Appeal No. 1997-2389
Application No. 08/987,233
the claimed assay. Essentially, the present claimed assay requires a qualitative step
wherein the microbes which may be present in the sample are collected on a membrane
and that membrane is contacted with a non-selective medium to permit growth of the
microbes present. The medium is then analyzed for a metabolic product which indicates
the presence of the specific microbe to be determined and for the presence of another
metabolic by-product which confirms the presence of said microbe. Only then is the
sample subjected to a quantitative assay to determine the amount of the specific microbe
originally present in the liquid sample. It is not questioned that Jolley describes an assay
which reasonably corresponds to the second assay step of the claims on appeal.
However, Jolley does not describe or suggest the use of a qualitative assay to be
preformed prior to the quantitative step. While Mattiasson may be read to describe a
qualitative step prior to the quantitative step, that qualitative step relies on the specific
binding of the microbe to a membrane. The subsequent culturing and determination of the
metabolites associated with the culturing of the microbes bound to the membrane is
performed not to confirm the presence of the microbes,
but to determine the amount of microbe present in the sample. Mattiasson is not
concerned with detecting the presence of metabolic by-products which indicates the
presence of the specific microbe to be determined. Thus, in order to arrive at the claimed
invention starting with Jolley, one would first have to add a qualitative step involving a
culturing of the microbes distributed on the membrane and then assaying the medium after
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