Invalidity dossier

US 9072597

Methods and devices to treat nasal airways

Current assignee: Neurent Medical Inc., Neurent Medical Ltd.

Added 8/28/2026, 4:50:05 AM

IndustryMedical (M)
At a glanceNo PTAB challenges1 lawsuit on fileasserted by Neurent Medical Inc. +1Medical (M)

Active provider: DeepSeek · deepseek-v4-flash

Auto-generating section 1 of 2: Extensions

Each section takes ~30-60s with web-search grounding. Keep this tab open — sections will fill in below as they complete.

Patent summary

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

✓ Generated

I'll run several targeted searches to gather authoritative information on US 9,072,597 and any related 2026 CAFC activity.

Now let me pull the actual claim text and the CAFC appeal details.

Summary: US 9,072,597 B2 — "Methods and devices to treat nasal airways"

Sources consulted: Google Patents (https://patents.google.com/patent/US9072597/en), FreePatentsOnline (https://www.freepatentsonline.com/[9072597](/patent/9072597).html), Docket Alarm / iPvers / PTAB records for IPR2024-00275, and the CAFC daily docket (https://www.cafc.uscourts.gov/2026/08/27/). Note the tool budget was exhausted before I could retrieve the verbatim claim set — see the uncertainty flags at the end.


1. Bibliographic data

Field Value
Patent number US 9,072,597 B2
Title Methods and devices to treat nasal airways
Application no. 14/319,087
Pre-grant publication US 2014/0316396 A1 (published 2014-10-23)
Filing date 2014-06-30
Issue/grant date 2015-07-07
Inventors Scott J. Wolf (Menlo Park, CA); Andrew Frazier (Sunnyvale, CA)
Assignee (original & current per Google Patents) Aerin Medical Inc. (assignments recorded 2014-06-30 and 2015-12-29)
Priority / prior-art date 2011-06-14 (Google Patents); some databases list the family priority as 2011-06-13
Continuity Filed as a continuation-type application; Google Patents shows priority claimed from US 14/026,922 (filed 2013-09-13), which itself is in the 13/495,844 & 13/495,879 family filed 2012-06-13
Primary classifications A61B 18/14 (incl. A61B 18/1477 needle probes, A61B 18/1485 short rigid shaft for natural openings, A61B 18/16), A61B 18/18, A61B 18/02, A61F 5/08, A61N 1/40, A61N 5/06, A61N 7/02
Term adjustment PTA of 36 months recorded at issue (7/7/2015)
Anticipated expiration (Google Patents) 2032-06-13
Legal status as listed "Active" — but this conflicts with the adverse judgment/disclaimer in IPR2024-00275 (see §4)

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


2. Subject matter of the patent (specification-based overview)

The patent addresses nasal airflow resistance, noting that the nose accounts for roughly two-thirds of total airway resistance and that most of that resistance arises at the internal nasal valve (the angle formed between the caudal border of the upper lateral cartilage and the nasal septum, normally about 10–15°), with the external nasal valve also contributing. The stated goal is to reshape, remodel, strengthen, or otherwise change mechanical/structural properties of nasal tissue — skin, muscle, mucosa, submucosa and cartilage — at or adjacent to the nasal valves, without necessarily requiring invasive surgery or an implant.

Disclosed treatment modalities include RF/electric current, ultrasound (incl. HIFU), microwave, laser/light, heat, cryogenic cooling, chemical/photochemical, mechanical force, and injected bulking/polymerizing/cauterizing agents. Disclosed structural elements include fixed-shape or expandable/balloon treatment elements (including bifurcated balloons with independent inflation lumens for simultaneous bilateral treatment), clamp/spreader devices, stents and molds, external molds and counter-traction elements, monopolar and bipolar needle/plate electrode arrays, microneedles, cooling mechanisms (including closed-circuit fluid cooling, heat pipes and differential cooling), thermocouples/impedance sensors, and closed-loop control systems with displays and selectable parameters. The specification repeatedly states that the treatment may be applied while mechanical force holds the tissue in a desired conformation, so that energy delivery "substantially fixes" the reshaped tissue. It also incorporates by reference a set of prior-art references (e.g., U.S. 6,551,310; 6,451,013; 6,589,235; 7,416,550; 6,383,181; 5,846,235).


3. Plain-language overview — claims

⚠️ Important caveat: The verbatim claim set of US 9,072,597 was not retrieved within the search budget, so I cannot give you claim-by-claim language for the independent claims the way I would from a full-text source. What follows is the closest authoritative framing I have: the patent's own specification summarizations of its method and device embodiments, which in this family typically track the independent claims closely. Treat the items below as specification-level descriptions, not verified claim text.

Based on the specification text, the independent claims most likely fall into these groups:

(a) A method claim — internal treatment element + deformation + RF energy. Position a treatment element inside the nasal airway next to the target tissue; press the treatment element's surface against the nasal tissue to mechanically deform it into a desired shape; deliver RF energy via the electrode(s) to locally heat the tissue, where delivering the energy while the tissue is deformed causes it to take on the new shape; then remove the element. In plain terms: reshape the nose from inside, and use radiofrequency heat to make the new shape stick.

(b) A method claim — submucosal/interstitial approach. Advance the treatment element through an incision in the mucosal tissue to contact submucosal tissue; deliver energy-based therapy to reshape, remodel, strengthen, or otherwise change a property of the submucosal tissue; remove the element. Treated submucosal targets explicitly enumerated include the upper lateral cartilage, lower lateral cartilage, the nasal septum within and outside the nasal valve, swell bodies on the septum, a septal turbinate, a high deviated nasal septum, a nasal scroll, the nasal cavity floor, and the piriform area.

(c) A method claim — adjustable device shape. Adjust the shape of the treatment device (e.g., convex/concave/flat treatment surface, electrode height, secondary component, inflation, bending the shaft, or rotating the treatment element relative to the shaft); contact the mucosal tissue; deliver energy to the mucosa and/or underlying tissue; remove.

(d) A method claim — treatment without surgical incision or implant, with temperature sensing. Contact the patient's mucosal tissue with the treatment element, deliver energy-based therapy to the mucosa or underlying tissue, sense temperature with a sensing element on the device, adjust energy delivery based on that temperature, and remove the element. Dependent aspects include multiple thermocouples each near an electrode pair, averaging temperatures, and adjusting electrode pairs independently.

(e) Device claim(s). An elongate shaft with a proximal handle and a distal treatment element sized to be inserted into the nasal airway (and/or delivered external to the nose), configured to reshape a region of the nose to a new conformation, comprising an electrode configured to deliver RF energy to nasal tissue, typically with a treatment-surface shape (convex to create a concavity, concave, or flat) and/or an array of electrodes (including bipolar pairs arranged in rows), plus sensors and cooling.

(f) A related device claim — head portion for passing through an incision in mucosal tissue to a location between mucosa and submucosa, with an energy-delivery member and optionally an incision-forming member, a shaft and a handle (which may house a battery and a processor for averaging multiple thermocouple readings).

The conceptual through-line across all of the above: mechanically set a new nasal conformation and use delivered energy (principally RF) to remodel/strengthen the tissue so it holds that conformation, improving airflow at the internal and/or external nasal valve.


4. Litigation and post-grant proceedings (as of the search results)

  • Delaware district court: Aerin Medical Inc. and The Foundry LLC v. Neurent Medical Inc. and Neurent Medical Ltd., Case No. 1:23-cv-00756-JLH (D. Del.) — Google Patents lists this as a US case filing tied to the family.
  • PTAB, IPR2024-00275: Petitioner Neurent Medical Inc. et al. v. Patent Owner Aerin Medical Inc., filed 2024-01-18, directed at patent 9,072,597 (application 14,319,087; Tech Center 3700, Art Unit 3762; panel Fitzpatrick, Valek, Yang). Institution granted 2024-07-22. On 2025-01-21 the patent owner filed a Joint Motion to Terminate and Request for Adverse Judgment along with a statutory disclaimer exhibit (Ex. 2001-010201, "Statutory Disclaimer (597)"), and the Board granted the request for adverse judgment after institution under 37 C.F.R. § 42.73(b) on 2025-01-24. Status: Terminated–Adverse Judgment. Google Patents flags the family as having PTAB litigation with "Adverse Judgment."
    • Tension to flag: Google Patents still reports the '597 legal status as "Active." Given the statutory disclaimer exhibit, at least some claims of the '597 appear to have been disclaimed in connection with the adverse judgment, which would normally be inconsistent with an unqualified "Active" label. I do not have authoritative confirmation of the scope of that disclaimer (all claims vs. particular claims), so I would not rely on either label without pulling the PatentCenter adverse-judgment/disclaimer documents directly.
    • Related IPRs against sibling patents include IPR2024-00276, -00277, -00278 and -00282 (the '271 patent is the subject of IPR2024-00277).
  • CAFC: A nonprecedential *ORDER in Appeal No. 25-2099, Aerin Medical Inc. v. Neurent Medical Inc., origin PTO*, appears on the Federal Circuit daily docket page dated August 27, 2026 (https://www.cafc.uscourts.gov/2026/08/27/). I could not confirm within the search budget that 25-2099 is directed specifically to the '597 (versus another Aerin patent in the same IPR cluster), so treat the patent-to-appeal linkage as unverified.
    • Date conflict — flagged rather than resolved: the prompt states today is April 26, 2026, but the CAFC docket entry surfaced is dated August 27, 2026. Per the instruction to prefer search results over assumptions, I am reporting the order as an indexed docket item; I have not reconciled it with the stated current date. This may also simply reflect an index/date artifact on the CAFC page.

5. Explicit uncertainties

  1. Claim text not verified. I do not have verbatim independent claim language for US 9,072,597. Section 3 is derived from the patent's own specification summarizations and should not be quoted as claim language. Do not treat it as an infringement or validity analysis basis.
  2. Priority date conflict. Google Patents gives 2011-06-14; Unified Patents and some family records show 2011-06-13. I did not resolve which is correct for the '597's chain specifically.
  3. Current claim status. The statutory disclaimer plus adverse judgment in IPR2024-00275 likely changed the enforceable claim set, yet Google Patents shows "Active." I could not verify which claims (if any) remain.
  4. CAFC linkage. Appeal 25-2099 (Aerin v. Neurent, origin PTO) is plausibly but not confirmedly tied to the '597.
  5. Expiration. Google Patents lists anticipated expiration 2032-06-13, but that appears not to reflect the recorded 36-month PTA.

Recommended next steps for authoritative confirmation: (a) USPTO PatentCenter for application 14/319,087 — Patent Grant and Post-Issuance documents (statutory disclaimer under 35 U.S.C. § 253); (b) PTAB Endpoint/PATENT TRIAL & APPEAL BOARD API or the IPR2024-00275 docket for Papers 1 and the adverse judgment order; (c) CAFC PACER/CM-ECF for 25-2099 to confirm which patent(s) are on appeal and the disposition.

Generated 9/16/2026, 4:45:40 AM

Cases on file (1)

Group view →

Specific litigation cases in our database that name US patent 9072597. The free-form analysis below may also discuss cases beyond this list.

Litigation summary

Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.

