US 10894011

I'll verify the bibliographic data against the authoritative patent text I have, then check current USPTO/CAFC records for this specific patent number.

Let me pull the full claim set and check the CAFC docket.

Let me pin down the remaining independent claims of the '011 patent.

U.S. Patent No. 10,894,011 — Concise Summary

Searches performed against the specific number 10,894,011 (and its application 16/842,209) only; no similar-number substitutions were used. Bibliographic data below is taken from the authoritative patent text supplied (Google Patents record), cross-checked against the Justia claim rendering and the IPR2024-00280 record. Where I could not verify something, I say so.

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1. Bibliographic data

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2. Abstract (verbatim, as issued)

"Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems."

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3. Plain-language overview of the independent claims

Critical caveat first — the claims do not match the title/abstract. The title, abstract, and specification are about delivering a botulinum light chain and electroporating/sonoporating cell membranes. The granted independent claims contain no toxin, no light chain, no poration, and no permeabilization limitation at all. They are pure handheld energy-delivery apparatus claims directed to reducing nasal congestion. This corrects/flags the reconstruction used in the earlier "Prior art" section of this analysis (which assumed a toxin+poration claim scope); the earlier § 102 "bottom line" should be treated as withdrawn.

Independent claim 1 — handheld energy-delivery apparatus (verbatim, per the IPR record and Justia):

• Purpose: apparatus for treating a nasal condition by altering function of a patient's nasopharyngeal passage.
• (a) a hand-held elongate body with proximal and distal portions, the distal portion sized to sit inside the nasopharyngeal passage while the proximal portion stays outside it.
• (b) an energy transmission element in the distal portion that delivers energy to target tissue in the nasopharyngeal passage.
• (c) an energy source coupled to that element, supplying energy at parameters selected so that nasopharyngeal cells are altered and nasal congestion is reduced.

Independent claim 23 — temperature-based apparatus: an apparatus with an elongate body (proximal/distal, distal configured for the nasopharyngeal passage) and, instead of an "energy transmission element," a transmission element configured to change the temperature of the target tissue in the nasopharyngeal passage so as to disrupt neural activity there and thereby reduce nasal congestion. (Text quoted as rendered by Justia with elision; see uncertainty note.)

Dependent claims show the intended scope: 2 at least one electrode; 3 ultrasound transducer; 4 microwave antenna; 5 RF generator; 6 ultrasound generator; 7 AC or DC source; 8–10 element movable/laterally extendable; 12 sensing element; 14 monitoring system indicating degree of treatment; 15 agent delivery element for a therapeutic agent; 21 disable adrenergic cells; 24–27 (depend on 23) thermal transfer, disable adrenergic cells, block/disrupt acetylcholine production, fluid-filled transmission element.

Practical read: "handheld wand that puts RF/ultrasound/microwave/heat into the nasopharyngeal passage and reduces congestion." That is what an accused device (Neurent's NEUROMARK bipolar-RF handpiece) would be measured against — not the BoNT story in the abstract.

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4. Contradiction / disclosure flags (required)

1. Abstract vs. claims. The abstract describes BoNT light chain + membrane permeabilization; the independent claims recite none of it. Flagged, not reconciled.
2. Earlier "Prior art" section. Its reconstructed claim scope ("nasal BoNT-LC + energy poration") is wrong for the granted claims, as already noted in the earlier "Obviousness" section. The Tier-1 toxin references (Sanders '605, First '768, US 2005/007441, etc.) are not the art that reads on claims 1/23; the relevant art is intranasal RF/electrosurgical art (Saadat, Makower, Fang, Edwards-535, Stern).
3. Two independent claims, not three? The pre-grant publication US 2020/0238064 appears to have had three independent claims — 1, 16 (agent-delivery element), and 23 (temperature). In the granted patent the agent-delivery element appears as dependent claim 15. I could not confirm verbatim whether the granted set contains a third independent claim. Flag as unverified.
4. Claim 23 untested in the IPR. IPR2024-00280 challenged only claims 1–2, 5, 8–10, 12, 14. Claim 23 (the temperature independent claim) and claims 3–4, 6–7, 11, 13, 15–22, 24–29 were not challenged and remain untested.

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5. USPTO / PTAB / CAFC status for this exact patent (as of this review)

• IPR2024-00280, Neurent Medical Inc. & Neurent Medical Ltd. v. The Foundry, LLC — filed Jan. 18, 2024; instituted July 23, 2024; hearing June 17, 2025; Final Written Decision July 21, 2025 holding the challenged claims unpatentable; status "Final Written Decision – Appealed." Panel: Snedden (lead), Mitchell, Majors (TC 1600, AU 1645). Grounds on the record include Saadat (US 10,307,200) anticipation/obviousness and Makower + Fang + Edwards-535 obviousness; the Board also found the claims entitled to no earlier than an Oct. 22, 2019 effective filing date. No claims are formally canceled yet — cancellation awaits the appeal.
• CAFC No. 25-2121 — listed in the patent's litigation metadata as the Federal Circuit case for this patent. My searches this session returned no Federal Circuit docket page, briefing status, or 2026 argument date for 25-2121; I therefore cannot confirm the parties, the issues, or the current posture from a primary source. (The earlier sections noted the PTAB docket shows a Patent Owner notice of appeal, implying The Foundry/Aerin is the appellant.) Flagged as unverified.
• D. Del. C.A. No. 23-756 (JLH) (consolidated), Aerin Medical Inc. and The Foundry, LLC v. Neurent Medical Inc. and Neurent Medical Ltd. — filed July 11, 2023; the '011 patent is one of eight asserted patents in the Amended Complaint; the case was stayed in its entirety on Aug. 8, 2024 pending the Foundry IPRs' Final Written Decisions, with joint status-report scheduling activity in 2025 after the FWDs issued. (I did not verify whether the stay has since been lifted.)
• Related 2026 signal: the sibling Foundry/Aerin IPRs -00277, -00278, -00669 are also recorded as "Final Written Decision – Appealed," while -00279 was not appealed (IPVerse snapshot updated May 14, 2026).

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6. What I could not verify (explicit uncertainty)

1. Verbatim full text of all 29 claims (beyond claims 1–2, 5, 8–10, 12, 14 and the fragments of 3–4, 6–7, 15, 21, 23–27 quoted above).
2. Whether the granted set has a third independent claim (the published version's claim 16).
3. CAFC No. 25-2121 docket details and any 2026 disposition.
4. Whether the patent's maintenance fees are current and whether any PTA extends the stated July 21, 2026 expiration.
5. Current USPTO Patent Center "References Cited" list (not retrieved; the earlier Prior-art section's caveat stands).

Primary sources: authoritative Google Patents text (https://patents.google.com/patent/US10894011/en); claims rendering at https://patents.justia.com/patent/10894011; IPR2024-00280 papers (https://ptacts.uspto.gov/, https://www.docketalarm.com/cases/PTAB/IPR2024-00280/NEURENT_MEDICAL_INC._v._The_Foundry_LLC/); D. Del. joint status report (C.A. No. 23-756-JLH).

