Invalidity dossier
US 11865291
Hemostasis valves and methods of use
Current assignee: Imperative Care, Inc.
Added 9/26/2026, 8:31:20 AM
Active provider: DeepSeek · deepseek-flash
Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
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
- 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.
- PTAB petitioner field: Google Patents' "Petitioner: (blank)" line and the Darts/Unified attribution could mislead — the real petitioner is Imperative Care, Inc.
- 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).
- 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.
- Imperative Care, Inc. v. Inari Medical, Inc.filed May 9, 2025IPR2025-00989Patent Trial and Appeal Board, U.S. Patent and Trademark Officeinstituted, pending
Defendants: Inari Medical, Inc.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
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:
- Order Denying Motion for Preliminary Injunction, Case 5:24-cv-03117-EKL, Dkt. 136 (N.D. Cal. Sept. 29, 2025) — https://www.docketalarm.com/cases/PTAB/IPR2025-00289/Imperative_Care_Inc._v._Inari_Medical_Inc/docs/10-02-2025-Petitioner/Exhibit-1037-2025_09_29_136_ORDER_Denying_Motion_for_Preliminary_Injunction_re_Dkt83.pdf
- First Amended Complaint (listing nine asserted patents incl. '291) — https://www.docketalarm.com/cases/PTAB/IPR2025-00289/Imperative_Care_Inc._v._Inari_Medical_Inc/docs/04-28-2025-Patent_Owner/Exhibit-2006-Exhibit_2006___First_Amended_Complaint_for_Patent_Infringement.pdf
- Google Patents litigation links (same case via both division docket numbers): https://portal.unifiedpatents.com/litigation/California%20Northern%20District%20Court/case/3%3A24-cv-03117 and .../case/5%3A24-cv-03117
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:
- Institution Decision, Paper 10 (Oct. 23, 2025) — https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2025-00989/Imperative_Care_Inc._v._Inari_Medical_Inc/10-23-2025-Board/Institution_Decision__Grant-10-_Decision_Granting_Institution_of_Inter_Partes_Review/
- Petition as filed (May 9, 2025) — https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1557876](/patent/1557876)/download-documents?artifactId=IdExGyGqYAb1SGDlTwdXAWAllAk8bKhA29uZNCuHH6PAUmV5aMnD9PA
- Unified Patents PTAB page — https://portal.unifiedpatents.com/ptab/case/IPR2025-00989
- Google Patents "PTAB case IPR2025-00989 filed (Pending - Instituted)" — https://patents.google.com/patent/[US11865291](/patent/US11865291)/en
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.
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
- 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)/.
- 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."
- 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.
- 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).
- 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.
- 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.
? · 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.
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/andhttps://assignment.uspto.gov/patent/index.htmlare 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.
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:
- References cited on/against the face of the patent (examiner/IDS citations, and the PCT/EP search-report citations on the family pages).
- 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.
I'll build the §103 analysis on the prior-art record already assembled. First, let me pull the actual claim set of the '291 patent and the operative details of the four asserted references, so the element-by-element mapping rests on the primary documents rather than summaries.
I have the full claim set and the operative exhibit list. Now let me pin down Garrison's disclosure, claims 19–20, and the Board's institution reasoning on motivation to combine and reasonable expectation of success.
Now let me pull the Board's institution-decision reasoning for this patent specifically, plus the tail claims (19–20) of the published claim set.
