Ex Parte SAMARITANI et al - Page 16



            (3) the extent to which claim 1 would preclude similar practices                             
            which we hold to have been obvious over the practice which is                                
            explicitly described in the prior art.                                                       
                                                   a.                                                    
                  It appears from the prior art that once upon a time the                                
            "art" used natural hCG as the primary source for pharmaceutical                              
            application.  Apparently, natural hCG is quite stable, at least                              
            if we are to believe EPO.  According to EPO, some natural hCG                                
            products do not need stabilizers, although we note that a                                    
            "bulking agent" amount of mannitol (now understood to be a                                   
            stabilizer) is said to have been added to hCG prior to                                       
            lyophilization.  Natural contaminants are said to be a                                       
            possibility for explaining why natural hCG remained stable after                             
            lyophilization.  EPO reveals, however, that as more pure hCG came                            
            to be, stabilization problems developed.                                                     
                  Somewhere along the line hCG in recombinant form [r-hCG]                               
            came to exist--all would recognize that r-hCG would be quite                                 
            pure.  Hence, given its purity, it reasonably would have been                                
            expected from EPO that r-hCG would need a stabilizer.  The PCT                               
            application confirms what one skilled in the art would have                                  
            divined from EPO.  According to the PCT application, sucrose is                              
            "the solution" to stability problems.                                                        
                  To be sure, the PCT application at first blush would appear                            
            to be a basis for one skilled in the art to tout sucrose in favor                            
            of mannitol, saying that (1) the "most stable formulations"                                  

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