Appeal No. 1997-0472
Application No. 08/259,152
26. An aqueous solution consisting essentially of
(1) t-PA and
(2) an anionic polymer or a salt thereof,
said aqueous solution having a pH in
the range of within -2 to +2 pH units from
the isoelectric point of the t-PA and an
ionic strength of at most 0.05 mol/R,
said t-PA prior to dissolution in said
aqueous solution having a solubility of at
most 2.0 mg/ml measured at a pH of about
7.3 in a 1/15 M phosphate buffer solution,
whereby the solubility of said t-PA is
increased, with the use of said anionic
polymer or said salt thereof, to a degree
such that said t-PA is dissolved in said
aqueous solution.
The examiner relies upon the following reference as
evidence of obviousness:
Dussourdd'Hinterland, et al. (D'H) 4,083,961 Apr. 11, 1978
The appealed claims are directed to an aqueous solution
consisting essentially of tissue-type plasminogen activator
(t-PA) and an anionic polymer, such as dextran sulfate or a
salt thereof. According to appellants, it is known in the art
that t-PA is extremely insoluble, whereas "[t]he claimed
compositions provide t-PA in a form suitable for use which
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