Litigation Involving U.S. Patent No. 10,894,011

Based on my searches (Docket Alarm, CourtListener, Finnegan case pages, PTAB/IPR databases, and the Google Patents litigation metadata for the '011 patent), the known proceedings are as follows:

1. District Court — Aerin Medical Inc. et al. v. Neurent Medical Inc. et al., No. 1:23-cv-00756 (D. Del.)

• Plaintiffs: Aerin Medical Inc.; The Foundry, LLC (owner of the '011 patent)
• Defendants: Neurent Medical Inc.; Neurent Medical Ltd.
• Jurisdiction: U.S. District Court for the District of Delaware (Judge Hall, per Finnegan's case page)
• Case number: 1:23-cv-00756 (also referenced as DDE-1-23-cv-00756)
• Filing date: July 11, 2023 (complaint with jury demand); amended complaint filed October 16, 2023, expressly asserting U.S. Patent No. 10,894,011 (along with Nos. 9,072,597; 9,415,194; 10,610,675; 11,033,318; 11,241,271; 11,679,077; and 11,766,286)
• Status: Pending. Defendants moved to dismiss for failure to state a claim (Oct. 2023); the docket reflects scheduling orders, claim-construction activity, and stay orders. No final judgment was found in my search.

2. Inter Partes Review — Neurent Medical Inc. v. The Foundry, LLC, IPR2024-00280 (P.T.A.B.)

• Petitioner: Neurent Medical Inc.
• Patent Owner: The Foundry, LLC
• Jurisdiction: Patent Trial and Appeal Board
• Proceeding number: IPR2024-00280 (challenging U.S. Patent No. 10,894,011, application 16/842,209)
• Filing date: January 18, 2024
• Institution decision: July 23, 2024
• Final Written Decision: July 21, 2025
• Status: "Final Written Decision – Appealed" (i.e., the FWD has been appealed to the Federal Circuit). Note: Google Patents labels the PTAB data source as "Unified Patents PTAB Data," but the actual petitioner identified in Docket Alarm/IPR databases is Neurent Medical Inc.

3. Federal Circuit Appeal — No. 25-2121 (Fed. Cir.)

• The Google Patents record for the '011 patent lists a Court of Appeals for the Federal Circuit case, No. 25-2121 (data via Unified Patents litigation records).
• Given the IPR2024-00280 status of "Appealed" and the timing, this appeal most likely corresponds to the appeal of the PTAB's Final Written Decision in IPR2024-00280 (i.e., Neurent Medical Inc. v. The Foundry, LLC).
• Caveat: My searches did not return a directly confirmable caption, filing date, or current status for CAFC No. 25-2121, so I cannot state its docket details with high confidence. I recommend verifying on PACER or the CAFC docket for the precise parties and status.

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Summary: The '011 patent is being asserted by The Foundry, LLC and Aerin Medical Inc. against Neurent Medical Inc./Ltd. in Delaware (1:23-cv-00756), and is the subject of Neurent's IPR2024-00280, which resulted in a Final Written Decision on July 21, 2025 that has been appealed (CAFC No. 25-2121). I did not find any other district-court cases, ITC investigations, or additional IPRs directed specifically to this patent number in my searches.

I'll verify the PTAB proceedings on this patent through targeted searches.

I've confirmed the core proceeding. Now let me get the FWD claim-level outcome, the petition grounds, and the CAFC appeal status.

I have sufficient verified data. Here is the PTAB proceedings report for US Patent 10,894,011.

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Proceedings overview

One AIA trial proceeding is on file for US 10,894,011 — IPR2024-00280 — and it is the worst-case outcome for the patent owner short of finality: the Board instituted, held the challenged claims unpatentable as obvious, and issued a Final Written Decision on 2025-07-21 that is now on appeal (CAFC docket 25-2121). There are zero active proceedings, zero settlements, zero institution denials, and zero claims yet formally canceled (cancellation awaits the appeal's end). Bottom line for a defendant: the only claims Neurent chose to challenge — 1-2, 5, 8-10, 12, and 14 — have been found unpatentable by an instituted Board panel, so the patent is badly wounded and the district-court infringement case (D. Del. 1:23-cv-00756) is stayed on that basis; but the FWD is not final, so the claims are not yet canceled and the patent owner is litigating the appeal.

Data-source flag: The canonical USPTO ODP block in this prompt reports no PTAB proceedings (the ODP ingest has not indexed this case). Web-verified records (PTACTS, DocketAlarm, IPVerse, Bloomberg Law, Finnegan) confirm IPR2024-00280. Treat the web-verified proceeding as authoritative. Also note the Google Patents "Petitioner: Unified Patents" label on the IPR link is a data-license attribution, not the petitioner — the actual petitioner is Neurent Medical Inc. and Neurent Medical Ltd. (WilmerHale).

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IPR2024-00280 — Neurent Medical Inc. & Neurent Medical Ltd. v. The Foundry, LLC

• Type: Inter Partes Review (35 U.S.C. § 311)
• Filed: 2024-01-18
• Status: "Final Written Decision - Appealed" — i.e., trial completed; FWD issued 2025-07-21; appeal pending at the Federal Circuit. (USPTO ODP structured block: none on file — discrepancy flagged above.)
• Judge panel: Sheridan K. Snedden (lead), Susan L. C. Mitchell, Timothy G. Majors (Tech Center 1600; Art Unit 1645)
• Petition grounds: § 103 obviousness over combinations of prior art. Per Bloomberg Law's FWD coverage (2025-07-22), the Board found the challenged claims obvious over combinations including (i) minimally invasive, catheter-based devices/systems for treating sinusitis and other ENT disorders, (ii) a reference on nasal endoscopy combined with multiple radiofrequency treatments for perennial allergic rhinitis, and (iii) additional art (snippet truncated). The specific reference identities and ground-by-ground mapping for this petition could not be verified verbatim from available sources — the sibling Foundry IPRs (IPR2024-00279, IPR2024-00669) used a Saadat / Deem / Makower / Fang reference set, but I will not assert those were the '011 grounds without the petition in hand.
• Claims challenged: Claims 1-2, 5, 8-10, 12, and 14 of US 10,894,011 (verified from Patent Owner's Request for Oral Argument, Paper, dated 2025-03-11, PTACTS).
• Institution decision: Granted — "DECISION Granting Institution of Inter Partes Review, 35 U.S.C. § 314," issued 2024-07-23. The Board rejected the patent owner's threshold challenges (e.g., the PO's POSITA arguments), consistent with its parallel decisions in the other Foundry IPRs.
• Final Written Decision (Paper 41, 2025-07-21): The Board determined the challenged claims unpatentable as obvious over the prior art (Bloomberg Law, 2025-07-22). I could not retrieve the FWD text itself to quote the panel's claim-by-claim reasoning, so I will not attribute specific findings to specific claims beyond the headline result. Termination date recorded: 2025-07-21. (Hearing was held 2025-06-17, per the DocketAlarm hearing-transcript entry; it had originally been scheduled for 2025-04-29.)
• Settlement / termination: No settlement. The proceeding terminated by FWD, not by agreement.
• Appeal: Yes — appealed to the Federal Circuit, docketed as 25-2121 (recorded in the Google Patents litigation links for this patent). Because the FWD was adverse to the patent owner, the appeal was presumptively brought by The Foundry/Aerin; I could not verify from available sources the appellant's identity, the issues on appeal, or any 2026 CAFC disposition — flag that as unverified.
• Defensive value: Very high, but not yet final. A defendant can point to a fully-tried, instituted IPR in which the Board found the asserted claims unpatentable — the same claims Neurent is accused of infringing in D. Del. 1:23-cv-00756 (which Judge Hall stayed on 2024-08-08 pending the Foundry IPR FWDs). Once the CAFC mandate issues (or appeal is dismissed), the Director will cancel claims 1-2, 5, 8-10, 12, and 14, and any infringement theory built on them dies with them. Until then, they remain technically in force — so the demand/assertion exposure is real but the trajectory is strongly in the defendant's favor.

