Ex Parte Rosenbloom - Page 3


                 Appeal No. 2004-0340                                                         Page 3                    
                 Application No. 09/847,121                                                                             

                        “The second active ingredient of the compositions . . . is an aldose                            
                 reductase inhibitor.  Numerous suitable aldose reductase inhibitors are known to                       
                 persons skilled in the art.”  Page 5.  One specific example is quercetin.  Page 6,                     
                 lines 11-12.  “The aldose reductase inhibitor is used in an amount that provides                       
                 substantially the same level of aldose reductase inhibition as 13-21.4 mg/kg body                      
                 weight of the patient per day of quercetin.”  Page 6, lines 24-25.                                     
                        “Another active ingredient in the compositions . . . is the antioxidant.”                       
                 Page 6, lines 31-32.  Preferred antioxidants include “ascorbyl palmitate, ascorbic                     
                 acid (vitamin C), vitamin A, [and] vitamin E.”  Page 7, lines 11-12.  “Ascorbyl                        
                 palmitate may be used in amounts of 11-28.6 mg/kg body weight of the patient                           
                 per day. . . .  When vitamin E is employed as mixed tocopherols, an amount of                          
                 about 4-11.4 IU per kg body weight of the patient, per day may be employed. . . .                      
                 When vitamin A is employed, an amount of about 170-357.1 IU per kg body                                
                 weight of the patient, per day, is employed.”  Page 7, lines 22-31.                                    
                        “Dosages may be administered 1-10 times per day. . . .  Thus, the                               
                 composition of the invention may comprise anywhere from one tenth of the daily                         
                 minimum dosage of the various active ingredients up to a maximum of the daily                          
                 maximum dosage of the various active ingredients.”  Page 10, lines 22-28.                              
                                                      Discussion                                                        
                        The claims are directed to a composition comprising three compounds:                            
                 vitamin D3 (or a specific derivative thereof) in an amount effective to promote                        
                 synthesis of nerve growth factor; an aldose reductase inhibitor in an amount                           
                 effective to inhibit aldose reductase; and “an effective amount of an antioxidant.”                    





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