An Issued Life Science MPF U.S. Patent Claim: Ex Parte Gleave

Ex parte Gleave is a landmark decision to the extent PTAB approved a pharmaceutical composition claim under 35 USC §112(f), otherwise known as means-plus-function (MPF) claims.

35 USC §112(f) reads “an element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.”

Section 112(f) provides a tool for patent applicants to, in a controlled way, literally cover equivalents by providing for literal infringement by structure, material, or acts that perform the same function. Historically MPF claims have been used in the mechanical and electrical/ computer fields. According to P.J. Federico’s 1952 commentary on the then-brand new 1952 Patent Act, life science MPF claims were contemplated from the birth of the statutory provision:

The last paragraph of section 112 relating to so-called functional claims is new. It provides that an element of a claim for a combination (and a combination may be not only a combination of mechanical elements, but also a combination of substances in a composition claim, or steps in a process claim) may be expressed as a means or step for performing a specified function, without the recital of structure, material or acts in support thereof.

For patent drafters practicing in the U.S. life sciences, the means-plus-function claim format may provide more accuracy and clarity than purely structural characterization and may end up providing broader scope. This alternative claim format is worth considering.

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*Stacy Lewis is a law clerk at Finnegan