Appeal 2007-0852
Application 09/919,195
“[E]nablement requires that the specification teach those in the art to make
and use the invention without ‘undue experimentation.’ In re Wands, 858 F.2d
731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). That some experimentation may
be required is not fatal; the issue is whether the amount of experimentation
required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed.
Cir. 1991) (emphasis in original). “The key word is ‘undue,’ not
‘experimentation.’” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219
(CCPA 1976).
Given the Specification does not describe any compound known to have the
claimed RARβ antagonist activity, it also fails to enable the claimed method for
the treatment or prevention of alveolar destruction in a mammal comprising the
step of administering a therapeutically effective amount of an RARβ antagonist
having specific RAR modulating activity to said mammal, and such antagonist is
not specific to at least one other RAR receptor subtype.
While we acknowledge that the Specification provides evidence that RAR
antagonists were known in the prior art, we find no evidence of RAR antagonists
that meet the claimed requirement of being “not specific to at least one other RAR
receptor subtype.” Thus, even if methods of determining which compounds meet
this limitation were known in the art, absent even a single working example, it is
our opinion that it would require undue experimentation to carry out the full scope
of the claim. The amount of guidance or direction needed to enable the invention is
inversely related to the amount of knowledge in the state of the art as well as the
predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA
1970). In this case, because no evidence has been presented that RAR antagonists
with the claimed characteristics have been identified or even exist, it is clearly
unpredictable that compounds within the scope of claim 13 could be found.
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