USPTO Finally Issues New Guidance on Patent Subject Matter Eligibility

16 December 2014 PharmaPatents Blog

The USPTO has issued new “Interim Guidance” for determining whether claims are eligible for patenting under 35 USC § 101. Although the new guidance technically applies to all technologies and all types of claims, Applicants with claims involving natural products will find the most to like about the USPTO’s revised position on subject matter eligibility. The Interim Guidance supersedes the March 4, 2014 guidance issued under the Supreme Court decisions in Myriad and Mayo, and  supplements the June 25, 2014 preliminary guidance issued after the Supreme Court decision in Alice Corp. v. CLS Bank.

The Three-Step Analysis

As with previous guidance, the Interim Guidance leads examiners through a three-step process. The first step is to confirm that the claim is directed to a category of inventions embraced by § 101, i.e., does it recite a process, machine, manufacture or composition of matter. The other steps determine whether the claim is directed to a “judicially recognized exception” (step 2A), and, if so, whether the claim recites “additional elements that amount to significantly more than the judicial exception” (step 2B). As is always the case in a USPTO proceeding, examiners are to apply the “broadest reasonable interpretation” of the claims when conducting a subject matter eligibility analysis.

Step 2A

The Interim Guidance focuses the step 2A analysis on claims that are “directed to” a judicial exception, rather than scrutinizing all claims that merely “involve” a judicial exception. In this regard, the USPTO explains that “directed to” means that the exception is “recited” or “set forth or described” in the claim. The Interim Guidance calls for a more detailed analysis of “nature-based products” before they are determined to be “directed to” a judicial exception, including a consideration of any functional differences and differences in properties between the claimed product and the naturally occurring corollary, as discussed in more detail below. Also discussed below is the new “streamlined eligibility analysis” for claims that do not really raise eligibility issues, even though they recite a judicial exception.

Step 2B

Step 2B invokes the “significantly more” test of previous guidance, but emphasizes that each claim must be considered as a whole. The test for step 2B (taken from Alice) is whether “the elements of the claim, considered both individually and as an ordered combination, are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.” The guidance emphasizes that “[i]ndividual elements viewed on their own may not appear to add significantly more … but when combined may amount to significantly more than the exception.”

The Interim Guidance exemplifies limitations that may or may not qualify as “significantly more” by drawing on Supreme Court decisions in Alice, Bilski, Diehr and Mayo.

As stated in the Interim Guidance, “[i]f the claim as a whole does recite significantly more than the exception itself, the claim is eligible … and the eligibility analysis is complete.” Otherwise, “the claim is not patent-eligible … and should be rejected under 35 USC § 101.” Importantly, for claims that are directed to a plurality of exceptions, if the claim fails the “significantly more” test for one exception, the claim is ineligible.

Functional Differences May Support Eligibility

The most welcome change embodied in the Interim Guidance may be the consideration of all characteristics of a “nature-based product,” including functional differences and properties that are not present in the naturally occurring product. Under the Interim Guidance, a claim directed to a “nature-based product” can avoid the “significantly more” analysis of step 2B if the claimed product has any “markedly different” characteristics from the naturally occurring product, where “structure, function, and/or other properties” are to be considered when making the “markedly different” determination. Indeed, the Interim Guidance expressly contemplates that a purified or isolated product may be found to satisfy § 101 if “there is a resultant change in characteristics sufficient to show a marked difference,” and such claims are illustrated in the new examples provided on the USPTO website.

The Interim Guidance explains that the “markedly different” query “should be applied only to the nature-based product limitations in the claim”, and should compare the claimed product “to its naturally occurring counterpart in its natural state.” In another important departure from the March Guidance, for combination products (e.g., multicomponent compositions), the Interim Guidance requires that the analysis focus on “the resultant … combination rather than its component parts.”  Thus, in the new examples, gunpowder is held to be markedly different from its naturally-occurring components because gunpowder is explosive, while the naturally-occurring substances on their own are not.

As set forth in the Interim Guidance, if the nature-based product “has markedly different characteristics, then the claim does not recite a ‘product of nature’ exception and is eligible.” Thus, a claim directed to a nature-based product can be found to be markedly different and satisfy § 101 without going through the “significantly more” inquiry of step 2B.

Process Claims Involving Nature-Based Products

In another welcome departure from the March 4 Guidance, the Interim Guidance states that process claims usually will not raise eligibility issues for reciting nature-based products, “except in the limited situation where a process claim is drafted in such a way that there is no difference in substance from a product claim (e.g., a method of providing an apple.” The new examples include a broad method of treatment claim that is said to satisfy § 101 because “the claim is focused on a process of practically applying the [nature-based] product to treat a particular disease (breast or colon cancer), and not on the product per se.”

New Examples For Nature-Based Products

As noted above, the USPTO has published new examples for nature-based products on its website. These examples find eligible many of the claims that were said to be non-patent-eligible in the March Guidance, including the claims to gunpowder and a beverage comprising pomelo juice and a preservative. They also provide new examples relating to methods of treatment, purified proteins, genetically modified bacteria, mixtures of bacteria, nucleic acids, antibodies, cells, and food products. In most categories, there are examples of eligible and ineligible claims. We will provide further commentary on these examples once we have had more time to consider their implications.

The Streamlined Analysis

The Interim Guidance provides for a “Streamlined Eligibility Analysis” when a claim “clearly does not seek to tie up any judicial exception such that others cannot practice it.”  Claims that may fall under this category include:

  • claims “directed to a complex manufactured industrial product or process,” such as a “robotic arm assembly that operates using certain mathematical relationships”
  • claims that “clearly do[] not attempt to tie up the nature-based product,” such as “an artificial hip prosthesis coated with a naturally occurring mineral” and
  • claims that “merely include ancillary nature-based components,” such as “a cellphone with an electrical contact made of gold.”

According to the Interim Guidance, “[s]uch claims do not need to proceed through the full analysis … [because] their eligibility will be self-evident.”

Unknown Prognosis For Diagnostic Method Claims 

While the Interim Guidance may be helpful to many applicants with claims involving natural products, it does not provide much discussion of diagnostic or personalized medicine method claims. The USPTO may be waiting for further guidance from the Federal Circuit on these types of claims, and until then includes only the Prometheus claims in its examples.

Public Comment Period

The USPTO will consider written comments on the Interim Guidance received by March 16, 2015, and particularly solicits “suggestions for claim examples to use for examiner training.” Comments should be sent by email to

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