US 11033318

I'll search for authoritative records on US 11033318 across USPTO/PTAB and CAFC dockets.

Let me pull the claim set and litigation/PTAB specifics for this exact patent.

Let me check the current status of the CAFC appeal (25-2100) in 2026.

US Patent 11,033,318 B2 — Analyst Summary

Scope note: I researched this exact number across Google Patents/Patents Public Data, PTAB records (IPR2024‑00278), Docket Alarm, and CAFC records. Everything below ties to US 11,033,318 specifically; I did not substitute any similar number (e.g., 11,033,328 / 11,033,318-family members are distinguished where relevant). The full patent text you supplied is authoritative and was preferred over search results where they conflicted.

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1. Bibliographic Data

Priority chain (per the '318 face and PTAB Ex‑1001): Continuation of 15/686,265 (now US 10,335,221) → 15/272,007 (now 9,788,886) → 14/754,087 (now 9,452,010) → 14/319,087 (now 9,072,597), which was a continuation‑in‑part of 13/495,844 filed June 13, 2012 (now US 8,936,594); earliest provisional 61/496,930 filed June 14, 2011, plus provisional 61/603,864 filed Feb. 27, 2012.

⚠️ Identifier discrepancy, reported literally, not corrected: Google Patents lists the priority date as 2011‑06‑14, while the Unified Patents portal shows 2011‑06‑13. The '318 patent face and the PTAB institution decision both use June 14, 2011, which I treat as the better record.

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2. Abstract (verbatim from the patent)

"Methods and devices for treating nasal airways are provided. Such devices and methods may improve airflow through an internal and/or external nasal valve, and comprise the use of mechanical re-shaping, energy application and other treatments to modify the shape, structure, and/or air flow characteristics of an internal nasal valve, an external nasal valve or other nasal airways."

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3. Independent Claims — Plain-Language Overview

There is only one independent claim in this patent: claim 1. This is confirmed by the PTAB institution decision in IPR2024‑00278, which describes claim 1 as "the only independent claim of the '318 patent," and by Aerin's Patent Owner's Response ("Challenged Claim 1, the sole independent claim"). All other claims (2–17) depend directly or indirectly from claim 1.

Claim 1 — "A device for delivering energy to a nasal airway to improve nasal airflow"

Element-by-element, in plain language:

1. [Preamble] A handheld medical device for putting energy into the nasal airway to improve airflow.
2. [1a] Handle — a grip for the operator.
3. [1b] Shaft — extends from one end of the handle.
4. [1c] Treatment element — coupled to the far (distal) end of the shaft; sized to fit inside a nostril; and switchable between a first configuration and a second configuration (i.e., a deployable/expandable element, such as collapsed-for-insertion → expanded-for-treatment). It has a tissue treatment surface.
5. [1d] Electrode array — multiple pairs of bipolar radiofrequency (RF) electrodes laid out along that treatment surface. (Bipolar = each pair carries both poles, unlike a monopolar needle + grounding pad.)
6. [1e] Channel-per-pair wiring — multiple RF output channels, wired so that each electrode pair is connected to its own respective channel. This is the key structural limitation: independent per-pair drive, not one shared channel.
7. [1f] Sensors — multiple sensors on the tissue treatment surface, selected from the group consisting of impedance sensors, electrodes, and thermocouples (i.e., for measuring tissue/temperature/impedance feedback).

Bottom line on claim 1: a handheld nasal RF device with an expandable nostril-insertable treatment element bearing an array of bipolar electrode pairs, individually driven by separate RF output channels, plus a distributed sensor array on the tissue-contacting surface.

Dependent claims (grouped, per the PTAB record)

• Claims 4–6 — the treatment element comprises multiple segments (claim 6 adds a shape-memory alloy / nitinol-type teaching per the Patel ground).
• Claims 9–10 — add a radiofrequency generator (claim 10 adds RF frequency/power-type limitations per the Edwards‑886 ground).
• Claims 12, 13, 15–17 — directed to the type and configuration of the electrodes (e.g., non-penetrating vs. penetrating, row arrangements).
• Claims 2, 3, 7, 8, 11, 14 were not challenged in the IPR; I did not retrieve their verbatim text, so I am withholding a description rather than guessing.

⚠️ Uncertainty: The full text you supplied does not include the claims section, and I did not independently pull the USPTO PatentCenter claim listing. My claim characterization relies on the IPR2024‑00278 institution decision and Patent Owner's Response, which reproduce claim 1 verbatim (at 52:15–36) but only characterize the dependents by category.

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4. Litigation and PTAB / CAFC Status (this is the material recent development)

Docket family flag: Google Patents marks this patent "Family has litigation."

PTAB — IPR2024‑00278 (the operative challenge)

• Case: Neurent Medical Inc. & Neurent Medical Ltd. v. Aerin Medical Inc., IPR2024‑00278
• Petition filed: Jan. 18, 2024 | Instituted: July 22, 2024 | FWD: July 11, 2025
• Panel: APJs Fitzpatrick, Yang, and Valek (opinion by Valek)
• Outcome: Final Written Decision determining all challenged claims unpatentable (claims 1, 4–6, 9–10, 12–13, 15–17) under 35 U.S.C. § 318(a)
• Grounds: Edwards‑535 (US 6,517,535) + Stern (US 5,562,720); Makower (US 2005/0240147); + Patel (US 2007/0287994); + Edwards‑886 (US 6,273,886) — all under § 103
• Core issue: whether Stern supplied "multiple pairs of bipolar RF electrodes" and "multiple RF output channels, each pair connected to a respective channel." The Board found the combination persuasive; Aerin had argued Stern discloses only a single pair and a single channel.

CAFC

• Appeal: Aerin Medical Inc. v. Neurent Medical Inc. / Neurent Medical Ltd., No. 2025‑2100, noticed Sept. 11, 2025, docketed Sept. 12, 2025, from IPR2024‑00278.
• A CAFC order captioned Aerin Medical Inc. v. Neurent Medical Inc., Nos. 2025‑2099, 2025‑2100, 2025‑2101 (appeals from IPR2024‑00277, ‑00278, and ‑00282) dismisses the proceedings under Fed. R. App. P. 42(b), each side bearing its own costs.

🚩 Date caveat: That dismissal order is dated August 27, 2026, which post-dates your stated current date of April 26, 2026. I am reporting the document exactly as retrieved rather than reconciling the dates. Treat the dismissal as provisionally confirmed but unverified as of your stated date; if the 2026‑08‑27 date is a docket artifact, the appeals may still be pending.

District Court

• Delaware: Aerin Medical Inc. and The Foundry LLC v. Neurent Medical Inc. and Neurent Medical Ltd., No. 1:23‑cv‑00756‑JLH (D. Del.) — identified by both parties in the IPR as the related matter involving the '318 patent.
• Companion IPRs on Aerin patents in the same campaign: IPR2024‑00275, ‑00276, ‑00277, ‑00279, ‑00280, ‑00282.

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5. What I could not confirm

• Verbatim text of dependent claims 2, 3, 7, 8, 11, 14 — not challenged in the IPR and not reproduced in the sources I retrieved.
• Current (April 2026) live status of CAFC No. 2025‑2100 — the only outcome record I found is the FRAP 42(b) dismissal order dated Aug. 27, 2026, which is inconsistent with your stated current date.
• Whether a Rule 36 or substantive CAFC opinion issued before dismissal — no merits opinion surfaced in my searches; the disposition appears to be voluntary dismissal rather than affirmance on the merits.
• Docket Alarm reports "PTA 36 Months" for application 16/412,982 while the patent face states 168 days. These are inconsistent; I flag rather than reconcile them.

I'll search for litigation specifically tied to US 11,033,318.

Let me pin down the Delaware docket details, the consolidation, and the CAFC appeal status.

Let me check for any other district court cases involving the '318 patent and the current posture of the Delaware case.

Litigation Involving US Patent 11,033,318 — Case-by-Case

Building on the prior summary (which covered the PTAB and CAFC dockets), here is the full litigation picture for the specific patent 11,033,318 ("the '318 patent"). Searches were run against Docket Alarm's patent-indexed search (patent:(11033318)), CourtListener/RECAP, Justia Dockets, RPX Insight, and the PTAB/CAFC records.

Bottom line: The '318 patent has been asserted in exactly one district court action, plus one related IPR (and its appeal). I found no other plaintiffs, defendants, or jurisdictions.

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1. District Court — the operative infringement case

The '318 patent's role in the case. It is one of eight patents-in-suit: the '597, '194, '675, '011, '318, '271, '077, and '286 patents. Aerin owns the '318 patent by assignment from inventors Scott J. Wolf and Andrew Frazier (Amended Complaint ¶¶33–34). The complaint asserts claims 1, 4, 5, 6, 9, 10, 12, 13, 15, 16, and 17 of the '318 patent against the Neuromark system, and pleads direct (§271(a)), induced (§271(b)), and contributory (§271(c)) infringement, plus willfulness based on pre-suit notice (including Aerin's Sept. 28, 2022 letter to Neurent CEO Brian Shields identifying the '318 patent) and Neurent's citation of the '318 patent's published application (US 2019/0282289) during prosecution of its own applications.

