Ex Parte CUNNINGHAM et al - Page 11


                  Appeal No. 2003-1469                                                           Page 11                     
                  Application No. 08/479,886                                                                                 

                  74.  The variant of claim 54 wherein said variant is covalently attached to a                              
                  polyethylene glycol molecule.                                                                              
                         The instant specification discloses that the helices 1 and 2 of human                               
                  growth hormone span amino acids 6-33 and 72-92, respectively.  See page 15.                                
                  Thus, the loop linking helices 1 and 2 apparently is made up of amino acids 34-                            
                  71; the C-terminal 2/3 of that loop would therefore correspond to amino acids 46-                          
                  71.  The specification also discloses that helix 4 of human growth hormone spans                           
                  amino acids 155-184.  See page 15.  Thus, the C-terminal 1/2 of that helix would                           
                  correspond to amino acids 169-184.  In other words, the claims in the two                                  
                  applications appear to define substantially similar products, albeit in different                          
                  terms.  Of course, the claims of the ‘883 application are limited to mammalian                             
                  growth hormone variants, while the instant claims are not; the claims therefore do                         
                  not appear to be directed to identical subject matter.                                                     
                         Upon return of this case, the examiner should consider whether the claims                           
                  of this application and application 08/479,883 are unpatentable for obviousness-                           
                  type double patenting.  If so, a provisional rejection on that basis should be made                        
                  in both applications.                                                                                      
                         The examiner should also note that a restriction requirement precludes a                            
                  double patenting rejection only if the claims in the respective applications are                           
                  maintained consonant with the restriction requirement.  “Consonance requires                               
                  that the line of demarcation between the ‘independent and distinct inventions’                             
                  that prompted the restriction requirement be maintained.  Though the claims may                            
                  be amended, they must not be so amended as to bring them back over the line                                






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