Invalidity dossier

US 11865291

Hemostasis valves and methods of use

Current assignee: Imperative Care, Inc.

Added 9/26/2026, 8:31:20 AM

IndustryMedical (M)
At a glanceNo PTAB challenges1 lawsuit on fileasserted by Imperative Care, Inc.Medical (M)

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Patent summary

Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.

✓ Generated

I'll verify the patent's identity and check the USPTO/PTAB and Federal Circuit dockets as requested.

Let me pull the actual claim language and confirm current ownership and any appellate activity.

US 11,865,291 B2 — Verification Summary

Bottom line: The identifier 11,865,291 resolves to a real, currently-in-force Inari Medical patent that is the subject of both live district-court litigation and an instituted PTAB review. I found no Federal Circuit docket for this patent in my searches; the PTAB proceeding is still pending, so a CAFC appeal would not yet be expected.


1. Bibliographic data (from the patent record)

Field Value
Patent number US 11,865,291 B2
Title Hemostasis valves and methods of use
Application no. 18/142,518
Filing date (this application) May 2, 2023
Date of patent (issue) January 9, 2024
Pre-grant publication US 2023/0270991 A1 (Aug. 31, 2023)
Inventors Benjamin E. Merritt; John C. Thress; Paul Lubock
Assignee / current owner Inari Medical, Inc. (Irvine, CA)
Earliest priority Sept. 6, 2017 — provisional 62/554,931
Legal status Active; anticipated expiration listed as 2038-08-30 (Google Patents states this is an assumption, not a legal conclusion)
CPC A61M 39/06 (primary), A61M 39/0613, A61M 2039/062, A61M 2039/0673, A61B 17/3207

Continuity chain (as recited in the patent's own Cross-Reference section): divisional of 17/705,189 (filed Mar. 25, 2022) → continuation of 17/226,318 (filed Apr. 9, 2021) → continuation of 16/117,519 (filed Aug. 30, 2018, issued as US 11,000,682) → benefit of provisional 62/554,931 (Sept. 6, 2017).

Ownership note: In the Oct. 23, 2025 PTAB institution decision, Inari Medical identified itself as "a wholly-owned subsidiary of Stryker Corporation" (institution decision, Paper 10). The patent face lists Inari Medical, Inc. as assignee. I did not independently verify the corporate-transaction details.

2. Abstract (verbatim, as published)

"Devices, systems, and methods for sealing medical devices, particularly during intravascular access, are disclosed herein. Some aspects relate to a hemostatic valve for sealing a wide range of medical devices, such as catheters, wires, embolectomy systems. The valve can include an elongate member having a first end, a second end, and a central lumen extending therebetween. A reinforcement structure extends along at least a portion of the elongate member and is coupled to the elongate member. A shell defining a first aperture and a second aperture may be included, which first and second apertures can be fluidly coupled by the elongate member. A tensioning mechanism is coupled to the shell and to the elongate member, the tensioning mechanism can be moveable between a first configuration wherein the tensioning mechanism is collapsed and the central lumen is sealed and a second configuration wherein the central lumen is open."

3. Plain-language overview

The patent covers a "garrote"-style hemostasis valve for large-bore thrombectomy/aspiration catheters. A soft, compliant collapsible tube (e.g., silicone) sits in a housing between the catheter and the outside world. A thin filament (nylon, nitinol, stainless steel, silicone, etc.) is looped around that tube. One or more spring-biased buttons pull the filament ends; tightening the loop cinches the tube shut (sealing with or without a tool inside), and depressing the buttons releases tension to open it. Key variants include a braided-mesh reinforcement sheath between the tube and filament (adhered only near the tube ends, uncoupled in the middle) and overlapping/interlocking "bight" embodiments. Claimed benefits include single-handed operation, sealing around tools of widely varying diameter, and a seal that is reinforced rather than compromised by vacuum aspiration (applied through a side port).

4. Independent claims (plain language) — with confidence flags

The patent has 20 claims (claim 20 appears in the published claim set). Independent claims in the challenged/asserted set include:

  • Claim 1 — hemostasis valve (verbatim text confirmed via the IPR record): "A hemostasis valve, comprising: a support; an actuator having at least a first member movably coupled to the support; a collapsible tubular sidewall defining a lumen carried by the support; a filament formed in a loop around the tubular sidewall, the filament having at least a first end portion extending away from the loop to the first member; and a spring configured to move the first member in a direction that pulls the first end portion away from the tubular sidewall, reducing a diameter of the lumen in response to reducing a diameter of the loop."
  • Claim 18 — aspiration catheter system: directed to an aspiration catheter system incorporating the hemostasis valve of the claim 1 type (per the IPR institution decision and Patent Owner's Preliminary Response). In plain terms: an aspiration catheter with a proximal hemostasis valve whose lumen is in communication with the catheter lumen, plus the constricting mechanism.
  • Claim 12 appears to head a separate claim group (it is addressed independently in the IPR petition, with claims 13–17 depending from it), and claim 20 also recites a filament-in-a-loop/button arrangement. I could not confirm the exact wording or independence status of claims 9–12 and 20 from the sources available to me, so treat those as provisional.

Related dependent-claim content confirmed from the record: claim 2 adds a second movable member; claim 3 adds a second filament end portion running to the second member; claim 4 requires "the first end portion, the loop, and the second end portion [be] one continuous filament."

5. Related USPTO/PTAB and court activity (as of this review)

  • *IPR2025-00989 — Imperative Care, Inc. v. Inari Medical, Inc.,* challenged claims 1–8 and 12–19. Petition filed May 9, 2025; institution granted Oct. 23, 2025 on all challenged claims (37 C.F.R. § 42.108(a); SAS v. Iancu). Grounds: Schaffer (US 2003/0225379 A1) alone or with Hartley (US 2003/0116731 A1) / Eller (US 9,980,813 B1) for claims 1–8, 12–17, 19; and Garrison (US 2015/0173782 A1) with Schaffer (± Hartley/Eller) for claims 18–19. Petitioner stipulated under Sotera not to pursue the same grounds in district court. Note: the Google Patents page labels the petitioner as "Unified Patents" — that is the data source (Unified Patents' portal); the actual petitioner is Imperative Care, Inc. (portal record).
  • District court: Inari Medical, Inc. v. Imperative Care, Inc. (and Truvic Medical, Inc.), No. 3:24-cv-03117 (also docketed as 5:24-cv-03117-EKL), N.D. Cal., filed May 21, 2024. The '291 patent is one of nine asserted patents (First Amended Complaint asserts 11,974,910; 11,969,333; 11,554,005; 11,744,691; 11,844,921; 11,697,011; 11,697,012; 11,865,291; and 12,016,580). Inari's motion for preliminary injunction was denied Sept. 29, 2025 (Dkt. 136) — but that motion was premised on the '921 and '910 patents, not the '291 patent.
  • Federal Circuit: No 2026 CAFC docket for 11,865,291 was found in my searches. Given the IPR was only instituted in Oct. 2025, a final written decision (and any resulting appeal) would post-date this review.

6. Discrepancies / uncertainty to flag

  1. Priority date: the patent's own text says Sept. 6, 2017; one third-party aggregator (Unified Patents) displays "2017-09-05." The patent document governs.
  2. PTAB petitioner field: Google Patents' "Petitioner: (blank)" line and the Darts/Unified attribution could mislead — the real petitioner is Imperative Care, Inc.
  3. Case number variants 3:24-cv-03117 and 5:24-cv-03117 refer to the same N.D. Cal. action at different divisional venues, and the presiding judge changed over time (YGR → EKL).
  4. Claim text: I have verbatim claim 1 only; claims 9–12 and 20 are described indirectly. If you need litigation-grade claim charts, pull the issued claim set from USPTO PatentCenter rather than relying on this summary.

Generated 9/27/2026, 9:14:24 PM

Cases on file (1)

Group view →

Specific litigation cases in our database that name US patent 11865291. The free-form analysis below may also discuss cases beyond this list.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

I'll research litigation involving US patent 11865291. Let me search multiple sources.

Let me dig deeper into specific cases and verify which ones involve the '291 patent.

Let me verify a few additional points, including whether the Inquis case involves the '291 patent and check for any other cases.

Litigation Involving U.S. Patent No. 11,865,291

Based on searches of Unified Patents' litigation/PTAB portal, PTAB dockets, CourtListener/PACER-derived records, and the patent's Google Patents page, the '291 patent ("Hemostasis valves and methods of use," Inari Medical, Inc.; priority date Sept. 6, 2017; granted Jan. 9, 2024) is currently at issue in one district-court action and one instituted PTAB inter partes review. No other assertion of the '291 patent appears in the record.


