USPTO Releases Revised Subject Matter Eligibility Guidance

16 December 2014 Personalized Medicine Bulletin Blog

On December 15th, 2014, the USPTO released its much anticipated revised subject matter eligibility examination guidance to assist patent examiners to evaluate inventions that may be related to any one of the three judicial exceptions to subject matter eligibility under 35 U.S.C. § 101 – law of nature, natural phenomena, and/or an abstract idea. 2014 Interim Guidance on Patent Subject Matter Eligibility (“Interim Guidance“). The Interim Guidance is to be published in the Federal Register on December 16th, 2014, and is to effective on that date. It is to be applied to all pending and newly filed applications.

This Interim Guidance, unlike the prior guidance of March 2014 (see my prior posts of March 5th and March 7th, 2014), encourages an evaluation of the claim as a whole. In addition, it does not consider a claim that is directed to a combination of natural products as per se ineligible because the individual elements separately are natural products.

The Interim Guidance is stated to offer the USPTO’s current view of the subject matter eligibility of all inventions related to a judicial exception in view of the Supreme Court’s recent decisions on the topic, namely Alice Corp. Pty. Ltd. v. CLS Bank Int’l, et al., 573 U.S. __, 134 S.Ct. 2347 (2014); Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S.Ct. 2107 (2013); and Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __, 132 S.Ct. 1289 (2012). However, unlike the prior guidance, the USPTO indicates that this Interim Guidance is intended to be an iterative processes continuing with periodic supplements based on developments in jurisprudence and public feedback.

Two Step Analyses for Products and Processes

The Interim Guidance first notes that prior to conducting the subject matter eligibility analysis for products and processes, the claim is construed consistent with its broadest reasonable interpretation. After this initial construction, a two-step analysis is applied to the claim. In step 1, the examiner should first determine if the claim is related broadly to patentable subject matter – i.e., is the claimed invention a process, machine or a composition of matter (step 1)? If no, then the claim is not eligible subject matter under 35 U.S.C. Section 101. In yes, then the claim is analyzed to determine if it relates in whole or part to a judicial exception to patent-eligibility (step 2A). If not, then the claim satisfies Section 101. If the claim is determined to relate in part to a judicial exception, then the claim is analyzed to determine if the claim recites additional elements that amount to significantly more than the judicial exception (step 2B). The analysis will only proceed to step 2B when the claim is directed to an exception – that is when no markedly different characteristics are shown. Interim Guidance on page 9.

Unlike the 2014 Guidance, all claims (product and process) with an element falling within a judicial exception are analyzed under the same framework. In addition, a claim including a product of nature exception is to be compared to the naturally-occurring counterpart to identify markedly different characteristics based on structure, function and/or properties. Interim Guidance on page 9.

A broad claim that may be determined to be “tie up” and pre-empt others from using the law of nature, natural phenomenon, or abstract idea will be more closely evaluated to establish that the claim does not pre-empt the field or all uses of the technology. If the claim is determined not to tie up future innovation, a streamlined eligibility review should be applied.

Step 2A

Products of nature are to be evaluated to determine if the claimed invention exhibits markedly different characteristics from its naturally occurring counterpart. Thus a claim that relate to multiple natural products, e.g., a bacterium and milk, should be evaluated as whole for markedly different characteristics, rather than separately evaluating the bacterium and milk. Interim Guidance on page 16.

To determine if the claim as whole recites a product that is markedly different from its natural counterpart, an examiner is encouraged to look to a difference in a product’s structure, function, and/or other properties. Exemplary differences are noted to be a change in the biological or pharmacological functions or activates, chemical or physical properties, changes in phenotype, or changes in structure and form, whether chemical, genetic or physical. Interim Guidance on page 19. Importantly, the Interim Guidance indicates that a product that is purified or isolated will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the natural counterpart. Interim Guidance on page 18. It is noted in the Interim Guidance that for claims based are a single based product of nature, once a markedly different characteristic is shown, no further analysis is necessary. This is an admitted significant change from the earlier March 2014 guidance. Guidance on page 19. As noted on page 20 of the Interim Guidance:

Thus, a claim can be found eligible based solely on a showing that the nature-based product in the claim has markedly different characteristics.

Step 2B

For a claim that does not recite something “markedly different” from the natural counterpart, the Interim Guidance looks to Mayo for a framework to determine if the claim is patent-eligible. Here, the Interim Guidance does not depart significantly from the prior March 2014 guidance in that the claim must be analyzed to determine if elements other than those related to a judicial exception amount to something more than the exception itself. The Interim Guidance provides examples of what is and is not “significantly more” as recently interpreted by the courts.

Streamlined Eligibility Analysis

The Interim Guidance indicates that for the purpose of efficiency in examination, a streamlined eligibility analysis can be used if the claim when viewed as a whole, does not tie up any judicial exception such that others cannot practice it. In such cases, a full blown eligibility analysis is not needed. Interim Guidance on page 24-25.

Finally, the Interim Guidance provides several examples where the new analytical framework is applied to fact patterns from recent Section 101 decisions.

A Balanced Approach

The Interim Guidance addresses the concerns raised by the public against the guidance issued in March of 2014 – namely that the USPTO applied with too broad a brush the recent Supreme Court decisions regarding the judicial exceptions, thereby effectively precluding from patent-eligibility almost any claim that recited in part a judicial exception. The USPTO’s new analysis, focusing on the claims as a whole and an analysis of the “markedly different” properties of the claimed subject matter (as compared to the natural counterpart product) is a balanced approach. As such, isolated natural products and combinations of natural products will satisfy Section 101 if the claimed invention as a whole is different from the natural counterpart product as measured by one of several noted properties. The Interim Guidance also appears to indicate that a claim that recites a natural phenomenon, such as a diagnostic process or method, will satisfy Section 101 if the claim sufficiently limits the practical application of the natural phenomenon.

Public Comments Are Invited

The public is invited to submit written comments up to 90 days from publication of the Interim Guidance in the Federal Register (on or about March 16, 2015).

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