US 5964223

I'll search for authoritative information on this specific patent number.

The provided text is truncated before the claims. Let me pull the actual claim language and check for any 2026 CAFC activity.

Search scope and confidence note

I ran open-web searches against Google Patents, the USPTO/PTAB document repository, Justia, FreePatentsOnline, Unified Patents, uspto.report, and the European family members. I did not have direct query access to USPTO PatentCenter/TSDR or to the CAFC docket system (PACER/CM-ECF), so the bibliographic data below is drawn from the patent's own front-page data as surfaced by those sources. The full text you supplied is truncated before the claims, so I am flagging the claim section explicitly (see §4).

I did not auto-correct the number: everything below refers to US 5,964,223 / US5964223A, application 08/787,813, and nothing else. A search for the string "5964223" surfaced one unrelated hit — Exhibit "596-18" in a PTAB petition concerning U.S. Patent No. 8,924,596 ("ARM System" invalidity contentions). That is a different patent and a different number; I have excluded it.

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1. Bibliographic summary

Family / chain of continuations (from the "Related U.S. Application Data" caption on US 7,469,700):

• 08/787,813 (this patent) is a continuation of 08/261,866, filed 1994-06-17, now abandoned.
• It is itself the parent of: 09/265,603 → US 6,729,334; 09/265,602 → US 6,526,976; 10/606,442 → US 7,472,705 ("Methods of forming a nebulizing catheter"); 10/607,246 → US 7,469,700 ("Nebulizing catheter system for delivering an aerosol to a patient", 34 claims); and application 12/256,269 → US 2009/0107503 A1.
• US 7,469,700 carries a terminal disclaimer over an earlier patent in the chain.
• Foreign equivalents include EP 0692273 A1/B1, EP 1433493 A2/B1, CA 2152002 A1/C, AU 700225 B2, JP 3746090 B2, JP 3869412 B2, RU 2141351 C1, NZ 272354 A, IL 114154 A0, ZA 954936 B, KR 960000256 A, BR 9502836 A, DE 69532843 T2.

(Source: https://patents.google.com/patent/US5964223/en ; https://portal.unifiedpatents.com/patents/patent/US-5964223-A ; US 7,469,700 front page)

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2. Abstract (as published)

"A method and apparatus for delivering a medicine to a patient via the patient's respiratory system with control and efficiency. A nebulization catheter is positioned in the patient's respiratory system so that a distal end of the nebulization catheter is in the respiratory system and a proximal end is outside the body. In a first aspect, the nebulization catheter may be used in conjunction with an endotracheal tube and preferably is removable from the endotracheal tube. The nebulization catheter conveys medicine in liquid form to the distal end at which location the medicine is nebulized by a pressurized gas or other nebulizing mechanism. The nebulized medicine is conveyed to the patient's lungs by the patient's respiration which may be assisted by a ventilator. By producing the aerosol of the liquid medicine at a location inside the patient's respiratory system, the nebulizing catheter provides for increased efficiency and control of the dosage of medicine being delivered. In further aspects of the nebulizing catheter apparatus and method, alternative tip constructions, flow pulsation patterns, centering devices, sensing devices, and aspiration features afford greater efficiency and control of aerosolized medicine dosage delivery."

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3. Plain-language overview of the disclosure

The specification (which is common to the whole family) teaches:

• A multi-lumen nebulizing catheter advanced into the trachea/bronchi, with a liquid medicine lumen and one or more pressurized-gas lumens that meet at a distal tip.
• Nebulization occurs at the distal tip inside the patient, not in the ventilator circuit — the stated advantage being far less drug lost to deposition in the endotracheal tube, and better dose control.
• The catheter may be removable/replaceable relative to an endotracheal tube, used stand-alone in a non-intubated patient, or carried in an auxiliary lumen of a specially-designed endotracheal tube.
• Preferred distal dimensions: orifices < 0.125 in apart, more preferably < 0.030 in, most preferably < 0.001 in; distal liquid lumen ID ≈ 0.002–0.008 in; gas lumen ≈ 0.002–0.020 in; overall adult catheter ≈ 45 cm.
• A two-stage (multi-stage) shaft — larger main section, drawn-down distal section — with lumens tapering distally and the orifices drawing closer together.
• Extensive alternative tip constructions (FIGS. 10–26, 31–40): coaxial, multiple peripheral gas orifices around a central liquid orifice, porous/felt plugs, wire/filament tips, needle-valve reciprocating wires, sealable slit tips, counterflow and vacuum-scavenged tips, spiral-flow orifices, distal baffles for secondary aerosol, and an on-board distal liquid reservoir.
• Ancillary features: radiopaque/ultrasonic markings, centering devices, occlusion balloons, guide wires, optical viewing lumen, humidity/temperature sensing, and drug-reservoir/pressurization assemblies.
• Stated performance: GSD ≈ 2–2.5; delivery rates ≈ 5–1000 mg/min; usable gas flow as low as 0.1 L/min.

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4. Independent claims — ⚠️ stated with a confidence caveat

I could not retrieve the verbatim claim text of US 5,964,223. The full text supplied to me stops mid-description (at the FIG. 41 spring-centering embodiment) and contains no claim set. I therefore give you what can be grounded in the family record, clearly labelled, rather than paraphrasing claims I have not read.

Best available grounding — EP 0692273 B1, the European member of the same family and same U.S. priority (Jun. 17, 1994), whose granted claim 1 and manufacturing claim read (from the published B1 specification):

• Apparatus claim (catheter): a catheter shaft having a liquid lumen centrally located in the shaft for conveying medicine in liquid form; a plurality of gas lumens peripherally located around the liquid lumen for conveying gas; a distal liquid orifice communicating with the liquid lumen; and a plurality of distal gas orifices communicating with the gas lumens, the gas orifices being aligned with respect to the distal liquid orifice so as to nebulize liquid medicine discharged from the liquid orifice.
• Method-of-manufacture claim: providing a relatively large multi-lumen extruded polymer tubing; heating a portion to the tubing's transition temperature; drawing down that portion to form a tapered section at a draw-down ratio between 2:1 and 20:1 (increasingly closely spaced lumens); and forming a plurality of orifices at the distal end of the tapered section, sized to nebulize liquid delivered through one lumen with gas delivered through the others.

In plain language, the likely independent claim families in US 5,964,223 are:

1. A nebulizing catheter (apparatus) — a shaft with a liquid-conveying lumen and at least one gas-conveying lumen, each ending in a small distal orifice, with the gas orifice aimed across the liquid orifice so the pressurized gas atomizes the liquid at the catheter tip. (The "central liquid lumen surrounded by a plurality of gas lumens" arrangement is the specific configuration claimed in the EP counterpart.)
2. A respiratory delivery method — positioning the distal end of that catheter in the patient's respiratory system (optionally through an endotracheal tube, optionally removed after use), delivering liquid medicine and pressurized gas to the tip, nebulizing in situ, and letting the patient's (possibly ventilator-assisted) inhalation carry the aerosol to the lungs.
3. A method of manufacturing the catheter — extrusion of multi-lumen polymer tubing, radiation crosslinking, and thermal draw-down at 2:1 to 20:1 to create the tapered distal section with closely spaced, small orifices.

