Ex Parte Polonsky et al - Page 9


                     Appeal No.  2005-0258                                                                           Page 9                        
                     Application No.  09/768,877                                                                                                   
                     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.                                               
                     (bracketed material in original).                                                                                             
                              The Lilly court explained that                                                                                       
                              a generic statement such as. . . ‘mammalian insulin cDNA,’ without                                                   
                              more, is not an adequate written description of the genus because                                                    
                              it does not distinguish the 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.                                                                                                
                     Id. at 1568, 43 USPQ2d at 1406.  Finally, the Lilly court set out exemplary ways                                              
                     in which a genus of cDNAs could 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.                                                                                                                           
                              Our appellate reviewing court revisited the issue of describing DNA.  See                                            
                     Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed.                                                     
                     Cir. 2002).  The Enzo court held that a claimed DNA could be described without,                                               
                     necessarily, disclosing its structure.  The court adopted the standard that “the                                              
                     written description requirement can be met by ‘show[ing] 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,                                         







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