Appeal No. 2002-1367 Page 6
Application No. 08/981,964
subject to feedback regulation at the level of enzyme activity, or subject to
feedback regulation at the level of the amount of protein. See id. at 5.
Appellants argue further that:
[C]ontrary to the Examiner’s assertion that feedback
regulation would occur at least in part by regulation of transcription,
there is no teaching or suggestion cited by the Examiner that would
show that a person of ordinary skill in the art would have
reasonably believed that the ACoAT gene promoter was able to
confer sterol responsiveness when operably linked to a reporter
system. As discussed above, even if control at the level of enzyme
activity was discarded as a possibility, there is no evidence that a
person of ordinary skill in the art would conclude that control was at
the level of promoter-regulated transcription instead of controlling
steps like protein degradation, degradation of RNA transcripts,
splicing of transcripts to produce mRNA, transport of RNA or mRNA
from nucleus to cytoplasm, assembly of ribosomes on mRNA, or
translation of mRNA by ribosomes to produce protein.
Id. at 7.
The examiner responds by contending that:
[O]ne of ordinary skill in the art would reasonably expect that
an if an [sic] enzyme is regulated at the level of protein synthesis
that this regulation would be effected at least in part by regulation of
gene transcription as gene transcription is the first step in the
protein synthesis pathway and regulation of the first step of a
pathway is in most cases the most efficient means of accomplishing
regulation without unnecessarily expending cellular resources (i.e.,
gene transcription utilizes large amounts of both energy resources
and metabolic resources which would be wasted if the transcript
was not then translated). While examples of all of the various
means of regulating protein levels can be found in nature,
regulation of transcription is by far the most commonly found
means of doing this and in fact is the way mammalian cells regulate
sterol biosynthesis. While as appellants note mammalian cells are
often very wasteful of resources in order to maintain flexibility, fungi
are not mammalian cells and wasteful use of resources is less
common in lower eukaryotes and bacteria where such resources
are likely to be in short supply. Furthermore, one
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