On March 4, 2014, the United States Patent and Trademark Office issued a memorandum and quick reference sheet on the “2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products”.  The interested reader is invited, and patent practitioners are urged, to read the source documents via the above links.  It should be noted that these USPTO documents are guidelines for examining patents (not statute), and are based on cited court decisions.

The guidelines remind examiners that 35 USC §101 “is not the sole tool for determining patentability”, that 35 USC §102, 103, 112 are also applicable, and that there are no changes (in these guidelines) “to examination of claims reciting an abstract idea”.  Focus, here, is on natural products recited or involved in the claims.  A flow diagram walks through the process of determining whether a claim qualifies as eligible subject matter, which it does if the claim is directed to one of the four statutory categories and does not recite or involve a judicial exception, or if the claim recites “something significantly different than the judicial exception(s)”.

Emphasis (in eligibility determination) is placed on the phrase “significantly different”, which can be shown in a claim in various ways.  Elements or steps “that practically apply the judicial exception in a significant way”, and/or “features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature” weigh towards patent eligibility of the subject matter.  A balance test is suggested, in which relevant factors are evaluated similarly to the MPEP 2164.01(a) and the Wands analysis (for evaluating whether undue experimentation is required).

Weighing against eligibility are factors including reciting what “appears to be a natural product that is not markedly different in structure from naturally occurring products”, “a high level of generality”, and additional elements or steps that are “well-understood, purely conventional or routine”, are “insignificant extra solution activity”, or “that amount to nothing more than a mere field of use”.  Significantly, however, if there is a marked difference between what is recited and what is seen in nature, even if this difference “came about as a result of routine activity or via human manipulation of natural processes”, this “does not prevent the market difference from weighing in favor of patent eligibility.”  This is important to note in claims drafting practice and the drafting of the specification – emphasizing what is different from nature may well prove useful during patent prosecution.

Weighing towards eligibility, in example cases analyzed in the guidelines, are factors including structural difference or functional difference from what occurs in nature, such as a name, character or use that is a product of human ingenuity, “specific dosage and treatment” limitations that do not foreclose others from using a product in other ways, manipulating a product in “a particular and significant way”, use of a product in a manner that is not “well-known, routine or conventional”, additional claimed elements that “narrow the scope of the claim so that others are not foreclosed from using the natural products in other ways”, physically interrelating “in a significant way” elements that include natural products, doing more than just describing natural products, including elements “in addition to the natural products”, and being “more than the discovery of some of the handiwork of nature”.  More factors weighing towards eligibility include method steps that result in changes that don’t foreclose others from using the natural products in other ways, and instructions that apply natural products in some manner that is more particular than general instructions to apply or use them.

While we are free (on a personal level) to agree or disagree with outcomes of the various cases, the analysis in these guidelines makes a good read and gives us insights as to legal underpinnings of the factors involved in determining patent eligibility of claims involving nature per the judicial exceptions.

The USPTO guidelines thus provide lists of factors, and examples of how these factors are applied in the analysis of the various cited cases in weighing for or against patent eligibility of the claims.  Patent practitioners can cast a critical eye towards proposed claims, in the drafting process, and gain an insight as to how these claims might be viewed under examination in light of these factors and the weighing test.  Also, patent practitioners can apply analysis of these factors during patent prosecution, to argue for eligibility of claims.  Familiarity with these USPTO guidelines thus provides a useful part of the toolkit.  This is all part of the art of patenting.