2:23-cv-00229
Willow Innovations Inc v. Chiaro Technology Ltd
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Willow Innovations, Inc. (Delaware)
- Defendant: Chiaro Technology Ltd. (United Kingdom)
- Plaintiff’s Counsel: O'Melveny & Myers LLP
- Case Identification: 2:23-cv-00229, E.D. Tex., 06/21/2024
- Venue Allegations: Plaintiff alleges venue is proper because Defendant, a foreign corporation, has committed acts of infringement in the district by offering for sale and selling its products through its own website and through authorized retailers, such as Walmart and Target, which have a physical presence in the district.
- Core Dispute: Plaintiff alleges that Defendant’s Elvie Pump and associated mobile applications infringe eight U.S. patents (six utility, two design) related to wearable, in-bra breast pump technology.
- Technical Context: The technology at issue involves compact, self-contained, wearable breast pumps designed to be worn inside a user's bra, offering greater discretion and mobility compared to traditional breast pump systems.
- Key Procedural History: The complaint alleges that Defendant had pre-suit knowledge of the asserted patents, asserting that they were cited during the patent prosecution of Defendant’s own patent applications. The complaint also notes that Defendant’s FDA pre-market notification for the Elvie Pump cited Plaintiff’s Willow Pump as an FDA-cleared predicate device.
Case Timeline
| Date | Event |
|---|---|
| 2014-07-22 | Earliest Priority Date for ’816, ’228, ’624, ’619, ’229 Patents |
| 2016-02-10 | Earliest Priority Date for ’005, ’995, ’625 Patents |
| 2018-09-14 | Defendant launches Elvie Pump system |
| 2018-11-06 | ’D995 Patent Issued |
| 2019-09-03 | ’816 Patent Issued |
| 2019-10-08 | ’228 Patent Issued |
| 2020-04-21 | ’005 Patent Issued |
| 2020-06-23 | ’229 Patent Issued |
| 2020-07-28 | ’624 Patent Issued |
| 2021-11-30 | ’619 Patent Issued |
| 2023-02-07 | ’D625 Patent Issued |
| 2024-06-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 10,398,816 - "Breast pump system with flange"
- Patent Identification: U.S. Patent No. 10,398,816, "Breast pump system with flange," issued September 3, 2019.
The Invention Explained
- Problem Addressed: The patent’s background section describes prior art breast pumps as being "awkward and cumbersome," difficult to transport, painful, and often requiring an AC power source or rapidly draining batteries (Compl. ¶22; ’816 Patent, col. 1:23-34). It also notes that existing systems can cause discomfort from nipple chafing and are "clearly visible" when in use (Compl. ¶22; ’816 Patent, col. 1:31-34, 1:49-55).
- The Patented Solution: The invention is a wearable breast pump system designed to fit discreetly within a user's bra and "present a natural look" (Compl. ¶23; ’816 Patent, col. 2:14-18). A key aspect is the flange design, which, by maintaining "at least a latch suction level at all times," reduces nipple movement and friction, allowing for a lower profile and more comfortable component compared to the prior art (Compl. ¶¶23-24; ’816 Patent, col. 19:64-20:15). The complaint includes a figure comparing the patented flange (Fig. 8) with a prior art flange (Fig. 9) to illustrate this lower profile (Compl. ¶24).
- Technical Importance: The invention sought to provide a more discrete, comfortable, and portable breast pumping solution, addressing key usability drawbacks of traditional systems (Compl. ¶22; ’816 Patent, col. 1:35-49).
Key Claims at a Glance
- The complaint asserts independent Claim 1 (Compl. ¶68).
- Essential elements of Claim 1 include:
- An automated breast pump system configured to fit within a bra.
- A breast pump shell housing a milk flow path.
- A pumping mechanism contained completely within the shell.
- A fluid container directly engaged and supported by the shell.
- A flange attached to the shell, including a rigid nipple receiving portion and a bottom portion below it.
- An external computer that automatically tracks pumping and communicates with the pumping mechanism.
- The pumping mechanism creates a suction force from the rigid nipple receiving portion, with the suction force and milk flow path both directed "generally upward" relative to the bottom of the flange.
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
U.S. Patent No. 10,434,228 - "Breast pump system and methods"
- Patent Identification: U.S. Patent No. 10,434,228, "Breast pump system and methods," issued October 8, 2019.
The Invention Explained
- Problem Addressed: The patent identifies the problem of residual milk remaining in the system's tubing after a pumping session is complete, which can lead to milk loss if not properly purged (Compl. ¶29; ’228 Patent, col. 41:8-11).
