Ex Parte Gonda et al - Page 5


               Appeal Number: 2006-1762                                                                                             
               Application Number: 09/848,774                                                                                       

               argument by the appellants, both applied references describe structural devices to precisely                         
               control the amount of a medicament delivered.  Velasquez resorts to precise measuring of small                       
               amounts in equal sized depressions for use in an inhaler.  Schenk resorts to a metering chamber.                     
               To the extent the appellants mean to argue that neither reference teaches how to translate those                     
               structural controls into the precise amounts of insulin needed to be deposited for inhalation, we                    
               again note the broad ranges both disclosed and claimed in the appellants’ application that suggest                   
               the precise amount is not critical to the invention, or more properly, the precise amount is highly                  
               dependent on the individual patient and therefore cannot be claimed with precision.  Again, we                       
               note that the appellants’ disclosure at p. 21 supports this high degree of variability among                         
               patients.  We further note that the claim does not recite any structural mechanism for precisely                     
               matching the amounts of insulin with the patient.  Therefore the appellants’ arguments that                          
               neither reference teaches how to translate those structural controls into the precise amounts of                     
               insulin needed to be deposited for inhalation are unpersuasive.                                                      
                    We further note that the appellants have attempted to portray the examiner’s rejection as an                    
               obvious to try application, followed by an admonition that the law does not support such a                           
               theory.  However, our reviewing court has stated that “it is not inventive to discover the optimum                   
               or  workable ranges by routine experimentation.”  In re Geisler, 116 F.3d 1465, 43 USPQ2d                            
               1362 (Fed. Cir. 1997).  Therefore, we find the appellant's arguments as to such optimization to                      
               be unpersuasive.                                                                                                     
                    As to claims 25, 26, 31 and 35, the appellants repeat the above arguments and they are                          
               equally unpersuasive as to these claims.  The appellants further argue claim limitations of                          
               repetition (claim 25, 26 and 31 -  [See Brief at p. 14-17]) and of lowering the glucose level to an                  
               acceptable level (claim 31 -  [See Brief at p. 16]) and of controlling the glucose levels (claims 25,                
               26, 31 and 35 - [See Brief at p. 14-17]).  We note Shenk’s inhaler is inherently repeatable in                       
               operation, and that the lowering of glucose levels to an acceptable level and controlling the                        
               glucose levels are both highly dependent upon the particular patient and a person of ordinary                        
               skill in the art would monitor the patient’s vital statistics to achieve the desired result in view of               
               the high variability among patients as a matter of course.  Therefore, we find the appellant's                       
               arguments to be unpersuasive.                                                                                        



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