Procedural timeline (from the CourtListener/RECAP docket):

• Jul. 11, 2023 — Complaint filed; summons issued.
• Jul. 12, 2023 — Neurent Medical Inc. served.
• Oct. 2, 2023 — Neurent motion to dismiss / partial dismissal (D.I. 12); Oct. 16, 2023 — Amended Complaint (D.I. 17).
• Mar. 21, 2024 — Answer and counterclaims (D.I. 40).
• May 7, 2024 — Protective order resolving a prosecution-bar dispute (Dkt. 66, 68); the court adopted defendants' "bright-line" bar preventing barred attorneys from arguing motions to amend in IPRs. This is the decision written up in the Jones Day PTAB Litigation Blog ("District Court Charts Middle Ground In Prosecution Bar").
• Jul. 8, 2024 — Court denied Neurent's partial-dismissal motion (D.I. 74).
• Aug. 8, 2024 — Court entered the parties' stipulation staying the case until the PTAB issues a final written decision in each pending IPR against the Aerin/Foundry patents (D.I. 93).
• Nov. 26, 2024 — Aerin moved to consolidate with C.A. No. 24-1070-JLH and stay the consolidated case (D.I. 96).
• Feb. 28, 2025 — Court granted consolidation in part; ordered a stipulation/order of consolidation and an interim schedule.
• Sep. 18, 2025 — Amended Complaints filed (D.I. 133, 134); Oct. 2, 2025 — Answers/counterclaims (D.I. 144) and further motions to dismiss.
• Aug. 19, 2025 / Dec. 23, 2025 — Orders setting/resetting claim construction briefing and scheduling deadlines.

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2. Consolidated companion case (does not itself assert the '318 patent)

⚠️ Note on scope: This case is often reported alongside the '318 litigation because it is now consolidated with it, but the '318 patent is not one of the patents asserted in the '1070 action. Separately, Neurent's counterclaim in the '756 action added an infringement claim against Aerin on U.S. Patent No. 11,998,262 ("the '262 patent") — again, a Neurent patent, not the '318.

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3. PTAB proceeding on the '318 patent (adversarial, but not district court litigation)

Related IPRs in the same campaign (each on a different patent, not '318): IPR2024-00275, -00276 (terminated — adverse judgment after Aerin disclaimed all challenged claims), -00277 ('271 patent), -00279/-00280/-00281 (Foundry patents), -00282 ('286 patent), and -00669.

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4. Federal Circuit appeal

🚩 Date anomaly — flagged, not reconciled: That dismissal order is dated August 27, 2026, which post-dates the stated current date of April 26, 2026. I am reporting the document exactly as retrieved. Treat the dismissal as provisionally confirmed but unverified as of April 26, 2026; if the 2026-08-27 date is a docket artifact, the appeal of IPR2024-00278 may still be pending. Note also that IPR2024-00278's docket still shows "Final Written Decision — Appealed" as its status on the PTAB aggregators.

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5. What is not litigation on this patent (to avoid confusion)

• IPR2025-01124, -01125, -01126, -01127 (filed June 2025) — Aerin Medical as petitioner against Neurent Medical, status "Discretionary Denial." These challenge Neurent's patents, not the '318 patent.
• IPR2024-00669 — Neurent against The Foundry, LLC on a Foundry patent; not the '318.
• No foreign litigation on the '318 patent surfaced in my searches beyond the Darts-IP "first worldwide family litigation" flag on the Google Patents page, which points to the same U.S. Aerin/Neurent family dispute.

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6. Caveats and open items

1. No other district court cases. I found no case, in any district, in which a party other than Neurent is accused of infringing the '318 patent, and no case in which Aerin is a defendant specifically on the '318 patent.
2. Case-number formatting. The '756 action is rendered as 1:23-cv-00756, 1:23-cv-00756-JLH, 23-756 (JLH), and 23-756 (GBW) across sources. I have reported each literally rather than harmonizing; Judge Jennifer L. Hall (JLH) is the consistent presiding judge in PACER records.
3. Current (April 26, 2026) posture. The last docket events I could retrieve run through December 23, 2025 (claim-construction scheduling orders). Whether the stay was lifted following the July 11, 2025 FWDs — and how the appeal dismissal (if effective) affects the stay — is not confirmable from the sources retrieved. I am withholding a conclusion on the present stay status rather than guessing.
4. The '318 patent is patentably invalidated in the PTAB's judgment (all challenged claims held unpatentable), which is why the district court case was stayed; the operative question for the litigation going forward is the fate of that FWD on appeal.

I'll reconcile the canonical ODP block (which shows no AIA trials) against the IPR surfaced in the prior sections, and verify claim-level outcomes.

Now let me verify the Federal Circuit disposition and check for any second IPR on this patent.

Let me check whether the appeals were dismissed pursuant to settlement, and whether the PTO has issued certificates canceling the claims.

Proceedings overview

The structured ODP block says zero AIA trials on US 11,033,318 — that is wrong. The "PTAB proceedings on file" block states: "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest." That ingest is stale. The primary record shows one IPR on this exact patent — IPR2024-00278 — which went to a Final Written Decision holding every challenged claim unpatentable, and whose appeal was dismissed in 2026. I am reporting the ODP block literally and then overriding it with the primary documents, as your instructions permit ("web search may surface older or recently-filed proceedings the ODP hasn't indexed yet — flag any you find").

Bottom line for a defendant: this patent is a dead letter. IPR2024-00278 went to a FWD on 2025-07-11 holding claims 1, 4–6, 9, 10, 12, 13, and 15–17 unpatentable under 35 U.S.C. § 318(a), and the Federal Circuit dismissed Aerin's appeal under Fed. R. App. P. 42(b) on 2026-08-27. There are no active proceedings, no institution denials, and no settlements-that-preserved-claims. If a demand letter cites the '318 patent today, it is citing a patent whose independent claim 1 has been canceled by the Board and whose cancellation is now final on appeal. This is the opposite of a "hardened" patent.

Because only one proceeding exists on this patent, the "one per proceeding" format below covers it; the rest of the campaign (which is on other Aerin/Foundry patents) is handled in the Strategic Summary so it is not confused with the '318 docket.

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IPR2024-00278 — Neurent Medical Inc. & Neurent Medical Ltd. v. Aerin Medical Inc.

• Type: Inter Partes Review (AIA), 35 U.S.C. § 311

• Filed: 2024-01-18

• Status: "Final Written Decision - Appealed" (verbatim from the PTAB aggregators: Docket Alarm, IPVerse/GreyB, Ex Parte). Plain-English gloss: the FWD issued; Patent Owner noticed appeal; and the CAFC dismissed that appeal under FRAP 42(b) on 2026-08-27, so the FWD is final. The aggregator status string has not been refreshed to reflect the dismissal.

• Judge panel: APJs Michael J. Fitzpatrick, Zhenyu Yang, and Michael A. Valek; opinion authored by Valek. (Same panel as the companion IPRs.)

• Petition grounds: All grounds were § 103 obviousness. Petition challenged claims 1, 4–6, 9, 10, 12, 13, and 15–17.

  • Ground I: Edwards-'535 (US 6,517,535) + Stern (US 5,562,720) — claims 1, 4, 5, 9, 10, 12, 13, 15–17.
  • Ground involving Makower (US 2005/0240147) + Stern — claims 1, 4–6, 12, 13, 15–17.
  • Additional grounds added Patel (US 2007/0287994) and Edwards-'886 (US 6,273,886) to reach specific dependent claims (segmented/shape-memory treatment element; RF generator/frequency limitations).
  • ⚠️ Flag — ground numbering conflict in my sources. The third-party petition summary at ai-lab.exparte.com labels the Makower+Stern combination "Ground II," while Aerin's own Patent Owner's Response labels the surviving reference to that combination as "Ground IV" ("Petitioners' proposed combinations of Edwards-535 and Stern (Ground I) and Makower and Stern (Ground IV)"). I cannot reconcile the numbering without the face of the Petition. The grounds are reliable; the sequential numbers are not. Treat "Ground I = Edwards-'535 + Stern" as confirmed and the intervening ground numbers as unsettled.

• Institution decision: Instituted 2024-07-22 (Paper 9), granting trial on all challenged claims — a 100% institution. The Board's institution reasoning per the decision caption was a § 314 grant; I did not retrieve the full institution text, so I am not characterizing the panel's institution-stage reasoning beyond the fact of full institution.

• Final Written Decision: Issued 2025-07-11 (Paper 37). Caption: "JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a)." Holding, quoted: "we find that Petitioner has shown by a preponderance of the evidence that all of the challenged claims are unpatentable."

  • Claim-level verdict, quoted exactly as the FWD states the claim set: "claims 1, 4-6, 9, 10, 12, 13, and 15-17."
    • Canceled/unpatentable: 1, 4, 5, 6, 9, 10, 12, 13, 15, 16, 17 (all 11 challenged claims).
    • Held patentable: none. The panel found all challenged claims unpatentable; no challenged claim survived.
    • Not addressed by the FWD (not challenged): 2, 3, 7, 8, 11, 14. Do not read the FWD as having passed on these — it did not.
  • Dispositive issue (the crux): the two limitations added during prosecution to overcome Makower — (i) "multiple pairs of bipolar radiofrequency electrodes" and (ii) "multiple radiofrequency output channels connected with the multiple pairs of bipolar radiofrequency electrodes, wherein each pair … is connected with a respective one of the multiple radiofrequency output channels." Aerin's position, quoted from its Response: "Petitioners rely upon only a single reference (Stern) as allegedly teaching these claim limitations for all grounds. However, Stern fails to do so. As shown herein, Stern teaches a device comprising only a single pair of bipolar radiofrequency electrodes and a single radiofrequency output channel." The Board rejected that and adopted Petitioner's reading of Stern's switching/output-channel architecture. Cross-examination admissions of Petitioner's expert (Martin transcripts, Exs. 2003–2005) were the battleground Aerin tried to use; the Board was not persuaded.
  • Oral argument: heard 2025-04-23 (transcript, Paper 36).

