Integra LifeSciences Corp. et al v. HyperBranch Medical Technology, Inc

Filing 483

REPORT AND RECOMMENDATION regarding preambles of asserted claims of U.S. Patent Nos. 8,535,705 and 7,009,034. Please note that when filing Objections pursuant to Federal Rule of Civil Procedure 72(b)(2), briefing consists solely of the Objections (n o longer than ten (10) pages) and the Response to the Objections (no longer than ten (10) pages). No further briefing shall be permitted with respect to objections without leave of the Court. Objections to R&R due by 1/30/2018. Signed by Judge Christopher J. Burke on 1/16/2018. (mlc)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
INTEGRA LIFESCIENCES CORP.,
)
INTEGRA LIFESCIENCES SALES LLC, )
CONFLUENT SURGICAL, INC., and
.)
INCEPT LLC,
)
)
)
Plaintiffs,
)
V.
)
)
)
HYPERBRANCH MEDICAL
TECHNOLOGY, INC.,
)
)
)
Defendant.

Civil Action No. 15-819-LPS-CJB

REPORT AND RECOMMENDATION
1.

In this action filed by Plaintiffs Integra LifeSciences Corp., Integra

LifeSciences Sales LLC, Confluent Surgical, Inc. and Incept LLC (collectively, "Plaintiffs" or
"Integra") against Defendant HyperBranch Medical Technology, Inc. ("HyperBranch" or
"Defendant"), Plaintiffs allege infringement of a number of patents (collectively, the "patents-insuit" or "asserted patents"), including United States Patent Nos. 8,535,705 (the "'5705 patent")
and 7,009,034 (the "'034 patent"). Presently before the Court is the question of whether the
preambles from asserted claims 1, 6, 12 and 17 of the '5705 patent and asserted claim 10 of the
'034 patent are limiting. (See D.I. 402 at 23-24; D.I. 443 at 27; D.I. 467 at 3 & n.1; D.I. 482 at
151 (hereinafter, "Tr.")) 1 For the reasons set out below, the Court recommends that the District

The parties provided argument regarding this issue in the context of
HyperBranch's "Motion for Summary Judgment of Non-Infringement and Invalidity of the
Patents-in-Suit," in which HyperBranch moved for summary judgment with respect to various
issues. (D.I. 393, 402) Quick disposition of this issue has been requested, as it may guide the
parties as they undergo additional expert discovery and related inquiry into Plaintiffs'
"biocompatibility" theory. (See D.I. 467 at 3) Thus, this Report and Recommendation solely
addresses the limited question of whether the preambles in these claims are limiting.

Court find that the preambles are limiting.
2.

The question of whether language in a preamble constitutes a claim limitation is

a question oflaw. Rotatable Techs. LLC v. Motorola Mobility LLC, 567 F. App'x 941,943 (Fed.
Cir. 2014). "While it is true that preamble language is often treated as nonlimiting in nature, it is
not unusual for [the United States Court of Appeals for the Federal Circuit] to treat preamble
language as limiting[.]" Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006).
Generally, "a preamble limits the invention if it recites essential structure or steps, or if it is
necessary to give life, meaning and vitality to the claim." Catalina Mktg. Int 'l, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (internal quotation marks and citation

omitted); see also Intellectual Ventures I LLC v. AT & T Mobility LLC, C.A. No. 12-193-LPS,
2015 WL 1393386, at *24 (D. Del. Mar. 24, 2015). A preamble may also be construed as
limiting when the claim limitations in the body of claim "rely upon and derive antecedent basis
from the preamble[.]" Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332, 1339 (Fed. Cir.
2003). On the other hand, when the claim body recites a structurally complete invention and the
preamble language is used merely to state the purpose or intended use of the invention, the
preamble is generally not treated as limiting the scope of the claim. Catalina, 289 F.3d at 808.
3.

There is no "litmus test" for determining whether preamble language is limiting.

Id. Rather, whether such language is limiting is assessed in regard to "the facts of each case in

light of the claim as a whole and the invention described in the patent." Storage Tech. Corp. v.
Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003); see also Catalina, 289 F.3d at 808

("Whether to treat a preamble as a limitation is a determination resolved only on review of the
entire ... patent to gain an understanding of what the inventors actually invented and intended to
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encompass by the claim.") (internal quotation marks and citation omitted).
4.

