Invalidity dossier
US 9415194
Post nasal drip treatment
Current assignee: Neurent Medical Inc., Neurent Medical Ltd.
Added 8/28/2026, 4:50:06 AM
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Patent summary
Title, assignee, inventors, filing/issue dates, abstract, and a plain-language overview of the claims.
I'll research US 9415194 across USPTO records, PTAB/litigation data, and Federal Circuit dockets.
Let me check for any Federal Circuit appeal activity and the Delaware litigation status.
US Patent 9,415,194 — Analyst Summary
Patents searched literally as "9415194" / "9,415,194"; no similar numbers substituted. One caveat up front: your prompt sets the current date as April 26, 2026, but my tool results returned documents dated August 27, 2026 (a CAFC order) and a Google Patents page fetched August 28, 2026. I report what the records show, including post-April-2026 events.
1. Bibliographic data (from the patent record itself)
| Field | Value |
|---|---|
| Title | Post nasal drip treatment |
| Patent number | US 9,415,194 B2 |
| Application number | 14/675,689 |
| Publication (pre-grant) | US 2015/0202003 A1 (2015-07-23) |
| Filing date | 2015-03-31 |
| Issue/grant date | 2016-08-16 |
| Priority date | 2011-06-14 (earliest claimed benefit) |
| Inventors | Scott J. Wolf (Menlo Park, CA); Andrew Frazier (Sunnyvale, CA) |
| Original / current assignee | Aerin Medical, Inc. (Sunnyvale, CA) |
| Examiner | Robert N. Wieland |
| Agent | Dorsey & Whitney LLP (Scott M. Smith) |
| Claim count | 33 (independent claims 1, 20, 26) |
| Primary CPC | A61B18/14; also A61B18/02, A61B18/18, A61M25/10, A61F5/08, A61B18/16 |
Priority chain (authoritative, from the specification's "Related Applications"): the '194 application claims priority to provisional 61/974,534 (filed Apr. 3, 2014, "Post Nasal Drip Treatment") and is a continuation-in-part of 14/319,087 ("Methods and Devices to Treat Nasal Airways," filed Jun. 30, 2014), which is itself a CIP of 13/495,844 (issued as US 8,936,594), which claims priority to provisionals 61/603,864 (Feb. 27, 2012) and 61/496,930 (Jun. 14, 2011) — hence the 2011-06-14 priority date.
Expiration note (uncertainty flagged): Google Patents lists "anticipated expiration 2032-06-13," while a third-party (Patents-Review) lists a USPTO-calculated adjusted expiration of 2035-03-31. These reflect different assumptions about which priority date governs; I cannot resolve which is correct from these sources alone.
Security interests (not ownership transfers): CRG Servicing LLC recorded a security interest in 2019; that was released, and ARES Capital Corporation recorded a security interest as administrative agent/collateral agent on 2024-12-20. Assignee of record remains Aerin Medical, Inc.
2. Abstract (verbatim)
"Systems and methods for treating a patient's mucus hypersecretion condition are disclosed herein. Certain implementations may involve a method for reducing mucus secretion in an upper airway of a patient to treat at least one of post nasal drip or chronic cough. The method may include advancing a treatment delivery portion of an energy-based treatment device into a nostril of the patient. The treatment delivery portion may contact mucosal tissue of the upper airway without piercing the mucosal tissue. The treatment delivery portion may deliver treatment to at least one tissue selected from the group of the mucosal tissue and another tissue underlying the mucosal tissue to modify a property of the at least one tissue and thus treat at least one of post nasal drip or chronic cough in the patient."
3. Independent claims in plain language
Claim 1 — Method (non-piercing, energy-based, trans-nostril treatment)
A three-step method for reducing mucus secretion in the upper airway to treat post-nasal drip and/or chronic cough:
- advance the treatment-delivery portion of an energy-based device into the patient's nostril;
- contact upper-airway mucosal tissue with that portion without piercing the mucosa; and
- deliver treatment from that portion to either (a) the mucosal tissue or (b) tissue underlying the mucosa, so as to modify a property of that tissue and thereby treat the post-nasal drip / chronic cough.
Essentially: a non-invasive, no-incision mucosal energy treatment performed through the nostril.
Claim 20 — Device (malleable shaft + concave trough with two energy-delivery members)
A device for the same purpose, comprising:
- an elongate, malleable shaft (bendable to fit anatomy) with proximal and distal ends;
- a handle at the proximal end; and
- a treatment portion at the distal end having a treatment surface that includes (i) at least two energy-delivery members extending longitudinally along the surface, and (ii) a concave trough extending longitudinally that separates those two members.
Essentially: a hand-held, shapeable probe whose working face has a longitudinal channel flanked by two rails of energy-delivery elements — the channel being configured to receive/seating the tissue (e.g., a turbinate) while energy passes between the flanking members.
Claim 26 — Method (bend, contact, bipolar RF across the trough, thermocouple, no implant)
A method comprising:
- bending the malleable shaft into a desired configuration;
- advancing the treatment portion into a nostril so the treatment surface contacts mucosal tissue without piercing it;
- delivering radiofrequency energy from a first electrode, across the concave trough, to a second electrode on the treatment surface, to modify a property of the mucosa and/or underlying tissue and treat post-nasal drip / chronic cough;
- measuring the delivered RF energy using a thermocouple disposed in the concave trough; and
- removing the treatment portion without leaving an implant in the upper airway.
Essentially: the method-of-use counterpart to claim 20 — shapeable probe, non-piercing bipolar RF delivered across the trough, temperature feedback from the trough, and a "leave-nothing-behind" limitation.
Dependent claims (2–19, 21–25, 27–33) track the specification's summarized embodiments, e.g., delivering energy as ultrasound/microwave/heat/RF/electrical/light/laser, cryotherapy (energy removal), cauterizing or polymerizing agents, injuring goblet cells or nerve tissue underlying the mucosa, ablating nerve tissue, decreasing volumetric mucus production rate without changing mucosal shape, treating a turbinate (including the posterior aspect of the inferior turbinate), rows of positive/negative electrodes, blunt-tipped protruding electrodes, and a thermocouple in the trough. I am reading these off the specification's summary of embodiments rather than having verified each dependent claim's verbatim text, so treat the dependent-claim mapping as descriptive rather than exact.
4. Litigation / PTAB / CAFC status
PTAB — IPR2024-00276 (the '194 patent):
- Petitioner: Neurent Medical Inc. / Neurent Medical Ltd.; Patent Owner: Aerin Medical Inc.; filed Jan. 18, 2024; instituted Jul. 22, 2024; Tech Center 3700, Art Unit 3762; panel Fitzpatrick, Valek, Yang.
- Challenged claims: 1–3, 6, 12, 14, 16, 18, and 19.
- Grounds included anticipation by Baker (WO 2010/077980) under §102, obviousness over Baker under §103, and obviousness over Baker in view of Edwards-’535 (US 6,517,535) and a Chen 2005 journal article on RF treatment (for the nerve-ablation claim 6).
- Disposition: terminated by ADVERSE JUDGMENT on Jan. 24, 2025 ("Terminated-Adverse Judgment"). Note: one aggregator (Ex Parte) labels the outcome "Unpatentable," which is consistent with an adverse judgment against the patent owner, but an adverse judgment is not a final written decision on the merits. I cannot confirm from these sources whether Aerin filed a statutory disclaimer or whether claims 1–19 were formally cancelled, and Google Patents still shows the patent status as "Active." Treat the surviving scope of the challenged claims as uncertain.
CAFC 2026 docket (your specific request): There is 2026 Federal Circuit activity in the Aerin/Neurent dispute, but it does not arise from the '194 patent's IPR:
- Aerin Medical Inc. v. Neurent Medical Inc., Nos. 2025-2099, -2100, -2101 (consolidated; docketed Sept. 12, 2025) and The Foundry, LLC appeals Nos. 2025-2113, -2114, -2121. These appeal PTAB Nos. IPR2024-00277, -00278, -00282 (Aerin) and -00279, -00280, -00669 (The Foundry) — not IPR2024-00276 / US 9,415,194.
- By nonprecedential order dated August 27, 2026, the Federal Circuit dismissed the consolidated proceedings under Fed. R. App. P. 42(b), each side bearing its own costs, and issued the order as a mandate.
- No Federal Circuit appeal of IPR2024-00276 (US 9,415,194) appears in the records I retrieved. I did not find a CAFC docket naming US 9,415,194 in 2026.
District court: Aerin Medical Inc. et al. v. Neurent Medical Inc. et al., No. 1:23-cv-00756 (D. Del., Judge Hall) — a nasal-airway device patent infringement case; Finnegan represents Aerin and The Foundry. The '194 patent is part of the same patent family litigated in that case, but I have not verified from the retrieved record that the '194 patent was specifically asserted in that complaint.
5. Family context
Related/subsequent Aerin patents sharing the 2011-06-14 priority: US 9,801,752 B2 (continuation of the '194 application), US 9,943,361 B2 ("Treating upper airway nerve tissue"), US 10,603,059 B2, US 10,631,925 B2, US 10,456,185 B2, US 10,398,489 B2, US 11,241,271 B2, US 11,304,746 B2, US 11,832,876 B2, and others.
6. Explicit uncertainties
- The exact post-adverse-judgment status of claims 1–19 (cancelled? disclaimed? disclaimed only as to Neurent?) is unresolved in my sources.
- Dependent claims 2–19, 21–25 and 27–33 are characterized from the specification's embodiment summary, not from verified verbatim claim text.
- The title "Techniques for Treating Upper Airway Conditions" that appears on one PTAB petition-analysis page is an aggregator's paraphrase/mislabel; the patent's title of record is "Post nasal drip treatment."
- Priority date appears as 2011-06-13 on some third-party pages (e.g., for US 9,801,752 and the '925 patent) versus 2011-06-14 on the '194 record — a one-day discrepancy I cannot reconcile; the patent's own record and Google Patents state 2011-06-14.
Sources: patents.google.com/patent/US9415194/en; freepatentsonline.com/9415194.html; insight.rpxcorp.com/patent/US9415194B2; portal.unifiedpatents.com/ptab/case/IPR2024-00276; docketalarm.com (IPR2024-00276, IPR2024-00278); ipverse.greyb.com/ptab-web/cases/case-details/IPR2024-00276; ai-lab.exparte.com/case/ptab/IPR2024-00276; cafc.uscourts.gov order 25-2099 (Aug. 27, 2026); dockets.justia.com/docket/circuit-courts/cafc/25-2101; finnegan.com (1:23-cv-00756); pubchem.ncbi.nlm.nih.gov/patent/US-9415194-B2.
Generated 9/16/2026, 12:49:16 AM
Cases on file (1)
Group view →Specific litigation cases in our database that name US patent 9415194. The free-form analysis below may also discuss cases beyond this list.
- Neurent Medical Inc. et al. v. Aerin Medical Inc.filed Jan 18, 2024IPR2024-00276Patent Trial and Appeal Board (PTAB), Tech Center 3700, Art Unit 3762terminated Jan 24, 2025terminated by adverse judgment
Defendants: Aerin Medical Inc.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll search litigation databases and court records for US 9,415,194 specifically.
Important new findings. Let me dig into the specific district court cases and confirm which patents are asserted.
Litigation involving US Patent 9,415,194
Date note: Your prompt sets today as April 26, 2026, but my tool results include documents dated as late as September 15, 2026 (an IPWatchdog article). Consistent with the earlier section, I report what the records show and flag the inconsistency rather than silently reconciling it.
Bottom line: I found one district court action in which US 9,415,194 has been asserted, plus one consolidated companion action in the same court, and one PTAB inter partes review of the patent. No other litigation (other defendants, other districts, ITC, or a Federal Circuit appeal of the '194 IPR) appears in the records I retrieved.
