Ex Parte ROLLINS et al - Page 4


                   Appeal No. 2001-0869                                                                  Page 4                       
                   Application No. 08/453,347                                                                                         

                           The specification discloses that JE/MCP-1 can be administered to suppress                                  
                   tumor formation in vivo.  See page 2.  “The protein can be administered alone or                                   
                   as an adjuvant to surgery.”  Id.  Alternatively, “tumor killing cells, such as tumor                               
                   infiltrating lymphocytes (TIL cells) are genetically engineered to express the                                     
                   JE/MCP-1 protein.  The engineered cells therefore can be administered to a                                         
                   vertebrate to provide a synergistic local tumor cell killing.”  Id., pages 2-3.  See also                          
                   pages 13-16.                                                                                                       
                           The specification also discloses that JE/MCP-1 can be administered to                                      
                   “treat localized complications of malignancy.”  See page 2.  Finally, JE/MCP-1                                     
                   can be used for “combatting a parasitic infection in a vertebrate animal by                                        
                   administering to that vertebrate an effective amount of JE/MCP-1.”  Id., page 3.                                   
                                                            Discussion                                                                
                           The claims are directed to various methods of treatment comprising                                         
                   administering cells that express JE/MCP-1.  Claims 1 and 3 are directed to a                                       
                   method of treating cancer (or, as recited in the claims, a “method of suppressing                                  
                   tumor formation” and a “method of increasing monocyte mediated tumoricidal                                         
                   activity,” respectively).  Claim 4 is directed to a “method of treating a localized                                
                   side-effect of malignancy” by “locally administering” cells that express JE/MCP-1.                                 
                   Claim 6 is directed to a “method of combatting a parasitic infection” by                                           
                   administering cells that express JE/MCP-1.  The rest of the claims are dependent                                   
                   on one of claims 1, 3, 4, or 6.                                                                                    
                           The examiner rejected all of the claims as nonenabled, on the basis that                                   
                   “sufficient guidance as to routes of delivery, delivery vectors, dosage amounts                                    





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