Appeal No. 1997-1093
Application No. 08/272,281
Second, glycine is a known stabilizer of fibrinogen which can be used to precipitate
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fibrinogen from supernatant liquid (see e.g., Kumpe et al. at col. 2, lines 10-40). Third, the
file history suggests that a combination of a high salt precipitation of fibrinogen plus at
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least two adsorption steps may be necessary. If it is determined that an additional
method step(s) is required to obtain a fibrinogen solution which "maintains its ability to
function when stored at 4-25EC for four weeks," the examiner should take a step back and
reassess the patentability on the claims on appeal.8
Secondly, the language of the dependent claims is inconsistent with some claims
reciting "processed stable fibrinogen solution as claimed in ... " (e.g., claim 2), while others
recite "stable fibrinogen solution as claimed in ... " (e.g., claim 12). We also note that the
6Kumpe et al., U.S. Patent No. 4,960,757, was originally submitted with appellants' Information
Disclosure Statement filed September 8, 1993 (Paper No. 5).
7According to the amendment filed July 8, 1994 (Paper No. 14),
The presently claimed invention employs a high salt precipitation of fibrinogen
combined with at least two adsorption steps using aluminum hydroxide, a sparingly soluble
salt of an alkaline earth metal or an anion exchanger. Importantly, the present invention
uses a process whereby the fibrinogen is not adsorbed by the adsorbent ... rather it
remains in the supernatant during ... all of the adsorption steps ... . This process results in
a fibrinogen solution that is stable for at least four weeks when stored at 4-25EC. [Page 5,
first full paragraph, emphasis in the original.]
Also see the amendment filed April 19, 1995 (Paper No. 16) at page 5, first full paragraph.
8 We also note that Kotitschke et al. U.S. Patent No. 5,009,003 (made of record by the examiner
on the PTO-892 accompanying the Office action mailed April 13, 1993 (Paper No. 2)), uses ethyl alcohol
and glycine to precipitate fibrinogen and Factor XIII from a supernatant obtained after anion exchange
adsorption of citrated plasma.
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