Five Things You Need to Know About the USPTO Interim Guidelines on 101

15 January 2015 PharmaPatents Blog

The USPTO issued interim guidelines on 101 (“Interim Guidance”) on December 15, 2014. We summarized the Interim Guidance in this post here, and now highlight five things practitioners and stakeholders need to know as they consider how to apply the Interim Guidance to specific claims. 

1. The Interim Guidance Supersedes the March 4, 2014 Guidance

The Interim Guidance supersedes the March 4, 2014 Guidance, which means that the March Guidance no longer should be applied to evaluate patent eligibility. Applicants facing a rejection issued under the March Guidance should respond under the Interim Guidance.

(I have been informed that Examiners will not be reissuing Office Actions to apply the Interim Guidance instead of the March Guidance.)

2. The USPTO Posted “Natural Products” Examples on Its Website

While not mentioned in the Interim Guidance itself, the USPTO posted 17 pages of examples applying the Interim Guidance to claims involving “natural products” on its website. Applicants facing a rejection of such claims should refer to the examples, which find eligible many types of claims that would have been rejected under the March Guidance.

3. The Interim Guidance Permits a Streamlined Review of Certain Types of Claims

One of the many complaints about the March Guidance was that it required a lengthy analysis of all claims involving a “judicial exception,” even when the claims clearly were not directed to a product of nature, law of nature, or abstract idea. The Interim Guidance addresses this problem by calling for a “streamlined” review of a claim that, “when viewed as a whole, clearly does not seek to tie up any judicial exception such that others cannot practice it.”

In addition to providing examples of product claims that could be found eligible under a streamlined analysis, the Interim Guidance states that “[a] process claim is not subject to the markedly different analysis for nature-based products used in the process, 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.’).” Additionally, the examples include a relatively broad therapeutic method claim that is found to be patent eligible.

4. The Interim Guidance Does Not Shine New Light on Diagnostic Method Claims

The Interim Guidance should be helpful for defending the patent eligibility of product claims, but does not provide much new guidance for diagnostic method claims. For example the Interim Guidance still calls for a determination of “whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exception.” Although the Interim Guidance abolishes the multi-factored analytical framework of the March Guidance, it still refers to the Supreme Court cases from which those factors were drawn when illustrating what may or may not qualify as something “significantly more.” Thus, applicants facing rejections of diagnostic method claims may want to consider whether the claims recite elements that would satisfy the machine-or-transformation test, that add “a specific limitation other than what is well-understood, routine and conventional in the field, or … unconventional steps that confine the claim to a particular useful application,” or “[o]ther meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.”

5. The Interim Guidance Was Issued Before the Federal Circuit Decision in Myriad II

The USPTO issued the Interim Guidance on December 15, 2014, two days before the Federal Circuit issued its decision in Myriad II, which I summarized in this post here). While I do not believe that the Interim Guidance is inconsistent with the Myriad II decision, applicants with primer or method claims similar to those at issue in Myriad II may want to consider the impact of that case.

More Insight on the Interim Guidance

The USPTO is hosting a public forum on the Interim Guidance on January 21, 2015, at the USPTO’s Alexandria campus, and will provide broad access to the forum via WebEx. At the forum, the USPTO will provide an overview of the Interim Guidance, and give selected participants an opportunity to present their views. I have been selected to speak on Myriad II, and look forward to hearing from the other presenters. 

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