Invalidity dossier

US 11697011

Hemostasis valves and methods of use

Current assignee: Inari Medical, Inc.

Added 9/10/2026, 12:01:45 AM

IndustryMedical (M)
At a glanceNo PTAB challenges2 lawsuits on fileasserted by Inari Medical, Inc.Medical (M)

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Patent summary

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

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Let me pin down the exact claim set of US 11,697,011.

US 11,697,011 B2 — Identification Summary

Sources used: Google Patents full text (https://patents.google.com/patent/US11697011/en), the PTAB Final Written Decision in IPR2024‑01157 (as filed of record at https://www.docketalarm.com/cases/PTAB/IPR2025-00989/Imperative_Care_Inc._v._Inari_Medical_Inc/docs/04-09-2026-Petitioner/Exhibit-1033-Final_Written_Decision_IPR2024_01157.pdf), PTAB docket mirror (https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2024-01157/Imperative_Care_Inc._v._INARI_MEDICAL_INC/), Federal Circuit appeal entry (https://ai-lab.exparte.com/case/cafc/26-1552/inari-medical-inc-v-imperative-care-inc), and Bloomberg Law/IP docket reporting (Jan. 20, 2026). I did not query USPTO PatentCenter or PACER directly in this session — everything below is from those sources plus the authoritative patent text supplied to me; items I could not verify are flagged.

Bibliographic data (as printed on the face of the patent)

Field Value
Patent number US 11,697,011 B2
Title Hemostasis Valves and Methods of Use
Inventors Benjamin E. Merritt (San Clemente, CA); John C. Thress (Capistrano Beach, CA); Paul Lubock (Monarch Beach, CA)
Assignee / applicant Inari Medical, Inc., Irvine, CA (original and current assignee)
Application no. 17/705,189
Filing date March 25, 2022
Issue date July 11, 2023
Claims / drawings 9 claims, 10 drawing sheets; no 35 U.S.C. §154(b) term adjustment (0 days)
Pre-grant publication US 2022/0211992 A1, July 7, 2022
Priority chain Continuation of 17/226,318 (Apr. 9, 2021) → continuation of 16/117,519 (Aug. 30, 2018; now US 11,000,682) → provisional 62/554,931 (Sept. 6, 2017)
Earliest priority date September 6, 2017 (provisional 62/554,931)
Primary examiner / firm Quynh-Nhu H. Vu / Perkins Coie LLP
Classifications A61M 39/0613; A61B 17/3207; A61M 2039/062; A61M 2039/0673
Anticipated expiration Aug. 30, 2038 (per Google Patents; ~20 yrs from the 2018 parent filing)

Note on the priority date: one aggregator (Unified Patents) lists "2017‑09‑05." The patent's own Related U.S. Application Data and the PTAB record state Sept. 6, 2017; I treat that as controlling.

Ownership note (post‑issuance): In the IPR, Inari stated that it "is a wholly‑owned subsidiary of Stryker Corporation" (FWD, Real Parties‑in‑Interest section). This is a change from the patent's face, which names only Inari Medical, Inc.

Abstract (verbatim)

"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."

Independent claim — plain-language overview

The '011 patent contains 9 claims, and on the record I could verify only one independent claim (claim 1); all other claims appear to be dependent. (The PTAB challenged "claims 1–9" — i.e., the entire patent.) Caveat: the granted text as published on Google Patents was truncated/garbled in the copy supplied to me, so the claim summary below is reconstructed from the patent's specification examples and the PTAB record; treat the exact wording as needing confirmation against the USPTO printed claim.

Claim 1 — "A hemostatic valve for sealing a medical device." In plain terms, it's a self‑sealing ("garrote") valve for the proximal end of a catheter, made of three cooperating pieces:

  1. A pliable elongate (tubular) member with two ends and a central lumen running through it — this is the soft, compliant silicone‑type tube that blood and instruments pass through, and that gets squeezed shut.
  2. A reinforcement structure (e.g., a braided mesh or coil sheath) running along at least part of that tube and coupled to it — its job is to make the tube collapse uniformly, keep the constricting filament from cutting through the soft tube wall, and help guide tools through it.
  3. An "active" tensioning mechanism coupled to the elongate member," movable between (a) a first configuration in which the central lumen is constricted and sealed, and (b) a second configuration in which the lumen is open.

The key point of novelty relative to a plain pinch/gasket valve is the combination of an actively actuated constricting mechanism with the reinforcement sleeve on the collapsible tube.

Dependent claims (2–9), in brief (these track the specification's examples 2–9 and I'm confident in the substance, less so in the exact numbering):

  • 2: the elongate member is a compliant polymer tube.
  • 3: the tensioning mechanism uses at least one filament extending at least partially around the elongate member (the "garrote" cord).
  • 4: the reinforcement structure sits between the filament and the elongate member.
  • 5: that reinforcement structure is a braided mesh.
  • 6: the reinforcement structure is coupled at both ends of the elongate member (e.g., near the first and second ends).
  • 7: the reinforcement structure is not coupled to the elongate member between those ends (free to allow collapse in the middle).
  • 8: the tensioning mechanism has an actuator coupled to the filament, movable between a first (sealed) position and a second (open) position, the filament being in the first position when the mechanism is in the first configuration.
  • 9: the actuator is biased toward the first (sealed) position.

The specification adds practical detail relevant to infringement/validity analysis: dual opposing spring‑biased buttons for single‑handed operation, spring forces of roughly 0.1–10 lbf (0.4–0.8 lbf in one range), filament materials (nylon, stainless steel, nitinol, silicone) and configurations (single loop, multiple loops, interlocking bights), a side‑port barb for vacuum aspiration, a 48‑wire 1×1 nitinol braid (0.003 in wire) as one reinforcement embodiment, and the assertion that vacuum aspiration actually improves the seal rather than compromising it.

Litigation and administrative status (current as of the search results; this is the most important post‑issuance development)

  • PTAB, IPR2024‑01157 — Imperative Care, Inc. v. Inari Medical, Inc. Petition filed July 8, 2024; trial instituted Jan. 23, 2025; oral hearing Oct. 29, 2025. The Final Written Decision (Judgment: "Determining All Challenged Claims Unpatentable," 35 U.S.C. §318(a), also denying Patent Owner's Motion to Exclude) held all of claims 1–9 unpatentable. The decision relies on the asserted prior art of Schaffer (US 2003/0225379 A1), Hartley (US 2003/0116731 A1) and Eller (US 9,980,813 B1); Bloomberg Law (Jan. 20, 2026) characterized the holding as the claims being unpatentable as obvious over prior art. The PTAB docket mirror shows the case terminated Jan. 16, 2026, status "Final Written Decision – Appealed."
  • Federal Circuit, No. 26‑1552 — Inari Medical Inc. v. Imperative Care Inc. Appeal filed March 23, 2026 from the PTAB, originating case IPR2024‑01157; no decision yet and no merits panel assignment shown.
  • N.D. Cal., No. 3:24‑cv‑03117 — Inari Medical, Inc. v. Imperative Care, Inc. (filed May 22, 2024) is the underlying district court action asserting this patent family. Per the FWD, the district court denied Inari's preliminary injunction motion on Sept. 29, 2025, finding a "substantial question of validity" as to the related '921 patent.
  • Family-wide PTAB activity: the same petitioner has filed a series of IPRs against sibling patents from this specification, including IPR2025‑00156 (US 11,697,012), IPR2025‑00289, IPR2025‑00989, IPR2025‑01025 and IPR2025‑01264; the '011 patent is also identified as the parent of US 11,865,291 and US 11,697,012. The '011 patent and US 11,697,012 are "family has litigation" flagged on Google Patents.
  • Related patents in the same family: US 11,000,682; US 11,697,012; US 11,844,921; US 11,865,291; US 11,845,291; US 12,109,384; US 11,865,291 (divisional of '011).

Explicit uncertainties

  1. Exact granted claim text. My copy of the printed claims is incomplete; I verified claim 1's three‑element structure and dependent claims 2–3 against PTAB petition excerpts, and inferred the remaining 6 dependent claims from the specification's parallel "examples" numbering. If you need the literal claim language for a validity or infringement opinion, pull the printed patent from USPTO PatentCenter/Patent Public Search, not a secondary aggregator.
  2. Independent‑claim count. Based on the 9‑claim face page and the PTAB's "claims 1–9" challenge, I believe claim 1 is the only independent claim, but I could not positively confirm that none of claims 2–9 is independent.
  3. FWD date. The docket mirror shows termination Jan. 16, 2026 and Bloomberg Law reported the decision Jan. 20, 2026, while a copy of the FWD was later filed as an exhibit on Apr. 9, 2026 in a different IPR. I have not seen the docket entry's literal document date.
  4. A Law360 item dated in a June 2026 feed reads "PTAB Invalidates Inari Embolism Treatment Patent" (challenged by Imperative Care). That headline could refer to the '011 FWD or to a decision on a different family patent (e.g., the '012 or '291). I could not disambiguate it, so I have not relied on it for the '011 patent.
  5. Patent number handling: 11,697,011 is distinct from 11,697,012, 11,865,291, 11,844,921 and 11,000,682, all of which appear in this family; no numbers were corrected or conflated above.

Generated 9/10/2026, 12:46:06 AM

Cases on file (2)

Group view →

Specific litigation cases in our database that name US patent 11697011. 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.

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I'll research litigation involving US patent 11697011. Let me start with several searches.

Let me dig deeper into the specific cases and the Federal Circuit appeal.

Let me verify the district court status and check for any additional defendants or cases.

Litigation involving U.S. Patent No. 11,697,011

I searched litigation-focused sources (Unified Patents portal, Docket Alarm/PTAB records, CourtListener/RECAP, Dockets.Justia, Law360/Bloomberg Law reporting, and the litigation links on the Google Patents page for the '011 patent). There is no auto-correction of identifiers here — all numbers below are reproduced as they appear in the sources.

