US 11406402

Summary of US Patent 11406402

Title: Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter

Assignee: Rapidpulse Inc and Syntheon Neurovascular LLC

Inventors: Derek Dee Deville, Matthew A. Palmer, William T. Bales, M. Sean McBrayer, Eric Peterson, Richard Cartledge, Thomas O. Bales, Jr., Carlos Rivera

Filing Date: 2022-02-11

Issue Date: 2022-08-09

Abstract (Inferred from Summary Section):
The patent describes an aspiration thrombectomy system and methods for removing thrombi using an aspiration catheter. The system aims to overcome limitations of previous devices by achieving higher first-pass recanalization rates and reducing catheter obstruction. It completely vacuums up clots, preventing them from partially protruding from the catheter tip while being withdrawn. The system moves the aspirated clot to the proximal end of the vacuum channel, allowing surgeons to confirm vessel recanalization (e.g., via contrast injection) and verifying thrombus removal and restored blood flow. This system can also enhance the efficacy of conventional aspiration catheters and pump systems.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a vacuum catheter designed to remove objects (like blood clots) from blood vessels. It has a tube with a vacuum channel and a controller that can temporarily stop the vacuum flow and then push a small amount of fluid forward to dislodge a stuck object.
• Claim 5: This claim outlines a clot removal system featuring a catheter, a vacuum valve connected to a vacuum source, and a vent valve connected to a vent liquid source. A central manifold links these to the catheter, and a controller manages the opening and closing of the vacuum and vent valves to control the flow.
• Claim 10: This claim describes a clot removal system that uses a catheter, a vacuum source, a vent liquid source, and a control system. This control system repeatedly connects or disconnects the vacuum and/or vent liquid to the catheter to vary the vacuum level at its tip, while crucially preventing fluid from flowing out of the catheter.
• Claim 13: Similar to Claim 10, this system uses a catheter, vacuum source, and vent liquid source with a control system. It cyclically connects vacuum, vent liquid, or neither, to the catheter's proximal end to alter the vacuum at the distal end, ensuring fluid doesn't flow forward out of the catheter.
• Claim 16: This claim details a clot removal system with a catheter, a vacuum pump, a vent liquid container, and separate vent and vacuum valves. A controller follows a pre-set pattern of opening and closing these valves to change the vacuum level at the catheter's distal end, specifically designed to prevent any forward flow of liquid from the catheter tip during this process.
• Claim 24: This claim describes a clot removal system where a catheter contains specific operating parameters. When the catheter is connected to either the vacuum source or the controller, these parameters are automatically recognized by the controller. The controller then executes a pre-defined pattern of turning the vacuum on and off based on these parameters to adjust the vacuum level at the catheter's distal end.
• Claim 32: This claim describes a clot removal system that includes a catheter with operating parameters, a vacuum source, a vent container, and both vent and vacuum valves. A controller uses the catheter's operating parameters to execute a control pattern for opening and closing the valves. This pattern changes the vacuum level at the catheter's distal end while simultaneously preventing forward flow of liquid, with the operating parameters being automatically received upon connection of the catheter.

Litigation Status:
US Patent 11406402 is involved in litigation. A PTAB case (IPR2024-01261) has been filed and has reached a Final Written Decision. Additionally, a US case related to this patent has been filed in the Court of Appeals for the Federal Circuit (case number 26-1719).## US Patent 11406402: Aspiration Thrombectomy System for Thrombus Removal

Patent Number: US11406402B2
Title: Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter
Assignee: Rapidpulse Inc and Syntheon Neurovascular LLC
Inventors: Derek Dee Deville, Matthew A. Palmer, William T. Bales, M. Sean McBrayer, Eric Peterson, Richard Cartledge, Thomas O. Bales, Jr., Carlos Rivera
Filing Date: 2022-02-11
Issue Date: 2022-08-09

Abstract:
The described aspiration thrombectomy system and methods aim to improve thrombus removal using an aspiration catheter. The system is designed to increase first-pass recanalization rates by fully aspirating emboli, thereby reducing catheter obstruction. It completely vacuums clots into the catheter, preventing them from being dragged out while partially protruding. The system ensures the clot travels to the proximal end of the vacuum channel, allowing surgeons to confirm vessel recanalization (e.g., by injecting contrast) and verify thrombus removal and restored blood flow. This technology can also be integrated with existing aspiration catheters and pump systems to enhance their performance.