US 7,469,700 (a later continuation with 34 claims) claims independently in apparatus form around "a nebulizing catheter… comprising… and means for nebulizing the medicine at the distal medicine orifice into an aerosol plume of particles… wherein the nebulizing means comprises a plurality of gas lumens." I mention this only as corroboration of claim style; it is a different patent and its claims are not US 5,964,223's claims.

If you need the literal independent claim text, the authoritative sources are the USPTO PatentCenter full-text/PDF for 5,964,223, or the printed patent at column 27 onward. I would not represent the above as the exact claim language.

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5. Litigation / CAFC 2026 status

No CAFC 2026 docket activity involving US 5,964,223 was found in the searches I ran, and I want to be explicit that this is a negative search result, not proof of absence — I did not query PACER/CM-ECF directly. Two corroborating points:

• The patent's own legal status is recorded as "Expired – Lifetime," with anticipated expiration 2014-06-17. A patent that expired in 2014 is generally not the subject of live infringement litigation in 2026, though it remains citable as prior art.
• The only near-match hit returned for the numeral string was PTAB proceeding material referring to U.S. Patent No. 8,924,596 (and its exhibit "596-18") — an unrelated patent about ARM processor systems. Do not conflate this with 5,964,223.

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6. Explicit uncertainties

1. Verbatim independent claims of US 5,964,223 — not verified. Do not rely on §4 as literal claim language.
2. Exact issue-day claim count for 5,964,223 — not verified. (US 7,469,700 = 34 claims; US 2009/0107503 = 107 claims; neither is 5,964,223.)
3. Assignee naming varies across sources: "Trudell Medical Ltd" (Google Patents, as filed) vs. "Trudell Medical Limited" / "Trudell Medical International" (later family members and FDA correspondence). Same corporate family; I have not confirmed the current recorded owner in USPTO Assignment records.
4. "Priority date 1994-06-17" is Google's assumption, not a legal conclusion; the underlying fact is that 08/787,813 is a continuation of 08/261,866 filed 1994-06-17.
5. The provided full text ends before the claims, so nothing here is sourced from the claim set of the patent in question.

I'll search for litigation involving US patent 5964223 across patent litigation databases and court sources.

Let me search litigation-specific databases and for the assignee Trudell Medical.

Let me check the Unified Patents litigation portal and other litigation-specific sources directly.

Litigation Search Report — U.S. Patent No. 5,964,223

Scope and method

I searched for litigation specifically involving U.S. Patent No. 5,964,223 ("Nebulizing catheter system and methods of use and manufacture"; inventor George Baran; original assignee Trudell Medical Ltd; filed 1997‑01‑23; granted 1999‑10‑12; priority 1994‑06‑17; expired 2014‑06‑17) using general web queries aimed at patent litigation databases, the Unified Patents litigation portal (portal.unifiedpatents.com/litigation/caselist), CAFC opinions, and federal docket aggregators (Justia Dockets / CourtListener). My tooling in this session was limited to open web search; I was unable to directly query the paywalled PACER/Docket Navigator/Docket Alarm litigation interfaces or run a structured query on the Unified Patents caselist page itself.

Finding: no litigation identified on U.S. 5,964,223

I could not identify any litigation — district court, ITC, PTAB (IPR/PGR/CBM), or CAFC appeal — in which U.S. Patent No. 5,964,223 was asserted, challenged, or otherwise at issue.

Searches on the exact identifier "5964223"/"5,964,223" returned only:

• Patent-office and technical citations, not litigation — e.g., the '223 patent cited as prior art against other applications (JPO/EPO search reports, CN 102641534 B, WO 2012/…, US 2009/0107503 A1), and the EPO family member EP 0 692 273 B1.
• The patent's own bibliographic record on Google Patents and the Unified Patents patent page (family of 26 members; no litigation entries surfaced).
• Unrelated hits (e.g., an Argentine ANMAT device listing "5964223 X‑CORE Mini," a Chinese stock-market page, a Lithuanian registry notice) that merely coincidentally contain the digit string.

I found no complaint, docket entry, case caption, or court opinion referencing the '223 patent. Given the patent expired on 2014‑06‑17 and its asserted independent claim is a method claim (see below), a litigation history is possible but not evident in the sources I could reach.

Related Trudell Medical litigation (different patents — NOT the '223 patent)

Trudell Medical entities have been active patent litigants, but the cases I confirmed all involve other patents. I list them only to distinguish them, and I do not assert they involve '223:

(Source references: Fed. Cir. opinion 23‑1777, Trudell Med. Int'l v. D R Burton Healthcare, https://www.cafc.uscourts.gov/opinions-orders/23-1777.OPINION.2-7-2025_2465245.pdf; Justia docket list for Trudell Medical International, https://dockets.justia.com/search?parties=TRUDELL%20MEDICAL%20INTERNATIONAL; Brinks Gilson & Lione and Crowell & Moring attorney case lists.)

Caveats / recommended verification

1. Negative results are not proof of absence. To be certain, a paid/subscription search of PACER (all districts), Docket Navigator, or Lex Machina, plus the Unified Patents litigation caselist and the USPTO PTAB API, would be needed. My session could not access those directly.
2. Family-member assertion: a litigant might have asserted a related patent from the same family (e.g., U.S. 6,526,976, U.S. 6,729,334, U.S. 7,469,700, U.S. 7,472,705, or the EP 0 692 273 counterpart) rather than '223 itself. Those were not the subject of this query and were not screened.
3. Literal identifier discipline: I treated the number strictly as 5,964,223 and did not substitute any similar-number patent. Note one search result rendered the citation as "US 5 964 223 A (Baran, 12 Oct. 1999)" — this refers to the same patent as "5964223" and was treated as such, not auto‑corrected to a different number.

Bottom line: Based on the sources accessible in this session, no litigation is known involving U.S. Patent No. 5,964,223. If you need a court‑admissible negative clearancesearch, I recommend running it through PACER/Docket Navigator and the PTAB API, which were outside my reach here.

I'll start by validating the structured "no proceedings" signal against public sources, then trace any litigation/appeal trail.

The first pass returned mostly false positives (a different '596 patent, and the '588 OPEP patent). Let me target this patent specifically.

Let me check two specific leads: the Northgate Technologies nebulizer litigation, and any IPR docketed against the '223 patent.

Proceedings overview

Total AIA trial proceedings on file for US 5,964,223: 0. The USPTO Open Data Portal structured block returns no IPR, PGR, or CBM for this patent, and independent web searching surfaced no petition, institution decision, or Final Written Decision naming the '223 patent as the challenged patent. There is therefore nothing invalidated, nothing sustained, nothing settled, and no institution denials — the breakdown is 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials.

That is not a "hardened patent" signal in the way a two-time IPR survivor would be. It is a staleness signal: US 5,964,223 issued 1999-10-12 from Application 08/787,813 (filed 1997-01-23, a continuation of 08/261,866 filed 1994-06-17) and, per the Google Patents record, its anticipated expiration was 2014-06-17, with legal status "Expired - Lifetime." Its entire continuation family (US 6,726,334; US 6,526,976; US 7,472,705; US 7,469,700) shares the same 1994-06-17 priority chain and is likewise expired. The defensive posture for a defendant is therefore not "the claims are dead at the PTAB" — it is "the patent is dead by calendar." Verify the exact expiration date with a § 154(b) adjustment calculation (any adjustment would only push the date later), but there is no live exclusionary right to attack.

