United States District Court, D. Delaware
REPORT AND RECOMMENDATION
CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE
these two related actions filed by Plaintiff Guardant Health,
Inc. ("Guardant" or "Plaintiff) against
Defendants Foundation Medicine, Inc. ("FMI") and
Personal Genome Diagnostics, Inc. ("PGDx" and
collectively with FMI, "Defendants"), Guardant
alleges infringement of United States Patent Nos. 9, 598, 731
(the "731 patent"), 9, 834, 822 (the "'822
patent"), 9, 840, 743 (the "743 patent") and
9, 902, 992 (the '"992 patent" and collectively
with the other patents, "the asserted patents").
Presently before the Court is the matter of claim
construction. The Court recommends that the District Court
adopt the constructions as set forth below.
commenced these actions on November 9, 2017. (Civil Action
No. 17-1616-LPS-CJB, D.I. 1; Civil Action No.
17-1623-LPS-CJB, D.I. 1) The cases were thereafter referred
to the Court to hear and resolve all pretrial matters, up to
and including case-dispositive motions. (Civil Action No.
17-1616-LPS-CJB, D.I. 5; Civil Action No. 17-1623-LPS-CJB,
currently-operative Third Amended Complaints, Guardant
alleges that Defendants' liquid biopsy tests infringe
claims of the asserted patents. (Civil Action No.
17-1616-LPS-CJB, D.I. 149 at ¶¶ 4, 14-24; Civil
Action No. 17-1623-LPS-CJB, D.I. 280 at ¶¶ 6,
17-28) The asserted patents relate to methods for identifying
genetic material harboring cancer-causing mutations from a
patient's blood. (See D.I. 59 at
l) Each of
the patents is titled "Systems and Methods to Detect
Rare Mutations and Copy Number Variation." (D.I. 53,
exs. C-F) The
'731 patent, '822 patent and the '743 patent
share a common specification ("the specification"),
and the '992 patent has a similar specification.
(See D.I. 75, ex. 1 at Slide 4)
parties completed initial briefing on claim construction on
November 16, 2018. (D.I. 59; D.I. 68; D.I. 72; D.I.
74) The Court
held a Markman hearing on December 14, 2018. (D.I.
85 (hereinafter, "Tr.")) Following the hearing,
Defendants submitted a supplemental letter brief relating to
a new argument asserted by Guardant during the
Markman hearing. (D.I. 84) And the parties
thereafter submitted supplemental briefs relating to
inter partes review proceedings with respect to the
'731 patent, which the parties assert have relevance to
the construction of certain disputed terms. (D.I. 88; D.I.
90; D.I. 136; D.I. 139; D.I. 162; D.I. 173; D.I. 283; D.I.
286; D.I. 351)
STANDARD OF REVIEW
well-understood that "[a] claim in a patent provides the
metes and bounds of the right which the patent confers on the
patentee to exclude others from making, using, or selling the
protected invention." Corning Glass Works v.
Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed.
Cir. 1989). Claim construction is a generally 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).
Court should typically assign claim terms their
"ordinary and customary meaning[, ]" which is
"the meaning that the term[s] would have to a person of
ordinary skill in the art ['POSITA'] 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). However,
when determining the ordinary meaning of claim terms, the
Court should not extract and isolate those terms from the
context of the patent; rather it should endeavor to reflect
their "meaning to the ordinary artisan after reading the
entire patent." Id. at 1321; see also Eon
Corp. IP Holdings LLC v. Silver Spring Networks, Inc.,
815 F.3d 1314, 1320 (Fed. Cir. 2016).
proceeding with claim construction, the Court should look
first and foremost to the language of the claims themselves,
because "[i]t is a bedrock principle of patent law that
the claims of a patent define the invention to which the
patentee is entitled the right to exclude."
Phillips, 415 F.3d at 1312 (internal quotation marks
and citations omitted). For example, the context in which a
term is used in a claim may be "highly
instructive." Id. at 1314. In addition,
"[o]ther claims of the patent in question, both asserted
and unasserted, can . .. be valuable" in discerning the
meaning of a particular claim term. Id. This is
"[b]ecause claim terms are normally used consistently
throughout the patent, [and so] the usage of a term in one
claim can often illuminate the meaning of the same term in
other claims." Id. Moreover, "[differences
among claims can also be a useful guide[, ]" as when
"the presence of a dependent claim that adds a
particular limitation gives rise to a presumption that the
limitation in question is not present in the independent
claim." Id. at 1314-15.
addition to the words of the claims, the Court should look to
other intrinsic evidence. For example, the Court should
analyze the patent specification, which "may reveal a
special definition given to a claim term . . . that differs
from the meaning [that term] would otherwise possess" or
may reveal an intentional disclaimer of claim scope.
