Appeal No. 2001-0562 Page 7
Application No. 08/460,478
The rejection of claims 122 and 123:
According to the examiner (Answer, page 6) the subject matter of claims
122 and 123 is “not described in the specification in such a way as to enable one
skilled in the art to which it pertains, or with which it is most nearly connected, to
make and/or use the invention.” In response to appellants’ argument (Brief,
pages 11-12), the examiner argues (Answer, pages 20-21):
Assay 9.2 (specification[,] page 20) is relevant to treatment of
Parkinson’s Disease using an art accepted model for testing
treatment of Parkinson’s Disease, … [the examiner argues that]
claims 122 and 123 are not commensurate in scope with the
method employed in Assay 9.2, nor with the teachings in the
specification, for example at page 9. The adenovirus in Assay 9.2
comprised nucleic acid encoding tyrosine hydroxylase and under
transcription control of the RSV LTR promoter, not a generic
neurotransmitter-synthesizing enzyme (as recited in claim 122)
expressed under transcription control of any and all promoters.
Claim 123 limits the neurotransmitter-synthesizing enzyme to
tyrosine hydroxylase (not tyrosine kinase…). Also, the adenovirus
was administered to the striatum of the brain (spec. page 20, line
10), not to the brain generally. As claimed, the invention embraces
administering the adenovirus to any and all regions of the brain, not
just to the striatum. The specification at pages 4-5 discloses a
number of promoters, in general, that can be linked to the “gene”,
in general, in the adenovurs. The only promoter explicitly taught for
incorporation into an adenovirus for treatment of Parkinson’s
Disease is the RSV LTR promoter. Furthermore, “ependymal,
neural and glial promoters” are not specific promoters, but classes
of promoters, and the specification does not disclose any specific
promoters that fall into these classes of promoter. The
specification must teach those of skill in the art how to make and
how to use the invention as broadly claimed, not as narrowly
disclosed.
Here the rejection under 35 U.S.C. §112, first paragraph, is more of a
series of conclusions by the examiner than a fact-based, reasoned explanation
as to why a person skilled in the art would not be able to make and use the
claimed invention throughout its scope without undue experimentation. As set
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