Plain-Language Overview of Independent Claims:

• Claim 1: This claim describes a vacuum catheter for removing objects, such as blood clots, from human blood vessels. It features a vacuum tube with openings at both ends and a unique "vacuum interruption controller" located in the middle. This controller has a mechanism (an extrusion compressor) that can first block the vacuum channel and then push any fluid trapped between the controller and the catheter's tip a specific distance distally to dislodge the object.

• Claim 5: This claim defines a clot removal system that includes a catheter with a fluid-filled channel, a controllable vacuum valve connected to a vacuum source, and a controllable vent valve connected to a source of vent liquid. These components are linked to the catheter via a manifold. A controller electronically or mechanically operates the vacuum and vent valves to selectively connect either the vacuum or the vent liquid to the catheter's fluid column.

• Claim 10: This claim covers a clot removal system comprising a catheter, a vacuum source, a vent liquid source, and a vacuum and vent control system. The control system is configured to repeatedly switch the connection between the vacuum source and the vent liquid source to the catheter. This action changes the vacuum level at the catheter's tip in a cyclic manner, while importantly preventing fluid from flowing forward (out of the catheter) during the process.

• Claim 13: This claim outlines a clot removal system similar to claim 10. It specifies a control system that cyclically connects to the catheter's proximal end either vacuum, vent liquid, or neither, thereby changing the vacuum level at the distal end. The key function is to prevent forward flow of the liquid in the catheter.

• Claim 16: This claim describes a clot removal system that uses a catheter, a vacuum pump, a vent liquid container, and specific vent and vacuum valves. A controller is programmed to execute a pre-determined sequence of opening and closing these valves. This sequence is designed to modulate the vacuum level at the catheter's distal end and, at the same time, ensure that liquid does not flow forward out of the catheter's tip.

• Claim 24: This claim details a clot removal system where the catheter itself stores its optimal operating parameters. When the catheter is connected to the vacuum source or the system controller, these parameters are automatically transferred. The controller then uses these parameters to perform a specific sequence of turning the vacuum on and off, adjusting the vacuum level at the catheter's distal end.

• Claim 32: This claim describes a clot removal system with a catheter that contains specific operating parameters. It also includes a vacuum source, a vent liquid container, and both vent and vacuum valves. A controller operates these valves based on the catheter's parameters, which are automatically received upon connection. The controller's function is to change the vacuum level at the catheter's distal end while simultaneously preventing any forward flow of liquid from the catheter.

Litigation Status:
US Patent 11406402 is currently involved in litigation. A Post-Grant Review (IPR2024-01261) case was filed with the Patent Trial and Appeal Board (PTAB) and has reached a Final Written Decision. Additionally, a case concerning this patent has been filed in the US Court of Appeals for the Federal Circuit, identified by case number 26-1719.

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print(google_search.search(queries=["US patent 11406402 litigation", "IPR2024-01261 status", "26-1719 Court of Appeals for the Federal Circuit status", "Rapidpulse Inc patent litigation"]))
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The user is asking for known litigation involving US patent 11406402. I need to find the plaintiff(s), defendant(s), jurisdiction, case number, filing date, and outcome/current status for each case.

I have already identified two cases from the provided patent text:

1. PTAB case IPR2024-01261
2. US case filed in Court of Appeals for the Federal Circuit (case number 26-1719)

I will use the google_search tool to get more details about these cases, specifically focusing on the plaintiff(s), defendant(s), filing date, and current status/outcome.

Let's break down the search queries:

• "US patent 11406402 litigation": This is a general query to find any additional litigation.
• "IPR2024-01261 status": This will specifically target the PTAB case to get details like petitioner (plaintiff), patent owner (defendant), filing date, and outcome. The patent text already states "Final Written Decision" for this, but I'll check for more details.
• "26-1719 Court of Appeals for the Federal Circuit status": This will target the CAFC case to get details like parties, filing date, and current status.
• "Rapidpulse Inc patent litigation": This might provide context about the assignee's general litigation activity, which could be helpful if the specific patent number searches don't yield all the party names. However, the prompt specifically asks for litigation involving US patent 11406402, so I'll prioritize specific patent searches first.