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Strategic summary

Claims CANCELED vs. SUSTAINED vs. UNTESTED. No claims of '011 are formally canceled yet — the FWD is on appeal and no certificate of cancellation has issued. If the CAFC affirms (or the appeal is abandoned), claims 1-2, 5, 8-10, 12, and 14 will be canceled. No challenged claim was sustained as patentable (per the Bloomberg summary, the Board found the challenged claims unpatentable). Claims 3-4, 6-7, 11, 13, and 15+ (if any) were never challenged and remain untested — a defendant asserting invalidity defenses should map the surviving claim set from the patent as granted and consider whether any untested claim reads on the accused product.

Estoppel landscape. § 315(e)(2) estoppel binds only Neurent Medical Inc. and Neurent Medical Ltd. and their privies — they cannot re-litigate in the Delaware case any ground they raised or reasonably could have raised in IPR2024-00280. That is strategically irrelevant here because Neurent won at the Board and will use the FWD offensively. For a new defendant not in privity with Neurent, the IPR creates no estoppel: all § 102/§ 103 grounds remain available, and the Board's favorable obviousness findings plus its already-issued institution decision are powerful templates. The practical caution: with the appeal pending, the FWD is not yet final, so a district court may stay any new invalidity fight until the CAFC resolves 25-2121.

Pattern signals. This is one front of a coordinated eight-IPR wave Neurent filed the same day (2025-01-18) against the Foundry/Aerin rhinitis-treatment portfolio: IPR2024-00275, -00276 (Aerin patents; terminated — adverse judgment), -00277, -00278 (Aerin; FWD — appealed), -00279 ('675 patent, Foundry; FWD), -00280 ('011 patent, Foundry; FWD — appealed), -00282, and -00669 ('077 patent, Foundry — refiled after -00281 was terminated on 2024-04-24; FWD — appealed). Notably, the defense then counter-attacked: Aerin filed its own IPRs against Neurent's patents (IPR2025-01124 through -01127), all of which the Board discretionarily denied per IPVerse. No defensive aggregator (e.g., Unified Patents) is in the chain — this is a commercial competitor dispute (Aerin's VivAer/RhinAer vs. Neurent's Neuromark). The Foundry's litigation posture is aggressive (Finnegan + Greenberg Traurig, PTAB appeals), so expect the CAFC fight to be fully contested.

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Recommended next steps

1. Pull the FWD (Paper 41, 2025-07-21) and the institution decision (2025-07-23) from USPTO PTACTS/PTAB E2E (case IPR2024-00280; also mirrored at DocketAlarm and the Unified Patents PTAB portal, https://portal.unifiedpatents.com/ptab/case/IPR2024-00280). Confirm the claim-by-claim disposition and grounds before drafting any invalidity papers — I could not verify verbatim claim-level findings from the sources available.
2. Monitor CAFC docket 25-2121 (CourtListener/PACER). Key dates to watch: appellant's brief deadline, oral argument, and the mandate. The IPR one-year trial clock already ran (institution 2024-07-23 → FWD 2025-07-21, within the statutory window). Once the mandate issues, the Director's certificate canceling claims 1-2, 5, 8-10, 12, 14 is a ministerial next step.
3. In the Delaware case (1:23-cv-00756-JLH) — currently stayed since 2024-08-08 pending the FWDs — be ready to argue for continued stay through the CAFC appeal, and then to leverage the FWD (estoppel against Foundry/Aerin's infringement theories on the challenged claims, if affirmed). If you are a new defendant, do not rely on Neurent's estoppel — run your own § 102/§ 103 analysis and, if the appeal drags, consider a fresh IPR on any untested claims (3-4, 6-7, 11, 13, 15+) before the 1-year bar date from service of a complaint.

Bottom line: The patent is not dead yet, but the only IPR on file ended with the Board holding every challenged claim unpatentable, and the patent owner's appeal (25-2121) is the only thing keeping claims 1-2, 5, 8-10, 12, and 14 alive. That is about as good a defensive posture as a defendant can face from a first-touch IPR — proceed on the assumption the challenged claims fall, and build the defense around the untested remainder.

I have reached the search limit for this session. Based on the authoritative patent text provided, USPTO-side records surfaced through Google Patents, the IPR2024-00280 record, and the D. Del. docket (1:23-cv-00756), here is the full analysis. One transparency note up front: I could not retrieve reel/frame numbers from the USPTO Assignment Center directly, so reel/frame citations below are marked unverified; all party names and dates come from the Google Patents legal-event feed on the authoritative patent text and from court/PTAB filings.

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Inventors

• Mark E. Deem (Mountain View, CA) — co-founder/principal of The Foundry (medical device incubator, Menlo Park, CA). Repeat medical-device inventor; also listed on the many family members (7,608,275; 8,133,497; etc.).
• Hanson Gifford (Woodside, CA) — co-founder/principal of The Foundry; same pattern.

Pattern check: No unusual departure pattern. Both inventors are founders/principals of the original assignee itself, and the chain never left their orbit — this is the opposite of the "inventors flee, portfolio fire-sale" pattern. The invention traces to provisional 60/702,077 (July 22, 2005) and 60/747,771 (May 19, 2006), with the inventors assigning to their own company.

Original assignee

• Entity on the issued patent: The Foundry, LLC (California LLC, 4040 Campbell Ave. Suite 110, Menlo Park, CA 94025 — a real operating address, per the Amended Complaint in 1:23-cv-00756).
• Line of business: Medical device innovation incubator / venture developer. It does not itself manufacture; it develops and licenses platform technologies through portfolio companies.
• Product embodying the claims: Not shipped by Foundry itself, but practiced through Aerin Medical Inc., which the IPR2024-00280 mandatory notices identify as "the exclusive licensee of the '011 patent in the field of medical device treatments of the nasal cavity for any purpose." Aerin markets the FDA-cleared RhinAer® Stylus (cleared/launched March 2020 for chronic rhinitis) and VivAer® Stylus (January 2018), which embody the nasal-treatment claims.
• Current status: Operating. Active in litigation as patent owner and co-plaintiff.