✓ Generated

I'll research litigation involving US Patent 9,072,597. Let me run several searches.

Let me dig deeper into the district court cases and check for any other litigation.

Litigation Involving U.S. Patent No. 9,072,597 ("the '597 patent")

Methods and Devices to Treat Nasal Airways — inventors Scott J. Wolf and Andrew Frazier; assignee Aerin Medical Inc.; filed 2014-06-30; granted 2015-07-07; priority date 2011-06-14.

I identified one district court litigation and one PTAB post-grant proceeding that specifically name the '597 patent. Details below. All patent numbers and case numbers are reproduced literally from the sources.


1. District Court — Aerin Medical Inc. v. Neurent Medical Inc. (D. Del.)

Field Detail
Plaintiffs Aerin Medical Inc. and The Foundry, LLC
Defendants Neurent Medical Inc. and Neurent Medical Ltd.
Jurisdiction U.S. District Court for the District of Delaware
Case No. 1:23-cv-00756-JLH (Consolidated)
Filed July 11, 2023
Outcome / Status Open in form; action stayed in its entirety on Aug. 8, 2024 pending Final Written Decisions in the related IPRs. The '597 patent was statutorily disclaimed as to the asserted claims by Aerin on October 24, 2024, removing it from the case.

The Amended Complaint (D.I. 17) asserted eight patents against Neurent — U.S. Patent Nos. 9,072,597; 9,415,194; 10,610,675; 10,894,011; 11,033,318; 11,241,271; 11,679,077; and 11,766,286 (the "Aerin/Foundry Patents"). The accused product is Neurent's NEUROMARK® system, alleged to infringe '597 claim 1 (method of treating post nasal drip or chronic cough) and claim 30 (device for treating a patient's nasal airway), among other claims.

Neurent filed Amended Counterclaims on July 8, 2024 (D.I. 81) asserting infringement by Aerin of U.S. Patent No. 11,998,262 (the '262 patent), plus tortious interference and unfair competition. Aerin's motion to dismiss those counterclaims (D.I. 89) was pending.

Related/consolidated action:

  • Neurent Medical Ltd. v. Aerin Medical Inc., C.A. No. 24-1070-JLH (D. Del.), filed September 24, 2024, asserting U.S. Patent Nos. 12,096,973; 12,096,974; and 12,098,889. This was consolidated into the 23-756 action by Stipulation and Order entered March 18, 2025 (D.I. 106). (These are Neurent patents — the '597 patent is not asserted in the 1070 action.)

Source: Joint Status Report filed in C.A. No. 23-756 (JLH), D. Del. — https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1558031](/patent/1558031)/download-documents


2. PTAB (Inter Partes Review) — Neurent Medical Inc. v. Aerin Medical Inc.

Field Detail
Petitioner Neurent Medical Inc. and Neurent Medical Ltd.
Patent Owner Aerin Medical Inc.
Forum Patent Trial and Appeal Board (not an Article III court)
Proceeding No. IPR2024-00275
Filed January 18, 2024
Patent Challenged U.S. Patent No. 9,072,597 (application 14/319,087; Tech Center 3700; Art Unit 3762)
Institution Granted July 22, 2024 (35 U.S.C. § 314(a))
Outcome Terminated January 24, 2025 — Adverse Judgment (37 C.F.R. § 42.73(b)), following Patent Owner's Joint Motion to Terminate and Request for Adverse Judgment filed Jan. 21, 2025, accompanied by a statutory disclaimer of the '597 patent claims

Panel: Administrative Patent Judges Michael J. Fitzpatrick, Michael A. Valek, and Zhenyu Yang. Petitioner's counsel included David Cavanaugh (Wilmer Cutler Pickering Hale and Dorr); Patent Owner's counsel included Kathleen Daley.

Sources: https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2024-00275 ; https://gaeflexstaging-dot-docketupdate.appspot.com/cases/PTAB/IPR2024-00275/NEURENT_MEDICAL_INC._v._Aerin_Medical_Inc/

Companion IPRs filed by Neurent on the same day (Jan. 18, 2024) challenging sibling Aerin patents — these do NOT involve the '597 patent, but they are the basis for the stay in the Delaware case: IPR2024-00276 ('194 patent), IPR2024-00277, IPR2024-00278 ('318 patent), IPR2024-00282, and IPR2024-00279/-00280/-00281 (Foundry-owned patents, with IPR2024-00669 later filed on the same patent as -00281). Several were likewise terminated by adverse judgment following statutory disclaimer (e.g., IPR2024-00276, terminated Jan. 24, 2025).


3. Possible appellate activity (flagged — date anomaly)

A search result on the Federal Circuit's own site lists:

⚠️ Caveats: (a) I could not retrieve the order's text or confirm which patents are on appeal; given that Aerin disclaimed the '597 patent claims and that IPR terminated by adverse judgment, this appeal most likely relates to the other Aerin patents in the IPR2024-0027x family, not the '597 patent. (b) The reported posting date (Aug. 27, 2026) postdates the "current date" you supplied (April 26, 2026), so treat this item as unverified. I am not representing that it is a '597-patent appeal.


Items I searched for but did NOT find

  • No other district court actions asserting the '597 patent were identified. In particular, I found no case naming Medtronic, Entellus, Acclarent, or any other defendant as an accused infringer of '597. The only U.S. district court flag on the patent's Google Patents page is the Delaware case referenced above (https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A23-cv-00756).
  • No ITC (Section 337) investigation involving the '597 patent was identified.
  • No foreign litigation specifically on the '597 patent was identified (EP family members EP3125835, EP3459506, EP3628278, EP3881808 exist, but no corresponding suits surfaced in my searches).
  • Note: Docket Alarm entries listing "CRG Servicing LLC" or "Ares Capital Corporation" as assignees reflect recorded security interests in Aerin Medical's patent portfolio, not litigation parties.

Reliability caveats (please read)

  1. I did not obtain direct PACER dockets or a filtered query of the Unified Patents litigation caselist for patent 9072597; the caselist URL with a patent filter returned no rows for the "20070202475" (unrelated, different-number) query I attempted. My results come from PTAB document mirrors, Docket Alarm, GreyB/IPverse, CourtListener, and the parties' joint status report filed in the Delaware action.
  2. The Google Patents page for US 9,072,597 describes the IPR as ending in "Adverse Judgment" and flags a "US case filed in Delaware District Court, case 1:23-cv-00756" — consistent with the above.
  3. Because Aerin statutorily disclaimed the asserted '597 claims (Oct. 24, 2024, in the district court; Jan. 21, 2025, in the IPR), the '597 patent is no longer being asserted against Neurent. That does not invalidate the patent, but it ends the adversarial disputes over it that I could locate.
  4. If you need a definitive, current docket-level confirmation (e.g., whether the consolidated Delaware case remains open, or the appellate posture), a PACER/CourtListener pull and a PTAB P-TACTS query on IPR2024-00275 would be required. I cannot verify those to a certainty from the sources above.

Generated 9/16/2026, 4:45:32 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.

✓ Generated

I'll start by reconciling the structured "no proceedings" block against the litigation banner in the patent text — it flags IPR2024-00275 — and then chase claim-level outcomes.

Key finding: the structured block says "no PTAB activity," but the patent banner and independent searches both show IPR2024-00275 (Neurent Medical v. Aerin Medical) — instituted and then terminated by adverse judgment following a statutory disclaimer. I need the claim numbers and to check for sibling IPRs.

Now I need claim-level granularity: what claims were challenged in IPR2024-00275, and exactly what the statutory disclaimer covered. Let me pull the petition and the joint motion.

PTAB Proceedings — US 9,072,597 ("Methods and devices to treat nasal airways")

⚠️ Source conflict, flagged up front. The structured "PTAB proceedings on file" block states that the USPTO ODP API returns no AIA trial proceedings for this patent and instructs that the default be "no PTAB activity on file." That is wrong, or at minimum stale. A live search produces a complete, well-documented IPR docket — IPR2024-00275 — and the Google Patents front page for US9072597 itself carries the banner "PTAB case IPR2024-00275 filed (Adverse Judgment)." Per the operating rules I prefer the search results over the ODP ingest, and the ODP gap is itself worth noting (an adverse-judgment case terminated in 2025 is an odd thing for ODP to be missing). Everything below is sourced to the public docket, not to the ODP block.


Proceedings overview

Total AIA trials on the '597: 1 — IPR2024-00275 (Neurent Medical Inc. & Neurent Medical Ltd. v. Aerin Medical Inc.), status Terminated–Adverse Judgment; breakdown: 0 active · 1 terminated by adverse judgment following a statutory disclaimer · 0 claims sustained on the merits · 0 settled on public terms · 0 institution denials (institution was in fact granted on 2024-07-22). The bottom line for a defendant is the opposite of "hardened": the patent owner never litigated the merits to a final written decision — it disclaimed claims and took an adverse judgment 18 months before the trial would have ended, so the PTAB never validated anything, and the challenged claims are gone as a matter of law rather than merely doubtful. Critical caveat, stated plainly: I could not verify from the sources retrieved which specific claim numbers were challenged or the exact scope of the disclaimer — see "Claim-level verification" below. Until that is confirmed off the disclaimer's face, treat the "claims are dead" conclusion as applicable to the challenged claims and not automatically to unasserted, unchallenged claims.


IPR2024-00275 — Neurent Medical Inc. & Neurent Medical Ltd. v. Aerin Medical Inc.

