US 11679077

US Patent 11,679,077 B2 — Summary

Bibliographic data (per Google Patents / USPTO records)

Abstract (verbatim)

"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."

Independent claims — plain-language overview

Important caveat: The full verbatim text of the granted claims was not retrievable from the sources available in my searches (the specification was obtained, but the claims section was truncated). The following is reconstructed from the specification plus the IPR2024-00669 record, which quotes claim language. Treat the exact wording as unverified.

• Claim 1 (apparatus for treating rhinitis): An apparatus for treating rhinitis in a nasal cavity. Per the IPR record (Petition expert declaration quoting Ex.1001/USP077, claim 1), it comprises an elongate body, multiple radiofrequency electrodes, and a radiofrequency generator coupled with the proximal portion of the elongate body for supplying radiofrequency energy to the multiple RF electrodes to treat a target tissue in the nasal cavity and thus treat rhinitis. Notably, the granted claim as characterized in the IPR does not require neurotoxin delivery — the IPR expert expressly opined that the '077 patent claims energy-only RF treatment of nasal tissue (as opposed to electroporation-mediated toxin delivery described in the specification).
• Remaining independent claims: I do not have authoritative verbatim text. Based on the specification and family history, the remaining independent claims likely cover related apparatus/method variants for treating rhinitis or nasal tissue via catheter-carried energy applicators (RF electrodes, ultrasound transducers), with dependent claims addressing electrode configurations, energy parameters, and nasal-anatomy targeting (e.g., nasopharynx, sinuses, goblet cells). I cannot confirm the exact count or scope of the other independent claims with high confidence — this is a gap you should verify against the USPTO Patent Center / Google Patents claims tab.

Litigation / PTAB / CAFC status (as found in searches)

• IPR2024-00669 — Neurent Medical Inc. et al. v. The Foundry, LLC et al. (PTAB, filed Apr. 3, 2024; institution Jul. 23, 2024). Status per GreyB/IPverse: "Final Written Decision – Appealed"; termination date Jul. 21, 2025. Patent Owner: The Foundry, LLC; Petitioner counsel: Cavanaugh et al.; Patent Owner counsel: Daley et al.
• IPR2024-00281 — PTAB case against the same patent, status: Procedural Termination (per Google Patents litigation links).
• Delaware District Court — Case 1:23-cv-00756 (per Google Patents litigation link).
• CAFC case 25-2114 — Listed in Google Patents as a Court of Appeals for the Federal Circuit case involving this patent family. My search of "CAFC 2026 dockets" returned no 2026 docket entries, so I cannot confirm current CAFC activity, party names, or the subject matter of the appeal (it may be the appeal of IPR2024-00669's Final Written Decision). Do not rely on my characterization of the CAFC case without checking PACER/CAFC records.

Uncertainties / notes

1. Claims text: I could not retrieve the complete granted claims; the claim 1 description above comes from the IPR record, not the official claims tab. Confirm on USPTO Patent Center.
2. Minor date discrepancies between sources: Google Patents shows filing Jan. 19, 2021 and grant Jun. 20, 2023; Unified Patents shows application date Jan. 18, 2021 and grant Jun. 19, 2023. Priority date shows Jul. 22, 2005 (Google) vs. Jul. 21, 2005 (Unified); the specification states Provisional 60/702,077 was filed Jul. 22, 2005.
3. CAFC 2026 activity: Not verified — no results returned for CAFC 2026 docket entries in my searches.

Based on my searches, US Patent 11,679,077 (US11679077B2, "Systems and methods for delivery of a therapeutic agent," owned by The Foundry, LLC) is involved in the following known litigation and PTAB proceedings:

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1. District Court – Delaware

Aerin Medical Inc. and The Foundry, LLC v. Neurent Medical Inc. and Neurent Medical Ltd.

• Jurisdiction: U.S. District Court for the District of Delaware
• Case No.: 1:23-cv-00756 (later docketed as 1:23-cv-00756-JLH; initially assigned to Judge Gregory B. Williams, subsequently Judge Jennifer L. Hall)
• Filing date: July 11, 2023
• Plaintiffs: Aerin Medical Inc. and The Foundry, LLC
• Defendants: Neurent Medical Inc. and Neurent Medical Ltd.
• Nature: Patent infringement (35 U.S.C. § 271) – Aerin and The Foundry asserted eight patents, including the '077 patent, against Neurent's NEUROMARK nasal-airway treatment device.
• Status (as of available records): Active/ongoing, but stayed. After the PTAB instituted IPR2024-00669 (July 23, 2024), the court entered an order staying the case (July 29, 2024), and the case was consolidated with related matters (Nov. 26, 2024). Neurent filed counterclaims (including infringement of a Neurent patent, tortious interference, and unfair competition); Aerin/The Foundry moved to dismiss those counterclaims (briefing Aug. 2024), and the case remained active through 2025 (oral argument requests, scheduling entries). No final judgment identified in my searches.

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2. PTAB – Inter Partes Review IPR2024-00281 (procedurally terminated)

Neurent Medical Inc. et al. v. The Foundry, LLC et al.

• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case No.: IPR2024-00281
• Filing date: January 18, 2024
• Petitioner: Neurent Medical Inc. (and Neurent Medical Ltd.)
• Patent Owner: The Foundry, LLC
• Patent challenged: US 11,679,077 (i.e., '077)
• Status: Terminated – The Board granted Petitioners' opposed motion to withdraw the petition and dismissed the proceeding prior to institution (35 U.S.C. § 314), April 24, 2024. Petitioner fee refund approved June 10, 2024. (Petitioners sought withdrawal/refiling because grounds based on a 2019 priority date were not yet IPR-eligible; Patent Owner opposed the withdrawal.)

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3. PTAB – Inter Partes Review IPR2024-00669 (Final Written Decision – appealed)

Neurent Medical Inc. et al. v. The Foundry, LLC et al.

• Jurisdiction: Patent Trial and Appeal Board (PTAB)
• Case No.: IPR2024-00669
• Filing date: April 3, 2024
• Petitioner: Neurent Medical Inc. (and Neurent Medical Ltd.)
• Patent Owner: The Foundry, LLC
• Patent challenged: US 11,679,077 (i.e., '077)
• Institution decision: July 23, 2024 (trial instituted)
• Final Written Decision: ~July 21, 2025 – the Board determined all challenged claims unpatentable under 35 U.S.C. § 318(a) and dismissed Patent Owner's motion to exclude.
• Status: Appealed – the Final Written Decision has been appealed (see CAFC case below). Panel: Sheridan Snedden, Susan Mitchell, Timothy Majors.

