Ex Parte Maggiore et al - Page 9

                Appeal 2006-2897                                                                                
                Application 10/074,715                                                                          

                                                 ANALYSIS                                                       
                       The ultimate question before us is whether Appellants’ claimed                           
                preserving composition, “consisting essentially of” a chelating agent and a                     
                cell lysing agent and “being capable of preserving thyroid stimulating                          
                hormone,” would have been obvious in view of Steaffens’ stabilizing                             
                composition comprising these two agents and additional components.  The                         
                answer to this question depends upon our interpretation of claim 12,                            
                including its language “consisting essentially of” and “being capable of                        
                preserving thyroid stimulating hormone.”  The answer also depends upon                          
                our understanding of what the Examiner must show to make a prima facie                          
                case of obviousness.                                                                            
                       Giving claim 12 its broadest reasonable interpretation, its preserving                   
                composition requires two components—“about 0.05 to about 0.5 weight                             
                percent of a chelating  agent” and “about 5 to about 25 weight percent of a                     
                cell lysing agent” in an aqueous medium.  Due to the language “up to,” the                      
                recited the antifreeze and preservative agents are optional.  Steaffens clearly                 
                discloses preserving compositions having a chelating agent and a cell lysing                    
                agent in amounts that encompass or overlap Appellants’ claimed ranges.                          
                The language “consisting essentially of” excludes other components that                         
                materially affect the claimed composition.  In each of Steaffens’                               
                embodiments, Steaffens includes additional components, i.e., a blocking                         







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