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IP Alert
IP Alert: USPTO Issues Interim Guidance on Subject Matter Eligibility

January 8, 2015

Many inventors are familiar with the novelty and obviousness tests for patentability in the United States. In recent years, the third test for patentability—subject matter eligibility—has received a considerable amount of attention from the courts. The U.S. Supreme Court issued a number of opinions in this area, culminating recently in Alice Corp. v. CLS Bank International. Subsequent to Alice, the Court of Appeals for the Federal Circuit has issued a number of important opinions in this area. 

In response to the judicial activity in this area, over the past few years the U.S. Patent and Trademark Office (USPTO) has issued a number of guidelines to help patent examiners assess their patent applications for subject matter eligibility. In December of 2014, the USPTO issued its most recent set of guidelines in interim form, and opened a 90-day comment period to solicit public input. Notably, this interim guidance does not have the force and effect of law, and a failure of any particular patent examiner to follow the interim guidance is not in itself a proper basis for either an appeal or a petition. This interim guidance supplements, rather than supplants, Section 2106 of the Manual of Patent Examining Procedure regarding the determination of eligibility under 35 U.S.C. 101.

The interim guidance suggests a particular decision matrix for examiners to follow and provides a flowchart that depicts the USPTO’s proposed step-by-step analysis:


In many ways, these guidelines track the Supreme Court’s guidance in Mayo Collaborative Services v. Prometheus Laboratories, Inc. Generally, the guidelines instruct the examining corps (1) first to determine whether the claim is directed to one of the “judicially recognized exceptions” to statutory subject matter eligibility, and, if so, (2) to then determine whether the claim adds additional elements that amount to “significantly more” than the judicial exception.

Judicial exceptions can include law of nature, natural phenomena, and abstract ideas. The guidelines provide a few examples of “laws of nature” and “natural phenomena”:

•  An isolated DNA sequence
•  A correlation that is the consequence of how a certain compound is metabolized by the body
•  Electromagnetism to transmit signals
•  The chemical principle underlying the union between fatty elements and water

The guidelines also provide several examples of “abstract ideas”:

•  Mitigating settlement risk
•  Hedging risk
•  Creating a contractual relationship
•  Using advertising as an exchange or currency
•  Processing information through a clearinghouse
•  Comparing new and stored information and using rules to identify options
•  Using categories to organize, store and transmit information
•  Organizing information through mathematical correlations
•  Managing a game of bingo
•  The Arrhenius equation for calculating the cure time of rubber
•  A formula for updating alarm limits
•  A mathematical formula relating to standing wave phenomena
•  A mathematical procedure for converting one form of numerical representation to another

The USPTO’s prescribed analysis differs from prior guidance in at least two potentially significant regards. First, under the USPTO’s schema, all types of claims that are subject to a judicial exception to patent eligibility are subject to the identical analysis. Second, claims that specify a “nature-based product” are analyzed in step 2A to identify whether the claim is “directed to” a product of nature. The written guidance states that the USPTO interprets “directed to” to signify that the claim recites the exception rather than simply having something to do with the exception. Under this analysis, USPTO examiners are to compare the nature-based product in the claim to its naturally occurring counterpart, and to identify markedly different characteristics based on structure, function, or properties. The guidelines acknowledge that even a small change can result in markedly different characteristics compared to a product’s naturally occurring counterpart. The analysis proceeds to step 2B only when no markedly different characteristics are shown.

In determining at step 2A whether a given claim is directed to one of the judicially recognized exceptions, the guidelines specifically note that a given claim element may fall under more than one such exception. As one example, the guidelines note that mathematical formulas have been treated by the courts as both abstract ideas and laws of nature. Rather than trying to narrow down which exception may somehow be more “correct,” the guidelines specify that it is sufficient to identify that the claimed concept aligns with at least one judicial exception. That said, the guidelines also caution that such a claim must not have a preemptive effect with respect to any of the recited exceptions. If there are a number of judicial exceptions present in a claim, the claim must succeed with respect to each such judicial exception.

When the nature-based product is produced by combining multiple components, the markedly different characteristics analysis should be applied to the resultant nature-based combination rather than its individual component parts. Process claim are subject to this analysis only when the USPTO determines that there is no difference in substance from a corresponding product claim.

If the analysis reaches step 2B, the USPTO must then determine whether the claim recites “significantly more” than the judicial exception, as per the Court’s guidance in Mayo. The guidelines suggest that this step can be viewed as a “search for an inventive concept” [citation omitted]. The guidelines note that the claim must be considered as a whole, and that while individual elements of the claim may not appear to add significantly in this regard, the combination of such individual elements may nevertheless amount to the “significantly more” being sought.

Specific examples of “significantly more” identified in the guidelines include these:

•  Improvements to another technology or technical field
•  Improvements to the functioning of a computer in and of itself
•  Applying the judicial exception with, or by use of, a particular machine
•  Effecting a transformation on 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
•  Adding unconventional steps that confine the claim to a particular useful application
•  Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.

Specific examples of what fails to constitute “significantly more” include these:

•  Adding the words “apply it” (or any equivalent) with the judicial exception
•  Merely implementing 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
•  Adding insignificant extra solution activity to the judicial exception (such as the mere gathering of data in conjunction with a law of nature or abstract idea)
•  Simply generally linking use of the judicial exception to a particular technological environment or field of use

The above guidance should be regarded as tentative. It is not certain that the USPTO’s final guidelines will be published in the same form as the interim guidelines, and it is also not certain that these guidelines will comport with future court decisions on subject matter eligibility. In the meantime, those currently seeking patent protection can at least be mindful of how the USPTO is undertaking its charter to examine patent applications for subject matter eligibility.

For more information, please contact Fitch Even partner Steven G Parmelee, author of this alert.

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