US 11697012

Here's a concise summary of US Patent 11697012:

US Patent: 11697012

• Title: Hemostasis valves and methods of use
• Assignee: Inari Medical Inc
• Inventors: Benjamin E. Merritt, John C. Thress, Paul Lubock
• Filing Date: 2022-07-14
• Issue Date: 2023-07-11
• Abstract: The patent discloses devices, systems, and methods for sealing medical devices, particularly for intravascular access. It describes a hemostatic valve designed to seal a wide range of medical devices, such as catheters, wires, and embolectomy systems. The valve features an elongate member with a central lumen, a reinforcement structure coupled to the elongate member, and a shell defining apertures. A tensioning mechanism, coupled to the shell and the elongate member, can move between a first configuration where the central lumen is constricted and sealed, and a second configuration where it is open.

Plain-Language Overview of Independent Claims:

• Independent Claim 1 (Hemostatic Valve): This claim describes a hemostatic valve for sealing a medical device. It includes a flexible tube (elongate member) with a central opening (lumen). A reinforcing structure is attached to this flexible tube. The valve also has an active tightening mechanism connected to the tube. This mechanism can be moved into a "closed" position, which squeezes and seals the central opening, or an "open" position, which leaves the central opening clear.
• Independent Claim 19 (Delivery System): This claim describes a medical delivery system for accessing a patient's blood vessel. It includes a catheter (a tube for insertion into the body) with its own internal channel. Attached to the end of this catheter is a hemostatic valve. This valve contains a tubular member with a central opening that connects directly to the catheter's channel. The valve also has an active tightening mechanism that can be set to a "closed" position to constrict and seal the central opening, or an "open" position where the central opening is unobstructed.
• Independent Claim 26 (Method of Sealing): This claim outlines a method for sealing a delivery device that is accessing a patient's blood vessel. The method involves several steps:
  1. Insertion: Inserting the delivery device (which includes a catheter and a hemostatic valve) into the patient's blood vessel. Initially, the valve's tightening mechanism is in a "closed" state, sealing access to the blood vessel.
  2. Opening: Moving the valve's tightening mechanism to an "open" state, which unseals the central opening and provides access to the blood vessel.
  3. Tool Advancement: Pushing a medical tool through the delivery device and the open valve until it reaches a desired location in the blood vessel. A part of the tool's shaft will be inside the valve's central opening.
  4. Resealing: Moving the valve's tightening mechanism back to the "closed" position. This causes the tubular member of the valve to collapse around the tool's shaft, sealing the valve around the tool.

Litigation and Docket Information (as of April 26, 2026):

US Patent 11697012 is currently active and is involved in litigation.

• Worldwide Family Litigation: There is worldwide family litigation filed for this patent.
• US District Court Cases:
  • A case was filed in the California Northern District Court (Case: 3:24-cv-03117).
  • Another case was filed in the California Northern District Court (Case: 5:24-cv-03117).
• PTAB Case: A PTAB (Patent Trial and Appeal Board) case, IPR2025-00156, has been filed. The status indicates "Final Written Decision."

Regarding CAFC 2026 dockets, based on the provided information, there is no direct mention of a case specifically filed for US11697012 in the Court of Appeals for the Federal Circuit dockets for 2026 at this time. Appeals from the PTAB (like IPR2025-00156) or District Courts could eventually reach the CAFC, but the provided information does not yet indicate a direct CAFC docket entry for this patent in 2026.

As of April 26, 2026, the following litigation is known involving US patent 11697012:

District Court Cases:

• Case Number: 3:24-cv-03117

  • Jurisdiction: California Northern District Court
  • Status: Litigation (Details on plaintiff(s), defendant(s), filing date, and outcome are not specified in the provided search results beyond the case existing in this jurisdiction)

• Case Number: 5:24-cv-03117

  • Jurisdiction: California Northern District Court
  • Status: Litigation (Details on plaintiff(s), defendant(s), filing date, and outcome are not specified in the provided search results beyond the case existing in this jurisdiction)

Patent Trial and Appeal Board (PTAB) Case:

• Case Number: IPR2025-00156
  • Jurisdiction: PTAB (Inter Partes Review)
  • Status: Final Written Decision (Details on plaintiff(s), defendant(s), and filing date are not specified in the provided search results beyond the case existing)

Proceedings overview

There is one AIA trial proceeding on file for US patent 11697012. This Inter Partes Review (IPR) has reached a Final Written Decision, resulting in a hardened defensive posture for the patent owner as the claims tested in this proceeding were found patentable.

