US 5800399

I'll search for authoritative information on US 5800399, including any 2026 CAFC docket activity.

Let me check for any litigation or PTAB proceedings involving this patent or its family.

US 5,800,399 — Analyst Summary

Caveat on method: I searched the open web (which surfaces USPTO/Google Patents/Justia/Espacenet records) rather than querying a dedicated USPTO PatentCenter or CAFC CM/ECF endpoint. I found no CAFC 2026 docket entry, appeal, or PTAB proceeding mentioning US 5,800,399. I also excluded one false-positive hit — a Florida corporate filing listing FEI No. "20‑5800399" for Tinez Construction Inc. — which is a tax ID, not this patent. Treat the "no litigation" finding as a negative search result, not authoritative proof.

Bibliographic data (from the patent text and Google Patents)

Inventor-name discrepancy to flag: Google Patents renders the second inventor as "Zino Altman," whereas the EP 0 826 388 A3 publication of the same family lists "Altman, Zinovy." I am reporting both literally without correcting either.

Abstract (verbatim)

"Intravenous catheter insertion devices produced by a low cost method of assembling a catheter structure and cannula holder body. Also disclosed is an extruded cannula and blood chamber securement structure. Moreover, there is also provided a novel structure for the realization of simplified extruded catheter insertion devices in which an extruded plastic element is connected with a steel cannula for attachment to a blood chamber or housing to enable a low cost construction rendering the catheter insertion device simple and inexpensive in assembly and construction for economically disposable single usage thereof."

Independent claim 1 (method) — plain language

A two-step method of securing a cannula to a chamber structure such as a blood chamber:

• (a) Place an elongated cannula in a fixed, sealed position running through an axial central through‑bore of an extruded plastic cylindrical member (a "chopped" extrusion acting as a gasket/plug). The longer part of the cannula sticks out one end and ends in a sharp point for venipuncture; a shorter length protrudes from the other end.
• (b) Fasten a chamber structure to that cylindrical member. The chamber's open end has a diameter closely matching the cylinder's outer diameter, and the two are joined by pushing a portion of the cylinder's axial length into the chamber opening in press‑fitted sealing engagement — i.e., no adhesive, no ultrasonic welding.

Notably, the claim does not itself require an interference fit; that limitation appears only in dependent claim 2.

Independent claim 21 (apparatus) — plain language

The structural counterpart of claim 1: an arrangement comprising (a) the same elongated cannula fixed and sealed through the through‑bore of an extruded plastic cylindrical member, with a major length + sharp point projecting from one end and a shorter length from the other, and (b) a chamber structure whose end opening closely conforms to the cylinder's outer diameter, with the cylinder inserted into the chamber in press‑fitted sealing engagement.

Key dependent claims (context for scope)

• Interference fit between cylinder OD and chamber opening (claims 2/22); magnitude "about 0.001 to 0.020 inches" (claims 3/23).
• Cylinder cut to length from a continuously extruded tubular extrudate (4/24).
• Chamber formed from an extruded (5/25) or molded (6/26) hollow cylindrical body.
• Separate finger hold sleeve (7, 8 / 27, 28) or integrally molded finger hold (9/29).
• Molded one‑piece catheter with hub interference‑fitted onto the cylinder (10/30); nose‑guard + housing‑with‑finger‑holds variant (11/31).
• Cylinder and chamber unitarily formed from one extruded member (12/32).
• Blood chamber venting: porous plug (14/34), laser‑cut vents (15/35), or crimped end forming a partial vent (16/36).
• Materials: gasket from extruded urethane, PEBAX, or crosslinked polyolefin filled with mica, DE, or silica gel (17/37); finger hold from stiff lubricious opaque nylon, polyester, polyolefin (18/38); chamber from clear ABS, polypropylene, modified acrylic (19/39); removable extruded plastic sheath over catheter and cannula (20/40).

Internal inconsistency worth noting: dependent claims 3 and 23 recite an interference of "about 0.001 to 0.020 inches," while the specification's description of the same press‑fit states "0.001 to 0.020 mm." I am reporting both as written; the units do not agree between claim and description.

Prior-art citations and family

• US prior art cited (12): US 4,046,144 (McFarlane); US 4,193,399; US 4,193,400; US 4,655,750; US 4,904,240; US 5,013,304; US 5,053,014; US 5,066,284; US 5,181,523; US 5,234,410; US 5,250,033; US 5,575,777.
• Foreign family members (same priority, US 08/703,706): EP 0 826 388 B1, CA 2,213,923 C, JP H10113394 A, AU 720031 B2, CN 1188188 C, KR 100460181 B1, BR 9706346 A, DE 69731157 T2, ES 2230589 T3, MY 119223 A, SG 64436 A1, TW 492327 U, HK 1003871 B. The family also appears in EP 1572154 B1's citation list and several later Becton Dickinson / Carefusion / Smiths Medical ASD flash‑chamber and catheter‑hub patents cite it.

Uncertainty notes

• The assignee chain ends at MEDEX, INC. in the recorded assignments; Google Patents additionally shows Smiths Medical ASD Inc and Ethicon Endo Surgery Inc as current assignees, with its standard disclaimer that assignees "may be inaccurate." I cannot verify the ultimate current owner from the sources retrieved.
• The patent expired 2016‑08‑27 (Google Patents "Anticipated expiration"); the last fee payment shown is year 12 on 2010‑01‑29. Because it is expired, a 2026 CAFC appeal on the merits would be unusual — consistent with my failure to find any 2026 docket activity.
• I have no authoritative 2026 docket information for this patent and cannot rule out a proceeding that is not publicly indexed in the sources I searched.

I'll research litigation involving US patent 5800399. Let me search multiple sources.

Let me search litigation-specific databases and repositories.

Let me search dedicated litigation databases directly.

Answer: No litigation involving US Patent 5,800,399 was found

I searched for litigation specifically tied to US Patent 5,800,399 ("Low-cost method of assembling an extruded cannula holder for a catheter insertion device"; Bogert, Altman & Koehler; filed 1996‑08‑27; granted 1998‑09‑01) using general web search and litigation-oriented queries aimed at sources such as the Unified Patents litigation portal, Justia federal dockets, RPX Insight‑style databases, Docket Alarm, PACER/CAFC‑adjacent results, and the assignees' names (Johnson & Johnson Medical, Ethicon Endo‑Surgery, Medex, Smiths Medical).

Result: I found no district court case, CAFC appeal, ITC investigation, PTAB proceeding, or foreign court action in which US 5,800,399 was asserted, challenged, or otherwise at issue.

Important caution about identifier collisions (do NOT auto-correct)

Because the string "5800399" appears in many unrelated contexts, several apparent hits are false positives and should not be attributed to this patent:

• "Signify North America Corp. v. Lepro Innovation Inc., No. 2:22-cv-02095 (D. Nev.)" — discusses an unrelated short‑form "'399 patent" (LED/lighting technology). This is not US 5,800,399.
• Florida corporate filing, FEI No. 20‑5800399 (Tinez Construction Inc.) — a tax/entity identifier, not a patent.
• JP 5800399 B — a Japanese patent number, unrelated.
• EP 1 572 154 B1 — merely cites US 5,800,399 in a prior‑art/reference list; a citation is not litigation.
• "Transonic Systems v. Non‑Invasive Medical Technologies" — discusses a different patent (the '989 patent), not 5,800,399.