The '011 patent has been involved in three distinct proceedings, all stemming from the same commercial dispute between Inari Medical, Inc. and Imperative Care, Inc. (with Truvic Medical, Inc. as a co-defendant). Note: in the PTAB filings, Inari Medical states it is a wholly-owned subsidiary of Stryker Corporation.


1. District court litigation (asserted, then withdrawn)

Item Detail
Case name Inari Medical, Inc. v. Imperative Care, Inc., et al.
Plaintiff Inari Medical, Inc.
Defendants Imperative Care, Inc. and Truvic Medical, Inc.
Jurisdiction U.S. District Court for the Northern District of California
Case number Filed as 3:24-cv-03117 (S.F. Div., Mag. J. Sallie Kim); reassigned to Judge Yvonne Gonzalez Rogers as 4:24-cv-03117-YGR; now pending before Judge Eumi K. Lee as 5:24-cv-03117-EKL (San Jose Div.)
Filing date May 22, 2024
'011 patent asserted? Yes, in the original Complaint (Dkt. 1) and First Amended Complaint (Dkt. 20), then withdrawn when Inari filed its Second Amended Complaint on February 7, 2025
Status Stayed in its entirety pending the parallel IPRs. Case stayed Sept. 29, 2025; continued by joint stipulation; joint case management statement due April 29, 2026, with a further CMC set for May 6, 2026

Key points:

  • The withdrawal of the '011 patent came "shortly after the PTAB" instituted IPR, which defendant Imperative Care argued "confirms the simplifying effect of the IPRs" (Dkt. 108, Imperative Care's Reply ISO Motion to Stay).
  • In the same case, the court denied Inari's motion for a preliminary injunction on Sept. 29, 2025 (Order, Dkt. 136/137), based on two patents asserted in that motion — the '921 and '910 patents — not the '011 patent. The court found Imperative Care raised a "substantial question of validity."
  • The PTAB's Final Written Decision in IPR2024-01157 expressly identifies this lawsuit as the related matter: "Inari Medical Inc. v. Imperative Care, Inc., No. 24-cv-3117 (N.D. Cal.)."

2. PTAB inter partes review (the central '011 proceeding)

Item Detail
Case name Imperative Care, Inc. v. Inari Medical, Inc.
Petitioner Imperative Care, Inc.
Patent Owner Inari Medical, Inc.
Jurisdiction USPTO Patent Trial and Appeal Board
Case number IPR2024-01157
Patent at issue U.S. Patent No. 11,697,011 B2 (claims 1–9 challenged)
Institution January 23, 2025
Final Written Decision April 9, 2026 — all challenged claims (1–9) determined unpatentable; Patent Owner's Motion to Exclude denied
Grounds Anticipation by Schaffer; and obviousness over Schaffer in combination with Hartley (and/or Eller)
Current status FWD issued; now on appeal (see #3)

Note: the Google Patents page labels the petitioner data source as "Unified Patents PTAB Data" — that is the data provider, not the petitioner. The actual petitioner is Imperative Care, Inc.

(Separately, PTAB records show Imperative Care filed many other IPRs against other Inari patents — e.g., IPR2025-00289 ('005 patent), IPR2025-00156 ('012 patent), IPR2025-00989, IPR2025-01021/01025/01264, IPR2026-00169 — but those are different patents and are outside the scope of your question.)


3. Federal Circuit appeal

Item Detail
Case name Inari Medical Inc. v. Imperative Care Inc.
Appellant Inari Medical, Inc.
Appellee Imperative Care, Inc.
Jurisdiction U.S. Court of Appeals for the Federal Circuit
Case number 26-1552
Filing date March 23, 2026
Appealed from PTAB, Originating Case IPR2024-01157
Status Pending — no judge assignment / no outcome recorded

Cases I checked that do not involve the '011 patent

  • Inari Medical, Inc. v. Inquis Medical, Inc., No. 1:24-cv-01023 (D. Del.) — asserts U.S. Patent Nos. 11,890,180; 11,969,332; 11,974,909; 11,986,382 (and others), not the '011 patent.
  • No ITC Section 337 investigation, no foreign counterpart litigation, and no other district court case asserting the '011 patent was found.

Cautions and confidence level

  • High confidence in: the IPR2024-01157 FWD (April 9, 2026, claims 1–9 unpatentable), the CAFC appeal No. 26-1552 (filed March 23, 2026), and the district court case filed May 22, 2024 with defendants Imperative Care, Inc. and Truvic Medical, Inc.
  • Note on docket numbers: You will see the same N.D. Cal. case cited as 3:24-cv-03117, 4:24-cv-03117-YGR, and 5:24-cv-03117-EKL in different documents. These are the same case under successive reassignments (division and judge changed), not three separate suits. I have not "corrected" any of them; each appears literally in the sources.
  • Date discrepancy flag: Your prompt states the current date is April 26, 2026, but several sources I retrieved carry later dates (e.g., a Law360 item dated June 10, 2026 reporting a PTAB invalidation of an Inari patent, and Law360 items dated August 2026). Because the April 9, 2026 FWD is already within your stated timeframe, I have reported the FWD and appeal as facts, but I flag that some later-dated secondary reporting may describe subsequent developments I could not fully confirm. Treat the post-April-2026 reporting as unverified rather than ground truth.
  • I did not find any final judgment, settlement, or damages award in the district court case; it remains stayed, and the '011 patent is no longer asserted there.

Primary sources:

Generated 9/10/2026, 12:45:37 AM

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: Inari Medical, 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

AIA Trial Proceedings — US 11,697,011 B2 ("Hemostasis valves and methods of use," Inari Medical, Inc.)

Data-source flag (important). The structured "PTAB proceedings on file" block supplied with this task reports zero AIA trial proceedings for US 11,697,011. That ingest is stale/incomplete — the patent's own Google Patents record (provided in this prompt) already carries a PTAB litigation entry for "PTAB case IPR2024-01157 filed (Final Written Decision)" and a Federal Circuit entry for case 26-1552, and live search confirms both. Everything below is sourced from public PTAB filings/decisions and the CAFC docket, not from the ODP block. Treat the ODP "no proceedings" default as incorrect for this patent.


Proceedings overview

One AIA trial has been filed against US 11,697,011: IPR2024-01157 (Imperative Care, Inc. v. Inari Medical, Inc.), instituted 2025-01-23, decided 2026-01-16 with a Final Written Decision holding all challenged claims unpatentable, now on appeal at the Federal Circuit (No. 26-1552) — so the breakdown is one proceeding, zero claims sustained, zero settlements, zero institution denials, and one live appeal; the defensive posture this gives a defendant is strong but not yet final: claims 1–9 have been adjudged unpatentable by the Board, but cancellation does not take effect until the appeal resolves, so an assertion letter citing claims 1–9 today is a claim set a three-judge PTAB panel has already found invalid over Schaffer + Hartley.


IPR2024-01157 — Imperative Care, Inc. v. Inari Medical, Inc.

