United States District Court, D. Delaware
INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant.
HONORABLE LEONARD P. STARK UNITED STATES DISTRICT JUDGE.
Magistrate Judge Burke issued a 34-page Report and
Recommendation ("Report'*) (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., Integra LifeSciences Sales LLC,
Confluent Surgical, Inc., and Incept LLC's (collectively,
"Plaintiffs" or "Integra") motion for
summary judgment of infringement of the Predetermined
Thickness claims (D.I. 399);
on March 23, 2018, HyperBranch objected to the Report (D.I.
641) ("Objections" or "Objs."),
contending it (1) 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;
on April 2, 2018, Integra 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;"
the Court has considered the parties' objections and
responses de novo, 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)(1); Fed.R.Civ.P. 72(b);
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) are DENIED.
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.
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 composition' that,
when deposited on the tissue of a patient, can cause a
visually observable change that indicates that a crosslinked
hydrogei having a predetermined thickness has been
formed." (Report at 23-24 n.14) In addition, the Report
properly found that "there is no requirement in the
claim that, for Defendant's infringement to be complete,
a user must actually apply the hydrogei to a patient's
tissue and look for the observable change in doing so."
(Id. at 15 n.l 1) HyperBranch contends the
Report's conclusion "reads several limitations out
of the claim" (Objs. at 3), but HyperBranch's
interpretation - requiring the alleged infringer to apply the
hydrogei to a patient's tissue to be liable - reads
limitations into the claim where
16. A method for formulating a polymer composition that
crosslinks to form a hydrogei, 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 hydrogei 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 other.
The method of claim 16, wherein the polymer composition
crosslinks to form a hydrogei within about 60 seconds after
being applied to a substrate.
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 hydrogei
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 phrase 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 term 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 observable change.
See SiRF Tech., Inc. v. Int'l 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 parties perform these actions does not preclude a
finding of direct infringement").
Report also properly found the tangential exception to
prosecution history estoppel applies here. The Court agrees
with HyperBranch that it is the visualization
agent that must cause the visually observable
change (Objs. at 10), but the narrowing amendment HyperBranch
points to bears no relation to what constitutes a
visualization agent or whether that visualization agent must
comprise dye alone or, rather, a combination of dye and air
bubbles. (See Report 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 found that the visualization agent as described and
claimed in the '034 patent encompassed dye alone without
any presence of air bubbles (see D.I. 307 at 12-13),
the Court 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").
Court has considered each of the other arguments raised by
HyperBranch in its Objections de novo and finds that
each of ...