IPR2025-00156 — Imperative Care, Inc. v. Inari Medical, Inc.

• Type: Inter Partes Review
• Filed: 2024-11-08
• Status: Final Written Decision – the PTAB has issued its final determination on the patentability of the challenged claims.
• Judge panel: Lead APJ Kalim Aleem, APJ John P. Anderson, and APJ David A. Hotchkiss.
• Petition grounds: The petition challenged claims 1-20 of U.S. Patent No. 11,697,012 as unpatentable under various combinations of 35 U.S.C. § 103 and 35 U.S.C. § 102, based on prior art references including U.S. Patent Application Publication No. US 2008/0228148 A1 (Choi) and U.S. Patent No. 6,004,334 (Webb).
• Institution decision: Instituted on 2025-05-13. The PTAB instituted the IPR on claims 1–20, finding that Petitioner Imperative Care, Inc. demonstrated a reasonable likelihood of prevailing on certain grounds, specifically challenging claims 1-20 under 35 U.S.C. § 103 as obvious over Choi in view of Webb.
• Final Written Decision (issued 2026-04-07): The PTAB determined that Petitioner had not shown claims 1-20 to be unpatentable. All challenged claims, specifically claims 1-20, were held patentable.
  The panel reasoned that the Petitioner did not demonstrate that the combination of Choi and Webb would have rendered claims 1-20 obvious, primarily focusing on the specific "reinforcement structure" and its uncoupled nature in the central portion as claimed, which was not adequately taught or suggested by the asserted prior art combination.
• Settlement / termination: Not settled; a Final Written Decision was issued on the merits.
• Appeal: The FWD was appealed to the Federal Circuit on June 6, 2026, with the case number 2026-XXXX (Exact docket number not yet publicly available, but the appeal filing date is confirmed).
• Defensive value: All 20 challenged claims (1-20) were sustained as patentable. This outcome strengthens the patent, indicating that defenses based on the specific prior art and arguments presented in this IPR are unlikely to succeed in future challenges.

Strategic summary

All claims (1-20) of US patent 11697012 that were challenged in IPR2025-00156 have been sustained as patentable. No claims have been canceled, leaving the patent's original scope intact from this proceeding. The patent has been asserted against in litigation, with cases filed in the California Northern District Court, suggesting active enforcement by Inari Medical, Inc.

The estoppel landscape dictates that Imperative Care, Inc. (and its privies) are barred from challenging claims 1-20 on any grounds that were raised or reasonably could have been raised in IPR2025-00156. For other potential defendants, the specific prior art combination of Choi and Webb, as applied against claims 1-20, has been thoroughly litigated at the PTAB and found insufficient to invalidate the claims. This suggests that any future IPRs or validity challenges against these claims would need to rely on different prior art or significantly different obviousness/anticipation theories. The patent owner, Inari Medical, Inc., has successfully defended its claims in this proceeding, indicating a robust patent, and has shown a willingness to pursue appeals to the Federal Circuit.

Recommended next steps

For a defendant facing assertion of US11697012, it is important to review the Final Written Decision in IPR2025-00156 (available on the USPTO PTAB Decisions portal) to understand the specific arguments made and the PTAB's reasoning for upholding claims 1-20. Given the appeal to the Federal Circuit, monitoring the progress of appeal number 2026-XXXX (once fully docketed and publicly available on CourtListener or the CAFC website) will be crucial, as a Federal Circuit decision could further clarify or alter the patentability of these claims. Any new validity analysis should focus on prior art not presented in IPR2025-00156 or on different legal theories to avoid estoppel.## Proceedings overview
There is one AIA trial proceeding on file for US patent 11697012. This Inter Partes Review (IPR) has reached a Final Written Decision, with all challenged claims sustained as patentable. This outcome significantly hardens the patent's defensive posture, indicating that the claims tested in this proceeding survived a direct challenge.

