On December 16, 2014, the U.S. Patent and Trademark Office (USPTO) released an interim guidance memorandum (the "Interim Guidance") for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. Section 101 in view of recent Supreme Court decisions. The USPTO is seeking public comment on the Interim Guidance along with additional suggestions for claim examples.

The Interim Guidance sets forth a revised flowchart with several questions for analyzing subject matter eligibility under Section 101. The edits to the revised guidelines are presented with deletions in double- bracketed text and insertions in underlined text.

  1. Is the claim directed to one of the four statutory categories (i.e., a process, machine, manufacture or composition of matter)? If yes, proceed to Question 2; if no, then reject the claim as drawn to ineligible subject matter.
  2. Does the claim recite or involve judicial exception(s) (which include abstract ideas, laws of nature/natural principles, natural phenomena [[and natural products]])? If no, then the claim qualifies as eligible subject matter; if [[maybe or]] yes, then proceed to Question 3 [[unless the claim recites or involves an abstract idea—then use MPEP 2106 to analyze the claim for eligibility]].
  3. Does the claim [[as a whole]] recite [[something]] additional elements that amount tosignificantly more different than the judicial exception(s)? If yes, then the claim qualifies as eligible subject matter; if no, then reject the claim as drawn to ineligible subject matter.

Notable changes from the prior Guidance are that all claims (product and process) with a judicial exception are subject to the same steps, and claims including a nature-based product are analyzed in step 2 to identify whether the claims are directed to a "product of nature" exception. The analysis compares the nature-based product in the claim to its naturally occurring counterpart to identify markedly different characteristics based on structure, function and/or properties. The claim proceeds to step 3 only when the claim is directed to an exception.

According to the Interim Guidance, natural products are considered laws of nature/natural principles and natural phenomena. The Interim Guidance stresses that the "markedly different characteristics" analysis should be applied only to the nature-based product limitations in the claim to determine whether the nature-based- products are “product of nature” exceptions. 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 to its component parts.

The "markedly different characteristics" analysis compares the nature-based-product limitation to its naturally occurring counterpart in its natural state. In the case of a nature-based combination, the closest counterpart may be the individual nature-based components that form the combination. Therefore, a mixture of naturally occurring products may now may be considered patentable subject matter, depending on the "markedly different characteristics" analysis.

Markedly different characteristics can be expressed as the product's structure, function and/or other properties, and they are evaluated based on what is recited in the claim on a case-by-case basis. Examples when determining whether there is a marked difference include: biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic or physical.

The Interim Guidance also sets forth a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception. Limitations that may qualify as "significantly more" include technological improvements, improvements to computer functioning, effecting a transformation or reduction to a different state or thing, or adding unexpected limitations.

The examples set forth in the Interim Guidance are from recent Supreme Court decisions and utilize the flowchart model to analyze claims for subject matter eligibility.

The interpretation of the Interim Guidelines by the USPTO, especially with respect to an interpretation of what is "markedly different," may continue to raise more questions than answers, and it will take some time to ascertain what the USPTO considers "markedly different."