US 5053014

I'll run targeted searches for this exact patent number before summarizing.

Now let me check for any CAFC litigation involving this patent.

US Patent 5,053,014 — verified search results

Note on search scope: I searched for the exact number 5053014 / 5,053,014. No Court of Appeals for the Federal Circuit docket (2026 or otherwise) involving this patent was found. The only 5053014 hits outside patent databases were an unrelated CourtListener investment record ID (financial-disclosure entry 5053014, Bank of America cash) — not a patent case. Everything below is from the patent record itself (Google Patents, USPTO.report, EveryPatent, EPO Global Dossier), and the full text supplied in my working context.

Bibliographic data

Assignment chain (per Google Patents reassignment records): Critikon, Inc. → Johnson & Johnson Medical Inc. (1997, merger/name change) → Ethicon, Inc. (2004) → New Endo, Inc. (2004) → Ethicon Endo-Surgery, Inc. (2004) → Medex, Inc. (2004). Google's "current assignee" field lists Ethicon Endo Surgery Inc and Smiths Medical ASD Inc; Google expressly cautions these listings may be inaccurate. Treat the assignment chain as recorded-but-unverified.

Foreign family (18 members, all claiming the Feb 1, 1990 US priority): EP0440479B1, JP3298649B2, KR0173314B1, CN1031863C, AU646424B2, CA2035251C, DE69115064T2, DK0440479T3, ES2089125T3, PT96620B, GR1001056B, AR247338A1, BR9100416A, MX173223B, ZA91779B, NZ236898A, HK2397A.

Abstract (verbatim)

"A catheter hub assembly is disclosed wherein the assembly contains a membrane useful in preventing backflow of blood into the flash chamber. The hub assembly contains a membrane opener which operates upon the insertion of a luer locking mechanism into the catheter hub. This membrane opener allows flow of nutritional fluid into the body by causing the opening of the membrane during use of the catheter after removal of the catheter needle."

Plain-language overview of the independent claims

Claim 1 — an over-the-needle I.V. catheter assembly with five elements: (a) a semi-tubular needle housing with an open top; (b) a flash chamber inside that housing carrying a hollow needle from its distal end; (c) a tubular needle guard sliding inside the housing, with a distal aperture through which the needle passes, and which contains the flash chamber; (d) a catheter + catheter hub mounted on the guard's distal end; and (e) a valve and valve-opener assembly inside the hub, where the opener (i) is slidably seated in the hub, (ii) is not engageable with the needle guard (i.e., needle-guard motion does not actuate it), and (iii) is actuated instead by attaching a luer assembly to the hub — the luer contacts the opener, which slides and opens the valve. In plain terms: the valve is opened by the infusion connector, not by the needle or the safety guard.

Claim 6 — a catheter assembly with the same four structural elements (a)–(d) as claim 1, plus (e) "a valve and valve opener assembly emplaced in said hub such that said opener is not engageable with said needle guard." Claim 6 is essentially claim 1 minus the slidable-emplacement and luer-actuation limitations; it protects the broader combination of the needle-guard/flash-chamber architecture with a guard-independent valve/opener in the hub. Claim 8 (dependent on 6) adds the luer-actuation feature back in.

Dependent claims, briefly:

• 2 (on 1): valve is one-way — permits flow opener-side → catheter-side, blocks catheter-side → opener-side when the opener is not engaged.
• 3 (on 2): valve halts flow at about 3 psi (specification explains normal venous outflow is ~2 psi).
• 4 (on 2): valve is a duck-bill valve.
• 5 (on 4): needle retracts out of the valve while the seal is maintained.
• 7 (on 6): same one-way flow behavior, tied to the nose-shaped end not being engaged with the membrane.
• 8 (on 6): luer attachment causes the opener to contact the luer and slide to open the valve.
• 9 (on 6): valve seals flow from catheter side to flash-chamber side.
• 10 (on 6): halts flow at about 3 psi.
• 11 (on 6): duck-bill valve.
• 12 (on 6): opener has a nose-shaped end insertable within the membrane to open it.

Technical context and prior art

The specification frames the invention as applying the valve principle of US 3,585,996 (Reynolds et al., Levoy S Corp, 1971 — the pilot-tube-opens-a-disc-valve arterial catheter unit) to an I.V. catheter. Other cited references include US 4,096,860 (McLaughlin), US 4,177,814 (Knepshield), US 4,365,630 (McFarlane), US 4,664,654 (Strauss), US 4,758,225 and US 4,935,010 (Cox, Pharmacia), US 4,832,696 (Luther), US 4,834,718 (McDonald), US 4,842,591 (Luther), US 4,850,961 (Wanderer), US 4,874,377 (Newgard), US 4,917,668 (Haindl), US 4,917,669 (Bonaldo).

The described structure: a one-directional ("duck-bill") valve membrane 110 seated in the catheter hub 52, opposed by a cylindrical membrane opener 120 with nose-shaped opening means 122, retained by a collar mechanism 160. The introducer needle punctures the membrane (FIG. 4a); on needle withdrawal the membrane reseals against backflow (FIG. 4b); attaching the luer assembly 150 to hub flanges 58 forces the opener's nose into the membrane to open it for infusion (FIG. 4c). The patent emphasizes two design goals: (1) no frictional drag on needle retraction, and (2) no increase in luer-attachment force or reduction in flow rate.

Caveats / uncertainty

• CAFC 2026 dockets: nothing found. I cannot state authoritatively that no such docket exists, only that no search result linked patent 5,053,014 to any Federal Circuit appeal, IPR, or district-court case. Given the patent's anticipated expiration on 2010-02-01 (over 16 years before the current date), a live 2026 CAFC appeal on this patent would be unusual; if a 2026 docket exists it would likely concern an expired patent, a family member, or an unrelated ID collision. I did not verify this against PACER or the CAFC docket system directly.
• No reexamination, reissue, or IPR records for 5,053,014 surfaced in my searches; only its appearance as a cited reference (US-5053014-$) in later prosecution search histories (e.g., Art Unit 3763, Woehr et al.) and as prior-art art in other patents' tables.
• Claim drafting note: claims 7 and 12 (both depending from claim 6) refer to a "membrane" and a "nose-shaped end," whereas claim 6 recites a "valve" and "valve opener." This is an apparent antecedent-basis looseness in the granted text (the specification uses "membrane opener," "nose-shaped opening means," and "valve membrane" interchangeably, and claim 1 uses "valve opener" with no nose-shaped-end recitation). I'm flagging it as an observation, not a legal conclusion.
• The assignee information comes from Google Patents' reassignment tables, which Google itself disclaims as possibly inaccurate. The original assignee (Critikon, Inc., Tampa, FL) is corroborated across EveryPatent, USPTO.report, and the printed patent front page.

Primary sources: https://patents.google.com/patent/US5053014/en · https://uspto.report/patent/grant/5053014 · http://www.everypatent.com/comp/pat5053014.html · EPO Global Dossier family record for EP0440479B1 (http://data.epo.org/gpi/EP0440479B1.pdf).

I'll search for litigation involving US patent 5053014 across patent litigation databases.

Let me search more targeted litigation databases.

Let me run additional targeted searches to confirm whether this specific patent was ever asserted.

Litigation Search Report: US Patent 5,053,014

Bottom Line

No litigation specifically asserting US 5,053,014 as a patent-in-suit was found in the sources searched (Google Patents litigation data, Docket Alarm/PTAB records, USPTO PTAB filings, CourtListener/FindLaw, and general web search).

Important caveat on methodology/confidence: I was unable to directly retrieve results from the Unified Patents litigation caselist or PACER/CourtListener dockets for this specific number before my search steps were exhausted. So my conclusion is grounded in the searches that did run and should be treated as a negative result from available sources, not a certified "no litigation exists" finding. I'd recommend an independent confirmation via Unified Patents, Docket Navigator, or PACER before relying on it.

Why US 5,053,014 Appears in Search Results — But Not as a Defendant's Accused Patent

The number shows up in search hits only in prior-art / citation contexts, not in any case caption as the asserted patent:

None of these are infringement suits, declaratory judgment actions, or PTAB challenges directed at the '014 patent.

A Related—But Distinct—Case Often Confused With This One

Critikon, Inc. v. Becton Dickinson Vascular Access, Inc. (Fed. Cir. 1997, 120 F.3d 1253; district court D. Del.; appeal in the same docket family as Fed. Cir. No. 96-1273) involved Critikon, Inc. — the same original assignee as US 5,053,014. However, that case did NOT assert US 5,053,014. The patents-in-suit were the Lemieux patents and the Dombrowski patent; the appellate ruling turned on inequitable conduct (failure to disclose U.S. 4,834,718, the McDonald patent, during Lemieux reissue). I flag this only because it dominates search results for "Critikon catheter litigation" and is not a case about the '014 patent. Do not conflate the two.

Patent Status (relevant to why litigation is unlikely)

Per Google Patents, US 5,053,014:

• Original assignee: Critikon, Inc.
• Filing/Priority date: 1990-02-01
• Grant date: 1991-10-01
• Legal status: Expired – Lifetime (anticipated expiration 2010-02-01)
• Current assignees listed: Ethicon Endo Surgery Inc; Smiths Medical ASD Inc (via recorded assignments)
• Extensive international family (EP 0440479B1, JP 3298649B2, CA 2035251C, AU 646424B2, etc.)

The patent expired in 2010, and the operative 20-year enforcement window (1991–2010) predates most modern searchable PACER/docket databases' coverage of the original assignee's suits.

Recommended Next Steps to Confirm

1. Unified Patents litigation portal – search at https://portal.unifiedpatents.com/litigation/caselist (the site you specified) using the exact number 5053014.
2. Docket Navigator / Lex Machina – filter by patent number 5,053,014.
3. PACER – search the Critikon, Inc. (M.D. Fla. / D. Del.) and later Smiths Medical / Ethicon docket histories.
4. CourtListener/RECAP – full-text search "5,053,014" and "5053014".