1. District Court: Inari Medical, Inc. v. Imperative Care, Inc.

Item Detail
Plaintiff Inari Medical, Inc. (a wholly-owned subsidiary of Stryker Corporation per its PTAB mandatory notices)
Defendant Imperative Care, Inc. (incl. its Truvic subsidiary/unit)
Court / Jurisdiction U.S. District Court for the Northern District of California (San Jose Division)
Case No. 5:24-cv-03117 (originally docketed as 3:24-cv-03117; also styled 24-cv-03117-EKL / 5:24-cv-03117-EKL-SVK)
Filing date May 22, 2024 (per Inari's PTAB mandatory notice and Imperative Care's IPR petition)
Accused product Imperative Care's Symphony Thrombectomy System
Status Active but stayed pending IPR. Preliminary injunction DENIED (Sept. 29, 2025). Case stayed; the stay was continued by joint stipulation/order on Jan. 28, 2026. No trial date set.
Judge E. K. Lee (EKL)

Key documents/citations:

Notes on the '291 patent in this case: Inari asserted the '291 patent among a large and fluctuating set of patents (the First Amended Complaint asserted U.S. Pat. Nos. 11,974,910; 11,969,333; 11,554,005; 11,744,691; 11,844,921; 11,697,011; 11,697,012; 11,865,291; and 12,016,580). Infringement contentions assert claims 1–8, 12–17, and 19 of the '291 patent. The PI motion itself rested on only two patents (the '921 and '910 patents), and the court denied it on Sept. 29, 2025, finding serious validity questions and no irreparable harm. The court later stayed the case in light of the parallel IPRs. (Source: VitalLaw summary — https://www.vitallaw.com/news/patent-n-d-cal-preliminary-injunction-denied-in-thrombectomy-system-dispute/ipm0146bdf38bf1b142478851e1db1ec0a23f)

Note: I did not find that the '291 patent was separately asserted in a Delaware action. The Delaware case Inari Medical, Inc. v. Inquis Medical, Inc., No. 1:24-cv-01023-CFC (D. Del., filed Sept. 11, 2024) involves different, non-priority-related Inari patents (U.S. Pat. Nos. 11,890,180; 11,969,332; 11,974,909; 11,986,382) and not the '291 patent.


2. PTAB: Imperative Care, Inc. v. Inari Medical, Inc. — IPR2025-00989

Item Detail
Petitioner Imperative Care, Inc.
Patent Owner Inari Medical, Inc.
Proceeding Inter partes review, IPR2025-00989 (contested PTAB proceeding)
Patent challenged U.S. Patent No. 11,865,291
Filing date May 9, 2025
Institution Instituted on all challenged claims — Oct. 23, 2025 (claims 1–8 and 12–19)
Status Pending / trial instituted. Patent Owner Response filed Jan. 15, 2026; Petitioner objections Jan. 23, 2026; Petitioner notice of deposition of PO's expert (Paul Zalesky) Mar. 16, 2026. A final written decision would be expected roughly one year after institution (~Oct. 2026).
Grounds Schaffer (US 2003/0225379) anticipation/obviousness; Schaffer + Hartley (US 2003/0116731); Schaffer + Eller (US 9,980,813); and Garrison (US 2015/0173782) + Schaffer [± Hartley/Eller], under §§102/103
Panel APJs Fredman, Jeschke, Majors

Sources:

This IPR is the staying proceeding referenced by the district court, and Imperative Care filed a Sotera stipulation (agreeing not to pursue in district court the grounds raised or reasonably raisable in the IPR) to support institution.


Related context (not assertions of the '291 patent)

The same parties are litigating a parallel family of IPRs filed by Imperative Care against other Inari patents that are related by priority to the '291 patent (all sharing the Sept. 6, 2017 priority), including:

  • IPR2024-01157 ('011 patent) — instituted
  • IPR2025-00156 ('012 patent) — instituted
  • IPR2025-00728 ('921 patent)
  • IPR2025-01021 ('333 patent)
  • IPR2025-01025 ('910 patent)
  • IPR2024-01257 ('691 patent), IPR2025-00289 ('005 patent)

These are cited here only to show the family context; they do not concern the '291 patent itself.


Summary

  • One known district-court litigation involving U.S. 11,865,291: Inari Medical, Inc. v. Imperative Care, Inc., No. 5:24-cv-03117 (N.D. Cal.), filed May 22, 2024 — PI denied Sept. 29, 2025; case stayed pending IPR (stay continued Jan. 28, 2026).
  • One known PTAB proceeding: IPR2025-00989, Imperative Care, Inc. v. Inari Medical, Inc., filed May 9, 2025, instituted Oct. 23, 2025, still pending.
  • No other litigation asserting the '291 patent was found (e.g., no separate Delaware action and no ITC investigation tied to this patent).

Caveats: Patent numbers and case identifiers are reported literally as they appear in the sources. Some docket details (e.g., the precise original filing date and incremental status after Jan. 28, 2026) could not be independently confirmed from PACER in this session; the most recent confirmable events are the January 2026 stay filings and the March 2026 deposition notice in the IPR. Where a search result differs from anything in my background knowledge, I have treated the search result as the ground truth.

Generated 9/27/2026, 9:14:17 PM

Proceedings on file (0)

All PTAB activity →

AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.

Current assignee: Imperative Care, Inc.

No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.

PTAB challenges

AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.

✓ Generated

I'll start by researching the PTAB proceedings, litigation, and current status.

Key finding: the structured block says no AIA trials, but web sources show IPR2025-00989 against the '291 patent. Let me verify details, the panel, and whether there are other IPRs.

Excellent — I have a full docket. Now let me check for any additional IPRs against the '291 patent, the oral hearing/FWD timeline, and family-proceeding outcomes.

PTAB Proceedings — US 11,865,291 B2 ("Hemostasis valves and methods of use")

⚠️ Data-integrity flag up front. The structured "PTAB proceedings on file" block in this prompt states the USPTO ODP API returns no AIA trial proceedings for this patent. That is wrong as of today. A live, fully-instituted IPR against US 11,865,291 exists — IPR2025-00989 — and Google Patents' own litigation panel lists it ("PTAB case IPR2025-00989 filed (Pending - Instituted)"). The ODP ingest is stale. Everything below is sourced from the PTAB docket (Petition, POPR, Institution Decision, PO Response, Petitioner Reply) and third-party dockets. I did not find a second IPR against the '291 patent; one petition is on file.


Proceedings overview

One (1) AIA trial proceeding on file against US 11,865,291: IPR2025-00989 (Imperative Care, Inc. v. Inari Medical, Inc.), filed 2025-05-09, instituted on all challenged claims on 2025-10-23, and still pending — zero claims canceled, zero claims sustained, none settled, no institution denial. Bottom-line defensive posture for a defendant today: the patent is under live, merits-level attack but is not yet narrowed — you cannot yet tell a court or a plaintiff that any claim of the '291 patent is dead, and any invalidity theory built on Schaffer/Hartley/Eller/Garrison will be decided by the Board within roughly the next month (FWD statutorily due 2026-10-23).


IPR2025-00989 — Imperative Care, Inc. v. Inari Medical, Inc.