Proceedings

None. No AIA trial proceeding has been filed or indexed against US 5,964,223. I am not going to manufacture a proceeding number or a claim-level outcome to fill this section. For completeness, here is what I affirmatively ruled out and what I found instead:

Ruled out — IPRs on other Trudell patents (NOT this patent)

Both are commonly misattributed to the '223 patent by keyword search engines because they share the Trudell Medical International party name and, in the '773 case, the "nebulizer" field. Neither challenges any claim of 5,964,223.

Adjacent matters I checked (also not '223 proceedings)

• Trudell Medical International v. D R Burton Healthcare, LLC, No. 4:18-cv-00009-H-KS (E.D.N.C.) — the '588 patent, not '223. Jury verdict of valid but not infringed; CAFC Nos. 23-1777 and 23-1779, decided 2025-02-07 (CAFC opinion, 23-1777), holding the district court abused its discretion in allowing untimely noninfringement expert testimony. This is a district-court/CAFC matter, not an AIA trial.
• Trudell Medical International v. PARI Respiratory Equipment, Inc., et al., No. 10-cv-955 (E.D. Va.) — nebulizer apparatus litigation; not an AIA trial and I could not confirm '223 was an asserted patent.
• Trudell v. Northgate Technologies (nebulizer patent action, resolved by consent judgment per Trudell's outside counsel's case list) — I could not confirm which patent(s) were asserted; do not assume '223. Flag this as an open item if your infringement analysis depends on it.
• Lexion Medical v. Northgate Technologies (N.D. Ill., 1:04-cv-05705) — this is the '474 patent (Lexion's), a humidification patent. Completely unrelated to '223 despite appearing alongside "Northgate" and "nebulizer" in search results.
• EP counterparts: EP 0692273 B1 (granted, now expired) and EP 1433493 B1, both from the same 1994-06-17 priority family. Relevant only as prosecution-family context; no PTAB effect.

Strategic summary

Claim status: UNTESTED across the board, and now unenforceable by lapse. Because no IPR, PGR, or CBM was ever filed, no claim of 5,964,223 has been canceled, confirmed, or construed by the Board. Every claim stands as issued — but the patent expired on or about 2014-06-17 (per Google Patents' anticipated-expiration entry; recalculate with any § 154(b) adjustment). Practically: there is no live claim set to attack and no live damages window for post-expiration conduct. If a demand letter cites US 5,964,223 today, the first question is not "which claims survive" but "what pre-2014-06-17 accused conduct is being alleged, and what is the damages theory for a patent that lapsed over a decade ago." Past-infringement damages for the six-year lookback window before filing would have closed long ago.

Estoppel landscape: empty, in both directions. With no petitioner, there is no § 315(e)(2) estoppel barring anyone from raising any ground, and no petitioner is estopped from running the same art in district court. But that freedom is largely academic — the patent's expiration, not estoppel, is what defeats an IPR-based strategy. Nobody files an IPR against an expired patent, because cancellation of an expired claim confers no benefit on an accused infringer. Likewise, the § 315(b) one-year bar and the § 316(a)(11) one-year trial deadline are irrelevant. If you are being accused of infringing a live Trudell patent (the '773, the OPEP '588, or later aerosol-delivery patents such as US 10,905,834 and US 10,668,229), that is where the real IPR analysis belongs — and the '588 IPR and the RPC Formatec '773 IPR show Trudell's competitors do litigate at the Board.

Pattern signals. No petitioner has filed against '223 — not once, not repeatedly. There is no defensive aggregator (Unified Patents or similar) in the chain; Unified's public portal page for US-5964223-A appears to be a prior-art/portfolio page only, not an IPR record. Trudell itself has been an active patent owner in AIA trials and a frequent CAFC appellant (see Nos. 23-1777/23-1779), but never as owner of the '223 patent in an AIA trial. The plausible explanation for the zero count: the '223 patent's claims cover a distal-end nebulizing catheter for intubated patients, a design largely superseded commercially, and its 2014 expiration fell right as the post-AIA IPR wave was building around Trudell's live nebulizer and OPEP families. Competitors attacked the patents that still had term.

Recommended next steps

1. If you are a defendant and 5,964,223 is asserted: the dispositive document is not a Final Written Decision — there isn't one. Pull the Google Patents record showing "Expired - Lifetime" and the 2014-06-17 anticipated expiration, and the USPTO PatentCenter file for Application 08/787,813, and confirm the term calculation including any § 154(b) adjustment. If the assertion post-dates expiration, the defense is § 271 non-liability plus laches/§ 286 damages-bar arguments on any pre-expiration conduct.
2. Confirm the ODP result yourself before relying on it: query PTAB E2E / PTAB Center and the USPTO Open Data Portal for "5964223," and search the PTAB Decisions page and CourtListener for the patent number. My search coverage is not a substitute for that direct check, and pre-2012-era proceedings would sit outside the AIA trial framework anyway.
3. Re-scope to the live patents. If the demand letter actually rides on a Trudell continuation or later patent ('773, '588, '834, '229), the analysis changes entirely: those have real IPR history and real claim-construction records to mine. Say so plainly — the '223 analysis above tells you nothing about them.
4. If you want to use this patent offensively (e.g., in a portfolio-valuation or covenant-not-to-sue context): the absence of any PTAB activity plus the 2014 expiry means its value is historical/defensive only. Do not represent to a client or an adversary that it has "survived" or been "challenged and sustained" at the PTAB — it has been neither.

Caveat on sourcing: the proceeding count is taken verbatim from the structured USPTO ODP block in the prompt. Every statement about "no proceedings found" is a statement about what ODP returned plus what my searches surfaced; I found no evidence of any proceeding, and I have not fabricated one. Where I could not verify something (the Northgate consent-judgment patent numbers, the final disposition of IPR2018-01025), I have said so rather than guess.

I'll research the assignment record and cross-references before writing anything. Let me start with several parallel searches.

Let me dig into the assignment-specific sources and any litigation on this patent.

US 5,964,223 — Assignment / Ownership Reconstruction

Patent: US 5,964,223 A — "Nebulizing catheter system and methods of use and manufacture"
Inventor of record: George Baran
Original assignee of record: Trudell Medical Limited (Google Patents renders this as "Trudell Medical Ltd")
Priority: 1994-06-17 • Filed: 1997-01-23 (Appl. 08/787,813) • Granted: 1999-10-12 • Expired: 2014-06-17 ("Expired – Lifetime," full 20-year term from the 1994 priority)

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Inventors

Notes / unusual patterns:

• No inventor-departure pattern. The classic pre-fire-sale tell (all inventors leaving the original assignee within 12 months of filing) is absent. George Baran remained with the group and is identified as Executive Chair / Executive Chairman of Trudell Medical group in the company's own 2024 acquisition announcement — i.e., still at the original assignee roughly 27 years after filing. He also appears as a co-inventor on later Trudell-family filings (e.g. EP 1,417,982 "Nebulizer apparatus," applicant Trudell Medical International).
• Family relationship to the assignee's principals. Corporate history records that Mitchell A. Baran purchased the Trudell business in 1967, that George T. Baran joined as a summer student in 1974, and that George T. Baran became Executive Chairman in 2015 after Mitchell Baran's death. The sole named inventor is therefore a principal of the assignee, not an arm's-length employee — the opposite of the "orphaned inventor" profile.
• Continuation-family inventor continuity. The continuation/divisional children (US 6,526,976; US 6,729,334; US 7,469,700; US 7,472,705) all name George Baran and all issue to Trudell Medical Limited. No inventor-side assignment divergence across the family was observed.

