Appeal No. 1999-2330
Application No. 08/219,200
Appellants argue that they have ?provided in vivo data confirming the in vitro
results using a homologous molecule, namely CTLA4Ig (see Applicants’ response
dated August 24, 1992 of parent application, namely, U.S. Serial No. 722,101). This in
vivo data strengthens Applicants' in vitro data.” Brief, page 14. Furthermore appellants
argue that NIH has approved several protocols involving the use of CD28. Id.
Appellants argue that this cuts against the Patent Office’s argument that the art in this
area is so unpredictable that in vitro data are not acceptable. Brief, page 15.
Additionally, appellants argue that ample guidance is provided by applicants as to how
to make the B7 fusion proteins and how to carry out the claimed methods. Brief,
page 17.
Factors to be considered by the examiner in determining whether a disclosure
would require undue experimentation have been summarized by the board in Ex parte
Forman, [230 USPQ 546, 547 (Bd Pat App Int 1986)]. They include (1) the quantity of
experimentation necessary, (2) the amount of direction or guidance presented, (3) the
presence or absence of working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-
ability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737, 8
USPQ2d 1400, 1404 (Fed. Cir. 1988).
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