On November 2, 2016, the U.S. Patent and Trademark Office (USPTO) issued a memorandum ("November 2016 Memo")¹ to its patent examiners, updating them on recent subject matter eligibility decisions from the U.S. Court of Appeals for the Federal Circuit. The memorandum indicates that the USPTO's basic subject matter eligibility framework remains unchanged, but notes that recent Federal Circuit decisions provide additional information on how to evaluate subject matter eligibility. Although the main Federal Circuit cases discussed in the November 2016 Memo, McRO, Inc. dba Planet Blue v. Bandai Namco Games America Inc.² and BASCOM Global Internet Services v. AT&T Mobility LLC,³ relate to software patents, principles from the cases should be applicable to evaluation of other types of claimed subject matter, including biotechnology.

Patent examiners use a two-step test for their basic subject matter eligibility framework.⁴ The first step involves determining what the claims are "directed to." If the claims are "directed to" subject matter courts have said is not eligible for patenting (e.g., laws of nature, natural phenomena, or abstract ideas), the examiner moves to the second step to determine if the claims recite elements that are "significantly more" than the ineligible concept. The November 2016 Memo addresses both steps of the two-step test, and highlights are discussed below.

With respect to the first step, the November 2016 Memo indicates that "improvements in computer-related technology" that are eligible for patenting are "not limited to improvements in the operation of a computer or a computer network per se, but may also be claimed as a set of 'rules' (basically mathematical relationships) that improve computer-related technology by allowing a computer to perform a function not previously performable by a computer."⁵ The claims at issue in McRO recited computer-implemented rules that improved automatic lip synchronization and facial expression animation. The November 2016 Memo notes that in prior art methods "human artists did not use the claimed rules" but instead relied on subjective determinations in animating faces. The McRO case has implications for the patentability of claims reciting methods of analyzing biological information. If steps of the methods involve "rules" not normally used to analyze biological information, patent applicants can argue that the methods are directed to a patent-eligible improvement in technology rather than to an abstract idea.

The November 2016 Memo provides examples of indications that a claim is directed to an "improvement in computer-related technology." For instance, "a teaching in the specification about how the claimed invention improves a computer or other technology" can be an indication.⁶ The USPTO explains that "the McRO court relied on the specification's explanation of how the claimed rules enabled the automation of specific animation tasks that previously could not be automated when determining that the claims were directed to improvements in computer animation instead of an abstract idea." In view of McRO, patent applications with claims reciting methods of analyzing biological information should include a description of how steps of the methods enable performance of the methods and generation of a result, and such descriptions from the specification can be used to argue patent eligibility. Another example of an indication that a claim is directed to an "improvement in computer-related technology" is "a particular solution to a problem or a particular way to achieve a desired outcome defined by the claimed invention, as opposed to merely claiming the idea of a solution or outcome."⁷ To support arguments for patent eligibility, patent claims that recite methods of analyzing biological information can be drafted to include specific steps for arriving at a result.

Also, with respect to the first step, when patent examiners analyze a claim to determine what it is "directed to," the November 2016 Memo indicates that examiners should consider the claim as a whole and should not overgeneralize the claim or simplify the claim to its "gist" or core principles.

With respect to the second step of the two-step test (i.e., determining whether the claim recites elements that are "significantly more" than the ineligible concept), the November 2016 Memo notes that "examiners should consider the additional elements in a claim in combination, as well as individually," as a non-conventional and non-generic arrangement of known, conventional elements may amount to "significantly more" than the ineligible concept.⁸ This guidance is similar to the guidance provided by the USPTO in a May 4, 2016, memorandum to patent examiners. When faced with a subject matter eligibility rejection on claims reciting methods of analyzing biological material, patent applicants can consider arguing that the combination of elements or steps of the claims are not conventional.

The November 2016 Memo notes that several recent Federal Circuit cases have discussed absence of "preemption" as "confirming the analysis that the claimed invention is not directed to a judicial exception (CellzDirect)⁹ or includes an inventive step (BASCOM). The McRO court discusses the absence of preemption in determining that the claimed invention was not 'directed to' a judicial exception."¹⁰ When patent applicants argue that claims do not preempt all applications of an alleged ineligible concept, the USPTO instructs examiners to reconsider their subject matter eligibility analysis.

Finally, the November 2016 Memo indicates that "given the large and ever-increasing number of precedential decisions, examiners should avoid relying upon or citing non-precedential decisions...unless the facts of the application under examination uniquely match the facts at issue in the non-precedential decision."¹¹ The precedential decisions include another recent Federal Circuit case finding computer-related claims patent eligible, Amdocs (Israel) Ltd. v. Openet Telecom, Inc., No. 2015-1180 (Fed. Cir. Nov. 1, 2016), which the USPTO indicates will be discussed in a forthcoming update to the USPTO's subject matter eligibility guidance.

In summary, the November 2016 Memo indicates that factors patent examiners should consider when evaluating subject matter eligibility include whether the claims include specific "rules" that have not previously been used and whether the patent specification describes how those rules provide a result. The November 2016 Memo also notes that examiners should consider a claim as a whole in the first step of the subject matter eligibility analysis and the combination of elements in a claim should be considered when assessing whether the claim recites significantly more than eligible concept. Although the November 2016 Memo relates to Federal Circuit cases in the area of computer software, the holdings of the Federal Circuit cases should be applicable to claims reciting analysis of biological information. The November 2016 Memo illustrates that the USPTO is continuing to update its examiners regarding precedential Federal Circuit cases on subject matter eligibility, and the Federal Circuit continues to provide guidance on subject matter that is eligible for patenting. The USPTO indicates that it will update its subject matter eligibility guidance in view of the recent Federal Circuit decisions, as well as feedback from patent stakeholders.