Case: Aria Diagnostics, Inc. v. Sequenom, Inc., No. 2012-1531 (Fed. Cir. Aug. 9, 2013) (precedential). On appeal from N.D. Cal. Before Rader, Dyk, and Reyna.

Procedural Posture: Defendant in a declaratory judgment action appealed the district court’s denial of a preliminary injunction against the plaintiff’s allegedly infringing activities. CAFC vacated and remanded.

  • Injunctions: “To reverse a denial of a preliminary injunction, the appellant ‘must show not only that one or more of the findings relied on by the district court was clearly erroneous, but also that denial of the injunction amounts to an abuse of the court’s discretion upon reversal of the erroneous findings.’” The district court erred in some aspects of its analysis regarding a preliminary injunction. These mistakes resulted in the district court’s denying the preliminary injunction even though the court had found that price and market erosion would occur, which are valid grounds for finding irreparable harm under the Federal Circuit’s precedent. Thus, the Federal Circuit remanded on this issue.
  • Claim Construction: The district court erroneously construed “paternally inherited nucleic acid” as “DNA sequence known [in advance] to be received only from the father which is not possessed by the mother.” This claim term describes the method of isolating and identifying any paternal characteristics by comparison to maternal characteristics, without limitation to only paternal characteristics known in advance. Furthermore, rather than providing a clear intention to limit the claims to the embodiments described, the specification states that the embodiments “do not in any way limit the scope of the invention.” Even if the specification did clearly limit the claims, the embodiments are not limited to sequences known in advance to have come from the father. The district court also erroneously construed “amplifying” to mean “increasing the concentration of a paternally inherited nucleic acid relative to other DNA in the sample,” a construction undermined by both the specification and the prosecution history. “To the contrary, the claim language requires ‘amplifying’ paternally inherited nucleic acid, without any mention of an effect on the quantity of other nucleic acid.”
  • Claim Construction (prosecution disclaimer): The prosecution history did not support importing the “known in advance” limitation into the “paternally inherited nucleic acid” term. The applicant’s amendments and remarks made no reference to “advance timing,” and thus did not indicate a clear and unmistakable disavowal.
  • Patent Eligibility (Section 101): The Supreme Court decided Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (Myriad) after the district court had found there was a substantial question over whether the asserted claims were directed to eligible subject matter. Because the district court did not have the benefit of Myriad and also in light of the Federal Circuit’s disagreement with the district court’s claim construction, the Federal Circuit remanded on the issue of subject matter eligibility.