DCT
8:20-cv-00630
Breathe Tech Inc v. Inogen Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Breathe Technologies, Inc. (Delaware)
- Defendant: Inogen, Inc. (Delaware)
- Plaintiff’s Counsel: Riley Safer Holmes & Cancila LLP
- Case Identification: 8:20-cv-00630, C.D. Cal., 03/31/2020
- Venue Allegations: Plaintiff alleges venue is proper in the Central District of California because Defendant Inogen has a regular and established place of business in Goleta, California, and has committed acts of infringement at that location. This filing follows a prior action in the Northern District of California, which was transferred to this district after Inogen objected to venue there.
- Core Dispute: Plaintiff alleges that Defendant’s Sidekick TAV Tidal Assist Ventilator system infringes a patent related to non-invasive, non-sealing ventilation technology.
- Technical Context: The technology concerns wearable, non-invasive ventilation systems that provide mechanical breathing support to patients with respiratory disorders, aiming to combine the mobility of oxygen therapy with the therapeutic benefit of traditional ventilators.
- Key Procedural History: The complaint alleges that Plaintiff previously sued Defendant in the Northern District of California, but the case was transferred to the current district upon Defendant’s venue objection. The complaint also alleges that two of the patent’s named inventors, Gregory Kapust and Todd Allum, left Plaintiff to found New Aera, the company that developed the accused product and was later acquired by Defendant. Plaintiff further alleges it informed Defendant of the infringement prior to Defendant’s acquisition of New Aera.
Case Timeline
| Date | Event |
|---|---|
| 2009-09-03 | U.S. Patent No. 9,132,250 Priority Date |
| 2015-09-15 | U.S. Patent No. 9,132,250 Issue Date |
| 2018-05-16 | Accused TAV System commercial release announced |
| 2019-11-05 | Inogen discloses potential infringement lawsuit in SEC filing |
| 2019-11-21 | Prior lawsuit filed by Breathe against Inogen in N.D. Cal. |
| 2020-03-31 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,132,250 - "Methods, Systems and Devices for Non-Invasive Ventilation Including a Non-Sealing Ventilation Interface With an Entrainment Port and/or Pressure Feature"
- Patent Identification: U.S. Patent No. 9132250, "Methods, Systems and Devices for Non-Invasive Ventilation Including a Non-Sealing Ventilation Interface With an Entrainment Port and/or Pressure Feature," issued September 15, 2015.
The Invention Explained
- Problem Addressed: The patent describes a technical challenge in respiratory therapy: traditional mechanical ventilation (MV) systems are effective but obtrusive and immobilize the patient, while simple oxygen therapy allows for mobility but does not mechanically assist in the work of breathing (’250 Patent, col. 2:18-32; Compl. ¶¶8-9).
- The Patented Solution: The invention is a non-sealing nasal interface that provides ventilatory support without fully enclosing the patient’s nose or mouth. A jet nozzle delivers gas into the interface, which creates a negative pressure zone that entrains ambient air through a port (a Venturi effect). The combined stream of delivered gas and entrained air then creates a positive pressure area further down the flow path, providing mechanical support to the patient's breathing while allowing the patient to remain mobile and breathe ambient air normally (’250 Patent, Abstract; col. 2:54-62).
- Technical Importance: This approach sought to provide the mechanical breathing assistance of traditional MV therapies with the mobility and reduced obtrusiveness of oxygen therapies (Compl. ¶10).
Key Claims at a Glance
- The complaint asserts independent Claim 1 and reserves the right to assert other claims (Compl. ¶27).
- The essential elements of independent claim 1 include:
- A system for providing ventilatory support comprising: a gas source, a gas delivery circuit, and a nasal interface.
- The nasal interface is adapted to allow a patient to breathe ambient air through it and has a gas flow path with a distal end opening.
- A nozzle is positioned at a proximal end of the nasal interface.
- An entrainment port is associated with the nasal interface, with at least a portion of the port located between the nozzle and the distal end opening.
- The nozzle delivers gas into the interface to create a "negative pressure area" in the gas flow path at the entrainment port.
- The nasal interface and nozzle create a "positive pressure area" between the entrainment port and the distal end gas flow path.
- A combination of gas from the source and air entrained through the port provides "ventilatory support".
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the Sidekick TAV Tidal Assist Ventilator system ("TAV System"), which is alleged to comprise a Nasal Pillows Interface, TAV Controller, TAV compatible oxygen concentrator, and Supply Tubing (Compl. ¶¶23, 30).
Functionality and Market Context
- The complaint alleges the TAV System is a noninvasive ventilator system brought to market in 2018 (Compl. ¶23). It is alleged to include a nasal interface with entrainment ports that allow a patient to breathe ambient air, a nozzle in fluid communication with a gas source, and that a combination of gas from the source and entrained air provides ventilatory support to the patient (Compl. ¶28). An introductory frame from a promotional video for the TAV System is included in the complaint, showing its commercial release was announced at the 2018 Conference of the California Society of Pulmonary Rehabilitation (Compl. ¶23).
IV. Analysis of Infringement Allegations
The complaint references a claim chart in its Exhibit 2, which was not available for this analysis; the following table is constructed based on the narrative allegations.
