Ex parte SHIBLEY et al. - Page 11




              Appeal No. 1997-2512                                                                                           
              Application No. 08/118,905                                                                                     

                                    “The present invention overcomes the problems described above and                        
                             provides a method (and a corresponding vaccine) for the immunization of                         
                             cats against T. gondii challenge which eliminates the phenomenon of oocyst                      
                             shedding in the vaccinated cats.                                                                
                                    Broadly speaking, the method of the invention involves administering                     
                             to cats (preferably orally) an effective amount of a vaccine comprising a                       
                             specific mutant of T. gondii which has been found to immunize 84% of cats                       
                             without the need of chemoprophylaxis.”                                                          

              See column 2, lines 38-47.  The T. gondii vaccine is the subject of dependent claim 15                         

              and falls within the scope of “biological or pharmaceutical material” as recited in appealed                   
              claim 12.  See page 4, line 8 to page 10, line 21.                                                             
                      Frenkel describes the administration of the vaccine to cats as follows:                                
                                    “Clones of Ara-A resistant Toxoplasma were grown in human                                
                             fibroblast tissue cultures for short periods of time, but were normally                         
                             maintained as chronic infections in mice.  These were injected either                           
                             subcutaneously (sc) or intraperitoneally (ip) and to prevent illness and permit                 
                             development of bradyzoites in tissue cysts, the mice were treated from days                     
                             3 to 14 with sulfamerazine-sodium (Sigma Chemical Co., St. Louis, MO) 15                        
                             mg/ 100 ml of water, given ad libitum to drink.  After at least one month, a                    
                             mouse infected with a particular strain was killed, bled to be checked for the                  
                             development of antibody, and a brain smear examined by light microscopy                         
                             for the presence of cysts of Toxoplasma.  The carcass of a mouse infected                       
                             with a given candidate strain was then fed to one or several seronegative,                      
                             weaned kittens and the feces were examined for the presence of oocysts                          
                             over the next 30 days.”                                                                         












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