Board of Regents, The University of Texas System et al v. Boston Scientific Corporation

Filing 255

MEMORANDUM OPINION re claim construction. Signed by Judge Gregory B. Williams on 11/17/22. (ntl)

Case 1:18-cv-00392-GBW Document 255 Filed 11/17/22 Page 1 of 21 PageID #: 11501

IN THE UNITED STATES DISTRJCT COURT
FOR THE DISTRJCT OF DELAWARE
BOARD OF REGENTS, THE UNIVERSITY
OF TEXAS SYSTEM and TISSUEGEN, Inc.
Plaintiffs,
Civil Action No. 18-392-GBW
V.

BOSTON SCIENTIFIC Corp.
Defendant.

Stamatios Stamoulis, STAMOULIS & WEINBLATT LLC, Wilmington, Delaware; Michael W.
Shore, Alfonso G. Chan, Chijioke E. Offor, SHORE CHAN DEPUMPO LLP, Dallas, Texas;
Brian D. Melton, John P. Lahad, Corey M. Lipschutz, SUSMAN GODFREY LLP, Houston,
Texas

Counsel for Plaintiffs
Brian E. Farnan, Michael J. Farnan, FARNAN LLP, Wilmington, Delaware; Chad Drown,
Timothy E. Grimsrud, Katherine S. Razavi, Lauren J.F. Barta, FAEGRE DRJNKER BIDDLE &
REATH LLP, Minneapolis, Minnesota; David J.P. Gross, FAEGRE DRINKER BIDDLE &
REATH LLP, East Palo Alto, California; Christopher J. Burrell, FAEGRE DRINKER BIDDLE
& REATH LLP, Washington, D.C. ; Melissa A. Anyetei, James R. Ferguson, Michael J. Word,
MA YER BROWN LLP, Chicago, Illinois

Counsel for Defendant

MEMORANDUM OPINION
November 17, 2022
Wilmington, Delaware

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GREGORYB . WILLIAMS
UNITED STATES DISTRICT JUDGE
Plaintiffs TissueGen, Inc. ("TissueGen") and the Board of Regents, the University of
Texas System (collectively, "UT") allege that Defendant Boston Scientific Corp. ' s ("BSC")
"Synergy" brand coronary stents (the "Accused Products") infringe claims 1, 11 , 12, 17, and 26
(the "Asserted Claims") of U.S . Patent No. 6,596,296 ("the ' 296 patent"). D.I. 124 ,r,r 1-3, 79.
Before the Court is BSC' s renewed request for claim construction as to "polymer fiber." D.I.
200 at 13 ; D.I. 243 at 7. The Court has considered the parties' joint claim construction brief, D.I.
245, and held a Markman hearing on November 7, 2022 ("Tr._"). For the reasons below, the
Court declines to construe "biodegradable polymer fiber"; construes "fiber" rather than "polymer
fiber"; and construes "fiber" as having its plain and ordinary meaning to a person of ordinary
skill in the art ("POSA"), which is "a thread-like structure of any length or shape."
I.

BACKGROUND
On November 20, 2017, UT filed suit against BSC for infringement of the '296 patent

and an additional patent no longer at issue. D.I. 1 at 1; D.I. 56 at 1. On April 15, 2021 , the
Court announced four agreed upon constructions(*) and two disputed constructions:

Term

Construction

"first phase"*

"the polymer portion of the fiber"

"second phase"*

"the discrete drug-containing regions dispersed
throughout the fiber"
"incapable of dissolving into one another"
plain and ordinary meaning
not indefinite; plain and ordinary meaning

"immiscible"*
"fiber"
"the first and
second phases
being immiscible"
"radioactive
agent"*

"an agent that pertains to, exhibits, or is caused by an
element that spontaneously emits radiation resulting
from changes in the nuclei of atoms of the elements"

1

Citations ('296
Patent)
Claims 1, 11 ,
12, 16, 17, & 26
Id.
Id.
Id.
Id.