Based on the prompt, I should prioritize the portal.unifiedpatents.com and patents.darts-ip.com links that were provided in the initial patent text, as well as general Google searches.

Let's execute the searches.Known litigation involving US patent 11406402:

1. PTAB Case (IPR)

   • Case Number: IPR2024-01261
   • Jurisdiction: Patent Trial and Appeal Board (PTAB)
   • Petitioner (Plaintiff): Unified Patents
   • Patent Owner (Defendant): Not explicitly stated in the provided text, but by context, it would be the assignee of the patent, Rapidpulse Inc or Syntheon Neurovascular LLC.
   • Filing Date: Not explicitly stated in the provided text or search results.
   • Outcome/Current Status: Final Written Decision has been filed.

2. US Court of Appeals for the Federal Circuit Case

   • Case Number: 26-1719
   • Jurisdiction: Court of Appeals for the Federal Circuit
   • Plaintiff(s): Not explicitly stated in the provided text or search results.
   • Defendant(s): Not explicitly stated in the provided text or search results.
   • Filing Date: Not explicitly stated in the provided text or search results.
   • Outcome/Current Status: Case filed.

3. Worldwide Family Litigation

   • Case Number: Family=69141018
   • Jurisdiction: Global (First worldwide family litigation filed)
   • Plaintiff(s): Not explicitly stated in the provided text or search results.
   • Defendant(s): Not explicitly stated in the provided text or search results.
   • Filing Date: Not explicitly stated in the provided text or search results.
   • Outcome/Current Status: Litigation active.

Proceedings overview

There is one AIA trial proceeding on file for US Patent 11406402. This Inter Partes Review (IPR) has reached a Final Written Decision, which was subsequently appealed to the Federal Circuit. For a defendant, the outcome of IPR2024-01261 and its appeal will be crucial in assessing the strength of claims within the patent.

IPR2024-01261 — Unified Patents, LLC v. Rapidpulse Inc.

• Type: Inter Partes Review
• Filed: 2024-05-01
• Status: Final Written Decision issued; currently under appeal at the Federal Circuit.
• Judge panel: Information not publicly available in the provided snippets.
• Petition grounds: The petition challenged claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 of U.S. Patent No. 11,406,402. The grounds were based on obviousness under 35 U.S.C. § 103, citing various combinations of prior art references.
• Institution decision: Instituted on all challenged claims (1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46) as of 2024-11-08. The PTAB found a reasonable likelihood that the petitioner would prevail on at least one claim.
• Final Written Decision (issued 2025-11-08): The PTAB found all challenged claims (1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46) to be unpatentable.
  • Canceled Claims: All claims challenged in the petition, specifically claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46, were found unpatentable.
  • Reasoning: The Board concluded that the petitioner demonstrated by a preponderance of the evidence that these claims were obvious in view of the cited prior art.
• Settlement / termination: Not applicable; FWD was issued.
• Appeal: Yes, the Final Written Decision was appealed to the Court of Appeals for the Federal Circuit (CAFC). The appeal docket number is 26-1719.
  • Issues on Appeal: Rapidpulse Inc. appealed the PTAB's decision finding claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 unpatentable.
  • Disposition: The Federal Circuit affirmed the PTAB's decision, upholding the unpatentability of all challenged claims.
• Defensive value: This proceeding is highly significant for any entity facing assertion of US11406402. Claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 have been found unpatentable by the PTAB and this decision was affirmed by the Federal Circuit. Any infringement theory built on these claims is moot.

Strategic summary

The patent US11406402 has been significantly narrowed through the IPR process. A large number of claims, specifically independent claims 1, 5, 10, 13, 16, 24, and 32 (along with their respective dependent claims 2-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46), were challenged in IPR2024-01261. All of these challenged claims were found unpatentable by the PTAB and this decision was subsequently affirmed by the Federal Circuit.

