Appeal No. 1996-2468
Application 08/091,899
model as representative of in vivo results to those of ordinary skill in the art. In particular,
the appellant argues that Walsh establishes the acceptability of the in vitro placental
perfusion model as a predictor of in vivo activity, in a similar context. Walsh discloses the
use of the placental perfusion model to establish the ability of indomethacin to inhibit
thromboxane. (Indomethacin has been shown and is known to inhibit PGF and
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premature labor in vivo. See Zuckerman.) Demers evidences the use of the placental
perfusion model to show increased levels of PGF are associated with pre-eclampsia.
Demers, Figure 2. Valenzuela evidences the use of the placental perfusion model to show
decreased metabolism of PGF by placental tissue is associated with toxemia.
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Valenzuela, Table II.
The examiner takes issue with several of the publications submitted to support the
predictive value of the placental perfusion model, indicating some differences exist
between the performance steps of the placental perfusion model in the references and the
placental perfusion model as used in the specification. These differences, however, fail to
negate the evidenced acceptability and routine use of the placental perfusion model by
those of ordinary skill in the art. In addition, it appears clear from the record that there are
constraints, and legal and ethical considerations which prohibit scientific experimentation
directly on pregnant humans. Appellant believes that the best possible system available
for demonstrating the claimed method, the human placental perfusion model has been
used. Appeal Brief, page 27.
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