If you'd like, I can run these specific follow-up searches once tool access is restored.

I'll verify the structured "no proceedings" default with targeted searches before writing up.

Confirmed the "no proceedings" default. Let me pin down the context in which the '014 patent does appear in PTAB records, so I describe it accurately.

One more round: the Federal Circuit disposition of the appeals where the '014 patent served as the invalidating art, plus a check on ID-collision traps.

Proceedings overview

Total AIA trial proceedings on US 5,053,014: 0. The canonical structured block states verbatim that "The USPTO ODP API returns no AIA trial proceedings for this patent as of the most recent ingest," and my web searches corroborate that — no IPR, PGR, or CBM has ever named Van Heugten's '014 patent as the challenged patent (breakdown: 0 active / 0 claims invalidated / 0 claims sustained / 0 settled / 0 institution denials).

Defensive posture: There is no FWD to cite against this patent, and no § 315(e)(2) estoppel has attached to it — but that turns out to be irrelevant, because the patent expired on 2010-02-01 (anticipated expiration, per the record; filing/priority 1990-02-01, grant 1991-10-01). A defendant facing an assertion of the '014 patent today is facing an expired patent, not a hardened one; the absence of PTAB activity here is a function of (a) the patent's 1991–2010 enforcement window pre-dating the AIA trial regime's practical use, and (b) the claims' 12-claim, two-independent-claim scope being attacked without, so far as the record shows, any petitioner bothering to challenge the '014 itself. The single most important thing to understand is the inverse relationship below: the '014 patent's own claims were never challenged, but its disclosure was successfully used by Becton Dickinson to invalidate another company's claims.

⚠️ Read this before you search further — two ID-collision traps

1. "the '014 patent" in PTAB/CAFC documents usually is not this patent. Citations to "the '014 patent" in PTAB and Federal Circuit papers frequently refer to U.S. 8,020,014 B2, which was the subject of IPR2018-01312 and IPR2018-01661 and a subsequent CAFC appeal (CourtListener RECAP gov.uscourts.cafc.19561, where the patent owner argued that retroactive IPR application to "the '014 patent" violated due process, and the Board on remand held claims 1–5, 12–16, 18, and 20 unpatentable). None of that is US 5,053,014. Do not import it.
2. "Van Heugten" is a recurring prior-art name, not a recurring patent-under-attack name. U.S. 5,053,014 (Ex. 1006, "Van Heugten") is cited in blood-control IPRs as invalidating art — i.e., it is the sword, not the shield. There are also later "Van Heugten" patents (e.g., US 7,883,505, WaveTec Vision) that are unrelated subject matter and were not verified to be the same inventor.

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Proceedings on file

None. There is nothing to report for this patent, and I will not manufacture entries. Per the task constraint ("If no PTAB activity exists, say so plainly"), the plain statement is: no AIA trial proceeding has ever been instituted on US 5,053,014.

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Where the '014 patent actually shows up in PTAB records (proceedings on other patents)

These are included because they are the only PTAB records in which this patent appears, and they are strategically far more informative than a null result. Every heading below is a proceeding on a different patent. US 5,053,014 is Ex. 1006 ("Van Heugten"), a prior-art reference.

IPR2017-01587 — Becton, Dickinson and Company v. B. Braun Melsungen AG

• Patent under attack: U.S. 9,149,626 B2 (not the '014 patent)
• Type: Inter Partes Review
• Filed: 2017 (petition June 2017; notice of filing date published 2017)
• Status: FWD issued — challenged claims held unpatentable over the '014 patent as the sole instituted ground
• Judge panel: Scott A. Daniels, Michael L. Woods, Robert L. Kinder (APJs)
• Petition grounds: § 103(a); multiple combinations were pleaded, including Van Heugten ('014) + Arnett, Van Heugten + Faust, and Woehr '108 + Tauschinski + Arnett. Claims at issue: 11 and 20.
• Institution decision: Partially instituted. The patent owner's own account of the decision records that "The sole instituted ground of patentability for the original claims was under 35 U.S.C. § 103(a) over U.S. Patent No. 5,053,014 ('Van Heugten') (Ex. 1006) (claims 11 and 20)." The Board declined to institute on the Van Heugten + Arnett and Woehr '108/Tauschinski/Arnett combinations, reasoning that a POSITA would not have modified Tauschinski's or Van Heugten's valve actuating element with Arnett's plunger elements. (PO Reply in Support of Contingent Motion to Amend, IPR2017-01587)
• Final Written Decision: Claims 11 and 20 unpatentable. The panel framed the dispute narrowly and decided it for the petitioner: "Patent Owner does not dispute that Van Heugten discloses all but one of the limitations in claims 11 and 20 — that Van Heugten's valve has a slit. … Petitioner has shown by a preponderance of the evidence that claims 11 and 20 would have been obvious in view of Van Heugten." The Board resolved the "slit" dispute against the patent owner: a POSITA would understand the '014 patent's duck-bill disclosure and its puncturing-by-needle disclosure to yield a slit, and would not read the '014 specification's Reynolds discussion as teaching away. It further credited the '014 patent's own valve-opener structure (membrane opener 120, nose-shaped means 122) and needle guard 30 as teaching the claimed "valve actuating element" and "needle protective device." (FWD, IPR2017-01587)
• Settlement / termination: none disclosed before FWD; the proceeding went to a patent owner contingent Motion to Amend (proposed substitute claim 21 adding a metallic resilient portion) that was adjudicated alongside the merits.
• Appeal: A Notice of Appeal dated 2019-02-08 is on file for this proceeding. I could not verify the Federal Circuit docket number or disposition within my search budget — treat the appeal outcome as unverified and check CAFC/CourtListener before relying on it.
• Defensive value (for the '014 patent): This is the case that gives US 5,053,014 its teeth. The Board invalidated a modern B. Braun blood-control catheter claim set using the '014 disclosure alone, without secondary references — strong evidence that the '014 patent's teaching (hub-seated valve + sliding opener that is not actuated by the needle guard) is broad enough to read on today's blood-control safety catheters. If you are accused of infringing a competitor's blood-control patent, the '014 patent is a first-call Ex. 1006.

IPR2017-01588 — Becton, Dickinson and Company v. B. Braun Melsungen AG

• Patent under attack: U.S. 8,460,247 B2 (not the '014 patent)
• Type: Inter Partes Review
• Filed: 2017
• Status: FWD issued — petitioner's grounds rejected; all challenged claims survived
• Judge panel: Daniels, Woods, Kinder
• Petition grounds: § 103, eight grounds pleaded; claims 12, 13, 20–23, 29; art included Woehr, Callaway, Sutton, Villa, and Nakajima combinations. Van Heugten ('014) appears in the record principally through the parties' exhibit practice, not as an instituted ground — the instituted and litigated grounds were the Woehr/Callaway/Sutton/Villa/Nakajima combinations.
• Institution decision: Partially instituted 2017-12-21 (4 of 8 grounds). Modified 2018-05-07 to institute on all eight grounds after SAS Inst. Inc. v. Iancu; the parties then filed a joint motion to limit the proceeding back to the four originally instituted grounds, which the Board granted.
• Final Written Decision: Entered 2018-12-12. "Petitioner has not met its burden of showing, by a preponderance of the evidence, that any of claims 12, 13, 20–23, or 29 of the '247 patent is unpatentable." The patent owner's contingent Motion to Amend was denied as moot. (FWD, IPR2017-01588)
• Settlement / termination: none; decided on the merits.
• Appeal: a Notice of Appeal dated 2019-02-08 is on file in the companion proceeding IPR2017-01586 (see below); disposition unverified.
• Defensive value (for the '014 patent): Marginal and indirect — it shows the Board is willing to reject § 103 attacks on this general catheter family when the asserted combinations require motivation that the panel finds wanting. It does not validate any claim of the '014 patent.

IPR2017-01586 — Becton, Dickinson and Company v. B. Braun Melsungen AG

• Patent under attack: U.S. 8,328,762 B2 (not the '014 patent)
• Type: Inter Partes Review
• Status: FWD issued — claims 18 and 22 unpatentable; claim 25 sustained
• Judge panel: Daniels, Woods, Kinder
• Petition grounds: § 103; claims 18, 22, 25; instituted on all grounds. Grounds table: Woehr + Tauschinski (§ 103, claims 18, 22, 25); Van Heugten (§ 103, claims 18 and 22); Van Heugten + Lynn (§ 103, claim 25); Van Heugten + Tauschinski (§ 103, claim 22).
• Final Written Decision: "Petitioner has shown, by a preponderance of the evidence, that claims 18 and 22 of the '762 patent are unpatentable. Petitioner has not shown by preponderance of the evidence that claim 25 of the '762 patent is unpatentable." Notably, claim 25 — the claim whose ground paired Van Heugten with Lynn — survived. (FWD, IPR2017-01586)
• Appeal: Notice of Appeal dated 2019-02-08. Docket number and disposition unverified.
• Procedural note worth knowing: The institution decision in IPR2017-01586 (Paper 8, Dec. 15, 2017) is designated precedential as to § III.C.5, first paragraph — it is cited in later Board decisions precisely for that proposition. I did not verify what that paragraph holds; confirm before citing it.
• Discovery note: On 2018-02-28 the panel granted the patent owner's motion to compel production of 31 litigation documents (designated confidential in B. Braun Melsungen AG v. Becton, Dickinson & Co., No. 1:16-cv-00411 (D. Del.)), holding they were inconsistent with petitioner's positions on objective indicia and thus routine discovery under 37 C.F.R. § 42.51(b)(1)(iii). The Board rejected the argument that a stipulated judgment of non-infringement mooted relevance. (Order, Conduct of the Proceeding; Lexology summary)
• Defensive value (for the '014 patent): None directly. Relevant only as evidence that the '014 patent is a well-worn Ex. 1006 in this art and that its use as § 103 art produces mixed results depending on the secondary reference chosen.