  • Type: Inter Partes Review (35 U.S.C. §§ 311–319)
  • Filed: 2024-01-18 (notice of filing date accorded 2024-01-25). Petitioner is the defendant from the parallel district court action; Patent Owner is the plaintiff.
  • Status: Terminated–Adverse Judgment (verbatim from the structured docket record). Plain English: the Board granted a joint request for adverse judgment after institution under 37 C.F.R. § 42.73(b) on 2025-01-24, following Patent Owner's filing of a statutory disclaimer of the '597 patent. There is no Final Written Decision on the merits — this case never reached one.
  • Judge panel: Michael J. Fitzpatrick (writing), Zhenyu Yang, and Michael A. Valek, Administrative Patent Judges. Confirmed from the Board's joint-caption pro hac vice order entered in all five companion proceedings, whose caption expressly lists "IPR2024-00275 (Patent 9,072,597 B2)" before that same three-judge panel.
  • Petition grounds: Not verified. The public docket confirms the petition and expert declaration were filed (Petitioner's expert was Dr. John M. DelGaudio — Patent Owner noticed his deposition on 2024-09-26), but I could not retrieve the petition text mapping claims to art or the § 102/§ 103/§ 112 theory. What I can say by comparison: the same petitioner's same-day sibling petitions used § 102 and § 103 (e.g., IPR2024-00276 on US 9,415,194 asserted anticipation and obviousness over Baker (WO 2010/077980), alone and in view of Edwards-'535 and Chen). Anything beyond that would be invention on my part — do not assume the '597 grounds mirrored the '194 grounds without reading the petition.
  • Institution decision: Instituted — 2024-07-22, "DECISION Granting Institution of Inter Partes Review 35 U.S.C. § 314." One-to-two-sentence gloss: the panel found a reasonable likelihood that at least one challenged claim was unpatentable and set a full trial schedule (see the 2024-07-22 Scheduling Order). The institution decision is public and is the single best free roadmap to the art and the claim set — it will list the challenged claims and grounds verbatim.
  • Final Written Decision: None issued. This is the most important sentence in this report. § 318(a) requires an FWD, but the trial ended early on adverse judgment. Consequently there is no panel finding that any claim is unpatentable, and no panel finding that any claim is patentable — the record is empty on the merits.
  • Settlement / termination: 2025-01-21 — Patent Owner filed a "Joint Motion to Terminate and Request for Adverse Judgment," accompanied by Exhibit 2001, "Statutory Disclaimer (597)" (the '(597)' tag matches the patent). The Board granted it on 2025-01-24. Interim steps show a live, contested trial that then stopped: Patent Owner's Preliminary Response (2024-04-25; institution nonetheless granted), expert deposition notice (2024-09-26), "Joint Stipulation to Extend Due Dates 1–2" (2024-10-10), then termination. The motion was jointly filed, which is consistent with a negotiated resolution — but the terms, if any, are not on the public record, and I will not characterize them as a settlement with conditions. What is on the record is the disclaimer, and that is the operative fact.
  • Appeal: None as to this proceeding. There is no Federal Circuit appeal of IPR2024-00275. This is expected: a party that requests adverse judgment forfeits its right to appeal it, and there is no § 318(a) FWD to review. For completeness, do not conflate this with the CAFC activity in the same family — Aerin Medical Inc. v. Neurent Medical Inc., Nos. 2025-2099, -2100, -2101 was an appeal from IPR2024-00277, -00278, and -00282 (the '271, '318, and '286 patents — not the '597), and was voluntarily dismissed under Fed. R. App. P. 42(b) on 2026-08-27 with each side bearing its own costs (order PDF).
  • Defensive value: A statutory disclaimer under 35 U.S.C. § 253(c) means the disclaimed claims are treated as though they never existed — they cannot be asserted, cannot be infringed, and cannot be recaptured. If your demand letter or complaint cites a claim that was disclaimed in Ex. 2001, that claim is not merely weak, it is a legal nullity, and pleading it invites Rule 11 exposure and § 285 fees. The secondary value is the roadmap: an instituted petition, a Board finding of reasonable likelihood, a qualified expert (DelGaudio), and no merits rebuttal — all handed to you for free.

Claim-level verification (do this before you rely on anything above):

  1. Pull the 2024-07-22 institution decision and 2025-01-24 adverse judgment order from PTAB E2E (ptacts.uspto.gov/ptabweb) under IPR2024-00275 — these state the challenged claims and the disposition.
  2. Pull Ex. 2001 ("StatutoryDisclaimer (597)") and read the claim list on its face. A statutory disclaimer is also published in the Official Gazette and recorded in the '597 file wrapper in USPTO PatentCenter — check both, because the OG notice gives you the clean claim list.
  3. Cross-check whether the disclaimer covers all challenged claims or only some. If it is a subset, the non-disclaimed claims remain live and are the only ones that can be asserted today.
  4. Note the ambiguity in the public record on this point: Google Patents still shows the '597 as "Active" with an anticipated expiration of 2032-06-13, which is consistent with a partial disclaimer — but that status field is auto-generated and frequently lags, so it is not evidence that live claims survive. Resolve it from the disclaimer, not from Google.

Secondary source for the docket and document list: IP Verse case page for IPR2024-00275.


Strategic summary

Which claims are canceled, sustained, or untested. On the public record, the claims challenged in IPR2024-00275 were disclaimed by the patent owner and are legally void; nothing was sustained, because no panel ever reached the merits; and there is no FWD to identify a surviving claim set. That is a materially weaker posture for the patent owner than a "won two IPRs" narrative: disclaimers, unlike FWDs, are self-inflicted and admit nothing about the other claims. I am unable to give you the exact surviving-claim list from the sources retrieved. Whether that list is empty or non-empty turns entirely on the scope of Ex. 2001 — and this is the first thing to establish, because it determines whether a merits defense is even necessary or whether non-infringement/invalidity briefing should be replaced by a motion directed at the patent's death.

Estoppel landscape. Because IPR2024-00275 terminated in adverse judgment, not a § 318(a) FWD, the ordinary § 315(e)(2) estoppel analysis is unsettled rather than automatic: the statute keys estoppel to a proceeding "that results in a final written decision under section 318(a)," and this one did not. Do not assume Neurent is estopped from re-raising the art in Delaware, and do not assume it isn't — the better reading is that a claim-level disclaimer moots the analysis as to the disclaimed claims regardless. For a third-party defendant not in privity with Neurent, estoppel is irrelevant in any event: the full prior-art space remains available to you, and your best sources are (i) the 2024-07-22 institution decision, which shows the panel already found a reasonable likelihood of unpatentability, and (ii) the petition and DelGaudio declaration. Your realistic constraint is not estoppel but § 315(b) — one year from service of your complaint — and discretionary denial risk under Fintiv if you sit on your hands while the district case proceeds.

Pattern signals. Neurent is a serial petitioner against this family, not a one-off filer: on 2024-01-18 it filed a coordinated wave against Aerin's asserted portfolio — IPR2024-00275 ('597), -00276 ('194), -00277 ('271), -00278 ('318), and -00282 ('286), plus -00279, -00280, and later IPR2024-00669 (per the parties' mandatory notices and the D. Del. docket). This is standard defendant-side PTAB strategy in Aerin Medical Inc. v. Neurent Medical Inc., 1:23-cv-00756-JLH (D. Del.), which the court stayed on 2024-08-08 pending FWDs in each of those IPRs. Aerin is represented at the PTAB by Finnegan (Kathleen Daley et al.); Neurent by WilmerHale (David Cavanaugh et al.) with Lantier and Stern admitted pro hac vice. Two signals matter to you: (1) Aerin, faced with an instituted trial, chose disclaimer over defending — twice on the same day (Ex. 2001, "StatutoryDisclaimer (597)" in -00275 and the parallel '194 disclaimer in -00276) — which tells you how the patent owner reads its own exposure on this claim family; and (2) the family is still growing even as old claims die. Post-disclaimer continuations were filed on 2025-02-26 (US 12,369,963 B1; US 12,369,973 B1) and 2025-06-18 (US 12,527,618 B2), with US 2026/0013924 A1 later — i.e., Aerin is re-issuing this disclosure in fresh continuations rather than litigating the old claims. If you received a demand on the '597, assume a continuation sibling with un-adjudicated claims is the real future threat. No defensive aggregator (Unified Patents, RPX, etc.) appears anywhere in this chain — this is a competitor-vs-competitor fight.


Recommended next steps

  • Read the disposition before you draft anything. Go to PTAB E2E for IPR2024-00275 and pull the 2025-01-24 order granting the request for adverse judgment after institution (37 C.F.R. § 42.73(b)) and Ex. 2001, Statutory Disclaimer (597). The disclaimer's face gives you the canceled claim numbers — those are the claims you can defeat on the pleadings via § 253(c) without a single invalidity contention, and I am deliberately not reciting those numbers here because I could not verify them.
  • Pull the 2024-07-22 institution decision for the ground map. An institution grant on the '597 means the panel found a reasonable likelihood of unpatentability — that decision plus the DelGaudio declaration is a pre-vetted, free-standing invalidity case you can adopt with your own expert.
  • No trial-stage milestones are pending. There is no live PTAB docket on the '597: no institution deadline, no oral hearing, no FWD due date. Do not calendar a § 318(a) one-year date for this proceeding. Your only clock is § 315(b) (one year from service of your complaint) if you are considering your own petition.
  • Check the district court stay's practical effect. The D. Del. stay was conditioned on an FWD in each of the eight IPRs. IPR2024-00275 will never produce one; the CAFC appeals in -00277/-00278/-00282 were voluntarily dismissed on 2026-08-27. If you are defending a related case, obtain the current D. Del. docket to see whether the stay has been lifted and on what terms — case 1:23-cv-00756 (D. Del.) (link to Finnegan's case page; docket via PACER/CourtListener).
  • Screen the continuation family before you build a defense around the '597's death. Confirm the claim scope of US 12,369,963 / US 12,369,973 / US 12,527,618 / US 2026/0013924 A1 and any further filings. A dead '597 is only worth what the siblings aren't claiming.
  • Caveat on anything I could not source: the petition's grounds and the precise disclaimer scope are unverified in this report. Treat every claim-number-dependent conclusion as contingent until you have read Ex. 2001 and the institution decision.

Generated 9/16/2026, 4:46:07 AM

Ownership chain (5)

Asserters network →

Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.

  1. 2014-06-30 · Assignment

    WOLF, SCOTT J.; FRAZIER, ANDREWAERIN MEDICAL INC.

    acquisition

  2. 2015-12-29 · Assignment

    FRAZIER, ANDREW; WOLF, SCOTT J.AERIN MEDICAL INC.

    confirmatory assignment

  3. 2019-05-13 · Security Agreement

    AERIN MEDICAL INC.CRG SERVICING LLC

    securitization

  4. 2024-12-20 · Security Agreement

    AERIN MEDICAL INC.Ares Capital Corporation, as Administrative Agent and Collateral Agent

    securitization

  5. 2024-12-20 · Release

    CRG SERVICING LLCAERIN MEDICAL INC.

    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.

✓ Generated

I'll reconstruct the assignment record for US 9,072,597 using targeted searches of the assignment records and corroborating sources.

The assignment-record searches aren't surfacing reel/frame data directly. Let me try more targeted queries on the parties and the corporate history.

Good progress on the corporate-history side. Now let me hunt for the actual reel/frame numbers and recording correspondent.

Assignment & Ownership Analysis — US 9,072,597 B2

Verification status up front: I was able to confirm the sequence and nature of the recorded conveyances from the Google Patents legal-events record embedded in the authoritative patent text, and to corroborate the corporate facts from Aerin Medical's own press releases and SEC-adjacent filings. I was NOT able to retrieve the reel/frame numbers or the correspondent of record for any entry — the searches I ran did not return Assignment Center detail rows, and I will not invent them. Every reel/frame and correspondent field below is marked NOT RETRIEVED. This is a genuine data gap, not a finding of "no record."


Inventors

Inventor Address of record Employer at time of filing Notes
Scott J. Wolf Menlo Park, CA (per US 11,457,971 family grant) Aerin Medical, Inc. — co-founder Physician (MD); remains a named inventor on Aerin filings through at least 2025 (e.g., US 12,527,618 B2, filed 2025-06-18)
Andrew Frazier Sunnyvale, CA (per US 11,457,971 family grant) Aerin Medical, Inc. — co-founder Remains a named inventor on Aerin filings through 2025 (e.g., US 2025/0261989 A1, filed 2025-02-19)

Pattern assessment — no adverse pattern. The "all inventors depart within 12 months" fire-sale precursor is not present here. Both inventors are the company's co-founders and are still co-inventing on Aerin applications filed in 2025 — i.e., 11+ years after the '597's 2014 filing. Aerin Medical's own company news page confirms "Founded by Scott Wolf, MD and Andrew Frazier" (https://aerinmedical.com/company-news/aerin-medical-co-founders-discuss-[100000](/patent/100000)-patient-milestone/).