Obviousness Analysis — U.S. Patent No. 11,865,291 B2
35 U.S.C. § 103, built on the Prior-Art record above
0. Corrections and reconciliations with the earlier sections
Per the standing instruction to flag contradictions rather than silently harmonize, five items in the earlier Prior-Art section need refinement now that I have the operative petition table, the full claim set, and the Board's institution-stage reasoning:
| # | Earlier statement | What the primary record now shows | Effect |
|---|---|---|---|
| 1 | Eller post-dates the 2017 priority date (inferred issue date 2018-05-29), so its §102 qualification was "unconfirmed" | The '291 petition's own prior-art statement says: "Eller (Ex. 1007) published on October 29, 2015" — i.e., Petitioner treats it as §102(a)(1) art | Material. If the Oct. 29, 2015 date is correct, Eller qualifies outright. If the exhibit instead is the granted patent (issue 2018-05-29), Eller still qualifies as §102(a)(2) art if its effective filing date precedes the critical date — and §102(a)(2) art is fully available for §103. Either way the Ground 4 combination is not defeated by the date issue. The discrepancy is a scrivener's-risk item to verify against the printed document, not a substantive defense. |
| 2 | Ground 1 was described as Schaffer §102 against "claim 1 (and dependents)" and "claims 2–9" affected | Petition table: Ground 1 (§102) = claims 1–3, 5–8, 12–17, 19; Ground 2 (§103, Schaffer alone) = the same set; Grounds 3–4 = claims 1–8, 12–17, 19; Grounds 5–7 = claims 18–19 | Material. Claim 4 is deliberately excluded from the Schaffer-alone grounds — because claim 4 requires "one continuous filament," which Schaffer's two discrete U-shaped members 55 cannot supply. Claim 4 appears only in the Schaffer+Hartley/Eller grounds. Claims 9–11 are excluded from every ground. |
| 3 | "Claim 12 appears to head a separate claim group" | Claim 12 is a dependent claim of claim 1 ("The hemostasis valve of claim 1 wherein the direction is a first direction, and wherein the first member is actuatable in a second direction…") | Resolves the earlier provisional flag. There are only two independent claims in the challenged set: claim 1 and claim 18. |
| 4 | Claim 19's wording unverified | Claim 19 literally recites "The aspiration catheter system of claim 1…" — but claim 1 is a hemostasis valve, not a system | Confirmed antecedent-basis defect. Petitioner declined to stipulate a correction and argued both readings (§VII of the petition, invoking Valencell). This is a §112 issue riding alongside the §103 issue — see §8.3 below. |
| 5 | "20 claims; claim 20 also recites a filament-in-a-loop/button arrangement" | The challenged set stops at claim 19; I could not retrieve verbatim text for a claim 20 | Do not rely on a claim 20. Flag as unverified. If claim 20 exists and was not challenged, it is outside the IPR and outside the estoppel perimeter — but I cannot confirm it exists. |
Governing law: The '291 patent claims priority to Sept. 6, 2017; the AIA versions of §§ 102/103 apply. All four asserted references pre-date that date on Petitioner's face-of-the-petition showing (Schaffer 2003-12-04; Hartley 2003-06-26; Eller 2015-10-29; Garrison 2015-06-25), and Petitioner expressly pleads §102(a)(1) for each. Note the incidental oddity that Petitioner's expert repeatedly frames the POSA date as "August 2018" (the 16/117,519 filing date) rather than September 2017 — immaterial to these four references, which are all more than a decade earlier, but it signals that Petitioner has built in a fallback in case the provisional priority claim is ever attacked.
1. Legal framework actually being applied
Four Graham inquiries, with the KSR gloss on motivation:
- Scope and content of the prior art — all four references are, on their face, hemostasis-/stasis-valve art for intravascular catheters. They are analogous art under either Unwired Planet prong: same field of endeavor (hemostasis valves for intravascular procedures) and reasonably pertinent to the problem the '291 inventor faced (sealing a catheter lumen against blood loss without impairing tool passage). The petition pleads this expressly and cites In re Nilssen, 851 F.2d 1401, 1403 (Fed. Cir. 1988), for the presumption of POSA awareness.
- Differences between the claimed invention and the prior art — the only genuinely contested difference is the single term "filament … formed in a loop" and its functional corollary, "reducing a diameter of the loop." Everything else (support, actuator with movable member, collapsible tubular sidewall/lumen, spring biasing the member) is present in Schaffer on Petitioner's mapping and is largely unrebutted by Patent Owner at institution.
- Level of ordinary skill — per the institution decision: an undergraduate degree in mechanical engineering or a related field, plus 2–4 years of design/engineering experience with endovascular devices (or equivalent).
- Objective indicia — thin in this record; see §9.
Key doctrinal anchors the Board relied on at institution (all quoted/cited in the '291 proceeding file, and mirrored verbatim in the companion '005 and '012 institution decisions): the obviousness question "is not whether the prior art disclosed the very thing claimed," Masimo Corp. v. Apple Inc., No. 2022-1894, 2024 WL 111647, at *3 (Fed. Cir. Jan. 10, 2024); a combination need not be the "preferred, or the most desirable" one, In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004); only a "suitable option," Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021); and extra "creativity" in executing the combination does not defeat obviousness, Facebook, Inc. v. Windy City Innovations, LLC, 973 F.3d 1321, 1343 (Fed. Cir. 2020).
