Ex Parte SAMARITANI et al - Page 13



                  great for a stable preparation containing more than one                                
                  gonadotropin.                                                                          
                  B.    Discussion                                                                       
                        1.    Scope of claim 1                                                           
                                                   a.                                                    
                  We begin our analysis by construing the scope of applicants'                           
            claim 1.  As noted above, claim 1 reads:                                                     
                        A stable, liquid pharmaceutical composition comprising                           
                  recombinant human Chorionic Gonadotropin and a stabilizing                             
                  amount of mannitol.                                                                    
                  The composition must:                                                                  
                        (1) be in "liquid" as opposed to "solid" form;                                   
                        (2) be capable of being used as a pharmaceutical;                                
                        (3) contain hCG in "recombinant" as opposed to a                                 
                              natural form; and                                                          
                        (4) contain a "stabilizing" amount of mannitol.                                  
                  The so-called "preamble" states that the composition is                                
            "stable".                                                                                    
                                                   b.                                                    
                  Our appellate reviewing court has provided guidance with                               
            respect to the weight to be given words in a preamble.  Bristol-                             
            Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368,                             
            1373, 58 USPQ2d 1508, 1513 (Fed. Cir.  2001) (if the body of the                             
            claim sets out the complete invention, and the preamble is not                               
            necessary to give "life, meaning and vitality" to the claim,                                 
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