The USPTO has issued new “interim” guidance for determining whether claims are eligible for patenting under 35 USC 35 U.S.C. § 101. Assuming the guidance document is published in the December 16, 2014 Federal Register, it will be effective as of that date, and apply to all pending and newly filed applications.

Stakeholders and practitioners in the biotechnology, chemical, and pharmaceutical fields are likely to be relieved that the guidance takes a more reasonable approach than the March 4, 2014 guidance issued under the Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _132 S. Ct. 1289, 101 USPQ2d 1961 (2012), Stakeholders and practitioners in the computer sciences and business methods fields may not find much new beyond the preliminary instructions issued June 25, 2014 in the wake of the Supreme Court decision in Alice Corp. v. CLS Bank Int’l, 573 U.S. ___, 134 S. Ct. 2347 (2014), although the new guidance provides a small number of general examples of what might be patent eligible. All may be disappointed that the guidance does not provide any more specific examples beyond the claims addressed in Supreme Court and Federal Circuit decisions.

The Interim Guidance applies to all technology fields and all types of claims. As with previous guidance, the Interim Guidance leads examiners through a three-step process, illustrated by a flow-chart. (Interim Guidance, page 9.) Assuming the claim recites a process, machine, manufacture or composition of matter (step 1), the heart of the analysis lies in determining 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). In conducting an analysis under the guidance, examiners are to apply the “broadest reasonable interpretation” of the claims.

Step 2A

The Interim Guidance provides for more discretion in step 2A than the March 4 guidance did. Rather than capturing claims that merely “involve” a judicial exception, step 2 of the Interim Guidance only captures claims “directed to” an exception. The USPTO explains that “directed to” means that the exception is “recited” or “set forth or described” in the claim. (Interim Guidance, page 11.) While many claims captured in step 2A will require an analysis under step 2B, the Interim Guidance offers a “streamlined eligibility analysis” for claims that don’t really raise eligibility issues, and also provides for a more detailed analysis of “nature-based products” before they are determined to be “directed to” a judicial exception in step 2A, including a consideration of any functional differences between the claimed product on the naturally occurring product, as discussed in more detail below.

Step 2B

Step 2B invokes the “significantly more” test of previous guidance, but emphasizes that each claim must be considered individually and as a whole. The test for step 2B 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.” (Interim Guidance, page 20.) 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.” (Interim Guidance, page 21.) Similar to previous guidance, step 2B requires that an eligible claim “applies the exception in a meaningful way.” (Interim Guidance, page 21).

The Interim Guidance exemplifies limitations that may or may not qualify as “significantly more” by drawing on Supreme Court decisions. Examples that may support eligibility include “[i]mprovements to another technology or technical field”, “[i]mprovements to the functioning of the computer itself”, “[a]pplying the judicial exception with, or by use of, a particular machine”, “[e]ffecting a transformation or reduction of a particular article to a different state or thing,” and “adding unconventional steps that confine the claim to a particular useful application.” (Interim Guidance pages 21-22).

As noted 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 U.S.C. § 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.

Avoiding Step 2B in a 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.” (Interim Guidance, page 24). 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;” or claims that “merely include ancillary nature-based components,” such as “a cellphone with an electrical contact made of gold.” (Interim Guidance, page 25). According to the Interim Guidance, “[s]uch claims do not need to proceed through the full analysis… [because] their eligibility will be self-evident.” (Interim Guidance, page 24).

Functional Differences May Support a Determination of “Markedly Different”

The Interim Guidance calls for a more detailed analysis of claims reciting a “nature-based product” before it is captured in step 2A. 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. In an important departure from the March 4 Guidance, the Interim Guidance calls for the consideration of “structure, function, and/or other properties” when making the “markedly different” determination (Interim Guidance, page 18). 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.” (Interim Guidance, page 18.)

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.” (Interim Guidance, pages 16, 17). In another important departure from the March 4 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.”

As set forth in the Interim Guidance, if the nature-based product “has markedly different characteristics, 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” query of step 2B.

Interestingly, the Interim Guidance also 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.”

New Examples for Nature-Based Products

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, which should help examiners apply the Interim Guidance to a wide variety of claimed inventions, and give stakeholders and practitioners an idea of which types of claims should be found to satisfy [section] 101 under the Interim Guidance.

Relation to Previous Guidance

The Interim Guidance supplements the June 25, 2014 preliminary guidance issued in the wake of the Supreme Court decision in Alice Corp. v. CLS Bank Int’l, No. 13-298, which was previously discussed here, and supersedes the March 4, 2014 guidance issued under the Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _132 S. Ct. 1289, 101 USPQ2d 1961 (2012), previously discussed here, here, and here. Accordingly, Examiners should no longer apply the multi-factor analysis set forth in the March 4 guidance.

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.”