The USPTO and Laws of Nature, Natural Products and Natural Phenomena

New Approach to Patentable Subject Matter

The United States Patent Office periodically issues guidance for examiners often in response to a recent court decision or new statute.  These guidelines (the Guidance) do not have the force of law but nevertheless establish the specific procedures that the Examiners apply during examination of patent applications.

Examination guidelines were issued on 4 March 2014  to address two  recent court decisions related to the subject matter eligibility of certain claims under 35 U.S.C. § 101. Examiners will use tests described in the Guidance to determine the patent eligibility of any claim related to laws of nature, natural phenomena and natural products.

To do so, the Guidance articulates a test with three key questions:

1. Is the claimed invention directed to one of the four statutory patent-eligible, subject-matter categories: process, machine, manufacture, or composition of matter?

2. Does the claim recite or involve one or more judicial exceptions?

3. Does the claim as a whole recite something significantly different than the judicial exception(s)?

The rest of the Guidance explains how to apply the analysis under the questions.  The Guidance states that “a significant difference can be shown in multiple ways, such as: (1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature.” The Guidance also provides a list of factors to consider in the analysis.  The factors do not provide complete clarity though, as they are interpreted as part of a balancing test. Additionally, not all factors or supporting evidence will be applicable in all cases.

The full text of the Guidance is available here.



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