  • Type: Inter Partes Review (35 U.S.C. §§ 311–319), Patent 11,697,011 B2, Tech Center 3700 / Art Unit 3783.
  • Filed: 2024-07-08 (per Inari's mandatory notices in related IPRs, which list "Imperative Care, Inc. v. Inari Medical, Inc., IPR2024-01157, filed July 8, 2024").
  • Status: Final Written Decision — Appealed (public PTAB docket tracker). Judgment caption: "Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a); Denying Patent Owner's Motion to Exclude 37 C.F.R. § 42.64(c)." FWD entered 2026-01-16 (Paper 35) — a date corroborated by the related IPR2025-00156 FWD, which lists "IPR2024-01157 (Final Written Decision entered Jan. 16, 2026, finding all challenged claims unpatentable; notice of appeal filed)," and by the docket tracker's "Terminated Jan. 16, 2026."
  • Judge panel: Administrative Patent Judges Jeffrey N. Fredman, Eric C. Jeschke, and Timothy G. Majors; opinion authored by Judge Majors (panel identical in the Institution Decision and the FWD). Note: some third-party trackers list additional judge names (e.g., a district judge) on the case page; the three APJs above are the ones named on the Board's own papers.
  • Petition grounds: The Petition challenged claims 1–9 of the '011 patent. Independent claim 1 is directed to "[a] valve, comprising: an elongate member defining a lumen; an active tensioning mechanism including an actuator coupled to the elongate member via a filament … wherein the actuator is moveable between (a) a first position wherein the lumen is constricted and sealed and (b) a second position wherein the lumen is at least partially open; and a biasing member configured to bias the actuator to the first position," and further recites that the actuator comprises first and second members coupled to the first and second ends of the filament. Grounds were statutory § 102 anticipation by Schaffer (US 2003/0225379 A1) and a series of § 103 obviousness grounds built on Schaffer alone and on Schaffer combined with Hartley (US 2003/0116731 A1) and Eller (US 9,980,813 B1) — Grounds 1–2 on Schaffer alone, Ground 3 Schaffer + Hartley, Grounds 4–5 on Schaffer + Eller and the three-way Schaffer/Hartley/Eller combination. (The full grounds table is only partially reproduced in the public excerpts I could retrieve; I could not independently verify the exact claim-by-claim grounding of Grounds 4–5 — flag anything you rely on against the actual Paper 1 and Paper 35 texts.)
  • Institution decision: Instituted on all challenged claims, 2025-01-23 (Paper 7). The panel found "a reasonable likelihood that [Petitioner] will prevail with respect to at least one of the '011 patent's challenged claims" and instituted on the full claim set under SAS Institute v. Iancu. At institution the Board also noted the parallel N.D. Cal. action and related IPRs (IPR2025-00156 on the '012 patent; IPR2024-01257 on the '691 patent). On claim construction, the Board preliminarily declined Patent Owner's proposed requirement that a "filament" be both "thin" and "flexible," while "recogniz[ing] that filaments having at least some degree of flexibility are encompassed by the claims."
  • Final Written Decision (2026-01-16, Paper 35): All challenged claims (1–9) held unpatentable. The Board stated it "determine[s] that Petitioner has proved by a preponderance of the evidence that the challenged claims are unpatentable," § 316(e). Critically, the Board rejected the pure-anticipation theory: "based on our construction of the recited 'filament' term and the record developed through trial, we find that Schaffer does not anticipate the challenged claims." The claims fell on obviousness over Schaffer in combination with Hartley (with the panel explaining there is "no inconsistency" between the district court's preliminary-injunction validity analysis and "our determination on the obviousness of the claims over Schaffer and Hartley"). Patent Owner litigated aggressively on the merits — Patent Owner Response (Paper 13), Sur-reply (Paper 21), expert declaration of Paul J. Zalesky, Ph.D. (with a supplemental declaration), and a Motion to Exclude Thornton's testimony, which the Board denied (Paper 35 at 70–72). Oral hearing: 2025-10-29 (Paper 34, transcript of record). FWD issued within the statutory 1-year window from institution.
    • Claim-level granularity caveat: the judgment is at the "all challenged claims unpatentable" level; the public excerpts I retrieved do not set out a claim-by-claim disposition table. I cannot tell you with certainty whether each of claims 1–9 fell on the same ground, and I am not going to invent one.
  • Settlement / termination: None. No adverse-judgment or settlement termination; the case was decided on the merits and is now on appeal.
  • Appeal: Yes. Notice of appeal filed by Inari; Federal Circuit No. 26-1552, Inari Medical, Inc. v. Imperative Care, Inc., appeal from the PTAB originating in IPR2024-01157, docketed 2026-03-23 (consistent with the 63-day appeal window from the 2026-01-16 FWD). As of 2026-09-10 the appeal is pending with no disposition — no panel opinion, no Rule 36 affirmance, no remand. (Google Patents' litigation block for this patent also lists CAFC case 26-1552.)
  • Related district court context (matters for the estoppel/stay analysis): Inari Medical, Inc. v. Imperative Care, Inc., No. 3:24-cv-03117 (N.D. Cal.), filed 2024-05-22. The district court denied Inari's preliminary injunction motion on 2025-09-29 (finding Imperative Care raised "a substantial question of validity" on the '921 patent, a family member), and the case was stayed in view of the related IPRs (joint stipulation to continue the stay filed 2026-01-28).
  • Defensive value: A defendant facing assertion of claims 1–9 of the '011 patent now holds a PTAB FWD holding every one of those claims unpatentable over Schaffer + Hartley — that is the single most valuable invalidity exhibit you can attach to a response letter or a stay motion, and it is corroborated by the Board's parallel holding in IPR2025-00156 (FWD 2026-04-07) invalidating all challenged claims of sibling U.S. 11,697,012. But do not overstate it: because the FWD is on appeal, the claims have not been cancelled and Inari (a wholly-owned Stryker subsidiary) can still assert them — the correct posture is "PTAB has invalidated these claims; the appeal is the last stand," not "the claims are dead."

Strategic summary

Claim status. Imperative Care challenged the entire set it identified — claims 1–9 — and the Board held all of them unpatentable (FWD 2026-01-16). There are therefore no claims of the '011 patent that survived the IPR: nothing was "sustained," and the only "untested" universe would be any claims of the '011 patent beyond claim 9, if such claims exist — I could not verify the patent's total claim count from the sources available, and the public record only speaks to claims 1–9. Practically, the pre-appeal status is "held unpatentable, not yet cancelled": the Board's unpatentability judgment becomes a cancellation only once appellate review is exhausted in Imperative Care's favor, so a defendant should treat claims 1–9 as presumptively invalid but technically still in force until CAFC No. 26-1552 resolves. The important nuance for your invalidity theory is that the Board rejected anticipation by Schaffer alone and rested on § 103 over Schaffer + Hartley — so build obviousness, not anticipation, and expect the patent owner to attack the motivation-to-combine finding on appeal.

Estoppel landscape. Under § 315(e)(2), Imperative Care and its privies are now barred from asserting, in the N.D. Cal. action or any other civil action, any ground they raised or reasonably could have raised in IPR2024-01157 — i.e., Schaffer-based anticipation and the Schaffer/Hartley/Eller obviousness combinations are off the table for Imperative Care. There is no statutory estoppel against any other defendant, so a different accused infringer could file its own IPR on the '011 patent, but it would run into § 325(d) discretion (the same Schaffer/Hartley/Eller art, and the Board's prior findings) and, more practically, into the fact that a merits winner already exists — meaning a fresh petition is likely pointless and an intervening-rights/problematic posture for the patent owner rather than for the challenger. Two overlapping considerations cut the other way for a defendant: (1) the appeal could reverse or remand, so do not build a case that depends entirely on the Board's combination rationale; and (2) if § 315(e)(2) estoppel is in play for Imperative Care, the patent owner has an incentive to look for other defendants and other family members.

Pattern signals. This is a portfolio-wide war, not a one-patent spat. Imperative Care is the sole petitioner and has filed a rolling series of IPRs against Inari/Stryker patents in and around this family — IPR2024-01157 ('011), IPR2024-01257 ('691 — institution denied), IPR2025-00156 ('012 — instituted, FWD 2026-04-07 invalidating all challenged claims), IPR2025-00289 ('005), IPR2025-00728 ('921), IPR2025-00989 ('291), IPR2025-01021 ('333), IPR2025-01025 ('910), IPR2025-01264 ('580), and IPR2025-01562 (instituted, pending). Inari has fought hard at the discretionary-denial stage — filing four successive § 314(a)/§ 325(d) requests, all denied by the Director (including a decision by Deputy Under Secretary Coke Morgan Stewart referring the petitions to the Board) — and has appealed the '011 loss. There is no defensive aggregator (e.g., Unified Patents) in the chain: the petitioner is a direct market competitor (Imperative Care, represented by Knobbe Martens), and the patent owner is Inari Medical, identifying itself in these proceedings as a wholly-owned subsidiary of Stryker Corporation (Perkins Coie), which matters for both the litigation budget you should expect and the credibility of any "small innovator" framing. The same prior-art nucleus (Schaffer, Hartley, Eller, Garrison) is being reused across the family, which is a strong signal that the family's garrote-valve claims are structurally vulnerable rather than rescued by any one claim's wording.


Recommended next steps

  • If you have a demand letter citing claims 1–9 of the '011 patent: respond with the IPR2024-01157 FWD, which states the Board "determines that Petitioner has proved by a preponderance of the evidence that the challenged claims are unpatentable" and bears the caption "Determining All Challenged Claims Unpatentable." Pull the decision from the PTAB docket (PTAB E2E, case IPR2024-01157) or the public copy filed as an exhibit in IPR2025-00989: FWD text (Paper 35) — https://www.docketalarm.com/cases/PTAB/IPR2025-00989/Imperative_Care_Inc._v._Inari_Medical_Inc/docs/04-09-2026-Petitioner/Exhibit-1033-Final_Written_Decision_IPR2024_01157.pdf?download=true ; case index: https://www.docketalarm.com/cases/PTAB/IPR2024-01157/Imperative_Care_Inc._v._INARI_MEDICAL_INC/ ; institution decision (Paper 7, 2025-01-23): https://www.docketalarm.com/cases/PTAB/IPR2024-01157/Imperative_Care_Inc._v._INARI_MEDICAL_INC/docs/01-23-2025-Board/Institution_Decision__Grant-7-Institution_Decision__Granting_Institution_of_Inter_Partes_Review_35_USC_%C2%A7_314.pdf
  • Do not treat the claims as cancelled yet. The appeal is live. Monitor CAFC No. 26-1552, Inari Medical, Inc. v. Imperative Care, Inc. (docketed 2026-03-23; appeal from IPR2024-01157) — https://ai-lab.exparte.com/case/cafc/26-1552/inari-medical-inc-v-imperative-care-inc — and calendar the briefing and any oral-argument date. The issues on appeal will center on the Board's claim construction of "filament" (the Board rejected anticipation by Schaffer on that construction) and on the motivation-to-combine/expectation-of-success findings for Schaffer + Hartley.
  • If litigation is threatened or filed against you, move to stay pending the appeal and cite the parallel N.D. Cal. stay (where the court continued the stay in January 2026 while the family IPRs resolve) plus the Board's family-wide holdings — the '011 FWD (2026-01-16) and the '012 FWD (2026-04-07) both invalidating all challenged claims over Schaffer + Hartley. The patents are also weak candidates for injunctive relief post-eBay given the PTAB record.
  • Do not file a copycat IPR on the '011 patent unless you have genuinely new art. A second petition on Schaffer/Hartley/Eller invites § 325(d) denial and buys little with a merits FWD already on the books. Preserve your resources for the other asserted family members (e.g., the '921, '910, '580, '291, '012, '333 patents), and note that IPR2024-01257's institution denial shows the Board is not rubber-stamping Imperative Care's petitions.
  • Check your § 315(e)(2) posture and any indemnity/privy relationships. If you are in privity with Imperative Care, the estoppel from the 2026-01-16 FWD bars the Schaffer/Hartley/Eller grounds in court; if you are a fresh defendant, those grounds remain available to you as IPR grounds (and the FWD remains powerful evidence under Procter & Gamble / Kimberly-Clark for a substantial-question-of-validity showing).
  • Escalate the ODP data gap. The structured "PTAB proceedings on file" block for this patent is wrong; if your workflow depends on it, re-pull PTAB E2E and Docket Alarm before relying on "no PTAB activity" for any patent in this family.

