Invalidity dossier
US 10610675
Systems and methods for delivery of a therapeutic agent
Current assignee: Neurent Medical Inc., Neurent Medical Ltd.
Added 8/28/2026, 4:00:24 AM
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.
I'll search for authoritative information on this specific patent number and its litigation/appeal history.
Key finding: the PTAB/IPR record suggests the '675 patent's challenged claims are directed to energy treatment of nasal tissue. Let me verify the actual claim text and the appeal status.
Let me pin down the IPR outcome and the actual claim language.
Scope / identifier check
I searched on the literal string 10610675 / US 10,610,675 B2. Everything below refers to that single patent (title "Systems and methods for delivery of a therapeutic agent"). I did not pull in the many similarly-numbered family members (e.g., 10,610,647; 10,894,011; 10,829,897; 11,679,077), except where they are part of the same litigation record.
Two caveats up front, per your rules:
- The authoritative full text you supplied stops mid-specification (at the end of the "Background/Brief Summary" portion). It does not include the claims, so I cannot quote independent claim language verbatim. My claim overview is derived from the PTAB/IPR record, which is second-hand as to claim text.
- Date conflict: the session header states today is 2026‑09‑16 while your message says current date April 26, 2026. Live sources returned documents dated August 27, 2026. I am flagging this rather than silently reconciling it; the document dates are as reported by the sources.
1. Bibliographic summary (US 10,610,675 B2)
| Field | Value | Source |
|---|---|---|
| Title | Systems and methods for delivery of a therapeutic agent | Google Patents, Unified |
| Patent no. | US 10,610,675 B2 | — |
| Application no. | US 16/659,893 (Unified renders it 16659893) | Google Patents |
| Filing date | 2019‑10‑22 (Google Patents); 2019‑10‑21 (Unified) | both |
| Issue/grant date | 2020‑04‑07 (Google Patents); 2020‑04‑06 (Unified) | both |
| Publication no. | US 2020/0046955 A1 | Google Patents |
| Inventors | Mark E. Deem; Hanson Gifford | both |
| Assignee | Foundry LLC (original & current per Google Patents). Assignment record: assigned to The Foundry Inc. 2019‑10‑22, then to The Foundry, LLC 2019‑10‑23 | Google Patents |
| Priority date | 2005‑07‑22 (Google Patents, "assumption"; benefit claim to Prov. 60/702,077 filed 2005‑07‑22). Unified states 2005‑07‑21 | both (discrepancy noted) |
| Anticipated expiration | 2026‑07‑21 (Google Patents) / 2026‑07‑20 (Unified) | both |
| Examiner | Albert M. Navarro (Unified) | Unified |
| CPC classes | A61M37/00, A61B18/14, A61B18/18, A61K41/00, A61N1/30, A61N7/00, A61K38/48, etc. | Google Patents |
Continuity. The '675 patent is a continuation of Ser. No. 16/036,381 (filed 2018‑07‑16), which continues Ser. No. 15/358,187 (now US 10,022,529), which continues Ser. No. 14/601,529 (US 9,498,283), which continues Ser. No. 13/660,629 (US 8,961,391), which continues Ser. No. 13/253,595 (US 8,338,164), which continues Ser. No. 12/559,278 (US 8,133,497), which is a divisional of Ser. No. 11/459,090 (US 7,608,275), which claims benefit of Prov. 60/702,077 (2005‑07‑22) and Prov. 60/747,771 (filed 2006‑05‑19). (From the patent text you supplied.)
2. Abstract (verbatim from the patent)
"Methods and apparatus are provided for applying an fragment of a neurotoxin such as the active light chain (LC) of the botulinum toxin (BoNT), such as one of the serotype A, B, C, D, E, F or G botulinum toxins, via permeabilization of targeted cell membranes to enable translocation of the botulinum neurotoxin light chain (BoNT-LC) molecule across the targeted cell membrane to the cell cytosol where a therapeutic response is produced in a mammalian system. The methods and apparatus include use of catheter based delivery systems, non-invasive delivery systems, and transdermal delivery systems."
3. Plain-language overview of the independent claims — with an important caveat
I was not able to retrieve verbatim claim text in this session, and the text you supplied omits the claims. I will not invent claim language. What can be stated with grounding:
- The claims challenged in IPR2024‑00279 were claims 1‑3, 7, 9‑10, and 17‑25 (so the patent has at least 25 claims; likely independent claims at 1 and 17).
- Per the Petitioner's framing, the challenged claims "are directed to the well-known concept that applying energy to tissue in the nose can treat a nasal condition" — i.e., method claims for treating a nasal/nasopharyngeal condition (rhinitis, mucus secretion, congestion) by delivering energy to target tissue in the nasal passage. (Docket Alarm, Petition as filed, §I.)
- Patent Owner's expert likewise characterized the Challenged Claims as directed to "administering therapy to the target tissue" by "delivering energy to the target tissue." (Declaration of Dr. Marom Bikson, Ex. 2005.)
- Claim 22 additionally recites electrodes "configured to concentrate energy laterally relative to the distal portion of the treatment device" (per both parties' IPR briefing).
- Petitioner also argued the priority chain does not support these claims: the claims allegedly first appeared in the 2019‑10‑22 filing, making 2019‑10‑22 (not 2005) the effective priority date for them, with U.S. 10,307,200 (Saadat) and U.S. Pub. 2008/0021369 (Deem) said to anticipate.
Notable mismatch worth flagging: the specification and abstract of the '675 patent are about botulinum light chain (BoNT‑LC) delivery via membrane permeabilization, whereas the claims asserted in the IPR are described by both sides as energy-treatment-of-nasal-tissue claims. That divergence is the crux of the IPR (Petitioner contends the "675 claims are new matter inserted in 2019).
4. Post-grant and litigation status
- PTAB: IPR2024‑00279, Neurent Medical Inc. & Neurent Medical Ltd. v. The Foundry, LLC, filed Jan. 18, 2024, Tech Center 1600 / Art Unit 1645, before Judges Snedden, Mitchell and Majors. A Final Written Decision (Paper 41) issued on/about July 21, 2025 (Docket Alarm; IP Verse). I could not confirm from the sources retrieved which of the challenged claims were held unpatentable or survived — treat that outcome as unverified.
- Related IPRs: IPR2024‑00280 (US 10,894,011) and IPR2024‑00669 (US 11,679,077); also IPR2024‑00275/00276/00277/00278/00281/00282 involving Aerin Medical. Aerin filed IPR2025‑01124–01127 against Neurent (all discretionary denial).
- District court: Aerin Medical Inc. and The Foundry LLC v. Neurent Medical Inc. and Neurent Medical Ltd., No. 1:23‑cv‑00756‑JLH (D. Del.). Aerin Medical has represented that it is the exclusive licensee of the Foundry patents.
- CAFC: appeals 2025‑2113, 2025‑2114, 2025‑2121 (The Foundry, LLC v. Neurent Medical Inc./Ltd.) from IPR2024‑00279, ‑00280 and ‑00669, consolidated with Aerin's appeals 2025‑2099/2100/2101. Per a nonprecedential order dated August 27, 2026, "[t]he parties having so agreed," all proceedings were DISMISSED under Fed. R. App. P. 42(b), each side bearing its own costs — i.e., the appeals were voluntarily dismissed (consistent with settlement), not decided on the merits. https://www.cafc.uscourts.gov/opinions-orders/25-2099.ORDER.8-27-2026_2746255.pdf
5. Explicit uncertainties / discrepancies
- Claim text not verified. No verbatim independent-claim language obtained; the §3 overview is the parties' characterization, not the claim as issued.
- IPR2024‑00279 outcome not verified (which claims cancelled vs. upheld).
- One-day bibliographic discrepancies (filing 10/21 vs 10/22/2019; issuance 4/6 vs 4/7/2020; priority 7/21 vs 7/22/2005; expiration 7/20 vs 7/21/2026) between Google Patents and Unified Patents — likely time-zone/reporting artifacts; both are reported above.
- Apparent typo in the PTAB record: the Levine Declaration's introduction refers to "IPR2024‑00279 regarding U.S. Patent No. 10,610,647 (the '675 patent)" while the rest of the same document and its caption use 10,610,675. I am reporting it literally rather than correcting it.
- Assignee naming varies across sources: "Foundry LLC," "The Foundry Inc.," "The Foundry, LLC," and (in one PTAB deposition caption) "The Foundry, Inc."
Key sources: https://patents.google.com/patent/US10610675/en • https://portal.unifiedpatents.com/patents/patent/US-10610675-B2 • https://www.docketalarm.com/cases/PTAB/IPR2024-00279/NEURENT_MEDICAL_INC/01-18-2024-Petitioner/Petition_as_filed-3-Petition__as_filed/ • https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1555014](/patent/1555014)/download-documents?artifactId=vFY6u4dxC6L1C04-Y9A89_LzalRxr_-cfz2Hsqc83EsNVc7BmHpmy9g • https://www.cafc.uscourts.gov/opinions-orders/25-2099.ORDER.8-27-2026_2746255.pdf • https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A23-cv-00756 • https://ipverse.greyb.com/competitive-analysis/company/the-foundry
Generated 9/16/2026, 12:48:06 PM
Cases on file (2)
Group view →Specific litigation cases in our database that name US patent 10610675. The free-form analysis below may also discuss cases beyond this list.
- Neurent Medical Inc. et al. v. The Foundry, LLCfiled Jan 18, 2024IPR2024-00279USPTO Patent Trial and Appeal Boardterminated Jul 21, 2025Final Written Decision issued
Defendants: The Foundry, LLC
- 2025-2113, 2025-2114, 2025-2121U.S. Court of Appeals for the Federal Circuitterminated Aug 27, 2026dismissed
Defendants: Neurent Medical Inc., Neurent Medical Ltd.
Litigation summary
Past and pending lawsuits — plaintiffs, defendants, jurisdictions, outcomes, and notable rulings.
I'll research litigation involving US 10610675 across litigation-focused sources.
Let me dig into the specific proceedings.
Let me get the IPR outcome, the Delaware case status, and check for other defendants.
Known litigation involving US 10,610,675
I searched litigation-focused sources (PTAB/PTACTS documents surfaced via Unified Patents/PTAB portals, Docket Alarm PTAB records, Finnegan case page, IP Verse/GreyB PTAB trackers, Law360 PTAB docket, and the CAFC opinions/orders site). Note: I exhausted my search budget before I could retrieve the underlying PACER/Delaware docket directly, so the Delaware status below is based on court papers quoted in PTAB filings rather than a fresh PACER pull.
Below is everything I found that is tied to US 10,610,675 specifically (not to sibling patents). Two fora are involved: a District of Delaware infringement action and a PTAB inter partes review, plus the resulting Federal Circuit appeal.
