Appeal No. 1997-4379
Application No. 08/278,437
Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997)
(quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)).
As set forth in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404, (Fed. Cir.
1988):
Factors to be considered 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 unpredictability
of the art, and (8) the breadth of the claims. (footnote omitted).
However, as set forth in Enzo Biochem., Inc. v. Calgene, Inc., 188 F.3d 1362, 1371,
52 USPQ2d 1129, 1136 (Fed. Cir. 1999) “the Wands factors ‘are illustrative, not
mandatory. What is relevant depends on the facts.’ [citation omitted]”
The examiner’s position with respect to the rejection under 35 U.S.C. § 112,
first paragraph, is that it would require undue experimentation to use the claimed
compositions. Specifically, the examiner argues (Examiner’s Answer, pages 4-5) that
The claimed … alpha amino acids would read on a myriads [sic, myriad]
of natural or synthetic amino acids, singly or in combination that have
neither been described, taught nor contemplated in the spec.
…
[I]t is not clear as to the kind of modifications … the ones that are modified
without the peptide losing its bioactivity and at the same time having the
desired improved chemical and biological stability.
…
[T]he spec. fails to show whether such modifications in disulfide bridge
result in the retention of the bioactivity of the peptide and more
importantly, in the desired stability of the peptide.
…
Except for the method of modifying the single peptide, malformin, the
spec. is devoid of any enabling disclosure for any other disulfide modified
peptide or for the activity of even the single disulfide modified peptide.
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