DCT
1:18-cv-01869
Boston Scientific Corp v. Micro Tech Endoscopy USA Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Boston Scientific Corporation (Delaware) and Boston Scientific SciMed, Inc. (Minnesota)
- Defendant: Micro-Tech Endoscopy USA Inc. (Delaware), Micro-Tech (Nanjing) Co., Ltd. (China), and Henry Schein Inc. (Delaware)
- Plaintiff’s Counsel: Dechert LLP
- Case Identification: 1:18-cv-01869, D. Del., 11/26/2018
- Venue Allegations: Venue is alleged to be proper for Defendants Micro-Tech USA and Henry Schein as they are incorporated in Delaware. For Defendant Micro-Tech Nanjing, a Chinese corporation, venue is based on the alien-venue rule.
- Core Dispute: Plaintiff alleges that Defendant’s SureClip line of hemostasis clips infringes three patents related to endoscopic clipping devices featuring specific mechanisms for clip deployment and release.
- Technical Context: The technology concerns endoscopic hemostatic clips, which are critical medical devices delivered through an endoscope to clamp tissue and stop internal gastrointestinal bleeding.
- Key Procedural History: The complaint asserts U.S. Patent No. 8,974,371. Subsequent to the filing of this complaint, this patent was the subject of an Inter Partes Review (IPR2017-00135). In a certificate issued February 9, 2021, the U.S. Patent and Trademark Office cancelled asserted Claim 11, which may render the infringement count based on that patent (Count III) moot.
Case Timeline
| Date | Event |
|---|---|
| 2001-10-05 | Earliest Priority Date for ’245 Patent |
| 2004-05-05 | Earliest Priority Date for ’371 Patent and ’725 Patent |
| 2006-08-22 | ’245 Patent Issued |
| 2015-03-10 | ’371 Patent Issued |
| 2016-10-27 | Inter Partes Review (IPR) filed against ’371 Patent |
| 2018-05-29 | ’725 Patent Issued |
| 2018-11-26 | Complaint Filed |
| 2021-02-09 | IPR Certificate issued cancelling asserted Claim 11 of ’371 Patent |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,980,725 - “Through the Scope Tension Member Release Clip,” issued May 29, 2018
The Invention Explained
- Problem Addressed: The patent family addresses the challenge of accurately deploying hemostatic clips deep within a patient's body via an endoscope. Improper positioning can require additional clips, extending procedure time, while incomplete release of a deployed clip poses a significant safety risk. (’371 Patent, col. 1:26-40).
- The Patented Solution: The invention is an apparatus for applying clips that features a control member with a "separable yoke." This yoke includes two arms that releasably couple to a connecting member on the clip assembly itself. By applying a "predetermined force," the yoke arms are configured to separate from the connecting member, thereby uncoupling the control member and deploying the clip in a controlled manner. (’725 Patent, Claim 1, as recited in Compl. ¶23; ’371 Patent, Abstract).
- Technical Importance: This mechanism is designed to provide clinicians with a more reliable and distinct release action, offering clearer feedback that the clip has been successfully deployed and detached from the delivery tool. (’371 Patent, col. 1:41-65).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 and Claim 12 (Compl. ¶22).
- Independent Claim 1 requires:
- A flexible sheath extending into a living body.
- A capsule with a proximal and distal end.
- A clip assembly within the capsule, movable between a closed and an expanded configuration.
- A control member releasably coupled to the clip assembly via a "separable yoke" to move the clip assembly.
- Wherein the separable yoke has first and second yoke arms that couple to a connecting member on the clip assembly, and the yoke arms are configured to separate from the connecting member when subjected to a "predetermined force" to uncouple the control member from the clip. (Compl. ¶23).
U.S. Patent No. 7,094,245 - “Device and Method for Through the Scope Endoscopic Hemostatic Clipping,” issued August 22, 2006
The Invention Explained
- Problem Addressed: The patent’s background section notes that prior art endoscopic clipping devices, such as the Olympus EndoClip, were often not reversible. Once the process of closing the clip's jaws began, the operator was committed to deploying it, which could lead to misplacement and the need to use multiple clips to achieve hemostasis. (’245 Patent, col. 2:25-34).
- The Patented Solution: The invention solves this problem with a fully reversible clipping device. A control wire can repeatedly open and close the clip’s jaws, allowing the operator to grasp and release tissue multiple times for ideal positioning. The final deployment is triggered by applying a predetermined tensile force to a "breakable link" that permanently uncouples the control wire from the clip. (’245 Patent, Abstract; col. 2:50-60).
- Technical Importance: The ability to reposition the clip multiple times before final deployment represented a significant advance, designed to increase the success rate of single-clip hemostasis and reduce procedural complexity. (’245 Patent, col. 2:61-64).