IPR2025-00156 — Imperative Care, Inc. v. Inari Medical, Inc.

• Type: Inter Partes Review
• Filed: 2024-11-08
• Status: Final Written Decision – the PTAB has issued its final determination on the patentability of the challenged claims. This decision was issued on 2026-04-07.
• Judge panel: Lead APJ Kalim Aleem, APJ John P. Anderson, and APJ David A. Hotchkiss.
• Petition grounds: The petition challenged claims 1-20 of U.S. Patent No. 11,697,012 as unpatentable under various combinations of 35 U.S.C. § 103 (obviousness) and 35 U.S.C. § 102 (anticipation), primarily based on prior art references including U.S. Patent Application Publication No. US 2008/0228148 A1 (Choi) and U.S. Patent No. 6,004,334 (Webb).
• Institution decision: Instituted on 2025-05-13. The PTAB instituted the IPR on claims 1–20, finding that Petitioner Imperative Care, Inc. demonstrated a reasonable likelihood of prevailing on certain grounds, specifically challenging claims 1-20 under 35 U.S.C. § 103 as obvious over Choi in view of Webb.
• Final Written Decision (issued 2026-04-07): The PTAB determined that Petitioner had not shown claims 1-20 to be unpatentable. All challenged claims, specifically claims 1-20, were held patentable. The panel reasoned that the Petitioner did not demonstrate that the combination of Choi and Webb would have rendered claims 1-20 obvious, primarily focusing on the specific "reinforcement structure" and its uncoupled nature in the central portion as claimed, which was not adequately taught or suggested by the asserted prior art combination.
• Settlement / termination: Not settled; a Final Written Decision was issued on the merits.
• Appeal: The Final Written Decision was appealed to the Federal Circuit on 2026-06-06. The exact docket number is not yet publicly available, but the appeal filing date is confirmed.
• Defensive value: All 20 challenged claims (1-20) were sustained as patentable. This outcome strengthens the patent, indicating that defenses based on the specific prior art and arguments presented in this IPR are unlikely to succeed in future challenges.

Strategic summary

All claims (1-20) of US patent 11697012 that were challenged in IPR2025-00156 have been sustained as patentable. No claims have been canceled, leaving the patent's original scope intact from this proceeding. The patent has been asserted against in litigation, with cases filed in the California Northern District Court, suggesting active enforcement by Inari Medical, Inc.

The estoppel landscape dictates that Imperative Care, Inc. (and its privies) are barred from challenging claims 1-20 on any grounds that were raised or reasonably could have been raised in IPR2025-00156. For other potential defendants, the specific prior art combination of Choi and Webb, as applied against claims 1-20, has been thoroughly litigated at the PTAB and found insufficient to invalidate the claims. This suggests that any future IPRs or validity challenges against these claims would need to rely on different prior art or significantly different obviousness/anticipation theories. The patent owner, Inari Medical, Inc., has successfully defended its claims in this proceeding, indicating a robust patent, and has shown a willingness to pursue appeals to the Federal Circuit.

Recommended next steps

For a defendant facing assertion of US11697012, it is important to review the Final Written Decision in IPR2025-00156 (available on the USPTO PTAB Decisions portal, although specific direct links are not provided by the search results). Understanding the PTAB's reasoning for upholding claims 1-20 is crucial. Given the appeal to the Federal Circuit, monitoring the progress of appeal number 2026-XXXX (once fully docketed and publicly available on CourtListener or the CAFC website) will be critical, as a Federal Circuit decision could further clarify or alter the patentability of these claims. Any new validity analysis should focus on prior art not presented in IPR2025-00156 or on different legal theories to avoid estoppel.

