US 11554005

US patent 11554005, titled "System for treating embolism and associated devices and methods," was issued to Inari Medical Inc. on January 17, 2023. The inventors are Ben Merritt, Jacqueline Macias, Brian Michael Strauss, and Thomas Tu. The patent was filed on July 14, 2022.

The abstract describes a system for treating embolism that includes a catheter subsystem, a tubing subsystem, and a pressure source. The catheter is designed to be positioned within a blood vessel near clot material. The tubing subsystem connects the catheter to a pressure source, with a fluid control device to connect or disconnect them. The pressure source can generate and store a vacuum when the fluid control device is closed, and then apply this stored vacuum to the catheter's lumen when the device is opened, thereby aspirating clot material from the blood vessel.

A plain-language overview of the independent claims is as follows:

• Claim 1 (System Claim): This claim describes a system for treating embolisms. It comprises a catheter system with a catheter that goes inside a patient's blood vessel, having a distal end near a blood clot, and a valve connected to the catheter. A tubing system connects this catheter system to a pressure source. This tubing system includes a control device to connect or disconnect the pressure source from the catheter. The pressure source is designed to create and hold a vacuum when the control device is closed. When the control device is opened, the stored vacuum is applied to the catheter to suck out the clot material.
• Claim 11 (Method Claim - Single Catheter): This claim outlines a method for treating an embolism. It involves positioning a catheter in a patient's blood vessel near a clot. A pressure source is connected to the catheter via a fluid control device, which can connect or disconnect the two. The method then involves activating the pressure source to create and store a vacuum while the fluid control device is closed. Finally, the fluid control device is opened to apply this stored vacuum to the catheter, removing the clot material.
• Claim 17 (System Claim - Nested Catheters): This claim describes a system for treating embolism using two catheters. It includes a first catheter system with a first catheter and valve, and a second catheter system with a second, smaller catheter and valve. The smaller second catheter can be inserted through the first catheter. There's a first pressure source connected to the first catheter system via a first control device, and a second pressure source connected to the second catheter system via a second control device. The second pressure source is configured to generate and store a vacuum when its control device is closed, and then apply this vacuum to the second catheter when the device is opened to aspirate clot material.
• Claim 20 (Method Claim - Nested Catheters): This claim describes a method involving the use of nested catheters. It includes placing a first catheter inside a patient, then advancing a second catheter through the first catheter until its distal end is near clot material. A second pressure source is activated to generate and store a vacuum while a second fluid control device is closed. The method concludes by opening this second fluid control device to apply the stored vacuum to the second catheter, aspirating the clot material.

Regarding litigation, patent US11554005 is currently active. There is a PTAB case, IPR2025-00289, which was filed and is currently pending/instituted. Additionally, two US district court cases related to this patent family were filed in the California Northern District Court: 5:24-cv-03117 and 3:24-cv-03117. No specific CAFC 2026 dockets directly naming US11554005 were found in the search results.

Known litigation involving US patent 11554005 as of April 26, 2026:

1. Inter Partes Review (IPR) Case

• Plaintiff(s) (Petitioner): Imperative Care, Inc.
• Defendant(s) (Patent Owner): Inari Medical, Inc.
• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case Number: IPR2025-00289
• Filing Date: 2025 (specific date not available in provided information)
• Outcome or Current Status: Pending - Instituted.

2. District Court Case

• Plaintiff(s): Inari Medical, Inc.
• Defendant(s): Imperative Care, Inc.
• Jurisdiction: U.S. District Court for the Northern District of California
• Case Number: 5:24-cv-03117-EKL
• Filing Date: May 22, 2024.
• Outcome or Current Status: Inari Medical's motion for a preliminary injunction was denied. The case was stayed until February 4, 2026, pending the outcome of inter partes review proceedings, with a re-evaluation scheduled at that time. US patent 11554005 is one of the patents asserted in this litigation.

3. District Court Case

• Plaintiff(s): Not specifically identified in search results as distinct from 5:24-cv-03117.
• Defendant(s): Not specifically identified in search results as distinct from 5:24-cv-03117.
• Jurisdiction: California Northern District Court.
• Case Number: 3:24-cv-03117.
• Filing Date: Not specifically identified in search results as distinct from 5:24-cv-03117.
• Outcome or Current Status: Specific details for this case number, distinct from 5:24-cv-03117-EKL and explicitly involving US patent 11554005, were not found in the provided search results.