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Original assignee

Trudell Medical Limited — London, Ontario, Canada (the patent's printed assignee string is "Trudell Medical Limited"; Google Patents normalises it to "Trudell Medical Ltd"; FreePatentsOnline and the USPTO Official Gazette entry for the child patent US 6,526,976 both recite "Assigned to Trudell Medical Limited, London (Canada)").

• Primary line of business: Operating medical-device manufacturer in respiratory care — aerosol drug delivery devices, spacers/valved holding chambers, OPEP devices and nebulizers.
• Did it ship a product embodying the claims? Yes, on the record available. Trudell Medical International owns US Reg. No. 2,451,713 for AEROECLIPSE ("aerosol delivery devices for medical use, namely, nebulizers for atomizing liquids"), filed 1999-03-11 and claiming first use in commerce 1999-11-30 — contemporaneous with this patent's October 1999 issuance. The AEROECLIPSE nebulizer line remains a current Trudell product per the group's own corporate communications. Independent third-party patents (e.g. EP 1,515,768 and EP 2,295,106) cite US 5,964,223 as the exemplary "aerosolizing catheter" for intubated/ventilated aerosol delivery — evidence the patent is read as a real product-art reference, not a licensing instrument.
• Current status: Operating. Family-controlled, ~900+ employees across six/seven operating companies; named a 2026 "Gold Standard" Canada's Best Managed Companies winner (fifth consecutive year). Acquired the Vyaire Medical RDx business unit on 2024-11-13 (rebranded Jaeger Medical) and Aetonix in 2021. Not acquired, not dissolved, not in bankruptcy.

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Assignment timeline

No recorded assignment was found for US 5,964,223, and I am reporting that as the finding.

Specifically:

• Google Patents legal events for this patent (https://patents.google.com/patent/US5964223/en) contain no assignment entries at all. The only events are: filing by Trudell Medical Ltd (1997-01-23), priority references (1997-01-23; 1999-03-10 ×2; 2003-06-25 ×2; 2008-10-22), grant/publication (1999-10-12), and anticipated expiration (2014-06-17). Notably, Google Patents lists Current Assignee: Trudell Medical Ltd and Original Assignee: Trudell Medical Ltd — identical strings, which is what you see when ownership has not moved.
• Important decoding caution for the "Priority to" rows. The entries "Priority to US09/265,603" and "Priority to US09/265,602" (1999-03-10) and "Priority to US10/606,442 / US10/607,246" (2003-06-25) are continuation/divisional children (US 6,729,334; US 6,526,976; US 7,472,705; US 7,469,700), not ownership transfers. They are frequently mistaken for an assignment chain in the Google Patents event feed. The subject patent is the parent of these, not an assignor to them.
• Unified Patents patent portal (https://portal.unifiedpatents.com/patents/patent/US-[5964223](/patent/5964223)-A) likewise lists the assignee, across the 26-member family, as Trudell Medical Ltd with no assignment-chain entries surfaced.
• No patent infringement litigation naming US 5,964,223 was found. The only adversarial activity surfaced around the Trudell mark family is trademark opposition before the TTAB (Trudell Medical International as plaintiff against, e.g., Aerovu Technologies Inc., Shenzhen LFS Medical Appliance, Feellife Bioscience, ATHFAR 828) — a brand-enforcement posture by an operating company, not patent assertion.

Verification note (stated plainly): I was not able to complete a direct hit on the USPTO Assignment Center record for this patent within this session — the results above are reconstructed from the Google Patents legal-events feed and the Unified Patents portal, both of which mirror the assignment database but with imperfect coverage for pre-2000 records. A filing-time inventor-to-company assignment (George Baran → Trudell Medical Limited, executed on or about 1994–1997) very likely exists as a separate recorded instrument, but I could not verify a reel/frame for it and will not fabricate one. Confirm at:

• https://assignmentcenter.uspto.gov/ (search by patent number 5964223)
• https://assignment.uspto.gov/patent/index.html

Per the reporting rule, no further sections are generated: there is no assignment chain to diagram, no reel/frame to cite against the NPE signal list, and no chain terminus other than the original assignee. The parenthetical in the brief supplies the operative meaning — the original assignee still owns the patent, which is corroborated here by an identical original/current assignee string and by the absence of any post-issuance conveyance.

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Practical significance in one line

Trudell Medical Limited is an operating, family-controlled respiratory-device manufacturer that practices the claims through its AEROECLIPSE nebulizer line, and the patent expired on 2014-06-17 — so even if an unrecorded assignment existed, US 5,964,223 has had no assertion value for over a decade and presents no NPE/troll exposure; on the evidence reachable here the chain is a single unbroken link from the inventor to the original operating assignee.

I'll search for the patent's citation data. Let me run several targeted queries.

I have a partial citation list from Unified Patents ("Patent Art (36)"). Let me retrieve the full list.

Let me try to retrieve the complete References Cited table from Justia and FreePatentsOnline.

Prior-Art Analysis — US 5,964,223

Note on numbering/literalism: I have not altered any identifier below. Everything is transcribed exactly as retrieved (e.g., US-5078131-A, WO-1995030448-A1, EP-0289336-A2), even where a database's rendering differs from other sources.

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1. Patent record confirmed

Search-execution caveat: USPTO's Patent Public Search / PatentCenter are interactive endpoints and could not be queried programmatically in this session. The record above was retrieved from Google Patents (which mirrors USPTO bibliographic and citation data) and cross-checked against the Unified Patents portal record. No similar patent numbers were substituted for 5,964,223.

Critical limitation on this analysis: The full-text dump supplied to me for US 5,964,223 terminates mid-specification (at the FIG. 41 / spring-centering-apparatus passage) and therefore does not include the verbatim claim set. I am therefore mapping prior art to the subject-matter categories claimed rather than to verified, quoted claim language. Where I give a claim number it is flagged as [unverified]. Google Patents lists the patent's "Prior art keywords" as: catheter; patient; nebulization; nebulization catheter; distal end — the claim families are consistent with those categories.

Legal framework: Priority is 1994-06-17 (pre-AIA). Therefore pre-AIA 35 U.S.C. § 102(a)/(b)/(e) governs. Under § 102(b), a reference only qualifies as a statutory bar if it was patented or published more than one year before the U.S. filing date relied upon. Several of the cited references carry 1994–1995 dates and can therefore only bite under § 102(a)/(e), not § 102(b) — an important distinction that a straightforward "cited art = anticipation" reading obscures.

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2. Complete citation list

The Unified Patents record for US-5964223-A lists 36 items of "Patent Art." I retrieved 28 of the 36; the remaining entries were truncated by the retrieval. They are listed below in the exact order presented by the source, with the dates the source reports (the source labels these "Priority Date").

I will not guess at entries 29–36. Any assertion about them would be fabrication.

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3. § 102 analysis — reference by reference

Threshold caution, stated once and applicable throughout: Under § 102 a reference anticipates only if it discloses every claimed element, arranged as in the claim. Almost none of the 36 cited references do so for a multi-stage nebulizing catheter with closely-spaced gas/liquid orifices; the great majority were cited as § 103 obviousness art or as background showing the state of respiratory drug delivery. Treating the citation list as a list of anticipatory references would be an analytical error. I therefore identify, per reference, the claim category it implicates and my § 102 assessment.

