DCT

1:17-cv-00688

Confluent Surgical Inc v. HyperBranch Medical Technology Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00688, D. Del., 06/06/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware as Defendant is a Delaware corporation registered to do business in the state and maintaining a registered agent there.
  • Core Dispute: Plaintiffs allege that Defendant’s surgical sealant applicators infringe six U.S. patents related to spray applicator assemblies for mixing and dispensing multi-component medical materials.
  • Technical Context: The technology at issue involves applicator devices designed to mix and apply multi-component bioadhesives or tissue sealants, which are used for wound closure in surgical procedures, including minimally invasive endoscopic surgery.
  • Key Procedural History: The complaint alleges that Defendant has had knowledge of at least two of the patents-in-suit, U.S. Patent Nos. 8,210,453 and 9,517,478, since January 26, 2017, a date preceding the filing of the lawsuit. This allegation forms the basis for a claim of willful infringement.

Case Timeline

Date Event
2008-04-25 Earliest Priority Date for ’483 and ’021 Patents
2008-09-12 Earliest Priority Date for ’453, ’468, ’946, ’478 Patents
2011-10-11 U.S. Patent No. 8,033,483 Issues
2012-07-03 U.S. Patent No. 8,210,453 Issues
2013-12-31 U.S. Patent No. 8,616,468 Issues
2014-11-04 U.S. Patent No. 8,876,021 Issues
2015-08-11 U.S. Patent No. 9,101,946 Issues
2016-12-13 U.S. Patent No. 9,517,478 Issues
2017-01-26 Alleged date of Defendant's knowledge of ’453 & ’478 Patents
2017-06-06 Complaint Filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 9,517,478 - "Spray Applicator"

Issued December 13, 2016 (’478 Patent)

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of applying bioadhesives in surgical settings, particularly in endoscopic procedures. These materials are often composed of multiple reactive components that must be mixed immediately prior to application to prevent premature polymerization and hardening, which would render the applicator useless. (Compl., Ex. A, ’478 Patent, col. 1:21-39).
  • The Patented Solution: The invention is a spray applicator assembly that keeps components separate until the point of application. It features a connector for component sources, an elongated body, and a tip with an internal mixing chamber. A key component is an "insert member" placed inside the mixing chamber, which contains at least one "radially extending slot." This structure is designed to create turbulence and force the components to mix thoroughly just before being sprayed from the tip's outlet. (’478 Patent, Abstract; col. 5:16-24).
  • Technical Importance: This design offers a method for reliable and controlled application of multi-component sealants in minimally invasive surgery, where precision and prevention of clogging are critical. (’478 Patent, col. 1:35-39).

Key Claims at a Glance

  • The complaint asserts claims 1-10. (Compl. ¶24). Independent claim 1 is representative.
  • Claim 1 of the ’478 Patent requires:
    • A connector portion for a first component, a second component, and pressurized air.
    • An elongated portion extending from the connector.
    • A tip assembly connected to the elongated portion, defining a mixing chamber and an outlet.
    • An insert member within the mixing chamber, with its distal end defining an annular recess and at least one radially extending slot to facilitate mixing.
  • The complaint asserts infringement of dependent claims 2-10, which add limitations such as the number and configuration of slots, the presence of a connector, and specific materials. (Compl. ¶24).

U.S. Patent No. 8,210,453 - "Spray Applicator"

Issued July 3, 2012 (’453 Patent)

The Invention Explained

  • Problem Addressed: Similar to the ’478 patent, this invention seeks to solve the problem of applying multi-component bioadhesives through an endoscopic port without premature mixing. (’453 Patent, col. 1:19-39).
  • The Patented Solution: The patent describes a spray assembly comprising a connector, an elongated member with separate lumens for two components and a pressurized fluid, and a tip with a mixing chamber. The innovation centers on an "insert member" within the mixing chamber that has radially extending slots on both its first (proximal) and second (distal) ends. This dual-end slot configuration is designed to ensure thorough mixing of the components before they exit the tip. (’453 Patent, Abstract; col. 5:16-24).
  • Technical Importance: The use of a multi-lumen shaft and a dual-ended mixing insert provides a robust system for delivering precisely mixed, multi-component materials in demanding surgical environments. (’453 Patent, col. 1:19-27).

Key Claims at a Glance

  • The complaint asserts claims 1, 2, 4, and 5. (Compl. ¶24). Independent claim 1 is representative.
  • Claim 1 of the ’453 Patent requires:
    • A connector for two components and a pressurized fluid.
    • A tip with an opening and a mixing chamber.
    • An elongated member between the connector and tip with three separate lumens (one for each component and one for the fluid).
    • An insert member in the mixing chamber with at least one radially extending slot on a first end and at least one on a second end, each configured to mix the components.
  • The complaint also asserts dependent claims 2, 4, and 5. (Compl. ¶24).

