DCT
1:19-cv-01508
PureWick Corp v. Sage Products LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: PureWick Corporation (California)
- Defendant: Sage Products, LLC (Delaware)
- Plaintiff’s Counsel: Shaw Keller LLP
- Case Identification: 1:19-cv-01508, D. Del., 08/12/2019
- Venue Allegations: Venue is asserted in the District of Delaware based on Defendant's incorporation in that state.
- Core Dispute: Plaintiff alleges that Defendant’s PrimaFit™ External Urine Management System for Females infringes two patents related to external urine collection and management devices.
- Technical Context: The technology involves external, non-invasive catheters designed to manage female urinary incontinence, aiming to reduce the risk of infections and skin damage associated with traditional diapers or indwelling catheters.
- Key Procedural History: The complaint alleges that Defendant learned of the ’508 patent and the applications leading to the ’376 patent during confidential discussions regarding a potential acquisition of Plaintiff in 2016, a year before Defendant launched its competing product. Subsequent to the filing of this complaint, in an Inter Partes Review proceeding (IPR2020-01426), the U.S. Patent and Trademark Office cancelled claims 1, 3-8, and 17-19 of the ’508 patent, including the asserted independent apparatus claim 1. The asserted independent method claim 10 was not subject to the cancellation.
Case Timeline
| Date | Event |
|---|---|
| 2010-07-21 | ’508 Patent Priority Date |
| 2012-10-16 | ’508 Patent Issue Date |
| 2014-03-19 | ’376 Patent Priority Date |
| 2016-06-01 | PureWick and Sage representatives meet to discuss business |
| 2016-07-01 | PureWick and Sage enter Mutual Confidentiality Agreement |
| 2017-06-01 | PureWick acquired by C.R. Bard, Inc. |
| 2017-10-01 | Accused PrimaFit™ Product Launch Date (approximate) |
| 2019-03-12 | ’376 Patent Issue Date |
| 2019-08-12 | Complaint Filing Date |
| 2020-08-10 | IPR Filed on ’508 Patent |
| 2023-10-25 | IPR Certificate issues cancelling claims of ’508 Patent |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,287,508 - "Using Moisture-Wicking Article Wrapped Over Openings In An Elongated Urine Collecting Container For Drawing Urine From A Region Surrounding An Urethral Opening," issued October 16, 2012
The Invention Explained
- Problem Addressed: The patent's background describes prior art systems for collecting urine that utilize absorbent pads and notes a need for improved methods of transporting urine away from a person's body. (’508 Patent, col. 1:13-52).
- The Patented Solution: The invention is a urine collection device featuring a container with an "array of openings." A separate moisture-wicking article is wrapped over these openings. In use, the device is placed against the body, and a vacuum is applied to draw urine through the wicking article and the container's openings into a chamber, from which it is transported away. (’508 Patent, Abstract; col. 2:7-27). This design uses a permeable container structure coupled with a wicking over-wrap to manage fluid collection.
- Technical Importance: This approach provided a method for actively drawing urine away from the skin using a vacuum, aiming to reduce wetness and improve hygiene compared to passive absorption methods. (’508 Patent, col. 2:46-52).
Key Claims at a Glance
- The complaint asserts independent claims 1 (apparatus) and 10 (method). (Compl. ¶¶23, 34).
- Note: Independent claim 1 and several dependent claims were subsequently cancelled in an Inter Partes Review.
- Independent Method Claim 10 (Surviving):
- (a) providing a urine collection device including a container with a chamber, an array of openings for urine to enter the chamber, and an outlet port;
- (b) securing a moisture-wicking article over the array of openings by wrapping and securing it;
- (c) disposing the secured article in contact with the region surrounding a urethral opening so urine is drawn into the article; and
- (d) drawing the urine from the article through the array of openings and into the chamber.
- The complaint alleges infringement of claims 1-19, thereby reserving the right to assert other claims. (Compl. ¶22).
U.S. Patent No. 10,226,376 - "Apparatus And Methods For Receiving Discharged Urine," issued March 12, 2019
The Invention Explained
- Problem Addressed: The patent identifies the discomfort, risk of infection, and hygiene issues associated with traditional urinary catheters and bed pans as the problem to be solved. (’376 Patent, col. 2:8-18).
- The Patented Solution: The invention is an apparatus with three key structural layers: a fluid impermeable outer "casing," an internal "fluid permeable support," and a "fluid permeable membrane" disposed on the support. (’376 Patent, Abstract). The casing defines a reservoir and has an elongated opening to expose the membrane. Urine passes through the membrane and support into the reservoir, where it is withdrawn by a tube. This multi-component structure provides a more defined assembly for fluid collection. (’376 Patent, col. 4:51-58).
