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

United States District Court, D. Delaware

March 27, 2018

INTEGRA LIFESCIENCES CORP., INTEGRA LIFESCIENCES SALES LLC, CONFLUENT SURGICAL, INC., and INCEPT LLC, Plaintiffs,
v.
HYPERBRANCH MEDICAL TECHNOLOGY, INC., Defendant. Test Description Gross Observations Histological Observations

          REPORT AND RECOMMENDATION

          CHRISTOPHER J. BURKE UNITED STATES MAGISTRATE JUDGE

         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-in-suit" 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 issue of claim construction regarding what the Court will refer to herein as the "biocompatible" claim terms. These terms are found in the preambles of the asserted claims of the '5705 patent and the '034 patent. (D.I. 520, 525, 544, 546)

         2. The Court incorporates by reference herein the discussion of general principles of claim construction set out in its July 27, 2017 Report and Recommendation. (D.I. 307 at 5-7)

         3. The Court has recently determined that the preambles from asserted claims 1, 6, 12 and 17 of the '5705 patent[1] and asserted claim 10 of the '034 patent[2] are limiting. (D.I. 483, 543) These preamble phrases require a "biocompatible ... hydrogel" or a "[biocompatible] composition[, ]" respectively. (D.I. 520 at 1; D.I. 525 at 3-4; see also D.I. 483 at 8) The present dispute is the proper claim construction for the "biocompatible hydrogel/composition" limitations of these claims. (D.I. 520, 525, 544, 546) Plaintiffs propose that "biocompatible" be construed to mean '"not harmful to living tissue.'"[3] (D.I. 520 at 1) Defendant proposes that "biocompatible hydrogel/composition" be construed to mean '"a hydrogel/composition formed from crosslinked biocompatible precursors.'" (D.I. 525 at 4) For the following reasons, the Court recommends that Defendant's proposal be adopted.

         4. The asserted patents themselves do not expressly define "biocompatible." In support of its proposal, then, Defendant starts elsewhere. It asserts that the term "biocompatible" is a broad one, with no universally accepted definition to a person of ordinary skill in the art ("POSITA"). (D.I. 525 at 4 (citing D.I. 528 at ¶ 15)); see also Marine Polymer Techs., Inc. v. HemCon, Inc., 672 F.3d 1350, 1358 (Fed. Cir. 2012) (noting that "the district court did not find that 'biocompatible' had a plain and ordinary meaning to one skilled in the art"). Defendant's expert, Dr. Anthony Lo wman, opined that "biocompatible" is a "term of degree that is inherently qualitative and open to subjectivity across a broad range of different accepted levels of 'biocompatibility.'" (D.I. 528 at ¶ 15) And indeed, the asserted patents support the notion that "biocompatible" is a term of degree, with the '034 patent's specification explaining 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." ('034 patent, col. 1:52-54 (emphasis added)) Defendant also points out that dictionaries do not provide a universal definition for "biocompatible." One general-purpose dictionary defines "biocompatible, " for example, to mean "compatible with living tissue, as a prosthetic material or device that is not rejected or does not cause infection[, ]" (D.I. 528, ex. 27), while the Williams Dictionary of Biomaterials (''Williams Dictionary") provides a "preferred" definition for "biocompatibility" as "the ability of a material to perform with an appropriate host response in a specific application[, ]" (id., ex. 26 at 40). The Williams Dictionary explains that alternate definitions such as "the quality of not having toxic or injurious effects on biological systems" are "not recommended since [they] do not address the positive or desired component of interactions between biomaterials and host tissue." (Id.) All of these sources, then, suggest that the construction of "biocompatible" should not be unduly narrow.

         5. From there, Dr. Lowman helps to move things forward by explaining that a POSITA understands that hydrogels are necessarily associated with being biocompatible "because they are water-swollen materials with properties that mimic human tissue[.]" (D.I. 527 at ¶ 23; see also D.I. 415, ex. 146 at ¶ 58 ("Hydrogels have been recognized as ideal candidates for biomedical applications because their water-swollen networks are highly biocompatible."))[4]Relatedly, the Court agrees with Defendant that: (1) the specifications of the asserted patents presume that when the recited crosslinked precursors are used to make a hydrogel, the result will be a "biocompatible hydrogel"; and (2) the patents make no mention of any relative degree of biocompatibility of the hydrogel. (D.I. 525 at 6; see also D.I. 546 at 2-3; D.I. 527 at ¶¶ 19, 24, 27; D.I. 528 at ¶ 16)