IPR2017-01589 and IPR2017-01590 — Becton, Dickinson and Company v. B. Braun Melsungen AG

• Patents under attack: U.S. 8,597,249 B2 (‑01589) and U.S. 9,370,641 B2 (‑01590)
• Type: Inter Partes Review | Status: filed and instituted (both appear on the Board's docket with institution decisions issued 2017-12-21 and were litigated together with the four proceedings above)
• Relevance to the '014 patent: These proceedings generated the file-history exhibit (Ex. 2005, file history of U.S. 9,370,641) and search-string exhibits in which "US-5053014-$" appears as a Boolean prior-art search term — which is why searching for "5053014" surfaces IPR2017-01588/01589/01590 dockets at all. That is a citation, not a challenge. I did not retrieve their FWDs and make no claim about their outcomes.

Institution denials in the same wave — IPR2017-01583, -01584, -01585

The Board denied institution in these three proceedings (recorded in the FWDs of IPR2017-01586 and IPR2017-01588). They are noted only to close the loop on the BD v. B. Braun family; none concerns the '014 patent.

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Strategic summary

Claim status on US 5,053,014: all 12 claims UNTESTED. No claim of this patent has been canceled, confirmed, or construed by the Board, because no petition has ever challenged it. Claims 1 and 6 (the independents) and claims 2–5 and 7–12 stand exactly as granted on 1991-10-01. Note the drafting quirk flagged in the earlier summary — claims 7 and 12 (depending from claim 6) recite a "membrane" and "nose-shaped end" while claim 6 recites a "valve" and "valve opener" — a potential § 112 antecedent-basis vulnerability that is entirely untested at the Board.

Estoppel landscape: clean. Because no IPR, PGR, or CBM was ever filed against the '014 patent, no § 315(e)(2) estoppel attaches to any party with respect to these claims. A defendant today would face no estoppel bar arising from PTAB activity on this patent — every prior-art ground is theoretically available, subject to § 325(d) (art already before the Office, e.g., the fourteen references cited on the face of the patent, including Reynolds US 3,585,996) and IPR's §§ 102/103-only, patents-and-printed-publications-only limits. In practice, the estoppel question is academic: the patent expired 2010-02-01, so there is no ongoing § 271(a) infringement and any damages recovery would be limited by 35 U.S.C. § 286's six-year lookback to conduct before the 2010 expiry — conduct that is now far beyond any limitations period.

Pattern signals. (1) Same-petitioner behavior runs the other way. Becton Dickinson filed at least eight IPRs against B. Braun's catheter family (‑01583 through ‑01590) — but never against US 5,053,014. (2) Defensive-aggregator involvement: none. No Unified Patents or RPX-filed proceeding on this patent appears. (3) Patent-owner appellate aggressiveness: not applicable to this patent. The 2019-02-08 notices of appeal belong to B. Braun, which was the patent owner defending its own later Woehr-family patents — a curious inversion from the usual narrative and a reminder that the '014 patent was on the other side of that fight. (4) Prosecution-history spillover is the dominant source of false hits. Nearly every "5053014" PTAB search hit is a Boolean prior-art string or an exhibit caption inside someone else's blood-control case.

The one genuinely useful takeaway for a defendant: if a demand letter asserts US 5,053,014 today, the sender is asserting a patent that expired 2010-02-01 and whose assignees of record (via the merger/name-change chain: Critikon → Johnson & Johnson Medical → Ethicon → New Endo → Ethicon Endo-Surgery → Medex; with Ethicon Endo Surgery Inc and Smiths Medical ASD Inc listed as current assignees) are operating companies, not NPEs. That combination — expired patent, operative-company chain of title — is a strong signal of a baseless or mistaken assertion. The correct first response is not an IPR petition; it is a § 286 / expiration letter.

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Recommended next steps

If you are a defendant being asserted against (or are evaluating an assertion of) US 5,053,014:

1. Lead with expiry, not validity. The patent expired 2010-02-01 (anticipated expiration per the Google Patents legal-status record; priority and filing 1990-02-01, grant 1991-10-01). Demand a basis for any pre-2010 damages theory and test it against 35 U.S.C. § 286. Verify status directly at the USPTO Patent Center for application 07/474,595.
2. If validity still matters (e.g., a late-accrued damages theory or a family-member dispute), you have a clean slate. No estoppel, no FWD. The strongest art is almost certainly the art the applicant was not asked about — the '014 patent's entire claim 1 hinges on the negative limitation that the valve opener "is not engageable with said needle guard," which is where the earlier-cited Luther (US 4,832,696 / 4,842,591), McDonald (US 4,834,718), and Newgard (US 4,874,377) references become interesting. Before filing anything, run a fresh § 102(b) search on pre-1990-02-01 art.
3. Do not file an IPR as a reflex. IPR is available for an expired patent, but the return is poor: no amendment is available to the patent owner, claim construction runs under Phillips, and the leverage is minimal against a patent with no forward-looking exclusionary value.

If you are prosecuting or litigating against a modern blood-control catheter patent and want to know how good this art is:

1. Cite the '014 patent's winning record. The defensible, citable proposition is: in IPR2017-01587, the PTAB held claims 11 and 20 of U.S. 9,149,626 obvious under 35 U.S.C. § 103(a) over U.S. 5,053,014 alone, on the sole instituted ground. Get the FWD from PTAB E2E (search Case IPR2017-01587) or the Docket Alarm docket, and quote it directly rather than paraphrasing. Also check IPR2017-01586, where the Board rejected the Van Heugten + Lynn combination on claim 25 — the pairing you choose matters, and pairing the '014 patent with the wrong secondary reference is a documented loser.
2. Verify the appeal before you rely on the FWD. Notices of appeal dated 2019-02-08 are on file in IPR2017-01586 and IPR2017-01587, but I could not verify the CAFC docket numbers or disposition within my search budget. Check CourtListener's Federal Circuit docket for the notices and any opinion. If the appeals were resolved adversely to the petitioner on the Van Heugten ground, the citation value of the '014 patent as invalidating art changes materially.
3. Confirm the null result independently. Run the exact number 5,053,014 in Unified Patents' litigation portal and against the USPTO PTAB API. My null result matches the structured ODP block, but I hit a step cap before completing an ex parte reexamination and reissue check for a possibly pre-1991 or mid-1990s reexam record — a reexam certificate would not be an AIA trial and would not appear in the ODP trial data, so it is worth one explicit look at the USPTO Patent Center "Transaction History" for application 07/474,595.

Flagged uncertainty (do not treat as findings): (i) the appeal dispositions in IPR2017-01586/‑01587; (ii) whether the precedential portion of IPR2017-01586 Paper 8 bears on anything relevant here; (iii) whether any ex parte reexamination or reissue was ever filed on the '014 patent — my last search on that point was cut off by my step limit, so I have no basis to say one way or the other; (iv) whether the WaveTec Vision "Van Heugten" is the same inventor — name match only, unverified.

I'll search the USPTO assignment records and related sources for this patent's chain of title.

Let me search for the reel/frame records and the corporate chain details.

Let me try to pin down the actual reel/frame numbers and the Medex divestiture context.

Assignment / Chain-of-Title Reconstruction — US 5,053,014

⚠️ Sourcing limitation stated up front (read before relying on anything below). I was cut off by a search-step cap before I could query assignmentcenter.uspto.gov directly. Every conveyance below is taken from the Google Patents reassignment mirror of the USPTO Assignment Database for US5053014 (https://patents.google.com/patent/US5053014/en), which reproduces conveyance type, assignor, assignee, and execution/recording dates. That mirror does not render reel/frame numbers or the correspondent of record. I therefore report no reel/frame numbers and no correspondent data — I will not invent them. Those two fields require a direct Assignment Center pull (search by patent number 5,053,014 or application 07/474,595). Flagging this as a methodological gap, not a finding.

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Inventors

Pattern observations:

• Sole inventor, same-day assignment. The assignment was executed and recorded on 1990-02-01 — the same day the application was filed. This is the ordinary employment / obligation-to-assign pattern for a corporate R&D inventor. It is not a red flag, and it directly contradicts one of the classic fire-sale precursors (inventors departing within 12 months of filing).
• No evidence of inventor departure in the record I retrieved. There is no inventor-side assignment, release, or quitclaim after the 1990 execution.
• Unverified name-match caution: the earlier PTAB section flagged a "Van Heugten" associated with WaveTec Vision (US 7,883,505). That is a name match only; I did not verify identity, and nothing in this chain depends on it.

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Original assignee

Critikon, Inc. (a corporation of Florida; Tampa, FL) — named on the issued patent as original assignee.

• Relationship to a parent: Critikon was a Johnson & Johnson company. That is corroborated structurally by the recorded chain itself (1997 merger into Johnson & Johnson Medical Inc.) rather than by an independent corporate-registry pull.
• Primary line of business: acute-care monitoring and vascular access — Critikon-branded invasive blood-pressure monitoring products (e.g., DINAMAP) and, through the J&J vascular-access line, peripheral IV catheters. The J&J/Ethicon Endo-Surgery vascular access business sold in 2003 was described as "a leading provider of peripheral intravenous catheters (PIVCs)… PROTECTIV and ACUVANCE Safety I.V. catheters and OPTIVA, JELCO and CATHLON conventional I.V. catheters" (Infection Control Today, 2003-05-28).
• Did they ship a product embodying the claims? Unclear / not verified at product level. The product lineage is real and squarely in the claimed subject matter — a PROTECTIV PLUS safety IV catheter 510(k) (K030571) was filed by Ethicon Endo-Surgery, Inc. in 2003, i.e., the successor entity to this patent's chain, covering the safety/conventional IV catheter family. But I did not verify that any specific product practices claims 1 or 6. Do not treat "the family shipped catheters" as "the claims were practiced."
• Current status: Critikon, Inc. no longer exists as a separate legal entity. It was merged into Johnson & Johnson Medical Inc. per the assignment recorded 1997-05-22. Its vascular-access business was then carved out and sold. (I did not verify, within this step budget, the separate disposition of the Critikon monitoring business — treat that as unverified.)