- Technical Importance: This layered construction provides a specific, engineered structure for an external catheter, potentially offering improved fit, comfort, and fluid management compared to less-defined absorbent systems. (’376 Patent, col. 3:45-50).
Key Claims at a Glance
- The complaint asserts independent claim 1. (Compl. ¶57).
- Independent Apparatus Claim 1:
- a fluid impermeable casing with a reservoir, an outlet, and a longitudinally elongated opening;
- a fluid permeable support within the casing, extending across the opening, and distinct from the reservoir;
- a fluid permeable membrane disposed on the support across the elongated opening; and
- a tube with one end in the reservoir, extending behind the support and membrane, and out through the fluid outlet.
- The complaint alleges infringement of claims 1-14, thereby reserving the right to assert other claims. (Compl. ¶56).
III. The Accused Instrumentality
Product Identification
- The PrimaFit™ External Urine Management System for Females. (Compl. ¶14).
Functionality and Market Context
- The accused product is described as an "external urine management system" that uses an "ultra-soft wicking fabric" to absorb and divert urine away from the skin. (Compl. ¶¶19, 25). The collected urine is then "absorbed into the system's core and suctioned into a collection canister," a process which relies on a vacuum source. (Compl. ¶¶19, 25). A marketing image from the accused product's brochure highlights its main features, including a wicking fabric and a connection port for tubing. (Compl. ¶20, Ex. 3).
- The complaint positions the PrimaFit™ product as a direct competitor to Plaintiff's PureWick™ solution, alleging that the two companies operate in a "two-competitor field." (Compl. ¶¶14, 70).
IV. Analysis of Infringement Allegations
’508 Patent Infringement Allegations
| Claim Element (from Independent Claim 10) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| (a) providing a urine collection device that includes a container defining a chamber for collecting urine, wherein the container is closed, except for having an array of openings through which urine can be drawn into the chamber and at least one outlet port... | The PrimaFit™ product is alleged to be a device with a "spun-fiber container that defines a chamber for collecting urine," where the "spaces between the fibers of the container create an array of openings." (Compl. ¶¶36-38). | ¶36-38 | col. 7:40-47 |
| (b) securing a moisture-wicking article over the array of openings by wrapping the article over the array and securing the article; | The PrimaFit™ product allegedly includes a moisture wicking material that is secured over the array of openings. (Compl. ¶¶39-40). | ¶39-40 | col. 7:48-50 |
| (c) disposing the secured moisture-wicking article in contact with a region of the person or animal surrounding an urethral opening so that urine from the urethral opening is drawn into the moisture-wicking article; | Product instructions and diagrams allegedly show the PrimaFit™ is positioned in contact with the region surrounding the urethral opening to absorb urine. A diagram illustrates this intended placement. (Compl. ¶19, Ex. 3). | ¶41 | col. 7:52-55 |
| (d) drawing the urine from the moisture-wicking material through the array of openings and into the chamber from the disposed moisture-wicking article. | The PrimaFit™ system allegedly uses suction to draw urine absorbed by the wicking fabric into the system's core and then into a collection canister. (Compl. ¶42). | ¶42 | col. 8:1-3 |
’376 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a fluid impermeable casing having a fluid reservoir at a first end, a fluid outlet at a second end, and a longitudinally extending fluid impermeable layer... | The PrimaFit™ product is alleged to have an impermeable casing, a reservoir, and an outlet, as identified in an annotated photograph. (Compl. ¶58). | ¶58 | col. 36:9-13 |
| a fluid permeable support disposed within the casing with a portion extending across the elongated opening, wherein the fluid permeable support is distinct from and at least proximate to the fluid reservoir; | The complaint alleges the PrimaFit™ product includes a "fluid permeable support" inside the casing that is "distinct from and at least proximate to the fluid reservoir," identified with photographs. (Compl. ¶60). | ¶60 | col. 36:16-19 |
| a fluid permeable membrane disposed on the support and covering at least the portion of the support that extends across the elongated opening... | The PrimaFit™ product is alleged to include a "fluid permeable membrane disposed on the support" and covering the relevant portion, as shown in an annotated photograph. (Compl. ¶61). | ¶61 | col. 36:20-24 |
| a tube having a first end disposed in the reservoir and extending behind at least the portion of the support and the portion of the membrane disposed across the elongated opening and extending through the fluid outlet to a second, fluid discharge end. | Annotated photographs are used to allege that the PrimaFit™ product includes a tube extending from the reservoir, behind the support and membrane, and through the outlet to a discharge end. (Compl. ¶62). | ¶62 | col. 36:25-29 |
- Identified Points of Contention:
- Scope Questions: For the ’508 patent, a central dispute may arise over the term "array of openings." The complaint alleges that the inherent porosity of the accused product's fabric—the "spaces between the fibers"—constitutes this array. (Compl. ¶28). A close-up photograph of the accused product purports to show this "array of openings." (Compl. ¶28). The defense may argue that this term, in the context of the patent's specification and figures showing discrete perforations, requires manufactured holes rather than the natural structure of a textile.
