Ex parte MONTE - Page 5

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

                hydrolyzing enzyme, i.e., a protease (claims 1 and 7-9).  All claims require 0.025 to 100                                      
                milligrams of protease per liter of infant milk formula.                                                                       

                         Thibault and Martinez both describe hypoallergenic milk products containing                                           
                partially hydrolyzed whey proteins prepared by enzymatic hydrolysis using a mixture of                                         
                chymotrypsin/trypsin.  Thibault uses an enzyme mixture having a chymotrypsin/trypsin                                           
                activity ratio between 1.5 and 3.0 under defined conditions until the alpha-lactalbumin is                                     
                totally eliminated, followed by separation of the enzymes and residual unhydrolyzed                                            
                proteins (c. 2, ll. 36-50; c. 3, ll. 46-53), principally serum albumin and immunoglobulins (c.                                 
                7, ll. 23-26).  Martinez uses an enzyme mixture having a trypsin/chymotrypsin activity ratio                                   
                of 1.3 to 18 (i.e., a chymotrypsin/trypsin activity of about 0.8 to about 5.6) to result in a 4 to                             
                10% degree of hydrolysis (c. 2, ll. 11-18; c. 3, ll. 16-21) and discloses packaging infant                                     
                formula hydrolysate in any type of conventional container, e.g., glass, plastic, coated metal                                  
                cans, etc. (c. 6, ll. 24-26).  Optionally, Martinez preheats the protein solution prior to                                     
                hydrolysis to insure denaturation of whey protein fractions, e.g., BSA and immunoglobulin                                      
                (c. 3, ll. 25-28).                                                                                                             
                         Karjalainen has been discussed above.  The examiner found that "Karjalainen                                           
                teaches that ABBOS is the BSA peptide responsible for triggering diabetes because anti-                                        

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