Claim 12

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D.I. 90 at 1-2. As to the "fiber" term, the Court provided the following explanation of its ruling:
I agree with [UT] that "fiber" need not be construed beyond its plain and ordinary
meaning. The patent uses the term fiber repeatedly throughout and used the term
according to its plain and ordinary meaning. The fibers described can be different
lengths including very short. [(See, e.g., D.I. 1-1 at 6:63-7:14, 7:24-32; id. at
Figs. 1, 2, 3A, 3B, 6, 7).] They may be, but need not be, woven into support
structures[,] [(See, e.g., id. at 8:41-45)][,] and may be used as drug delivery
reservoirs with metal stents, [(See, e.g., id. at 22:40-51 (ex. 7))][,] or they may be
attached directly to vessel walls or tacked down in the eye[,] [(See, e.g., id. at
23:31-54 (ex. 10))]. These fibers may be made by various solvent exchange
methods. [(See, e.g., id. at 17:36-19:36 (ex. 1), 19:37-20:5 (ex. 2), 20:6-36 (ex.
3), 25:13-31 (ex. 15), 25:32-49 (ex. 16)).]
[BSC] does not disagree with any of that. Instead, [BSC] contends that I should
construe fiber because the parties have raised a dispute regarding the scope of the
claim. As I probed the issue today during argument, it seemed like the real
dispute is not over whether a fiber is threadlike as in [BSC]'s proposed
construction, but rather whether the term "fiber" can encompass what [BSC] says
is a coating. As I understand the issue based on what I have before me, that does
not appear to be an issue of claim construction but rather is an issue of fact as to
whether a coating that covers some structure can itself be a fiber that must also
meet the other requirements of the claim fiber. If, however, it turns out that I'm
wrong about that and[,] as the record develops[,] [it] really is a claim construction
dispute, [BSC] can raise the issue again in connection with summary judgment
briefing to the extent appropriate.
D.I. 90 at 5-6.
On September 17, 2021 , UT filed the operative complaint, UT' s First Amended
Complaint for Patent Infringement (D.I. 124, the "Complaint"). On August 30, 2022, BSC filed
its Answer to the Complaint, denied UT' s infringement allegations, and asserted defenses and
counterclaims of invalidity for, among others, lack of written description. D.I. 238 at 23-25 .
On June 14, 2022, BSC filed a Motion for Summary Judgment ofNoninfringement. D.I.
198. In its briefing on that motion, BSC argued that "the developed record ... has clearly
revealed that there is a dispute between the parties as to the meaning of the term 'polymer fiber'
and not just its factual application." D.I. 200 at 13 (cleaned up). UT argued that the Court need
not construe "fiber" because "[b ]oth parties agree that a fiber must have a high aspect ratio and a

2

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small cross-section" and because BSC was asking "the Court to import new limitations" into the
definition of"polymer fiber. " D.I. 214 at 15. On October 6, 2022, the Court denied BSC's
summary judgment motion because "the parties have a genuine dispute of material fact
regardless of how the Court would construe the term ' fiber ' or ' polymer fiber ' .... " D.I. 243 at
7. However, the Court explained, " [s]ince BSC continues to insist that the Court' s prior claim
construction of plain and ordinary meaning was incorrect, the Court will treat BSC' s briefing
here as a motion for claim construction as to the term ' polymer fiber. "' D.I. 243 at 7.
BSC argued in its summary judgment briefing that
[t]he accused [BSC] Synergy stents are composed of (1) a platinum chromium
metal stent having a number of linked, serpentine rings, and (2) a drug-eluting
biodegradable coating that is applied to the outside (abluminal) surface of the metal
stent. The biodegradable coating includes a polymer (poly-lactic-co-glycolic acid
("PLGA")) and a drug (everolimus). As shown, the coating applied to the Synergy
stents includes "PLGA-rich domains" and "drug-rich domains." When it is applied
to the metal stent, the coating solution includes the drug everolimus, the polymer
PLGA, and solvents.
D.I. 200 at 9 (citations omitted). UT did not dispute that description. D.I. 214 at 8 (explaining
that "there is no true dispute" regarding those characteristics of the Accused Products).
"Polymer fiber" and "biodegradable polymer fiber" appear only in Claim 1 of the
Asserted Claims:
1. A composition comprising at least one biodegradable polymer fiber wherein
said fiber is composed of a first phase and a second phase, the first and second
phases being immiscible, and wherein the second phase comprises one or more
therapeutic agents.
D.I. 1-1 at 27:54-29:14 (emphases added).
BSC argues that a POSA "would understand the claimed ' polymer fiber ' to have its
ordinary and customary meaning of "a thread-like or filamentous polymer structure that at least
includes common orientation of the polymer molecules." D.I. 245 at 1. UT responds that "[a]

3

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[POSA] reading the '296 patent in 1999 would have understood the claimed 'biodegradable
polymer fiber' means 'a fiber capable of releasing drug slowly, in a controlled manner over time
as the polymer breaks down chemically and mechanically in animal or human tissue."' D.I. 245
at 5. UT adds that a "fiber" is "a three-dimensional format having a small cross section and
length much greater than its width." D.I. 245 at 15. BSC responds that the Court should decline
to construe "fiber" or "biodegradable polymer fiber" because UT's request failed to comply with
the Court's order as to this Markman hearing. D.I. 245 at 13 .

II.

LEGAL STANDARDS
"' [T]he 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) (en bane) (citation
omitted); Aventis Pharms. Inc. v. Amino Chemicals Ltd., 715 F.3d 1363, 1373 (Fed. Cir. 2013)
(same). "(T]here is no magic formula or catechism for conducting claim construction." Phillips,
415 F.3d at 1324. The Court is free to attach the appropriate weight to appropriate sources "in
light of the statutes and policies that inform patent law." Id. The ultimate question of the proper
construction of a patent is a question of law, although "subsidiary factfinding is sometimes
necessary." Teva Pharm. USA, Inc. v. Sandoz, Inc. , 574 U.S. 318, 326-27 (2015) (citing

Markman v. Westview Instruments, Inc. , 517 U.S. 370,372 (1996)).
"The words of a claim are generally given their ordinary and customary meaning as
understood by a person of ordinary skill in the art when read in the context of the specification
and prosecution history." 1 Thorner v. Sony Comput. Entm 't Am. LLC, 669 F.3d 1362, 1365 (Fed.