U.S. Patent No. 8,876,021 - "Silicone Spray Tip"

Issued November 4, 2014 (’021 Patent)

Technology Synopsis

This patent focuses on preventing clogs in applicator tips used for reactive bioadhesives. The solution is to construct the spray tip from a flexible material like silicone. The flexibility allows the tip to expand under pressure to dislodge any hardened material, while the inherent non-wetting (hydrophobic) properties of silicone help prevent clogs from forming in the first place. (Compl., Ex. C, ’021 Patent, col. 3:50-col. 4:5).

Asserted Claims

Claims 14-16. (Compl. ¶24).

Accused Features

The applicators for the Adherus AutoSpray Dural Sealant and/or Adherus AutoSpray Extended Tip (ET) Dural Sealant. (Compl. ¶24).

U.S. Patent No. 8,033,483 - "Silicone Spray Tip"

Issued October 11, 2011 (’483 Patent)

Technology Synopsis

A related patent to the ’021 Patent, this invention describes a complete applicator assembly with a manifold, shaft, and tip. The tip assembly itself defines multiple chambers (first, intermediate, and final) and uses an insert to promote mixing. The patent specifies that the tip assembly and/or the insert can be composed of silicone, leveraging its flexible and unclogging properties. (Compl., Ex. D, ’483 Patent, Abstract; col. 3:50-col. 4:2).

Asserted Claims

Claims 19, 20, and 21. (Compl. ¶24).

Accused Features

The applicators for the Adherus AutoSpray Dural Sealant and/or Adherus AutoSpray Extended Tip (ET) Dural Sealant. (Compl. ¶24).

U.S. Patent No. 8,616,468 - "Spray Applicator"

Issued December 31, 2013 (’468 Patent)

Technology Synopsis

This patent describes a spray assembly featuring an elongated member with an inner multi-lumen shaft and a surrounding outer sleeve, which together define a vent lumen. The assembly includes a tip with a mixing chamber and an insert member having slots on both its proximal and distal ends to induce a swirling motion that thoroughly mixes the components. (Compl., Ex. E, ’468 Patent, Abstract; col. 5:40-54).

Asserted Claims

Claims 1, 2, 4, 5, and 7. (Compl. ¶24).

Accused Features

The applicators for the Adherus AutoSpray Dural Sealant and/or Adherus AutoSpray Extended Tip (ET) Dural Sealant. (Compl. ¶24).

U.S. Patent No. 9,101,946 - "Spray Applicator"

Issued August 11, 2015 (’946 Patent)

Technology Synopsis

This patent details a spray assembly where the insert member within the mixing chamber has an annular recess and at least one radially extending slot at its distal end. A key feature is the potential for a cavity to be formed between the distal end of the elongated fluid-delivery portion and the proximal end of the insert, creating a space for initial mixing to occur before the components encounter the insert's mixing slots. (Compl., Ex. F, ’946 Patent, Abstract; col. 8:3-12).

Asserted Claims

Claims 1-5, 7-9, 11, and 12. (Compl. ¶24).

Accused Features

The applicators for the Adherus AutoSpray Dural Sealant and/or Adherus AutoSpray Extended Tip (ET) Dural Sealant. (Compl. ¶24).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are the "applicator for its Adherus AutoSpray Dural Sealant and/or the applicator for its Adherus AutoSpray Extended Tip (ET) Dural Sealant" (the "Adherus Applicators"). (Compl. ¶24).

Functionality and Market Context

The complaint alleges that Defendant designs, manufactures, and sells restorable surgical sealants and the applicators used to apply them. (Compl. ¶15). These applicators are described as assemblies for mixing components of a polymer or synthetic material for wound closure and dispensing the resulting mixture as a bioadhesive or tissue sealant. (Compl. ¶21). The complaint does not provide specific technical details on the design or operation of the Adherus Applicators, instead referring to exemplary infringement charts in Exhibits G-P, which were not filed with the public complaint. (Compl. ¶24, 15).
No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint alleges that the Adherus Applicators infringe the asserted claims either literally or under the doctrine of equivalents. (Compl. ¶24). However, the complaint provides its detailed infringement analysis in Exhibits G through P, which were not available for this analysis. The complaint's narrative does not contain sufficient detail to construct a claim chart mapping specific product features to claim elements. The infringement theory is broadly that the Adherus Applicators incorporate the patented technology for mixing and dispensing multi-component surgical sealants. (Compl. ¶¶ 21, 24).

