Ex parte GHIONE et al. - Page 17


                            Appeal No. 1995-3257                                                                                                                                                  
                            Application 08/056,382                                                                                                                                                




                            GRIFFIN, BUTLER, WHISENHUNT                                                                                                                                           
                            And KURTOSSY                                                                                                                                                          
                            STE. PH-1                                                                                                                                                             
                            2300 NINTH STREET, SOUTH                                                                                                                                              
                            ARLINGTON, VA    22204-2316                                                                                                                                           


























                            HCL/dal                                                                                                                                                               
                            1"With regard to the prevention of alopecia, the Examiner does not                                                                                                    
                            consider 8 day old Wistar rats to be an accepted model system; the                                                                                                    
                            growth of first hair in a development stage characterized by rapid                                                                                                    
                            growth and cell division is not analogous to the growth of hair in an                                                                                                 
                            adult animal.  Further, the prevention of inhibition of new hair growth                                                                                               
                            is not analogous to the prevention of hair loss....  It has not been                                                                                                  
                            established that the growth of hair on rats is analogous to human hair                                                                                                
                            growth on the scalp (as opposed to other body hair), nor is it                                                                                                        
                            believable that methods such as those disclosed in the current                                                                                                        
                            specification as filed would have an analogous effect regardless of the                                                                                               
                            type of hair growth to which they were applied.  Therefore, applicants                                                                                                
                            have not taught how to use the method of the invention for prevention or                                                                                              
                            treatment of alopecia....  The model system has not been shown to be                                                                                                  
                            predictive of the effect achieved in humans; in the current case, as no                                                                                               

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