Context on why no litigation is plausible

• The patent's anticipated expiration was 2016‑08‑27, and Google Patents lists its legal status as "Expired – Lifetime," so its enforceable window has closed.
• Ownership history shows transfers among Johnson & Johnson Medical → Ethicon, Inc. → New Endo, Inc. → Ethicon Endo‑Surgery, Inc. → Medex, Inc. (a Smiths Medical entity), with no recorded assignment indicating a litigation‑driven transfer.
• Its technology (low‑cost extruded cannula holder/blood chamber securement for disposable IV catheters) is generally a manufacturing‑cost patent, and I found no evidence of it being used offensively.

Caveats

• I could not exhaustively query every paywalled litigation database (e.g., full PACER, Lex Machina, Docket Navigator, RPX) within this session; absence of results in my searches is not a legal guarantee that no suit ever existed.
• Some very old or sealed actions, foreign suits, or proceedings where the patent was pled under an expired/reissued variant could be missed.

If you need a certifiable negative-on-information, the recommended verification steps are: search PACER's national index / Docket Navigator for "5,800,399" as a patent-in-suit; check the Unified Patents litigation portal and RPX Insight by patent number; and review the USPTO Patent Trial and Appeal Board (PTAB) and the Court of Appeals for the Federal Circuit dockets. On the record available here, the correct answer is that no litigation is known for US 5,800,399.

I'll verify the ODP-derived "no proceedings" baseline against public sources before drafting.

Let me do a couple more targeted checks — including defensive-aggregator activity and the patent's expiration status, which bear on whether a PTAB challenge is even possible.

Proceedings overview

Zero AIA trial proceedings. The USPTO Open Data Portal returns no IPR, PGR, or CBM proceedings for US 5800399, and my independent searches (PTAB petition/decision databases, Google Patents' litigation and "Cited By" records, and CourtListener) surfaced no challenge — the bottom line for a defendant is that the patent itself, not the PTAB, is what disposes of this: US 5800399 expired on 2016-08-27 (20-year term from the 1996-08-27 filing; status "Expired - Lifetime"), so it cannot support prospective injunctive relief, and any residual past-damages theory is now time-barred under 35 U.S.C. § 286.

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Proceedings overview (detail)

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No proceedings to itemize

There are no {PROCEEDING_NUMBER} — {Petitioner} v. {Patent Owner} entries to write up. I will not manufacture proceeding numbers to fill the template; the correct output for this patent is that the section is empty.

Verification performed (all searched 2026-09-27):

⚠️ Search-hygiene warning — "the '580 patent" is a trap

My searches surfaced a large volume of PTAB decisions, claim-construction briefs, and ex parte reexaminations referring to "the '580 Patent." None of them are US 5800399. The confusable ones are:

• US 9,039,580 B1 (Woodway USA / LifeCore — exercise treadmill safety device). Subject of IPR2023-00836, plus an active district court case. Sources: PTACTS petition documents, IPR2023-00836, Woodway v. LifeCore claim construction.
• Rembrandt's '580 patent (communication modulation — US 8,023,580 / 8,457,228 family, subject of IPR2014-00514 and IPR2020-00509/00510). Sources: Docket Alarm, IPR2020-00509, Docket Alarm, IPR2020-00510.

If someone on your team cites "the IPR on the '580 catheter patent," that proceeding does not exist. Don't let it into a brief or an invalidity contention chart.

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Strategic summary

Claim status. All 40 claims of US 5800399 — method claims 1–20 and arrangement/apparatus claims 21–40 — were never tested at the PTAB. There is no canceled claim and no sustained claim, because there has been no adjudication. Independent claims 1 and 21 (the press-fitted, interference-fit extruded cylindrical member / chamber structure securement) remain formally intact. The patent sits at "Expired - Lifetime" on the ODP record (anticipated expiration 2016-08-27, per the Google Patents legal-status events). Contrast this with claims that are judicially dead — here the claims are alive on paper but the enforcement right has run out.

Why no IPR ever attached. This is worth understanding, because it is a reason, not an accident:

1. The patent's commercial window was narrow and low-value. The specification itself is candid: the invention is aimed at "developing or undeveloped so-called 'third world' countries," explicitly to make catheters cheap enough to be "economically disposable after only a single use." A patent that concedes its market is low-margin single-use disposables in cost-constrained geographies does not generate the damages exposure that funds a $300k–$500k IPR campaign. PTAB challenges follow money, not claim scope.
2. The patent was never asserted in a campaign that I can find. No district court litigation asserting US 5800399 appears in CourtListener or in Google Patents' litigation records. No assertion → no petitioner → no IPR.
3. AIA trial availability was real but unused. IPR has been available since 2012-09-16, giving roughly a four-year window before expiration. PGR was never available (pre-AIA patent, filed 1996-08-27). CBM would have required a "covered business method" patent — a cannula/blood-chamber securement is a mechanical medical device, not a financial-services method, so CBM was never a viable vehicle.
4. Ownership drifted away from the innovator. Johnson & Johnson Medical → Ethicon, Inc. (merger, effective 1997-12-18) → New Endo, Inc. (effective 2001-12-31) → Ethicon Endo-Surgery, Inc. (name change) → Medex, Inc. (assignment effective 2003-05-21); ODP's "current assignee" list also shows Smiths Medical ASD Inc. A patent that has been warehoused through four corporate transactions and is close to expiry is exactly the profile that never attracts a defensive aggregator like Unified Patents — my search found no Unified Patents involvement.

Estoppel landscape. There is none. Section 315(e)(2) estoppel is petitioner-and-privy-specific and attaches only to a petitioner that received a final written decision. With zero petitioners, zero FWDs, and zero IPRs, no party anywhere is estopped from raising any ground — every § 102/§ 103 theory against claims 1–40, on any reference, is legally unburdened. That is cold comfort, because the far simpler answer is that you should not need an invalidity defense at all (see below).

Cross-reference: this is a patent family worth compartmentalizing. The same specification/family is the subject of several sibling US patents (e.g., the "Coated one-piece composite plastic catheter and cannula" and "Blown-in-place blood gasket for a safety catheter" documents listed as similar). If a plaintiff is working a catheter-insertion portfolio, attack the unexpired members, not this one — but be alert that a pleading might cite 5800399 as background art or as a priority-chain anchor.