  • Type: Inter Partes Review (35 U.S.C. §§ 311–319)
  • Filed: 2025-05-09
  • Status: "Pending — Instituted" / third-party dockets report "Trial Instituted" (Unified Patents portal: "Pending"; ipverse: "Trial Instituted"; Google Patents: "Pending - Instituted"). Plain English: the Board took the case on the merits; no final decision has issued.
  • Judge panel: APJs Jeffrey N. Fredman, Eric C. Jeschke, and Timothy G. Majors (Majors authored the Institution Decision and the Scheduling Order). One docket listing also shows APJ Eumi K. Lee associated with the case file. Panel composition for the FWD is subject to change.
  • Petition grounds (challenged claims 1–8 and 12–19 — i.e., all claims except 9–11):
    • Ground 1 — § 102 anticipation of claims 1–8, 12–17, 19 by Schaffer (US 2003/0225379 A1, Schaffer et al.).
    • Grounds 2–4 — § 103 obviousness of the same claims over Schaffer alone, or Schaffer + Hartley (US 2003/0116731 A1), or Schaffer + Eller (US 9,980,813 B1).
    • Grounds 5–7 — § 103 obviousness of claims 18–19 over Garrison (US 2015/0173782 A1) + Schaffer, optionally with Hartley or Eller.
    • No § 112 grounds. Supporting exhibits include the Schaffer certified file history (Ex. 1008), Schaffer '616 (US 5,429,616), Trerotola (US 6,776,770), Brady (WO 2018/019829 A1), and the Expert Declaration of Troy Thornton (Ex. 1003). Patent Owner's expert is Paul J. Zalesky, Ph.D.
    • Central dispute: claim construction of "filament." Petitioner: a filament is "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes" and need not be thin or flexible. Patent Owner: "a thin, flexible length of material formed by one or more strands." This is a carry-over fight from the sibling IPRs, where Patent Owner successfully argued Schaffer's U-shaped actuating members are rigid and therefore not a "filament formed into a loop."
  • Institution decision: Instituted on 2025-10-23 — on all challenged claims and all asserted grounds (Petitioner sought SAS-style full institution). The panel found a reasonable likelihood of prevailing "with respect to at least one of the '291 patent's challenged claims" and, per SAS Institute v. Iancu, 584 U.S. 357 (2018) and 37 C.F.R. § 42.108(a), took the whole petition. Two procedural notes: (1) the case was referred to a merits panel under the March 26, 2025 "Interim Processes for PTAB Workload Management" memo because Patent Owner declined to file a discretionary-denial brief (Notice of Referral to Board Panel, Chief Clerk Erica Swift) — so no Fintiv/§ 325(d) discretionary denial obstacle remains; (2) the panel addressed the POSA level (undergraduate degree in mechanical engineering or related field + 2–4 years of design/engineering experience with endovascular devices) and engaged the "filament" construction dispute.
  • Final Written Decision: None issued as of 2026-09-27. Statutory deadline under 35 U.S.C. § 316(a)(11) is 2026-10-23 (one year from institution), extendable up to six months for good cause. No claim has been canceled and no claim has been held patentable on the merits.
  • Key trial-stage events on the docket:
    • 2025-05-29 — Patent Owner Mandatory Notice (identifies Inari Medical, Inc. as a wholly-owned subsidiary of Stryker Corporation, and itself as RPI).
    • 2025-06-13 — Notice of Filing Date Accorded.
    • 2025-09-15 — Patent Owner Preliminary Response (Paper 6) + Ex. 2001 (Zalesky decl.).
    • 2025-10-03 — Petitioner's Reply to POPR (Paper 8) submitted with Board authorization.
    • 2025-10-23 — Institution Decision (Paper 10) + Scheduling Order (Paper 11).
    • 2026-01-15 — Patent Owner's Response (Paper 15) + supplemental Zalesky declaration (Ex. 2009).
    • 2026-01-23 — Petitioner's § 42.64(b) objections to PO evidence (Paper 16).
    • 2026-04-09 — Petitioner's Reply to Patent Owner's Response (Paper 19), with new exhibits 1033–1041 (including the FWDs from family IPRs, Dr. Zalesky's 2026-03-24 deposition transcript, and secondary references Wong and Kees).
    • Hearing: the Board's schedule places the oral argument in the run-up to the October 2026 FWD window; treat the exact hearing date as "confirm before citing" — docket extracts in this family show hearing dates being tracked at the district court (one stipulation exhibit references a July 2026 argument date for a related IPR).
  • Settlement / termination: None. Both parties are actively litigating the merits; no joint motion to terminate, no adverse judgment.
  • Appeal: N/A yet. No FWD, therefore no § 141 appeal is ripe. No Federal Circuit docket for the '291 patent was found.
  • Related district court case (context for any assertion analysis): Inari Medical, Inc. v. Imperative Care, Inc., No. 24-cv-03117 (N.D. Cal.) (Google Patents also lists a duplicate N.D. Cal. docket number 5:24-cv-03117). Imperative Care moved to stay pending IPR on 2025-04-02; Inari's motion for preliminary injunction was denied (Dkt. 136, 2025-09-29); the parties filed a joint stipulation on 2026-01-28 to continue the litigation stay pending the IPR decisions and to vacate the case management conference. The case is effectively parked behind this and the sibling IPRs.
  • Defensive value: The '291 patent is not hardened and not dead — it is mid-trial. If you are being asserted on claims 1–8 or 12–19, a defendant-side IPR is off the table (statutory bar) but you can ride the Board's decision: (a) if the FWD cancels claims, the cancellation is immediately usable in your case, subject to appeal; (b) if the FWD sustains the claims, Imperative Care will be estopped under § 315(e)(2) as to everything it raised or reasonably could have raised on those claims — which narrows their future invalidity runway but does nothing to help you, and an Inari win at the Board materially hardens the patent. Note also that claims 9–11 are untested in this proceeding — if the demand letter/infringement contentions reach claims 9–11, no IPR record exists against them.

Strategic summary

Which claims are canceled vs. sustained vs. untested. As of 2026-09-27: canceled: none. Sustained: none. Untested in this IPR on the merits: all of 1–8 and 12–19 (instituted but undecided), and 9–11 (never challenged). Do not represent to any court that any claim of US 11,865,291 has been invalidated, and do not represent that any claim has been upheld. The only "hardened" signal in the family comes from sibling patents, not this one: Patent Owner's Preliminary Response repeatedly leans on the Board's earlier rulings in IPR2024-01157 (US 11,697,011) and IPR2025-00156 (US 11,697,012) that Schaffer's U-shaped actuating members are "substantially rigid" and that a "flexible filament" is required to form a reducible loop. I was not able to confirm from the sources retrieved whether the FWDs in IPR2024-01157 and IPR2025-00156 canceled or sustained claims — Petitioner filed those FWDs as exhibits (Exs. 1033 and 1038) in the '291 record on 2026-04-09, so they are on the docket and should be pulled and read before relying on the family narrative. Those are different patents (the '011 and '012) and have no direct estoppel effect on the '291 patent.

Estoppel landscape. § 315(e)(2) estoppel attaches only when an IPR "results in a final written decision." No FWD has issued, so no estoppel has attached yet. When it does (statutorily due 2026-10-23), it will bind Imperative Care and its privies — not you — as to claims 1–8 and 12–19 on any ground raised or reasonably raisable. Practical consequences for a defendant being asserted today: (1) grounds based on Schaffer, Hartley, Eller, or Garrison will be spoken for if the FWD lands; (2) claims 9–11 are outside the estoppel perimeter because they were never challenged — grounds against those claims remain fully available to any party; (3) if you are a privy of Imperative Care (e.g., a co-defendant in the same supply chain or an indemnitee), the estoppel will capture you, so keep your district-court invalidity contentions clean of the Schaffer/Hartley/Eller/Garrison theories now.

Pattern signals. No defensive aggregator. The petitioner is Imperative Care, Inc., a direct competitor in the thrombectomy space (represented by Knobbe Martens: Joshua J. Stowell, Joseph R. Re, Brian C. Barnes); Patent Owner Inari Medical, now a wholly-owned Stryker subsidiary, is represented by Perkins Coie (Joseph Hamilton, Paul Parker, Matthew Williams). This is an ordinary competitor-vs-competitor war, not Unified Patents or a hedge-fund-funded campaign — note that Google Patents' attribution of the PTAB entry to "Unified Patents PTAB Data" is a data-source label; Unified Patents is not the petitioner. Imperative Care has not filed multiple IPRs against this patent — the multiplicity is spread across the family: IPR2024-01157 ('011), IPR2024-01257 ('691), IPR2025-00156 ('012), IPR2025-00289 ('055), IPR2025-00728 ('921), IPR2025-00989 ('291 — this patent), IPR2025-01021 ('333), IPR2025-01025, IPR2025-01562, and a record reference to a further 2026 filing. Inari has pursued PTAB appeals/violations of the family aggressively in the district court (including a denied preliminary-injunction motion and a stay now continued pending the IPRs). No settlement anywhere in the chain.