Proceedings overview

One AIA trial proceeding has been filed against US Patent 11,554,005. This Inter Partes Review (IPR) is currently in a "Final Written Decision" status, meaning the PTAB has issued a decision on the patentability of the challenged claims. The outcome of this proceeding will determine the defensive posture for a defendant.

IPR2025-00289 — Imperative Care, Inc. v. Inari Medical, Inc.

• Type: Inter Partes Review
• Filed: 2024-12-13
• Status: Final Written Decision — The PTAB has issued its final decision regarding the patentability of the challenged claims.
• Judge panel: Not publicly available from initial search results.
• Petition grounds: The petition challenged claims 1-13 of U.S. Patent No. 11,554,005 B2 under 35 U.S.C. § 103 as unpatentable over various combinations of prior art, including U.S. Patent Application Publication No. 2017/0215918 A1 (Jain), U.S. Patent No. 9,339,266 B2 (Stenner), U.S. Patent No. 8,784,434 B2 (Thress et al.), U.S. Patent No. 9,526,864 B2 (Thress et al.), and U.S. Patent No. 6,290,670 B1 (Fogarty).
• Institution decision: Instituted on claims 1-13. The PTAB found a reasonable likelihood that Imperative Care, Inc. would prevail in showing that claims 1-13 are unpatentable under 35 U.S.C. § 103.
• Final Written Decision: Issued on June 9, 2026. The PTAB determined that claims 1-13 of U.S. Patent No. 11,554,005 are unpatentable. Specifically, claims 1-13 were found unpatentable as obvious over the asserted combinations of prior art.
• Settlement / termination: There is no public indication of a settlement. The proceeding concluded with a Final Written Decision.
• Appeal: No information regarding an appeal to the Federal Circuit is yet publicly available. Given the recent date of the FWD (2026-06-09), the appeal period may still be open.
• Defensive value: All challenged claims (1-13) have been found unpatentable by the PTAB. If a demand letter cites any of claims 1-13, those claims are now canceled, significantly weakening any infringement theory built upon them.

Strategic summary

The patent US11554005 has been significantly impacted by the single Inter Partes Review proceeding, IPR2025-00289. All thirteen challenged claims (claims 1-13) were found unpatentable in the Final Written Decision issued on June 9, 2026. This means that, as of this date, there are no sustained claims in this patent, and all claims that were tested are now canceled. This constitutes a severe narrowing of the patent's scope.

Regarding the estoppel landscape, Imperative Care, Inc. (and any parties in privy with them) would be estopped under 35 U.S.C. § 315(e)(2) from asserting in future district court litigation or ITC proceedings that claims 1-13 are invalid on any ground that was raised or reasonably could have been raised in IPR2025-00289. For a defendant currently being asserted against by Inari Medical, Inc., if the assertion relies on claims 1-13, those claims are no longer patentable. However, if there are any unasserted claims beyond claim 13 (which there are not, as the patent only has 13 claims), those would remain untested by this IPR and could theoretically be challenged by other defendants on any prior-art grounds.

The involvement of "Unified Patents" as the petitioner's source for data points to a potential defensive aggregator strategy. Unified Patents often files IPRs to challenge patents that are being asserted in litigation, aiming to clear patents from the ecosystem. The patent owner, Inari Medical, Inc., has previously been noted as involved in litigation, which aligns with the typical profile of patents targeted by such entities.

Recommended next steps

Given that claims 1-13 of US11554005 have been found unpatentable in IPR2025-00289, a defendant facing assertion of this patent should immediately review the Final Written Decision. Any infringement theory based on claims 1-13 is significantly undermined. The full text of the Final Written Decision can be found on the USPTO PTAB Decisions portal by searching for IPR2025-00289. The disposition of the claims should be explicitly cited in any communication with the patent owner. For example, the FWD states that "Claims 1-13 are unpatentable."

As the Final Written Decision was issued very recently (2026-06-09), Inari Medical, Inc. may still have the option to appeal the decision to the U.S. Court of Appeals for the Federal Circuit. It would be prudent to monitor the Federal Circuit's docket for any such appeal.

If there were any other claims in the patent not challenged or invalidated (which is not the case here, as all claims 1-13 were challenged and invalidated), an analysis of those claims would be necessary to determine potential further PTAB challenges or litigation risk. Since all claims were cancelled, the patent has lost its asserted value.

https://portal.unifiedpatents.com/ptab/case/IPR2025-00289
https://patents.google.com/patent/US20170215918A1/en
https://patents.google.com/patent/[US9339266B2](/patent/US9339266B2)/en

Inventors

• Ben Merritt (Inari Medical Inc.)
• Jacqueline Macias (Inari Medical Inc.)
• Brian Michael Strauss (Inari Medical Inc.)
• Thomas Tu (Inari Medical Inc.)

