US 5013304

I'll run targeted searches to confirm the patent record and check for any litigation or CAFC activity.

Search Results: US 5013304

Searches run: Google Patents full text for "US5013304," a Google Patents/Justia/FreePatentsOnline cross-check, and a CAFC/litigation-oriented query ("5013304 patent litigation CAFC"). Result: no litigation, IPR, or CAFC 2026 docket activity directed at patent 5013304 was found. The only third-party hits are citations of 5013304 as prior art inside other patents' IDS/reference lists and inside keyword search strings in an exhibit (Exhibit 2005-60) from IPR2017-01588, which is an inter partes review of U.S. Pat. 8,460,247 — a different patent. 5013304 itself was never the subject of that proceeding.

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Bibliographic record (per Google Patents / USPTO assignment records, fetched 2026-09-30)

Ownership chain (literal record): BFD, Inc. → security interest to The CIT Group/Credit Finance, Inc. (recorded 1995-07-24; assignor "Alpha Pro Tech, Ltd., formerly known as BFD Industries, Inc.") → release of that security agreement recorded 2000-10-10. Note the security interest and its release are not outright assignments of title; Google's "Current Assignee: BFD Inc" field sits in tension with the Alpha Pro Tech naming in the record. I cannot authoritatively resolve the chain of title from these sources alone — flagging that as an uncertainty.

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Abstract (as printed)

"An intravascular catheter assembly includes a catheter needle sheath having a retractable needle which is moved upon slidable movement of a handle member that is slidably mounted in the housing of the catheter needle sheath. The catheter needle safety sheath is insertable into a catheter or into a catheter adapter and backflow device which is in turn insertable into the catheter. The backflow device includes an elastomeric diaphragm disposed therein which re-seals upon withdrawal of the needle therefrom and advantageously prevents excessive fluid leakage from the catheter. The catheter needle safety sheath provides an improved means for disposing of the used needle since the handle member may be slidably moved in a rearward direction so as to retract the needle within the sheath. Both the catheter needle safety sheath as well as the catheter adapter and backflow device prevent unnecessary exposure to bodily fluids which may transmit diseases and thereby enhance the safety of the operators of these devices."

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The five claims — plain-language overview

The patent has 5 claims, 2 of which are independent (claims 1 and 3), both drafted as apparatus claims for an "intravascular catheter assembly."

Claim 1 (independent) — three-part assembly:

• (a) Catheter member: a plastic needle tube that receives a needle for vein insertion, an internal catheter passageway, and a hub that opens rearwardly.
• (b) Catheter adapter and backflow device: a front adapter end that seats fluid-tight into the catheter's rear hub; an adapter cavity communicating with the catheter; a rear adapter hub; and a self-closing valve between the cavity and the rear hub. The valve is an elastomeric diaphragm that re-seals by the diaphragm material returning to its original position to fill the puncture opening left by the needle (i.e., re-sealing by material recovery, not by compressive structural confinement). A needle can be passed through the valve.
• (c) Catheter needle safety sheath: an elongated hollow housing with an elongated slot and a tapered front end sized to fit the rear adapter hub; a retractable needle slidably housed inside; a needle hub on the needle's rear end; a fin-shaped handle on the needle hub projecting through the slot so the operator can slide the needle out the front or retract it into the housing; and a needle hub end member on the rear of the needle hub, slidably disposed in the sheath's rear portion.

Claim 2 (dependent on 1): the adapter/backflow device is cylindrical and made of lightweight transparent plastic suitable for prolonged tissue, blood, and therapeutic-fluid contact.

Claim 3 (independent) — same (a) and (b) as claim 1, but a different sheath handle: the sheath in claim 3 has the slotted housing, tapered front end, retractable needle, and needle hub — but instead of the fin-shaped handle it requires a tab-shaped handle with a roughened upper surface mounted on the needle hub.

Claim 4 (depends on 3): adds (a) a wedge member on the front of the tab-shaped handle that frictionally engages the tapered front portion of the sheath slot to lock the handle forward, and (b) a retraction hole at the front inner surface of the sheath housing allowing the needle to retract through it while preventing the needle from projecting back through it. (Note the claim's preamble reads "The catheter needle safety sheath housing of claim 3," even though claim 3 is an assembly claim — a drafting inconsistency worth flagging.)

Claim 5 (depends on 4): the handle has two slide slots that slidably engage the sheath housing.

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Notable claim/description mismatches (literal reading)

• The Summary of the Invention describes element (c) as a "needle hub support member mounted on a rearward end of said needle hub member"; claim 1 instead recites a "needle hub end member" slidably disposed in the rear portion of the housing. The specification elsewhere describes the end member 18 as a vent/filter element, so the claim and summary terminology do not map cleanly onto one another.
• The retraction-hole feature (convex-shaped retraction hole 13a in the spec; claimed generically in claim 4) and the wedge/forward-lock feature are recited only in the claim-3/claim-4 line, not in claim 1's fin-handle line.
• The specification's "Definitions" extract on Google Patents contains a garbled/duplicated abstract sentence; the printed Abstract section quoted above is the authoritative version.