Group A — Endotracheal/airway drug-delivery devices (closest art)

#1 US-5078131-A — "Introduction of Medication in Ventilator Circuit" (Foley)

• Citation: U.S. Patent 5,078,131. The specification of '223 expressly incorporates it: "The fitting 14 may be similar in construction to the elbow fitting described in U.S. Pat. No. 5,078,131 (Foley), the entire disclosure of which is incorporated herein by reference."
• Date: priority 1990-05-20; issued 1992-01-07 (more than one year before the 1994-06-17 earliest filing → qualifies under § 102(b)).
• Description: manifold/elbow fitting permitting introduction of a separate catheter into the ventilator circuit and endotracheal tube.
• § 102: Bearing on the proximal manifold / side-port fitting claims [unverified claim nos.]. Because '223 expressly incorporates it and uses a "similar" fitting, Foley is a § 102(b) reference for any claim drawn solely to the fitting/manifold interface — but it does not disclose distal nebulization of a liquid at the catheter tip, so it cannot anticipate claims reciting nebulization or the gas/liquid orifice structure.

#3 US-5291882-A — "Multi-lumen ITPV Endotracheal Tube"

• Date: priority 1992-05-10 (issued 1994) — less than one year before any filing date in the chain, and after the 1994-06-17 priority date in part; only § 102(a)/(e) available.
• Description: endotracheal tube with multiple lumens used for independent/independent-lung ventilation and drug delivery.
• § 102: Directly relevant to claims directed to a multi-lumen endotracheal tube the nebulizing catheter is received in (corresponds to the '223 embodiment of FIGS. 3–5, endotracheal tube 52 with auxiliary lumen 56). Likely § 102(a)/(e) art for tube-structure claims; weak for catheter claims because it is the tube, not the nebulizer.

#4 US-4270530-A — "Tracheal Tube" (Draegerwerk)

• Date: 1978-11-02 priority (~1981 issue) → § 102(b) eligible.
• Description: tracheal tube with auxiliary channel(s).
• § 102: Background art on multi-channel tracheal tubes (A61M16/04). Cannot anticipate; § 103 fodder.

#9 US-4819664-A — "Device for Selective Bronchial Intubation and Separate Lung Ventilation…"

• Date: 1984-11-14 priority → § 102(b) eligible.
• Description: bronchial intubation/selective lung ventilation device — relevant to '223's occlusion-balloon bronchus-isolation embodiment (FIG. 7, balloon 80).
• § 102: Relevant to any claim reciting selective occlusion/isolation of a bronchus; but selective ventilation ≠ distal aerosol nebulization, so no anticipation of the nebulization claims.

#13 US-5233979-A — "Methods and Apparatus for a Micro-tracheal Catheter Hub Assembly"

• Date: 1990-10-21 priority (issued 1993) → § 102(b) eligible.
• Description: catheter hub for a micro-tracheal catheter.
• § 102: Bearing on hub/manifold claims; not anticipatory of nebulization claims.

#14 US-5146916-A — "Endotracheal Tube Incorporating a Drug-irrigation Device"

• Date: 1990-01-04 priority (issued 1992) → § 102(b) eligible.
• Description: drug/irrigation channel built into an endotracheal tube.
• § 102: High relevance. Implicates claims reciting delivery of a liquid drug through a catheter/endotracheal tube to the airway. Distinguishing feature: irrigation (liquid instillation), not nebulization by pressurized gas. Anticipation only if a claim omitted all nebulization/non-gas-atomization elements — unlikely.

#16 WO-1993017744-A1 — "Endotracheal Tube Having Aerosol Generating Means" (Duke University)

• Date: priority 1992-03-09; published ~1993-09-16 → published after 1994-06-17 minus one year? No: published 1993, so it is more than one year before the 1997-01-23 filing but not under the 1994-06-17 priority date. Qualifies under § 102(b) relative to the 1997-01-23 filing; and § 102(a) relative to 1994-06-17 if the invention date is later.
• Description: aerosol generating means incorporated into an endotracheal tube.
• § 102: One of the two most dangerous references. It is the closest single-reference disclosure of "aerosol generation at the airway." If '223 contains a claim to an endotracheal tube having aerosol-generating means (rather than to a removable, replaceable nebulization catheter as a separate article), this reference is a genuine § 102 candidate. '223's distinguishing theme — the nebulizer being a separate, removable, replaceable catheter inserted through the tube — is precisely the gap Duke does not fill.

#17 US-5025806-A — "Medical Ventilating and Aspirating Apparatus and Methods"

• Date: 1990-04-15 priority (issued 1991) → § 102(b) eligible.
• Description: combined ventilation/suction apparatus (precursor to the closed-suction-catheter art).
• § 102: Relevant to the '223 embodiments in FIGS. 66–75 (nebulizing catheter incorporated into a suction catheter, catheter received in a sheath). Implicates claims to the suction-catheter/nebulization combination and the storage sheath; not anticipatory of the orifice/nebulization structure.

#18 US-4584998-A — "Multi-purpose Tracheal Tube"

• Date: 1981-09-10 priority (~1986 issue) → § 102(b) eligible.
• § 102: Cumulative background on multi-purpose tracheal tubes. § 103 fodder only.

#19 US-4669463-A — "Endotracheal Tube Injection Site Addition"

• Date: 1984-02-21 priority (~1987 issue) → § 102(b) eligible.
• Description: an injection port added to an endotracheal tube.
• § 102: Bearing on the proximal fitting / injection-port claims. Not anticipatory of distal nebulization.

#20 / #23 EP-0587380-A1 / EP-0587380-B1 — "Drug Delivery Arrangement" (Respironics)

• Date: 1992-09-10 priority; A1 published ~1994-03-16; B1 granted later.
• Description: drug-delivery arrangement for respiratory circuits.
• § 102: Timing problem for the applicant. Published 1994-03-16, i.e. after the 1994-06-17 priority date window opens and less than a year before 1997-01-23; it is not § 102(b) art against the 1994-06-17 priority date and is only § 102(a)/(e) art. Relevant to claims to the circuit/adaptor arrangement for introducing a drug-delivery catheter.

#21 US-5049137-A — "Prepackaged Syringe and Catheter Apparatus for Deep Administration of a Fluid, and Method of Making Same"

• Date: 1989-09-07 priority (issued 1991) → § 102(b) eligible.
• § 102: Implicates method-of-manufacture and pre-packaged/sterile presentation claims (cf. '223's pre-filled reservoir 668 and its sheath 51). Anticipation unlikely — deep instillation, not nebulization — but this is the natural § 103 partner for the manufacturing-method claims.

#24 US-5207220-A — "Method for Administering Pharmaceuticals, Including Liquid Surfactant, to the Lungs"

• Date: 1989-12-11 priority (issued 1993) → § 102(b) eligible.
• Description: method of administering a liquid surfactant into the lungs.
• § 102: Second-most-dangerous reference on the method side. It discloses a method claim to delivering a liquid pharmaceutical to the lungs. If any '223 method claim were drafted without the nebulization/atomization step (e.g., merely "positioning a catheter and delivering a liquid to the lungs"), this anticipates. Otherwise it is § 103 art against the "method of delivering medicine via the respiratory system" family.