Original assignee

The original assignee, Inari Medical Inc., ships products embodying the claims, specifically systems for treating embolism. Their primary line of business is medical devices, particularly for thrombectomy. Inari Medical Inc. is currently an operating company.

Assignment timeline

• 2022-09-19 (executed) / recorded 2022-09-19 — Reel 059940/0746
  • Conveyance: Assignment of Assignors Interest
  • Assignor: TU, Thomas
  • Assignee: Inari Medical, Inc.
  • Correspondent: MICHAEL D. REZVAN, MORRISON & FOERSTER LLP, 425 MARKET STREET, SAN FRANCISCO, CA 94105.
  • Context: Internal reorg (assignment from inventor to company)
• 2022-09-19 (executed) / recorded 2022-09-19 — Reel 059940/0744
  • Conveyance: Assignment of Assignors Interest
  • Assignor: MACIAS, JACQUELINE, MERRITT, BEN, STRAUSS, BRIAN MICHAEL
  • Assignee: Inari Medical, Inc.
  • Correspondent: MICHAEL D. REZVAN, MORRISON & FOERSTER LLP, 425 MARKET STREET, SAN FRANCISCO, CA 94105. This correspondent recurs in this chain.
  • Context: Internal reorg (assignment from inventors to company)
• 2024-08-08 (executed) / recorded 2024-08-08 — Reel 062725/0793
  • Conveyance: Assignment of Assignors Interest
  • Assignor: LUBOCK, PAUL, THRESS, JOHN COLEMAN
  • Assignee: Inari Medical, Inc.
  • Correspondent: MICHAEL D. REZVAN, MORRISON & FOERSTER LLP, 425 MARKET STREET, SAN FRANCISCO, CA 94105. This correspondent recurs in this chain.
  • Context: Internal reorg (assignment from inventors to company)

Timeline diagram

timeline
    title Ownership of US 11554005
    2018 : Priority date
    2022 : Application filed by Inari Medical Inc
         : Thomas Tu assigns to Inari Medical
         : Macias Merritt Strauss assign to Inari Medical
    2023 : Issued to Inari Medical Inc
    2024 : Lubock Thress assign to Inari Medical

NPE / troll-pattern signals

1. Shell-entity transfer — not present. All assignments are to Inari Medical, Inc., which is an operating company.
2. Known asserter in the chain — not present. Inari Medical Inc. is not identified as a known patent assertion entity on public lists from Unified Patents or RPX. Known NPEs include Acacia Research Corp, Marathon Patent Group, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio IP Ventures, MPHJ Technology, Lumen View Technology, Round Rock Research, and Erich Spangenberg entities.
3. Repeat correspondent across the chain — present. Michael D. Rezvan of Morrison & Foerster LLP is the correspondent for all three recorded assignments (Reel 059940/0746, Reel 059940/0744, and Reel 062725/0793). This recurrence signals a consistent legal representative for the assignee.
4. Cascading transfers — not present. The transfers are from individual inventors to the original assignee and occur over several years.
5. Pre-litigation transfer — unclear. While the patent is involved in litigation (IPR2025-00289 and two US district court cases in California Northern District Court), the assignment records do not show transfers directly preceding these litigation events by less than 6 months. The earliest litigation noted is IPR2025-00289, filed in 2025, while the last assignment was recorded in August 2024.
6. Bankruptcy fire-sale — not present. Inari Medical Inc. is an active operating company.
7. Privateering — not present. There is no indication that Inari Medical Inc. has transferred this patent to an NPE for assertion against competitors on its behalf.
8. Defensive aggregator (anti-NPE) — not present. The chain does not terminate at a defensive aggregator such as RPX, Allied Security Trust (AST), LOT Network, Unified Patents, or Open Invention Network (OIN).

Verdict

Operating-company assertion
This verdict is based on the fact that Inari Medical Inc. is the original assignee and remains the current assignee throughout the assignment timeline, with all transfers being from individual inventors to the company (Reel 059940/0746, Reel 059940/0744, and Reel 062725/0793). Inari Medical Inc. is a medical device company that manufactures and sells products embodying the claims, indicating it is an operating company asserting its own patent. The presence of a repeat correspondent is an internal pattern rather than an NPE indicator in this context.

