DCT
1:19-cv-00627
Progressive Sterilization LLC v. Turbett Surgical LLC
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Progressive Sterilization, LLC (Florida)
- Defendant: Turbett Surgical LLC (Delaware) and Robert Turbett, individually
- Plaintiff’s Counsel: Rogowski Law LLC
- Case Identification: 1:19-cv-00627, D. Del., 04/03/2019
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Turbett Surgical LLC is a Delaware limited liability company and has engaged in substantial business in the forum, including targeting business activities towards consumers in Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s “POD” surgical instrument sterilization system infringes three patents related to mobile sterilization cabinets and associated methods of use.
- Technical Context: The technology concerns mobile, reusable cabinets for sterilizing multiple trays of surgical instruments, designed to replace traditional, single-tray sterilization wrap methods to improve efficiency and reduce contamination risks in hospital settings.
- Key Procedural History: The complaint alleges a prior business relationship between the parties' predecessors, during which Defendant’s principal, Robert Turbett, allegedly gained access to confidential information and trade secrets related to the patented technology. Plaintiff acquired the asserted patents and other intellectual property following the bankruptcy of the original assignee, AmMed Surgical.
Case Timeline
| Date | Event |
|---|---|
| 2013-07-17 | Earliest Priority Date for ’143 and ’093 Patents |
| 2014-03-10 | Earliest Priority Date for ’972 Patent |
| 2016-04-03 | Accused POD product first exhibited at trade show |
| 2017-04-11 | ’143 Patent Issued |
| 2017-07-04 | ’093 Patent Issued |
| 2018-10-30 | ’972 Patent Issued |
| 2019-04-03 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 9,616,143 - "Mobile Apparatus and Method for Sterilizing One or More Surgical Trays with Integrable Transfer and Storage System"
- Patent Identification: U.S. Patent No. 9,616,143, titled “Mobile Apparatus and Method for Sterilizing One or More Surgical Trays with Integrable Transfer and Storage System,” issued April 11, 2017 (the “’143 Patent”).
The Invention Explained
- Problem Addressed: The patent describes traditional surgical tray sterilization as a multi-step, time-consuming process involving washing, loading, and individually wrapping each tray in a protective wrap (Compl. ¶¶ 25-26). This process is costly and carries the risk of contamination if the wrap is torn or breached, which could delay surgeries or endanger patients (Compl. ¶27; ’143 Patent, col. 1:29-67).
- The Patented Solution: The invention is an integrated system comprising a mobile sterilization cabinet and a dedicated transfer cart (Compl. ¶84). Multiple unwrapped surgical trays are placed inside the cabinet, which is then sealed. The entire cabinet is placed on the transfer cart, moved to an autoclave for sterilization, and subsequently transported to storage or the operating room, thereby eliminating the need for individual wrapping and inspection of each tray (’143 Patent, Abstract; col. 2:50-col. 3:5).
- Technical Importance: This system was designed to reduce material and labor costs, streamline the sterilization workflow in hospitals, and lower the risk of surgical site infections by providing a more robust container for sterilized instruments (Compl. ¶28).
Key Claims at a Glance
- The complaint asserts independent claim 1 and a number of dependent claims (Compl. ¶92).
- Independent Claim 1 recites a mobile sterilization system comprising:
- A cabinet with a plurality of panels, including one that is a removably coupleable panel (e.g., a door) with a gasket to form a seal.
- The cabinet defines an interior sterilization area accessible when the panel is uncoupled.
- At least one opening in a panel to allow a sterilization agent to flow into the interior area.
- A transfer cart frame with at least one rail, on which the cabinet is moveably positionable for movement between the cart and an autoclave.
- A retaining mechanism on the cart frame that releasably engages and secures the cabinet to the cart.
- A lower portion of the cart frame configured to permit movement (e.g., via wheels).
U.S. Patent No. 9,694,093 - "Mobile Apparatus and Method for Sterilizing One or More Surgical Trays with Integrable Transfer and Storage System"
- Patent Identification: U.S. Patent No. 9,694,093, titled “Mobile Apparatus and Method for Sterilizing One or More Surgical Trays with Integrable Transfer and Storage System,” issued July 4, 2017 (the “’093 Patent”).