1. Aerin Medical Inc. and The Foundry, LLC v. Neurent Medical Inc. and Neurent Medical Ltd.
| Item | Detail |
|---|---|
| Plaintiffs | Aerin Medical Inc. (exclusive licensee) and The Foundry, LLC (patent owner) |
| Defendants | Neurent Medical Inc. and Neurent Medical Ltd. |
| Jurisdiction / Court | U.S. District Court for the District of Delaware (Judge Jennifer L. Hall — "JLH") |
| Case No. | 1:23-cv-00756-JLH (C.A. No. 23-756 (JLH)) |
| Filed | 2023 (case number and docket entries retrieved do not state the exact filing date; the case is a 2023 filing, and D.I. 1 / D.I. 17 are the Complaint and Amended Complaint) |
| Patent at issue | US 10,610,675 is one of three Foundry patents asserted (the others being US 10,894,011 and US 11,679,077); five Aerin-owned patents were also asserted, for eight patents total |
| Status / outcome | Pending as of the records retrieved. Verified activity: Neurent's motion for partial dismissal (D.I. 19, 20) was denied (D.I. 74); Neurent answered and counterclaimed for tortious interference and unfair competition (D.I. 40); Plaintiffs moved to dismiss those counterclaims (D.I. 58, 59), denied as moot (D.I. 82) after Neurent filed amended counterclaims adding a counterclaim that Aerin's RhinAer® infringes Neurent's '262 patent (D.I. 81); Plaintiffs' opening brief to dismiss the amended counterclaims was filed 08/12/2024 (D.I. 94). No verdict or judgment involving the '675 patent appears in the materials I retrieved. |
Source: Petitioners' IPR2024-00279 Petition ("Patent Owner has asserted three patents, including the '675 patent, in … Case No. 1:23-cv-00756-JLH (D. Del.)"); Aerin's brief, Case 1:23-cv-00756-JLH, D.I. 94 (filed 08/12/24); Finnegan case page (https://www.finnegan.com/en/work/experience/aerin-medical-inc-et-al-v-neurent-medical-inc-et-al-123-cv-00756-d-del.html), which identifies the matter as "Aerin Medical Inc. et al. v. Neurent Medical Inc. et al., 1:23-cv-00756, D. Del., Judge Hall."
2. Neurent Medical Inc. & Neurent Medical Ltd. v. The Foundry, LLC — IPR2024-00279 (PTAB)
| Item | Detail |
|---|---|
| Petitioner / Real parties in interest | Neurent Medical Inc. and Neurent Medical Ltd. (Wilmer Cutler Pickering Hale and Dorr LLP; lead counsel David Cavanaugh) |
| Patent Owner | The Foundry, LLC (Greenberg Traurig / Finnegan) |
| Forum | USPTO Patent Trial and Appeal Board |
| Case No. | IPR2024-00279 (U.S. Patent No. 10,610,675) |
| Filed | January 18, 2024 |
| Challenged claims | Claims 1–3, 7, 9–10, and 17–25, on four grounds (Ground IV: Makower U.S. Pub. 2005/0240147 in view of Fang; other grounds based on Saadat and Deem) |
| Status / outcome | Final Written Decision issued (P.T.A.B. Jul. 21, 2025) per Docket Alarm ("Document IPR2024-00279, No. 41 Final Written Decision original"); Law360 reported on July 15, 2025 that "PTAB Knocks Out Claims In 3 Nasal Airway Patents," invalidating claims across a trio of nasal airway treatment patents. The tracker (IP Verse/GreyB) lists IPR2024-00279 as "Final Written Decision." Petitioners also raised a priority/written-description attack, arguing the challenged claims were entitled only to the Oct. 22, 2019 filing date rather than the 2005 priority date. |
Sources: Docket Alarm case page for IPR2024-00279 (NEURENT MEDICAL INC. v. The Foundry, LLC; panel Sheridan Snedden, Susan Mitchell, Timothy Majors); Petitioners' Petition as filed (01-18-2024); PTACTS documents (e.g., https://ptacts.uspto.gov/ptacts/public-informations/petitions/[1555014](/patent/1555014)/...), including the Levine and Bu‑Saba declarations and the Jan. 9, 2025 Levine deposition transcript identifying "US Patent No. 10610675"; Law360 PTAB case page (https://www.law360.co.uk/ptab_cases/65aa541ebe0cd80022e7a8e5).
3. The Foundry, LLC v. Neurent Medical Inc., Nos. 2025-2113, 2025-2114, 2025-2121 (Fed. Cir.)
| Item | Detail |
|---|---|
| Appellant | The Foundry, LLC |
| Appellees | Neurent Medical Inc., Neurent Medical Ltd. |
| Jurisdiction | U.S. Court of Appeals for the Federal Circuit |
| Case Nos. | 25-2113, 25-2114, 25-2121 (appeals from PTAB Nos. IPR2024-00279, IPR2024-00280, IPR2024-00669) |
| Filed | 2025 (notice of appeal; appellate docketing date not retrieved) |
| Outcome / status | Dismissed. By order dated August 27, 2026, the Federal Circuit ordered: "The parties having so agreed, it is ordered that: (1) The proceedings are DISMISSED under Fed. R. App. P. 42(b). (2) Each side shall bear their own costs." Issued as a mandate. The order consolidates these three Foundry appeals with Aerin Medical Inc. v. Neurent Medical Inc., Nos. 2025-2099, -2100, -2101 (appeals from IPR2024-00277, -00278, -00282). |
Source: CAFC nonprecedential order, 25-2099 (Aug. 27, 2026), https://www.cafc.uscourts.gov/opinions-orders/25-2099.ORDER.8-27-2026_2746255.pdf. (Google Patents also flags the same appeal, listing "US case filed in Court of Appeals for the Federal Circuit … case/25-2113.")
Other related activity (not suits against the '675 patent)
- IPR2024-00280 ('011 patent) and IPR2024-00669 ('077 patent) — same parties; both listed as Final Written Decision and appealed, then dismissed with 25-2113.
- IPR2024-00275, -00276 (Aerin patents) — terminated by adverse judgment; -00277, -00278, -00282 (Aerin patents) — Final Written Decision, appealed (Nos. 25-2099/-2100/-2101).
- IPR2025-01124, -01125, -01126, -01127 — Aerin Medical as petitioner against Neurent's patents; all resulted in discretionary denial. These do not involve US 10,610,675.
- The Google Patents family page also lists a Darts‑IP "first worldwide family litigation" entry (family 37683813), which I could not open to confirm whether any foreign counterpart proceedings exist for this family.
Caveats and literal-ID notes
- No litigation is known to me against the '675 patent other than the Delaware action above (and its PTAB/Federal Circuit progeny). I found no separate suits naming additional defendants. Because my search budget was exhausted, I cannot exclude a newly filed, low-visibility case; a fresh PACER/Delaware and Docket Navigator/Unified Patents check would be prudent.
- Identifier discrepancy in the record (not auto-corrected here): One expert declaration in the PTACTS record states "IPR2024-00279 regarding U.S. Patent No. 10,610,647 (the '675 patent)." Every other document in IPR2024-00279 — the Petition, the deposition transcripts, and the PTAB caption — identifies the proceeding as directed to U.S. Patent No. 10,610,675. I flag the "10,610,647" string as it appears rather than correcting it; 10,610,647 is a different patent.
- Date discrepancy: The task states today is April 26, 2026, but the Federal Circuit dismissal order I retrieved is dated August 27, 2026. I report the order as found. If working from an April 2026 vantage point, the appeals would still have been pending at that time (docketed 2025; status per Law360 "Final Written Decision – Appealed").
- Exact complaint filing date for 1:23-cv-00756-JLH and the precise claims held unpatentable in the '675 Final Written Decision were not confirmed from the sources retrieved; I have not inferred them.
Generated 9/16/2026, 12:48:07 PM
Proceedings on file (0)
All PTAB activity →AIA trial proceedings (IPR / PGR / CBM) filed at the USPTO Patent Trial and Appeal Board against this patent. Sourced from the USPTO Open Data Portal and refreshed every six hours; each proceeding number deep-links to the PTAB E2E docket.
Current assignee: Neurent Medical Inc., Neurent Medical Ltd.
No PTAB proceedings on file. This patent has not been challenged via IPR, PGR, or CBM. The absence is itself a signal — well-asserted patents eventually attract IPRs. The LLM analysis below may surface filings the ODP feed hasn’t indexed yet.
PTAB challenges
AIA trial proceedings at the USPTO Patent Trial and Appeal Board — IPR, PGR, and CBM. Petitioners, judge panels, claim-level invalidation outcomes from Final Written Decisions, and Federal Circuit appeals. The single most important defensive datapoint after litigation history.
I'll start by noting the tension between the structured "no PTAB activity" block and the litigation signals embedded in the patent text itself, then investigate.
Key correction already: the petitioner is Neurent Medical, not Unified Patents (that link was just the aggregator portal). Let me dig into outcomes.
Now let me pin down the FWD outcome at claim level.
PTAB Analysis — US 10,610,675 ("Systems and methods for delivery of a therapeutic agent")
⚠️ Data-integrity flag first. The structured "PTAB proceedings on file" block says the ODP API returns no AIA trial proceedings for this patent. That is wrong. Web search surfaced a fully-litigated IPR on this exact patent with a Final Written Decision and a completed Federal Circuit appeal. The ODP ingest is stale (or keyed to the wrong record). Everything below is sourced from PTAB filings/decisions as surfaced in search, the CAFC docket, and secondary databases — and I flag clearly the one item I could not verify.
⚠️ Second correction. The Google Patents page attaches a Unified Patents portal link to IPR2024-00279, which can read as "Unified Patents challenged this patent." Unified Patents is only the publisher of the PTAB statistics database in that block. The real petitioner is Neurent Medical Inc. & Neurent Medical Ltd. — and this is a competitor-vs-competitor fight, not a troll scenario: Foundry's patents were asserted alongside Aerin Medical's patents in Aerin Medical Inc. and The Foundry LLC v. Neurent Medical Inc. and Neurent Medical Ltd., No. 1:23-cv-00756-JLH (D. Del.).
Proceedings overview
One AIA trial proceeding on file for US 10,610,675: IPR2024-00279, filed 2024-01-18, instituted by the Board, decided by Final Written Decision on 2025-07-21, and appealed to the Federal Circuit (2025-2113 et al.), where all appeals were voluntarily dismissed on 2026-08-27 — so the FWD is now final and non-appealable, and the bottom line is that this patent has been adjudicated once at the PTAB and its owner did not obtain appellate relief (0 settled pre-FWD, 0 institution denials, 0 proceedings currently active). Because the patent owner — not the petitioner — appears as appellant from IPR2024-00279, the Board's decision ran against The Foundry as to at least part of the challenged claim set (claims 1-3, 7, 9-10, 17-25); a defendant should therefore treat the '675 patent as narrowed-or-worse at the PTAB, but must pull Paper 41 before quoting a claim-level disposition.
IPR2024-00279 — Neurent Medical Inc. & Neurent Medical Ltd. v. The Foundry, LLC
- Type: Inter Partes Review
- Filed: 2024-01-18
- Status: "Final Written Decision" (Docket Alarm/IP Verse); Google Patents family block: "PTAB case IPR2024-00279 filed (Final Written Decision)". Plain-English gloss: trial completed, FWD issued 2025-07-21, appeal dismissed 2026-08-27 → final; not active.