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Recommended next steps

If you are a defendant and a demand letter cites US 5800399:

1. Lead with expiration, not invalidity. The patent expired 2016-08-27 and the ODP status is verbatim "Expired - Lifetime." A patent owner cannot obtain an injunction, an ongoing royalty, or a prospective design-around demand on an expired patent. Any theoretically recoverable past damages are subject to the six-year lookback of 35 U.S.C. § 286, measured from the date the complaint is filed — so a complaint filed today (2026-09-27) can reach back only to roughly 2020-09-27, a period entirely after expiration. On those dates the § 286 window and the patent term do not overlap. Say that in the first paragraph of your response letter.
2. Confirm the maintenance-fee / expiration posture in writing. Pull the USPTO Patent Center record for US 08/703,706 and the fee-payment history (ODP shows 4-, 8-, and 12-year fee payments through the 2010-01-29 entry, consistent with a full-term run to the 2016-08-27 anticipated expiration). Attach it to the file.
3. Do not spend money on an IPR. There is no live proceeding, and filing an IPR against an expired patent to obtain a certificate canceling claims you cannot be liable for prospectively is a poor use of budget — and the Board would likely treat the request as moot on the injunction question. If you need a cancellation certificate for portfolio-cleanliness reasons (e.g., a covenant or an acquisition diligence), that is a different, deliberate decision — not a defensive reflex.
4. Check for a covenant-not-to-sue or an assignment-chain gap. The Ethicon → Medex (2003) and Smiths Medical ASD lineage matters: verify your adversary actually holds enforceable title to the '399 patent, and check whether any prior settlement in the family carries a covenant covering it.
5. Redirect diligence to live patents. If the assertion is portfolio-wide, identify which asserted patents are unexpired and work the PTAB angle there. For those, run the same "Cited By" and litigation-database check I ran here — and be careful to distinguish them from the two unrelated "'580 patents" flagged above.

Bottom line: No PTAB activity exists on US 5800399 — and there never will be. The absence is itself informative: this was a low-cost, low-margin device patent aimed at developing-world single-use disposables, it was never litigated, and it was allowed to expire. For a defendant today, the patent is a dead letter. Your memo should say so plainly rather than reaching for an invalidity narrative the PTAB never gave you.

I'll verify the assignment chain and check for litigation/assertion history before reconstructing the record.

Let me check for litigation history, the Medex→Smiths transfer, and the current corporate status.

Assignment & Ownership Reconstruction — US 5,800,399

Patent: US 5,800,399 A — "Low-cost method of assembling an extruded cannula holder for a catheter insertion device"
App. No.: 08/703,706 | Filed: 1996-08-27 | Issued: 1998-09-01 | Status: Expired – full term reached 2016-08-27
Source of record used: Google Patents legal-events table for US5800399 (which mirrors USPTO reassignment data), cross-checked against Smiths Group plc and UK OFT/CMA merger documents.

Data-quality caveat up front: my source exposes reel/frame numbers, execution/recording dates and assignor/assignee names, but it does not expose the correspondent (recording attorney/agent) field for any of the five records. That field lives in the per-record detail view of USPTO Assignment Center. I have therefore not listed correspondents rather than guess at them — this is the single biggest gap in this reconstruction and is called out again under Signal 3.

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Inventors

All three executed the assignment between 1996-08-14 and 1996-08-19 — i.e., roughly 8–13 days before the 1996-08-27 filing date. That is a routine "sign on the way out the door to the PTO" pattern, not a departure signal.

Unusual-pattern check — negative. There is no evidence of inventors leaving the original assignee, no inventor-side re-assignment, no separate inventor-owned continuation, and no individual inventor appearing later in the chain. This is a plain corporate-employee inventorship profile. The three inventors signed to J&J Medical and disappear from the record thereafter — which is what you want to see in a clean operating-company chain.

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Original assignee

Johnson & Johnson Medical, Inc. (record lists the assignee's address of record as Texas), a Johnson & Johnson operating subsidiary.

• Line of business: Professional medical products — this patent's subject matter (a chopped-extrusion cannula holder / blood-chamber securement for an IV catheter insertion device) is squarely in the Jelco IV-catheter and needle line, which J&J ran through Ethicon Endo-Surgery. The specification's explicit cost-minimization framing ("developing or undeveloped countries," "economically disposable after only a single use") is a commercial-strategy statement, and the claims (1–40) cover the physical cannula/hub/blood-chamber architecture, not a research curiosity.
• Did they ship a product embodying the claims? Probable but not directly verified in this session. No marketing materials, product numbers or catalogue evidence surfaced. I can state with confidence only that the asserted chain runs through the J&J IV-access (Jelco) business, which was a commercial catheter line; I cannot name a specific SKU.
• Current status: J&J Medical, Inc. as a separate legal entity no longer exists — it merged into Ethicon, Inc. effective 1997-12-18 (Reel 014675/0320). The Jelco vascular-access business itself was sold to Medex, Inc. in May 2003.

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Assignment timeline

Five assignments are recorded against this patent. All five are reflected in the Google Patents legal-events table; all reel/frame numbers below are from that table.

• 1996-08-14 / 1996-08-19 (executed, per signing dates) / recorded 1996-08-27 — Reel 008183/0055

  • Conveyance: Assignment
  • Assignor: Bogert, David L.; Altman, Zino; Koehler, Thomas
  • Assignee: Johnson & Johnson Medical, Inc. (Texas)
  • Correspondent: not exposed in the retrieved record — verify in Assignment Center
  • Context: original employee invention assignment, filed contemporaneously with the application.

• 1997-12-18 (effective) / recorded 2004-05-25 — Reel 014675/0320

  • Conveyance: Merger ("ASSIGNOR: JOHNSON & JOHNSON MEDICAL, INC.")
  • Assignor: Johnson & Johnson Medical, Inc.
  • Assignee: Ethicon, Inc. (New Jersey)
  • Correspondent: not exposed — verify in Assignment Center
  • Context: internal J&J corporate reorganization; J&J Medical absorbed by Ethicon. Recorded ~6.4 years late.

• 2001-12-31 (effective) / recorded 2004-06-15 — Reel 014734/0642

  • Conveyance: Assignment
  • Assignor: Ethicon, Inc.
  • Assignee: New Endo, Inc. (New Jersey)
  • Correspondent: not exposed — verify in Assignment Center
  • Context: internal reorganization of the Ethicon Endo business into a new holding entity, in preparation for carve-out. Recorded ~2.5 years late.

• 2001-12-31 (effective) / recorded 2004-06-28 — Reel 014788/0206

  • Conveyance: Change of Name
  • Assignor: New Endo, Inc.
  • Assignee: Ethicon Endo-Surgery, Inc. (New Jersey)
  • Correspondent: not exposed — verify in Assignment Center
  • Context: change of name only — no change in beneficial ownership.

• 2003-05-21 (effective) / recorded 2004-08-12 — Reel 015035/0753

  • Conveyance: Assignment ("ASSIGNOR: ETHICON ENDO-SURGERY, INC.")
  • Assignor: Ethicon Endo-Surgery, Inc.
  • Assignee: Medex, Inc. (California)
  • Correspondent: not exposed — verify in Assignment Center
  • Context: corporate divestiture — the sale of J&J's Jelco vascular-access business to Medex, Inc. (confirmed independently: Smiths Group's 2004 acquisition release states Medex "acquired the vascular access business of Ethicon Endo-Surgery ('Jelco') from Johnson & Johnson in May 2003"). This is a business-unit sale, not a patent monetization transfer.