• Settlement / termination: No settlement. The proceeding ran to a merits FWD and terminated 2025-07-11. The later FRAP 42(b) dismissal of the appeal was "the parties having so agreed" — which ordinarily signals a global resolution, but I did not retrieve any public settlement agreement, and the terms, if any, are not in the record I reviewed. I am withholding a conclusion on whether a business settlement underlies the dismissal.

• Appeal: Yes. Patent Owner Aerin Medical Inc. filed a Notice of Appeal 2025-09-11 (Paper 38), docketed at the Federal Circuit as No. 2025-2100 on 2025-09-12. It was consolidated on appeal with Aerin's appeals from IPR2024-00277 and IPR2024-00282 (Nos. 2025-2099, 2025-2100, 2025-2101), and in the same order with The Foundry's appeals from IPR2024-00279, -00280, and -00669 (Nos. 2025-2113, -2114, -2121).

  • Disposition: DISMISSED under Fed. R. App. P. 42(b), each side to bear its own costs, by nonprecedential order of 2026-08-27: https://www.cafc.uscourts.gov/opinions-orders/25-2099.ORDER.8-27-2026_2746255.pdf (also at https://www.cafc.uscourts.gov/08-27-2026-25-2099-aerin-medical-inc-v-neurent-medical-inc-order-25-2099-order-8-27-2026_2746255/). The order states "The parties having so agreed, it is ordered that: (1) The proceedings are DISMISSED under Fed. R. App. P. 42(b)" and "ISSUED AS A MANDATE."
  • No merits ruling. This is a voluntary dismissal by agreement, not an affirmance. There is no Rule 36 judgment and no substantive CAFC opinion on the obviousness holding. The practical effect, however, is that the FWD stands as the final agency decision — the Board's cancellation of claims 1, 4–6, 9, 10, 12, 13, and 15–17 is not subject to further appeal.
  • ✅ Prior-section date anomaly — now resolved. Earlier sections flagged that the 2026-08-27 dismissal "post-dates the stated current date of April 26, 2026." With today's date of 2026-09-16, the dismissal is in the past and consistent. There is no anomaly: treat the dismissal as confirmed and effective.
  • ⚠️ One thing I could not confirm: whether the Director has issued the § 318(b) certificate canceling the claims (which normally issues once the FWD is final and the appeal is resolved). I found no certificate document. The legal effect of cancellation follows from the FWD's finality, but the paper certificate itself is unverified.

• Defensive value: Devastating to any assertion of this patent. The sole independent claim (claim 1) is canceled, and every other claim in the patent depends from claim 1 — so the dependent claims 4–6, 9, 10, 12, 13, and 15–17 fall with it, and even the untested dependent claims 2, 3, 7, 8, 11, and 14 cannot be separately asserted because they incorporate a canceled base claim. An infringement theory built on the '318 patent today is not merely weak; it is untenable, and pressing it after the FWD became final invites fee-shifting and Rule 11 exposure. Pull the FWD before responding to any demand letter that cites 11,033,318 and quote the disposition line verbatim.

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Strategic summary

Claim status on US 11,033,318. The patent has 17 claims, one independent (claim 1). IPR2024-00278 challenged 11 of them and the Board held all 11 — claims 1, 4–6, 9, 10, 12, 13, 15–17 — unpatentable. No challenged claim was sustained. The six claims the Board never touched — 2, 3, 7, 8, 11, and 14 — are all dependents of claim 1; because claim 1 is canceled, they are inoperative and cannot be asserted on their own. Net effect: the entire patent is neutralized, not merely narrowed. There is no "surviving claim" set to design around. Because the appeal was dismissed rather than decided, there is no CAFC precedent on the obviousness holding and no chance of a remand reviving the claims — but also no affirmance opinion to cite as estoppel-generating precedent.

Estoppel landscape. Under 35 U.S.C. § 315(e)(2), Petitioners Neurent Medical Inc. and Neurent Medical Ltd. (the only named real parties in interest) and their privies are estopped in the Delaware action from asserting invalidity on any ground raised or that reasonably could have been raised in IPR2024-00278. That estoppel is now largely academic — the claims are canceled, so there is nothing left to invalidate or to infringe. For a different, non-privy defendant, § 315(e)(2) estoppel does not attach, but it also does not matter: the Board's unpatentability determination, unappealed and final, is available as highly persuasive authority (and the cancellation would be dispositive if the certificate has issued). Note that PTAB FWDs do not have collateral-estoppel effect on district courts, so a court technically retains power to reach a different conclusion — but no rational defendant would spend the money when the claims are already canceled at the PTO. The prior-art grounds remain on the table for a non-privy challenger: Edwards-'535 (US 6,517,535) + Stern (US 5,562,720), Makower (US 2005/0240147) + Stern, plus Patel (US 2007/0287994) and Edwards-'886 (US 6,273,886). Those are the proven kill-shots if any claim somehow resurrects.

Pattern signals and one attribution trap. This is a competitor-vs-competitor fight, not a troll or defensive-aggregator case. The petitioner is Neurent Medical, Aerin's direct commercial rival (Neuromark vs. RhinAer/VivAer), and the proceeding is one of a nine-plus-IPR parallel campaign the parties fired at each other in 2024–2025: on the Aerin/Foundry side, IPR2024-00275, -00276 (terminated by adverse judgment after Aerin disclaimed all challenged claims), -00277 ('271 patent), -00278 ('318 — this proceeding), -00279, -00280, -00281 (terminated), -00282 ('286 patent), and -00669; and on the Neurent side, IPR2025-01124/-01125/-01126/-01127 (Aerin as petitioner against Neurent's '262, '889, '973, '974 patents), which were met with discretionary denial. Only IPR2024-00278 concerns the '318 patent — do not attribute any of the sibling outcomes to this patent. Aerin appealed the adverse FWDs (Nos. 2025-2099/2100/2101 and, for Foundry, 2025-2113/2114/2121) and then walked away from all of them on 2026-08-27 via a single agreed FRAP 42(b) dismissal, which is the classic signature of a global settlement reached while the appeals were pending.

⚠️ Attribution trap to flag. Google Patents' litigation banner for this patent links the PTAB case to portal.unifiedpatents.com/ptab/case/IPR2024-00278 and labels the source "Unified Patents PTAB Data." Unified Patents is not the petitioner — that string is a Creative Commons data-licensing attribution for the patent-search platform, not a party identity. The PTAB and Docket Alarm records both name Neurent Medical Inc. and Neurent Medical Ltd. as petitioners and real parties in interest. There is no defensive aggregator anywhere in this chain.

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Recommended next steps

1. If you are a defendant and you have been accused on 11,033,318, cite the FWD now. Link directly to the Final Written Decision: https://www.docketalarm.com/cases/PTAB/IPR2024-00278/Neurent_Medical_Inc._v._Aerin_Medical_Inc/docs/07-11-2025-Board/Final_Written_Decision__original-37-Final_Written_Decision__original.pdf and quote the disposition verbatim: "JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a)" and "we find that Petitioner has shown by a preponderance of the evidence that all of the challenged claims are unpatentable." Pair that with the CAFC dismissal order (FRAP 42(b), 2026-08-27) to establish finality. Position: claims 1, 4–6, 9, 10, 12, 13, and 15–17 are canceled; the remaining dependents 2, 3, 7, 8, 11, and 14 cannot be asserted because they depend from canceled claim 1.
2. No trial-stage milestones are pending on this patent. IPR2024-00278 terminated at FWD on 2025-07-11; the statutory § 316(a)(11) one-year clock is spent, and the appeal is dismissed. There is nothing to wait for.
3. Verify the § 318(b) certificate. Request from Patent Center / the USPTO Patent Public Search the certificate canceling claims 1, 4–6, 9, 10, 12, 13, and 15–17. I could not retrieve it; its issuance would convert the cancellation from a matter of the FWD's finality into a paper record you can attach to a motion or a case-dispositive letter.
4. Check the Delaware docket for the downstream effect. The '318 was one of eight patents-in-suit in Aerin Medical Inc. and The Foundry, LLC v. Neurent Medical Inc. and Neurent Medical Ltd., C.A. No. 1:23-cv-00756-JLH (D. Del.), which had been stayed pending the FWDs. Confirm whether the parties' agreed dismissal of the appeals was accompanied by a stipulated dismissal of the litigation and whether the stay was lifted. I did not confirm this — do not assume it.
5. Correct the ODP record. The structured ODP block asserting "no AIA trial proceedings" for 11,033,318 is demonstrably stale and should not be relied on for this patent. If you are running a portfolio screen, re-pull from PTAB E2E / PTAB Decisions rather than the ODP ingest. Cite: PTAB E2E / PTAB Decisions, IPR2024-00278 (paper 37, FWD, 2025-07-11); Docket Alarm docket for IPR2024-00278; Federal Circuit No. 2025-2100 (consolidated with 2025-2099, 2025-2101) order of 2026-08-27; IPVerse/GreyB case page for IPR2024-00278.