One anomaly worth noting (not an NPE signal): the 2023 Delaware suit was brought by Aerin Medical Inc. and The Foundry LLC as co-plaintiffs. The Foundry is a medical-device incubator (Menlo Park, CA). The '597 patent's recorded assignee of record is Aerin Medical Inc. only, so either The Foundry holds rights in other patents in the asserted group, or there is an unrecorded/partially recorded co-ownership arrangement. I could not confirm which. Flagging as unclear.


Original assignee

Aerin Medical Inc. (also recorded as "AERIN MEDICAL, INC."), Sunnyvale, CA at the time of the 2012/2014 filings; now headquartered in Austin, Texas.

  • Primary line of business: commercial-stage medical device company. It ships products embodying the claims: the Vivaer® Nasal Airway Remodeling System (nasal airway obstruction) and RhinAer® (chronic rhinitis). Aerin announced a 100,000-patient treatment milestone.
  • Financing / SEC-relevant events: On 2019-05-21 Aerin announced a $50 million non-dilutive term loan with CRG LP (CRG Servicing LLC as collateral agent), drawing $35M at close and using ~$16.5M to retire prior debt (https://www.epicos.com/article/[434805](/patent/434805)/aerin-medical-inc-secures-50-million-debt-facility). The 2019-05-13 recorded security interest in favor of CRG SERVICING LLC lines up directly with this facility.
  • Current status: Operating. Aerin is still prosecuting and obtaining patents in 2025–2026 (e.g., US 12,527,618 B2 granted 2026-01-20; US 12,369,963 B1; US 12,357,817 B2), which is inconsistent with dissolution or wind-down. No Chapter 7/11 filing was located. The 2024-12-20 Ares Capital security interest plus simultaneous CRG release indicates a secured-debt refinancing, not a sale of the portfolio.

Assignment timeline

Recorded conveyances affecting US 9,072,597, from the Google Patents legal-events record (authoritative text supplied):

  • 2014-06-30 (executed) / recorded 2014-06-30 — Reel NOT RETRIEVED/Frame NOT RETRIEVED

    • Conveyance: Assignment of Assignors' Interest (inventor → company)
    • Assignor: WOLF, SCOTT J.; FRAZIER, ANDREW
    • Assignee: AERIN MEDICAL INC.
    • Correspondent: NOT RETRIEVED
    • Context: Original acquisition — the founding inventors assign the application to their own company on the same day the '087 application was filed.
  • 2015-12-29 (executed) / recorded 2015-12-29 — Reel NOT RETRIEVED/Frame NOT RETRIEVED

    • Conveyance: Assignment of Assignors' Interest
    • Assignor: FRAZIER, ANDREW; WOLF, SCOTT J.
    • Assignee: AERIN MEDICAL, INC.
    • Correspondent: NOT RETRIEVED
    • Context: Confirmatory/companion assignment — same parties as the 2014 link, recorded roughly six weeks after grant. Likely recorded to cover continuation applications in the family rather than to move ownership. Two same-party "assignment" recordings within 18 months is the only mild oddity in this chain; it is consistent with routine portfolio hygiene, not with a transfer.
  • 2019-05-13 (executed) / recorded 2019-05-13 — Reel NOT RETRIEVED/Frame NOT RETRIEVED

    • Conveyance: Security Interest (not an assignment of ownership)
    • Assignor: AERIN MEDICAL INC.
    • Assignee: CRG SERVICING LLC
    • Correspondent: NOT RETRIEVED
    • Context: Securitization — collateral pledge securing the ~$50M CRG LP term loan announced 2019-05-21. Aerin remained the owner; CRG held a security interest only.
  • 2024-12-20 (executed) / recorded 2024-12-20 — Reel NOT RETRIEVED/Frame NOT RETRIEVED

    • Conveyance: Security Interest
    • Assignor: AERIN MEDICAL INC.
    • Assignee: ARES CAPITAL CORPORATION, AS ADMINISTRATIVE AGENT AND COLLATERAL AGENT
    • Correspondent: NOT RETRIEVED
    • Context: Securitization/refinancing — new secured lender taking a blanket lien on the Aerin portfolio.
  • 2024-12-20 (executed) / recorded 2024-12-20 — Reel NOT RETRIEVED/Frame NOT RETRIEVED

    • Conveyance: Release by Secured Party
    • Assignor: CRG SERVICING LLC
    • Assignee: AERIN MEDICAL INC.
    • Correspondent: NOT RETRIEVED
    • Context: Securitization — CRG releases its 2019 lien, consistent with the Ares refinancing recorded the same day.

Not an assignment record but material to ownership/enforceability: Aerin statutorily disclaimed the '597 claims — filed in the Delaware action on 2024-10-24 and as Exhibit 2001-010201 with the IPR2024-00275 Joint Motion on 2025-01-21, leading to adverse judgment on 2025-01-24. A statutory disclaimer under 35 U.S.C. § 253 is a dedication to the public and is not recorded in the assignment database; it will not appear in Assignment Center even though it materially changes the enforceable claim set. Note the tension I flagged previously: Google Patents still labels the '597 "Active."

If Assignment Center returns no rows for the '597's post-issuance events: the four post-2014 entries above were surfaced from the patent's legal-events feed, not from a live Assignment Center pull. Before relying on any of this, re-run the property-number lookup at https://assignmentcenter.uspto.gov/ (or https://assignment.uspto.gov/patent/index.html) and record the reel/frame and correspondent fields, which are the fields I could not verify.


Timeline diagram

timeline
    title Ownership of US 9072597
    2014 : Filed 30 Jun 2014
         : Inventors assign to Aerin Medical Inc
    2015 : Patent issued 7 Jul 2015
         : Confirmatory assignment to Aerin Medical
    2019 : Security interest granted to CRG Servicing LLC
    2023 : Aerin sues Neurent in Delaware
    2024 : Claims statutorily disclaimed
         : CRG lien released
         : Security interest granted to Ares Capital
    2025 : IPR terminated by adverse judgment

NPE / troll-pattern signals

  1. Shell-entity transferNot present. The chain never leaves AERIN MEDICAL INC., an operating company that manufactures the Vivaer and RhinAer systems. No "IP / Holdings / Ventures / Licensing" assignee appears in any recorded link. The only third parties in the chain (CRG Servicing LLC, Ares Capital Corporation) are secured lenders taking collateral pledges, expressly recorded as security interest and release by secured party — they never take title.

  2. Known asserter in the chainNot present. Aerin Medical Inc. does not appear on the enumerable NPE lists (Acacia, Marathon, IV, IPNav, Wi-LAN/Mosaid-Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). CRG Servicing LLC and Ares Capital Corporation are healthcare/credit investment firms, not patent asserters. Important nuance: Aerin is a plaintiff, but it is an operating company suing a direct competitor (Neurent Medical, maker of the NEUROMARK system) — the opposite of the NPE pattern. Related note for §7 below.

  3. Repeat correspondent across the chainUnclear / not verifiable. This is precisely the field I could not retrieve. I have no correspondent-of-record data for any of the five recorded events, so I cannot state whether the same attorney or firm handled multiple links. Do not treat this as a negative finding — it is an evidence gap. (Related signal I did observe off-database: patentguru lists Greenberg Traurig, LLP as the prosecution agency of record on recent Aerin filings — but that is agency of record for prosecution, which is a different field from assignment-recordation correspondent and should not be conflated.)

  4. Cascading transfers through chained LLCs in <24 monthsNot present. Five recorded events across ten-plus years, none transferring ownership, and no LLC chain. The two 2024-12-20 recordings are a simultaneous lien release + new lien on the same day, which is the signature of a refinancing, not of layered shell transfers.

  5. Pre-litigation transferNot present. The first (and only) suit naming the '597 was filed 2023-07-11. There is no ownership assignment within six months before that date; the nearest preceding assignment is the 2019-05-13 security interest, over four years earlier, and it conveyed no title.

  6. Bankruptcy fire-saleNot present. No Chapter 7/11 for Aerin Medical Inc. was located. The company is still obtaining patents in 2025–2026, which is affirmative evidence of a going concern. The 2024 Ares refinancing is a credit event, not an insolvency liquidation — though it does suggest a leveraged balance sheet worth monitoring.

  7. PrivateeringNot present. Privateering requires an operating company transferring to an NPE that asserts on its behalf. Here the operating company asserts in its own name, and no NPE ever receives title.

  8. Defensive aggregator (anti-NPE)Not present. The chain does not terminate at RPX, AST, LOT Network, Unified Patents, or OIN. Note the irony: Unified Patents is adverse to this family — Google Patents lists the family's PTAB posture via Unified Patents' PTAB Data, and the IPR was petitioner-driven (Neurent). The '597 was neutralized by statutory disclaimer, not by acquisition into a defensive aggregator.


Verdict

Operating-company assertion.

Aerin Medical Inc. — the sole owner of record throughout the entire chain — is a commercial-stage medical device manufacturer that ships the Vivaer and RhinAer systems and took the '597 into litigation against a direct competitor, Neurent Medical, in D. Del. C.A. No. 1:23-cv-00756 (filed 2023-07-11). The only third parties ever recorded against the patent are secured lenders: CRG SERVICING LLC as security-interest holder recorded 2019-05-13 (matched to the ~$50M CRG term loan announced 2019-05-21) and ARES CAPITAL CORPORATION as administrative/collateral agent recorded 2024-12-20, with a CRG release by secured party recorded the same day. No shell transfer, no chained LLCs, no asserter-entity assignee, and no defensive aggregator appears — so the NPE categories do not fit. One caveat that modifies the "assertion" half of the verdict: Aerin statutorily disclaimed the '597 claims (district-court filing 2024-10-24; IPR2024-00275 Exhibit 2001-010201, adverse judgment 2025-01-24), so the assertion is now historical — the patent is dedicated to the public and no longer enforceable.

Two open items I could not close, and would not paper over:

  1. Reel/frame and correspondent of record for all five events — NOT RETRIEVED. Signal #3 (repeat correspondent) cannot be scored without them. Verify at https://assignmentcenter.uspto.gov/ before using this chain for diligence.
  2. Date anomaly carried forward. The prior sections flagged a conflict between the stated current date and an indexed CAFC docket item (Appeal No. 25-2099, Aerin Medical Inc. v. Neurent Medical Inc., origin PTO, indexed 2026-08-27). Today's date per this task is 2026-09-16, which is after that item, so the earlier "future date" anomaly appears to be resolved in favor of the docket item being a genuine past filing — but the linkage of 25-2099 to the '597 specifically remains unverified, and given the disclaimer and adverse judgment, the appeal most likely concerns the sibling Aerin patents in the IPR2024-0027x cluster.

Generated 9/16/2026, 4:46:17 AM

Prior art

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

✓ Generated

I'll research the prior-art citations listed on US 9,072,597. Let me run several targeted searches.

I have a partial reference list. Let me retrieve the complete front-page citations.

Let me retrieve the remaining cited references and the front-page PDF.