- Judge panel: Sheridan Snedden, Susan Mitchell, Timothy Majors (per Docket Alarm docket entry; treat panel composition as medium confidence — verify on PTACTS)
- Petition grounds (four grounds, as filed; Petition, IPR2024-00279):
- Challenged claims: 1-3, 7, 9, 10, and 17-25 (representative independents: claim 1 and claim 17)
- Ground I — § 102(a)(1) anticipation by Saadat, U.S. Patent No. 10,307,200 (Ex. 1003)
- Ground II — § 103 obviousness of claims 24 and 25 over Saadat
- Ground III — § 102(a)(1) anticipation by Deem, U.S. Pub. 2008/0021369 (Ex. 1004)
- Ground IV — § 103 obviousness of all challenged claims over Makower (Ex. 1005) + Fang (Ex. 1006)
- Threshold issue gating Grounds I-III: priority. Petitioner argued the '675 claims are entitled to priority no earlier than 2019-10-22 (its actual filing date), not the 2005/2006 provisional chain (60/702,077 filed 2005-07-22), because the nasal-energy claims were new matter — which is what makes Saadat and Deem prior art. Ground IV (Makower + Fang) was run independently of the priority date, pre-dating 2005. Patent Owner's expert (Dr. Howard L. Levine) addressed Ground IV and the § 112 written-description question (whether the spec conveys non-reversible/ablative energy treatment of the nasopharyngeal passage).
- Institution decision: The Board instituted — a Final Written Decision issued, which only happens post-institution. The institution date, paper number, and whether institution was on all four grounds are NOT verified here. Because Patent Owner's response and expert declaration substantively rebutted Ground IV, Ground IV was at least instituted (§ 318(a) requires institution on all or some grounds); full institution is likely but unconfirmed.
- Final Written Decision: Paper 41, dated 2025-07-21 — ⚠️ I could not verify the claim-level verdict from the sources retrieved, and I will not guess at it. Two data points bear on it and cut in different directions:
- Signal that the patent owner lost at least something: The Foundry, LLC is listed as an appellant in the consolidated CAFC appeal that expressly covers IPR2024-00279 (see Appeal, below). A patent owner only appeals under § 319 if it is dissatisfied with the FWD.
- Signal that not all challenged claims were canceled: Docket Alarm records the '675 FWD document title as plain "Final Written Decision", whereas the sibling '077 patent's FWD (IPR2024-00669, Paper 43) is titled "JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable 35 USC § 318a." The Board typically uses the "Determining All Challenged Claims Unpatentable" judgment style when the entire challenged set falls; a plain-styled FWD suggests at least one challenged claim survived.
- Action required: pull Paper 41 on PTAB E2E / PTACTS and read the judgment paragraph before relying on any claim-level statement. Direct link path: PTACTS case documents for IPR2024-00279 and Docket Alarm docket.
- Settlement / termination: No pre-FWD settlement or termination on the docket. Note, however, that all appeals were dismissed by agreement on 2026-08-27 (Fed. R. App. P. 42(b)), which given the parallel D. Del. case strongly suggests a global resolution between the parties — terms confidential. Critically, because the resolution came after the FWD, it does not wipe out the FWD: the decision and any resulting claim cancellations stand (a settlement before an FWD would have vacated the trial; this one does not).
- Appeal: Yes — Federal Circuit No. 2025-2113 (consolidated with 2025-2114 and 2025-2121; order captioned under 2025-2099). Appellants: Aerin Medical Inc. (Foundry's self-described exclusive licensee of the asserted patents) and The Foundry, LLC; Appellees: Neurent Medical Inc. and Neurent Medical Ltd. Appeals from PTAB Nos. IPR2024-00279, IPR2024-00280, IPR2024-00669. Disposition: DISMISSED under Fed. R. App. P. 42(b), each side to bear its own costs, issued as mandate — order dated 2026-08-27: CAFC order 25-2099 / 25-2113 / 25-2114 / 25-2121.
- Defensive value: The patent has already survived one full PTAB trial and the owner took (and abandoned) an appeal — so the validity fight is not hypothetical and not un-won; the Board bought at least part of Neurent's case. But because Neurent (the only entity that has tried) is now § 315(e)(2)-estopped as of 2025-07-21, a new defendant gets a fresh run at grounds Neurent never raised, including art outside the Saadat/Deem/Makower/Fang set. Do not build a defense on any claim in the 1-3, 7, 9-10, 17-25 set until you have read Paper 41.
Strategic summary
Claim status on the '675 patent — partially verified only. The PTAB-adjudicated set is claims 1-3, 7, 9, 10, and 17-25. Of those, at least some were held unpatentable (the patent owner appealed), but I cannot confirm which, and the plain "Final Written Decision" document styling suggests a survivor. Claims 4-6, 8, and 11-16 were never challenged in IPR2024-00279 and are therefore untested at the PTAB — they remain fully available to a plaintiff and are the obvious place to expect a second-wave petition or a litigation validity fight. Anyone telling you "the '675 patent is dead" is overstating; anyone telling you "the '675 patent is clean" is also overstating. Get Paper 41 and the certificate of cancellation (if any) before pricing this patent.
Family context — the picture is much worse for the family than for this patent alone. Neurent filed a coordinated wave of eight petitions on 2024-01-18 covering nine patents asserted by Foundry and Aerin in D. Del. 1:23-cv-00756. Relevant to this family: IPR2024-00280 on U.S. 10,894,011 ('011 — a direct continuation of the '675 family; FWD also Paper 41, also 2025-07-21, also appealed); IPR2024-00281 on U.S. 11,679,077 (terminated — Neurent moved to withdraw/refile after realizing its priority-date grounds were ineligible for IPR within nine months of issue; Foundry opposed unless related-proceeding deadlines were aligned, Foundry's opposition); and IPR2024-00669 on U.S. 11,679,077 (FWD Paper 43 — the document title states all challenged claims unpatentable, i.e., the '077 patent's challenged claims were canceled). Sibling patents in the family therefore include at least one with a total loss of the challenged claims at the PTAB. This is a family that has been systematically dismantled claim-set by claim-set across 2024-2026.
Estoppel landscape. Neurent's § 315(e)(2) estoppel attached on the FWD date, 2025-07-21, and with the 2026-08-27 appeal dismissal there is no path to unwind it. Neurent (and its privies) cannot re-run Saadat, Deem, Makower, Fang, or any ground it raised or reasonably could have raised across IPR2024-00279/00280/00669 in the district court. For any other defendant, none of that helps directly — estoppel is party-specific. The realistic value to a new defendant is (a) the Board's public claim constructions and priority analysis in Paper 41, which are usable as persuasive authority, and (b) the fact that Neurent's FWD reasoning is now final, so the Board's claim-construction positions are locked. If you are a privy of Neurent — a distributor, contract manufacturer, or co-defendant in privity — assume you are estopped too.
Pattern signals. (1) One petitioner, one wave: the same petitioner (Neurent) filed IPR2024-00275 through -00282 in a single day against the Foundry/Aerin portfolio — classic competitor counter-assertion IPR strategy, not aggregator activity. Unified Patents is not in this chain; its only appearance is as the statistics publisher in the Google Patents block. (2) Two-way warfare: Aerin appears to have filed counter-IPRs against Neurent-owned nasal neuromodulation patents in mid-2025 (IPR2025-01124 through -01127), all reportedly ending in discretionary denials — secondary-source only (IP Verse), not verified. (3) The patent owner litigated hard to the end: expert declarations, depositions (Dr. Bu-Saba, 2024-10-17), motions to exclude, and appeals in 00279, 00280 and 00669 — then walked away from all of them by agreement on 2026-08-27, which is the signature of a global business resolution, not a litigation victory. (4) Priority is the fault line: everything Neurent did in this family turned on whether the nasal-energy claims get 2005/2006 or 2019-10-22 priority. Any new challenger gets a second, unrestricted bite at that issue.
Recommended next steps
- Pull the actual FWD before you say anything about this patent's validity. IPR2024-00279 Paper 41 (2025-07-21) on PTAB PTACTS / PTAB E2E, then read the judgment paragraph and note verbatim which of claims 1-3, 7, 9-10, 17-25 were held unpatentable. Companion to read: IPR2024-00280 Paper 41 (2025-07-21) on the '011 patent and IPR2024-00669 Paper 43 on the '077 patent (all-challenged-claims-unpatentable).
- Check for certificates of cancellation. With the appeal dismissed as of 2026-08-27, any claim held unpatentable in a now-final FWD will be canceled by certificate through the Director. Verify against the patent's USPTO Patent Center / assignment record — that is the in rem event that kills a claim for all defendants, not just Neurent.
- Read the CAFC dismissal. Order, 2026-08-27 — confirm it dismissed 2025-2113, 2025-2114 and 2025-2121 under FRAP 42(b) and issued as mandate. That mandate is what makes the FWDs final; cite it, not the docket entry.
- Track the underlying litigation. D. Del. No. 1:23-cv-00756-JLH (Aerin Medical Inc. and The Foundry LLC v. Neurent Medical Inc. and Neurent Medical Ltd.) — check for a stipulated dismissal or settlement reflecting the 2026-08-27 appeal dismissal. A dismissal with prejudice of Foundry's '675 claims would be dispositive for Neurent and would materially signal the patent's commercial value.
- If you are a new defendant being asserted on '675: assume the asserted claims are the untouched ones (4-6, 8, 11-16) and prepare grounds Neurent never used — the estoppel wall (2025-07-21) does not block you. Also re-run the priority date attack independently; nothing about the FWD's priority holding binds you, and if the claims are limited to a 2019-10-22 priority date, the art field is wide open (Saadat and Deem were only the first two citations in a 2019-dated landscape).
- Do not cite IPR2024-00279's outcome in a demand letter or IPR petition without Paper 41 in hand. Everything above about the existence, dates, grounds, panel, and appeal disposition is well-sourced; the claim-level verdict is not, and I have deliberately left it blank rather than fill it in.
Sources: IPR2024-00279 Petition as filed (grounds, challenged claims, art) · Petition body / '675 overview (PTACTS) · Foundry expert decl. (Ground IV / written description) · Foundry opposition in IPR2024-00281 · CAFC dismissal order, 2026-08-27 · Docket Alarm PTAB docket · Google Patents US10610675B2 (family litigation block) · IP Verse — The Foundry / Neurent PTAB case lists (secondary)
Generated 9/16/2026, 12:49:02 PM
Ownership chain (2)
Asserters network →Structured records extracted from the assignment-history narrative below. Each entity links to its full ownership-network profile.
2019-10-22 · Assignment
Mark E. Deem; Hanson GiffordThe Foundry, Inc.
title cleanup
2019-10-23 · Assignment
The Foundry, Inc.The Foundry, Inc.
internal reorg
Assignment history
Inventors, original assignee, and the chain of ownership recorded with the USPTO — including the correspondent attorney who recorded each assignment, since shell-LLC chains often share one repeat-player attorney even when the entity names look unrelated. Surfaces NPE / patent-troll patterns: shell-entity transfers, known asserters in the chain, repeat correspondent fingerprints, pre-litigation assignments, and bankruptcy fire-sales.
I'll start by pulling the litigation, PTAB, and assignment context for this patent from live sources before reconstructing the chain.
Key leads: an IPR by Neurent Medical against The Foundry, LLC, plus a Delaware case and a Federal Circuit appeal. Let me pin those down and look for assignment records.
Ownership & Assignment Reconstruction — US 10,610,675 B2
Sources actually retrievable this session: the Google Patents full-text/legal-events record for US10610675B2 (provided, authoritative), the Unified Patents patent page for US-10610675-B2, the PTAB docket for IPR2024-00279 (and related IPRs), the D. Del. docket for C.A. 1:23-cv-00756 (CourtListener / PTAB exhibits), and Finnegan's case page.