2. The claim set in play
Independent claims (2):
- Claim 1 — hemostasis valve. support; actuator with ≥1 first member movably coupled to the support; 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. aspiration catheter defining a lumen + proximal end portion; plus the claim-1 valve structure,
wherein the lumen of the tubular sidewall is selectively fluidly couplable to the lumen of the aspiration catheter; the spring limitation recites decouplingto fluidly decouple the lumen of the tubular sidewall from the lumen of the aspiration catheter; and a final limitation requiring the first member be actuatable in a second direction to increase the diameter and fluidly couple the two lumens.
Dependents (mapped, verbatim-confirmed for 2–19): 2 (second member movably coupled to support); 3 (filament's second end portion extends to the second member); 4 ("the first end portion, the loop, and the second end portion are one continuous filament"); 5 (first and second members biased to place both end portions under tension to seal around a device); 6 (same, but to close the lumen); 7 (direction away from longitudinal axis); 8 (direction orthogonal to longitudinal axis); 9 (spring between first member and support); 10 (first member is a button); 11 (button depressible in second direction to increase diameter); 12 (first member actuatable in second direction to increase diameter); 13 (first direction opposite second); 14 (both directions orthogonal to longitudinal axis); 15 (second member + second end portion + second spring, opposed directions); 16 (first direction opposite second); 17 (one member actuatable in the other's direction — "and/or"); 19 (defective dependency on claim 1).
Prosecution-history overlay that matters for §103: In the parent application the Examiner issued a restriction requirement (Sept. 20, 2022); Applicant elected Species I (Figs. 1–5) and Species IB (Fig. 6) — i.e., the filament-in-a-loop species — and not the bight species of Figs. 8–9. The Notice of Allowance distinguished Hartley (no "first spring"), Wong (no constricting mechanism with a loop-formed filament), and Myers (no first filament). Patent Owner uses the election to argue that "a first filament formed into a loop" excludes U-shaped members/bights. The Board engaged this argument at institution but did not treat it as dispositive.
3. The two candidate combinations, at the level of independent claims
3.1 Schaffer alone — §103 (Ground 2), and §102 (Ground 1)
| Claim 1 limitation | Schaffer (US 2003/0225379 A1, Ex. 1005) mapping asserted |
|---|---|
| "a support" | housing 20 (actuator buttons 261 carried in cylindrical openings) |
| "an actuator having at least a first member movably coupled to the support" | actuator buttons 261, depressible into the housing |
| "a collapsible tubular sidewall defining a lumen carried by the support" | seal module 100 / seal member 165, at least partially collapsed by compressive force 67; containment structure 160 |
| "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" | contested. Petitioner maps to the two U-shaped actuating members 55, arguing (a) "filament" is a broad genus in the '291 spec that includes "flat wire, sheet, or tape," which Schaffer's ribbon-like members resemble; and (b) claim 4's "one continuous filament" shows claim 1 does not require singularity — so two sub-filaments together can constitute "a filament." Petitioner's illustrated loop diameter does reduce as the members are drawn together. |
| "a spring configured to move the first member in a direction that pulls the first end portion away from the tubular sidewall" | springs 210 biasing buttons 261 to the closed position |
| "reducing a diameter of the lumen in response to reducing a diameter of the loop" | Fig. 32 closed/sealed state; Fig. 34 open state |
Weakness: The Federal Circuit-adjacent reasoning in the sibling institution decision for the '012 patent (IPR2025-00156) is that Schaffer's members are rigid, so their "shape and dimension … cannot reduce or otherwise change during operation," and thus cannot be "formed into a loop" whose diameter reduces. The Board in the '012 case refused to institute on Schaffer-alone anticipation. The '291 panel nevertheless instituted Grounds 1–2 — a genuine intra-family asymmetry, presumably driven by the '291's broader claim 1 (no "flexible" adjective, and claim 4's continuity requirement cutting the other way).
3.2 Schaffer + Hartley — §103 (Ground 3) ← the primary obviousness theory
Hartley (US 2003/0116731 A1, Ex. 1006) supplies the missing element: a flexible string 14 looped around a resilient cylindrical diaphragm 8, with the string's ends tightened by a rotary actuator to constrict the diaphragm lumen — and expressly re-opening when tension is released. Hartley is cited for exactly the two contested limitations: a flexible "filament" and a loop whose diameter reduces. The combination is Schaffer's valve architecture (spring-biased opposed buttons + collapsible seal module) with Hartley's string substituted for the U-shaped members.
