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

United States District Court, D. Delaware

August 18, 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"), Integra LifeSciences Sales LLC ("Integra Sales"), Confluent Surgical, Inc. ("Confluent") and Incept LLC ("Incept") (collectively, "Plaintiffs") against Defendant HyperBranch Medical Technology, Inc. ("HyperBranch" or "Defendant"), 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 three 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 three disputed terms addressed herein in the order in which the parties addressed them at the Markman hearing.

         A. "chemical groups that are prone to aqueous hydrolysis"

         The term "chemical groups that are prone to aqueous hydrolysis" is found in the independent claims of the '566 patent and the '418 patent. Plaintiffs propose that the term be construed to mean "[c]hemical groups susceptible to reaction with water to break chemical bonds and to degrade[.]" (D.I. 230 at 24) Defendant proposes that it be construed to mean'" [c]hemical linkages that are susceptible to degradation through reaction with water to break chemical bonds, such as an ester, carbonate, or amide linkage[.]"' (D.I. 231 at 8) The term's usage in claim 1 of the '566.patent is representative:

1. A polymeric coating for a substrate comprising: water, a biocompatible visualization agent, and a biodegradable hydrogel, that is essentially completely degradable in vivo by hydro lytic degradation, with the hydrogel having an interior and an exterior, with the exterior having a substrate coating surface, and the visualization agent being at least partially disposed within the interior, wherein the hydrogel comprises chemical groups that are prone to aqueous hydrolysis and is thereby degradable in vitro by exposure to aqueous solution, and wherein the visualization agent has a predetermined concentration that indicates a predetermined thickness of the hydrogel as deposited on the substrate.

('566 patent, col. 39:2-15 (emphasis added))

         The most significant dispute between the parties is whether it is proper for the construction of this term to include the language "such as an ester, carbonate, or amide linkage." (See D.I. 230 at 25; D.I. 241 at 13) For its part, Defendant asserts that the patents expressly identify these as exemplary linkages that are susceptible to degradation by reaction with water to break their chemical bonds. (D.I. 231 at 8-9) For support, it points to a portion of the '566 patent specification, which describes an embodiment of the invention as a hydrogel that has "water, a biocompatible visualization agent, and crosslinked hydrophilic polymers that form a hydrogel after contact with the [patient's] tissue.. . . The polymers preferably also have a hydrolytically biodegradable portion or linkage, for example an ester, carbonate, or an amide linkage.'1'' ('566 patent, col. 6:22-25, 44-47 (emphasis added))[2] Defendant contends that inclusion of these examples in the construction ensures that Plaintiffs will not "exclude them from the scope of the claims[.]" (D.I. 231 at 9)

         Plaintiffs raise a few different concerns with Defendant's proposal. The Court will address them in turn.

         First, Plaintiffs assert that Defendant's construction improperly seeks to "limit this term to 3 specific chemical species: (1) esters; (2) carbonates and (3) amides." (D.I. 230 at 25) And Plaintiffs then point to the specification as describing "a number of chemical species that can be used without limitation to only the three named by Defendant[.]" (Id.) The portion of the specification that Plaintiffs cite here is entitled "Biodegradable Linkages[, ]" and it teaches that:

If it is desired that the biocompatible crosslinked polymer be biodegradable or absorbable, one or more precursors having biodegradable linkages present in between the functional groups may be used. The biodegradable linkage optionally also may serve as the water soluble core of one or more of the precursors. In the alternative, or in addition, the functional groups of the precursors may be chosen such that the product of the reaction between them results in a biodegradable linkage. For each approach, biodegradable linkages may be chosen such that the resulting biodegradable biocompatible crosslinked polymer will degrade or be absorbed in a desired period of time. Preferably, biodegradable linkages are selected that degrade under physiological conditions into non-toxic products.
The biodegradable linkage may be chemically or enzyxnatically hydrolyzable or absorbable. Illustrative chemically hydrolyzable biodegradable linkages include polymers, copolymers and oligomers of glycolide, dl-lactide, 1-lactide, caprolactone, dioxanone, and tritnethylene carbonate. Illustrative enzymatically hydrolyzable biodegradable linkages include peptidic linkages cleavable by metalloproteinases and collagenases. Additional illustrative biodegradable linkages include polymers and copolymers of poly(hydroxy acid)s, poly(orthocarbonate)s, poly(anhydride)s, poly(lactone)s, poly(amino acid)s, poly(carbonate)s, and poly(phosponate)s.

('566 patent, col. 10:19-44 (cited in D.I. 230 at 25)) In light of this teaching, Plaintiffs assert, Defendant's proposal would improperly exclude these exemplary embodiments of the limitation. (D.I. 241 at 13; see also D.I. 230 at 26 ("[Because] there is no expression of manifest exclusion[, ] there is no basis to limit this claim limitation to certain embodiments advanced by the Defendant[.]"))

         Defendant's proposal would do no such thing. The proposal recites "chemical linkages .. . such as an ester, carbonate, or amide linkage." The plain import of that construction, then, is not to limit the term to only encompassing an ester, carbonate or amide linkage, but instead to provide these three chemical species as exemplary chemical groups that would fall within the scope of the claim term. (D.I. 243 at 7; D.I. 244 at ¶ 11; Tr. at 155) The other examples listed in the patent would not be excluded by this language.

         Plaintiffs next argue that it is especially improper to import these embodiments into the construction because they relate to a different concept-i.e., "hydrolytically degradable"-rather than to "chemical groups that are prone to aqueous hydrolysis" (the claim term at issue). (D.I. 241 at 13) But it is clear from the claims that the claim language at issue here has a direct relation to the concept of "hydrolytic degradation." Claim 1 of the '566 patent, set out above, recites a hydrogel "that is essentially completely degradable in vivo by hydrolytic degradation .. . wherein the hydrogel comprises chemical groups that are prone to aqueous hydrolysis and is thereby degradable in vitro by exposure to aqueous solution[.]" ('566 patent, col. 39:4-12 (emphasis added)) And thus, polymers with a "hydrolytically biodegradable portion or linkage" such as an ester, carbonate or an amide linkage, would be "susceptible to [aqueous] hydrolysis[, ]" which Defendant's expert states means the same thing as "hydrolytic degradation." (D.I.232at¶83)[3]

         During the Markman hearing, Plaintiffs' counsel additionally asserted that Defendant's construction is improper because it utilizes the term "linkages" instead of "groups." (Tr. at 138) That is, the claim language recites "chemical groups that are prone to aqueous hydrolysis" whereas Defendant's construction (and the portion of the specification that the construction relies upon) refers to "linkage[s]." According to Plaintiffs, the linkage that is formed is "part of a group"-"the group encompasses more than just the linkage." (Id. at 139-40) Defendant retorted that "the patent uses these terms [']linkages['] and [']groups['] synonymously." (Id. at 156) Dr. Lowman likewise appears to view them as synonymous in this context, opining that "the Asserted Patents ...


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