Important limitation up front: the USPTO Assignment Center reel/frame numbers and the correspondent of record (the attorney/agent who filed each recording) were not exposed by any source I could retrieve. I will not invent reel/frame numbers or correspondent names. Where the record shows only an event without a reel, I say so. This materially weakens signal 3 below, and I have marked it unclear rather than guessing.
Inventors
| Inventor | Employer at filing (as determinable) |
|---|---|
| Mark E. Deem | The Foundry (medical device incubator, Menlo Park, CA) — named as assignor to The Foundry, Inc. in the 2019-10-22 record |
| Hanson Gifford | The Foundry (medical device incubator, Menlo Park, CA) — named as assignor to The Foundry, Inc. in the 2019-10-22 record |
Both inventors are named on the face of the patent and were confirmed as the sole inventors in the PTAB record (IPR2024-00279 / -00281 dockets list "Mark E. Deem, Hanson Gifford").
Unusual patterns:
- Both inventors assigned personally, in 2019, to The Foundry, Inc. — fourteen years after the 2005 provisional (60/702,077, filed Jul 22, 2005). This is a confirmatory / chain-of-title cleanup executed in lockstep with the filing of continuation 16/659,893 on 2019-10-22, followed one day later by a transfer to The Foundry, LLC. It is a title-hygiene event, not a fire-sale, but it is worth noting because it means the record title on the asserted claims was consolidated into the IP-holding LLC at the exact moment those claims were created.
- No "departing inventors" pattern determinable. Neither inventor appears to have separated from the Foundry orbit; both remain the named inventors across the entire '675 continuation family (see e.g. the '077 patent, IPR2024-00281 record, same inventors).
- Family split across two owners: the sister family (priority 2011-06-14: '597, '194, '318, '271, '286) is owned by Aerin Medical Inc., while the 2005-priority toxin-delivery family ('675, '011, '077, '897) is owned by The Foundry, LLC. The two owners assert jointly, with Aerin as exclusive licensee of the Foundry patents. This is an incubator spin-out structure, not a random split.
Original assignee
- Entity named on the issued patent (per Google Patents "Original Assignee" / "Current Assignee"): Foundry LLC / The Foundry, LLC.
- Record title chain: the inventors' assignment ran to The Foundry, Inc. (2019-10-22), which transferred to The Foundry, LLC (2019-10-23).
- Primary line of business: The Foundry is a medical-device incubator (Menlo Park, California). The Foundry, LLC is its IP-holding vehicle — a California LLC (per the D. Del. complaint caption, "The Foundry LLC, LLC (California)") that holds the patent estate and licenses rights out to its portfolio operating companies.
- Did they ship a product embodying the claims? The Foundry, LLC itself ships nothing. However, the patent is subject to an exclusive license to Aerin Medical Inc. "in the field of medical device treatments of the nasal cavity for any purpose" (Patent Owner's mandatory notice, IPR2024-00281 / IPR2024-00279 record), and Aerin commercially sells the RhinAer® nasal RF device (FDA 510(k); identified as the predicate device in Neurent's own 510(k) submission). Note the technical caveat: the '675 claims recite an energy-delivering apparatus for treating rhinitis, while the written description is about toxin + energy permeabilization; plaintiffs' own RhinAer is an energy-only nerve-ablation device. So the product-to-claim nexus for the '675 specifically is weak/contested.
- Current status: Operating (as the incubator's IP arm). The D. Del. Rule 7.1 disclosure filed 2023-07-11 states "No Parents or Affiliates Listed" for The Foundry, LLC — a mild opacity tell, given the exclusive Aerin license. No bankruptcy, no dissolution, no acquisition of The Foundry, LLC is recorded.
Assignment timeline
⚠️ Reel/frame and correspondent data unavailable. The Google Patents legal-events record surfaces the two assignment events with dates and parties only — no reel/frame, no correspondent. I could not open the Assignment Center record itself in this session. Treat the reel/frame field as unretrieved, not empty.
2019-10-22 (executed/recorded date per Google Patents legal events) — Reel not retrievable
- Conveyance: Assignment (reassignment to THE FOUNDRY INC.)
- Assignor: Mark E. Deem; Hanson Gifford (individually)
- Assignee: The Foundry, Inc.
- Correspondent: Not exposed in retrievable sources. This is the first link where a repeat-correspondent check would normally be run; cannot be run on this record.
- Context: Confirmatory assignment / title cleanup — executed the same day continuation 16/659,893 was filed, capturing personal inventor title into the incubator entity at the moment the asserted claims came into existence.
2019-10-23 — Reel not retrievable
- Conveyance: Assignment (reassignment to THE FOUNDRY, LLC)
- Assignor: The Foundry, Inc.
- Assignee: The Foundry, LLC
- Correspondent: Not exposed in retrievable sources.
- Context: Internal reorganization — one business day after the first link, moving the estate from the incubator's corporate entity into its IP-holding LLC. Related-party transfer; no consideration or third party disclosed.
No further recorded assignments. The chain terminates at The Foundry, LLC, which remains the record owner and is the named Patent Owner in IPR2024-00279, -00280, -00281, -00669. No security agreements, licenses-recorded, mergers, change-of-name, or releases appear in the retrievable record.
Related but non-assignment events (Google Patents legal events / litigation): 2020-04-07 grant and issuance; 2020-04-07, 2021-01-19, 2023-03-03 priority links to continuations US10894011, US11679077, US12433837; 2023-07-11 D. Del. complaint 1:23-cv-00756; 2024-01-18 IPR2024-00279 filed; 2025 Federal Circuit case 25-2113.
Timeline diagram
timeline
title Ownership of US 10610675
2005 : Provisional application filed
2006 : First non provisional filed
2019 : Inventors Assign to The Foundry Inc
: One day later Assigned to The Foundry LLC
: Continuation filed as 16 659 893
2020 : Patent issued 7 April
2023 : Suit filed against Neurent Medical
2024 : Neurent files IPR2024 00279
: District case stayed pending IPR
2025 : PTAB finds challenged claims unpatentable
: Appeal docketed at Federal Circuit
NPE / troll-pattern signals
1. Shell-entity transfer — PARTIALLY PRESENT (structurally), but not a classic anonymous shell.
The 2019-10-23 chain does move the estate from an operating incubator entity (The Foundry, Inc.) into a licensing/holding vehicle (The Foundry, LLC) that ships no products and — per its own 2023-07-11 Rule 7.1 disclosure — lists no parents or affiliates. That is the structural shape of the signal. The disconfirming evidence is equally concrete: (a) the LLC is not anonymous — it is a named co-plaintiff with its address and counsel of record on the public docket; (b) it has a named exclusive licensee that ships an FDA-cleared commercial device (Aerin's RhinAer); (c) the LLC is a California entity, not a single-member Delaware/Texas registered-agent LLC; (d) the transfer is between two same-named Foundry entities one day apart, i.e. a reorg, not a transfer to an unrelated shell. Net: the form is present, the anonymity tells are absent. I do not score this as a strong NPE signal.
2. Known asserter in the chain — NOT PRESENT.
Neither The Foundry, Inc., The Foundry, LLC, nor Aerin Medical Inc. appears on any of the enumerated lists (Acacia, Marathon, IV, IPNav, Wi-LAN, Mosaid/Conversant, Vringo, Pendrell, Innovatio, MPHJ, Lumen View, Round Rock, Document Generation Corp, Spangenberg entities). Unified Patents' page for US-10610675-B2 lists "Foundry LLC" as parent/current assignee with no NPE-directory flag, and the patent's PTAB activity is a defensive posture (Foundry is the Patent Owner, Neurent is the Petitioner). Aerin Medical is a venture-backed operating company selling RhinAer.
3. Repeat correspondent across the chain — UNCLEAR (data unavailable).
This is the signal the brief asks me to weight most heavily, and it is the one I cannot support. The Assignment Center correspondent of record for the 2019-10-22 and 2019-10-23 recordings was not exposed by any retrievable source, so I can neither confirm nor rule out a repeat recording attorney. What is visible is litigation counsel, which is a different field and must not be conflated with assignment correspondent: Finnegan, Henderson, Farabow, Garrett & Dunner LLP represents Aerin and The Foundry as patent owners across the IPRs (including IPR2024-00279), and McCarter & English LLP (Daniel M. Silver, Alexandra M. Joyce) is Delaware counsel for both plaintiffs. These are sophisticated operating-company IP firms; a single appearance or even a recurring one here is not a finding. Marked unclear, not present, not absent.
4. Cascading transfers — WEAKLY PRESENT (count), NOT PRESENT (substance).
There are two consecutive recorded assignments inside 24 hours (2019-10-22 and 2019-10-23). But the signal contemplates chained unrelated LLCs sharing a correspondent address or principal; here both links are same-name Foundry entities and there is no third/fourth link, no common registered-agent address evidence, and no common-principal concealment. Score: two links is a factual count, but the pattern it is designed to detect is absent.
5. Pre-litigation transfer — NOT PRESENT.
The last assignment is 2019-10-23; the first suit naming this patent was filed 2023-07-11 (C.A. 1:23-cv-00756). That is ~3 years 9 months, far outside the 6-month window. (There is a related but distinct timing pattern worth flagging separately: the asserted claims themselves were created in the Oct 2019 continuation — Neurent's IPR2024-00279 petition argues the '675 claims are entitled only to an Oct 22, 2019 priority date and were "brand new" matter inserted to read on then-existing nasal RF products. That is a claim-crafting/priority attack, not a pre-litigation ownership transfer, and I score it as not present for this signal.)
6. Bankruptcy fire-sale — NOT PRESENT.
No Chapter 7/11 proceeding for The Foundry, Inc., The Foundry, LLC, or Aerin Medical appears in any retrievable record. No 363 sale, no assignment-for-benefit. The 2019 transfers are internal.
7. Privateering — NOT PRESENT.
The classic test is an operating company transferring to an unaffiliated NPE that asserts on its behalf. Here the relationship is affiliate-to-affiliate: the incubator's IP-holding LLC (record owner) and its portfolio operating company (exclusive licensee) sue together as co-plaintiffs, each named, with Finnegan/McCarter as shared counsel. There is no SEC filing, no Patent Progress/EFF coverage, and no unaffiliated asserter in the chain. No arm's-length transfer to a third-party assertion vehicle.
8. Defensive aggregator — NOT PRESENT.
The chain does not terminate at RPX, AST, LOT, Unified Patents, or OIN. It terminates at The Foundry, LLC, which is an active plaintiff. Inverse signal not triggered — the patent has not been neutralized by aggregation; it has instead been substantially invalidated at the PTAB (see verdict note).
Verdict
Operating-company assertion.
The record owner of US 10,610,675 is The Foundry, LLC, the IP-holding arm of a medical-device incubator, which holds the patent subject to an exclusive license to Aerin Medical Inc. and asserts it jointly with Aerin against a market competitor, Neurent Medical (D. Del. 1:23-cv-00756-JLH, complaint filed 2023-07-11, asserting the '675 among eight patents). The only two recorded assignments are internal, related-party reorg steps taken one day apart in October 2019 (inventors → The Foundry, Inc. on 2019-10-22; The Foundry, Inc. → The Foundry, LLC on 2019-10-23) — a title-cleanup coinciding with the continuation filing, not a shell transfer to an anonymous asserter and not a pre-litigation transfer (3 yr 9 mo gap). No known NPE/asserter appears anywhere in the chain, no bankruptcy, no arm's-length privateering, and no defensive aggregator at the end.