'250 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A system for providing ventilatory support comprising: a gas source; a gas delivery circuit; | The TAV System is alleged to include a gas source (TAV compatible oxygen concentrator) and a gas delivery circuit (Supply Tubing). | ¶28, ¶30 | col. 4:22-23 |
| a nasal interface adapted to allow a patient to breathe ambient air through the nasal interface; | The TAV System includes a nasal interface with entrainment ports that enable a patient to breathe ambient air through the interface. | ¶28 | col. 3:15-18 |
| a gas flow path through the nasal interface, wherein the gas flow path comprises a distal end gas flow path opening; | The TAV System's nasal interface is alleged to have the necessary structure to create a gas flow path. | ¶28 | col. 4:24-26 |
| a nozzle positioned on a proximal end of the nasal interface at a distance from the distal end gas flow path opening; and | The TAV System's nasal interface is alleged to include a nozzle in fluid communication with the gas delivery circuit and gas source. | ¶28 | col. 4:27-30 |
| an entrainment port associated with the nasal interface, wherein at least a portion of the entrainment port is between the nozzle and the distal end gas flow opening, | The TAV System's nasal interface is alleged to include entrainment ports. | ¶28 | col. 4:31-35 |
| wherein the nozzle delivers gas into the nasal interface to create a negative pressure area in the gas flow path at the entrainment port, | The complaint does not explicitly allege the creation of a negative pressure area but asserts that the TAV System meets every element of the claim. This function is implied by the allegation of entrainment. | ¶29 | col. 4:42-45 |
| wherein the nasal interface and the nozzle create a positive pressure area between the entrainment port and the distal end gas flow path, and | The complaint does not explicitly allege the creation of a positive pressure area but asserts that the TAV System meets every element of the claim. | ¶29 | col. 4:46-49 |
| wherein a combination of gas from the gas source and air entrained through the entrainment port provide ventilatory support. | The complaint alleges that a combination of gas from the gas source and entrained air provides ventilatory support to the patient. | ¶28 | col. 4:50-53 |
Identified Points of Contention
- Technical Questions: The complaint alleges infringement of Claim 1 but does not provide specific evidence detailing how the accused TAV System creates the claimed "negative pressure area" and "positive pressure area". A key technical question will be what evidence exists that the accused product’s fluid dynamics match the specific positive and negative pressure zones required by the claim's functional limitations.
- Scope Questions: The case may raise the question of what level of breathing assistance constitutes "ventilatory support." The defense could argue the TAV System is primarily an oxygen delivery device and that any "support" is incidental and does not rise to the level required by the patent.
V. Key Claim Terms for Construction
The Term: "ventilatory support"
Context and Importance: This term is central to distinguishing the patented invention from prior art oxygen therapy devices, which do not mechanically assist breathing. The defendant may argue its device does not provide "support" in the claimed sense. Practitioners may focus on this term because its definition determines whether the accused device falls within the scope of the patent at all.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification uses the term broadly, stating that the combination of supplied gas and entrained air "provide ventilatory support" without requiring a specific quantitative threshold (’250 Patent, col. 4:18-19).
- Evidence for a Narrower Interpretation: The specification links the concept to "reducing the work of breathing" and "increasing airway pressure" (’250 Patent, col. 3:15-20, col. 24:24-26). A party could argue that "ventilatory support" requires a measurable reduction in work of breathing or a specific increase in airway pressure to be infringing.
The Term: "negative pressure area"
Context and Importance: The creation of a "negative pressure area" is the core mechanism for entraining ambient air and is a critical functional limitation of Claim 1. Proving that the accused device performs this function is essential for the plaintiff's infringement case.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The abstract and summary of the invention describe the creation of a negative pressure area generally as a result of the nozzle delivering gas into the interface (’250 Patent, Abstract).
- Evidence for a Narrower Interpretation: The specification states the negative pressure area is created "at the entrainment port" and may be approximately -5 to -40 cmH2O (’250 Patent, col. 4:44-45, col. 4:58-59). Figures such as Figure 26 visually depict this zone with a "-" symbol, suggesting a specific location and character.
VI. Other Allegations
Indirect Infringement
- The complaint alleges both induced and contributory infringement. Inducement is alleged based on Defendant providing "TAV Instructions" with the TAV System that instruct patients on its assembly and use (Compl. ¶¶38-39). Contributory infringement is alleged on the basis that the "Nasal Pillows Interface" is a material component, especially made for infringing use, and is not a staple article of commerce with substantial non-infringing uses (Compl. ¶¶33-34).
Willful Infringement
- The complaint alleges willfulness based on both pre-suit and post-suit knowledge. It alleges that New Aera, the original developer of the accused product, was founded by two of the ’250 patent's named inventors (Compl. ¶¶21-22, 35). It further alleges that Plaintiff explicitly notified Defendant Inogen of the infringement prior to Inogen's acquisition of New Aera, and that Inogen acknowledged this risk in an SEC filing and established an $8 million escrow account to indemnify itself against infringement claims (Compl. ¶¶25-26, 41).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question will be one of functional proof: Can Plaintiff demonstrate that the accused TAV System, in operation, generates the specific, spatially-related "negative pressure area" and "positive pressure area" as functionally required by Claim 1? The complaint's allegations on this point are currently conclusory.
- A key legal and factual issue will concern willfulness: Given the allegations that the patent's own inventors developed the accused product and that Defendant received express pre-acquisition notice of infringement, the court will need to determine Defendant's state of mind and whether its conduct rose to the level of egregious behavior required for enhanced damages.