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4. Court of Appeals for the Federal Circuit – Appeal 25-2114

Appeal of the IPR2024-00669 Final Written Decision (US Patent 11,679,077)

• Jurisdiction: U.S. Court of Appeals for the Federal Circuit
• Case No.: 25-2114
• Filing date: 2025 (docket number format indicates 2025 filing; exact date not verified in my searches)
• Parties: The appeal arises from IPR2024-00669 (Neurent v. The Foundry). Given that the Board's Final Written Decision invalidated all challenged claims of the '077 patent, the appellant is expected to be patent owner The Foundry, LLC (with appellees Neurent and/or the Director of the USPTO), but I could not verify the precise caption, party roles, or current disposition from the available search results.
• Status: Pending/undetermined as of my last search (the PTAB docket for IPR2024-00669 is marked "Final Written Decision – Appealed"). I do not have confirmation of any CAFC decision.

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Summary Table

Caveats: (1) I could not independently verify the current disposition of the CAFC appeal (25-2114) or the final outcome of the Delaware case; the above reflects the most recent docket information available in my searches. (2) Neurent filed a series of related IPRs (IPR2024-00275 through -00282, -00669) against other patents in the same family (e.g., '011, '675, etc.), but only IPR2024-00281 and IPR2024-00669 directly challenge the '077 patent itself.

Proceedings overview

There are two AIA trial proceedings on file for US 11,679,077 — both inter partes reviews filed by Neurent Medical Inc. / Neurent Medical Ltd. against patent owner The Foundry, LLC — with one procedurally terminated before institution (IPR2024-00281) and one reaching a Final Written Decision finding all challenged claims (1–8 and 11) unpatentable (IPR2024-00669, now on appeal to the Federal Circuit). Bottom line for a defendant: every claim Neurent actually challenged has been found unpatentable by the Board — but the FWD is on appeal, so the claims have not yet been formally canceled by a Director's certificate, and the district-court case asserting the patent is stayed pending the PTAB/CAFC path.

Flag re: the "PTAB proceedings on file" block. The USPTO ODP ingest shows no proceedings for this patent, but that is stale: web search independently confirms both IPR2024-00281 and IPR2024-00669 (IPVerse PTAB dockets; DocketAlarm; UniCourt; Finnegan matter page; PTACTS filings), including the IPR2024-00669 FWD issued ~2025-07-21.

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IPR2024-00669 — Neurent Medical Inc. et al. v. The Foundry, LLC et al.

• Type: Inter Partes Review
• Filed: 2024-04-03
• Status: "Final Written Decision – Appealed" (plain English: the Board ruled all challenged claims unpatentable on 2025-07-21; patent owner has appealed to the Federal Circuit)
• Judge panel: Sheridan Snedden (lead), Susan Mitchell, Timothy Majors (per DocketAlarm)
• Petition grounds: Challenged claims 1–8 and 11 (per Patent Owner's expert declaration of Dr. Marom Bikson). Six grounds, all obviousness (§ 103):
  • Grounds 1–4: § 103/§ 102 over Saadat and Deem, premised on Petitioner's theory that the claims were stripped of priority back to a post-2019 date (i.e., that new matter was added during prosecution). Patent Owner's Preliminary Response argued the '077 patent is entitled to at least a 2021-07-21-style 2006 priority date (via the '090 application's incorporation of the '771 provisional), making those references non-prior art, and additionally urged § 325(d) denial.
  • Grounds 5–6: § 103 over Makower (US 2005/0240147, catheter-based ENT/sinusitis devices) + Fang ("Nasal endoscopy combined with multiple radiofrequency for perennial allergic rhinitis," 25(7) J. First Mil. Med. Univ. 876 (2005)) + Edwards (US 6,517,535), and further + Stern (US 5,562,720) for dependent claim 4. The petition's argument sections mapped dependent limitations to this art (e.g., Fang for inferior-turbinate targeting; Makower/Fang/Edwards/Stern for multi-electrode RF configurations and bipolar RF; a console/RF generator; temperature-sensor feedback).
• Institution decision: Instituted — 2024-07-23 (IPVerse institution date; no part of the institution decision was retrievable in my search to quote).
• Final Written Decision: Issued 2025-07-21 (Paper 43). Judgment caption (verbatim, per DocketAlarm): "Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a) Dismissing Patent Owner's Motion to Exclude 37 CFR § 42.64(c)." Bloomberg Law's summary: the Board determined the challenged claims "unpatentable as obvious over prior art," including art on "minimally invasive, catheter based devices, systems and methods for treating sinusitis and other ear, nose, and throat disorders" (Makower), "nasal endoscopy combined with multiple radiofrequency for perennial allergic rhinitis" (Fang), and related teachings (Edwards/Stern). Claim-level outcome: all challenged claims — 1, 2, 3, 4, 5, 6, 7, 8, and 11 — were held unpatentable; no challenged claim was held patentable. I could not retrieve the full FWD text to quote the panel's per-claim reasoning verbatim; the judgment line above is the authoritative disposition.
• Settlement / termination: No settlement. The proceeding terminated by operation of the FWD (statutory one-year deadline from institution; termination date 2025-07-21). Patent Owner's motion to exclude was dismissed.
• Appeal: Yes — appealed to the Federal Circuit. Google Patents' litigation data lists CAFC case 25-2114 for this patent family, and IPVerse carries the status "Final Written Decision – Appealed." I could not verify the caption, party roles, briefing, or disposition of 25-2114 from available sources (no CAFC opinion located); the appellant is expected to be The Foundry, LLC. Check PACER/CAFC before relying on this.
• Defensive value: If you are Neurent (or someone asserting energy-only RF nasal-airway treatment), every claim asserted against you in Delaware (claims 1–8, 11) has been found unpatentable — an infringement theory built on those claims is now fighting an uphill FWD + obviousness record. Because the appeal is pending, the claims are not yet formally canceled; but the district case (1:23-cv-00756) is stayed, and this FWD is the single most valuable validity document in existence for this patent.

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IPR2024-00281 — Neurent Medical Inc. et al. v. The Foundry, LLC et al.

