Patentees in the software and life sciences industries are paying close attention to new guidance issued by the U.S. Patent Office on the patent eligibility of technology in those areas.  The guidance, released May 5, 2016 (the “May Update”) provides patent applicants with some new tools in rebutting prevalent Office rejections in these areas.  Patent applicants may now have greater latitude to challenge the Office’s finding that a claim adds only “well-understood, routine, and conventional” activities to an otherwise abstract idea.  In particular, the May Update explains that mere public knowledge of an activity is insufficient to make that activity “well-understood, routine, and conventional.”

The law surrounding patentable subject matter has been a rapidly-developing area of law since the Supreme Court's Mayo and Alice decisions in 2012 and 2014.  This has created uncertainty in the patent prosecution process—especially for applications in the software, business method, and life science spaces.  While the May Update will not completely dispel the uncertainty, it begins to provide some much-needed additional guidance in the process. 

The May Update—which provides an updated set of examination instructions for analyzing the subject matter eligibility of patent claims under 35 U.S.C. § 101—supplements the USPTO's two, previously-issued examination instructions: the 2014 Interim Guidance on Patent Subject Matter Eligibility and the July 2015 Update: Subject Matter Eligibility.  While not a substantive rule-making, the May Update is guidance to the U.S. Patent Examiners developed as a matter of internal Office management, and offers insight into the instructions provided to Examiners in their evaluation of pending patent applications.  The May Update places a particular focus on how examiners should formulate subject matter eligibility rejections and evaluate an applicant's response to a subject matter eligibility rejection.  The May Update includes a memorandum with examination guidelines, a new set of example analysis in life sciences, an index of eligibility examples, a listing of court decisions covering subject matter eligibility, and a Federal Register notice

The May Update indicates that when analyzing claims for subject matter eligibility, examiners should follow the two-part analysis of claims described originally in Mayo and further described in the 2014 Interim Eligibility Guidance.  The May Update supplements this analysis by placing renewed emphasis on formulating rejections that not only identify a judicial exception recited in the claim but also explain why the claim language corresponds to the judicial exception.  Such an explanation should include, for example, explaining why the concept is a concept that courts have identified as an abstract idea or explaining why it is considered a law of nature or natural phenomenon.  The explanation has often been missing from Examiner rejections that may only summarily state that a claim corresponds to an abstract idea or law of nature.

With a judicial exception identified, the May Update instructs examiners to reject the claim as subject matter ineligible “only if it is readily apparent to an examiner . . . that the additional elements do not amount to claiming significantly more than a judicial exception.”  In this analysis, the May Update also stresses that “it is particularly critical to address the combination” of elements in a claim when analyzing subject matter eligibility.  In discussing the significantly more analysis, the May Update expands on the concept of a claim element being significantly more than a judicial exception.  “Significantly more” has been understood to be, among other things, something other than what is well-understood, routine, and conventional in the art.  This rationale can be an important tool in rebutting a subject matter eligibility rejection, but the contours of well-understood, routine, and conventional had been ill-defined by previous examination guidelines.

The May Update describes that a prior art search does not necessarily resolve whether a claim element is well-understood, routine, and conventional because the test is not whether the element is novel.  The May Update provides the example that even if an activity is discussed in several widely-read scientific journals or used by a few scientists, mere knowledge of the activity is not sufficient to make the activity well-understood, routine, and conventional.  Instead, the evaluation is based on whether the element is “widely prevalent and its combination with any other additional elements is well-understood, routine, conventional activity.”  This distinction may allow for Applicants to rebut eligibility rejections by demonstrating that the technology asserted to be “well-understood” may be known, but not widely prevalent, resulting in an increased likelihood the claim would enjoy patent eligibility.

After discussing formulating a proper 35 U.S.C. § 101 rejection, the May Update next turns to evaluating an applicant’s response to a rejection.  In this section, the May Update again emphasizes the importance of considering claim elements both individually and in combination.  The May Update provides the example of generic computer components that individually perform merely generic computer functions, but that the combination of functions may not be generic and would therefore amount to something significantly more.  The May Update provides the example that a CPU that performs mathematical calculations would be a generic computer component performing a generic computer function.  However, as shown in the Patent Office’s “Digital Image Processing” example, such generic computer functions can, in combination, amount to significantly more by improving the functioning of a computer.  USPTO, Examples: Abstract Ideas, pp. 7–10 (January 27, 2015).

The May Update next discusses particular responses that an applicant may make and how the examiner should respond.  For example, if the applicant challenges the identification of the judicial exception, the Examiner is instructed to explain why the claim is similar to a concept identified in a case.  If the applicant argues that a feature is not well-understood, routine, and conventional, “it is especially necessary for the examiner to fully reevaluate his or her position” when the additional elements are not discussed in the specification as being well-understood, routine, and conventional.  Further, the examiner is directed to consider whether rebuttal evidence should be provided to support the record.  The May Update notes that when considering applicant’s addition of a generic computer component, that the USPTO considers In re Alappat to be superseded, such that simply programming a general purpose computer to perform generic computer functions does not automatically overcome an eligibility rejection.  33 F.3d 1526 (Fed. Cir. 1994) (finding that a specially programmed computer is transformed into a special-purpose computer).  The May Update also notes that preemption is not a standalone test for eligibility and that questions of preemption are inherent in and resolved by the two-part Mayo framework.  Arguments by patent applicants that a claim does not preempt all uses of an abstract idea are therefore not likely to be successful if the claim is failing under the two-part Mayo test.

The May Update provides six different examples of eligibility analysis in the life sciences space.  These extensive examples relate to vaccines, diagnosing and treating diseases, dietary sweeteners, screening for gene alterations, paper-making machines, and hydrolysis of fat. 

While the May Update provides additional guidance, it is likely that applicants will continue to face significant uncertainty regarding subject matter eligibility in the software and life science fields.  The Federal Register notice indicates that the USPTO is seeking public comment on subject matter edibility issues on an “on-going basis,” so more is likely to come on subject matter eligibility in the Alice-Mayo era.  Refinements and updates will likely continue for the foreseeable future.