Appeal No. 2001-1392 Page 4
Application No. 08/900,586
According to the examiner (Answer1, page 4) the Baker method “comprises
determining the concentration of an analyte or analytes in a sample of body fluid by
providing a device for performing immunoasssays … through which a fluid sample
can flow by capillarity.” The examiner finds (Answer, bridging sentence, pages 4-5)
that Baker discloses the use of a device and method “for measuring the ratio of the
concentrations of two analytes … in a urine sample.” While the examiner
recognizes (Answer, page 5) that “[t]he claimed invention is … a method of
determining the concentrations of multiple analytes in a sample, … using the ratio of
control analytes … [to normalize] the concentration of a specific target analyte,” the
examiner fails to mention that Baker does not disclose such a method.
To overcome the deficiency in Baker, the examiner relies on Besch and Yip.
According to the examiner (id.) Besch disclose an assay method to determine “the
concentration of two analytes in urine (creatinine and estriol), with the determination
of creatinine levels providing an analyte/creatinine ratio.” The examiner finds (id.)
that the Yip method “determines the concentration of proteins and creatinine with
subsequent determination of protein/creatinine ratios to normalize urine
concentrations of protein analytes in urine samples….” Therefore the examiner
concludes (id.) “[t]he claimed invention appears to be an obvious variation of the
reference teachings of determining the concentration of two analytes in fluids then
normalizing the first analyte using the concentration of the second analyte.”
1 Paper No. 12, mailed July 20, 1999.
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