DCT
1:24-cv-01108
Route 92 Medical Inc v. Q'Apel Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Route 92 Medical, Inc. (Delaware)
- Defendant: Q'Apel Medical, Inc. (Delaware)
- Plaintiff’s Counsel: Knobbe, Martens, Olson & Bear, LLP; Phillips, McLaughlin & Hall, P.A.
- Case Identification: 1:24-cv-01108, D. Del., 10/07/2024
- Venue Allegations: Venue is based on Defendant's incorporation in Delaware, establishing residence in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Hippo-Cheetah aspiration system, used for treating ischemic stroke, infringes five patents related to neurovascular catheter systems and methods.
- Technical Context: The technology concerns medical devices for mechanical thrombectomy, a time-critical procedure to remove blood clots from cerebral arteries to treat acute ischemic stroke.
- Key Procedural History: The complaint alleges that Defendant’s current CEO, Jodie Fam, is a former consultant for Plaintiff who was heavily involved with the development and strategy of Plaintiff's competing Tenzing technology and associated intellectual property, a fact which may be material to the allegations of knowledge for willful and indirect infringement.
Case Timeline
| Date | Event |
|---|---|
| 2011-08-05 | Earliest Priority Date for ’239 and ’944 Patents |
| 2013-12-23 | Earliest Priority Date for ’582 Patent |
| 2015-02-04 | Earliest Priority Date for ’555 Patent |
| 2016-11-01 | Route 92 engaged Jodie Fam as a consultant |
| 2018-01-01 | Fam attended first use of Tenzing catheter in Germany |
| 2018-05-17 | Earliest Priority Date for ’770 Patent |
| 2019-02-26 | U.S. Patent No. 10,213,582 issues |
| 2019-10-29 | U.S. Patent No. 10,456,555 issues |
| 2020-05-12 | U.S. Patent No. 10,646,239 issues |
| 2020-07-20 | Final consulting agreement between Route 92 and Fam |
| 2021-05-10 | Fam's consulting relationship with Route 92 ends |
| 2021-05-01 | Fam joins Q'Apel as VP and General Manager |
| 2023-01-01 | Q'Apel announces release of Hippo-Cheetah system |
| 2024-01-16 | U.S. Patent No. 11,871,944 issues |
| 2024-03-12 | U.S. Patent No. 11,925,770 issues |
| 2024-07-01 | Q'Apel names Jodie Fam Chief Executive Officer |
| 2024-10-07 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,213,582 - "Methods and systems for treatment of acute ischemic stroke"
- Patent Identification: 10213582, "Methods and systems for treatment of acute ischemic stroke," issued February 26, 2019. (Compl. ¶28).
The Invention Explained
- Problem Addressed: The patent's background section describes the technical challenges and time-critical nature of treating acute ischemic stroke, particularly the difficulty of navigating catheters through tortuous blood vessels from a traditional femoral (groin) access point. (’582 Patent, col. 1:36-56).
- The Patented Solution: The invention discloses methods and systems for treating stroke via a transcarotid approach, which provides a shorter and more direct access route to the cerebral arteries. The patented solution involves advancing a specific coaxial catheter system through the internal carotid artery to the treatment site. (’582 Patent, Abstract; col. 3:6-21).
- Technical Importance: This direct-access approach is intended to reduce procedure time and minimize the risk of dislodging embolic material from the aortic arch, a known complication of the transfemoral route. (’582 Patent, col. 5:1-10).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶34).
- The essential elements of Claim 1 include:
- Assembling a coaxial system of devices comprising a catheter and a tapered inner member extending through and distal to the catheter.
- Advancing the assembled system together through the internal carotid artery from a transfemoral access site.
- Further advancing the assembled system together after the catheter's distal end is distal to a petrous portion of the internal carotid artery.
- The complaint reserves the right to assert additional claims. (Compl. ¶35).
U.S. Patent No. 10,456,555 - "Rapid aspiration thrombectomy system and method"
- Patent Identification: 10456555, "Rapid aspiration thrombectomy system and method," issued October 29, 2019. (Compl. ¶29).
The Invention Explained
- Problem Addressed: The patent identifies the challenge of quickly navigating interventional devices to a cerebral occlusion through complex and delicate anatomy, where traditional multi-step guidewire-based approaches can be slow and risky. (’555 Patent, col. 1:28-52).
- The Patented Solution: The invention proposes a method using a coaxial system where an outer catheter and a tapered inner member are advanced together to the occlusion site without a guidewire. The tapered inner member is designed to facilitate navigation through tortuous arterial segments. (’555 Patent, Abstract; col. 18:6-14).
- Technical Importance: Advancing the system without a guidewire simplifies the procedure, reduces the number of device exchanges, and potentially shortens the critical time to restore blood flow. (’555 Patent, col. 18:6-14).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶47).
- The essential elements of Claim 1 include:
- Assembling a coaxial system of devices comprising a catheter and a tapered inner member.