Assignment timeline

Only two recorded assignments appear in the USPTO/Google Patents legal-event feed for this patent, both recorded the same week the application (16/842,209) was filed. No post-issuance transfers are recorded; the patent remains with The Foundry, LLC. (Reel/frame numbers not retrievable in this session — verify in Assignment Center; the event descriptions below are verbatim from the Google Patents legal-event feed in the authoritative patent text.)

• 2020-04-07 (recorded) — Reel/Frame: unverified — search "16/842,209" in Assignment Center

  • Conveyance: Assignment of Assignors Interest (recorded against the application the same day it was filed)
  • Assignor: Mark E. Deem; Hanson Gifford
  • Assignee: The Foundry, Inc.
  • Correspondent: not retrievable in this session (the application's prosecution was under Customer Number 021971; litigation/PTAB counsel is Finnegan, Henderson, Farabow, Garrett & Dunner)
  • Context: Standard inventors-to-company assignment; no NPE tell.

• 2020-04-08 (recorded) — Reel/Frame: unverified — search "The Foundry, Inc." in Assignment Center

  • Conveyance: Assignment of Assignors Interest
  • Assignor: The Foundry, Inc.
  • Assignee: The Foundry, LLC
  • Correspondent: not retrievable in this session
  • Context: Internal reorganization — conversion of the entity from Inc. to LLC (the same Menlo Park business), executed one day after the inventors' assignment. Not a transfer to a third party.

There are no recorded post-issuance assignments (nothing after the Jan. 19, 2021 grant). This is itself the key finding: the original assignee still owns the patent — no shell-entity chain exists. The secondary-scraper label "The Foundry (Supernatural)" on Golden wiki is a data artifact and is not corroborated by USPTO records or court filings.

Timeline diagram

timeline
    title Ownership of US 10894011
    2005 : Priority provisional filed
    2020 : Application 16/842-209 filed
         : Deem and Gifford assign to Foundry Inc
         : Foundry Inc converts to Foundry LLC
    2021 : Patent granted to Foundry LLC
    2023 : Suit filed vs Neurent in Delaware
    2024 : Neurent IPR instituted
    2025 : IPR final written decision appealed
    2026 : Anticipated term expiration

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The only transfer to an LLC (2020-04-08) is an Inc.→LLC conversion of the same operating business, whose real Menlo Park address is on the court record. No "IP / Patents / Holdings" name, no registered-agent address, no single-purpose Delaware LLC.

2. Known asserter in the chain — not present. Neither The Foundry, LLC nor Aerin Medical Inc. appears on the public NPE lists (Acacia, Marathon, Intellectual Ventures, Wi-LAN, Conversant, Vringo, Pendrell, Innovatio, MPHJ, Spangenberg entities, etc.). Aerin is a product company with FDA clearances; Foundry is a known incubator.

3. Repeat correspondent across the chain — unclear. I could not retrieve the correspondents of record for the two recorded assignments in this session. What is documented: prosecution was under Customer Number 021971, and PTAB/Delaware counsel for both Foundry and Aerin is Finnegan (lead: Kathleen A. Daley, Reg. 36,116; Customer Number 22,852) per the IPR2024-00280 mandatory notices — but that is litigation counsel, not an assignment correspondent, and Finnegan also represents operating companies, so no NPE inference is supportable.

4. Cascading transfers — not present. Two assignments, one day apart, both April 2020, reflecting inventors→company and company conversion. No chained LLCs, no multi-hop fire-sale.

5. Pre-litigation transfer — not present. The last recorded assignment is April 2020; the first suit naming the '011 patent (1:23-cv-00756, D. Del.) was filed July 11, 2023 — more than three years later. The chain was not arranged to enable assertion.

6. Bankruptcy fire-sale — not present. No Chapter 7/11 for Foundry; no court-ordered patent sale.

7. Privateering — not present. This is the inverse of privateering: an operating exclusive licensee (Aerin, which ships RhinAer and VivAer) co-suing with the owner against a direct competitor (Neurent's NEUROMARK® system for treating rhinitis — see Amended Complaint ¶1, ¶8). Standard exclusive-licensee co-plaintiff structure, not an NPE fronting for a practicing company.

8. Defensive aggregator (anti-NPE) — not present. Chain terminates at The Foundry, LLC, not RPX/AST/LOT/Unified/OIN.

Verdict

Operating-company assertion.

The '011 patent remains with The Foundry, LLC (no post-issuance assignments), and its exclusive licensee, Aerin Medical Inc., ships FDA-cleared products (RhinAer®/VivAer®) that practice the nasal-treatment claims; the July 11, 2023 Delaware suit is a competitor-vs-competitor enforcement against Neurent's NEUROMARK system, with the IPR2024-00280 Final Written Decision now on appeal at the CAFC (docket 25-2121). No shell transfers, no cascading LLC chain, no pre-litigation transfer, and no known NPE in the chain — none of the eight signals support a troll characterization. Note the term context: Google Patents lists an anticipated expiration of 2026-07-21 (20 years from the July 21, 2006 filing of parent 11/459,090), which is relevant background for the ongoing appeal but does not change the ownership analysis.

Verification link: https://assignmentcenter.uspto.gov/ — search Patent No. 10894011 or Application No. 16/842,209 to confirm the two 2020 assignments and capture reel/frame numbers and correspondents of record (not retrievable in this session).

I've reached the search limit for this session, so I'll provide the analysis based on the verified patent text and search results obtained, with clear flags on what could not be independently verified.

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Important caveat up front

I was unable to retrieve the official USPTO front-page "References Cited" list for US 10,894,011 B2 in this session (search limit reached; the provided patent excerpt also truncates before the claims/references sections). The Google Patents page for this patent does not render its citation list in the search snippets I obtained, and I could not pull USPTO Patent Center/PatFT.

What I can reliably report is the set of prior-art references expressly cited and incorporated in the specification of US 10,894,011 itself (Background of the Invention and incorporated-by-reference passages). These are the strongest proxies for the examiner-cited art, since the specification was drafted against them and the examiner's "References Cited" typically overlaps heavily with the applicant's disclosed art for a continuation of this family. I have also cross-checked family-member records (e.g., US 2010/0087775 A1, a sibling application shown in search results) that confirm the family's nasal-toxin-delivery lineage.

Treat the claim-level anticipation assessments below as conditional — the granted claim set was not verifiable verbatim (see the earlier section flagging this). I assess against the reconstructed independent claims: (1) nasal-cavity delivery of a botulinum toxin light chain (BoNT-LC) fragment to target cells combined with energy-induced reversible cell-membrane poration; (2) a delivery system (catheter/structure + energy applicator + toxin source); (3) nasopharynx/paranasal-sinus-targeted delivery with non-target shielding (olfactory bulb); (4) energy-parameter-limited variants (e.g., ~1–500 V pulses, ~5 μs–100 ms; or ultrasound/sonoporation parameters).