• Type: Inter Partes Review
• Filed: 2024-01-18
• Status: "Terminated" — plain English: procedurally terminated before institution; the Board granted Petitioners' opposed motion to withdraw the petition and dismissed without prejudice under 35 U.S.C. § 314 (Termination Decision 2024-04-24; fee refund approved 2024-06-10)
• Judge panel: Sheridan Snedden, Susan Mitchell, Timothy Majors (per DocketAlarm)
• Petition grounds: Multiple § 102/§ 103 grounds against the '077 patent — some premised on a pre-AIA priority date and others on a post-AIA priority date. This created a novel timing problem: the petition was filed ~7 months after grant (grant 2023-06-20; 9-month IPR deadline 2024-03-21), and Petitioner feared Patent Owner would argue the pre-AIA-priority grounds made the patent ineligible for IPR (and eligible only for PGR, whose window had passed) under 35 U.S.C. § 311(c). Petitioner's stated plan was to withdraw and refile the identical challenge after the 9-month window closed, eliminating the timing dispute.
• Institution decision: None — dismissed prior to institution.
• Final Written Decision: None.
• Settlement / termination: Not a settlement — a procedural withdrawal. Patent Owner opposed the motion (arguing inefficiency and seeking schedule coordination with related IPRs 2024-00279/-00280), but the Board granted dismissal without prejudice on 2024-04-24. Petitioner refiled the challenge as IPR2024-00669.
• Appeal: None.
• Defensive value: No merits holding — this proceeding binds no one on validity. Its practical significance is strategic: it shows Neurent deliberately engineered the § 311(c) timing issue away and then succeeded on the merits in the refiled IPR2024-00669. For a new defendant, the withdrawal means no estoppel attached here, and the refiled proceeding's FWD gives you a fully-developed obviousness roadmap.

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Strategic summary

Claims CANCELED vs. SUSTAINED vs. UNTESTED. The Board's FWD in IPR2024-00669 found all challenged claims — 1–8 and 11 — unpatentable under 35 U.S.C. § 318(a). No claim that was challenged was sustained. However, cancellation is not yet formal: the FWD is on appeal (CAFC 25-2114), and the Director's certificate under § 318(b) will not issue until the appeal is resolved. Claims 9–10 (and any claims beyond 11) were never challenged — they are untested and technically remain in force. Given that the challenged set included independent claim 1 (the apparatus-for-treating-rhinitis claim quoted in the IPR record) and independent/expanded claims 11, the practical core of the patent is what is on the FWD chopping block; the untested remainder is the only live exposure.

Estoppel landscape. Under § 315(e)(2), Neurent (and its privies) are estopped in the Delaware litigation and any later proceeding from raising any ground it raised, or reasonably could have raised, in IPR2024-00669 — which covers Makower, Fang, Edwards, Stern, Saadat, and Deem, and all obviousness combinations of them. But estoppel is personal: a new defendant who is not Neurent or a privy is free to use the exact same art — indeed, the FWD gives you a pre-loaded, Board-endorsed § 103 combination (Makower + Fang + Edwards, + Stern for claim 4) that you can assert in your own IPR petition or as an invalidity defense, subject to your own § 315(b) one-year-from-service filing clock.

Pattern signals. Neurent filed a coordinated wave of eight IPRs against the Foundry/Aerin family — IPR2024-00275 through -00282 plus -00669 (Finnegan matter page) — but only two targeted the '077 patent itself (-00281, -00669). The withdrawal-and-refile maneuver shows deliberate timing strategy, not weakness. Patent Owner (Finnegan; lead counsel Kathleen Daley; expert Marom Bikson) defended hard — opposing the withdrawal, filing expert declarations on priority and the Makower FIG. 5H device, and moving to exclude evidence — but lost on the merits. There is no defensive-aggregator involvement (e.g., Unified Patents): the "Unified Patents PTAB Data" attribution on Google Patents is a data-source credit, not a party. The underlying fight is commercial — Aerin/The Foundry's nasal-airway patents (with Aerin as exclusive licensee of the '077 patent) versus Neurent's NEUROMARK device — playing out in Delaware (1:23-cv-00756, stayed after institution) and at the PTAB.

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Recommended next steps

• If you are a defendant being asserted against under the '077 patent today: the first move is to obtain IPR2024-00669's Final Written Decision (Paper 43, ~2025-07-21) and cite its judgment: "Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a) Dismissing Patent Owner's Motion to Exclude." Public copies: DocketAlarm – IPR2024-00669 docket and Bloomberg Law case summary. The Makower/Fang/Edwards(/Stern) combination is your § 103 roadmap; if you're not Neurent, file your own IPR (or raise the FWD art as an invalidity defense) — § 315(e)(2) estoppel does not bind you.
• Monitor the appeal: CAFC 25-2114 (status unverified — check PACER/CAFC records). Until the CAFC affirms and the mandate issues, the claims are not formally canceled; if you're litigating now, move to stay pending the appeal, and be ready for the possibility of a remand or reversal.
• The untested claims (9–10 and any beyond 11) are your residual risk. If the demand letter cites those specifically, they were never before the Board — you'll need your own grounds (the FWD's art is a strong starting point) and your own petition within one year of service under § 315(b).
• If you are Neurent: the estoppel bar is already locked in from IPR2024-00669; your validity position is the FWD itself, and the Delaware case should be re-assessed for judgment/termination now that the Board's invalidity holding is on the books (subject to the pending appeal).
• Caveats I could not verify: the full FWD text (per-claim reasoning), the institution decision's reasoning, and the CAFC 25-2114 caption/disposition were not retrievable from my sources — verify each on USPTO PTAB E2E (PTAB portal) and the CAFC docket before relying on them in filings.

Based on the available records (Google Patents legal-event data for the '077 patent, Plainsite assignment abstracts, legacy-assignments.uspto.gov PDFs, and PTAB/IPR dockets), here is the assignment-chain reconstruction. Important upfront caveat: I could not retrieve the official reel/frame numbers for the two assignments recorded against application 17/151,938 itself from the USPTO Assignment Center in my searches. The conveyance events, parties, and dates below come from Google Patents' legal-event feed (which mirrors USPTO assignment records); family-level reel/frame evidence from Plainsite and legacy-assignments.uspto.gov is cited where available. Verify final reel/frames on the USPTO Assignment Center search page linked at the end.

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Inventors

Pattern note: Both inventors are the founding principals of the original assignee (The Foundry, Inc., a medical-device incubator founded by Deem, Gifford, and colleagues). No post-filing exodus: both still appear as assignors to The Foundry, LLC in family records as late as the 2012 assignment recorded at reel 051470/0794 (executed May 2012, recorded Jan. 9, 2020), a decade after the 2005–2006 priority filings. This is the opposite of the "inventors depart → portfolio fire-sale" pattern.

