On December 16, 2014, the United States Patent and Trademark Office (USPTO) published long-awaited guidelines intended to help examiners determine the patent eligibility of a wide range of inventions from isolated genetic materials to computer-implemented methods. The new guidelines revise those published by the office earlier this year (discussed here), which drew heated criticism from some in the patent community as too vague with respect to examination of certain inventions and too onerous with respect to others.

The newly published 2014 Interim Guidance on Patent Subject Matter Eligibility elaborates on the two-part test for patent-eligibility set forth by the Supreme Court in Mayo v. Prometheus and reiterated in Alice v. CLS Bank:

  • Part 1: Determine whether the claim is “directed to” an invention that is judicially excepted from patenting, to wit, a law of nature, natural phenomenon, or abstract idea; and 
  • Part 2: If the claim is directed to a judicial exception, determine whether any element(s) in the claim ensure that the claim amounts to significantly more than the judicial exception.

The guidelines flesh out through case law and technical examples key terms used in application of that two-part test, for example how the USPTO will determine whether a claim is “directed to” a judicial exception, and what “laws of nature,” “natural phenomena,” and “abstract ideas” mean. The guidelines also specify how the USPTO will undertake the “markedly different/significantly more” analysis, to determine whether a claim that recites a judicial exception might otherwise be patent eligible.

Notably, the guidelines adopt an expansive definition of “directed to,” making the two-part Mayo test applicable to a broader range of claims than practitioners might have expected under the case law. However, the guidelines exempt from the Mayo test claims that “clearly do not tie up the judicial exception.” According to the guidelines, a claim will not be subjected to a full patent-eligibility analysis if it recites a law of nature, natural phenomenon, or abstract idea, yet, “when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it.” The guidelines offer as examples, a claim directed to a robotic arm assembly having a control system that operates using certain mathematical relationships, a claim directed to an artificial hip prosthesis coated with a naturally occurring mineral, a claim that is directed to a cellphone with an electrical contact made of gold, and a claim directed to a plastic chair with wood trim.

The USPTO seeks public comment on the new guidelines during a 90-day window ending March 16, 2015, and is scheduled to hold a public forum on the subject in mid-January 2015. The USPTO indicates that it will weigh public feedback, together with the outcome of several appeals pending before the Court of Appeals for the Federal Circuit, in preparing finalized procedures for use by examiners to determine subject matter eligibility under 35 U.S.C. 101.