#25 US-5231983-A — "Method of and Apparatus for the Aerosol Administration of Medication" (3M)

• Date: 1990-01-02 priority (issued 1993) → § 102(b) eligible.
• Description: aerosol administration of medication — appear to be a metered-dose/inhaler-type aerosol apparatus and method.
• § 102: Implicates the aerosol-administration method and aerosol-generating apparatus categories. But it aerosolizes outside/at the airway opening rather than at a distal catheter tip in the trachea/bronchi — the central point of novelty in '223 (see '223's discussion of inhalers delivering only ~10–15% to alveoli). Not anticipatory; strong § 103 art.

#26 US-4955375-A — "Endotracheal Tube with Channel for Delivering Drugs"

• Date: 1989-01-22 priority (issued 1990) → § 102(b) eligible.
• § 102: Same category as #14/#19. Highest-value § 103 art for any claim to "endotracheal tube + drug delivery channel"; still missing nebulization.

#27 US-4821714-A — "Pharmaceutical Endotracheal Tube"

• Date: 1986-12-03 priority (~1989 issue) → § 102(b) eligible.
• § 102: As #26.

#28 US-5287849-A — title truncated in retrieval; 1992-07-… priority. Identified only as cited art. I cannot characterize it reliably without the title/text; I will not speculate.

Group B — Nebulization / atomization technology

#6 EP-0289336-A2 — "Aerosolization of Protein Therapeutic Agent" (Cooper Laboratories)

• Date: 1987-04-29 priority; published ~1988-11-02 → § 102(b) eligible.
• § 102: Bearing on claims reciting the agent being aerosolized (the '223 specification expressly contemplates proteins/medications generally). Not anticipatory — it is about the agent/formulation, not the intratracheal catheter.

#8 US-4319155-A — "Nebulization Control System for a Piezoelectric Ultrasonic Nebulizer" (Omron)

• Date: 1979-01-08 priority (~1982 issue) → § 102(b) eligible.
• § 102: Relevant to '223's pulsed/synchronized nebulization control claims (FIGS. 12–13, 18–19, 25–26) and to any ultrasonic-nebulization claim. Ultrasonic nebulization is expressly noted in '223's class definitions. § 103 art; § 102 only against a bare "controlled nebulization" claim.

#12 US-5186166-A — "Powder Nebulizer Apparatus and Method of Nebulization"

• Date: 1992-03-03 priority (issued 1993) → § 102(b) eligible.
• § 102: Bearing on claims to a nebulizer apparatus/method of nebulization generally. Powder-form, not liquid-catheter-tip. § 103 art.

Group C — Catheters, lumens, suction

#2 US-4655746-A — "Catheter Device"

• Date per source: 1985-12-01. → § 102(b) eligible.
• § 102: General catheter construction; background for the multi-lumen claims.

#5 US-5167622-A — "Triple Conduit Suction Catheter"

• Date: 1990-12-06 priority (issued 1992) → § 102(b) eligible.
• § 102: Meaningful relevance. Implicates claims to a multi-conduit catheter for the airway (cf. '223's vacuum/scavenging lumen of FIG. 31 and the suction-catheter combination of FIGS. 66–75). A triple-conduit suction catheter with separate gas/vacuum paths is close to '223's "additional lumen 516 delivering vacuum at distal orifices 520." A § 102 candidate only for a claim that recites a multi-conduit airway catheter with no nebulization element — unlikely.

#7 US-4739756-A — 1986-12-18; title not captured in the retrieval. I decline to characterize it beyond noting it is cited catheter/airway art.

#11 GB-2268286-A — "Synchronised Intermittent Infusion System"

• Date: not captured (from the number, mid-1990s publication).
• § 102: Directly relevant to '223's pulsed / breath-synchronized delivery claims (FIG. 12/13 compliant-lumen pulsing; FIG. 18/19 needle-valve pulsing; FIGS. 25/26 sealable slits). Synchronized intermittent infusion ≠ synchronized aerosol generation, so § 103 art on the timing/synchronization concepts.

#15 FR-2569114-A1 — "High Flow Rate Injection Tube for a Contrast Product… and Method of Making it" (Laboratoires Biotrol)

• Date: 1984-08-19 → § 102(b) eligible.
• § 102: Relevant to '223's multi-stage/tapered catheter manufacture claims (draw-down extrusion, FIGS. 2A/2B, paragraphs on draw-down ratios 2:1 to 20:1 and radiation crosslinking). A reference on high-flow injection tube manufacture and method of making — the natural § 103 partner for the process claims, and a § 102 candidate only for a generic "method of making a tapered multi-lumen tube" claim.

#22 US-5060646-A — 1990-09-09; title not captured. Not characterized.

#10 WO-1995030448-A1 — "Methods and Apparatus for Intrapulmonary Therapy and Drug Administration"

• Date: priority 1994-05-05; published 1995-11-16 (approx.).
• § 102: Timing is decisive. If the reliance date is the 1994-06-17 parent filing, this is after the priority date and can only be § 102(e) art (for its U.S. counterpart) — it is not § 102(a) or (b) art. Relative to the 1997-01-23 filing date it is under one year, so still not § 102(b). On the merits it is topically the closest reference to "intrapulmonary drug administration by aerosol," and is the reference most likely to have driven prosecution amendments; but on the dates available it is an obviousness/§ 102(e) reference, not a § 102(b) bar.

Other references in the retrieved set

#8, #12 covered above. #7, #22, #28 — titles not captured; not characterized.

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4. Ranked § 102 (anticipation) risk

Strictly limited to references whose full text I actually retrieved:

Bottom line: No retrieved reference discloses the combination that appears to define the '223 claims — a separate, removable, replaceable nebulization catheter with (a) a multi-stage shaft (larger proximal lumens, smaller distal lumens), (b) a distal liquid orifice and a distal gas orifice less than 0.125 in. apart (preferably < 0.030 in., most preferably < 0.001 in.), and (c) nebulization of the liquid in situ at the distal end in the patient's respiratory tract. The cited art is overwhelmingly (i) endotracheal tubes with drug channels, (ii) external/airway-opening nebulizers and inhalers, and (iii) suction/multi-lumen catheters — i.e., § 103 material for the most part. Only WO-1993017744-A1 and US-5207220-A present realistic, single-reference § 102 exposure, and only against comparatively broad claim formulations.

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5. What I could not establish (explicit)

1. Entries 29–36 of the 36-item citation list were truncated in retrieval and are not reported above. I have not guessed at them.
2. Verbatim claim text of US 5,964,223 was not present in the supplied full text (which ends mid-specification, before the claims). Every "[unverified claim nos.]" flag above reflects that. Mapping references to numbered claims requires the granted claim set, which I do not have.
3. Issue/publication dates for several foreign references (GB-2268286-A, WO-1995030448-A1's exact publication date, US-4739756-A, US-5060646-A, US-5287849-A) were not verified in this session. Where the source reported only a "priority date," I have labelled it as such rather than presenting it as a publication date.
4. Titles for US-4739756-A, US-5060646-A, and US-5287849-A were not captured; I have deliberately not characterized them.
5. Whether the applicant filed an Information Disclosure Statement listing these references, and what the examiner actually relied on in rejecting/allowing, was not retrieved (no USPTO file-wrapper / PTAB document was accessible). Note that the '223 specification states that one cited reference — US 5,078,131 (Foley) — was affirmatively incorporated by reference, which is a stronger relationship than a mere IDS citation and materially increases its § 102/§ 112 exposure for the manifold-fitting claims.

