Appeal No. 1997-3020
Application 08/149,101
Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, 1366, 42 USPQ2d, 1001, 1005 (Fed.
Cir. 1997); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385, 231 USPQ
81, 94 (Fed. Cir. 1986). As indicated, the specification describes the hybrid cytokines are
useful for treating the indications for which their native counterparts are employed, and
describes several of the known, prior art uses for the native cytokines. The examiner has
not explained why the hybrid cytokines would not be useful in the same manner.
In the Examiner’s Answer (Paper No. 22, May 16, 1997), the examiner states on
page 5 that “This, then, makes the claimed Invention unpredictable and therefore undue
experimentation would be incurred by one of ordinary skill in the art to use the claimed
Invention,” and on page 14 that one “cannot pick and choose "-helices from the native
cytokines of this invention to make a hybrid cytokine having a predictable function.” Again,
in making these statements, it does not appear that the examiner has taken into
consideration the proper legal standards concerning issues of enablement under 35
U.S.C. § 112, first paragraph, in that the examiner has not presented a fact-based analysis
concerning how and why any experimentation needed to practice the invention would be
“undue.” As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564,
37 USPQ2d 1618, 1623 (Fed. Cir. 1996),
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 Patent
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