Confidence and open items. High confidence on: proceeding number, parties, filing/institution/FWD dates, panel, challenged claim set, all-challenged-claims-unpatentable outcome, and the FRAP 42(b) dismissal. Explicitly uncertain: (a) the sequential ground numbering (Ground I confirmed; Grounds II/IV conflict between sources); (b) whether the FWD addresses any claim beyond the 11 challenged claims (it does not, as best I can tell); (c) whether a written settlement agreement exists behind the agreed dismissal; (d) issuance of the § 318(b) certificate; and (e) the current post-dismissal posture of the Delaware stay. I have flagged rather than guessed on each.

I'll research the assignment records and cross-reference ownership details before building the chain.

Let me dig into the corporate/ownership details and the security-interest financing.

Let me try to pin down actual reel/frame recordation identifiers.

Assignment Record — US Patent 11,033,318 B2

Sourcing note (read first). I could not reach assignmentcenter.uspto.gov or assignment.uspto.gov directly from this environment, and the retrieval of the raw index rows (which carry the reel/frame and correspondent fields) failed. What I do have is the Google Patents legal-events block for US 11,033,318, which mirrors the USPTO assignment index for this patent (same conveyance descriptions and recording dates). Everything below is grounded in those entries plus court/SEC records. I am not supplying reel/frame numbers or correspondent names because I did not retrieve them, and I will not fabricate them. Treat the reel/frame and correspondent columns as an explicit gap in this analysis, not as "no data exists."

⚠️ Contradiction flagged. The previously generated sections repeatedly referenced "your stated current date of April 26, 2026." The current task header states today is 2026-09-16. This matters: the CAFC FRAP 42(b) dismissal dated 2026-08-27 that the earlier sections flagged as a date anomaly is now a past event and is consistent. I therefore no longer treat that dismissal as unverified — but I have not independently re-retrieved the order, so I mark it provisionally confirmed. The earlier "April 26, 2026" framing should be disregarded.

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Inventors

Basis: the recorded "ASSIGNMENT OF ASSIGNORS' INTEREST" entries name Wolf, Scott J. and Frazier, Andrew as assignors and Aerin Medical, Inc. as assignee (recorded 2019-08-05). The patent names only these two inventors.

Pattern check — no adverse pattern.

• No 12-month inventor exodus. Both inventors re-appear as named inventors on later Aerin continuations in the same family (e.g., US 12,053,227, filed 2021-12-27, inventors Wolf (Menlo Park) and Frazier (Sunnyvale); assignee Aerin Medical Inc. (Sunnyvale, CA)). Continuity across a decade of filings is the opposite of the pre-fire-sale tell.
• No inventorship churn or corrective assignment appears in the record.
• ⚠️ Uncertainty: the earliest priority provisional (61/496,930, 2011-06-14) predates the '982 filing by eight years. I could not verify who the inventors' employer was in June 2011 specifically; Aerin Medical is described as founded in 2011, so the 2011 employer is likely Aerin or its immediate predecessor, but I will not state that as fact.

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Original assignee

Aerin Medical Inc. (also rendered "Aerin Medical, Inc."), a Delaware corporation; at issue its principal place of business was 2526 Leghorn Street, Mountain View, CA 94043, and it is later reported at 232 E Caribbean Drive, Sunnyvale, CA (Mountain View/Sunnyvale both appear across records — reported literally, not harmonized).

• Did it ship a product embodying the claims? — Yes, and it still does. The '318 family covers Aerin's temperature-controlled RF nasal technology. Aerin announced FDA clearance and launch of the VivAer® Stylus in January 2018 and the RhinAer® Stylus in March 2020 (RhinAer's 510(k) clearance being December 2019). This is the same RF generator + wand-like stylus architecture recited in the '318 patent's claim 1 (expandable treatment element, bipolar electrode array, per-pair RF channels, distributed sensors).
• Primary line of business: ENT/medical device — non-invasive, temperature-controlled radiofrequency systems for nasal airway obstruction (VivAer) and chronic rhinitis (RhinAer), sold to otolaryngologists for in-office use. Aerin's own litigation pleading describes it as "in the business of developing, manufacturing, and marketing innovative solutions for chronic rhinitis and nasal airway obstruction."
• Current status: OPERATING. Not acquired, not dissolved, not in bankruptcy. It is a private, venture-backed company; it closed a $60M equity financing led by Ally Bridge Group with participation from KCK MedTech, Questa Capital, and OrbiMed; CEO Matt Brokaw; and in March 2026 announced that more than 200,000 patients had been treated with RhinAer and VivAer.
• Related entity — The Foundry, LLC (California LLC, 4040 Campbell Ave. Suite 110, Menlo Park, CA 94025). The Foundry is a co-plaintiff with Aerin in the Delaware action and Neurent characterizes certain asserted patents as "owned by The Foundry LLC and allegedly exclusively licensed by" Aerin. However, the '318 patent itself is owned by Aerin Medical Inc., not The Foundry — the '318 is simply grouped with the "Aerin/Foundry Patents" in the case. Foundry's Rule 7.1 disclosure lists no parents or affiliates, so I cannot confirm a corporate link from the record; the affiliation is inferred from joint assertion, not proven by an assignment.

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Assignment timeline

The Assignment Center / assignment index does contain records for this patent. There is no post-issuance ownership transfer — the patent has never left the Aerin orbit. The complete chain is a single inventor→company assignment plus a single collateral lien:

• Executed date not retrieved / recorded 2019-08-05 — Reel/frame: not retrieved ⚠️

  • Conveyance: Assignment of Assignors' Interest (Assignment)
  • Assignor: Scott J. Wolf; Andrew Frazier
  • Assignee: AERIN MEDICAL, INC.
  • Correspondent: not retrieved — I could not obtain the recorded correspondent field. (Litigation counsel of record for Aerin is Finnegan, Henderson, Farabow, Garrett & Dunner — per-case counsel Sahlsten, Jakes, Daley, Joyce, Silver, Galleher — but I have no evidence Finnegan filed the assignment recording, and I will not attribute that.)
  • Context: Original acquisition — the inventors' routine assignment of rights to their employer/company.
  • Note on duplication: the index shows two Aerin-received entries both dated 2019-08-05 with the same assignors and the same "ASSIGNMENT OF ASSIGNORS' INTEREST" description, one under "AERIN MEDICAL, INC." and one under "AERIN MEDICAL INC." This is characteristic of one assignment recorded against both the parent and the '982 continuation, or of a duplicate recordation — I report both literally rather than merging them.

• Executed/recorded 2024-12-20 — Reel/frame: not retrieved ⚠️

  • Conveyance: Security Interest (Security Agreement)
  • Assignor: AERIN MEDICAL INC.
  • Assignee: ARES CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
  • Correspondent: not retrieved
  • Context: Securitization / collateral lien — not an ownership transfer. Corroborated by SEC filings: Ares Capital Corporation reports a first lien senior secured loan to Aerin Medical Inc. (health care equipment), coupon 11.06%, SOFR(S) + 6.75%, acquisition date 12/2024, maturity 12/2030, principal ≈ $14.0M, also reflected in the Ares Strategic Income Fund 10-K for FY2024. The December 2024 loan date matches the December 2024 security-interest recording on the '318 patent.

• No release-of-security, merger, change-of-name, license, or corrective assignment appears in the retrieved record.

Bottom line for this section: the '318 patent remains owned by Aerin Medical Inc. The only ownership conveyance in its entire history is the 2019-08-05 inventor assignment. The 2024-12-20 Ares record is a lien, which encumbers the portfolio but does not change title. No transfer to an asserter or holding LLC exists in the record.

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Timeline diagram

timeline
    title Ownership of US 11033318
    2011 : Earliest priority provisional filed
    2012 : Nonprovisional filed by Aerin
    2019 : Application 16 412 982 filed
         : Inventors assign rights to Aerin Medical Inc
    2021 : Patent issues June 15
    2023 : Aerin and The Foundry sue Neurent
    2024 : Security interest recorded to Ares Capital
    2025 : PTAB finds challenged claims unpatentable
         : Aerin appeals to Federal Circuit
    2026 : Federal Circuit appeal dismissed

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NPE / troll-pattern signals

Adjacent fact worth flagging (not an NPE signal): the Ares Capital security interest means the Aerin/Foundry portfolio, including the '318 patent, is pledged as loan collateral with a 2030 maturity. A foreclosure or restructuring could, in principle, move title — but as of the record retrieved, no such transfer has occurred, and a secured lender's collateral agent is not an NPE.

Also relevant to value, not to NPE status: the asserted claims of the '318 patent (1, 4–6, 9–10, 12–13, 15–17) were all held unpatentable in IPR2024-00278 (FWD 2025-07-11), and Aerin's appeal (CAFC Nos. 2025-2099/2100/2101) was dismissed under FRAP 42(b) per the order dated 2026-08-27. That diminishes assertion value but does not change the ownership analysis.

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Verdict

Operating-company assertion.

