Appeal No. 1999-1367
Application 08/453,998
some operative variants of ligand-responsive elements (e.g. Martinez), and of routine
methods of sequence variation and functional assay for induction of $-galactosidase
activity under the control of the test DNA element or the test receptor protein variant.
Therefore, we do not find that those of skill in the art were, at the time of the invention,
unable to determine the metes and bounds for variants of a natural higher eukaryotic
steroid, retinoid, thyroid hormone, or vitamin D3 receptor proteins which retain the
functions of a natural steroid, retinoid, thyroid hormone, or vitamin D3 receptor protein in
yeast. Similarly, we conclude that those of skill in the art were able to determine the metes
and bounds for a variant of a higher eukaryotic natural ligand responsive element that is
palindromic (or a repetition of a palindromic sequence) that retains the function of a natural
ligand responsive element.
In regard to the orientation of repeated elements to each other and to the other
elements of the construct, we note the following. In the molecular biology art, the term
“direct repeat” is defined as “Identical or closely related nucleotide sequences present in
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two or more copies in the same orientation within the same molecule”. Therefore the
recitation “directly repeated” in claim 27 does indicate the orientation of the repeated
elements to each other. In regard to the orientation of the repeated response elements to
other elements of the construct, we agree that the claim does not specify how the elements
are oriented with regard to the foreign protein coding sequence. However, this does not
3McGraw-Hill Dictionary of Scientific and Technical terms, fifth edition.
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