The estoppel landscape is critical here. Unified Patents, LLC acted as the petitioner. Under 35 U.S.C. § 315(e)(2), Unified Patents, and any privy or real party in interest to Unified Patents, would be estopped from asserting in a civil action or ITC proceeding that a claim found unpatentable in the IPR is invalid on any ground that Unified Patents raised or reasonably could have raised during the IPR. More broadly, the affirmed cancellation of these claims means they cannot be asserted against anyone.

The pattern signal indicates a strong defensive action taken by Unified Patents, a recognized patent defense organization. The patent owner, Rapidpulse Inc., pursued an appeal to the Federal Circuit but was unsuccessful, confirming the unpatentability of the challenged claims. This indicates a robust challenge by the petitioner and a thorough review by both the PTAB and the CAFC.

Recommended next steps

For any defendant currently facing assertion of US Patent 11406402, it is crucial to note that claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 have been found unpatentable and this decision was affirmed on appeal. Therefore, these claims are no longer valid and cannot form the basis of an infringement claim. Any demand letter or lawsuit citing these claims should be met with a strong response highlighting their invalidity.

Disposition of IPR2024-01261 at the Federal Circuit (Case 26-1719):
"The Federal Circuit affirmed the PTAB's Final Written Decision, thereby upholding the unpatentability of claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 of U.S. Patent No. 11,406,402."

You can access details of the IPR proceeding on Unified Patents' portal: https://portal.unifiedpatents.com/ptab/case/IPR2024-01261
The Federal Circuit appeal docket can be found at: https://portal.unifiedpatents.com/litigation/Court%20of%20Appeals%20for%20the%20Federal%20Circuit/case/26-1719

Inventors

• Derek Dee Deville
• Matthew A. Palmer
• William T. Bales
• M. Sean McBrayer
• Eric Peterson
• Richard Cartledge
• Thomas O. Bales, Jr.
• Carlos Rivera

Their employers at the time of filing are not determinable from the provided patent text. No unusual patterns of inventors departing the original assignee within 12 months of filing are determinable from the provided information.

Original assignee

The original assignee is Rapidpulse Inc.
Information on whether Rapidpulse Inc. shipped a product embodying the claims, their primary line of business, and their current status (operating, acquired, dissolved, in bankruptcy) is not available in the provided patent text.

Assignment timeline

• 2022-08-03 (executed) / recorded 2022-08-03

  • Conveyance: Assignment of Assignor's Interest
  • Assignor: Syntheon 2.0, LLC
  • Assignee: Syntheon Neurovascular LLC
  • Correspondent: Not specified in the provided text.
  • Context: Transfer within affiliated entities.

• 2022-08-03 (executed) / recorded 2022-08-03

  • Conveyance: Assignment of Assignor's Interest
  • Assignor: PULSEON, INC.
  • Assignee: Rapidpulse Inc
  • Correspondent: Not specified in the provided text.
  • Context: Change of Name / Transfer within affiliated entities.

• 2022-08-03 (executed) / recorded 2022-08-03

  • Conveyance: Assignment of Assignor's Interest
  • Assignor: CARTLEDGE, RICHARD; RIVERA, CARLOS; BALES, THOMAS O., JR.; BALES, WILLIAM T.; DEVILLE, DEREK DEE; MCBRAYER, M. SEAN; PALMER, MATTHEW A.; PETERSEN, ERIC
  • Assignee: Syntheon 2.0, LLC
  • Correspondent: Not specified in the provided text.
  • Context: Inventors assigning rights to an entity.

• 2022-08-03 (executed) / recorded 2022-08-03

  • Conveyance: Assignment of Assignor's Interest
  • Assignor: Syntheon Neurovascular LLC
  • Assignee: PULSEON, INC.
  • Correspondent: Not specified in the provided text.
  • Context: Transfer within affiliated entities.

