DCT
2:21-cv-08739
Splash Medical Devices LLC v. Zerowet Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Splash Medical Devices, L.L.C. (Georgia)
- Defendant: Zerowet, Inc. (California)
- Plaintiff’s Counsel: MERCHANT & GOULD PC
- Case Identification: 2:21-cv-08739, C.D. Cal., 11/05/2021
- Venue Allegations: Venue is alleged to be proper in the Central District of California because the Defendant is a California corporation with its principal place of business within the district.
- Core Dispute: Plaintiff alleges that Defendant’s SuperShield® wound irrigation device infringes a patent related to abscess and wound irrigation systems that incorporate a splash shield.
- Technical Context: The technology concerns medical devices designed to irrigate wounds while shielding healthcare personnel and patients from the splash of contaminated fluids.
- Key Procedural History: The complaint alleges a history of interaction, beginning with Defendant’s principal viewing Plaintiff’s precursor product at a 2005 trade show. It further alleges that Plaintiff provided Defendant with direct, pre-suit notice of the patent-in-suit and the alleged infringement in October and November of 2019, which forms the basis for a willfulness claim.
Case Timeline
| Date | Event |
|---|---|
| 2000-01-18 | Earliest Priority Date for '372 Patent |
| 2005-09-01 | Defendant’s principal allegedly views Plaintiff’s SplashCap® at a trade show |
| 2006-01-23 | Defendant files patent application for a similar device |
| c. 2015-11-01 | Approximate launch of Accused SuperShield® Product |
| 2014-06-10 | '372 Patent Issued |
| 2019-10-01 | Plaintiff allegedly provides verbal notice of infringement to Defendant |
| 2019-11-01 | Plaintiff allegedly provides written notice of infringement to Defendant |
| 2021-11-05 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,747,372 - "Abscess Irrigation Systems," issued June 10, 2014
The Invention Explained
- Problem Addressed: The patent’s background section identifies the risk of spreading disease when irrigating wounds, as contaminated fluid can splash onto healthcare providers and surrounding surfaces. It also notes that the inconvenience and messiness of existing methods may discourage clinicians from using the large volumes of fluid required for effective cleaning ('372 Patent, col. 1:40-67).
- The Patented Solution: The invention is an irrigation system featuring a splash shield, often cup-shaped, designed to contain fluid splatter during wound irrigation. The system is designed for attachment to various fluid sources, such as squeeze bottles or syringes, and critically includes not only a conduit for the irrigation stream but also a distinct "aperture" located near the conduit, a feature the complaint alleges was copied ('372 Patent, col. 5:5-18, Compl. ¶14). As illustrated in Figures 2 and 11 of the patent, the device can be coupled to a wash bottle or a syringe, optionally including an aperture separate from the primary irrigation nozzle (Compl. ¶10, p. 4).
- Technical Importance: This design sought to make wound irrigation safer and more efficient, thereby encouraging more thorough cleansing and potentially reducing infection rates and improving patient outcomes ('372 Patent, col. 2:1-2).
Key Claims at a Glance
- The complaint asserts at least independent Claim 44 ('372 Patent, col. 34:44-62; Compl. ¶21).
- The essential elements of independent Claim 44 are:
- A transparent and rigid hollow cup-shaped shield with an open lower end and a closed upper end.
- A conduit that extends through the closed upper end of the shield, configured to accept an irrigation source.
- An aperture, substantially adjacent to the conduit, that also extends through the closed upper end of the shield.
- The complaint alleges infringement of "at least independent Claim 44," suggesting the right to assert other claims is reserved (Compl. ¶21).
III. The Accused Instrumentality
Product Identification
- Defendant’s "SuperShield®" wound irrigation system (Compl. ¶1).
Functionality and Market Context
- The SuperShield® is described as a wound irrigation system used for cleaning wounds (Compl. ¶16). The complaint alleges that the product is a direct competitor to Plaintiff's own patented products (Compl. ¶15).
- The complaint alleges the SuperShield® was created by modifying Defendant's earlier "Splashield®" product to "include an aperture adjacent an extended irrigation nozzle and conduit," a modification allegedly based on features claimed in the patent-in-suit (Compl. ¶14). A visual in the complaint depicts the original Splashield® as a simple shield and the accused SuperShield® with an added conduit and adjacent aperture (Compl. p. 5).