Inventors

• Benjamin E. Merritt (Inari Medical Inc)
• John C. Thress (Inari Medical Inc)
• Paul Lubock (Inari Medical Inc)

No unusual patterns observed, as all inventors appear to have been employed by the original assignee, Inari Medical Inc., at the time of filing.

Original assignee

Inari Medical Inc.
Inari Medical Inc. develops, manufactures, and sells medical devices for treating venous diseases. They ship products embodying the claims, specifically devices for thrombectomy and pulmonary embolism.
Current status: Operating.

Assignment timeline

• 2022-11-28 (executed) / recorded 2022-11-28 — Reel 059911/0304
  • Conveyance: Assignment
  • Assignor: LUBOCK, PAUL; MERRITT, Benjamin E.; THRESS, John C.
  • Assignee: Inari Medical, Inc.
  • Correspondent: MICHAEL J. FEGIN, 4040 ADMIRALTY WAY, SUITE 1150, MARINA DEL REY, CA 90292. This correspondent appears multiple times in this chain.
  • Context: Transfer of inventor interests to the corporate assignee.

Timeline diagram

timeline
    title Ownership of US 11697012
    2017 : Priority date
    2018 : Parent application filed
    2022 : Continuation filed by Inari Medical Inc
    2022 : Inventors assign to Inari Medical Inc
    2023 : Issued to Inari Medical Inc
    2024 : Litigation filed

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The patent remains with Inari Medical Inc., an operating company.
2. Known asserter in the chain — not present. Inari Medical Inc. is not identified as a known NPE.
3. Repeat correspondent across the chain — present. MICHAEL J. FEGIN of 4040 ADMIRALTY WAY, SUITE 1150, MARINA DEL REY, CA 90292 is listed as the correspondent on reel 059911/0304.
4. Cascading transfers — not present. Only one assignment from the inventors to the operating company is recorded.
5. Pre-litigation transfer — unclear. While litigation has been filed, the only assignment on record (inventors to Inari Medical Inc.) predates the litigation filing and is a typical inventor assignment to the company. There is no transfer from Inari Medical Inc. to another entity immediately preceding litigation.
6. Bankruptcy fire-sale — not present. Inari Medical Inc. is an active, operating company.
7. Privateering — not present. The patent remains with the operating company.
8. Defensive aggregator (anti-NPE) — not present. The patent is held by an operating company.

Verdict

Operating-company assertion. The patent is currently assigned to Inari Medical Inc., an operating company that develops and sells medical devices. The recorded assignment is from the individual inventors to Inari Medical Inc. (Reel 059911/0304), which is a standard practice for employees. There are no subsequent transfers to suggest a shell entity or NPE involvement, and Inari Medical Inc. has litigation on file, suggesting assertion of their own products.

USPTO Assignment Center search for US11697012: https://assignmentcenter.uspto.gov/

To identify the most relevant prior art for US Patent 11697012, I need to access its cited references from the USPTO database. Since I cannot directly search the USPTO database in real-time, I will proceed by outlining the process for a human analyst to perform this task and explain what information would be gathered.

Process for Identifying Most Relevant Prior Art:

1. Access USPTO Patent Public Search: A patent analyst would navigate to the USPTO Patent Public Search website.
2. Search for US11697012B2: The patent number "11697012" would be entered into the search interface. The USPTO search system typically handles various formats, but generally, omitting commas and spaces for utility patents is recommended.
3. Locate "Cited References" or "References Cited" Section: Once the patent document for US11697012B2 is retrieved, the analyst would look for a section listing "Cited References" or "References Cited." This section enumerates the prior art documents that the patent examiner and/or applicant considered relevant during the prosecution of the patent.
4. Extract Information for Each Cited Reference: For each patent or publication listed in the "References Cited" section, the following information would be extracted:

   • Full Citation: The complete patent number, publication number, or other identifier, along with the inventor(s)/applicant(s) and issue/publication date.

   • Publication/Filing Date: Both the filing date and publication/issue date are crucial for a 35 U.S.C. § 102 analysis.

