Interference No. 104,436 Paper98
Shyamala v. Hillman Page 14
design of a therapeutic based on modulating MIP polypcptide activity, affecting
ME? gene expression, expressing genetic variants of MIP for therapeutic effect
such as mimicry of MIP activity or modulation of MIP activity, for example
inhibition of MIP activity, for the purpose of affecting a MIP mediated pathway,
for example an MKK3 activation pathway, or a p38 MAPK signal transduction
activation pathway.
Gene therapy techniques can be applied in the invention for treatment of a
disease characterizable by excessive MEP poIypeptide mediated MKK3 activation,
or MIP polypeptide mediated p38 MAPK signal transduction pathway activation
using a genetic variant of MIP, for example a dominant negative MIP polypeptide
or by using a peptide inhibitor of MIP activity, for example inhibitors of MIP
binding to MKK3. The polynucleotide encoding the MIP polypeptide, the MIP
polypeptide variant, or an inhibitor of MIP activity may be engineered for
administration by a gene therapy protocol, provided the polynucleotide encoding
for example, the dominant negative or the modulator or inhibitor is capable of
expression in a patient.
[103] Shyamala did not, at the time of filing the provisional applications, identify any
0 disease in a patient characterizable by-aberrant MIP polypeptide mediated
activity;
0 condition diagnostically associated with overexpression of MEP by
identifying MiP transcript in brain or spleen tissues; or
0 condition treatable by modulating MIP polypeptide activity, affecting MIP
gene expression, or expressing genetic variants of MIP for therapeutic
effect.
[1041 Rather than simply lacking knowledge of the mechanism by which N1IP works in disease or other
medical conditions, Shyamala failed to identify a disease or medical condition for which MIP is
known to have a role.
[105] We find no connection between these disclosures and a known real-world utility at the time of
filing. Shyarnala's repeated use of "may" to describe these utilities is telling because it shows that
they are not grounded on actual knowledge.
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