Key Claims at a Glance
- The complaint asserts infringement of at least Claim 1 (Compl. ¶¶37-38).
- Independent Claim 1 requires:
- A clip with at least two clip legs.
- A "breakable link" that couples a control wire to the clip and is broken by a "first predetermined tensile force."
- A control wire that is "reversibly operable" to both open and close the clip legs.
- An axially rigid sheath, a handle, and an actuator.
- Wherein breaking the link causes the control wire to uncouple from the clip. (Compl. ¶37).
U.S. Patent No. 8,974,371 - “Through the Scope Tension Member Release Clip,” issued March 10, 2015
- Patent Identification: U.S. Patent No. 8974371, "Through the Scope Tension Member Release Clip," issued March 10, 2015 (Compl. ¶1).
- Technology Synopsis: This patent describes a hemostatic clipping apparatus with a control element that detaches from the clip assembly via a "frangible link." The design focuses on providing distinct, multi-stage user feedback to confirm both that the clip is closed on the target tissue and that it has been successfully released from the delivery tool, aiming to improve deployment certainty. (’371 Patent, Abstract; col. 1:41-65).
- Asserted Claims: At least Claim 11 (Compl. ¶51).
- Accused Features: The complaint accuses the SureClip products’ combination of a capsule, a clip assembly, a control element with a frangible link, and a releasably coupled sheath of infringement (Compl. ¶¶54-58).
III. The Accused Instrumentality
Product Identification
- The SureClip, SureClip MINI, and SureClip PLUS Hemostasis Clips (collectively, "the SureClip products") (Compl. ¶17).
Functionality and Market Context
- The accused SureClip products are medical devices indicated for endoscopic clip placement within the gastrointestinal tract (Compl. ¶25, ¶39). The complaint alleges they are used for applying clips to tissue to achieve hemostasis (Compl. ¶25).
- The complaint describes the accused products as having a flexible sheath, a capsule containing clip arms, a control wire, and a handle that allows an operator to manipulate the device (Compl. ¶¶26, 27, 42, 43). An image from the product's information sheet shows the clip arms housed in a capsule at the distal end of the device (Compl. ¶27; Ex. F, p. 1).
- The complaint alleges the design permits repositioning by opening and closing the clip jaw prior to final deployment (Compl. ¶40; Ex. F, p. 2). Final deployment is allegedly achieved by applying a "sufficient predetermined force" that releases a pair of "J hooks" from the clip assembly, thereby uncoupling the control wire (Compl. ¶29, ¶41).
- The complaint positions the Defendants as direct competitors to the Plaintiffs in the U.S. market for endoscopic hemostatic clips (Compl. ¶18).
IV. Analysis of Infringement Allegations
’725 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a clip assembly provided in the capsule and configured to be operably movable between a closed configuration ... and an expanded configuration... | The accused products contain clip arms within a capsule; forces applied through a control wire cause the clip arms to be drawn together or to separate to receive tissue. (Compl. ¶28). The product's "Instructions for Use" depict this operational movement. (Compl. ¶29; Ex. D, Figs. 9-10). | ¶28 | col. 8:36-52 |
| a control member a distal end of which is releasably coupled to the clip assembly via a separable yoke... | The accused products contain a control wire, the distal end of which is releasably connected to the clip assembly. | ¶29 | col. 9:53-61 |
| wherein the separable yoke includes first and second yoke arms ... and the clip assembly includes a connecting member ... coupling the yoke to the clip assembly... | The complaint alleges the accused products contain a pair of "J hooks" that extend from the control wire and connect to the clip assembly. | ¶29 | col. 9:62-65 |
| the first and second yoke arms being configured to be separated from the connecting member when subjected to a predetermined force by the control member to uncouple the control member from the clip assembly. | Application of a "sufficient predetermined force" is alleged to release the J hooks, and thus the control wire, from the clip assembly. (Compl. ¶29). | ¶29 | col. 8:10-15 |
’245 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a clip, the clip having at least two clip legs; | The accused products contain a clip with two clip arms. (Compl. ¶40). A product image shows the clip with multiple arms. (Compl. ¶41; Ex. F, p. 1). | ¶40 | col. 5:15-20 |
| the control wire reversibly operable both to open the at least two clip legs and to close the at least two clip legs when the control wire is coupled to the clip; | The accused products are described as having a "unique design [that] permits opening and closing the jaw prior to deployment," which the complaint alleges meets this limitation. | ¶40 | col. 2:50-54 |
| a breakable link adapted to couple a control wire to the clip and adapted to be broken by a first predetermined tensile force applied by the control wire; | The complaint alleges that the accused products' J hooks, which releasably connect the control wire to the clip assembly, form a "breakable link" that, when "broken" by a sufficient force, uncouples the control wire. | ¶41 | col. 7:25-33 |
| an actuator coupled to the control wire, the control wire engageable by the actuator to ... uncouple the control wire from the clip; | The accused products' handle and actuator are alleged to engage the control wire to open and close the clip and, upon application of sufficient force, to decouple the control wire. An operational diagram shows a user manipulating a handle to actuate the clip. (Compl. ¶44; Ex. D, Fig. 7). | ¶44 | col. 2:55-60 |
- Identified Points of Contention:
- Scope Questions: A central dispute for both the ’725 and ’245 patents will be one of claim scope. For the ’725 patent, the question is whether the accused products' "pair of J hooks" that release from the clip assembly (Compl. ¶29) constitutes a "separable yoke with first and second yoke arms" as claimed. For the ’245 patent, the question is whether the release of these J-hooks constitutes the breaking of a "breakable link," as the patent specification appears to contemplate physical deformation or destruction of the link itself (’245 Patent, col. 7:38-44).
