Ex parte MELLO et al. - Page 11

                 Appeal No. 95-2655                                                                                                                     
                 Application 07/912,029                                                                                                                 

                 compared.  The McCulley article compares Vitrax (E. Weck),                                                                             
                 Amvisc, Healon and two laboratory formulations using the same                                                                          
                 concentration of Vitrax SH (sodium hyaluronate).  Neither                                                                              
                 McCulley nor the declarant Mello identifies these laboratory                                                                           
                 compositions .  However, it appears that the best results7                                                                                                                
                 occurred with these lab formulations.  For the first                                                                                   
                 procedure, the lab formulations were nontoxic while Vitrax                                                                             
                 caused some transient acute damage (although it was much less                                                                          
                 toxic than Amvisc or Healon).  For the second procedure (to                                                                            
                 simulate leaving the material in place after surgical                                                                                  
                 closure), all of the commercial preparations (Vitrax, Amvisc,                                                                          
                 and Healon) were toxic.  The McCulley article further states                                                                           
                 that the lab formulations using Weck SH were tolerated longer                                                                          
                 than any of the commercial products.  To properly evaluate the                                                                         
                 comparisons in the McCulley article, the compositions of each                                                                          
                 preparation would have to be known to determine if the claimed                                                                         
                 subject matter was compared against the closest prior art.                                                                             

                          7Mello does identify the Vitrax formulation as being                                                                          
                 “substantially identical” to the ionic composition of appealed                                                                         
                 claim 9 (Declaration, page 1).  VITRAX™ is identified by a                                                                             
                 product information sheet , filed on Oct. 1, 1993,as Paper No.                                                                         
                 30.  Neither appellants nor declarant state whether the Vitrax                                                                         
                 (E. Weck) of the McCulley article is equivalent to VITRAX™.                                                                            

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