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Assignment timeline

Chronological, per the Google Patents reassignment record (which mirrors USPTO Assignment Database entries). Reel/frame and correspondent: not retrieved — see the sourcing limitation above.

• 1990-02-01 (executed) / recorded 1990-02-01 — Reel —/— (not retrieved)

  • Conveyance: Assignment of assignors' interest
  • Assignor: VAN HEUGTEN, ANTHONY Y.
  • Assignee: CRITIKON, INC., a corporation of Florida
  • Correspondent: not retrieved
  • Context: Employment / obligation-to-assign transfer to the original corporate assignee, executed the same day the application was filed.

• 1997-05-22 (executed) / recorded 1997-05-22 — Reel —/— (not retrieved)

  • Conveyance: Merger and change of name
  • Assignor: CRITIKON, INC.
  • Assignee: JOHNSON & JOHNSON MEDICAL INC.
  • Correspondent: not retrieved
  • Context: Internal corporate reorganization inside Johnson & Johnson; name change only / merger, not a sale.

• 2004-05-25 (executed) / recorded 2004-05-25 — Reel —/— (not retrieved)

  • Conveyance: Merger
  • Assignor: JOHNSON & JOHNSON MEDICAL, INC.
  • Assignee: ETHICON, INC.
  • Correspondent: not retrieved
  • Context: Internal J&J reorganization — this is the first step of the 2004 restructuring that produced "New Endo, Inc." and the Ethicon Endo-Surgery name change.

• 2004-06-15 (executed) / recorded 2004-06-15 — Reel —/— (not retrieved)

  • Conveyance: Assignment of assignors' interest
  • Assignor: ETHICON, INC.
  • Assignee: NEW ENDO, INC.
  • Correspondent: not retrieved
  • Context: Internal reorganization vehicle. "New Endo, Inc." is not an NPE — it is the interim entity in the J&J 2004 re-incorporation, as proved by the very next recording thirteen days later.

• 2004-06-28 (executed) / recorded 2004-06-28 — Reel —/— (not retrieved)

  • Conveyance: Change of name
  • Assignor: NEW ENDO, INC.
  • Assignee: ETHICON ENDO SURGERY, INC.
  • Correspondent: not retrieved
  • Context: Pure change of name — confirms the 2004-06-15 "assignment" was an internal reorg step, not a transfer to a third party.

• 2004-08-12 (executed) / recorded 2004-08-12 — Reel —/— (not retrieved)

  • Conveyance: Assignment of assignors' interest
  • Assignor: ETHICON ENDO-SURGERY, INC.
  • Assignee: MEDEX, INC.
  • Correspondent: not retrieved
  • Context: Operating-company asset divestiture — J&J exited the peripheral IV catheter business. Medex, Inc. acquired the Ethicon Endo-Surgery Vascular Access business (announced 2003-05-28; Medex's own Q3-2004 release describes the asset acquisition from Ethicon Endo-Surgery, the "JELCO peripheral intravenous catheter business," as of 2003-05-21). The August 2004 recording is the patent-level papering of that deal. One Equity Partners (Bank One / JPMorgan private equity) was the majority shareholder of Medex at the time — a sponsor-backed roll-up, not a shell.

After 2004-08-12 the record is silent. No further assignments, security agreements, licenses, releases, or corrections appear in the recorded conveyances. Notably, no security agreement was ever recorded against this patent (a common feature of distressed or finance-driven chains).

Downstream corporate context (no new USPTO recording required, because these were share purchases, not patent assignments):

• c. 2005 — Smiths Group plc acquired Medex (Smiths Medical Holdco Ltd / Forest Acquisition Corp. merger with the Medex entity; announced 2004-12-06, UK OFT merger notice January 2005; Smiths' 2006 interim results describe "the addition of Medex"). Medex, Inc. appears in the Smiths Medical subsidiary roster, and Smiths Medical ASD, Inc. is the Smiths Medical operating subsidiary — consistent with Medex, Inc. having been renamed, though I did not verify that rename directly and flag it as unverified.
• 2022-01-06 — ICU Medical, Inc. (Nasdaq: ICUI) closed its acquisition of Smiths Medical 2020 Limited (the holding company of Smiths Group's global medical device business and its subsidiaries) for ~$2.35B cash plus 2.5M ICUI shares, per ICU Medical's 8-K filed 2022-01-07 and the company's 2022 10-K. ICU Medical's post-closing "Vascular Access – Smiths Medical" product line expressly includes Jelco safety and conventional peripheral IV catheters.
• Result: the economic owner of the Medex/Smiths Medical entity that owns this patent today is ICU Medical, Inc. — with no corresponding USPTO assignment recorded, because the change happened above the entity holding title.

Contradiction flag to resolve with the earlier sections: the earlier summary lists Google's "current assignee" field as Ethicon Endo Surgery Inc and Smiths Medical ASD Inc. The recorded chain shows Ethicon Endo-Surgery, Inc. conveying away to Medex, Inc. in 2004. The most likely explanation is that Google's "current assignee" rendering is picking up the assignor field of the 2004-08-12 conveyance (a known artifact of that mirror). Treat Smiths Medical ASD, Inc. — now under ICU Medical as the operative titleholder of record, and treat "Ethicon Endo Surgery Inc" as a stale/artifactual listing. This does not contradict the earlier sections so much as resolve an ambiguity they flagged.

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Timeline diagram

timeline
    title Ownership of US 5053014
    1990 : Filed by Van Heugten
         : Assigned to Critikon Inc
    1997 : Critikon merged into J and J Medical
    2003 : J and J sells vascular access unit
    2004 : J and J Medical merged into Ethicon Inc
         : Ethicon transfers to New Endo Inc
         : New Endo renamed Ethicon Endo Surgery
         : Ethicon Endo Surgery sells to Medex
    2010 : Patent expires
    2022 : Smiths Medical acquired by ICU Medical

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NPE / troll-pattern signals

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Verdict

Defensive / non-asserting.

Justification (2–3 sentences): The complete recorded chain — 1990-02-01 Van Heugten → Critikon, Inc.; 1997-05-22 Critikon → Johnson & Johnson Medical Inc. (merger/name change); 2004-05-25 → Ethicon, Inc. (merger); 2004-06-15 → New Endo, Inc.; 2004-06-28 New Endo → Ethicon Endo-Surgery, Inc. (change of name); 2004-08-12 Ethicon Endo-Surgery → Medex, Inc. — is a pure corporate-restructuring-and-divestiture chain with no shell entity, no known asserter, no security agreement, and no post-2004 recordings, terminating in an operating medical-device business (Medex → Smiths Medical ASD → ICU Medical, Inc., 2022-01-06). Zero of the eight NPE signals is affirmatively present (one — the 2004-06 through 2004-08 cascade — is mechanically present but fully explained by J&J's internal reorganization plus the Ethicon Endo-Surgery vascular-access divestiture). Caveat on the category: the chain does not literally terminate at a defensive aggregator, so this verdict reflects the non-asserting posture (an expired patent, held by operating companies, never asserted in any litigation or PTAB record) rather than an aggregator neutralization. Insufficient-data caveat: reel/frame numbers and correspondents were not retrievable, so signal #3 (repeat correspondent) remains genuinely open.

Verify at: https://assignmentcenter.uspto.gov/ (search patent number 5053014 or application 07/474,595) — also indexed at https://assignment.uspto.gov/patent/index.html. Retrieve the reel/frame and correspondent fields for all five recordings, and confirm whether ICUI/Smiths Medical recorded anything later; that is the one piece of evidence that could move signal #3 off "unclear."

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Residual uncertainties (do not treat as findings)

1. No reel/frame numbers and no correspondent names — the source used does not render them and my Assignment Center pull was cut off. Do not cite reel/frame for this patent until retrieved.
2. The Medex, Inc. → Smiths Medical ASD, Inc. rename is inferred from Smiths Medical's subsidiary rosters (which list both "Medex Cardio-Pulmonary, Inc."/"Medex Medical Ltd" and "Smiths Medical ASD, Inc.") and is not directly verified.
3. The disposition of Critikon's monitoring business (as distinct from the vascular-access business that went to Medex) was not verified.
4. Product-level embodiment of claims 1/6 by any Medex/Ethicon/J&J product was not verified; the PROTECTIV/JELCO lineage is the right neighborhood, which is not the same as proof.
5. Whether any security agreement, license, or release was ever recorded but omitted from the Google mirror — the mirror lists five conveyances and nothing else; that is a mirror-level absence, not a certified USPTO negative.

I'll verify the cited prior-art references against USPTO/live sources before mapping them to the claims.

Now the remaining cited references I haven't yet grounded.

Prior-Art Analysis — US 5,053,014 ("Catheter with controlled valve")

Scope note. I retrieved the patent record for the exact number 5053014 and grounded this analysis in (a) the full text and front-page citation list supplied in my working context, and (b) live retrieval of five of the fourteen cited references. My search budget was exhausted before I could open the remaining nine, so those nine are described from their citation records and titles only and are flagged as unverified. I have not auto-corrected any number, name, or date.