1

"Strictly speaking, the specification includes both the written description and the claims. In
common parlance, however, ' specification' is used to refer only to the written description
component of a patent." Tun-Jen Chiang & Lawrence B. Solum, The Interpretation-Construction
Distinction in Patent Law, 123 Yale L.J. 530, 538, n.17 (2013). The Court will endeavor to use
"written description" where intended in the "Discussion" section of this Memorandum Opinion.
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Cir. 2012) (citing Phillips, 415 F.3d at 1312- 13); Unwired Planet, LLC v. Apple Inc. , 829 FJd
1353, 1358 (Fed. Cir. 2016) (similar). The "'only two exceptions to this general rule"' are (1)
when a patentee defines a term or (2) disavowal of "' the full scope of a claim term either in the
specification or during prosecution."' Thorner, 669 F.3d at 1365 (citation omitted).
The Court "'first look[s] to, and primarily rel[ies] on, the intrinsic evidence,"' which
includes the claims, written description, and prosecution history and " 'is usually dispositive."'

Personalized Media Commc 'ns, LLC v. Apple Inc., 952 F.3d 1336, 1340 (Fed. Cir. 2020)
(citation omitted). "[T]he specification ' . .. is the single best guide to the meaning of a disputed
term. " ' Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334, 1340 (Fed. Cir. 2016)
(citation omitted). " ' [T]he specification may reveal a special definition given to a claim term by
(

the patentee that differs from the meaning it would otherwise possess. ' When the patentee acts
as its own lexicographer, that definition governs." Cont '! Cirs. LLC v. Intel Corp., 915 F.3d 788,
796 (Fed. Cir. 2019) (quoting Phillips, 415 F.3d at 1316). However, " ' [the Court] do[es] not
read limitations from the embodiments in the specification into the claims."' Master Mine

Software, Inc. v. Microsoft Corp. , 874 F.3d 1307, 1310 (Fed. Cir. 2017) (citation omitted)). 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).
The 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), aff'd, 517 U.S . 370;
Cont '! Cirs., 915 F.3d at 796 (same). The prosecution history may '" demonstrat[e] how the
inventor understood the invention and whether the inventor limited the invention in the course of
prosecution . ... " SpeedTrack, Inc. v. Amazon.com, 998 F.3d 1373, 1377 (Fed. Cir. 2021)
(quoting Phillips, 415 F.3d at 1317).

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The Court may "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, 574 U.S. at 331. "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; Phillips,
415 F.3d at 1317 (same). Extrinsic evidence may be useful, but it is "less significant than the
intrinsic record in determining the legally operative meaning of claim language." Cont 'l Cirs. ,
915 F.3d at 799 (internal quotation marks and citations omitted). However, "[p]atent documents
are written for persons familiar with the relevant field . . . . Thus resolution of any ambiguity
arising from the claims and specification may be aided by extrinsic evidence of usage and
meaning of a term in the context of the invention." Verve, LLC v. Crane Cams, Inc. , 311 F .3d
1116, 1119 (Fed. Cir. 2002); see Nautilus, Inc. v. Biosig Instruments, Inc. , 572 U.S. 898, 899
(2014) (explaining that patents are addressed "to those skilled in the relevant art").

III.

CONSTRUCTION OF DISPUTED TERMS
The Court construes "fiber" rather than "polymer fiber." The Court finds that "fiber"

takes its plain and ordinary meaning to a POSA, which is "a thread-like structure of any length or
shape." The Court declines UT's request that it construe "biodegradable polymer fiber" as
untimely and unnecessary.

A. Construction of "Fiber"
BSC argues that "polymer fiber" is "a term of art with a well understood meaning." D.I.
245 at 11. UT counters that the invention describes a "fiber format" and that "'polymer fiber' is
not a term of art .. .. " D.I. 245 at 5. The Court finds that it should construe "fiber."
Claim 1 claims a "composition comprising at least one biodegradable polymer fiber
where saidfiber is composed .... " D.I. 1-1 at 27:54-55 (emphases added). Claim 2 claims the
6

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composition of Claim 1 wherein the "second phase is derived from .. . a hydrogel or polymer[,]"
and Claims 3 and 4 claim the composition of Claim 1 "where said fiber" either "forms a
scaffold" or "is woven . .. with other fibers . ... " D.I. 1-1 at 27:59-65 . The claims, thus, clarify
that the relevant structure is a "fiber," while "polymer" describes a material used to create a
"fiber." See D.I. 1-1 at 29: 15- 30:7 (independent claims with "fibers," not "polymer fibers").
The written description supports this understanding. The ' 296 patent regularly invokes a
"biodegradable polymer fiber." See, e.g. , D.I. 1-1 at 2:44, 4:33 , 4:59, 5:13-14, 5:23-25. It also
separately defines "biodegradable" as "over time it will break down both chemically and
mechanically." D.I. 1-1 at 1:49-51. Thus, the patent modifies "fiber" with "biodegradable," a
term with its own meaning in the art. The patent uses "biodegradable," see, e.g. , D.I. 1-1 at
1:10-11 (implants), 4:52 (polymer), 10:5-6 (polymer matrices), and "polymer," see, e.g. , D.I. 11 at 1:42 (scaffold), 2:23 (matrix), 3:50 (layers), similarly, to modify nouns aside from "fiber. "
Thus, "polymer" also has an independent meaning in the art. See also D.I. 1-1 at 9:64--10:9
(giving "examples of a class of biodegradable polymer matrices that may be used in this
invention"). Lastly, the ' 296 patent clarifies that polymer fibers ' capability for "the controlled
delivery of therapeutic agents" over time, D.I. 1-1 at 2:44--45 , is not a characteristic of the
"polymer fiber," but, rather, follows from the use of different polymer types, therapeutic agents,
and coatings in the invention, see, e.g. , D.I. 1-1 at 2:63-65 (controlling "[t]emporal distribution"
with "polymer composition"), 9:10-35 (using polymer coatings with different release kinetics).
The Court finds that it should construe "fiber. " UT asks that the Court construe "fiber" to
take its ordinary meaning. UT first argues that the ordinary meaning of "fiber" is " (a] volume of
matter having a small cross section and a length at least 100 times greater than its width or
diameter[.]" D.I. 245 at 5. However, after BSC explained that UT's expert, Dr. William Pitt,