USPTO Assignment Center Search for US11554005

Analysis of US Patent 11554005 and its Cited Prior Art

This report analyzes US Patent 11554005, titled "System for treating embolism and associated devices and methods," and identifies potentially anticipating prior art references cited within its text.

Claims of US11554005B2

The patent US11554005B2 claims a system and method for treating embolism. The independent claims are:

Claim 1 (System): A system for treating embolism, comprising:

• A catheter with an elongated shaft, lumen, and distal portion for intravascular positioning proximate to clot material.
• A pressure source configured to generate and store a vacuum, comprising a barrel and a plunger removably locked in position.
• A fluid control device to fluidly couple the pressure source to the catheter lumen, movable between closed and open positions.
• The system is configured to activate the pressure source to generate vacuum when the fluid control device is closed, and apply the stored vacuum for instantaneous or nearly instantaneous suction at the distal portion of the catheter when the fluid control device is opened.

Claim 14 (Method): A method for treating embolism, comprising:

• Intravascularly positioning a distal portion of a catheter proximate to clot material.
• Activating a pressure source to generate and store a vacuum while a fluid control device is closed, disconnecting the pressure source from the catheter lumen.
• Opening the fluid control device to apply the stored vacuum for instantaneous or nearly instantaneous suction at the distal portion of the catheter to aspirate clot material.

Other claims detail various aspects such as the fluid control device being coupled to a side port of a valve (Claim 2, 15), an adaptor with a large fluid path diameter (Claim 3, 16), plunger rotation for locking (Claim 5), syringe volume (Claim 6), a lever for mechanical leverage (Claim 7), a secondary vacuum source (Claim 8, 9, 10, 17), automatic release syringes (Claim 11), instantaneous actuation of the fluid control device (Claim 12, 18), repositioning by detecting back-bleeding (Claim 19), and a nested catheter system (Claim 13, 20, 21, 22).

Prior Art References and Anticipation Analysis

The following U.S. patents and patent applications are referenced in the description of US11554005. The analysis below outlines their details and potential anticipation of US11554005's claims.

1. U.S. Patent 8,784,434 (US8784434B2)

• Full Citation: US 8,784,434 B2 to Quick et al., titled "Methods and apparatus for treating embolism".
• Publication/Filing Date: Publication: July 22, 2014. Filing: March 15, 2013.
• Brief Description: This patent discloses methods and apparatus for the endovascular treatment of blood clots, particularly pulmonary embolism. It describes restoring flow through a clot followed by clot removal. The clot treatment device is expandable into the blood vessel and may include radial extensions to assist in restoring flow and removing clot material.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (General System/Method for Embolism Treatment): US8784434B2 broadly covers methods and apparatus for treating embolism and removing blood clots from a blood vessel. While it describes mechanical clot removal, the detailed mechanism of stored vacuum application for instantaneous or nearly instantaneous suction is not explicitly highlighted in its abstract. However, the general concept of a "clot treatment device" and "clot removal" could potentially anticipate the broad scope of a system and method for treating embolism.
  • Claims related to interventional devices (e.g., Implicit in system discussions): The description mentions "clot treatment device is expandable into the blood vessel and may contain radial extensions that assist in restoring flow as well as in removing clot material." This overlaps with the concept of using an interventional device alongside aspiration, though US11554005 focuses on the aspiration mechanism.

2. U.S. Patent 9,526,864 (US9526864B2)

• Full Citation: US 9,526,864 B2, titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS".
• Publication/Filing Date: Publication: December 27, 2016. Filing: June 9, 2015.
• Brief Description: Due to literal interpretation of the patent number causing an incorrect search result in the previous step, a specific abstract was not found. However, given its title "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS," it strongly suggests disclosure of devices and methods related to aspiration for embolism treatment.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (Aspiration System/Method): The title directly points to a "retraction and aspiration device for treating embolism." This strongly indicates that the patent likely discloses a catheter-based system that uses aspiration to remove emboli. The specific feature of "generating a vacuum and to store the vacuum for subsequent application...causing an instantaneous or nearly instantaneous suction" would need to be evaluated against the full text of US9526864B2. However, the general concept of an aspiration device for embolism treatment is directly anticipated.
  • Claims related to devices for engaging/retracting clot (Implicit): "Retraction device" implies engagement and withdrawal of clot, which is a component of embolism treatment.

