Ex parte MONTE - Page 2




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


                                           1.  An article of manufacture for use in altering the appearance to the                                                                        
                                immune system of an infant of protein sections of bovine serum albumin,                                                                                   
                                said article of manufacture comprising                                                                                                                    
                                           (a)        a sealed container;                                                                                                                 
                                           (b)        a nutritionally balanced milk formulation in said sealed                                                                            
                                                      container, said milk formulation including bovine serum                                                                             
                                                      albumin and including an active protease enzyme in a                                                                                
                                                      concentration of 0.025 to 100 milligrams of said enzyme per                                                                         
                                                      liter of said milk formulation, said protease enzyme in said                                                                        
                                                      container cleaving protein-to-protein bonds to alter the                                                                            
                                                      structure of said bovine serum albumin.                                                                                             
                                           2.  A dietary enzymatic process for enabling the immune system of an                                                                           
                                infant to distinguish between the ABBOS amino acid section of bovine                                                                                      
                                serum albumin and the p69 amino acid section of insulin-producing beta                                                                                    
                                cells, comprising the steps of                                                                                                                            
                                           (a)        preparing an infant milk formula, said infant milk formula being                                                                    
                                                      prepared by                                                                                                                         
                                                      (i)        sterilizing a milk formulation including bovine serum                                                                    
                                                                 albumin;                                                                                                                 
                                                      (ii)       adding a sterilized protease enzyme to said milk                                                                         
                                                                 formulation in a concentration of 0.025 to 100                                                                           
                                                                 milligrams of said enzyme per liter of said milk                                                                         
                                                                 formulation;                                                                                                             
                                           (b)        packaging said infant milk formula prepared in step (a) in a                                                                        
                                                      sealed container such that while said milk formula is in said                                                                       
                                                      container, said protease enzyme cleaves peptide bonds of                                                                            
                                                      said bovine serum albumin to alter the ABBOS amino acid                                                                             
                                                      section of the bovine serum albumin such that anti-ABBOS                                                                            
                                                      antibodies produced by an infant ingesting said infant milk                                                                         
                                                      formula will not attack the p69 amino acid section of insulin-                                                                      
                                                      producing beta cells in the infant; and,                                                                                            
                                           (c)        feeding the infant by opening said container and administering                                                                      
                                                      said infant milk formula to the digestive tract of the infant such                                                                  
                                                      that the infant's immune system is exposed to the altered                                                                           
                                                      ABBOS amino acid section of the bovine serum albumin.                                                                               



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