Identified Points of Contention

  • Technical Questions: A primary technical question will be whether the Adherus Applicators contain a physical structure that performs the same function in substantially the same way to achieve the same result as the claimed "insert member". The specific geometry, number, and function of any mixing features within the accused devices will be compared to the patents' descriptions of "radially extending slots" that create a swirling or turbulent flow.
  • Scope Questions: The litigation may focus on the proper construction of the term "insert member". The patent embodiments consistently depict this as a discrete component placed inside the applicator tip. A potential point of contention is whether this term can be construed to read on a mixing structure that is integrally molded or formed as part of the tip, rather than being a separate, inserted piece.

V. Key Claim Terms for Construction

For the ’453 Patent

  • The Term: "insert member"
  • Context and Importance: This term is the structural heart of the claimed invention's mixing mechanism. The entire infringement analysis for several of the patents will depend on whether the accused devices contain a structure that meets the court's definition of an "insert member".
  • Intrinsic Evidence for a Broader Interpretation: The claims use the general term "member," which could be argued to encompass any structure, whether separate or integral, that is "configured to be received in the mixing chamber." (’453 Patent, col. 6:46-47).
  • Intrinsic Evidence for a Narrower Interpretation: The specification and figures consistently depict the "insert member" (e.g., element 80) as a physically separate component that is placed inside the mixing chamber (74) of the tip (70). (’453 Patent, Figs. 10, 14). Language such as "insert 80 is received immediately adjacent to, or flush against, the distal end of mixing chamber 74" suggests two distinct parts coming into contact. (’453 Patent, col. 4:56-59).

For the ’478 and ’453 Patents

  • The Term: "radially extending slot"
  • Context and Importance: This term defines the specific mixing geometry of the insert. Whether the channels or passages in the accused device meet this structural and functional limitation will be a key factual dispute.
  • Intrinsic Evidence for a Broader Interpretation: The term itself is primarily structural, and a party could argue that any slot extending from a central axis in a radial direction meets the plain meaning of the term.
  • Intrinsic Evidence for a Narrower Interpretation: The specification repeatedly links this structure to a specific function: creating a "turbulent or swirling motion." (’453 Patent, col. 5:21-24). Figures such as Fig. 13C of the ’453 patent show the slots (82a) as curved and angled, not merely straight, to impart this swirl. A defendant might argue that the term should be limited to structures that are angled to create this specific type of mixing action, not just any radial passage.

VI. Other Allegations

Indirect Infringement

The complaint alleges multiple forms of indirect infringement. It claims induced infringement under 35 U.S.C. § 271(b), based on allegations that Defendant encourages and intends for its customers to use the Adherus Applicators in an infringing manner, which may point to evidence from user manuals or instructions for use. (Compl. ¶31). It also alleges contributory infringement under § 271(c), asserting that the accused applicators are a material part of the invention, are not staple articles of commerce, and are known to be especially made for an infringing use. (Compl. ¶45). Finally, it alleges infringement for supplying components from the U.S. for combination abroad under both § 271(f)(1) and § 271(f)(2). (Compl. ¶¶ 38, 52).

Willful Infringement

Willfulness is alleged based on both pre-suit and post-suit knowledge. The complaint asserts Defendant was aware of the ’453 and ’478 patents since at least January 26, 2017, and that continued infringement thereafter has been deliberate. (Compl. ¶25). For all patents-in-suit, it alleges knowledge as of the filing of the complaint, forming a basis for willful infringement for any post-filing conduct. (Id.). Plaintiffs seek treble damages as a result. (Compl., p. 13, ¶g).

VII. Analyst’s Conclusion: Key Questions for the Case

  • Structural and Functional Equivalence: A central factual question will be one of technical comparison: does the internal mechanism of the Adherus Applicators operate in substantially the same way as the claimed inventions? Specifically, does it employ a structure analogous to the claimed "insert member" with "radially extending slots" to achieve mixing, or does it rely on a fundamentally different mixing technology?
  • Definitional Scope of Core Components: The case will likely involve significant disputes over claim construction. A key legal question will be how broadly to define terms like "insert member". The court's decision on whether this term is limited to a separate physical component, as shown in the patents' embodiments, or can encompass an integral feature of the applicator tip could be dispositive for infringement.
  • Pre-Suit Knowledge and Willfulness: A critical issue for damages will be the allegation of willfulness. The case will examine what notice or knowledge, if any, Defendant had of the patents prior to the lawsuit, particularly concerning the alleged awareness date of January 26, 2017. The evidence supporting this date will determine whether Defendant faces a risk of enhanced damages for deliberate infringement.