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Integra Lifesciences Corp. v. Hyperbranch Medical Technology, Inc.

United States District Court, D. Delaware

August 30, 2017

INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
v.
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant.

          REPORT AND RECOMMENDATION

          CHRISTOPHER J. BURKE, UNITED STATES MAGISTRATE JUDGE.

         In this action filed by Plaintiffs Integra LifeSciences Corp., Integra LifeSciences Sales LLC, Confluent Surgical, Inc. and Incept LLC (collectively, "Plaintiffs") against Defendant HyperBranch Medical Technology, Inc. ("Defendant" or "HyperBranch"), Plaintiffs allege infringement of United States Patent Nos. 6, 566, 406 (the '"406 patent"), 7, 009, 034 (the '"034 patent"), 7, 332, 566 (the "'566 patent"), 7, 592, 418 (the '"418 patent"), 8, 003, 705 (the '"3705 patent") and 8, 535, 705 (the '"5705 patent") (collectively, the "patents-in-suit" or "asserted patents"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions set forth below for the four terms discussed in this Report and Recommendation.[1]

I. BACKGROUND

         The Court incorporates by reference herein the factual and procedural background about this case and the patents-in-suit that was set out in the Court's July 27, 2017 Report and Recommendation regarding claim construction. (D.I. 307 at 2-5)

         II. STANDARD OF REVIEW

         The Court also incorporates by reference herein the discussion of general principles of claim construction, as well as the legal standard relating to the definiteness requirement, which were also set out in its July 27, 2017 Report and Recommendation. (Id. at 5-7, 30-32)

         III. DISCUSSION

         The Court takes up the four disputed terms in the order in which the parties addressed them at the Markman hearing.

         A. "the first biocompatible precursor, the second biocompatible precursor, and the third biocompatible precursor are reactable with each other to form a crosslinked hydrogel" "the first biocompatible precursor, the second biocompatible precursor, and the third biocompatible precursor are reactable with each other"[2]

         The term that is ultimately at issue here is "the first biocompatible precursor, the second biocompatible precursor, and the third biocompatible precursor are reactable with each other to form a crosslinked hydrogel[, ]" which is found in certain claims of the '3705 patent, including claim 4. Plaintiffs propose that the term be construed to mean "the electrophilic functional groups of the first biocompatible precursor are readable with the primary amine functional groups of the second and third biocompatible precursors to form a crosslinked hydrogel[, ]" while Defendant proposes that the term be construed to mean "the first biocompatible precursor, the second biocompatible precursor, and the third biocompatible precursor each react with the other two [to form a crosslinked hydrogel.]" (D.I. 230 at 8-9 (internal quotation marks omitted); D.I. 231 at 27) Claim 4 of the '3705 patent is set out below:

         4. A kit comprising:

a first biocompatible precursor having at least two electrophilic functional groups, and a second biocompatible precursor comprising at least two primary amine functional groups, a third biocompatible precursor comprising at least two primary amine functional groups and, an applicator; wherein the first biocompatible precursor, the second biocompatible precursor, and the third biocompatible precursor are reactable with each other to form a crosslinked hydrogel, are resistant to enzymatic degradation, and at least one of the first, second, or third biocompatible precursors comprises at least one isolated hydrolytically degradable ester group; wherein the applicator is configured to mix at least the first precursor, the second precursor, and the third precursor to form a crosslinked hydrogel in situ comprising covalent bonds formed by reaction of the functional groups of the precursors and further comprising the at least one isolated hydrolytically degradable ester group;
wherein the hydrogel comprises a sufficient number of the at least one isolated hydrolytically degradable ester groups in the crosslinked hydrogel so that the crosslinked hydrogel is degradable in less than about 180 days, is resistant to enzymatic degradation, and is degradable by hydrolysis of the at least one isolated hydrolytically degradable ester group; and wherein the kit further comprises instructions that comprise directions for making a hydrogel that is degradable in an amount of time, with the amount of time being less than about 180 days.

