Processing All Things Federal Circuit
July 26, 2022 - Last Week in the Federal Circuit

Last Week In The Federal Circuit (July 18-22): Diagnosing Section 101 Eligibility


Precedential opinions: 3

Non-precedential opinions: 10

Rule 36: 0

Longest pending case from argument: Zafer Construction Company v. United States, No. 21-1547 (104 days)

Shortest (non-Rule 36) pending case from argument: Tie between Polaris Innovations Limited v. Advanced Micro Devices, Inc., No. 21-1917 (13 days), and Davis v. McDonough, No. 21-1904 (13 days)

Case of the week: CareDx, Inc. v. Natera, Inc., No. 22-1027

Panel: Judges Lourie, Bryson, and Hughes, with Judge Lourie writing the opinion

You should read this case if: you have a matter involving patent eligibility, particularly in the medical diagnostics field

The Supreme Court recently declined to take up patent eligibility in American Axle, leaving any clarification of Section 101 (by the Court or Congress) for another day. But in the meantime, the Federal Circuit will continue deciding Section 101 issues under existing case law. In our case of the week this week, the Federal Circuit applied those precedents to invalidate medical diagnostics claims.

The patents at issue claim methods for diagnosing organ transplant rejection. When a recipient’s body rejects a transplanted organ, the recipient’s immune system destroys the donated organ’s cells, releasing the donor’s DNA into the recipient’s blood in the form of cell-free DNA (cfDNA). The claims here involve measuring the resulting increases in donor cfDNA levels to identify potential organ rejection. They include four steps: (1) collecting a blood sample from the transplant recipient, (2) determining the genotypes of the donor and the recipient, (3) sequencing the cfDNA from the recipient’s blood sample, and (4) determining the amount of donor cfDNA in the sample.

The district court eventually held the claims invalid under Section 101, but only after a winding procedural history. The court denied the defendants’ motion to dismiss on Section 101 grounds. After expert discovery, the court initially denied summary judgment on Section 101 based on factual disputes about the conventionality of the relevant techniques. The defendants asked the district court to certify the summary-judgment denial for immediate appeal under 28 U.S.C. § 1292(b). The district court then changed course and granted the defendants summary judgment of ineligibility.

The Federal Circuit affirmed. At step one of the Alice/Mayo patent eligibility framework, the Court held that the claims were directed to natural phenomena: the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection. The Court explained that “the claims boil down to collecting a bodily sample, analyzing the cfDNA using conventional techniques, . . . identifying naturally occurring DNA from the donor organ, and then using the natural correlation between heightened cfDNA levels and transplant health to identify a possible rejection.” It analogized to previous cases, such as the Supreme Court’s Mayo decision, holding medical diagnostic claims ineligible for similar reasons. And it distinguished other cases upholding diagnostic claims, noting that the claims there involved an unconventional “method of preparation or a new measurement technique.”

At Alice/Mayo step two, the Court concluded that nothing in the claims “transforms the natural phenomena into a patentable invention.” The patents’ shared specification “admits that each step” in the claims “requires only conventional techniques and commercially available technology.” For example, the specification expressly noted that “any technique known in the art” could be used to collect the transplant recipient’s blood sample and that “well known” techniques could be used to sequence the cfDNA in the sample.

Nor did the ordered combination of steps provide an inventive concept for step two purposes. The specification indicated that “collecting a sample, genotyping, sequencing, and quantifying” was “a straightforward, logical, and conventional method for detecting cfDNA.” In particular, that sequence of steps had been “previously used in other contexts, including cancer diagnostics and prenatal testing.”

Finally, the Court disagreed with the plaintiffs’ procedural challenges to the district court’s decision. For instance, the Court saw no reversible “irregularity” in the district court “backtracking on its initial denial of summary judgment.” It observed that the district court “was entitled to reconsider its summary judgment decision” based on further arguments about the record evidence on conventionality.