The subject matter eligibility hurdle continues to loom for drafters of diagnostic claims. The goal is to draft claims that will be construed under the line of the few cases with diagnostic claims that have survived a §101 challenge:

Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (new method);

XY, LLC v. Trans Ova Genetics, LC, 968 F.3d 1323 (Fed. Cir. 2020) (improved technique); and

Vanda Pharm. Inc. v. West-Ward Pharm., 887 F.3d 1117 (Fed. Cir. 2018) (dosage adjustment steps not routine or conventional),

while avoiding those like the ones rejected in CareDx, Inc. v. Natera, Inc., 40 F.4th 1371 (Fed. Cir. 2022), cert. denied, 2023 U.S. LEXIS 3355 (U.S., Oct. 2, 2023) (natural law and conventional steps).

Some suggestions that may be helpful to secure claims that will be valid and enforceable and clear the subject matter eligibility hurdle:

  • Recite a practical application and/or tangible result;
  • Recite at least one concrete/physical step;
  • Recite at least one non-routine/unconventional element;
  • Consider pairing diagnostic features with an active treatment step (g., a method comprising diagnosing a patient then treating the patient in a specific manner based on the diagnosis); and/or
  • Choose a clear preamble, and continue with language consistent with that preamble:
    • A method of treatment . . .
    • A method of preventing . . .
    • A method of [achieving X tangible/measurable result] . . .

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.