Ex Parte PARADISSIS et al - Page 5


                 Appeal No. 2001-1909                                                         Page 5                    
                 Application No. 09/016,786                                                                             

                 Claims 50 and 59 of the preliminary amendment were further amended (see                                
                 paper no. 5) to change, most notably, the administration of the composition from                       
                 the original “substantially continuous 24-hour basis” to the current administration                    
                 “at night.” The dependency of claim 56 was also changed from claim 52 to claim                         
                 50. Appellants (paper no. 5, p. 3) have stated that the basis for these changes                        
                 can be found in the specification at page 10, lines 11-23, reproduced supra.                           
                 Remaining claims 51-55, 57-58 and 60-61 remain unchanged.                                              
                        Claims 50 is illustrative of the claims on appeal. It is directed to a process                  
                 for “optimizing the regeneration, maintenance or repair of nerve tissue that                           
                 occurs naturally during sleep in a human” involving administering a composition                        
                 containing certain B-complex vitamins to a human. Claim 50 has two salient                             
                 features:                                                                                              
                        1) the composition to be administered is one “consisting essentially of at                      
                 least one water soluble B complex vitamin” independently selected from the                             
                 group consisting of  vitamins B (folic acid), B1 (thiamine), B2 (riboflavin), B3                       
                 (niacinamide), B55 (pantothenic acid),  B6 (pyridoxine), and B12; and,                                 
                        2) the “administration” takes place “at night.”                                                 

                                                                                                                        
                 a method of improving the regeneration of nerve tissue, call for administering at least one            
                 pharmaceutically-acceptable B complex vitamin “on a substantially continuous 24-hour basis.”           
                 According to the dependent claims, the continuous 24-hour administration can be accomplished           
                 by a controlled release dosage (claim 33) that is administered once every 24 hours (claim 34) or       
                 the total dosage can be administered in portions over a 24-hour period (claim 35) by administering     
                 a controlled dosage twice every 24 hours (claim 36). The remaining claims are directed to the          
                 types of vitamins and agents (claims 32 and 40) and dosage forms (claims 37-39) that can be            
                 administered.                                                                                          
                 5 There is a misspelling in claim 50. The claim as written specifies “Pantothenic Acid (Vitamin B3),   
                 In fact, pantothenic acid is another name for vitamin B5. This should be corrected.                    
                                                                                                                       





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