On July 14, 2016, the U.S. Patent and Trademark Office issued new subject matter eligibility guidance for life science claims following a ruling by the Federal Circuit in Rapid Litigation Management v. CellzDirect, No. 15-1570 (Fed. Cir. July 5, 2016), and the Supreme Court’s decision to deny certiorari in Sequenom v. Ariosa, (788 F.3d 1371 (Fed. Cir. 2015) (cert. denied). The USPTO noted that the cases do not change the subject matter eligibility framework, but rather “provide additional information and clarification on the inquiry for determining whether claims are directed to a judicial exception” (step one of the Mayo/Alice test).[1]

The USPTO’s review and discussion of each case in light of the subject matter eligibility framework is summarized below.

Rapid Litigation Management v. CellzDirect, No. 15-1570 (Fed. Cir. July 5, 2016)

In CellzDirect, the Federal Circuit found the claimed methods of cryopreserving hepatocyte cells patent eligible under 35 U.S.C. § 101 as not being directed to a judicial exception.

The USPTO’s review of CellzDirect focused on a few key findings by the Federal Circuit in regards to the Mayo/Alice two-step subject matter eligibility framework. First, the Court emphasized that the "directed to" analysis of a process claim requires more than "merely identify[ing] a patent-ineligible concept underlying the claim" and instead requires an analysis of whether "the end result of the process, the essence of the whole, was a patent-ineligible concept." As the claims in CellzDirect were found to focus on a process for achieving a desired outcome (a preservation of multi-cryopreserved viable hepatocytes) as opposed to simply observation or detection, the Federal Circuit found that these claims, like many claims reciting methods of producing things or treating disease with a pharmaceutical compound, were not directed to a judicial exception. The USPTO further noted that this need to analyze the focus of the claims in the first step of the Mayo/Alice framework was also emphasized in an earlier Federal Circuit decision – Enfish.[2]

Although the Court held that the claims in Cellzdirect did not invoke step one of the Mayo/Alice framework, it found that the claims would have been patentable even under step two of the Mayo/Alice test. The Court ruled that it was incorrect to assume that “all process claims that employ only independently known steps will be unpatentable" but rather that the “the claims must be considered ‘as a whole,’ i.e., ‘both individually and as an ordered combination.’”[3] Thus, "a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.” Given that “[t]he individual steps of freezing and thawing were well known, but a process of preserving hepatocytes by repeating those steps was itself far from routine and conventional,” the Court found that the new combination of steps rendered the process patentable.[4]

Second, the USPTO further noted that the Court determined that these claims, which apply a law of nature, were distinguishable from the claims in Mayo and Sequenom that “amounted to nothing more than observing or identifying the ineligible concept itself.”[5]

Sequenom v. Ariosa, (788 F.3d 1371 (Fed. Cir. 2015) (cert. denied)

The USPTO noted that the Supreme Court’s June 27, 2016 decision to deny a petition for a writ of certiorari in Sequenom v. Ariosa did not substantively change their subject matter eligibility guidelines. The Supreme Court’s decision allowed the Federal Circuit’s ruling invalidating Sequenom’s method claims to stand.

To briefly review the panel’s decision, the Federal Circuit relied on the two-step framework previously provided in the Supreme Court cases Mayo and Alice (Steps 2A and 2B in the subject matter eligibility guidelines) to determine that the claims were A) directed to a natural phenomenon (the presence of cell-free fetal DNA in maternal plasma/serum) and B) did not recite an inventive concept that transformed the claim into a patentable invention because they relied on routine and conventional steps (amplifying and detecting steps).

Practical Considerations

The USPTO’s review and summary of these two decisions is particularly helpful in evaluating the Office’s key takeaways from each decision. Their review of CellzDirect clarifies that the first step of the Mayo/Alice framework is invoked only by claims that are “directed to” a natural law or phenomenon. Process claims that touch upon a natural law or phenomenon may avoid invoking the first step of the Mayo/Alice framework if "the end result of the process, the essence of the whole” is not directed to the law of nature or natural phenomenon.

Thus, in light of the updated subject matter guidelines, practitioners drafting process claims should avoid claims with end results that may be viewed as observing or identifying natural phenomena, as such claims will likely be viewed as being “directed to” natural phenomena. Drafting claims that recite end results that do not focus on natural phenomena or natural laws (e.g. “methods of producing things or methods of treating disease”)[6] will be more likely to avoid issues of subject matter ineligibility under 35 U.S.C. § 101. The claim preamble may also provide an effective tool for asserting that the claims are not directed to natural phenomena or natural laws.[7]

CellzDirect further provides meaningful guidance for overcoming the second step of the Mayo/Alice test and distinguishing Sequenom. As noted above, the Court found that not “all process claims that employ only independently known steps will be unpatentable.”[8]

“[I]n examining claims under step two, we must view them as a whole, considering their elements ‘both individually and as an ordered combination. . .Thus, a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.”[9]

In finding the claims to be patent-eligible, the Court found evidence that the prevailing wisdom taught against the new combination to be particularly compelling. Consequently, this may provide a particularly valuable approach to overcome step two of the Mayo/Alice test.