Aerin Medical Inc. is the original and current assignee of US 11,033,318 by the single recorded inventor assignment dated 2019-08-05, has never transferred ownership to any third party, and ships products embodying the claims — the VivAer (launched January 2018) and RhinAer (launched March 2020) temperature-controlled RF systems. It is asserting the patent, alongside its affiliate The Foundry, LLC, against a direct competitor (Neurent Medical) in D. Del. C.A. No. 1:23-cv-00756. The only other recorded entry, the 2024-12-20 security interest to Ares Capital Corporation as administrative/collateral agent, is a collateral lien secured by a first-lien senior secured loan (SOFR(S)+6.75%, maturing 12/2030) — it encumbers the asset but transfers no ownership, and it is not an NPE signal.

Verification: https://assignmentcenter.uspto.gov/ (search patent number 11033318) — and the mirrored legal-events record at https://patents.google.com/patent/US11033318/en. Please confirm the reel/frame and correspondent fields at the Assignment Center directly, since those two columns are the only material gaps in this reconstruction and are exactly the fields the task asks to be captured carefully.

Explicit non-findings / gaps, stated plainly so they are not mistaken for evidence:

1. Reel/frame numbers — NOT RETRIEVED for any entry. No numbers are asserted above.
2. Correspondent of record — NOT RETRIEVED for any entry. Signal 3 is therefore unclear, not negative.
3. Execution dates — NOT RETRIEVED; only recording dates (2019-08-05 and 2024-12-20) are stated.
4. No records were found of any assignment to a licensing entity, NPE, or defensive aggregator, and none is inferred from Aerin's corporate structure or from The Foundry, LLC's name.

I'll research the prior-art citations for US 11,033,318 specifically, including the references cited on the patent face and the IPR grounds.

Let me pull the full "References Cited" list from the patent and the details of the key IPR references.

Let me get the specific bibliographic details of each key reference.

Prior-Art Analysis for US 11,033,318 B2 — Scope, Method, and Caveats First

Method. I ran targeted searches against Google Patents, the IPR2024‑00278 record (Petition, Patent Owner Response, Petitioner Reply, expert exhibits), Unified Patents' "Patent Art (232)" listing, and a PubMed/patent mirror that reproduces the '318 front-page citation lists. Where retrievable, I identify the reference by its own number, filing/publication date, and content.

Three hard caveats, stated up front rather than papered over:

1. I could not retrieve the verbatim (56) "References Cited" block from the '318 patent face in this session. The tool-call budget expired while I was pulling bibliographic records. What I have is (a) the Google Patents "Citations (93)" listing, (b) the partial front-page list reproduced in Aerin's Ex‑2009 (from IPR2024‑00277), and (c) the Unified Patents "Patent Art (232)" list. These are reconstructions, not the certified front page. I flag every entry whose numbering I could not fully verify.
2. The '318 record's operative prior-art attacks are § 103 obviousness, not § 102 anticipation. This is the single most important framing point for your question. Every ground in IPR2024‑00278 is a combination (Ground I: Edwards‑'535 + Stern; Ground II: Edwards‑'535 + Stern + Patel; Ground III: Makower + Stern; Ground IV: Makower + Stern; Ground V: + Edwards‑'886). No single cited reference is on record as anticipating issued claim 1. Claim 1 was deliberately narrowed during prosecution precisely to escape a § 102 anticipation rejection over Makower. So the honest § 102 answer is: most of these references do not anticipate any claim as issued; they are § 103 art. I map them below anyway, claim by claim, because you asked.
3. Pre‑AIA vs. AIA. The earliest priority date is June 14, 2011 (Google) / June 13, 2011 (Unified) — before March 16, 2013. If the § 112 support chain holds, pre‑AIA § 102 (including § 102(b) "more than one year before" and § 102(e)) governs. The dominant references here are 1996–2005, so they are prior art under any regime. This distinction is noted but not dispositive for the references listed.

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Part A — The Substantive References (the ones that actually did work)

These are the five references the Board and the examiner relied on. They are the "most relevant prior art" in the operative sense.

Claim‑by‑claim synthesis for Part A (the Board's mapping, not mine):

• Claim 1 — Grounds I/II/III/IV, all § 103 (Edwards‑'535 + Stern; Makower + Stern).
• Claims 4–5 — § 103; Stern's segmented bladder read onto the "multiple segments" limitation (the Board accepted that a Stern "segment" powered by the Fig. 15 bipolar schematic contains a pair of electrodes).
• Claim 6 — § 103 over Edwards‑'535 + Stern + Patel (shape-memory alloy).
• Claims 9–10 — § 103 adding Edwards‑'886.
• Claims 12, 13, 15–17 — § 103 (electrode type/arrangement; claim 15's two-row arrangement mapped to Stern).
• Claims 2, 3, 7, 8, 11, 14 — not challenged; no § 102 position on them appears anywhere in the record I retrieved.

⚠️ Contradiction flag with the previously generated sections: The prior summary states claim 10 "adds RF frequency/power-type limitations per the Edwards‑886 ground." My searches returned the same association but also returned Ground II as "Edwards‑'535 + Stern + Patel," while the Petitioner Reply text I retrieved labels the Makower+Stern ground as "Ground IV." The Ex Parte abstract labels Makower+Stern as Ground II. The ground numbering is internally inconsistent across the Petition, the Reply, and the third-party abstract. I am not reconciling them; the mapping of references to claims is stable, but the Ground numbers are not.

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Part B — Face-Cited / Examiner-Cited References (the "References Cited" population)

Google Patents reports 93 citations. These are overwhelmingly Somnus/Edwards airway-ablation family and nasal-dilator art. Representative entries, grouped by what they actually teach:

B1. Somnus Medical Technologies / Stuart D. Edwards airway-ablation family (the dominant block)

US 5,718,702; US 5,738,114; US 5,743,870; US 5,743,904; US 5,746,224; US 5,800,429; US 5,807,306; US 5,820,580; US 5,823,197; US 5,827,277; US 5,843,021; US 5,843,077; US 5,846,235; US 5,879,349; US 5,938,659; US 6,045,549; US 6,096,033; US 6,102,907; US 6,109,268; US 6,126,657; US 6,131,579; US 6,139,546; US 6,152,143; US 6,165,173; US 6,179,803; US 6,210,355; US 6,228,079; US 6,231,569; US 6,293,941; US 6,309,386; US 6,371,926; US 6,391,028; US 6,416,491; US 6,425,151; US 6,451,013; US 6,502,574; US 6,551,310; US 6,562,036; US 6,575,969; US 6,589,235; US 6,659,106.

Description: RF/energy ablation of upper-airway and turbinate tissue (including turbinate ablation, tongue-base ablation, uvula/soft-palate treatment) via catheters, expandable members, and needle electrodes; several teach multiplexed or independently-driven electrode outputs. Representative concrete examples:

• US 5,622,439 ("Method and apparatus for treatment of air way obstructions," filed Aug. 18, 1995) expressly states "Each RF electrode 18 is connected to resources which generate an independent output for each RF electrode 18" and describes a multiplexer coupled to RF electrodes 18 to provide ablation at different sites and at different time periods. This is a substantive § 102/§ 103 teaching directly on the "multiple output channels" limitation — and it sits inside the cited-art block.
• US 5,728,094 (Edwards, filed May 3, 1996) and US 5,738,114 / 5,811,798 / 5,707,349 / 5,711,702 / 5,730,719 / 5,743,870 / 5,746,224 — the Somnus airway-obstruction series.
• US 5,846,235 and US 6,383,181 — cryogenic-therapy delivery (cited in the '318 specification itself).

§ 102 exposure: Individually these are largely directed to turbinates, tongue base, uvula and palate — not to the internal/external nasal valve. Their anticipation value is therefore limited: they do not by themselves disclose "reshape a region of the nose… at a nasal valve." Their real role is § 103 as evidence that nasal RF ablation with expandable elements and independently-driven electrode outputs was known.

B2. External / internal nasal dilators (cited in the '318 specification by name)

• US 5,533,499 — Johnson, nasal dilator ("Breathe Right"-type strip).
• US 7,114,495 — Lockwood, nasal dilator.
• US 7,055,523 — Brown, "Internal nasal dilator and delivery mechanism" (Brown Innovation LLC; priority 2005).
• US 6,978,781 — Jordan, "Nasal dilator" (2005).

Description: Mechanical, non-energy nasal dilators. § 102 exposure: essentially none for the '318's energy-delivery claims — the '318 specification cites them expressly as the inadequate prior approaches being improved upon.

B3. Electrosurgical / thermocouple instrumentation

• US 4,411,266 — Cosman, "Thermocouple radio frequency lesion electrode."
• US 4,532,924 — "Multipolar electrosurgical device and method."
• US 4,565,200 — Cosman, "Universal lesion and recording electrode system."
• US 4,887,605 — Angelsen et al. (12/1989), laser-treatment elements (cited in the '318 specification).

§ 102 exposure: none for the nasal-reshaping method; relevant only to the temperature-sensing and multipolar-electrode dependent claims (a § 103 / § 112-support role).

B4. Method-of-treatment / cartilage-reshaping references (cited in the '318 specification)

• US 6,589,235 — "Cartilage reshaping by radiofrequency heating."
• US 7,416,550 — controlling/monitoring shape change in tissue such as cartilage.
• US 6,551,310 — endoscopic ablation at a controlled depth (RF, non-ionizing UV, warm fluid, microwave); cited in the specification.
• US 6,451,013 — ablating tissue at a targeted depth from within a body lumen; cited in the specification.

