USPTO Issues Prometheus Examination Guidelines

09 July 2012 PharmaPatents Blog

On July 3, 2012, the USPTO issued its 2012 Interim Procedure for Subject Matter Eligibility Analysis 0f Process Claims Involving Laws of Nature.  According to the introduction, the guidelines are “for use by USPTO personnel in determining subject matter eligibility of process claims involving laws of nature under 35 USC § 101,”  in view of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  The guidelines walk a careful line between following Supreme Court precedent without eviscerating the ability to obtain patents on methods that involve laws of nature, natural phenomena, or naturally occurring correlations.

The Basic Framework

The guidelines outline a three-step inquiry for examining claims that may fall under Prometheus:

1.  Is the claimed invention directed to a process, defined as an act, or a series of acts or steps?
If no, this analysis is not applicable. For product claims, see the Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. § 101 issued August 24, 2009.
If yes, proceed to Inquiry 2.

2. Does the claim focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a natural principle herein)? (Is the natural principle a limiting feature of the claim?)
If no, this analysis is complete, and the claim should be analyzed to determine if an abstract idea is claimed (see the 2010 Interim Bilski Guidance).
If yes, proceed to Inquiry 3.

3. Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? (Is it more than a law of nature + the general instruction to simply “apply it”?)
If no, the claim is not patent-eligible and should be rejected.
If yes, the claim is patent-eligible, and the analysis is complete.

The guidelines include a discussion of this framework and a list of factors that may be helpful in answering Inquiry 3. The guidelines emphasize consideration of the claim as whole, but indicate that “there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.” 

The guidelines warn that the additional step must not be an “insignificant extra-solution activity,” “data-gathering,” or “well-understood, routine, [or] conventional.” At the same time, the guidelines make clear that the step need not be novel and non-obvious to carry the claim across the patent-eligibility threshold.

The guidelines indicate that the following subject matter does not require such close scrutiny:

Claims that do not include a natural principle as a limitation do not raise issues of subject matter eligibility under the law of nature exception. For example, a claim directed to simply administering a man-made drug that does not recite other steps or elements directed to use of a natural principle, such as a naturally occurring correlation, would be directed to eligible subject matter. Further, a claim that recites a novel drug or a new use of an existing drug, in combination with a natural principle, would be sufficiently specific to be eligible because the claim would amount to significantly more than the natural principle itself.

The Examples

The guidelines include one general example of a claim that is not patent-eligible under this framework, and two specific examples of claim sets with some claims that are patent-eligible and some that are not. These examples should be helpful to practitioners, whether they are drafting, prosecuting, evaluating or challenging claims in view of Prometheus. While most claims will not fall directly under one of these examples, the examples should at least serve as a useful frame of reference for a Prometheus analysis.  

The Importance Of The State Of The Art

It is telling that the guidelines set up each example by providing a summary of the state of the art. Indeed, such an approach is consistent with the Supreme Court’s analysis in Prometheus--how else can you decide that the method recites more than “well-known, routine or conventional” steps? On the other hand, it is interesting that the guidelines emphasize that the requirement for a step that is not conventional does not require any single step to be novel and non-obvious.

Patenting After Prometheus

In view of these guidelines, Applicants seeking to patent methods that relate to “natural principles” may want to consider whether their methods can be described in terms of the use of a new drug or in terms of a new use of an existing drug (in conjunction with the natural principle). Moving forward, applicants may be able to set the stage in their patent applications to support patent-eligibility by highlighting any and all non-conventional steps that apply the natural principle in order to satisfy § 101, while also demonstrating the novelty and non-obviousness of their methods as a whole in order to satisfy § 102 and § 103. Patent holders who have concerns about the validity of granted method claims may want to consider whether pursuing a reissue application is appropriate or whether they might want to avail themselves of the new Supplemental Examination proceedings that will become available September 16, 2012.

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