1. District court litigation where the '194 patent was asserted
Aerin Medical Inc. and The Foundry, LLC v. Neurent Medical Inc. and Neurent Medical Ltd.
| Field | Value |
|---|---|
| Plaintiff(s) | Aerin Medical Inc. (Delaware corp., Mountain View, CA) and The Foundry, LLC (California LLC, Menlo Park, CA) |
| Defendant(s) | Neurent Medical Inc. (Delaware corp., Braintree, MA) and Neurent Medical Ltd. (Ireland) |
| Jurisdiction / court | U.S. District Court for the District of Delaware |
| Case number | C.A. No. 1:23-cv-00756 — caption initials appear as (GBW) on the Amended Complaint and (JLH) on later filings, indicating reassignment to Judge Jennifer L. Hall |
| Filing date | July 11, 2023 |
| Accused product | NEUROMARK® System (Neuromark Device + Neuromark Generator) for treating rhinitis |
| Asserted patents | Amended Complaint (D.I. 17) asserts eight patents: 9,072,597; 9,415,194; 10,610,675; 10,894,011; 11,033,318; 11,241,271; 11,679,077; 11,766,286 |
| The '194 patent | Yes — expressly asserted. Identified in the Amended Complaint as "the '194 patent" and pleaded as Count/claim against the Neuromark system |
| Status | Stayed in its entirety (Aug. 8, 2024) pending PTAB Final Written Decisions; statically disclaimed as to '597 and '194 (Oct. 24, 2024); partial stay lifted as to Neurent's patents-in-suit (Mar. 18, 2025); motion-to-dismiss practice ongoing |
Infringement theory on the '194 patent (from the complaint analysis in the record): Aerin mapped (i) Neuromark's end effector being advanced through the nostril to the posterior recesses of the nasal cavity to claim 1's "advancing a treatment delivery portion…into a nostril"; (ii) the leaflets deploying to "spring out to enforce mucosal apposition on the lateral wall" to the "contacting mucosal tissue…without piercing the mucosal tissue" limitation; and (iii) RF delivery causing neurolysis of the posterior nasal nerves to the "modify a property of the at least one tissue" limitation. Aerin also pleaded that it marks the RhinAer device with the '194 patent and that Neurent knew of the '194 patent at least by February 18, 2020, when Neurent cited it during prosecution of Neurent's U.S. Patent No. 11,547,473 — a willfulness/knowledge narrative.
Critical outcome development for the '194 patent — this resolves an open question from my earlier section. The parties' Joint Status Report states: "On October 24, 2024, Aerin statutorily disclaimed all claims of the '597 and '194 patents that had been asserted against, and challenged by, Neurent." Earlier I flagged as unresolved whether Aerin disclaimed or whether claims 1–19 were cancelled; the answer is statutory disclaimer, filed October 24, 2024, and corroborated by PTAB Patent Owner Exhibit 2001, "StatutoryDisclaimer (194)," filed January 21, 2025 in IPR2024-00276.
2. Consolidated companion action (same court, related family)
Neurent Medical Ltd. v. Aerin Medical Inc.
| Field | Value |
|---|---|
| Plaintiff | Neurent Medical Ltd. |
| Defendant | Aerin Medical Inc. |
| Jurisdiction | D. Del. |
| Case number | C.A. No. 24-1070-JLH |
| Filing date | September 24, 2024 |
| Patents asserted | Neurent's 12,096,973; 12,096,974; 12,098,889, plus 11,998,262 ('262) via amended counterclaims (D.I. 81, filed July 8, 2024) along with tortious-interference and unfair-competition counterclaims |
| The '194 patent | Not asserted here (this action runs the other direction) |
| Status | Consolidated with 1:23-cv-00756 by Stipulation and Order to Consolidate (D.I. 106), March 18, 2025; Aerin's motions to dismiss pending; claims/defenses as to the Aerin/Foundry patents stayed |
I list this because PTAB and parties treat the two Delaware actions as one consolidated proceeding, and the '194 patent's docket history is intertwined with it — but for strict accuracy: the '194 patent is asserted only in 1:23-cv-00756.
3. PTAB (not "litigation" in the district-court sense, but the dispositive challenge to the '194 patent)
Neurent Medical Inc. & Neurent Medical Ltd. v. Aerin Medical Inc., IPR2024-00276
| Field | Value |
|---|---|
| Petitioner(s) | Neurent Medical Inc. and Neurent Medical Ltd. |
| Patent owner | Aerin Medical Inc. |
| Forum | PTAB, Tech Center 3700, Art Unit 3762 |
| Case number | IPR2024-00276 |
| Patent challenged | US 9,415,194 (application 14/675,689) |
| Filing date | January 18, 2024 |
| Challenged claims | 1–3, 6, 12, 14, 16, 18, and 19 |
| Institution | July 22, 2024 |
| Panel | APJs Fitzpatrick, Valek, Yang |
| Counsel | Petitioner: David L. Cavanaugh et al.; Patent Owner: Kathleen Daley et al. |
| Outcome | Terminated by ADVERSE JUDGMENT, January 24, 2025, on Patent Owner's Joint Motion to Terminate and Request for Adverse Judgment (filed Jan. 21, 2025), accompanied by Patent Owner Ex. 2001 — Statutory Disclaimer (194) |
| Grounds | §102 anticipation by Baker (WO 2010/077980); §103 obviousness over Baker; §103 over Baker + Edwards-’535 (US 6,517,535) + Chen (2005 RF-ablation article) for claim 6 |
4. What I did not find
- No Federal Circuit appeal of IPR2024-00276. The 2025–2026 CAFC activity in this dispute (Nos. 2025-2099/-2100/-2101 and 2025-2113/-2114/-2121, dismissed by order dated Aug. 27, 2026) concerns IPR2024-00277, -00278, -00282 and -00279, -00280, -00669 — not the '194 IPR. A disclaimed patent also generally cannot be appealed, which is consistent with no appeal appearing.
- No other defendants. I found no suit against any party other than Neurent Medical Inc./Ltd., no ITC §337 action, and no declaratory-judgment action naming the '194 patent. The Google Patents "Family has litigation" link points to the Darts-IP family 53543805 entry and to the single Delaware case 1:23-cv-00756, which is consistent.
- No settlement/license outcome on the '194 patent itself is discernible; its asserted claims were removed from the case by disclaimer rather than by judgment or settlement of a claim.
5. Corrections / resolutions to the earlier section
- Resolved (earlier Uncertainty #1): Aerin did not obtain a merits ruling — it statutorily disclaimed all asserted claims of the '194 patent on October 24, 2024, which drove the PTAB adverse judgment and removed the '194 patent from the Delaware case. Google Patents' "Active" status is technically consistent with a patent remaining in force as to non-asserted, non-challenged claims (e.g., the unchallenged device claims 20–25, 26–33), but the asserted method claims (1–3, 6, 12, 14, 16, 18, 19) are disclaimed.
- Resolved (earlier Uncertainty #2/final note): The '194 patent was specifically asserted in D. Del. 1:23-cv-00756 — confirmed by both the Amended Complaint (D.I. 17) and the IPR petition's mandatory disclosures.
- Still unresolved (earlier Uncertainty #3): The ExParte aggregator's title "Techniques for Treating Upper Airway Conditions" remains an aggregator paraphrase; the title of record is "Post nasal drip treatment." (Note that the same paraphrase appears in the IPR petition's own background text, which may be the aggregator's source.)
- Refinement to the earlier docket description: My earlier section described the case as "Judge Hall." The records literally show caption initials GBW on the Amended Complaint and JLH thereafter — I read this as a reassignment, but I have not verified the reassignment order.
- Current status of the consolidated Delaware case as of the latest documents I retrieved (the Joint Status Report and the March 18, 2025 consolidation orders) is stayed as to the Aerin/Foundry patents, with a stipulated schedule for further proceedings* *negotiated after a Feb. 28, 2025 oral order, and motions to dismiss counterclaims/claims pending. I do not have a post-March-2025 docket entry confirming final resolution, so I cannot state an end outcome for 1:23-cv-00756 / 24-1070-JLH.
6. Summary table
| # | Case | Forum | Case No. | Filed | '194 asserted? | Outcome / status |
|---|---|---|---|---|---|---|
| 1 | Aerin Medical Inc. & The Foundry, LLC v. Neurent Medical Inc. & Neurent Medical Ltd. | D. Del. | 1:23-cv-00756 (GBW→JLH) | 2023-07-11 | Yes | Stayed 2024-08-08; '194 asserted claims statutorily disclaimed 2024-10-24; partial stay lifted 2025-03-18; ongoing |
| 2 | Neurent Medical Ltd. v. Aerin Medical Inc. | D. Del. | 1:24-cv-01070-JLH | 2024-09-24 | No | Consolidated with #1 on 2025-03-18; motions to dismiss pending |
| 3 | Neurent Medical Inc. & Ltd. v. Aerin Medical Inc. (IPR) | PTAB | IPR2024-00276 | 2024-01-18 | Yes (claims 1–3, 6, 12, 14, 16, 18, 19) | Instituted 2024-07-22; adverse judgment / terminated 2025-01-24 after statutory disclaimer |
Sources: ptacts.uspto.gov petition 1555011 (IPR2024-00276 petition, Ex. 1001 = US 9,415,194); ptacts.uspto.gov petition 1558031 (D. Del. Joint Status Report, C.A. No. 23-756 (JLH)); ptacts.uspto.gov petition 1558030 (Aerin IPR2025-01125 papers reproducing D.I. 94 in 1:23-cv-00756); docketalarm.com Exhibit 1035 (D. Del. Amended Complaint, Aerin/Foundry v. Neurent, 23-756 (GBW)); ipverse.greyb.com IPR2024-00276; ai-lab.exparte.com IPR2024-00276; gaeflexstaging-dot-docketupdate.appspot.com IPR2024-00276 docket; insight.rpxcorp.com litigation document 15289625 (D. Del. complaint excerpts); finnegan.com case page (1:23-cv-00756 and the associated IPRs); docketalarm.com IPR2024-00278 institution decision (related-matter disclosures); patents.google.com/patent/US9415194/en.
Generated 9/16/2026, 4:45:41 AM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
Current assignee: Neurent Medical Inc., Neurent Medical Ltd.
No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
I'll reconcile the structured "no PTAB activity" default against the IPR identified in the earlier section, and fill in claim-level detail.
Key data point: an adverse judgment terminated the IPR. Let me determine whether it was a statutory disclaimer, a request for adverse judgment, or a settlement, and check for any second proceeding.
Found it — a statutory disclaimer was filed with a joint motion to terminate. Now I need the exact scope of the disclaimer.
Proceedings overview
One AIA trial proceeding has been filed on US 9,415,194: IPR2024-00276 (Neurent Medical Inc. et al. v. Aerin Medical Inc.). It is terminated — not by a Final Written Decision, but by a joint motion to terminate with a request for adverse judgment after the patent owner statutorily disclaimed the challenged claims. Net: 0 claims invalidated on the merits, 1 proceeding closed by disclaimer + adverse judgment, 0 proceedings active, 0 institutions denied. Bottom line for a defendant: the challenged method claims (1–3, 6, 12, 14, 16, 18, 19) are gone by statutory disclaimer, so any demand letter, infringement contention, or damages theory built on claim 1 is untenable — but the patent's device/trough claims (notably independent claims 20 and 26) were never challenged and were never adjudicated, so the patent is not "hardened"; it is untested as to its surviving claims.
⚠️ Conflict flagged: the structured "PTAB proceedings on file" block states the USPTO ODP API returns no AIA trial proceedings for this patent. That is contradicted by documentary evidence below (PTAB docket entries, the Board's institution decision hosted on ptacts.uspto.gov, and the Federal Circuit/Google Patents litigation links). I treat the ODP block as stale/incomplete — consistent with the possibility that its ingest predates or omits adverse-judgment terminations. All findings below are sourced to the documents cited.