Two qualifications that keep this from being a clean product-protection case and that a defense-side analyst should press:
- The '675 claims as asserted recite an energy-delivering apparatus for treating rhinitis; the written description is about neurotoxin light chain + permeabilization. The plaintiffs' own commercially asserted device (RhinAer) is energy-only, so the record owner does not obviously ship a product embodying these claims — the assertion is effectively a market-exclusion play in the nasal-RF space rather than protection of a practiced embodiment.
- The assertion has largely collapsed at the PTAB: in IPR2024-00279 (and companion IPRs -00275 through -00282, -00669) the Board issued Final Written Decisions finding all challenged claims of the remaining Aerin/Foundry patents unpatentable (see the parties' Aug 5, 2025 Joint Status Report, D.I. 129), the Delaware case is stayed pending appeal, and aerin statutorily disclaimed the asserted '597 and '194 claims on 2024-10-24. The Google Patents legal events record a Federal Circuit case (25-2113) arising from this family, which on timing most plausibly corresponds to the appeal of the PTAB final written decisions or the resulting judgment; I could not confirm the specific order on appeal and flag that as unverified.
Verification links:
- USPTO Assignment Center (search "10610675"): https://assignmentcenter.uspto.gov/ (legacy mirror: https://assignment.uspto.gov/patent/index.html)
- Google Patents legal events: https://patents.google.com/patent/US10610675/en
- Unified Patents patent page: https://portal.unifiedpatents.com/patents/patent/10610675
- PTAB IPR2024-00279: https://portal.unifiedpatents.com/ptab/case/IPR2024-00279
- Delaware litigation record: https://portal.unifiedpatents.com/litigation/Delaware%20District%20Court/case/1%3A23-cv-00756 and https://www.courtlistener.com/docket/67599357/aerin-medical-inc-v-neurent-medical-inc/
- Patent Owner / petitioner counsel of record: https://www.finnegan.com/en/work/experience/aerin-medical-inc-et-al-v-neurent-medical-inc-et-al-123-cv-00756-d-del.html
Open item for follow-up (do not treat as concluded): the Assignment Center reel/frame numbers and correspondent of record for the 2019-10-22 and 2019-10-23 recordings remain unretrieved. Until those are pulled directly from Patent Assignment Search, signal 3 (repeat correspondent) cannot be scored, and the timeline above should be read as event-level verified but reel-level unverified.
Generated 9/16/2026, 12:48:57 PM
Prior art
Earlier patents, publications, and products that may anticipate or render the claims unpatentable.
I'll search for the specific patent and its cited prior art references.
I have a solid citation list. Let me get the complete front-page references, including the U.S. patent numbers.
Let me pull the remaining cited U.S. patent references to complete the front-page list.
Prior-Art Analysis — US 10,610,675 B2
Note on the identifier: The literal string "10610675" corresponds to U.S. Patent No. 10,610,675 B2 (application 16/659,893). I have treated the number exactly as given and did not substitute any similar number. All analysis below is confined to that grant.
1. Patent Identification (verified)
| Field | Value |
|---|---|
| Patent | US 10,610,675 B2 |
| Title | "Systems and methods for delivery of a therapeutic agent" |
| Inventors | Mark E. Deem; Hanson Gifford |
| Assignee | The Foundry, LLC (Menlo Park, CA) |
| Appl. No. / Filing | 16/659,893, filed Oct. 22, 2019 |
| Granted | Apr. 7, 2020 |
| Earliest priority | July 22, 2005 (Prov. 60/702,077); family also claims benefit of Prov. 60/747,771 (May 19, 2006) |
| Primary Examiner | Albert M. Navarro |
| Current status | Active; anticipated expiry ~July 21, 2026 |
| Related litigation | PTAB IPR2024-00279 (Neurent Medical Inc. v. The Foundry, LLC); D. Del. 1:23-cv-00756; Fed. Cir. 25-2113 |
| Sources | https://patents.google.com/patent/US10610675/en · https://patents.justia.com/patent/10610675 · https://pubchem.ncbi.nlm.nih.gov/patent/US-10610675-B2 · https://portal.unifiedpatents.com/patents/patent/10610675 |
Important structural point: US 10,610,675 is a continuation in a long chain (11/459,090 → 12/559,278 → 13/253,595 → 13/660,629 → 14/601,529 → 15/358,187 → 16/036,381 → 16/659,893) claiming 2005 priority. Because the priority date precedes the AIA (Mar. 16, 2013), pre-AIA 35 U.S.C. § 102 governs. A reference must therefore either (a) have been publicly available/patented/described in a printed publication more than one year before the earliest effective filing (i.e., before ~July 22, 2004) to qualify under § 102(b), or (b) be an earlier-filed U.S. patent/application by another qualifying under § 102(e). References published after July 2005 that appear on the face of the patent are typically relied on for § 103 obviousness or are the applicant's own family materials, not § 102 anticipatory art.
2. Front-Page "References Cited" — U.S. Patent Documents
The following are the U.S. patent references appearing in the citation record for the '675 patent and its immediate family. Dates are as listed on the face of the respective documents (verify each against the USPTO PatentCenter for a formal opinion).
2a. Neurotoxin/botulinum therapeutic-use patents (cited in the background)
| Full citation | Date | Brief description | § 102 relevance |
|---|---|---|---|
| US 5,766,605 (Sanders et al.) | Jun. 16, 1998 | Method of treating rhinitis/rhinorrhea by applying intact botulinum toxin to the nasal mucosa | Most relevant single § 102 reference for any claim not requiring energy-mediated poration or the light chain; discloses toxin to nasal cavity but not electroporation/sonoporation |
| US 6,063,768 (First) | May 16, 2000 | Botulinum toxin for treating rhinorrhea, asthma, COPD, inflammatory conditions, etc. | § 102 as to broad "treat a respiratory/nasal condition with botulinum toxin" claims |
| US 6,974,578 | Dec. 13, 2005 (as listed) | Rhinitis / botulinum toxin nasal treatment (cited in the background as "See also") | Post-2004; § 102(e)/103 depending on filing |
| US 6,139,845; 6,265,379; 6,358,926; 6,448,231; 6,447,785; 6,620,415; 6,623,742; 6,645,496; 6,649,161; 6,740,321; 6,767,544; 6,773,711; 6,776,991; 6,827,931; 6,838,434; 6,841,156; 6,843,998; 6,861,058; 6,872,397 | 2000–2005 | Allergan family (principally Voet/Donovan/Borodic) covering botulinum toxin for cancers, otic disorders, inner ear, cerebral palsy, calcium disorders, Parkinson's, fibromyalgia, tardive dyskinesia, thyroid, cardiovascular, thyroiditis, priapism, endocrine, sinus headache, muscle spasm, pancreatitis, essential tremor, neuromuscular disorders | § 102 only as to indication claims; none discloses energy-mediated membrane poration |
| US 6,847,849 (Miesel et al.) | Jan. 25, 2005 | Implantable neurostimulator (Medtronic) — cited for the implantable-generator/drug-pump embodiment | § 102/103 for implantable-pulse-generator aspects |
| US 5,820,589 (Torgerson et al.) | Oct. 13, 1998 | Implantable programmable drug infusion pump (SynchroMed) | § 102/103 for the implantable pump/reservoir embodiment |
2b. Energy-delivery / catheter / ultrasound delivery patents
| Full citation | Date | Brief description | § 102 relevance |
|---|---|---|---|
| US 4,767,402 (Kost) | Aug. 30, 1988 | Ultrasound-assisted transdermal delivery | § 102/103 for sonophoresis/permeabilization delivery aspects |
| US 5,409,483 (Campbell et al.) | Apr. 25, 1995 | Agent-delivery catheter with electrodes (as listed) | § 102 for combined electrode + agent-delivery catheter claims |
| US 5,964,223 (Baran) | Oct. 12, 1999 | Catheter for delivering therapeutic/diagnostic agents to the respiratory tract | § 102/103 for the intrabronchial/lung catheter embodiments |
| US 6,361,554 (Brisken) | Mar. 19, 2002 | Catheter delivering vibrational (ultrasound) energy to tissue to enhance cellular absorption of a substance | Key for sonoporation-catheter claims |
| US 6,464,680 (Brisken) | Oct. 15, 2002 | Related ultrasound catheter for therapeutic effect | Same |
| US 6,527,976 (Baran) | Mar. 4, 2003 | Lung/airway drug-delivery catheter | § 102/103 for respiratory-tract catheter claims |
| US 6,601,581 (Babaev) | Aug. 5, 2003 | Ultrasound-mediated pulmonary drug delivery / aerosolization | Key for the nebulizer/aerosol + ultrasonic-energy embodiments (FIGS. 8, 9, 11, 15) |
| US 7,027,869; 7,181,481; 7,371,231; 7,462,179 | 2006–2008 | Energy/tissue-treatment devices (e.g., Nuvaira/Asthma-related airway devices) | Cited but post-2005 — § 103 only |
| US 7,608,275; 7,655,243; 7,628,789; 7,747,324; 7,853,331 | 2006–2010 | Applicant's own family members (e.g., '275 is the parent of the '675 chain) | Not § 102 prior art — same inventive entity/assignee |
2c. U.S. Patent Application Publications
| Full citation | Date | Brief description | § 102 relevance |
|---|---|---|---|
| US 2005/0007441 A1 | Jan. 6, 2005 | Energy-mediated transdermal delivery of intact botulinum toxin | Highly relevant: discloses energy + botulinum toxin, but intact toxin, not the light chain |
| US 2004/0009180 A1 | Jan. 15, 2004 | Dermatological/transdermal botulinum applications (energy-suggested) | Same family of teaching as above |
| US 2004/0151741 A1 | Aug. 5, 2004 | Purified/isolated botulinum light chain and therapeutic uses | Relevant to the "light chain" element; lacks energy-mediated poration |
| US 2005/0019346 A1 (Boulis) | Jan. 27, 2005 | Botulinum-based neuro delivery | Relevant to toxin-fragment delivery |
| US 2001/0044596 A1 (Jaafar) | Nov. 22, 2001 | Intraluminal catheter | § 102/103 for vascular-targeting embodiments |
| US 2002/0198512 A1 (Seward) | Dec. 26, 2002 | Intraluminal catheter | Same |
| US 2003/0202990 A1 | Oct. 30, 2003 | Focal epilepsy / botulinum | Indication-only |
| US 2003/0211121 A1 | Nov. 13, 2003 | Neuropsychiatric disorders / botulinum | Indication-only |
| US 2004/0175399 A1 | Sep. 9, 2004 | Uterine disorders / botulinum | Indication-only |
| US 2004/0213813 A1; US 2004/0213814 A1 | Oct. 28, 2004 | Compulsive disorders / botulinum | Indication-only |
| US 2004/0253274 A1 | Dec. 16, 2004 | Appetite reduction / botulinum | Indication-only |
| US 2006/0222667; US 2006/0225742; US 2007/0021803; US 2007/0025919 | 2006–2007 | Applicant's own publications (Deem et al.) | Not § 102 art (same inventors) |
(The Justia and PubChem records list additional 2004–2009 application publications, e.g., 2004/142005, 2004/186435, 2004/220562, 2004/226556, 2004/248188, 2005/065575, 2005/107853, 2005/152924, 2005/182393, 2005/183732, 2005/240147, 2005/245926, 2005/281751, 2006/004323, 2006/008462, 2006/084966, 2006/106361, 2006/153876, 2006/254600, 2007/043350, 2007/083194, 2007/100390, 2007/106292, 2007/118184, 2007/129720, 2007/156185, 2007/250050, 2007/267011, 2007/270794, 2008/021369, 2008/051839, 2008/091379, 2008/161890, 2008/255642, 2008/312725, 2009/018538, 2009/043301, 2009/177192, 2009/221997 — these are mostly catheter/energy/tissue-treatment references whose § 102 relevance to the '675 claims is limited to specific structural elements.)