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Original assignee

• The Foundry, Inc. (later restructured as The Foundry, LLC, Menlo Park, CA — 199 Jefferson Drive per recorded documents; earlier address 604-D Fifth Avenue, Redwood City, CA).
• Line of business: Medical-device incubator/developer. The Foundry conceived and developed the neuromodulation/neurotoxin-delivery technology and spun out operating companies (e.g., Ardian/renal denervation). It does not itself market a rhinitis product; the litigating co-plaintiff Aerin Medical Inc. ships the RhinAer device (FDA 510(k)-cleared nasal airway remodeling), which Aerin marks with the family's patent numbers (per RPX litigation documents quoting the Delaware complaint).
• Current status: Operating and active — still the named patent owner in IPR2024-00669 and IPR2024-00281 (PTAB lists "Patent Owner: The Foundry, LLC") and co-plaintiff in D. Del. 1:23-cv-00756. Not dissolved, not in bankruptcy.

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Assignment timeline

Two conveyances are recorded against US 11,679,077 (per Google Patents legal events for this patent number). Exact reel/frame numbers were not verifiable in my searches — noted per entry. Supporting family-level reel/frame evidence is cited where available.

• 2021-01-19 recorded (execution date not shown in available data; original family assignment executed by Deem on 2006-05-23 per Plainsite abstract) — Reel/frame not verified (family records: original recording at reel 043816/0683, corrected at reel 044173/0235 per Plainsite)

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: Mark E. Deem; Hanson Gifford
  • Assignee: The Foundry, Inc.
  • Correspondent: not available from retrieved records (prosecution power of attorney for the family is Customer Number 021971)
  • Context: Recorded on the day application 17/151,938 was filed — standard practice of recording the inventor→company assignment at continuation filing; this is the same chain that has covered the family since 2006.

• 2021-01-20 recorded (execution date not shown) — Reel/frame not verified

  • Conveyance: Assignment of Assignors' Interest
  • Assignor: The Foundry, Inc.
  • Assignee: The Foundry, LLC
  • Correspondent: not available from retrieved records
  • Context: Internal reorganization/name-formalization (The Foundry, Inc. → The Foundry, LLC), recorded one day after the continuation filing. Consistent with the family-level 2012 assignment at reel 051470/0794 (assignors including Deem and Gifford to The Foundry, LLC) and the EP/INPI records showing The Foundry, LLC at 199 Jefferson Drive, Menlo Park.

No other assignments (no transfer to Aerin Medical, no security agreement, no license recordation, no merger, no release) appear in the available legal-event data for this patent. The chain terminates at The Foundry, LLC, which matches the PTAB record ("Patent Owner: The Foundry, LLC").

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Timeline diagram

timeline
    title Ownership of US 11679077
    2005 : Provisional priority filing
    2006 : Original inventors assignment to Foundry Inc
    2021 : Continuation filed
         : Assigned to Foundry Inc
         : Assigned to Foundry LLC
    2023 : Patent issued
    2024 : IPR filed by Neurent
         : Delaware suit filed 2023

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NPE / troll-pattern signals

1. Shell-entity transfer — Not present. The Foundry, LLC is a Delaware LLC, but it is a functioning medical-device incubator with a real operating address (199 Jefferson Drive, Menlo Park, per reels 051470/0794 and EP/INPI records), not a registered-agent service address; the name carries no "IP / Licensing / Holdings" suffix; and the transfer is an internal reorg from The Foundry, Inc. within the same founder-run enterprise.

2. Known asserter in the chain — Not present. Neither The Foundry, LLC nor Aerin Medical appears on public NPE lists (Acacia, Marathon, Intellectual Ventures, Wi-LAN, Conversant, Vringo, Pendrell, Spangenberg entities, etc.). Unified Patents' portal lists the parent as "Foundry LLC," an operating incubator, and the challenger (Neurent) is itself an operating company.

3. Repeat correspondent across the chain — Unclear. I could not retrieve correspondent-of-record names for the two '077 recordings (reel/frames unverified), so I cannot confirm or exclude a repeat-correspondent tell. Family prosecution was under a standard customer number (021971). This is a data gap, not a finding.

4. Cascading transfers — Not present. Only two links (inventors → Foundry Inc → Foundry LLC), recorded on consecutive days at continuation filing, both within the same corporate family. No chained third-party LLCs, no <24-month pass-through.

5. Pre-litigation transfer — Not present as an NPE tell. The Jan. 2021 recordings predate the first infringement suit (D. Del. 1:23-cv-00756, filed July 11, 2023) by ~2.5 years and coincide with the continuation filing date, not with litigation preparation. No assignment was recorded in the six months before suit.

6. Bankruptcy fire-sale — Not present. The Foundry has never been in Chapter 7/11; no court-ordered patent sale.

7. Privateering — Not present. The asserting coalition is The Foundry, LLC (developer/incubator) plus Aerin Medical, an operating company that ships the RhinAer device and marks it with the family's patent numbers (per RPX documents quoting the complaint's § 287(a) allegations). The defendant (Neurent) is a direct competitor with its Neuromark device. This is classic operating-company assertion against a competitor, not an operating company hiding behind an NPE.

8. Defensive aggregator (anti-NPE) — Not present. The chain terminates at The Foundry, LLC, not RPX, AST, LOT Network, Unified Patents, or OIN. (Note: the patent is being actively asserted, so it has not been "neutralized.")

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Verdict

Operating-company assertion.

The assignment chain is a clean two-step inventor → incubator → LLC internal reorganization (recorded Jan. 19–20, 2021, at continuation filing), and the current owner, The Foundry, LLC, is a functioning medical-device developer whose co-plaintiff, Aerin Medical, ships a practicing product (RhinAer) against a named competitor (Neurent). No shell transfers, no known-asserter entities, no bankruptcy, no privateering, and no pre-suit transfer appear in the records; the only NPE-adjacent data point (correspondent names) is unverifiable rather than indicative. The litigation posture — operating companies asserting against a competitor — is the decisive signal.

Verification link: USPTO Patent Assignment Search — https://assignmentcenter.uspto.gov/ (patent search: https://assignment.uspto.gov/patent/index.html#/patent/search) — search "11679077" to confirm the reel/frame numbers for the 2021-01-19 and 2021-01-20 recordings, which I could not retrieve in this session.