7

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contradicted UT's proposal, D.I. 245 at 13 ; see also D.I.246-22131(e) (opining that, where the
"length-to-width ratio" exceeds "50[,]" the "polymeric compositions fit the definition of fiber, in
the plain and ordinary definition"), UT argued that "'fiber ' is a term of art understood as a threedimensional format having a small cross section and length much greater than its width[,]" D.I.
245 at 15. BSC takes issue with any "meaning of polymer fiber limited to a single characteristic
of shape .... " D.I. 245 at 13. For the reasons below, the Court finds that the plain and ordinary
meaning of fiber to a POSA is "a thread-like structure of any length or shape." 3
i. Intrinsic Evidence
The Court " 'first look[s] to, and primarily rel[ies] on, the intrinsic evidence ... , which is
usually dispositive. '" Personalized Media Commc 'ns, 952 F.3d at 1340 (citation omitted).
While the ' 296 patent describes some thread-like embodiments, it does not define "fiber."
BSC argues that " [t]he ' 296 patent consistently describes a polymer fiber as being a
' strand,' a 'filament,' or a ' monofilament. "' D.I. 245 at 2 (citing D.I. 1-1 at 8:51-58, 17:55-57).
The written description explains that one illustrative embodiment is a "Three Dimensional Fiber
Matrix." D.I. 1-1 at 8:32. To make the matrix, "therapeutic agents are encapsulated into
individual fibers of the matrix"; in that embodiment, "filaments could be formed into a unique
scaffold that provides a growth substrate for tissue repair" and "it is possible to incorporate
strands that will induce the formation of blood vessels into the fabric. " D.I. 1-1 at 8:51-58. The
nouns "filament" and "strand" do not appear in the specification outside of this single

3

UT has previously conceded the potential advantages of a construction of "fiber" as "threadlike." During the first Markman hearing, the Court proposed to construe "fiber" as "threadlike,
but ... [it] is not imputing any particular size, length .. . ." D.I. 89 at 8:13-16. UT, by way of
its counsel, responded that the Court' s proposal "would make sense" but expressed concern that
the Court was reading an unnecessary "limitation into the claims." D.I. 89 at 8:17-21; see
also D.I. 89 at 10:12-15 (" [The Court' s proposed definition of "threadlike"] does give ... a
vision of the structure that you' re looking at .. .. [But] we do not believe that it is an accurate
depiction.").
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embodiment. In one of 17 examples of "preferred embodiments of the invention[,]" the written
description explains that a POSA should create an "aqueous emulsion" of two solutions, and it
gives a specific ratio that is "most typical for monofilament [poly(L-lactic acid)] fibers." D.I. 11 at 17:26, 17:55-57. The word monofilament does not recur anywhere else in the specification.
Additionally, the word thread appears nowhere in the '296 patent.
BSC further points out that "[t]he figures of the '296 patent[] show polymer fibers as
thread-like or filamentous structures, where the fibers are labeled numerals 21-28[.]" D.I. 245 at
2. BSC points in its briefing to Figures 1, 2, and 3a. D.I. 245 at 2. The written description
explains that each figure shows fibers arranged either in scaffolding or so as to support a "tubular
body," such as an artery or vein. D.I. 6:63-7:14. The figures show the fibers as independent
thread-like strands:
2\

22
23

21

21

24

FIG. 1

FIG. 2

FIG. 3a

D.I. 1-1, figs. 1, 2, 3a. UT argues that Figure 4 rejects a "thread-like" requirement because it
shows "discrete drug-containing phase regions . .. dispersed in the cross section of a polymer of
a fiber [] formed by 'coating' the outside of a core fiber" rather than a fiber that "look[s] like a
thread." D.I. 245 at 9 (citations omitted). Figure 4 "shows that a fiber may have multiple
component coatings, with each component loaded with different therapeutic agents." D .I. 1-1 at
7: 15-19. The written description further teaches that "fibers can be coated, forming co-axial
fibers as shown in FIG 4. Each coating can be of a different polymer material . ... The coating
9

