USPTO Issues New Guidelines on Patentable Subject Matter

The USPTO recently issued new guidelines for patent examiners to use in determining whether a claimed invention meets the baseline criteria to be eligible for patent protection. Recent Supreme Court cases have significantly altered these criteria. Section 101 of the Patent Code says:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Supreme Court to Decide if Isolated Human Genes Are Patentable

The U.S. Supreme Court recently granted review of a decision by the Court of Appeals for the Federal Circuit affirming that isolated human genes are eligible for patent protection. The Court granted review of a single question:

Are human genes patentable?

Supreme Court to Review Scope of Patentable Subject Matter

The U.S. Supreme Court agreed to review the en banc decision of the Court of Appeals for the Federal Circuit in In re Bilski (545 F.3d 943). In that decision, the Federal Circuit rejected its previous “useful, concrete and tangible result” test for patentable subject matter articulated in State Street (149 F.3d 1368). Finding that test inadequate or inappropriate, the court articulated two tests for patentability that are commonly referred to as the “machine-or-transformation” test. Under the new test, a claimed process is patentable if “(1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”