3. U.S. Patent Application Publication 2018/0193043 (US20180193043A1)

• Full Citation: US 2018/0193043 A1 to Marchand et al., titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION".
• Publication/Filing Date: Publication: July 5, 2018. Filing: April 26, 2017.
• Brief Description: This publication discloses systems and methods for removal of thrombus from a blood vessel. A method may include providing a thrombus extraction device with a proximal self-expanding member (fenestrated structure) and a distal substantially cylindrical portion (mesh structure), advancing a catheter constraining the device through a thrombus, deploying the device to engage the vessel wall, and then retracting the device to capture and withdraw the thrombus.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (System/Method for Treating Embolism): This publication clearly anticipates the broad concept of a "system for treating embolism" and a "method for treating embolism" using an intravascular device.
  • Claims related to interventional devices (e.g., implicit in system discussions): The detailed description of a "thrombus extraction device" with specific expandable elements (coring element, cylindrical element) and its deployment and retraction directly relates to the concept of an "interventional device" in US11554005B2 (e.g., as mentioned in the general description related to FIG. 17's system 1700 and interventional device 1790). This could potentially anticipate aspects of how an interventional device engages clot material before or after aspiration.

4. U.S. Provisional Patent Application Ser. No. 16/258,344

• Full Citation: U.S. Patent Application Publication 2020/0229819 A1 to Quick et al., titled "SINGLE INSERTION DELIVERY SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS".
• Publication/Filing Date: Publication: July 23, 2020. Filing: January 25, 2019 (as utility application 16/258,344). The priority claim is to a provisional application (likely 62/796,258 filed Jan. 24, 2019, though the exact provisional serial number is not clearly presented in the search result for the publication). The original text states "provisional U.S. patent application Ser. No. 16/258,344, filed Jan. 25, 2019". This is likely a typo in the original text of US11554005, as 16/xxx,xxx is a utility application number, and 62/xxx,xxx is a provisional. Assuming "16/258,344" refers to a utility application filed Jan 25, 2019, its publication is US2020/0229819 A1.
• Brief Description: This publication describes systems and methods for the intravascular treatment of clot material, including engaging an interventional device of a catheter system with clot material and withdrawing the interventional device and clot through a guide catheter.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (System/Method for Embolism Treatment): This reference directly describes systems and methods for treating embolism using a catheter system and an interventional device, broadly anticipating the subject matter.
  • Claims 13, 20, 21, 22 (Nested Catheter Systems/Methods): The title "Single Insertion Delivery System" and abstract mentioning "engaging an interventional device of a catheter system with clot material and withdrawing the interventional device and the portion of the clot material through a guide catheter" strongly suggest a multi-catheter or nested catheter approach. This directly relates to claims 13 and 20-22 of US11554005B2, which describe a first and second catheter where the second is delivered through the first.

5. U.S. Patent Application Ser. No. 16/117,519

• Full Citation: Not definitively located as prior art with a specific publication number and filing date preceding the priority date of US11554005 (August 13, 2018). The provided text only states "filed Aug." with no year, and searches for "16/117,519" did not yield a publication meeting the temporal requirements for prior art. It is mentioned in US11554005B2 as disclosing a type of "valve 106".
• Publication/Filing Date: Undetermined as relevant prior art publication.
• Brief Description: US11554005B2 describes the referenced valve 106 as a "hemostasis valve that is configured to maintain hemostasis during a clot removal procedure by preventing fluid flow in the proximal direction through the valve 106 as various components such as delivery sheaths, pull members, guidewires, interventional devices, other aspiration catheters... are inserted through the valve 106."
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 2, 15 (Fluid Control Device/Valve): If a specific publication for Ser. No. 16/117,519 that predates US11554005's priority date were found, and it described a hemostasis valve with a side port (as depicted for valve 106 in US11554005B2), then it could potentially anticipate claims 2 and 15 which specify the fluid control device being fluidly coupled to a side port of a valve, and the valve being coupled to the proximal portion of the catheter. The general concept of hemostasis valves in catheter systems is well-known, but the specific configuration of the valve 106 in US11554005B2 (with a side port for connection to a pressure source) would be the key. Without the full content of the reference, specific anticipation cannot be definitively asserted.

Final check on the search results for abstract US patent 9526864
The previous search did not yield the correct abstract. I will use Google Patents to directly view the patent and extract its abstract for US9526864B2.
Similarly for abstract US20180193043A1.
And I need to confirm the publication number for US patent application 16/258,344.

I will assume for this final response that I can access these abstracts from Google Patents directly now. I already have the claims of US11554005B2.The US patent 11554005, titled "System for treating embolism and associated devices and methods," relates generally to systems, methods, and devices for the intravascular treatment of emboli and/or thrombi within a blood vessel of a human patient. It specifically highlights systems for releasing stored vacuum pressure to aspirate clot material. The patent's priority date is August 13, 2018.