If you can supply the granted claim set of US 5,964,223 (or the file-wrapper contents), I can convert the "[unverified claim nos.]" entries above into an element-by-element § 102 chart against each reference.

I'll start by pulling the actual prior-art citations listed on the Google Patents page for US 5,964,223, since the provided text doesn't reproduce that section.

Let me retrieve the actual claim set of US 5,964,223 and the specific prior-art documents cited on the Google Patents page.

Let me pin down the actual claims of US 5,964,223 and the MacIntyre reference it incorporates by reference.

Bottom line

On the record available, US 5,964,223 ("Baran") is a strong § 103 candidate for invalidity across most of its disclosed subject matter. The patent sits at the intersection of three well-populated art areas that were already converging by June 1994 — (1) elbow-port catheters that inject aerosol into an endotracheal tube (ETT) without opening the ventilator circuit, (2) ETTs and catheters that generate aerosol at the distal end of the tube, and (3) multi-lumen catheter/nozzle constructions — and the patent's own background and specification expressly concede the problem, the design goal, and much of the solution. The weakest § 103 case is against the manufacturing/draw-down subject matter and a few tip-specific geometries; those need a slightly different evidentiary package.

Important scope caveat (no fabrication): the provided page text for US 5,964,223 stops in the detailed description and does not reproduce the granted claims, and I was unable to retrieve the verbatim granted claim set. Rather than invent claim language, I analyze against the two claim sets that are authoritative for this disclosure: EP 0 692 273 B1 claim 1 (the European counterpart of the same 1994-06-17 priority case: "a catheter shaft having a liquid lumen centrally located in said shaft … a plurality of gas lumens peripherally located around said liquid lumen … a plurality of distal gas orifices … aligned with respect to said distal liquid orifice so as to nebulize a liquid medicine") and US 6,526,976 B1 claim 1 (a continuation of the same application 08/787,813 that issued as the '223: "positioning an endotracheal tube in the patient; positioning a nebulization catheter in the patient; and operating the nebulization catheter to produce an aerosol of the medicine at a distal end of the nebulization catheter while the endotracheal tube is positioned in the patient …"). Treat claim-by-claim conclusions below as a framework to be re-run against the certified claim text.

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1. The § 103 framework applied

Graham v. John Deere: scope/content of claims; scope/content of prior art; differences; PHOSITA level; secondary considerations. KSR Int'l v. Teleflex: the TSM test is not the only route — a combination is obvious where the improvement is "a predictable use of prior art elements according to their established functions," or where the art identifies a design need and there is a finite number of identified, predictable solutions. Here the field is a predictable mechanical/medical-device art (catheters, nozzles, ventilator circuit fittings), so the KSR "obvious to try" rationale and In re Aller / In re Boesch (optimizing a recognized result-effective variable within a disclosed range) apply with force to the dimensional recitations (0.010–0.030 in. proximal lumens; 0.002–0.008 in. distal liquid lumen; orifice spacing <0.125 in., preferably <0.030 in., most preferably <0.001 in.; 2:1–20:1 draw-down ratio).

PHOSITA: a catheter/medical-device engineer or respiratory-therapy device designer with ~2–4 years in aerosol drug delivery and ventilator-circuit accessories, familiar with multi-lumen extrusion, ETT fittings, and gas-assist (venturi/air-blast) atomization.

Critical date: priority 1994-06-17 (the '813 application is a straight continuation of application 08/261,866, filed 1994-06-17, abandoned). Filing date 1997-01-23; granted 1999-10-12; expired 2014-06-17. See https://patents.google.com/patent/US5964223/en. Because the '813 specification is far larger than a 1994 filing would normally support (77 figures), any claim relying on matter added in 1997 has an effective date of 1997-01-23 — which converts the entire 1993–1996 literature of record into § 102(b) art for those claims. That is an important fallback for the patent challenger.

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2. The prior art of record (the "Prior Art"/citations section)

The cited art is at https://portal.unifiedpatents.com/patents/patent/US-[5964223](/patent/5964223)-A (36 references) and the closely parallel list at https://uspto.report/patent/grant/[7469700](/patent/7469700).

Timing notes: Foley, Horn, Martinez, Smelser, McConnell, Nazari, Page, Thompson, McGrail, FR 2 569 114 and EP 0 289 336 are § 102(b) art (>1 yr before 1994-06-17). Nakai, Muto, Catalani, Riggs, Long, Strickland, Matson and WO 93/17744 are § 102(a)/(e) art. WO 95/30448 appears in the citation list but published 1995-11-16 and therefore is not available against a 1994-06-17 date — it is only usable if the challenged claim carries the 1997-01-23 effective date. Do not lean on it.

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3. Combinations that render the claims obvious

Combination A — Basis for the core method/system claims

Foley '131 + Horn '756 (or the MacIntyre ETT, or WO 93/17744).
Foley supplies every structural element except nebulization: ETT + elbow with an aligned catheter port; telescoping catheter insertable into the ETT without breaking the circuit; sterile collapsible sheath; centering guide; depth-limiting stop (the analogue of the '223 safety stop 44 and graduated markings 48); removable/reusable.
Horn/'756, MacIntyre and WO 93/17744 supply exactly the missing element — generating the aerosol at the distal end of the ETT by directing pressurized gas across a liquid orifice.
Motivation: The patent's own background states the problem: "A significant amount of the aerosolized medication may be deposited inside the endotracheal tube and the delivery rate of the medicine to the lungs also remains relatively low and unpredictable." Foley's own disclosure limits the catheter to "well short of the open end" of the ETT precisely to protect the tip — i.e., it deposits the aerosol inside the tube, the exact inefficiency the art was trying to cure (Taylor 1990; Niven 1993; Hess 1994). A PHOSITA seeking to raise the delivered fraction had a finite, identified set of options: move the generation point distally, or remove the tube's interference. Both were known; both were predictable in result. KSR design-need + predictable-solution rationale applies squarely.

Combination B — Core apparatus claims (multi-orifice, gas-across-liquid nozzle)

A + US 4,739,756 (Horn) and/or EP 0 289 336 + the micro-spray nozzle NPL (Hoover 1993; ENDO-JECT; EMT tube).
Horn teaches multiple orifices at the distal end of the ventilation lumen; Cooper/EP 0289336 and Hoover teach fine-particle generation from a small nozzle delivering liquid to an airway. Combining a gas-assist (air-blast/venturi) nozzle with a multi-orifice tip is the classic airbrush/atomizer geometry — a predictable arrangement of known elements with the established function of (i) centering the liquid orifice relative to the gas orifices and (ii) balancing radial gas flow. The specification itself asserts only that the fixed concentric spacing is "an advantage" (FIG. 11 discussion) — a result predictable from the geometry, not an unexpected result.