   • Brief Description: A concise summary of the invention disclosed in the prior art reference. This would typically involve reviewing the abstract, a representative claim, and relevant figures and portions of the specification.

   • Potential Anticipating Claims (35 U.S.C. § 102): This requires a claim-by-claim comparison of US11697012's independent claims (Claims 1, 19, and 26, as previously summarized) against the disclosures of each prior art reference. Anticipation under 35 U.S.C. § 102 means that every element of a claim in US11697012 is found, either explicitly or inherently, in a single prior art reference.

   • Determining Anticipation:

     • For Claim 1 (Hemostatic Valve): Does the prior art disclose an elongate member (flexible tube), a reinforcement structure coupled to it, and a tensioning mechanism that constricts/seals the lumen, all as claimed?
     • For Claim 19 (Delivery System): Does the prior art show a catheter with a lumen, a hemostatic valve coupled to it, a tubular member with a central lumen fluidly coupled to the catheter lumen, and a tensioning mechanism that constricts/seals the central lumen?
     • For Claim 26 (Method of Sealing): Does the prior art describe a method that includes inserting a delivery device (catheter + hemostatic valve), moving the tensioning mechanism to open, advancing a tool, and then returning the tensioning mechanism to seal around the tool?

Without the ability to perform this live search and detailed review of the cited prior art documents, I cannot provide the specific list of prior art references and their detailed anticipation analysis.

Disclaimer: This analysis is based on the provided patent text and general knowledge of patent law. A definitive determination of anticipation requires a thorough review of each cited prior art document and expert legal interpretation.

Obviousness Analysis under 35 U.S.C. § 103

This analysis will focus on the obviousness of US patent 11697012, considering the prior art references and the arguments raised in IPR2025-00156. The PTAB's Final Written Decision in IPR2025-00156 is a critical input, as it already addressed an obviousness challenge to claims 1-20 based on Choi and Webb.

Prior Art References

• US 2008/0228148 A1 (Choi): This patent application publication was a primary reference in IPR2025-00156.
• U.S. Patent No. 6,004,334 (Webb): This patent was also a primary reference in IPR2025-00156.

PTAB's Finding on Obviousness (IPR2025-00156)

In IPR2025-00156, the PTAB instituted an Inter Partes Review on claims 1-20 of US patent 11697012, finding a reasonable likelihood that Petitioner Imperative Care, Inc. would prevail on grounds of obviousness under 35 U.S.C. § 103 over Choi in view of Webb. However, in its Final Written Decision issued on 2026-04-07, the PTAB ultimately determined that the Petitioner had not shown claims 1-20 to be unpatentable.

The PTAB's reasoning for upholding claims 1-20 as patentable centered on the Petitioner's failure to demonstrate that the combination of Choi and Webb would have rendered the claims obvious. Specifically, the panel found that the prior art combination did not adequately teach or suggest the particular "reinforcement structure" and its "uncoupled nature in the central portion" as claimed in US 11697012.

Analysis of Obviousness Beyond IPR2025-00156

Given the PTAB's decision, any new obviousness challenge against claims 1-20 of US patent 11697012 using Choi and Webb would face significant hurdles due to estoppel for Imperative Care, Inc. (and its privies). For other parties, the PTAB's ruling indicates that this specific combination of prior art was deemed insufficient to establish obviousness for claims 1-20. Therefore, a new obviousness argument would likely need to:

1. Introduce New Prior Art: Identify and present different prior art references not considered in IPR2025-00156.
2. Present Different Combinations: Formulate obviousness arguments based on novel combinations of prior art.
3. Address the "Reinforcement Structure" Feature: If the reinforcement structure with its uncoupled central portion is a distinguishing feature, any new argument must effectively address how this feature would have been obvious in light of the new or re-combined prior art.

General Principles of Motivation to Combine

To establish obviousness, a motivation to combine prior art references must be demonstrated. This motivation doesn't necessarily have to be explicitly stated in the prior art. It can be implicitly contained, or it can be reasoned from knowledge generally available to a person of ordinary skill in the art (POSITA), established scientific principles, or legal precedent. The Federal Circuit has emphasized that "a reason for combining must exist." This can include a design need or market pressure to solve a problem, especially when there are a finite number of identified, predictable solutions.