Post-Medex (downstream ownership, not visible as a recorded USPTO assignment in my source):

• 2004-12-06 — Smiths Group plc announced acquisition of privately held Medex, Inc.; completed early 2005. Medex was 83.2% owned by One Equity Partners (JPMorgan Chase PE affiliate) and had itself been formed via a February 2001 management buyout from Saint-Gobain Performance Plastics Corp. (Smiths Group plc press release, 2004-12-06; UK OFT decision ME/1448/04, published 2005-01-26).
• Google Patents lists Smiths Medical ASD, Inc. (and, oddly, Ethicon Endo Surgery Inc) as "current assignee." No reel/frame for a Medex → Smiths Medical assignment appears in the legal-events table I retrieved. Either the transfer was never separately recorded (title passing by corporate acquisition is often not re-recorded when the acquired entity survives), or Google's legal-events extraction dropped it. Flagged as unverified.
• 2022-01 — Smiths Medical (parent of Smiths Medical ASD) was acquired by ICU Medical, Inc. (high-confidence general knowledge; I was unable to verify inside this session's search budget — treat as directional.)
• 2016-08-27 — statutory 20-year term reached; patent expired, "Expired – Lifetime." No further assertion is legally possible.

Maintenance-fee record (corroborates continuous operating-company stewardship, no lapses): 4-year fee 2002-02-13; 8-year fee 2006-02-28; 12-year fee 2010-01-29. No security agreements, licenses, releases or corrections are recorded against this patent.

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Timeline diagram

timeline
    title Ownership of US 5800399
    1996 : Assigned to Johnson and Johnson Medical
         : Application filed 27 Aug 1996
    1997 : J and J Medical merges into Ethicon Inc
    1998 : Patent US 5800399 issues
    2001 : Ethicon assigns to New Endo Inc
         : New Endo renamed Ethicon Endo Surgery
    2003 : Jelco business sold to Medex Inc
    2004 : All four successor records filed at USPTO
    2005 : Smiths Group acquires Medex
    2016 : Patent expires at end of full term

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NPE / troll-pattern signals

Signals present: 0. Signals unclear: 1 (correspondent recurrence — data gap).

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Verdict

Operating-company assertion — with an explicit qualification.

Justification: the chain is entirely operating-company title, moving J&J Medical (Reel 008183/0055) → Ethicon, Inc. (014675/0320) → New Endo / Ethicon Endo-Surgery (014734/0642; 014788/0206) → Medex, Inc. (015035/0753) → Smiths Medical, and it terminates in an entity that genuinely manufactures IV catheters. Zero NPE signals are present, and the four-record burst in mid-2004 is explained by late recording of 1997/2001/2003 instruments to one corporate family, not by an assertion-driven cascade.

Qualification I must state plainly: the "assertion" prong of this category is not satisfied — no suit naming this patent exists, and the patent expired 2016-08-27, so it cannot be asserted today. The honest characterization is therefore operating-company ownership, historically non-asserted. If your taxonomy permits a sixth label, "Operating-company portfolio / non-asserted" would be strictly more accurate than "Operating-company assertion."

Two residual gaps to close:

1. Correspondent of record on all five reels — not retrievable from my source; this is the only way to complete Signal 3.
2. The Medex → Smiths Medical link — no reel/frame located; Google Patents nonetheless names Smiths Medical ASD, Inc. as current assignee, so the transfer exists in substance even if unrecorded.

Verify at:

• USPTO Assignment Center — https://assignmentcenter.uspto.gov/ (search "5800399")
• Legacy Assignment Search UI — https://assignment.uspto.gov/patent/index.html
• Google Patents legal events — https://patents.google.com/patent/US5800399/en
• Supporting M&A corroboration — https://www.smiths.com/news-and-insights/news/2004/925-million-acquisition-moves-smiths-into-medical-devices-big-league and https://www.gov.uk/cma-cases/smiths-group-plc-medvest-holding-corporation-inc-medex-inc

I'll search the USPTO/public databases for US 5,800,399 and each of its cited references.

Now let me search the remaining cited references.

US 5,800,399 — Prior-Art Analysis (Tracing the Cited References)

Method note and search limitation

I confirmed the target record directly: US 5,800,399 A, "Low-cost method of assembling an extruded cannula holder for a catheter insertion device," App. No. US 08/703,706, filed 1996-08-27, granted 1998-09-01 — matching the record already established in the prior section. No results for other numbers were substituted.

Important limitation on this pass: the external search tool cut me off after five reference queries (a hard step cap), so I fully retrieved full text for only US 4,046,144, US 4,193,399, US 4,193,400, US 4,655,750 plus the EP search report for the family member EP 0 826 388 A3. For the remaining cited references I have bibliographic data (number, title, assignee, filing/issue dates) and the examiner's/EPO's own relevance categorization, but not the full specifications. Where a description rests on the title rather than retrieved text, I flag it. Per the operating rules I am not filling gaps from memory with false confidence.

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Key structural point that governs the whole analysis

Every anticipation question here turns on the same two-element gate in claim 1 (and its mirror, claim 21):

1. (a) an elongated cannula fixed in sealed position through an axial central through-bore of an extruded plastic cylindrical member, with a major length + sharp point on one side and a shorter length on the other; and
2. (b) a chamber structure whose end opening "closely conforms" to the cylinder's OD, fastened by inserting a portion of the cylinder into the chamber in press-fitted sealing engagement.

A § 102 reference must disclose all of this in one document. A reference that shows only a cannula-in-hub, a flash chamber, or a vent plug is § 103 material at best. The patent itself concedes that molded-body cannula retention was old (its own FIGS. 1–4, described as "current state of the art"), so the novelty resides in the extruded plug + press-fit chamber combination.

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A. The twelve references cited by the examiner

All twelve were examiner-cited (asterisked in the Google Patents citation table). Everything predating 1995‑08‑27 is § 102(b) art; US 5,575,777 is § 102(e) art (U.S. patent granted on an application filed 1993‑11‑15, before the '399 filing date, though it issued after).

A.1 — US 4,046,144 (McFarlane) — retrieved

Description: Over‑the‑needle catheter placement assembly. Needle/hub 12/18 forms a flash chamber 20 vented via a filter disk 50 (TYVEK). Catheter 16 has a yieldable rubbery housing 24; retention means 54 is a "short, tubular segment… telescoped over the end of the cannula… fixed to the end zone of the catheter as by a tight fit." FIG. 6 shows the Teflon catheter end turned back on itself to form a mechanical lock.

§ 102 assessment: Does not anticipate any claim. The cannula is fixed in a molded hub 18, not an extruded through‑bore plug; the rubbery housing is vulcanized/bonded, and the "tight fit" is a catheter-tube retention, not a chamber pressed over an extruded gasket. § 103 relevance: claims 1/21 (press-fit tubular component), 5/6 (hollow body housing), 14/34 (vent/filter disk at the chamber's distant end).

A.2 — US 4,193,399 (Robinson; Travenol) — retrieved

Description: A porous plastic self-venting plug 26 seated in the flashback‑chamber port of an over‑the‑needle device. Critically for this patent, the spec states the plug "may conveniently be integrally formed by molding, although other formation techniques such as extrusion, may be utilized," and in a through‑the‑needle unit the plug "may be utilized to anchor the proximal end of the stylet."

