Ex Parte Fahy - Page 2


             Appeal No. 2006-0148                                                              Page 2                
             Application No. 09/933,309                                                                              

             intrathymic biopsy renders the host tolerant to the graft itself, either by eliminating or              
             anergizing immune cells that attack the biopsy in the thymus. . . . The main problem                    
             with this method is that it requires a functioning thymus gland of significant mass in                  
             order to be effective.  The human thymus begins to involute before the age of 20 and                    
             becomes severely atrophied by the age of 40.”  Specification, pages 2-3.                                
                    The specification discloses that “[t]he concurrent administration of human growth                
             hormone or an HGH releaser and DHEA [dehydroepiandrosterone] . . . surprisingly                         
             reverses thymic involution in older individuals and in others with thymic insufficiency.”               
             Pages 14-15.  “By regenerating the previously atrophied thymus, this coadministration                   
             of HGH and DHEA allows intrathymic transplantation in elderly or involuted individuals                  
             as a route to permanent grafting of tissues and organs without immunosuppression and                    
             without rejection.”  Page 15.                                                                           
                                                    Discussion                                                       
             1.  Claims                                                                                              
                    Claims 16-22 and 32-34 are pending and on appeal.  Claim 16 is the only                          
             independent claim and reads as follows:                                                                 
                    16. A method for transplanting organs and grafting tissue into a patient                         
             comprising steps of:                                                                                    
                    restoring immune system function by regenerating the patient’s involuted thymus;                 
                    injecting the immunological equivalent of the tissue or organ to be transplanted                 
             into the patient, into the regenerated thymus (or, in the case of bone marrow cells,                    
             peripherally); and                                                                                      
                    then transplanting said organ or grafting said tissue.                                           








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