Generated 9/10/2026, 12:46:34 AM

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 2022-06-15 · Assignment

    LUBOCK, PAUL; MERRITT, BENJAMIN E.; THRESS, JOHN C.Inari 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 research the assignment record for US 11697011, starting with the inventor chain, the original assignee, and the reported Stryker relationship flagged in my earlier litigation summary.

Confirmed the Stryker merger. Now let me try to pin down the actual USPTO recordation details (reel/frame and correspondent) and the predecessor patent's assignment history.

Let me make a few more targeted attempts at the reel/frame and correspondent data, plus check for any post-Stryker merger recordation.

Assignment & Ownership Analysis — US 11,697,011 B2

Scope note, read first. The USPTO Assignment Center (https://assignmentcenter.uspto.gov/ / https://assignment.uspto.gov/patent/index.html) is a JavaScript-gated database that I could not query directly in this session; my searches surfaced the assignment event data (as mirrored in Google Patents legal events and in the patent's own front-page/applicant record) but not the reel/frame number or the recording correspondent. I state that gap explicitly below rather than inventing values. Everything asserted as fact is cited; everything unknown is labeled unknown.


Inventors

Inventor Residence of record Employer at filing
Benjamin E. Merritt San Clemente, CA Inari Medical, Inc. (application names Inari as applicant under (71))
John C. Thress Capistrano Beach, CA Inari Medical, Inc.
Paul Lubock Monarch Beach, CA Inari Medical, Inc. (serial device inventor; named on numerous Inari filings)

Front-page data ("(71) Applicant: Inari Medical, Inc., Irvine, CA (US)"; "(72) Inventors: Benjamin E. Merritt…; John C. Thress…; Paul Lubock…") is reproduced in Petitioner's Exhibit 1012 in IPR2025-00989, a copy of the '011 patent itself: https://gaeflexstaging-dot-docketupdate.appspot.com/cases/[PTAB](/ptab)/IPR2025-00989/Imperative_Care_Inc/05-09-2025-Petitioner/Exhibit-1012-US_Patent_No_11,697,011_%E2%80%9Cthe_%E2%80%99011_patent%E2%80%9D/

Unusual patterns — assessment: None of the classic fire-sale precursor signals. The same three-inventor team recurs across the entire Inari hemostasis-valve family filed by Inari as applicant (e.g., US 11,000,682; 11,844,921; 11,865,291; 11,697,012; 12,109,384), and Merritt and Thress continue to appear as Inari inventors on applications filed into 2023–2024 (see, e.g., US 11,974,910 and US 12,016,580 front pages). That is the opposite of an "all inventors departed within 12 months of filing" pattern — inventorship is stable and captive to the operating company. Confidence: high on the inventor list; moderate on "employer at filing," which I infer from the applicant-of-record designation plus the recorded employment assignment (below), not from an employment contract I have seen.


Original assignee

Inari Medical, Inc., Irvine, California — assignee on the face of the issued patent ("(73) Assignee: Inari Medical, Inc., Irvine, CA (US)").

Cross-reference flag (contradiction): my earlier litigation section recorded Inari's PTAB filings stating it is "a wholly-owned subsidiary of Stryker Corporation." The above confirms that as of 2025-02-19. There is no contradiction between the two sections here — but see the date-discrepancy note at the end.


Assignment timeline

Recorded assignments found for US 11,697,011 B2: exactly one.

  • 2022-06-15 (recorded) — Reel/Frame not retrievable (see below)
    • Conveyance: Assignment of assignors' interest (inventor → company employment assignment)
    • Assignor: LUBOCK, Paul; MERRITT, Benjamin E.; THRESS, John C.
    • Assignee: Inari Medical, Inc.
    • Correspondent: Unknown / not retrieved — I could not obtain the recording correspondent's name, firm, or address from any accessible source, and I will not guess one. For context only (and not a substitute): the patent's front page lists Perkins Coie LLP as the attorney/agent, or firm, of record for prosecution ("(74) Attorney, Agent, or Firm — Perkins Coie LLP"). Prosecution counsel of record and assignment-recording correspondent are different roles and are frequently different firms; I have not verified they are the same here.
    • Context: Internal employment/obligation-to-assign transfer to the founder-operator, executed as a confirmatory recordation against continuation application 17/705,189; not a sale, not a transfer to an asserter.
    • Source: Google Patents legal events / reassignment record for US 11,697,011 B2 ("2022-06-15 — Assigned to Inari Medical, Inc. … Assignors: LUBOCK, PAUL, MERRITT, Benjamin E., THRESS, John C."): https://patents.google.com/patent/US11697011/en

Reel/frame — plain statement of the gap. I could not retrieve the reel and frame number for this recordation (or for the family's earlier confirmatory assignments). The search sources returned the event but not the recordation identifier. I am reporting this as missing data rather than supplying a plausible-looking number. It can be verified by searching patent number 11697011 at https://assignmentcenter.uspto.gov/ (or the legacy interface at https://assignment.uspto.gov/patent/index.html), which will display Reel/Frame, conveyance type, execution/recordation dates, and the correspondent of record.

Related upstream filing fact (not a separate assignment): the '011 patent is a continuation of application 17/226,318 (filed 2021-04-09), itself a continuation of application 16/117,519 (filed 2018-08-30, now US 11,000,682), claiming benefit of provisional 62/554,931 (filed 2017-09-06). The 2018 non-provisional was filed with Inari Medical, Inc. named as applicant, which indicates the inventors' assignment obligation was already in place at or before that filing — the 2022-06-15 recordation appears to be a confirmatory filing against the later continuation rather than the original conveyance. Source: '011 front page, "Related U.S. Application Data," as reproduced in the IPR2025-00989 Exhibit 1012 linked above; also https://patents.google.com/patent/US11697011/en

Post-Stryker recordation — not found. I found no USPTO assignment record reflecting the 2025-02-19 Stryker merger. This is expected rather than anomalous: Inari was the surviving corporation in the § 251(h) merger and remained the record titleholder, so no change-of-owner recordation to Inari's patent chain is legally required. I cannot confirm from the sources available whether Inari/Stryker nonetheless filed a confirmatory "merger" conveyance against this patent; treat that as unverified, not as a "no."


Timeline diagram

timeline
    title Ownership of US 11697011
    2017 : Provisional filed by three inventors
    2018 : Non-provisional filed naming Inari as applicant
    2021 : Parent patent issues as 11000682
    2022 : Continuation 17705189 filed by Inari
         : Inventors assign rights to Inari Medical
         : Application published as US20220211992A1
    2023 : US 11697011 granted to Inari Medical
    2024 : Inari sues Imperative Care and Truvic
    2025 : Stryker acquires Inari wholly
    2026 : Inari appeals to Federal Circuit
         : PTAB finds claims 1-9 unpatentable

NPE / troll-pattern signals

# Signal Call Evidence
1 Shell-entity transfer Not present The only recorded transfer is inventors → Inari Medical, Inc. (recorded 2022-06-15, per the legal events at https://patents.google.com/patent/US11697011/en). No "IP / Holdings / Licensing / Ventures" entity, no registered-agent address, no single-purpose LLC appears anywhere in the chain. Current owner is a commercial manufacturer with named FDA-clearance-track products.
2 Known asserter in the chain Not present No assignee in the chain matches Acacia, Marathon, Intellectual Ventures, IPNav, Wi-LAN/Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, or any Spangenberg vehicle. Inari is the plaintiff in a competitor-vs-competitor suit (Inari Medical, Inc. v. Imperative Care, Inc., N.D. Cal. 3:24-cv-03117, filed 2024-05-22), which is the profile of an operating company enforcing against a rival, not an NPE monetization program.
3 Repeat correspondent across the chain Unclear — cannot be assessed The recording correspondent is not retrievable from the sources reached, and with only one recorded assignment in the chain there is in any event no recurrence to measure. I am flagging this as a data gap, not as a negative finding. The recurrence test can only be run after pulling the correspondent field from Assignment Center; note that Perkins Coie LLP appears as the front-page prosecution firm, and a single large-firm appearance would not be a finding even if confirmed.
4 Cascading transfers Not present One recorded assignment in the entire chain; no chained LLC-to-LLC hops, no shared correspondent addresses, no sub-24-month multi-step sequence.
5 Pre-litigation transfer Not present The sole recorded assignment (recorded 2022-06-15) predates the first suit naming the '011 patent (2024-05-22) by roughly 23 months — far outside the 6-month window — and it is an inventor→employer confirmatory assignment rather than a transfer to an assertion vehicle.
6 Bankruptcy fire-sale Not present No Chapter 7/11 for Inari. The exit was a $4.94B all-cash tender offer and § 251(h) merger at $80.00/share, announced 2025-01-06 and closed 2025-02-19; Inari survived as Stryker's wholly owned subsidiary. Source: 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
7 Privateering Not present Inari did not transfer the patent to a third-party monetizer. It kept title and litigated itself, and its parent (Stryker) is a large, diversified operating company. No SEC disclosure of an NPE-transfer/royalty-back arrangement surfaced.
8 Defensive aggregator (anti-NPE) Not present Chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN; it terminates at Inari Medical, Inc. (Stryker subsidiary). Nuance worth recording: the Google Patents page attributes the PTAB/litigation data on that page to "Unified Patents PTAB Data" / "Unified Patents Litigation Data" — that is the data provider, not the petitioner or an owner. The IPR2024-01157 petitioner is Imperative Care, Inc. Do not read this as defensive-aggregator ownership.

Verdict

Operating-company assertion.

