DCT
5:25-cv-05690
Anoxia Medical Inc v. Alembic LLC
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Anoxia Medical Inc. (Delaware)
- Defendant: Alembic, LLC (Delaware)
- Plaintiff’s Counsel: Venable LLP
- Case Identification: 5:25-cv-05690, N.D. Cal., 07/07/2025
- Venue Allegations: Venue is alleged to be proper based on Defendant maintaining a principal place of business in the Northern District of California.
- Core Dispute: Plaintiff alleges that Defendant’s neurovascular aspiration catheters infringe two patents related to catheter assemblies with hybrid structural reinforcements for removing blood clots.
- Technical Context: The technology is in the field of interventional medical devices, where catheters are guided through blood vessels to treat conditions like ischemic stroke by aspirating thromboembolic material.
- Key Procedural History: The complaint alleges Plaintiff provided Defendant with actual notice of infringement for both asserted patents via an email on March 28, 2025. It further notes that Defendant responded on June 4, 2024, asserting it had identified prior art that may invalidate the claims of one of the patents. The chronological inconsistency in these dates as presented in the complaint may itself become a point of inquiry.
Case Timeline
| Date | Event |
|---|---|
| 2017-05-04 | Earliest Priority Date for '703 and '024 Patents |
| 2021-08-24 | U.S. Patent No. 11,096,703 Issues |
| 2023-07-XX | Alleged first manufacturing and sale of Accused Products |
| 2024-02-06 | U.S. Patent No. 11,890,024 Issues |
| 2024-06-04 | Defendant allegedly responds to notice email with invalidity contentions |
| 2025-03-28 | Plaintiff allegedly sends notice email to Defendant |
| 2025-07-07 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 11,096,703 - CATHETER ASSEMBLY FOR BLOOD CLOTS REMOVAL
- Patent Identification: U.S. Patent No. 11,096,703, "CATHETER ASSEMBLY FOR BLOOD CLOTS REMOVAL," issued August 24, 2021.
The Invention Explained
- Problem Addressed: The patent describes a challenge in endovascular procedures where catheters used to aspirate blood clots must be both flexible enough to navigate complex and delicate vessels (e.g., in the brain) and robust enough to resist kinking or collapsing under suction (U.S. Patent No. 11,096,703, col. 2:5-14). The patent notes that simply increasing a catheter's inner diameter to improve aspiration flow often compromises these necessary performance characteristics (U.S. Patent No. 11,096,703, col. 2:1-5).
- The Patented Solution: The invention is an endovascular catheter constructed with a "hybrid reinforcement" in its wall, which specifically consists of a helical coil and an overlying braid (U.S. Patent No. 11,096,703, col. 14:15-20, FIG. 8). This structure is intended to provide thinner, more flexible walls while improving "pushability, steerability, torque, and non-kinking features" compared to non-reinforced catheters (U.S. Patent No. 11,096,703, col. 14:2-6).
- Technical Importance: This hybrid reinforcement approach represents an effort to overcome the traditional trade-off between a catheter's inner lumen size (for aspiration efficacy) and its trackability and structural integrity (for safety and deliverability) in neuro-interventional procedures (U.S. Patent No. 11,096,703, col. 2:10-14).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 (Compl. ¶36).
- Claim 1 of the ’703 Patent recites:
- An endovascular catheter with an elongate flexible body and a catheter wall.
- The wall includes an inner liner, a "hybrid reinforcement," and a "variable outer jacket."
- The hybrid reinforcement comprises a helical coil and a braid that "encircles the helical coil."
- A radiopaque marker is positioned on the distal end of the body.
- The distal ends of the coil and braid terminate between the distal and proximal ends of the marker.
- The catheter has a "thickness ratio of the inner diameter to the outer diameter 0.80 or higher."
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 11,890,024 - CATHETER ASSEMBLY FOR BLOOD CLOTS REMOVAL
- Patent Identification: U.S. Patent No. 11,890,024, "CATHETER ASSEMBLY FOR BLOOD CLOTS REMOVAL," issued February 6, 2024.