IPR2024-00276 — Neurent Medical Inc. and Neurent Medical Ltd. v. Aerin Medical Inc.
- Type: Inter Partes Review (35 U.S.C. §§ 311–319; AIA)
- Patent challenged: US 9,415,194 B2 (application 14/675,689)
- Filed: 2024-01-18
- Status: "Terminated-Adverse Judgment" (verbatim, per PTAB docket/IP Verse). Plain English: the Board closed the case without a merits trial decision after Patent Owner moved for adverse judgment.
- Judge panel: Administrative Patent Judges Michael J. Fitzpatrick, Michaela (Michael) Valek, and Zhenyu Yang (per Docket Alarm and Ex Parte case page). Tech Center 3700, Art Unit 3762.
- Counsel: Petitioner — David Cavanaugh et al.; Patent Owner — Kathleen Daley et al. (per IP Verse). Finnegan represents Aerin Medical Inc. and The Foundry, LLC as patent owners across the parallel IPR series.
- Petition grounds (claims challenged: 1–3, 6, 12, 14, 16, 18, and 19 — all method claims; independent claim 1 was the sole independent claim challenged):
- Ground 1 — § 102 anticipation by Baker (WO 2010/077980) as to claims 1–3, 12, 14, 16, 18, 19. Baker teaches treating rhinitis/post-nasal drip via an energy-based (acoustic/ultrasound) device inserted into a nostril, with a flexible/deformable inflatable chamber contacting mucosa without piercing.
- Ground 2 — § 103 obviousness over Baker as to claims 1–3, 12, 14, 16, 18, 19 (alternative theory; post-nasal drip as a known rhinitis symptom, and selecting the inferior turbinate/posterior aspect as an obvious design choice).
- Ground 3 — § 103 obviousness over Baker in view of Edwards-’535 (US 6,517,535) and Chen (March 2005 journal article on RF treatment) as to claims 1–3, 6, 12, 14, 16, 18, 19 (claim 6 requires ablating nerve tissue underlying the mucosa).
- No § 112 ground was asserted.
- Institution decision: Instituted 2024-07-22. The Board's decision found Petitioner's proposed level of ordinary skill sufficient at the institution stage and analyzed the asserted ground(s); the decision text I retrieved presents the § 102 Baker ground table for claims 1–3, 12, 14, 16, 18, 19. (Source: Board decision document served via USPTO PTACTS, petition file 1555011.) Note: the challenged claims and ground table in the institution decision confirm claims 20 and 26 were not challenged.
- Final Written Decision: None issued. The PTAB docket shows "FWD —" (blank) for this case. Therefore no claim was held unpatentable on the merits by the Board. The "Outcome: Unpatentable" label on the Ex Parte aggregation page is an artifact of the adverse judgment, not a merits holding — do not cite it as an invalidity decision.
- Settlement / termination (the decisive event):
- 2024-10-24 — Aerin statutorily disclaimed all claims of the '597 and '194 patents that had been asserted against, and challenged by, Neurent (source: D. Del. filing text served via USPTO PTACTS, petition file 1558031).
- 2025-01-21 — Patent Owner filed "Motion for Adverse Judgment — Joint Motion to Terminate and Request for Adverse Judgment," attaching Ex. 2001 – Statutory Disclaimer (194) (source: PTAB docket entry, Docket Alarm mirror).
- 2025-01-24 — Board terminated the proceeding with adverse judgment (PTAB docket / IP Verse "Termination Date").
- The joint motion indicates the parties jointly sought termination, which is often (though not necessarily) settlement-adjacent; the terms of any agreement are not public and I will not speculate about them. What is public and controlling is the statutory disclaimer, not a confidential license.
- ⚠️ Precision caveat: the disclaimer scope is described in the District of Delaware filing as "all claims ... asserted against, and challenged by, Neurent," and the IPR challenged set is 1–3, 6, 12, 14, 16, 18, 19. Whether the disclaimer swept in additional asserted-but-unchallenged claims (e.g., independent claims 20 and 26, if asserted in the Delaware case) is not resolved by the records I retrieved. Verify against the disclaimer document in the '194 file wrapper before relying on claims 20/26 as live.
- Appeal: No Federal Circuit appeal of IPR2024-00276 was identified. The CAFC activity in this dispute (consolidated Nos. 2025-2099, -2100, -2101 and 2025-2113, -2114, -2121) involves PTAB Nos. IPR2024-00277, -00278, -00282, -00279, -00280, and -00669 — other patents in the family, not the '194 patent — and those consolidated proceedings were dismissed by nonprecedential order dated 2026-08-27 under Fed. R. App. P. 42(b), each side bearing its own costs. A patent owner who disclaims and requests adverse judgment has no adverse FWD to appeal, so the absence of a '194 appeal is expected.
- Parallel district court posture (context): Aerin Medical Inc. et al. v. Neurent Medical Inc. et al., No. 1:23-cv-00756 (D. Del., Judge Jennifer L. Hall). On 2024-08-08 the court granted the parties' stipulated stay until the PTAB issues a final written decision in each of IPR2024-00275, -00276, -00277, -00278, -00279, -00280, -00669, and -00282. Because no FWD ever issued in -00276 (adverse judgment instead), the stay condition for that case was never literally satisfied. Aerin filed a motion to consolidate and stay on 2024-11-26, which is worth checking for its current status.
- Defensive value: This is the strongest defensive fact available on the '194 patent. Independent claim 1 — the claim an infringement case would be built on — was statutorily disclaimed, and disclaimed claims are treated as though they never existed and cannot be asserted. A plaintiff pressing claim 1 (or 2, 3, 6, 12, 14, 16, 18, 19) today is asserting a claim the owner has surrendered, which exposes it to a motion to dismiss, a Rule 11 risk, and potential § 285 fee exposure. But do not over-read it: because no FWD issued and claims 20/26 were never challenged, this proceeding gives you zero estoppel-generated invalidity findings and zero PTAB-tested roadmap for the surviving claims.
Strategic summary
Claim survival map (as best the public record supports). Canceled by Board decision (FWD): none. Surrendered by patent owner's statutory disclaimer: claims 1–3, 6, 12, 14, 16, 18, and 19 — the full IPR challenged set — plus any additional claims that were asserted in the Delaware case and thus described as disclaimed on 2024-10-24 (unverified). Untested / potentially live: claims 4, 5, 7–11, 13, 15, 17, and 20–33, including independent claim 20 (elongate malleable shaft + handle + treatment surface with at least two longitudinally extending energy-delivery members separated by a concave trough) and independent claim 26 (bend shaft → non-piercing contact → bipolar RF delivered across the trough → measure with a trough thermocouple → remove without leaving an implant). Those two claims are the commercially meaningful ones and, critically, no tribunal has ever construed or tested them against prior art. Treat the '194 patent as narrowed but not adjudicated.
Estoppel landscape — read this carefully, it cuts both ways. Because no Final Written Decision was issued, the § 315(e)(1)/(2) statutory estoppel that normally arises "after the petitioner requests or institution of a review ... and a final written decision" is, by the statute's own terms, not triggered against Neurent — the Board's adverse judgment under 37 C.F.R. § 42.73(b) is a judgment, but it is not a final written decision, and I have not verified any Board or Federal Circuit authority applying § 315(e) to an adverse-judgment termination in this case. Practical consequence for a different defendant: the prior art Neurent assembled (Baker WO 2010/077980, alone and in view of Edwards-’535 and the Chen 2005 article) may be re-runnable by a non-privy petitioner against the surviving claims, and the PTAB's institution decision already contains the Board's own framing of claim 1's limitations — a useful, free roadmap. Conversely, the patent owner cannot invoke a favorable merits holding to insulate the surviving claims, because it obtained none.
Pattern signals. This is a coordinated multi-patent campaign, not a one-off. Neurent filed a cluster of IPRs on the same day (2024-01-18): IPR2024-00275 ('597 patent), -00276 ('194), and -00277 ('271) at minimum, with the wider PTAB docket spanning -00275 through -00282 plus IPR2024-00669. The patent owner's response was equally systematic: a blanket statutory disclaimer of all asserted-and-challenged claims of both the '597 and '194 patents on 2024-10-24, followed by joint motions to terminate with requests for adverse judgment. That is a portfolio-surrender-and-fight-elsewhere strategy, not a defense on the merits — the patent owner conceded these claims and redirected to other family members. No defensive aggregator (e.g., Unified Patents) appears in this chain; the petitioner is a direct market competitor (Neurent Medical) represented by Cavanaugh; and the later CAFC appeals in this family were dismissed by consent on 2026-08-27, so there is no live appellate precedent being generated here. Note also that Google Patents still lists the '194 patent as "Active" notwithstanding the disclaimer — a real trap for anyone who checks status on an aggregator instead of the Office's own disclaimer record.
Recommended next steps
- Pull the disclaimer and pin its exact scope before you do anything else. The controlling documents are (a) the statutory disclaimer under 35 U.S.C. § 253(b) in the '194 file wrapper, and (b) Ex. 2001 – "StatutoryDisclaimer (194)" filed 2025-01-21 in IPR2024-00276. If your demand letter or complaint cites any of claims 1, 2, 3, 6, 12, 14, 16, 18, or 19, respond that those claims were disclaimed; disclaimed claims are treated as never having existed and are not assertable, which supports a motion to dismiss that count, a Rule 11 letter, and a § 285 fee argument.
- Do not assume claims 20–33 are safe. Independently confirm whether the 2024-10-24 disclaimer (described as covering "all claims ... asserted against, and challenged by, Neurent") also swept in independent claims 20 and 26. If it did, the patent has essentially no remaining asserted scope and the commercial threat is over. If it did not, claims 20 and 26 are live, unadjudicated, and the place to focus your invalidity work.
- For a live claim 20/26 fight, build your own IPR rather than relying on Neurent's record. Because no FWD issued, there is no § 315(e) estoppel finding and no Board claim construction to lean on. Reuse the institution-decision roadmap (the Board's claim-1 limitation framing and the Baker / Edwards-’535 / Chen combination) but re-cast it against the trough-and-malleable-shaft limitations, which Neurent never had to address.
- No PTAB deadlines remain for IPR2024-00276. Instituted 2024-07-22, so the statutory 1-year FWD deadline would have been on or about 2025-07-22 under 35 U.S.C. § 316(a)(11); the case closed early on 2025-01-24 and there is no oral hearing and no FWD to await. For any new petition on the surviving claims, the § 315(b) one-year bar runs from service of a complaint on that petitioner — a separate defendant's clock is its own.
- Verify the Delaware stay was actually lifted. The 2024-08-08 stay was conditioned on an FWD issuing in each of eight IPRs, including -00276; no FWD issued there, and Aerin moved to consolidate and stay on 2024-11-26. Check the 1:23-cv-00756 docket and Judge Hall's most recent order before assuming the case is dormant.
- Treat aggregator labels as unreliable. The "Outcome: Unpatentable" and title "Techniques for Treating Upper Airway Conditions" on the Ex Parte page are artifacts; the title of record is "Post nasal drip treatment," and the operative event is a disclaimer + adverse judgment, not an invalidity holding. Cite the PTAB docket and the disclaimer exhibit, not the aggregator summary.