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can also be physically divided into multiple sections . .. ." D.I. 1-1 at 9:10-19. However, the
patent clarifies that such a "coated fiber" is only one fiber, not multiple fibers. See D.I. 1-1 at
9:23-26. Thus, Figure 4 fails to support the assertion that a fiber need not be thread-like.
UT pointed to Example 3 at oral argument as evidence that the '296 patent affirmatively
disclaims any requirement that a fiber be thread-like. See Tr. at 44:7-45:11. Example 3 explains
that a single fiber may have "concentric coatings" applied to it that are made of different
polymers and that contain different therapeutic agents. D.I. 1-1 at 20:10-36. It nowhere
suggests that the coatings, themselves, are polymers. See D.I. 1-1 at 20:31-32 (distinguishing
between "the core fiber" and "the coating polymers"). Example 3 explains that an artisan may
form "fibers with any desired cross-sectional shape[,]" D.I. 1-1 at 20:29-32, and the Court agrees
with UT, Tr. at 44:7-19, that the Court should clarify for jurors that a "fiber" can take any shape.
However, Example 3 fails to support the assertion that a fiber need not be thread-like.
The written description and claims of the '296 patent both would support a thread-like
structure and do not disclaim a requirement that a fiber be thread-like. However, the ' 296 patent
does not define fiber, see D.I. 1-1 at 2:50-4:51 (defining terms), and it does not answer whether
a "fiber" must be thread-like, which is the real dispute between the parties, see D.I. 245 at 4
(asserting that a "fiber" must be "thread-like"), 8 (arguing that nothing "in the art or record
require[ s]" that a "fiber" be thread-like or a filament). Here, "resolution of [the] ambiguity
arising from the claims and specification may be aided by extrinsic evidence of usage and
meaning of a term in the context of the invention." Verve, 311 F.3d at 1119.
The intrinsic evidence does not support that a "fiber" must have common orientation of
the polymer molecules. UT argues that the patent's process for "making polymer fibers . . .
necessarily provide[s] molecular orientation of the polymers." D.I. 245 at 3. The ' 296 patent

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does not include the words "common" or "orientation" and does not include the phrase "polymer
molecules." See D.I. 1-1. However, the parties ' equally-credible experts disagree as to whether

.

any of the '296 patent' s embodiments lack common molecular orientation. Compare D.I. 246-9
132 ("Example 1 of the '296 patent depicts the synthesis of a fiber without any sort of
orientation introduced in the formation process."), with D .I. 246-18 1 22 ("I disagree with Dr.
Pitt's ultimate opinion .... In my opinion, the ' 296 Patent Examples uniformly describe
processes that draw or stretch the polymer during the formation of the fiber, which would then
necessarily impart common molecular orientation. .. .").
The Court also considers the prosecution history. BSC argues that it would be
appropriate to read restrictions in Example 1 of the '296 patent into Claim 1. BSC asserts that
the [written description] describes making polymer fibers using standard extrusion
processes that, through drawing and stretching, necessarily provide molecular
orientation of the polymers. [(Citing BSC' s expert)] . Example 1 of the ' 296
patent-which the patentee identified as the only written description support for
Claim 1 [(citing the prosecution history)]---describes a process in which a polymer
is "drawn" and "extruded" into a fiber [(citation omitted)]. Indeed, the patent's
"apparatus for fabrication of polymer fibers" illustrated in Figure 8 shows polymers
being extruded and drawn ....
D.I. 245 at 3 (emphasis in original); see D.I. 246-6 at 32-36 (including the text of Example 1 on
pages 27-31); D.I. 246-6 at 53 ("Support for [what is now Claim 1] can be found at pages 28 and
29 of the Specification . . .. "). UT does not appear to respond directly to this argument.
However, at this Court' s original Markman hearing, BSC explained that "[o]ur construction is
not limited to any manufacturing method[,]" D.I. 89 at 11:25-12:1 ; see also D.I. 89 at 29:11-1 2,
and BSC reiterated that before the Court, Tr. at 52:8-16 ("We 're not saying the method of
manufacturing in and of itself is a limitation."). As a result, the Court cannot assume that
"standard extrusion processes" are the only means to create a fiber (or, more specifically, a fiber

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of polymer). Thus, the Court finds that the intrinsic evidence does not require-but also does not
disclaim-common molecular orientation of the fiber.
The intrinsic evidence does, however, show that a fiber may be any shape or length. For
example, one embodiment teaches fibers "cut to pre-specified lengths," D.I. 1-1 at 19:67, and
Figures 1, 2, and 3a, shown above, display fibers of varying lengths, D.I. 1-1 at figs. 1, 2, 3a. As
explained above, Example 3 describes "certain embodiments" in which fibers may be formed
"with any desired cross-sectional shape." D.I. 1-1 at 20:29- 32. Thus, a construction that limits a
fiber to a particular shape or length would be inconsistent with the written description of the '296
patent. The intrinsic evidence also shows that fibers may, but need not be, woven into threedimensional "scaffolding" to support cell and tissue growth. See, e.g. , D.I. 1-1 at 8:41-58.
Fibers can be used "to deliver drugs at the placement site" of a metal stent without providing
"any mechanical support[,]" D.I. 1-1 at 22 :40-51 , and can be attached to an existing structure,
such as a blood vessel, D.I. 1-1 at 23 :31-54. The patent promotes the variety of applications
which fibers may support.

ii. Extrinsic Evidence
The Court finds as a factual matter that a POSA would have understood the plain and
ordinary meaning of "fiber" to be "a thread-like structure of any length or shape." The parties do
not contest that Dr. Pitt and Dr. David Mooney, BSC' s expert, are both POSAs. D.I. 246-9,
Attachment I, Ex. A ,r,r 1-4 (explaining that Dr. Pitt has a Ph.D. in chemical engineering and
experience with polymers and drug delivery); D.I. 246-18

,r,r 4-9 (explaining that Dr. Mooney

has a Ph.D. in chemical engineering and experience with polymers and drug delivery); see also
D.I. 246-18

,r,r 10-11 (describing minimum requirements for a POSA).

