Appeal 2007-3395 Application 10/260,733 tumor's ('a sample') genetic make-up can be 50% 47,XXX and 50% 45 X,-X cells." (Specification at 2, ¶ 5).5 [5] Determining the presence or degree of genetic mosaicism in a cell population can be helpful in determining the cause of a disease (e.g., cancer or an inherited disease) or for diagnosing or prognosing its cause (Specification at 2, ¶ 5). [6] Instead of analyzing the chromosomes from individual cells, karyotyping using array-based CGH analyzes the DNA sequence copy number of the total genomic DNA extracted from the cells (Specification at 2, ¶ 6). [7] From a DNA copy number perspective, the genome profile of a tumor made up of 50% 47,XXX cells and 50% 45 X,-X cells is said to be no different from a reference population of 100% 46,XX cells (Specification at 2-3, ¶ 6). [8] However, "the genetic mosaicisms observed in clinical samples will likely only rarely involve cell populations whose combined genetic profiles completely mask the presence of a mosaic population" (Specification at 3, ¶ 7). [9] The methods described in Appellant's specification are said to be "sufficiently sensitive to detect clonally distinct (by karyotypic criteria) cell populations within a more dominant background cell population" (Specification at 14, ¶ 42). 5 The standard way of describing karyotypic information is to (a) give the total number of chromosomes, (b) identify the sex chromosomes and (c) identify any other abnormalities that may be present. A normal male karyotype, 46,XY, means the cell contains 46 chromosomes, including one X and one Y. 6Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: September 9, 2013