I'll research this systematically, starting with the patent's own citation records.

Let me try to pull the patent's own front-page citation lists and the USPTO record.

Let me try to retrieve the actual front-page "References Cited" list from the granted patent document itself.

Prior-Art Analysis — US Patent No. 11,679,077 B2

Patent: US 11,679,077 B2, "Systems and methods for delivery of a therapeutic agent"
App. No. 17/151,938 · Filed 2021-01-19 · Issued 2023-06-20 · Priority 2005-07-22 (Prov. 60/702,077) / 60/747,771 (2006-05-19)
Inventors Mark E. Deem; Hanson Gifford · Assignee The Foundry, LLC
Google Patents "prior art keywords": energy, toxin, delivery, catheter, cell · Prior art date: 2005-07-22
Examiner: Albert M. Navarro, TC 1600

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0. Method, scope, and candid limitations

What I could and could not verify — read this before using the tables below:

1. The '077 patent's own front-page "(56) References Cited" list was NOT retrievable in this session. The Google Patents text digest provided for US11679077B2 includes the bibliography, classifications, specification, and abstract, but the HTML does not surface the line-item citation list, and my targeted queries for the '077 PDF front page ("References Cited" / U.S. PATENT DOCUMENTS) returned other patents' front pages. This is a gap.
2. What I did retrieve, and why it is a sound stand-in: the front-page "(56) References Cited" list of US 10,610,675 — the immediate parent of the '077 patent in the same continuation chain (see Related Applications). Because the '077 patent is a straight continuation sharing the same specification and priority (16/842,209 ← 16/659,893 ('675) ← 16/036,381 ← … ← 11/459,090), the examiner's cited-art list on the '675 front page is expected to be substantially reproduced on the '077 front page, typically augmented by art cited in the intervening years. I use it as the proxy and label it as such — do not represent it to the USPTO or a court as the verbatim '077 (56) list without pulling the '077 PDF.
3. I also cross-checked against the art actually applied against the '077 claims at the PTAB (IPR2024-00669), whose exhibit list is authoritative for what the challenger treated as the operative prior art. That is where the material §102/§103 art lives.
4. Claim text is not verbatim-verified. I quote claim elements as reproduced in Petitioner's claim chart (Exhibit Z) and in Dr. Bikson's declaration. Treat wording as reliable-in-substance, unverified-in-form.

Cross-reference flag (contradiction with the prior "Obviousness" section): that section states the instituted-ground references "all predate [the priority] date, so all are §102 prior art," listing Makower (published Oct. 27, 2005). Makower's publication date is AFTER the July 22, 2005 priority date. Makower qualifies as prior art only under §102(e) (pre-AIA) as a U.S. application publication deemed prior art as of its filing date, April 21, 2004 — not because its publication predates the priority date. Fang (July 20, 2005) does predate by two days; Edwards-535 (2003) and Stern (1996) predate comfortably. This distinction matters if a post-AIA priority date were ever successfully asserted.

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1. Patent citations on the family front page (proxy: US 10,610,675, "References Cited")

Full citation, date, and description. Dates are as they appear in the printed list; the parenthetical is my characterization of relevance.

1A. U.S. Patent Application Publications

★ = the reference that matters most for the granted claims.

1B. U.S. Patents cited/relied on in the same family front matter

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2. References cited in the specification (the '077 patent's own Background/Description)

These are the citations on the face of the disclosure (and, where noted, in the Related Applications/Background of the family). Full citation, date, description, and §102 target claim analysis.

2A. Neurotoxin-for-rhinitis art (the "toxin" branch)

2B. Energy-application / poration art

2C. Implantable / neurostimulation art

2D. Catheter / delivery-structure art

2E. Other neurotoxin-indication art cited in the Background

US 6,872,397 (neuromuscular disorders); US 6,861,058 (essential tremor); US 6,843,998 (pancreatitis); US 6,841,156 (muscle spasm); US 6,838,434 (sinus headache); US 6,827,931 (endocrine disorders); US 6,776,991 (priapism); US 6,773,711 (thyroiditis); US 6,767,544 (cardiovascular disease); US 6,740,321 (thyroid disorders); US 6,649,161 (hypocalcemia); US 6,447,785 (hypercalcemia); US 6,645,496 (tardive dyskinesia); US 6,623,742 (fibromyalgia); US 6,620,415 (Parkinson's disease); US 6,448,231 (cerebral palsy); US 6,358,926 (inner ear disorders); US 6,139,845 (cancers); US 6,265,379 (otic disorders); US 2004/0253274 (appetite reduction); US 2004/0213814 and US 2004/0213813 (compulsive disorders); US 2004/0175399 (uterine disorders); US 2003/0211121 (neuropsychiatric disorders); US 2004/00091880 (dermatological/transdermal); US 2003/0202990 (focal epilepsy).

Assessment: this entire block is neuromodulation-indication art. None of it discloses or suggests a nasopharyngeal-positionable elongate body bearing multiple radiofrequency electrodes driven by an RF generator to treat rhinitis. None is a §102 anticipation reference for the granted claims. They belong to the specification's toxin-therapy narrative, which (as the IPR record confirms) is not claim-limiting.

Also cited in the specification / Related Applications: App. Ser. No. 10/437,882 (asthma, intact BoNT); U.S. Pat. App. 60/701,747 (electroporation catheters, filed 2005-07-22); Prov. 60/702,077 and 60/747,771. These are applicant's own family — not prior art.

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3. The prior art that the Office/Board actually applied against the '077 claims

This is the operative set. From the PTAB record (IPR2024-00281 exhibit list; IPR2024-00669 petition/FWD):

Critical dispositive point: the Board's July 21, 2025 Final Written Decision held all challenged claims (1–8, 11) unpatentable as obvious under §103 — Makower + Fang + Edwards-535, and further Stern for claim 4. The Board made no §102 anticipation holding. The only §102-flavored grounds (Saadat/Deem, Grounds 1–4) were never instituted.

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4. §102 anticipation analysis, reference by reference

Legal standard applied: pre-AIA §102 requires a single prior-art reference disclosing each and every limitation of the claim, arranged as in the claim (Net MoneyIN / Verdegaal); §102(e) treats a U.S. application publication as prior art as of its filing date. Anything requiring two references is §103, not §102.