Sources: PTAB docket and timeline, IPR2024-00276 — docketalarm.com/cases/PTAB/IPR2024-00276/Neurent_Medical_Inc._v._Aerin_Medical_Inc/ (filed 2024-01-18; terminated 2025-01-24; panel Fitzpatrick, Valek, Yang; "Motion for Adverse Judgment – Joint Motion to Terminate and Request for Adverse Judgment," 2025-01-21; "Ex. 2001-010201StatutoryDisclaimer (194)"); ipverse.greyb.com/ptab-web/cases/case-details/IPR2024-00276 (status "Terminated-Adverse Judgment"; institution 2024-07-22; termination 2025-01-24; counsel); Board institution decision and District of Delaware filing text served via USPTO PTACTS (ptacts.uspto.gov/ptacts/public-informations/petitions/1555011 — challenged claims 1–3, 6, 12, 14, 16, 18, 19; claim 1 reproduced; Baker § 102 ground table; PTACTS petition file 1558031 — "On October 24, 2024, Aerin statutorily disclaimed all claims of the '597 and '194 patents that had been asserted against, and challenged by, Neurent"); ai-lab.exparte.com/case/ptab/IPR2024-00276 (aggregator; panel and dates); finnegan.com work experience page (1:23-cv-00756, D. Del., Judge Hall; IPR2024-00275, -00276, -00277, -00278, -00279, -00280, -00282, -00669); cafe.uscourts.gov order in Nos. 2025-2099 et al. (2026-08-27 dismissal under Fed. R. App. P. 42(b)).
Generated 9/16/2026, 4:45:54 AM
Ownership chain (4)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
? · recorded 2015-12-29 · Assignment
? · recorded 2019-05-13 · Security Agreement
AERIN MEDICAL INC.CRG SERVICING LLC
securitization
? · recorded 2024-12-20 · Release
CRG SERVICING LLCAERIN MEDICAL INC.
securitization
? · recorded 2024-12-20 · Security Agreement
AERIN MEDICAL INC.ARES CAPITAL CORPORATION
securitization
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll research the assignment record for US 9415194 across USPTO Assignment Center, Google Patents legal events, and cross-referencing sources.
Let me dig for the specific recorded assignment entries and the parties' business status.
Assignment & Ownership Analysis — US 9,415,194 B2 ("Post nasal drip treatment")
Working note on sourcing: I could not directly query the USPTO Assignment Center interface (assignmentcenter.uspto.gov / assignment.uspto.gov) with my available tools, and my searches for reel/frame numbers returned nothing. The ownership events below are drawn from the patent record's own legal-events table (Google Patents, fetched 2026-08-28), the PTAB/docket annotations, and Ares Capital's SEC filings. Where reel/frame numbers and correspondent-of-record fields were not retrievable, I have marked them "not retrieved" rather than supplying placeholder values — I will not fabricate reel/frame data. Expected Assignment Center result set for a search on 9415194: four records (one Assignment, two Security Agreements, one Release).
Inventors
| Inventor | Recorded address (per patent front page) | Employer at filing |
|---|---|---|
| Scott J. Wolf | Menlo Park, CA | Aerin Medical, Inc. — application filed 2015-03-31 with Aerin as applicant; both inventors executed an assignment of their interest to Aerin (recorded 2015-12-29) |
| Andrew Frazier | Sunnyvale, CA | Aerin Medical, Inc. (same basis) |
Pattern check — no fire-sale precursor. The classic "portfolio fire-sale" tell (all inventors departing the assignee within 12 months of filing) is not observable here. To the contrary, the same two-inventor pair recurs across the Aerin continuation family carrying the same 2011-06-14 priority (the record links US 15/215,762 → US 9,801,752 B2; US 15/429,947 → US 10,603,059 B2; US 15/596,195 → US 9,943,361 B2; US 15/952,985 → US 10,631,925 B2). A two-person inventor team filing continuations together for a decade is the signature of a committed operating-company R&D core, not of a liquidating estate. Caveat: I verified the inventor-pair recurrence from family linkage in the patent record, not from USPTO employment records; actual departure dates are not in evidence.
Original assignee
Aerin Medical, Inc. — now of 2565 Leghorn Street, Mountain View, CA 94043 (per Ares Capital SEC filings); the 2015 assignment and the printed patent show the earlier Sunnyvale, CA address.
- Business: "Developer and manufacturer of non-invasive nasal treatment solutions" — Ares Capital Corporation Form 10-K / Annual Report 2024, consolidated schedule of investments (aerin entry under Health Care Equipment and Services). This is an operating, revenue-stage device company, not a licensing vehicle.
- Product embodying the claims: Aerin commercializes in-office, temperature-controlled radiofrequency nasal devices (the VivAer platform) — i.e., it practices the non-piercing endonasal-energy treatment claimed in independent claims 1 and 26.
- Status: Operating and privately held, not acquired or dissolved, and no bankruptcy filing found in the retrieved record. Capital structure per the Ares filings: a first lien senior secured loan (acquired 12/2024, maturing 12/2030, ~11.6% coupon), Series G preferred shares (12/2024), and earlier Series A preferred / preferred units (07/2022). Aerin is a borrower and preferred issuer to Ares, not an Ares subsidiary.
- Additional live fact — adverse PTAB outcome: IPR2024-00276 (Neurent Medical Inc. v. Aerin Medical Inc.), challenging claims 1–3, 6, 12, 14, 16, 18, 19, was terminated by Adverse Judgment on 2025-01-24, which sits awkwardly beside Google Patents' "Active" status flag. Ownership analysis is unaffected (an adverse judgment affects claim scope, not title), but it materially affects the patent's assertion value. Flag for contradiction review: my prior section noted that an aggregator labeled this outcome "Unpatentable," while the PTAB caption is a judgment rather than a final written decision; whether these claims were statutorily disclaimed or formally cancelled remains unresolved.
Assignment timeline
Only one title transfer and three lien/release records appear in this chain over ~11 years. Reel/frame and correspondent columns could not be retrieved; see note above.
Executed [date not retrieved] / recorded 2015-12-29 — Reel not retrieved / Frame not retrieved
- Conveyance: Assignment (ASSIGNMENT OF ASSIGNORS INTEREST)
- Assignor: Andrew Frazier; Scott J. Wolf (individually)
- Assignee: AERIN MEDICAL, INC.
- Correspondent: not retrieved
- Context: Founding-company inventor assignment — the routine employee/contractor title clean-up that puts the operating company of record; recorded ~9 months after the 2015-03-31 filing.
Executed [date not retrieved] / recorded 2019-05-13 — Reel not retrieved / Frame not retrieved
- Conveyance: Security Agreement (SECURITY INTEREST) — lien, not a transfer of title
- Assignor: AERIN MEDICAL INC.
- Assignee: CRG SERVICING LLC, as secured party
- Correspondent: not retrieved
- Context: Securitization — venture-debt collateral mortgage over the patent portfolio. CRG Servicing LLC is a life-science lender (CRG = Capital Royalty Group), not an acquirer.
Executed [date not retrieved] / recorded 2024-12-20 — Reel not retrieved / Frame not retrieved
- Conveyance: Release (RELEASE BY SECURED PARTY)
- Assignor: CRG SERVICING LLC
- Assignee: AERIN MEDICAL INC.
- Correspondent: not retrieved
- Context: Lien discharge on payoff — the CRG facility was retired as part of the December 2024 refinancing; title reverts clean to Aerin of record.
Executed [date not retrieved] / recorded 2024-12-20 — Reel not retrieved / Frame not retrieved
- Conveyance: Security Agreement (SECURITY INTEREST) — lien, not a transfer of title
- Assignor: AERIN MEDICAL INC.
- Assignee: ARES CAPITAL CORPORATION, as Administrative Agent and Collateral Agent
- Correspondent: not retrieved
- Context: Securitization / refinancing — new first lien senior secured loan (12/2024, maturing 12/2030) plus Series G preferred, per Ares' own 2024 annual report. Same-day recording with the CRG release indicates a single closing.
Important interpretation guardrail: the PTAB docket aggregator (Docket Alarm) displays "Assignee | CRG SERVICING LLC" on IPR2024-00276. That is an artifact of reading the security interest record into an assignee field. CRG never held title to the '194 patent, and the lien was released and recorded on 2024-12-20. Anyone consuming that docket field literally would misstate the owner.
Title chain, stripped to essentials: Wolf + Frazier → Aerin Medical, Inc. (2015) — and Aerin Medical, Inc. is still the owner of record today. The 2019 and 2024 entries are encumbrances, and the 2024 CRG entry is a discharge.
Timeline diagram
timeline
title Ownership of US 9415194
2011 : Priority date 14 Jun
2015 : Application filed 31 Mar
: Inventors assign to Aerin Medical
2016 : Patent granted 16 Aug
2019 : Security interest to CRG Servicing
2023 : Aerin sues Neurent in Delaware
2024 : IPR filed by Neurent
: CRG release recorded
: Security interest to Ares Capital
2025 : PTAB adverse judgment
NPE / troll-pattern signals
Shell-entity transfer — NOT PRESENT. No assignment to any "IP / Licensing / Holdings / Ventures" entity exists in the chain. The only title transfer runs to the operating company (Aerin, recorded 2015-12-29), and the two lien entries name institutional lenders (CRG Servicing 2019-05-13; Ares Capital 2024-12-20) acting as collateral agents, not as patent-holding vehicles.
Known asserter in the chain — NOT PRESENT. Neither Aerin Medical nor CRG Servicing nor Ares Capital appears on the NPE rosters cited in my brief (Acacia, Marathon, IV, IPNav, Wi-LAN/Mosaid-Conversant, Vringo, Pendrell, Round Rock, etc.). Aerin profiles as the defensive/operating party to an IPR (patent owner in IPR2024-00276, respondent not petitioner), which is the inverse of the asserter posture.
Repeat correspondent across the chain — UNCLEAR / NOT RETRIEVABLE. Correspondent-of-record data was not obtainable for any of the four entries. One weak structural observation: the CRG release and the Ares security agreement were recorded the same day (2024-12-20), which is consistent with a single lender's counsel and a single borrower's counsel handling one refinancing closing — but I cannot name the attorney or firm, and a single closing is not the recurrence signal your brief defines. I decline to score this as present.
Cascading transfers — NOT PRESENT. Over ~11 years there is one title transfer and two lien records. Nothing resembling chained LLC-to-LLC assignments inside 24 months, no shared addresses among assignees, no common principals between CRG (2019 lender) and Ares (2024 lender) in evidence.
Pre-litigation transfer — NOT PRESENT. The only title transfer is dated/recorded 2015-12-29, roughly 7.5 years before the D. Del. suit (No. 1:23-cv-00756, filed 2023). The nearest-in-time ownership-adjacent event, the Ares collateral mortgage, came on 2024-12-20, roughly 16 months after the complaint — a financing date, not a standing- or venue-engineering date. Neither falls inside the 6-month window.
Bankruptcy fire-sale — NOT PRESENT on the retrieved record. No Chapter 7/11 event, no §363 sale, and no trustee or receiver as assignor. The 2024-12-20 CRG release reads as a payoff, not a distressed liquidation; Ares' simultaneous new-money first lien at ~11.6% is refinancing behavior. Caveat: I was unable to complete dedicated bankruptcy-docket searches before hitting tool limits; treat "not present" as "not found," not as affirmatively disproven.
Privateering — NOT PRESENT. Aerin does not transfer to an NPE; Aerin itself maintains the portfolio and litigates directly against a named competitor, Neurent Medical Inc./Neurent Medical Ltd. — a direct rival in the nasal neuromodulation field (the IPR petitioner). This is symmetric competitor-versus-competitor warfare, the opposite of the privateering structure.
Defensive aggregator (anti-NPE) — NOT PRESENT. The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. Note one easy-to-misread detail on the Google Patents page: the "Petitioner: Unified Patents PTAB Data" string is a data-source license attribution for the PTAB field, not a statement that Unified Patents filed IPR2024-00276. The petitioner of record is Neurent Medical. Similarly, the "Family has litigation" and Darts-IP/Unified links are metadata attributions, not party identities.
Verdict
Operating-company assertion.
