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

United States District Court, D. Delaware

January 16, 2018




         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 question of whether the preambles from asserted claims 1, 6, 12 and 17 of the '5705 patent and asserted claim 10 of the '034 patent are limiting. (See D.I. 402 at 23-24; D.I. 443 at 27; D.I. 467 at 3 & n.1; D.I. 482 at 151 (hereinafter, "Tr."))[1] For the reasons set out below, the Court recommends that the District Court find that the preambles are limiting.

         2. The question of whether language in a preamble constitutes a claim limitation is a question of law. Rotatable Techs. LLC v. Motorola Mobility LLC, 567 Fed.Appx. 941, 943 (Fed. Cir. 2014). "While it is true that preamble language is often treated as nonlimiting in nature, it is not unusual for [the United States Court of Appeals for the Federal Circuit] to treat preamble language as limiting[.]" Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006). Generally, "a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning and vitality to the claim." Catalina Mktg. Int'l, Inc. v., Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (internal quotation marks and citation omitted); see also Intellectual Ventures I LLC v. AT & T Mobility LLC, C.A. No. 12-193-LPS, 2015 WL 1393386, at *24 (D. Del. Mar. 24, 2015). A preamble may also be construed as limiting when the claim limitations in the body of claim "rely upon and derive antecedent basis from the preamble[.]" Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003). On the other hand, when the claim body recites a structurally complete invention and the preamble language is used merely to state the purpose or intended use of the invention, the preamble is generally not treated as limiting the scope of the claim. Catalina, 289 F.3d at 808.

         3. There is no "litmus test" for determining whether preamble language is limiting. Id. Rather, whether such language is limiting is assessed in regard to "the facts of each case in light of the claim as a whole and the invention described in the patent." Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003); see also Catalina, 289 F.3d at 808 ("Whether to treat a preamble as a limitation is a determination resolved only on review of the entire .. . patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.") (internal quotation marks and citation omitted).

         4. Turning first to the '5705 patent, claim 1 of that patent recites:

1. A method of making a biocompatible degradable hydrogel to treat a medical condition of a patient comprising:
identifying a medical condition for treatment by use of a hydrogel formed in situ in a patient and fully degradable in a patient in less than about 180 days; and
mixing a first precursor with a second precursor in situ in the patient to form the hydro gel for treatment of the medical condition, 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; and wherein
(i) the first precursor is selected to have only one or two chemically hydrolytically degradable ester bonds per every electrophilic functional group on the first precursor; and
(ii) the second precursor comprises at least three nucleophilic functional groups; wherein the biodegradable groups of the hydrogel consist of the esters and the hydrogel as placed in situ in the patient is essentially fully degradable in a patient in less than about 180 days, and wherein mixing the first and the second synthetic hydrophilic polymer precursors forms crosslinking covalent bonds that are reaction products of the electrophilic and the nucleophilic groups, wherein essentially every ester bond in the hydrogel is separated from other ester bonds in the hydrogel by at least three covalent bonds when the hydrogel is formed.

('5705 patent, col. 30:34-65)[2]

         5. HyperBranch argues that the preamble language of claim 1 of the '5705 patent (i.e., "[a] method of making a biocompatible degradable hydrogel to treat a medical condition of a patient comprising") is non-limiting because it describes only an intended use, with the body of claim 1 itself defining a structurally complete invention. (D.I. 402 at 23) The claim body covers a "first precursor" and "second precursor" that are biocompatible, and according to HyperBranch, that is all that is required to satisfy the claim in terms of biocompatibility. (Id.) HyperBranch further asserts that the preamble is non-limiting because: (1) there is no antecedent basis in the preamble for any of the elements recited in the claim body; and (2) the preamble was not relied upon during prosecution to distinguish the invention over the prior art. (Id.) For its part, Integra argues that "a biocompatible hydrogel" in the preamble of claim 1 of the '5705 patent is an affirmative limitation because the references to "hydrogel" in the claim body refer back to the preamble, and because the biocompatibility of the hydrogel is a fundamental aspect of the inventions described in the patent. (See Integra's Opposition to Defendant's Summary Judgment of Invalidity Slide Presentation, Slide 11)

         6. The Federal Circuit has explained that where language in the preamble recites additional structure underscored as important by the patent specification, the preamble may operate as a claim limitation. Catalina, 289 F.3d at 808; see also, e.g., Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (explaining that to determine whether preamble language is a structural limitation, the court should "examin[e] the entire patent record to determine what invention the patentee intended to define and protect"). Here, the Court believes that the preamble's reference to "a biocompatible ... hydrogel" is in fact a reference to structure that the intrinsic record describes as being very important to the invention.[3]

         7. For one, the title of the '5705 patent itself is "Biocompatible Polymers and Hydrogels and Methods of Use." ('5705 patent at 1) Moreover, the remainder of the specification repeatedly describes the invention as relating to "biocompatible crosslinked polymers." For instance, the Abstract explains that "[biocompatible crosslinked polymers, and methods for their preparation and use, are disclosed[.]" (Id.) The "Field of the Invention" section of the patent notes that the invention relates to "biocompatible crosslinked polymers[.]" (Id., col. 1:16-17) The "Summary of Invention" section also repeatedly notes that objects of the invention are to provide "biocompatible crosslinked polymers" and methods for their use. (Id., col. 4:21-61) As yet another example, the "Detailed Description of the Invention" section of the patent begins by stating that "[t]he novel biocompatible ...

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