Ex parte GAULER et al. - Page 4


                       Appeal No.  1997-2744                                                                                                                     
                       Application No.  08/243,520                                                                                                               
                       determine the effect of a compound on osteoporosis, i.e.; an overiectomized [sic]                                                         
                       rat.  Isgaard teaches that the claimed known active agent would have activity to                                                          
                       increase long bone growth.”  The examiner finds (Answer, page 4) that “[r]egardless                                                       
                       [of appellants arguments and the Guler Declaration] the suggestion in the Mueller                                                         
                       reference that the claimed known active agents can be used to treat osteoporosis is                                                       
                       deemed sufficient suggestion to use applicants claimed active agents to treat the                                                         
                       medical disorder osteoporosis.”                                                                                                           
                                 Appellants emphasize the conclusion in Mueller that “[c]ortical bone mass                                                       
                       was only weakly affected by OVX [ovariectomy] and by treatment with either [IGF-1                                                         
                       or parathyroid] hormone,” arguing (Brief, page 6) that “the ovariectomized rat model                                                      
                       they used was inadequate to study the effect of IGF-1 on cortical bone since OVX                                                          
                       did not appear to significantly affect such bone.”  Appellants then argue (Brief, page                                                    
                       9) with reference to the Guler Declaration that the “103 rejection is based on an                                                         
                       improper ‘obvious to try’ standard.”                                                                                                      
                                 According to appellants, the Guler Declaration establishes (Brief, page 10)                                                     
                       that:                                                                                                                                     
                                 (1) “it could not be predicted from Isgaard that IGF-1 would be effective in                                                    
                                      the treatment of osteoporosis of cortical bone” …;                                                                         
                                 (2) “Mueller pertains to trabecular bone, not cortical bone” …; and                                                             
                                 (3) “any results obtained with respect to trabecular bone cannot be                                                             
                                      extrapolated to cortical bone since the two bone types are structurally                                                    
                                      and metabolically different.”                                                                                              


                                                                                                                                                                 
                       5 Paper No. 31, mailed January 5, 1995.                                                                                                   

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