Interference No. 104,436 Paper 98
Shyamala v. Hillman. Page 16
[115] Assuming that Dr. Shyamala believed she was inventing a tissue assay, it is not clear given the
very small sample of possible tissues and the limited information produced (relative MIP
expression level) that anyone of ordinary skill in the art would have considered such an assay to
have a credible utility.
[116] Shyamala did not disclose a method for determining tissue type until filing the involved
application; that is, Shyarnala did not disclose the method in the provisional applications.
[117] Instead, as previously noted, Shyamala's provisional applications speculated that MIP
overexpression could be used to diagnose a disease [1029 at 33:9-26].
[118] Shyamala does not offer an explanation for the gap between the putative invention of the tissue
assay and its eventual first disclosure in Shyamala's involved application.
[119] According to Shyamala (Paper 89 at 29), assays including the tissue expression assay were
disclosed in the provisional applications.
[120] Shyamala provisionally disclosed [1029 at 4:1-5]:
Still another embodiment is a method of diagnosis of a disease in a patient
characterizable by aberrant MIP polypeptide mediated activity including one
selected from the group consisting of MKK3 associated activity and GT?
mediated cellular response by providing a MIP antibody, contacting a patient
tissue sample with the antibody, and detecting the amount of the MIP polypeptide
present.
[121] This disclosure does not teach a tissue assay. Instead, it speculates that one could assay for an
unidentified disease characterized by aberrant MIP activity.
[122] ShyamalaprovisionaIly disclosed [1029 at 5:8-12]:
Any portion of the MIP gene is useful as a probe for MIP transcription
activation in a tissue blot or for analysis of cells expressing MIP under, for
example, regulatable conditions, or as a diagnostic probe for a MIP-associated
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