Justification: the chain contains a single recorded assignment — inventors Merritt, Thress and Lubock to Inari Medical, Inc., recorded 2022-06-15 (https://patents.google.com/patent/US11697011/en) — and every subsequent ownership event keeps the patent inside the same operating enterprise, ending with Inari's survival as a wholly owned Stryker subsidiary in the 2025-02-19 $4.94B § 251(h) merger. There is no shell entity, no known-NPE assignee, no cascading transfer, no bankruptcy sale, and the only enforcement action is Inari suing its direct commercial competitor Imperative Care/Truvic — the classic operating-company posture. The one caveat is signal #3 (repeat correspondent): unresolved because the recording correspondent and reel/frame could not be retrieved, so a fuller correspondent-recurrence check remains open; that gap does not change the ownership conclusion.

Verification links:


Two integrity flags for the file

  1. Date discrepancy across sections (pre-existing). My earlier litigation section noted the prompt then stated the current date as April 26, 2026; this task states 2026-09-10. I treat neither as authoritative and have not recomputed any date from them. Post-April-2026 developments remain flagged as unverified secondary reporting in that earlier section.
  2. Internal ordering inconsistency in the earlier litigation section (pre-existing). That section lists the CAFC appeal No. 26-1552 as filed 2026-03-23 while the IPR2024-01157 Final Written Decision is dated 2026-04-09 — an appeal before the FWD it would ordinarily challenge. I reproduce both above without correction per the "do not auto-correct identifiers" rule, but the ordering warrants confirmation against the Federal Circuit docket rather than being relied on as-is. This has no bearing on the assignment conclusion, which rests on the 2022-06-15 recordation and the 2025-02-19 merger.

Confidence summary: high on inventor identity, original assignee, and operating-company/Stryker status; high on "only one recorded assignment" as the record visible to me, but with the explicit caveat that I could not load Assignment Center itself, so a reel/frame-level verification pass is still owed.

Generated 9/10/2026, 12:46:30 AM

Prior art

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

✓ Generated

I'll research the specific prior art cited in and against US 11,697,011. Let me run several targeted searches.

I have substantial material. Let me verify the specific citation lists and the FWD outcome.

Prior Art Analysis — U.S. Patent No. 11,697,011 B2

Patent: U.S. 11,697,011 B2, "Hemostasis Valves and Methods of Use" (Inari Medical, Inc.; inventors Merritt, Thress, Lubock)
Appl. No.: 17/705,189, filed Mar. 25, 2022; published as US 2022/0211992 A1 (Jul. 7, 2022); granted Jul. 11, 2023
Priority: Provisional 62/554,931 filed Sep. 6, 2017 (continuation chain through 17/226,318 → 16/117,519, now U.S. 11,000,682)
Effective filing date applied: September 6, 2017 → AIA §§ 102/103 apply
Claims: 9 total; only claim 1 is independent. Claim 1 recites: a tubular member defining a lumen configured to slidably receive a catheter; a constricting mechanism including at least one filament and an actuator (first portion of filament around the tubular member; second portion with ends extending in different directions; actuator first/second members coupled to those ends, movable between a sealed first position and an open second position); and a biasing system biasing both members to the first position. Claims 2–9 add pliability, a complete loop, buttons, pressure-differential/vacuum sealing, orthogonal axes, compression springs, and "pull to constrict."

Because the '011 patent is in the same family as the '921 patent and the '012 patent, the same art appears across all three (and across the '291 patent), so the analysis below draws on the PTAB record in IPR2024-01157 and the closely parallel records.


Part 1 — The prior art actually cited against the '011 patent (most relevant)

These are the references Imperative Care, Inc. asserted in IPR2024-01157, the only proceeding that has substantively adjudicated the '011 claims. The Board's grounds table was:

Ground Reference(s) / Basis Claims challenged
1 Schaffer — § 102 1–9
2 Schaffer — § 103 1–9
3 Schaffer + Hartley — § 103 1–9
4 Schaffer + Eller — § 103 1–9
5 Hartley + Eller — § 103 1–3, 5, 6, 9

(Source: IPR2024-01157 Final Written Decision, § II.E; see also the institution decision, Paper 7, Jan. 23, 2025.)

1. Schaffer — U.S. Patent Pub. No. 2003/0225379 A1

  • Full citation: Schaffer et al., Composite fluid stasis valve, U.S. Patent Application Publication No. 2003/0225379 A1 (published Dec. 4, 2003).
  • Publication date: December 4, 2003 (prior art under § 102(a)(1), well before the Sept. 6, 2017 priority date).
  • Description: A "composite fluid stasis valve" for catheters that "blocks the flow of gas or fluid completely and immediately with or without an instrument in place within the gas/fluid path" ([0008]). It has a housing 20, a seal module 100 whose third central seal member 165 defines a lumen 193 (sized to pass a catheter, guidewire, needle or fiber), two oppositely disposed actuators 50 with spring-loaded actuator buttons, and U-shaped actuating members 55 that are "at least partially circumferentially disposed about" the seal module and collapse it under spring force 210 when the buttons are undepressed (Fig. 32). Depressing the buttons releases the actuating members so the seal module retracts and the lumen opens (Fig. 34). This is the single-reference anticipation ground.
  • § 102 analysis — claims 1–9 (asserted): Petitioner asserted Schaffer anticipates all of claims 1–9, mapping (a) seal module 100 / lumen 193 to the "tubular member defining a lumen"; (b) the U-shaped actuating members 55 to "at least one filament"; (c) the opposing buttons to the actuator "first member"/"second member"; and (d) the springs to the "biasing system."
  • What actually happened: The Board construed "filament" as requiring flexibility and held that Schaffer does not anticipate the challenged claims. It stated: "based on our construction of the recited 'filament' term and the record developed through trial, we find that Schaffer does not anticipate the challenged claims." So although Schaffer is the closest single reference and the only reference asserted under § 102, the anticipation ground failed. (The related district court, by contrast, found a "substantial question of validity" as to the sibling '921 patent based on Schaffer anticipation — an express divergence the Board addressed and explained.)

2. Hartley — U.S. Patent Pub. No. 2003/0116731 A1

  • Full citation: Hartley, Access valve, U.S. Patent Application Publication No. 2003/0116731 A1 (published June 26, 2003).
  • Publication date: June 26, 2003 (§ 102(a)(1) art).
  • Description: An access valve for laparoscopic/intralumenal deployment devices. A flexible string 14 (also described as a "suture or band," a "flexible member") extends around a cylindrical elastomeric diaphragm 8 and is attached by knots 16, 18 at its ends to a single rotary actuator 12. Rotating the actuator pulls "the string 14 ... in both directions at once and hence the cylindrical diaphragm 8 to be constricted" (Figs. 3 relaxed / 4 constricted), allowing the valve to "close over a range of diameters of devices passed through the valve or ... close completely down to be self-sealing."
  • § 102 analysis — no claim, alone: Hartley was asserted only under § 103 (Grounds 3 and 5), never as a standalone anticipation. On its face Hartley does not disclose the claim-1 "actuator compris[ing] a first member coupled to the first end of the filament and a second member coupled to the second end" (Hartley uses one rotary actuator controlling both string ends), nor the claimed "biasing system" biasing first and second actuator members to the closed position. So Hartley does not anticipate any of claims 1–9 individually.
  • Role: Substituted into Schaffer as the "filament." Hartley and Eller (plus Schaffer) are the references the Board's obviousness holding rests on. Notably, Hartley is also cited on the face of the '011 patent (see Part 2) — it was already of record.

3. Eller — U.S. Patent No. 9,980,813 B2

  • Full citation: Eller, Selective fluid barrier valve devices and methods of treatment using such devices, U.S. Patent No. 9,980,813 B2 (issued May 29, 2018); published as U.S. 2015/0305756 A1 on October 29, 2015.
  • Dates: Issued May 29, 2018; published Oct. 29, 2015 — the publication date is the operative § 102(a)(1) date (the issue date falls after the Sept. 6, 2017 priority date, as Petitioner acknowledged).
  • Description: "Selective fluid barrier valve devices" for percutaneous insertion of devices into a body passage such as the vascular system. A device 810 has a housing 816, a single actuator 818, a sleeve 820, and a wire member 822 with "a first end 924 attached to the housing 816 ... and a second end 926 attached to the actuator 818"; multiple wire members on a single actuator are also disclosed. A coil/wire that can be looped around the tubular member and constricted.
  • § 102 analysis — no claim, alone: Asserted only under § 103 (Grounds 4 and 5). Eller lacks the claim-1 arrangement in which a single filament's two ends are coupled to two different actuator members (Eller's first end is fixed to the housing, the second to the actuator), and does not disclose the claimed biasing system biasing both actuator members closed. Eller therefore does not anticipate any of claims 1–9 individually.
  • Role: The third "filament" alternative in the successful obviousness combination. Like Hartley, Eller is also cited on the face of the '011 patent.

4. Garrison — U.S. Patent Pub. No. 2015/0173782 A1

  • Full citation: Garrison et al., U.S. Patent Application Publication No. 2015/0173782 A1 (published June 25, 2015).
  • Dates: Published June 25, 2015 (§ 102(a)(1)).
  • Description: Systems/devices for accessing the (cerebral) arterial vasculature and aspirating clot material.
  • § 102 analysis: Garrison was not part of the '011 patent's five grounds. It appears only in the sibling '291 patent petition (Grounds 5–7: Garrison + Schaffer [+ Hartley/Eller] for claim 18) and in the '910 patent arguments (Garrison + Laub). It is directed to aspiration catheters, not to a constricting-filament valve, so it does not anticipate any '011 claim.

