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13 March, 2014

USPTO issues guidance for determining subject matter eligibility of claims reciting or involving laws of nature, natural phenomena and natural products.

On 4 March 2014, the USPTO issued their guidance memorandum to implement a new procedure for assessing patent eligibility (for further details see here). This guidance is intended to take into account both of the recent Supreme Court Decisions in this area; Association for Molecular Pathology v. Myriad Genetics, Inc. and Mayo Collaborative Services v. Prometheus Laboratories Inc.

The Guidance applies to all claims which recite or involve laws of nature/natural principles, natural phenomena and/or natural products. The Guidance provides a three step test for assessing the claims. The Guidance also provides details on how to analyse the critical third question; “does the claim as a whole recite something significantly different than the judicial exception(s)?” and lists factors that weigh towards and against eligibility.

The Guidance also provides a number of useful practical examples, which confirm that the eligibility question will apply to all natural products and combinations (including proteins) and that reciting a pair of nucleic acid primers which would not exist as such in nature together may not pass the eligibility threshold. Indeed there must be a “marked difference” in structure from the natural product in order to be patent eligible.

On first review, the Guidance appears to be a positive step for applicants attempting to pursue method claims compared to the current practice of the USPTO Examiners. In particular, conventional steps may be sufficient to overcome the eligibility question provided that they impart limitations on the claim scope and relate to the natural products in a significant way.