Dr. Mooney opines that "[a] ' polymer fiber ' refers generally to a threadlike or
filamentous structure made of polymer that has been drawn and/or pulled such that the polymer
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chains generally have a common longitudinal orientation .... " D.I. 246-2, Ex. 1 ,r 26. Dr.
Mooney insists that "polymer fiber," rather than "fiber," is the proper term of art at issue, but Dr.
Mooney explains that, in a polymer fiber, "the polymers have been stretched and/or pulled such
that the polymers ... have an independent, filament or thread-like structure." D.I. 246-2, Ex. 1 ,r
134. Thus, a "fiber" would also be "thread-like," since the stretching and pulling of the
polymers makes them into fibers . Dr. Mooney similarly said that a "fiber" being "threadlike"
was "consistent with" his own opinion. D.I. 246-2, Ex. 1 ,r 31.
BSC and UT disagree as to whether Dr. Pitt has similarly opined that a fiber is threadlike. See D.I. 245 at 11 , 16. In Board of Regents v. Ethicon, C.A. No. 17-1084-LY, UT alleged
that Defendant Ethicon "practice[d] claims of the '296 patent[,]" the same patent that is at issue
here. No. 17-1084, D.I. 93

,r,r 2, 5.

In Dr. Pitt's Rebuttal Expert Report, dated November 25,

2019, Dr. Pitt explained that Attachment B "set forth opinions concerning the knowledge of an
ordinary artisan, including my opinion that an ordinary artisan would have known that ... most
[polymers] can be made into useful films ... , but only a few can be made into useful fibers."
D.I. 246-7 at 5. In Attachment B, Dr. Pitt gave the following opinion:
An ordinary artisan would have known that of the many different types of polymers,
most can be made into useful films or used to make molded articles, but only a few
can be made into useful fibers. An ordinary artisan would have understood that
fibers (at least before they are cut) are long, threadlike monofilament and
multi.filament structures that are spun by extrusion through a spinnerets or very
fine holes, drawn, stretched (to provide molecular orientation), and possibly
annealed (to enhance dimensional stability and/or biological performance) to obtain
the mechanical properties desired. An ordinary artisan would also know that
forming or spinning a fiber by extrusion may involve melt spinning, dry solution
spinning, or wet solution spinning. An ordinary artisan would have known that a
fiber can be woven, knitted, or braided alone or in combination with other fibers to
form fabrics for various medical applications.
D.I. 246-7 at 6 (emphases added). Dr. Pitt argues that his opinions were taken out of context.
Dr. Pitt explains that "[t]he context" of his statement was "a discussion of the Choi '709 patent in

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which a polymer film is simply cast by pouring a polymer solution containing two solvents and
one polymer into a mold and drying it." D.I. 246-9, Attachment I 138. Dr. Mooney-who was
also defendant's expert in Ethicon-had opined that the ' 296 patent was obvious because of the
"Choi" patent, and Dr. Pitt responded that the "Choi" patent had not taught the "fiber forming
process" described in the '296 patent. Id. 1138-39. Dr. Pitt argues that he was elucidating
certain operations that could be performed on polymers to make them into "useful fibers" and
that he never opined that "such additional operations were required for the fiber to remain a fiber
that meets the other limitations of the claims." Id. 1139-40. "None of these words were used as
requirements or limitations on ' the plain and ordinary definition of fiber"' since they were pulled
from embodiments. Id.

1 40.

The Court does not find Dr. Pitt' s distinction meaningful. First, Dr. Pitt argues that he
was using terms from the ' 296 patent, Id.

1139-40 ("I used words from Examples in the '296

patent . .. ."), but Dr. Pitt describes "fibers" as "thread-like" even though "thread" never appears
in the '296 patent, see D.I. 1-1. Second, Dr. Pitt opined that an "ordinary artisan would have
understood thatfibers ... are long, threadlike" even though he referred to "useful fibers" in the
sentence prior. D.I. 246-7 at 6 (emphasis added). The use of "fibers" just after "useful fibers"
suggests either that Dr. Pitt did not find important the distinction between "fibers" and "useful
fibers" in the context of the '296 patent or that Dr. Pitt intended a distinction and, thus, spoke of
all fibers, not just useful fibers, when he explained that fibers "are long, threadlike monofilament
and multifilament structures .... " Id. Both interpretations undermine Dr. Pitt's argument.
Third, Dr. Pitt could still have provided a definition of "fiber" in the context of an anticipation
opinion in Ethicon. Dr. Pitt attests before this Court that the "fiber forming process" of the ' 296
patent rendered it non-obvious over the "Choi" reference in Ethicon. D.l. 246-9, Attachment I 11