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’703 Patent, the ’024 Patent addresses the same technical problem of balancing aspiration efficacy with catheter performance and safety in delicate vasculature (U.S. Patent No. 11,890,024, col. 2:5-14).
- The Patented Solution: The ’024 Patent also discloses a catheter with a hybrid reinforcement of a helical coil and braid (U.S. Patent No. 11,890,024, col. 14:15-20, FIG. 8). The claims of this patent introduce different specific limitations to define the invention, such as the material composition of the inner liner (U.S. Patent No. 11,890,024, Claim 1).
- Technical Importance: This patent builds on the same technical platform as the ’703 Patent, seeking to protect a particular embodiment of the hybrid-reinforced catheter design (U.S. Patent No. 11,890,024, col. 1:5-8).
Key Claims at a Glance
- The complaint asserts infringement of at least independent Claim 1 (Compl. ¶56).
- Claim 1 of the ’024 Patent recites:
- An endovascular catheter with an elongate flexible body and a catheter wall.
- The wall includes an inner liner, a "hybrid reinforcement," a distal tip, and a "variable durometer outer jacket."
- The hybrid reinforcement comprises a helical coil and a braid that "encircles the helical coil."
- A radiopaque marker is positioned on the distal end of the body.
- The distal ends of the coil and braid terminate between the distal and proximal ends of the marker.
- The inner liner is "at least partially made of PTFE."
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- Defendant’s APRO70 and APRO55 catheters (the "Accused Products") (Compl. ¶2).
Functionality and Market Context
- The complaint alleges the Accused Products are aspiration catheters used for endovascular applications (Compl. ¶25). Promotional materials cited in the complaint describe the products as having "excellent trackability," "durability," and a "unique Coil + Braid design" to optimize navigability (Compl. ¶30). The complaint includes a promotional image highlighting the "Coil + Braid design at the tip" of the APRO catheter (Compl. p. 8; ¶30). The products are allegedly manufactured by Defendant Alembic and distributed in the U.S. by Medtronic Neurovascular (Compl. ¶29, 32). A photograph of the APRO70 catheter packaging is provided, which identifies "Alembic LLC" as the manufacturer (Compl. p. 9; ¶33).
IV. Analysis of Infringement Allegations
The complaint references claim chart exhibits (Exhibits D and F) that were not attached to the publicly filed document. The following analysis is based on the narrative allegations and evidence presented in the body of the complaint.
’703 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a hybrid reinforcement comprises a helical coil and a braid that encircles the helical coil | The Accused Products are marketed as having a "unique Coil + Braid design" which is alleged to be the claimed hybrid reinforcement. A promotional image is presented depicting this construction (Compl. p. 8). The complaint also presents a side-by-side comparison of the patent's Figure 8 and a sketch from the accused product's literature to show similarity (Compl. p. 10-11). | ¶15, 30, 40 | col. 14:15-20 |
| wherein the catheter has an inner and an outer diameter, and a thickness ratio of the inner diameter to the outer diameter 0.80 or higher | The complaint alleges that based on specifications from the distributor’s website, the APRO70 and APRO55 catheters have inner-to-outer diameter ratios of 0.843 and 0.833, respectively, both of which are higher than the claimed 0.80 threshold. A table of these dimensions is included in the complaint (Compl. p. 8). | ¶16, 31 | col. 16:9-10 |
- Identified Points of Contention:
- Structural Questions: A central question will be whether the "Coil + Braid design" of the APRO catheters is structurally identical to the claimed "hybrid reinforcement... wherein a braid... encircles the helical coil." The precise physical arrangement of these components in the accused devices will be a key factual issue for discovery.
- Measurement Questions: The infringement allegation for the "thickness ratio" relies on publicly available product specifications. A potential dispute may arise over the precise method of measuring the inner and outer diameters and whether those measurements are consistent along the catheter's length, as the claim does not specify the location for this measurement.