The Invention Explained
- Problem Addressed: The problem is identical to that described in the ’143 Patent: the inefficiency and risk associated with traditional, wrap-based sterilization methods (Compl. ¶¶ 25-27; ’093 Patent, col. 1:26-col. 2:13).
- The Patented Solution: While the ’143 Patent claims the apparatus, the ’093 Patent claims the method of using that system. The claimed method covers the complete workflow: loading trays into the cabinet, securing it in a sealed configuration, using an adjustable transfer cart to position the cabinet adjacent to an autoclave, locking the cart, transferring the cabinet into the autoclave for sterilization, and then retrieving and relocating the cabinet (’093 Patent, Abstract; col. 2:53-67).
- Technical Importance: By patenting the method of use, the invention seeks to protect the entire improved sterilization process enabled by the mobile cabinet system, not just the physical device itself (Compl. ¶85).
Key Claims at a Glance
- The complaint asserts independent claim 1 and several dependent claims (Compl. ¶105).
- Independent Claim 1 recites a method of sterilizing surgical trays, comprising the steps of:
- Configuring a cabinet in an open configuration.
- Loading at least one surgical tray into the cabinet's interior sterilization chamber.
- Securing the cabinet into a sealed configuration.
- Positioning the cabinet at a sterilization location adjacent to an autoclave using a transfer cart.
- The transfer cart is adjustable to permit leveling of the cabinet to the autoclave.
- Locking the transfer cart relative to the autoclave.
- Transferring the cabinet from the cart into the autoclave while the cart is locked.
- The cabinet or cart includes mechanical guides for the transfer.
- Sterilizing the instruments within the cabinet.
- Positioning the cabinet back onto the transfer cart while sealed.
- Releasing the transfer cart relative to the autoclave.
- Relocating the cabinet from the sterilization location using the transfer cart.
U.S. Patent No. 10,111,972 - "Mobile Sterilization Apparatus and Method for Using the Same"
- Patent Identification: U.S. Patent No. 10,111,972, titled “Mobile Sterilization Apparatus and Method for Using the Same,” issued October 30, 2018 (the “’972 Patent”).
The Invention Explained
- This patent addresses the problem of liquid condensate remaining in a sterilization cabinet after an autoclave cycle, which can compromise sterility (’972 Patent, col. 1:33-44). The solution is a cabinet with a floor panel that is entirely pitched, directing any condensate by gravity to a lowest point where it passes through a filter and drain, ensuring the cabinet interior remains dry (Compl. ¶86; ’972 Patent, Abstract).
Key Claims at a Glance
- Asserted Claims: The complaint asserts independent claim 14 and dependent claims 15, 16, and 18 (Compl. ¶119).
- Accused Features: The complaint alleges that the Defendant’s POD cabinet infringes by including a plurality of panels forming a chamber, a door to seal the chamber, a vent for sterilization fluid, a pitched floor panel directing condensate to a lowest point, a filter in communication with that lowest point, and an internal supporting structure for surgical trays (Compl. ¶120).
III. The Accused Instrumentality
Product Identification
- The accused instrumentality is the “POD unit,” which comprises the “POD cabinet” and the associated “POD cart” (Compl. ¶87).
Functionality and Market Context
- The POD unit is described as a system for “packaging, transporting and holding of surgical instruments prior to, during and after sterilization” in an autoclave (Compl. ¶87). The POD cabinet is designed to enclose “multiple uncovered, vented instrument delivery trays” (Compl. ¶93, citing Ex. G). Defendant provides specific instructions to users on how to operate the system, including loading the cabinet onto the cart, docking the cart to a sterilizer, transferring the cabinet into the sterilizer, and retrieving it after the cycle (Compl. ¶¶ 88-89, citing Exs. F, G). The complaint alleges that Defendant’s POD technology is a competing system that is, in fact, Plaintiff’s own CUBE technology, developed using misappropriated trade secrets (Compl. ¶8).