However, simply showing that claim elements were known in the prior art is not sufficient to establish a motivation to combine. Moreover, when disputed claim elements are disclosed together in a single embodiment within a single prior art reference, there is no requirement to provide a separate motivation to combine them.

Potential Obviousness Arguments (Hypothetical, considering PTAB's outcome)

While the PTAB found against obviousness using Choi and Webb, it's illustrative to consider how a hypothetical obviousness argument might be constructed, focusing on the elements of the claims and the general state of the art for hemostasis valves.

Claim 1 describes a hemostatic valve with an elongate member (pliable, with a central lumen), a reinforcement structure coupled to it, and an active tensioning mechanism. The tensioning mechanism is movable between a first (constricted/sealed) and second (open) configuration.

Claim 19 describes a delivery system with a catheter and a hemostatic valve. The valve has a tubular member with a central lumen fluidly coupled to the catheter lumen, and an active tensioning mechanism movable between sealed and open configurations.

Claim 26 describes a method of sealing a delivery device, including inserting the device with the valve (tensioning mechanism in first configuration), moving the mechanism to a second configuration, advancing a tool, and returning the mechanism to the first configuration to seal around the tool.

Assuming a POSITA in the field of medical devices, particularly those for intravascular access, they would be aware of various hemostasis valve designs aimed at minimizing blood loss and maintaining sterility during procedures.

To overcome the PTAB's decision regarding Choi and Webb, a new argument would need to introduce references that clearly teach or suggest:

• Pliable Elongate Member with Central Lumen: This is a fundamental component of hemostasis valves, broadly known in the art. Many prior art valves would feature a flexible component to seal around inserted instruments.
• Reinforcement Structure: The core of the PTAB's decision was the specific nature of the reinforcement structure. A new prior art combination would need to show a motivation to include a reinforcement structure in a hemostasis valve that is uncoupled in its central portion. The purpose of such a structure is to facilitate uniform collapse of the elongate member, prevent the filament from cutting it, and guide tools.
• Active Tensioning Mechanism with Filament(s): The use of filaments to constrict a tubular member for sealing is a known mechanism in various medical devices. Filaments can be made of polymers or metals. The mechanism being "active" (e.g., manually actuated with buttons) and moving between open and sealed configurations is also a common design goal in medical devices for user control and safety.
• Self-Adjustment: The self-adjusting nature of the tensioning mechanism to seal around different tool sizes is a key advantage.

Hypothetical Motivation to Combine (General):

A POSITA would generally be motivated to combine features from different hemostasis valve designs to improve performance, ease of use, and patient safety. For example, if a prior art reference (different from Choi or Webb) disclosed a hemostasis valve with an effective tensioning mechanism and another reference disclosed a reinforcement structure for a flexible tube, a POSITA might combine these elements to:

• Improve Seal Integrity: A reinforcement structure, particularly one that aids in uniform collapse, could enhance the sealing ability of a tensioning mechanism, especially when a vacuum is applied during aspiration.
• Prevent Damage to the Elongate Member: Filaments, if not properly guided or supported, could cut or tear the pliable elongate member. A reinforcement structure positioned between the filament and the elongate member would prevent such damage, providing a durable and reliable seal.
• Facilitate Tool Insertion/Retraction: A well-designed reinforcement structure could also guide tools through the valve, reducing the risk of snagging or damage to the valve components.
• Accommodate Various Tool Sizes: A self-adjusting tensioning mechanism combined with a suitable reinforcement could allow the valve to seal around a wider range of tool sizes, increasing the versatility of the delivery system.

The challenge in any new obviousness argument would be to identify specific prior art that, when combined, would teach or suggest the uncoupled central portion of the reinforcement structure and provide a clear motivation for this specific design choice. The PTAB's decision highlights that this particular feature was not sufficiently obvious from Choi and Webb.