Aurinia Pharmaceuticals Inc (AUPH)

[rosemountbomber]

From ST:

"substitute for reasoned analysis and evidentiary support...."). Instead, addressing
only the percentage decrease, the Petition argues that "setting Papp aside, it would
have been obvious to a person of ordinary skill in the art treating a patient with.
voclosporin to monitor the patient's renal function through eGFR," and "upon
observing a 20-40% drop in eGFR, [a person of ordinary skill] would have either
reduced the dosage of the calcineurin inhibitor or stopped treatment."
Pet., 33:
EXI003, 985. The vague reference to "monitoring]" is nowhere linked to the
"decreases... to below a predetermined value" claim limitation. Again, the Petition
and its declarant address only the percentage of eGFR decrease and not the resulting
decreased eGFR value itself. And the Petition is further silent as to what eGFR value
would motivate a person of ordinary skill in the art to reduce or stop treatment. See
Pet., 33; EX1003, 985.
Denial of institution based on Petitioner's failure to address the "decreases.
to below a predetermined value in the range of 50-90 ml/min/1.73 m? between said
first and second time points" limitation is consistent with other petitions considered
and denied by the Board. In IntelGenX, for example, petitioner challenged as"