En Banc Activity / Opinions

As we previously reported, yesterday the Federal Circuit issued a modified panel opinion in Illumina, Inc. v. Ariosa Diagnostics, Inc., a patent case we have been tracking because Ariosa Diagnostics filed a petition for rehearing en banc. In the modified panel opinion, Judges Lourie and Moore maintained their original position, reversing the district court, which had held that the claims at issue were not directed to patent-eligible subject matter. While the modified panel opinion did not change the holding of the court, it did more explicitly lay out the facts of the case that affected the court’s reasoning. Judge Reyna still dissented, but also issued a modified opinion. Here is a summary of the modified opinions.

Illumina originally filed suit against Ariosa Diagnostics, Inc., Roche Sequencing solutions, Inc., and Roche Molecular Systems Inc. (collectively “Roche”), alleging infringement of Illumina’s ’751 and ’931 patents. Roche moved for summary judgment, alleging that the patents are invalid under 35 U.S.C. § 101. The district court granted the motion, held that the claims were directed at ineligible subject matter, and entered judgment in favor of the defendants.

In the Federal Circuit’s original disposition, a panel majority including Judges Lourie and Moore reversed the district court, holding that the claims were directed to patent-eligible subject matter.

Roche subsequently filed a combined petition for panel and en banc rehearing.

Yesterday, the court granted panel rehearing to the extent that the panel issued modified opinions. Then the full court denied rehearing en banc.

Judge Lourie wrote both the original and modified panel majority opinions. The description of the relevant facts remains mostly the same in both the original and modified opinions:

“In 1996, Drs. Dennis Lo and James Wainscoat discovered cell-free fetal DNA in maternal plasma and serum, the portion of maternal blood samples that other researchers had previously discarded as medical waste.” . . . They applied for a patent, and . . . [i]n 2015, we held that the claims of that patent were invalid under 35 U.S.C. § 101 because they were directed to “matter that is naturally occurring” . . . The present case involves [Illumina’s] two patents that are unrelated to the patent held invalid in Ariosa, but . . . begin by acknowledging the natural phenomenon that was at issue in Ariosa. . . . The patents then identify a problem that . . . although it was known that cell-free fetal DNA existed in the mother’s bloodstream, there was no known way to distinguish and separate the tiny amount of fetal DNA from the vast amount of maternal DNA. The inventors of the ’751 and ’931 patents attempted to find a solution to that problem. . . . Specifically, they claim methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA.

There is one key fact that the court adds to the modified opinion that affects its analysis: “[T]he inventors found that 70% of all DNA fragments smaller than 300 base pairs were fetal.” Further, the court explains that the claims of the ’751 patent included an inventor-chosen size parameter of 500 base pairs. These inventor-chosen metrics seemingly influenced the court’s reasoning in the modified panel opinion.

The reasoning of the original majority opinion rested largely on the fact that Illumina’s claims were “directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA” rather than a bare discovery of a natural phenomenon. The court asserted those methods included “specific process steps—size discriminating and selectively removing DNA fragments that are above a specified threshold—to increase the relative amount of fetal DNA as compared to maternal DNA in the sample.” The court explained that the concrete nature of the claimed process steps, which included centrifugation, chromatography, electrophoresis, and nanotechnology, sufficiently demonstrated that one of Illumina’s claims was directed at a “method of preparation” and not merely a naturally phenomenon.

In the majority’s modified opinion, this original reasoning remains. The majority, however, also emphasizes the importance of 300 and 500 as the size parameters for the base pairs. The court explains that these parameters “are not dictated by any natural phenomenon,” but rather are “human-engineered parameters that optimize the amount of maternal DNA that is removed from the mixture and the amount of fetal DNA that remains in the mixture.” The modified opinion focuses on these parameters in addition to the “physical process steps that change the composition of the mixture.” The modified opinion places heavy emphasis on these parameters with the specified methods of preparation playing a supporting role in the court’s decision.

In both the original and modified opinions the court rejected Roche’s argument that the current claims are no more eligible than the claims at issue in Ariosa. The court’s reasoning, though, varies slightly in its wording.

In the original opinion, the court contrasted the current claims with those of Ariosa by pointing out that the current claims “are directed to more than just the correlation between a DNA fragment’s size and its tendency to be either fetal or maternal.” Rather, the court explained, “the claimed method removes some maternal DNA from the mother’s blood to prepare a fraction of cell-free DNA that is enriched in fetal DNA.”

The modified opinion arrives at the same conclusion that the claims are different from those in Ariosa, but it explains in greater detail why the new claims are different. In the modified opinion, the court explains that the claimed methods “exploit that natural size distribution during the sample preparation steps to remove some maternal DNA from the mother’s blood.” Further, it points out that “even the ‘analyzing’ step of the claims is not directed to analyzing the discovered natural phenomenon, but to analyzing something else entirely, namely, ‘fetal chromosomal aberrations.’” Based on this difference, the court concluded that the claims in the present case were distinguishable from those that were held to be invalid in Ariosa.

Ultimately, the majority concluded that the claims were not directed to a patent-ineligible concept. Thus, it reversed the district court’s grant of summary judgment and remanded the case for further proceedings.

Judge Reyna again dissented.

In his original dissent, Judge Reyna asserted that the claims were directed to a natural phenomenon and therefore not patent eligible. He pointed to many other cases in which the court held a claim to be directed to ineligible subject matter when the claimed advance was based on a “surprising and unexpected finding.” Here he argued that the claimed advance was the inventors’ “surprising” discovery “that cff-DNA tends to be shorter than cell-free maternal DNA.” In his opinion this renders the claim invalid. He criticized the majority for allegedly “ignor[ing] the claimed advance inquiry altogether.” Further, Judge Reyna asserted that “[a] process that merely changes the composition of a sample of naturally occurring substances, without altering the naturally occurring substances themselves, is not patent eligible.”

In his modified dissent, in addition to his discussion of the claimed advance, Judge Reyna placed more focus on the claims “involving” a fundamental natural phenomenon. Again, he pointed out that “[t]he substances present throughout the process are naturally occurring substances, and the claimed method steps do not alter those substances.” Thus, he claimed that the method “involved” a natural phenomenon under the Supreme Court’s step-one analysis. And he again criticized the majority for not addressing the claimed advance inquiry in the modified opinion.

Following issuance of the modified panel opinion, the full court denied the petition for en banc rehearing. Notably, none of the court’s judges issued any opinion dissenting from the denial of en banc rehearing