By Kevin E. Noonan --
On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update to Subject Matter Eligibility Guidance"). Absent from this analysis was the Federal Circuit's decision in Ariosa v. Sequenom, then on petition for certiorari before the Supreme Court. Since the issue date of this Guidance, the Supreme Court denied certiorari in the Sequenom case, and the Federal Circuit handed down its decision in Rapid Litigation Management v. CellzDirect. Last Friday, the Office issued a Memorandum on these decisions.
The Memorandum, under Deputy Commissioner for Patent Examination Policy Robert Bahr's signature, comes right to the point:
These cases do not change the subject matter eligibility framework, and the USPTO's current subject matter eligibility guidance and training examples are consistent with these cases.
and then discusses each case and its relationship to how the PTO will implement the recent case law.
With regard to CellzDirect, the Memorandum cites the Federal Circuit decision as "highlight[ing] several important points." The first is the Court's emphasis on whether a claim is "directed to" a law of nature, which "requires more than 'merely identify[ing] a patent-ineligible concept underlying the claim.'" Rather, the Office understands the CellzDirect decision to require "an analysis of whether 'the end result of the process, the essence of the whole, was a patent-ineligible concept.'" By focusing on "a process for achieving this desired outcome," according to the Memorandum, the Federal Circuit concluded the claims at issue were patent eligible, "like thousands of other claims that recite methods of producing things [the mixed cultures of hepatocytes that were the subject of the claims] or methods of treating disease" (a welcome extrapolation of the Federal Circuit's decision but an extrapolation just the same and one not supported expressly by the Court's decision). The Memorandum also referenced the Federal Circuit's Enfish decision, and asserts that the distinction between the CellzDirect decision and the Sequenom and Supreme Court's Mayo decision was that the latter decisions "amounted to nothing more than observing or identifying the ineligible concept itself." This section of the Memorandum concludes with the statement that "[t]he USPTO's current subject matter eligibility guidance [set out in the 2014 Interim Eligibility Guidance, July 2015 Update, and the May 2016 Update memoranda to examiners] and training examples are consistent with these points."
Turning to the denial of certiorari in the Sequenom case, the Memorandum is succinct: its Guidance was consistent with the Federal Circuit's decision, and denial of Sequenom's certiorari petition changes nothing ("While this panel decision is a precedential Federal Circuit panel decision, the denial of the petition for a writ of certiorari does not elevate its significance in this regard"). While true, this statement does not resolve the apparent conflict between the Federal Circuit's affirmance that Sequenom's claim 1:
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises
amplifying a paternally inherited nucleic acid from the serum or plasma sample and
detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.
is patent ineligible, with the Guidance's treatment of claim 1 of Example 29
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.
to be patent eligible. The Federal Circuit reasoned in Sequenom that:
It is undisputed that the existence of cffDNA in maternal blood is a natural phenomenon. Sequenom does not contend that Drs. Lo and Wainscoat created or altered any of the genetic information encoded in the cffDNA, and it is undisputed that the location of the nucleic acids existed in nature before Drs. Lo and Wainscoat found them. The method ends with paternally inherited cffDNA, which is also a natural phenomenon. The method therefore begins and ends with a natural phenomenon. Thus, the claims are directed to matter that is naturally occurring.
While the Office provides the following reasoning regarding claim 1 of Example 29:
[C]laim 1 is eligible because steps (a) and (b) of the claim "do not recite or describe any recognized exception" [the example cites Mayo Collaborative Services v. Prometheus Laboratories, Inc. in support of this determination, which the example indicates stands for the proposition that the recited steps of administering a drug to a patient and determining the resultant level of 6-thioguanine in the patient "are not themselves natural laws"]. As a result, the analysis of this claim ends with Step 2A of analytic framework set forth in the Interim Guidance (i.e., determining whether the claim is directed to a judicial exception), and the example notes that there is no need to proceed with Step 2B of the analytic framework (i.e., determining 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).
The extent to which these disparate analyses can be reconciled will depend, of course, on future case law, leaving the question of subject matter eligibility in its current state of uncertainty.