Integra LifeSciences Corp. et al v. HyperBranch Medical Technology, Inc
MEMORANDUM ORDER re 555 REPORT AND RECOMMENDATION is ADOPTED -- 399 MOTION for Partial Summary Judgment and 393 MOTION for Summary Judgment are DENIED in part. Signed by Judge Leonard P. Stark on 4/10/18. (ntl)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
INTEGRA LIFESCIENCES CORP.,
INTEGRA LIFESCIENCES SALES LLC,
CONFLUENT SURGICAL, INC., and
C.A. No. 15-819-LPS-CJB
WHEREAS, Magistrate Judge Burke issued a 34-page Report and Recommendation
("Repo1i") (D.I. 555), dated March 13, 2018, recommending the Court: (1) deny Defendant
HyperBranch Medical Technology, Inc ' s ("Defendant" or "HyperBranch") motion for summary
judgment of non-infringement of claim 20 of the ' 034 patent, claim 4 of the '566 patent, and
claims 8 and 23 of the '418 patent (the "Predetermined Thickness" claims) (D.I. 393); and
(2) deny Plaintiffs Integra LifeSciences Corp., lntegra LifeSciences Sales LLC, Confluent
Surgical, Inc. , and Incept LLC's (collectively, "Plaintiffs" or "lntegra") motion for summary
judgment of infringement of the Predetennined Thickness claims (D.I. 399);
WHEREAS, on March 23, 2018, HyperBranch objected to the Report (D.I. 641)
("Objections" or "Objs."), contending it (l) improperly read limitations out of claim 20 of the
'034 patent and (2) failed to consider material aspects of the prosecution history surrounding
"visualization agent" amendments in recommending denial of HyperBranch' s motion for
summary judgment of non-infringement under the doctrine of equivalents;
WHEREAS , on April 2, 2018, lntegra responded to HyperBranch's Objections (D.I. 665)
("Response" or "Resp."), contending the Report properly interpreted and construed claim 20 and
the prosecution history surrounding "visualization agent;"
WHEREAS, the Court has considered the parties' objections and responses de nova, see
St. Clair Intellectual Prop. Consultants, Inc. v. Matsushita Elec. Indus. Co., Ltd., 691 F. Supp.
2d 538, 541-42 (D . Del. 2010); 28 U.S.C. § 636(b)(l); Fed. R. Civ. P. 72(b);
NOW THEREFORE, IT IS HEREBY ORDERED that:
HyperBranch's Objections (D.I. 641) are OVERRULED, Judge Burke' s Report
(D.I. 555) is ADOPTED, and the parties ' motions (D.I. 393, 399) 1 are DENIED. 2
HyperBranch contends that the Report (1) wrongly construes claim 20 of the ' 034
patent and (2) erroneously finds the tangential exception to prosecution history estoppel applies.
(Objs. at 2, 7) The Court disagrees with HyperBranch.
The Report properly found that "in order to infringe the method of claim 20, one
has to (1) formulate a polymer composition that comprises electrophilic functional groups and
nucleophilic functional groups and (2) 'select a visualization agent for the polymer
The w1derlying Report, and accordingly, this Order, solely addresses the portions of the parties '
motions (D.I. 393, 399) related to infringement of the Predetermined Thickness claims. (See
Report at 1 n.2, 2 n.3)
lntegra repeatedly faults HyperBranch for raising the same arguments it made unsuccessfully to
Judge Burke. (See, e.g. , Resp. at 5-8) This is not a basis for overruling HyperBranch's
objections. "To the contrary, with limited (if any) exception, parties objecting to a Magistrate
Judge's report or order are required to adhere to the arguments, evidence, and issues they
presented first to the Magistrate Judge. Far from being inappropriate, rehashing is exactly what
parties are expected to do." Masimo C01p. v. Philips Elec. N. Am. Corp., 62 F. Supp. 3d 368,
377 (D. Del. 2014).
composition' that, when deposited on the tissue of a patient, can cause a visually observable
change that indicates that a crosslinked hydro gel having a predetennined thickness has been
formed." (Report at 23-24 n.14) In addition, the Rep01i properly found that "there is no
requirement in the claim that, for Defendant' s infringement to be complete, a user must actually
apply the hydrogel to a patient' s tissue and look for the observable change in doing so." (Id. at
15 n.11) HyperBranch contends the Repo1i's conclusion "reads several limitations out of the
claim" (Objs. at 3), but HyperBranch's interpretation - requiring the alleged infringer to apply
the hydrogel to a patient's tissue to be liable - reads limitations into the claim where none exist.