Part 2 — References cited by the '011 patent (front-page "References Cited")

The granted patent's References Cited section (reproduced in Ex. 1012/Ex. 1001 of the IPRs) lists a very large number of U.S. patent documents — mostly an applicant-submitted IDS sweep of general catheter/thrombectomy/clot-removal art (e.g., Fogarty 3,435,826; Palmer; Dubrul; Ferrera; etc.). Those bulk IDS citations are not relied on and are not § 102 anticipation candidates. The references flagged with an asterisk on the front page (the convention for examiner-considered references, i.e., more directly relevant) are:

Ref. Kind/date Title/field (description) § 102 relevance to '011
US 2003/0116731 A1 (Hartley) Pub. Jun. 26, 2003; F16K 7/06 Access valve; string around elastomeric diaphragm No standalone anticipation (see § 102 analysis above); asserted in § 103 combination
US 9,980,813 B2 (Eller) Issued May 29, 2018 (pub. Oct. 29, 2015); F16K 7/06 Selective fluid barrier valve; wire member to actuator No standalone anticipation; asserted in § 103 combination
US 7,775,501 B2 (Kees) Aug. 10, 2010; F16K 7/065 (251/5) Tube-clamp / pinch-type valve in the same "squeeze-a-tube" class Does not disclose a flexible filament looped around the tube with opposed spring-biased actuator members; no anticipation
US 3,675,657 A (Gauthier) Jul. 11, 1972; A61B 17/132, 606/203 Surgical/vascular clamp or tourniquet-type device Different mechanism/field; no anticipation of claim 1
US 4,551,862 A (Haber) Nov. 12, 1985; A61F 2/0036, 600/491 Implant/measurement-type device Unrelated to a constricting-filament hemostasis valve; no anticipation
US 2011/0144592 A1 (Wong) Jun. 16, 2011; A61M 39/0613, 604/175 Hemostasis valve/access-site art (same A61M 39/06 class as the '011) Closest in classification, but I could not retrieve its text within this search; no documented anticipation of claim 1

Non-patent citations on the '011 face (general background only, not § 102 art): European Patent Application No. 13838945.7 Extended European Search Report (dated Apr. 15, 2016); Gibbs et al., British Heart Journal 1994; Gupta, JAPI 2008; Konstantinides, Pulmonary Embolism Hotline 2012; and ISRs/WOs for PCT/US13/61470, PCT/US2014/046567, PCT/US2014/061645, PCT/US13/71101.

Key prosecution observation: Schaffer — the only § 102 reference ever asserted — was not of record during prosecution, whereas Hartley and Eller were expressly considered by the examiner (in the sibling '291 record the Notice of Allowance references Hartley and explains that the reason for allowance was the claimed spring/biasing function; Eller appears in the accompanying Notice of References Cited). The successful IPR obviousness challenge therefore rests on art the examiner had already seen.


Part 3 — Additional references used in the related IPR family (completeness; not '011 grounds)

  • U.S. Patent No. 5,429,616 to Schaffer ("Schaffer '616") — issued 1995; a related Schaffer valve reference exhibited in IPR2025-00989.
  • U.S. Patent No. 6,776,770 B2 to Trerotola — issued Aug. 17, 2004.
  • WO 2018/019829 A1 to Brady et al. — published Feb. 1, 2018 (post-priority publication; would require an earlier effective date to qualify).
  • U.S. Patent No. 7,682,380 B2 to Thornton — issued 2010.
  • The '011 PCT counterpart, WO 2019/050765 A1 (published Mar. 14, 2019) — same family, not art against itself.

Bottom line — § 102 anticipation

  1. Only one reference was ever asserted to anticipate the '011 claims: Schaffer (US 2003/0225379 A1), against claims 1–9. The PTAB rejected that ground, holding Schaffer does not anticipate because "filament" was construed as requiring flexibility and Schaffer's U-shaped actuating members do not meet that construction.
  2. No other single reference anticipates any of claims 1–9. Hartley, Eller, and Garrison were pleaded only under § 103; none discloses a single filament whose two ends are coupled to two different actuator members plus a biasing system biasing both members to the closed position, as claim 1 requires.
  3. The claims nonetheless fell. The Final Written Decision determined all challenged claims 1–9 unpatentable as obvious over Schaffer in combination with Hartley and/or Eller (and Hartley + Eller), i.e., § 103, not § 102. Bloomberg Law's Jan. 20, 2026 report characterized the holding as unpatentability "as obvious over prior art" describing (i) a valve blocking gas/fluid flow with or without an instrument (Schaffer), (ii) an access valve for laparoscopic/intralumenal devices (Hartley), and (iii) selective fluid barrier valve devices (Eller).
  4. Net: For the '011 patent, the potential § 102 references are the front-page examiner-cited art (Hartley, Eller, Kees, Gauthier, Haber, Wong) plus Schaffer; on the developed record, none of them operated as an anticipation reference — the invalidity rests entirely on obviousness combinations.

Contradictions and confidence flags (per operating rules)

  • Contradiction flagged with the earlier litigation summary: that summary gave the Final Written Decision date as April 9, 2026. The FWD document header in IPR2024-01157 reads "Date: January 16, 2026," the Docket Alarm PTAB docket for IPR2024-01157 shows "Terminated Jan. 16, 2026," and Bloomberg Law reported the decision on Jan. 20, 2026. The "April 9, 2026" date corresponds to when the FWD was filed as Exhibit 1033 in a different IPR (IPR2025-00989), not to the FWD's own date. The CAFC appeal (No. 26-1552, filed Mar. 23, 2026) is also consistent with a mid-January FWD. I therefore treat the FWD date as January 16, 2026, and flag the earlier "April 9, 2026" as an error to be corrected going forward.
  • High confidence: the existence, dates, and content of Schaffer (US 2003/0225379 A1, Dec. 4, 2003), Hartley (US 2003/0116731 A1, Jun. 26, 2003), and Eller (US 9,980,813 B2; pub. Oct. 29, 2015); the five grounds in IPR2024-01157; and that the Board found no § 102 anticipation by Schaffer but held claims 1–9 obvious.
  • Lower confidence / not independently verified: the precise mechanical descriptions of the front-page examiner-cited references Kees (7,775,501), Gauthier (3,675,657), Haber (4,551,862), and Wong (2011/0144592) — I identified them from the granted patent's References Cited page and their classification codes but did not retrieve their full texts, so their descriptions above are class/title-level inferences and should be verified against the documents themselves before being relied on.
  • Search limitation: I was unable to retrieve Google Patents' machine-readable "Patent Citations" (including the full "Cited By") list for US 11,697,011 within this session; the front-page list in Part 2 is drawn from the granted patent's own References Cited section as reproduced in the IPR exhibits. A definitive "each patent citation" answer would require pulling the complete citation export from USPTO PatentCenter/Global Dossier for Appl. No. 17/705,189.

Primary sources:

Generated 9/10/2026, 12:46:58 AM

Obviousness

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

✓ Generated

Obviousness Analysis — U.S. Patent No. 11,697,011 B2 ("Hemostasis Valves and Methods of Use")

Analyst note on inputs. This section builds on the previously generated Litigation summary and does not repeat it. It uses (a) the "Prior art keywords" and reference set reflected on the Google Patents page for the '011 patent, and (b) the prior-art record actually litigated against the '011 claims at the PTAB in IPR2024-01157 (Imperative Care, Inc. v. Inari Medical, Inc.), which is the only substantive §103 record that exists for this patent. One contradiction with the prior section is flagged in §9 below.


1. The operative prior art set (the "Prior Art section" of this page)

The Google Patents page for the '011 patent lists the following prior-art keywords: filament / elongate member / valve / configuration / actuator. Those four/five terms map one-for-one onto the limitations of claim 1, and they are precisely the concepts on which the IPR was decided.

Tag Reference Identity Status
Schaffer US 2003/0225379 A1 (Schaffer et al.), pub. Dec. 4, 2003 Stasis/hemostasis valve with a collapsible seal module 100 (elongate tubular structure 101, lumen 193), two opposing actuators 50 with actuator buttons 261 and U-shaped actuating members 55, spring-biased (spring 210) to a collapsed/sealed first position §102(b)-type art (pre-2017 publication)
Hartley US 2003/0116731 A1 (Hartley), pub. June 26, 2003 Access valve for laparoscopic/intraluminal devices: cylindrical diaphragm 8, flexible member/string 14 wound circumferentially (preferably twice) around the diaphragm, both ends knotted (knots 16, 18) to a rotary actuator 12 §102(b)-type art
Eller US 9,980,813 B2 (Eller), pub. Oct. 29, 2015, iss. May 29, 2018 Selective fluid barrier valve: housing 16, actuator 18, sleeve 20, wire member 22/822 disposed around ≳50–100% of the sleeve's outer circumference (Fig. 21) §102(a)(1)/(a)(2) art
Garrison US 2015/0173782 A1 (Garrison et al.) Asserted only as a secondary reference against the sibling '012 patent (not asserted against '011 claim 1)

Petitioner's asserted grounds against claims 1–9 of the '011 patent were:

Ground § Reference(s) / basis Claims
1 102 Schaffer 1–9
2 103 Schaffer 1–9
3 103 Schaffer + Hartley 1–9
4 103 Schaffer + Eller 1–9
5 103 Hartley + Eller 1–3, 5, 6, 9

Source: IPR2024-01157 Final Written Decision ("FWD"), § II.E (grounds table).


2. The legal standard and the three findings that drive the result

Under AIA §103 and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Board resolves the Graham factors and then asks two questions: (i) would a POSA have been motivated to combine the references, and (ii) would the POSA have had a reasonable expectation of success? CRFD Rsch., Inc. v. Matal, 876 F.3d 1330, 1340 (Fed. Cir. 2017).

Three predicate findings decide this case:

(a) Priority / prior-art status. Earliest possible priority is September 6, 2017 (provisional 62/554,931; continuation chain through 16/117,519, filed Aug. 30, 2018, and 17/226,318). The Board applied the AIA §§102/103 and noted the priority date was uncontested, and that Patent Owner did not dispute that Petitioner's references qualify as prior art. Schaffer and Hartley (both 2003) and Eller (2015 publication) all predate September 2017 by years.

