Updated Mayo/Myriad/Alice Patent Eligibility Interim Guidance

On December 16, 2014, the USPTO finally issued updated and significantly revised Interim Guidance to the Examiners for examination of patent claims for patent eligibility, in response to a significant amount of substantive criticism of the Guidelines issued on March 4, 2014, which was based on the Supreme Court decisions in the Mayo and Myriad cases. In addition, the USPTO has added more information related to the examination of computer-related inventions and business methods, in view of the Supreme Court’s recent decision in Alice. There are a lot of changes in the new Guidance, some of it substantive, and some of it disappointingly not actually amounting to any change at all upon closer examination. Furthermore, there was dicta in a new Federal Circuit decision regarding diagnostic methods in the Myriad vs. Ambrey litigation, decided on December 17, 2014, which suggests a further distinction that might apply to certain types of diagnostic methods.

  • Importantly, the tedious and difficult multifactorial analysis in the prior Guidance is more or less eliminated.
  • Footnote 2 of the new Guidance summarizes the main differences between the March 4, 2014, Guidelines and these new Guidelines: T
    • The application of the overall analysis is based on claims directed to judicial exceptions (defined as claims reciting the exception, i.e., set forth or described), rather than claims merely “involving” an exception. For instance, process claims that merely use a nature-based product are not necessarily subject to an analysis for markedly different characteristics (“streamlined eligibility analysis”). However, how this will be implemented in practice is not clear.
    • The test for determining whether a claim is directed to a “product of nature” exception is separated from the analysis of whether the claim includes significantly more than the exception.
    • Additionally, the markedly different analysis for a “product of nature” focuses on characteristics that can include not only a product’s structure, but also function, and/or other properties as compared to its naturally occurring counterpart in its natural state.
  • Step 2 is now a two part analysis, as set forth in Mayo and reiterated in Alice:
    • Step 2A is now reworded to exclude the word “involving,” but “directed to” still includes the concept of the claim “reciting” a judicial exception.
      • The Examiner must identify at least one judicial exception.
      • The concern with “tying up the use of naturally occurring things” is indicated as central to the judicial exceptions of “products of nature” and “natural phenomena.”
        • In Myriad v. Ambrey, primers that correspond to genomic sequences, and general methods for comparing sequences to find alterations, were found to be patent ineligible as, respectively, products of nature and abstract ideas.
      • If the claim is determined to not be directed to a “product of nature” or “natural phenomenon” that ties up the use of naturally occurring things, then the claim is patent eligible and needs no further eligibility analysis.
      • In the new Myriad v. Ambrey decision, dicta suggested that method claims that were not so broad and abstract as the claims 7 and 8 that were found to be patent ineligible in their decision, with reference to claim 21 which was not involved in the case, might be patent eligible: “Thus, the detection in claim 21 is limited to the particular mutations the inventors discovered … for the specific purpose of identifying increased susceptibility to specific cancers.”
      • Our first impression of the change in the Guidance, in conjunction with the dicta in Myriad v. Ambrey, is that it could be used to distinguish, per se, diagnostic method claims that are specific in both diagnostic methodology (and don’t “improperly tie up the nature-based product”), that include the inventive concept (e.g., specific correlations), and that include a specific purpose for the method, and they may be able to avoid further eligibility analysis.
    • Step 2B is now “Determine 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.”
      • Improvements to another technology or technical field
      • Improvements to the functioning of the computer itself
      • Applying the judicial exception with, or by use of, a particular machine
      • Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment
    • It is important to consider the claim as whole. Individual elements viewed on their own may not appear to add significantly more to the claim, but when combined may amount to significantly more than the exception.
    • There is no explicit “balancing” of factors for and against patent eligibility in this analysis; any element may be sufficient to ensure that the claim amounts to significantly more than the judicial exception.
    • However, if the there are multiple judicial exceptions claimed, and the claim fails the analysis for one exception, the claim is patent ineligible.
  • Examples
    • The Guidance itself includes multiple examples that are based on Supreme Court decisions in which the Court formed the 101 doctrines , and then a second set of Supreme Court and Federal Circuit cases explained in terms of the Guidance.
    • The USPTO simultaneously published a few additional hypothetical examples directed to nature-based products, which expressly replace the prior examples in the March 4, 2014 Guidelines, as well as the examples in the Examiner Training materials published on March 19, 2014.
    • The USPTO further announced that this guidance is the latest – but not necessarily the last – iteration of our ongoing implementation of these Supreme Court decisions. Additional explanatory example sets relating to claims that do and do not amount to significantly more than a judicial exception are being developed and will be issued at a future date, taking into account suggestions already received from the public comments, future public comments, and any further judicial developments.
    • Specifically, this Interim Guidance is open to public comment for 90 days, until March 16, 2015. The USPTO is in particular encouraging submission of additional claim examples.
  • We encourage our clients to submit examples for inclusion in the Examiner Training materials, for both natural products, abstract ideas, as well as relating to the more general issues regarding what is “significantly more” in various contexts.
    • Examples should be provided in a form similar to how the Guidance structured them.
    • We would be happy to help with these submissions as well.



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