Appeal No. 1995-2611
Application 07/808,452
Enablement
In view of its brevity, we reproduce the examiner’s statement of the rejection as it
appears in the paragraph bridging pages 3-4 of the Answer:
The enablement of modified mature tat or rev with the listed cleaving
agents such as Zn(II) or staphylococcal nuclease has not been demonstrated
in the specification. Only tat24-phen has been enabled. It would require
undue experimentation to make and test these modified binding proteins for
RNA cleavage because site-directed Cys substitutions and chemical
alkylation of the binding protein to the agents would have unpredictable
results and unpredictable activity.
As observed by appellants at page 6 of the Appeal Brief, the examiner is concerned that
one skilled in the art could not make and use the claimed invention throughout its scope
without undue experimentation.
As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37
USPQ2d 1618, 1623 (Fed. Cir. 1996):
In unpredictable art areas, this court has refused to find broad generic claims
enabled by specifications that demonstrate the enablement of only one or a
few embodiments and do not demonstrate with reasonable specificity how to
make and use other potential embodiments across the full scope of the
claim. See, e.g., In re Goodman, 11 F.3d 1046, 1050-52, 29 USPQ2d
2010, 2013-15 (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharmaceutical Co.,
927 F.2d. 1200, 1212-14, 18 USPQ2d 1016, 1026-28 (Fed. Cir.), cert.
denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d at 496, 20 USPQ2d at
1445. Enablement is lacking in those cases, the court has explained,
because the undescribed embodiments cannot be made, based on the
disclosure in the specification, without undue experimentation. But the
question of undue experimentation is a matter of degree. The fact that some
experimentation is necessary does not preclude enablement; what is
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