- The Patented Solution: The invention provides an automated method for pumping milk where the milk is pumped "upwardly through the milk flow path relative to a bottom of the breast contacting structure" (Compl. ¶31; ’228 Patent, col. 50:44-47). This upward flow path is intended to prevent the loss of milk out of the system. The complaint references patent figures 39A and 39B, which illustrate arrangements for preventing milk loss (Compl. ¶30).
- Technical Importance: The invention addresses the technical challenge of efficiently collecting all expressed milk and preventing loss from the device, particularly in a wearable system where orientation can vary (Compl. ¶32).
Key Claims at a Glance
- The complaint asserts independent Claim 1 (Compl. ¶82).
- Essential elements of Claim 1 include:
- An automated method of pumping milk from a breast.
- Providing a breast pump system configured to fit within a bra, including a housing, breast contacting structure, milk flow path, and collection container.
- The milk flow path and collection container are contained within the housing.
- Forming a seal between the system and the breast.
- Pumping milk from the breast to the collection container "upwardly through the milk flow path relative to a bottom of the breast contacting structure."
- The complaint does not explicitly reserve the right to assert dependent claims for this patent.
Multi-Patent Capsules
Patent Identification: U.S. Patent No. 10,625,005, "Breast pump assembly with remote interface," issued April 21, 2020.
Technology Synopsis: The patent addresses the need for a wearable breast pump that can be easily monitored and controlled (Compl. ¶35). The solution provides a remote user interface on an external device (e.g., a smartphone) that allows for two-way wireless communication to control pump functionality, track milk volume, and store session data (Compl. ¶36). The complaint references Figures 30 and 31 from the patent, which depict an exemplary remote user interface for setting milk volume goals (Compl. ¶36).
Asserted Claims: Independent Claim 1 (Compl. ¶96).
Accused Features: The Elvie Pump's wireless connectivity to its mobile application, which allows users to control the pump and track pumping history (Compl. ¶¶64, 97).
Patent Identification: U.S. Patent No. 10,722,624, "Breast pump assembly with breast adapter," issued July 28, 2020.
Technology Synopsis: This patent describes an automated system for controlling pumping cycles in a wearable, in-bra pump (Compl. ¶¶40, 43). The invention includes a sensor to detect when the milk container is full and a controller that "automatically changes application of suction" based on the phase of milk expression, such as switching from a "letdown phase" to an "expression mode" upon sensing letdown (Compl. ¶¶43, 44, 110).
Asserted Claims: Independent Claim 1 (Compl. ¶110).
Accused Features: The Elvie Pump system's automated operation, including its sensors and controller for managing pumping cycles (Compl. ¶¶64, 111).
Patent Identification: U.S. Patent No. 11,185,619, "Breast pump system with pressure sensor," issued November 30, 2021.
Technology Synopsis: The patent addresses the desire to easily and accurately monitor the volume of milk pumped by a wearable system (Compl. ¶48). The invention provides a system with a "non-contact pressure sensor" that measures vacuum levels to derive or calculate the volume of milk produced, and a wireless transmitter to send this information to a controller or external device (Compl. ¶¶49-50).
Asserted Claims: Independent Claim 1 (Compl. ¶124).
Accused Features: The Elvie Pump's use of a pressure sensor to measure vacuum levels and its wireless transmitter for communicating with the mobile application (Compl. ¶¶64, 125).
Patent Identification: U.S. Patent No. 10,688,229, "Breast pump system and methods," issued June 23, 2020.
Technology Synopsis: This patent describes a wearable, portable, self-powered breast pump system where the components are "collectively sized and shaped to fit within a user's bra" (Compl. ¶¶60, 62). A key feature is the maintenance of a "latch suction" throughout the pumping session to ensure a secure seal and efficient operation within a compact, in-bra form factor (Compl. ¶¶59, 166). The complaint references Figure 65 from the patent, which illustrates the system in use inside a bra (Compl. ¶61).
Asserted Claims: Independent Claim 1 (Compl. ¶166).
Accused Features: The overall wearable, portable, and self-powered configuration of the Elvie Pump that is sized and shaped to fit within a user's bra (Compl. ¶¶64, 167).
Patent Identification: U.S. Design Patent No. D832,995, "Breast pump," issued November 6, 2018.
Technology Synopsis: This patent claims the ornamental design for a breast pump as shown in its figures (Compl. ¶53).
