Ex Parte SAMARITANI et al - Page 15



            (page 20), nothing in the specification would support a                                      
            definition of "stable" in the claims as requiring stability for a                            
            24-week period or any other particular period.                                               
                  We also note that the claim otherwise requires a                                       
            "stabilizing" amount of mannitol.  Various tests are described in                            
            which varying amounts of mannitol are mixed with r-hCG.  Use of                              
            the amounts of mannitol set out in the specification presumably                              
            would result in a "stable" composition.  Hence, it can be argued                             
            that "stable" adds nothing to the claim which is not already                                 
            there by virtue of the limitation requiring a stabilizing amount                             
            of mannitol.  Accordingly, we decline to give any weight to the                              
            word "stable" in the preamble of claim 1.  However, even if we                               
            did give the term some weight, in light of the fact that                                     
            applicants' claim 1 is to be construed broadly consistent with                               
            the specification, we would hold that "stable" at best would mean                            
            that the composition is stable for any period of time.                                       
                  Nothing in claim 1 requires that the liquid pharmaceutical                             
            composition be in liquid form for any particular time.  Hence,                               
            the claim reads on lyophilized r-hCG/mannitol compositions which                             
            have been reconstituted to liquid form just prior to                                         
            administration.                                                                              
                        2.    Prima facie obviousness                                                    
                  An understanding of our rationale in support of obviousness                            
            requires, inter alia, (1) an understanding of the broad scope of                             
            claim 1, (2) practices said to be used in the prior art and                                  

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