Appeal No. 2002-0766 Page 3
Application No. 08/793,053
also discloses that a subset of those tested over age 60 showed decreased
expression of osteocalcin and osteonectin by preosteoblasts. See pages 40-41.
The specification concludes that
these aspects of the invention have diagnostic and, perhaps,
prognostic utility in connection with certain bone disorders. For
example, the use of multi-parameter flow cytometry and
immunophennotyping [sic] may allow the diagnosis and prediction
of outcomes (prognosis) of various bone disorders such as primary
osteoporosis. . . . The pattern of antigenic expression in human
bone precursor cells observed by the inventors shows that elderly
individuals (≥ 60 years of ag[e]) are of two types: those with
statistically high bone antigen content, and those with significantly
low antigen content (compared to age-matched controls). This
suggests that these values may reflect the disease status of the
affected individual’s bone function.
Page 41. See also page 72:
The physiological and clinical significance of such alterations may
be that the immunophenotype of these two populations of elderly
individuals reflects the status of their bone cell function. In their
fifties or sixties, most individuals (male and female) show varying
degrees of osteoporosis. Thus, the identification of alterations in
bone protein expression undoubtedly demonstrates the basis for
known elevations in these proteins (osteocalcin (BGP) and
osteonectin) in the plasma of elderly individuals. The identification
of a subpopulation of elderly individuals might thus demonstrate a
group of individuals with more severe disease.
Discussion
The claims are directed to a method of “identifying a subject at risk of
developing an age-related bone disorder,” comprising obtaining cells from the
subject, enriching for bone precursor cells, and quantifying the amount of
osteocalcin or osteonectin expressed by the bone precursor cells. An increased
amount of osteocalcin or osteonectin, relative to that expressed by a young or
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