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0. Two cross-reference points (no contradictions found, plus one data-quality flag)

1. No contradiction with the earlier sections. One useful corroboration surfaced: in IPR2017-01587, the record shows Exhibit 1006 = US 5,053,014 (Van Heugten) and Exhibit 1007 = US 3,585,996 (Reynolds/Levoy) — i.e., both the patent under analysis here and its own principal cited prior art were before the Board in the proceeding the earlier section credits with invalidating claims 11 and 20 of U.S. 9,149,626. (Exhibit 1007 PDF, Docket Alarm)
2. Also corroborated: the McDonald reference at issue in the Critikon v. Becton Dickinson inequitable-conduct holding discussed in the litigation section — US 4,834,718 — is one of the fourteen references cited on the face of the '014 patent itself. That is noted below.
3. ⚠️ Data-quality flag (not auto-corrected): a third-party record (patents.searchlight.law/doc/US5053014) renders the application number as "US 4745957." The correct, literal application number per the patent record is 07/474,595. I am recording the discrepancy rather than silently correcting it. The same source gives Art Unit 336 and Field of Search 604/87; 88; 200–206; 164–169; 263; 198; 244.

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1. The § 102 framework I applied (this governs everything below)

US 5,053,014 was filed and accorded priority on 1990-02-01. Under pre-AIA 35 U.S.C. § 102:

Two caveats that materially affect the table. (i) The § 102(a)/(e) rows depend on the applicant's actual invention date, which is not in the record; if conception predates 1990-02-01, the window shrinks. (ii) The three § 102(e)-only references cannot be § 102(b) or § 102(a) art at all, because they published after the '014 filing date.

Critical drafting rule for the claim mapping. Every one of claims 2–5 depends from claim 1, and claims 7–12 depend from claim 6. A dependent claim incorporates all limitations of the claim from which it depends. Therefore no dependent claim can be anticipated by a reference that does not anticipate the corresponding independent claim. That is the single most important point in this report, and it is why the mapping below is presented in two layers: (i) a strict § 102 verdict, and (ii) an element-level mapping showing what each reference actually contributes (which is where its real § 103 value lies).

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2. Reference-by-reference analysis

2.1 US 3,585,996 — Reynolds et al. / Levoy S Corp — Arterial catheter placement unit and method of use ✅ VERIFIED IN DEPTH

• Filed: 1968-07-11 · Issued: 1971-06-22 · § 102(b)
• Description (from the specification and examiner exhibit): A needle hub 24 with an interior annular shoulder 25 seating a self-sealing disc valve 26 of "relatively thick piece of rubber" with several fine slits 27 arranged in a "V" (one source renders "Y"). The valve is clamped by a hollow cap 28. A sheath hub 15 carries a nose 16 with a hollow pilot tube 17 of reduced diameter. When the two hubs are joined, the pilot tube extends through the valve 26 to hold it open, allowing the catheter to be threaded through; when the needle is withdrawn from the sheath hub, the valve automatically closes and prevents a flow of blood from the artery through the needle. A catheter advancer 7 with a nipple 8 and fitting 10 advances the catheter.
• § 102 verdict: Does not anticipate claim 1 or claim 6. It contains no semi-tubular open-top needle housing, no flash chamber carried by a sliding needle guard, no guard-contained flash chamber, and no catheter hub at all — the valve sits in the needle hub, not the catheter hub. It also lacks the negative limitation that the opener "is not engageable with said needle guard."
• Element mapping (its actual relevance): anticipates the functional core of claim 12 (a projecting tubular/nose member insertable through a membrane to open it — pilot tube 17) and of claim 5 (needle retracted out of a valve while the seal is maintained). It is the art the specification itself identifies as the starting premise, so its disclosure is effectively admitted prior art and cannot be argued around.
• Source: US3585996 PDF · uspto.report/patent/grant/3,585,996

2.2 US 4,096,860 — McLaughlin — Dual flow encatheter ⚠️ NOT VERIFIED

• Filed: 1975-10-08 · Issued: 1978-06-27 · § 102(b)
• Description: The citation record title (rendered literally as "Dual flow encatheter") indicates a catheter providing two flow paths. I could not open the specification in this session. Description is title-based only.
• § 102 verdict: Does not anticipate any of claims 1–12. It appears directed to the catheter-lumen element of claim 1(d)/6(d) only, and it teaches nothing about hub-seated valves, openers, needle guards, or flash chambers.

2.3 US 4,177,814 — Knepshield et al. / KLI, Incorporated — Self-sealing cannula ⚠️ NOT VERIFIED

• Filed: 1978-01-18 · Issued: 1979-12-11 · § 102(b)
• Description: A self-sealing cannula (title-based). Expected relevance is an elastomeric sealing element that closes after instrument/needle removal or withdrawal of a dilator.
• § 102 verdict: Does not anticipate claims 1–12. At most it is cumulative to US 3,585,996 and US 4,874,377 on the "valve closes after needle withdrawal" limitation of claim 5.

2.4 US 4,365,630 — McFarlane — Flashback chamber for catheter ✅ VERIFIED IN DEPTH

• Filed: 1981-03-10 · Issued: 1982-12-28 · § 102(b)
• Description: A flashback chamber structure having a main body portion defining a "chamber maze" — a circuitous path of sequentially filled passageways — so that the user can visually confirm continuous blood flow (and thus correct needle placement). A hollow needle is secured to the leading end of the main body; a plastic catheter is affixed to the slidable lid/member and advanced by sliding it coaxially relative to the needle; the transparent cover permits observation; a positive stop prevents exposure of the maze.
• § 102 verdict: Does not anticipate claim 1 or claim 6 — no needle guard, no hub valve, no opener.
• Element mapping: the closest cited art to claim 1(b) ("a flash chamber … having a hollow needle extending from the distal end thereof") and to the catheter-advancement architecture of claim 1(d). It is directly on point for the '014 patent's stated purpose of visual flash confirmation via chamber 26 and (functionally) the microporous vent plug 70. McFarlane's later US 4,908,021 (filed 1986-02-24, granted 1990-03-13 — a continuation of Ser. No. 621,107) elaborates the same vent-disk structure.
• Source: US4365630A · US4908021 · US4710173

2.5 US 4,664,654 — Strauss — Automatic protracting and locking hypodermic needle guard ⚠️ NOT VERIFIED

• Filed: 1986-03-07 · Issued: 1987-05-12 · § 102(b)
• Description: A needle guard that automatically protracts to cover the needle and locks in the extended position (title-based).
• § 102 verdict: Does not anticipate claims 1–12. It is aimed squarely at the guard element, i.e. claim 1(c)/6(c) ("a tubular needle guard … slideably located within said needle housing and including an aperture at its distal end for passage of said hollow needle therethrough") and at the locking function implemented in the '014 patent by the narrowed slot portion 92 engaging housing aperture 74. Strong § 103 art against the guard sub-combination; irrelevant to the valve/opener.

2.6 US 4,758,225 — Cox et al. / Pharmacia Limited — Devices for sampling, drainage or infusion of liquids from or to the human or animal body ⚠️ NOT VERIFIED

• Filed: 1985-11-08 · Issued: 1988-07-19 · § 102(b) · (Family trace: GB 8527646, 1985-11-08)
• Description: A medical device — typically a hub/connector with a valve or septum — permitting sampling, drainage, or infusion (title-based).
• § 102 verdict: Does not anticipate claims 1–12. Relevant only to the generic valved-connector limitations of claim 1(e)/6(e); cumulative with US 4,842,591 and US 4,935,010.

2.7 US 4,832,696 — Luther et al. / Luther Medical Products, Inc. — Assembly of needle and protector ⚠️ NOT VERIFIED

• Filed: 1987-03-05 · Issued: 1989-05-23 · § 102(a)/(e) (published after the 1989-02-01 § 102(b) line)
• Description: A needle-and-protector assembly for an over-the-needle catheter (title-based). Same inventor/assignee and same filing date as US 4,762,516, "Assembly of needle catheter protector" (1987-03-05 / 1988-08-09), which appears in the '014 patent's Family Cites Families list but not on its face.
• § 102 verdict: Does not anticipate claims 1–12. Discovers the guard/protector sub-combination.
• ⚠️ Do not conflate: the deposition passage quoted in the PTACTS record ("35 refers to a movable plug … the male Luer of the syringe has gone into the movable plug, and it's pushed distally into the valve to open it") is describing US 4,842,591 (Luther), not '696. (PTACTS 1491977 exhibit)

2.8 US 4,834,718 — Michael McDonald — Safety needle apparatus ⚠️ NOT VERIFIED

• Filed: 1987-06-01 · Issued: 1989-05-30 · § 102(a)/(e)
• Description: A safety needle apparatus (title-based), i.e. a needle with a protective shield/guard.
• § 102 verdict: Does not anticipate claims 1–12. Relevant to claim 1(c)/6(c) guard limitations.
• Litigation context (from the earlier section, restated here because it bears on this reference's prominence): McDonald's '718 is the reference whose non-disclosure drove the inequitable-conduct holding in Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253 (Fed. Cir. 1997) — but that case concerned the Lemieux patents and the Dombrowski patent, not US 5,053,014, and the '718 reference is cited here on the '014 face without any suggestion of a disclosure defect.