§ 102 assessment: This is the only examiner-cited U.S. reference that expressly contemplates an extruded plug, and it also discloses a plug anchoring a stylet — so it is the closest single item on claim 1(a). It still fails claim 1 as a whole: the plug is a vent closure at the chamber port, not a through‑bored gasket through which the cannula passes, and there is no "chamber pressed onto the cylinder OD." Potential § 102 hit: claim 14/34 (porous plug venting the chamber) is arguably anticipated. § 103 relevance: claims 1/21, 4/24.

A.3 — US 4,193,400 (Loveless; The Deseret Company) — retrieved

Description: Hypodermic needle 12 secured in a molded hub 26 merging into a light‑transmitting blood detection chamber 16 (unitarily molded with the hub). Breather plug 20 closes the chamber, with narrow side-wall slits 22 formed during molding. Also claims a manufacturing method for the plug.

§ 102 assessment: No anticipation of claim 1/21 — the cannula is molded into the hub, not set in an extruded through‑bored gasket, and the chamber is integral, not press‑fitted. Potential § 102 hit: claim 14/34 (plug closing a blood chamber). § 103 relevance: claims 1/21, 13/33, 15/35 (slit venting).

A.4 — US 4,655,750 (Manresa, Inc.) — retrieved

Description: Closed catheter system with an enclosed guide wire in a lay‑flat bag. A centering plug is retained within the skirt of the needle hub and has a through‑guideway aligned with the needle bore (claim 20(e): "positioning a centering plug so that its forward end is retained within the skirt portion of the needle hub"); claim 10 recites the plug "molded of porous plastic." (Assignee Manresa, Inc. confirmed in the record; my search surfaced a related Vaillancourt patent US 4,652,256 but did not confirm the '750 inventor directly — I am not asserting an inventor name.)

§ 102 assessment: The closest single-reference teaching of a through‑passaged plug press‑retained in a hub skirt, but the moving member is a guide wire, not a cannula, the body is a needle hub, and the plug is molded. No § 102 anticipation. § 103 relevance: claims 1/21 (plug with through‑bore retained in a bore/skirt), 7/8 and 27/28 (sleeve on a hub).

A.5 — US 4,904,240 (Hoover)

§ 102 assessment: Full text not retrieved this session. On title/bibliographic data alone this is an IV-start device (blood chamber / flashback context), i.e. § 103 background against claims 1/21, 13/33. I cannot responsibly assert anticipation of any specific claim without the text. Confidence: low.

A.6 — US 5,013,304 (BFD, Inc.)

§ 102 assessment: Full text not retrieved. Generic intravascular catheter assembly → § 103 background for claims 1/21, 10/30. No basis to assert anticipation. Confidence: low.

A.7 — US 5,066,284 (Vent for flashback plug)

§ 102 assessment: Full text not retrieved. The title is directly on‑point for the venting limitations. Potential § 102 target: claims 14/34 and 15/35 (vented flash plug/blood chamber). § 103 relevance: claims 1/21, 13/33. Confidence: medium (title alone).

A.8 — US 5,181,523 (Wendelborn)

§ 102 assessment: Full text not retrieved. Blood-viewing chamber art → § 103 relevance to claims 13/33 (chamber = blood chamber) and 14/34. No asserted anticipation. Confidence: low.

A.9 — US 5,053,014 (Critikon, Inc.)

§ 102 assessment: Full text not retrieved. A valved catheter → § 103 background only. No claim on the '399 face is anticipated by a valve patent. Confidence: low.

A.10 — US 5,234,410 (VLV Associates)

§ 102 assessment: Full text not retrieved. Catheter-assembly art → § 103 background for claims 1/21, 5/6, 25/26. No anticipation asserted. Confidence: low.

A.11 — US 5,250,033 (Interventional Thermodynamics)

§ 102 assessment: Full text not retrieved. This is the least on‑point of the twelve — a peel-away sheath/proximal fitting teaches a removable sheath, which touches only the optional claim 20/40 (removable extruded plastic sheath) and, loosely, claim 1/21. No anticipation. Confidence: low.

A.12 — US 5,575,777 (Becton Dickinson)

§ 102 assessment: Full text not retrieved. A retractable-needle safety set is structurally remote from the extruded-plug/press-fit chamber invention. Its realistic role is § 103 against claim 11/31 (nose guard / safety housing) and as general safety-art background. No § 102 anticipation. Confidence: medium on the characterization, low on any claim mapping.

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B. The most relevant prior art is not in the U.S. list — it is in the EPO search report

This is the single most important finding for your question. The family counterpart's search report (on EP 0 826 388 A3, the European publication of the same priority US 08/703,706) cites a different, closer set of references — these appear in Google Patents as the "Family Cites Families (6)" list. The EPO's own relevance coding is reproduced below (retrieved verbatim from the EP 0 826 388 A3 search report PDF).

B.1 — US 4,269,186 (Loveless et al.) — closest art, first leg of the § 103 pair

Description (from title/family data; full text not retrieved this session): A Loveless/Deseret air-bleed plug for an intravenous needle assembly — a family sibling of the examiner-cited US 4,193,400 (same title and same June 1978 filing window).

§ 102 assessment: Because the EPO coded it "Y" and not "X," the EPO did not treat it as anticipating claims 1/21; it treated it as one of two references whose combination renders those claims obvious. So no § 102 anticipation on the EPO's own view. The claims most at § 103 risk from this reference (alone or paired) are 1–6, 9, 10, 13, 21–26, 29, 30, 33.

B.2 — US 4,403,990 (Garver, Sr.) — closest art, second leg of the § 103 pair

Description (title/family data; full text not retrieved): By its title, a support assembly for a cannula — i.e., structurally directed at exactly the "hold a cannula in a body" problem the '399 patent addresses.

§ 102 assessment: Also coded Y, not X → no anticipation on the EPO's view. It is the single most relevant reference on the functional subject matter (cannula support) and, combined with US 4,269,186, is what the EPO relied on against the independent claims. § 103 claims at risk: 1–6, 9, 10, 13, 21–26, 29, 30, 33.

B.3 — US 4,334,536 (Pfleger)

Description (title/EPO pinpoint; full text not retrieved): A hypodermic syringe needle assembly; the EPO pinpointed col. 2, ll. 18–62 and fig. 3 as A-category (background/related) art against the independent claims.

§ 102 assessment: A-category only → no anticipation. § 103 background for claims 1/21.

B.4 — US 5,249,610 (Cassou et al.)

Description (EPO pinpoint; full text not retrieved): Cassou is named on FR 2 680 101 in the same family list (an artificial-insemination single-use nozzle). The EPO pinpointed a tube/plug interference passage at col. 5, l. 66 – col. 6, l. 24, fig. 2.

§ 102 assessment: A-category → no anticipation; § 103 background for 1/21.

B.5 — US 5,120,319 (Van Heugten et al.; Critikon)

Description: A flash tube (flashback chamber) for an IV catheter.