§ 102 exposure: These are the closest art to the method aspects (cartilage conformation change), but they are cartilage-generic, not nasal-valve-specific, and they do not disclose the claimed bipolar-pair/per-channel architecture. § 103 relevance only.

B5. Other face-cited background art

US 1,798,902 (Raney); US 3,901,241 (cryosurgical instrument); US 4,011,872 (Olympus coeloma apparatus); US 4,196,724 (Frecker, tongue-locking device, 1978); US 4,421,381/4,423,812 (cassette receptacle); US 4,901,737 (Toone, snoring reduction); US 4,906,203; US 5,534,499; US 5,542,916; US 5,611,798; US 5,624,439; US 5,674,191; US 5,707,349; US 5,729,094; US 5,730,719; US 5,733,280; US 5,738,114; US 5,743,870; US 5,743,904; US 5,746,224; US 5,800,429; US 5,807,306; US 5,816,095; US 5,817,049; US 5,820,580; US 5,823,197; US 5,827,277; US 5,843,021; US 5,843,077; US 5,846,235; US 5,879,349; US 5,938,659; US 6,045,549; US 6,096,033; US 6,102,907; US 6,109,268; US 6,126,657; US 6,131,579; US 6,139,546; US 6,152,143; US 6,165,173; US 6,179,803; US 6,210,355; US 6,228,079; US 6,231,569; US 6,293,941; US 6,309,386; US 6,371,926; US 6,383,181; US 6,391,028; US 6,416,491; US 6,425,151; US 6,451,013; US 6,502,574; US 6,551,310; US 6,562,036; US 6,575,969; US 6,589,235; US 6,659,106; US 6,911,027; US 6,978,781; US 7,055,523; US 7,097,641; US 7,114,495; US 7,322,993; US 7,361,168; US 7,416,550; US 7,442,191; US 7,655,243; US 7,678,069; US 7,780,730; US 7,824,394; US 7,850,683; US 7,997,278; US 8,114,062; US 8,128,617; US 8,137,345; US 8,317,781; US 8,317,782. Plus WO 99/07299, WO 01/43653, WO 03/024349, and CN 101325919.

⚠️ Do not read this list as prior art against the '318 patent en bloc. It is contaminated with Aerin's own family (US 8,936,594; 8,986,301; 9,027,597; 9,072,597; 9,125,677; 9,179,964; 9,179,967; 9,237,924; 9,247,989; 9,415,194; 9,433,463; 9,452,010; 9,452,087; 9,486,278; 9,526,571; 9,687,288; and the '318's own parents 14/319,087; 14/754,087; 15/272,007; 15/686,265). Members of the same family sharing the June 14, 2011 priority date are not § 102 art against the '318 patent unless a specific claim's effective filing date is later. Any assertion that, e.g., US 9,072,597 anticipates the '318 patent would be a self-collision error, not anticipation.

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Part C — Non-Patent Literature and Other Art Identified

• Hytönen (2009) — relied on as IPR Ex‑1022 ("U.S. Patent App. No. … (2009) ('Hytönen')"). Full citation not confirmed in this session. Per the exhibit index it is a § 103 reference, not a § 102 reference.
• Cole, "The Four Components of the Nasal Valve," Am. J. Rhinology 17(2):107–110 (2003) and Cole, "Biophysics of Nasal Air Flow," Am. J. Rhinology 14(4):245–249 (2000) — background physiology, cited in the specification.
• Stewart MG et al., NOSE scale, Otolaryngol Head Neck Surg 2004;130:157–63 — outcome-measure background.
• Buckley et al., "High-resolution spatial mapping of shear properties in cartilage," J. Biomech. 43(4):796–800 (2010) — cited on a related Aerin family member's face.
• Uddströmmer (1940); Van Dishoeck (1942); Bridger & Proctor (1970); Bachman & Legler (1972); Haight & Cole (1983); Mink (1903) — historical nasal-valve literature recited in the specification.

§ 102 exposure: none. These are background/support references, not anticipatory art.

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Part D — Direct Answer to the § 102 Question

Which cited reference(s) potentially anticipate which claim(s)?

1. As issued, no single reference in the record anticipates claim 1. Claim 1 requires, conjunctively: (a) multiple pairs of bipolar RF electrodes on the tissue treatment surface; (b) multiple RF output channels; and (c) each pair connected with a respective one of those channels. The prosecution history — confirmed in the IPR record — shows that Makower (US 2005/0240147) produced a § 102 anticipation rejection against the broader claim, and Aerin overcame it by amendment adding exactly limitations (a) and (c). So the § 102 threat from Makower was, by construction, extinguished for the issued claim. What remained was a § 103 gap-fill using Stern (US 5,562,720).
2. US 5,562,720 (Stern) is the reference that carries the § 102-adjacent substance — it discloses multiple bipolar pairs with per-pair channel switching. But the Board applied it in combination, i.e., § 103, because Stern is endometrial ablation art and the claims are nasal-airway claims.
3. US 6,517,535 (Edwards‑'535) anticipates only a pre-narrowment nasal RF device with an expandable member; against issued claim 1 it is § 103 art.
4. US 2007/0287994 (Patel) and US 6,273,886 (Edwards‑'886) are § 103-only references directed to claim 6 (shape-memory segments) and claims 9–10 (RF generator), respectively.
5. Every other cited reference — the Somnus/Edwards airway-ablation block, the nasal dilators, the electrosurgical instrumentation, and the non-patent literature — is § 103 background art at best. Their collective relevance is that nasal RF ablation with expandable elements and independently-driven electrode channels was known before June 2011, which is precisely the theory on which the Board held all challenged claims unpatentable (FWD, July 11, 2025).

Bottom line: For US 11,033,318, the operative "most relevant prior art" is the five-reference set US 6,517,535 + US 5,562,720 + US 2005/0240147 + US 2007/0287994 + US 6,273,886, deployed as a § 103 mosaic. The only reference with a documented § 102 history is Makower (US 2005/0240147), and it anticipated only the pre-amendment claim.

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Part E — What I Could Not Confirm (stated rather than guessed)

1. The verbatim (56) "References Cited" list and its exact sub-categories (patent documents vs. publications vs. non-patent literature; "cited by examiner" vs. "cited by applicant"). My Part B list is a reconstruction from Google Patents, Ex‑2009, and Unified Patents, and I have not verified each number's presence on the certified front page.
2. Titles, inventors, assignees, and exact dates for US 5,562,720 (Stern), US 2007/0287994 (Patel), US 6,273,886 (Edwards‑'886), and Hytönen (2009). Only US 6,517,535 (Edwards; filed Nov. 9, 1999; issued Feb. 11, 2003; Gyrus ENT) was fully reverified.
3. The internal Ground-numbering inconsistency in IPR2024‑00278 (Grounds II/IV swapped as between the Petition/Reply and third-party abstracts) — flagged, not resolved.
4. Whether any § 102 ground was asserted against the unchallenged dependent claims 2, 3, 7, 8, 11, 14 — no such position appears in any source I retrieved.
5. The date anomaly already flagged in the prior sections (the Federal Circuit FRAP 42(b) dismissal order dated Aug. 27, 2026, versus the stated current date of April 26, 2026) is not resolved by anything in this prior-art search.

I'll ground the prior-art reference disclosures before building the §103 analysis.

Let me pull the remaining references and the FWD specifics.

Now the FWD specifics and any objective-indicia record.

Obviousness Analysis of US 11,033,318 B2 under 35 U.S.C. § 103

Analyst note on scope: This section builds on the earlier bibliographic, claim, and litigation summaries and does not repeat them. I treat the supplied patent text as authoritative, and I use the prior-art record of this page (the "Prior art keywords" field, the references cited in the specification, and the references on which the '318 claims were actually tested in IPR2024‑00278). Where the prior-art records contradict anything, I prefer the record. All statutory citations are to § 103; where the record invokes AIA § 102 subsections I report that literally.

Identifier discipline: I use US 11,033,318, application 16/412,982, IPR2024‑00278, and the reference names exactly as they appear in the record (Edwards‑535, Stern, Makower, Patel, Edwards‑886, "Edwards-'886" with the typographic apostrophe), and I do not normalize the 2011‑06‑13 / 2011‑06‑14 discrepancy.

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1. The "Prior Art" record on this page — what it actually contains

The supplied page carries a "Prior art keywords" field reading, literally: nasal; tissue; treatment; electrodes; energy. That field is a Google Patents text-classification artifact, not a reference list. The page as supplied does not include a formatted "Cited By," "Similar Documents," or "Prior Art" tabular listing, so a § 103 analysis cannot be run off that field alone.

I therefore use, in order of weight:

(a) The references cited in the '318 specification itself (the applicant's own admission of the art):

• U.S. Pat. No. 5,533,499 (Johnson) and U.S. Pat. No. 7,114,495 (Lockwood) — external nasal dilator strips.
• U.S. Pat. No. 7,055,523 (Brown) and U.S. Pat. No. 6,978,781 (Jordan) — temporary intranasal devices.
• U.S. Pat. No. 6,551,310, U.S. Pat. No. 6,451,013, U.S. Pat. No. 4,887,605 — endoscopic/controlled-depth ablation and laser treatment elements.
• U.S. Pat. No. 6,589,235 and U.S. Pat. No. 7,416,550 — cartilage reshaping by radiofrequency heating and controlling/monitoring shape change in tissue such as cartilage.
• U.S. Pat. No. 6,383,181 and U.S. Pat. No. 5,846,235 — cryogenic therapy delivery elements (incorporated by reference).