Turning first to the '5705 patent, claim 1 of that patent recites:

1. A method of making a biocompatible degradable hydro gel to
treat a medical condition of a patient comprising:
identifying a medical condition for treatment by use of a hydrogel
formed in situ in a patient and fully degradable in a patient in less
than about 180 days; and
mixing a first precursor with a second precursor in situ in the patient
to form the hydro gel for treatment of the medical condition,
with the first biocompatible synthetic hydrophilic polymer precursor
having a water solubility of at least 1 gram per 100 milliliters and
comprising at least two electrophilic functional groups; and the
second biocompatible synthetic hydrophilic polymer precursor
comprising at least two nucleophilic amine functional groups; and
wherein
(i) the first precursor is selected to have only one or two
chemically hydrolytically degradable ester bonds per every
electrophilic functional group on the first precursor; and
(ii) the second precursor comprises at least three nucleophilic
functional groups;
wherein the biodegradable groups of the hydro gel consist of the
esters and the hydrogel as placed in situ in the patient is essentially
fully degradable in a patient in less than about 180 days, and
wherein mixing the first and the second synthetic hydrophilic
polymer precursors forms crosslinking covalent bonds that are
reaction products of the electrophilic and the nucleophilic groups,
wherein essentially every ester bond in the hydrogel is separated
from other ester bonds in the hydrogel by at least three covalent
bonds when the hydrogel is formed.
('5705 patent, col. 30:34-65)2
5.

HyperBranch argues that the preamble language of claim 1 of the '5705 patent

(i.e., "[a] method of making a biocompatible degradable hydrogel to treat a medical condition of
a patient comprising") is non-limiting because it describes only an intended use, with the body of
claim 1 itself defining a structurally complete invention. (D.I. 402 at 23) The claim body covers

2

Claims 6, 12 and 17 of the '5705 patent depend from claim 1.
3

a "first precursor" and "second precursor" that are biocompatible, and according to HyperBranch,
that is all that is required to satisfy the claim in terms ofbiocompatibility. (Id) HyperBranch
further asserts that the preamble is non-limiting because: (1) there is no antecedent basis in the
preamble for any of the elements recited in the claim body; and (2) the preamble was not relied
upon during prosecution to distinguish the invention over the prior art. (Id) For its part, Integra
argues that "a biocompatible hydro gel" in the preamble of claim 1 of the '5705 patent is an
affirmative limitation because the references to "hydrogel" in the claim body refer back to the
. preamble, and because the biocompatibility of the hydro gel is a fundamental aspect of the
inventions described in the patent. (See Integra's Opposition to Defendant's Summary Judgment
of Invalidity Slide Presentation, Slide 11)
6.

The Federal Circuit has explained that where language in the preamble recites

additional structure underscored as important by the patent specification, the preamble may
operate as a claim limitation. Catalina, 289 F.3d at 808; see also, e.g., Rowe v. Dror, 112 F.3d
473,478 (Fed. Cir. 1997) (explaining that to determine whether preamble language is a structural
limitation, the court should "examin[e] the entire patent record to determine what invention the
patentee intended to define and protect"). Here, the Court believes that the preamble's reference
to "a biocompatible ... hydrogel" is in fact a reference to structure that the intrinsic record
describes as being very important to the invention. 3
7.

For one, the title of the '5705 patent itself is "Biocompatible Polymers and

Hydrogels and Methods of Use." ('5705 patent at 1) Mor~over, the remainder of the

3

The other language in the preamble recites aspects of the invention that are
duplicative of language in the body of the claim.
4

specification repeatedly describes the invention as relating to "biocompatible crosslinked
polymers." For instance, the Abstract explains that "[b]iocompatible crosslinked polymers, and
methods for their preparation and use, are disclosed[.]" (Id) The "Field of the Invention"
section of the patent notes that the invention relates to "biocompatible crosslinked polymers[.]"

(Id, col. 1: 16-17) The "Summary of Invention" section also repeatedly notes that objects of the
invention are to provide "biocompatible crosslinked polymers" and methods for their use. (Id,
col. 4:21-61) As yet another example, the "Detailed Description of the Invention" section of the
patent begins by stating that "[t]he novel biocompatible crosslinked polymers of this invention
are formed from the reaction of precursors having electrophilic and nucleophilic functional
groups." (Id, col. 5:58-60)
8.

In the context of this patent, biocompatible crosslinked polymers are

biocompatible crosslinked hydrogels. HyperBranch itself confirms this. (See, e.g., D.I. 94 at 5
(explaining, in opposing Integra's motion for preliminary injunction, that the asserted patents are
"directed to '[b]iocompatible cross-linked polymers' (i.e., hydrogels) and methods for making
them") (emphasis added); see also D.I. 97 at ,r 41 (HyperBranch's expert Dr. Lowman describing
the asserted patents as all disclosing "biocompatible cross-linked polymers or hydrogels and
methods for making hydrogels"); D.I. 10, ex. 13 at ,r 34 (Integra's expert Dr. Mays explaining
that the asserted patents "are directed to methods of making biocompatible polymer hydrogels"))
The specification of the related '034 patent also indicates that biocompatible crosslinked
hydrogels are the same thing as biocompatible crosslinked polymers. It explains that "[s]everal

biocompatible crosslinked hydrogels may be produced using the crosslinkers and functional
polymers described in FIGS. 1 to 5. Preferred combinations of such polymers suitable for

5

producing such biocompatible cross/inked polymers are described in Table 2." ('034 patent, col.
22:40-44 (emphasis added))
9.