Recommended next steps

  1. Pull the two operative Board papers immediately and calendar the deadline: Institution Decision, IPR2025-00989, Paper 10 (2025-10-23) — which instituted on claims 1–8 and 12–19 on all seven grounds — and the Scheduling Order, Paper 11 (2025-10-23). FWD is statutorily due 2026-10-23 absent a § 316(a)(11) extension (max six months). Dockets: Unified Patents case page — https://portal.unifiedpatents.com/ptab/case/IPR2025-00989; Docket Alarm — https://www.docketalarm.com/cases/PTAB/IPR2025-00989/Imperative_Care_Inc._v._Inari_Medical_Inc/; PTAB E2E search by proceeding number at https://e2e.uspto.gov. For the full-text papers captured above, the mirror is https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2025-00989/Imperative_Care_Inc._v._Inari_Medical_Inc/ and the public petition file is at https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557876](/patent/1557876)/.
  2. Do not build a defense on "this patent has already been invalidated." It has not. If a demand letter or complaint cites claims 1–8 or 12–19, the honest posture is "instituted IPR pending, FWD due 2026-10-23," not "claims canceled."
  3. If the FWD cancels claims: cite the FWD's disposition paragraph verbatim (claim-by-claim) and immediately move to supplement your invalidity contentions/terminate those claims; note the § 315(e)(2) estoppel that will bind Imperative Care so you can plan the estoppel-free art you still hold.
  4. If the FWD sustains claims: expect a hardened patent and an Inari/Stryker enforcement posture backed by a merits win; shift to non-infringement, § 112, and art outside the Schaffer/Hartley/Eller/Garrison quartet, and note that claims 9–11 remain challengeable by anyone who has not yet filed (statutory § 315(b) one-year bars from service of the complaint still govern — confirm your own service date).
  5. Preserve grounds on claims 9–11 and on any claims added by reissue/re-exam if Inari seeks to cure; the Board's briefing identified the "filament"-must-be-flexible construction as the linchpin, and Inari may attempt to lock that in.
  6. Verify before repeating two items I could not fully confirm from the retrieved sources: (a) the exact oral hearing date in IPR2025-00989 (docket extracts suggest a mid-2026 argument window); and (b) the outcomes of the sibling FWDs in IPR2024-01157 ('011 patent) and IPR2025-00156 ('012 patent), which were filed as Exs. 1033/1038 in this record. A 2026 reference to IPR2026-00094 also appears in a related Board notice, but I could not confirm which patent it targets — flag it as unverified rather than attributing it to the '291 patent.

Generated 9/27/2026, 9:14:51 PM

Ownership chain (1)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. ? · recorded 2023-08-10 · Assignment

    Paul Lubock; Benjamin E. Merritt; John C. ThressInari Medical, Inc.

Assignment history

Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.

✓ Generated

I'll reconstruct this ownership chain from primary and secondary sources. Let me run several searches in parallel.

Key facts are emerging. Let me verify the Stryker acquisition, the assignment record specifics, and Inari's corporate history.

Ownership & Assignment Analysis — US 11,865,291 B2

Patent: US 11,865,291 B2 — "Hemostasis valves and methods of use"
App. No. 18/142,518, filed 2023-05-02; granted 2024-01-09; anticipated expiration 2038-08-30
Priority: 2017-09-06 (Prov. 62/554,931)
Continuity: divisional of 17/705,189 → continuation of 17/226,318 → continuation of 16/117,519 (now US 11,000,682) → provisional 62/554,931

Access caveat (read first): I could not retrieve the underlying Assignment Center records directly — https://assignmentcenter.uspto.gov/ and https://assignment.uspto.gov/patent/index.html are JavaScript applications that my search tooling cannot query, and no third-party index surfaced reel/frame numbers for this patent. Consequently, no reel/frame number, execution date, or correspondent name from the assignment record is stated below, because I will not invent them. The assignment events described come from Google Patents' legal-events feed, which mirrors the number and parties of the USPTO records but does not expose the reel/frame. Verify at: https://assignmentcenter.uspto.gov/ (search patent number 11865291).


Inventors

Inventor Residence on the face of the patent Employer at time of filing
Benjamin E. Merritt San Clemente, CA Inari Medical, Inc. (Irvine, CA)
John C. Thress (also "John Coleman Thress") Capistrano Beach, CA Inari Medical, Inc.
Paul Lubock Monarch Beach, CA Inari Medical, Inc.

Basis: The '291 patent front page is not reproduced in full in the fetched text, but the same three inventors are named on the sibling continuation US 12,109,384 B2 ("Hemostasis valves and methods of use," Inari Medical, Inc., Irvine, CA), and Merritt + Lubock appear in the same Inari family in the Belgian patent-register excerpt for Inari's corresponding EP case (Inari Medical, Inc., 6001 Oak Canyon, Suite 100, Irvine, CA 92618). All three are named as assignors on the recorded Inari assignment (see below).

Pattern notes:

  • No unusual departure pattern. Nothing in the retrieved record shows inventors leaving Inari within 12 months of filing. The contrary: Thress and Merritt remained prosecuting-era Inari personnel — they are named inventors on follow-on Inari patents issued as late as 2024 (US 11,974,910; US 12,109,384), which is inconsistent with a pre-fire-sale inventor exodus.
  • Paul Lubock is a serial medtech inventor/entrepreneur (long-standing Southern California device-inventor profile, Monarch Beach residence on the family's patents). His presence is a genuine-innovation signal, not a troll-script signal.
  • No inventorship was changed, reassigned, or disclaimed in any source retrieved.

Original assignee

Inari Medical, Inc., Irvine, California (principal address of record in the family: 6001 Oak Canyon, Suite 100, Irvine, CA 92618).

  • Was it an operating company? Yes, unambiguously. Inari was a commercial medical-device manufacturer, NASDAQ-listed (ticker NARI), that developed and sold the FlowTriever (pulmonary embolism) and ClotTriever (deep vein thrombosis) mechanical/aspiration thrombectomy systems. Inari's own complaint in Inari Medical, Inc. v. Imperative Care, Inc. describes it as "the world's leading developer of catheter-based aspiration and/or mechanical thrombectomy devices" and states the USPTO "has issued Inari over fifty United States patents." FlowTriever received FDA clearance in November 2016, expanded PE clearance in May 2018; 2024 revenue estimated at ~$603M.
  • Do its products embody the claims? Effectively yes. The '291 patent is a garrote hemostasis valve patent — a valve component of Inari's aspiration thrombectomy capital hardware, not a standalone licensed abstraction. Inari asserted the '291 patent (alongside seven+ sibling patents) against a direct competitor's competing thrombectomy system, which is the classic operating-company product-vs-product posture.
  • Current status: acquired, and now operating as a subsidiary. On 2025-02-19 Stryker Corporation (NYSE: SYK) completed its ~$4.94 billion all-cash acquisition of Inari via a tender offer by Eagle 1 Merger Sub, Inc. followed by a merger under an Agreement and Plan of Merger dated 2025-01-06. Inari survived the merger as a wholly-owned subsidiary of Stryker; Inari shares ceased trading and were delisted from Nasdaq. Stryker's announcement: https://investors.stryker.com/press-releases/news-details/2025/Stryker-completes-acquisition-of-Inari-Medical-Inc.-providing-entry-into-the-high-growth-peripheral-vascular-segment/default.aspx
    • Important: because Inari was the surviving corporation in a stock-and-merger acquisition, the record owner of the '291 patent remains Inari Medical, Inc. The change of control is a securities event, not a patent conveyance, and does not itself require a recorded patent assignment. Do not read the Stryker deal as an assignment link.
  • Not bankrupt. No Chapter 7/11 proceeding appears anywhere in the record; the exit was a $4.9B cash sale.

Assignment timeline

Chronological list of recorded conveyances appearing in the sources I could reach:

  • Executed date not shown in retrieved sources (inventor assignment ordinarily executed on/around the 2018 filing) / recorded 2023-08-10 — Reel/frame: not retrievable; unverified
    • Conveyance: Assignment (recorded as "ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS)")
    • Assignor: Paul Lubock; Benjamin E. Merritt; John C. Thress (the three named inventors)
    • Assignee: Inari Medical, Inc.
    • Correspondent: Not retrievable. I can say only that Inari's patent prosecution counsel of record for this family is Perkins Coie LLP (attorney of record on sibling US 12,109,384 B2; and Inari's litigation counsel of record in N.D. Cal., including Amanda Tessar, Daniel T. Keese, Ramsey M. Al-Salam, Ruben T. Kendrick, Trevor J. Bervik). This is prosecution/litigation counsel, not a verified assignment-record correspondent — do not treat it as a repeat-correspondent finding. Knobbe, Martens, Olson & Bear LLP (Joshua J. Stowell, Joseph R. Re, Brian C. Barnes) is adverse counsel for the IPR petitioner and is not in this chain.
    • Context: Standard founder/employee-to-company confirmation assignment — routine original-ownership perfecting, not an acquisition, reorg, securitization, or transfer-to-asserter. Its 2023-08-10 recordation date falls between the 2023-05-02 filing of this divisional and the 2024-01-09 grant, consistent with a housekeeping recordation at issuance rather than a change in beneficial ownership.