         6. With respect to the '034 patent, for instance, under the heading "Preparation of Biocompatible Polymers[, ]" the specification 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." ('034 patent, col. 22:40-44; see also Id. at Abstract ("Biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed in which the biocompatible crosslinked polymers are formed from water soluble precursors having electrophilic and nucleophilic functional groups capable of reacting and crosslinking in situ. Methods for making the resulting biocompatible crosslinked polymers biodegradable or not are provided ....") (emphasis added)) Further, the specification explains that Figure 8 "depicts the preparation of an electrophilic water soluble crosslinker or functional polymer... its crosslinking reaction with a nucleophilic water soluble functional polymer to form a biocompatible crosslinked polymer product[.]" (Id., col. 4:27-31 (emphasis added))[5]And the specification of the '034 patent also indicates elsewhere that the reactive precursor species that are used to form the hydrogel are themselves biocompatible. (See, e.g., id, col. 2:18-19 ("The present inventors have realized that use of color in biocompatible crosslinked polymers and precursors greatly improves their performance[.]"); id., col. 4:49-51 ("FIG. 13 shows the variation in gelation time with the concentration of biocompatible crosslinkedpolymer precursors, and with the solution age of the 4 arm 10 kDa carboxymethyl-hydroxybutyrate-N-hydroxysuccinimidyl PEG [] electrophilic functional polymer" (emphasis added); id, col. 4:60-62 ("The present inventors have realized that use of color in biocompatible crosslinked polymers and/or reactive precursor species improves the performance of crosslinked networks of polymers and/or reactive precursor species ...."))

         7. Similarly, with respect to the '5705 patent, claim 1 itself recites a "method of making a biocompatible degradable hydrogel... comprising ... mixing a first precursor with a second precursor .. . 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... wherein mixing the first and the second synthetic hydrophilic polymer precursors forms crosslinking covalent bonds[.]" ('5705 patent, col. 30:34-61 (emphasis added)) Dr. Lowman thus opines that "the preamble's 'biocompatible ... hydrogel' is the hydrogel that results from the crosslinking of the claimed biocompatible precursors." (D.I. 527 at ¶ 18) And like the specification of the '034 patent, the. specification of the '5705 patent indicates that when the disclosed precursors are used, a biocompatible hydrogel necessarily will result. (Id. at ¶ 19; see also, e.g., '5705 patent, Abstract ("Biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed in which the biocompatible crosslinked polymers are formed from water soluble precursors having electrophilic and nucleophilic groups capable of reacting and crosslinking in situ."); id, col. 16:60-64 ("Several biocompatible crosslinked polymers 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 1 and Table 2.")) As HyperBranch points out, "[t]here is no ... teaching that any of the hydrogels disclosed [in the asserted patents] are anything but 'biocompatible.'" (D.I. 546 at 2)

         8. The Court now turns to why, in its view, Plaintiffs' proposal (that "biocompatible" in the context of these patents means "not harmful to living tissue") is not supported by the record. First, Plaintiffs assert that their proposal, which comes from the Oxford-Dictionary, is the plain and ordinary meaning of the term. (D.I. 520 at 1 (citing D.I. 523, ex. 1 at ¶ 10); D.I. 466, ex. 7 (Oxford Dictionary defining "biocompatible" as "(especially of material used in surgical implants) not harmful or toxic to living tissue")) However, as described above, Defendant demonstrated (with support from Dr. Lowman and citations to various dictionary definitions) that the term "biocompatible" does not have any one universally accepted meaning to aPOSITA.

         9. Second, it is important to consider how Plaintiffs are interpreting their proposal. Plaintiffs assert that the POSITA would understand that: (1) whether a hydrogel is "not harmful to living tissue" is determined by "gross observation of foreign body response and histological evaluation of tissue for inflammation[;]" and (2) a hydrogel that, when used on tissue, results in tissue that appeared "normal with no inflammation or that showed histological mild inflammation" would be considered "biocompatible." (D.I. 520 at 3-6 (citing D.I. 523, ex. 1 at ¶¶ 8, 26)) Thus, in Plaintiffs' view, a hydrogel would not be biocompatible if, when used on tissue, it causes at least moderate inflammation of the tissue. (D.I. 544 at 5; see also D.I. 527 at 35 (Dr. Lowman explaining that Dr. Mays is using '"not harmful to living tissue'" as a proxy for "the absence of any histological testing that indicates at least moderate inflammation of the tissue"); D.I. 525 at 9-10 (Defendant asserting if the Court does not adopt HyperBranch's construction, it should include the actual standard being applied by Plaintiffs and construe the full term as '"not harmful to a patient as demonstrated by the absence of any histological testing that indicates moderate or severe tissue inflammation'"))

         10. With the asserted patents themselves not expressly defining "biocompatible" (or using the terms "harm" or "harmful" in connection with biocompatibility), where are Plaintiffs gleaning their interpretation of what "not harmful to living tissue" means in the context of these patents? Plaintiffs first point to United States Patent No. 6, 312, 725 ("Wallace"), which expressly defines the term "biocompatible" as "the ability of the compositions of the present invention to be applied to tissues without eliciting significant inflammation and fibrosis or other adverse tissue responses." (D.I. 423, ex. E (hereinafter, "Wallace"), col. 3:64-67)[6] Plaintiffs focus on two tables in Wallace, Table 3 and Table 4 (depicted below), which relate to Example 4 (entitled "Enhanced Biocompatibility of Thioester-linked Formulations"). (Wallace, cols. 12:55-13:35)

         TABLE 3

         Grading Key for Biocompatibility Experiments

Score

Gross Observations

Histological Observations

all tissues appeared normal

all tissues appeared normal, no inflammation

mild foreign body response

mild inflammation

moderate foreign body response

moderate inflammation

marked foreign body response

marked inflammation

severe foreign body response

severe inflammation


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