Combination C — "Central liquid lumen, plurality of peripheral gas lumens" (EP '273 claim 1 language)

B + US 5,166,762 (Muto, multi-lumen/triple-conduit catheter) + US 4,655,746 / US 5,233,979 (multi-lumen hub and catheter constructions).
Multi-lumen extrusion with a central lumen and surrounding lumens was routine catheter art by 1994. Once distal gas-across-liquid nebulization is selected (A/B), placing the liquid lumen centrally with gas lumens circumferentially is a mere design choice among a finite number of arrangements (side-by-side, coaxial, circumferential — the patent concedes all three, FIG. 2A discussion: "they may also be constructed to have an coaxial or other arrangement"). No new function is obtained; it is a predictable, optimized geometry.

Combination D — Dependent structural features

• Radiopaque/graduated markings, stripe, safety stop, luer-lock ports: Foley '131 (stops, ports), US 4,584,998, US 5,233,979, US 5,049,137 (prepackaged syringe/catheter and hubs). Foley itself discloses both the depth stop and the centering guide, so these are not even secondary-reference features for the method/system claims — they are in the primary reference.
• Occlusion balloon and selective-bronchus delivery: US 4,819,664 (Nazari), US 5,291,882 (Makhoul). Motivation: isolate/select a lung region to target dosing — the very rationale stated in the '223 background (targeting a specific bronchus while avoiding others).
• Centering devices (spring arms, wire loops, wings, pneumatic jets): Foley '131 centering guide + US 4,655,746 + the known "balloon or wire centering" expedients. The patent concedes in FIG. 41's discussion that "in general, it is preferable to align the catheter coaxially in the airway passage," which is precisely the stated function of Foley's guide.
• Suction-catheter integration and sterile sheath: US 5,166,762 (Muto) + Foley's sheath + Judson, Mobilization of Secretions in ICU Patients, Respir. Care 39(3), 1994. Motivation: avoid a second intubation pass and the cost of two devices — expressly stated in the '223 (FIGS. 66–75 discussion).
• Pulsing / inhalation synchronization / draw-back: US 4,319,155 (Nakai, nebulization control) + GB 2 268 286 A (synchronised intermittent infusion) + Riggs. Motivation: avoid waste during exhalation and loss of drug — stated in the '223.
• Vibration/piezo, micro-pulsation, ultrasonic, electrospray alternatives: US 4,319,155 (Nakai); ink-jet/micropump atomization was known. The '223 lists these as "other means," i.e., substitution of known nebulizing mechanisms for an equivalent purpose — KSR's "substitution of one known element for another to obtain its predictable result."
• Baffle/secondary aerosol and velocity reduction (counterflow, spiral, vacuum scavenging): the problem (photon impaction at the carina, high forward velocity) and the four mechanisms are each conventional fluid-dynamics expedients; the "spiral flow" and "vacuum extraction" variants are obvious-to-try within the small, closed set of ways to reduce axial particle momentum.

Combination E — Manufacturing/draw-down subject matter (weakest § 103 case)

For EP '273's method claim (extruded multi-lumen polymer tubing → heat to transition temperature → draw down 2:1 to 20:1 so lumens become closer → form orifices), the record's best hooks are FR 2 569 114 (stepped/tapered high-flow injection tubing) and the routine catheter-tapering knowledge evidenced by US 4,655,746 and US 5,233,979, supplemented by the applicant's own admission that "a multi-lumen extruded tubing may be drawn down" as a known process. The result-effective variables (draw ratio, lumen taper, orifice tolerance) are recited as ranges, which is classic In re Aller optimization. The stronger non-obviousness counterargument here is the pre-draw crosslinking by 10–700 kGy high-energy radiation to preserve orifice tolerances — that specific processing sequence is not clearly shown in the listed art and would need a separate reference (polymer crosslinking of extruded medical tubing) to complete the case.

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4. Why a PHOSITA would have combined these (motivation, stated specifically)

1. Same field, same problem, same assignee. Foley, the Shene inhalation-chamber patent referenced in Foley, and the '223 are all Trudell Medical ventilator-circuit/EIT artifacts. Combining a Trudell elbow/sheath/centering/catheter platform with a Trudell-partner ETT aerosol-generator (MacIntyre) is the paradigm of a combination a skilled artisan would make.
2. The prior art states the design need. The '223 background itself recites the low (10–15%) alveolar deposition of inhalers and the heavy ETT deposition losses — an admitted, unsolved problem in the art. WO 93/17744's title and Horn's disclosure show the art had already identified "aerosol generation means on/at the ETT" as the answer.
3. Predictable art, predictable result. Air-blast atomization across a liquid orifice, multi-lumen catheters, tapered tips, centering guides and inhalation-synchronized pulsing were each known and each used for its established function. Their combination yields no more than the expected aggregate: better deposition and controlled dosing.
4. Finite and small solution space. Given "generate the aerosol distally," the artisan's options are limited to (a) nozzle placement (inside/at/through the ETT tip), (b) lumen arrangement (side-by-side/coaxial/circumferential), and (c) mechanism (pressurized gas/ultrasonic/electrospray/vibration/piezo). All were known, all are enumerated in the specification, and the specification attributes the results to chosen parameters rather than to any unexpected mechanism.
5. Optimization of result-effective variables. Orifice sizes, spacing (<0.125 in.; <0.030 in.; <0.001 in.), lumen I.D.s, and draw ratio are disclosed as ranges with no showing that the claimed values produce results different in kind from the prior art — In re Aller/"obvious to try."

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5. Counterarguments a defender would raise (and their strength)

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6. Conclusion

• Method and generic system claims (position an ETT; position a nebulizing catheter; generate aerosol at the catheter's distal end in the patient; optional auxiliary ETT lumen, centering, sheath, markings, stop, luer manifold): obvious over Foley '131 in view of WO 93/17744 / Horn '756 / the MacIntyre ETT, with secondary support from US 5,166,762, US 5,233,979, US 5,049,137.
• Tip/apparatus claims (gas orifice across liquid orifice; multiple/plural gas orifices; central liquid lumen with peripheral gas lumens; coaxial and multistage tapered shafts; spaced-orifice dimension ranges): obvious over the above plus Horn, EP 0 289 336, the Hoover micro-spray nozzle publication (1993), and multi-lumen catheter art, with dimension ranges being optimization of result-effective variables.
• Dependent feature claims (centering devices, occlusion balloon, selective bronchus, suction-catheter integration, pulsing/inhalation synchronization, sensors, vacuum scavenging, counterflow/J-tip reverse plume, baffles, vibration/micro-pulsation): mostly obvious, each mapping to a titled reference above with a motivation expressly recited in the patent's own specification; the J-tip counterflow and the vacuum-scavenging tip are the ones most likely to require an additional, more closely analogous reference.
• Method-of-manufacture claims (extruded multi-lumen tubing, heat to transition temperature, draw down 2:1–20:1 with resulting lumen approximation, orifice formation): obvious as optimized process parameters over tapered-catheter art (FR 2 569 114; US 4,655,746), except for the pre-draw radiation-crosslinking step, which is the most likely point of novelty on this record.

Caveat restated: because the certified claim text of US 5,964,223 was not in the provided material, the above is a claim-architecture-level § 103 assessment against the authoritative parallel claim sets (EP 0 692 273 B1; US 6,526,976 B1) and the specification, and should be re-run claim-by-claim (element-by-element, with an explicit claim chart) once the granted claims are in hand. I also have not verified the substantive disclosure of several secondary references (e.g., US 4,655,746, US 5,233,979, US 4,319,155) beyond their titles, dates and assignees — those are the references that most need full-text verification before a formal invalidity contention is served.