Asserted Claims: The design as shown and described (Compl. ¶138).
Accused Features: The overall ornamental appearance of the Elvie Pump, which the complaint alleges is the same as or substantially identical to the patented design (Compl. ¶¶138-139). The complaint provides a visual comparison of the patent's Figure 1 and photographs of the Elvie Pump (Compl. ¶138).
Patent Identification: U.S. Design Patent No. D977,625, "Breast pump," issued February 7, 2023.
Technology Synopsis: This patent claims the ornamental design for a breast pump as shown in its figures (Compl. ¶55).
Asserted Claims: The design as shown and described (Compl. ¶152).
Accused Features: The overall ornamental appearance of the Elvie Pump, which the complaint alleges is the same as or substantially identical to the patented design (Compl. ¶¶152-153). The complaint provides a visual comparison of the patent's Figure 1 and photographs of the Elvie Pump (Compl. ¶152).
III. The Accused Instrumentality
Product Identification
- The accused products are the "Elvie Pump" and any mobile applications designed for use in conjunction with it (collectively, the "Accused Products") (Compl. ¶64).
Functionality and Market Context
- The Elvie Pump is described as a wearable, hands-free, in-bra electric breast pump (Compl. p. 6). The system is battery-powered and communicates wirelessly with a mobile application that allows users to monitor milk volume, track pumping history, and control the pump (Compl. ¶¶64, 74, 97). The complaint alleges that Defendant has established itself as a "major manufacturer and distributor" in the consumer breastfeeding market and has used the technology to secure over $150 million in funding (Compl. ¶¶7-8). The complaint provides a screenshot from Walmart.com showing the product available for sale and in-stock for pickup at a store in Marshall, Texas, illustrating its presence in the district (Compl. p. 6).
IV. Analysis of Infringement Allegations
The complaint references, but does not include, claim chart exhibits detailing the infringement allegations. The following tables summarize the infringement theory for the lead patents based on the claim elements recited in the complaint and the general description of the Accused Products.
’816 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| [1a] a breast pump configured to fit within a bra... | The complaint alleges the Elvie Pump is a wearable pump designed to fit inside a bra. | ¶69 | col. 2:14-18 |
| [1b] a breast pump shell housing a milk flow path; | The complaint alleges the Elvie Pump has a shell containing a milk flow path. | ¶69 | col. 2:5-8 |
| [1c] a pumping mechanism, the pumping mechanism contained completely within the breast pump shell; | The complaint alleges the Elvie Pump contains a self-contained pumping mechanism. | ¶69 | col. 2:20-23 |
| [1d] a fluid container configured to directly engage and be supported by the breast pump shell, wherein the fluid container is connected to the milk flow path; | The complaint alleges the Elvie Pump uses a milk collection container that attaches to the main pump body. | ¶69 | col. 1:59-62 |
| [1e] a flange attached to the breast pump shell and configured to receive the breast, the flange including a rigid nipple receiving portion... | The complaint alleges the Elvie Pump uses a flange with a rigid portion for receiving the nipple. | ¶69 | col. 19:56-63 |
| [1f] an external computer that automatically tracks pumping and communicates with the pumping mechanism; | The complaint alleges the Elvie Pump's accompanying mobile application on a smartphone serves as the external computer. | ¶69 | col. 20:31-39 |
| [1g] wherein the pumping mechanism...is configured to create a suction force...the suction force and the milk flow path both being directed generally upward relative to the bottom portion of the flange. | The complaint alleges the Elvie Pump's mechanism creates suction and that the milk flow path is directed upward. | ¶69 | col. 50:56-67 |
’228 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| [1a] providing a breast pump system configured to fit within a bra...including a breast pump housing, a breast contacting structure, a milk flow path, and a collection container; | The complaint alleges Elvie provides a wearable, in-bra breast pump system with these components. | ¶83 | col. 1:42-45 |
| [1b] the milk flow path and the collection container contained within the breast pump housing; | The complaint alleges the Elvie Pump's milk path and container are within its housing. | ¶83 | col. 1:59-62 |
| [1c] forming a seal between the breast pump system and the breast; | The complaint alleges the use of the Elvie Pump involves forming a seal with the user's breast. | ¶83 | col. 41:21-23 |
| [1d] pumping milk expressed from the breast to the collection container; | The complaint alleges the Elvie Pump performs the function of pumping milk into its container. | ¶83 | col. 1:17-22 |
| [1e] wherein the milk is pumped from the breast to the collection container upwardly through the milk flow path relative to a bottom of the breast contacting structure. | The complaint alleges the Elvie Pump's milk flow path is directed upwardly. | ¶83 | col. 41:8-15 |
- Identified Points of Contention:
- Scope Questions: A central question for both the ’816 and ’228 patents may be the construction of the terms "generally upward" and "upwardly." The analysis will depend on how the accused product operates in various user positions and how the court defines the "bottom portion of the flange" or "bottom of the breast contacting structure" as a reference point.