§ 102 assessment: EPO's mapping is the useful part: it flags this art as closest to claims 11/31 (nose guard + housing with integral finger holds) and claims 14/34 (porous plug/vents in the blood chamber). Because it is A-category, no anticipation; it is an § 103 reference for the flash-chamber/venting and nose-guard dependent claims. Confidence: medium (mapping is EPO's, not mine).

B.6 — US 5,542,932 (Daugherty)

Description: A bloodless flashback vent — a vented flashback chamber.

§ 102 assessment: A-category / no anticipation. Notably it is the only EPO-cited item that is § 102(a) rather than § 102(b) art. § 103 relevance: claims 14/34, 13/33. Confidence: medium on role, low on claim mapping.

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C. Consolidated § 102 conclusion

No retrieved reference, taken alone, discloses every element of independent claim 1 or claim 21. The two independent claims require the combination of (i) a cannula fixed and sealed through the through-bore of an extruded plastic cylindrical member with the specified major/shorter projections, and (ii) a chamber press-fitted sealingly onto that member's OD. Each retrieved reference supplies at most one side of that gate:

Bottom line: The genuine anticipation/obviousness pressure on this patent comes from a two-reference § 103 combination — US 4,269,186 (Loveless) + US 4,403,990 (Garver) — applied by the EPO against independent claims 1 and 21 and their dependents 2–6, 9, 10, 13, 21–26, 29, 30, 33, with A-category support from Pfleger, Cassou, Van Heugten and Daugherty. The examiner's twelve U.S. citations are, on the evidence retrieved, § 103/background art, not § 102 anticipations, with the narrow exceptions that claim 14/34 (porous vent plug) is arguably anticipated by US 4,193,399, and possibly US 5,066,284.

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D. Caveats you should carry forward

1. Retrieval gap. US 4,904,240; 5,013,304; 5,066,284; 5,181,523; 5,053,014; 5,234,410; 5,250,033; 5,575,777; and the EPO cites US 4,269,186; 4,403,990; 4,334,536; 5,249,610; 5,120,319; 5,542,932 were not opened as full texts in this session. Their descriptions above are title/assignee/EPO-coding-derived and are confidence-flagged. Any definitive anticipation call on those requires reading the specifications — particularly US 4,403,990 (its title literally reads on "support assembly for a cannula").
2. Category semantics matter. The EPO's "Y" coding is, by definition, "particularly relevant if combined with another document" — it is an obviousness, not an anticipation, signal. I have not upgraded any "Y" or "A" reference to § 102 on my own.
3. Pre-AIA framework. Because the '399 application was filed 1996‑08‑27, the applicable statute is pre-AIA 35 U.S.C. §§ 102/103; US 5,575,777 is § 102(e) art and US 5,542,932 is § 102(a) art.
4. Cross-reference to the earlier section: the previously flagged internal inconsistency — dependent claims 3/23 reciting "about 0.001 to 0.020 inches" vs. the specification's "0.001 to 0.020 mm" — affects claim scope but is not a prior-art issue. The earlier-flagged inventor-name discrepancy (Google's "Zino Altman" vs. EP's "Altman, Zinovy") also stands, unreconciled.
5. Expiry. As established earlier, the patent expired 2016‑08‑27, so this art mapping is of historical/validity-interest value rather than current-enforcement value.

I'll ground this analysis in the actual disclosures of the cited prior art rather than relying on my training data. Let me pull the reference abstracts.

Let me pull the remaining cited references to map their disclosures accurately.

Obviousness Analysis — US 5,800,399 under 35 U.S.C. § 103

Builds on the claim summary and bibliographic sections above; claim numbers and reference numerals are used as given there. Nothing in the prior sections is repeated except where needed for the argument.

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0. Preliminary caveats on this analysis

A. Record limits. I was able to retrieve and verify the actual disclosure text of only a subset of the references on this page: US 4,046,144 (McFarlane), US 4,193,399 (Travenol), US 4,193,400 (Deseret), US 4,403,990 (Baxter/Garver), and US 4,655,750 (Manresa). For the remaining examiner citations — US 4,904,240; US 5,013,304; US 5,053,014; US 5,066,284; US 5,181,523; US 5,234,410; US 5,250,033; US 5,575,777 — and for the "Family Cites Families" items I did not reach full text for (US 4,269,186; US 4,334,536; US 5,120,319; US 5,542,932; FR 2,680,101), I mark my assertions as provisional and do not rest the primary grounds on them. Anything I say about those is flagged.

B. One highly relevant reference is not on this page. The closest art I found to the challenged claims — US 4,496,352 / US 4,413,992 / US 4,574,456 (Soika, Baxter Travenol) — is not listed in either the "Patent Citations (12)" or "Family Cites Families" tables of the US 5,800,399 page. I will cite it as corroborating context only, expressly noting it is outside the page's prior-art section. Why this matters is discussed in §7.

C. Practical posture. Per the earlier sections, the patent expired 2016‑08‑27. This is therefore a retrospective validity analysis (relevant, e.g., to later patents that cite US 5,800,399 as art, or to hypothetical reexamination), not a live-controversy one.

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1. The person of ordinary skill in the art (POSITA)

The field is disposable over‑the‑needle IV catheter/venipuncture devices and their manufacture. A POSITA would be a mechanical or biomedical-device engineer with roughly 2–4 years' experience in the design and high-volume assembly of cannula/needle housings, blood-chamber ("flashback") assemblies, and extruded/injection-molded medical plastics — or a bachelor's degree plus equivalent experience. The POSITA is charged with knowledge of (i) the runout/trueness problem that arises when a thin steel cannula is insert-molded under thousands of psi (a problem the patent itself recites as background), (ii) interference/press-fit design for plastic-to-plastic sealing, (iii) extrusion and "cut-to-length" as standard low-cost alternatives to injection molding, and (iv) flashback venting options (porous plugs, slits, filters).

This is a low-skill, mature, cost-driven art. That cut favors the challenger, because almost every claim limitation is a design/process choice rather than a technical discovery. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (predictable variations, known techniques, and design incentives support obviousness).

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2. Claim construction of the limitations that carry the case

Two independent claims matter: claim 1 (method) and claim 21 (apparatus), with claims 2–20 / 22–40 dependent. Six limitations carry the weight:

Construction point germane to §103: In claim 21 "extruded" is, at most, a product-by-process characterization. It should be given patentable weight only if it imparts a structural difference. It likely does not (an extruded tube and a molded tube of the same material geometry are structurally indistinguishable for these purposes) — which weakens any argument that "extruded" rescues claim 21 over art that merely renders extrusion obvious.

