Appeal No. 1997-3020
Application 08/149,101
certainty a claimed hybrid’s activity is not a criteria for enablement under 35 U.S.C. § 112,
first paragraph.
The examiner has criticized concerning example 2 on pages 16 through 18 of the
specification on the basis that all of the different hybrid cytokines tested, having different
native "-helical regions, demonstrate the same activity concerning the growth of Il-6-
dependent cells 7TD1. Therefore, the examiner is of the opinion that these results
underscore the unpredictability of the activity of the claimed hybrids. However, the
examiner has again misapplied the standard of enablement based solely on predictability
in assessing the evidence presented in example 2. This example presents data which
indicate that the hybrid cytokines prepared had activity levels approximately equivalent to
leukemia inhibitory factor (LIF) in supporting the growth of 7TD1 cells. Therefore, example
2 demonstrates that claimed hybrid cytokines can be made and used for supporting the
growth of 7TD1 cells.
The examiner has further criticized examples 3 through 7 on pages 18 through 20 of
the specification by stating that these examples evidence the unpredictability of the
invention because they fail to correlate particular "-helices to particular biological
properties. However, we agree with appellants that precise knowledge of the particular
biological activities inherent in the native "-helices is not necessary for the enablement of
the claims on appeal. The activity of the hybrid cytokines can be determined through the
practice of the routine in vitro tests as described on page 14 of the specification. The
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