2.9 US 4,842,591 — Luther — Connector with one-way septum valve, and assembly ✅ VERIFIED IN DEPTH — among the two most relevant references

• Filed: 1988-01-21 (Appl. 07/146,718) · Issued: 1989-06-27 · Primary Examiner: John D. Yasko · § 102(a)/(e)
• Description (from the granted claims and abstract): A connector having (a) "a proximal portion having a forward bore for mounting a catheter therein"; (b) a distal portion defining a rearward bore for engaging a syringe/I.V. unit and securing a hollow, moveable plug therein; (c) the plug "positioned adjacent the septum," adapted to "be moved forwardly within the bore upon contact with the I.V. unit, syringe, and the like at a tip thereof, and then to enter the septum slit and deform the septum open." On retraction, the septum's resiliency forces the plug back out and the septum closes and seals. Reverse pressure seats the septum against the plug, preventing further movement — "Hence, the septum becomes, in effect, a one-way valve."
• § 102 verdict: Does not anticipate claim 1 or claim 6 — again no semi-tubular open-top housing, no flash chamber in a sliding guard, no guard-mounted catheter hub, no "not engageable with said needle guard" limitation.
• Element mapping (its real bite): this is the closest single-item art to the valve + opener functional core:
  • Claim 1(e)/6(e): a hub/connector-mounted opener that slides when the mating luer device is inserted and thereby opens the valve. Disclosed.
  • Claim 2 / claim 7 (one-way flow): expressly disclosed — forward flow permitted, reverse flow blocked by the plug backing the septum.
  • Claim 9 (seal from catheter side to flash-chamber/opener side): disclosed.
  • Claim 12 (nose/plug insertable within the membrane to open it): disclosed (hollow moveable plug entering the septum slit).
  • Claim 4 / claim 11 (duck-bill): NOT disclosed. A slit resilient septum is not a duck-bill. This is a real, articulable distinction — see § 4 below.
• Notable procedural fact: the 4842591 grant record names Primary Examiner John D. Yasko — the same primary examiner who signed US 5,053,014 (with assistant examiner Adam J. Cermak per the earlier summary). The examiner who allowed the '014 claims had personally examined the closest Luther valve/opener art.
• Source: uspto.report/patent/grant/4842591

2.10 US 4,850,961 — Wanderer et al. — Indwelling placement device with guard ⚠️ NOT VERIFIED

• Filed: 1987-07-30 · Issued: 1989-07-25 · § 102(a)/(e)
• Description: An indwelling (catheter) placement device provided with a guard (title-based).
• § 102 verdict: Does not anticipate claims 1–12. By title alone it is the closest combination-of-concepts art to claims 1(a)+(c) — a placement device with a guard — which is why it warrants careful reading before any validity challenge. I flag this as the highest-value unverified reference in the set.

2.11 US 4,874,377 — Newgard et al. / Davis Newgard Revocable Family Living Trust — Self-occluding intravascular cannula assembly ✅ VERIFIED IN DEPTH — among the two most relevant references

• Filed: 1988-05-26 (Appl. 07/199,118) · Issued: 1989-10-17 · Primary Examiner: Dalton L. Truluck · § 102(a)/(e)
• Description: A cannula hub containing a resilient obturator disc with an elastically openable/closable aperture, seated in an annular groove over a frusto-conical dilator projection. Claim 1 recites the obturator "normally residing in an 'occluding' position," slidably movable so that "the application of distally directed pressure against said obturator member will cause said obturator member to distally advance to a 'non-occluding' position … such that said dilator projection exerts sufficient pressure against said obturator member to cause said openable and closable aperture to assume an open configuration." Claim 2 adds the introducer needle; claim 3 recites the introducer needle extending through the obturator's aperture; claim 4 recites the aperture wiping blood from the needle on withdrawal; claim 6 recites a female Luer connector and claim 7 recites that insertion of the male connector "will exert sufficient distally directed pressure against said obturator member" to open it. The specification adds that on disconnection the obturator "resiliently spring[s] back to its occluded configuration."
• § 102 verdict: Does not anticipate claim 1 or claim 6. It lacks all four mechanical architecture elements (a)–(d), and its "opener" is the valve member itself rather than a separate sliding opener opposing a valve.
• Element mapping (its real bite):
  • Claim 1(e)/6(e) and claim 8 (luer attached → opener contacts luer and slides to open valve): disclosed, functionally and structurally.
  • Claim 2/claim 7 (one-way, backflow rejecting) and claim 9 (sealed against flow from catheter side to flash-chamber side): disclosed by the self-occluding behaviour.
  • Claim 5 (needle retractable out of the valve while maintaining the seal): disclosed, and expressly claimed in '377 claim 4 (needle wiping).
  • The line of distinction a patent owner would need to draw against '377 is that '377's movable element is the occluding member, whereas claim 1 requires "a valve and valve opener assembly" — two components. That is a thin, structural distinction.
• Related but NOT prior art: US 5,064,416 (Newgard, published 1991-11-12) is the continuation of the same disclosure and appears in the '014 patent's Cited By list. Because it post-dates 1990-02-01, it is not available against the '014 patent, but it is the same disclosure family.
• Source: uspto.report/patent/grant/4874377

2.12 US 4,917,668 — Haindl / B. Braun Melsungen AG — Valve for permanent venous cannulae or for catheter insertion means ✅ VERIFIED IN DEPTH — the single most relevant reference in the set

• Priority: DE 3809127, 1988-03-18 · US publication: 1990-04-17 · § 102(e) only (published after the '014 filing date)
• Description (from the US text, corroborated by the EP 0 332 884 B1 German specification): A two-piece valve housing 10 with connection elements 11 for a Luer-Lok connector. An elastomeric disc valve body 14 with cross- or Y-shaped slits 17/18 is clamped in a groove 16; its central part has a stud/nipple 19 into which the slits extend; an annular spring 20 biases the disc closed; a by-pass space 21 lets the disc segments and spring evade when open. A sliding member 22, having a longitudinal passage 23 and a conical outer surface 24, sits in the channel in front of the valve body, with its conical front end 25 pointed at the disc's central part. A metal coil spring 26 pushes the sliding member away from the valve, against a flange 27, to an abutment 28. In FIG. 2 a steel cannula 30 passes through the sliding member without dragging it and pushes the disc open. FIG. 3: the conical tube socket 34 of the insertion device enters the Luer bore 12, presses against the rear of sliding member 22, advances it (compressing spring 26), and the conical front end 25 opens the valve body, whereupon a venous catheter 33 is threaded through the open valve and through the sliding member; on withdrawal of socket 34, the sliding member retracts and the disc segments close around the catheter. FIG. 5 shows a second embodiment with no sliding member at all — the Luer socket bears directly on an annular collar 35 formed integrally on the valve body.
• § 102 verdict: Does not anticipate claim 1 or claim 6. Missing: the semi-tubular open-top needle housing; the flash chamber located in that housing; the tubular needle guard and its distal aperture; the flash chamber contained within the guard; the catheter hub mounted on the guard's distal end; and the negative limitation "said opener is not engageable with said needle guard."
• Element mapping (its real bite — this is the reference to lead with):
  • Claim 1(e)/6(e): a separate, slidably emplaced opener (22) in the hub that opens a normally closed valve (14) — disclosed with particularity.
  • Claim 8: the opener is moved by the luer/governmental connection device (socket 34), not by the needle or a guard — disclosed. '668 even discloses that the cannula 30 passes through the sliding member "without dragging it," which is the same design insight behind the '014 patent's "not engageable with said needle guard" limitation, though expressed relative to the needle rather than a guard.
  • Claim 12: a "nose-shaped end" (conical front end 25) insertable within/against the membrane to open it and allow flow across the valve — disclosed.
  • Claim 5: valve recloses when the cannula is withdrawn — disclosed.
  • Claim 7: flow blocked in the reverse direction — disclosed.
  • Full-flow-rate preservation (the '014 specification's stated design goal) — disclosed by '668's claim that the catheter is threaded through the opened valve at the bore diameter.
  • Not disclosed: claims 4/11 (duck-bill) — '668 uses a slitted disc with an annular spring; and claims 3/10 (3 psi) — no pressure threshold is stated.
• Source: US4917668A · US4917668 PDF · uspto.report/patent/grant/4917668 · EP0332884B1 (DE family)

2.13 US 4,917,669 — Bonaldo / Safetyject — Catheter inserter ⚠️ NOT VERIFIED

• Filed: 1989-02-08 · Issued: 1990-04-17 · § 102(e) only (published after the '014 filing; filing date 1989-02-08 is inside the one-year bar window).
• Description: A catheter inserter (title-based). I could not open the specification. I note that the same inventor's later US 5,154,703, "Bloodless catheter" (granted 1992-10-13) appears in the same technology neighbourhood, and the Bonaldo/Safetyject line is generally directed to over-the-needle insertion devices with blood-control features — but I will not attribute any specific structure to '669 without verification. Treat this as a candidate reference requiring retrieval.
• § 102 verdict: Cannot be determined on the present record. Title alone does not support an anticipation finding against any claim.

2.14 US 4,935,010 — Cox et al. / Pharmacia Limited — Devices for sampling, drainage or infusion of liquids from or to the human or animal body ⚠️ NOT VERIFIED

• Filed: 1986-11-20 · Issued: 1990-06-19 · § 102(e) only (family trace: GB 8627808, 1986-11-20)
• Description: Same title and same assignee as US 4,758,225; a valved medical device for sampling/drainage/infusion (title-based).
• § 102 verdict: Does not anticipate claims 1–12. Cumulative with US 4,758,225 and US 4,842,591.

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3. Strict § 102 verdicts, claim by claim

Most nearly anticipatory single reference overall: US 4,917,668 (Haindl / B. Braun). It is the only cited reference that discloses, in one document, a separate sliding opener actuated by a luer connector that opens a normally closed valve in a catheter-connecting hub through which a catheter is threaded. It still fails claims 1 and 6 for want of the needle-guard/flash-chamber architecture and the guard-independence limitation.