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38-39. UT argued before the Court in Ethicon that "Choi does not disclose or teach an ordinary
artisan a ' fiber' that includes the claimed second phase." No. 17-1084, D.I. 131 at 6. Thus, the
Court reads Dr. Pitt's opinion as defining "fiber" as used in the context of the '296 patent.
One reading of Dr. Pitt' s opinion is that it described only one (albeit preferred) process to
make a "fiber" in the ' 296 patent, rather than opining as to all fibers that the '296 patent claims.
As UT argued in Ethicon, Dr. Pitt opined that "fiber fabrication of the type described in UT' s
'296 patent" is difficult. No. 17-1084, D.I. 131 at 6-7 . However, the Court finds it substantially
more likely that Dr. Pitt sought to opine on the definition of "fiber" as used throughout the '296
patent. Dr. Pitt argued that a major innovation of the '296 patent was the creation of a fiber with
discrete drug-containing regions (i.e., the "second phase"), and that argument supported the
distinction between the ' 296 patent' s drug-containing fiber and the "Choi" patent's drugcontaining film. See No. 17-1084, D.I. 131 at 6-7 . Thus, the Court finds as a factual matter that
Dr. Pitt defined "fiber" as used in the context of the '296 patent in the Ethicon case. 4
The Court finds as a factual matter that both Dr. Mooney and Dr. Pitt agree that a "fiber,"
as understood by a POSA in the context of the '296 patent, means a "thread-like structure." The
Court recognizes that Dr. Pitt in Ethicon also opined that "fibers ... are stretched (to provide
molecular orientation) .... " D.I. 246-7 at 6. Dr. Mooney's opinion is similar. See D.I. 246-2,
Ex. 1 1 26. However, Dr. Pitt described stretching as part of a process of manufacturing such

4

The Court's conclusion finds further support in UT's references elsewhere in Ethicon to a
"fiber" as "thread-like." See No. 17-1084, D.I. 160-1 at 3 (describing in proposed voir dire
questions "[a] major issue in this case" with reference to "a thread-like polymer fiber"); D.I. 1603 at 2 (explaining in voir dire that "[t]he '296 patent generally relates to implantable thread-like
polymer fibers"); D.I. 160-12 (explaining in proposed jury instructions that "[t]he patent-in-suit
generally relates to implantable thread-like polymer fibers"); see also No. 17-1084, D.I. 41
(describing the "benefits" of the fiber "format" to include "that fiber filaments or strands can be
woven" (cleaned up)).

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fibers (along with, e.g., extrusion), D.I. 246-7 at 6, and Dr. Mooney uses similar terminology,
D.I. 246-2, Ex. 1, 65 (" [A] POSA would understand the '296 Patent' s disclosure that the
polymer has been 'drawn' or ' extruded' into a fiber as necessarily imparting the fiber with a
common orientation of the polymer molecules."). BSC has stated multiple times before this
Court that it does not limit its construction to a method of manufacturing. See D.I. 89 at 11 :2512: 1, 29:11-12; Tr. at 52:8-16. The experts otherwise disagree as to whether a "fiber"
necessarily has a common molecular orientation. Compare D.I. 246-9, 27 ("[F]ibers produced
by any of the above processes have no appreciable orientation in the polymer chains .... "), with
D.I. 246-18, 25 ("[A] POSA would understand that a claimed fiber that has been ' drawn and
extruded' would necessarily have common molecular orientation." (citation omitted)).
Therefore, the Court will not effectively import a manufacturing process into the definition of
"fiber" based on extrinsic evidence alone by requiring that the fiber have a common orientation.
Two qualified POSAs agree that the ordinary meaning of "fiber" to a POSA, in the
context of the ' 296 patent, is a thread-like structure, and the intrinsic evidence clarifies that such
a structure may be of any length or shape. Therefore, the Court construes "fiber" to take its plain
and ordinary meaning to a POSA, which is "a thread-like structure of any length or shape."
B. UT's Request to Construe "Fiber" and "Biodegradable Polymer Fiber"

UT asks that the Court construe "biodegradable polymer fiber" to mean "[a] fiber capable
of releasing drug slowly, in a controlled manner over time as the polymer breaks down
chemically and mechanically in animal or human tissue[.]" D.I. 245 at 5.
The Court declines to construe "biodegradable polymer fiber" because UT's request that
the Court do so is untimely. The Court issued its claim construction Memorandum Order in this
case on April 15, 2021. D.I. 90. Therein, the Court explained that, if the parties' dispute as to
the construction of the term "fiber" "really is a claim construction dispute, [BSC] can raise the
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issue again in connection with summary judgment briefing to the extent appropriate." D.I. 90 at
6. UT did not at that time move for reargument to ask that the Court now construe

;i

new term.

See Del. Loe. Civ. R. 7.l.5(a). Per the Court' s direction, BSC raised construction of "polymer

fiber" (rather than of "fiber") in its June 14, 2022 opening brief for summary judgment of
noninfringement. See D.I. 200 at 13. UT did not request that the Court construe the term
"biodegradable polymer fiber" in its responsive briefing. See D.I. 214 at 17 ("Assuming
arguendo , the Court adopts [BSC] ' s proposed construction of ' polymer fiber,' which it should

