United States District Court, D. Oregon
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.
OPINION AND ORDER
Michael H. Simon, District Judge
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
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.
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).
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
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).
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).
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.
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).
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
(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
(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).
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 ...