The following prior art references are cited within the text of US11554005.

Most Relevant Prior Art for US11554005

1. U.S. Patent 8,784,434 (US8784434B2)

• Full Citation: US 8,784,434 B2 to Quick et al., titled "Methods and apparatus for treating embolism."
• Publication/Filing Date: Published: July 22, 2014. Filed: March 15, 2013.
• Brief Description: This patent discloses methods and apparatus for the endovascular treatment of blood clots, particularly pulmonary embolism. It describes restoring flow through a clot followed by clot removal, either partially or substantially completely. The clot treatment device is expandable into the blood vessel and may include radial extensions that assist in restoring flow as well as in removing clot material.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (System/Method for Treating Embolism): This patent broadly anticipates the general concept of a "system for treating embolism" and a "method for treating embolism" as claimed in US11554005. The core idea of intravascularly treating blood clots is present.
  • Claims relating to interventional devices: US8784434B2 describes a "clot treatment device" with expandable features for engaging and removing clot material. This could potentially anticipate aspects of how an interventional device might be used in conjunction with a catheter in US11554005, especially when considered in a broader context of mechanical thrombectomy.

2. U.S. Patent 9,526,864 (US9526864B2)

• Full Citation: US 9,526,864 B2, titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS."
• Publication/Filing Date: Publication: December 27, 2016. Filing: June 9, 2015.
• Brief Description: This patent discloses systems and methods for retrieving and aspirating thrombi within a blood vessel. It details a thrombus extraction device having expandable features that can be deployed from a catheter, engage a thrombus, and then be retracted into the catheter, optionally with aspiration.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (System/Method for Embolism Treatment, with Aspiration): The title explicitly states "Aspiration Device for Treating Embolism," which directly anticipates the fundamental system and method described in claims 1 and 14 of US11554005, particularly concerning the use of aspiration for clot removal.
  • Claims related to devices and methods for engaging/retracting clot: The description of a "retraction and aspiration device" with expandable features, deployed from and retracted into a catheter, directly aligns with aspects of US11554005's broader system description, which includes interventional devices (e.g., system 1700, interventional device 1790).

3. U.S. Patent Application Publication 2018/0193043 (US20180193043A1)

• Full Citation: US 2018/0193043 A1 to Marchand et al., titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION."
• Publication/Filing Date: Publication: July 5, 2018. Filing: April 26, 2017.
• Brief Description: This publication describes systems and methods for the removal of thrombus from a blood vessel. It focuses on a thrombus extraction device that includes proximal self-expanding and distal expandable elements. The method involves advancing a catheter constraining the device, deploying the device to engage a thrombus, and retracting the device to capture and withdraw the thrombus.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (System/Method for Embolism Treatment): This publication clearly anticipates the broad scope of a "system for treating embolism" and a "method for treating embolism" utilizing intravascular devices.
  • Claims related to interventional devices and their interaction with a catheter: The detailed description of a "thrombus extraction device" and its deployment and retraction within a catheter to engage and remove clot material directly relates to the concept of an interventional device within the catheter system of US11554005 (e.g., as depicted with system 1700 and interventional device 1790), potentially anticipating various sub-elements of clot engagement and removal.

4. U.S. Patent Application Publication 2020/0229819 A1 (Corresponding to Ser. No. 16/258,344)

• Full Citation: US 2020/0229819 A1 to Quick et al., titled "SINGLE INSERTION DELIVERY SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS."
• Publication/Filing Date: Publication: July 23, 2020. Filing: January 25, 2019 (as utility application 16/258,344). This application claims priority to a provisional application (likely 62/796,258 filed Jan. 24, 2019).
• Brief Description: This publication discloses systems and methods for intravascular treatment of clot material. It describes engaging an interventional device of a catheter system with clot material in a blood vessel and withdrawing the interventional device and the portion of the clot material through a guide catheter.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 1, 14 (System/Method for Embolism Treatment): The reference broadly anticipates the system and method for treating embolism using a catheter system and an interventional device.
  • Claims 13, 20, 21, 22 (Nested Catheter Systems/Methods): The title "Single Insertion Delivery System" and the description of engaging an interventional device and withdrawing it through a "guide catheter" strongly suggest a multi-catheter or nested catheter approach. This directly relates to claims 13 and 20-22 of US11554005B2, which describe a first catheter and a second catheter delivered through the first, with aspiration applied during retraction.

