Last month, in Ni-Q, LLC v. Prolacta Bioscience, Inc., District Judge Michael H. Simon of the U.S. District Court for the District of Oregon granted a motion for summary judgment filed by Plaintiff Ni-Q, LLC that the asserted claims of U.S. Patent No. 8,628,921, which is assigned to Defendant Prolacta Bioscience, Inc. ("Prolacta"), are invalid under 35 U.S.C. § 101 for failure to claim patent-eligible subject matter. The District Court also determined on summary judgment that Ni-Q did not infringe the asserted claims of the '921 patent, even if those claims had been found valid. We previously reported on this case in 2017 when the District Court denied Ni-Q's motion for judgment on the pleadings under Rule 12(c) of the Federal Rules of Civil Procedure that the claims of the '921 patent were invalid under 35 U.S.C. § 101 for failure to claim patent-eligible subject 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. Prolacta responded by filing a counterclaim against Ni-Q for money damages and injunctive relief, asserting that Ni-Q had infringed claims 1, 2, and 9 of the '921 patent.
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 claim 1 recites (emphasis in opinion):
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.
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 construing the claims, the parties stipulated and the District Court adopted that the term "wherein a match" means "a determination that the marker(s) in the biological sample and donated fluid or milk are the same and that there are no additional unmatched marker(s)." The District Court also construed the term "processing" to mean: "One or more of the following: filtering, heat-treating, separating into cream and skim, adding cream to the skim, or pasteurizing." Following the District Court's construction of the claims, Ni-Q filed a motion for partial summary judgment, arguing that in view of the Court's claim construction, claims 1, 2, 4, 6-9, and 11 of the '921 patent were invalid under 35 U.S.C. § 101 for being directed to patent-eligible subject matter, and that it did not infringe the claims of the '921 patent because it did not perform all of the steps of the asserted claims.
With respect to the issue of validity, Ni-Q argued that the asserted claims were invalid under 35 U.S.C. § 101 because they are directed to a patent-ineligible natural law with no inventive concept to transform the natural law into patent-eligible subject matter. More specifically, Ni-Q argued that the presence of identity markers such as DNA and proteins in a woman's tissue or milk is natural, and the nutritional levels required by the patent occur naturally. Prolacta responded by asserting that the claims are directed to producing safer milk that is standardized with optimal nutritional values, contending that the claimed method recites steps for selecting for processing safe milk from health-screened donors and manufacturing a nutrient-enhanced human milk product.
With respect to the first step of Alice/Mayo framework, the District Court agreed with Ni-Q that "the asserted claims are directed to the laws of nature," and that "[t]he presence of identity markers such as DNA in a woman's mammary fluid and other biological tissue is natural." The Court explained that "[a]lthough the patent describes the human action of testing the original reference sample and the mammary fluid sample and comparing them, that does not convert the claim to patent-eligible subject matter," adding that "[t]he relationship of the markers in the samples exists naturally." The Court determined that "Claim 1 merely describes the natural law that two different biological samples from the same individual contain the same identity markers and thus can be tested and compared."
The District Court found Prolacta's argument that the claims are directed to producing safer milk that is standardized with optimal nutritional value to be unpersuasive, pointing out that the steps recited in claim 1 "require no step, method, or process relating to safety or the health screening of donors," but rather "merely require testing a reference sample of a donor, testing a sample of the donated mammary fluid, comparing the two test results, and processing only the mammary fluid when the two tests match," and noting that "[t]here is nothing in Claim 1 . . . that requires testing the donor for disease or drug use or anything else relating to health or safety." According to the Court, claim 1 "is about identification—it does not suggest that its goal or purpose relates to safety or health concerns." The Court also found to be unavailing Prolacta's argument that claim 1 covers a method of standardizing optimal nutrient level, noting that claim 1 "does not require that nutrient levels of donated mammary fluid be altered," but instead "merely requires that after processing is complete, the mammary fluid consist of wide-ranging levels of nutrients that, as conceded by Prolacta, are naturally found in human breast milk." In finding that "Claim 1 . . . is impermissibly directed to a patent-ineligible subject," the Court concluded that:
Claim 1 is a broad claim that is not limited to a particular application of natural law. It is not limited to commercial human breast milk production, to certain processing that alter the makeup of the breast milk, or to testing breast milk donors for viruses, bacteria, drugs, or other health issues and then ensuring that later-donated milk matches the originally-screened donor. Indeed, it purports to cover any use where: (1) a donor has donated a reference sample and mammary fluid that are tested for a match; (2) if there is a match, the donated mammary fluid is processed using any of the five types of processing; and (3) after processing, the mammary fluid contains the identified nutrient ranges. Because these nutrient ranges are found naturally in breast milk, the claim's covered use could include, for example, researchers who are testing the efficacy of DNA comparisons between breast milk and other biological samples and in so doing heat-treat or pasteurize the milk.
With respect to the second step of the Alice/Mayo analytic framework, Ni-Q argued that Prolacta's comparison of DNA to match the reference sample to the donated mammary fluid was not new or inventive, and that because processing can include pasteurization, that is also not a new or innovative step. Prolacta responded that three aspects of the claims are new or inventive: (1) applying DNA analysis to mammary fluid; (2) selecting mammary fluid for processing based on a matching processing that ensured the donated fluid was from a specific subject, thereby eliminating the risk of communicable diseases in donated milk; and (3) requiring the recited nutrient ranges.
The District Court rejected Prolacta's second and third arguments, stating that "the elimination of health concerns and communicable diseases in processed milk is not contained in any of the asserted claims (and therefore cannot provide an inventive concept) and the required nutrient ranges may not require any processing other than pasteurization of donated milk, which is not new or inventive." The Court also took issue with Prolacta's first argument, noting that "nothing in the claims requires screening of the donor," and therefore, that Prolacta's "new application" -- i.e., the genetic link between screened donors and donated milk and excluding milk containing DNA from unknown and unscreened donors –- "is not the application in the claims." The Court also noted that the claims "do not require the matching be through maternal DNA," and that "[a]ny identity marker will suffice." The Court therefore concluded that "the claims add no new or inventive concept not already known in the art," and that "[c]onsidering the steps 'as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately,'" quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79 (2012). Thus, the Court found the claims to also "fail at step two" of the Alice/Mayo framework.
Turning to the issue of infringement, Ni-Q asserted that it does not perform the "wherein a match" step of the asserted claims and therefore did not literally infringe the '921 patent or infringe the '921 patent under the doctrine of equivalents. In particular, Ni-Q asserted that in view of the District Court's claim construction, the "wherein a match" step requires a determination that there are no additional unmatched markers between the biological sample and the donated fluid or milk, and that it never determined that there were no additional unmatched markers. The Court again agreed with Ni-Q, finding that "the '921 Patent requires a determination that the milk processed had no additional unmatched markers," and determining that "because Ni-Q processed the milk and did not make that determination before processing, Ni-Q did not infringe the patent" (emphasis in opinion). The District Court also concluded that Ni-Q did not infringe the '921 patent under the doctrine of equivalents because "[t]he purpose of the second step of the 'wherein a match' requirement—making sure there are 'no unmatched markers'—is to prevent contamination from unscreened donors," and "Ni-Q does nothing equivalent to that step to prevent contamination from other donors."
The District Court therefore granted Ni-Q's motion for summary judgement, finding that there were no genuine issues of material fact, the asserted claims of the '921 patent are invalid under 35 U.S.C. § 101, and that Ni-Q did not infringe the asserted claims even if they were valid.
Ni-Q, LLC v. Prolacta Bioscience, Inc. (D. Or. 2019)
Opinion and Order by District Judge Simon
