Integra LifeSciences Corp. v. HyperBranch Medical Technology, Inc, 1:15-cv-00819

Background

Plaintiffs (Integra et al.) sued HyperBranch for infringement of six patents asserting hydrogels that are biodegradable and include visualization agents; this Report & Recommendation addresses claim construction for Group C terms.
Three disputed claim terms: (1) "chemical groups that are prone to aqueous hydrolysis," (2) "the biodegradable groups of the hydrogel consist of the esters," and (3) "essentially completely degradable."
Parties submitted competing constructions and relied on intrinsic record (claims, specification, prosecution history) and extrinsic expert declarations; a Markman hearing was held.
Key intrinsic evidence: specification lists exemplary biodegradable linkages (esters, carbonates, amides, polyesters, polyanhydrides, etc.) and examples showing a small amount of gel could remain while achieving desired results.
Prosecution history for the '5705 patent shows applicants amended claims to add the "consist of the esters" language to distinguish prior art and stated that adding non-ester biodegradable materials would place the precursor outside the claims.
The Magistrate Judge recommends specific constructions for the three terms but leaves open the possibility that Defendant may later pursue indefiniteness for the term of degree at summary judgment.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Meaning of "chemical groups that are prone to aqueous hydrolysis"	Term means chemical groups susceptible to reaction with water to break bonds; should not be limited to three examples	Should be construed to "chemical linkages... susceptible to degradation through reaction with water, such as an ester, carbonate, or amide linkage" to identify exemplars and avoid exclusion	Court adopted Defendant's formulation as exemplary language: construed to mean chemical linkages susceptible to hydrolytic degradation, such as ester, carbonate, or amide linkages
Scope of "the biodegradable groups of the hydrogel consist of the esters"	Means esters are the only biodegradable groups responsible for in‑patient degradation within the claimed time, and does not exclude other biodegradable groups per se	"Consist of" is limiting: hydrogel contains no biodegradable linkages other than esters; prosecution history confirms narrowing to esters to overcome prior art	Court held "consist of" is exclusionary and construed the phrase to mean the hydrogel does not contain any biodegradable linkages other than ester linkages
Meaning / definiteness of "essentially completely degradable"	Means degradation is nearly, though not entirely, complete (small remainder allowed)	Term is indefinite (subjective "essentially"), lacks objective boundaries in intrinsic record	Court construed term to mean "degradable to the extent that no more than a small amount of the hydrogel remains," but left open Defendant's ability to challenge indefiniteness later at summary judgment

Key Cases Cited

Conoco, Inc. v. Energy & Envtl. Int'l, L.C., 460 F.3d 1349 (Fed. Cir. 2006) ("consisting of" signifies exclusion/restriction)
Vehicular Techs. Corp. v. Titan Wheel Int'l, Inc., 212 F.3d 1377 (Fed. Cir. 2000) ("consisting of" means claim covers only recited elements)
Norian Corp. v. Stryker Corp., 363 F.3d 1321 (Fed. Cir. 2004) (limitation that does not relate to the invention may be treated differently)
Shire Dev., LLC v. Watson Pharms., Inc., 848 F.3d 981 (Fed. Cir. 2017) ("rare exception" to strict application of "consisting of")
Anchor Wall Sys., Inc. v. Rockwood Retaining Walls, Inc., 340 F.3d 1298 (Fed. Cir. 2003) (words of approximation explained)
Sonix Tech. Co., Ltd v. Publ'ns Int'l Ltd, 844 F.3d 1370 (Fed. Cir. 2017) (claim terms read in context of the invention)
Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364 (Fed. Cir. 2014) (terms must inform skilled artisan of claim scope when read in context)
Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (U.S. 2014) (definiteness standard for patent claims)