Ex Parte Maggiore et al - Page 10

                Appeal 2006-2897                                                                                
                Application 10/074,715                                                                          

                agent and a detergent.  However, there is no evidence of record that these                      
                additional components would materially affect the composition of claim 12.1                     
                       In this regard, Appellants’ specification teaches that detergents                        
                (“surfactants”) can be added, presumably without materially impacting the                       
                claimed compositions.  Further, while Appellants argue that serum proteins                      
                (one of Steaffens’ blocking agents) would raise “potential storage stability                    
                issues” (Br. at 6), the Examiner reasonably concluded that the antimicrobial                    
                preservatives used by both Steaffens and Appellants would address any such                      
                issues.  See Ans. at 7.  Thus, the Examiner reasonably concluded these                          
                additional components would not materially affect the novel and basic                           
                characteristics of Appellants’ claimed composition.  In such a situation, and                   
                given the difficulty the Office has in determining whether additional                           
                components would materially affect a claimed invention, the burden is on                        
                Appellants to make such a showing.  They have failed to so do.2                                 
                       The interpretation of claim 12 also requires us to consider the claim                    
                language “being capable of preserving thyroid stimulating hormone.”  The                        
                situation is analogous to that relating to “consisting essentially of.”  The                    
                Examiner reasonably concluded Steaffens’ additional components would not                        
                materially affect the basic and novel characteristics of the claimed invention.                 
                It reasonably follows that Steaffens’ compositions inherently would be                          
                                                                                                               
                1 Appellants argue these components are “important, as active ingredients,”                     
                in Steaffens.  Br. at 4.  But that is not the test.  See the discussion supra at                
                pp. 7-8.                                                                                        
                2 Appellants further argue there is no teaching or suggestion “to omit the                      
                serum protein and detergent.”  Unless these components materially affect the                    
                claimed invention, which Appellants have not shown, their omission is not                       
                required.                                                                                       
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