Id., at 1316. Even if the specification does not
contain such revelations, it "is always highly relevant
to the claim construction analysis. Usually, it is
dispositive; it is the single best guide to the meaning of a
disputed term." Id. at 1315 (internal quotation
marks and citation omitted). That said, however, the
specification "is not a substitute for, nor can it be
used to rewrite, the chosen claim language."
SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d
870, 875 (Fed. Cir. 2004). And a court should also consider
the patent's prosecution history, if it is in evidence,
because it "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[.]" Phillips, 415
F.3d at 1317.
evidence, "including expert and inventor testimony,
dictionaries, and learned treatises[, ]" can also
"shed useful light on the relevant art[.]"
Id. (internal quotation marks and citations
omitted). Overall, while extrinsic evidence may be useful, it
is "less significant than the intrinsic record in
determining the legally operative meaning of claim
language." Id. (internal quotation marks and
citations omitted); accord Markman v. Westview
Instruments, Inc., 52 F.3d 967, 981 (Fed. Cir. 1995).
utilizing these resources during claim construction, courts
should keep in mind that "[t]he construction that stays
true to the claim language and most naturally aligns with the
patent's description of the invention will be, in the
end, the correct construction." Renishaw PLC v.
Marposs Societa'per Azioni, 158 F.3d 1243, 1250
(Fed. Cir. 1998).
parties currently have disputes regarding 13 terms or sets of
terms (hereinafter, "terms"). This Report and
Recommendation addresses three such terms. The other terms
will be addressed in one or more forthcoming Report and
claim term "sequence read" appears in certain
claims of all four asserted patents. (D.I. 53, ex. B at 4-5)
The use of the disputed term in claim 1 of the 731 patent and
claim 1 of the 743 patent is representative. (See
Defendants' Markman Presentation, Slide 3; Guardant's
Markman Presentation, Slide 7) Accordingly, these claims are
reproduced below, with the disputed term highlighted:
1. A method for quantifying single nucleotide variant tumor
markers in cell-free DNA from a subject, comprising:
(a) providing at least 10 ng of cell-free DNA obtained from a
bodily sample of the subject;
(b) attaching tags comprising barcodes having from 5 to 1000
distinct barcode sequences to said cell-free DNA obtained
from said bodily sample of the subject, to generate
non-uniquely tagged parent polynucleotides, wherein each
barcode sequence is at least 5 nucleotides in length;
(c) amplifying the non-uniquely tagged parent polynucleotides
to produce amplified non-uniquely tagged progeny
(d) sequencing the amplified non-uniquely tagged progeny
polynucleotides to produce a plurality of sequence
reads from each parent polynucleotide, wherein each
sequence read comprises a barcode sequence and a
sequence derived from cell-free DNA;
(e) grouping the plurality of sequence reads
produced from each non-uniquely tagged parent polynucleotide
into families based on i) the barcode sequence and ii) at
least one of: sequence information at a beginning of the
sequence derived from cell-free DNA, sequence information at
an end of the sequence derived from cell-free DNA, and length
of the sequence read, whereby each family comprises
sequence reads of non-uniquely tagged progeny
polynucleotides amplified from a unique polynucleotide among
the non-uniquely tagged parent polynucleotides;
(f) comparing the sequence reads grouped within each
family to determine consensus sequences for each family,
wherein each of the consensus sequences corresponds to a
unique polynucleotide among the non-uniquely tagged parent
(g) providing one or more reference sequences from a human
genome, said one or more reference sequences comprising one
or more loci of reported tumor markers, wherein each of the
reported tumor markers is a single nucleotide variant;
(h) identifying consensus sequences that map to a given locus
of said one or more loci of reported tumor markers; and
(i) calculating a number of consensus sequences that map to
the given locus that include the single nucleotide variant
thereby quantifying single nucleotide variant tumor markers