Appeal No. 1996-2468
Application 08/091,899
vivo method is not enabled, i.e., the specification fails to teach the “how to use” component
of the in vivo method because the in vitro model is not predictive of in vivo activity.
The examiner’s first point of contention is that “the specification does not establish
that the placental perifusion [sic] model is representative of the effects of
IGF-I in vivo.” Examiner’s Answer, page 10. The examiner states that the placental
perfusion model does not address the role of insulin-like growth factor binding proteins
(IGF-BP) that would have been known to modulate the activity of IGF-I in vivo. Examiner’s
Answer, page 10 and Geisthovel. The examiner supposes that IGF-I would have been
known to exert a variety of other biological effects in vivo not accounted for in the placental
perfusion model. In our opinion, the examiner raises legitimate issues with respect to the
predictive ability of the placental perfusion model and arguably presents a prima facie
case of lack of enablement.
Once the examiner has established a reasonable basis to question the enablement
provided for the claimed invention, the burden falls on the appellant to present persuasive
arguments, supported by suitable proofs where necessary, that one skilled in the art would
be able to make and use the claimed invention using the disclosure as a guide. See In re
Brandstadter, 484 F.2d 1395, 1406, 179 USPQ 286, 294 (CCPA 1973).
The appellant responds to the argument that the placental perfusion model is not
representative of the effects of IGF-I in vivo, with the submission of four publications which
the appellant indicates are evidence of the acceptability of the in vitro placental perfusion
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