Ex Parte Sun et al - Page 5




              Appeal No. 2003-1993                                                                                            
              Application No. 09/470,526                                                                                      
                      In claims involving chemical materials, generic formulae usually indicate                               
                      with specificity what the generic claims encompass.  One skilled in the art                             
                      can distinguish such a formula from others and can identify many of the                                 
                      species that the claims encompass.  Accordingly, such a formula is                                      
                      normally an adequate description of the claimed genus . . . [H]owever, a                                
                      generic statement such as “vertebrate insulin cDNA” or “mammalian                                       
                      insulin cDNA,” without more, is not an adequate written description of the                              
                      genus because it does not distinguish the claimed genus from others,                                    
                      except by function.  It does not specifically define any of the genes that                              
                      fall within its definition.  It does not define any structural features                                 
                      commonly possessed by members of the genus that distinguish them                                        
                      from others.  One skilled in the art therefore cannot, as one can do with a                             
                      fully described genus, visualize or recognize the identity of the members                               
                      of the genus.  A definition by function, as we have previously indicated,                               
                      does not suffice to define the genus because it is only an indication of                                
                      what the gene does, rather than what it is.                                                             
              Id.                                                                                                             
                      The Lilly court also stated that “[a] written description of an invention involving a                   
              chemical genus, like a description of a chemical species, ‘requires a precise definition,                       
              such as by structure, formula, [or] chemical name,’ of the claimed subject matter                               
              sufficient to distinguish it from other materials.”  Id. at 1567, 43 USPQ2d at 1405.                            
              Finally, the court addressed the manner by which a genus of cDNAs might be                                      
              described.  “A description of a genus of cDNAs may be achieved by means of a                                    
              recitation of a representative number of cDNAs, defined by nucleotide sequence, falling                         
              within the scope of the genus or of a recitation of structural features common to the                           
              members of the genus, which features constitute a substantial portion of the genus.”  Id.                       
              at 1568, 43 USPQ2d at 1406.                                                                                     




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