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3. Graham/KSR framework and the real point of novelty

Under Graham v. John Deere Co., 383 U.S. 1 (1966), the §103 question is whether the differences between the claims and the art would have been obvious. The prior art on this page already discloses every functional element of the challenged claims in some prior reference:

1. A hollow plastic plug/cylinder sealingly penetrated by a cannula or stylet — US 4,193,399 (Travenol) expressly: "In through-the-needle catheter forwarding devices where a stiffener or stylet is required for the catheter, the self venting plug may be utilized to anchor the proximal end of the stylet."
2. A hollow cylindrical plastic plug press-/snug-fit into the end of a blood chamber to seal it — US 4,193,400 (Deseret): the plug is "shown in its installed or assembled position snugly around the trailing end of air detection chamber 16 forming an air tight seal therewith," described as "an elongated axially hollow plastic cylindrical body 28" with an "exterior annular flange 30."
3. Securing a cannula in a plastic member by sliding fit + interference/conformance fit, with no adhesive — US 4,403,990 (Baxter/Garver): the thermoplastic member "normally slid[es]ly receives the needle 18," and the elastomeric member forms an "interference fit of the first portion 14 within the second portion 16" to constrict the first portion "into a conformance fit about the member 12," the embodiment being "specifically envis[isioned] … as a plastic support hub for a cannula, such as a catheter, hypodermic needle, or phlebotomy needle."
4. A cannula joined to a housing by a "tight fit" tubular segment, with a vented blood/flash chamber — US 4,046,144 (McFarlane): retention means "comprise a short, tubular segment … telescoped over the end of the cannula"; "The segment is fixed to the end zone of the catheter as by a tight fit"; flash chamber vented by a "filter disk 50."
5. A removable protective shroud/sheath over the needle — US 4,046,144 ("an elongate protector shroud 81 of rigid plastic … sized to receive the rim of the hub").

What is genuinely different in the challenged claims is the combination and the selection of extrusion as the forming method — i.e., (a) chop an extruded tube to serve as the cannula-holding gasket, and (b) press the chamber onto it. Neither is a technical advance; both are manufacturing-cost choices. That is the classic §103 posture.

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4. Reference-by-reference fit (verified disclosures)

US 4,193,399 — Travenol "Self venting plug" (1977/1980) — verified
Discloses a plug seated "securely but removably" in a flashback-chamber port, having a "male sealing section 28 … rearward main body portion 30." Two sentences are decisive:

• On extrusion: "Plug 26 may conveniently be integrally formed by molding, although other formation techniques such as extrusion, may be utilized." → Expressly suggests making such a plug by extrusion.
• On anchoring the cannula/stylet: "the self venting plug may be utilized to anchor the proximal end of the stylet." → Teaches a plastic plug as the cannula-retention element.

US 4,193,400 — Deseret "Air bleed plug" (1978/1980) — verified
Discloses a hollow plastic cylindrical plug with an annular flange "snugly around the trailing end of [the] blood detection chamber … forming an air tight seal," with the needle "secured in fluid tight relation within a hollow cylindrical plastic needle hub" and the hub/chamber "molded together as one integral part." Also discloses its air slits "preferably formed during injection molding of air bleed plug 20" — i.e., the vent-by-slits concept (relevant to claims 15/35), but via molding rather than laser.

US 4,046,144 — McFarlane (1975/1977) — verified
Catheter placement assembly; tubular retention segment "telescoped over the end of the cannula" and "fixed … as by a tight fit"; molded polypropylene parts; vented flash chamber with "filter disk 50"; *"elongate protector shroud 81."

US 4,403,990 — Baxter/Garver "Support assembly for a cannula" (1981/1983) — verified — listed under Family Cites Families, not the 12 examiner citations
Discloses a two-member assembly for "a plastic support hub for a cannula, such as a catheter, hypodermic needle, or phlebotomy needle": a thermoplastic tubular member with an axial bore that "normally slidingly receives the needle," nested in a second member by an "interference fit" that constricts it into a "conformance fit about the member 12." This is the press-fit-without-adhesive cannula-securement teaching.

US 4,655,750 — Manresa "Closed system catheter with guide wire" (1985/1987) — verified
Discloses a "centering plug" in the needle hub "molded of porous plastic" providing a guideway/fluid seal about a wire, and securing a sleeve "by at least one crimp" (claims 10 and 14). Supports: porous-plastic plugs (claims 14/34) and crimp closure (claims 16/36).

Provisional (not verified this session): US 4,904,240; US 5,013,304; US 5,053,014; US 5,066,284; US 5,181,523; US 5,234,410; US 5,250,033; US 5,575,777; US 4,269,186; US 4,334,536; US 5,120,319; US 5,542,932; FR 2,680,101. By title/assignee these are flash-chamber, vent-plug, valve, safety-needle and introducer-sheath references that plausibly supply secondary teachings (venting, finger grips, sheath, needle protection), but I do not rely on them below.

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5. The combinations

Ground 1 (primary): US 4,193,399 in view of US 4,403,990

Mapping to claim 1 / 21:

• Element (a) — cannula fixed sealed through the axial bore of a plastic cylinder, longer end with sharp point out one side, shorter end out the other: US 4,193,399 discloses the plastic plug that "anchor[s] the proximal end of the stylet," with the stylet necessarily extending out both sides of the plug (into the flash chamber, and out the front as the piercing needle). Its "male sealing section 28" and "rearward main body portion 30" supply the cylindrical member. US 4,403,990 supplies the express teaching that the cannula member is "elongated and tubular" with an "axially extending bore" that receives the needle in a normal sliding fit and is secured by interference/conformance fit — the "fixed sealed position."
• Element (b) — chamber with an end opening closely conforming to the cylinder OD, fastened by inserting the cylinder into the chamber in press-fitted sealing engagement: US 4,193,399 discloses the plug being "seated securely" in the chamber port; US 4,403,990 expressly frames the securing mechanism as an "interference fit" between a tubular member and a surrounding bore — the exact "press-fitted sealing engagement" of claim 1(b) and the "interference fit" of claims 2/22.
• "Extruded" (claims 1/21) and "cut to length from a continuously extruded tubular extrudate" (claims 4/24): US 4,193,399 expressly names extrusion as an alternative forming technique for such plugs. Cutting an extrusion to length is the ordinary and only sensible way to convert an extrudate into a plug — KSR, 550 U.S. at 417 (a known technique applied in a predictable way). US 4,403,990 reinforces the "assemble simple tubular members" theme.

Motivation to combine (the critical §103 element):

1. Same field, same problem, same function. All three references are venous-entry/catheter devices; both US 4,193,399 and US 4,403,990 concern holding/securing a cannula relative to a plastic body.
2. Art-recognized problem the patent itself concedes. The patent's own background states that insert-molding a thin cannula under "thousands of psi" makes runout hard to hold and produces high rejects. A POSITA reading US 4,193,399's extrusion suggestion and US 4,403,990's interference-fit cannula hub would have been motivated to stop molding the cannula into the body and instead press the cannula into a separately formed extruded segment — precisely the claimed approach — to improve runout and cut rejects.
3. Cost/design incentive. The references themselves are cost-motivated (a self-venting reliable, low-reject plug in US 4,193,399; a support assembly hub in US 4,403,990). The patent's stated goal — economically disposable single-use devices for low-resource markets — is a design incentive that KSR recognizes as a motivation.
4. No teaching away. US 4,193,399 affirmatively teaches extrusion as an option; the art nowhere criticizes press-fitting a separately extruded gasket, so there is no "teaching away" defense.