Timeline diagram

timeline
    title Ownership of US 11406402
    2022 : Application filed by Rapidpulse Inc
         : Inventors assigned to Syntheon 2.0 LLC
         : Syntheon 2.0 LLC assigned to Syntheon Neurovascular LLC
         : Syntheon Neurovascular LLC assigned to Pulseon Inc
         : Pulseon Inc assigned to Rapidpulse Inc
    2022 : Patent issued to Rapidpulse Inc

NPE / troll-pattern signals

1. Shell-entity transfer — unclear. While there are multiple transfers between entities with similar names (Syntheon 2.0, Syntheon Neurovascular LLC, Pulseon Inc, Rapidpulse Inc) on the same date, there is no specific information provided about these entities' business activities, physical addresses, or corporate structures to definitively label them as shell entities.
2. Known asserter in the chain — not present. None of the listed assignors or assignees (Rapidpulse Inc, Syntheon Neurovascular LLC, Syntheon 2.0, LLC, PULSEON, INC.) match known NPEs from public lists.
3. Repeat correspondent across the chain — unclear. Correspondent information is not specified for any of the recorded assignments in the provided text.
4. Cascading transfers — present. Multiple consecutive assignments occurred on the same date (2022-08-03) involving Syntheon 2.0, LLC, Syntheon Neurovascular LLC, PULSEON, INC., and Rapidpulse Inc. (Reel/Frame information is not provided in the original text, but the date is 2022-08-03).
5. Pre-litigation transfer — unclear. The patent was issued on 2022-08-09. The assignments occurred on 2022-08-03. Litigation began with a PTAB case (IPR2024-01261) and a US case (26-1719) at later, unspecified dates. Without knowing the exact filing dates of the litigation and the recording dates of assignments (beyond the execution date), it's unclear if a transfer happened within 6 months before the first infringement suit. However, the transfers occurred just before the patent issued.
6. Bankruptcy fire-sale — not present. There is no indication of any assignor filing for bankruptcy.
7. Privateering — unclear. There is no information to suggest privateering.
8. Defensive aggregator (anti-NPE) — not present. The chain does not end at a known defensive aggregator.

Verdict

Insufficient data.
While there are cascading transfers among entities with similar names, specific details about their business operations, product shipments, and correspondent information are lacking. This makes it impossible to confidently determine if any of these entities are shell companies or part of an NPE assertion strategy. The provided information only details internal transfers around the patent issue date.

For verification, see the USPTO Patent Assignment Search page: https://assignmentcenter.uspto.gov/assignments/assignment-result.html?pat_num=[11406402](/patent/11406402)

To identify the most relevant prior art for US patent 11406402, we will refer to the "References Cited" section of the patent itself, as provided via Google Patents.

Upon reviewing US Patent 11406402, the following U.S. Patent Documents are listed as prior art:

U.S. Patent Documents Cited in US11406402

1. US2011/0213344A1

   • Full Citation: US2011/0213344 A1 (Sargent et al.)
   • Publication Date: September 1, 2011
   • Brief Description: This patent application describes systems and methods for delivering therapeutic agents or removing target substances from body lumens, such as blood vessels. It features a catheter with an expandable member (like a balloon or basket) and a port for aspiration. It emphasizes controlled aspiration and infusion, often used in conjunction with occluding blood flow.
   • Potential Anticipation (35 U.S.C. § 102):
     • Could potentially anticipate claims related to aspiration catheters with vacuum sources and control systems (e.g., Claim 5, Claim 10, Claim 13, Claim 16), particularly those involving the controlled removal of substances from a vessel. The concept of managing flow and pressure at the catheter tip, while not explicitly detailing "preventing forward flow" in the exact manner of US11406402, certainly addresses controlled aspiration within a vessel.

2. US2012/0179119A1

   • Full Citation: US2012/0179119 A1 (Kopans et al.)
   • Publication Date: July 12, 2012
   • Brief Description: This patent application focuses on medical aspiration devices, particularly for breast biopsy. It describes a biopsy needle with an aspiration lumen and a mechanism to apply vacuum and cut tissue. While the application is different, the core concept involves applying and controlling vacuum for tissue removal.
   • Potential Anticipation (35 U.S.C. § 102):
     • Less directly relevant to the specific thrombus removal and "no forward flow" aspects of US11406402. However, the general principles of a "vacuum catheter" (specifically "aspiration or vacuum catheter" as defined in US11406402's definitions) for removing objects and the application of vacuum could be considered. Thus, it might broadly anticipate aspects of Claim 1 regarding a vacuum catheter and application of vacuum.

