Ex parte JANOFF et al. - Page 2




              Appeal No. 1999-0161                                                                                            
              Application 08/441,567                                                                                          




                      Claims 14, 50 and 61 are illustrative of the claims on appeal and read as follow:                       
                      14.  A method for determining the presence of lupus anticoagulants in a patient's                       
              plasma which comprises the steps of:                                                                            
                      (a)  obtaining first and second samples of the patient's plasma;                                        
                      (b)  combining a detergent and a phospholipid so as to obtain an aqueous                                
              suspension comprising the particles1 containing the detergent and the phospholipid;                             

                      (c)  incubating the first sample with the aqueous suspension;                                           
                      (d)  performing a lipid-dependent diagnostic assay on both the first and second                         
              samples, the assay producing a positive reading when used on a sample which contains                            
              lupus anticoagulants; and                                                                                       
                      (e)  comparing the results of the assays performed on the first and second samples,                     
              the presence of a normal result for the first sample and a positive result for the second                       
              sample being indicative of the patient having lupus anticoagulants;                                             
              wherein the phospholipid has a hexagonal (Hll) phase organization in aqueous detergent-                         
              free media, wherein the detergent is a lupus assay-compatible detergent, wherein the                            
              particles comprising the phospholipid and detergent have diameters of less than about                           
              50nm, wherein the phospholipid remains in suspension at a temperature of 25AC for at                            
              least one hour, and wherein the detergent, in combination with the phospholipid, is capable                     
              of inhibiting lupus anticoagulant, and not interfering with the anticoagulant effect of heparin,                
              anti-Factor antibodies and factor deficiencies.                                                                 


                                                                                                                              
                      1  See specification page 5, paragraph 2, and Brief, page 2, paragraph 2.                               





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