In light of the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., and Mayo Collaborative Services v. Prometheus Lab, Inc., the USPTO issued guidelines for determining whether a claim reflects a significant difference from what exists in nature and, thus is patent eligible.
Effective March 4, 2014, all claims reciting or involving a judicial exception including laws of nature/natural principle, natural phenomena, and/or natural products should be examined using the new guidelines. Claims reciting an abstract idea whether alone or in combination with other judicial exceptions will continue to be analyzed for subject matter eligibility using the existing guidance in MPEP §2106(II).
Process for Analyzing Subject Matter Eligibility
The Guidelines provides three questions for analyzing subject matter eligibility:
Is the claimed invention directed to one of the four statutory patent eligible subject matter categories: process, machine, manufacture, or composition of matter?
- No – the claim is not eligible for patent protection.
- Yes – proceed to Question 2.
Does the claim recite or involve a judicial exception?
- No – the claim is patent eligible and the analysis is complete.
- Yes – or if it is unclear whether the claim recites or involves a judicial exception, proceed to Question 3.
Does the claim as a whole recite something significantly different than the judicial exception(s)?
- If it recites an abstract idea use the analysis under MPEP §2106(II).
- Otherwise follow the analysis of “significantly different”.
Process for Analyzing Significantly Different
The Guidelines provides six factors for determining whether a claim is significantly different from what exists in nature. To avoid potential claim rejection, practitioners should carefully review the factor-based analysis outlined in the Guidelines. A significant difference is demonstrated if: (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 not a judicial exception).
If the factor-based analysis indicates that the claim as a whole is not significantly different from the judicial exception(s), the claim is not patent eligible and should be rejected under 35 U.S.C. §101. If the factor-based analysis indicates that the claim as a whole is significantly different from the judicial exception(s), the claim is patent eligible, and the analysis is complete.
The last section of the Guidelines provides examples of claims directed to different subject matter utilizing the factor-based analysis. Although guidance was prompted from Myriad and Mayo, the Guidelines encompass nucleic acids and natural products.