- Advancing the assembled system together within a petrous portion of an internal carotid artery.
- Performing this advancement while a guidewire is not present.
- The complaint reserves the right to assert additional claims. (Compl. ¶48).
U.S. Patent No. 10,646,239 - "Methods and systems for treatment of acute ischemic stroke"
- Patent Identification: 10646239, "Methods and systems for treatment of acute ischemic stroke," issued May 12, 2020. (Compl. ¶30).
- Technology Synopsis: The patent describes a system comprising a catheter and an inner member with specific physical characteristics. The invention addresses the need for improved trackability and flexibility by claiming an inner member with a tapered distal portion and a transition in flexibility, where the distal end is more flexible than the distal end of the outer catheter. (’239 Patent, Abstract).
- Asserted Claims: Independent claim 1. (Compl. ¶59).
- Accused Features: The complaint alleges the Hippo-Cheetah system comprises a catheter (Hippo) and an inner member (Cheetah) with a tapered distal portion and a flexibility profile where the Cheetah's distal end is more flexible than the Hippo's distal end. (Compl. ¶¶63-66).
U.S. Patent No. 11,871,944 - "Methods and systems for treatment of acute ischemic stroke"
- Patent Identification: 11871944, "Methods and systems for treatment of acute ischemic stroke," issued January 16, 2024. (Compl. ¶31).
- Technology Synopsis: This patent addresses the "ledge effect," a phenomenon where a mismatch in diameter between an outer catheter and an inner component creates a ledge that can impede advancement through an artery. The invention is a system with a catheter and a flexible inner member whose distal portion has at least two regions with different outer diameters, configured to minimize the step formed by the leading edge of the outer catheter. (’944 Patent, Abstract).
- Asserted Claims: Independent claim 1. (Compl. ¶76).
- Accused Features: The complaint alleges the Cheetah inner member has a distal portion with a first region and a second, smaller-diameter region designed to minimize the ledge effect relative to the Hippo catheter, and that Defendant's own marketing materials advertise this feature. (Compl. ¶¶82, 85).
U.S. Patent No. 11,925,770 - "Aspiration catheter systems and methods of use"
- Patent Identification: 11925770, "Aspiration catheter systems and methods of use," issued March 12, 2024. (Compl. ¶32).
- Technology Synopsis: This patent describes an aspiration catheter system with highly specific, quantified flexibility characteristics. The claims define the flexibility of a "catheter advancement element" (inner member) and the overall system by referencing bending forces at precise distances from the distal end and requiring a specific ratio between different "flexibility slopes." (’770 Patent, Abstract).
- Asserted Claims: Claim 6. (Compl. ¶93).
- Accused Features: The complaint makes detailed allegations that the Hippo-Cheetah system meets the specific numerical limitations of the patent regarding bending forces, points along the catheter, and the ratio of flexibility slopes. (Compl. ¶¶96-100).
III. The Accused Instrumentality
Product Identification
- Defendant’s Hippo featuring Cheetah aspiration system (“Hippo-Cheetah system”). (Compl. ¶25).
Functionality and Market Context
- The Hippo-Cheetah system is a medical device for use in the revascularization of patients with acute ischemic stroke. (Compl. ¶36). It consists of a coaxial assembly: an outer aspiration catheter (Hippo) and a tapered inner member (Cheetah). (Compl. ¶37). The system is designed to be advanced as a single unit to navigate tortuous cerebral arteries to reach and remove a blood clot. (Compl. ¶38). Marketing materials cited in the complaint promote the system’s “trackability for effortless navigation” and ability to “glide along as a single system.” (Compl. ¶38). A composite image from Defendant's website shows a photograph of the assembled Hippo-Cheetah system and a corresponding schematic diagram identifying the outer Hippo catheter and the inner Cheetah member. (Compl. p. 9).
IV. Analysis of Infringement Allegations
’582 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| assembling a coaxial system of devices comprising: a catheter...and a tapered inner member extending through the catheter lumen... | The accused Hippo-Cheetah system is a coaxial system with the Hippo catheter and the tapered Cheetah inner member. | ¶37 | col. 16:45-53 |
| advancing the assembled coaxial system of devices together through the internal carotid artery from a transfemoral access site... | The assembled Hippo-Cheetah system is advanced together from a transfemoral access site through the internal carotid artery. | ¶38 | col. 18:6-14 |
| further advancing the assembled coaxial system of devices together after the distal end of the catheter is distal to a petrous portion of the internal carotid artery. | The Hippo-Cheetah system is advanced together after its distal end is positioned distal to the petrous portion of the internal carotid artery. | ¶39 | col. 18:6-14 |
- Identified Points of Contention:
- Scope Questions: Claim 1 recites advancement from a "transfemoral access site," whereas the patent's focus is on a transcarotid system. A potential issue for the court is whether a method claim reciting a transfemoral step is fully supported by a specification that emphasizes a transcarotid approach as the solution to problems with transfemoral access.
