Appeal 2007-3395
Application 10/260,733
principal of the array CGH approach is simple.
Equitable amounts of total genomic DNA from
cells of a test sample and a reference sample (e.g.,
a sample from cells known to be free of
chromosomal aberrations) are differentially labeled
with fluorescent dyes and co-hybridized to the
array of BACs [bacterial artificial chromosomes],
which contain the cloned genomic DNA fragments
that collectively cover the cell's genome. The
resulting co-hybridization produces a fluorescently
labeled array, the coloration of which reflects the
competitive hybridization of sequences in the test
and reference genomic DNAs to the homologous
sequences within the arrayed BACs.
Theoretically, the copy number ratio of
homologous sequences in the test and reference
genomic DNA samples should be directly
proportional to the ratio of their respective
fluorescent signal intensities at discrete BACs
within the array. [Specification at 2, ¶ 4, bracketed
text added.]
[3] Further according to the specification, "[t]he methods of the invention
are used to determine the karyotype of a cell population, which
includes an [sic] determination of the genetic mosaicism of a cell
population, including the number of karyotype subpopulations in a
sample and the percent of the cell population having a particular
karyotype" (Specification at 18, ¶ 55).
[4] Genetic mosaicism is said to be defined as "the presence of two or
more chromosomally distinct cell lines or cell lineages within a
sample or a reference population of cells. For example, a solid
5
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