In Ni-Q, LLC v. Prolacta Bioscience, Inc., the United
States District Court for the District of Oregon invalidated under
35 USC § 101 Prolacta's patent on testing milk to
establish or confirm the identity of the donor. The decision was
made on Ni-Q's motion for summary judgement, and illustrates
the reach of recent Federal Circuit jurisprudence on
"diagnostic" methods.
The Patent At Issue
The patent at issue was Prolacta's U.S. Patent No. 8,628,921. A summarized in the court decision,
the claimed methods were "intended to standardize nutritional
content in donated human mammary fluid and to ensure that the donor
of a given sample is a match to a previously-identified
donor." Prolacta said the invention addressed "two
different problems—human replacement milk that is
nutritionally standardized (particularly important for preterm
babies), and milk that is certifiably from a particular
donor."