- Technical Questions: For the ’376 patent, the claims require both a "fluid permeable support" and a "fluid permeable membrane" that are "distinct" from each other. The infringement analysis will question whether the accused product's layered wicking core truly contains two separate and distinct components that map to these claim elements, or if it is a single, integrated component that Plaintiff has analytically separated to fit the claim language.
V. Key Claim Terms for Construction
The Term: "array of openings" (’508 patent, claim 10)
- Context and Importance: This term's construction is critical for the ’508 patent infringement analysis. The complaint’s theory hinges on this term being broad enough to read on the natural, interstitial spaces within a woven or non-woven fabric. Practitioners may focus on this term because its interpretation will determine whether a porous fabric material can meet a limitation seemingly illustrated with discrete, manufactured holes.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the container has openings which may be "slotted perforations... openings in a porous material such as frits in a porous glass container, or openings in a mesh screen in the wall of the container," suggesting the term is not limited to a single type of opening. (’508 Patent, col. 3:36-41).
- Evidence for a Narrower Interpretation: Figure 1 of the patent depicts the "array of openings" (16) as a series of distinct, parallel, manufactured slots. (’508 Patent, Fig. 1). An argument could be made that the claims should be limited to such disclosed embodiments, where "array" implies a regular, ordered pattern of discrete holes, not the random porosity of a fabric.
The Term: "fluid permeable support" that is "distinct from" the fluid reservoir (’376 patent, claim 1)
- Context and Importance: The claim requires a "support" that is structurally "distinct from" a "membrane." The viability of the infringement claim depends on demonstrating that the accused product contains two such separate components. Practitioners may focus on this term because the case could depend on whether the accused product's potentially integrated wicking core can be legitimately characterized as two "distinct" parts.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language only requires the components to be "distinct," which could be interpreted to mean compositionally different layers, even if they are laminated or bonded together. The patent describes the support and membrane as separate items but does not define a required degree of physical separability. (’376 Patent, Abstract).
- Evidence for a Narrower Interpretation: The exploded view in Figure 34 shows the permeable support (1840) and permeable membrane (1830) as two physically separate and differently textured components before assembly. (’376 Patent, Fig. 34). This could support an interpretation that "distinct" requires the components to be non-integral and physically separable.
VI. Other Allegations
- Indirect Infringement: The complaint alleges both induced and contributory infringement for both patents. The inducement theory is based on Defendant allegedly providing product documentation, such as an "Instructions for Use" manual and a "Patient Education Card," that instruct customers to use the PrimaFit™ product in an infringing manner. (Compl. ¶¶47, 72). The contributory infringement theory is based on allegations that the PrimaFit™ product is a material part of the invention, is not a staple article of commerce, and is especially adapted for an infringing use. (Compl. ¶¶49, 74).
- Willful Infringement: Willfulness is alleged for both patents. For the ’508 patent, willfulness is based on alleged pre-suit knowledge dating back to at least June 2016, when Plaintiff allegedly disclosed the patent to Defendant during business discussions. (Compl. ¶¶46, 53). For the ’376 patent, willfulness is based on the allegation that Defendant, as a direct competitor in a small market, "knew or should have known" of the patent when it issued in March 2019 because it was aware of the underlying priority applications. (Compl. ¶¶69-70, 78).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of definitional scope: can the term "array of openings" in the ’508 patent, which is illustrated with discrete manufactured slots, be construed to cover the inherent interstitial pores of the accused product's wicking fabric? The outcome of this claim construction dispute may be dispositive for that patent.
- A key evidentiary question will be one of structural mapping: does the accused PrimaFit™ product contain two "distinct" components that correspond to the claimed "fluid permeable support" and "fluid permeable membrane" of the ’376 patent, or is there a fundamental mismatch between the product's integrated construction and the patent's multi-component claim structure?
- A central strategic question, arising from events post-dating the complaint, will be the impact of the Inter Partes Review: how does the cancellation of the ’508 patent's primary independent apparatus claim (Claim 1) affect the overall litigation strategy and potential damages model, leaving Plaintiff to rely on the surviving method claim (Claim 10) for that patent?