On December 16, 2014, the United States Patent and Trademark Office (USPTO) published its 2014 Interim Eligibility Guidance of Subject Matter Eligibility for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 of the United States Patent Act.

The Guidance does not have the force and effect of law. Rather, the Guidance sets out the USPTO's interpretation of the subject matter eligibility requirements in light of recent decisions by the United States Supreme Court and the United States Court of Appeals for the Federal Circuit, and advises the public and USPTO personnel on how these court decisions impact the subject matter eligibility requirements of 35 U.S.C. 101.

The Guidance supplements the June 25, 2014, Preliminary Instructions in light of the Supreme Court decision in Alice Corporation Pty Ltd v CLS Bank International et al1 and supersedes the March 4, 2014, Procedure for Subject Matter Eligibility Analysis of Claims Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products issued in view of the Supreme Court decisions in Association for Molecular Pathology v Myriad Genetics Inc2 andMayo Collaborative Services v Prometheus Laboratories Inc.3  

The Guidance intends to offer a comprehensive view of subject matter eligibility in line with AliceMyriadMayo, and the related body of case law, and is responsive to the public comments received pertaining to the March 2014 Procedure and the June 2014 Preliminary instructions.

The Guidance includes a decision-making flowchart which asks:

  • Is the claim "directed to" one of the four statutory categories?
  • Is the claim "directed to" a judicial exception?
  • Does the claim recite additional elements that amount to "significantly more" than the judicial exception?

Is the Claim Directed to a Statutory Category?

The four statutory categories include a process, machine, manufacture and composition of matter. The subject matter of the claim must be directed to one of the four subject matter categories.

If the claim is not directed to one of the four statutory categories, the claim is not eligible for patent protection and should be rejected under 35 U.S.C. 101, for at least this reason.

If the claim is directed to one of the four subject matter categories, then the eligibility analysis may proceed further.

Is the Claim Directed to a Judicial Exception?

The judicially recognized exceptions include a law of nature, a natural phenomenon, and an abstract idea. A determination must be made as to what the applicant has invented by reviewing the entire application disclosure and construing the claims in accordance with their broadest reasonable interpretation.

A claim to a process, machine, manufacture or composition of matter that is not directed to any judicial exceptions is eligible and needs no further eligibility analysis.

A claim that is directed to at least one exception requires further analysis to determine whether the claim recites a patent-eligible application of the exception.

Abstract Ideas

Abstract ideas have been identified by the courts, by way of example, to include fundamental economic practices, certain methods of organizing human activities, an idea "of itself," and mathematical relationships/formulas.

Laws of Nature/Natural Phenomena

Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/substances and substances that do not have "markedly different" characteristics compared to what occurs in nature. A claim that recites a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state is directed to a “product of nature” exception.

The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. When there is no naturally occurring counterpart to the nature-based product, the comparison should be made to the closest naturally occurring counterpart.

Markedly different characteristics can be expressed as the product's structure, function, and/or other properties, and will be evaluated based on what is recited in the claim on a case-by-case basis.

If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a “product of nature” exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception.

If the claim includes a nature-based product that has markedly different characteristics, the claim does not recite a “product of nature” exception and is eligible.

Does the Claim Recite Additional Elements that Amount to "Significantly More" than the Judicial Exception?

A determination must be made as to whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to "significantly more" than the judicial exception.

The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:

  • Improvements to another technology or technical field;
  • Improvements to the functioning of the computer itself;
  • Applying the judicial exception with, or by use of, a particular machine;
  • Effecting a transformation or reduction of a particular article to a different state or thing;
  • Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or
  • Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.

Limitations that were found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:

  • Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer.
  • Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry;
  • Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or
  • Generally linking the use of the judicial exception to a particular technological environment or field of use.

If the claim as a whole does recite significantly more than the exception itself, the claim is eligible and the eligibility analysis is complete.

If there are no meaningful limitations in the claim that transform the exception into a patent-eligible application, such that the claim does not amount to significantly more than the exception itself, the claim is not patent-eligible and should be rejected under 35 U.S.C. 101.

Conclusion

The Guidance is effective as of December 16, 2014, and applies to all patent applications filed before, on, or after that date. Public comment is invited and must be received on or before March 16, 2015.