Claim 20 depends from claim 16. Both claims are reproduced below:
A method for fonnulating a polymer composition that crosslinks to form a
hydro gel, the method comprising selecting a concentration of visualization
agent for the polymer composition such that the visualization agent causes
a visually observable change that indicates that a crosslinked hydrogel
having a predetermined thickness has been formed on the tissue of a
patient wherein the polymer composition comprises electrophilic
functional groups and nucleophilic functional groups that crosslink to each
The method of claim 16, wherein the polymer composition crosslinks to
fonn a hydrogel within about 60 seconds after being applied to a substrate.
The only method step of claim 16 (and of claim 20) is "selecting" the
visualization agent. The other limitations - i.e. , that the visualization agent "causes a visually
observable change" and that the visually observable change " indicates that a crosslinked hydrogel
having a predetermined thickness has been formed on the tissue of a patient" - are not steps in
the asserted method but, instead, are characteristics of the visualization agent that is selected.
See Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1290-91 (Fed Cir. 2015) (finding
claim limitation was "not a step in the claimed method," but was instead only "a plu-ase that
characterizes the claimed pre-processing parameters," as limitation was "not used as a verb ... ,
but instead is a part of a phrase that conveys information about" claimed method parameters); see
also SimpleAir, Inc. v. Google, Inc., 2015 WL 5883129, at *2 (E.D. Tex. Oct. 6, 2015) ("[N]ot
every tenn in a claim limitation identifies a separate component that must be present in the
claimed system."). For one to infringe the method of claim 16 (or claim 20), the alleged infringer
need "select a concentration of visualization agent" that has the above listed characteristics.
Contrary to HyperBranch's contentions, the alleged infringer need not actually apply the hydrogel
to a patient' s tissue and look for an obse1v able change. See SiRF Tech. , Inc. v. Int '! Trade
Comm 'n, 601 F.3d 1319, 1331 (Fed. Cir. 2010) (finding certain actions, though necessary to
claim performance, were not required by claims and, therefore, "the fact that other patties
perform these actions does not preclude a finding of direct infringement"). 3
The Report also properly found the tangential exception to prosecution history
estoppel applies here. The Comi agrees with HyperBranch that it is the visualization agent that
must cause the visually observable change (Objs. at 10), but the naITowing amendment
HyperBranch points to bears no relation to what constitutes a visualization agent or whether that
HyperBranch also contends it "had no meaningful opportunity to respond" to Integra's argument
that there is no requirement in claim 20 that, for one to infringe, one must affirmatively apply the
hydrogel to tissue or use the color or transparency to assess thickness. (Objs. at 2-3) However,
lntegra's expert, Dr. Jimmy Mays, opined in September 2015 that "all that is required is
' selecting a concentration of a visualization agent' to achieve an intended use or effect along with
the other characteristics of the polymer composition." (D.l. 10 Ex. 131129) Moreover,
Integra's contention was made in response to HyperBranch' s arguments to the contrary (see D.I.
441 at 30) (HyperBranch stating "Plaintiffs' allegations that ' hydrogel has been deposited on the
substrate' and that HyperBranch demonstrates products outside of a surgical environment do not
establish that HyperBranch forms, or is liable for forming, a hydrogel on the tissue of a patient as
required by claim 20") (internal citations omitted), and HyperBranch was given an opportunity to
respond during oral argument (see D.I. 482 at 26-28, 36-37).
visualization agent must comprise dye alone or, rather, a combination of dye and air bubbles.
(See Repoti at 29-30) Moreover, the components of a visualization agent, for purposes of
infringement, are not, as HyperBranch contends, undisputed. (Objs. at 7) During claim
construction, the Court held that "the term 'visualization agent' should not be construed in such a
way as to encompass air or air bubbles alone." (D.I. 307 at 13; D.I. 379 at 5) While the Court
fow1d that the vis ualization agent as described and claimed in the '034 patent encompassed dye
alone without any presence of air bubbles (s ee D.I. 307 at 12-13), the Comi did not preclude a
finding that a combination of dye and air bubbles could be equivalent to a visualization agent
under the doctrine of equivalents. Such a factual dispute is properly left to the jury. See Graver
Tank & Mfg. Co. v. Linde Air Prods. Co. , 339 U.S . 605, 509-10 (1950) (explaining that
equivalence is a question of fact often requiring consideration of "credibility, persuasiveness and
weight of evidence").
The Court has considered each of the other arguments raised by HyperBranch in
its Objections de nova and finds that each of them lacks merit and requires no further discussion.
HONORABLE LEONARD P. STARK
UNITED STATES DISTRICT JUDGE
April 10, 2018
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