DCT
5:24-cv-06569
3B Medical Mfg LLC v. Precision Medical Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: 3B Medical Mfg LLC (Florida)
- Defendant: Precision Medical Inc (Pennsylvania)
- Plaintiff’s Counsel: Freemann Law Offices; Carlson Gaskey & Olds
- Case Identification: 5:24-cv-06569, E.D. Pa., 12/09/2024
- Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Pennsylvania because Defendant is incorporated and maintains a place of business within the district.
- Core Dispute: Plaintiff, an exclusive licensee, alleges that Defendant’s Live Active Five line of portable oxygen concentrators and associated removable cartridges infringes four U.S. patents related to the mechanical design, fluid dynamics, and component arrangement of such devices.
- Technical Context: The technology concerns portable medical devices that use vacuum swing adsorption to concentrate oxygen from ambient air for patients requiring supplemental oxygen therapy, a market driven by the need for lightweight, efficient, and ambulatory solutions.
- Key Procedural History: Plaintiff notes that two of the asserted patents have recently survived validity challenges at the Patent Trial and Appeal Board (PTAB). A petition for inter partes review (IPR) against U.S. Patent No. 10,357,628 was denied institution. A separate IPR against U.S. Patent No. 11,389,614 concluded with a final written decision upholding the validity of all asserted claims. Plaintiff also alleges providing pre-suit notice of infringement to Defendant on two separate occasions, first in November 2020 and again in September 2024.
Case Timeline
| Date | Event |
|---|---|
| 2005-02-09 | Earliest Priority Date for Asserted Patents |
| 2009-10-20 | U.S. Patent No. 7,604,005 Issues |
| 2018-03-16 | Plaintiff obtains exclusive license to Asserted Patents |
| 2019-07-23 | U.S. Patent No. 10,357,628 Issues |
| 2020-07-07 | U.S. Patent No. 10,702,669 Issues |
| 2020-11-30 | Plaintiff sends first notice letter regarding ’005, ’628, ’669 Patents |
| 2022-07-19 | U.S. Patent No. 11,389,614 Issues |
| 2022-12-23 | IPR petition filed against the ’614 Patent |
| 2023-02-10 | IPR petition filed against the ’628 Patent |
| 2023-09-01 | PTAB denies institution of IPR against the ’628 Patent |
| 2024-06-18 | PTAB upholds validity of asserted claims of the ’614 Patent |
| 2024-09-27 | Plaintiff sends second notice letter adding the ’614 Patent |
| 2024-12-09 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 7,604,005 - Adsorbent Cartridge for Oxygen Concentrator
The Invention Explained
- Problem Addressed: The patent describes a need for improved portable oxygen systems for ambulatory patients, noting that existing solutions like high-pressure cylinders and liquid oxygen dewars are often heavy, require frequent refilling at specialized stations, and pose safety concerns (’005 Patent, col. 1:35-67).
- The Patented Solution: The invention is a removable cartridge for a portable oxygen concentrator that uses a vacuum swing adsorption process. The cartridge contains multiple "gas separation columns" filled with an adsorbent material (like zeolite) that preferentially adsorbs nitrogen from ambient air, thereby producing a stream of concentrated oxygen for the user (’005 Patent, Abstract; col. 3:9-13). The modular cartridge design facilitates user replacement of the adsorbent material, which degrades over time.
- Technical Importance: This approach enabled the development of smaller, lighter, and more user-friendly portable oxygen concentrators that do not require refilling from external tanks, enhancing patient mobility (’005 Patent, col. 2:48-55).
Key Claims at a Glance
- The complaint asserts independent claim 10 (Compl. ¶39).
- Essential elements of claim 10 include:
- A removable cartridge for a portable oxygen concentrator
- An outer casing
- A plurality of gas separation columns within the casing, each containing an adsorbent material that preferentially adsorbs nitrogen, and having a first and second end
- A plurality of inlet ports in the outer casing, each connected to the first end of one of the columns
- A plurality of outlet ports in the outer casing, each connected to the second end of one of the columns
U.S. Patent No. 10,357,628 - Removable Cartridge For Oxygen Concentrator
The Invention Explained
- Problem Addressed: The technical problem is identical to that described in the ’005 Patent, focusing on the limitations of traditional ambulatory oxygen systems (’628 Patent, col. 1:18-col. 2:50).
- The Patented Solution: This patent, from the same family as the ’005 Patent, claims a complete portable oxygen concentrator system comprising a main "cartridge module" with a receptacle and a "separation cartridge" that is "selectively removable." The claims focus heavily on the structural and directional relationships between the cartridge, its removal direction, the orientation of its inlet/outlet, and the adsorbent bed's axis (’628 Patent, Abstract; col. 10:28-48). The invention specifies that the direction of cartridge removal and the orientation of the inlet/outlet are "substantially parallel."