3.3 Garrison + Schaffer (± Hartley/Eller) — §103 (Grounds 5–7) for claims 18–19
Garrison (US 2015/0173782 A1, Ex. 1011) supplies the aspiration-catheter-system half of claim 18: a clot-treatment/aspiration system with an aspiration source drawing clot through a catheter, and — critically — an express teaching/suggestion that the hemostasis valve used with its system "can be a static seal-type passive valve, or an adjustable-opening valve such as a Tuohy-Borst valve 227 or rotating hemostasis valve (RHV) (see FIG. 6)" (Garrison ¶ [0062]). Schaffer's valve is an adjustable-opening valve. Garrison also supplies the fluid-coupling/decoupling functionality of claim 18 through its flow-control valve between catheter lumen and aspiration source.
4. Motivation to combine — the rationales a POSA would have had
This is the heart of the §103 analysis. Six independent, mutually reinforcing rationales are available (MPEP § 2143 categories in brackets):
(a) Simple substitution of one known element for another to obtain a predictable result [MPEP 2143(A)(2)]. Both Schaffer's U-shaped members and Hartley's string perform the same function in the same way on the same structure — they are circumferential constricting elements pulled at their ends to collapse a collapsible lumen. As the Board put it at institution: "Schaffer's two actuating members apply a constricting force to the valve's seal module when pulled by opposing spring-actuated buttons; replacing those members with a single string (or wire) would provide substantially the same function and meet the claim language." That is the classic substitution fact pattern, and the result — a constricted, sealed hemostasis lumen — is predictable.
(b) Same field of endeavor / analogous art; presumption of POSA awareness [MPEP 2143(A); Unwired Planet; In re Nilssen]. All four references are hemostasis-valve references. Since the artisan is presumed to know the field, no express cross-reference between references is required — only a reason to make the combination, which (a) and (c) supply.
(c) The problem the '291 patent itself identifies is the problem the art already framed. The '291 Background states that traditional valves "may not seal adequately for all interventional applications or tools, and/or the operation of some valves may be complicated for operator use." Petitioner's motivation is written to that exact statement of the problem: a flexible loop conforms more precisely to irregular/multiple tool profiles than a rigid U-shaped member, and Hartley expressly teaches that its string "can close over a range of diameters of devices passed through the valve or can close completely down to be self-sealing" (Hartley ¶ [0037]) — i.e., a known technique to improve a similar device in the same way [MPEP 2143(A)(3)].
(d) Finite number of identified, predictable solutions — "obvious to try" [KSR, 550 U.S. 398, 421 (2007); MPEP 2143(A)(5)]. Petitioner's expert opined that a POSA in this window had "a finite number of predictable hemostasis valves to choose" and that the known adjustable-opening valves were "simple mechanical structures that operate in a predictable way." On that record, identifying Hartley's string or Eller's wire as candidate constricting elements was not the exploration of a "new technology" or an unbounded research program.
(e) Design incentive / market forces [MPEP 2143(A)(4)]. All three valve references are addressed to the same clinical pressure — achieving hemostasis with or without an instrument in place during minimally invasive catheter procedures. The incentive to improve seal conformance across the growing range of interventional tool diameters (the '291 patent's own stated motivation) existed independently of the '291 disclosure, which is what defeats a hindsight challenge.
(f) Express teaching, suggestion, or motivation in the references [MPEP 2143(A)(1)] — for Grounds 5–7 specifically. Garrison names the valve class: "an adjustable-opening valve such as a Tuohy-Borst valve 227 or rotating hemostasis valve (RHV)." Schaffer is an adjustable-opening hemostasis valve; Hartley and Eller are rotating hemostasis valves. So the Garrison combination does not require any inference about what a POSA would pick — Garrison tells the artisan which valve category to select, and the secondary references supply species within that named genus.
Additional rationales specific to the Garrison side of the combination:
- Predictable, known-method attachment. Combining Schaffer's valve with Garrison's aspiration catheter "would merely entail the combination of known elements … according to known methods (attaching the valve to a proximal hub on the catheter or forming it integrally with the hub)," yielding the predictable result of preventing blood loss and air ingress.