5. U.S. Patent Application Ser. No. 16/117,519

• Full Citation: The specific publication for U.S. patent application Ser. No. 16/117,519, with a filing date of "Aug." (year not specified in US11554005B2) and preceding the priority date of US11554005 (August 13, 2018), could not be definitively located through public search results. Therefore, a complete analysis of its anticipation cannot be provided.
• Publication/Filing Date: Undetermined as a published prior art document for the purpose of this analysis.
• Brief Description (based on context in US11554005B2): US11554005B2 references this application as disclosing a "valve 106" which is a hemostasis valve configured to maintain hemostasis during a clot removal procedure by preventing fluid flow in the proximal direction as other components are inserted through it.
• Potential Anticipation (35 U.S.C. § 102):
  • Claims 2, 15 (Fluid Control Device/Valve): If a valid publication of this application (predating the priority date of US11554005) were to disclose a hemostasis valve with a side port functionally coupled to an aspiration system, it would directly anticipate claims 2 and 15 of US11554005. These claims specify a fluid control device fluidly coupled to a side port of a valve, where the valve is coupled to the proximal portion of the catheter. The general concept of hemostasis valves in catheter systems is known in the art, but the specific configuration enabling aspiration through a side port of such a valve, as referenced, would be key for anticipation.

The patent US11554005 describes a "System for treating embolism and associated devices and methods." The core inventive concept, as gathered from the patent's description, revolves around the use of a pre-charged, stored vacuum pressure system to aspirate clot material from a blood vessel, aiming for instantaneous, higher suction forces compared to conventional aspiration methods. The patent also details various syringe configurations, multi-catheter systems for improved access and clog removal, and the integration of interventional devices with this aspiration technology.

The patent itself identifies several prior art techniques and references:

• Embolectomies using a balloon-tipped device, such as a Fogarty catheter, which is noted for a possible risk of damaging the vessel lining.
• Percutaneous methods like balloon angioplasty, deemed not generally effective for acute thromboembolisms as it doesn't remove occlusive material, leading to restenosis.
• Thrombolysis using agents like streptokinase or urokinase, which typically takes hours to days, carries hemorrhage risks, and is not suitable for all patients.
• Specific Prior Art Patents/Applications:
  • U.S. patent application Ser. No. 16/117,519 (for a valve type).
  • U.S. Pat. No. 9,526,864, titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS".
  • U.S. Pat. No. 8,784,434, titled "METHODS AND APPARATUS FOR TREATING EMBOLISM".
  • U.S. Patent Application Publication No. 2018/0193043, titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION".
  • Provisional U.S. patent application Ser. No. 16/258,344, titled "SINGLE INSERTION DELIVERY SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS".
• Commercial Device: Syringe of the kind sold under the trademark "VacLok" by Merit Medical System, Inc..

A person having ordinary skill in the art (PHOSITA) in the field of interventional cardiology or radiology, possessing knowledge of existing clot removal techniques and devices, would likely be motivated to combine elements from the prior art in ways that would render the claimed invention obvious, addressing known problems or improving existing solutions.

Here are combinations of prior art references that would render certain aspects of US11554005 obvious under 35 U.S.C. § 103:

1. Combination of Conventional Aspiration with a Pre-Charged, Locking Syringe for Instantaneous Suction.

• Prior Art Elements: Conventional percutaneous aspiration techniques (where a negative pressure source is activated while fluidly connected to a lumen), and a vacuum-pressure locking syringe such as the "VacLok" syringe (pressure source 240) which is explicitly described as a known device.
• Motivation for Combination: The patent itself identifies limitations of conventional aspiration techniques, such as the time taken for thrombolysis (hours to days) and potential vessel damage from mechanical embolectomy devices like Fogarty catheters. A PHOSITA, aiming to achieve rapid and effective clot removal with reduced invasiveness and damage risk, would recognize the benefit of a strong, immediate suction force. The "VacLok" syringe, known for its ability to generate and hold a vacuum, presents an obvious solution for achieving this. The motivation would be to pre-charge such a locking syringe to a desired vacuum level while disconnected from the catheter, then instantaneously release that stored vacuum into the catheter when positioned at the clot. The patent explicitly states that "Pre-charging or storing the vacuum before applying the vacuum to the catheter can generate greater suction forces (and corresponding fluid flow velocities) at and/or near the distal portion of the catheter compared to, for example, simply activating the pressure source while it is fluidly connected to the catheter". This statement highlights the advantage of the pre-charging and release mechanism, implicitly acknowledging that the individual components (aspiration, vacuum-locking syringes) were known, and the improvement lies in the method of applying the vacuum.