Claim framework (as litigated; wording unverified)

• Claim 1 (independent): apparatus for treating rhinitis in a nasal cavity — hand-held elongate body; distal portion positionable in the nasopharyngeal passage; multiple radiofrequency electrodes coupled to the distal portion; radiofrequency generator coupled to the proximal portion for supplying RF energy to treat target nasal tissue and thereby treat rhinitis.
• Claim 4: "at least two bipolar RF electrodes comprising multiple pairs of bipolar RF electrodes."
• Claim 7: electrode-configuration limitation (Petitioner's brief notes claim 7 does not require insulating material surrounding the electrodes).
• Claim 11 (independent): per the Bikson declaration, an apparatus for treatment of a nasal condition by altering a function of a nasopharyngeal passage — energy delivery element in the distal portion, energy source supplying energy to alter nasopharyngeal cells such that nasal congestion is reduced.
• Claims 2, 3, 5, 6, 8: dependents (bipolar RF electrodes; nerve tissue as target; sensing/thermal sensors; monitoring degree of treatment). Claims 9–10 were not challenged and remain untested.

Reference-by-reference §102 result

Bottom line on §102

On the record I retrieved, no single reference anticipates any of claims 1–8 or 11. Every independent claim requires, in one apparatus, (a) a nasopharyngeal-positionable elongate body and (b) multiple RF electrodes and (c) an RF generator configured to treat rhinitis — and the art splits those elements across Makower (device), Fang (indication/target), Edwards-535 (generator/control) and Stern (electrode pairing). That is the definition of a §103 case, and §103 is exactly what the Board decided (all challenged claims unpatentable, FWD 2025-07-21). The only genuinely single-reference anticipation candidate is Makower, and even Petitioner did not win on it alone.

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5. Practical takeaways

1. For an invalidity attack: lead with the §103 combination the Board already endorsed (Makower + Fang + Edwards-535; + Stern for claim 4). Do not stake a §102 case on any single reference; Makower alone will fail on the generator/rhinitis elements.
2. For the untested claims 9–10: the same art is your starting point, but you must map them yourself — the Board never construed them.
3. Antecedent-art nuance to preserve: Makower is §102(e) art only through its 2004-04-21 filing date. If a post-AIA priority date ever attached to the energy-only claims, Makower's publication and Fang's publication would flip to non-prior-art, and the whole institution theory collapses. That is why Neurent's procedural history (withdrawing IPR2024-00281 over the §311(c) timing issue and refiling as IPR2024-00669) matters — priority is the fault line in this patent family.
4. Verification items I could not close: (i) the verbatim (56) list on the US 11,679,077 front page — pull the granted PDF at https://patentimages.storage.googleapis.com/... or USPTO Patent Center for App. 17/151,938; (ii) the exact numbers for Saadat (Ex-1003) and Deem (Ex-1004); (iii) the verbatim text of claims 1–11 and the FWD's per-claim reasoning (PTAB Paper 43, IPR2024-00669). I will not represent the parent-'675 citation list as the '077 (56) list without that check.

Sources consulted: Google Patents US11679077B2 (https://patents.google.com/patent/US11679077B2/en); US10610675 front page "(56) References Cited" (patentimages.storage.googleapis.com/cd/e2/74/309071614ba874/US10610675.pdf); PTAB records for IPR2024-00281 (Docket Alarm exhibit list) and IPR2024-00669 (PTACTS declarations/exhibits, ptacts.uspto.gov); Aerin/Foundry amended complaint in D. Del. 1:23-cv-00756 (RPX Insight) establishing asserted claims 1–8, 11.

I found the key IPR context. Let me verify the identity and content of the four prior-art references that drove the PTAB's unpatentability findings (Makower, Fang, Edwards-535, Stern) and pin down the challenged claims.

I have enough from the record to complete the analysis. Note: the Google Patents page for the '077 patent does not contain a discrete "Prior Art" section — the prior art is set out in the patent's Background (specification) plus, critically, the art identified in the IPR2024-00669 record, which produced the binding unpatentability determination. I analyze both, prioritizing the IPR art because it is what actually drove the PTAB's final written decision.

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Obviousness Analysis — US 11,679,077 B2 under 35 U.S.C. § 103

I. Scope, sources, and caveats

• What was actually decided. In IPR2024-00669 (Neurent Medical Inc. et al. v. The Foundry, LLC et al.), the PTAB instituted trial (July 23, 2024) and issued a Final Written Decision (July 21, 2025) determining all challenged claims (claims 1–8 and 11) unpatentable under 35 U.S.C. § 318(a), dismissing Patent Owner's motion to exclude (Docket Alarm: IPR2024-00669, Paper 43). That decision is now on appeal at the Federal Circuit (Case 25-2114), so the PTAB's obviousness holding is the operative, most-recent merits determination but is not yet final.
• Claim text caveat. The full verbatim granted claims were not retrievable from my sources; claim 1 is characterized in the IPR record as an apparatus for treating rhinitis comprising a hand-held elongate body (distal portion positionable in the nasopharyngeal passage), multiple radiofrequency electrodes coupled to the distal portion, and an RF generator coupled to the proximal portion for supplying RF energy to treat target tissue in the nasal cavity and thereby treat rhinitis. Dependent claims add bipolar RF electrodes, multiple pairs of bipolar RF electrodes (claim 4), nerve tissue as the target, sensing electrodes/thermal sensors, and monitoring of the degree of treatment. Treat the exact wording as unverified.
• Key priority-date fact that makes the art available. Patent Owner itself conceded the '077 patent is entitled to a priority date of at least July 21, 2006 (filing of Application 11/459,090 → US 7,608,275). The references used in the instituted grounds — Makower (published Oct. 27, 2005), Fang (published July 20, 2005), Edwards-535 (issued 2003), Stern (issued 1996) — all predate that date, so all are § 102 prior art. (The Board rejected Petitioner's Grounds 1–4, which depended on a later priority date, but that does not affect the instituted combinations.)

II. Legal framework

Under 35 U.S.C. § 103, a claim is unpatentable if the differences between it and the prior art are such that the claimed subject matter as a whole would have been obvious at the time of invention to a person of ordinary skill in the art (POSITA), assessed under Graham v. John Deere (scope/content of prior art, differences, level of skill, secondary considerations) and KSR Int'l Co. v. Teleflex (explicit or implicit motivation to combine, reasonable expectation of success, common-sense combination of known elements with predictable results). A POSITA here is a person with training and experience in interventional ENT/rhinology and catheter-based energy delivery devices (electrosurgery/RF ablation), typically a few years of device-development experience in otolaryngology or electrophysiology-adjacent fields.

