Ex parte GAULER et al. - Page 5


                  Appeal No.  1997-2744                                                                                         
                  Application No.  08/243,520                                                                                   
                          The examiner dismisses the Guler Declaration (Answer, page 4) as “opinion                             
                  only since it does not set forth how the trabecular bone and cortical bone differ                             
                  structurally and metabolically.”  The examiner erred in dismissing the Guler                                  
                  Declaration without consideration.  As set forth in In re Lindell, 385 F.2d 453, 456,                         
                  155 USPQ 521, 524 (CCPA 1967) “some weight ought to be given to a                                             
                  persuasively supported statement of one skilled in the art on what was not obvious                            
                  to him” [citation omitted].                                                                                   
                          Furthermore, as explained by appellants (Reply Brief, pages 2-4):                                     
                                         Dr. Guler stated the following with respect to the                                     
                                 distinctions between cortical bone and trabecular bone:                                        
                                         In this regard, the skeleton is made up of both cortical,                              
                                         or compact bone, and trabecular or cancellous bone.                                    
                                         … Trabecular bone has a higher turnover rate than                                      
                                         cortical bone (about eight times as high).  Based on the                               
                                         foregoing, it is my opinion that any results obtained with                             
                                         respect to trabecular bone cannot be extrapolated to                                   
                                         cortical bone since the two bone types are structurally                                
                                         and metabolically different.                                                           
                                         …                                                                                      
                                 Dr. Guler distinguished the structure and metabolism of                                        
                                 immature bone found in young mammals as studied in Mueller                                     
                                 from that of mature bone which is the locus of cortical bone                                   
                                 osteoporosis …                                                                                 
                                         Cortical bone osteoporosis, which can be caused by                                     
                                         post-menopausal estrogen deficiency, is a disease of                                   
                                         mature bone and mature bond differs both structurally                                  
                                         and metabolically from immature bone. … [T]he                                          
                                         composition of mature bone differs from immature                                       
                                         bone.  For example, bone is made up of a matrix                                        
                                         component and several salts.  Newly formed bone                                        
                                         generally has a considerably higher percentage of                                      
                                         matrix in relation to salts as compared with mature,                                   
                                         compact bone.  Thus, any results from studies                                          
                                         concerning immature bone cannot be extrapolated to                                     
                                         mature bone.                                                                           



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