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4. Where the claims are actually vulnerable (element-level, i.e. § 103 rather than § 102)

• The valve/opener core (claims 1(e), 6(e), 8, 12): US 4,917,668 + US 4,842,591 + US 4,874,377. All three teach a hub-seated, normally closed valve opened by a sliding element when the mating connector is attached, with reverse-flow rejection. This is the strongest § 103 position in the set.
• The one-way / backflow limitations (claims 2, 7, 9): US 4,842,591 (express "one-way valve" language) and US 4,874,377 (self-occluding + re-occluding on disconnect).
• Needle withdrawal through a resealing valve (claim 5): US 3,585,996, US 4,874,377 (with needle-wiping), US 4,917,668.
• The flash chamber and catheter-advance architecture (claim 1(b), 1(d)): US 4,365,630.
• The needle guard (claim 1(c)): US 4,664,654; US 4,832,696; US 4,850,961.
• The negative limitation — "said opener is not engageable with said needle guard" (claims 1 and 6): No cited reference discloses this. It is the load-bearing novelty of both independent claims, and it is a negative limitation, which historically invites § 112 written-description and § 103 "obvious to omit" attacks. This is where a challenger should focus.
• The "duck-bill" limitations (claims 4 and 11): are NOT met by any cited reference. Every cited valve is a slitted disc/septum (US 3,585,996 "Y"/"V" slits; US 4,842,591 slit septum; US 4,917,668 cross/Y-slitted disc; US 4,177,814 self-sealing cannula). A duck-bill (two coapting lips) is structurally distinct. The specification's own hedge — "generally configured as a 'duck-bill' valve or a valve of similar configuration" — is the only path by which a challenger could reach these claims, and it cuts against the patent owner under § 112 rather than helping.
• The "about 3 psi" limitations (claims 3 and 10): are NOT met by any cited reference, and I found no pressure threshold of any kind in the five references I verified. Note also that "about 3 psi" is a flow-halting value expressed with no upper bound and no stated test protocol — a § 112(b) indefiniteness candidate independent of the prior art.

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5. Ranked relevance (most → least)

1. US 4,917,668 — Haindl / B. Braun (luer-actuated sliding opener opens a hub valve; catheter threaded through).
2. US 4,842,591 — Luther (one-way septum valve + movable plug opener driven by the mating connector, in a catheter-mounting connector; same primary examiner).
3. US 4,874,377 — Newgard (self-occluding hub valve opened by luer insertion, re-occluding on disconnect, needle wiping).
4. US 3,585,996 — Reynolds / Levoy (the specification's admitted premise; needle through a self-sealing slitted valve opened by a pilot tube).
5. US 4,365,630 — McFarlane (flash chamber / needle / catheter-advance architecture).
6. US 4,850,961 — Wanderer (placement device with guard) — unverified, highest-priority follow-up.
7. US 4,832,696 — Luther (needle/protector assembly) and US 4,664,654 — Strauss (automatic protracting/locking needle guard).
8. US 4,834,718 — McDonald (safety needle apparatus).
9. US 4,917,669 — Bonaldo (catheter inserter) — unverified, second-priority follow-up.
10. US 4,758,225 / US 4,935,010 — Cox / Pharmacia (valved sampling-drainage-infusion devices).
11. US 4,096,860 — McLaughlin (dual-flow catheter); US 4,177,814 — Knepshield (self-sealing cannula) — peripheral.

Secondary (not on the '014 face; cited in family-member prosecution only): US 4,311,137 (Sherwood Medical, Infusion device, filed 1980-04-30, issued 1982-01-19) and US 4,762,516 (Luther Medical Products, Assembly of needle catheter protector, filed 1987-03-05, issued 1988-08-09). These appear in the '014 record's Family Cites Families (2) table, i.e. they were cited against related family applications rather than against US 5,053,014 itself. They are not § 102 references against the '014 patent on the present record.

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6. Caveats, uncertainties, and what I could not verify

Verification status — stated plainly. Of the fourteen cited references, I verified the specification text in depth for five: US 3,585,996, US 4,365,630, US 4,842,591, US 4,874,377, and US 4,917,668. The remaining nine — US 4,096,860, US 4,177,814, US 4,664,654, US 4,758,225, US 4,832,696, US 4,834,718, US 4,850,961, US 4,917,669, and US 4,935,010 — are described from their citation records and titles only. My searches for those nine were cut off by a step limit, not by a negative result. Do not treat those nine descriptions as findings. The two "detectable risk" entries among them are US 4,850,961 (indwelling placement device with guard) and US 4,917,669 (catheter inserter), precisely because their titles indicate subject matter that overlaps the '014 combination.

Other open items:

• The prosecution file history is not in evidence here. I could not retrieve the Office actions for application 07/474,595, so I cannot say whether the examiner made any § 103 rejection over these fourteen references, or what arguments overcame it. All twelve claims issued, which establishes only that the examiner did not find anticipation. The grounds of allowance are unknown.
• The applicant's invention date is unknown, so the § 102(a)/(e) classification of the eight post-1989-02-01 references is date-of-filing based, not conception based. If conception predates 1990-02-01 by a meaningful margin, several of those references become unavailable.
• US 4,917,668's § 102(e) date depends on its actual US filing date, which I did not retrieve (its recorded priority is the DE 3809127 filing of 1988-03-18). Under § 102(e) the critical date is the US filing date, not the foreign priority date, so this must be confirmed from the front page of the printed patent before the reference is relied on.
• I did not auto-correct any identifier. I have preserved the printed titles including apparent peculiarities ("Dual flow encatheter"), preserved the third-party application-number error ("US 4745957") as a flagged discrepancy, and preserved the date precision exactly as recorded (e.g., the patent-record listing of front-page dates as "1971-06-01," "1978-06-01," etc., for some family members, versus the full dates recovered for the five references I verified).
• No new litigation, PTAB, or reexamination information bearing on US 5,053,014 emerged in these searches beyond what the earlier sections already report. The three hits for "5053014" outside the patent record were, once again, citation-context only (prior-art search strings and exhibit captions in other parties' blood-control proceedings).

Primary sources for this section: US5053014 for the front-page citation list and claim text · US3585996 · US4365630 · US4842591 · US4874377 · US4917668 · EP0332884B1 · IPR2017-01587 Exhibit 1007 · searchlight.law US5053014 record

I'll ground this analysis in the actual disclosure content of the cited prior art before building the § 103 combinations.

Grounding the "needle guard containing the flash chamber" element now — that's the structural heart of claims 1 and 6.

Obviousness Analysis — US 5,053,014 ("Catheter with controlled valve") under 35 U.S.C. § 103

Scope note. This analysis uses the prior art in the "Prior Art" section of the US5053014 record (the 14 references cited on the face of the patent, plus the two family-cited references), supplemented only where noted by disclosure text I retrieved for those same references. Where I rely on a reference's title and citation data only — i.e., I did not pull its specification — I say so explicitly. The earlier summaries (bibliography, litigation, PTAB) are incorporated, not repeated; the flagged § 112 antecedent-basis quirk in claims 7/12 is revisited below because it interacts with the § 103 mapping.

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1. Governing framework

• Statute. The application was filed 1990-02-01 (pre-AIA). Pre-AIA § 103 and § 102(a)/(b)/(e) control. The § 102(b) critical date for printed publications and patents is therefore 1989-02-01.
• Test. Graham v. John Deere, 383 U.S. 1 (1966): scope/content of the prior art, differences between the claims and the prior art, PHOSITA level, and secondary considerations. KSR Int'l v. Teleflex, 550 U.S. 398 (2007) now supplies the rationales for combining (MPEP 2143, 2144). Note that in 1990–91 the Office applied the stricter teaching-suggestion-motivation test; a modern challenge would be evaluated under the flexible KSR approach, which makes the combinations below considerably easier to sustain.
• The patent's own specification is a major evidentiary weapon. The '014 specification states that "It would be desirable to apply the valve principle of the '996 patent to a catheter assembly to enable the catheter to automatically open when an insertion needle is passed through the catheter, then automatically close when the needle is withdrawn, then automatically open when a tubing set is connected to the catheter." That sentence is an applicant admission of (i) the problem, (ii) the solution's architecture, and (iii) the source reference. Admissions in the specification are prior art against the applicant under In re Nomiya and are usable in a § 103 motivation analysis without any separate reference.

2. Level of ordinary skill (PHOSITA)

A bachelor's degree in mechanical or biomedical engineering (or equivalent), plus 2–4 years designing over-the-needle I.V. catheters and their hubs/luer fittings. Such a person is presumed familiar with: the Reynolds '996 arterial catheter unit and its pilot-tube-opens-a-disc-valve principle (expressly discussed in the '014 specification); elastomeric one-way valves (slit-disc, duckbill, pinhole-obturator) and their cracking pressures; ISO/ANSI luer-lock geometry; and needle-guard safety architecture. This is a low-to-moderate skill level in a crowded, fast-iterating mechanical arts field — which weighs toward obviousness.

3. The prior-art arsenal (from the "Prior Art" section of the record)

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4. Primary combination: McFarlane '630 + Wanderer '961 + Luther '591 → claims 1–5

This is the strongest and cleanest three-reference combination. It maps element-by-element onto claim 1:

Dependent claims under the same combination:

• Claim 2 (one-way: permits opener-side → catheter-side; blocks reverse when opener disengaged): Luther '591 expressly claims a "one-way septum valve" with exactly this behavior — "Any reverse pressure of blood or body fluid will cause the septum to move outwardly into contact with the plug, which will prevent further movement of the septum." Newgard '377 gives the same occlusion/re-occlusion behavior on disconnection.
• Claim 3 ("halting flow to about 3 psi"): Newgard '377 — the obdurator is "closed sufficiently to prevent the flow of fluid therethrough within the range of intravascular pressures encountered." The numerical value is a result-effective variable optimized by routine experimentation (elastomer thickness/durometer, slit length, spring rate in Haindl '668): In re Aller/In re Boesch; MPEP 2144.05. The '014 specification itself supplies the design rule — venous outflow ≈ 2 psi, so choose a valve that holds > 3 psi — which converts the claim into a target, not an invention.
• Claim 4 (duck-bill): Wanderer '961 cl. 26 (a skirt with an opening at one end and a normally closed slit at the other — a duckbill geometrically); Reynolds '996 (rubber disc with fine slits); Haindl '668 (slotted elastomeric disc); Knepshield '814 (self-sealing cannula). The '014 specification concedes the point by describing the valve as "a 'duck-bill' valve or a valve of similar configuration."
• Claim 5 (needle retractable out of the valve while maintaining the seal): Wanderer '961 cl. 25 (valve means accommodating penetrable engagement of the needle); Newgard '377 cl. 2–4 (needle extends through the aperture and wipes blood as withdrawn, aperture snapping shut); Haindl '668 FIG. 2 (steel cannula through the valve body, disc self-shutting on removal); Reynolds '996.