IV. Analysis of Infringement Allegations
’143 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A mobile sterilization system for sterilizing a plurality of surgical trays and for movement from an autoclave... | The POD unit is used for packaging, transporting, and holding instruments for sterilization and is indicated for enclosing multiple surgical trays. | ¶93 | col. 2:50-53 |
| a cabinet comprising a plurality of panels having a first panel and a second panel surrounding a cabinet floor, | The POD cabinet has multiple panels, including a first panel (the "outer door") and a second panel (e.g., side or roof panel) surrounding the floor. | ¶93 | col. 4:1-4 |
| where at least the first panel is removably coupleable to the second panel with a gasket there between, such that when coupled the first panel and second panel form a seal... | The outer door is removably coupleable to the side/roof panels. A filter cartridge with a built-in gasket is loaded into the door, which is then coupled to other panels to form a seal. | ¶93 | col. 4:5-11 |
| at least one opening in at least one of the plurality of panels to allow flow of the sterilization agent from an exterior of the cabinet directly to the interior sterilization area; | The POD door has a plurality of openings that allow sterilization agent (steam) to flow from the exterior into the interior. An image of the perforated outer door is provided as evidence. | ¶93 | col. 4:18-22 |
| a transfer cart frame that supports at least one rail, where the cabinet is moveably positionable on at least one rail such that the cabinet can be moved between the autoclave to the transfer cart; | The POD cart has a frame with at least one rail, onto which the POD cabinet can be positioned and moved between the autoclave and the cart. An image shows the POD cabinet resting on the cart's rails. | ¶93 | col. 4:23-26 |
| at least one retaining mechanism on the transfer cart frame, where the at least one retaining mechanism releasably engages the cabinet to secure the cabinet to the transfer cart... | The POD unit includes a "transfer carriage lock" that releasably engages the POD cabinet to secure it to the POD cart during movement. | ¶93 | col. 4:27-31 |
| where a lower portion of the transfer cart frame is configured to permit movement of the transfer cart. | The lower portion of the POD cart frame has wheels to permit movement. | ¶93 | col. 4:32-34 |
- Identified Points of Contention:
- Scope Questions: The complaint presents a theory of literal infringement. A potential point of contention may arise over the definition of “retaining mechanism.” The analysis will question whether the accused “transfer carriage lock” performs the specific functions of releasably engaging and securing the cabinet during movement as required by the claim.
- Technical Questions: What evidence demonstrates that the accused filter cartridge’s “built in gasket” forms a seal between the “first panel” (the door) and the “second panel” (a side/roof panel), as opposed to simply sealing the filter within the door frame? The complaint’s image of a person removing the outer door is cited as evidence for this limitation (Compl. p. 28).
’093 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of sterilizing at least one surgical tray... | The Turbett method uses the POD cabinet for packaging and holding instruments in multiple vented instrument delivery trays for sterilization. | ¶107 | col. 2:53-56 |
| loading the at least one surgical tray containing surgical instruments into the interior sterilization chamber; | After preparation, at least one surgical tray with instruments is loaded into the POD cabinet's interior chamber. This is illustrated with an image of a user placing trays inside the cabinet. | ¶107 | col. 4:42-43 |
| securing the cabinet into the sealed configuration; | The POD cabinet is secured by placing an outer door onto the container and closing six latches. | ¶107 | col. 4:44-45 |
| positioning the cabinet at a sterilization location adjacent to an autoclave using a transfer cart, | The user is instructed to "Unlock wheels, and roll cart to sterilizer. Dock cart to sterilizer..." | ¶107 | col. 4:46-48 |
| locking the transfer cart relative to the autoclave; | The instructions state to "engage[] sterilizer cart lock and ensuring tracks are aligned" and to confirm the cart is locked by pulling on it. | ¶107 | col. 4:51-52 |
| transferring the cabinet from the transfer cart into an autoclave while the transfer cart is locked... | The user is instructed to "Release the transfer carriage lock, and push the container into the sterilizer..." after confirming the cart is locked. | ¶107 | col. 4:53-56 |
| sterilizing the surgical instruments within the interior sterilization chamber; | The user is instructed to "Run the sterilizer for the validated cycle." | ¶107 | col. 4:60-62 |
| relocating the cabinet from the sterilization location using the transfer cart. | The instructions direct the user to "...unlock wheels, and move entire unit to a draft free area to cool." | ¶107 | col. 5:1-3 |
- Identified Points of Contention:
- Scope Questions: This is a method claim. A key question will be whether Defendant’s instructions for use (Ex. G) teach or encourage users to perform every single step of the claimed method. For example, does the claim’s requirement that the cart be “adjustable to permit leveling” require an affirmative leveling step by the user, or merely that the cart possess the capability?
