Roche Diagnostics Corporation v. Meso Scale Diagnostics, LLC
Filing
114
MEMORANDUM OPINION re claim construction. Signed by Judge Leonard P. Stark on 10/9/2018. (etg)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ROCHE DIAGNOSTICS CORPORATION,
Plaintiff,
V.
MESO SCALE DIAGNOSTICS,LLC,
Defendant.
C.A.NO. 17-189-LPS
MESO SCALE DIAGNOSTICS,LLC,
Counterclaim Plaintiff,
ROCHE DIAGNOSTICS CORPORATION,and
BIOVERIS CORPORATION,
Counterclaim Defendants.
Joel Friedlander, Christopher M.Foulds, and Christopher P. Quinn, FRIEDLANDER &
GORRIS,P.A., Wilmington, DE
James T. McKewon,Jeffrey N. Costakos, Eric L. Maasen, and Rachel M.Blise, FOLEY &
LARDNER,LLP,New York, NY
Attorneys for Plaintiff and Counterclaim Defendants
Jack B. Blumenfeld and Jeremy A. Tigan, MORRIS,NICHOLS,ARSHT & TUNNELL LLP,
Wilmington,DE
Adam K. Mortara, Steven E. Derringer, and J. Scott McBride,BARTLITT BECK HERMAN
PALENCHAR & SCOTT LLP, Chicago,IL
Nosson D. Knobloch, Daniel R. Brody,and Daniel C. Taylor, BARTLITT BECK HERMAN
PALENCHAR & SCOTT LLP,Denver, CO
Attorneys for Defendant and Counterclaim Plaintiff
MEMORANDUM OPINION
October 9,2018
Wilmington, Delaware
STARK,U.S. Di^rict Judge:
Plaintiff Roche Diagnostics Corporation brought a declaratoryjudgment suit against
Defendant Meso Scale Diagnostics, LLC("Meso" or "Defendant") seeking confirmation that it
does not infringe Meso's exclusive license rights of patented diagnostics detection technology
known as electrochemiluminescence("ECL"). (See D.I. 1) Meso filed counterclaims against
Roche Diagnostics Corporation and Bioveris Corporation (collectively,"Roche") asserting
infringement often patents. (See D.I. 42-1) Four patents are at issue for purposes ofclaim
construction: U.S. Patent Nos. 5,846,485 (the "'485 patent"), 6,165,729(the "'729 patent"),
6,271,041 (the "'041 patent"), and 6,316,607(the "'607 patent"). The '485,'729, and '041
patents share a common specification and claim compositions and methods for performing ECL
measurements, while the '607 patent claims specific compounds or compositions that are formed
as part ofthe ECL process. (See D.I. 76 at 2, 5)
Presently before the Court is the issue of claim construction. The parties submitted
technology tutorials(see D.I. 73, 74), objections to such technology tutorials(see D.I. 84, 85),
and claim construction briefs (see D.I. 75, 76, 82, 83). The Court held a claim construction
hearing on August 7,2018, at which both sides presented oral argument. (See Transcript("Tr."))
I.
LEGAL STANDARDS
The ultimate question ofthe proper construction of a patent is a question oflaw. See
Teva Pharm. USA, Inc. v. Sandoz, Inc.., 135 S. Ct. 831,837(2015)
(cUmg Markman v. Westview
Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "It 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 V. AWHCorp.,415 F.3d 1303, 1312(Fed. Cir. 2005)(internal quotation marks omitted).
1
"[T]here is no magic formula or catechism for conducting claim construction." Id. at
1324. Instead, the Court is free to attach the appropriate weight to appropriate sources "in light
ofthe statutes and policies that inform patent law." Id.
"[T]he words ofa 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 ofthe invention, i.e., as ofthe effective filing date ofthe patent application."
Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning ofa
claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321
(internal quotation marks omitted). The patent specification "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." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576,1582(Fed. Cir. 1996).
While "the claims themselves provide substantial guidance as to the meaning of particular
claim terms," the context ofthe surrounding words ofthe claim also must be considered.
Phillips, 415 F.3d at 1314. Furthermore,"[o]ther claims ofthe patent in question, both asserted
and unasserted, can also be valuable sources of enlightenment...[bjecause claim terms are
normally used consistently throughout the patent." Id. (internal citation omitted).
It is likev^se true that "[djifferences among claims can also be a useful guide.... For
example, 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 131415 (internal citation omitted). This "presumption is especially strong when the limitation in
dispute is the only meaningful difference between an independent and dependent claim, and one
party is urging that the limitation in the dependent claim should be read into the independent
claim." SunRace Roots Enter. Co., Ltd. v. SRAMCorp.^ 336 F.3d 1298,1303(Fed. Cir. 2003).
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. It bears emphasis that "[e]ven
when the specification describes only a single embodiment,the claims ofthe 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)
Liebel-Flarsheim Co. v. Medrad, Inc., 358
F.3d 898,906(Fed. Cir. 2004))(internal quotation marks omitted).
In 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), affd,517 U.S. 370(1996). The prosecution history, which is "intrinsic evidence,"
"consists ofthe complete record ofthe proceedings before the PTO [Patent and Trademark
Office] and includes the prior art cited during the examination ofthe patent." Phillips, 415 F.3d
at 1317. "[Tjhe prosecution history can often inform the meaning ofthe 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
be." Id.
In some cases,"the district court 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 ofa 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. For instance, technical dictionaries can assist the court in determining the meaning of a
term to those of skill in the relevant art because such dictionaries "endeavor to collect the
accepted meanings ofterms used in various fields of science and technology." Phillips, 415 F.3d
at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of
the technical aspects ofthe patent is consistent with that ofa 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." Id. Nonetheless, courts must not lose sight ofthe 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. Furthermore,"statements made by a patent
owner during an IPR [inter partes review] proceeding ... can be considered for claim
construction." AylusNetworks, Inc. v. Apple Inc., 856 F.3d 1353,1362(Fed. Cir. 2017).
Overall, while 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 ofthe intrinsic evidence." Id. at 1318-19. Where the
intrinsic record unambiguously describes the scope ofthe 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).
Finally,"[t]he construction that stays true to the claim language and most naturally aligns
with the patent's description ofthe invention will be, in the end,the correct construction."
Renishaw PLC v. Marposs Societa'per Azioni, 158 F.3d 1243, 1250(Fed. Cir. 1998). It follows
that"a claim interpretation that would exclude the inventor's device is rarely the correct
interpretation." Osram GmbHv. Int'l Trade Comm% 505 F.3d 1351, 1358(Fed. Cir. 2007)
Modine Mfg. Co. v. U.S. Int'l Trade Comm'n^ 75 F.3d 1545, 1550(Fed. Cir. 1996)).
II.
CONSTRUCTION OF DISPUTED TERMS'
A.
'485 Patent Terms
1.
"kit"2
Roche
"a set ofreagents packaged and sold together"
Meso
"a set of materials for use together"
Court
"a set of materials packaged to be used together'
The parties' proposed constructions differ in three respects:(1) whether the set consists of
reagents or materials,(2) whether the set of reagents or materials needs to be packaged together,
and (3) whether the set of reagents or materials needs to be sold together.
With respect to the first dispute, both parties agree that the claims refer only to reagents
and no other materials. However, Roche also conceded that the distinction is immaterial. {See
Tr. at 15, 31-32) The Court will use materials in its construction.
Turning to the second issue, Roche argues that "the ordinary meaning [ofthe term 'kit']
is a set of materials that are packaged together." {Id. at 13) Meso counters that the set of
materials need only be used together and that nothing in the claims requires the materials also to
be packaged together. {See id. at 17-18) For example, Meso contends that"when all of th[e]
'The Court will adopt the parties' agreed-upon constructions.
^This term appears in claims 1-3, 7,10-16,18-19,21-22, and 24-30 ofthe '485 patent, as
well as claim 2 ofthe '729 patent and claim 2 ofthe '041 patent.
ingredients are assembled [by the end user] per the seller's instructions for the purpose of being
used together, then that would be a kit." {Id. at 27;see also id. at 24) But the Court agrees with
Roche that Meso's position renders the word "kit" meaningless, because the claims already
specify that the materials must be used together. {See id. at 7-8) Meso even concedes that, in its
view, if"a kit" were removed from the claim,"the scope would probably be very similar" -an
outcome the Court believes would be improper. {Id. at 32-33) The Court further agrees with
Roche that it is unnecessary to consider extrinsic evidence because the ordinary meaning of"kit"
to a person of ordinary skill in the art requires that the set of materials is packaged for use
together, and that those materials exist in some known relationship to one another at some
moment prior to the time of use. Although it is an odd result that infringement here may turn on
how the materials are packaged,that is the consequence of how the patentee drafted the claims.