(b) The four references that actually decided the '318 claims in IPR2024‑00278 (per the Petition's Ground table, reproduced in the institution decision):

Ground table as instituted (verbatim structure from the institution decision, Ex. 1001 cites at 52:15–36 and 52:45–54:16):

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2. Level of ordinary skill in the art (the second Graham factor)

The record supports a POSITA with a bachelor's degree in biomedical/mechanical/electrical engineering (or equivalent), plus roughly 2–4 years of experience designing energy-delivery or RF surgical devices, or a medical degree with surgical/otolaryngology experience plus comparable device experience — the level reflected in the parties' competing expert declarations (Ex. 1002, Dr. Gregory T. Martin, for Petitioner; Ex. 2001, Dr. Marom Bikson, for Patent Owner). No party appears to have staked a claim-construction or validity position on the precise skill level, and the Board's analysis does not turn on it.

Practically, the POSITA here is a device engineer working in the well-trodden overlap of (i) RF electrosurgery generators/systems and (ii) expandable intraluminal treatment elements — a field with decades of dense prior art (Edwards‑535, Stern, Edwards‑886, Makower all sit in it).

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3. Scope and content of the prior art (first Graham factor)

3.1 Edwards‑535 — the base device

Edwards‑535 teaches an expandable apparatus (element 132) that conforms to the surface of a nasal concha / turbinate and delivers RF energy to mucosal tissue to improve airflow. Its disclosure is explicit that:

• the energy delivery member may include multiple "ring electrodes 156," and energy "may be independently delivered to each [electrode]" (Ex. 1010 at 8:18–25);
• its system can deliver "bipolar or monopolar energy" (id. at 10:52–57);
• RF energy is "preferably" in the MHz range (id. at 11:46–12:4).

Critically — and this is the pivot of the whole § 103 case — Edwards‑535 "omits details on how to implement such energy delivery": it does not teach how to pair bipolar electrodes or wire them. That omission is what the Petition characterized as a device "ready for improvement."

3.2 Stern — the missing implementation

Stern is directed to selective destruction of the endometrium using ablative RF while sparing the underlying myometrium. Its apparatus includes a conventional RF generator 158, a separate power source controller 156, a computer 164, an application device 124 with an electrode balloon 150, and a reference/belt electrode 154 (FIG. 12; 10:36–55). FIG. 15 shows a voltage source 228, electrodes 220, 222, 224, 226, a grounding pad 230, and nine switches 232–240. Per the Institution Decision and Petition, Stern's switching scheme connects each bipolar pair to voltage source 228 via separate output channels to accomplish independent activation of each pair.

3.3 Makower — nasal applicability

Makower (US 2005/0240147 A1) is directed to "devices, systems and methods for diagnosing and treating sinusitis and other disorders of the ears, nose and/or throat," and discloses an electrosurgical device with an expandable, multi-strut treatment element and bipolar electrodes (FIG. 5H being the embodiment the parties focused on in the companion proceedings). Makower was the Examiner's identified closest prior art against the family, and the '318 claims were amended during prosecution to avoid Makower.

3.4 Patel and Edwards‑886 — narrow, claim-specific supplements

• Patel supplies multiple-segment / shape-memory-alloy (nitinol, superelastic spline) expandable structures relevant to claim 6.
• Edwards‑886 shares a common inventor with Edwards‑535 and teaches bipolar RF mucosal ablation with a sinusoidal waveform at 460 kHz and generator power in the 5–75 W band — squarely relevant to claims 9 and 10.

3.5 Admitted art in the '318 specification

The '318's own Background/admissions are damaging and independently support § 103:

• U.S. Pat. No. 6,589,235 is described as teaching "methods and device for cartilage reshaping by radiofrequency heating," and U.S. Pat. No. 7,416,550 as teaching "methods and devices for controlling and monitoring shape change in tissues, such as cartilage." The '318 specification then states that "energy may be delivered into the cartilage tissue to cause a conformational change and/or a change in the physical properties of the cartilage," and that energy may be delivered "using needles, probes or microneedles" through the overlying mucosa.
• The specification expressly states that "sensing the temperature involves sensing multiple temperatures with multiple thermocouples located at or near multiple electrode pairs," and that "each of the electrode pairs is adjustable separately from adjustment of any other of the electrode pairs."

Those passages are essentially a road map to the challenged claim limitations, written by the applicant.

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4. Differences between claim 1 and the prior art (third Graham factor) — limitation-by-limitation

Claim 1 (Ex. 1001 at 52:15–36, reproduced verbatim in the Institution Decision) is the sole independent claim. Mapping:

The only genuinely contested limitations are [1d] and [1e]. Everything else was effectively conceded or mapped without dispositive dispute.

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5. Motivation to combine, and reasonable expectation of success

5.1 Analogous art

Both Edwards‑535 and Stern are in the same field of endeavor — RF ablation devices that insert an expandable member carrying surface electrodes into a body cavity to ablate mucosal tissue — and are reasonably pertinent to the problem the '318 addresses. Stern need not be nasal art for this purpose: the pairing-and-wiring solution is a general RF-power-distribution technique, not a uterine-specific one. The Petition frames it exactly this way: the references are "in the same field as the '318 patent and … reasonably pertinent to solving the problems addressed in the '318 patent—treating tissue in a body cavity—with the same types of solutions—applying bipolar RF energy to tissue via an expandable device having surface electrodes."

5.2 The KSR rationales actually available

(1) Known technique applied to a known, improvement-ready device. Edwards‑535 expressly discloses the goal ("energy … may be independently delivered to each [electrode]") but omits the implementation. Stern supplies a known technique — pair the electrodes, give each pair its own output channel via a switching scheme. Under KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007), "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill."

(2) Predictable results / simple substitution. The combination introduces no new mechanism of action: it swaps Stern's known power-distribution architecture into Edwards‑535's known electrode-bearing expandable member. "[A]pplying Stern's known bipolar pairing technique to Edwards‑535's known device … to yield predictable results."

(3) Teaching, suggestion, or motivation in the references themselves. Stern expressly touts the benefits of its pairing scheme — precise control of current location, directing heat to targeted tissue while protecting surrounding areas, and more uniform heating. Those benefits are especially compelling in the nose, where the mucosa is thin and overlies cartilage: over-treatment risks cartilage damage and necrosis, under-treatment risks incomplete remodeling. "[U]sing Stern's known bipolar pairing technique would have improved Edwards‑'535's similar device in the same way as Stern's."

(4) Design incentive / duplication of parts. The record also reflects the rationale that providing two rows of electrode pairs and per-pair channels permits simple, selective energy application and control, and can be implemented by duplicating known parts rather than inventing new ones.

5.3 Reasonable expectation of success

The petition's showing was that the combination "involve[d] using a known technique (pairing bipolar electrodes and wiring them to individual output channels) to improve similar devices … in the same way," producing "predictable results." Because Edwards‑535 itself acknowledges that independent per-electrode delivery is desired, and because wiring electrodes to independent generator channels was routine RF-generator engineering, the Board found a reasonable expectation of success. This is a predictable-results posture, not an "obvious to try" posture — which makes it the stronger form of a § 103 case.

5.4 Independent § 103 route via the prosecution history

There is a second, independent § 103 theory that does not depend on Edwards‑535 at all: Makower + Stern. Makower was the Examiner's closest prior art, and the applicant amended the claims to overcome Makower by adding exactly (i) multiple pairs of bipolar electrodes and (ii) multiple output channels each connected to a respective pair. Stern — not before the Examiner — teaches precisely those added features. A claim limitation added to escape art, and then shown to be taught by art that was not considered, is a classic § 103 alignment. The Petition made this the centerpiece of Ground II.

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6. The dependent claims

6.1 Claims 4–6 (treatment element comprising multiple segments)

• Claims 4–5: Stern's segmented expandable bladder with electrodes on the expandable member supplies the multiple-segment treatment element. Motivation: segmenting the expandable member allows different regions to expand to different configurations — exactly the '318's own stated design goal ("the treatment element 32 may expand with various locations on the element expanding to different configurations or not expanding at all to achieve a desired shape").
• Claim 6: adds shape-memory-alloy teaching. Edwards‑535 + Stern + Patel (Ground 1 of the claim-6 attack; also reached via Makower + Stern). The rationale is the well-known superelastic benefit: a nitinol/superelastic treatment element can be collapsed for trans-nostril delivery and self-expand to a preselected treatment shape, which the Petition supported with the Board's acceptance that "nitinol has very good thermo…" properties (Ex. 1061, Szold, cited in the Martin declaration).

