How does the USPTO evaluate utility in the context of human or animal treatment methods?
The USPTO evaluates utility for human or animal treatment methods using the same standards as other inventions, but with some specific considerations. According to MPEP 2107.01:
“Inventions asserted to have utility in the treatment of human or animal disorders are subject to the same legal requirements for utility as inventions in any other field of technology.”
The MPEP emphasizes that pharmacological or therapeutic inventions providing any “immediate benefit to the public” satisfy 35 U.S.C. 101. Importantly:
“Office personnel should not construe 35 U.S.C. 101, under the logic of ‘practical’ utility or otherwise, to require that an applicant demonstrate that a therapeutic agent based on a claimed invention is a safe or fully effective drug for humans.”
This means that while applicants must show credible utility for their claimed treatment methods, they don’t need to provide the level of proof required for FDA approval. The USPTO recognizes that patent protection often comes at an early stage in drug development, well before human trials are completed.
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