Appeal No. 2006-0275 Page 5
Application No. 09/964,667
Cir. 1988).[2] That some experimentation may be required is not fatal; the issue
is whether the amount of experimentation is ‘undue.’” In re Vaeck, 947 F.2d 488,
495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (emphasis original). In any case,
as explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564,
37 USPQ2d 1618, 1623 (Fed. Cir. 1996), undue experimentation has little to do
with the quantity of experimentation; it is much more a function of the amount of
guidance or direction provided:
[T]he question of undue experimentation is a matter of degree. The
fact that some experimentation is necessary does not preclude
enablement; what is required is that the amount of experimentation
“must not be unduly extensive.” Atlas Powder Co. v. E.I. DuPont
de Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413
(Fed. Cir. 1984).
The examiner cites a number of references as evidence of “the
unpredictability and the problems faced in the antisense art” (Answer, page 7).
The problems or challenges enumerated by the examiner are essentially these:
identification of an appropriate target in the disease process; identification of an
antisense molecule that can interfere with the disease process through specific
recognition and affinity; delivery of antisense oligonucleotides to the brain; the
complexity of cellular uptake of antisense oligonucleotides; physical barriers due
2 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 (BdPatAppInt 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).
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
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