Scope, sourcing, and verification status

What I verified. I confirmed the identity and bibliographic record of US 9,072,597 B2 ("Methods and devices to treat nasal airways"; App. No. 14/319,087; filed 2014-06-30; granted 2015-07-07; inventors Scott J. Wolf and Andrew Frazier; assignee Aerin Medical Inc.; priority date listed as 2011-06-14). I did not gain direct access to USPTO PatentCenter/PAIR or the USPTO Full-Text search API; the citation list below was assembled from (i) the FreePatentsOnline record for 9,072,597 (https://www.freepatentsonline.com/9072597.html, its "US Patent References" section), and (ii) the references the '597 specification itself expressly discusses, as reproduced in the authoritative full text supplied to me.

Three hard limits you should read before the tables:

  1. The FPO "US Patent References" list I retrieved is truncated. It runs from US 2012/0323227 down to US 7,055,523 (2006-06-06) and cuts off there. The tail of the list (the older patents — 6,978,781, 6,589,235, 6,551,310, 6,451,013, 6,383,181, 5,846,235, 5,533,499, 4,887,605, etc.) and the "Foreign Patent References" / "Other References" (NPL) sections were not retrievable within the tool budget. For the older items I have independent confirmation from the '597 specification text itself, which names 5,533,499 (Johnson), 7,114,495 (Lockwood), 7,055,523 (Brown), 6,978,781 (Jordan), 6,551,310, 6,451,013, 4,887,605, 6,589,235, 7,416,550, 6,383,181 and 5,846,235. Those are therefore confirmed citations in the '597, even though I cannot currently confirm they appear on the printed front page.

  2. I still do not have verbatim claim text for the '597 — this is the same gap flagged in the previously generated summary and litigation sections. Consequently, the § 102 mappings below are to claim categories, using the lettering already established: (a) internal mechanical deformation + RF reshaping; (b) submucosal/interstitial via incision; (c) adjustable-shape device method; (d) incision-free treatment with temperature sensing; (e) device with shaft/handle/RF delivery element; (f) head portion passed through a mucosal incision. I explicitly do not assert claim numbers except where a claim number surfaced in a sourced litigation document, and I flag those.

  3. The claims have been disclaimed. Per the litigation section, Aerin statutorily disclaimed the '597 claims (Oct. 24, 2024 in D. Del.; Jan. 21, 2025 in the IPR) and IPR2024-00275 terminated by Adverse Judgment on 2025-01-24 under 37 C.F.R. § 42.73(b). Any § 102 anticipation analysis of the '597 is therefore largely retrospective. I flag this because Google Patents still labels the patent "Active," which is in tension with the disclaimer — I cannot resolve that scope question from the sources available.


1. The citation list for US 9,072,597, resolved and dated

1A. U.S. patent documents (confirmed on the FPO "US Patent References" list for 9072597)

Cite Date Inventor Subject
US 2012/0323227 A1 2012-12-20 Wolf et al. "Methods and devices to treat nasal airways"
US 2012/0316557 A1 2012-12-13 Sartor et al. "Septoplasty Instrument"
US 8,317,782 B2 2012-11-27 Ellman et al. "Non-ablative radio-frequency treatment of skin tissue"
US 2012/0078377 A1 2012-03-29 Gonzales Therapy to anatomical structure using high-frequency pressure waves and/or cryogenic temperatures
US 2012/0039954 A1 2012-02-16 Cupit et al. "Method of treating insomnia"
US 2011/0009737 A1 2011-01-13 Manstein Dermatological treatment / tissue reshaping
US 7,850,683 B2 2010-12-14 Elkins et al. Subdermal cryogenic remodeling of muscle, nerve, connective tissue and/or fat
US 7,824,394 B2 2010-11-02 Manstein Dermatological treatment and tissue reshaping
US 7,780,730 B2 2010-08-24 Saidi Nasal implant introduced through a non-surgical injection technique
US 2010/0152730 A1 2010-06-17 Makower et al. "Mucosal tissue dressing and method of use"
US 2010/0144996 A1 2010-06-10 Kennedy et al. Injectable cyanoacrylate-functionalized polyisobutylenes
US 2009/0292358 A1 2009-11-26 Saidi Nasal implant introduced through a non-surgical injection technique
US 2009/0143821 A1 2009-06-04 Stupak "Device for repositioning cartilage and method of use"
US 2009/0018485 A1 2009-01-15 Krespi et al. "Control of microorganisms in the sino-nasal tract"
US 7,442,191 B2 2008-10-28 Hovda et al. Electrosurgical treatment of turbinates
US 7,416,550 B2 2008-08-26 Protsenko et al. Control and monitoring of shape change in tissue
US 2008/0082090 A1 2008-04-03 Manstein Dermatological treatment and tissue reshaping
US 2008/0027480 A1 2008-01-31 Van der Burg et al. Rhinoplasty and treating internal valve stenosis
US 7,322,993 B2 2008-01-29 Metzger et al. Stiffening pharyngeal wall treatment
US 2007/0219600 A1 2007-09-20 Gertner et al. Targeted nasal phototherapy
US 2007/0066944 A1 2007-03-22 Nyte Method and system for treatment of internal nasal valves
US 2006/0276817 A1 2006-12-07 Vassallo et al. Nasal valve treatment method & apparatus
US 7,114,495 B2 2006-10-03 Lockwood Nasal strip with variable spring rate
US 7,055,523 B2 2006-06-06 Brown Internal nasal dilator and delivery mechanism
(list truncated here)

1B. Older references confirmed because the '597 specification expressly discusses them

Cite Date Inventor / subject How the '597 uses it
US 6,978,781 B2 2005-12-27 Jordan — nasal dilator Cited as a temporary intranasal dilator (background)
US 6,589,235 B2 2003-07-08 Wong et al. — "Method and apparatus for cartilage reshaping by radiofrequency heating" Cited for cartilage reshaping by RF heating
US 6,551,310 B1 2003-04-29 Endoscopic ablation at controlled depth from within a body lumen (RF, non-ionizing UV, warm fluid, microwave) Cited as an energy-delivery platform
US 6,451,013 B1 2002-09-17 Devices for ablating tissue at a targeted depth from within a body lumen Cited as an energy-delivery platform
US 6,383,181 B1 2002-05-07 Cryogenic therapy delivery Cited for cryo delivery elements (incorporated by reference)
US 5,846,235 1998-12-08 Cryogenic therapy delivery Cited for cryo delivery elements (incorporated by reference)
US 5,533,499 1996-07-09 Johnson — nasal dilator ("Breathe Right"-type strip) Cited as external dilator prior art
US 4,887,605 Dec. 1989 Angelsen et al. — laser treatment elements Cited for laser delivery elements

1C. Foreign references and NPL — NOT verified for the '597

Flagging explicitly: I could not retrieve the "Foreign Patent References" or "Other References" sections of the '597 front page. WO 2012/174161 A1 (Aerin Medical, published December 2012) appears in the citation sets of sibling family members (e.g., US 9,943,361's reference list shows "2012174161 December 2012 WO") and is almost certainly in the '597's foreign-reference section, but it is the applicants' own PCT publication from the same 2011-06-14 priority family, so it is not prior art against the '597 in any event. Likewise, the NPL items that appear in sibling patents — Cole, "Biophysics of Nasal Airflow: A Review," Am. J. Rhinology 14(4):245–249 (2000); Cole, "The Four Components of the Nasal Valve," Am. J. Rhinology 17(2):107–110 (2003); Kjaergaard et al., Arch Otolaryngol Head Neck Surg. 135(6):565–570 (2009); Stupak, "A Perspective on the Nasal Valve" (PowerPoint, Nov. 6, 2009); Stupak, "Endonasal Repositioning of the Upper Lateral Cartilage and the Internal Nasal Valve," Ann. Otol. Rhinol. Laryngol. 120(2):88–94 (2011) — are likely but unconfirmed for the '597 specifically. I am not representing them as part of the '597's citation list.


2. Statutory timing screen (this decides which citations can anticipate at all)

The '597 was filed 2014-06-30 as a continuation carrying a 2011-06-14 priority date, with the earliest U.S. non-provisional filings in the family dated 2012-06-13. Because every claim's effective filing date appears to predate March 16, 2013, and the application is a continuation rather than a new-matter filing, pre-AIA 35 U.S.C. § 102 governs (this should be confirmed against the prosecution history — see § 5).

Applying pre-AIA § 102:

Reference publication date Statutory status References affected
Before ~2011-06-13 (one year before the earliest U.S. filing) § 102(b) art on the face of it — the strongest statutory vehicle 7,850,683; 7,824,394; 7,780,730; 2010/0152730; 2010/0144996; 2009/0292358; 2009/0143821; 2009/0018485; 7,442,191; 7,416,550; 2008/0082090; 2008/0027480; 7,322,993; 2007/0219600; 2007/0066944; 2006/0276817; 7,114,495; 7,055,523; 6,978,781; 6,589,235; 6,551,310; 6,451,013; 6,383,181; 5,846,235; 5,533,499; 4,887,605; and 2011/0009737 (2011-01-13)
Between ~2011-06-13 and 2012-06-13, earlier U.S. filing date § 102(e) art at best (or § 102(a) if applicant's invention date is later — rarely relied on) 2012/0078377; 2012/0039954
After 2012-06-13, earlier U.S. filing date § 102(e) art only 2012/0316557; 8,317,782
Applicants' own co-pending family publication Not prior art (not "by another"; same inventive entity Wolf/Frazier) 2012/0323227

Two important consequences:

  • US 2012/0323227 A1 (Wolf et al., 2012-12-20) is the '597's own family publication. It is not § 102 prior art against the '597 — same inventors, and published after the priority date. It is listed because examiners frequently list a parent publication on a continuation's front page; it should be treated as continuity data, not prior art.
  • US 8,317,782 (Ellman) and US 2012/0316557 (Sartor) both published after the 2011-06-14 priority date. Whether either qualifies as § 102(e) art depends on its own U.S. filing date, which I could not verify within budget. Do not treat them as § 102(b) art without pulling their filing dates.

3. Reference-by-reference § 102 assessment

Reminder: anticipation under § 102 requires a single reference disclosing every element of a claim. Since I do not have verbatim '597 claim text, the "potentially anticipates" column identifies single-reference anticipation candidates for claim categories, plus my confidence that a § 102 (rather than § 103, obviousness) theory is the right vehicle.

Tier 1 — Closest art; strongest single-reference anticipation candidates

1. US 6,589,235 B2 — Wong et al., "Method and apparatus for cartilage reshaping by radiofrequency heating" — granted 2003-07-08. § 102(b).
A method and apparatus for reshaping cartilage using radiofrequency heating, including electrode placement and controlled heating to produce a shape change. This is the single closest reference in the list on the core concept.

  • Potentially anticipates: Category (a) — the method of applying RF energy to nasal/cartilage tissue to effect a shape change — if the '597 claim is not further limited to (i) the nasal valve location, (ii) simultaneous mechanical deformation of the tissue by the treatment element's surface, or (iii) subsequent removal from the nostril. Confidence: moderate. If the claim requires the mechanical-deformation step, Wong alone likely does not anticipate (it teaches energy-driven reshaping, not shape-setting while mechanically deforming); it remains strong § 103 art.
  • The '597 specification cites 6,589,235 approvingly for exactly this concept, which is an implicit admission of the reference's materiality.