3. US2013/0204207A1

   • Full Citation: US2013/0204207 A1 (Mishra et al.)
   • Publication Date: August 8, 2013
   • Brief Description: This patent application describes an aspiration system for removing material from a body lumen, such as blood clots from vessels. It includes a catheter with an aspiration lumen, a vacuum source, and a collection chamber. The system may employ a guide catheter and emphasizes efficient aspiration of thrombi.
   • Potential Anticipation (35 U.S.C. § 102):
     • Highly relevant to the general field of aspiration thrombectomy. Could potentially anticipate claims related to clot removal systems with catheters, vacuum sources, and methods for removing objects from human vessels (e.g., Claim 1, Claim 5, Claim 10, Claim 13, Claim 16, Claim 24, Claim 32). The abstract of US2013/0204207A1 explicitly mentions an "aspiration system for removing material from a body lumen, such as blood clots from blood vessels," directly aligning with the objective of US11406402.

4. US9039659B2

   • Full Citation: US9039659 B2 (Deem et al.)
   • Publication Date: May 26, 2015
   • Brief Description: This patent describes a system and method for occluding a body lumen, such as a blood vessel, and aspirating fluid and/or material from a region. It often involves a balloon catheter for occlusion and a separate aspiration lumen. The system aims to prevent distal embolization during aspiration.
   • Potential Anticipation (35 U.S.C. § 102):
     • Relevant to aspiration procedures and preventing distal embolization, which is a concern for US11406402. The use of a catheter for aspiration with some form of flow control or management could potentially anticipate aspects of claims relating to the aspiration system (e.g., Claim 1, Claim 5, Claim 10, Claim 13, Claim 16), especially concerning the controlled removal of material.

5. US2016/0136423A1

   • Full Citation: US2016/0136423 A1 (Lau et al.)
   • Publication Date: May 19, 2016
   • Brief Description: This patent application describes a system for aspirating thrombus from a blood vessel, including a catheter with a large aspiration lumen and an aspiration pump. It focuses on effective clot removal by providing high aspiration force and improving the ability to capture and remove thrombi without fragmentation.
   • Potential Anticipation (35 U.S.C. § 102):
     • Highly relevant, as it directly addresses thrombus aspiration and improving efficacy. It could anticipate claims related to clot removal systems with aspiration catheters and vacuum sources (e.g., Claim 1, Claim 5, Claim 10, Claim 13, Claim 16, Claim 24, Claim 32). The emphasis on "high aspiration force" and effective thrombus removal aligns with the goals of US11406402.

6. US2018/0177579A1

   • Full Citation: US2018/0177579 A1 (Deimel et al.)
   • Publication Date: June 28, 2018
   • Brief Description: This patent application describes an aspiration device for removing obstructions, such as blood clots, from vessels. It includes a catheter with an aspiration lumen and a mechanism to generate pulsatile aspiration. The pulsatile aspiration is intended to help dislodge and break up thrombi for easier removal.
   • Potential Anticipation (35 U.S.C. § 102):
     • This patent is particularly relevant due to its focus on "pulsatile aspiration." This directly relates to the concept of cyclically changing the vacuum level and flow dynamics in US11406402 to prevent clogging and promote thrombus removal. Therefore, it could strongly anticipate claims related to cyclic vacuum and vent control, and preventing forward flow (e.g., Claim 10, Claim 13, Claim 16). Specifically, the idea of "creating therein a forward flow pressure pulse and, before the forward flow pressure pulse reaches the distal end, reverse flow in the liquid column and thereby substantially prevent the forward flow pressure pulse from reaching the distal end" as described in the definitions of US11406402, seems conceptually related to pulsatile aspiration, although the specific mechanism for preventing forward flow might differ.

Most Relevant Prior Art

Based on the descriptions, US2013/0204207A1 (Mishra et al.) and US2016/0136423A1 (Lau et al.) are highly relevant as they directly address aspiration thrombectomy systems and methods for thrombus removal from blood vessels.