- Simplification of the operator's task. Schaffer's springs bias the valve closed when the buttons are not pressed, eliminating the need for the operator to manually close the valve mid-procedure — a recognized, articulable design benefit that supplies motive independent of the claims.
- Schaffer's own stated interoperability. Schaffer discloses a valve "for use with catheters," a seal module proximally connected to a connecting member "sized and configured to attach in fluid communication" to a body passage, and expressly contemplates "a catheter, guidewire, needle, or fiber" and a "guidewire and catheter … placed into the same lumen 193." That is the POSA's reasonable expectation of success for pushing Garrison's catheter 2030 through the valve.
Doctrinal responses to the obvious counter-motivation defense. Because Patent Owner's central attack is "no motivation to combine / change in principle of operation," it is worth stating the applicable limits now:
- It is not necessary that the combination be the best or simplest. In re Fulton, 391 F.3d at 1200; Intel v. Qualcomm, 21 F.4th at 800 ("suitable option"). Patent Owner's "there are simpler alternatives that would fix any sealing problem" argument "presumes the obviousness inquiry ends at a problem's simplest solution. That is incorrect."
- Extra executional creativity is not a bar. Facebook v. Windy City, 973 F.3d at 1343.
- Identity between prior art and claim is not required. Masimo v. Apple, 2024 WL 111647, at *3 (quoting Fleming v. Cirrus Design Corp., 28 F.4th 1214, 1222 (Fed. Cir. 2022)).
5. Element-by-element mapping of the dependent claims
| Claim | Additional limitation | Supplied by | Notes |
|---|---|---|---|
| 2 | second member movably coupled to support | Schaffer — two opposed actuator buttons 261 | Unrebutted at institution |
| 3 | filament's second end portion extends away from loop to the second member | Schaffer — second actuating member 55 to second button | Contested derivative of claim 1's "filament" |
| 4 | first end portion + loop + second end portion = one continuous filament | Hartley string 14 (or Eller wire 822) | Not mapped to Schaffer alone. Substituting Hartley/Eller yields a single continuous element; Schaffer's two members do not. Petition's demonstrative: string knotted at each end to a separate button, looped at least once around the seal module. |
| 5 | both members biased to tension both end portions enough to seal around a device through the lumen | Schaffer springs 210 + Hartley's express "close over a range of diameters … or close completely down to be self-sealing" | The "self-sealing across diameters" teaching is the load-bearing evidence |
| 6 | same bias sufficient to close the lumen | Schaffer Fig. 32 (fully sealed, no instrument) | |
| 7 | direction is away from the longitudinal axis | Schaffer springs pull buttons radially outward from the seal module | |
| 8 | direction is orthogonal to the longitudinal axis | same; the '291 spec itself states filament axis 152 is perpendicular to central axis 154 | |
| 9 | spring positioned between the first member and the support | Schaffer spring 210 between button 261 and housing 20 | Unchallenged — see §8.4 |
| 10 | first member is a button | Schaffer actuator button 261 | Unchallenged |
| 11 | button depressible in a second direction to increase lumen diameter | Schaffer — pressing buttons releases the compressive force so the containment structure "retract[s] to an uncollapsed configuration" | Unchallenged |
| 12 | first member actuatable in a second direction to increase diameter | same | Contested only via claim 1 |
| 13 | first direction opposite the second | Schaffer's opposed buttons/springs | |
| 14 | both directions orthogonal to the longitudinal axis | Schaffer's radial actuation | |
| 15 | second member + second end portion + second spring, opposed directions | Schaffer's two buttons, two springs 210 (and Hartley's string as the single continuous body spanning both) | |
| 16 | first direction opposite the second | Schaffer | |
| 17 | one member actuatable in the other's direction (and/or) | Schaffer — the pairing of opposed buttons | |
| 18 | aspiration-catheter system + selective coupling/decoupling | Garrison for the aspiration system/lumen; Schaffer (+Hartley/Eller) for the valve structure and the decoupling-by-spring/coupling-by-depression function | See §5.1 |
| 19 | system of "claim 1," member actuatable to increase diameter and fluidly couple the lumens | Schaffer's button depression → "gases and fluids can pass therethrough"; Schaffer expressly ties its valve to syringe/aspiration use | Defective dependency — see §8.3 |
5.1 Claim 18 specifically
Claim 18 is the claim where the Garrison rationale must do real work, because claim 18 adds a structural element — an aspiration catheter with its own lumen — absent from Schaffer:
- "An aspiration catheter defining a lumen and having a proximal end portion" → Garrison's catheter 2030 and the system of Garrison Figs. 32–35, expressly described as "systems for treating an artery with active aspiration."
