Ex parte MITA et al. - Page 5




                   Appeal No. 1997-3135                                                                                                                             
                   Application 08/208,497                                                                                                                           



                   Abelson reports that topical administration of the calcium channel blocker Verapamil                                                             
                   elicited a significant and sustained reduction of intraocular pressure in human subjects with                                                    
                   ocular hypertension.  According to Abelson, this finding is supported by a previous study                                                        
                   where oral administration of the calcium channel blocker Nitrendipine caused a significant                                                       
                   drop in intraocular pressure.  See Abelson, page 157, left-hand column, last paragraph,                                                          
                   referring to Monica et al. “the effect of a calcium-channel blocking agent on intraocular                                                        
                   pressure,” American Journal of Ophthalmology, 96:814 (1983).  On the other hand,                                                                 
                                                                                                                                         1                          
                   Abelson acknowledges that his results conflict with those of Beatty and Associates,  who                                                         
                   found a slight increase in pressure (1 or 2mm Hg) in humans who had received topical                                                             
                   Verapamil.  See  Abelson's discussion of the Beatty reference at page 155, right-hand                                                            
                   column, first full paragraph; and the paragraph bridging pages 157-58.  Abelson also                                                             
                   discloses that Diltiazem, another calcium channel blocker, did not lower intraocular                                                             
                   pressure in a pilot study of ten ocular hypertensive subjects (unpublished data).  See                                                           
                   Abelson, page 158, left-hand column, last full paragraph.                                                                                        
                            In sum, Abelson does not disclose using calcium channel blockers, generically, for                                                      
                   treating glaucoma.  According to Abelson, the topical administration of Verapamil elicited                                                       
                   a significant and sustained reduction of intraocular pressure in human subjects with ocular                                                      

                            1Beatty et al., “Elevation of intraocular pressure by calcium channel blockers,” Arch.                                                  
                   Ophthalmol., 102:1072 (1984).                                                                                                                    

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