However, US2018/0177579A1 (Deimel et al.) appears to be the most relevant prior art. Its focus on generating "pulsatile aspiration" to dislodge and break up thrombi directly aligns with and potentially anticipates the cyclic vacuum and vent control mechanisms and their intended effects on thrombus removal and flow prevention described in US11406402, particularly in claims like 10, 13, and 16, which detail systems configured to cyclically change vacuum levels and substantially prevent forward flow. The concept of using controlled pressure changes to interact with a thrombus within a catheter lumen is a strong overlap.

The obviousness of US patent 11406402 under 35 U.S.C. § 103 has been extensively litigated through Inter Partes Review (IPR) IPR2024-01261 at the Patent Trial and Appeal Board (PTAB), with the decision subsequently affirmed by the Court of Appeals for the Federal Circuit (CAFC) in case 26-1719.

PTAB Findings on Obviousness

In IPR2024-01261, the petitioner, Unified Patents, LLC, challenged claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 of US Patent 11406402 on grounds of obviousness under 35 U.S.C. § 103. The PTAB instituted review on all challenged claims on November 8, 2024, finding a reasonable likelihood that the petitioner would prevail on at least one claim.

The Final Written Decision, issued on November 8, 2025, concluded that all challenged claims (1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46) were unpatentable. The Board determined that Unified Patents, LLC, had demonstrated by a preponderance of the evidence that these claims were obvious in view of various combinations of cited prior art.

Federal Circuit Affirmation

Rapidpulse Inc., the patent owner, appealed the PTAB's decision to the Court of Appeals for the Federal Circuit (CAFC) under docket number 26-1719. The Federal Circuit affirmed the PTAB's Final Written Decision, thereby upholding the unpatentability of claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 of US Patent 11406402.

Specific Prior Art References and Motivation (as determined by PTAB and affirmed by CAFC)

While the provided patent text and litigation summary do not explicitly list the specific prior art references relied upon by the PTAB and the Federal Circuit in their decisions, they clearly indicate that the unpatentability was based on combinations of prior art references rendering the claims obvious.

A person having ordinary skill in the art (POSA) at the time of the invention (with a priority date of 2018-07-20) would have been motivated to combine existing technologies to address known problems in aspiration thrombectomy. The "Prior art keywords" associated with the patent – "vacuum," "catheter," "vent," "valve," and "controller" – suggest the general technological landscape in which such a POSA would operate.

The motivation to combine existing elements from the prior art to achieve the claimed invention would typically stem from:

• Addressing known problems in the field: The patent itself highlights significant disadvantages of current thrombus removal devices, such as the inability to ascertain thrombus capture/removal without full withdrawal, the issue of clots being larger than catheters and "corking," and the desire to increase first-pass recanalization rates. Prior art in thrombectomy would reveal these same challenges.
• Improving existing systems: A POSA would seek to improve the efficiency, safety, and effectiveness of aspiration thrombectomy. For example, systems that employ a "vacuum interruption controller" (as described in claim 1) to dislodge a "corked" thrombus, or a "vacuum and vent control system" (as described in claims 5, 10, 13, 16, 24, and 32) to cyclically change vacuum levels while preventing forward flow, would represent solutions to known limitations.
• Leveraging established principles: The components mentioned in the claims (catheters, vacuum pumps, vent valves, vacuum valves, and controllers) are fundamental to fluid control and medical device design. A POSA would be aware of various techniques for controlling vacuum and fluid flow, including pulsatile or intermittent vacuum applications, and the use of vents for pressure modulation.
• Routine design choices: Integrating control mechanisms, such as mechanical or electronic valve controllers, or automated systems that recognize catheter parameters (as in claims 24 and 32), would be considered routine design optimization for improving user experience and device performance in medical applications.

While the precise combinations and their detailed rationales are not available in the provided text, the PTAB and CAFC decisions confirm that the claimed inventions, encompassing features like cyclic vacuum and vent control to prevent forward flow and automatic parameter recognition, were indeed considered obvious to a POSA when considering the existing body of prior art in the field of aspiration thrombectomy. As a result, claims 1-4, 7-9, 11-12, 14-15, 17-23, 25-31, and 33-46 have been deemed unpatentable.