Appeal 2007-3395
Application 10/260,733
[15] One form of aggressive breast cancer is said to result from gene
amplification and overexpression of the Her-2/neu gene located on
chromosome 17 at band q12 (Bao at col. 1, ll. 35-38).
[16] Overexpression of the Her-2 gene, prior to gene amplification, is said
to occur at an earlier, less aggressive stage of the disease (Bao at col.
1, ll. 42-46).
[17] Thus, proper management of breast cancer is said to require both
measurement of Her-2 gene expression and Her-2 gene copy number,
i.e., two separate tests on a tissue sample (Bao at col. 1, ll. 46-49).
[18] Bao describes methods for simultaneously measuring gene expression
and chromosome abnormalities in the same tissue sample using array-
based CGH (Bao at col. 2, l. 57 to col. 3, l. 3; col. 6, ll. 23-28).
[19] The Bao method comprises cohybridizing first, second and at least
one reference nucleic acid populations, each labeled with a different
fluorescent marker, to an array of nucleic acid target elements
immobilized on a solid substrate and measuring the presence and
intensity of each marker at each target element of the array (Bao at
col. 2, l. 66 through col. 3, l. 12; col. 3, ll. 31-55).
[20] The nucleic acid target elements may comprise total genomic DNA6
(Bao at col. 7, l. 33 through col. 8, l. 26, esp. col. 7, ll. 63-66; col. 34,
ll. 1-31).
6 Genomic DNA is all the DNA sequences comprising the total genetic
information (genome) of a cell or organism. Since cDNA is DNA copied
from an mRNA by reverse transcription, cDNA lacks the introns present in
genomic DNA. See e.g., MOLECULAR CELL BIOLOGY, 5th ed., W.H.
Freeman and Company, New York, NY (2004), at G-3 and G-9.
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