No other recorded assignment appears for this patent. Google Patents' legal-events feed for US 11,865,291 shows exactly one assignment entry (the 2023-08-10 Inari recordation) and no transfer to any IP holding company, licensing vehicle, or assertion entity. The 2025 Stryker merger produced no assignment entry because none was required (surviving-corporation structure).

If Assignment Center shows additional records for this patent beyond the single inventor-to-Inari link (e.g., a merger or change-of-name record naming Stryker), that record would be the only other link in the chain — but I did not observe one and will not assert one exists.


Timeline diagram

timeline
    title Ownership of US 11865291
    2017 : Provisional filed by Merritt Thress Lubock
    2018 : Non-provisional filed by Inari Medical
         : Inventors assign rights to Inari Medical
    2022 : Continuation filed in same family
    2023 : Divisional application filed
         : Inventor assignment recorded at USPTO
    2024 : Patent issued to Inari Medical
         : Inari sues Imperative Care for infringement
    2025 : Stryker completes 4.9B acquisition of Inari
         : Imperative Care files IPR2025-00989

NPE / troll-pattern signals

1. Shell-entity transfer — NOT PRESENT. The only recorded conveyance is inventors → Inari Medical, Inc., an entity whose address is a real corporate campus (6001 Oak Canyon, Suite 100, Irvine, CA) and whose product line (FlowTriever, ClotTriever, RevCore, InThrill) is documented in FDA clearances and its own court pleadings. No "IP/Patents/Licensing/Holdings/Ventures" suffix appears anywhere in the record; no Delaware or Texas single-purpose LLC appears; no registered-agent-service address appears.

2. Known asserter in the chain — NOT PRESENT. Neither Inari Medical, Inc. nor Stryker Corporation matches any entry on the enumerated NPE lists (Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). Independently, Unified Patents' own portal classifies the patent owner as "Operating Company" and the challenger as "SME" (portal.unifiedpatents.com/ptab/case/IPR2025-00989). Note carefully: the IPR petitioner is the competitor Imperative Care, Inc., not Unified Patents or any defensive aggregator.

3. Repeat correspondent across the chain — UNCLEAR (data unavailable). There is only one link in the chain to test for recurrence, and its recorded correspondent is not retrievable through my tools. A single appearance is not a finding in any event. Flagged as a genuine gap, not as a negative finding.

4. Cascading transfers — NOT PRESENT. No consecutive LLC-to-LLC conveyances exist; there is no second link at all. No shared correspondents, addresses, or common principals to evaluate.

5. Pre-litigation transfer — NOT PRESENT. The transfer to a new party happened in the opposite direction and after the fact: Inari was the plaintiff (not an assignee) in Inari Medical, Inc. v. Imperative Care, Inc., N.D. Cal. Case No. 3:24-cv-03117 / 5:24-cv-03117-EKL-SVK, filed on/about 2024-05-21/22 — over nine months after the 2023-08-10 assignment recordation, and the assignment at issue is the original inventor-to-company link, not a transfer into an assertion vehicle. Stryker's acquisition (completed 2025-02-19) came after suit was filed, so it cannot have been arranged to enable assertion.

6. Bankruptcy fire-sale — NOT PRESENT. No bankruptcy filing by Inari appears in the record. The exit was a tender offer at $80.00/share cash, ~$4.94B total equity value; 48,504,444 shares (~81.69%) tendered. Contrast the Kodak/Nortel/Polaroid fact pattern — this is a premium strategic sale, not a distressed asset dump.

7. Privateering — NOT PRESENT. The inverse of interest here: the patent moved from a mid-cap operating company to a larger operating company (Stryker), and the assertion is Inari asserting its own patents, in its own name, against a direct competitor (Imperative Care/Truvic) in the same product market — not an operating company handing patents to an NPE to sue on its behalf. No SEC disclosure, EFF, or Patent Progress coverage characterizes this family as a privateering arrangement.

8. Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. The patent remains live and asserted (IPR2025-00989, petition filed 2025-05-09, instituted 2025-10-23 on claims 1–8 and 12–19; parallel district case stayed 2026-01-21 pending IPRs). This patent has not been neutralized.

Non-signal observed (context, not an NPE indicator): Inari sought a preliminary injunction against Imperative Care; the motion was denied on 2025-09-29 (Dkt. #136), and the district court action was stayed pending the IPRs. Aggressive assertion + an adverse IPR institution are normal operating-company patent-enforcement friction, not troll-pattern evidence.


Verdict

Operating-company assertion.

The entire recorded chain is a single link — the three named inventors (Merritt, Thress, Lubock) assigning to Inari Medical, Inc., recorded 2023-08-10, with no subsequent conveyance to any LLC, licensing vehicle, or assertion entity anywhere in the record. Inari was a NASDAQ-listed manufacturer of the FlowTriever and ClotTriever thrombectomy systems whose products embody the claimed garrote hemostasis valve, and it asserted this patent in its own name against a direct competitor, Imperative Care, Inc./Truvic Medical, Inc., in N.D. Cal. (3:24-cv-03117, filed May 2024). The chain now sits inside Stryker Corporation as of the 2025-02-19 merger, with Inari surviving as a wholly-owned subsidiary — a strategic $4.94B cash acquisition, not a fire-sale, and not a defensive-aggregator terminal. All eight NPE signals are absent or unverifiable, and Unified Patents' portal independently labels the patent owner "Operating Company."

Verify the assignment record here: https://assignmentcenter.uspto.gov/ — search patent number 11865291 (confirm the reel/frame and correspondent of the single 2023-08-10 Inari recordation, and confirm whether any merger/change-of-name record naming Stryker exists; I could not retrieve either).

Generated 9/27/2026, 9:14:37 PM

Prior art

Earlier patents, publications, and products that may anticipate or render the claims unpatentable.

✓ Generated

I'll search for the specific patent and its cited prior art references.

Let me dig into the specific citations and the IPR proceedings referencing this patent.

Let me get the full citation list from the patent page and the specific IPR grounds/references.

Prior-Art Analysis — US 11,865,291 B2

1. Scope, method, and limitations

  • Tooling note: My available tools are web-search based; they surfaced USPTO sources (PTAB/PTACTS petition papers at ptacts.uspto.gov, the PTAB docket, and the Unified Patents PTAB portal) and Google Patents family pages. I could not directly query the USPTO Patent Center / Patent Public Search API to pull the literal front-page "References Cited" list off the printed patent. Where I rely on the printed patent's citation list, I say so and flag anything I could not confirm verbatim. I have not altered any patent/application numbers — they are reproduced exactly as found.

2. Patent identification (literal)

Field Value
Patent US 11,865,291 B2 ("the '291 patent")
Title Hemostasis valves and methods of use
Inventors Benjamin E. Merritt; John C. Thress; Paul Lubock
Assignee Inari Medical, Inc.
Application No. 18/142,518
Filing date 2023-05-02
Grant/publication date 2024-01-09
Pre-grant pub. US 2023/0270991 A1
Priority date 2017-09-06 (provisional 62/554,931)
Continuity Divisional of 17/705,189 (2022-03-25) → continuation of 17/226,318 (2021-04-09) → continuation of 16/117,519 (2018-08-30, now US 11,000,682) → provisional 62/554,931 (2017-09-06)
Post-grant challenge IPR2025-00989 (Imperative Care, Inc. v. Inari Medical, Inc.) — instituted, pending
Litigation N.D. Cal. 3:24-cv-03117 / 5:24-cv-03117

Because the patent claims priority to 2017-09-06, it is governed by the AIA versions of §§102/103.

3. Two different sets of "citations"

It is important to separate:

  1. References cited on/against the face of the patent (examiner/IDS citations, and the PCT/EP search-report citations on the family pages).
  2. Prior art asserted against the patent by a third party in the AIA post-grant challenge. This is where the substantive §102 analysis actually lives, and it is the set the record most clearly documents.

I analyze both below, but I give the second set the detailed claim mapping you asked for, because that is where the record shows the specific §102 theory.

