The U.S. Patent and Trademark Office (USPTO) recently released updated interim guidelines for determining whether an invention is directed to patent-eligible subject matter under 35 U.S.C. § 101. Although the impact of the new guidelines remains to be seen, they present a much less restrictive approach to evaluating patent eligibility. This new approach is expected to allow more inventions to be found patent-eligible while also significantly reducing the number of applications subjected to a detailed patent eligibility analysis. The new guidelines, which were prepared in view of recent U.S. Supreme Court decisions in Alice Corp., Myriad, and Mayo, supersede the previous USPTO interim guidelines issued in March 2014.

The new guidelines make clear that, to be patent-eligible, the claimed invention “must be directed to one of the four statutory categories” (i.e., a process, machine, manufacture, or composition of matter), and  “must not be wholly directed to subject matter encompassing a judicially recognized exception” (i.e., a law of nature, natural phenomenon, or abstract idea).

This approach calls for an examiner to initially determine what the applicant has invented in accordance with the broadest reasonable interpretation of the claims. Based on this interpretation, the examiner will then determine whether the claim as a whole is directed to a judicial exception.    

Under the new guidelines, the framework for determining patent eligibility during prosecution adapts recent case law into three key questions:

  • Step 1 – Is the claim to a process, machine, manufacture, or composition of matter? (No – ineligible, Yes – proceed to next step)
  • Step 2A – Is the claim directed to a law of nature, natural phenomenon, or an abstract idea? (Yes – proceed to next step, No – eligible)
  • Step 2B – Does the claim recite additional elements that amount to “significantly more” than the judicial exception? (Yes – eligible, No – ineligible)

The new guidelines also provide a detailed analysis of these steps, as well as copious examples relevant to each of the three judicially created exceptions. The analysis and examples point to a few important takeaways concerning the future of patent prosecution.

First, for inventions having natural components, the new guidelines provide patent applicants with greater ability to demonstrate that the judicially recognized exceptions are inapplicable. Nature-based products, even those having all-natural components, can be patent-eligible if they exhibit “markedly different characteristics” from their naturally occurring counterparts in their natural states. Such “markedly different characteristics” can include a product’s structure, function, and/or other properties and will be evaluated on a case-by-case basis.

Second, for software-related inventions, the new guidelines suggest that the USPTO is taking a more balanced approach to patent ineligibility in the context of software related inventions. Notably, the new guidelines include DDR Holdings, LLC. v., a Federal Circuit decision, released about a week ago, providing a recent example of a software patent found eligible under the Mayo test. The new guidelines also include a balanced collection of examples of case law that place the post-Alice preliminary guidelines released in June in a more clearly defined context.

Specifically, a portion of the new guidelines provides commentary on pre-Alice case law in the context of the Mayo test affirmed in Alice. Relating these pre-Alice cases to the Mayo test may bolster software-related inventions during patent prosecution by legitimizing anew, in the minds of examiners, prior case law favorable to software patents. The new guidelines also look favorably upon software inventions used in complex manufacturing by encouraging examiners to use a streamlined analysis where claims are limited to a practical application.

This alert is the first in a two-part series of Ballard Spahr legal alerts on the USPTO interim guidelines. In the next installment, coming Friday, we will explain what the guidelines mean for chemical, pharmaceutical, and biotech inventions.

Ballard Spahr’s Intellectual Property Department counsels clients on patent, trademark, unfair competition, copyright, trade secret, Internet, licensing, and trade dress matters. We offer strategic due diligence guidance to companies, universities, and investors during mergers and acquisitions or portfolio restructuring. We also work with early stage growth companies and entrepreneurs in commercializing their IP assets.

For more information, please contact Joseph P. Anderson III at 678.420.9448 or

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