’024 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a hybrid reinforcement comprises a helical coil and a braid that encircles the helical coil | As with the ’703 Patent, the allegation relies on the advertised "Coil + Braid design" of the Accused Products (Compl. p. 8, 14). | ¶23, 30, 59 | col. 14:15-20 |
| and wherein the inner liner is at least partially made of PTFE | The complaint does not provide specific factual allegations in the narrative to support this element, stating instead that an attached claim chart (Exhibit F, not provided) shows that the product meets this limitation. | ¶57 | col. 14:56-59 |
- Identified Points of Contention:
- Material Composition: The primary point of contention for the ’024 Patent appears to be factual: is the inner liner of the APRO catheters made of Polytetrafluoroethylene (PTFE)? The complaint provides no public evidence for this, suggesting it will be a central topic for technical discovery and product tear-downs.
- Scope Questions: The term "variable durometer outer jacket" is recited in the claim. The parties may dispute what degree of variation in material hardness along the catheter's length is sufficient to meet this limitation, potentially leading to a claim construction dispute.
V. Key Claim Terms for Construction
The Term: "variable durometer outer jacket" (from Claim 1 of the '024 Patent)
- Context and Importance: This term defines a key structural feature of the catheter body. The scope of "variable" will be critical. If construed narrowly to require multiple, distinct segments of different hardness, it may be more difficult to prove infringement. If construed broadly to cover any continuous or gradual change in hardness, the claim's scope would be wider. Practitioners may focus on this term because its definition could determine whether a wide range of catheter manufacturing techniques fall within the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself does not specify the number of segments or the degree of variation, which may support an interpretation that any non-uniform durometer along the length meets the limitation.
- Evidence for a Narrower Interpretation: The specification provides a specific example of an outer jacket "made of five discrete tubular segments," each with a specific Pebax material grade (U.S. Patent No. 11,890,024, col. 16:11-24, FIG. 9). A defendant may argue this detailed embodiment limits the claim's scope to catheters with similarly distinct, segmented variations.
The Term: "thickness ratio of the inner diameter to the outer diameter 0.80 or higher" (from Claim 1 of the '703 Patent)
- Context and Importance: This quantitative limitation is central to the infringement allegation against the '703 Patent. The dispute is less likely to be about the definition of the words and more about the methodology of measurement. The outcome of the infringement analysis for this claim could depend entirely on how and where this ratio is measured on the accused devices.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent states, "It is desirable that the catheter wall thickness ratio is 0.80 or higher," without specifying a location or method of measurement (U.S. Patent No. 11,096,703, col. 16:9-10). Plaintiff may argue this suggests a general or average characteristic of the catheter.
- Evidence for a Narrower Interpretation: A defendant may argue that for a device with potentially varying dimensions along its length, the claim is indefinite unless the location of measurement is specified or implied from the specification. The lack of such a specification could be a basis for an invalidity challenge.
VI. Other Allegations
- Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). It asserts Defendant had knowledge of the patents as of at least the March 28, 2025 notice letter and intended to cause infringement by its customers (e.g., Medtronic and end-user surgeons) through promotion, sale, and user instructions (Compl. ¶45-48, 65-68). The complaint provides a screenshot of a Medtronic webpage as evidence of promotion and sale to these customers (Compl. p. 12).
- Willful Infringement: Willfulness is alleged based on Defendant continuing to infringe after receiving actual notice on March 28, 2025 (Compl. ¶42, 62). The complaint also makes a more general allegation of knowing and willful infringement "at least as of the time they designed the APRO catheters," suggesting a theory of copying (Compl. ¶58).
VII. Analyst’s Conclusion: Key Questions for the Case
A central issue will be one of factual proof: Can Plaintiff Anoxia demonstrate through technical evidence, such as product testing and analysis, that the APRO catheters possess the specific structural and material characteristics required by the asserted claims, particularly the "thickness ratio" of the '703 patent and the "PTFE inner liner" of the '024 patent?
The case may also turn on a question of claim scope: How will the court construe the term "variable durometer outer jacket"? The resolution of this issue—whether it is limited by the specific five-segment embodiment in the specification or given a broader meaning—will significantly impact the infringement analysis for the '024 patent.
Finally, a critical battleground will be patent validity. The complaint acknowledges that Defendant has already raised an invalidity defense based on prior art (Compl. ¶60). The strength of this yet-unidentified prior art, and whether it can render the asserted claims obvious or anticipated, will be a determinative factor in the litigation.