Patentability:

For an object to be patentable, it must not be a naturally occurring composition or a human organism.

Disclosure of utility:

• A claimed invention must have a specific and substantial utility.
  • This excludes using a complex invention for landfill (this is obviously not a credible utility).
• An applicant need only provide one credible assertion of specific utility for each claimed invention to satisfy the utility requirement.
• Any rejection based on lack of utility should include a detailed description as to why the claimed invention has no special or substantial utility.
  • The examiner should provide documented evidence regardless of thepublication date.
• The invention has a well established utility if a person of ordinary skill in the art would immediately appreciate why the invention is useful based on the characteristics of the invention and the utility is specific, substantial and credible.
• Where an asserted special and substantial utility is not credible, a prima facie showing of no specialization or substantial utility must establish that it is more likely than not that a person skilled in art would not consider any special and substantial utility asserted by applicant for the claimed invention as credible.

An applicant may overcome a rejection by an examiner who established a prima facie showing of no specific and substantial credible utility for a claimed invention by:

• Providing reasoning or arguments.
• Amending the claims.
• Providing evidence in the form of a declaration under 37 C.F.R. 1.132.
• Providing evidence in the form of a printed publication rebutting the basis or logic of prima facie showing.

Even the mere identification of a pharmacological activity of a compound that is relevant to an asserted pharmacological use provides an “immediate benefit to the public”.