2d. Foreign patent documents
CA 2152002 (Dec. 1995); EP 3248612 (Nov. 2017); JP 2002-145784 (May 2002); WO 91/19529 (Dec. 1991); WO 95/19805 (Jul. 1995); WO 99/34831 (Jul. 1999); WO 00/62699 (Oct. 2000); WO 2004/006954 (Jan. 2004); WO 2004/048519 (Jun. 2004); WO 2004/077987 (Sep. 2004); WO 2004/101028 (Nov. 2004); WO 2005/032646 (Apr. 2005); WO 2005/048988 (Jun. 2005); WO 2007/014003 (Feb. 2007 — applicant's own PCT).
3. Non-Patent Literature Cited
| Reference | Date | Relevance |
|---|---|---|
| Shaari et al., Otolaryngol. Head Neck Surg. 112:566–571 ("Rhinorrhea is Decreased in Dogs After Nasal Application of Botulinum Toxin") | 1995 | Sanders' canine nasal BoNT work — most relevant NPL; supports § 102/103 against nasal-toxin claims, but uses intact toxin and no energy |
| Ünal et al., Acta Otolaryngol. 123:1060–1063 | 2003 | BoNT-A into turbinates for allergic rhinitis |
| Weaver, "Electroporation: A General Phenomenon…," J. Cell. Biochem. 51:426–435 | 1993 | Electroporation fundamentals — supports § 103 for the "poration" element |
| Chang, "Cell Poration and Cell Fusion Using an Oscillating Electric Field," Biophys. J. 56:641–652 | 1989 | Poration waveforms |
| Guzman et al., J. Pharm. Sci. 91(7):1693–1701; Ultrasound Med. Biol. 29(8):1211–1222 | 2002/2003 | Sonoporetic delivery of macromolecules — supports § 103 for sonoporation of ~50 kDa LC |
| Sundaram et al., Biophys. J. 84:3087–3101 | 2003 | Ultrasound-induced membrane permeabilization |
| Chaddock et al., Protein Expr. Purif. 25:219–228 | 2002 | Expression/purification of catalytically active, non-toxic BoNT/A endopeptidase (light chain) |
| Simpson, Pharmacol. Rev. 33:155–188; Simpson et al., Methods Enzymol. 165:76–85 | 1981/1988 | BoNT structure/activity |
| Bittner et al., J. Biol. Chem. 264:10354–10360; De Paiva et al., FEBS Lett. 277:171–174; Ahnert-Hilger et al., J. Neurochem. 52:1751–1758 | 1989–1990 | Isolated BoNT light chain inhibits exocytosis; liposome delivery |
| Bigalke & Shoer, Handb. Exp. Pharmacol. 145:407–443 | 1999/2000 | Clostridial neurotoxins |
| Kistner & Habermann, Naunyn-Schmiedebergs Arch. Pharmacol. 345:227–234 | 1992 | Reductive cleavage of BoNT/tetanus toxin |
| Kreitman, Nat. Biotechnol. 21:372–374; Buzzi, Cancer Res. 42:2054–2058 | 1982/2003 | Ricin/diphtheria toxin — supports the alternative-neurotoxin claims |
4. Which References Potentially Anticipate (§ 102)
Caveat on claims: I was not able to retrieve the verbatim granted claim set of the '675 patent in this session. The mapping below is keyed to the claim categories that the specification and the family's claim sets support (I have labelled these as paraphrases, not quotes): (i) methods of delivering a botulinum/neurotoxin light-chain fragment to target cells by applying energy that causes reversible poration; (ii) systems comprising a catheter/energy applicator + toxin source; and (iii) nasal-cavity/nasopharynx applications (balloon catheters, occlusion, external mask sonoporation).
Anticipation requires a single reference disclosing every element. On that standard:
US 5,766,605 (Sanders) and Shaari et al. (1995) — Best § 102 candidates if any claim is drafted around "treating rhinorrhea/rhinitis by delivering botulinum toxin to the nasal membrane." Both are before the July 22, 2004 § 102(b) critical date. They do not anticipate any claim that requires (a) the light chain rather than intact toxin, or (b) energy-mediated poration, since both use intact toxin applied passively (gauze/instillation).
US 2005/0007441 A1 and US 2004/0009180 A1 — Closest on the energy + botulinum toxin combination, and therefore the strongest § 102 / § 103 candidates against broad claims that do not expressly require the light chain. Neither discloses the light chain.
US 2004/0151741 A1 and US 2005/0019346 A1 — Closest on the light-chain element, but neither discloses energy-mediated poration.
US 6,601,581 (Babaev) and US 6,361,554 / 6,464,680 (Brisken) — Anticipate only discrete structural/method elements (ultrasound aerosol delivery; vibrational-energy catheters for enhanced cellular uptake); they lack the neurotoxin/light-chain teaching.
Every other reference in § 2 (Allergan indication patents, the Jaafar/Seward intraluminal catheters, the tissue-treatment device patents, and the applicant's own family/Deem publications) discloses at most one or two elements and is properly a § 103 (obviousness) reference, not a § 102 anticipatory reference.
Consequence: No single cited reference discloses the full combination (botulinum light chain + energy-mediated reversible membrane poration + targeted nasal/tissue delivery). The '675 patent therefore most plausibly survives § 102 on the face of its citation record, with the real invalidity risk residing in § 103 combinations (e.g., Sanders/Shaari + Weaver/Chang/Guzman; or US 2005/0007441 + US 2004/0151741). This is consistent with the pending IPR2024-00279, where the petitioner (Neurent Medical) would be expected to press § 103 rather than pure § 102.
5. Limitations & Confidence
- High confidence: patent identity/fields, priority/filing dates, the front-page citation membership of the major references (Google Patents, Justia, PubChem, Unified Patents all agree), and the pre-AIA § 102 framework.
- Medium confidence: exact issue dates and one-line characterizations of the smaller Allergan indication patents and application publications, where I have relied on the listing pages rather than reading each document.
- Lower confidence / could not verify: the verbatim claim language of US 10,610,675 (my claim-category mapping is a paraphrase inferred from the specification and family), and the complete, exact ordering of the front-page "References Cited" list (the aggregated third-party databases disagree slightly on which family-internal documents are listed as "citations" versus "cited by"). For a formal § 102/§ 103 opinion, each date and each claim limitation should be re-verified against the documents themselves in USPTO PatentCenter.
Generated 9/16/2026, 12:49:02 PM
Obviousness
Combinations of prior art that suggest the claimed invention would have been obvious under 35 U.S.C. § 103.
I'll ground this in the prior art available on the patent's own page plus the IPR record, and verify a few reference details.
I have the claim text and grounds. Let me confirm the IPR outcome and one reference detail.
Obviousness Analysis — U.S. Patent No. 10,610,675 B2 under 35 U.S.C. § 103
Prepared: April 26, 2026 (per task header) · Patent: US 10,610,675 B2 ("the '675 patent"), Systems and methods for delivery of a therapeutic agent · Inventors: Mark E. Deem; Hanson Gifford · Assignee: The Foundry, LLC
0. What this section builds on, and three corrections to the earlier sections
I build on the Patent summary and Litigation summary above and do not repeat them. Three corrections/updates, flagged per your rules:
| Earlier section said | Now verified | Effect here |
|---|---|---|
| "Claim text not verified; §3 overview is the parties' characterization" | Independent claims 1 and 17 are now verified verbatim from the IPR2024‑00279 Petition (Ex. 1001, 27:39‑50, 28:22‑31). See §2 below. | The §3 characterization ("energy treatment of nasal tissue") is confirmed — the mismatch with the BoNT‑LC specification is real, not a drafting artifact of the pleadings. |
| "IPR2024‑00279 outcome not verified" | Still not fully verified. Docket Alarm records Paper 41, Final Written Decision, P.T.A.B. Jul. 21, 2025 for IPR2024‑00279. The companion IPR2024‑00669 FWD (Paper 43) is explicitly captioned "Determining All Challenged Claims Unpatentable"; the ‑00279 and ‑00280 FWD entries in the same docket index do not carry that caption. | I treat the ‑00279 merits outcome as unconfirmed. Do not assume all claims were cancelled. |
| Date conflict (session header 2026‑09‑16 vs. task 2026‑04‑26) | Unresolved; and the CAFC dismissal order in the earlier section is dated 2026‑08‑27, i.e., after the April 26, 2026 task date. | Flagged, not reconciled. The §103 analysis below is date-agnostic because it turns on reference dates, not on today's date. |
On the prior-art set. The Google Patents page text supplied to me does not include a separate "Prior Art" citation list; what the page does contain is (a) the references cited in the specification itself, and (b) the IPR record's reference set. I analyze both and say which is which. Everything below is tied to a specific reference with an identifier I did not alter.
1. The reference set (all identifiers literal)
Group A — Nasal / ENT energy delivery (the operative prior art for these claims)
| Ref. | Identity | Date | Status vs. '675 |
|---|---|---|---|
| Makower | US 2005/0240147 A1, Devices, systems and methods for diagnosing and treating sinusitis and other disorders of the ears, nose and/or throat (Makower, Chang; Exploramed II / Acclarent) | Filed 2004‑04‑21; pub. 2005‑10‑27 | Prior art in every priority scenario (pre‑AIA §102(e) as of the 2004 filing date; also cited by the Examiner as "closest prior art") |
| Fang | Fang C‑x. & Zhen S‑s., Nasal endoscopy combined with multiple radiofrequency for perennial allergic rhinitis, 25(07) J. First Mil. Med. Univ. 876 (2005) | Publicly available 2005‑07‑20 | Prior art in every scenario (pre‑AIA §102(a)/(b)) |
| Saadat | US 10,307,200 B2, Apparatus and methods for treating rhinitis (Saadat; Arrinex) | Filed 2018‑05‑17; issued 2019‑06‑04; priority 2013‑09‑30 / 2014‑06‑22 | Only if the claims are not entitled to 2005 priority |
| Edwards‑535 / Edwards etc. | RF turbinate ablation family (cited in the IPR record, e.g., Ex. 1008) | 1990s | Prior art in every scenario |
Group B — Applicant's own family / membrane-permeabilization art
| Ref. | Identity | Date | Note |
|---|---|---|---|
| Deem '369 | US 2008/0021369 A1 (Deem et al.) | Pub. 2008‑01‑24 | Publication of identical specification text (same inventive entity, Deem/Gifford). Available under AIA §102(a)(1) as a printed publication only in the 2019-priority scenario; not "by another" for §102(a)(2)/pre-AIA §102(e) purposes |
| Deem app. 10/437,882 | Devices and methods for treating asthma with local delivery of intact botulinum toxin (cited in the '675 specification) | Filed 2003‑05‑13 | Prior art in every scenario |
| Babaev '581 | US 6,601,581 | 2003 | Ultrasound pulmonary delivery |
| Brisken '554 / '680 | US 6,361,554; US 6,464,680 | 2002 | Vibrational/ultrasonic energy to enhance cellular absorption |
| Baran '223 / '976 | US 5,964,223; US 6,526,976 | 1999 / 2003 | Respiratory-tract catheters |
| Kost '402 | US 4,767,402 | 1988 | Transdermal ultrasound-assisted delivery |
Group C — Neurotoxin / nasal-mucosa therapy (motivation art)
| Ref. | Identity | Date | Note |
|---|---|---|---|
| Sanders '605 | US 5,766,605 (Sanders et al.) | 1998 | BoNT topically onto nasal mucosa / into SPG reduces rhinitis symptoms; the '675 patent's own background concedes this art |
| Ünal 2002 | Ünal et al., Acta Otolaryngol 123:1060‑1063 (2002) | 2002 | BoNT‑A injected into turbinates of allergic-rhinitis patients |
| Sharri 1995 | Otolaryngol. Head Neck Surg. 112:566‑571 | 1995 | Reports the Sanders canine work |
| Chaddock 2002; US 2004/0151741; US 2005/0019346 | BoNT light-chain purification / therapeutic use | 2002–2005 | Relevant to §112, not to these energy-only claims |
All Group A–C references are cited on the face of, or within, the '675 patent document/page or are in the IPR record for this patent.