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Most relevant prior art for US 10,894,011

Tier 1 — Nasal botulinum delivery (directly on point for the nasal-treatment claims)

1. U.S. Pat. No. 5,766,605 — Sanders et al.

• Full citation: U.S. Patent No. 5,766,605, "Methods for treating rhinitis and other disorders using botulinum toxin," issued June 23, 1998 (cited in the specification as "U.S. Pat. No. 5,766,605 to Sanders").
• Description: Discloses introduction of intact botulinum toxin into the nasal passages to reduce mucus secretion, including Dr. Sanders' canine experiments referenced in the '011 patent's Background; targets epithelial/goblet cells in the nasal membrane responsible for mucus hypersecretion.
• § 102 potential: Strongest single-art candidate for any method claim that reaches the nasal membrane with a botulinum toxin to block mucus secretion. However, it discloses intact BoNT, not the light-chain fragment, and no energy-mediated permeabilization. It therefore would not anticipate the full reconstructed independent method claim (which requires both LC fragment and poration energy), but could anticipate a narrower claim or a claim limitation set lacking those elements. It is the primary art for the "nasal target region / goblet cell / mucus hypersecretion" limitations.

2. U.S. Pat. No. 6,063,768 — First

• Full citation: U.S. Patent No. 6,063,768, "Use of botulinum toxins for treating conditions of the head and neck," issued May 16, 2000 (cited in the specification as "U.S. Pat. No. 6,063,768 to First").
• Description: Discloses treating rhinorrhea, asthma, COPD, and other neurogenic conditions by administration of botulinum toxin — the specification cites it for exactly the "therapeutic target conditions" list.
• § 102 potential: Same analysis as Sanders — relevant to the condition/target-tissue limitations (rhinorrhea, nasal mucus production) but lacking the LC-fragment and energy-poration elements of the independent claims.

3. U.S. Pat. No. 6,974,578 (cited in the Background as "See also")

• Full citation: U.S. Patent No. 6,974,578 (nasal/otolaryngologic botulinum toxin delivery context cited in the Background near the Sanders discussion). Date not verifiable in this session; treat issue date as ~2005 (verify on PatFT).
• Description: Additional nasal/sinus botulinum delivery disclosure cited by the applicants as background.
• § 102 potential: Secondary nasal-delivery art; same element gaps as Sanders/First.

Tier 2 — Energy-mediated permeabilization + agent delivery (on point for the poration claims)

4. U.S. Pat. No. 6,601,581 — Babaev

• Full citation: U.S. Patent No. 6,601,581, "Apparatus and method for delivery of pharmaceutical agents using ultrasound," issued August 5, 2003 (specification: "U.S. Pat. No. 6,601,581 to Babaev," incorporated by reference in its entirety).
• Description: Ultrasound aerosolization/nebulization delivery of therapeutic agents, including pulmonary delivery techniques expressly incorporated by the '011 specification for the sonoporation aerosol embodiments (FIGS. 9, 11, 15).
• § 102 potential: Discloses the energy-delivery modality (ultrasound) combined with agent delivery to respiratory targets, but not botulinum LC nor nasal-cavity goblet-cell targeting. Relevant to the sonoporation and aerosolized-LC limitations; alone it would not anticipate the full independent claims.

5. U.S. Pat. No. 6,361,554 and U.S. Pat. No. 6,464,680 — Brisken

• Full citation: U.S. Patent Nos. 6,361,554 and 6,464,680 (ultrasonic/vibrational-energy catheters; specification: "various catheters useful for delivering vibrational energy to tissue … to Brisken," incorporated by reference in their entirety). Dates: ~2002 (verify on PatFT).
• Description: Catheter-based ultrasonic energy delivery "for various therapeutic effects, such as enhancing cellular absorption of a substance" — i.e., the drug-uptake/poration catheter concept the '011 system claims build on.
• § 102 potential: Strong for the system claim element "energy applicator on a catheter configured to enhance cellular uptake of a therapeutic agent." Lacks botulinum LC and nasal-cavity limitation, so not full anticipation of the independent system claim unless those limitations are absent.

6. U.S. Pat. No. 4,767,402 — Kost et al.

• Full citation: U.S. Patent No. 4,767,402, "Ultrasound enhancement of transdermal drug delivery," issued August 30, 1988 (specification: "U.S. Pat. No. 4,767,402 to Kost," incorporated by reference in its entirety).
• Description: Ultrasound-mediated enhancement of drug passage across a membrane — the foundational sonophoresis/transdermal-poration disclosure the '011 specification cites for its transdermal BoNT-LC embodiment (FIG. 14).
• § 102 potential: Discloses energy-mediated permeabilization + agent transport generically. Lacks botulinum LC, nasal cavity, and catheter delivery; relevant to the generic poration limitations.

7. U.S. Patent Application Publication US 2005/007441 (as printed in the specification)

• Full citation: The specification states "Energy-mediated transdermal delivery of intact botulinum toxin is suggested in US2005/007441 and 2004/0009180." Note: the printed identifier "US2005/007441" appears truncated/irregular (likely US 2005/0007441 or similar — verify on PatFT; I am flagging, not auto-correcting). Date: 2005 publication.
• Description: Energy-mediated (e.g., iontophoresis/electroporation) transdermal delivery of intact botulinum toxin.
• § 102 potential: This is the closest single reference to the "energy + botulinum toxin" combination in the family — it discloses energy-mediated delivery of botulinum toxin, but transdermal and intact-toxin, not nasal LC fragment. Potentially the strongest § 102 threat to any claim reading on "applying energy to enhance botulinum toxin delivery to target cells" without the nasal-LC limitations.

8. U.S. Patent Application Publication US 2004/0091880 (printed in the specification as "US2004/00091880")

• Full citation: US 2004/0091880 A1 (dermatological/transdermal botulinum toxin applications; the "US2004/00091880" string in the specification appears to be a typographical variant — flagged, not corrected). Date: 2004.
• Description: Transdermal/dermatological botulinum toxin delivery.
• § 102 potential: Similar to #7 — energy/transdermal botulinum delivery art; gaps on nasal LC fragment.

Tier 3 — Botulinum light-chain fragment disclosures (on point for the LC-fragment claims)

9. U.S. Patent Application Publication US 2004/0151741 and US 2005/0019346

• Full citation: US 2004/0151741 A1 and US 2005/0019346 A1 (specification: "The purification and possible therapeutic uses of botulinum light chain are described in US2004/0151741, US2005/0019346, and Chaddock et al. (2002)"). Dates: 2004 and 2005 publications.
• Description: Purification and therapeutic use of the botulinum toxin light chain (the very fragment claimed in '011).
• § 102 potential: Disclose the LC fragment and its intracellular catalytic mechanism, but in the cited context without the nasal-cavity + energy-poration delivery combination. Relevant to the "BoNT-LC fragment" claim element; not standalone anticipation of the combined method.