Aerin Medical, Inc. is the owner of record on a clean, uninterrupted title chain: the inventors assigned to Aerin (recorded 2015-12-29), Aerin never transferred title to any third party, and the only other recorded conveyances are a lender's security interest (CRG Servicing, recorded 2019-05-13), a secured-party release (recorded 2024-12-20), and a replacement security interest to Ares Capital as administrative and collateral agent (recorded 2024-12-20). Aerin is an FDA-regulated device manufacturer that ships product embodying the claims — Ares Capital's own 2024 annual report describes Aerin as a "Developer and manufacturer of non-invasive nasal treatment solutions" — and it asserts the family against Neurent Medical, a direct competitor (D. Del. 1:23-cv-00756; IPR2024-00276 filed against the '194 patent by Neurent). Six of the eight NPE signals are affirmatively absent; the two remaining (correspondent recurrence, bankruptcy) are unscored for lack of retrievable data, and neither the reel/frame nor correspondent records I could not obtain would be expected to change the verdict absent new evidence of a title transfer to a non-practicing entity.
Verification links:
- USPTO Assignment Center: https://assignmentcenter.uspto.gov/ (search "9415194")
- USPTO Assignment Search (legacy index): https://assignment.uspto.gov/patent/index.html (search "9415194")
- Patent record / legal events: https://patents.google.com/patent/US9415194/en
- PTAB: https://portal.unifiedpatents.com/ptab/case/IPR2024-00276
Retrieval gaps you should close manually (I did not guess at these): (a) execution dates and reel/frame numbers for all four recorded entries; (b) the correspondent of record on each — the single most valuable field for the recurrence test in signal 3; (c) confirmation of whether the 2025-01-24 adverse judgment resulted in a statutory disclaimer of claims 1–19; (d) whether the search "9415194" returns any fifth record not surfaced in the patent's legal-events table.
Generated 9/16/2026, 4:45:52 AM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll research the prior-art citation record for US 9,415,194 specifically.
Let me pull the specific citation tables for the '194 patent.
Let me get the Justia and FreePatentsOnline citation lists for the '194 patent directly.
Prior-Art Analysis — US 9,415,194 B2 ("Post nasal drip treatment")
Scope note / rule compliance: I searched for the identifier "9415194" / "9,415,194" only. No similar numbers (e.g., 9415193, 9415195) were substituted, and nothing below is auto-corrected. Building on the previously generated section (bibliography, claims 1/20/26, IPR2024-00276), this section addresses the citation record and §102 mapping and does not repeat those findings.
Flagged contradiction (required by the operating rules): The previously generated section notes that tool results returned documents dated August 27–28, 2026, and it flagged your prompt's then-date of April 26, 2026. This task again sets the current date as April 26, 2026. I cannot reconcile the two; I report record contents as retrieved and do not adjust dates.
1. Verification gap you should know about before relying on this
The authoritative full text supplied in your message does not contain the "Patent Citations" / "References Cited" table — the Google Patents fetch is truncated after the classification list and the "Definitions" narrative (it cuts off in the figures/Family section). I therefore reconstructed the front-page citation list from FreePatentsOnline, Justia, and PubChem entries for the '194 record. Consequences:
- The list below is complete for what those mirrors expose, but I cannot certify it is the entire front-page list (FPO's snippet truncates mid-list at US 7,442,191).
- Titles I could read verbatim from the retrieved snippets are marked ✅. Titles marked ⚠️ are numbers I could not title-verify in this session — I do not assert their titles or content.
- "Cited By" tables I retrieved are forward citations (later patents citing the '194), which are not prior art to the '194. Do not confuse those with the "Patent Citations" (backward) list. Many Aerin/Arrinex/TriAgenics hits in my search results are forward citations.
2. Legal framing that drives the mapping (important for this patent)
Three distinctions materially change which references are §102-available:
- The '194 is a continuation-in-part. Per the priority chain (provisional 61/974,534 filed 2014‑04‑03; CIP of 14/319,087 filed 2014‑06‑30; which is a CIP of 13/495,844 → provisionals 61/603,864 and 61/496,930, 2011‑06‑14), claims are only entitled to 2011‑06‑14 if the subject matter is supported by the 2011 disclosure ("Post nasal drip" / mucus-production subject matter appears to be new matter added in the 2014–2015 CIPs). Claims supported only by the later disclosure carry an effective filing date of 2014‑04‑03 or 2015‑03‑31.
- That moves the §102 date forward for the PND-specific claims, making references published 2011–2014 (e.g., the Baker intranasal publication, the Danek "reducing mucus in airways" publication) potentially §102(b)/(a)(1) art, not merely §102(e). This is likely the single most important analytic point for this patent.
- Pre-AIA vs. AIA: the '194's application was filed 2015‑03‑31 (post‑AIA), so claims not entitled to pre‑2013 priority are examined under AIA §102(a)(1)/(a)(2); claims entitled to 2011 priority under pre-AIA §102(b)/(e). Most of the front-page references below predate 2011 and are therefore §102(b) art either way.
3. Table A — Cited references with publication dates before 2011‑06‑14 (strongest §102(b) posture)
| Reference | Date | Brief description | Claims potentially anticipated (§102) |
|---|---|---|---|
| US 7,442,191 B2 ✅ — "Systems and methods for electrosurgical treatment of turbinates" | Issued 2008‑10‑28 | Electrosurgical (RF) treatment of nasal turbinates; energy delivered to turbinate tissue to shrink/ablate it | Claim 1 (energy-based device advanced into the nose, contacting turbinate/mucosal tissue, modifying tissue). Anticipation is imperfect — the reference is directed to nasal obstruction/rhinitis, not to reducing mucus secretion to treat PND/chronic cough. Best characterized as §103 art against claim 1, not clean §102. Also relevant to claim 16/17-type turbinate limitations |
| US 6,391,028 B1 ✅ — "Probe with distally oriented concave curve for arthroscopic surgery" (Oratec Interventions) | Issued ~2002 | RF probe whose working end carries a concave curve for seating tissue | Claims 20 and 26 — the "concave trough" limitation. Anticipates the concavity element (though not the two longitudinal energy-delivery members flanking a longitudinal trough) |
| US 6,299,341 B1 ✅ — "Method and apparatus for impedance measurement in a multi-channel electro-surgical generator" | Issued 2001‑08‑28 | Multi-channel RF generator with per-channel impedance sensing | Dependent claims reciting independent/multiplexed channels and feedback (spec.-linked dependents on claims 1 and 26); §102 only if combined with an intranasal delivery teaching |
| US 7,850,683 B2 ✅ — "Subdermal cryogenic remodeling of muscles, nerves, connective tissue, and/or adipose tissue (fat)" (Elkins; Myoscience/Pacira) | Issued 2010‑12‑14 | Cryogenic (energy-removal) nerve treatment via needle cryoprobes | The cryotherapy dependents (energy removal + nerve ablation), and it is the closest analog to the spec.'s cryo-nerve-ablation embodiment |
| US 7,824,394 B2 ✅ — "Method and apparatus for dermatological treatment and tissue reshaping" (Manstein) | Issued 2010‑11‑02 | Non-invasive RF/thermal treatment arrays for tissue reshaping | Claim 1 (non-piercing contact delivery to modify a tissue property) in combination with intranasal art; §103, not clean §102 |
| US 2011/0009737 A1 ✅ — "Method and apparatus for dermatological treatment and tissue reshaping" (Manstein) | Publ. 2011‑01‑13 | Continuation-family counterpart of the above | Same as 7,824,394; §102(a)/(b) only as to non-piercing energy-to-tissue elements |
| US 2011/0282268 A1 ✅ — "Methods and Systems for Delivery of Fluids and Aerosols to Tissue Surfaces, Cavities and Obstructed Passages such as Intranasal Ostia" (Baker) | Publ. 2011‑11‑17 | Intranasal fluid/aerosol delivery device | See §4 below — this is Baker-family art; the WO 2010/077980 sibling was the primary IPR reference. Relevant to the "substance/cauterizing-agent delivery" dependents |
| US 2009/0018485 A1 ✅ — "Control of microorganisms in the sino-nasal tract" (Krespi et al.) | Publ. 2009‑01‑15 | Intranasal energy/substance treatment of sinonasal tissue | Background §102(a)/(b) art; weak on mucus-secretion/PND purpose |
| US 2009/0143821 A1 ✅ — "Device for repositioning cartilage and method of use" (Stupak) | Publ. 2009‑06‑04 | Nasal cartilage reshaping/repositioning device | Dependent claims directed to changing mucus path/tissue conformation (spec. ¶ re: diverting mucus flow) — §102(a)/(b) |
| US 2010/0152730 A1 ✅ — "Mucosal tissue dressing and method of use" (Makower) | Publ. 2010‑06‑17 | Dressings/applicators applied to mucosa | Non-energy dependent claims (delivering a substance to mucosa); §102(a)/(b) |
| US 2010/0144996 A1 ✅ — "Injectable cyanoacrylate-functionalized polyisobutylenes" (Kennedy et al.) | Publ. 2010‑06‑10 | Injectable, in-situ polymerizing liquid | The "injecting a polymerizing liquid" dependent claim (spec.-summary embodiment); §102(a)/(b) |
| US 7,780,730 B2 ✅ and US 2009/0292358 A1 ✅ — "Nasal implant introduced through a non-surgical injection technique" (Saidi) | 2010‑08‑24 / 2009‑11‑26 | Injectable nasal implants | Claim 26's "without leaving an implant" negative limitation. Caveat: under usual practice a reference silent as to implants does not affirmatively disclose the negative limitation; these are therefore §103 art, and are the most useful for arguing the "no implant" element was a known alternative |
| US 7,416,550 B2 ✅ — "Method and apparatus for the control and monitoring of shape change in tissue" | Issued 2008‑08‑26 | Closed-loop control/monitoring of tissue shape change | Dependent claims reciting control/feedback and measurement (claims 26–33 family) |
| US 8,317,782 B2 ✅ — "Non-ablative radio-frequency treatment of skin tissue" (Ellman; Cynosure) | Issued 2012‑11‑27 (filed 2006‑10‑12) | Non-ablative RF skin treatment | §102(e) only (published after the 2011 priority date); relevant to non-ablative "modify a property" limitations |
| US 8,137,345 B2 ✅ — "Electrosurgical devices for tonsillectomy and adenoidectomy" (McNall et al.) | Issued 2012‑03‑20 | ENT electrosurgical device | §102(e); structural analog for the ENT treatment-portion claims |
| US 2012/0078377 A1 ✅ — "Systems, devices and methods for providing therapy to an anatomical structure using high frequency pressure waves and/or cryogenic temperatures" (Gonzales) | Publ. 2012‑03‑29 (filed 2010‑09‑23) | Pressure-wave/cryo therapy to anatomical structures | §102(e) (prior filing, later publication) — relevant to the cryotherapy dependents |
| US 2012/0039954 A1 ✅ — "Method of treating insomnia" (Cupit et al.) | Publ. 2012‑02‑16 | Intranasal nerve/energy treatment for a non-nasal condition | §102(e); useful §103 support for "treat a condition by nasal energy delivery" |
| US 2012/0316557 A1 ✅ — "Septoplasty Instrument" (Sartor et al.) | Publ. 2012‑12‑13 | Nasal septal surgical instrument | §102(e); structural background only |
Older surgical-ablation family (Somnus Medical Technologies / Edwards; now Olympus/ArthroCare lineage). The front-page list also cites a long block of 1990s–2000s airway-ablation patents. Titles I could verify from the retrieved snippets:
- US 5,817,049 A ✅ — "Method for Treatment of Airway Obstructions" (assignee of record: Olympus Surgical Technologies America)
- US 5,843,021 A ✅ — "Cell Necrosis Apparatus"
- US 5,743,904 A ✅ — "Precision Placement of Ablation Apparatus" (Somnus Medical Technologies)
- US 5,730,719 A ✅ — "Method and Apparatus for Cosmetically Remodeling a Body Structure"
- US 5,807,306 A ✅ — "Polymer Matrix Drug Delivery Apparatus"
- US 6,102,907 A ✅ — "Apparatus and device for use therein and method for ablation of tissue"
⚠️ Numbers retrieved without title/content verification in this session (from the PubChem citation list for US‑9415194‑B2, listed literally and not characterized by me): US 4,887,605; 5,348,008; 5,533,499; 5,624,439; 5,674,191; 5,707,349; 5,717,702; 5,728,094; 5,738,114; 5,743,870; 5,743,904; 5,746,224; 5,800,429; 5,810,740*; 5,816,095; 5,820,580; 5,823,197; 5,827,277; 5,843,077; 5,846,235; 5,879,349; 6,045,549; 6,096,033; 6,109,268; 6,126,657; 6,131,579; 6,139,546; 6,152,143; 6,165,173; 6,179,803; 6,210,355; 6,228,079; 6,231,569; 6,309,386; 6,371,926; 6,383,181; 6,416,491; 6,425,151; 6,431,174; 6,451,013; 6,551,310; 6,562,036; 6,575,969; 6,589,235; 6,659,106; 6,911,027; 6,978,781; 7,055,523; 7,114,495 — plus published applications US 2002/016588; 2002/128641; 2003/144659; 2003/208194; 2003/225403; 2005/119643; 2005/222565. I will not assign these to claims without verifying their disclosures; several (e.g., the Somnus/Edwards airway-ablation and turbinate patents) are, on their face, the most likely §102(b) candidates against claim 1's "energy-based device … into a nostril … modify a property of tissue" elements, and they warrant a manual full-text pull.
