United States District Court, D. Delaware
ARCHERDX, INC. and THE GENERAL HOSPITAL CORPORATION d/b/a MASSACHUSETTS GENERAL HOSPITAL, Plaintiffs,
QIAGEN SCIENCES, LLC, QIAGEN LLC f/k/a QIAGEN INC., QIAGEN BEVERLY, LLC f/k/a QIAGEN BEVERLY, INC., QIAGEN GAITHERBURG, LLC f/k/a QIAGEN GAITHERSBURG, INC., QIAGEN GMBH, QIAGEN N.V. and JONATHAN ARNOLD, Defendants.
MARYELLEN NOREIKA, UNITED STATES DISTRICT JUDGE
Wilmington this 12th day of December 2019:
announced at the hearing on November 12, 2019, IT IS HEREBY
ORDERED that the disputed claim terms of U.S. Patent No. 10,
017, 810 (“the '810 Patent”) are construed as
1. “universal oligonucleotide tail adaptor” means
“a nucleic acid molecule comprised of two strands (a
blocking strand and an amplification strand) and comprising a
first ligatable duplex end and a second unpaired end”
('810 Patent, claims 1, 15, & 16);
2. “blocking strand” means “a strand of the
universal oligonucleotide tail adaptor that comprises a
5' duplex portion” ('810 Patent, claims 1-4
3. “amplification strand” means “a strand
of the universal oligonucleotide tail adaptor that comprises
an unpaired 5' portion, a 3' duplex portion, and a
3' T overhang, and nucleic acid sequences identical to a
first and second sequencing primers” ('810 Patent,
claims 1-4 & 16);
4. “second target-specific primer” means “a
single-stranded oligonucleotide comprising a 3' portion
comprising a nucleic acid sequence that can specifically
anneal to a portion of the known target nucleotide sequence
comprised by the amplicon resulting from step (b), and a
5' portion comprising a nucleic acid sequence that is
identical to a second sequencing primer” ('810
Patent, claims 1 & 16);
5. “known target nucleotide sequence” means
“a portion of a target nucleic acid for which the
sequence (e.g. the identity and order of the nucleotide bases
comprising the nucleic acid) is known” ('810
Patent, claims 1, 13, 14, & 16); and
6. “second adaptor primer” means “a nucleic
acid molecule comprising a nucleic acid sequence identical to
a portion of the first sequencing primer and is nested with
respect to the first adaptor primer” ('810 Patent,
claims 1 & 16).
addition, for the reasons set forth below,
7. “nested” means “annealed to a nucleic
acid sequence 3' downstream and in the same direction as
another molecule . . .” ('810 Patent, claim 1).
parties briefed the issues (see D.I. 123) and
submitted a Joint Claim Construction Chart containing
intrinsic evidence (see D.I. 134, Ex.
They also submitted an extensive Appendix that included three
expert declarations. (D.I. 124). Defendants submitted a
tutorial describing the relevant technology (see
D.I. 140). The Court carefully reviewed all submissions in
connection with the parties' contentions regarding the
disputed claim terms, heard oral argument and expert
testimony (see D.I. 143), and applied the following
legal standards in reaching its decision.
ultimate question of the proper construction of the patent
[is] a question of law, ” although subsidiary
fact-finding is sometimes necessary. Teva Pharms. USA,
Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837-38 (2015).
“[T]he words of a claim are generally given their
ordinary and customary meaning [which is] the meaning that
the term would have to a person of ordinary skill in the art
in question at the time of the invention, i.e., as of the
effective filing date of the patent application.”
Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.
Cir. 2005) (en banc) (internal citations and quotation marks
omitted). Although “the claims themselves provide
substantial guidance as to the meaning of particular claim
terms, ” the context of the surrounding words of the
claim also must be considered. Id. at 1314.
“[T]he ordinary meaning of a claim term is its meaning
to the ordinary artisan after reading the entire
patent.” Id. at 1321 (internal quotation marks
patent specification “is always highly relevant to the
claim construction analysis . . . [as] it is the single best
guide to the meaning of a disputed term.” Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
Cir. 1996). It is also possible that “the specification
may reveal a special definition given to a claim term by the
patentee that differs from the meaning it would otherwise
possess. In such cases, the inventor's lexicography
governs.” Phillips, 415 F.3d at 1316.
“Even when the specification describes only a single
embodiment, [however, ] the claims of the patent will not be
read restrictively unless the patentee has demonstrated a
clear intention to limit the claim scope using words or
expressions of manifest exclusion or restriction.”
Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d
1367, 1372 (Fed. Cir. 2014) (internal quotation marks
omitted) (quoting Liebel-Flarsheim Co. v. Medrad,
Inc., 358 F.3d 898, 906 (Fed. Cir. 2004)).
addition to the specification, a court “should also
consider the patent's prosecution history, if it is in
evidence.” Markman v. Westview Instruments,
Inc., 52 F.3d 967, 980 (Fed. Cir. 1995) (en banc),
aff'd, 517 U.S. 370 (1996). The prosecution
history, which is “intrinsic evidence, . . . consists
of the complete record of the proceedings before the [Patent
and Trademark Office] and includes the prior art cited during
the examination of the patent.” Phillips, 415
F.3d at 1317. “[T]he prosecution history can often
inform the meaning of the claim language by demonstrating how
the inventor understood the invention and whether the
inventor limited the invention in the course of prosecution,
making the claim scope narrower than it would otherwise
cases, courts “will need to look beyond the
patent's intrinsic evidence and to consult extrinsic
evidence in order to understand, for example, the background
science or the meaning of a term in the relevant art during
the relevant time period.” Teva, 135 S.Ct. at
841. Extrinsic evidence “consists of all evidence
external to the patent and prosecution history, including
expert and inventor testimony, dictionaries, and learned
treatises.” Markman, 52 F.3d at 980. Expert
testimony can be useful “to ensure that the court's
understanding of the technical aspects of the patent is
consistent with that of a person of skill in the art, or to
establish that a particular term in the patent or the prior
art has a particular meaning in the pertinent field.”
Phillips, 415 F.3d at 1318. Nonetheless, courts must
not lose sight of the fact that “expert reports and
testimony [are] generated at the time of and for the purpose
of litigation and thus can suffer from bias that is not
present in intrinsic evidence.” Id. Overall,
although extrinsic evidence “may be useful to the
court, ” it is “less reliable” than
intrinsic evidence, and its consideration “is unlikely
to result in a reliable interpretation of patent claim scope
unless considered in the context of the intrinsic
evidence.” Id. at 1318-19. Where the intrinsic
record unambiguously describes the scope of the patented
invention, reliance on any extrinsic evidence is improper.
See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182
F.3d 1298, 1308 (Fed. Cir. 1999) (citing Vitronics,
90 F.3d at 1583).
primary purpose of the definiteness requirement is to ensure
that the claims are written in such a way that they give
notice to the public of the extent of the legal protection
afforded by the patent, so that interested members of the
public, e.g. competitors of the patent owner, can
determine whether or not they infringe.” All Dental
Prodx, LLC v. Advantage Dental Prods., Inc., 309 F.3d
774, 779-80 (Fed. Cir. 2002) (citing Warner-Jenkinson Co.
v. Hilton-Davis Chem. Co., 520 U.S. 17, 28-29 (1997)).
Put another way, “[a] patent holder should know what he
owns, and the public should know what he does not.”
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
Ltd., 535 U.S. 722, 731 (2002).
patent claim is indefinite if, “viewed in light of the
specification and prosecution history, [it fails to] inform
those skilled in the art about the scope of the invention
with reasonable certainty.” Nautilus, Inc. v.
Biosig Instruments, Inc., 134 S.Ct. 2120, 2129 (2014). A
claim may be indefinite if the patent does not convey with
reasonable certainty how to measure a claimed feature.
See Teva Pharm. USA, Inc. v. Sandoz, Inc., 789 F.3d
1335, 1341 (Fed. Cir. 2015). But “[i]f such an
understanding of how to measure the claimed [feature] was
within the scope of knowledge possessed by one of ordinary
skill in the art, there is no requirement for the
specification to identify a particular measurement
technique.” Ethicon Endo-Surgery, Inc. v. Covidien,
Inc., 796 F.3d 1312, 1319 (Fed. Cir. 2015).
claim construction, definiteness is a question of law, but
the Court must sometimes render factual findings based on
extrinsic evidence to resolve the ultimate issue of
definiteness. See, e.g., Sonix Tech. Co. v.
Publications Int'l, Ltd., 844 F.3d 1370, 1376 (Fed.
Cir. 2017); see also Teva, 135 S.Ct. at 842-43.
“Any fact critical to a holding on indefiniteness . . .
must be proven by the challenger by clear and convincing
evidence.” Intel Corp. v. VIA Techs., Inc.,
319 F.3d 1357, 1366 (Fed. Cir. 2003); see also Tech.
Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338
(Fed. Cir. 2008).