Digest of Univ. of Utah Research Found. v. Ambry Genetics Corp., No. 2014-1361, -1366 (Fed. Cir. Dec. 17, 2014) (precedential). On appeal from D. Utah. Before Prost, Clevenger, and Dyk.

Procedural Posture: Patent owner appealed the district court’s denial of a preliminary injunction. CAFC affirmed.

  • Patent Eligibility (Section 101): The CAFC held that claims directed to single-stranded DNA primers and screening methods using those DNA primers were directed to ineligible subject matter under 35 U.S.C. § 101. The CAFC explained that the single-strand DNA primers were structurally identical to DNA strands found in nature. Citing the Supreme Court case that had previously addressed some of the same patents at issue, Association for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013), the CAFC noted that the fact that the primers are synthetically replicated is irrelevant. The CAFC also dismissed the patent owner’s argument that short single-strand DNA primers are not naturally occurring, stating that the Supreme Court made clear, “separating [DNA] from its surrounding genetic material is not an act of invention.” Id at 2117. The CAFC went on to the explain that the method claims were also directed to patent-ineligible subject matter because they are a combination of an unpatentable abstract idea with routine and conventional steps, noting that “the non-patent-ineligible elements of claims 7 and 8 do not add ‘enough’ to make the claims as a whole patent-eligible.”