Ni-Q, LLC v. Prolacta Bioscience, Inc. (D. Or. 2017)

by McDonnell Boehnen Hulbert & Berghoff LLP
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Last week, in Ni-Q, LLC v. Prolacta Bioscience, Inc., District Judge Michael H. Simon of the U.S. District Court for the District of Oregon denied a motion for judgment on the pleadings under Rule 12(c) of the Federal Rules of Civil Procedure filed by Plaintiff Ni-Q that the claims of U.S. Patent No. 8,628,921, which is assigned to Defendant Prolacta Bioscience ("Prolacta"), are invalid under 35 U.S.C. § 101 for failure to claim patent-eligible matter.  Ni-Q had initiated the dispute between the parties by filing a complaint for declaratory judgment of noninfringement and invalidity of the '921 patent, as well as alleging a violation of the Oregon Unlawful Trade Practices Act.

The '921 patent, which is entitled "Methods for testing milk," is directed to methods for testing mammary fluid (including milk) to establish or confirm the identity of the donor of the mammary fluid.  Independent claims 1 and 13 recite:

1.  A method for determining whether a donated mammary fluid was obtained from a specific subject, the method comprising: (a) testing a donated biological sample from the specific subject to obtain at least one reference identity marker profile for at least one marker; (b) testing a sample of the donated mammary fluid to obtain at least one identity marker profile for the at least one marker in step (a); (c) comparing the identity marker profiles, wherein a match between the identity marker profiles indicates that the mammary fluid was obtained from the specific subject; and (d) processing the donated mammary fluid whose identity marker profile has been matched with a reference identity marker profile, wherein the processed donated mammary fluid comprises a human protein constituent of 11-20 mg/mL; a human fat constituent of 35-55 mg/mL; and a human carbohydrate constituent of 70-120 mg/mL.

13.  A method for processing a donated human breast milk obtained from a specific subject comprising: (a) testing a donated biological sample from the specific subject to obtain at least one reference identity marker profile for at least one marker; (b) testing a sample of the donated human breast milk to obtain at least one identity marker profile for the at least one marker in step (a); (c) comparing the identity marker profiles of steps (a) and (b), wherein a match between the identity marker profiles indicates that the donated human breast milk was obtained from the specific subject; (d) processing the donated human breast milk whose identity marker profile has been matched with a reference identity marker profile, wherein the processing comprises: (i) filtering the donated human breast milk; (ii) heat treating the donated human breast milk; (iii) separating the donated human breast milk into cream and skim; (iv) adding a portion of the cream to the skim to form a human milk composition; and (v) pasteurizing the human milk composition to produce a processed human breast milk composition; and wherein the processed donated human breast milk comprises a human protein constituent of 11-20 mg/mL; a human fat constituent of 35-55 mg/mL; and a human carbohydrate constituent of 70-120 mg/mL.

Prolacta receives human milk from donors and processes it to make fortifier and other products for use in feeding premature and other medically fragile infants.  Ni-Q is also engaged in the procurement, production, and sale of human milk-based products for use in feeding premature infants.  In response to Ni-Q's declaratory judgment action, Prolacta alleged infringement of the '921 patent by Ni-Q.

Ni-Q thereafter filed its Rule 12(c) motion for judgment on the pleadings, asserting that the claims of the '921 Patent are directed to the application of a natural phenomenon, namely, the identification of naturally occurring biological markers in the tissues of a milk donor and in the donor's milk.  Ni-Q also asserts that the claimed methods are implemented using previously known techniques, such as the analysis of DNA-, protein-, or antibody-based markers, and therefore add no inventive concept to save the patent from a finding of subject matter ineligibility.

Prolacta opposed Ni-Q's motion, arguing that because claim construction had not yet occurred, the claims must be construed entirely in Prolacta's favor (citing BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1351-52 (Fed. Cir. 2016)).  Prolacta also argued that Ni-Q, in its motion, relied on prior art cited on the face of the '921 patent, and that if the District Court were to consider those references, then the Court should employ the summary judgment standard under Rule 56 (citing Cobra Fixations CIE Ltee-Cobra Anchors Co., Ltd. v. Newell Operating Co., 2011 WL 1399785, *1 (M.D. N.C. 2011)).  Prolacta further argued that any ambiguities, including what the '921 patent specification or prior art discloses, must be resolved in favor of Prolacta's pleading under Rule 12(c) (citing Walling v. Beverly Enters., 476 F.2d 393, 396 (9th Cir. 1973), and Mettler-Toledo, Inc. v. B-Tek Scales, LLC, 671 F.3d 1291, 1297 (Fed. Cir. 2012)).  Finally, Prolacta submitted two declarations in opposition to Ni-Q's motion.

Ni-Q responded to Prolacta's opposition by arguing that the District Court should not adopt Prolacta's proffered claim construction because it was implausible (citing Atlas IP, LLC v. Exelon Corp., 189 F. Supp. 3d 768, 779 (N.D. Ill. May 17, 2016)).  Ni-Q also argued that if the District Court decided to adopt Prolacta's proffered claim construction, then Ni-Q should be entitled to judgment of infringement and the claims of the '921 patent should still be found to be directed to patent ineligible subject matter because the additional method steps relied upon by Prolacta would not save the claims under § 101.

In denying Ni-Q's motion, Judge Simon determined that "[a]fter reviewing the parties' arguments and evidence, including Prolacta's proffered claim construction, . . . it is premature to resolve the substantive disputes presented."  The Court expressed the belief that "a sound[] analysis and resolution of the pending dispute will benefit from an orderly claim construction procedure."

Ni-Q, LLC v. Prolacta Bioscience, Inc. (D. Or. 2017)
Order by District Judge Simon

DISCLAIMER: 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 situations.

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