Ex parte MONTE - Page 4

                Appeal No. 1997-3537                                                                                                           
                Application No. 08/395,867                                                                                                     

                appellant's brief (Paper No. 8, filed December 16, 1996) for the appellant's arguments                                         

                         As explained by Karjalainen (p. 302):                                                                                 

                         Abstract  Background.  Cow's milk has been implicated as a possible                                                   
                         trigger of the autoimmune response that destroys pancreatic beta cells in                                             
                         genetically susceptible hosts, thus causing diabetes mellitus.  Studies in                                            
                         animals have suggested that bovine serum albumin (BSA) is the milk protein                                            
                         responsible, and an albumin peptide containing 17 amino acids (ABBOS)                                                 
                         may be the reactive epitope.  Antibodies to this peptide react with p69, a                                            
                         beta-cell surface protein that may represent the target antigen for milk-                                             
                         induced beta-cell--specific immunity.                                                                                 
                Indeed, all of the diabetic patients studied by Karjalainen had elevated levels of anti-BSA                                    
                antibodies (but not of antibodies to other milk proteins), the bulk of which were specific for                                 
                ABBOS (abstract, p. 302; p. 303, c. 2, para. 4).                                                                               
                                                            THE INVENTION                                                                      
                         The claimed invention is directed to processes for enzymatically hydrolyzing BSA                                      
                (claims 6 and 11), in particular its 17 amino acid ABBOS portion (claims 2-5, 10 and 12-                                       
                14), in infant milk formula such that antibodies produced by an infant ingesting the                                           
                hydrolyzed milk formula will be reactive with an altered, i.e., hydrolyzed, ABBOS epitope                                      
                and, consequently, will not attack the p69 protein of the infant's pancreatic beta cells                                       
                (claims 2-5, 10 and 14); and, to sealed containers of infant milk formula containing                                           

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