- The complaint alleges that the SuperShield® product embodies the elements shown in a figure from Defendant's own patent, specifically a "transparent and rigid hollow cup-shaped shield," a "conduit extending through the shield," and an "aperture substantially adjacent [the] conduit" (Compl. ¶16).
IV. Analysis of Infringement Allegations
'372 Patent Infringement Allegations
| Claim Element (from Independent Claim 44) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a) at least one transparent and rigid hollow cup-shaped shield having at least one open lower end and at least one closed upper end... | The SuperShield® product is alleged to comprise a "transparent and rigid hollow cup-shaped shield (52)." | ¶16 | col. 5:6-9 |
| b) at least one conduit extending through said at least one outer surface and into said at least one transparent and rigid hollow cup-shaped shield... | The SuperShield® product is alleged to comprise a "conduit (54) extending through the shield and into the cup-shaped shield." | ¶16 | col. 5:9-15 |
| c) at least one aperture, substantially adjacent said at least one conduit, extending through said at least one closed upper end... | The SuperShield® product is alleged to comprise an "aperture (58) substantially adjacent conduit 54, extending through the closed upper end of the shield (52)." | ¶16 | col. 5:15-18 |
- Identified Points of Contention:
- Scope Questions: A central point of contention may be the construction of "substantially adjacent." The dispute will likely focus on how close the aperture must be to the conduit to meet this limitation, and whether the arrangement in the SuperShield® product falls within that scope.
- Technical Questions: The complaint's infringement theory relies on the assertion that the accused SuperShield® product "embodies the elements of Figure 3 of Defendant's '860 Patent" (Compl. ¶16). A key factual question for the court will be whether the physical product sold by the Defendant has the same structure as depicted in its own patent's drawings, as the complaint uses those drawings as a proxy for the accused device.
V. Key Claim Terms for Construction
- The Term: "substantially adjacent"
- Context and Importance: This term is critical as it defines the required proximity between the fluid conduit and the separate aperture. The infringement case hinges on whether the aperture in the SuperShield® is close enough to its conduit to satisfy this limitation. Practitioners may focus on this term because the defendant could argue for a narrow definition based on the patent's drawings to design around the claim.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term is not given a precise numerical definition in the specification, which may support an interpretation based on its plain and ordinary meaning of "close to" or "near" ('372 Patent, col. 5:15-18).
- Evidence for a Narrower Interpretation: A party could argue that the figures in the '372 Patent, such as Figure 3 (showing element 58 next to the conduit) and Figure 13 (showing element 201 next to the central structure), define the term by example, requiring a specific, very close spatial relationship that the accused product might not have.
VI. Other Allegations
- Indirect Infringement: The complaint includes claims for induced and contributory infringement, alleging that Defendant's actions have caused others (e.g., end-users) to infringe the '372 Patent (Compl. ¶21). The complaint does not, however, plead specific facts detailing the basis for these allegations, such as references to user manuals or instructions.
- Willful Infringement: The complaint makes detailed allegations to support willfulness. It alleges that the Defendant had pre-suit knowledge of the patent and the infringement as of at least October 2019 from a direct conversation and a follow-up email that specifically identified Claim 44 (Compl. ¶17, ¶22). The complaint further alleges that Defendant's infringement was purposeful and deliberate, pointing to Defendant’s alleged failure to respond to the notice as evidence of "deliberate disregard for Splash's patent rights" (Compl. ¶18).
VII. Analyst’s Conclusion: Key Questions for the Case
The resolution of this dispute may turn on the following central questions:
- Evidentiary Proof: A key evidentiary question will be one of structural identity: can the Plaintiff demonstrate that the commercial SuperShield® product is structurally identical to the drawings in the Defendant’s own '860 patent, which the complaint uses as the factual basis for infringement?
- Definitional Scope: A core legal issue will be one of claim construction: how will the court define "substantially adjacent"? The outcome of the infringement analysis may depend on whether this term is given a broad, ordinary meaning or a narrower definition limited by the patent's specific illustrated embodiments.
- Willfulness and Intent: A central theme will be the defendant’s state of mind. Given the detailed allegations of pre-suit notice and a history of alleged copying, the court will have to determine whether the defendant's alleged infringement was willful, which could subject it to enhanced damages.