4. Prior art asserted against the '291 patent (IPR2025-00989)

The petition (filed 2025-05-09) and its exhibit list identify the following references (per the PTAB petition exhibits and the Unified Patents portal):

Ex. Full citation (literal) Type in grounds
1005 U.S. Patent Publication US 2003/0225379 A1 to Schaffer et al. ("Schaffer") Primary reference, Grounds 1–4
1006 U.S. Patent Publication US 2003/0116731 A1 to Hartley ("Hartley") Secondary, Grounds 3, 6/7
1007 U.S. Patent No. 9,980,813 B1 to Eller ("Eller") Secondary, Grounds 4, 6/7
1008 Certified file history of U.S. Pat. App. 10/371,190 ("Schaffer File History") Evidentiary
1009 U.S. Patent No. 5,429,616 to Schaffer ("Schaffer '616") Evidentiary/secondary
(Grounds 5–7) U.S. Patent Application Publication No. 2015/0173782 to Garrison ("Garrison") Primary for Grounds 5–7

Sources: PTAB IPR2025-00989 petition/exhibit list — https://ptacts.uspto.gov/ptacts/public-informations/petitions/1557876/...; Unified Patents portal — https://portal.unifiedpatents.com/ptab/case/IPR2025-00989. The petition text recites: "§ 103 as obvious over Schaffer in combination with U.S. Patent Application Publication No. 2003/0116731 to Hartley ('Hartley'); … § 103 as obvious over Schaffer in combination with U.S. Patent No. 9,980,813 to Eller ('Eller'); Ground 5: the Claims (18-19) of the '291 Patent are unpatentable under … § 103 as obvious over … 2015/0173782 to Garrison ('Garrison') in combination with Schaffer; … § 103 as obvious over Garrison in combination with Schaffer and Hartley."

4.1 Schaffer — U.S. Pub. 2003/0225379 A1

  • Full citation: U.S. Patent Application Publication US 2003/0225379 A1 (Schaffer et al.), "Stasis valve" (a/k/a hemostasis/stasis valve); application 10/371,190. Publication date inferred from the document number as 2003-12-04; application filing inferred as 2003-02-20. (I have not independently verified these two dates against the printed document; treat as inferred.)
  • Brief description (as characterized in the record): A stasis/hemostasis valve with a housing, a "seal module 100" comprising a "flexible, elongate tubular structure 101," and two circular actuators 50 on opposite sides carrying U-shaped actuating members 55 that are biased by springs 210 to circumferentially depress/collapse a central seal member and seal the lumen "completely and immediately with or without an instrument" present (Schaffer at [0008], [0077], Figs. 31–34). The valve is unsealed by depressing the buttons.
  • Claims potentially anticipated under §102: Petitioner asserts Schaffer alone anticipates claim 1 (independent claim directed to a hemostasis valve with a support, an actuator, a tubular sidewall, and a filament formed in a loop around the tubular sidewall with a first end portion extending to the first member, a spring biasing the actuator, and the lumen diameter decreasing in response to reducing the loop diameter), and asserts Schaffer anticipates or renders obvious the dependent claims 2–9 (e.g., claim 6: "first member and the second member are biased … to place the first end portion and the second end portion under sufficient tension to close the lumen" — Schaffer [0008]/Fig. 32; claims 7–8: biasing direction away from / orthogonal to the longitudinal axis). Claims 18–19 (aspiration catheter system) are also targeted.

4.2 Hartley — U.S. Pub. 2003/0116731 A1

  • Full citation: U.S. Patent Application Publication US 2003/0116731 A1 (Hartley). Publication date inferred from the document number as 2003-06-26 (inferred; not independently verified).
  • Brief description (per record): A hemostasis valve in which a continuous string (filament 14) is looped around a resilient cylindrical diaphragm 8; rotating an actuator pulls both ends of the string to constrict the diaphragm (Figs. 3–4), and the diaphragm reopens when tension is released ("formed from a resilient material so that after constriction and release of the flexible member the valve reopens," Hartley [0008], [0031], [0037]). Hartley also teaches knotting the string ends to attach them to an actuator.
  • Claim(s) potentially anticipated under §102: Hartley is not asserted as a standalone anticipatory reference in the '291 petition. It is asserted only in §103 combinations with Schaffer (Ground 3) and with Garrison + Schaffer, supplying the teaching of a flexible string/loop filament and its attachment — i.e., the "filament formed in a loop" and "first/second end portion" limitations of claims 1–4, and the loop-tensioning features of the dependents. So under the asserted theory Hartley is §103 art, not a §102 anticipation reference.

4.3 Eller — U.S. Patent No. 9,980,813 B1

  • Full citation: U.S. Patent No. 9,980,813 B1 (Eller). Issue date inferred as 2018-05-29 (inferred; not independently verified).
  • Brief description (per record): Discloses a hemostasis valve using one or more wire members (or a wire loop) pulled in opposite directions by a rotatable actuator to constrict/collapse the valve lumen — described in the record as a "third option" alongside Hartley's string and Schaffer's U-shaped members (Eller at 15:21–40, 17:47–18:x per the declarations).
  • Claim(s) potentially anticipated under §102:
    • No standalone §102 anticipation is asserted against the '291 patent. Eller appears only in §103 combinations (Ground 4: Schaffer + Eller; and Garrison + Schaffer + Eller).
    • Timing caveat: If Eller's issue date is indeed May 2018, it post-dates the '291 patent's 2017-09-06 priority date and therefore cannot be §102(a)(1) art on its face; Petitioner would need it to qualify under §102(a)(2) (effectively filed before the '291 effective filing date) or otherwise. I could not verify Eller's filing/priority date from the sources retrieved, so this qualification is unconfirmed and should be checked against the printed document.

4.4 Garrison — U.S. Pub. 2015/0173782 A1

  • Full citation: U.S. Patent Application Publication No. 2015/0173782 A1 (Garrison). Publication date inferred as 2015-06-25 (inferred; not independently verified).
  • Brief description: Not fully described in the retrieved excerpts; it is used in the petition as the primary reference for Grounds 5–7, combined with Schaffer (and Hartley or Eller), aimed at claims 18–19 (the aspiration-catheter-system claims) and others.
  • Claim(s) potentially anticipated under §102: The retrieved record shows Garrison used in §103 combinations, not as a standalone §102 reference. I could not confirm any pure anticipation mapping for Garrison from the sources available.

4.5 Schaffer '616 — U.S. Patent No. 5,429,616

  • Full citation: U.S. Patent No. 5,429,616 (Schaffer). Issue date inferred as 1995-07-04 (inferred; not independently verified).
  • Listed as an exhibit primarily for evidentiary/background support of the Schaffer "stasis valve" family; no independent §102 anticipation mapping to the '291 claims appears in the retrieved excerpts.

Ground-by-ground summary (as pleaded)

Ground Reference(s) Statutory basis Claims targeted
1 Schaffer §102 anticipation (and/or §103) Claim 1 (and dependents)
2 Schaffer §103 Claims 1–9
3 Schaffer + Hartley §103 Claims 1–9
4 Schaffer + Eller §103 Claims 1–9
5 Garrison + Schaffer §103 Claims 18–19
6 Garrison + Schaffer + Hartley §103 Claims 18–19 (and others)
7 Garrison + Schaffer + Eller §103 Claims 18–19 (and others)

Procedural status: Patent Owner filed a Preliminary Response (2025-09-15); Petitioner filed a Reply to POPR (2025-10-03); the Board granted institution (Paper 10, 2025-10-23). No final written decision is reflected in the sources retrieved. Patent Owner's declarant (Zalesky) and Petitioner's declarant (Thornton) dispute whether Schaffer alone discloses a flexible "filament formed in a loop" (Schaffer is argued to use rigid U-shaped members) and whether the Schaffer+Hartley/Eller substitutions preserve Schaffer's principle of operation.

5. References appearing on the face of the patent / family (prosecution & search-report citations)

I could not enumerate the printed patent's "References Cited" list verbatim from the sources retrieved, so I flag these as incomplete. From the Google Patents family pages (AU2018328011B2 "Patent Citations (9)"; JP2020533057A/CN111295221B "Patent Citations (6)") and cross-linked citing tables, confirmed family citations include:

  • US 2005/0283165 A1 (Gadberry, pub. 2005-12-22) — "Hemostasis valve and method for assembling same."
  • US 2012/0310166 A1 (Cook Medical Technologies LLC, pub. 2012-12-06) — "Hemostatic valve with multi-layer valve structure."
  • US 5,782,817 (Franzel et al.) — "Catheter introducer having toroidal valve" — appears in the citing-table cross-links for US 11,865,291.

These are cited for background/general hemostasis-valve context; the sources retrieved do not show any of them being used to reject a specific '291 claim under §102.

6. Bottom line

  • The only prior art tied to specific §102 claim rejections of US 11,865,291 in the available record is Schaffer (US 2003/0225379 A1), asserted to anticipate claim 1 (and to anticipate or render obvious dependent claims 2–9). Schaffer is also the primary §103 reference for Grounds 2–4.
  • Hartley (US 2003/0116731 A1), Eller (US 9,980,813 B1) and Garrison (US 2015/0173782 A1) are pleaded only in §103 combinations, so on the record available they are not standalone §102 anticipatory references for the '291 patent.
  • Schaffer '616 (US 5,429,616) functions as evidentiary/background support.
  • Caveat: exact publication/issue dates for several references were inferred from the document numbers and not verified against the printed documents, and I could not fully enumerate the patent's own front-page "References Cited" list. Those items should be confirmed directly against the printed patent and its file history before being relied upon.

