Ex Parte Angello - Page 3


                 Appeal No. 2003-0736                                                           Page 3                    
                 Application No. 09/720,007                                                                               

                 page 4, but a preferred analog is 1-(aminomethyl)-cyclohexane acetic acid, also                          
                 known as gabapentin.  Page 3.  The specification theorizes that                                          
                         gabapentin could have a dual mechanism in the relief of acute renal                              
                         colic through its interference with central and peripheral pain                                  
                         pathways in addition to its potential to provide ureter smooth                                   
                         muscle relaxation.  Based on this possible dual mechanism                                        
                         gabapentin provides superior pain relief for renal colic relative to                             
                         existing analgesics.                                                                             
                 Page 7.                                                                                                  
                                                       Discussion                                                         
                         The claims are directed to a method of “treating a mammal suffering from                         
                 renal colic” by administering an effective amount of a GABA analog.  As the                              
                 specification makes clear, the effect of the treatment is simply to relieve the pain                     
                 associated with the passage of kidney stones, not to treat the renal colic per se.                       
                         The examiner rejected the claims as obvious in view of Singh, Wetzel, and                        
                 Field.  The examiner cited Singh and Wetzel as “teach[ing] that gabapentin                               
                 and/or pregabalin can be used as a pain killer for use in a variety of pain                              
                 syndromes,” although he acknowledged that “neither Singh nor Wetzel et al.                               
                 highlight that pain resulting from renal colic could be effectively relieved.”                           
                 Examiner’s Answer, page 3.  The examiner concluded that the claimed method                               
                 would have been obvious nonetheless, because                                                             
                         Singh and Wetzel et al. disclose the presently claimed actives for                               
                         the treatment of variety of pain disorders and Field et al. . . .                                
                         teaches that gabapentin or pregabalin can be used to relieve pain                                
                         without causing the side effects of morphine.  From the above, the                               
                         skilled artisan would have been motivated to employ either                                       
                         gabapentin or pregabalin for the treatment of pain associated with                               
                         renal colic because the actives were known to be useful for treating                             






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