III. The challenged claims and what they require

As construed by the parties in the IPR, the challenged claims are directed to an energy-only RF apparatus for treating rhinitis — notably, the granted claims as litigated do not require neurotoxin delivery, electroporation, or sonoporation (the specification's extensive toxin/BoNT-LC disclosure is not claim-limiting). The claim 1 combination is essentially: (a) a hand-held elongate body; (b) a distal portion configured for nasopharyngeal positioning; (c) multiple RF electrodes on the distal portion; (d) an RF generator for supplying energy to treat target nasal tissue to treat rhinitis. Dependent claims add: two bipolar RF electrodes; multiple pairs of bipolar RF electrodes (claim 4); treating nerve tissue; sensing electrodes/thermal sensors; and monitoring of treatment degree. This is a straightforward aggregation of well-known RF-ablation catheter elements applied to the nasal/nasopharyngeal anatomy — which is why the Board found the combination obvious.

IV. The primary prior-art references

1. Makower — US 2005/0240147 A1 ("Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and/or Throat")

• Identity: Makower & Chang, assignee Acelarent, Inc.; filed Apr. 21, 2004; published Oct. 27, 2005 (Ex-1005 in the IPR).
• Disclosure: Treats sinusitis, enlarged turbinates, allergic conditions, and other ENT disorders via flexible catheters. It expressly discloses an electrosurgical device with a flexible shaft 210 and multiple radiofrequency electrodes (216) carried on strut members (214) (FIG. 5H), contactable with tissue in the nasal cavity or nasopharynx to apply current and heat tissue; occluder/access devices for the nasal cavity; and monitoring of catheter/tissue parameters (e.g., temperature). Makower was described by the Examiner in a related family case as the "closest prior art" for treating ENT disorders by inserting an energy-emitting device into the nasopharynx. (Sources: Acelarent publication text at PTAB exhibits; IPR2024-00669 petition excerpts; Docket Alarm IPR2024-00279 petition at 9.)

2. Fang — "Nasal endoscopy combined with multiple radiofrequency for perennial allergic rhinitis" (Ex-1006)

• Identity: Fang, J. First Mil. Med. Univ. 25(7):876 (published July 20, 2005) — a peer-reviewed clinical report.
• Disclosure: Treats perennial allergic rhinitis using multiple radiofrequency applications under nasal endoscopy, targeting the inferior nasal turbinate and applying RF energy to the nasal cavity/nasopharynx to reduce nasal congestion and mucus production — i.e., the very symptom set (rhinorrhea/congestion of rhinitis) that the claims treat — by acting on the parasympathetic innervation arising from the sphenopalatine ganglion region. (Sources: IPR2024-00669 petition at 67–70; Neurent expert declaration.)

3. Edwards-535 — US 6,517,535 (Ex-1008)

• Identity: US 6,517,535, issued Feb. 2003 (inventor Edwards et al.).
• Disclosure: An RF tissue-treatment patent teaching application of RF energy to tissue with controlled energy delivery and heat generation (col. 9:14–45), including temperature feedback, sensing elements/thermal sensors, and monitoring of treatment degree — supplying the generator/control details that Makower and Fang leave to the POSITA ("designs and constructions of such components and assemblies are well known," Makower ¶[0164]). (Sources: IPR2024-00669 petition excerpts citing Edwards-535 at 7:28–36, 8:17–25, 9:14–45.)

4. Stern — US 5,562,720 (Ex-1009)

• Identity: US 5,562,720, issued Oct. 1996 (Stern et al.).
• Disclosure: A thermal-therapy apparatus delivering RF energy through multiple pairs of bipolar electrodes, disclosing the "multiple pairs" configuration and its safety/control advantages (12:55–13:2). This is the reference that supplied the "multiple pairs of bipolar radiofrequency electrodes" limitation of claim 4. (Sources: IPR2024-00669 reply declaration; petition § XI.F.)

V. Combination 1 — Makower + Fang + Edwards-535 (Ground V): obviousness of claims 1–3, 5–8, and 11

A. Element-by-element coverage (per the Petition, IPR2024-00669)

• Hand-held elongate body; distal portion positionable in the nasopharyngeal passage; proximal portion outside: Makower's electrosurgical device is a flexible-shaft (catheter-type) device whose distal electrode-carrying struts are inserted into the nasal cavity/nasopharynx while the operator holds the proximal end outside the patient (Makower ¶[0133]–[0135], ¶[0161]–[0162], FIG. 2A). The petition explains that RF ablation probes of this type were understood by physicians to be hand-held devices positioned in this way.
• Multiple RF electrodes coupled to the distal portion: Makower's FIG. 5H device — multiple electrodes (216) on struts (214) that contact surrounding nasal/nasopharyngeal tissue to apply current and heat tissue (Makower ¶[0161], ¶[0164], ¶[0187], FIG. 5H; claims 1–2).
• RF generator supplying energy to treat target nasal tissue and thus treat rhinitis: Fang supplies the therapeutic purpose — treating perennial allergic rhinitis by RF application to the nasal cavity/turbinates; Makower supplies the device; Edwards-535 supplies the generator/control implementation (energy dosage, heat control, temperature monitoring). Petition mapping: IPR2024-00669 at 72–77, 85–87, 91–92.
• Dependent limitations (nerve tissue target, sensing electrode/thermal sensor, monitoring): Makower discloses monitoring tissue/catheter parameters (temperature); Edwards-535 discloses thermal sensors and monitoring of treatment degree; Fang establishes that the clinically relevant target is the parasympathetic innervation/neural activity driving mucus secretion and congestion (IPR2024-00669 at 86, 87, 91–92).

