Dissecting Prometheus – My Wish List

25 March 2012 Personalized Medicine Bulletin Blog
Authors: Antoinette F. Konski

In his March 23rd Patently-O blog, Dennis Crouch posted a U.S. Patent and Trademark Office memorandum to examiners setting forth the Office’s current thinking on application of the U.S. Supreme Court’s recent Mayo v. Prometheus holding to patent examination. The memorandum preliminarily advises examiners to reject a patent claim under 35 U.S.C. § 101 if the claim is “effectively directed to the exception itself (a law of nature, a natural phenomenon, or an abstract idea)….” Once rejected, the applicant may explain “why the claim is not drawn solely to the exception and point to limitations in the claim that apply the law of nature, natural phenomena or abstract idea.”

All That and Something More

Prometheus’ invalidated claim is an example of the application of the Prometheus standard in the preliminary guidance, i.e., that claimed processes that rely on the relationship between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm are not patent eligible. To be patentable, the claim must have “additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.” The additional features or steps must be more than “well-understood, routine, conventional activity already engaged in by the scientific community.” Using the Supreme Court’s language, the Patent Office advises examiners that:

“[t]he Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.” Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.”

The Bilski “machine-or-transformation” test is still important and a useful guide to examiners in evaluating claims but this test should not trump the law of nature exclusion. Thus examiners are counseled to use the existing Interim Bilski Guidance issued July 27, 2010, with the following additional considerations:

  • examiners must continue to ensure that claims, particularly process claims, are not directed to an exception to eligibility such that the claim amounts to a monopoly on the law of nature, natural phenomenon, or abstract idea itself; and
  • a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.

My Wish List

In closing its preliminary guidance memorandum, the Patent Office promised further detailed guidance on patent subject matter eligibility under 35 U.S.C.§ 101. As a practitioner who counsels clients on what can be claimed and the language to satisfy the patent statutes, I hope the Office will provide practical guidance to the patent bar on this new evolving standard. Illustrative examples of patent-eligible technology that relies on natural phenomena would be particularly helpful to the patent bar as well as the interplay and weighting of the factors considered by the Office. For example, if a claimed process requires a novel and non-obvious tool, e.g., a monoclonal antibody with a requisite specificity – is that not patent-eligible? If a claimed process requires an algorithm to evaluate multiple biological processes – is that not patent-eligible? If a § 101 rejection is raised during examination, what evidence would rebut a presumption – an opinion declaration by one of skill in the art that the claims, as a whole, are not general applications of the laws of nature? Alternatively, if a claimed processes is limited to a single technique for application of the law of nature, e.g., should the claim satisfy § 101?

What is on your wish list?

For additional analysis on Prometheus and its possible impact, see my colleague Courtenay Brinckerhoff’s March 22nd post.

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