Appeal No. 1997-1093 Application No. 08/272,281 OTHER MATTERS Upon return of the application, the examiner should consider whether the claimed invention raises any issues under 35 U.S.C. § 112. It appears that claimed method may be incomplete in failing to recite all critically required method steps to obtain a fibrinogen solution which maintains its ability to function when stored at 4-25EC for four weeks. First, the only disclosure in the specification of a fibrinogen solution having the claimed stability was obtained not after treatment with two adsorbents, but after additional method steps. According to Example 1 on specification page 5: Cryoprecipitate from citrate plasma was dissolved in isotonic saline (2.8 l/kg). Subsequently, 5% (volume/volume) of an aluminum hydroxide suspension (1.5% weight/volume) was added, and the mixture was stirred for 15 min. The aluminum hydroxide was removed by centrifugation, and the same amount of aluminum hydroxide plus 5.25 g of QEA-Sephadex A-50 per kg of cryoprecipitate, was again added to the supernatant. Centrifugation was repeated. Glycine was added to the supernatant with stirring until the final concentration was 2.7 mol/l, and the resulting precipitate was removed by centrifugation and dissolved in isotonic saline (1.5 l/kg). The solution was mixed with glycine (final concentration 1.15 mol/l) and stirred for 30 min. This was followed by centrifugation, and the residue was discarded. The supernatant was mixed with glycine (final concentration 2.15 mol/l) and stirred for 30 min. The precipitate was removed by centrifugation, taken up in 0.05 mol/l NaCl, 0.005 mol/l trisodium citrate, 0.02 mol/l arginine, pH 7.5, and dialyzed against the same buffer. - 6 -Page: Previous 1 2 3 4 5 6 7 8 9 10 NextLast modified: November 3, 2007