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

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Precedential opinions: 3

Non-precedential opinions: 10

Rule 36: 0

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

Shortest (non-Rule 36) pending case from
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

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

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.

Because of the generality of this update, the information
provided herein may not be applicable in all situations and should
not be acted upon without specific legal advice based on particular

© Morrison & Foerster LLP. All rights reserved

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