On Monday, December 15th, the Patent Office released revised “Guidance” on the evaluation of subject matter patent-eligibility under s. 101. (A copy is available at the end of this post.) The “Guidance” is an attempt to unify the analyses that were set forth in earlier Guidelines post-Mayo and post-Alice, and apply to all classes of inventions. After stripping away the introductory material, and the case law summaries, there are only a few pages of substantive guidance.
The most important change to the notorious March 4th “Life Sciences Guidelines” is summarized in the Flowchart on page 9 and in section 3B. If a composition is a “nature-based product,” it is analyzed in step 2B to see if it is “markedly different” from “its naturally occurring counterpart in its natural state.” However, the revised Guidance pointedly drops the requirement that the product be structurally different. Now “markedly different characteristics can be expressed as the product’s structure, function and/or other properties and will be evaluated based on what is recited in the claim on a case-by-case basis.” That is a big “or”: