RainDance Technologies Inc. et al v. 10X Genomics Inc.
Filing
351
MEMORANDUM ORDER: Plaintiffs' Motion for Summary Judgment (D.I. 235 ) is GRANTED IN PART and DENIED IN PART, and Defendant's Motion for Summary Judgment of Non-Infringement and Invalidity (D.I. 242 ) is GRANTED IN PART and DENIED IN PART. Signed by Judge Richard G. Andrews on 6/26/2018. (nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BIO-RAD LABO RA TORIES, INC. and
THE UNIVERSITY OF CHICAGO,
Plaintiffs,
Civil Action No. l:15-cv-00152-RGA
V.
1OX GENOMICS , INC.,
Defendant.
MEMORANDUM ORDER
Presently before the Court are Plaintiffs' Motion for Summary Judgment (D.I. 235) and
Defendant's Motion for Summary Judgment of Non-Infringement and Invalidity (D.I. 242). The
issues are fully briefed. (D.I. 236, 243 , 263 , 273 , 289, 290). The Court held oral argument on
February 5, 2018. (D.I. 349). For the reasons set forth below, Plaintiffs' motion and
Defendant's motion are both granted in part and denied in part.
I.
BACKGROUND
On February 12, 2015, RainDance Technologies, Inc. and the University of Chicago filed
suit against 1OX Genomics, Inc. alleging infringement of six patents. (D.I. 1). Plaintiffs refer to
these patents as the Ismagilov patents.
On April 23, 2015 , RainDance and the University of Chicago filed an amended complaint
asserting an additional patent on behalf of RainDance only. (D.1. 12). On March 25 , 2016,
RainDance and the University of Chicago filed a second amended complaint in which they
asserted the RainDance patent and only five of the Ismagilov patents. (D.I. 32). The RainDance
patent was later dismissed. (D.I. 138). On May 30, 2017, Bio-Rad Laboratories, Inc. substituted
for RainDance. (D.I. 180).
The patents-in-suit relate to methods and systems for creating "plugs" in a microfluidic
system and for conducting reactions within those "plugs."
II.
LEGAL STANDARD
"The court shall grant 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 oflaw." Fed.
R. Civ. P. 56(a). The moving party has the initial burden of proving the absence of a genuinely
disputed material fact relative to the claims in question. Celotex Corp. v. Catrett, 477 U.S. 317,
330 (1986). Material facts are those "that could affect the outcome" of the proceeding, and "a
dispute about a material fact is ' genuine ' if the evidence is sufficient to permit a reasonable jury
to return a verdict for the nonmoving party." Lamont v. New Jersey , 637 F.3d 177, 181 (3d Cir.
2011) (quoting Anderson v. Liberty Lobby, Inc., 477 U.S. 242,248 (1986)). The burden on the
moving party may be discharged by pointing out to the district court that there is an absence of
evidence supporting the non-moving party's case. Celotex, 477 U.S. at 323.
The burden then shifts to the non-movant to demonstrate the existence of a genuine issue
for trial. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87 (1986);
Williams v. Borough of West Chester, Pa., 891 F.2d 458, 460-61 (3d Cir. 1989). A non-moving
party asserting that a fact is genuinely disputed must support such an assertion by: "(A) citing to
particular parts of materials in the record, including depositions, documents, electronically stored
information, affidavits or declarations, stipulations ... , admissions, interrogatory answers, or
other materials; or (B) showing that the materials cited [by the opposing party] do not establish
the absence .. . of a genuine dispute ... ." Fed. R. Civ. P. 56(c)(l).
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When determining whether a genuine issue of material fact exists, the court must view
the evidence in the light most favorable to the non-moving party and draw all reasonable
inferences in that party's favor. Scott v. Harris , 550 U.S. 372, 380 (2007); Wishkin v. Potter,
476 F.3d 180, 184 (3d Cir. 2007). A dispute is "genuine" only if the evidence is.such that a
reasonable jury could return a verdict for the non-moving party. Anderson, 477 U.S. at 247-49.
If the non-moving party fails to make a sufficient showing on an essential element of its case
with respect to which it has the burden of proof, the moving party is entitled to judgment as a
matter of law. See Celotex, 477 U.S. at 322.
Ill.
DISCUSSION
A. Plaintiffs' Motion for Summary Judgment
Plaintiffs seek summary judgment on two issues. The first is that Defendant infringes
claims 1, 10, and 11 of U.S. Patent No. 8,329,407 ("the ' 407 patent"). (D.I. 236 at 5). The
second is that the asserted claims of U.S. Patent No. 8,889,083 ("the ' 083 patent") are neither
anticipated nor obvious. (Id.) .
1. Infringement of Claims 1, 10, and 11 of the '407 Patent
As to claim 1 of the '407 patent, Plaintiffs argue there is no dispute that use of
Defendant's products "leads to performance of every single element" of that claim. (Id. at 11).
The parties' briefing focuses on two elements in particular. They are the preamble and step (d).
First, the preamble of claim 1 recites, "A method for conducting a reaction in plugs in a
microfluidic system .. . ." ('407 patent, claim 1). I previously found the preamble limiting
"only to the extent that it provides an antecedent basis for the terms ' microfluidic system' and
'reaction."' (D.1. 116 at 14). I construed "microfluidic system" to mean, "system comprised of
at least one substrate having a network of channels of micrometer dimension through which fluid
may be transported." (Id. at 7).
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Whether use of Defendant's products meets the preamble of claim 1 appears to turn on
whether the method is performed in a "microfluidic system." Plaintiffs' expert, Dr. Sia,
maintains that Defendant's GemCode Long Read product performs reactions in a microfluidic
system: "Specifically, after the reagents necessary for the PHASE reaction are packaged into
droplets, the droplets are collected in a standard Eppendorf tube and placed on a thermal cycler,
which is used to provide the suitable temperature conditions so that the PHASE reaction may
occur." (D.I. 238, Exh. B 1 124). He offers a similar opinion in regard to Defendant' s other
products. (See id.
11 125, 126).
Defendant' s expert, Dr. Huck, on the other hand, opines that
"the barcoding reaction [in Defendant' s products] takes place" during "thermal cycling" (see D.I.
274, Exh. E 1168, 72, 79), and " [t]he thermal cycler [is] not [a] component[] of a microfluidic
system" (id.
1 174).
Given the experts ' disagreement regarding whether the thermal cycler is
part of the "microfluidic system," there is a dispute of material fact as to whether use of
Defendant's products meets the preamble of claim 1.
Second, step (d) of claim 1 provides:
forming at least one plug of the aqueous fluid containing the at least one
biological molecule and the at least one reagent by partitioning the aqueous fluid
with the flowing immiscible carrier fluid at the junction of the at least two
channels, the plug being substantially surrounded by the immiscible carrier fluid
flowing through the channel, wherein the at least one plug comprises at least one
biological molecule and the at least one reagent for conducting the reaction with
the at least one biological molecule[.]
('407 patent, 78 :66-79:8).
Whether use of Defendant' s products meets step (d) appears to boil down to a claim
construction issue. More specifically, the parties seem to dispute whether the phrase, "the plug
being substantially surrounded by the immiscible carrier fluid flowing through the channel,"
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requires that the biological reaction occur in "the at least one plug" while "flowing through the
channel." (See D.I. 236 at 24- 27; D.I. 273 at 11-17).
The parties did not raise the disputed phrase in their joint claim construction brief.
Accordingly, I did not construe it in my Markman opinion. However, in deciding whether the
preamble of claim 1 was limiting, I stated that "it is clear that the reaction in question takes place
' in the at least one plug."' (D.I. 116 at 13- 14). I further stated, "Nothing in the body of the
claims further limits the location of the reaction." (Id. at 14). Thus, I did not conclude that the
claims limit the reaction to the "channel." In any event, I do not think the language upon which
Defendant now relies requires that the reaction take place in the plug while "flowing through the
channel." I think Defendant' s reading is too limiting. The plain reading of the disputed
language is that when the "at least one plug" is formed, it is "substantially surrounded by the
immiscible carrier fluid flowing through the channel."
While I decline to adopt Defendant' s construction, I will deny Plaintiffs' motion as to
claim 1 of the '407 patent because there is a dispute of material fact as to the outer limits of the
"microfluidic system" in the preamble. Similarly, I will deny Plaintiffs' motion as to claims 10
and 11. Claim 10 depends from claims 1, 8, and 9, and claim 11 depends from claims 1 and 8.
Thus, Plaintiffs' motion as to claims 10 and 11 depends in part on their arguments in regard to
the preamble of claim 1.
Accordingly, Plaintiffs' motion for summary judgment is DENIED as to claims 1, 10,
and 11 of the '407 patent.
2. Anticipation and Obviousness of the '083 Patent
Plaintiffs seek "summary judgment that the ' 083 patent is not invalid as anticipated or
obvious in view of estoppel arising from lOX' s failed attempt to invalidate the ' 083 patent in
inter partes review (' IPR')." (D.I. 236 at 30).
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I adopt my ruling in regard to IPR estoppel from the discovery conference held on
September 6, 2017. (See D.I. 224 at 29:11- 14; see also id. at 28:1- 21). In light of that ruling,
Plaintiffs' motion is GRANTED as to the asserted claims of the ' 083 patent. Defendant' s right
to appeal is preserved.
B. Defendant's Motion for Summary Judgment
Defendant seeks summary judgment of non-infringement of the ' 083 patent and U.S.
Patent Nos. 8,822,148 ("the ' 148 patent") and 7,129,091 ("the ' 091 patent"). (See D.I. 243). It
further seeks summary judgment of invalidity of claim 1 of the '407 patent. (See id.).
1. Non-Infringement of the '083 Patent
Defendant argues there is no dispute its microfluidic chips do not literally infringe the
' 083 patent because they contain fluorine. (See id. at 10). In other words, they do not meet the
patent' s requirement of a "non-flourinated microchannel." As Defendant points out, I previously
construed "non-flourinated microchannel" to mean, "microchannel that is not composed of a
material that includes fluorine atoms or that is treated to include fluorine atoms at its surface
(excluding the possible inclusion of impurities or contaminants)." (D.I. 116 at 16).
Defendant maintains, "To eliminate any dispute over the ' 083 patent, 1OX redesigned its
microfluidic chips to include fluorine." (D.I. 243 at 10). More specifically, "as of August 2017,
all current lOX products utilize microfluidic chips that include 0.02% Kynar 720 (polyvinylidene
fluoride). " (Id. (citation omitted)). According to Defendant, the fluorine in its products is not a
"contaminant" or an "impurity" because Defendant "intentionally included" it in its chips. (Id.
(emphasis omitted)). As support, Defendant cites excerpts from the Markman hearing. (See id.;
see also D.I. 349 at 49:14- 18).
Defendant' s reliance on what I said at the Markman hearing is unavailing. During
colloquy at that hearing, there was some discussion of "accidental impurities or [] impurities that
6
are perhaps known to exist, but are hard to get rid of." (See D.I. 105 at 115:2-4; see also id. at
111 :24-113 : 16). I did not define the words "impurity" or "contaminant" in my Markman
opinion, however.
In any event, there seems to be a dispute as to whether the 0.02% Kynar in Defendant' s
products is properly understood to be an impurity or a contaminant. Defendant' s expert, Dr.
Huck, opines that "a person of ordinary skill in the art would not have viewed intentionallyadded 0.02 % Kynar 720 as an impurity or contaminant." (D.I. 241 , Exh. 2 ,i 361). Plaintiffs'
expert, Dr. Sia., on the other hand, opines, "Such a trace amount of this additive is properly
characterized as no more than a ' contaminant' or an ' impurity,' which the Court's claim
construction exempts." (D.I. 238, Exh. B ,i 299). Thus, there is a genuine dispute of material
fact as to whether Defendant' s products literally infringe the "non-flourinated microchannel"
limitation in light of the way I have construed that term.
Defendant additionally moves for summary judgment of non-infringement under the
doctrine of equivalents. (See D.I. 243 at 10- 15). The core of Defendant's argument is that
prosecution history estoppel bars Plaintiffs from asserting infringement under that doctrine. (See
id. at 10). More specifically, Defendant maintains, "The ' non-flourinated' limitation was added
during prosecution of the application that resulted in the '083 patent to overcome the examiner' s
prior art rejection." (Id. at 11). It argues "the presumption of total surrender clearly applies"
because the "non-flourinated amendment narrowed the literal scope of the claim by altering the
claimed subject matter from encompassing all types of microchannels to only non-flourinated
microchannels." (Id. at 12 (emphasis omitted)). Defendant contends that Plaintiffs have failed
to rebut that presumption. (Id. at 13).
I disagree.
7
Under the Festa doctrine, the presumption that the patentee "surrendered all territory
between the original claim limitation and the amended claim limitation" applies where the
amendment "narrowed the literal scope of a claim" and was "made for a substantial reason
relating to patentability." Festa Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359,
1366-67 (Fed. Cir. 2003). The patentee may overcome the presumption of total surrender in
three ways. Id. at 1368. "Specifically, the patentee must demonstrate that the alleged equivalent
would have been unforeseeable at the time of the narrowing amendment, that the rationale
underlying the narrowing amendment bore no more than a tangential relation to the equivalent in
question, or that there was ' some other reason' suggesting that the patentee could not reasonably
have been expected to have described the alleged equivalent." Id. "Questions relating to the
application and scope of prosecution history estoppel [] fall within the exclusive province of the
court." Id.
Here, as a threshold matter, it seems clear to me that the presumption of total surrender
applies. The patentee in this case narrowed the scope of the claims by adding, among other
things, the term "non-flourinated" before "microchannel" in order to overcome the patent
examiner' s rejection in light of prior art references Quake and Ramsey. (See D.I. 247, Exh. K,
pp. 2, 7-8). Thus, the patentee narrowed the literal scope of the claims for a substantial reason
relating to patentability. See Festa, 344 F.3d at 1366-67.
In my opinion, however, Plaintiffs have overcome the presumption by demonstrating that
"the rationale underlying the narrowing amendment [bore] no more than a tangential relation to
the equivalent in question. " See id. at 1369 (alteration in original) (citation omitted). That
"criterion asks whether the reason for the narrowing amendment was peripheral, or not directly
relevant, to the alleged equivalent." Id. " [T]he inquiry into whether a patentee can rebut the
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Festo presumption under the 'tangential ' criterion focuses on the patentee's objectively apparent
reason for the narrowing amendment." Id. " [A]n amendment made to avoid prior art that
contains the equivalent in question is not tangential; it is central to allowance of the claim." Id.
In this case, in responding to the examiner' s prior art rejection and amending the claims,
the patentee wrote:
Quake reports that surfactants, such as a fluorinated oil, may be used in an
extrusion fluid (column 24, lines 18-20). Quake reports that the extrusion fluid
may coat the channel walls (column 19, lines 9-49). Coating channel walls with
an extrusion fluid that includes a fluorinated oil does not disclose or suggest the
elements of the amended claims of a non-flourinated microchannel, and a carrier
fluid including a fluorinated oil and a fluorinated surfactant having a hydrophilic
head group in the microchannel.
(D.I. 247, Exh. K, pp. 7-8).
It seems clear to me that the patentee, by amending the claims to require "a nonflourinated microchannel," sought to distinguish the "microchannel" in its system from the
channels described in Quake, which may be "coated with .. . surfactants, TEFLON, or
fluorinated oils" (id. , Exh. A 1 118) in order to "prevent material ... from adhering to the sides
of the channels" (id. 194). In other words, I think what Plaintiffs surrendered through their
amendment are "microchannel[s]" "coated" with fluorine for a purpose-not those containing de
minirnis amounts of fluorine that have no effect on how the "microchannel" functions in the
system. Nowhere in the Quake reference do I see the equivalent in question. Because I conclude
the reasons for the amendment bore no more than a tangential relation to the equivalent at issue, I
need not address Plaintiffs' argument that the equivalent was not foreseeable at the time of the
amendment. (See D.I. 263 at 13).
9
Defendant additionally argues, "Even if the Court were to find that prosecution history
does not apply, Plaintiffs still would be barred by the principle of ' specific exclusion' from
arguing infringement under the [doctrine of equivalents]." (D.1. 243 at 14).
Under Federal Circuit law, a patentee is barred from asserting infringement under the
doctrine of equivalents where the patentee "defin[ es] the claim in a way that clearly exclude[ s]
certain subject matter, [thereby] ... implicitly disclaim[ing] the subject matter that was
excluded." SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1346
(Fed. Cir. 2001 ). Thus, as the Federal Circuit has explained, "if a patent states that the claimed
device must be 'non-metallic,' the patentee cannot assert the patent against a metallic device on
the ground that a metallic device is equivalent to a non-metallic device." Id. at 1347.
Accordingly, Plaintiffs may not assert the ' 083 patent, which claims a "non-flourinated
microchannel," against a product containing a "fluorinated microchannel." As discussed above,
however, there is a dispute of material fact as to whether the microchannels in Defendant' s
products are properly understood to be "fluorinated. "
Finally, Defendant argues its products do not infringe the '083 patent because they
"lack[] a 'plug-fluid/microchannel wall interface,' as required by the claims." (D.I. 243 at 15).
According to Defendant, "Because the droplets formed in 1OX' s systems are completely
surrounded by oil, the droplets . . . never touch the microchannel wall." (Id. (citation omitted)).
Plaintiffs respond, "Nothing in the claims of the '083 patent requires the plug-fluid to be in
actual physical contact with the microchannel walls." (D.I. 263 at 14).
I agree with Plaintiffs.
As Plaintiffs point out, the claims require only that "the fluorinated surfactant is present
at a concentration such that surface tension at the plug-fluid/microchannel wall interface is
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higher than surface tension at the plug-fluid/carrier fluid interface." ('083 patent, 73 :18-21).
Thus, the focus in the claims is on the difference between the surface tensions at the two
interfaces, not on any physical contact between the plug-fluid and microchannel wall or between
the plug-fluid and carrier fluid. I see no support for Defendant' s attempt to limit the claims so as
to require direct contact. Defendant' s reading is too narrow. Thus, I cannot conclude as a matter
oflaw that Defendant's products do not infringe the ' 083 patent as to the "plugfluid/microchannel wall interface" limitation in the claims.
For the reasons stated above, Defendant's motion is DENIED as to the ' 083 patent.
2. Non-Infringement of the '148 Patent
Defendant seeks summary judgment of non-infringement of the '148 patent.
First, Defendant seeks summary judgment of non-infringement as to its Gem Code Long
Read product. (See D.I. 243 at 16- 17). In their opposition, Plaintiffs state they "do not dispute
that under the Court' s construction of the term ' target sequence,' 1OX' s Gem Code Long Read
product will not infringe the ' 148 patent. Plaintiffs[] reserve their right to challenge the Court' s
claim construction on appeal." (D.I. 263 at 16 n.6). Accordingly, Defendant's motion for
summary judgment of non-infringement of the ' 148 patent is GRANTED as to its GemCode
Long Read product.
Second, Defendant argues that its Chromium Genome/Exome product does not literally
infringe claim 1 of the ' 148 patent because the "Landlord" reaction "does not include a step in
which ' strands of DNA are denatured to form single-strand templates."' (D.I. 243 at 17-18).
Similarly, it argues there is no dispute its product does not infringe under the doctrine of
equivalents. (Id. at 20-22). According to Defendant, "Plaintiffs have not proffered any evidence
of how the results of Landlord reaction and [polymerase chain reaction] are the same." (Id. at 21
(emphasis omitted)).
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According to Defendant's expert, Dr. Quackenbush, the Landlord reaction constitutes
strand displacement, not denaturation. (D.I. 247, Exh. C 1221). He opines that "displacement
activity is distinct from denaturation in which heat .. . is used to separate entire double-stranded
DNA molecules." (Id. 1223). As support, Dr. Quackenbush cites various textbooks that
purportedly distinguish between strand denaturation and displacement. (Se e id.
1 225).
But none
seem to state that strand displacement is not denaturation. Plaintiffs' expert, Dr. Sia, on the other
hand, maintains that strand displacement is a form of denaturation. (See D.I. 238, Exh. B 11253 ,
452, 455 ; see also id. 11241- 55 (explaining why Landlord is a polymerase chain reaction)).
I think Defendant is essentially asking that I construe what the various textbooks cited by
Dr. Quackenbush say in regard to displacement and denaturation. But none of the excerpts to
which he cites are directly on point. It seems to me that whether strand displacement is in fact a
form of or equivalent to denaturation will be a battle of the experts at trial. Accordingly,
Defendant' s motion for summary judgment of non-infringement of the ' 148 patent is DENIED
as to its Chromium Genome/Exome product.
3. Non-Infringement of the '091 Patent
Defendant argues its products do not literally infringe the ' 091 patent because they do not
meet the requirement that "each plug comprises both the first and second plug-fluids so that the
reaction of the reagents substantially occurs in the plug." (See D.I. 243 at 22 (emphasis
omitted)). According to Defendant, "there is no dispute that at least some of the GEMS formed
in a 1OX instrument run do not contain a gel bead," and thus a reaction does not occur in every
GEM. (Id. at 23 (emphasis omitted)). As support for its position that "each" means "each and
every," Defendant cites statements I made at the Markman hearing. (Id. at 22).
In my opinion, Defendant is attempting to reargue its position from the Markman stage in
regard to the meaning of the word "each." Its reliance on statements I made during the hearing is
12
unavailing. While I declined to construe the word "each" in my Markman opinion, I stated, "I
think it is apparent from the claim language that the phrase ' each plug-fluid' is not meant to
include every plug-fluid in the Universe without expressly including such a limitation in the
construction of this term." (D.I. 116 at 19). I found no construction was necessary for the word
"each," "with the understanding that ' each' refers only to the plugs and plug-fluids in the claim
at issue and not plugs and plug-fluids generally." (Id. at 19- 20). Again, I decline to adopt
Defendant's narrow reading of the claims.
Defendant further seeks summary judgment of non-infringement of the ' 091 patent under
the doctrine of equivalents. (D.I. 243 at 25- 26).
Having reviewed the briefing and evidence presented by the parties, I conclude there is a
dispute of material fact as to whether Defendant's products infringe the ' 091 patent under that
doctrine. (Compare D.I. 238, Exh. B (Sia Report) ,i,i 202-03 , with D.I. 247, Exh. F (Huck
Report) ,i,i 301-02). I am not persuaded by Defendant's argument that summary judgment is
warranted as to infringement under the doctrine of equivalents because Dr. Sia "did not properly
consider whether l0X' s system was truly equivalent to the system described in the ' 091 patent
claims." (D.I. 243 at 26).
For the reasons stated above, Defendant's motion is DENIED as to the ' 091 patent.
4. Anticipation of the '407 Patent
Finally, Defendant seeks summary judgment of invalidity of claim 1 of the '407 patent on
the basis that the Quake reference "discloses all of the steps of claim 1." (D.I. 243 at 26-27). As
support, Defendant primarily relies upon paragraph [0170] of that reference. (See id. at 33 ("The
method of conducting reactions in droplets described in paragraph [0170] satisfies the disputed
limitations of claim 1 of the ' 407 patent. Accordingly, claim 1 . .. is invalid as anticipated by
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Quake ."); see also id. at 29- 32). Defendant criticizes Dr. Sia for failing to mention paragraph
[0170] anywhere in his report. (Id. at 31 ; see D.I. 349 at 118: 1- 11).
Having reviewed the briefing and the evidence presented by the parties, I conclude there
are material facts in dispute as to whether Quake anticipates claim 1 of the ' 407 patent.
(Compare, e.g., D.I. 247, Exh. X (Chang Report) ,i,i 301-04, with, e.g., D.I. 264, Exh. 17 (Sia
Rebuttal Report) ,i,i 87- 89). I will not grant summary judgment to Defendant on the basis that
Dr. Sia did not respond to Defendant's expert' s discussion of paragraph [0170] buried in a 1600page report.
Accordingly, Defendant's motion is DENIED as to the ' 407 patent.
IV.
CONCLUSION
For the foregoing reasons, Plaintiffs' Motion for Summary Judgment (D.I. 235) is
GRANTED IN PART and DENIED IN PART, and Defendant's Motion for Summary
Judgment of Non-Infringement and Invalidity (D.I. 242) is GRANTED IN PART and DENIED
IN PART.
It is SO ORDERED this 7bday of June 2018 .
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