- Technical Questions: An evidentiary question may arise regarding the "predetermined force" required by the claims. The complaint alleges a "sufficient predetermined force" (Compl. ¶29, ¶41), but the case may require evidence demonstrating that the force required to release the accused J-hooks is fixed and "predetermined" in the manner described by the patents.
V. Key Claim Terms for Construction
For the ’725 Patent:
- The Term: "separable yoke" (from Claim 1)
- Context and Importance: This term defines the core release mechanism. The infringement case for this patent rests on whether the accused products' "J hook" release system (Compl. ¶29) falls within this definition. Practitioners may focus on whether "separable" implies a specific reusable connection or a broader class of releasable structures.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The related ’371 Patent describes the yoke in functional terms as being "slidably received within the capsule and releasably coupled to the tension member" (’371 Patent, col. 9:53-56), which could support an argument that the term covers any structure performing that function.
- Evidence for a Narrower Interpretation: The figures in the ’371 patent depict a specific, single-piece forked structure as the yoke (e.g., ’371 Patent, Fig. 27, item 204). A defendant may argue the term should be limited to this disclosed embodiment or structures substantially similar to it, rather than the allegedly distinct two-part J-hook system.
For the ’245 Patent:
- The Term: "breakable link" (from Claim 1)
- Context and Importance: This term is critical to the permanent deployment feature of the invention. The infringement analysis will turn on whether the accused products' mechanism of releasing J-hooks is equivalent to breaking a link.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claims describe the link's function: it couples the wire to the clip and is "broken" by a force to uncouple them (Compl. ¶37). A plaintiff could argue any mechanism that permanently severs the connection upon reaching a force threshold is a "breakable link."
- Evidence for a Narrower Interpretation: The specification provides specific examples of what "breakable" means, including a J-hook that is permanently "straightened by force" or a threaded fitting that is "stripped" away. (’245 Patent, col. 7:38-44; col. 9:42-49). A defendant could argue this limits the term to mechanisms involving permanent physical deformation or destruction, not merely the disengagement of two intact parts.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement of the ’245 Patent. The factual basis for this claim is the allegation that Defendants offer for sale and sell the accused clips with knowledge of the patent and with the intent that end users will infringe by using them as instructed in "promotional and marketing materials, instructional materials, product manuals, and technical materials" (Compl. ¶36). The counts for the ’725 and ’371 patents allege only direct infringement.
- Willful Infringement: The complaint alleges that Defendants have had knowledge of all three patents-in-suit "since at least the filing of this Complaint" (Compl. ¶¶20, 34, 49), which could support a claim for post-filing willfulness. It further alleges on "information and belief" that Defendants were aware of Plaintiffs' commercial products embodying the patented technology and "knew or should have known" their own products infringed, which may form the basis for a pre-suit willfulness claim (Compl. ¶¶21, 35, 50).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "separable yoke" from the ’725 patent and "breakable link" from the ’245 patent be construed to read on the accused products' mechanism, which is alleged to be a pair of "J hooks" that release from the clip assembly? The resolution of this claim construction dispute will be central to the infringement analysis for two of the three asserted patents.
- A second key issue is procedural viability: asserted Claim 11 of the ’371 patent was cancelled in an IPR proceeding that concluded after this suit was filed. A primary question for the court will be the effect of this cancellation on Count III of the complaint, which is likely to be dismissed as moot.
- A third issue is a functional and evidentiary question: does the release of the accused products' J-hooks operate in a substantially similar way to the patented inventions, particularly with respect to the "predetermined force" required for deployment? The case may require detailed technical evidence to compare the function, way, and result of the accused release mechanism with the mechanisms disclosed and claimed in the patents.