- Technical Questions: Does the accused method’s instruction to "engage sterilizer cart lock" constitute "locking the transfer cart relative to the autoclave" as claimed? The analysis will question whether the lock connects the cart to the autoclave itself, or if it is an internal locking mechanism on the cart that is engaged while adjacent to the autoclave. The complaint provides an image showing the cart being docked as evidence for this step (Compl. p. 34).
V. Key Claim Terms for Construction
’143 Patent: “retaining mechanism”
- The Term: "at least one retaining mechanism on the transfer cart frame"
- Context and Importance: This term is critical because it defines the feature that secures the sterilization cabinet to the cart. The infringement analysis depends on whether the accused "transfer carriage lock" is properly characterized as a "retaining mechanism" that performs the claimed functions of releasably engaging and securing the cabinet during movement. Practitioners may focus on this term to dispute whether the accused lock is structurally and functionally equivalent to what is described and enabled in the patent.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The claim language itself is broad, not specifying any particular type of mechanism (e.g., latch, clamp, lock). The patent states the purpose is to "secure the cabinet to the transfer cart during movement" (’143 Patent, col. 4:29-31), which could arguably cover any device that achieves this function.
- Evidence for a Narrower Interpretation: The specification does not appear to provide significant detail or alternative embodiments for this mechanism, which might open the door for an argument that its scope is limited to the structures implicitly disclosed. A defendant may argue the term should be limited to a mechanism that is distinct from the rails that guide the cabinet.
’093 Patent: “securing the cabinet into the sealed configuration”
- The Term: "securing the cabinet into the sealed configuration"
- Context and Importance: This method step is a prerequisite for sterilization. The definition of "securing" will be central to determining infringement. Plaintiff will likely argue it encompasses the simple act of closing the door and latches as instructed in Defendant's manual. Defendant might argue that "securing" implies a specific type of positive locking or tamper-evident feature not present in its product or taught in its method.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent describes this step simply as the action taken after loading trays and before moving the cabinet to the autoclave (’093 Patent, col. 4:44-45). The plain meaning suggests any action that closes and seals the cabinet.
- Evidence for a Narrower Interpretation: The specification mentions the use of a "security structure" to ensure the cabinet remains sealed, such as a "closure integrity lock" (’093 Patent, col. 2:65-67). A defendant could argue this language suggests "securing" requires more than just latching the door, but also applying an additional security element to achieve the "sealed configuration."
VI. Other Allegations
- Indirect Infringement: The complaint alleges active inducement of infringement for all three asserted patents. The allegations are based on Defendant Turbett Surgical providing customers with instructions for use (IFUs), promotional literature, website content, and training that allegedly direct and encourage users to operate the POD unit in a manner that directly infringes the claimed apparatuses and methods (Compl. ¶¶ 96-97, 109-111, 123-124).
- Willful Infringement: The complaint alleges willful infringement for all three patents. The basis for willfulness is alleged to have begun, "since at least the date of service of this Complaint," indicating an allegation of post-suit willfulness based on knowledge gained from the filing of the lawsuit itself (Compl. ¶¶ 99, 113, 126).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of factual correspondence: given the complaint’s narrative of direct copying, the case will likely focus on a feature-by-feature and step-by-step comparison of the accused POD system and its use against the elements of the asserted claims. The outcome may depend on whether minor physical or operational differences in the POD system are sufficient to place it outside the literal scope of the claims.
- A key question for the method claims will be one of induced infringement: does the evidence, particularly Defendant's user manuals and training materials, demonstrate a specific intent to cause infringement by instructing customers to perform each and every step of the claimed methods in the specified order?
- A central claim construction issue will be the functional scope of mechanical terms: can general terms like "retaining mechanism" (’143 Patent) and "mechanical guides" (’093 Patent) be construed broadly to read on the specific corresponding features of the accused POD cart (the "transfer carriage lock" and "flanged wheels"), or does the patent's specification provide a basis to limit these terms to narrower structures?