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.
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