(*One PubChem entry appears as "US-5817049-A"; I list 5,810,740 only if separately present — I flag that I could not cleanly resolve every number in that block, so treat the block as a raw citation dump.)
4. IPR2024-00276 ground art — the most probative prior art of record
Per the previously generated section, the PTAB instituted review of claims 1–3, 6, 12, 14, 16, 18, 19 on the following art, and the proceeding ended in adverse judgment (terminated 2025‑01‑24) — which is not a merits decision but is strong evidence of the art's materiality:
| Reference | Date | Description | Claims argued |
|---|---|---|---|
| WO 2010/077980 A1 (Baker) | Publ. 2010‑07‑08 | Intranasal delivery of fluids/aerosols to sinonasal ostia and passages (family member of the cited US 2011/0282268 A1) | §102 anticipation of claim 1 and §103 over claim 1 (primary reference) |
| US 6,517,535 B2 ("Edwards‑'535") | Issued 2003‑02‑11 | Electrosurgical turbinate treatment (ArthroCare/Edwards lineage) | §103 (combined with Baker) |
| Chen et al., 2005 (journal article on RF treatment) | 2005 | RF energy tissue treatment for nerve ablation | §103 against claim 6 (nerve-ablation dependent) |
Analytical implication: the petitioner's theory was that Baker alone anticipates claim 1 — i.e., that claim 1's advance-into-nostril / non-piercing / deliver-to-mucosa-or-underlying-tissue elements were known, with the only contested question being the mucus/PND purpose. Note also that US 6,517,535 does not appear in the citation list I retrieved, so it entered via the IPR, not via the '194's front page — worth confirming against the printed patent before citing it as a §102 reference.
5. Applicant's own family and near-contemporaneous art (self/§102(e) citations)
These appear on the '194 front page but are Aerin's own work sharing the 2011‑06‑14 chain — §102(e)/(a)(2)-type art at most, and potentially excepted by common ownership (pre-AIA §103(c); AIA §102(b)(2)(C)):
- US 8,986,301 B2 ✅ "Methods and devices to treat nasal airways" (Wolf et al.), 2015‑03‑24
- US 9,072,597 B2 ✅ same title (Wolf et al.), 2015‑07‑07
- US 9,179,967 B2 ✅ "Devices to treat nasal airways" (Wolf), 2015‑11‑10
- US 2012/0323232 A1 ✅, US 2012/0323227 A1 ✅ (both "Methods and devices to treat nasal airways," Wolf et al., 2012‑12‑20) — published after the 2011 priority date but before the 2015 filing
- US 2014/0088463 A1 ✅ same title (Wolf et al.), 2014‑03‑27
Non-Aerin, high-interest §102(a)/(b) candidate:
- US 2013/0218158 A1 ✅ — "Methods of reducing mucus in airways" (Danek et al.), publ. 2013‑08‑22. This is, by title alone, the single closest non-Aerin citation to the '194's stated purpose. Its publication postdates 2011‑06‑14 but predates the 2014/2015 CIP filings — so its art status turns entirely on which claims get the 2011 date. If the PND/mucus-reduction claims rely on CIP-added matter (as the specification's structure suggests), Danek is §102(a)(1)/(b) art against those claims. This deserves a full-text comparison.
- US 2014/0114233 A1 ✅ — "Methods and systems for toxin delivery to the nasal cavity" (Deem et al.), publ. 2014‑04‑24 — relevant to the toxin/cauterizing-agent dependent claims, same effective-date caveat.
6. Ranking — most relevant prior art for US 9,415,194
- WO 2010/077980 A1 (Baker) — the only reference actually advanced to anticipate claim 1; §102(b) as to all claims entitled to the 2011 date.
- US 2013/0218158 A1 (Danek et al.) — closest in stated purpose (reducing airway mucus); §102(a)(1)/(b) or §102(a)(2) depending on the CIP effective date.
- US 7,442,191 B2 (Edwards/ArthroCare, turbinate electrosurgery) — closest in anatomy and mechanism; §102(b) for the device/advance-into-nose elements of claim 1, strongest as §103.
- US 6,391,028 B1 (Oratec, concave-curve probe) — closest to the claim 20/26 concave trough limitation.
- US 7,850,683 B2 (Elkins, cryogenic nerve remodeling) — closest to the cryotherapy/nerve-ablation dependents.
- US 7,416,550 B2 and US 6,299,341 B1 — closed-loop control/measurement dependents (claims 26–33 family).
- US 7,780,730 / US 2009/0292358 (Saidi) and US 2010/0144996 (Kennedy) — the "inject"/"no implant" dependent-claim cluster.
- US 6,517,535 (Edwards‑'535) — §103 support per the IPR, but not confirmed in the '194 citation list.
7. Explicit uncertainties
- The front-page citation table could not be fully retrieved (the authoritative Google Patents text supplied omits it; FPO snippets truncate). Section 3 is therefore provisionally complete, not certified.
- I did not title-verify the ~50 older US numbers in §3; I decline to characterize their disclosures. Any §102 mapping for them would be speculation.
- Effective-date allocation among claims 1–33 is unverified. The CIP/continuation-in-part structure means different claims may have 2011‑06‑14, 2014‑04‑03, or 2015‑03‑31 effective dates. Without that allocation, §102 availability of the 2011–2015 references (Baker pub., Danek, Deem, Gonzales, McNair/2012 art) is conditional.
- US 6,517,535's presence in the '194 citation list is unconfirmed — it is confirmed only in the IPR record.
- Post-adverse-judgment claim status (per the prior section) remains unresolved; any §102 conclusion as to claims 1–19 may be moot if they were cancelled or disclaimed.
- Date discrepancy: this task's date (April 26, 2026) conflicts with retrieved documents dated August 2026. Unreconciled.
Sources used in this section: patents.google.com/patent/US9415194/en; FreePatentsOnline.com/9415194.html; patents.justia.com/patent/9801752; patents.justia.com/patent/10456186; pubchem.ncbi.nlm.nih.gov/patent/US‑9415194‑B2; portal.unifiedpatents.com/patents/US‑9801752‑B2 and US‑10631925‑B2 (for citation blocks); insight.rpxcorp.com/patent/US9415194B2 (claim text); plus the IPR2024-00276 grounds recorded in the previously generated section.
Generated 9/16/2026, 4:46:20 AM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll research the prior-art references available for US 9,415,194 before building the §103 analysis.
Good — I have the IPR grounds. Now let me pull the actual prior-art references cited on the patent page so the §103 combos are grounded in the record.
Let me pull the full cited-reference list from the patent page and details on the Edwards reference used in the IPR.
Obviousness Analysis — US 9,415,194 B2 ("Post nasal drip treatment")
Scope note: This builds on the previously generated summary (bibliographic data, claim mapping, litigation/PTAB history). I do not repeat that content. One cross-reference flag appears in §1(c) below.
1. Threshold determinations that drive the §103 analysis
(a) Which §102/§103 regime applies — unresolved, and outcome-determinative
The '194 application was filed 2015-03-31, i.e., after the AIA's 2013-03-16 cutoff, but it is a continuation-in-part (via 14/319,087 → 13/495,844) that claims priority to 61/974,534 (filed 2014-04-03). Under the AIA transition provisions, because at least the "post nasal drip / mucus" subject matter appears to be new matter not present in the 2011-06-14 priority chain, AIA §§102/103 almost certainly govern. I could not verify from the retrieved record whether the Examiner resolved this, so I analyze under both windows:
| Effective filing date assumption | Prior-art window | Consequence |
|---|---|---|
| 2011-06-14 (full priority chain) | Pre-AIA §102(b) — art before 2011-06-14 | Baker (2010), Chen (2005), Hovda '191 (2008), Edwards-'535 (2003) all qualify |
| 2014-04-03 or 2015-03-31 (CIP new matter) | AIA §102(a)(1) | Same four references qualify plus the applicant's own Dec-2012 publications (see (b)) |
Either way, every reference relied on in the IPR grounds predates 2011-06-14, so the priority-date dispute does not change the outcome for those grounds. It only adds prior art.
(b) The applicant's own family publications become §102(a)(1) art if priority breaks
This is the most under-appreciated vulnerability. The patent's own cited-references list (FreePatentsOnline, https://FreePatentsOnline.com/[9415194](/patent/9415194).html) includes:
- US 2012/0323232 A1 and US 2012/0323227 A1 — Wolf et al., "Methods and devices to treat nasal airways," published 2012-12-20
- US 2014/0088463 A1 — Wolf et al., same title, published 2014-03-27
If the PND/mucus claims are entitled only to the 2014-04-03 or 2015-03-31 date, these published Wolf applications are §102(a)(1) prior art, and the common-ownership exception in §102(b)(2)(C) does not rescue them (it applies only to §102(a)(2) applications-as-filed art, not to §102(a)(1) publications). The 2012-12-20 publications fall outside the one-year grace period for either later date. A POSITA combining Wolf's 2012/0323232 nasal-airway energy delivery disclosure with Danek's mucus-reduction teaching reaches claim 1 without needing Baker at all.
(c) Cross-reference flag
The prior summary noted the PTAB record and Unified Patents list the family priority date as 2011-06-13, while Google Patents and the '194 record state 2011-06-14. I could not reconcile this. It is immaterial to §103 (all references predate both dates by years), but it matters if any reference is asserted to be within a one-year grace period — none of the ones below are.
(d) Level of ordinary skill in the art
A POSITA here is a physician-engineer team: a board-certified otolaryngologist and a medical device engineer with ~3–5 years in RF/energy-based surgical devices, familiar with (i) nasal/sinus anatomy including the turbinates and their glandular mucosa (goblet cells and submucosal glands), and (ii) bipolar/monopolar RF ablation instruments and their temperature-feedback controls. This mirrors the art units (3762) and the reference base (ArthroCare, Asthmatx, Somnus/Edwards, Baker).
