Ex Parte KRIEGER - Page 11

                Appeal  2007-4148                                                                              
                Application 09/148,012                                                                         

                of fertility by administration of a cholesterol lowering drug, probucal, . . .                 
                provides further support for the claimed method.”  (Br. 13.)                                   
                      We do not agree that the Specification’s examples or the Miettinen                       
                paper2 provide an enabling disclosure.  The Specification’s examples show                      
                only that an SR-BI-binding antibody can inhibit some of the activity of                        
                SR-BI in cells in vitro; they do not show that that level of inhibition inhibits               
                pregnancy or even that it can be achieved in a mammalian subject.  None of                     
                the other examples substantively contribute to the enablement of the method                    
                defined by claim 1.                                                                            
                      The Miettinen paper does not supply the enabling guidance missing                        
                from the Specification.  First, Miettinen was published after the effective                    
                filing date of the present application and therefore can be relied on only to                  
                confirm assertions made in the Specification.  See In re Glass, 492 F.2d                       
                1228, 1232 (CCPA 1974) (“[A]pplication sufficiency under § 112, first                          
                paragraph, must be judged as of its filing date.  It is an applicant’s obligation              
                to supply enabling disclosure without reliance on what others may publish                      
                after he has filed an application on what is supposed to be a completed                        
                invention.  If he cannot supply enabling information, he is not yet in a                       
                position to file.” (emphasis in original)).  The Specification does not assert                 
                that drugs that affect plasma cholesterol levels, without affecting SR-BI                      
                activity, can inhibit pregnancy.  In addition, as discussed above, Appellant                   
                has pointed to no evidence in the record that would show that cholesterol-                     

                                                                                                              
                2 Miettinen et al., “Abnormal lipoprotein metabolism and reversible female                     
                infertility in HDL receptor (SR-BI)-deficient mice,” Journal of Clinical                       
                Investigation, Vol. 108, pp. 1717-1722 (2001).                                                 
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