The much-anticipated subject-matter eligibility Guidance has finally been released by the U.S. Patent & Trademark Office (USPTO) for public inspection and comment. Although the new Guidance is being circulated for public comment—and is subject to revision—it is effective immediately for use in examining applications. The new Guidance supersedes the 9^th Edition of MPEP §2106, the March 2014 Mayo/Myriad Guidance, and the June 2014 Alice Guidance.

Differences from March/June Guidance

A number of points in the December Guidance remain unchanged from the March/June Guidance documents, but there are also important differences between the March and December documents.

• The March Guidance provided a three-step flowchart for determining subject-matter eligibility. The December Guidance revises this flowchart. The revisions are shown above, with deleted text marked in red and newly inserted text marked in green.
• The March Guidance was explicitly directed only to natural products/laws of nature (principally of interest to the biotech and pharmaceutical industries). The December Guidance also applies to abstract ideas (of interest to electronics and so-called “business method” patents).
• A claim came within the ambit of the March Guidance if it “recites or involves” a natural product/law of nature. The December Guidance only applies if the claim is “directed to” a natural product/law of nature. One is given to understand (Dec. Guidance pg. 11) that “directed to” is a narrower criterion.
• There is no longer a multi-factor balancing test for the last step of the analysis.
• If a claim involved a natural product or law of nature, the March Guidance required that one add enough structural elements to make the claim “significantly different” from the natural product. The December Guidance looks for a “marked difference,” between the claimed product and a natural product but will consider both structural and functional features as part of the “marked difference” analysis.
• Finally, the most important difference is that the March requirement for a “significant difference” has given way to a two-step analysis for a “marked difference” (Step 2A) followed (if the marked difference cannot be found) by a search for “significantly more” (Step 2B). This two-step analysis is discussed in more detail below.

The December Guidance is also paired with a new set of sample claims to illustrate how the Guidance is supposed to be applied. The new sample claims all relate to chemical and biotech inventions, but an additional set of samples relating to computer implemented inventions is also set to be released in the coming weeks.

Comments

As noted above, the December Guidance is supposedly narrower in its reach, because a claim can only be excluded as “ineligible subject matter” if it is “directed to” a product of nature, instead of merely “reciting” or “involving” a product of nature. Indeed, the December Guidance includes (pgs. 24 & 25) a “streamlined analysis” for claims that merely include—without being “directed to”—a natural product.

What does it mean to be “directed to”—instead of merely “including”—a natural product? The December Guidance says (pg. 15) that “[a] claim that recites a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state is directed to a ‘product of nature’ exception.” In other words, if a claim involves a product that is “markedly different” (structurally and/or functionally) from a natural product, then the claim is §101 eligible and does not need to proceed to the last step of the flow-chart (Step 2B) where the Examiner looks for “significantly more” than the natural product. Indeed, most of the sample claims that are listed as eligible end at Step 2A. Only once in the examples (pg. 15, “Claim 5”) does a claim fail Step 2A but end up §101 eligible because it satisfies Step 2B.

This new approach is elegantly exemplified in the new sample claims. They show, in particular, how the USPTO envisions the application of functional features to the “marked difference” analysis will work. For instance, the old example about gunpowder being ineligible because saltpeter, charcoal, and sulfur are all natural materials has been reversed. Instead, the USPTO is now taking the position that because the saltpeter/charcoal/sulfur mixture has a new functional property (viz. explosiveness), the mixture is §101 eligible, even if the individual components are not. Similarly, the old example concerning pomelo juice and vitamin E has been replaced with an example that says that so long as the vitamin E is claimed as an “effective amount of an added preservative,” this is enough to make the mixture §101 eligible.

The USPTO has also added examples to show that a structural difference without any known functional effect (see pg. 4, “Claim 3”) can impart §101 eligibility, and to show that a human-made version of a natural molecule (pg. 14, “Claim 1”) will not impart §101 eligibility. Intriguingly, the USPTO appears to be allowing applicants to get around Myriad by explicitly disclaiming a known natural sequence (see pg. 7, “Claim 5”; pg. 10, “Claim 2”). Following a suggestion that HDP made in its comments on the March Guidance (HDP comments pg. 4), the USPTO has also made clear that the burden is on the Examiner to prove that molecule actually occurs in nature before a rejection can be made (pg. 9, “Claim 2”). It is not enough that it could occur, or even that it probably occurs.

Finally, there are two new examples that bear particular mention as bookending a spectrum:

• The pg. 11, “Claim 3” analysis concerns a claimed nucleotide comprising a natural sequence (SEQ ID NO:1) and a fluorescent label. In this example, the fluorescent label is enough to make the claimed molecule “markedly different” from the natural nucleotide.
• The pg. 15, “Claim 4” analysis by contrast, concerns a population of naturally occurring cells “in a container.” In this example, the recitation of the “container” is not enough to make the claimed composition “markedly different” from the composition of naturally occurring cells (Step 2A), nor is the container “significantly more” (Step 2B).

There are two reasons given why the container is not enough to make pg. 15 “Claim 4” §101 eligible. (1) The “use of a container… is not only well-understood, routine and conventional… it is also required for growing and using the cells.” (2) “Additionally, the claim recites the container at such a high level of generality that it merely tells a scientist to use whatever container she wishes to use.”

Tagging nucleotides with a fluorescent label is also well-understood, routine, and conventional, but the pg. 11 “Claim 3” analysis says that the fluorescently labelled SEQ ID NO:1 is §101 eligible. Therefore, it cannot be the conventionality of the container that makes it not “significant” enough.

Rather, it would appear that the real concern is that a container is so necessary to cell culture that allowing this claim would “tie up” (Dec. Guidance pg. 11) all uses of the natural cells. Therefore, when thinking of additional structural elements to add to a claim to make the claim §101 eligible, be sure to ask yourself “would this claim ‘tie up’ all uses of the natural product?”. If the answer is “yes,” one probably needs a different structural element, or other elements, to move the claim across the line to §101 eligibility.

As noted above, the December Guidance is quite explicitly a work in process. If there are points about the new Guidance that you believe could be improved, please consider submitting comments. Meanwhile, if you have questions about how the new Guidance will affect claims pending in one or more of your applications, please contact an HDP attorney to discuss the matter in more detail.