(b) Level of ordinary skill. The Board adopted: an undergraduate degree in mechanical engineering or a related discipline, plus 2–4 years of design/engineering experience related to endovascular devices and the procedures that use them (hemostasis valves, catheters for minimally invasive vascular surgery). The Board expressly held a POSA "need not have had firsthand experience designing hemostasis valves" — only general experience with vascular devices and procedures. This matters because it forecloses the argument that the specific garrote-valve architecture was beyond ordinary skill.

(c) Claim construction of "filament" — the pivot of the whole case. Petitioner proposed "one or more threads, lines, cords, ropes, ribbons, flat wires, sheets, or tapes" (i.e., material-agnostic). Patent Owner proposed "a thin, flexible length of material." The Board:

  • accepted Petitioner's list of example structures (specification at 9:10–20);
  • but agreed with Patent Owner that the claimed filament must be flexible, reasoning from (i) the claim's "circumferentially constricts" language, (ii) the specification's "tightened"/"loosened" usage, (iii) the interchangeability of "tensioning mechanism" and "constricting mechanism," and (iv) extrinsic dictionary evidence ("a thin flexible threadlike object") and Petitioner's own expert's admission about ordinary meaning.

Consequence: Schaffer's rigid U-shaped actuating members 55 are not a "filament" → Grounds 1 and 2 (Schaffer alone) fail, and the Board so held ("we find that Schaffer does not anticipate the challenged claims," FWD §II.B n.3 / §§III.C, III.E). The case was therefore won on §103, not §102.


3. Claim 1 limitation-by-limitation under the surviving §103 combinations

Claim 1 (Ex. 1001, 22:20–39), the sole independent claim:

A valve, comprising: a tubular member defining a lumen configured to slidably receive a catheter; a constricting mechanism including at least one filament and an actuator coupled to the filament, the filament comprising a first portion extending around at least a portion of the tubular member and a second portion having a first end extending from the first portion in one direction and a second end extending from the first portion in another direction, and the actuator comprises a first member coupled to the first end of the filament and a second member coupled to the second end of the filament, wherein the first member and the second member of the actuator are moveable between (a) a first position wherein the filament circumferentially constricts the lumen to create a seal and (b) a second position wherein the filament is moved to at least partially open the lumen; and a biasing system configured to bias the first member and the second member to the first position.

Limitation Schaffer (primary reference) Hartley (Ground 3) Eller (Ground 4)
Tubular member w/ lumen to slidably receive a catheter Yes — seal module 100 = "flexible, elongate tubular structure 101," lumen 193, for "a catheter, guidewire, needle, or fiber," and a guidewire + catheter may share lumen 193 ([0056], [0074], Fig. 32) cylindrical diaphragm 8 with longitudinal aperture 3 sleeve 20 with lumen
At least one filament Rigid actuating members 55 — not a filament under the Board's construction Yes — string 14 = "flexible member," "string, suture or band" ([0017]) Yes — wire member 22/822; "suture or cable," any cross-section (round, oval, rectangular), compliant/flexible materials (15:61–16:6)
Filament first portion around the tubular member U-members partially circumferentially disposed about portion 108 of seal module ([0077]) Yes — string "wound preferably twice around the cylindrical diaphragm 8" ([0031]) Yes — wire disposed around >50%, or even >100% (≥1 full revolution) of the sleeve outer surface (Fig. 21; 24:50–57)
Filament second portion: first end in one direction, second end in another direction, each coupled to a respective first/second actuator member Two opposing buttons 261 Ends knotted at 16/18 — but to a single rotary actuator End 124 to housing, end 126 to actuator — single actuator
Actuator members movable between sealed 1st position and at-least-partially-open 2nd position Yes — buttons 261 depressed → actuators slide → tension released → lumen reopens ([0077]) rotation constricts / release reopens ([0008]) actuator rotation compresses sleeve (15:21–40; 17:38–43)
Biasing system biasing both actuator members to the first (sealed) position Yes — springs 210 provide the compressive load between the actuating member and the stationary member ([0077], Fig. 32) — —

The single point of novelty that survives against the art. Neither Hartley nor Eller couples the two opposite ends of a single filament to two separate, independently movable actuator members; Schaffer has two actuator members but rigid (non-filament) actuating members. Ground 3 and Ground 4 close that gap by substituting Hartley's string (or Eller's wire) for Schaffer's U-shaped actuating members, and routing the two string ends to Schaffer's two opposing buttons. That is the entire §103 question.


4. Why a POSA would have combined them (the motivations the Board credited)

4.1 Same field, same problem, same mechanism — the strongest structural rationales

  1. Both references are analogous art and solve the identical problem. Schaffer itself frames the prior-art gap as the inability of stasis valves to seal across a large number of instruments while "block[ing] the flow of gas or fluid completely and immediately with or without an instrument in place" ([0008]). Hartley states that looping the string around the diaphragm lets the valve "close over a range of diameters of devices passed through the valve or can close completely down to be self sealing" ([0031], [0037]). Petitioner's expert (Troy Thornton) testified the POSA would have seen Hartley as the answer to the very problem Schaffer identifies. Patent Owner did not contest this motivation.

  2. Similar mechanism of operation → predictable result. Both devices seal by pulling the constricting element(s) in opposite directions to compress a resilient lumen-defining member, and both rely on the resilience of that member to reopen when tension is released. Schaffer: seal module of "resilient material" that will "retract to an uncollapsed configuration" ([0003], [0077]); Hartley: "the cylindrical diaphragm is formed from a resilient material so that after constriction and release of the flexible member the valve reopens" ([0008]). Where the mechanisms correspond this closely, KSR makes the substitution of one known constricting element for another a textbook case.

  3. Simple substitution of one known element for another, with a predictable result. Petitioner framed Grounds 3/4 as a straight swap of Hartley's string (or Eller's wire) for Schaffer's U-shaped members — no change to the housing, springs, or actuators required. This is the KSR "substitution of known elements" rationale. Patent Owner's contrary theory (that the swap secretly requires a re-architecture — see §5) was rejected.

  4. Finite number of predictable solutions. As of September 2017 there were a finite number of ways to compress a resilient seal element in a hemostasis valve. The art itself supplies at least three: Schaffer's two U-shaped metal/plastic members, Hartley's single string, and Eller's one-or-more wire members. KSR ("finite number of identified, predictable solutions") and Fed. Cir. precedent ("not necessary to show that a combination is the best option, only that it be a suitable option," Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800) both support selection among them.

4.2 The "better seal / gap avoidance" rationale

  1. Tool-conformance advantage. Hartley's string encircles the lumen and can conform to a wider range of tool diameters and non-circular profiles. Conversely, Schaffer's U-shaped members are anchored to the buttons at a fixed spacing, so—even if they are flexible—they present a fixed radius of curvature that may not match the inserted instrument, potentially leaving small gaps. Thornton's demonstratives made exactly this point. Hartley's own disclosure of sealing "over a range of diameters" supplied the motivation, and the improvement in a known valve property (seal integrity across tool sizes) is a classic obviousness rationale. Patent Owner's rejoinder (that Schaffer's gelatinous third seal member 165 eliminates gaps) was answered by the fact that member 165 is optional in Schaffer's Figs. 30–34 ("The seal module 100 is formed of one or more seal members"; [0075]) and that Schaffer itself discloses non-gelatinous materials (modified vinyl, silicone, polyurethane; [0059], [0081]). A reference does not teach away merely because one disclosed embodiment is gap-free.

4.3 Reasonable expectation of success

  1. Trivial attachment. Hartley teaches attaching the string by knots at its terminal ends ([0031]). Thornton explained that a POSA could simply drill small holes in Schaffer's two buttons, thread each end of Hartley's string through, and knot it on the far side — expressly a matter of ordinary skill.

  2. No collateral redesign needed. The two mechanisms are functionally the same (concentric constriction by pulling ends in opposite directions), so Schaffer's buttons and springs would pull the string ends in opposite directions exactly as Schaffer's U-members are pulled. Depressing the buttons would slacken the string and let the lumen reopen. And if the lumen's resiliency needed tuning to work with a string, the prior art supplied a range of suitable materials (Schaffer's vinyl/silicone/polyurethane [0081]; Hartley's silicone rubber [0008], [0016]; Eller's NuSil MED-4755/4765/4014 at 36:27–60).

  3. Manufacturability. Hartley's strings would not complicate assembly beyond ordinary skill (e.g., a tapered fixture to introduce the collapsed seal module through pre-looped strings), and neither Hartley nor Schaffer flags durability or manufacturing as a constraint that would dissuade the combination.

4.4 Eller-specific motivations (Ground 4)

  1. Eller expressly describes the wire member forming a seal around one or more medical devices passed through the valve to prevent leakage around the device (15:21–40; 17:38–43; 18:3–8). It discloses that "any suitable number of wire members" may be used, including one (16:7–19; Figs. 15–17, 20–22), and that the wire can be a suture or cable with round, oval, rectangular, or other cross-sections (15:61–16:6) — squarely a "filament" under either party's construction. Attachment to the housing/actuator may be by adhesive, welding, fusing, or friction fit. Eller therefore provides an alternative, equally predictable constricting filament, with the same conformance benefit.

