Appeal No. 2001-1485
Application No. 08/532,211
(1) Solvent detergent viral inactivation results in an
increase in ACA (See Table 1, Specification, Page 11).
(2) Using the solvent detergent process to treat ISG and
subsequently treating that product according to Tenold does not
result in a product having acceptable ACA levels when measured
immediately. (Specification, paragraph bridging pages 2 and 3 and
Table 5).
(3) In contrast, holding (“incubating”) the solvent-detergent
inactivated samples results in marked lowering of ACA
(Specification, page 12, Table 3).
(4) The ACA results do not appear to correlate to the monomer
content (Specification, page 17, table 8).
(5) Tenold’s basic process (starting with non-solvent
detergent inactivated solutions) results in a 25 ACA (CH50/mL).
(Specification, page 11, table 1).
From this, it is apparent that the problem being addressed
places the question of whether a prima facie case of obviousness
exists in a different light. First, one must question whether the
teachings and results of Tenold can be combined with Neurath
successfully. See, for example, the paragraph bridging pages 2
and 3 of the specification. Tenold starts with an unmodified
human ISG (Tenold, column 4, lines 65-66) initially having an ACA
which is unacceptable for intravenous injection (although the
actual ACA level is not specifically described) (Tenold, Column 1,
8
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 Next
Last modified: November 3, 2007