USPTO Issues Interim Examination Guidelines for 35 U.S.C. §101 Statutory Subject Matter

Pending U.S. Supreme Court review of the Federal Circuit’s Bilski decision and recognizing that the state of the law in this area is in flux, the USPTO has issued instructions for its examiners to use in determining patentability under 35 U.S.C. §101.   The guidelines state that §101 patentability includes two requirements: (1) subject matter; and (2) utility.

Utility must be “specific, substantial and credible.”  The usefulness of the invention must be commensurate with the broadest reasonable interpretation of the claims viewed in light of the specification, from the vantage of one of ordinary skill in the relevant field.

To determine whether §101 subject matter has been met, the guidelines set forth a two part test: (1) whether the claimed invention falls within one of the four statutorily recognized classes: process, manufacture, machine or composition of matter; and (2) that the invention must not be wholly directed to subject matter encompassing a judicially recognized exception to patentability.  A claim that embraces both patentable and unpatentable subject matter, as read broadly, is not patentable.

The guidelines give samples of claims not meeting part one of the test, to include: transitory forms of signal transmission; a naturally occurring organism; a human per se;  a legal contractual agreement between two parties; a game defined as a set of rules; a computer program per se; and a company.

Judicially recognized exceptions for part two include:   abstract ideas; mental processes; laws of nature; natural phenomenon; physical phenomenon; scientific principles; systems that depend upon human intelligence alone; disembodied concepts; and disembodied mathematical concepts and formulas.  However, a claim that is limited to a particular practical application of an exception meets §101 muster.

The guidelines include further specific examples for use in examining patent applications and specific rules for process claims, including definitions set forth for the currently controversial “machine or transformation” test.  For these claims, the guidelines stress that recited structure or steps must be meaningful limitations and more than extra-solution activity.  Many believe that the Supreme Court will overturn the “machine or transformation” test, but in the meantime the U.S.P.T.O. will scrutinize patent applications under these guidelines.

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