Ex Parte Donoho et al - Page 23


                 Appeal No. 2003-1794                                                       Page 23                    
                 Application No. 09/804,969                                                                            

                 because they have been historically well-studied (e.g., yeast, Arabidopsis, C.                        
                 elegans, Drosophila).  Other organisms are of interest because they are used as                       
                 animal models for testing pharmaceuticals (e.g., mice, chimpanzees, rhesus                            
                 monkeys, rabbits), or because they are commercially valuable (e.g., pigs, cows,                       
                 corn, rice, tomatoes), or because they are pests (e.g., fungi such as Fusarium,                       
                 common weeds like ragweed, insects such as corn borers, nonnative invaders                            
                 such as zebra mussels, etc.), or because they are pathogens (e.g., Candida,                           
                 various bacteria, tapeworms, etc.).  Under Appellants’ proposed rule, every eight                     
                 base pair-long fragment of any gene of any of these organisms—and probably                            
                 most other organisms—would be found to have patentable utility because it could                       
                 be attached to a chip and used in “research” to see what happens to expression                        
                 of that gene under various conditions.                                                                
                        Appellants’ reasoning would also vitiate the enablement requirement,                           
                 since “[t]he enablement requirement is met if the description enables any mode                        
                 of making and using the invention.”  Johns Hopkins Univ. v. CellPro Inc., 152                         
                 F.3d 1342, 1361, 47 USPQ2d 1705, 1714 (Fed. Cir. 1998) (quoting Engel Indus.,                         
                 Inc. v. Lockformer Co.,  946 F.2d 1528, 1533, 20 USPQ2d 1300, 1304 (Fed. Cir.                         
                 1991)).  If we were to agree with Appellants that any expressed gene and any                          
                 eight base pair-long fragment thereof is useful in a DNA chip, then we would also                     
                 have to hold that the specification has taught those skilled in the art one mode of                   
                 using the invention.  Thus, Appellants’ rule of per se utility would also require a                   
                 corresponding rule of per se enablement.                                                              







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