6.2 Claims 9–10 (radiofrequency generator; power)

• Claim 9 adds a radiofrequency generator. Edwards‑535, Stern (generator 158 + power source controller 156), Makower, and Edwards‑886 each teach RF generators, so this limitation adds nothing patentable over the base combination.
• Claim 10 adds generator operating parameters. The record shows claim 10 reciting power of between 5 and 75 watts, and Edwards‑535 itself teaches that range. The Martin declaration also addressed the 460 kHz sinusoidal waveform taught by Edwards‑886, reasoning that a POSITA would have found it obvious to apply Edwards‑886's frequency/waveform because "Edwards‑'535 and Edwards‑'886 share a common inventor and are both related to similar devices used for similar purposes," and because 460 kHz was known to be adequate for RF ablation of mucosal tissue. Edwards‑535's "preferably MHz" statement was held not to teach away, since it was a preference (and the Petition argued it may be a typographical error for the more common kHz range — an argument the Board credited).
• Statutory note on parameter claims: a recitation of a known, result-effective operating range (5–75 W; ~460 kHz) is presumptively obvious where the art recognizes the variable as one to be optimized. That is the posture here.

6.3 Claims 12, 13, 15–17 (type/configuration of electrodes — e.g., two rows; penetrating vs. non-penetrating)

• Edwards‑535's ring electrodes 156 and Stern's two-row electrode layout supply the row/configuration limitations. The record shows the Board's Ground I reaching claims 12, 13, and 15–17 on Edwards‑535 + Stern, and Ground II reaching claims 12, 13, and 15–17 on Makower + Stern — i.e., the electrode-arrangement claims fell on the same two combinations as claim 1.
• The only real fight was whether Stern's FIG. 15 teaches "two rows of pairs" (see § 7.1).

6.4 Claims 2, 3, 7, 8, 11, 14 — not challenged; my § 103 view is withheld

These claims were not challenged in IPR2024‑00278 and their verbatim text was not recovered in this analysis. I therefore do not opine on their obviousness. However, I note a caution for anyone running a follow-on validity analysis: the '318 specification discloses, as described embodiments, cooling members, sensors for temperature and impedance, and an average of multiple thermocouple readings — features that map onto the typical subject matter of un-challenged dependent claims in this family. The Board in companion IPRs entertained analogous materials, and the Board's opinion in the '271 proceeding reflected Petitioner arguments about claims 9[a]/9[b] of the '318 relating to a generator configured to deliver energy "separately" and a "cable." If follow-on claims recite cooling, thermocouple averaging, or display/feedback elements, the '318's own specification and the cited U.S. Pat. Nos. 6,589,235 / 7,416,550 become the primary § 103 starting points. This is a flagged inference about unretrieved claim text, not a conclusion about claims 2, 3, 7, 8, 11, or 14.

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7. Where the § 103 case is vulnerable (the appeal issues)

7.1 Ground I/II — the "single pair, single channel" dispute

This was the issue, and it is worth stating precisely because it is what the FWD turned on and what Aerin noticed on appeal.

• Aerin's position (Dr. Bikson, Ex. 2001 ¶ 59): "Stern teaches a device configured to have at most a single pair of bipolar radiofrequency electrodes," and a single radiofrequency output channel. Aerin characterized Stern's FIG. 15 as showing "a voltage source 228, four electrodes 220, 222, 224, and 226, a grounding pad 230, and nine switches 232, 234, 236, …" — i.e., a monopolar arrangement with a return pad, which cannot be "multiple pairs of bipolar electrodes."
• Petitioner's position (Dr. Martin, Ex. 1002 ¶¶ 101, 116, 124, 143): "To accomplish independent activation of each electrode pair, Stern's switching scheme connects each bipolar pair to voltage source 228 via separate output channels."
• The Board sided with Petitioner and found all challenged claims unpatentable.

Analyst view: This is a factual question about what FIG. 15 discloses and how a POSITA would read it, which on appeal is reviewed for substantial evidence. The patentability determination rises or falls almost entirely on that reading. Note also that Aerin's reliance on the "plural" presumption (that "pairs" requires more than one pair) is a claim-construction argument that cuts for Aerin on the claim language but does not help if FIG. 15 really does show more than one pair — hence the factual fight.

7.2 Limitation [1f] (sensors)

I could not retrieve the Petition's verbatim mapping for limitation [1f] (multiple sensors on the tissue treatment surface selected from impedance sensors, electrodes, and thermocouples). The institution decision's analysis section and the Petition excerpts I recovered focus on [1d] and [1e]. Because [1f] is a closed Markush group ("selected from the group consisting of…"), any single prior-art sensor of that type satisfies it — but I am not asserting which reference the Petition used, because I did not verify it. This is an open item, not a finding.

7.3 Physical-combinability attack (Edwards‑535's expandable ring electrodes)

Aerin's expert raised a genuine mechanical objection during the Martin deposition: if Edwards‑535's ring electrodes are rigid metal rings wrapped around an expandable member, they "would not expand with the expandable member," and then "the electrodes [would not contact] the tissue, [and] they don't deliver radiofrequency energy to the tissue." Aerin's counsel pressed exactly this: "if the electrodes are not contacting the tissue, they essentially don't work for the purposes of radiofrequency ablation."

This is the strongest non-obviousness theory in the record: it attacks operability of the combination, not merely motivation. Its force depends on (i) whether Edwards‑535's ring electrodes are disclosed as expandable/conformal, and (ii) whether the Stern-derived electrode layout would be substituted for, or added to, Edwards‑535's rings. The Board rejected it; on appeal it is a substantial-evidence question.

7.4 Prosecution-disclaimer / claim-construction overlays

Because the claims were narrowed during prosecution to overcome Makower, and because the Board's construction of "each pair … connected with a respective one of the multiple radiofrequency output channels" is what makes Stern's switch architecture dispositive, the intrinsic record (the amendment and applicant's remarks) is the most likely source of an appealable construction error. If the claims are construed to require dedicated, discrete channels (rather than a switch-selectable common source), Stern's FIG. 15 architecture may or may not satisfy it — a tension the FRAP 42(b) dismissal (below) means was never resolved on the merits.

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8. Objective indicia of non-obviousness (fourth Graham factor)

I did not locate any secondary-considerations evidence in the retrieved record. The Petition, Institution Decision, and Patent Owner's Response excerpts I recovered address only the prima facie § 103 case and the Stern "single pair" dispute. I do not read the record as affirmatively showing that Aerin failed to present objective indicia — my targeted search for that material terminated early, so this is an open item rather than a negative finding.

If secondary considerations are to be assessed, the practitioner should test:

• Commercial success of the accused/patented commercial device, with a nexus to the specific claim limitations (here, the pairing + per-pair channel limitation narrowed during prosecution — a nexus to the amendment, not to nasal RF ablation generally).
• Long-felt need / failure of others in treating nasal valve obstruction non-invasively — which the '318 Background itself frames, while simultaneously citing stents, spreaders, Breathe Right-type strips, and intranasal devices as available solutions.
• Copying / industry praise, which would need to be tied to the claimed architecture rather than to the clinical result.

Nexus is the likely battleground: the commercial device's success may be attributable to the anatomical treatment method (which the specification discloses and which is not itself the challenged structure), rather than to the "multiple pairs, each with its own RF output channel" structure.

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9. Bottom line

Claims 1, 4–6, 9–10, 12–13, and 15–17 of US 11,033,318 are obvious under § 103 as determined in IPR2024‑00278 (Final Written Decision, July 11, 2025), on these combinations:

1. Edwards‑535 + Stern — claims 1, 4, 5, 9, 10, 12, 13, 15–17.
2. Edwards‑535 + Stern + Patel — claim 6.
3. Edwards‑535 + Stern + Edwards‑886 — claims 9, 10.
4. Makower + Stern — claims 1, 4–6, 12, 13, 15–17 (and Makower + Stern + Edwards‑886 for claims 9, 10).

The motivation to combine rests on four independent, KSR-consistent rationales: (i) applying a known technique (bipolar pairing + per-pair output channels) to a known device that is expressly improvement-ready because it omits exactly that implementation; (ii) predictable results from a substitution that changes no mechanism of action; (iii) the express benefits Stern claims for its pairing scheme — localized current, tissue protection, uniform heating — which are especially valuable in the thin-mucosa-over-cartilage environment of the nasal valve; and (iv) the applicant's own prosecution amendment, which narrowed over Makower by adding precisely the features Stern teaches. Claims 2, 3, 7, 8, 11, and 14 were never tested, and I withhold any opinion on them.

Posture caveat, carried forward and not reconciled: the earlier section flagged that the CAFC appeal (No. 2025‑2100, from IPR2024‑00278) appears dismissed under Fed. R. App. P. 42(b) by order dated August 27, 2026 — a date that post-dates the stated current date of April 26, 2026, and post-dates my own working date. I report it exactly as retrieved: if that dismissal is effective, the FWD's invalidation of claim 1 is unreviewed on the merits, and no court has passed on Aerin's "Stern teaches only a single pair / single channel" and "ring electrodes cannot expand" arguments. The district-court case (D. Del. 1:23‑cv‑00756‑JLH, stayed since Aug. 8, 2024 pending the FWDs) remains the forum where those invalidity issues would do their work through the lens of issue preclusion rather than direct review.

Primary sources: Google Patents US11033318B2 · Unified Patents IPR2024‑00278 portal · PTAB petition/exhibit filings (ptacts.uspto.gov petition 1555013) · IPR2024‑00278 case summary (Ex Parte) · IPR2024‑00278 docket (Docket Alarm) · GreyB IPVerse IPR2024‑00278 · Bloomberg Law, Case: Patents/Obviousness (P.T.A.B.), July 14, 2025