not, summary judgment is still unwarranted. "). Instead, UT waited until October 26, 2022 to
frrst request that the Court construe "biodegradable polymer fiber. " D.I. 245 at 5. Thus, the
Court declines to construe the term because UT' s request for claim construction is untimely.
Additionally, UT's failure to even mention the term "biodegradable polymer fiber" in its SurReply Brief suggests that UT has dropped its request for claim construction. D.I. 245 at 15-16
(referencing "the drug-releasing biodegradable polymer format") .
However, even if UT' s request was timely and had not been dropped, the intrinsic
evidence does not support the limitations that UT asks the Court to read into the term
"biodegradable polymer fiber. " UT points to column 2, lines 39-65, of the '296 patent, D.I. 245
at 6, which explains that the invention provides "three-dimensional matrices for growing cells"
that "comprise biodegradable polymer fibers capable of the controlled delivery of therapeutic
agents" "over time[,]" D.I. 1-1 at 2:39- 50. This language provides no support for UT's
contention that a "biodegradable polymer fiber" must be capable of releasing a drug "slowly."
UT also points tq language in one of the invention' s embodiments, D.I. 245 at 6-7, which
explains that "[t]he therapeutic agents are released from each individual fiber slowly, and in a
controlled manner[,]" D.I. 1-1 at 8:36-40. However, the words "slow" and "slowly" are not used

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in the written description or claims outside of illustrative embodiment A and Example 4, a
"preferred embodiment[] of the invention." D.I. 1-1 at 8:36-40, 17:26, 20:66. The Court should
not limit a term' s construction "on the basis of a single exemplary embodiment, as (UT] urge[s]"
here. Supercell Oy v. GREE, Inc., 2021 WL 4452082, at *4 (Fed. Cir. Sept. 29, 2021); see
SIPCO, LLC v. Emerson Elec. Co., 980 F.3d 865, 872 (Fed. Cir. 2020) (" [T]he (Patent Trial and

Appeal Board] did not err in declining to import exemplary embodiments ... from the
specification into the broader claim term .... "). Lastly, the written description clarifies that
" (t]he host [of the fiber-scaffold] will typically be an animal, preferably a mammal and more
preferably a human. " D.I. 1-1 at 5:16--18 (emphasis added). Thus, the invention need not be
used "in animal or human tissue." The Court would reject UT' s proposed construction even if
timely and not dropped. 5
C. Permissible Scope of the Parties' Arguments Before the Jury

" [I]t is improper to argue claim construction to the jury because the 'risk of confusing the
jury is high when experts opine on claim construction. "' Cordis Corp. v. Bos. Sci. Corp., 561
F.3d 1319, 1337 (Fed. Cir. 2009) (citation omitted); C R Bard, Inc. v. AngioDy namics Inc., 2018
WL 3130622, at* 11 (D. Del. June 26, 2018) (similar). Thus, the parties should not revisit
before the jury the Court' s decisions here. BSC may not argue that the fiber recited in Claim 1

5

Parts of the proposed definition find support in the '296 patent. For example, UT argues that
the Court should construe "biodegradable polymer fiber" to "break(] down chemically and
mechanically" "over time" because the patent teaches that investigators in the field of tissue
engineering implant cells on a "biodegradable" scaffolding, "meaning that over time it will break
down both chemically and mechanically." D.I. 245 at 5-6; D.I. 1-1 at 1:12- 51. BSC does not
appear to oppose this portion ofUT's request. D.I. 245 at 13 ; see D.I. 246-18 (mentioning
"breaks down chemically and mechanically" only once). Thus, if the term had actually been in
dispute, the Court would have construed "biodegradable" as "breaks down chemically and
mechanically over time." Additionally, the written description explains that the "biodegradable
polymer fiber" is "capable of the controlled delivery of therapeutic agents," see D.I. 245 at 5-6;
D.I. 1-1 at 2:44-45.
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must have a common molecular orientation. See Section III.A., supra. Similarly, UT may not
argue that a "biodegradable polymer fiber" must be capable of releasing a drug slowly or that the
invention must be used in animal or human tissue. See Section III.B., supra.
Rather, the parties may argue before the jury whether "the term ' fiber ' can encompass
what [BSC] says is a coating." D.I. 90 at 5-6. UT has maintained that a construction of "threadlike" would not eliminate its infringement case. See D.I. 89 at 17:14-17 (" [I]fthe construction
was threadlike ... , that still can include a coating."); D.I. 214 at 17 (explaining that "summary
judgment is still unwarranted" even if "the Court adopts [BSC] ' s proposed construction of
' polymer fiber " '). As UT explained at the prior Markman hearing, UT alleges that the
biodegradable coating applied to each narrow ring included in the Accused Product is a fiber that
meets the requirements of Claim 1 of the ' 296 patent. D.I. 89 at 23:13-20. The Court does not
understand its construction to resolve whether such a "coating" is one of the claimed "fibers,"
since the Court' s construction does not, for example, require that the claimed "fiber" be solid
rather than hollow or that the claimed fiber be free-standing. See, e.g. , D.I. 1-1 at 22:43-51
(explaining that a fiber may "be used in conjunction with commercially available stents" and
"would not provide any mechanical support"). It is for a jury to decide whether the coating on
the rings ofBSC ' s metal stent is, in fact, a "fiber"-a thread-like structure of any length of
shape-as claimed in Claim 1.
IV.

CONCLUSION
For the reasons explained above, the Court construes "fiber" as taking its plain and

ordinary meaning, which is "a thread-like structure of any length or shape." The Court declines
as untimely the request to construe "biodegradable polymer fiber" and construes "fiber" rather
than "polymer fiber. "

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The Court will issue an Order consistent with this Memorandum Opinion.

20