Appeal No. 2006-1517 Page 2
Application No. 09/976,423
Mutations in several genes have been linked to increased risk of surgery- and
anesthesia-related complications including malignant hyperthermia, sepsis, and
possible toxicity of anesthetics and other drugs. See page 2, lines 3-4 and 22-24; page
2, line 27 to page 3, line 2; and page 3, lines 12-13.
The specification discloses “a kit for generating a perioperative genomic profile
for a subject, comprising a reagent capable of detecting the presence of a variant allele
of two or more genes markers [sic] selected from [particular genes]; and instructions for
using the kit for generating the perioperative genomic profile for the subject.” Page 6,
lines 15-20.
“In some embodiments, a computer-based analysis program is used to translate
the raw data generated by the genomic profile (e.g., the presence or absence of a given
SNP [single nucleotide polymorphism; page 28, line 19] or mutation) into data of
predictive value for the clinician (e.g., probability of abnormal pharmacological
response, presence of underlying disease, or differential diagnosis of known
disease). . . . Thus, . . . the clinician, who is not likely to be trained in genetics or
molecular biology, need not understand the raw data of the genomic profile. The data is
presented directly to the clinician in its most useful form.” Page 50, lines 8-17.
“For example, in some embodiments . . . , a sample is obtained from a subject
and submitted to a genomic profiling service (e.g., clinical lab at a medical facility,
genomic profiling business, etc.) to generate raw data. . . . Once received by the
genomic profiling service, the sample is processed and a genomic profile is produced
(i.e., genomic data), specific for the medical or surgical procedure the subject will
undergo. The genomic profile data is then prepared in a format suitable for
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