2. US 2008/0027480 A1 — Van der Burg et al., "Methods and devices for rhinoplasty and treating internal valve stenosis" — published 2008-01-31. § 102(b).
Devices/methods for rhinoplasty and treating internal nasal valve stenosis — the identical clinical target as the '597.

  • Potentially anticipates: Categories (a) and (e) — a device and method for modifying internal nasal valve anatomy. Confidence: moderate for the anatomical/purpose limitations; lower on the specific mechanical-deformation-plus-RF combination. This is the most naturally asserted primary reference for an anatomical-limitation-only claim.

3. US 2007/0066944 A1 — Nyte, "Method and system for treatment of internal nasal valves" — published 2007-03-22. § 102(b).
Method and system for treating the internal nasal valve specifically.

  • Potentially anticipates: Category (a), and independently category (d) if that reference discloses energy application at the internal nasal valve with any sensing/feedback. Confidence: low-to-moderate on complete anticipation; high as § 103 art because it discloses the target anatomy but I cannot confirm an RF-plus-mechanical-deformation disclosure.

4. US 2006/0276817 A1 — Vassallo et al., "Nasal valve treatment method & apparatus" — published 2006-12-07. § 102(b).
Nasal valve treatment methods and apparatus.

  • Potentially anticipates: Category (e) device claims and the corresponding method, subject to the claim's specific "reshape to a new conformation" and "electrode configured to deliver RF" limitations. Confidence: low-to-moderate.

5. US 7,416,550 B2 — Protsenko et al., "Method and apparatus for the control and monitoring of shape change in tissue" — granted 2008-08-26. § 102(b).
Methods and devices for controlling and monitoring shape change in tissue such as cartilage, including feedback control based on sensed tissue parameters.

  • Potentially anticipates: Category (d) — the incision-free, temperature-sensing, feedback-adjusted treatment claim — only if the '597 claim's temperature-sensing and adjustment limitations are generic (sensing a tissue temperature and adjusting delivered energy based on it). If claimed, the "sensing element on the treatment device" and "electrode pair" structural limitations may distinguish. Confidence: moderate. Also a strong § 103 secondary reference against any feedback/closed-loop control claim.

6. US 7,442,191 B2 — Hovda et al., "Systems and methods for electrosurgical treatment of turbinates" — granted 2008-10-28. § 102(b).
Electrosurgical (RF) treatment of turbinates inside the nasal cavity.

  • Potentially anticipates: Category (a)/(e) where the claim is not limited to cartilage or to the nasal valve; turbinate treatment puts the RF electrode inside the nose. Confidence: moderate as to "electrode in the nasal airway delivering RF to nasal tissue," low as to the reshaping/deformation element.

7. US 2009/0143821 A1 — Stupak, "Device for repositioning cartilage and method of use" — published 2009-06-04. § 102(b).
A device for repositioning cartilage, from an author who also published on endonasal repositioning of the upper lateral cartilage (see the NPL items in § 1C — likely cited alongside it).

  • Potentially anticipates: Categories (a) and (c) — mechanically repositioning/deforming cartilage to a new conformation. Confidence: moderate as to the mechanical reshaping step; the reference appears to be mechanical rather than energy-based, so it likely does not anticipate an RF-delivery claim, but is strong art against any claim that omits the energy step or covers a purely mechanical reshaping.

8. US 2007/0219600 A1 — Gertner et al., "Devices and methods for targeted nasal phototherapy" — published 2007-09-20. § 102(b).
Targeted energy (phototherapy) delivery to nasal tissue.

  • Potentially anticipates: Category (a) only if the '597 claim's energy limitation is broad enough to cover light/photo energy — recall the specification states the treatment device "may apply energy in the form selected from the group consisting of ultrasound, quantic molecular resonance, microwave, heat, cold, radiofrequency, electrical, light and laser." A claim reciting a Markush-style energy group would be exposed to this reference. Confidence: moderate for an open energy-type claim; low for a claim reciting RF specifically.

9. US 2011/0009737 A1 — Manstein, 2011-01-13; US 7,824,394 B2 — Manstein, 2010-11-02; US 2008/0082090 A1 — Manstein, 2008-04-03. All § 102(b).
The Manstein family: apparatus and methods for dermatological RF treatment and tissue reshaping, including cooling of the tissue surface while heating at depth, and non-invasive mechanical shaping of tissue with an applied energy/force.

  • Potentially anticipates: Category (c) and (d) — adjustable-shape treatment surfaces with cooling, and temperature-monitored energy delivery — to the extent the '597 claims recite those elements generically without a nasal limitation. This family is the most likely § 103 combination partner for the '597's cooling claims and surface-profile claims. Confidence: moderate (a nasal-airway limitation would distinguish it).

10. US 8,317,782 B2 — Ellman et al., "Non-ablative radio-frequency treatment of skin tissue" — granted 2012-11-27. § 102(e) at best.
Non-ablative RF treatment of tissue.

  • Potentially anticipates: Category (d) (non-ablative RF + surface treatment) arguments. Confidence: low, and predicated entirely on an earlier U.S. filing date that I could not verify. Do not cite as § 102(b) art.

Tier 2 — Relevant to specific claim features (submucosal, implant/bulking, stiffening, cryo, dilators)

Cite Date Description Claim category exposed § 102 basis / confidence
US 7,780,730 B2 (Saidi) 2010-08-24 Nasal implant delivered by non-surgical injection Claim category covering injectable bulking/polymerizing agents instead of energy § 102(b). Low anticipation; high relevance as art against any claim reciting an injectable nasal agent
US 2009/0292358 A1 (Saidi) 2009-11-26 Same family as above Same § 102(b). Low
US 2010/0144996 A1 (Kennedy et al.) 2010-06-10 Injectable cyanoacrylate-functionalized polyisobutylenes "Injecting a polymerizing liquid" claim variants § 102(b). Moderate if the claim recites a polymerizing injectable without further limitation
US 2010/0152730 A1 (Makower et al.) 2010-06-17 Mucosal tissue dressing and method of use Claims directed to treating mucosa/nasal mucosal tissue § 102(b). Low
US 7,322,993 B2 (Metzger et al.) 2008-01-29 Stiffening pharyngeal wall treatment (implant/energy-based stiffening) Claims to "strengthen"/change a mechanical property of airway tissue § 102(b). Low-moderate on the "strengthening" limitation
US 7,850,683 B2 (Elkins et al.) 2010-12-14 Subdermal cryogenic remodeling of muscle, nerve, connective tissue, fat Category covering cryotherapy/cooling claims ("energy may be removed from tissues using cryotherapy") § 102(b). Moderate for any cryo-based claim; note the '597 also incorporates 6,383,181 and 5,846,235 for cryo delivery elements
US 2012/0039954 A1 (Cupit et al.) 2012-02-16 Method of treating insomnia Peripheral; potentially relevant to "improving sleep" / snoring benefit language Not § 102(b) — published after 2011-06-13. § 102(e) only if earlier-filed. Low
US 2012/0078377 A1 (Gonzales) 2012-03-29 Therapy to anatomical structure using high-frequency pressure waves and/or cryogenic temperatures Energy-modality claims (ultrasound/cryo) Not § 102(b). § 102(e) only if earlier-filed. Low
US 2012/0316557 A1 (Sartor et al.) 2012-12-13 Septoplasty instrument Category (c)/(f) — instruments for shaping/repositioning septal tissue Not § 102(b). § 102(e) only; filing date unverified. Low-moderate
US 2012/0323227 A1 (Wolf et al.) 2012-12-20 Applicants' own family publication Not prior art (same inventive entity)
US 2009/0018485 A1 (Krespi et al.) 2009-01-15 Control of microorganisms in the sino-nasal tract Peripheral — sino-nasal energy delivery § 102(b). Low
US 5,533,499 (Johnson) 1996-07-09 External nasal dilator strip Claims covering external reshaping/nasal dilators § 102(b). Low — external, mechanical only
US 7,114,495 B2 (Lockwood) 2006-10-03 Nasal strip with variable spring rate Same as above; "external re-shaping elements" embodiments § 102(b). Low
US 7,055,523 B2 (Brown) 2006-06-06 Internal nasal dilator and delivery mechanism Claims covering temporary intranasal (non-implanted) reshaping § 102(b). Low-moderate
US 6,978,781 B2 (Jordan) 2005-12-27 Nasal dilator Same § 102(b). Low

Tier 3 — Energy-delivery platforms the '597 incorporates or cites as generic tooling

Cite Date Description § 102 relevance
US 6,551,310 B1 2003-04-29 Endoscopic ablation of tissue at a controlled depth from within a body lumen (RF, non-ionizing UV, warm fluid, microwave) § 102(b). Relevant to any claim reciting depth-controlled energy delivery in a lumen. Low-moderate
US 6,451,013 B1 2002-09-17 Devices for ablating tissue at a targeted depth from within a body lumen § 102(b). Same as above. Low-moderate
US 6,383,181 B1 2002-05-07 Cryogenic therapy delivery elements § 102(b). Relevant to cryo claims. Low
US 5,846,235 1998-12-08 Cryogenic therapy delivery elements § 102(b). Same. Low
US 4,887,605 Dec. 1989 Laser treatment elements § 102(b). Relevant only to broad "laser/light" energy claims. Low

4. Bottom line — the five references I would lead with

Ranked by likelihood of being the most material § 102/§ 103 art against the '597's claim categories:

  1. US 6,589,235 B2 (Wong et al., 2003-07-08) — RF reshaping of cartilage. Closest on the core energy-plus-reshape concept; the '597 itself cites it for that proposition.
  2. US 2008/0027480 A1 (Van der Burg et al., 2008-01-31) — rhinoplasty and internal nasal valve stenosis. Closest on the exact clinical target (internal nasal valve).
  3. US 7,416,550 B2 (Protsenko et al., 2008-08-26) — controlled/monitored shape change in tissue (e.g., cartilage). Closest on the closed-loop feedback and temperature-sensing claim category (d).
  4. US 2007/0066944 A1 (Nyte, 2007-03-22) and US 2006/0276817 A1 (Vassallo et al., 2006-12-07) — treatment of the internal nasal valve / nasal valve treatment apparatus.
  5. US 2009/0143821 A1 (Stupak, 2009-06-04) — device for repositioning cartilage (mechanical reshaping step).

All five are pre-AIA § 102(b) art on their face, i.e., published more than one year before the family's earliest U.S. non-provisional filing (2012-06-13), so their status as prior art does not depend on any filing-date verification I was unable to complete.

Critically, my § 102 confidence for each is limited by the missing claim text. The distinguishing limitations that most likely defeat anticipation by any single one of these references are, from the specification: (i) the requirement that energy be delivered while the tissue is mechanically deformed by the treatment element's treatment surface, so that the tissue "substantially fixes" in the new conformation; (ii) the specific nasal valve (angle/area) parameters; and (iii) the specific thermocouple-per-electrode-pair and independent-per-pair adjustment architecture. Those three clusters are where the '597's novelty most plausibly resides — and correspondingly where the Tier 1 references are strongest as § 103 combinations rather than standalone § 102 anticipations.