2. The claims to be analyzed (verbatim, as reproduced in the IPR2024‑00279 Petition)
Claim 1 (independent):
"A method of treating a nasal condition of a patient comprising:
positioning a distal portion of a treatment device proximate to target tissue in a nasopharyngeal passage of a patient; and
administering therapy to the target tissue with the treatment device so as to disrupt neural activity such that mucus secretion is reduced in the nasopharyngeal passage;
wherein administering therapy comprises at least one of delivering energy to the target tissue and changing the temperature of the target tissue."
Claim 17 (independent):
"A method of treating a nasal condition of a patient comprising: [positioning a distal portion of a treatment device proximate to target tissue in a nasopharyngeal passage of a patient; and]
administering therapy to the target tissue with the treatment device to alter nasopharyngeal cells such that congestion in the nasopharyngeal passage is reduced;
wherein administering therapy comprises delivering energy to the target tissue."
Dependents (per the Petition's element‑by‑element mapping): 2 — energy from at least one energy delivery element on the treatment device; 3 — energy comprises RF energy; 7 — changing temperature comprises transferring thermal energy between device and tissue; 9 — contacting target tissue with a delivery portion; 10 — contact without penetrating; 18 — energy delivered from an energy delivery element (dep. 17); 19 — energy comprises RF; 20 — monopolar or bipolar electrode; 21 — plurality of electrodes; 22 — energy delivery element configured to concentrate energy laterally relative to the distal portion; 23 — at least one electrode on a lateral side of the distal portion; 24 — monitoring electrode/system on the device; 25 — monitoring electrode/system comprises a thermocouple or sensing electrode.
Two features of the claim set drive everything below:
- "Energy" is an unbounded genus. Claim 1 recites "delivering energy" or "changing the temperature"; claim 17 recites "delivering energy." No modality is required. Any known tissue‑energy modality used in the nasal passage on the identified target falls within the claim.
- The claims are method claims whose only real limitation is the treatment site + physiological result. The device elements are entirely in the dependents.
3. Legal framework applied
Under Graham v. John Deere and KSR Int'l v. Teleflex:
- Scope/content — §2 above; differences — §4–§6 below; PHOSITA level — a physician (ENT) or engineer with several years' experience in energy‑delivery catheters/probes and nasal anatomy, as both parties' experts assumed.
- Motivation may be implicit in the prior art, the nature of the problem, or common sense, and may be supplied by a reasonable expectation of success rather than an express teaching. KSR, 550 U.S. 398, 417–421.
- Four KSR rationales are directly available: (i) combining known elements by known methods to yield predictable results; (ii) simple substitution of one known energy modality for another; (iii) using a known technique to improve a similar device in the same way; (iv) "obvious to try" among a finite number of identified, predictable solutions.
4. Combination 1 — Makower + Fang (the priority‑independent § 103 ground)
This is the ground the Examiner himself half‑built during prosecution, and it is the only § 103 combination that survives regardless of the priority dispute, because both references predate the July 22, 2005 provisional.
4.1 Element‑by‑element
| Claim element | Makower | Fang | Combined |
|---|---|---|---|
| "method of treating a nasal condition" | ¶¶[0001], [0043], [0161], [0187], cl. 1 — sinusitis, turbinates, ENT disorders; Examiner: "treating disorders of the ear, nose and throat" | Treats perennial allergic rhinitis (876) | ✔ |
| "positioning a distal portion … proximate to target tissue in a nasopharyngeal passage" | [0043] — "flexible catheters or other … devices … are inserted [into] the … nasopharynx"; [0161] — electrosurgical devices inserted into the nasopharynx "to perform diagnostic or therapeutic procedures"; FIG. 5H — electrodes on strut members 214 contacting surrounding tissue | "Firing head" of the SHP‑I RF instrument aligned with the sphenopalatine foramen (876) — posterior in the nasal cavity, i.e., in the nasopharyngeal passage | ✔ |
| "administering therapy … so as to disrupt neural activity such that mucus secretion is reduced" | Energy‑emitting/electrosurgical devices for ENT procedures | "RF ablation of sphenopalatine foramen … block[s] the posterior parasympathetic fibers of the sphenopalatine nerve," "completely blocks the parasympathetic pathway of the nasal mucosa," which "reduces glandular secretion, and thus achieves the therapeutic purposes" (877) | ✔ |
| "at least one of delivering energy … and changing the temperature" | Energy‑emitting devices ([0161], cl. 1) | RF ablation (876–877) — RF ablation by definition heats tissue | ✔ |
4.2 Motivation to combine (three independent rationales)
- Same field, same problem, same mechanism. Makower and Fang both address nasal/ENT disorders and both operate by interrupting the parasympathetic supply to the nasal mucosa. Combination of references in the same field to address the same problem is the paradigm case. KSR; In re Kahn.
- Complementary teachings — one supplies what the other lacks. Makower supplies a minimally invasive, flexible, nasopharynx‑deployable energy‑emitting platform (its entire stated purpose: "flexible catheters as opposed to instruments having rigid shafts"); Fang supplies the therapeutic target and method (RF at the SPF to block the parasympathetic pathway) and clinical confirmation that glandular secretion is reduced. A POSITA reading Fang would need a device to deliver that RF into the nasal cavity/nasopharynx — Makower is exactly that. This is the classic "one reference for structure, one for method" combination.
- The Examiner already found Makower to be the closest prior art and allowed only on the specific gap Fang fills. The Notice of Allowance (Ex. 1022, 122) states Makower did "not teach or fairly suggest treating nasal conditions with a device so as to disrupt neural activity such that mucus secretion is reduced in the nasopharyngeal passage, and wherein the target tissue has a change in temperature." Fang supplies precisely that missing teaching and was not before the Office. Where the primary reference is the Examiner's own closest art and the secondary reference supplies the single articulated gap, the § 103 case is unusually clean.
4.3 Reasonable expectation of success
Fang reports RF ablation of the SPF producing the claimed physiological result in human patients. A POSITA contemplating Makower's catheter‑borne energy‑emitting device would expect, with reasonable confidence, that energizing at the same anatomical site with RF would produce the same block of parasympathetic signaling. In re Cortright; Pfizer v. Apotex. Predictability is high because the claimed result is the known physiological consequence of the known energy application at the known site — not a new mechanism.
4.4 PO's counterarguments of record and how they are answered
| PO/Levine argument | Answer |
|---|---|
| Makower FIG. 5H has a hollow interior; mucus/electrolyte would divert current away from tissue, so no reasonable expectation of success (Ex. 2003 Levine ¶¶ 21–23; POPR) | (a) Goes to one figure, not to Makower's disclosure as a whole — Makower teaches generally inserting energy‑emitting and electrosurgical devices into the nasopharynx to perform therapeutic procedures ([0161], cl. 1). (b) The operative energy delivery in the combination is Fang's RF technique; the claim requires only "a treatment device" positioned at the target, and Fang independently teaches positioning and energizing a nasal RF "firing head" at the SPF. (c) Clinical RF ablation of nasal tissue with fluid‑contacting electrodes was an established practice (Fang used a commercial "SHP‑I five‑organ radiofrequency therapy instrument"), so the diversion concern is a design detail, not a teaching‑away. |
| Motivation runs the wrong direction — a POSITA would look to Fang first, not Makower | § 103 does not require that the artisan start from the primary reference; it requires that the combined teachings suggest the claimed subject matter. Reading either reference first, the artisan who knows Fang's target and Makower's device has every reason to put them together. KSR, 550 U.S. at 420–21. |
| Fang's data is "inconclusive" on whether RF helps perennial allergic rhinitis | Fang expressly concludes RF ablation "completely blocks the parasympathetic pathway of the nasal mucosa," which "reduces glandular secretion, and thus achieves the therapeutic purposes." A reference need not prove efficacy to be enabling/suggestive; a reasonable expectation of success suffices. Also, the '675 claims do not require any particular degree of mucus reduction. |
| Makower is "almost entirely dedicated to improvements in flexible catheters" | Makower's own abstract and claims cover diagnosing and treating ENT disorders with energy‑emitting devices; the catheter discussion is the delivery vehicle, not a disclaimer of the therapeutic use. |
5. Combination 2 — Saadat + Fang (strongest ground if the claims get the Oct. 22, 2019 effective date)
If the challenged claims are entitled to no earlier priority than the Oct. 22, 2019 filing (the Petitioner's § 112/priority position, unproven in the sources I retrieved), Saadat alone reads on claims 1–3, 7, 9–10, 17–23, and Saadat in view of Fang (or Deem) covers 24–25. Even if the Board were to find a gap, the § 103 combination is overwhelming:
| Element | Saadat |
|---|---|
| Nasal condition | Title/abstract: "methods for treating rhinitis"; 2:16‑24 (rhinorrhea, congestion); cl. 1, 6 |
| Positioning distal portion at target tissue in nasopharyngeal passage | "T"-shaped distal end (FIG. 20E, element 355/356; FIG. 30) placed at the posterior nasal nerve; advanced through the nostril so the handle remains outside (30:34‑38, 31:10‑19, 33:41‑49) |
| Disrupt neural activity → reduced mucus secretion / congestion | 1:62‑66, 3:6‑14: ablating SPG‑derived nerves "leads to a decrease in or interruption of parasympathetic nerve signals that contribute to congestion and rhinorrhea" |
| Delivering energy / changing temperature | RF ablation; cl. 1 (ultrasound, RF or electrical), cl. 8 (bipolar RF) |
| Cl. 2/18 — energy delivery element | Electrodes 355, "monopolar, bipolar or multipolar" (31:10‑19); cl. 3, 9–12 |
| Cl. 3/19 — RF | Expressly recited |
| Cl. 7 — thermal energy transfer | RF ablation heats tissue — inherent |
| Cl. 9/10 — contact without penetration | Cl. 1: "contacting a mucosal surface of the nasal cavity with the treatment delivery portion"; dome‑shaped contact electrodes (cl. 3–4); cl. 11 (increase contact/pressure) |
| Cl. 20/21 — bipolar/monopolar; plurality of electrodes | cl. 3, 8–12 ("eight electrodes arranged in two lateral arrays") |
| Cl. 22/23 — lateral concentration / lateral electrode placement | Saadat's two lateral electrode arrays (cl. 10) and T‑shaped deployable end effector deliver radially outward relative to the shaft; and, in the alternative, Deem '369 FIG. 5A/6D expressly teaches electrodes "produc[ing] an electric field concentrated in a lateral direction from the catheter" |
| Cl. 24/25 — monitoring electrode / thermocouple | Deem '369 ¶[0096] — catheter "include[s] electrodes or other monitoring systems … located on the treatment catheter" and "thermocouple … sensing or stimulating electrodes"; Saadat's own RF ablation probes operate with temperature‑controlled generators (RF ablation consoles measure tissue temperature as a matter of course) |
Motivation to combine (Saadat + Deem '369 and/or Fang): Deem '369 is the '675 patent's own parent specification, describing in express terms the same catheter/electrode architectures that the '675 dependent claims recite (electrodes 30 and 32; lateral field concentration in FIG. 5A; monitoring/stimulating electrode; thermocouple). Combining Saadat's nasal‑targeting method with the electrode geometries of the applicant's own earlier disclosure requires no inventive insight — it is the substitution of a known electrode arrangement into a known nasal RF device to obtain a predictable field shape. KSR rationales (i), (ii) and (iii) all apply.
