New USPTO Guidelines for Interpreting Patent Eligibility under Myriad and Prometheus Cases

The United States Patent and Trademark Office (USPTO) just published new guidelines advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of patent eligible subject matter under 35 U.S.C. §101 under their Myriad and Prometheus holdings.

The guidelines require examiners to apply the Myriad and Prometheus holdings to any subject matter that could be characterized as a judicial exception to patent-eligibility: a law of nature, a natural principle, a natural phenomena or a natural product. If the claimed subject matter could fall within one of these judicial exceptions, examiners are then instructed to evaluate whether the claimed subject matter is something “significantly different” than the judicial exception. If the claimed subject matter is “significantly different,” it is considered to be patent eligible subject matter under 35 U.S.C. §101.

The guidelines state that claimed subject matter is considered to be “significantly different” if it can be shown that (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 (and thus is not a judicial exception).

The guidelines note six factors that would indicate that the claimed subject matter is significantly different from a judicial exception and therefore weighted toward eligibility:

1. the claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products;
2. the claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception;
3. the claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s);
4. the claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s);
5. the claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application; and
6. the claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.

The guidelines also note six factors that would indicate that the claimed subject matter is not significantly different from a judicial exception and therefore weighted against eligibility:

1. the claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products;
2. the claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered;
3. the claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s);
4. the claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field;
5. the claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s); and
6. the claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.

Finally, the guidelines indicate that if the totality of the relevant factors weigh toward eligibility, the claim qualifies as eligible subject matter. If on the other hand, the factors weigh against eligibility, the claim should be rejected.