Ex Parte PARADISSIS et al - Page 7


                 Appeal No. 2001-1909                                                         Page 7                    
                 Application No. 09/016,786                                                                             

                     1      50-52, 54                                                                                   
                     2      50-61            50-61                                                                      
                     3      56-61                                 56-61                                                 
                     4      56-57 and 59-61 56-57 and 59-61                       56-57 and 59-61                       
                 The table shows how confusingly the claims have been rejected over the prior                           
                 art. Some of the claims (e.g., claim 50) are rejected multiple times over the same                     
                 prior art combination. Other claims (e.g., claim 59) are rejected over seven                           
                 possible different art combinations: Koltringer; Koltringer/Zappia;                                    
                 Koltringer/Serfontein; Koltringer/Zappia/Briggs; Koltringer/Serfontein/Briggs;                         
                 Koltringer/Zappia/Briggs/Edgren; and, Koltringer/Serfontein/Briggs/Radebaugh.                          
                 Still other claims (e.g., claim 56) get both treatments.                                               
                       To add to the confusion, the discussion in the Examiner’s Answer does                           
                 not parallel the statements of the rejections.  The discussion is more consistent                      
                 with the claims being rejected as follows6:                                                            
                                                                                                                        
                 6  We reach this conclusion because, given that examiner cites Koltringer to show “a method of         
                 administration of folic acid [vitamin B] for the regeneration of nerve cell and nerve fibers,”         
                 Examiner’s Answer, p. 4, wherein the folic acid is administered “as a continuous infusion”,            
                 Examiner’s Answer, p. 6, it is fairly evident that Koltringer is being applied as the primary          
                 reference. Examiner concedes, however, that  Koltringer does not teach the claimed limitations of      
                 · “administration of the composition at night [per se],” Examiner’s Answer, p. 4, (see claims 50,      
                     51and 54);                                                                                         
                 ·  “the administration of [sic: the composition?] in a controlled release device,” Examiner’s          
                     Answer, p. 5, (see claims 52, 53, and 55);                                                         
                 · “a bilayer tablet containing a sustained release layer and an immediate release layer,”              
                     Examiner’s Answer, p. 8, (see claim 56); and,                                                      
                 · “the instant [bi-layer] tablet formulations,” Examiner’s Answer, p. 7, for example, a tablet         
                     which is enterically coated to reduce gastric irritation, (see claims 57 and 58, and 59-61).       
                  To address these limitations, examiner  relies on, respectively,                                      
                 · Koltringer (for its disclosure of a ”continuous infusion,” Examiner’s Answer, p. 6);                 
                 · Zappia (“teaches time release administration of B-complex vitamins,” Examiner’s Answer, p.           
                     6) or Serfontein (“teaches time release formulations for the treatment of nerve cells,”            
                     Examiner’s Answer, p. 6.);                                                                         
                 · Edgren or Radebaugh (both of which teach a “tablet formulation containing a sustained                
                     release layer and an immediate release layer,” Examiner’s Answer, p. 8); and,                      
                 · Briggs (“discloses controlled release formulations containing iron and B complex vitamins            
                     [which are] entirically coated and … teaches two layers, both are for controlled release …         
                     [and] indicates that the material in the outer layer is released in the upper gastrointestinal tract
                     and the second layer is for controlled release,” Examiner’s Answer, pp. 7-8).                      





Page:  Previous  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  Next 

Last modified: November 3, 2007