10. Chaddock et al. (2002), Protein Expression and Purification 25:219–228

• Full citation: Chaddock, J.A. et al., "Expression and purification of catalytically active, non-toxic endopeptidase derivatives of Clostridium botulinum toxin type A," Protein Expression and Purification 25 (2002) 219–228.
• Description: NPL disclosing recombinant BoNT/A light-chain (LC) fragments that are catalytically active but non-toxic absent the heavy chain — the scientific basis for the "non-toxic LC delivery" concept.
• § 102 potential: Anticipation is generally not found in NPL for the full system/method claims, but this reference is the key disclosure for the "active fragment/light chain, non-toxic outside the cytosol" limitations.

Tier 4 — Respiratory/bronchial catheters and implantable systems (less central)

11. U.S. Pat. No. 5,964,223 and U.S. Pat. No. 6,526,976 — Baran

• Full citation: U.S. Patent Nos. 5,964,223 (issued Oct. 12, 1999) and 6,526,976 (issued Mar. 4, 2003) (specification: "catheter devices and methods … set forth in U.S. Pat. Nos. 5,964,223 and 6,526,976 to Baran," incorporated by reference).
• Description: Catheters for treating the respiratory tract (asthma/bronchial), adapted in '011 to carry energy-transmission elements.
• § 102 potential: Relevant to the respiratory/bronchial system-claim limitations; not nasal-LC-specific.

12. U.S. Pat. No. 5,820,589 — Torgerson et al. and U.S. Pat. No. 6,847,849

• Full citation: U.S. Patent No. 5,820,589 (implantable programmable drug pump, issued Oct. 13, 1998) and U.S. Patent No. 6,847,849 (neurostimulation implantation; issue date ~2005 — verify). Specification incorporates both by reference for the fully implantable pulse-generator + drug-pump embodiment (FIG. 12).
• Description: Implantable infusion + stimulation hardware.
• § 102 potential: Background hardware; low anticipation relevance to the nasal method claims.

13. US 2001/0044596 — Jaafar and US 2002/0198512 — Seward

• Full citation: US 2001/0044596 A1 and US 2002/0198512 A1 (intraluminal catheter applications; incorporated by reference).
• Description: Intraluminal catheter devices for cardiovascular/neurotransmitter applications.
• § 102 potential: Low relevance; background catheter art.

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Additional non-patent literature (with § 103/102 relevance)

• Bigalke & Shoer (1999), Handbook of Experimental Pharmacology 45:407–443 — BoNT mechanism (acetylcholine release blockade); background for the mechanism-of-action limitations.
• Simpson, Schmidt & Middlebrook (1988), Methods Enzymol. 165:76–85 — the seven serotypes A–G; background for the "any of serotypes A–G" claim limitation.
• Chang (1989), Biophysical Journal 56:641–652 — cell poration/fusion using oscillating electric fields; incorporated for the AC/DC and DC-shifted RF pulse-shape limitations.
• Electroporation: A General Phenomenon for Manipulating Cells and Tissues, J. Cellular Biochemistry 51:426–435 (1993) — pulse-duration/voltage electroporation parameters (1–100 μs and 1–10 ms pulses; 1–1.5 V membrane potential; ≤120 V macromolecule transfer); the scientific basis for the energy-parameter claim limitations.
• Guzman et al. (cited in the specification) — sonoporation transport of molecules from 62 Da to 464 kDa, supporting the 50 kDa LC sonoporetic-delivery limitation.
• Sharri et al. (1995), Otolaryngol. Head Neck Surg. 112:566–571 and Unal et al. (2002), Acta Otolaryngol. 123:1060–1063 — clinical nasal botulinum delivery (turbinate injection for allergic rhinitis); corroborating nasal-delivery prior art.

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Bottom line on § 102 anticipation risk

• No single reference found in the specification's own citation set appears to disclose the full combination of (a) botulinum light-chain fragment, (b) delivered to the nasal cavity, (c) with energy-mediated reversible poration. That combination is the patent's core advance.
• The closest individual references, in order of § 102 threat to the reconstructed claims, are: Sanders '605 (nasal botulinum delivery) and US 2005/007441 / US 2004/0091880 (energy-mediated botulinum delivery) — each missing the LC-fragment or nasal/energy elements — followed by Babaev '581 and Brisken '554/'680 (energy-mediated agent delivery hardware).
• Because the actual granted claims and the examiner's front-page "References Cited" could not be retrieved this session, verify on USPTO Patent Center (Patent No. 10,894,011 / Application 16/842,209) before relying on this analysis. Note also that IPR2024-00280 (Neurent Medical Inc. v. The Foundry, LLC; Final Written Decision issued, now on appeal at the CAFC as docket 25-2121) presumably asserted the closest § 102/103 art against specific claims — retrieving that IPR record would materially refine the anticipation mapping, but it was not accessible within this session's search limit.

I'll try to pin down the actual claim text and the IPR grounds before building the § 103 analysis.

Major finding — the actual granted claims are apparatus claims with no toxin limitation. Let me pin down the remaining claim text and the FWD outcome.

Let me pull the dependent-claim text and the FWD outcome.

Obviousness Analysis — U.S. Patent No. 10,894,011 B2 (35 U.S.C. § 103)

Analyst note / date: April 26, 2026. This section builds on, and in one material respect corrects, the earlier-generated sections. All new findings below come from the IPR2024-00280 petition, institution decision, and docket records surfaced this session.

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0. MATERIAL CONTRADICTION WITH PRIOR SECTIONS — READ FIRST

The earlier-generated "Plain-Language Overview of the Independent Claims" and "Prior art" sections both state, correctly as to sourcing, that verbatim claims were unavailable, and then reconstruct the independent claims as (i) a method of delivering a BoNT light chain to nasal target cells with energy-mediated poration, and (ii) a corresponding system. The Prior Art section's "bottom line" is built on that reconstruction: "No single reference found in the specification's own citation set appears to disclose the full combination of (a) botulinum light-chain fragment, (b) delivered to the nasal cavity, (c) with energy-mediated reversible poration."

That reconstruction is wrong for the granted claims, and the "bottom line" is therefore inapplicable. The verbatim text of granted claim 1 is now available and quoted in the institution decision in IPR2024-00280 (Ex. 1001, 27:40–55):

1. Apparatus for treatment of a nasal condition by altering function of a nasopharyngeal passage of a patient, the apparatus comprising:
a hand-held elongate body having proximal and distal portions, the distal portion being configured for positioning in a nasopharyngeal passage of a patient with the proximal portion positioned outside the nasopharyngeal passage;
an energy transmission element in the distal portion configured to deliver energy to target tissue in the nasopharyngeal passage; and
an energy source operatively coupled to the energy transmission element for supplying energy thereto according to one or more parameters selected so as to alter nasopharyngeal cells in the target tissue such that nasal congestion is reduced.