(e) The adverse judgment — practical, not analytical, effect
IPR2024-00276 (Neurent v. Aerin, filed 2024-01-18), which challenged claims 1–3, 6, 12, 14, 16, 18, 19 on Baker-based §102/§103 grounds, was terminated by adverse judgment on 2025-01-24 (https://portal.unifiedpatents.com/ptab/case/IPR2024-00276; https://ai-lab.exparte.com/case/ptab/IPR2024-00276/doc/1010). An adverse judgment normally follows a patent-owner request for adverse judgment, i.e., statutory disclaimer or cancellation of the challenged claims, not a merits decision. As flagged previously, I cannot confirm from these sources what happened to the claims, and Google Patents still shows "Active." The obviousness analysis below therefore has its greatest practical value for the un-challenged dependent claims 20–33 and the later family members (US 9,801,752; 9,943,361; 10,603,059; 10,631,925, etc.) that share the same specification and recurring device architecture.
2. Prior-art inventory (the references available on the patent record)
| Ref. | Identity | Cited on the '194 record as | What it supplies | Known date |
|---|---|---|---|---|
| Baker | WO 2010/077980 | IPR ground 1 (anticipation) and grounds 2–3; family member US 2011/0282268 A1 also on the '194 IDS | Energy-based (acoustic/ultrasound) device inserted into a nostril; flexible/deformable inflatable chamber contacting mucosa without piercing; treats rhinitis and its symptoms including post-nasal drip; treats nasal passages and turbinates; expresses a goal of mucus reduction | 2010-07-08 |
| Edwards-'535 | US 6,517,535 | IPR ground 3 | Non-piercing RF device with an expandable member for ablating nasal tissue | ≤2003 |
| Chen | March 2005 journal article on RF treatment | IPR ground 3 | Clinical study: RF ablation of nerves within the inferior turbinate is highly effective for allergic rhinitis and reduces gland secretion | 2005-03 |
| Hovda | US 7,442,191 B2 (ArthroCare) — also US 2003/0208194 A1, US 6,063,079, US 5,827,277 | Front-page "US Patent References" list | Electrode terminal positioned adjacent the turbinates in the nasal cavity; high-frequency voltage via an electrically conductive fluid; removes a tissue segment/channel; scar-tissue formation shrinks the turbinates; thermal damage deliberately confined to the target site | 2008-10-28 |
| Danek | US 2013/0218158 A1 / US 8,443,810 B2 (Asthmatx) | Front-page cited-references list | Advancing a treatment device into an airway and treating the airway wall with energy to reduce the airway's ability to produce mucus / reduce mucus plugging; sub-mucosal treatment; modalities expressly include RF, heat, ultrasound, mechanical, chemical, radioactive | 2013-08-22 (pub.); priority 1998-06-10 |
| Wolf | US 2012/0323232 A1; US 2012/0323227 A1; US 2014/0088463 A1; US 8,986,301; US 9,072,597; US 9,179,967 | Front-page cited-references list (same family) | Applicant's own disclosure of energy devices/methods to treat nasal airways, including turbinate treatment | 2012-12-20 onward |
| Ellman | US 8,317,782 | Front-page cited-references list | Non-ablative RF treatment of tissue | 2012-11-27 |
| Elkins | US 7,850,683 | Front-page cited-references list | Subdermal cryogenic remodeling of nerves (energy-removal/cryo branch) | 2010-12-14 |
| Gonzales | US 2012/0078377 | Front-page cited-references list | Therapy to anatomical structures using high-frequency pressure waves and/or cryogenic temperatures | 2012-03-29 |
| McNall | US 8,137,345 | Front-page cited-references list | Electrosurgical devices for tonsillectomy/adenoidectomy (bipolar probes, upper-airway soft tissue) | 2012-03-20 |
| Makower / Saidi / Stupak / Sartor / Krespi / Deem / Cupit / Manstein | US 2010/0152730; US 7,780,730; US 2009/0143821; US 2012/0316557; US 2009/0018485; US 2014/0114233; US 2012/0039954; US 7,824,394 | Front-page cited-references list | Secondary: mucosal dressings, injectable nasal implants, cartilage repositioning, septoplasty instruments, sino-nasal antimicrobial control, nasal toxin delivery, skin RF with cooling | various |
Verification honesty: I retrieved the Baker/Edwards/'535/Chen characterization from the IPR petition analysis (https://ai-lab.exparte.com/case/ptab/IPR2024-00276/doc/1010), and the Hovda and Danek content from their own text (https://FreePatentsOnline.com/[7442191](/patent/7442191).html; https://patents.google.com/patent/US20130218158A1/en). I did not retrieve the full text of WO 2010/077980, US 6,517,535, or the Chen article; for those I rely on the PTAB record as the ground truth per the operating rules.
3. Claim 1 — method: advance into nostril, non-piercing mucosal contact, deliver treatment to mucosa or underlying tissue to modify a property
Claim elements: (i) energy-based device; (ii) advanced into a nostril; (iii) contact without piercing; (iv) treatment delivered to mucosa or underlying tissue; (v) modify a property of that tissue; (vi) to treat PND or chronic cough.
Combination 1A — Baker + Danek (primary; strongest)
| Element | Where taught |
|---|---|
| (i) energy-based device | Baker — acoustic/ultrasound energy |
| (ii) into a nostril | Baker — expressly |
| (iii) non-piercing contact | Baker — flexible/deformable inflatable chamber contacting tissue, per the IPR mapping |
| (iv) mucosa or underlying tissue | Baker (mucosal surface of nasal passage/turbinate); Danek (airway wall and sub-mucosal tissue) |
| (v) modify a property | Baker — ablates tissue, achieves mucus reduction without reshaping; Danek — reduces the airway's ability to produce mucus |
| (vi) PND / chronic cough | Baker — treats rhinitis and its symptoms including post-nasal drip; PND is a known cause of chronic cough |
Motivation to combine. Danek and Baker are in the same field (energy-based treatment of upper/lower airway mucosa to reduce secreted mucus) and address the same underlying problem — hypersecretion of airway mucus. Danek supplies the express therapeutic rationale the '194 asserts as its contribution: reduce mucus production by acting on the mucus-producing tissue of the airway wall, optionally at a sub-mucosal depth, using RF/heat/ultrasound. Baker supplies the trans-nostril, non-piercing delivery platform aimed at rhinitis and its PND symptom. A POSITA seeking to treat PND by reducing mucus output would look to both: Danek for the mechanism and Baker for the access route and device form factor. KSR factors present: same field of endeavor, combination of known elements with no change in their respective functions, and a finite number of identified, predictable solutions.
Reasonable expectation of success. Chen (2005) supplies clinical confirmation that RF treatment of turbinate tissue reduces gland secretion, i.e., that the causal chain in claim 1 actually works. That converts the combination from "worth trying" to "reasonably expected to work" — the KSR/Pfizer standard.
Anticipation overlay. As the IPR petitioner argued, Baker standing alone was alleged to disclose every limitation, including "post-nasal drip" by name — meaning claim 1 may fail at §102 and the §103 question is academic. I flag that as the petitioner's position, not an adjudicated finding.
Combination 1B — Hovda '191 + Danek (independent second path)
Hovda discloses positioning electrode terminal(s) adjacent the turbinates inside the nasosinal cavity and applying high-frequency voltage to create a tissue channel and scar tissue in the turbinates — this is mucosal/or submucosal property modification via RF without piercing (the electrode rides on conductive fluid). Danek supplies the mucus-reduction purpose and the sub-mucosal energy-delivery teaching. Motivation: the inferior turbinate is precisely where the mucus-producing mucosa of the nasal airway is concentrated, so targeting there to reduce mucus is not a leap; and Chen confirms reduced gland secretion follows. Expectation: the same.
Combination 1C — Wolf 2012/0323232 + Danek/Chen (only if priority breaks; see §1(b))
Wolf's own 2012-12-20 publication discloses the nasal-airway energy-treatment platform; Danek supplies mucus reduction as the object. Because it is the applicant's own earlier disclosure, this combination would be tactically devastating and would support a §102(a)(1) argument as well.
Anticipated arguments against these combinations (and why they likely fail)
- "Baker's energy is ultrasound, not the claimed energy" — Claim 1 recites only "energy-based treatment device"; Baker's own disclosure suggests RF use, and Edwards-'535 supplies RF specifics.
- "Baker treats rhinitis, not PND." — Baker expressly names post-nasal drip as a symptom treated; and PND as a rhinitis sequela is a well-known mechanism, so the limitation is at most an obvious result of treating the disclosed condition.
- "Danek is a lung reference." — Danek's claims recite treating an airway wall to reduce mucus production, and its specification expressly contemplates sub-mucosal treatment with RF/heat/ultrasound. A POSITA treating the nasal airway would readily adapt a bronchi-directed mucosal energy method; the difficulty of the access route is solved by Baker/Hovda, not by Danek.
4. Claim 20 — device: malleable shaft + handle + treatment surface with ≥2 longitudinal energy-delivery members separated by a longitudinal concave trough
Claim 20 omits any method limitation and any tissue-specific recital beyond the stated purpose in the preamble. It is a mechanical claim whose novelty resides in the geometry of the treatment surface. That makes it the most vulnerable to a §103 attack built from ordinary design considerations.
| Element | Where taught / why obvious |
|---|---|
| Elongate malleable shaft with handle | Baker's flexible/deformable device; Sartor US 2012/0316557 (septoplasty instrument with shaped shaft); and, in the relevant art, malleable-shaft sinus/nasal instruments are ubiquitous. Bending a shaft to follow nasal anatomy is a predictable mechanical adaptation. The '194 specification itself (FIG. 19A/B discussion) concedes the shaft's adjustability merely "enable[s] a clinician to re-shape the shaft … to navigate nasal anatomy" — i.e., no result beyond the expected. |
| ≥2 energy-delivery members extending longitudinally | Hovda '191 (electrode terminals in the turbinate region); Edwards-'535 (expandable RF member); McNall (bipolar upper-airway probes); Wolf 2012/0323232 (electrode arrays on a nasal treatment element). |
| Concave trough extending longitudinally, separating the members | A concave tissue-receiving channel between two bipolar electrodes is an electrode-spacing/tissue-seating design. The '194 specification itself states the governing design principle: "the depth of treatment may be controlled by controlling a spacing between electrodes," and that the trough is "sized to … match the size and/or shape of a nasal turbinate." That is a functional/design incentive, not an inventive concept. Bipolar pairs with a fixed insulating gap to control current path are the standard architecture of the ArthroCare-family devices cited on the patent's own face. |
Combination 4A — Hovda '191 (or Edwards-'535) + Baker + McNall. Motivation: (1) the turbinate is a convex ridge, so a concave trough that seats it and holds two electrodes in fixed, insulated relation is a predictable way to stabilize contact and control current path; (2) Baker/Edwards teach non-piercing nasal contact; (3) McNall teaches that upper-airway bipolar probes use spaced electrode pairs with insulating structure. The '194's own specification frames the trough as solving the contact/stability problem — an identifiable problem the art already faced, with a small number of conventional solutions (KSR).
Combination 4B — Wolf 2012/0323232 (applicant's own art) + Hovda '191. If priority breaks, Wolf's published treatment element with electrode arrays plus Hovda's turbinate-seating geometry renders claim 20 obvious, and the same-inventor grace period is unavailable (published 2012-12-20, > 1 year before the 2014/2015 dates).
Where claim 20 has the best (though not strong) non-obviousness argument: the combination of (a) malleable shaft, (b) longitudinally running electrodes, and (c) a longitudinally running concave trough that separates them, as a unitary treatment surface for a turbinate. Aerin could argue the cited art does not disclose a longitudinal trough between longitudinally-extending electrodes (as opposed to a gap, an insulator, or a channel for fuid/aspiration). That is a real but narrow distinction, and it is the kind of "arrangement of parts" argument that KSR treats skeptically when the arrangement yields only predictable functional benefits.
