Ex Parte XHONNEUX et al - Page 8




              Appeal No. 1996-2910                                                                                     
              Application 07/825,488                                                                                   

                     On return of this application, we recommend that the examiner reevaluate the                      
              patentability of claim 25 under 35 U.S.C. § 102 in light of the Van Lommen reference,                    
              the decisions in Schaumann and May, and the foregoing remarks.                                           
                     (2)  In making a patentability determination, “[a]nalysis begins with a key legal                 
              question -- what is the invention claimed?” since “[c]laim interpretation . . . will normally            
              control the remainder of the decisional process,” Panduit Corp. v. Dennison Mfg. Co.,                    
              810 F.2d 1561, 1567-68, 1 USPQ2d 1593, 1597 (Fed. Cir. 1987), cert. denied, 481 U.S.                     
              1052 (1987).                                                                                             
                     Claim 26 is directed to a pharmaceutical composition “consisting essentially of” a                
              pharmaceutically acceptable carrier, and as active ingredients, (a) the blood pressure                   
              reducing SRRR stereoisomer of ","’-[iminobismethylene]bis[6-fluoro-3,4-dihydro-2H-1-                     
              benzopyran-2-methanol] or a pharmaceutically acceptable acid addition salt thereof and                   
              (b) its enantiomer, RSSS, or a pharmaceutically acceptable acid addition salt thereof;                   
              the RSSS stereoisomer being present in an amount capable of potentiating the blood                       
              pressure lowering effect of the SRRR stereoisomer.  It is well settled that “the phrase                  
              ‘consisting essentially of’ limits the scope of a claim to the specified ingredients and                 
              those that do not materially affect the basic and novel characteristic(s) of a                           
              composition.”  In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976).                          
              Here, a basic and novel characteristic of the pharmaceutical composition of claim 26 is                  
              its blood pressure reducing or antihypertensive effect.  Thus, claim 26 is open to                       
              ingredients that do not materially affect its antihypertensive activity.                                 
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