The USPTO's new § 101 guidance memo provides instructions to the patent examining corps on how to formulate a subject matter eligibility rejection and evaluate an applicant’s response to it. The new guidance also provides several additional examples of subject matter that is and is not patent-eligible, including some long awaited examples of diagnostic methods. The memo provides no real surprises; it instructs examiners to apply the 2-step eligibility analysis. But the memo does emphasize the examiners' obligation to support any § 101 rejection using a reasoned rationale, and carefully consider any rebuttal arguments/evidence provided by the applicant. The memo also provides some additional insight into how the USPTO evaluates what is "well-understood, routine, or conventional" for purposes of determining whether claim elements add "significantly more."

The May 4, 2016 memo reiterates the 2-step eligibility analysis set forth in the 2014 Interim Guidance and instructs examiners on how to apply that analysis in formulating a rejection. The examiner should begin by identifying the judicial exception and explaining—"using a reasoned rationale"—why it is considered an exception. (Memo at 1.) This is step 2A of the eligibility analysis. The examiner should then identify any additional elements in the claim beyond the judicial exception and explain why "the additional elements taken individually, and also taken as a combination, do not result in the claim as a whole amounting to significantly more than the judicial exception." (Id. at 2; emphasis in original.) This is step 2B of the eligibility analysis.

Examiners are invited to rely on Federal Circuit and Supreme Court decisions for guidance as to types of subject matter that amount to abstract ideas. However, the memo also notes that examiners should not go beyond those concepts that are similar to what the courts have identified as abstract ideas. (Id. at 3.) The memo does not explain how examiners are expected to interpret the case law, other than by analogizing their facts.

The memo indicates that a prior art search "should not be necessary" to establish why any additional claim elements beyond the judicial exception are considered "well-understood, routine, conventional activity previously engaged in by those in the relevant field." (Id. at 4.) This is because finding the element in the art does not establish that it is routine or conventional. It also states that it is not sufficient for an examiner to show that a particular laboratory technique was discussed in several widely-read scientific journals. Unfortunately, the only real guidance that the memo provides on what does fall within the definition of this phrase is to repeat the phrase itself—the elements must be "well-understood, routine, conventional activity previously engaged in by those in the relevant field." (Id.) One concern raised by this somewhat circular definition is that the analysis becomes completely subjective—based entirely on the examiner’s perception of what is and is not conventional, routine, and well-known.

Examiners are reminded that an additional element may be enough to qualify as significantly more if it meaningfully limits the judicial exception, improves another technology or technical field, improves the functioning of a computer itself, or adds a specific limitation that is unconventional and confines the claims to a particular useful application. (Id. at 5.) Several of the new examples address the issue of what amounts to "significantly more."

The memo instructs examiners that "preemption is not a stand-alone test" for patent eligibility. (Id. at 7.) Thus, an applicant argument that a claim is specific and does not preempt all applications of the judicial exception, without more, will not overcome a § 101 rejection. "While a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible." (Id. at 6-7.)

The new § 101 examples provide insight into how the 2-step analysis should be applied in several hypothetical situations. The memo advises examiners that the examples are intended to be illustrative of the § 101 analysis and should not be used as the basis for a rejection. Although the memo warns examiners not to require applicants to model their claims or responses after the examples to attain eligibility (Id. at 5), the examples do provide some nuanced guidance as to how changes in language may make patent-eligible subject matter ineligible and vice versa, particularly in a diagnostics setting. This guidance provided by the examples should be valuable to both examiners and applicants, particularly those dealing with diagnostic methods.