- "selectively fluidly couplable to the lumen of the aspiration catheter" → Garrison's flow-control valve 3325 (3-way or 4-way stopcock / flow controller) that "may enable one device, the other device, both devices, or neither device to be connected to the aspiration source at any given time."
- The coupling/decoupling-by-actuation limitations → Schaffer's buttons: depressed = lumen open (coupled to any attached catheter); released = sealed (decoupled).
- The motivation is the strongest in the whole petition, because Garrison expressly names "an adjustable-opening valve such as a Tuohy-Borst valve … or rotating hemostasis valve (RHV)" as a suitable valve for its system, and Schaffer/Hartley/Eller are all members of exactly that named class.
6. What the Board found at institution (and what it did not decide)
The Board instituted on all seven grounds and all challenged claims (1–8, 12–19) on Oct. 23, 2025 under 37 C.F.R. § 42.108(a) and SAS Institute v. Iancu. On the record before it, the panel:
- Found Petitioner's claim-construction position on "filament" (not inherently flexible) at least reasonable enough to proceed, while noting Patent Owner's plain-and-ordinary-meaning position;
- Found the proposed Schaffer→Hartley substitution to be "a reasonably straightforward substitution of a known, alternative feature for constricting a hemostasis valve lumen and avoiding leaks";
- Rejected, at the preliminary stage, Patent Owner's "sticky seal module would retain the string," "harder to assemble," "durability," and "simpler alternatives" arguments as either premised on optional Schaffer features or as imposing a stricter standard than the law requires;
- Explicitly reserved the "principle of operation"/"intended purpose" question for a fully developed evidentiary record, inviting further argument (citing Plas-Pak Indus. v. Sulzer Mixpac, 600 F. App'x 755 (Fed. Cir. 2015), and Trivascular v. Samuels, 812 F.3d 1056, 1068–69 (Fed. Cir. 2016)).
Critical caution: institution requires only a reasonable likelihood as to at least one claim. The Board's preliminary findings are not findings of obviousness. On the merits record, Patent Owner has since filed its Response (Jan. 15, 2026) with a supplemental Zalesky declaration (Ex. 2009), and Petitioner replied (Apr. 9, 2026) with new exhibits 1033–1041 — including the final written decisions from the sibling IPRs on the '011 and '012 patents. Those FWDs are the single most probative documents in the record for predicting the '291 outcome and should be read before relying on any of the above, because the '012 record (as of institution) shows the Board declining to find Schaffer anticipatory while accepting Schaffer+Hartley as an obviousness combination.
7. Assessment: vulnerability by claim
| Claim(s) | Strongest §103 combination | Vulnerability | Confidence |
|---|---|---|---|
| 1 | Schaffer + Hartley | High — the single contested term ("flexible filament formed in a loop") is supplied by Hartley's express string-and-diaphragm teaching, and every other limitation is mapped without serious rebuttal | Moderate-High that the combination is legally sufficient; outcome turns on the "filament"/"loop" construction and the principle-of-operation defense |
| 2, 3, 5–8, 13–17 | Schaffer (± Hartley/Eller) | High — these depend on claim 1 and add limitations Schaffer maps directly | Moderate-High |
| 4 | Schaffer + Hartley (or Schaffer + Eller) — only | Moderate — requires the single-continuous-filament substitution, which is the very substitution in dispute | Moderate |
| 12, 19 | Schaffer (+Hartley/Eller); Garrison + Schaffer for 19 | Moderate — turn on claim 1 plus the bidirectional-actuation mapping | Moderate |
| 18 | Garrison + Schaffer (+Hartley/Eller) | Moderate-High — Garrison's express naming of "adjustable-opening / rotating hemostasis valve" is a strong, near-dispositive motivation | Moderate-High |
| 9, 10, 11 | none asserted | Untested. All three depend from claim 1 and would rise or fall with it, but no IPR record exists | N/A |
8. The defenses that could defeat these combinations
Building the analysis honestly requires naming the places where it can fail:
8.1 The "filament" construction. This is the linchpin. If "filament" is construed (as Patent Owner urges) as "a thin, flexible length of material formed by one or more strands," then:
- Ground 1 (§102, Schaffer alone) collapses — Schaffer's members are rigid and cannot be "formed in a loop" whose diameter reduces. This is precisely how the '012 panel reasoned.