The intrinsic record makes it clear, then, that making a "biocompatible hydrogel"

(by, inter alia, mixing a first and second biocompatible precursor) is an important feature of the
invention. To hold otherwise would seem divorced from reality. The Court therefore
recommends that the "biocompatible degradable hydro gel" language in the preamble of the
asserted claims of the '5705 patent be found to be a claim limitatiori. 4 See, e.g., Poly-Am., L.P. v.
GSE Lining Tech., Inc., 383 F.3d 1303, 1310 (Fed. Cir. 2004) (concluding that "blown-film" in

the preamble of a patent directed to a landfill liner was a claim limitation where the specification
is replete with references to the invention as a '"blown-film' liner, including the title of the
patent itself and the 'Summary of the Invention[,]' [t]he phrase is used repeatedly to describe the
preferred embodiments, and the entire preamble 'blown-film textured liner' is restated in" every
claim, thus demonstrating to the court that "the inventor considered that the 'blown-film'
preamble language represented an important characteristic of the claimed invention"); Rotatable
Techs., 567 F. App'x at 943 (holding that "selectively rotating" in the preamble limited the

claimed invention where, inter alia, the specification is replete with references to "selectively
rotating,"-in the title, abstract, background of the invention, summary of the invention,
description of the drawings, detailed description, and all independent claims-thereby

4

With respect to Integra's suggestion that the term "biocompatible degradable
hydrogel" provides antecedent basis for terms in the claim body and that this is evidence that the
phrase is limiting, the Court finds this argument a bit less persuasive. The first limitation in the
body of the claim recites "identifying a medical condition for treatment by use of a hydrogel[,]"
and therefore "a hydrogel" in that recitation could be said to provide antecedent basis for the
claim's later recitations of "the hydrogel." (See, e.g., '5705 patent, col. 30:36-38, 40)
6

"underscoring the importance of the feature to the claimed invention"); Script Sec. Sols. L. L. C. v.

Amazon.com, Inc., No. 2:15-CV-1030-WCB, 2016 WL 3959804, at *6-7 (E.D. Tex. July 22,
2016) (holding that the reference to "portable security alarm system" in the preamble is limiting
where "[p]ortability is a theme that runs throughout the [asserted] patent," with the title and
abstract referring to the system as "portable" and the specification repeatedly emphasizing the
portability of the system, rendering it "evident that the patentees simply used the preamble as the
vehicle for incorporating that requirement into the claims") (Bryson, J., sitting by designation). 5
10.

Turning to the '034 patent, claim 1 of that patent, from which asserted claim 10

depends, recites:

1. A method of preparing a composition suitable to coat a tissue of
a patient, the method comprising:
mixing reactive precursor species comprising nucleophilic
functional groups, reactive precursor species comprising
electrophilic functional groups, and a visualization agent such that
the nucleophilic functional groups and electrophilic functional
groups crosslink after contact with the tissue to form a hydrogel
having an interior and an exterior, with the exterior having at least
one substrate coating surface and the visualization agent being at
least partially disposed within the interior and reflecting or
emitting light at a wavelength detectable to a human eye to thereby
provide a means for visualization of the coating by a human eye.
('034 patent, cols. 39:56-40:2)

5

It is true that Integra does not point to instances in the prosecution history where
the patentees were distinguishing their invention from the prior art on the basis that it claimed
biocompatible hydro gels. But that is not a prerequisite to a Court's finding that a preamble
contains a claim limitation. See, e.g., Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376,
1380 (Fed. Cir. 2001) (rejecting the plaintiffs argument that the preamble phrase "correlated set"
was not limiting, where the plaintiff argued that the limitation was irrelevant to patentability, and
finding that the term was limiting because the specification described the invention as relating to
a correlated set of irons and because the term appeared in the preamble of every claim; thus, the
term did not simply refer to the prior art or to a possible use, but "describes and limits the
invention being claimed").
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11.