- Technical Importance: The claimed configuration addresses the specific mechanical design for integrating a user-replaceable separation cartridge into a compact, wearable device, focusing on usability and functional geometry (’628 Patent, col. 4:45-55).
Key Claims at a Glance
- The complaint asserts independent claim 1 (Compl. ¶69).
- Essential elements of claim 1 include:
- A portable oxygen concentrator comprising a cartridge module with a housing defining a receptacle
- A separation cartridge selectively removable from the receptacle by movement in a "first direction"
- The cartridge has a case, an inlet oriented in a "second direction opposite the first direction," an outlet oriented in the second direction, and a bed of adsorbent material
- A removable power pack, a pump, a user interface, and a carrying device
- The cartridge module housing at least partially surrounds the separation cartridge case
- The adsorbent bed is disposed along an axis, with specific spatial relationships for the inlet and outlet relative to the axis
- The "first direction" and "second direction" are substantially parallel to the axis
U.S. Patent No. 10,702,669 - Removable Cartridge For Oxygen Concentrator
- Technology Synopsis: This patent claims a removable cartridge with a specific geometric arrangement of its internal components. It requires first and second beds of adsorbent material disposed along parallel axes and a specific configuration of four fluid ports, where planes extending through pairs of these ports are substantially perpendicular to the adsorbent bed axes (Compl. ¶98; ’669 Patent, Abstract).
- Asserted Claims: Claim 1 is asserted (Compl. ¶98).
- Accused Features: The complaint alleges that the Live Active Five system and its replacement cartridges embody the claimed geometric arrangement of beds, axes, and ports (Compl. ¶99).
U.S. Patent No. 11,389,614 - Removable Cartridge For Oxygen Concentrator
- Technology Synopsis: This patent claims a portable oxygen concentrator with a removable separation cartridge defined by its internal fluid flow paths. It requires two parallel "lines" passing through the outlet and inlet, respectively, and specifies that fluid flowing along the first line (through the outlet) contacts the adsorbent bed, while fluid flowing along the second line (through the inlet) does not (’614 Patent, Abstract; Compl. ¶125).
- Asserted Claims: Claims 1-11 and 15 are asserted, with Claim 1 being the independent claim detailed in the complaint (Compl. ¶¶124-125).
- Accused Features: The complaint alleges that the Live Active Five system and its cartridges are configured with the claimed parallel fluid flow paths relative to the adsorbent bed (Compl. ¶126). The complaint's Exhibit 8 includes a diagram illustrating these alleged parallel flow paths in the accused product (Compl. Ex. 8, p. 5).
III. The Accused Instrumentality
Product Identification
- The Precision Medical Inc Live Active Five device, its system components, and its replacement cartridges (Compl. ¶12).
Functionality and Market Context
- The Live Active Five is a portable oxygen concentrator designed for ambulatory patients. The complaint provides a product photo showing a compact, portable unit with a user interface (Compl. p. 3). The infringement allegations center on the system's use of a user-replaceable cartridge containing adsorbent material to generate concentrated oxygen. One exhibit shows a user inserting a multi-column cartridge into the main device, illustrating the product’s modular design (Compl. Ex. 5, p. 1). The complaint alleges that Defendant has manufactured and sold this system since at least November 30, 2020, without changing its design despite receiving notice of infringement (Compl. ¶¶13, 15).
IV. Analysis of Infringement Allegations
’005 Patent Infringement Allegations
| Claim Element (from Independent Claim 10) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A removable cartridge for a portable oxygen concentrator, the cartridge comprising: an outer casing; | The accused product includes a removable cartridge with an outer casing that is inserted into the main concentrator unit. | ¶40 | col. 4:9-13 |
| a plurality of gas separation columns within the outer casing, each gas separation column containing an adsorbent material that preferentially adsorbs nitrogen, a first end, and a second end; | The accused cartridge contains multiple parallel columns, each filled with an adsorbent material to separate nitrogen from air. | ¶40 | col. 5:8-13 |
| a plurality of inlet ports in the outer casing, each inlet port connect to the first end of one of the columns; and | The cartridge has inlet ports at one end that connect to the first end of the respective columns. | ¶40 | col. 18:32-34 |
| a plurality of outlet ports in the outer casing, each outlet port connected to the second end of one of the columns. | The cartridge has outlet ports at the opposite end that connect to the second end of the respective columns. | ¶40 | col. 18:34-36 |
- Identified Points of Contention:
- Scope Questions: The primary dispute may center on the term "connect to". A court will have to determine whether the claim requires a direct, immediate connection between the ports on the casing and the ends of the columns, or if an indirect connection through internal manifolds or passages within the cartridge housing meets the limitation.
