Finding Another On-ramp to 101

• Jurisdiction: United States,Federal
• Author: D. Benjamin Borson
• Publication year: 2020
• Citation: Vol. 45 No. 2

Finding Another On-Ramp to 101

D. Benjamin Borson

Borson Law Group P.C.

ILLUMINA, INC., SEQUENOM, INC. V. ARIOSA DIAGNOSITCS, INC., ROCHE SEQUENCING SOLUTIONS, INC., ROCHE MOLECULAR SYSTEMS, INC. SLIP. OP. 2019-1419 (FEDERAL CIRCUIT. 17 MARCH 2020).

Introduction

The United States Supreme Court in Mayo Collaborative Services. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012) ("Mayo"), has curtailed many patent claims in the field of medical diagnostics, considering them to ineligible for patent protection because they were "drawn to natural phenomena" or "natural laws." In the intervening years, much attention has been paid to determining whether a claim is "directed to" a natural phenomenon. "Directed to" is a fundamental requirement for determining patent eligibility. Decisions about this question are implicated in the now well-cited Alice/Mayo test. However, the "directed to" analysis has not been made clear by the Supreme Court, and has been left, in the most part, to lower courts: the Court of Appeals for the Federal Circuit, district courts, and the USPTO to analyze this aspect of patent eligibility. Without clear guidance from the Supreme Court or the lower courts, the USPTO has developed the Alice/Mayo test according to its interpretations of the Supreme Court and the lower court decisions.

Under the Alice/Mayo test as articulated in the January 2019 guidance, the inquiry starts with determining the "broadest reasonable interpretation" of a claim. Then, the question in Step 1 is whether the claim is to a process, machine, manufacture, or composition of matter. If the answer is "yes," then Step 2A asks if the claim is "directed to" "a judicial exception," law of nature, natural phenomenon, product of nature, or abstract idea. If the answer in Step 2A is "yes" then Step 2B asks whether the claim recites additional elements that amount to significantly more than the judicial exception.

Under the revised Step 2A analysis of the October 2019 guidance, Prong One asks "does the claim recite an abstract idea, law of nature or natural phenomenon. If the answer to Prong one is "yes," then Prong Two asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If the answer to Prong Two is "yes," the claim is patent eligible. If the answer to Prong Two is "no," then the analysis proceeds to Step 2B.

Thus, according to the USPTO October update, the threshold question is not whether the claim is "directed to" a judicial exception, but rather, whether it "recites" a judicial exception.

It is well known that nearly all claims drawn to processes, manufactures, and compositions of matter rely to an extent upon a natural process. Thus, the question of whether a claim "recites" a judicial exception is sufficient to conclude that the claim is "directed to" the judicial exception.

This article analyzes the current state of the "directed to" question, as exemplified by the Illumina case, and as stated by the USPTO in its October 2019 supplement to the January 2019 Update on Subject Matter Eligibility.

Illumina v. Ariosa

Background

The underlying discovery in 1996 was that cell-free fetal DNA in maternal plasma and serum is useful to assist in the diagnosis of potential genetic diseases in the fetus. Prior to this discovery, detection of genetic disorders in the fetus required invasive procedures such as amniocentesis, which can cause harm to both the fetus and the mother. This discovery lead to the issue of Ariosa's U.S. Patent No. 6,258,540 (the '540 patent), with claims drawn to "a method for detecting the small fraction of paternally inherited cell-free fetal DNA in the plasma and serum of a pregnant woman."

In Ariosa Diagnostics, Inc. v. Sequenom, Inc. (788 F.3d 1371, 1373 (Federal Circuit 2015, "Ariosa"), the Federal Circuit held that claims of U.S. Patent No. 6,258,540 (the '540 patent) were ineligible for patenting because they "'were directed to "matter that is naturally occurring' -i.e., the natural phenomenon that cell-free fetal DNA exists in maternal blood." Slip Op. 2019-1419 at 2 bridging to 3.

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The current case (Illumina Slip. Op. 2019-1419), addresses two patents owned by Illumina, U.S. 9,580,751 (the '751 patent) and 9,738,931 (the '931 patent). The Northern district court of California in summary judgment held the claims to be ineligible, being drawn to natural phenomena, based on the prior decision in Ariosa in 2015.

A priority patent filed in Europe in 2003 led to both the '751 and '931 patents. The problem stated in the EP patent application is:

The major proportion (generally >90%) of the extracellular DNA in the maternal circulation is derived from the mother. This vast bulk of maternal circulatory extracellular DNA renders it difficult, if not impossible, to determine fetal genetic alternations [sic]... from the small amount of circulatory extracellular fetal DNA. Illumina, Slip Op. at 3.
[A]lthough it was known that cell-free fetal DNA existed in the mother's bloodstream (the '540 patent), there was not [a] known way to distinguish and separate the tiny amount of fetal DNA from the vast amount of maternal DNA. Id.

Therefore, at the time of the '751 and '931 patents, analysis of cell-free fetal DNA was uncertain because of the relatively small amount of fetal DNA in a sample of maternal blood.

The inventors of the '751 and '931 patents found a solution to this...