HyperBranch argues that the preamble language of this claim (i.e., "[a] method of

preparing a composition suitable to coat a tissue of a patient, the method comprising") is nonlimiting because it describes only a purpose or intended use of the composition-"suitable to
coat." (D.I. 463 at 21) For its part, Integra argues that "suitable to coat a tissue of a patient" is
an affirmative claim limitation describing a feature of the claimed composition, because the
preamble serves as antecedent basis for at least the terms "the tissue" and "the coating." (D .I.
443 at 27; Tr. at 135-36, 163) Furthermore, Integra asserts that in order to be "suitable to coat a
tissue of a patient," the claimed hydrogel must be biocompatible, (D.I. 443 at 27; Tr. at 136),
with biocompatibility being a fundamental aspect of the invention, (see Integra's Opposition to
Defendant's Summary Judgment oflnvalidity Slide Presentation, Slide 19). This latter aspect of
Integra's argument (i.e., that "suitable to coat a tissue of a patient" means that the composition
must be biocompatible) does not appear to be disputed by HyperBranch. (See, e.g., D.I. 463 at
21-22 (arguing that even if the preamble is found to be limiting, there is no genuine issue of
material fact that prior art reference Rhee teaches coating a surface of a synthetic implant and

"'biocompatible crosslinked polymers[,]"' and that there is thus no dispute that the reference
teaches the "preamble to claim 1" of the '034 patent) (emphasis in original))
12.

The Court agrees with Integra-that the preamble of claim 1 of this patent is also

limiting. It does so for two reasons.
13.

First, just as with the '5705 patent above, the '034 patent makes clear that the

invention disclosed therein is a biocompatible hydrogel and methods for its use. The title of the
'034 patent is "Biocompatible Crosslinked Polymers"-i.e., biocompatible crosslinked
hydro gels-and the Abstract and "Field of the Invention" section of the patent indicate that the

8

patent discloses "[b]iocompatible crosslinked polymers" and methods for their use. ('034 patent
at 1 & col. 1:24-26) The "Background of the Invention" portion of the specification explains that
"[h]ydrogels are especially useful for use in the body because they are more biocompatible than
non-hydrogels and are thus better tolerated in the body." (Id, col. 1:52-54) The "Summary of
the Invention" section of the specification repeatedly states that the "object" of the invention is to
provide "biocompatible crosslinked polymers" and methods for their preparation and use. (Id,
col. 3:20-60) And the specification later explains that "[s]everal biocompatible crosslinked
hydrogels may be produced using the crosslinkers and functional polymers described in FIGS. 1
to 5. Preferred combinations of such polymers suitable for producing such biocompatible
crosslinked polymers are described in Table 2." (Id, col. 22:40-44) Thus, with it clear that the
invention is indeed a method of preparing a biocompatible crosslinked hydro gel, the Court finds
that "[a] composition suitable to coat a tissue of a patient"-i.e., a "biocompatible"
composition-is a claim limitation.
14.

Second, the Court agrees that the preamble language "suitable to coat a tissue of a

patient" provides the necessary antecedent basis for the "the tissue" and "substrate coating
surface" limitations in the body of the claim. This further demonstrates that the preamble
language should be regarded as a claim limitation. See, e.g., Catalina, 289 F.3d at 808
(explaining that "dependence on a particular disputed preamble phrase for antecedent basis may
limit claim scope because it indicates a reliance on both the preamble and claim body to define
the claimed inventio_n"); see also Pacing Techs., LLC v. Garmin Int'!, Inc., 778 F.3d 1021, 1024
(Fed. Cir. 2015) ("Because the preamble terms 'user' and 'repetitive motion pacing system'
provide antecedent basis for and are necessary to understand positive limitations in the body of
9

claims in the [asserted] patent, we hold that the preamble to [the claim] is limiting."); Proveris

Sci. Corp. v. Innovasystems, Inc., 739 F.3d 1367, 1372-73 (Fed. Cir. 2014) (finding that the
preamble, which recites an apparatus for producing image data representative of at least one
sequential set of images of a spray plume, was a claim limitation, where the specification
identified the invention as producing a '"sequential set of images"' and a phrase in the claim
body clearly derived antecedent basis from the "'image data' that is defined in greater detail in
the preamble"); Script Sec. Sols., 2016 WL 3959804, at *7 n.2.
15.

For the foregoing reasons, the Court recommends that the preambles of the

asserted claims of the '5705 patent and the '034 patent be found to be limiting, in the manners
described above.
16.

This Report and Recommendation is filed pursuant to 28 U.S.C. § 636(b)(l)(B),

Fed. R. Civ. P. 72(b)(l), and D. Del. LR 72.1. The parties may serve and file specific written
objections within fourteen (14) days after being served with a copy of this Report and
Recommendation. Fed. R. Civ. P. 72(b)(2). The failure of a party to object to legal conclusions
may result in the loss of the right to de novo review in the district court. See Henderson v.

Carlson, 812 F.2d 874, 878-79 (3d Cir. 1987); Sincavage v. Barnhart, 171 F. App'x 924,925 n.1
(3d Cir. 2006). The parties are directed to the Court's Standing Order for Objections Filed Under
Fed. R. Civ. P. 72, dated October 9, 2013, a copy of which is available on the District Court's
website, located at http://www.ded.uscourts.gov.

Dated: January 16, 2018
Christopher J. Burke
UNITED STATES MAGISTRATE JUDGE

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