- Technical Questions: A key factual dispute will likely concern the actual fluid dynamics within the Elvie Pump. The case may require expert testimony to determine if the milk flow path and suction force are, in fact, "directed generally upward" as claimed in the ’816 Patent, and if the milk is pumped "upwardly" as required by the method in the ’228 Patent.
V. Key Claim Terms for Construction
The Term: "rigid nipple receiving portion" (’816 Patent, Claim 1)
Context and Importance: The term "rigid" is relative and its construction will be critical to determining if the Elvie Pump's flange meets this limitation. The dispute may turn on whether "rigid" implies a specific material hardness or structural inflexibility, or if it is defined in contrast to other components or the prior art. Practitioners may focus on this term because the patent uses it to distinguish its improved, lower-profile flange from prior art systems that allegedly caused more chafing (Compl. ¶¶22, 24).
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification does not appear to provide a specific definition of "rigid," which may support an argument for giving the term its plain and ordinary meaning.
- Evidence for a Narrower Interpretation: The patent contrasts its invention with prior art flanges (Compl. ¶24; ’816 Patent, FIG. 9). A party could argue that "rigid" should be construed in light of the problems the patent purports to solve, such as reducing nipple movement and friction, potentially tying the term to a specific functional outcome rather than just material property (’816 Patent, col. 19:64-20:11).
The Term: "directed generally upward" (’816 Patent, Claim 1) / "upwardly" (’228 Patent, Claim 1)
Context and Importance: These directional terms are central to the infringement allegations for two lead patents. Their construction will determine whether the accused product's internal fluid path infringes. The meaning of "upward" depends on the frame of reference—specifically, the "bottom portion of the flange" or "bottom of the breast contacting structure"—and the degree of deviation allowed by "generally."
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The term "generally" in the ’816 Patent suggests that the direction does not need to be strictly vertical and can accommodate some angular deviation, which could broaden the claim's scope.
- Evidence for a Narrower Interpretation: The specifications of both patents may contain figures or descriptions illustrating the intended orientation of the device and the milk flow path, which could be used to argue for a more specific, limited range of upward angles relative to the base of the device when properly worn (’228 Patent, col. 41:8-15). The problem solved by the ’228 patent—preventing milk loss—may imply an upward direction sufficient to counteract gravity.
VI. Other Allegations
- Indirect Infringement: The complaint alleges inducement of infringement under 35 U.S.C. § 271(b). It asserts that Defendant actively encourages infringement by designing the Accused Products and training customers on their use through supporting materials, videos, instructions, and product manuals available on its website (Compl. ¶¶74, 88). Contributory infringement is also alleged, based on the sale of products especially designed to operate in an infringing manner (Compl. ¶¶75, 89).
- Willful Infringement: Willfulness is alleged based on Defendant’s purported pre-suit knowledge of the asserted patents. The complaint claims that the patents-in-suit were cited during the prosecution of Defendant’s own patent applications, and that Defendant, as a direct competitor, monitors the patent landscape (Compl. ¶¶70-71, 76).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of technical operation and claim scope: Does the Elvie Pump’s internal fluid mechanics direct the milk flow path and/or suction force "upwardly" or "generally upward" relative to the device's base, as required by key claims? The resolution will depend on both the factual evidence of how the accused product functions and the court's construction of these critical directional terms.
- A second key issue will be one of design similarity: For the two asserted design patents, would an ordinary observer, familiar with the prior art, be deceived into thinking the design of the Elvie Pump is the same as the designs claimed in the ’D995 and ’D625 patents? This will be a visual and holistic comparison, supported by the side-by-side images provided in the complaint.
- An evidentiary question will be one of knowledge and intent: What evidence will be presented to establish that Defendant had pre-suit knowledge of the patents-in-suit and possessed the specific intent to encourage infringement by its customers, which are necessary elements for the claims of willfulness and induced infringement? The allegation that the patents were cited during Elvie’s own patent prosecution activities will be a central piece of evidence on this point.