Claim 1 contains no toxin limitation, no light-chain limitation, no "poration" limitation, and no membrane-permeabilization limitation. It is a pure energy-delivery apparatus claim. Consequently:

• The patent's own "core advance" (BoNT-LC + energy + nasal delivery) is not what the challenged claims cover.
• The Tier-1 references emphasized in the Prior Art section (Sanders '605; First '768; US 2005/007441; US 2004/0091880; Chaddock 2002; Babaev '581; Brisken; Kost) are not the most relevant art to the granted claims. The relevant art is intranasal/nasopharyngeal radiofrequency and electrosurgical art — Saadat, Makower, Fang, Edwards-535, Stern — which the Prior Art section did not identify at all because it had no access to the claims or the IPR record.
• The "§ 102 anticipation risk" conclusion in the Prior Art section should be treated as withdrawn.

I flag this explicitly rather than silently reconciling, per the operating rules on contradictions.

Residual uncertainty (unchanged and honest): The patent has 29 claims; only claims 1, 2, 5, 8–10, 12, and 14 were challenged. I have not obtained verbatim text for dependent claims 2, 5, 8–10, 12, 14, or for the untested claims 3–4, 6–7, 11, 13, 15–29. Where I map dependent claims below I say so and identify the source as the IPR record (Neurent's petition structure and its § 325(d) concession chart), not the patent's claim column.

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1. The legal frame and the POSITA

• POSITA (adopted by the Board at institution, unrebutted by Patent Owner): "a Doctor of Medicine (M.D.) or at least a bachelor of science degree in engineering or a related discipline and … at least three years of experience in the clinical use, design, development, and/or testing of medical devices, including medical devices that deliver energy to tissue. Less work experience may be compensated by a higher level of education, and vice versa." (IPR2024-00280 institution decision, § I.1, applying Petitioner's proposal at Pet. 18–19.)
• Governing law: Graham v. John Deere; KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (cited in the Petition's table of authorities). The field — intranasal electrosurgery — is a mature, predictable art, which matters under KSR's "known technique / obvious to try" rationales.
• Claim construction: Neither party proposed a construction; the Board declined to construe at institution (Nidec). Petitioner nonetheless argued the plain meaning of "nasopharyngeal" is "a passageway including the nasal cavity and pharynx" (Pet. 36–37 n.15, citing Exs. 1048, 1049, 1055). This favors the invalidity case: the broader the passage, the more squarely Makower's and Saadat's devices read on the "within the nasopharyngeal passage" limitation.

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2. Threshold predicate: the effective filing date drives which art is available

The Board found that the '011 specification — which contains the subject matter of the '771 provisional — does not provide written description support for the challenged claims, and that the claims are therefore entitled at best to an October 22, 2019 effective filing date (the filing of the parent in the chain into which the nasal disclosure was inserted). This is the linchpin of the Board's institution on Saadat and Deem. Per Petitioner's introduction (Pet., § I):

"Because the subject matter of the Challenged Claims was not described in any priority application prior to October 22, 2019 … the Challenged Claims are only entitled to priority on October 22, 2019. As of that date, Saadat, a patent application disclosing a radiofrequency (RF) energy device for treating nasal conditions like rhinitis, plainly anticipates or renders obvious the challenged claims[.]"

The Patent Owner's own prosecution statements are cited against it: Aerin represented that "the sole purpose of applying energy as described in Deem [i.e., U.S. 7,655,243] is to porate target cells to enhance uptake of a nerve toxin" (Ex. 1034, FH221-Aerin, 786). That admission is a § 103 accelerant — it establishes that the family's energy disclosure was toxin-delivery-directed and contains no teaching that energy alone in the nasopharyngeal passage reduces congestion, which is the very benefit now claimed.

Why this matters for § 103 (and the strategic point the prior sections missed): § 103 availability of art is date-dependent, so two cases must be run:

Key consequence: Petitioner's Ground 4 — "Ground IV renders the Challenged Claims obvious at any priority date" (Reply, § III) — is the priority-independent § 103 case. Even if the Federal Circuit reverses the priority holding, the obviousness case survives on Makower + Fang + Edwards-535. That is the combination to lead with.

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3. The combinations

Combination 1 (LEAD) — Makower + Fang + Edwards-535 (Neurent's Ground 4; instituted)

Motivation to combine (Pet. 77–83, supported by Ex. 1002 ¶¶ 177–192):

1. Same field, same problem, same mechanism. Fang supplies the clinical rationale — RF disruption at the nasal/sphenopalatine target reduces the symptoms of perennial allergic rhinitis; Makower supplies a device already configured and indicated for the nasal cavity/nasopharynx with expandable electrodes that contact the passage wall; Edwards-535 supplies a conventional RF generator. This is KSR rationale (C) — "use of a known technique to improve similar devices in the same way."
2. Edwards-535 is a "routine implementation step." Petitioner's express rationale: "Edwards-535, Makower, and Fang each teach delivering RF energy to tissue in the nasal cavity or nasopharynx … and Edwards-535 teaches a specific, routine implementation step for doing so" (Pet. 82–83). That is KSR rationale (B) — substitution of a known element (an RF generator) for the one the combination otherwise lacks.
3. Obvious to try / finite solutions. For a POSITA seeking to treat rhinitis by energy delivery in the nasopharyngeal passage, the identified solutions are few (RF/electrosurgical ablation at identified intranasal target sites), and all are predictable in this mature art.
4. No teaching away and no criticality. No reference teaches away from the combination; Petitioner argued below that PO "identifies no teaching away, skepticism, or actual failure" (Reply, § III.A). Claim 1 recites no numerical parameter, no duty cycle, no electrode count, no waveform — so no parameter-based nonobviousness argument is available.
5. Reasonable expectation of success. Makower affirmatively teaches its device touches adjacent nasopharyngeal tissue and cauterizes/heats tissue when current is applied; it also teaches that "sensing elements" may be attached so the physician can "monitor various parameters of the catheter and/or surrounding tissue (e.g., temperature, etc.)."

Combination 2 — Saadat (alone for § 102; + routine skill for § 103) (Neurent's Grounds 1 and 2; instituted)

Saadat, US 10,307,200 B2, "discloses 'devices and methods for ablating regions of tissue … within the nasal cavity for treating conditions such as rhinitis'" (Ex. 1003, 1:21–26), teaches that ablation of posterior nasal nerves "leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea in patients with chronic rhinitis" (3:6–14, 16:44–48), and shows a "T"-shaped RF ablation probe positioned in the posterior area including the nasal cavity and nasopharynx (FIGS. 20E, 30). The Board instituted Ground 2, finding a reasonable likelihood that claims 12 and 14 "would have been obvious in view of Saadat" — i.e., the dependent claims add nothing beyond Saadat plus the ordinary skill of a POSITA. Where Ground 1 (anticipation) fails for any element, Ground 2 supplies the § 103 backstop on the same reference plus routine skill, which is itself a permissible KSR rationale (D) — applying a known technique to a known device ready for improvement.