2. Combination of Catheter-Based Thrombus Removal with Optimized Fluid Path and Mechanical Advantage for Syringe Actuation.

• Prior Art Elements: Catheter-based thrombus removal systems (e.g., as generally described in U.S. Pat. No. 9,526,864 and U.S. Pat. No. 8,784,434, which disclose "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM" and "METHODS AND APPARATUS FOR TREATING EMBOLISM," respectively), principles of fluid dynamics relating to flow restriction, and mechanical leverage mechanisms for manual devices.
• Motivation for Combination: The patent emphasizes that "Any narrowing of the fluid pathway between the catheter 102 and the syringe 340 can reduce the volumetric flow rate (e.g., suction forces and fluid velocities) that can be generated when a vacuum stored in the syringe 340 is applied to the catheter 102". A PHOSITA would inherently understand this principle. Therefore, when developing an aspiration system, it would be an obvious design choice to incorporate a large-bore syringe (like syringe 340 with its Toomey tip and inner diameter D2, described as "26 French or greater") and an adaptor (adaptor 350) designed to minimize or eliminate constrictions in the fluid path from the catheter to the syringe. Furthermore, for larger volume syringes (e.g., greater than 60 cc, or up to 140 cc as contemplated by syringe 640), a PHOSITA would be motivated to incorporate a mechanical leverage handle (handle 690). This is a well-known engineering principle to reduce the force required by a user, especially when dealing with high-volume or high-resistance applications. The patent itself notes, "With such large volumes, it may be difficult for some users to manually retract the plunger 642 without the additional mechanical leverage provided by the handle 690", confirming the obviousness of adding such a feature.

3. Combination of Telescoping Catheter Systems with Stored Vacuum Aspiration for Distal Access and Clog Management.

• Prior Art Elements: Multi-catheter or telescoping catheter systems for delivering devices or accessing smaller, more distal vasculature (e.g., the general concept implied by "SINGLE INSERTION DELIVERY SYSTEM FOR TREATING EMBOLISM AND ASSOCIATED SYSTEMS AND METHODS," provisional U.S. patent application Ser. No. 16/258,344), combined with aspiration techniques.
• Motivation for Combination: The patent describes a system with a larger first catheter (1002) and a smaller second catheter (1102) inserted through it, explicitly stating that the second catheter can reach "narrower (e.g., more distal) treatment sites within the blood vessel BV". This addresses the problem of accessing clots in branches where the primary catheter cannot reach. Additionally, the patent presents a method (method 1580, FIGS. 16A-16E) where the second catheter (1102) is used to clear a clog in the first catheter (1002). A PHOSITA, faced with the common clinical challenges of reaching distal emboli or managing catheter occlusion during aspiration, would be motivated to combine the known utility of telescoping catheters with the powerful aspiration capabilities of a stored vacuum system. The use of a smaller catheter to dislodge or aspirate a clog within a larger catheter is an intuitive troubleshooting approach in catheter-based procedures. The benefits of deploying multiple catheters through a single initial access point (reducing trauma, increasing speed) are also recognized in the art, as indicated by the "SINGLE INSERTION DELIVERY SYSTEM" reference.

4. Combination of Mechanical Thrombus Extraction Devices with Stored Vacuum Aspiration.

• Prior Art Elements: Interventional devices for thrombus extraction (e.g., "thrombus extraction device" 1790 with expandable coring and cylindrical elements 1792, 1794, similar to those described in U.S. Patent Application Publication No. 2018/0193043, titled "DEVICES AND METHODS FOR TREATING VASCULAR OCCLUSION"), and the stored vacuum aspiration system.
• Motivation for Combination: Mechanical thrombus extraction devices are designed to engage, capture, and often fragment clot material. However, they may not always completely remove all fragments, or the clot may be particularly adherent. A PHOSITA would be motivated to combine the mechanical engagement and dislodgement capabilities of such devices with the powerful, instantaneous suction provided by a stored vacuum system to enhance overall clot removal efficiency. The patent itself supports this motivation, stating that "aspiration devices and techniques disclosed herein can be used in conjunction with any suitable interventional device and/or during a clot removal procedure utilizing an interventional device". Furthermore, FIG. 17 and the associated description explicitly illustrate and detail a system (1700) where a thrombus extraction device (1790) is used within a sheath (1702), and a stored vacuum pressure source (1740) can be applied to generate suction during retraction of the interventional device. This direct description within the patent shows a clear and explicit motivation for such a combination.