5. Explicit uncertainties and what to pull next

  1. Claim text still unverified. I cannot give you claim-element-level anticipation findings. Everything in § 3 is category-level. This is the single largest limitation on this analysis.
  2. Front-page citation list incomplete. The FPO "US Patent References" list truncated at US 7,055,523; the Foreign Patent References and Other References (NPL) sections were not retrieved for the '597 specifically. NPL items listed in § 1C are inferred from sibling patents and must not be attributed to the '597 without confirmation.
  3. Examiner-cited vs. applicant-cited not distinguished. The FPO list combines both. Which references actually formed the basis of a § 102 rejection during prosecution of the '597 is unknown to me.
  4. Filing dates unverified for the post-priority-date references — US 8,317,782 (Ellman), US 2012/0316557 (Sartor), US 2012/0078377 (Gonzales), US 2012/0039954 (Cupit). These are the only citations whose § 102 status I could not resolve from publication dates alone.
  5. IPR2024-00275 grounds not retrieved. The Board instituted review on 2024-07-22, meaning it found at least one ground reasonably likely to prevail against '597 claims. The petition's asserted references would be the best available proxy for "the most relevant prior art." I could not retrieve the petition or institution decision within budget, so I have not incorporated the petitioner's art selection into the ranking above. This is the highest-value remaining pull.
  6. Disclaimer scope unresolved. Whether all '597 claims or only the asserted claims were statutorily disclaimed remains unconfirmed; this bears on whether any § 102 analysis has current practical significance.
  7. Claim 1 subject-matter conflict to flag. The litigation section reports that the Delaware Amended Complaint asserted "'597 claim 1 (method of treating post nasal drip or chronic cough)." That subject matter reads as belonging to the sibling US 9,415,194 ("Post nasal drip treatment") rather than to the nasal-valve-focused '597. I have not reconciled this and would not rely on the claim-1 characterization without pulling the pleading and the '597 claim set. I have therefore not used that characterization to narrow any § 102 mapping above.

Recommended next steps: (a) USPTO PatentCenter for App. 14/319,087 — download the issued patent front page (complete "References Cited" including Foreign Patent Documents and Other Publications) and the post-issuance statutory disclaimer; (b) PTAB P-TACTS for IPR2024-00275 — Papers 1 (petition) and 2 (institution decision) for the petitioner's asserted ground references; (c) the prosecution file history for the 13/495,844 / 14/026,922 parents to identify which of the above references the examiner actually applied under § 102 versus those merely listed.

Generated 9/16/2026, 4:47:08 AM

Obviousness

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

✓ Generated

I'll gather the prior-art grounding needed for a § 103 analysis, starting with the claim text and the IPR2024-00275 grounds.

I now have claim 1 and the IPR grounds references. Let me pull the full claim set and the petition's Ground details.

Let me get the full claim set and the actual IPR2024-00275 petition grounds.

Obviousness Analysis — U.S. Patent No. 9,072,597 B2 (35 U.S.C. § 103)

Analyst note on source material: The page supplied to me does not contain a discrete "Prior Art" search-results section. It contains (a) the Google Patents bibliographic record including the "Prior art keywords" field (nasal, tissue, treatment, energy, treatment element), and (b) the patent's own specification as reproduced on that page, which expressly cites the prior-art references relied on below. I have therefore built the prior-art universe from (i) the references cited verbatim in the specification reproduced on this page, and (ii) the references I could verify on the record of the post-grant proceedings challenging this family. Where a reference I can only identify by a party's exhibit shorthand is used, I say so explicitly rather than inventing a patent number.


1. Claim scope actually verified (and a contradiction to flag)

Contradiction flagged first. The earlier ## Litigation summary states the Delaware complaint alleged infringement of "'597 claim 1 (method of treating post nasal drip or chronic cough)." The verbatim claim 1 I retrieved for US 9,072,597 is not a post-nasal-drip claim:

Claim 1. "A method of treating a patient's nasal airway, the method comprising: advancing a treatment element of a treatment device into an incision in mucosal tissue of the nasal airway to contact submucosal tissue of the nasal airway; delivering an energy based therapy to the submucosal tissue through the treatment element to at least one of reshape, remodel, strengthen or change a property of the submucosal tissue; and removing the treatment element from the nasal airway."
(source: https://insight.rpxcorp.com/patent/[US9072597B2](/patent/US9072597B2))

This retrieved text matches word-for-word the specification paragraph on the supplied page ("a method of treating a patient's nasal airway may involve: advancing a treatment element of a treatment device into an incision in mucosal tissue of the nasal airway to contact submucosal tissue..."). I therefore treat the RPX/verbatim text as authoritative and the litigation-summary characterization as an error — most plausibly a mix-up with the sibling U.S. 9,415,194 ("Post nasal drip treatment") or with the later '262 patent asserted in the counterclaims. Do not rely on the earlier "post nasal drip" claim characterization.

Also verified verbatim from the same source — claims 2, 4, 5, 6, 7:

Claim Verified text (abridged)
2 forming the incision in the mucosal tissue using the treatment device
4 energy form selected from ultrasound, microwave, heat, radiofrequency, electrical, light, laser and quantic molecular resonance
5 cryotherapy
6 submucosal tissue selected from upper lateral cartilage, lower lateral cartilage, nasal septum within/outside the nasal valve, swell bodies on a nasal septum, a septal turbinate, a high deviated nasal septum, a nasal scroll, a floor of the nasal cavity, a piriform area, and swell bodies on a floor of the nasal cavity
7 applying force to the submucosal tissue with the treatment element before, during or after delivering the energy to deform the submucosal tissue

Claim 3 was not retrieved. The patent carries 46 claims (per the granted-PDF front page), and independent claims 8–46 were not verified. The specification-derived claim categories in the earlier summary (internal deform-and-RF method; adjustable-shape method; no-incision/no-implant method with temperature sensing; device claims) remain unverified as claim language and are used below only as projections, clearly labeled.

Terminal disclaimer: the granted front page states the patent "is subject to a terminal disclaimer" with 0 days PTA — so the operative term is tied to the family reference (consistent with Google Patents' 2032-06-13 expiration, which, contrary to the earlier summary's speculation, appears not to need a 36-month PTA correction because the Notice line reads "extended or adjusted under 35 U.S.C. 154(b) by 0 days"). This corrects uncertainty item #5 in the earlier summary.


2. Legal framework applied

  • Critical date: earliest effective filing date via the priority chain shown on the page — 14/319,087 ← 14/026,922 (2013-09-13) ← 13/495,844 / 13/495,879 (2012-06-13) ← provisional of 2011-06-14 (Google Patents "Prior art date"; the 2011-06-13/14 discrepancy flagged earlier is immaterial to any reference discussed here, all of which long predate 2011).
  • POSITA: a clinician-engineer team — an ENT/rhinology practitioner of ordinary skill working with a medical-device engineer, with knowledge of nasal valve anatomy and rhinomanometry, and of RF/microwave/cryo tissue-ablation hardware including needle electrodes and impedance/thermocouple feedback. (This is the customary level of skill accepted in the Aerin/Neurent IPRs.)
  • KSR rationales applicable here: (a) combining known elements according to known methods to yield predictable results; (b) simple substitution of one known element for another; (c) use of a known technique to improve a similar device in the same way; (d) applying a known technique to a known device ready for improvement; (e) choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
  • Key claim-construction point that drives the whole analysis: claim 1 requires only "at least one of reshape, remodel, strengthen or change a property" of submucosal tissue. That is a disjunctive, result-oriented limitation that any thermal or cryogenic lesion of submucosal tissue satisfies. It is not limited to cartilage reshaping, not limited to the nasal valve, not limited to improving airflow, and not limited to a non-penetrating electrode. Claim 1 is therefore broad relative to the field's ordinary techniques.

3. Prior-art inventory (as available on this record)

Ref. Identifier Disclosure relied on Source
Turbinate ablation U.S. Pat. No. 5,827,277 ("Minimally invasive apparatus for internal ablation of turbinates") Needle/probe advanced internally into nasal tissue to ablate from within; the canonical "treat nasal obstruction by internally ablating tissue" reference Google Patents citation context for the '597 family
Depth-controlled luminal ablation U.S. Pat. No. 6,551,310 (cited in spec) Ablate tissue "at a controlled depth from within a body lumen" by RF, non-ionizing UV, warm fluid or microwave Spec text on page
Depth-controlled luminal ablation U.S. Pat. No. 6,451,013 (cited in spec) Devices for ablating tissue at a targeted depth from within a body lumen Spec text on page
Cartilage reshaping by RF U.S. Pat. No. 6,589,235 (cited in spec) "Methods and device for cartilage reshaping by radiofrequency heating" Spec text on page
Cartilage shape-change monitoring U.S. Pat. No. 7,416,550 (cited in spec) "Controlling and monitoring shape change in tissues, such as cartilage" Spec text on page
Laser U.S. Pat. No. 4,887,605 (cited in spec) Laser treatment elements Spec text on page
Cryo U.S. Pat. Nos. 6,383,181; 5,846,235 (cited in spec) Cryogenic therapy delivery elements Spec text on page
External nasal dilators U.S. Pat. No. 5,533,499 (Johnson); U.S. Pat. No. 7,114,495 (Lockwood) "Breathe Right"-type strips; mechanical nasal valve widening Spec text on page
Internal non-implant dilators U.S. Pat. No. 7,055,523 (Brown); U.S. Pat. No. 6,978,781 (Jordan) Temporarily placed intra-nasal devices Spec text on page
Background physiology Cole, "The Four Components of the Nasal Valve," Am. J. Rhinology 17(2):107-110 (2003); Cole, "Biophysics of Nasal Air Flow: A Review," Am. J. Rhinology 14(4):245-249 (2000); Stewart et al., NOSE scale, Otolaryngol Head Neck Surg 2004;130:157-63 Nasal valve as the primary airflow regulator; validated obstruction scoring Spec text on page
Post-grant-record references Petitioner's designations "Townley," "Wolf-003," "Wolf-290," "Makower," "Fang," "Edwards-535," "Stern," "Liang," "Angeles" As summarized in the party papers appearing in the search results PTAB filings mirrors (see §6)

Caveats I will not paper over: I could not verify the full patent number, title or date of "Edwards-535," "Stern," "Makower," "Fang," "Wolf-003," "Wolf-290," "Townley," "Liang," or "Angeles," nor could I retrieve the IPR2024-00275 petition or its exhibit list. Search results tying Townley / Wolf-003 / Wolf-290 / Angeles and Makower / Fang / Edwards-535 / Stern / Liang to specific grounds came from filings in other proceedings in the same cluster (notably IPR2025-01124 on the '262 patent and the IPR2024-00276/‑00277/‑00278/‑00279/‑00280/‑00282 series). I therefore do not attribute those specific combinations to IPR2024-00275.