Combination 3 — Saadat or Makower + Edwards-535, Stern '720, or Imran (for claims reciting electrode architecture / monitoring)

For any dependent claim reciting multiple or bipolar electrode pairs, or monitoring/feedback (see § 4 below), the record supply is:

• Stern, US 5,562,720 — "electroconductive expandable member" with "an array of separate electrodes," expressly bipolar and configured in "pairs" (2:26–40; FIG. 15 showing two pairs); used in the sibling IPR2024-00669 ground against a claim reciting multiple electrode pairs.
• Imran — teaches surface electrodes not facing a hollow interface (Ex. 1068, FIG. 1, 2:57–64, claims 1, 62–66), which directly answers Patent Owner's "electrodes face the hollow interior" attack on Makower FIG. 5H.
• Edwards-535 — generator-side control/sensing (temperature, impedance).

Combination 4 — contingency: if ANY claim (e.g., within untested claims 15–29) recites a neurotoxin light chain and/or poration

If the untested claims do recite the BoNT-LC + permeabilization subject matter, the § 103 case shifts to the reference set identified in the Prior Art section, and it is strong:

• Sanders '605 (nasal botulinum toxin to reduce mucus secretion; canine data) or First '768 (botulinum toxin for rhinorrhea) — supplies the toxin-to-nasal-membrane teaching, the field, and the motivation (the '011 Background itself concedes both).
• US 2005/007441 / US 2004/0091880 (energy-mediated delivery of botulinum toxin, transdermal) — supplies coupling of an energy field to botulinum administration (identifiers as printed in the specification; both flagged in the Prior Art section as irregular and to be verified, not corrected).
• Babaev '581, Brisken '554/'680, Kost '402, and Weaver (1993) J. Cell. Biochem. 51:426–435 — supply energy-mediated membrane permeabilization/poration hardware and the parameter ranges the specification itself recites (1–100 µs and 1–10 ms pulses; ≤120 V; 10–10,000 V/cm; 1 ns–0.1 s).
• Chaddock (2002), US 2004/0151741, US 2005/0019346 — supply catalytically active, non-toxic BoNT/A light chain.
• Motivation: each element is directed to the same therapeutic goal (deliver an active toxin fragment into a target cell), and the combination is the reason the specification's own "non-toxic LC" rationale exists (heavy-chain removal renders LC membrane-impermeant → an external permeabilization means is required). That is a textbook KSR explicit-motivation case, and the '011 family's own earlier patent (7,655,243) claimed the toxin version — evidence the combination was known within the same family.

(This contingency is not needed for the challenged claims, which contain no toxin element.)

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4. Claim-by-claim status (challenged claims)

Caveats: (a) The Board's Final Written Decision (Paper 41, 2025-07-21) is reported as holding all challenged claims unpatentable; I could not read the FWD text this session, so I do not attribute claim-by-claim findings or the specific winning ground to the Board verbatim. (b) Verbatim text of dependent claims 2, 5, 8–10, 12, 14 was not retrieved; the element mapping in the table is drawn from the petition's own section indices and Neurent's § 325(d) concession chart, not from the patent's claim column. Verify against Ex. 1001, cols. 27–29.

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5. Anticipated Patent Owner counterarguments and the rebuttals on the record

Takeaway for a § 103 brief: PO's only substantive nonobviousness theory is reasonable expectation of success as to Makower's FIG. 5H, plus lack of motivation. Both are element-level attacks on one reference in a three-reference combination, and both are answered by Makower's own text (expandable struts touching nasopharyngeal tissue; cautery/heating on applied current; integrated sensing elements) plus Imran. No claim requires a numerical energy parameter or a particular electrode geometry that any reference would have to teach away from.

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6. Secondary considerations

Nothing in the record supply supports objective indicia for the challenged claims:

• No unexpected results are asserted for the challenged subject matter — and the specification contains no efficacy data for energy-alone nasopharyngeal treatment (the Board's written-description finding is the mirror image of this).
• No long-felt need / failure of others evidence appears in the IPR record.
• Copying is theoretically available to PO (Neurent's NEUROMARK system is the accused product), but copying is weak where the prior art already discloses the commercial embodiment's configuration, and Neurent's own IPR position is that the accused configuration follows Saadat/Makower/Fang.
• Licensing (Aerin's exclusive license) is not evidence of nonobviousness absent a nexus.

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7. Bottom line

1. The single strongest § 103 combination is Makower (US 2005/0240147 A1) + Fang (2005) + Edwards-535 (US 6,517,535 B2). It maps every element of claim 1, it is supported by an express motivation (same field, same condition, same mechanism; Edwards-535 as a routine implementation step for the generator the combination otherwise lacks), and — critically — it works even if the Patent Owner wins the priority appeal, because Fang (2005-07-20) and Edwards-535 (2003) predate even the July 22, 2005 provisional and Makower qualifies from its April 21, 2004 US filing date.
2. Saadat (US 10,307,200 B2) supplies the § 102 case and the § 103 backstop for the monitoring claims (12, 14) — but it depends entirely on the October 22, 2019 effective filing date the Board found.
3. Deem (US 2008/0021369 A1) is not a usable § 103 reference on these facts: the Board denied Ground 3 precisely because Deem's disclosure mirrors the priority document that the Board found insufficient. Do not build a case on it.
4. The patent is expired or expiring. Google Patents records an anticipated expiration of 2026-07-21 — under three months from today. Any new IPR on the untested claims (3–4, 6–7, 11, 13, 15–29) would be institutionally unattractive and, for practical purposes, economically pointless; the live venue is the CAFC appeal of the 2025-07-21 FWD and the stayed Delaware case.
5. The appeal is by the Patent Owner, not the Petitioner. The Docket Alarm docket entry for IPR2024-00280 resolves the caveat flagged in the earlier Litigation/PTAB sections: "9/15/2025 — Patent Owner Notice: notice of appeal 42: Patent Owner's Notice of Appeal." That confirms The Foundry (with Aerin) is the appellant in CAFC No. 25-2121 — an appellant identity the earlier sections could not verify.

Verification steps (not completed — step limit reached):

• Read the FWD, Paper 41 (2025-07-21), for the claim-by-claim disposition and the ground(s) actually relied on: https://www.docketalarm.com/cases/PTAB/IPR2024-00280/NEURENT_MEDICAL_INC._v._The_Foundry_LLC/ ; https://portal.unifiedpatents.com/ptab/case/IPR2024-00280
• Capture verbatim dependent claims 2, 5, 8–10, 12, 14 and the full 29-claim set from Ex. 1001 (US 10,894,011, cols. 27–29): https://patents.google.com/patent/US10894011/en
• Check CAFC No. 25-2121 (CourtListener/PACER) for the 2026 briefing status and any mootness issue arising from the 2026-07-21 expiration date.