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On December 15, 2014, the U.S. Patent and Trademark Office issued new examination guidance for subject matter eligibility under 35 U.S.C. § 101 in view of recent U.S. Supreme Court decisions.  The guidance, entitled “2014 Interim Guidance on Patent Subject Matter Eligibility,” was published in the Federal Register on December 16, 2014, and can be downloaded as a PDF file from the following link:

http://www.uspto.gov/patents/law/exam/examguide.jsp

Initially we note that the Interim Guidance supplements the Preliminary Examination Instructions issued in view of the Supreme Court decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. __, 132 S. Ct. 2347 (2014), 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. The Interim Guidance also supersedes MPEP 2105 (“to the extent that it suggests that ‘mere human intervention’ necessarily results in eligible subject matter”) and MPEP 2106.01.  The Interim Guidance does not have the force and effect of law, and failure of USPTO personnel to follow the Interim Guidance is not a proper basis for an appeal or petition.

The USPTO has indicated that the Interim Guidance will be supplemented based on developments in the case law and public feedback.  In this regard, the USPTO is seeking written comments regarding the Interim Guidance, and held a public forum to discuss the new guidelines on January 21, 2015.  Written comments may be submitted until March 16, 2014.

The subject matter eligibility test set forth in the Interim Guidance sets forth a three-step test derived from recent Supreme Court decisions in Alice and Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012).  The three-step test is as follows:

  • Step 1: Determine whether a claim is directed to a statutory class.  A statutory class is a process, machine, manufacture, or composition of matter.  If the claim is not directed to a statutory class, the claim is ineligible for patent protection.  If the claim is directed to a statutory class, proceed to step 2.
  • Step 2: Determine whether the claim is directed to a Judicial Exception.  Judicial Exceptions include Laws of Nature, Natural Phenomena, and Abstract Ideas.  If the claim is not directed to a Judicial Exception, the claim is eligible for patent protection.  If the claim is directed to a Judicial Exception, proceed to step 3.
  • Step 3: Determine whether the claim recites additional elements that amount to “significantly more” than the Judicial Exception.  If the claim recites additional elements that amount to “significantly more” than the Judicial Exception, the claim is eligible for patent protection.  If the claim does not recite additional elements that amount to “significantly more” than the Judicial Exception, the claim is ineligible for patent protection. 

The Interim Guidance also explains that the underlying concern with respect to Judicial Exceptions is the risk that a claim will “tie up” the excepted subject matter and pre-empt others from using the judicial exception.  The “significantly more” standard described with respect to Judicial Exceptions is a requirement that the claim applies the Judicial Exception in a meaningful way, i.e., “more than a drafting effort designed to monopolize the exception”.  Patent eligibility is not provided by reciting only field-of-use limitations, extra-solution limitations, or additional limitations conventional in the field of the claim.

Interim Subject Matter Eligibility Guidance – Abstract Ideas

The Interim Guidance also provides a thorough discussion of Abstract Ideas, including examples of court-recognized Abstract Ideas, and examples of what can be found to be “significantly more” and what may not be considered “significantly more”.

Abstract ideas identified by courts (by way of example) include fundamental economic practices, certain methods of organizing human activities, an idea ‘of itself,’ and mathematical relationships/formulas. Specific examples of abstract ideas identified by courts and noted in the Interim Guidance include:

  1. mitigating settlement risk (Alice);
  2. hedging (Bilski);
  3. creating a contractual relationship (buySAFE);
  4. using advertising as an exchange or currency (Ultramercial);
  5. processing information through a clearinghouse (Dealertrack);
  6. comparing new and stored information and using rules to identify options (SmartGene);
  7. using categories to organize, store and transmit information (Cyberfone);
  8. organizing information through mathematical correlations (Digitech);
  9. managing a game of bingo (Planet Bingo);
  10. the Arrhenius equation for calculating the cure time of rubber (Diehr);
  11. a formula for updating alarm limits (Flook);
  12. a mathematical formula relating to standing wave phenomena (Mackay Radio); and
  13. a mathematical procedure for converting one form of numerical representation to another (Benson). 

Specific examples of what may qualify as “significantly more” when recited in a claim include:

  1. improvements to another technology or technical field;
  2. improvements to the functioning of [a] computer;
  3. applying the judicial exception with, or by use of, a particular machine;
  4. effecting a transformation or reduction of a particular article to a different state or thing;
  5. adding a specific limitation other than what is well-understood, routine and conventional in the field;
  6. adding unconventional steps that confine the claim to a particular useful application; and
  7. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.

Specific examples of what may not qualify as “significantly more” when recited in a claim include:

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

Interim Subject Matter Eligibility Guidance –Nature Based Products and Chemical/Biotechnology Considerations

Determining Whether a Claim is Directed to a Judicial Exception Such as a Product of Nature

  • A claim is “directed to” a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
  • As a part of this analysis, examiners should identify the judicial exception that is recited in the claim.
  • If the claim is directed to a product of nature, examiners should determine whether the recited product of nature has markedly different characteristics compared to what occurs in nature.
  • 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.
  • Process claims “that merely use a nature-based product” should not necessarily be subject to an analysis for markedly different characteristics.
  • If an examiner determines that a claim is not directed to a law of nature, natural phenomenon, or product of nature, no further analysis is required.
  • If an examiner determines that a claim, when viewed as a whole, is directed to invention that clearly does not seek to “tie up” a judicial exception, the examiner may “streamline” the eligibility analysis because the claim’s eligibility will be “self-evident.”
  • However, if there is any doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself, examiners should conduct the full analysis. 

Determining Whether a Claim Recites Additional Elements that Amount to Significantly More than the Judicial Exception

  • A claim that is directed to a judicial exception must be analyzed to determine whether the elements of the claim “are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.” 
  • The elements in addition to the judicial exception should be considered both individually and as an ordered combination.
  • The additional features must “ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception.”
  • As an example, the Interim Guidance indicates that Applicants may add “a specific limitation other than what is well-understood, routine and conventional in the field” or “unconventional steps that confine the claim to a particular useful application.”

Chemical/Biotechnology Examples

Examples of hypothetical eligible and ineligible claims are available for review on the USPTO website: http://www.uspto.gov/patents/law/exam/examguide.jsp

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