Ex parte PERSHADSINGH et al. - Page 9




                   Appeal No. 95-0885                                                                                                                                  
                   Application 07/725,327                                                                                                                              


                   generic to “essential hypertension.”  Considering the term “hypertension” in the context of its                                                     
                   ordinary meaning, we find that Hindley’s “hypertension” would include “essential hypertension.”                                                     
                             Both Mark and Kurtz I in their separate declarations set forth three reasons “why one of skill                                            
                   would have no reason to expect that essential hypertension is treatable with thiazolidines after reading                                            
                   the Hindley patent” (Mark declaration, ¶6(b) and Kurtz I declaration, ¶5(a)).  First, Hindley is                                                    
                   primarily directed to the use of thiazolidines to treat diabetes and therefore one skilled in the art                                               
                   would  read  Hindley  as  treating  other  diseases  associated  with  Type  II  diabetes,  including                                               
                   hypertension, cardiovascular disease such as vascular occlusions, and eating disorders such as                                                      
                   hyperphagia (overeating) or polydipsia (excessive thirst).  Second, if one reads Hindley as treating                                                
                   the general “sign” of hypertension, the reference is meaningless outside the context of diabetes                                                    
                   because the reference would be suggesting a treatment for hundreds of different clinical disorders                                                  
                   with no guidance to the medical doctor for using the Hindley’s compound to treat a specific disorder.                                               
                   The Mark declaration points out further that drugs effective for secondary hypertension conditions                                                  
                   such as glucocorticoid remediable aldosteronism can “dangerously exacerbate essential hypertension.”                                                
                   Third, one skilled in the art would not have a reasonable expectation that Hindley’s compound would                                                 
                   be effective against “essential hypertension” because the etiology of essential hypertension is                                                     
                   complex and involves multiple factors such as insulin resistance, impaired renal function, excess                                                   
                   sympathetic nervous system activity, excess salt intake, and insufficient potassium intake.  Because                                                
                   of these multiple factors, one skilled in the art would not have been led to conclude with a reasonable                                             
                   degree of certainty that Hindley’s thiazolidines would be useful to treat “essential hypertension.”                                                 
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