Result: Claims 1, 2, 21, 22 (and, prima facie, 4/24 and 5/25 as discussed) would have been obvious.

Ground 2: US 4,193,400 in view of US 4,403,990 (and optionally US 4,046,144)

US 4,193,400 supplies nearly the whole apparatus picture: a hollow plastic cylindrical plug with an annular flange, fitted snugly into the end of a blood chamber to form an airtight seal, with the needle secured "in fluid tight relation" in a plastic hub, and with a vent. US 4,403,990 supplies the express interference-fit means for securing a cannula in a tubular plastic member without adhesive, and the framing of the assembly as a cannula support hub. US 4,046,144 supplies the "tight fit" tubular retention segment and the vented flash chamber with a filter disk, and the protective shroud.

Motivation: combining the plug-and-chamber seal of US 4,193,400 (which yields the claim's press-fitted sealing engagement) with the interference-fit cannula-mounting of US 4,403,990 yields the claim structure; the motivation is the same cost/assembly/runout rationale as Ground 1, plus the specific recognition in US 4,193,400 that sealing the chamber end with a snug plug is a reliable, low-reject design.

Result: Claims 1, 2, 14, 21, 22, 34 (porous plug) and 20/40 (shroud, via US 4,046,144) are implicated.

Ground 3: US 4,046,144 in view of US 4,193,399

US 4,046,144 teaches a molded retention segment "telescoped over the end of the cannula" and fixed "as by a tight fit," plus a vented flash chamber (filter disk) and a rigid protector shroud. US 4,193,399 teaches (i) forming the corresponding plastic plug by extrusion if desired and (ii) the plug serving to anchor the stylet and seal the chamber port. Combining them (motivation: eliminate the "bonded or vulcanized" step McFarlane requires, improve runout, cut cost) renders the "extruded press-fit gasket" claims obvious. This is the best fallback ground where a tribunal is uncomfortable with US 4,403,990 because it appears under "Family Cites Families."

Ground 4: Optional 3-reference combination for the venting/no-adhesive sub-claims

US 4,193,400 (or US 4,655,750) + US 4,046,144 renders porous-plug venting (14/34) obvious. US 4,655,750 renders crimp closure (16/36) obvious ("secured … by at least one crimp"). US 4,193,400's "slits 22 … formed during injection molding" renders vent openings proximate the distal end (15/35) obvious; substituting laser cutting for molded slits is the application of a known cutting technique to a known structure with predictable results (KSR) — a fine point addressed in §6.

Ground 5 (corroborating only — NOT on this page): Baxter/Soika US 4,496,352 / 4,574,456

These disclose a cannula support assembly in which "second member … accommodates the cannula" and is "removably engageable in an interference fit relationship within … said first member bore," with an express claim that "said tubular bodies … are manufactured by extrusion" (US 4,496,352 cl. 6) and a method claim reciting "said fabrication steps … includes extruding each of the members" plus press-fitting. That is functionally the challenged invention. But it is not in this page's prior-art section, so I flag it: if it were added to the record, Grounds 1–3 would collapse into a near-anticipatory §103 (arguably §102) showing.

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6. Claim-by-claim disposition (claims 1–40)

Bottom line: Independent claims 1 and 21 are the whole case; if they fall under Ground 1 or 2, the dependent claims fall with them on the reasons in the table. The only claim family with a colorable survival argument is 11/31 (nose-guard + housing-with-integral-holds geometry), and even that is a weak obviousness case rather than a clear nonobviousness case.

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7. Anticipated rebuttals and secondary considerations

"Extruded" is the point of novelty. The patent's own figures (FIG. 7) admit that extrusion is used for a conventional gasket-like plug, and US 4,193,399 already names extrusion. Extruding the gasket while molding the chamber is not a "new use of an old technique"; it is the selection of the cheaper of two known forming methods for a given part, which is precisely the "predictable variation" KSR holds obvious.

"No adhesive / single assembly step" as a secondary consideration. Avoidance of adhesive is a result of the claimed structure, not independent evidence of nonobviousness; and US 4,403,990/US 4,046,144 already show press-fit/tight-fit joinder without adhesive, so the "result" was known.

Design around the "Family Cites Families" placement of US 4,403,990. A challenger should expect the patent owner to argue that US 4,403,990 was not before the examiner (it appears under "Family Cites Families," i.e., cited in a foreign counterpart's prosecution) and therefore deserves less weight in an "examiner fully considered the art" argument. This is a weight argument, not a teachings argument — US 4,403,990 remains prior art under §102(b) (published 1983). So Ground 1 should be pleaded with US 4,046,144 or US 4,193,400 as the primary and US 4,403,990 as the interference-fit teaching, or else as the alternate Ground 3, so the combination rests on examiner-cited art.

Long-felt need / nexus. The "need for low-cost disposable catheters in developing countries" is real and the patent repeats it. But for secondary considerations, the patent owner needs evidence that (i) the need was long-felt and unsolved by the art, and (ii) the claimed combination — not unrelated business factors — drove any success. The record here shows the art already solved both sub-problems (extruded plugs; press-fit cannula hubs), and the patent's own spec concedes that extrusion and press-fits were known; the asserted advantage is cost, which ordinarily lacks the nexus needed to rebut a strong prima facie case.

No unexpected results shown. None of claims 1–40 recite an unexpected or superior property; claim 3/23's "about 0.001 to 0.020 inches" is a routine tolerance that the specification itself contradicts (mm vs. inches), undermining any argument that the numeric range is critical.

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8. Conclusion and confidence

Conclusion: On the record of this page, claims 1–40 of US 5,800,399 are, more likely than not, invalid for obviousness under §103. The strongest, cleanest grounds are:

1. US 4,193,399 + US 4,403,990 — the extrusion suggestion and the press-fit cannula-hub teaching together render independent claims 1 and 21 (and the extrusion/interference dependents) obvious.
2. US 4,193,400 + US 4,403,990 ± US 4,046,144 — the snug hollow plug sealed in a blood chamber plus an interference-fit cannula member render claims 1/21 (and the venting/sheath dependents) obvious.
3. US 4,046,144 + US 4,193,399 — fallback where US 4,403,990's placement is contested.

Confidence: Moderate-to-high for independent claims 1/21 and the mechanical/venting/material dependents, resting as they do on disclosures I actually verified. Moderate for claims 11/31 (nose-guard geometry), where the art on this page is thinnest. Low for any reliance on the twelve citations I could not fully retrieve, which I excluded from the primary grounds.

Two explicit uncertainties to carry forward:

1. The genuine smoking-gun reference — Baxter/Soika US 4,496,352 / 4,413,992 / 4,574,456, expressly claiming extruded tubular members press-fit together with a cannula bore — is not on this page's prior-art section. If it is within §102(b) art relative to the 1996‑08‑27 priority date (it issued 1985, so it is), a challenger should add it, and the §103 case strengthens materially (arguably toward §102 for claims 1/21/4/5).
2. The claims' recited interference range is internally inconsistent (inches in the claims, "mm" in the specification); I have reported both literally and flag it as an additional vulnerability rather than resolving it.