. 08/879,422                                                                                   

                  claims to require that the treated patient have a “functional immune system.”                                
                  See Paper No. 18 (filed Jan. 28, 2000), page 2.  Appellants argued that “SCID                                
                  mice do not have a working immune system.  Since the mice are                                                
                  immunodeficient, without B or T lymphocytes, . . . [they] do not need                                        
                  immunosuppressive treatment prior to receiving foreign cells, such as TALL-104                               
                  cells.”  Id., page 3.                                                                                        
                          Finally, in the Appeal Brief, Appellants argue that “[t]he term ‘functional                          
                  immune system’ does not mean to the person of skill in the art that the patient’s                            
                  immune system is perfect, but simply that it is operational, i.e., that humoral                              
                  and/or cellular immune responses are functioning in the patient.”  Page 4.                                   
                  Appellants have cited two dictionaries as defining “functional” to mean “capable                             
                  of performing; operative,”4 or “performing or able to perform a function.”5  See the                         
                  Appeal Brief, pages 9-10.                                                                                    
                          On the basis of the record, including the claim as a whole, the                                      
                  specification, and the prosecution history, we agree with Appellants’                                        
                  interpretation of the claim language.  We construe a “functional immune system”                              
                  to be an immune system that can mount an effective humoral and/or cellular                                   
                  immune response to foreign antigens.  In other words, a patient with a functional                            
                  immune system is simply a patient who is not immunodeficient (e.g., not a SCID                               
                  mouse).  A functional immune system is not limited to those immune systems                                   
                  that work perfectly or that respond with 100% effectiveness to every potential                               
                                                                                                                               
                  4 The American Heritage Dictionary of the English Language, 3rd ed. (1996) (exhibit F attached to            
                  the Appeal Brief).                                                                                           

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