Appeal No. 1998-2195
Application No. 08/277,241
DIP.” Answer, page 4. The examiner nonetheless the claimed method as non-
enabled because
Appellants have failed to establish a direct correlation between the
levels of DIP production and the levels of hCG production. Further,
the instant specification does not provide a value or range of values
for DIP concentrations against which a practitioner could compare a
sample value and thereby achieve some meaningful result.
Answer, page 17. Thus, the examiner’s position is that the specification enables
those skilled in the art to carry out the physical steps of the claimed method—
isolating and quantifying the DIP produced by a subject’s decidual cells—but the
results of the method would not allow the skilled artisan to evaluate hCG
inhibition because the specification does not correlate a given level of DIP
production to a given level of hCG inhibition.
Appellants argue that the examiner has not met her burden of showing, by
evidence or scientific reasoning, that the specification is not enabling. In
particular, Appellants argue that
[s]ince it is disclosed that DIP controls trophoblast hCG production
by inhibiting production in a dose dependent manner, (See Figs. 4
and 5), clinicians can measure the quantity or concentration of DIP
and evaluate whether they are within a normal range under the
circumstances. The importance of the test is that by measuring the
level or concentration of DIP, the clinician will know if the trophoblast
cells are receiving the “right signal” from the decidua regarding the
level of hCG the trophoblast cells should be producing.
Appeal Brief, page 25.
Appellants also argue that it was routine in the art to measure
the levels of effector substances to evaluate the functional state of
hormone producing tissues. This has been done despite the
individual variability in hormone and effector substance
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