’628 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A portable oxygen concentrator, comprising: a cartridge module comprising a housing, the housing defining a receptacle; a separation cartridge selectively removable from the receptacle... | The accused system includes a main housing (the concentrator) that defines a receptacle for receiving a removable separation cartridge. | ¶70 | col. 4:10-13 |
| ...by movement relative to the receptacle in a first direction... | The complaint alleges the accused cartridge is removed from the receptacle by a linear upward movement, which it defines as the "first direction." A photograph in Exhibit 6 illustrates this upward removal path (Compl. Ex. 6, p. 2). | ¶70 | col. 10:31-33 |
| ...the separation cartridge comprising a case..., an inlet oriented in a second direction opposite the first direction, an outlet oriented in the second direction... | The accused cartridge allegedly has its inlet and outlet ports oriented to face downward, opposite the upward removal direction. This downward orientation is defined as the "second direction." | ¶70 | col. 10:33-36 |
| ...wherein the bed of adsorbent material is disposed along an axis... and wherein the first direction and the second direction are substantially parallel to the axis. | The complaint alleges the adsorbent beds are arranged along a vertical axis. It further alleges that the upward removal direction ("first direction") and the downward port orientation ("second direction") are both substantially parallel to this vertical axis. Exhibit 6, page 9 contains a diagram illustrating this alleged parallel relationship. | ¶70 | col. 12:44-48 |
- Identified Points of Contention:
- Technical Questions: A key factual question will be whether the accused device's directions of movement and component orientations are indeed "opposite" and "substantially parallel" as claimed. The defense may argue that the removal mechanism involves rotational or non-parallel movements, or that the port orientations deviate from a strictly parallel or opposite arrangement.
- Scope Questions: The term "substantially parallel" is a term of degree whose scope will be a central issue for claim construction. The analysis will depend on how much deviation from perfectly parallel is permitted by the patent's specification and prosecution history.
V. Key Claim Terms for Construction
- The Term: "substantially parallel to the axis" (from ’628 Patent, Claim 1)
- Context and Importance: This term is critical for defining the required geometric relationship between the physical axis of the adsorbent bed, the direction of cartridge removal, and the orientation of the fluid ports. Infringement will likely depend on whether the accused product's geometry falls within the scope of "substantially." Practitioners may focus on this term because terms of degree are frequently litigated, and its construction could either broadly cover similar designs or restrict the claim to the specific embodiment shown.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The use of the word "substantially" itself suggests the patentee did not intend to limit the claim to a perfectly parallel arrangement. The specification does not appear to provide an explicit numerical or angular limit, which may support an interpretation that covers minor, insignificant deviations from parallel.
- Evidence for a Narrower Interpretation: The figures in the patent consistently depict a perfectly parallel relationship between the components (e.g., ’628 Patent, Figs. 15-16). A defendant may argue that this consistent depiction limits the scope of "substantially" to arrangements that are visually or functionally indistinguishable from being perfectly parallel, and that any significant angular deviation falls outside the claim.
VI. Other Allegations
- Indirect Infringement: Plaintiff asserts induced infringement for all four patents. The complaint alleges Defendant had knowledge of the patents, at the latest, from the notice letters sent in November 2020 and September 2024 (Compl. ¶¶50, 80, 109, 136). It alleges Defendant intended to cause infringement by providing instructional literature, user manuals, and marketing materials that instruct customers on how to use the Live Active Five system in an infringing manner (Compl. ¶¶51-52, 81-82).
- Willful Infringement: Plaintiff alleges willful infringement for all patents based on Defendant's alleged knowledge from the pre-suit notice letters. The complaint contends that Defendant continued to make and sell the accused products without any design changes after being notified of the alleged infringement, constituting egregious, willful, and deliberate conduct (Compl. ¶¶45-46, 75-76, 104-105, 131-132).
VII. Analyst’s Conclusion: Key Questions for the Case
This case appears to present focused questions of claim scope and technical application, strengthened by the patents' recent successes in PTAB proceedings. The central issues for the court will likely be:
- A core issue will be one of definitional scope: can relational terms like "connect to" ('005 patent) and geometric terms of degree such as "substantially parallel" ('628 patent) be construed broadly enough to read on the specific mechanical and fluidic design of the accused Live Active Five system? The resolution of these terms will likely determine the outcome of the infringement analysis for the entire patent family.
- A key evidentiary question will be one of technical and temporal proof: given Plaintiff's allegations of pre-suit notice dating back to 2020, what evidence will establish Defendant's state of mind to support the claims for willful infringement? The court will need to examine the content of the notice letters and Defendant's conduct after receiving them.
- A final question will be the impact of prior PTAB decisions: how will the PTAB's denial of IPR institution for the '628 patent and its final written decision upholding the validity of the '614 patent influence settlement discussions and litigation strategy? While not binding on the district court for infringement, these outcomes may suggest a strengthened validity position for the Plaintiff.