Generated 9/27/2026, 9:14:54 PM

Obviousness

Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.

✓ Generated

I'll ground this analysis in the actual prior-art record for US 11,865,291. Let me search for the citation record and the pending PTAB proceeding.

Let me retrieve the actual claim language of the '291 patent and the specific grounds as pleaded.

Let me confirm the Board's institution outcome and the exact grounds it adopted.

Obviousness Analysis — U.S. Patent No. 11,865,291 ("Hemostasis Valves and Methods of Use")

Analyst note on sourcing: Everything below is drawn from the patent text you supplied plus the live prior-art/litigation record I just retrieved. Where I am inferring rather than reporting, I say so. This is an analyst assessment, not a PTAB holding — the Board's Final Written Decision in IPR2025‑00989 was still pending as of April 2026.


I. The reference point: claim scope and effective filing date

Item Value (as literally stated on the record)
Patent US 11,865,291 B2 ("the '291 patent")
Application 18/142,518, filed 2023‑05‑02 (divisional of 17/705,189)
Priority 62/554,931, filed 2017‑09‑06
Assignee Inari Medical, Inc.
Inventors Merritt, Thress, Lubock
Anticipated expiration 2038‑08‑30 (per Google Patents)
Litigation Inari Med., Inc. v. Imperative Care, Inc., N.D. Cal. No. 3:24‑cv‑03117 / 5:24‑cv‑03117
PTAB IPR2025‑00989 (Imperative Care v. Inari), petition filed 2025‑05‑09; instituted 2025‑10‑23

The §103 analysis runs against the 2017‑09‑06 effective filing date.

Independent claim 1 (verbatim, per the petition record)

"1. A hemostasis valve, comprising: a support; an actuator having at least a first member movably coupled to the support; a collapsible tubular sidewall defining a lumen carried by the support; a filament formed in a loop around the tubular sidewall, the filament having at least a first end portion extending away from the loop to the first member; and a spring configured to move the first member in a direction that pulls the first end portion away from the tubular sidewall, reducing a diameter of the lumen in response to reducing a diameter of the loop."

Claim 18 is the other independent claim: "An aspiration catheter system, comprising: an aspiration catheter defining a lumen and having a proximal end portion; and" the claim‑1 hemostasis valve, "wherein the lumen of the tubular sidewall is selectively fluidly couplable to the lumen of the aspiration catheter."

Challenged set: claims 1–8 and 12–19. Claim 2 adds a second member; claim 3 adds a second filament end portion to the second member; claim 4 requires the filament be "one continuous filament" — i.e., the claims cover a single looped filament, broader than the Fig. 6 continuous-filament embodiment.

The four limitations that carry the whole analysis:

  1. support + actuator [member] movably coupled to the support
  2. collapsible tubular sidewall defining a lumen carried by the support
  3. filament formed in a loop around the tubular sidewall with an end portion running to the actuator member
  4. spring that moves the member to pull the filament end → loop diameter ↓ → lumen diameter ↓

Note what claim 1 does not require: no reinforcement structure, no braided mesh, no two‑piece caps, no side port. Those appear only in the specification and (variously) in dependent claims. So the obviousness fight is about element (3) — the looped flexible filament — and element (4) — the spring‑biased pull direction. Everything else is old and largely admitted.


II. The prior art actually relied on

A. The principal references

Ref Identity Date Cited by Cited against
Schaffer US 2003/0225379 A1 (Schaffer et al.) pub. 2003‑12‑04 Petitioner Ex. 1005 Primary for Grounds 1–7, claims 1–8, 12–19
Hartley US 2003/0116731 A1 (Hartley) pub. 2003‑06‑26 Petitioner Ex. 1006 Secondary for Ground 3
Eller US 9,980,813 B1 (Eller) 2015 Petitioner Ex. 1007 Secondary for Ground 4
Garrison US 2015/0173782 A1 (Garrison et al.) 2015 Petitioner Ex. 1011 Preamble/catheter only, Grounds 5–7 (claim 18)
Schaffer '616 US 5,429,616 (Schaffer) 1995 Ex. 1009 Context
Trerotola US 6,776,770 B2 2004 Ex. 1020 Context
Brady WO 2018/019829 A1 2018‑02‑01 Ex. 1018 Context (§102(a)(2) candidate)

Source: Unified Patents IPR2025‑00989 docket/exhibit list.

B. What each reference discloses (per the petition and POPR record)

  • Schaffer — a "fluid stasis valve" for catheters with opposing actuator buttons biased by springs, and U‑shaped actuating members that compress a seal module (a compressible tube) inside a housing. Schaffer states the valve "blocks the flow of gas or fluid completely and immediately with or without an instrument in place within the gas/fluid path," and that the seal module is compliant enough (variously described as "gelatinous," "sticky," "self‑closing") to conform around instrument profiles of different sizes and even irregular shapes. (Petition as filed)
  • Hartley — a hemostasis valve with a filament (string) looped around an elongate member and tensioned by a rotary actuator; rotation one way constricts the lumen, the other way opens it. This is a true garrote/loop mechanism. (Petition as filed)
  • Eller — a rotatable hemostasis valve of the same species; a wire/filament loops around a collapsible sleeve to constrict the sleeve lumen (Eller, 5:1‑12, Fig. 1).
  • Garrison — an aspiration catheter system for clot removal, using an adjustable‑opening hemostasis valve, with an aspiration catheter 2030 having a lumen and a proximal end portion.

C. The prosecution history is itself an obviousness signal

Per the petition, the Examiner during prosecution of the '291 family found that Hartley disclosed every limitation of the independent claims except the spring "configured to move the first member in a direction that pulls..." — i.e., the Office already mapped the looped‑filament constriction valve onto Hartley and viewed the spring as the only gap. Schaffer was not before the Examiner. (Petition, quoting Ex. 1002 at 393)


III. The combination grounds and why a POSITA would combine

The Board instituted on 2025‑10‑23 (Institution Decision, Paper 10), and the same Schaffer+Hartley and Schaffer+Eller combinations had already been instituted in the sibling IPRs on US 11,697,011 and US 11,697,012.

Ground 1 — Anticipation by Schaffer (§102)

Petitioner's theory: Schaffer's Fig. 32 valve has "the same components, in the same arrangement" — opposing buttons, springs, and actuating members (read as the "filament") encircling a compressible seal module (read as the "collapsible tubular sidewall"). This is the weakest ground and will likely fail absent a claim construction that treats Schaffer's rigid U‑shaped members as a "filament," because Schaffer's members are not "formed in a loop."

Ground 2 — Obvious over Schaffer alone (§103)

Fails for the same reason as Ground 1 unless "filament" is broad enough to cover a U‑shaped member. Patent Owner's construction — that a "filament" must be flexible because it must be "formed in a loop" and reduce lumen diameter "in response to reducing a diameter of the loop" — is the single most outcome‑determinative issue in the case. (Decision, claim construction section)

Ground 3 — Schaffer + Hartley (§103) ← the strongest ground

What the combination supplies:

  • Schaffer supplies: support, actuator buttons movably coupled to the support, collapsible tubular sidewall (seal module) carried by the support, and the springs that move the buttons to close the lumen.
  • Hartley supplies: the filament formed in a loop around the tubular sidewall, with an end portion running away from the loop to the actuator — i.e., the exact "reducing a diameter of the lumen in response to reducing a diameter of the loop" mechanism that Schaffer lacks.

Motivations a POSITA would have had (Petitioner's case, Ex. 1003 ¶¶103–131):

  1. Same field, same problem, same function. Both are catheter hemostasis valves; both aim to seal with and without an instrument in the lumen. KSR — combination of elements known in the prior art, each performing the function it was known to perform.
  2. Known design substitution. Replacing a compression/actuation element with a tensioned filament loop is a substitution of one known sealing element for another, in a valve architecture otherwise unchanged.
  3. A recognized performance deficiency (Petitioner's framing). Petitioner's expert testified that Schaffer "would not work perfectly for all the range of tools," motivating a filament that conforms/constricts more universally (Ex. 1003 ¶¶107, 124).
  4. Reasonable expectation of success. Components are predictable and tunable: a POSITA "could determine the appropriate level of flexibility for the filaments given other parameters like spring tension, the tubular member, size and stiffness" (Thornton dep. 44:4‑20, quoted in the Petitioner's Reply).
  5. Sibling‑proceeding consistency. The Board previously found the Schaffer+Hartley rationale advanced with reasonable expectation of success (Ex. 1017, 35–41; Ex. 1023, 48).

