Appeal No. 2006-1517 Page 3
Application No. 09/976,423
interpretation by a treating clinician. For example, rather than providing raw sequence
data, the prepared format may represent a risk assessment for various treatment
options.” Page 50, line 22, to page 51, line 10.
Discussion
1. Claim construction
Claims 72-107 are pending and on appeal. Claims 72 and 106 are
representative and read as follows:
72. A kit for generating a perioperative genomic profile for a subject,
comprising:
a) reagents configured such that when exposed to a sample
containing target nucleic acid from a perioperative subject, said subject being a
patient scheduled for a surgical procedure that has not yet completed said
surgical procedure, are sufficient to detect the presence or absence of variant
alleles in two or more genes associated with two or more conditions selected
from the group consisting of BChE, CYP2D6, F5, F2, CACNAIS, MTHFR, MTR,
MTRR, CBS, TNFα and TNFβ so as to generate a genomic profile for use in
selecting a perioperative course of action for said subject; and
b) a computer program comprising instructions which direct a
processor to analyze data derived from use of said reagents.
106. A perioperative genomic profile kit having component parts
configured such that when exposed to a sample containing target nucleic acid
from a perioperative subject, said subject being a patient scheduled for a surgical
procedure that has not yet completed said surgical procedure, are sufficient to
detect the presence or absence of variant alleles in two or more genes
associated with two or more conditions selected from the group consisting of
BChE, CYP2D6, F5, F2, CACNAIS, MTHFR, MTR, MTRRR, CBS, TNFα and
TNFβ, so as to generate a genomic profile for use in selecting a perioperative
course of action for said subject and thereby providing a subject-specific clinical
pathway for said subject, comprising information to optimize perioperative care
that, based at least on the presence or absence of said variant alleles of two or
more genes associated with two or more conditions selected from the group
consisting of BChE, CYP2D6, F5, F2, CACNAIS, MTHFR, MTR, MTRR, CBS,
TNFα and TNFβ measured by said kit, directs a user to a specific clinical
pathway of medical intervention for said subject.
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