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Ni-Q, LLC v. Prolacta Bioscience, Inc.

United States District Court, D. Oregon

February 13, 2019

NI-Q, LLC, Plaintiff,

          Brenna K. Legaard and Angela E. Addae, Schwabe, Williamson & Wyatt PC, Of Attorneys for Plaintiff.

          Kristin L. Cleveland, Klarkquist Sparkman LLP, OR 97204; Orion Armon, Cooley LLP, Alexandra Mayhugh, Cooley LLP, Nicholas G. Lockhart, Cooley LLP, Of Attorneys for Defendant.


          Michael H. Simon, District Judge

         In this patent action, Plaintiff Ni-Q, LLC (“Ni-Q”) seeks a declaration that it has not infringed U.S. Patent No. 8, 628, 921 (“the '921 Patent”) (relating to methods for testing milk from human donors). Ni-Q also seeks a declaration that the '921 Patent is invalid. Ni-Q further seeks money damages and injunctive relief under Oregon's Unlawful Trade Practices Act. By counterclaim, Defendant Prolacta Bioscience, Inc. (“Prolacta”) seeks money damages and injunctive relief against Ni-Q. Prolacta alleges that the inventors of the '921 Patent have assigned their rights in that patent to Prolacta and that Ni-Q has infringed at least Claims 1, 2, and 9 of the '921 Patent. On June 12, 2018, the Court issued its Opinion and Order on Claim Construction. The Court adopted the parties' stipulated construction of the term “wherein a match.” The Court also construed the disputed term “processing” in the '921 Patent.

         Before the Court is Ni-Q's motion for partial summary judgment on two alternative grounds. First, Ni-Q argues that, based on the Court's construction of the term “processing, ” Claims 1, 2, 4, 6, 7, 8, 9, and 11 of the '921 Patent are invalid under 35 U.S.C. § 101 for failing to claim patentable subject matter. Second, Ni-Q argues that it has not infringed any claim of the '921 Patent because Ni-Q does not perform all of the steps required under the patent, as construed by the Court. For the reasons discussed below, Ni-Q's motion is granted on both grounds.


         A. Summary Judgment

         A party is entitled to summary judgment if the “movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). The moving party has the burden of establishing the absence of a genuine dispute of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). The court must view the evidence in the light most favorable to the non-movant and draw all reasonable inferences in the non-movant's favor. Clicks Billiards Inc. v. Sixshooters Inc., 251 F.3d 1252, 1257 (9th Cir. 2001). Although “[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . ruling on a motion for summary judgment, ” the “mere existence of a scintilla of evidence in support of the plaintiff's position [is] insufficient . . . .” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 255 (1986). “Where the record taken as a whole could not lead a rational trier of fact to find for the non-moving party, there is no genuine issue for trial.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (citation and quotation marks omitted).

         B. Invalidity Under 35 U.S.C. § 101

          “Whether a claim is drawn to patent-eligible subject matter under § 101 is a threshold inquiry” and “an issue of law.” In re Bilski, 545 F.3d 943, 950-51 (Fed. Cir. 2008). Section 101 provides: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” “The [Supreme] Court has long held that this provision contains an important implicit exception. ‘[L]aws of nature, natural phenomena, and abstract ideas' are not patentable.” Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012) (first alteration added, second alteration in original) (quoting Diamond v. Diehr, 450 U.S. 175, 185 (1981)).

         There is two-step test to determine patent eligibility under § 101. The first step is to determine whether the claims are directed to a patent-ineligible subject matter, such as a naturally occurring phenomenon. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347, 2355 (2014). The second step is to “consider the elements of each claim both individually and ‘as an ordered combination' to determine whether the additional elements ‘transform the nature of the claim' into a patent-eligible application.” Id. (quoting Mayo, 566 U.S. at 78). An “inventive concept” is “an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.'” Id. (alteration in original) (quoting Mayo, 566 U.S. at 72-73).

         C. Infringement

         An infringement analysis also involves a two-step process. Phil-Insul Corp. v. Airlite Plastics Co., 854 F.3d 1344, 1358 (Fed. Cir. 2017). “The court must: (1) determine the scope and meaning of the patent claims asserted; and (2) compare the properly construed claims to the allegedly infringing device.” Id. “With regard to the second step of the infringement analysis, the patentee must prove that the accused device embodies every limitation in the claim, either literally or by a substantial equivalent.” Conroy v. Reebok Int'l, Ltd., 14 F.3d 1570, 1573 (Fed. Cir. 1994).

         “Literal infringement exists when every limitation recited in the claim is found in the accused device.” Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1341 (Fed. Cir. 2016). In considering literal infringement at summary judgment, a court must resolve all inferences in favor of the patentee and may grant summary judgment against the patentee only if the court determines that no reasonable jury could find infringement. Id.

         “While infringement under the doctrine of equivalents is a question of fact, ‘[w]here the evidence is such that no reasonable jury could determine two elements to be equivalent, district courts are obliged to grant partial or complete summary judgment.'” Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1319 (Fed. Cir. 2015) (alteration in original) (quoting Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39 n.8 (1997)). In making this determination, “the range of equivalents cannot be divorced from the scope of the claims.” Vehicular Techs. Corp. v. Titan Wheel Int'l, Inc., 212 F.3d 1377, 1382 (Fed. Cir. 2000) (per curiam). Indeed, “by defining the claim in a way that clearly exclude[s] certain subject matter, ” a patent may “implicitly disclaim[] the subject matter that was excluded and thereby bar[] the patentee from asserting infringement under the doctrine of equivalents.” SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1346 (Fed. Cir. 2001) (alterations added).


         Claim 1 of the '921 Patent states as follows, with the terms construed by the Court in bold:

A method for determining whether a donated [human] 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 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.

ECF 25-1 ('921 Patent).

         The parties stipulated, and the 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).” ECF 86 at 7-8. The Court 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.” Id. at ...

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