Appeal No. 2004-1346 Page 21
Application No. 08/971,338
that abnormal levels of GDF-1 could be associated with developmental
anomalies or structural defects in the developing fetus.” We fail to see the nexus
between this vague, general disclosure in appellant’s specification and the
specific teaching in Rankin provided a decade after appellants earliest effective
filing date that GDF-1 regulates left-right patterning or axis formation in mice.
For clarity, we reproduce the asserted speculated uses of the claimed
invention as they appear on pages 12-14 of the specification, emphasis added:
[O]ne potential use for GDF-1 as a diagnostic tool is as a specific
marker for the presence of tumors arising from cell types that
normally express GDF-1 … one member of this superfamily,
namely, inhibin, has been shown to be useful as a marker for
certain ovarian tumors…
A second potential diagnostic use for GDF-1 is as an
indicator for the presence of developmental anomalies in prenatal
screens for potential birth defects. For example, abnormally high
serum or amniotic fluids [sic] levels of GDF-1 may indicate the
presence of structural defects in the developing fetus … another
embryonic marker namely, alpha fetoprotein, is currently used
routinely in prenatal screens for neural tube defects. Conversely,
abnormally low levels of GDF-1 may indicate the presence of
developmental anomalies directly related to the tissues normally
expressing GDF-1.
A third potential diagnostic use for GDF-1 is in prenatal
scrrns for genetic diseases that either directly correlate with the
expression or function of GDF-1 or are closely linked to the GDF-1
gene. Other potential diagnostic uses will become evident upon
further characterization of the expression and function of GDF-1.
… [O]ne potential therapeutic use for GDF-1 is as an anti-
cancer drug to inhibit the growth of tumors derived from cell types
that are normally responsive to GDF-1. … one member of this
superfamily, namely Mullerian inhibiting substance, has been
shown to be cytotoxic for human ovarian and endometiral tumor
cells either grown in culture … or when transplanted into nude
mice….
Conversely, if GDF-1 functions as a growth-stimulatory
factor for specific cell types, other potential therapeutic uses will be
apparent. For example, one member of this superfamily, namely,
activin, has been shown to function as a nerve cell survival
molecule. … Alternatively, if the target cells for GDF-1 in the
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