Ex Parte SANTOLI et al - Page 4


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

                  In re Sneed, 710 F.2d 1544,1548, 218 USPQ 385, 388 (Fed. Cir. 1983).  Words                                  
                  in a claim are given their ordinary definition unless they are clearly defined                               
                  otherwise in the specification.  See Optical Disc Corp. v. Del Mar Avionics, 208                             
                  F.3d 1324, 1334, 54 USPQ2d 1289, 1295 (Fed. Cir. 2000) (“Without evidence in                                 
                  the patent specification of an express intent to impart a novel meaning to a claim                           
                  term, the term takes on its ordinary meaning.”).                                                             
                          The claim language at issue in this case is the limitation that the patient                          
                  has “a functional immune system.”  This phrase is found in the following context:                            
                  “administering to a mammalian cancer patient with a functional immune system                                 
                  an effective amount of TALL-104 cells . . . in the absence of an                                             
                  immunosuppressive agent.”  Thus, in the context of the claim as a whole, a                                   
                  “functional immune system” is an immune system that would be suppressed by                                   
                  an immunosuppressive agent, i.e., an immune system that would mount an                                       
                  immune response to a foreign antigen unless such a response was                                              
                  pharmacologically suppressed.                                                                                
                          The specification sheds further light on what is meant by a “functional                              
                  immune system.”  The specification distinguishes between “immunodeficient” and                               
                  “immunocompetent” murine models.  See page 2.  The immunodeficient murine                                    
                  model used in the cited references is the SCID (severe combined                                              
                  immunodeficient) mouse.1  SCID mice “lack functional T cells and B cells.”  See                              

                                                                                                                               
                  1 See Cesano et al., “Reversal of acute myelogenous leukemia in humanized SCID mice using a                  
                  novel adoptive transfer approach,” Journal of Clinical Investigation, Vol. 94, pp. 1076-1084                 
                  (1994).  This reference is cited in the specification (page 2) and was made of record in Paper No.           
                  8, filed Nov. 10, 1998.                                                                                      

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