- Grounds 2–4 (§103) survive only through Hartley/Eller, and then only if the substitution is found to be a permissible one rather than an impermissible redesign.
If instead "filament" carries only its broadest reasonable meaning (Petitioner's position, leaning on the '291 spec's own "threads, lines, cords, rope, ribbon, flat wire, sheet, or tape"), Schaffer alone does more work.
8.2 Change in principle of operation / inoperability [MPEP 2143.01(V)–(VI)]. Patent Owner's best argument. Its four sub-parts:
- Schaffer's U-shaped members forcibly disengage the seal module; a looped string never disengages, so a "sticky/gelatinous/self-closing" seal module would stay stuck closed. The Board's response at institution — that the sticky material is an optional feature and that the string contacts the containment structure 160, not the seal material — is a factual finding open to attack on a full record.
- Rigid members permit a gap-opening assembly method (buttons compressed, seal module inserted between them); a limp string would not.
- Durability/manufacturability — machining vs. filament assembly.
- No reference discloses a single element whose two ends attach to two independent actuators — Schaffer's members attach one-per-button; Hartley's string attaches both ends to one rotary actuator; Eller's wire attaches one end to the housing and one to a single actuator. Petitioner's combination therefore adds an undisclosed arrangement, which Patent Owner characterizes as more than a "simple substitution." The Board answered this with Masimo/Fleming and Facebook, but it is the argument most likely to survive to an FWD and to appeal.
8.3 Claim 19's §112 defect. Claim 19 depends from "claim 1," which is not an aspiration catheter system. The petition contends the error is not "conspicuous or indisputable" and therefore cannot be corrected by the Board, and argues the claim is unpatentable under either dependency reading (citing Valencell). This does not make claim 19 obvious — it makes it potentially indefinite. For a defendant, the practical consequence is that claim 19 carries a §112 independent vulnerability that survives regardless of how the §103 fight is resolved, and §112 is not available in this IPR at all. (Cross-reference: the earlier PTAB section's advice to preserve grounds on unchallenged claims applies here analogously.)
8.4 The unchallenged claims 9–11. Claim 9 ("the spring is positioned between the first member and the support"), claim 10 ("the first member is a button"), and claim 11 (button depressible in a second direction to increase the lumen diameter) are outside IPR2025-00989 entirely. They are also unasserted in the district court (Inari asserted 1–8, 12–17, 19). This is a strategic gap in both directions: no estoppel attaches to them, no invalidity record exists against them, and no infringement record exists against them. Note, however, that on this record claims 9–11 look highly likely to be obvious for the same reasons as claim 1 (Schaffer's spring 210 sits between button 261 and housing 20; the actuator is a button; the button is depressible) — so their exclusion from the petition reads as a litigation-driven choice to challenge exactly the asserted set, not as any concession of strength.
8.5 Prosecution-history estoppel-flavored argument. Patent Owner's species election (Fig. 6 loop, not Figs. 8–9 bights) cuts against Petitioner's use of the '291's own Figs. 8–9 as evidence that two sub-filaments constitute "a filament." The Board engaged but did not resolve this. If Patent Owner wins the point, Petitioner's Ground 1 mapping of Schaffer's two members to a singular "filament" weakens — but Grounds 3–4 (Hartley's single continuous string) are unaffected, because Hartley supplies an actual loop.
8.6 The Garrison "different field" argument. Inari has argued elsewhere (its April 24, 2024 letter, Ex. 1028 in a related proceeding) that Garrison "relates to neurovascular procedures, whereas both Inari's products and the Symphony product are designed to treat deep vein thrombosis (DVT) and/or pulmonary embolisms (PE)," and that Inari patents have been allowed over Garrison. But note carefully how Inari framed that argument: it was that Garrison's catheter sizes (neurovascular, small French) do not read on DVT/PE claims reciting 16F/24F catheters. The '291 patent's claims 1–19 recite no French size and no clinical indication. So the "different field" argument, which has some purchase against the '382/'691/'333 claims, has essentially no purchase against the '291 valve claims — Garrison is used here only as a catheter-system host, not as a source of valve structure. That is an important asymmetry a defendant should not overlook.
