Ex Parte GROTENDORST et al - Page 5


                  Appeal No. 2002-0427                                                             Page 5                     
                  Application No. 08/179,656                                                                                  

                  Examiner’s Answer, page 10.  She concluded that “the specification lacks an                                 
                  adequate written description for variants and non-naturally occurring analogues                             
                  of the LDGF2 of SEQ ID NO:17” because, among other reasons, “[w]ith the                                     
                  exception of [SEQ ID NO:17], the skilled artisan cannot envision the detailed                               
                  chemical structure of the encompassed proteins, and therefore conception is not                             
                  achieved until reduction to practice has occurred,” and “[o]ne cannot describe                              
                  what one has not conceived.”  Id., page 11, citing Fiers v. Revel, 984 F.2d 1164,                           
                  25 USPQ2d 1601 (Fed. Cir. 1993), and Fiddes v. Baird, 30 USPQ2d 1481 (Bd.                                   
                  Pat. App. Int. 1993).                                                                                       
                         The Federal Circuit has recently addressed the written description                                   
                  requirement in the context of  DNA-related inventions.  See Enzo Biochem, Inc.                              
                  v. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002).  The Enzo                                
                  court adopted the standard that “the written description requirement can be met                             
                  by ‘showing that an invention is complete by disclosure of sufficiently detailed,                           
                  relevant identifying characteristics . . . i.e., complete or partial structure, other                       
                  physical and/or chemical properties, functional characteristics when coupled with                           
                  a known or disclosed correlation between function and structure, or some                                    
                  combination of such characteristics.’”  Id. at 1324, 63 USPQ2d at 1613                                      
                  (emphasis omitted, bracketed material in original).                                                         
                         While the invention at issue in Enzo was DNA, the holding of that case                               
                  would also seem to apply to a claimed protein.  The court adopted its standard                              
                  from the USPTO’s Written Description Examination Guidelines.  See 296 F.3d at                               
                  1324, 63 USPQ2d at 1613 (citing the Guidelines).  The Guidelines apply to                                   





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