Ex Parte Lal et al - Page 13


               Appeal No. 2006-1035                                                                          Page 13                   
               Application No. 09/925,140                                                                                              

                       The court also confronted facts similar to those here in University of Rochester v.                             
               G.D. Searle & Co., Inc., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).  In that case,                                  
               the patent claimed a method of selectively inhibiting the enzyme PGHS-2 (also known                                     
               as COX-2) by “administering a non-steroidal compound that selectively inhibits activity                                 
               of the PGHS-2 gene product in a human.”  Id. at 918, 69 USPQ2d at 1888.  The patent                                     
               “described in detail how to make cells that express either COX-1 or COX-2, but not both                                 
               . . . , as well as ‘assays for screening compounds, including peptides, polynucleotides,                                
               and small organic molecules to identify those that inhibit the expression or activity of the                            
               PGHS-2 gene product.[’]”  Id. at 927, 69 USPQ2d at 1895.                                                                
                       The court held that the disclosure of screening assays and general classes of                                   
               compounds was not adequate to describe compounds having the desired activity:                                           
               without disclosure of which peptides, polynucleotides, or small organic molecules have                                  
               the desired characteristic, the claims failed to meet the description requirement of                                    
               § 112.  See id. (“As pointed out by the district court, the ‘850 patent does not disclose                               
               just ‘which “peptides, polynucleotides, and small organic molecules” have the desired                                   
               characteristic of selectively inhibiting PGHS-2.’ . . .  Without such disclosure, the                                   
               claimed methods cannot be said to have been described.”).                                                               
                       Just as in University of Rochester, the present application discloses a broad                                   
               genus of chemical compounds (DNAs encoding amino acid sequences at least 90%                                            
               identical to SEQ ID NO:1) but the claims are limited to only those compounds having a                                   
               desired characteristic (encoding naturally occurring sequences).  Just as in University of                              
                                                                                                                                       
               (Fed. Cir. 1995)).  The Eli Lilly court concluded that “a fortiori, a description that does not render a                
               claimed invention obvious does not sufficiently describe that invention for purposes of § 112, ¶ 1.”  Id.               
               The same conclusion logically applies when the claim is directed to a genus of naturally occurring DNA                  
               sequences rather than a single naturally occurring sequence.                                                            





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