Ex Parte Fahy - Page 5


             Appeal No. 2006-0148                                                              Page 5                
             Application No. 09/933,309                                                                              

                    Thus, the specification makes clear that an “immunological equivalent” of a                      
             transplanted organ or tissue is a donor-specific cell or antigen that stimulates deletion or            
             anergy of the immune system cells that would otherwise cause rejection of the                           
             transplanted organ or tissue.  The specification states that one example of an                          
             immunological equivalent is “bone marrow cells.”  In our view, “the claims, read in light               
             of the specification, reasonably apprise those skilled in the art and are as precise as the             
             subject matter permits,” Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,                 
             1385, 231 USPQ 81, 94-95 (Fed. Cir. 1987), and therefore comply with the second                         
             paragraph of 35 U.S.C. § 112.                                                                           
             3.  Enablement                                                                                          
                    The examiner rejected claims 16-22 and 32-34 under 35 U.S.C. § 112, first                        
             paragraph, on the basis that the claimed method is not enabled by the specification’s                   
             disclosure.  The examiner reviewed several of the references submitted by Appellant to                  
             show thymic regeneration and lack of rejection following intrathymic injection of antigen               
             (Examiner’s Answer, pages 5-6) and concluded that, “[w]hile the literature submitted by                 
             Appellant teaches regeneration of age-involuted thymus, the experiments were only                       
             executed in rats, there was no significant improvement of cellular immune function and                  
             there were harmful side effects (reduced testosterone concentrations, hepatic tumors).”                 
             Id., page 7.                                                                                            
                    The examiner also faulted the level of disclosure in the specification, arguing                  
             that:                                                                                                   
                    •  “[t]he specification does not provide guidelines to determine thymic atrophy or               
             involution” (Examiner’s Answer, page 7);                                                                





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