('3705 patent, cols. 42:41-43:4 (emphasis added))

         From this representative claim, we know, then, that the claims at issue require three precursors-a first precursor, a second precursor, and a third precursor. (See D.I. 241 at 19) Further, the claims require that the first precursor has electrophilic functional groups, and the second and third precursors each have primary amine functional groups. (Id.) The crux of the dispute here is whether the construction for this term must require the second and third biocompatible precursors to react with each other to form a crosslinked hydrogel, as Defendant contends, or whether it instead requires the first biocompatible precursor to react with the second and third precursors to form a crosslinked hydrogel, as Plaintiffs propose. (See D.I. 230 at 9; D.I. 231 at 27-28) Plaintiffs' proposal would not require the second and third precursors to react with each other.

         The person of ordinary skill in the art ("POSITA") would consider the claims as a whole, Plaintiffs assert, and would know how to form a crosslinked hydrogel. (D.I. 230 at 9) Plaintiffs' expert, Dr. Jimmy Mays, then explained that in conjunction with this knowledge, the POSITA would additionally know that: "(1) electrophilic groups cannot react with other electrophilic groups; and (2) that primary amine groups cannot react with other primary amine groups." (D.I. 242, ex. 14 at ¶ 22; see also Tr. at 177) Thus, according to Plaintiffs, the POSITA would understand the claims at issue to teach that the first precursor (with electrophilic functional groups) reacts with the second and third precursors (both with primary amine functional groups) in order to form a crosslinked hydrogel. (D.I. 230 at 9 (citing D.I. 122, ex. 6 at ¶¶ 148-49); see also D.I. 242, ex. 14 at ¶ 21) With respect to the second and third precursors, Plaintiffs argue that the POSITA would know that the claims do not specifically identify any functional groups of the second and third precursors that would react with each other, and that those two precursors thus "do not react together [to form a crosslinked hydrogel][.]" (D.I. 230 at 9) Plaintiffs argue that this interpretation is in line with the patent's teaching that the claimed crosslinked hydrogels of the invention "are made by reacting electrophilic functional groups with primary amine functional groups [, ]" (id.), and in support, they cite to the following portion of the specification:

Some embodiments are methods for making a readily degradable hydrogel by providing at least a first biocompatible precursor having at least two electrophilic functional groups, providing at least a second biocompatible precursor comprising at least two primary amine functional groups; optionally providing at least a third biocompatible precursor comprising at least two primary amine functional groups; wherein the first precursor, the second precursor, and the third precursor are reactable with each other to form a crosslinked hydrogel, are resistant to enzymatic degradation, and at least one of the first, second, or third precursors includes at least one isolated hydrolytically degradable ester group. And mixing at least the first precursor, the second precursor, and optionally the third precursor to form a crosslinked hydrogel in situ including covalent bonds formed by reaction of the functional groups of the precursors and further including the at least one isolated hydrolytically degradable ester group[.]

         ('3705 patent, cols. 1:58-2:7 (emphasis added))[3]

         For its part, Defendant argues that Plaintiffs' proposal improperly reads out the requirement in the claims that the first precursor, the second precursor, and the third precursor "are reactable with each other." (D.I. 231 at 28; D.I. 243 at 18-19) Defendant points out that the plain meaning of'"each"' is '"every one of two or more considered separately'" and that '"each other'" means '"each one the other.'" (See D.I. 231 at 27 (citing D.I. 232, ex. 8 at 4)) The plain language of the claims, Defendant asserts, thus requires that "each of the three precursors considered separately must be able to react with each of the other two precursors." (Id. at 27-28)

         Defendant does not dispute that primary amine functional groups are not readable with each other to form a crosslinked hydrogel (and that, as a result, a second and third precursor that each contained only "at least two primary amine functional groups" could not react with each other to form a hydrogel). But Defendant argues that its proposed construction is nevertheless sensible, and points to the "comprising" language found in the claim term at issue. "Comprising, " notes Defendant, is a term that means that the claim does not exclude additional unrecited elements; it equates to '"including at least.'" (D.I. 243 at 19 (citing Mars, Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1375-76 (Fed. Cir. 2004)). Therefore, Defendant argues, since the claims at issue recite second and third precursors each "comprising at least two primary amine functional groups[, ]" this means that "the second and third biocompatible precursors could have other functional groups besides amines, which are indeed reactable with each other as the claim requires." (Id.; see also Tr. at 179 (Defendant's ...


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