5. Patent Owner's non-obviousness theories and why the Board rejected them

PO argument (Dr. Zalesky) Petitioner/Board response
Not a simple substitution — proposed combination eliminates one U-member and attaches a single string to two independently movable buttons, an arrangement found in none of Schaffer, Hartley, or Eller; the string would be controlled by two actuators rather than one Rejected. Both Hartley's string and Schaffer's U-members pull in opposite directions; routing the string to the two opposed buttons is a trivial mechanical change within ordinary skill, and the claim itself requires two coupled actuator members, so the modification is toward, not away from, the claim
Changes Schaffer's principle of operation Rejected. Both references constrict a resilient lumen by opposing tension; no change in operating principle
No motivation — Schaffer already seals without gaps (relying on member 165, the "gelatinous"/"sticky" self-closing material, [0059]) Rejected. The "sticky" member is one optional embodiment; Schaffer's Figs. 30–34 seal module need not include it ([0075]); Schaffer's own statement is only a "nearly fluid/gas tight seal" ([0059]); PO's argument that Schaffer always seals without gaps is contradicted by Schaffer's own expressed need to seal across a range of instruments
Other ways to improve Schaffer exist, so why this one? Rejected. "That a POSA would have found it obvious to modify Schaffer's valve in several ways … does not make any one way less obvious"; a POSA may be motivated to do more than one thing (Teva v. Amneal, 97 F.4th 915, 930)
Hindsight — proposed combination departs from the intended purpose of all three references Rejected. The motivation flows from the references themselves (Hartley [0037]; Eller 15:21–40, 17:38–43, 18:3–8), not from the '011 disclosure
Claim construction — "filament" must be thin and flexible Board adopted flexible, but declined to require "thin," and noted the construction does not affect Grounds 3–5 because PO conceded Hartley's string and Eller's wire are filaments

Result (FWD, Paper 35): all of challenged claims 1–9 determined unpatentable, on the §103 grounds; Patent Owner's Motion to Exclude denied. Bloomberg Law's contemporaneous summary (Jan. 20, 2026) describes the holding as obviousness over art describing (i) a valve blocking gas/fluid flow "with or without an instrument in place" (= Schaffer), (ii) an access valve for laparoscopic/intraluminal deployment devices (= Hartley), and (iii) selective fluid barrier valve devices (= Eller) — i.e., the Board rested on Schaffer + Hartley and/or Schaffer + Eller, not on anticipation.


6. Dependent claims 2–9

I have claim 1 verbatim and the FWD's illustration of claims 2 and 3. I do not have verbatim text for claims 4–9 of the '011 patent and will not fabricate it. What the record establishes:

  • Claim 2 ("the tubular member is pliable") → Schaffer's seal module is a "flexible, elongate tubular structure" of highly deformable, compliant material ([0049], [0051], [0054], [0059]); Hartley's diaphragm is preferably "an elastomeric material such as silicone rubber" ([0016]). Clearly obvious.
  • Claim 3 ("the first portion of the filament extends in a loop completely around the tubular member") → Hartley's string is "wound preferably twice around the cylindrical diaphragm" ([0031]); Eller discloses a wire member extending "at least one full revolution around the outer surface of the sleeve" (Fig. 21; 24:50–57). Clearly obvious.
  • Claims 4–9 → The Board recorded that "Patent Owner raises no arguments with respect to Dependent Claims 2 and 4 through 9 for any of the grounds" and that PO raised "no unique arguments concerning dependent claims 2–9." Because claim 1's §103 vulnerability is dispositive and the dependents add only conventional refinements (actuator biasing direction relative to the longitudinal axis; filament geometry; filament materials such as polymer or metallic — both directly met by Hartley's "string, suture or band" and Eller's steel/nitinol/polymer wires), the obviousness conclusion for claim 1 carries claims 4–9 on this record. The practical corollary: any appeal or follow-on validity challenge to the dependents would have to attack the claim-1 combination itself, because no independent dependent-claim record was developed.

7. Secondary considerations (objective indicia)

None were presented. Petitioner stated it was unaware of any objective indicia; Patent Owner's expert expressly offered "no opinions on secondary considerations" (Ex. 2008 ¶197); and at the oral hearing Petitioner noted "Patent Owner has not raised any evidence of secondary considerations." Formally, the Graham factor 4 is neutral, so the §103 balance rests entirely on scope/content of the art, the differences, and the POSA level — all of which favor unpatentability. If Inari were to revive objective-indicia arguments on appeal or in a future forum, the obvious candidates (commercial success of the Inari/Stryker aspiration platform; industry praise for the "garrote" single-handed valve; copying by Imperative Care) would require proof of nexus to the claim-1 combination — i.e., to the filament + two-actuator + bias architecture — and would be weighing against the record's admission that the art already taught string-based constriction (Hartley) and wire-based constriction (Eller).


8. Where the §103 analysis remains genuinely contestable

  1. The "filament" construction is the load-bearing issue. If a court or the Federal Circuit adopts Petitioner's broader construction (no flexibility requirement), Schaffer alone would anticipate claim 1 and the obviousness inquiry becomes largely academic. If the "flexible filament" construction holds, the case turns entirely on motivation to combine — where the Board credited Schaffer + Hartley / Schaffer + Eller. Inari's appeal (CAFC No. 26-1552) is therefore most likely to rise or fall on (a) claim construction of "filament" and/or (b) the motivation-to-combine/substantial-evidence question.
  2. The "single string to two independent buttons" modification. This is PO's most technically substantive point, and it is a KSR "additional modification beyond a bare substitution" argument rather than a pure motivation argument. It failed below, but it is the cleanest appellate hook.
  3. Consistency with the district court. The N.D. Cal. denied Inari's preliminary injunction on the '921 and '910 patents (order of Sept. 29, 2025) on the ground that Imperative Care raised "a substantial question of validity" based on Schaffer anticipation and Schaffer+other-art obviousness. The Board expressly reconciled its decision with that order (FWD §§II.B, and n.4), observing that the court had not construed any claims and that the §102 Schaffer analysis differed because the court did no claim construction. Note the two tribunals' §102 outcomes differ: the Board found Schaffer does not anticipate under its construction; the district court preliminarily found an anticipation challenge substantial on an unconstrued record.
  4. Parallel family exposure. The same prior art and the same motivations were accepted against sibling patents — IPR2025-00156 ('012 patent, FWD Apr. 7, 2026, all challenged claims unpatentable) and IPR2024-01157 ('011 patent) — which strengthens the systemic read that the filament-over-tube claim family, as a whole, is §103-fragile over Schaffer + Hartley/Eller.

9. Contradiction flags and record notes

  • Contradiction with the previously generated section — FWD date. The Litigation summary states the IPR2024-01157 Final Written Decision issued April 9, 2026. The PTAB record indicates the FWD was entered January 16, 2026 (Paper 35): the IPR2025-00156 FWD lists "IPR2024-01157 (Final Written Decision entered Jan. 16, 2026, finding all challenged claims unpatentable; notice of appeal filed)"; Docket Alarm's IPR2024-01157 docket shows "Terminated Jan. 16, 2026" and a Paper 35 dated January 16, 2026; and Bloomberg Law reported the decision on Jan. 20, 2026. The April 9, 2026 date appears to be the date the FWD was filed as Exhibit 1033 in a different proceeding (IPR2025-00989), not the FWD's own date. This is also internally consistent with the CAFC appeal (No. 26-1552) being filed March 23, 2026 — within the 63-day window from a January 16, 2026 judgment. I therefore treat January 16, 2026 as the FWD date and flag the April 9, 2026 date in the prior section as likely a filing-date conflation.
  • Characterization refinement, not a contradiction. The prior section describes the grounds as "Anticipation by Schaffer; and obviousness over Schaffer in combination with Hartley (and/or Eller)." That accurately reproduces what was asserted. The refinement here: the Board decided the case on §103 (Schaffer + Hartley and/or Schaffer + Eller, and the Hartley + Eller ground for claims 1–3, 5, 6, 9) and rejected the §102 Schaffer anticipation ground under its "flexible filament" construction.
  • Petitioner attribution. As noted previously, the "Unified Patents PTAB Data" label on the Google Patents page identifies the data provider; the actual petitioner is Imperative Care, Inc., not Unified Patents.
  • Date anomalies in secondary sources. Several retrieval hits are dated June 2026, i.e., after the stated current date of April 26, 2026 (e.g., a June 10, 2026 Law360 item, "PTAB Invalidates Inari Embolism Treatment Patent"). Per the standing instruction, I treat search results as ground truth where they conflict with training data, but these post-April-2026 items are temporally inconsistent with the current date supplied to me and I flag them as unverified rather than relying on them for the §103 analysis.
  • Claims 4–9 verbatim text. Not independently verified in this analysis; conclusions as to those claims are derived from the Board's statement that no unique dependent-claim arguments were made, not from claim-by-claim reading.

10. Bottom line

Under 35 U.S.C. §103, all of claims 1–9 of U.S. Patent No. 11,697,011 are obvious over the combination of Schaffer (US 2003/0225379 A1) with Hartley (US 2003/0116731 A1), and independently over Schaffer with Eller (US 9,980,813 B2), and (for claims 1–3, 5, 6, 9) over Hartley with Eller. Schaffer supplies the claimed valve architecture in full — collapsible tubular member with a catheter-receiving lumen, two opposing actuators, and a spring biasing system urging the actuators to the sealed first position. Hartley and Eller supply the one element Schaffer lacks under the Board's construction: a flexible filament whose first portion loops around the tubular member and whose end portions can be coupled to the two opposed actuator members. The motivation is supplied by the references themselves (the shared problem of sealing across a range of tool diameters and self-sealing with no tool; the identical "pull-in-opposite-directions" constriction mechanism; the finite set of known constricting elements; the improved conformance of a string/wire to irregular or off-size tools), and the expectation of success is supplied by the triviality of the attachment (Hartley's knots into holes in Schaffer's buttons) and the interchangeability of resilient lumen materials already disclosed across all three references. No secondary considerations were presented. The PTAB so held, finding all challenged claims unpatentable; the appeal is pending at the Federal Circuit as Inari Medical Inc. v. Imperative Care Inc., No. 26-1552.

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