The specification provides additional support for this conclusion. It provides that "[t]he
formation ofthe composition is suitably accomplished with a kit comprising one or more reagent
components necessary for the formulation step" and also identifies the components of"the
overall kit." ('485 patent at 14:12-17) The specification explains why "packaging ingredients
used to formulate the composition in a kit"(or in "kit form")is advantageous: providing
"standardized ingredients" can "improve the reliability and repeatability" ofan ECL assay and
"[u]se ofreagents and other materials in kit form ... offers a way to minimize the possibility of
degradation ofthe ingredients before use," as"a result ofthe kit format's being capable of
structuring so as to avoid combinations in which such degradation might occur." {Id. at 14:1727) The kit is formatted such that "[t]he component[s] ofthe kit is or are typically kept separate
by enclosing each in its own vial so as to eliminate cross-contamination prior to combination."
(Id. at 14:33-36) These advantages ofthe "kit form" would not make sense if a kit were just a set
of materials that an end user can purchase for creation of his own kit at the time of use.
Roche's construction is further supported by the prosecution history, as the patent
examiner allowed the claims after the applicant pointed out that the disclosure ofa kit was not
obvious when there was no reason to form a kit. (See D.I. 75 at 9-10; D.I. 82 at 2; Tr. at 11-13)
Finally, Roche contends that "sold together" was proposed as being inherent in packaging
together for delivery to the customer. (See Tr. at 11) Since Roche concedes that "sold" is not
necessary for the construction, and the Court agrees, the Court will not include "sold" in its
construction.
2.
"consists essentially of
Roche
'485 patent: "the contents of the kit include all ofthe recited reagents and cannot include any
other reagents whose presence would materially affect the basic and novel characteristics of
the claimed kit"
'729 and '041 patents: "the composition includes all ofthe recited reagents and cannot
include any other reagents whose presence would materially affect the basic and novel
characteristics ofthe claimed composition"
Meso
The term "consists essentially of is a legal term of art. The meaning ofthe term is properly
addressed as part ofjury instructions rather than during claim construction.
Alternatively,"including unlisted [[components]
[method steps]] that do not materially affect
the invention." (See American Intellectual Property Law Association's(AIPLA)2017 Model
Patent Jury Instructions)
Court
"including unlisted [components] that do not materially affect the basic and novel
characteristics ofthe claimed invention"
^This term appears in claims 1,11, and 26 ofthe '485 patent, as well as claims 1,9,12,
18, and 24 ofthe '729 patent and claim 1 ofthe '041 patent.
The Court finds that construing this claim now, when it has been fully briefed and argued,
will be helpful to the parties and the Court. There is no need to wait until jury instructions.
At oral argument, Meso stated it could accept "materially affect the basic and novel
characteristics ofthe claimed invention." (Tr. at 49-50) Thus,the only distinction between the
parties' proposed constructions is whether the construction should be one ofinclusion or
exclusion. The parties essentially agree as to what the limitation means, but only disagree as to
how to express it. (See id at 54) The Court concludes that a more inclusive construction is more
appropriate (and helpful) here.
3.
"separate component"'*
Roche
"a separate container in the kit enclosing one or more ofthe specified reagents"
Meso
Plain and ordinary meaning
Alternatively,"a separate item that is part ofthe kit"
Court
"one or more ofthe specified reagents enclosed in a separate contained portion ofthe kit"
The parties agree that the patent teaches that more than one reagent may be combined in a
single container. (See D.I. 75 at 12; D.I. 83 at 8) Their dispute stems from confusion over the
meaning of"component." Roche argues that "component" refers to a "container," while Meso
contends that "component" refers to the material inside the container itself. (See D.I. 75 at 13;
D.I. 76 at 13)
The patent refers to the three reagents as "reagent components" and states that the
''This term appears in claims 2-3, 7,10,and 29 ofthe '485 patent.
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"components" are "typically kept separate by enclosing each in its own vial." ('485 patent at
14:13-14,14:33-35) When the phrase "separate component" is used, the patent appears to be
referring to a contained space in the kit. {See, e.g., id. at 14:28-48)(noting one or two of three
types ofreagents can be included in one ofthree "separate components" depending on structural
format of kit) Any apparent contradiction in the specification as to whether "component" refers
to a reagent itself or the space that contains one or more reagents is resolved by interpreting
"component" or "separate component" as being both, i.e., the combination ofthe reagent(s) and
the space in the kit that it occupies.
B.
'607 Patent Terms
1.
"analyte of interest"^
Roche
"a substance whose presence in a sample is the object of detection in a specific assay"^
Meso
Plain and ordinary meaning
Alternatively,"a substance that is being measured or detected'
Court
"a substance that is being detected, directly or indirectly, and, optionally, also being measured,
directly or indirectly"
After discussing their arguments at the hearing, the parties ultimately agreed to the
following construction:"a substance that is heing detected, directly or indirectly, and, optionally,
also being measured, directly or indirectly." {See Tr. at 75-77) Accordingly,the Court will adopt
^This term appears in claims 6 and 10 ofthe '607 patent, as well as claims 44 and 56 of
the '729 patent.
^In its responsive brief, Roche agreed to change "chemical, hiochemical, or biological
substance" to just "substance." {See D.I. 82 at 8)
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that construction.
2.
"linkage —
between X and
Roche
"linkage —(CH2)m" "the portion ofthe structure ofthe compound, which is directly
covalently bonded to the X and Z substructural portions and bridges X and Z,is an alkylene
group — i.e., ofthe form —(CHj)^— where w is a positive integer"
Meso
"linkage —(CHj)^— between X and Z" -> "a moiety linking X and Z that contains(CHj)^"
Court
"a moiety linking X and Z that contains(CH2)m and,for listed Z choice (1), is formed from the
reaction between X and one ofthe listed A substructures ofZ(l)"
The central dispute between the parties was "whether the linkage must be ofthe form
—(CH2)m—(Roche's position) or whether it need only include —(CH2)m— as one ofits elements
(Meso's position)." (D.I. 75 at 16; see also D.I. 76 at 15) Following the hearing, the parties
agreed on the following construction:"a moiety linking X and Z that contains (CH2)ni and, for
listed Z choice (1), is formed from the reaction between X and one ofthe listed A substructures
ofZ(l)." (D.I. 97) Accordingly, the Court will adopt that construction.
^This term appears in claim 6 ofthe '607 patent.
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3.
"G is a moiety that reacts with a species"®
and "G reacts with a species"^
Roche
"G is a reactive functional group covalently attached to the compound structure as shown in
the claim that reacts to form a covalent linkage between the compound and a species listed in
the claim"
Meso
"G is a component ofthe compound containing at least one reactive functional group attached
to the compound structure as shown in the claim that reacts to form a covalent linkage with a
species from the groups listed in the claim"
Court
"G is a component ofthe compoimd as shown in the claim containing a reactive functional
group that reacts to form a covalent linkage with a species from the groups listed in the claim'
Each ofclaims 14 and 15 ofthe '607 patent claims a compound that has a substructure
that consists of —(CH2)n,—G "wherein G is a moiety that reacts with a species" from a selected
group. Each ofclaims 42 and 44 depends on claims 41 and 43, respectively, and provide that"G
reacts with a species" from a selected group. Claims 41 and 43,like claims 14 and 15, claim a
compound that has a substructure that consists of—(CH2)m—G wherein G must be one of eight
moieties.
The difference between the parties' proposed constructions is that"Roche defines G to be
'a reactive functional group,' whereas Meso defines G to be 'a component ofthe compound
containing at least one reactive functional group.'" (D.I. 75 at 18-19) Roche argues that "the
claim requires that G itselfis the structure that reacts with the species" and,therefore, G is the
reactive functional group. {Id. at 19) Roche further argues that "there is no support for a
®This term appears in claims 14 and 15 ofthe '607 patent.
^"This term appears in claims 42 and 44 ofthe '607 patent.
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construction that permits G to be a component of a compound containing at least one reactive
functional group as part ofsome larger unspecified structure." {Id.)
Meso contends that it "is not arguing that G is a component'ofsome larger unspecified
structure.'" (D.I. 83 at 14) Rather, Meso explains that when a compound reacts with another
substance, it "does so through its reactive functional groups-components that are a portion of
the compound and not necessarily the entire compound itself." {Id. at 15) Similarly, the moiety
G may be a larger moiety "with more than just a single reactive functional group." (D.I. 76 at 19)
In other words, Meso contends that "the moiety G contains, but is not limited to^ a reactive
functional group that forms a covalent linkage with the claimed species through G's reaction
with that species." (D.I. 83 at 15) Meso argues that Roche's construction narrowly limits G to
"only those specific atoms in the claimed compound directly forming a covalent linkage,"
whereas claims 41 and 42 expressly permit G to be a larger moiety that "contains not only the
atoms that participate in reactions with the 'species' ofthe asserted claims but also atoms that are
not required for these reactions." (D.I. 76 at 18-19)
In the Court's view,"a reactive functional group" refers to the chemical structure of a
moiety that directly reacts with the species. Roche's construction seems to narrow the claims to
instances in which G itself is the only reactive functional group, which is incorrect. However,
Meso's proposed construction is confusing, because it refers to G as both "a component ofthe
compound" and as having a group that is "attached to the compound structure." G cannot be
both part ofsomething and have a portion that is attached to that same thing. Thus,the Court
will adopt a modified construction as shown in the table above.
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III.
CONCLUSION
The Court construes the disputed terms as explained above. An appropriate Order
follows.
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