- Technical Questions: A key factual question will be whether the accused method, as performed by physicians using the Hippo-Cheetah system, necessarily includes the step of advancing the system "distal to a petrous portion of the internal carotid artery" as required by the claim.
’555 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| assembling a coaxial system of devices comprising: a catheter...and a tapered inner member extending through the catheter lumen... | The accused Hippo-Cheetah system is a coaxial system consisting of the Hippo catheter and the tapered Cheetah inner member. | ¶50 | col. 2:2-20 |
| advancing the assembled coaxial system of devices together within a petrous portion of an internal carotid artery... | The assembled Hippo-Cheetah system is advanced together within a petrous portion of the internal carotid artery. | ¶51 | col. 18:6-14 |
| ...wherein the assembled coaxial system of devices is advanced while a guidewire is not present. | The Hippo-Cheetah system may be advanced without a guidewire. | ¶51 | col. 18:6-14 |
- Identified Points of Contention:
- Scope Questions: The negative limitation "while a guidewire is not present" will likely be a central point of dispute. A question for the court may be whether this limitation requires that the system must be used without a guidewire, or if it is sufficient that the system is capable of being used, and is in fact sometimes used, in that manner.
- Technical Questions: The complaint alleges the system "may be advanced" without a guidewire (Compl. ¶51). The evidentiary burden will be on the plaintiff to demonstrate that this mode of operation constitutes direct infringement by users of the accused system.
V. Key Claim Terms for Construction
’582 Patent
- The Term: "advancing...together"
- Context and Importance: This term appears in two separate steps of claim 1. Its construction is critical because it defines the required relationship between the catheter and the inner member during advancement. Practitioners may focus on this term because the degree of simultaneous movement required to satisfy "together" could be disputed, especially if the components are adjusted relative to each other during the procedure.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes the components as being collectively introduced, which may suggest that minor, independent adjustments do not defeat the "togetherness" of the overall advancement. (’582 Patent, col. 7:5-6).
- Evidence for a Narrower Interpretation: The claim language recites advancing the "assembled coaxial system of devices," which could be construed to mean the assembly moves as a fixed, unadjusted unit. The patent also describes holding the inner member "fixed relative to the catheter" in other contexts. ('239 Patent, claim 1).
’555 Patent
- The Term: "while a guidewire is not present"
- Context and Importance: This negative limitation is fundamental to the infringement allegation against the '555 patent. The dispute will likely center on whether infringement occurs only when the accused system is used without a guidewire for the entire claimed step, or whether capability and instruction for such use are sufficient.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent repeatedly touts the advantages of a system that can be advanced without a guidewire, which may support a construction that the invention is the capability itself, not just its mandatory use in every instance. (’555 Patent, col. 18:6-14).
- Evidence for a Narrower Interpretation: As a method claim limitation, a defendant may argue that the absence of a guidewire is a required condition for the entire "advancing" step, and if a guidewire is used at any point during that step, the claim is not infringed. The claim language uses "while," which implies simultaneity with the action of advancing.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for all five patents-in-suit. Inducement is based on allegations that Defendant provides instructions, training, and marketing materials that encourage physicians to use the Hippo-Cheetah system in an infringing manner. (Compl. ¶¶41, 53, 70, 87, 102). Contributory infringement is based on allegations that the system constitutes a material part of the invention, is not a staple article of commerce, and is especially made or adapted for use in an infringing way. (Compl. ¶¶42, 54, 71, 88, 103).
- Willful Infringement: The complaint alleges willful infringement for all five patents. The basis for willfulness is alleged pre-suit knowledge derived from Defendant's CEO, Jodie Fam, a former consultant for Plaintiff who was allegedly familiar with Plaintiff's patent portfolio and technology. (Compl. ¶¶40, 52, 69, 86, 101). The complaint also establishes a basis for post-suit willfulness by stating Defendant has knowledge of the patents no later than the filing of the complaint. (Compl. ¶¶40, 52, 69, 86, 101).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of procedural evidence: Can Plaintiff prove that clinicians using the Hippo-Cheetah system perform the specific steps recited in the asserted method claims, particularly advancing the device "distal to a petrous portion of the internal carotid artery" (’582 Patent) and doing so "while a guidewire is not present" (’555 Patent)?
- A second key question will be one of technical specificity: For the apparatus-focused claims of the ’239, ’944, and ’770 patents, can Plaintiff demonstrate through testing and expert analysis that the physical construction of the Hippo-Cheetah system meets the precise dimensional, flexibility, and "flexibility slope" limitations recited in the patents?
- The case may also heavily feature a dispute over knowledge and intent, centered on the role of Defendant’s CEO. The extent of her prior knowledge of Plaintiff’s technology and patent strategy will be a critical factual question for the claims of indirect and willful infringement.