9. Objective indicia (Graham factor 4)
The record I retrieved shows little nexus-backed objective-indicia evidence for the '291 patent specifically:
- Copying / praise by an alleged infringer: Inari's Sept. 29, 2023 pre-suit letter states that "at least claims 1-4 and 7-14 of the '291 patent read directly on the hemostasis valve for the Symphony product." A patentee's own infringement theory is not evidence of copying by a competitor — but actual copying of the claimed structure by the accused would be probative. Whether the Symphony valve was designed from the '291 disclosure or independently (Imperative Care's own neurovascular heritage, per its expert's account of Penumbra/ADAPT lineage) is a contested factual matter not established in the sources I retrieved.
- Commercial success: Inari's FlowTriever/ClotTriever are commercially significant (≈$603M 2024 revenue; $4.94B Stryker acquisition), and the Symphony system is a commercial product. But commercial success of an aspiration system is weak evidence of the non-obviousness of a hemostasis-valve subcomponent absent a demonstrated nexus to the claimed valve features. No such nexus evidence appears in the retrieved record.
- Long-felt need / failure of others: The '291 Background articulates a long-standing need for valves that "seal adequately for all interventional applications or tools" with simplified operation. Whether that was a recognized, unmet need for which others tried and failed is not established in what I retrieved. Schaffer and Hartley, notably, both claimed to solve it — which cuts against "failure of others."
Bottom line for §9: objective indicia are unlikely to carry the day for the patent on this record unless Patent Owner develops nexus evidence and actual-copying evidence in the Response. This is the single largest evidentiary gap I cannot close from public sources, and I flag it rather than assert a conclusion.
10. Consolidated bottom line
- Six §103 combinations are on the table: Schaffer alone (Ground 2); Schaffer + Hartley (Ground 3); Schaffer + Eller (Ground 4); Garrison + Schaffer (Ground 5); Garrison + Schaffer + Hartley (Ground 6); Garrison + Schaffer + Eller (Ground 7). Ground 1 is a §102 anticipation theory, not a §103 theory.
- The independent-claim analysis for claim 1 rests almost entirely on one contested term. Every limitation but "filament … formed in a loop / reducing a diameter of the loop" is mapped to Schaffer without serious rebuttal at institution. Hartley (and in the alternative Eller) supplies the flexible loop; Garrison supplies the aspiration-system half of claim 18 — and Garrison supplies the motivation expressly, by naming "an adjustable-opening valve such as a Tuohy-Borst valve … or rotating hemostasis valve (RHV)" as suitable for its system.
- The motivations to combine are strong under MPEP § 2143: known-element-for-known-element substitution yielding a predictable result; known technique to improve a similar device; an express teaching in Garrison; a finite set of identified, predictable solutions (KSR "obvious to try"); and independent design/market incentives to seal around a widening range of tool diameters. Each survives the standard doctrinal countermeasures (Fulton, Intel, Facebook, Masimo).
- The genuine weak points are the principle-of-operation / inoperability defense, the construction of "filament," and the assembled-not-disclosed two-actuator arrangement — each of which the Board expressly left open for a developed record.
- Claims 9–11 are untested and outside the estoppel perimeter; claim 4 is only in the Hartley/Eller grounds; claim 19 carries a §112 defect in addition to the §103 exposure. Do not assert that any claim of US 11,865,291 is invalid — the FWD is statutorily due Oct. 23, 2026, and as of today zero claims are canceled and zero are sustained.
Items I could not verify and would confirm before relying on them: (a) the true publication/issue date and §102(a)(1) vs. §102(a)(2) status of Eller (Ex. 1007) — the petition's "Oct. 29, 2015" date conflicts with the 2018-05-29 issue date inferred earlier; (b) verbatim text of any claim 20; (c) the outcomes of the sibling FWDs in IPR2024-01157 ('011) and IPR2025-00156 ('012), filed as Exs. 1033/1038 in the '291 record on Apr. 9, 2026; and (d) the exact provenance of the institution-stage passages quoted in §4 and §6 — they appear in the '291 proceeding file (ptacts.uspto.gov/petitions/1557876) and are replicated verbatim in the companion '005 and '012 institution decisions, so treat the reasoning as the family's, and the '291 Paper 10 as the operative document.
Generated 9/28/2026, 11:21:51 PM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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