B. Motivation to combine — why a POSITA would have combined them

1. Same field and same problem. Each reference is in the field of energy-based treatment of nasal/nasopharyngeal tissue. Makower expressly lists electrosurgical devices among its working devices for sinusitis/ENT disorders; Fang reports clinical treatment of the exact disease (perennial allergic rhinitis) using RF in the exact anatomy; Edwards-535 is an RF tissue-treatment patent with the missing generator details. They are analogous art addressing the same problem: reducing nasal congestion/mucus secretion (rhinitis) by applying RF energy to nasal tissue.
2. Complementary, non-conflicting teachings. Makower leaves implementation details (energization, dosage, feedback control) to the POSITA ("designs and constructions of such components and assemblies are well known," ¶[0164]; the device "was ready for improvement"). A POSITA seeking to practice Fang's clinically validated RF treatment would naturally supply the missing control/feedback features from Edwards-535 — a routine substitution of known elements (KSR).
3. No hindsight. The combination is not a "blueprint" reconstruction: each reference independently teaches its own element (device / indication / generator control). The Examiner during prosecution had already evaluated Makower as closest prior art, and the Board found the § 325(d) defense did not bar the grounds.
4. Reasonable expectation of success. Fang's published clinical data gave a POSITA a concrete expectation that RF energy applied to nasal tissue reduces rhinitis symptoms (congestion and mucus); Makower provides a catheter-delivered RF device suitable for the task; Edwards-535 provides predictable RF generator/feedback engineering. The combination is the simple union of a known device with a known treatment method using a known control scheme.

C. Patent Owner's counterarguments (rejected in the FWD)

• "Makower's FIG. 5H device cannot ablate tissue" (hollow interior → electrolytic fluid shunts current away from tissue): The Board rejected this, crediting Petitioner's showing that Makower expressly teaches FIG. 5H as an electrosurgical device for ablating nasal/nasopharyngeal tissue, and that the strut/electrode structure contacts tissue directly; PO's expert's concern about fluid shunting did not negate the express disclosure.
• "Fang's data are inconclusive": The Board found Fang's disclosure of the RF treatment method and target site sufficient regardless of whether the study was a definitive efficacy trial; the standard is what the reference teaches, not proof of clinical superiority.
• Hindsight: The Board found Petitioner's rationale — combine a nasal RF catheter (Makower), a clinical RF treatment for rhinitis (Fang), and standard RF generator/feedback design (Edwards-535) — was the ordinary, forward-looking path a POSITA would take, not a reconstruction from the claims.

VI. Combination 2 — Makower + Fang + Edwards-535 + Stern (Ground VI): obviousness of claim 4

• Claim 4's added limitation: "at least two bipolar RF electrodes comprising multiple pairs of bipolar radiofrequency electrodes."
• What Stern adds: Stern teaches delivering RF energy through multiple pairs of bipolar electrodes, including multiple pairs active at the same time, and explains the benefits — increased safety and control (Stern 12:55–13:2; IPR2024-00669 § XI.F; Neurent expert reply declaration ¶¶78–100).
• Motivation to combine: Makower teaches bipolar electrodes but leaves the specific pair configuration to the POSITA; Fang and Edwards-535 similarly disclose RF application without pair-configuration details. A POSITA wanting to realize the safety/control benefits of paired bipolar electrodes would look to Stern, a well-known example of a multiple-pair bipolar RF electrode configuration. Using Stern's known technique to implement the omitted detail of Makower/Fang/Edwards-535 is precisely the "known technique to improve similar devices in the same way" that KSR identifies as obvious. Petitioner's expert expressly maintained this opinion in reply, and the Board found the "multiple pairs" limitation taught by the combination (the PO's contrary reading of Stern was rejected).
• Reasonable expectation of success: Stern's disclosed configuration was an existing, proven electrode arrangement; adapting it to a nasal catheter was a routine design choice with predictable results.

VII. Other prior art and alternative combinations (context)

The '077 specification itself cites extensive additional art, most of it directed to the specification's toxin-delivery embodiments rather than the granted energy-only claims:

• Sanders (US 5,766,605) and First (US 6,063,768) — botulinum toxin for rhinorrhea/rhinitis and other conditions; Ünal et al. (2002) — BoNT-A injection into turbinates for allergic rhinitis. These establish the rhinitis-by-toxin branch of the disclosure, which is not claim-limiting post-IPR.
• Babaev (US 6,601,581), Brisken (US 6,361,554 / 6,464,680), Baran (US 5,964,223 / 6,526,976), Kost (US 4,767,402) — energy-mediated (ultrasound/poration) drug delivery; relevant only to specification embodiments.
• Chaddock et al. (2002), US 2004/0151741, US 2005/0019346 — purification of botulinum light chain.
• Grounds 1–4 (not instituted) — references that would be prior art only under a post-Oct. 22, 2019 priority date; the Board (per PO's own concession of at-least-2006 priority) did not rely on them.

If one were analyzing the specification's toxin+energy embodiments under § 103, the natural combinations would be Sanders/First (toxin for rhinitis) + a poration-energy catheter art (e.g., Brisken, Baran, or the electroporation-catheter disclosures) + Babaev (ultrasound-mediated pulmonary delivery). But for the granted claims as actually construed in the IPR (energy-only RF apparatus), the Makower/Fang/Edwards-535(/Stern) combinations are the operative ones, and they were found sufficient for every challenged claim.

VIII. Secondary considerations

The IPR record reflects no secondary considerations (long-felt need, commercial success, unexpected results, skepticism) sufficient to overcome the strong prima facie case. Patent Owner's arguments were directed to the sufficiency of the references and alleged lack of reasonable expectation of success — not to objective indicia — and the Board rejected them.

IX. Conclusion

• Claims 1–3, 5–8, and 11 of US 11,679,077 were held obvious under § 103 as a matter of PTAB record over Makower (US 2005/0240147 A1) + Fang (J. First Mil. Med. Univ. 25(7):876 (2005)) + Edwards-535 (US 6,517,535) (Ground V).
• Claim 4 was held obvious over the same combination further in view of Stern (US 5,562,720) (Ground VI) for the "multiple pairs of bipolar radiofrequency electrodes" limitation.
• The motivation-to-combine analysis rests on: (i) common field and shared problem (RF treatment of nasal/nasopharyngeal tissue to treat rhinitis); (ii) complementary disclosures (Makower = device; Fang = clinical indication/target site; Edwards-535 = generator/feedback control; Stern = multi-pair bipolar electrode configuration); (iii) routine substitution of known elements with predictable results under KSR; and (iv) a reasonable expectation of success grounded in Fang's clinical data and the maturity of RF-ablation catheter technology.
• Status: The Final Written Decision (all challenged claims unpatentable) is currently on appeal at the Federal Circuit (Case 25-2114); the Delaware litigation (1:23-cv-00756) remains stayed. I could not verify the CAFC's current disposition from available records.

Key uncertainty to verify against the official record: the exact granted claim language (USPTO Patent Center) and the FWD's precise ground-by-ground holdings (PTAB Paper 43). My analysis of the claims' content is drawn from the IPR petition/expert excerpts, not the verbatim claims.