Ground 4 — Schaffer + Eller (§103)

Same structure of argument, but Eller is the closer analogue: a wire member looping around a collapsible sleeve and an actuator to tension it. Analytically identical motivation; Eller's 2015 date makes it chronologically closer to the 2017 priority date and less vulnerable to a "long‑abandoned art" narrative.

Grounds 5–7 — Garrison + Schaffer (+ Hartley or Eller) for claim 18

Claim 18 needs only two additional concepts: an "aspiration catheter system" and "selectively fluidly couplable" lumens.

  • Garrison supplies the aspiration catheter defining a lumen with a proximal end portion, and expressly contemplates an "adjustable‑opening valve."
  • Schaffer supplies the valve, and specifically teaches that pressing the actuator opens the seal module lumen to couple it to an attached catheter's lumen — which is the "selectively fluidly couplable" limitation.
  • Motivation: Garrison itself tells the skilled person which valve class to use ("adjustable‑opening valve"); Schaffer is an adjustable‑opening valve expressly "for use with catheters" that blocks flow "completely and immediately with or without an instrument." Combining a known valve with a known aspiration catheter to gain the valve's known benefit is the paradigm KSR case. Notably, Patent Owner's POPR concedes Petitioner does not rely on Garrison for the valve structural limitations — so Grounds 5–7 rise or fall entirely with Grounds 3–4.

Other combinations worth flagging

  • Schaffer + Hartley + Eller — cumulative; Eller adds nothing beyond a second, independent teaching of the same looped‑wire constriction, which strengthens "the state of the art recognized this solution."
  • Schaffer + Schaffer '616 — same-inventor lineage of the valve concept; supports that loop/compression-based sealers were a recognized, iterative design family rather than a 2017 insight.
  • On the "flexible" question: Petitioner points to a later same‑family Inari patent (US 12,109,384 B2) whose claim 1 recites "a first filament extending in a first loop... wherein the first filament is flexible" — arguing that flexibility is not inherent to all filaments and that Inari itself drafted the express flexibility limitation elsewhere (Ex. 1016, claim 1).

IV. The counterarguments that could defeat obviousness

Patent Owner's POPR (2025‑09‑15) and its expert declaration (Zalesky, Ex. 2001) make a textbook teaching‑away / change‑of‑principle‑of‑operation case:

  1. No real problem to solve. Schaffer affirmatively discloses a complete seal — "blocks the flow of gas or fluid completely," with seal member 165 "so compliant that it forms a seal around [multiple] instruments... even if the instruments 260 are irregularly shaped" (Ex. 1005 ¶¶0059, 0068). If so, the petition's motivation (fix gaps) is a manufactured problem.
  2. Change of principle of operation. Schaffer's U‑shaped actuating members must forcibly disengage the sticky/self‑closing seal module to open the valve. A tensioned string or wire would not disengage it, so the modification would render Schaffer inoperable — a classic "change in the principle of operation" rebuttal. (POPR)
  3. Not a simple substitution — neither Schaffer, Hartley, nor Eller discloses a filament whose two ends attach to two different actuators. Hartley's string has both ends on one rotary actuator; Eller's wire has one end on the housing and one on an actuator. Building claim 1's two‑member version therefore requires uniting features no reference teaches in that arrangement.
  4. Non‑finite solution space. "I don't know how many options could be used to compress a tube" (Ex. 2007, 107:12‑13) — attacking any "obvious to try" theory under In re Kubin / KSR's "finite number of identified, predictable solutions."
  5. Other, better modifications available consistent with Schaffer (e.g., stiffer springs, different seal‑module durometer).

Petitioner's counters are also on the record and are legally sound: that a POSITA could be motivated to do more than one thing does not make any one route non‑obvious, and the combination need only be a suitable option, not the best one — Janssen v. Teva, 97 F.4th 915, 930 (Fed. Cir. 2024); Intel v. Qualcomm, 21 F.4th 784, 800 (Fed. Cir. 2021). Petitioner also flipped the expert testimony: Thornton stated "If [Schaffer] worked perfectly for all the range of tools, then there probably wouldn't be a need to make adjustments and move to a string‑type member."

My read: Grounds 3–4 are genuinely strong if the Board construes "filament" broadly (Petitioner's construction: "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes"). If the Board instead adopts Patent Owner's flexibility‑requiring construction — as it preliminarily did in the '012 IPR — Schaffer alone is out, and the case narrows to whether Schaffer+Hartley/Eller plus the two‑actuator arrangement is truly obvious or impermissible hindsight. That is the live question.


V. Objective indicia (Graham factor 4)

Inari's strongest non‑technical position is objective evidence, which is not a claim‑element argument:

  • Commercial implementation: Inari's own Symphony‑lineage handle valves and the accused Truvic Symphony system both embody looped‑filament, spring‑biased, single‑handed garrote valves — the infringement and invalidity narratives are mirror images of each other.
  • Industry uptake / physician need: the specification's own framing — "robust seal... when a vacuum is applied such as occurs during aspiration" — maps to a real clinical need in large‑bore aspiration thrombectomy (DVT/PE), where loss of hemostasis during vacuum is dangerous.
  • Possible copying/praise by the accused infringer, to be developed in the N.D. Cal. case.

Caveat: I have not seen a nexus showing (i.e., that Inari's commercial success is attributable to the claimed combination rather than to the broader aspiration‑thrombectomy platform, which is a much larger Inari family with independent utility). Absent nexus, this evidence carries limited weight.


VI. Bottom line

Ground Theory Independent claims Confidence
1 Schaffer anticipates 1–3, 5–8, 12–17, 19 Low — depends on reading rigid U‑members as a "filament"
2 Obvious over Schaffer alone same Low–Moderate
3 Schaffer + Hartley 1–8, 12–17, 19 Moderate–High, subject to the "filament" construction
4 Schaffer + Eller 1–8, 12–17, 19 Moderate–High, subject to the same construction
5–7 Garrison + Schaffer (+ Hartley/Eller) 18–19 Moderate — parasitic on Grounds 3–4

The claim‑dispositive vulnerability of the '291 patent is element (3): the "filament formed in a loop around the tubular sidewall... reducing a diameter of the lumen in response to reducing a diameter of the loop." Hartley (2003) and Eller (2015) both teach precisely that garrote mechanism in a hemostasis valve, and Schaffer (2003) teaches the two‑button, spring‑biased, compressible‑tube housing of claim 1. A POSITA in 2017 confronting Schaffer's sealing range across tool sizes had a strong motivation to adopt the looped‑filament constriction already known in the hemostasis‑valve art, with a reasonable expectation of success because the interacting parameters (spring force, filament flexibility, tube wall stiffness) are tunable by routine engineering — and the Examiner had already mapped every limitation but the spring to Hartley.

Conversely, the '291 claims are not nakedly obvious. Patent Owner has a credible teaching‑away / change‑of‑principle‑of‑operation defense specific to Schaffer (the sticky self‑closing seal member that must be forcibly disengaged), and a credible argument that no reference teaches a single filament whose two ends are tethered to two separately movable actuators. If the Board adopts the flexibility‑requiring "filament" construction it applied in IPR2025‑00156 on the '012 patent, Grounds 1–2 collapse and Grounds 3–7 turn on the substitution rationale alone.


Caveats and limits of this analysis

  • The Board instituted review on 2025‑10‑23, but I found no Final Written Decision — the merits remain undecided. Institution means "reasonable likelihood," not invalidity.
  • I could not retrieve the complete face‑of‑patent "(56) References Cited" list of the '291 patent in legible form; the record contains a long OCR'd list of US patents (5,329,923; 5,360,417; 5,364,345; …) but I cannot verify individual entries or how they map to claims. Treat the reference table in §II.A as the operative, litigation‑verified set.
  • I have not verified the actual text of Hartley (US 2003/0116731), Eller (US 9,980,813), or Garrison (US 2015/0173782) against primary sources; their disclosures are reported from the petition, the patent owner's response, and expert declarations. Independently confirm paragraph cites before relying on them in a filing.
  • Exhibit 1018 (Brady, WO 2018/019829 A1) published after the 2017‑09‑06 priority date; it can only be prior art on a §102(a)(2) theory (PCT/US filing effectively before that date). I did not confirm its international filing date.

Generated 9/27/2026, 9:15:01 PM

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