Caveat: because Deem '369 shares the same inventive entity (Deem/Gifford) as the '675 patent, it is not available as §102(a)(2)/pre‑AIA §102(e) art; it is available only as a §102(a)(1)/§103 printed publication, and only if the claims are held to their 2019 effective date. The Saadat‑based grounds are therefore the most vulnerable to the priority ruling and the Makower+Fang ground is the least.
6. Combination 3 — Adding motivation art (Sanders '605, Ünal 2002, Sharri 1995) to either primary combination
The '675 patent's own background concedes that (a) Sanders showed BoNT introduced into canine nasal passages reduces mucus secretion; (b) Ünal injected BoNT‑A into turbinates of allergic‑rhinitis patients; and (c) the nasal epithelium/goblet cells "are responsible for the majority of mucus production in the nasal cavity membrane." Taken with Saadat/Fang/Makower, this art supplies what § 103 calls the problem to be solved: the art knew the target cells, knew where they are, and knew that interrupting their neural supply reduces secretion. It supplies the motivation for the method steps independently of any device reference and also rebuts any argument that the claimed result ("mucus secretion is reduced"; "congestion … is reduced") was unexpected. KSR, 550 U.S. at 418 (motivation from the nature of the problem).
7. Combination 4 — Dependent claims 24–25 (monitoring/sensing)
Standing alone, these are the weakest claims in the set and the easiest to invalidate:
- Deem '369 ¶[0096] expressly discloses "thermocouple … sensing or stimulating electrodes" on the same electroporation catheter.
- The '675 patent's own specification at p. 17 lists "electrodes or other monitoring systems either located on the treatment catheter, or external to the patient … including, thermocouple, ultrasound transducers, fiberoptics, sensing or stimulating electrodes" — i.e., the applicant treated monitoring electrodes as a routine, known adjunct, not an invention. An admission that a limitation is conventional is powerful § 103 evidence.
- RF ablation systems (including those of Saadat, and the SHP‑I instrument in Fang) routinely include temperature monitoring at the electrode; claim 25's "thermocouple or sensing electrode" is satisfied by the generator's standard temperature‑feedback electrode.
Motivation: monitoring tissue temperature at an RF electrode to control lesion formation is the ordinary practice of RF ablation; adding it to any of the primary combinations yields only predictable results. Ground II in the IPR was framed this way (claims 24–25 obvious over Saadat alone), and I agree that framing is sound.
8. Claim‑by‑claim summary
| Claim | Primary § 103 combination | Backup | Strength |
|---|---|---|---|
| 1 | Makower + Fang | Saadat (+ Fang) | Strong (priority‑independent) |
| 2 | Makower + Fang (Makower's energy‑emitting devices carry electrodes) | Saadat + Fang | Strong |
| 3 | Makower + Fang (Fang = RF) | Saadat cl. 8 | Strong |
| 7 | Makower + Fang (RF→thermal transfer, inherent) | Saadat (RF ablation heats tissue) | Strong |
| 9 | Makower + Fang (strut/tissue contact) | Saadat cl. 1, 3–4, 11 | Strong |
| 10 | Makower + Fang | Saadat (surface contact, non‑penetrating) | Moderate — needs a finding on non‑penetration |
| 17 | Makower + Fang | Saadat | Strong |
| 18 | Makower + Fang | Saadat | Strong |
| 19 | Makower + Fang | Saadat cl. 8 | Strong |
| 20 | Makower + Fang | Saadat cl. 3–4, 8 | Strong |
| 21 | Makower (FIG. 5H multi‑strut electrodes) + Fang | Saadat cl. 9–10 (two lateral arrays) | Strong |
| 22 | Makower + Fang + Deem '369 (FIG. 5A/6D lateral field concentration) | Saadat cl. 10 | Moderate–Strong (this is the element PO contested hardest) |
| 23 | Same as 22 | Saadat cl. 10 | Moderate–Strong |
| 24 | Makower/Fang/Saadat + Deem '369 ¶[0096] | '675 spec p. 17 admission; routine RF temperature feedback | Strong |
| 25 | Same as 24 | Same | Strong |
9. Contingency: the priority ruling gates half the case
| Scenario | Available prior art | Effect |
|---|---|---|
| Claims get Oct. 22, 2019 effective date (Petitioner's position) | Saadat; Deem '369; Makower; Fang; Edwards; Sanders; all of Group A–C | Claims 1–3, 7, 9–10, 17–25 invalid under § 102 and § 103 on multiple independent grounds |
| Claims get July 22, 2005 / July 21, 2006 date (PO's position) | Makower (§102(e), filed 2004‑04‑21); Fang (public 2005‑07‑20); Sanders '605; Ünal 2002; Sharri 1995; Kost '402; Babaev '581; Brisken '554/'680; Baran '223/'976; Deem app. 10/437,882 | Makower + Fang still invalidates claims 1–3, 7, 9, 17–21. Claims 22–25 rest on Makower + Fang + Deem '369 — and Deem '369 (pub. 2008‑01‑24) falls away in this scenario, so 22–25 would need a substitute teaching of lateral field concentration from a pre‑2005 electrode‑geometry reference (of which the art is replete) |
Practical takeaway: the § 103 case does not depend on winning the priority fight for claims 1–3, 7, 9, 17–21. It does for claims 22–25. That asymmetry is the single most important structural fact in the obviousness posture, and the prior sections' §3 note (that the priority/written‑description attack is "the crux") should be read as a corollary of this, not as the whole story.
10. Secondary considerations
The record I retrieved shows no evidence of the Graham objective indicia offered against these claims:
- No unexpected results with a nexus. The '675 specification contains no working example of energy-alone treatment of a nasal condition (per the Bu‑Saba declaration, ¶50 — "The '675 patent does not describe using any energy source alone to treat any condition, including rhinitis"). A broad genus claim ("energy," any modality) cannot be supported by unexpected results in a narrow embodiment. In re Kao.
- No teaching away. Fang and Saadat both affirmatively teach toward nasal RF ablation; Makower teaches toward nasopharyngeal energy devices. Nothing teaches away.
- Copying / commercial success arguments are weak here. Neurent's Neuromark and Aerin's RhinAer both apply bipolar RF to the posterior nasal nerves. But (a) copying a broad claim does not rebut a strong prima facie case where the claim reads on the prior art, and (b) any commercial success is attributable to the specific device claimed in the Aerin‑owned patents (e.g., US 11,033,318; US 11,241,271; US 11,547,473), not to the '675 patent's broad method claim. The nexus is the problem.
- Licensing (Foundry → Aerin exclusive license) is a business arrangement, not evidence of non‑obviousness.
11. Explicit uncertainties and where I would not overstate
- I have not verified the IPR2024‑00279 Final Written Decision outcome. Paper 41 exists (Jul. 21, 2025), but the docket index entry I retrieved does not carry the "All Challenged Claims Unpatentable" caption that the companion IPR2024‑00669 entry does. Law360's July 2025 headline ("PTAB Knocks Out Claims In 3 Nasal Airway Patents") suggests cancellation across the three Foundry patents, but I could not confirm the ‑00279 merits disposition from a primary document. Treat §8's strength ratings as an ex ante analysis, not as a report of the Board's holding.
- Claim 10 and claims 22–23 are the soft spots. Both parties fought hardest over claim 22's "concentrate energy laterally." My analysis shows it is reachable (Deem '369 FIG. 5A/6D, or Saadat's lateral electrode arrays), but the argument depends on a secondary reference and on the priority scenario.
- I have not independently read Makower, Fang, Saadat or Deem '369 in full. All element mappings above are quoted from the IPR2024‑00279 Petition, POPR, and expert declarations as surfaced in the searches, plus the Saadat front page. If a full-text reading shows that, e.g., Makower's energy‑emitting embodiments are narrower than its abstract suggests, the Makower+Fang ground weakens accordingly.
- The "IPR2024‑00279 regarding U.S. Patent No. 10,610,647 (the '675 patent)" string in one expert declaration remains uncorrected and unexplained; I flag it as it appears, consistent with the earlier sections.
- No foreign counterpart prior art was examined. The Darts‑IP family 37683813 entry was not retrievable, so I cannot say whether foreign prosecution produced different art (e.g., the CN/JP references cited against the Aerin family).
12. Bottom line
Independently of the priority dispute, Makower (US 2005/0240147) in view of Fang (2006 ⇒ publicly available 2005‑07‑20) renders claims 1–3, 7, 9, 17–21 obvious under § 103: Makower supplies a flexible, nasopharynx‑deployable energy‑emitting device and expressly contemplates its use to perform therapeutic ENT procedures; Fang supplies the therapeutic method (RF ablation of the sphenopalatine foramen to block the posterior parasympathetic fibers, reducing glandular secretion) that the Examiner expressly identified as the only missing limitation. The motivation is supplied by the identity of field, problem and mechanism, and by the fact that the two references are complementary rather than redundant; the reasonable expectation of success is supplied by Fang's clinical results at the same anatomical site.
If the claims are held to the Oct. 22, 2019 effective date, the case strengthens dramatically: Saadat (US 10,307,200) independently discloses every element of claims 1–3, 7, 9–10 and 17–23, and Deem (US 2008/0021369 ¶[0096], FIG. 5A/6D) — the applicant's own parent specification — supplies the "lateral field concentration" and "monitoring electrode/thermocouple" limitations of claims 22–25, with the applicant's own specification at p. 17 conceding that monitoring electrodes are conventional.
The most defensible combination to press is Makower + Fang, because it is the only one that does not depend on the priority ruling; the most likely to be contested is claim 22, because it requires the Deem '369 or Saadat lateral‑electrode teaching and because the Patent Owner built its record around defeating it.
Generated 9/16/2026, 12:49:24 PM
Extensions
Patent term adjustments, term extensions, continuations, divisionals, family members, and expiration dates.
Derivative works
Defensive disclosure: derivative variations of each claim designed to render future incremental improvements obvious or non-novel.
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