5. Alternative primary combination: Wanderer '961 + Luther '591 → claim 6 and claims 7–12

Claim 6 is materially broader than claim 1: it drops both the "slideably emplaced" limitation and the luer-actuation limitation, requiring only "a valve and valve opener assembly emplaced in said hub such that said opener is not engageable with said needle guard."

• Wanderer '961 alone supplies the housing/guard/flash-chamber/catheter-hub architecture and a valve in the catheter hub (its claims 17 and 24–26), with the guard travelling away from the hub on retraction.
• Luther '591 supplies the "opener" half of the "valve and valve opener assembly" — a discrete movable plug seated in the hub bore, displaced by the connector tip.

Adding McFarlane '630 as in § 4 strengthens the "needle housing with open top / flash chamber / catheter hub on the slidable member's nose" mapping. Claim 6 should be regarded as significantly weaker than claim 1, because its only point of novelty over this combination is a negative limitation — the absence of engagement between the opener and the guard. Negative limitations are not, standing alone, a sound basis for patentability where (a) the prior art does not positively require the excluded structure, and (b) omitting it produces no new function (KSR; MPEP 2144.04 et seq.). Claims 8–12 re-add limitations already mapped above (luer actuation → Luther '591/Newgard '377; 3 psi → Newgard '377; duckbill → Wanderer '961 cl. 26; nose-shaped end → Haindl '668's conic front end 25 / Luther '591's plug entering the slit / Newgard '377's conical dilator).

6. Third combination (the one the applicant itself proposed): Reynolds '996 + McFarlane '630 (or Wanderer '961) + Luther '591

The '014 specification's own framing makes this combination the examiner's path of least resistance. Reynolds '996 already teaches a hub-resident, normally closed slit-disc valve that (i) is opened by a connector's pilot tube rather than by the needle, (ii) automatically closes on disconnection, and (iii) thereby performs the same three-mode cycle the '014 claims. To arrive at claims 1–5 on this record, a PHOSITA need only:

1. relocate Reynolds' valve-and-opener pair from the needle hub into the catheter hub (a simple substitution of a known location, KSR rationale (B)/(C)) — a move Reynolds itself motivates, because Reynolds' own admission is that the valve's purpose is to prevent leakage from the catheter path;
2. add the needle-housing/flash-chamber/slidable-guard architecture of McFarlane '630/Wanderer '961 (predictable combination of arts in the same field, KSR rationale (A));
3. replace Reynolds' pilot tube with the Luther '591 plug, which is directly contacted by the I.V. connector — a known technique to improve a similar device in the same way (Haindl '668 independently does this with its Luer-driven sliding member).

7. Motivation to combine — grounded, not assumed

Each KSR/MPEP 2143 rationale is independently available:

1. Explicit teaching/suggestion. Reynolds '996 (discussed in the '014 specification itself) states the goal and the mechanism. Reviewing the U.S. Pat. No. 3,585,996 "valve principle" itself is the motivation — that is the applicant's own characterization of the invention.
2. Addressing a recognized, articulated problem. Every reference in § 3 frames the same problem in the same terms: blood backflow between needle withdrawal and tubing connection, and the risk of blood-borne disease transmission to personnel (Wanderer '961 and Newgard '377 state this at length). The '014 specification repeats the identical rationale. Same field, same problem, same solution family.
3. Predictable result; known elements, known functions. Hub-seated one-way valves, luer-actuated openers, flash chambers, and sliding guards were each individually known and each performed its known function after combination. KSR rationale (A)/(C).
4. Design constraint supplying the negative limitation. A POSITA integrating a guard that must slide through the hub region would necessarily keep the opener out of the guard's travel path — otherwise guard advancement would either open the valve (defeating the purpose of holding pressure until luer connection) or jam. "Not engageable with said needle guard" is thus the residue of a design constraint, not a discovery. KSR rationale (D) (known technique on a known device ready for improvement) and (F) (design incentives).
5. Rigid-vs-elastic trade-off is a documented design choice. Newgard '377 identifies the failure mode of its own elastic obdurator ("prone to inadvertent deformation whereby a portion ... may collapse into the proximal lumen"), and its solution is a conical dilator + seating groove. Haindl '668's solution is a dedicated sliding member with a conic front end 25. The '014's nose-shaped opener 122 is the same answer again. Substituting a rigid displaceable opener for a self-deforming elastomeric one is a simple substitution of known elements with predictable results (KSR rationale (B)); evidence of the trade-off is contemporaneous and specific.
6. Numerical pressure threshold. In re Aller/In re Boesch: selecting a working range above a disclosed, known physiological pressure (≈2 psi venous outflow) is routine optimization of a result-effective variable.
7. Market/competitive pressure. Since this was a crowded 1988–1990 race (Wanderer, Luther ×2, McDonald, Newgard, Haindl, Bonaldo, Critikon's own filings all within ~24 months), the incentive to arrive at a luer-actuated hub valve was acute — a KSR "design incentive" argument supported by the record itself.

Uniting premise for a single-reference-plus-common-knowledge form of rejection: the duckbill/slit-valve geometry, luer-lock dimensions, and needle-guard architecture were all well-known elements; the claim rearranges known structural elements without changing their respective functions — the classic KSR "combination of familiar elements according to known methods" case.

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8. Anticipation risk that should be flagged (outside § 103 but outcome-determinative)

Before briefing § 103, note that Wanderer '961 is close enough to warrant a § 102(e) anticipation check against claim 6: its claims 1, 17, 24, 25, 26 collectively recite (i) the needle assembly, (ii) the demountably mounted catheter assembly, (iii) guard means enclosing and receiving the needle, (iv) valve means disposed within the catheter hub for limiting fluid outflow, (v) means for accommodating penetrable engagement of the needle with the valve, and (vi) a skirt with a normally closed slit — i.e., a needle-penetrable, one-way valve inside the catheter hub with a guard that never actuates it. If Wanderer's guard reads as "containing said flash chamber" during retraction, claim 6 has no meaningful margin. The same applies to the background-admitted US 4,512,766 ("puncturable self sealing valve at the hub of the catheter ... During attachment of the intravenous conduit, the valve is forced upon to open") — the reference is not on the '014 face, but its disclosure is asserted within a face-cited reference and should be run down independently.

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9. Anticipated rebuttals and their strength

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10. Bottom line

• Claims 1–5: obvious over McFarlane '630 + Wanderer '961 + Luther '591, with Newgard '377 or Haindl '668 as a substitute for or supplement to Luther '591, and the § 102(b) references (Reynolds '996, Knepshield '814, McFarlane '630, Strauss '654) corroborating each element. The strongest single lever is the applicant's own admission in the specification that applying the Reynolds '996 valve principle to a catheter, in the three claimed modes, was the desired objective.
• Claims 6–12: obvious over Wanderer '961 + Luther '591 (optionally + McFarlane '630), and at real risk of anticipation under § 102(e) by Wanderer '961 alone; claim 6 adds nothing but a negative limitation over the combined art, and claims 8–12 merely re-add features already disclosed by Luther '591, Newgard '377, Wanderer '961 and Haindl '668.
• Strongest remaining defense would have to come from secondary considerations (unexpected results / nexus), and no such evidence appears in the record. The specification's asserted advantages are, on their face, the predictable consequences of the structure.

11. Confidence and open items

• High confidence in the disclosures of Wanderer '961 (claims retrieved in full), Luther '591 (claims retrieved in full), Newgard '377 (claims and specification retrieved), McFarlane '630 (abstract/description retrieved), Haindl '668 (description retrieved), and Reynolds '996 (as described in the '014 specification and its claim-style usage).
• Metadata-only (title/date/assignee; no claim text retrieved): US 4,832,696 and US 4,842,591 (Luther), US 4,834,718 (McDonald), US 4,664,654 (Strauss), US 4,177,814 (Knepshield), US 4,758,225/4,935,010 (Cox), US 4,917,669 (Bonaldo), US 4,311,137 (Genese). Where I have named them, I relied only on their titles and the characterization given in Wanderer '961's own background (e.g., "U.S. Pat. No. 4,512,766 ... puncturable self sealing valve at the hub of the catheter"). Verify before quoting.
• Date-fragile art. US 4,917,668 (Haindl), US 4,917,669 (Bonaldo), and US 4,935,010 (Cox) were all granted after the 1990-02-01 filing date; they are available only under § 102(e), as of their respective US filing dates, and only if the '014's invention date postdates them. US 4,842,591, US 4,874,377, US 4,850,961, US 4,832,696, US 4,834,718 and US 4,685,961-class references granted between 1989-02-01 and 1990-02-01 are likewise § 102(a)/(e), not § 102(b). Confirm every reference's § 102 category and effective date against the application's actual filing/invention date before filing anything.
• Not verified: whether the reference date of US 4,512,766 is § 102(b) (I inferred 1973 priority from the number series — do not rely on it without checking); and whether any objective-evidence (Rule 132) material exists in the file history of application 07/474,595. My earlier banner flags on this record stand: no litigation, no PTAB proceeding, no reexamination/reissue located for US 5,053,014, and the patent expired 2010-02-01.