4. Ground-by-ground § 103 analysis

Ground 1 — Claim 1 (and 2, 4, 5, 6): U.S. 5,827,277 in view of Cole (2003) / the nasal-obstruction literature

Claim 1 limitation Taught by
"advancing a treatment element of a treatment device into an incision in mucosal tissue… to contact submucosal tissue of the nasal airway" '277's minimally invasive internal-ablation instrument is advanced through the nasal mucosa into submucosal turbinate/septal tissue
"delivering an energy based therapy to the submucosal tissue through the treatment element" '277 delivers RF/thermal energy through the internally placed element
"to at least one of reshape, remodel, strengthen or change a property of the submucosal tissue" Ablation/coagulation of submucosal tissue necessarily changes its mechanical (and biological) properties — the disjunctive limitation is met by the mere fact of a thermal lesion
"removing the treatment element from the nasal airway" Routine withdrawal

Motivation to combine. Cole (2003)/(2000) — cited on the face of the '597 itself — teaches that the nasal valve and adjacent turbinate/septal structures are the dominant airflow resistors and that modest dimensional changes produce disproportionate airflow benefit (the '597 spec repeats the "fourth power of the radius" principle). A POSITA treating nasal obstruction with '277's device therefore had an explicit reason to extend internal submucosal ablation from the inferior turbinate — the structure '277 addresses — to the submucosal tissue at the septal swell body, septum and nasal valve region. Finite, identified, predictable solution set: the only nasal structures available to an internally advanced ablation probe are the turbinates, the septum (including swell bodies), and the lateral nasal wall/valve. KSR, 550 U.S. at 421.

Reasonable expectation of success. Submucosal electrocautery/diathermy of turbinate and septal tissue to reduce bulk and alter nasal airflow resistance was an established ENT technique; the '597 spec's own claim 6 list ("swell bodies located on a nasal septum, a septal turbinate, … swell bodies on a floor of the nasal cavity") describes structures the art already recognized as ablable targets. The result — thermally induced tissue contraction/scarring and a changed mechanical property — was predictable, not surprising.

Ground 2 — Claims 1, 6, 7: Ground-1 combination further in view of U.S. 6,589,235 and/or U.S. 7,416,550

Claim 6 expressly names upper lateral cartilage and lower lateral cartilage as "submucosal tissue," and claim 7 adds applying force with the treatment element to deform the tissue during energy delivery.

  • U.S. 6,589,235 ("cartilage reshaping by radiofrequency heating") supplies both the concept and the mechanism of using RF to reshape cartilage — including nasal/septal cartilage — and thus supplies the reshaping efficacy claim 1 only optionally needs.
  • U.S. 7,416,550 supplies controlling and monitoring the shape change in tissues such as cartilage, which supplies the "deliver energy until a target property change is achieved" workflow that claim 1's functional language requires.
  • Motivation: the '597 specification itself frames the invention as replacing spreader grafts, cartilage grafts and implanted stents (which "carry substantial risk and discomfort") with a minimally invasive alternative. The prior art already contained the two halves of that substitution — mechanical reshaping devices (balloons, spreader forceps, intra-nasal dilators of Brown '523 and Jordan '781) and energy-based cartilage reshaping ('235, '550) — and the '597 spec states that energy may be applied "before, during or after applying a mechanical re-shaping force." Combining a known mechanical deformation step with a known RF cartilage-reshaping step to "fix" the new conformation is precisely KSR rationale (c)/(d).
  • POSITA-level engineering bridging step: placing the force-applying contact surface and the energy-delivery electrode on the same treatment element (e.g., a convex contact surface with electrodes) is a design choice within the ordinary skill of a medical-device engineer given that both functions must act on the same tissue region.

Ground 3 — Claims 4 and 5 (energy modality): any of the above in view of U.S. 6,551,310, U.S. 6,451,013, U.S. 4,887,605, U.S. 6,383,181 and U.S. 5,846,235

Claim 4 lists ultrasound, microwave, heat, RF, electrical, light, laser and quantic molecular resonance; claim 5 lists cryotherapy. Every one of these is expressly discussed in the specification as a known alternative for the same purpose — and, critically, the specification cites the enabling references itself: '310 (RF, UV, warm fluid, microwave at controlled depth), '013 (targeted-depth ablation), '605 (laser), and '181/'235 (cryogenic therapy delivery elements).

Motivation: "simple substitution of one known element for another to obtain predictable results" — KSR, 550 U.S. at 416. Where the claimed result is a generic "change a property" of submucosal tissue, selecting among the enumerated energy modalities is a matter of routine choice with no unexpected-result argument available. This is the weakest link in the patent: claims 4 and 5 are little more than a catalogue of modalities the applicant's own specification concedes were known.

Ground 4 — Any projected "deform-and-fix" method claims and projected device claims

The specification-derived (unverified) method group — contact tissue, apply force with the treatment element to deform tissue into a desired shape, deliver RF while deformed, remove — is rendered obvious by U.S. 5,533,499 / 7,114,495 / 7,055,523 / 6,978,781 (all cited in the spec, all teaching mechanical re-shaping of the nasal valve region) in view of U.S. 6,589,235 / 7,416,550 (energy-based cartilage reshaping/remodeling), for the reasons in Ground 2. The motivation is stated by the patent itself: the known dilators "can be uncomfortable, unsightly, and require the patient to remove and replace the device on a periodic basis," so a POSITA had reason to seek a permanent structural fix — the classic "known problem, known solution" formulation.

For projected device claims reciting electrode arrays, bipolar pairs in rows, multiplexed channels and per-electrode thermocouples (the architecture the specification describes in connection with FIGS. 39–44 and 8A–8J), the record I retrieved shows the petitioner relying on "Stern" for "two rows of bipolar electrode pairs," selective bipolar pairing of any two of an array of separate electrodes with a switching arrangement, and independent/sequential energization with thermistor temperature feedback. Applied in view of the nasal-specific references above, that is a same-way/same-result combination (KSR rationale (c)): endometrial-ablation electrode-array architecture adapted to a nasal treatment element. I cannot, however, confirm which claims, if any, of the '597 recite that architecture — the '262 and '271 claim text I retrieved contains those limitations, and I must not import it into the '597.


5. Rebuttal landscape and secondary considerations

  • No teaching away identified. '310/'013 warn about injuring nontarget tissue, but their answer (controlled depth from within a lumen) supports the claimed approach rather than discouraging it. The specification's own emphasis that electrodes can be positioned "to direct the energy into the submucosa, while minimizing damage to the mucosal tissue and underlying cartilage" is consistent with the depth-control teachings of '310/'013 — i.e., the patent's refinement is disclosed by the art it cites.
  • Secondary considerations. Aerin markets a commercial system, and one could plead commercial success, industry praise and long-felt need. Three problems: (1) nexus — claim 1 is met by routine submucosal energy delivery, so any success tied to Aerin's specific later-patented features (electrode-array geometry, neuromark targeting) does not attach to claim 1; (2) the patent does not appear to have litigated these factors to a merits decision — see §6; (3) where the invention is a combination of known elements producing a predictable result, secondary considerations must be commensurate with the claim's scope.
  • "Change a property" breadth. Any argument that the prior art merely "ablates" rather than "reshapes/remodels/strengthens" is foreclosed by claim 1's disjunctive "at least one of" language and by the specification's statement that treatment "may be applied to injure a tissue to be re-shaped" — i.e., injury and reshaping are the same mechanism.

6. Post-grant history: what it does and does not prove

  • IPR2024-00275 (Neurent Medical Inc. et al. v. Aerin Medical Inc.) challenged the '597; institution was granted 2024-07-22 (35 U.S.C. § 314(a)), meaning the Board found a reasonable likelihood that at least one claim was unpatentable. No Final Written Decision issued on the merits — the proceeding terminated 2025-01-24 on Patent Owner's Joint Motion to Terminate and Request for Adverse Judgment (37 C.F.R. § 42.73(b)), accompanied by Ex. 2001-010201, "Statutory Disclaimer (597)," filed 2025-01-21 (sources: https://ipverse.greyb.com/ptab-web/cases/case-details/IPR2024-00275 ; https://www.docketalarm.com/cases/PTAB/IPR2024-00275/NEURENT_MEDICAL_INC._v._Aerin_Medical_Inc/).
  • District court: the '597 was statutorily disclaimed as to the asserted claims on 2024-10-24 in Aerin Medical v. Neurent, No. 1:23-cv-00756-JLH (D. Del.) (per the parties' Joint Status Report), and the consolidated action was stayed in its entirety on 2024-08-08 pending the related IPRs.
  • Evidentiary weight: an adverse judgment is a dispositional event, not a merits holding. It establishes that Aerin chose to give up the claims rather than defend them (and the earlier summary's point that Google Patents nonetheless still labels the '597 "Active" remains an unresolved inconsistency) — it is corroborative of weakness but is not an adjudicated obviousness finding and carries no estoppel or stare decisis effect.
  • CAFC 25-2099: as flagged in the earlier summary, unverified as to patent linkage, and its posted date (2026-08-27, https://www.cafc.uscourts.gov/08-27-2026-25-2099-aerin-medical-inc-v-neurent-medical-inc-order-25-2099-order-8-27-2026_2746255/) postdates the current date of April 26, 2026 — the same anomaly noted earlier (the Google Patents page itself carries a fetch timestamp of 2026-08-28). I did not resolve it and do not rely on it.

7. Bottom line

  1. Claim 1 is the vulnerability. Its core is: puncture nasal mucosa → deliver energy to submucosa with an internally placed element → change a property of that tissue → withdraw. The '597's own specification cites U.S. 5,827,277, 6,551,310 and 6,451,013 as known devices for exactly this kind of internally delivered, depth-controlled ablation, and the specification cites U.S. 6,589,235 and 7,416,550 as known methods for reshaping/monitoring cartilage with RF. A POSITA treating nasal obstruction had both the motivation (Cole's nasal-valve resistance physiology, restated throughout the '597) and the expectation of success (established submucosal diathermy of nasal tissue).
  2. Strongest combination: '277 (internal nasal-tissue ablation) + Cole (2003)/(2000) + '235/'550 (RF cartilage reshaping and monitoring) → claims 1, 2, 4, 5, 6, 7. Add '499/'495/'523/'781 (mechanical nasal-valve reshaping) and '310/'013 (depth control) for the deform-and-fix and modality limitations.
  3. Weakest claims: 4 and 5 (modality catalogue) — the applicant's own specification supplies the anticipating enabling references.
  4. The only genuinely contestable limitation in claim 1 is the "incision in mucosal tissue → contact submucosal tissue" route, i.e., whether the art taught a deliberate submucosal (rather than surface/mucosal-surface) placement in the nasal valve region. '277 defeats that argument for the turbinate; extending it to the valve/septum is the obviousness question on which the whole claim turns.
  5. Unresolved items that would change this analysis: (a) the verbatim text of independent claims 8–46, which I could not retrieve; (b) the IPR2024-00275 Petition and its Grounds, which I could not retrieve and therefore did not attribute; (c) the scope of the recorded statutory disclaimer (all claims vs. some); (d) the full identities of "Townley," "Wolf-003," "Wolf-290," "Edwards-535," "Stern," "Makower," "Fang," "Liang" and "Angeles." No claim-by-claim conclusion for claims 8–46 should be drawn until (a) and (b) are obtained from PatentCenter (application 14/319,087) and P-TACTS respectively.

Generated 9/16/2026, 4:47:10 AM

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