Ex Parte Reguri et al - Page 13

                Appeal 2007-0313                                                                                 
                Application 10/414,447                                                                           

                precipitate the compound (Specification 2-3), while Bühlmayer used ethyl                         
                acetate (Bühlmayer, col. 49, ll. 50-51).  Without more, those skilled in the                     
                art would not have concluded different crystallization solvents and systems                      
                necessarily yield different crystalline forms.                                                   
                       In fact, such a conclusion is counter to Appellants’ own teachings that                   
                any C4-C6 straight or branched chain ketone solvent and any aliphatic                            
                hydrocarbon will suffice (Specification 2, ¶¶ 0009-0010).  If the crystal                        
                structure is as sensitive to the crystallization solvent system as suggested,                    
                one would expect more precise teachings regarding that system.                                   
                       Another concern is that Appellants do not use “consisting of” or even                     
                “consisting essentially of” language to exclude valsartan in other forms.                        
                Thus, their claims include mixtures of crystals, as long as a crystal of the                     
                claimed form is present.  It follows that, even if only a trace amount of                        
                Bühlmayer’s crystalline compound is in crystalline Form I or II, Appellants’                     
                claims to these forms would be anticipated.  See Smithkline Beecham Corp.                        
                v. Apotex, 403 F.3d 1331, 1339-40, 74 USPQ2d 1398, 1403-04 (Fed. Cir.                            
                2005) (holding that a claim to “Crystalline paroxetine hydrochloride                             
                hemihydrate,” in essence, would cover a single molecule of hemihydrate).                         
                       It is the Office’s responsibility to prevent the issuance of invalid                      
                patents.  Yet the Office does not have the facilities to determine what form                     
                or admixtures of forms Bühlmayer’s crystalline compound takes.  Given the                        







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