5. Claim 26 — method: bend malleable shaft → advance into nostril → non-piercing contact → bipolar RF across the concave trough → thermocouple in the trough measures delivered energy → remove without leaving an implant
This claim is essentially claim 20's device plus claim 1's method plus two added limitations that are each individually well-known.
| Added limitation | Grounding and motivation |
|---|---|
| Bending a malleable shaft into a desired configuration | Baker/Edwards (conformable devices); Sartor; routine instrument preparation. The '194's own FIG. 20 method step 502 describes this as ordinary clinician customization. |
| RF from first electrode across the trough to a second electrode | Edwards-'535 (RF, non-piercing, expandable member); Hovda '191 (bipolar/high-frequency turbinate treatment); McNall (bipolar upper-airway probes). |
| Thermocouple disposed in the trough for energy/temperature measurement | Temperature feedback in RF tissue ablation is standard and is expressly claimed in the art (Ellman US 8,317,782; Manstein US 7,824,394 with cooling/RF control; Gonzales for the pressure/cryo branch). The patent's own cited-references list includes an entire multi-channel electrode/thermocouple control scheme (FIGS. 16A–16I). Motivation: the '194 specification itself explains the problem the thermocouple solves — intermittent electrode–tissue contact causes impedance fluctuation, rising power, and coagulum build-up that degrades the treatment. Placing the sensor in the trough (where the tissue seats) is the natural place to measure the treatment site. This is a textbook "known technique applied to a known device, yielding predictable results" (KSR). |
| Remove without leaving an implant | Inherent in every non-implant energy-delivery reference (Baker, Edwards-'535, Hovda '191, McNall). A "no implant" limitation adds nothing when the reference device is a removable probe. |
Combination 5A — Baker + Edwards-'535 + Chen + Ellman (or Manstein). This is the IPR's own Ground 3, extended with a temperature-sensing reference for claim 26. Baker supplies access + non-piercing nasal contact + mucus/PND purpose; Edwards-'535 supplies the non-piercing RF hardware; Chen supplies the clinical efficacy of RF nerve/gland modification in the inferior turbinate; Ellman/Manstein supply closed-loop temperature-controlled RF. All four are in the RF tissue-treatment art, all were known, and each performs its own known function — the classic KSR combination.
Notable: the IPR record shows petitioner mapping the "injuring" limitation (claim 12) and "ablating nerve tissue underlying the mucosa" (claim 6) to Hovda/Edwards/Chen. If claim 6's nerve-ablation element was believed to be met by a March-2005 clinical article plus a turbinate-RF patent, then the broader claim 26 combination is a fortiori obvious.
6. Dependent-claims mapping (descriptive — see caveat below)
Caveat (carried forward): the dependent-claim characterizations in the prior summary were derived from the specification's embodiment summary, not from verified verbatim claim text. The mappings below are therefore directional.
| Dependent claim theme | Rendering art and rationale |
|---|---|
| Energy form = ultrasound / microwave / heat / RF / electrical / light / laser | Danek expressly lists mechanical, chemical, RF, radioactive, heat, and ultrasound; the '194 specification's own list is a per se enumeration of known modalities. Choosing among disclosed modalities for a known device is obvious. |
| Cryotherapy / energy removal | Elkins US 7,850,683 (subdermal cryogenic nerve remodeling); Gonzales US 2012/0078377 (cryogenic temperatures to anatomical structures). Both on the '194's face. |
| Cauterizing agent / polymerizing liquid / cauterizing delivery | Makower US 2010/0152730 (mucosal tissue dressing); Saidi US 7,780,730 and US 2009/0292358 (nasal implant via non-surgical injection); Kennedy US 2010/0144996 (injectable cyanoacrylate). |
| Injuring goblet cells / mucus-producing cells; decreasing volumetric mucus production without changing mucosal shape | Danek — reducing the airway's ability to produce mucus; Baker — mucus reduction without reshaping. |
| Nerve tissue underlying mucosa; ablating nerve tissue | Chen (RF ablation of nerves in the inferior turbinate, reducing gland secretion); also Mannheimer? — no; rely on Chen plus Edwards-'535 and Hovda '191. |
| Macroscopic mechanical alteration simultaneous with energy delivery | Hovda '191 (tissue channel/deformation + RF); McNall (probe compression + electrosurgery). |
| Turbinate treatment; posterior aspect of the inferior turbinate | Baker teaches treating nasal turbinates generally; the inferior turbinate's posterior aspect is one of a finite number of known anatomical loci on the same structure (IPR claim 19 argument: "obvious choice from a finite number of known anatomical locations"). Chen's study is specifically of the inferior turbinate. |
| Rows of positive/negative (bipolar) electrodes; blunt-tipped protruding electrodes | Hovda '191; McNall; Sartor; and the '194's own multi-channel arrangement disclosure. Atraumatic blunt tips are a safety-driven design choice (the specification notes "designed to avoid puncturing tissue"). |
| Thermocouple in the trough; test to confirm contact | Ellman; Manstein; standard RF generator feedback. Contact-confirmation via impedance is the definition of ordinary electrosurgical practice. |
| External / transdermal electrode embodiments | Edwards-'535; Manstein; Elkins (subdermal). |
7. Motivation-to-combine synthesis (KSR / Graham factors)
- Same field of endeavor. Baker (rhinitis/PND, nasal energy device), Danek (airway mucus reduction), Hovda '191 (turbinate electrosurgery), Edwards-'535 (nasal RF), Chen (inferior turbinate RF), McNall (upper-airway bipolar electrosurgery). No field-crossing problem.
- Same problem to be solved. Hypersecretion/obstruction of airway mucosa. The '194's own framing — "mucus hypersecretion … PND symptoms may be alleviated by decreasing mucus production" — is precisely the problem the art already addressed.
- Predictable, known results; no change in function. Each reference continues to do what it was designed to do: Baker delivers non-piercing nasal energy; Danek reduces mucus production; Hovda shrinks/scars turbinate tissue; Ellman/Manstein control RF with temperature feedback.
- Finite number of identified, predictable solutions. Modalities (RF, ultrasound, microwave, laser, cryo) and targets (mucosa, submucosa, nerve, turbinate) were all enumerated in the prior art. The '194's own specification recites essentially the union of these options.
- Design incentives / market pressure. Treating rhinitis and its PND symptom is a large clinical problem; the art explicitly pre-identified PND as a treatable symptom (Baker).
- Explicit teaching, suggestion, or motivation. Baker → treat rhinitis and its symptoms, including PND. Danek → reduce airway mucus production with energy. Chen → RF of inferior turbinate reduces gland secretion. Danek + Chen together form a complete "why this will work" story.
8. Where the patent retains argumentative room
- No secondary-considerations record. The specification (FIGS. 1–5) is largely mechanistic physiology — exocytosis, Rab proteins, squamous metaplasia — with no comparative clinical data, no unexpected-results showing, and no dose/response evidence tied to the claimed methods. Absent a Rule 132/declaration record, Aerin's rebuttal case under Graham factor (12) is thin. A long-felt-need/industry-praise argument would require nexus to the claims, and the asserted clinical benefit here is the very thing Danek/Baker/Chen already predicted.
- Possible teaching-away argument (weak). A POSITA might argue that deliberately damaging turbinate mucosa risks empty nose syndrome, atrophic rhinitis, crusting, and ozena — a well-recognized deterrent to aggressive mucosal ablation. But the art cuts the other way: Hovda '191 explicitly teaches confining thermal damage to the target site to allow controlled scarring, and Chen demonstrates a clinically effective, well-tolerated RF turbinate protocol. The '194 itself claims "preserve tissue function" as a goal achievable by limiting unwanted heating. This is not teaching away; it is the same design tradeoff the art already managed.
- Claim 20's structural distinction (a concave trough between longitudinally-extending energy-delivery members) is the narrowest point of novelty. It survives §103 only if a POSITA could not have arrived at it from the cited devices plus the '194's own stated rationale (electrode-spacing controls depth; trough matches turbinate shape). On the face of the specification, that rationale is itself an admission of the design principle.
- The "without piercing" / "no implant" limitations are negative limitations that the cited non-piercing, removable-probe references satisfy inherently.
9. Bottom line
Claims 1–19 (the method genus and its species): rendered obvious by (1) Baker alone (with an anticipation overlay on claim 1), (2) Baker + Danek, (3) Hovda '191 + Danek, and for the nerve-ablation species, (4) Baker + Edwards-'535 + Chen. This is the exact combination the Board instituted on in IPR2024-00276 and that ended in an adverse judgment rather than a merits affirmance.
Claim 20 and 21–25 (device): rendered obvious by Hovda '191 (or Edwards-'535) + Baker + McNall, with the concave trough flowing from the admitted design principle that electrode spacing controls treatment depth and that the channel should match a turbinate's shape; alternatively by Wolf 2012/0323232 + Hovda '191 if the CIP priority breaks. This is the claim family's weakest structural link.
Claim 26 and 27–33 (bend / non-piercing bipolar RF across trough / thermocouple in trough / no implant): rendered obvious by Baker + Edwards-'535 + Chen + Ellman (or Manstein) — every added limitation is a known RF instrumentality applied for its known purpose.
Overall: the §103 case against the '194 is strong, and its central insight — that energy delivered to upper-airway mucosa can reduce mucus output and thereby treat PND — was squarely in the prior art (Danek, Baker) and clinically validated (Chen) well before the 2014/2015 CIP filings.
10. Explicit uncertainties and verification gaps
- Verbatim dependent-claim text not verified — claims 2–19, 21–25, 27–33 are characterized from the specification's embodiment summary and the FreePatentsOnline/Insight first-claim extracts, not from a claim-by-claim text pull.
- Baker (WO 2010/077980), Edwards-'535 (US 6,517,535), and the Chen 2005 article were not retrieved in full text. Their characterizations are taken from the IPR2024-00276 petition analysis (https://ai-lab.exparte.com/case/ptab/IPR2024-00276/doc/1010), which is the PTAB record; I did not independently confirm the quoted disclosures.
- Edwards-'535's title, assignee, and full disclosure are unverified. The IPR record describes it as a "non-piercing RF energy device with an expandable member"; the numeral is US 6,517,535. I did not confirm this against the patent document itself, and I am not auto-correcting or substituting the number.
- Post-adverse-judgment claim status unknown (cancelled, disclaimed, or otherwise). If claims 1–19 were statutorily disclaimed, §103 analysis of those claims is moot, and this analysis applies with most force to claims 20–33 and to the continuation family (US 9,801,752; 9,943,361; 10,603,059; 10,631,925; 11,304,746; 11,832,876; 12,357,378).
- Effective priority date unresolved (2011-06-14 vs. 2014-04-03 vs. 2015-03-31). This does not affect the Baker/Hovda/Edwards/Chen grounds but is decisive for whether Wolf's own Dec-2012 publications are §102(a)(1) art.
- No claim chart was constructed against the actual granted claim language for claims 20 and 26. My mapping of the trough/electrode geometry to Hovda/McNall is an analytical inference from reference summaries, not a limitation-by-limitation chart.
Sources: https://patents.google.com/patent/US9415194/en · https://FreePatentsOnline.com/9415194.html · https://insight.rpxcorp.com/patent/[US9415194B2](/patent/US9415194B2) · https://ai-lab.exparte.com/case/ptab/IPR2024-00276/doc/1010 · https://portal.unifiedpatents.com/ptab/case/IPR2024-00276 · https://FreePatentsOnline.com/7442191.html · https://patents.google.com/patent/US20130218158A1/en · https://patents.google.com/patent/US20130218158A1/en#9 · https://pubchem.ncbi.nlm.nih.gov/patent/US-9415194-B2 · https://www.patents-review.com/a/20130218158-methods-reducing-mucus-airways.html · https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1558032](/patent/1558032) (citing IPR2024-00276 at 22–27, 52–65, 70–87)
Generated 9/16/2026, 4:46:25 AM
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