Uncertainty disclosure: I have high confidence in the bibliographic data, claim text, and the absence of any CAFC/IPR challenge to 5013304, because these come from the patent's own full text plus corroborating patent-database records. I do not have authoritative information on the precise current chain of title (BFD Inc. vs. Alpha Pro Tech, Ltd.) or on any district-court litigation that may have occurred in the 1990s before fee lapse, and I would not assert either without a direct PACER/assignment-record pull.

I'll search for litigation records involving US 5,013,304 across patent litigation databases and court sources.

Let me check additional litigation-specific sources.

Let me check the specific litigation portals directly.

Litigation Search Results: US Patent 5,013,304

Bottom line: I found no record of any litigation — district court, CAFC, ITC, or PTAB — involving US Patent 5,013,304.

What I searched

Why "no litigation" is the credible answer here

Several independent characteristics of this patent corroborate the null result:

1. The patent was never in force long enough to be a valuable litigation target. Per the Google Patents legal-events record, the maintenance fee was not paid: a reminder was mailed 1994-12-13, lapse for failure to pay occurred 1995-05-07, and the patent lapsed effective 1995-05-10. It was formally recorded as expired due to nonpayment of maintenance fees under 37 CFR 1.362 (entry dated 2018-01-29). Google Patents lists the status as "Expired – Fee Related." A patent that lapsed roughly four years after issuance — within the pre-1995 regime where the first maintenance fee was due at 3.5 years — is an unlikely candidate for infringement suits.

2. The recorded post-issuance activity is financial, not adversarial. The chain is: BFD, Inc. (original assignee; assignment recorded 1989-04-14) → Alpha Pro Tech, Ltd. (formerly BFD Industries, Inc.) → CIT Group/Credit Finance, Inc. taking a security interest (recorded 1995-07-24, reel/frame 007570/0260) → release of that security agreement recorded 2000-10-10 (reel/frame 011164/0394). No license-and-sue activity, no assertion.

3. The only "hits" for the number are citations, not claims. The recurring appearances of "US-5013304" are in examiner/party prior-art citation lists (e.g., the S15/S39 search-history tables in the exhibit file for IPR2017-01588 concerning U.S. Pat. 8,460,247, and the Cite No. 1 reference listing at 85), and in the reference list of Justia's page for U.S. Pat. 7,715,918 ("5013304 | May 7, 1991 | Russell et al."). Being cited as prior art against someone else's patent is not litigation involving this patent.

Table of known litigation

Required caveats (per your instructions, and to avoid overstating certainty)

• I am reporting a negative finding. I do not have complete coverage of every federal court docket or of pre-1995 paper filings, and PACER itself requires paid, case-by-case access that I cannot query exhaustively here. A thoroughly negative result from public databases is strong but not conclusive evidence that no suit ever existed.
• The patent number was interpreted literally as 5,013,304. I did not return results for look-alike numbers. Note that "5013304" also appears as an unrelated CourtListener investment record ID; I excluded that as a non-patent match.
• If you need a court-grade negative statement (e.g., for a clearance, due-diligence, or damages opinion), the reliable confirmations would be: (a) a PACER "Patents" / civil case search on the patent number, (b) Lex Machina / Docket Navigator / Unified Patents litigation portal patent-number search, and (c) an assignment-abstract and maintenance-fee check through USPTO Patent Center, which I have partially reproduced above from the Google Patents legal-events record (source: https://patents.google.com/patent/US5013304/en).

Given the 1995 lapse, any litigation would almost certainly predate 1995 and would have concerned the 1989–1995 window; nothing of that kind surfaced.

I'll verify the structured-block default against the public record before writing this up.

Search results so far are all false positives from other patents ending in "304." Let me run more precise queries.

Let me check the PTAB docket sources and patent-owner-specific angles directly.

Proceedings overview

Total AIA trial proceedings on file for US 5,013,304: 0. There is no IPR, no PGR, no CBM, and no derivation proceeding naming this patent as the challenged patent — no active proceedings, no claims invalidated, no claims sustained, no settlements, and no institution denials, because no petition was ever filed. The USPTO Open Data Portal structured block returns no AIA trial proceedings for this patent, and my independent web check corroborates that null result (details and the false positives I had to discard are below).

The defensive posture this produces is not the usual "hardened by surviving IPRs" story and not the "claims are canceled" story either. It is a third, simpler posture: there is no PTAB record to exploit, and there never could have been a meaningful one, because the patent lapsed for failure to pay the 3.5-year maintenance fee — effective 1995-05-10, seventeen years before IPR practice began on 2012-09-16.

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Proceedings identified

None. There are no proceedings to rank by impact, so the template collapses to the following.

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Why the "0" is structural, not just empirical

Three independent features of this patent explain the null result, and they matter more than the search result does:

1. The patent was dead before AIA trials existed. Per the Google Patents legal-events record (fetched 2026-09-30, https://patents.google.com/patent/US5013304/en): maintenance-fee reminder mailed 1994-12-13; "LAPS — Lapse for failure to pay maintenance fees" recorded 1995-05-07; "FP — Lapsed due to failure to pay maintenance fee," effective 1995-05-10. IPR became available 2012-09-16. A challenger in 2013 had no live patent to attack prospectively.
2. PGR was categorically unavailable. Post-grant review under 35 U.S.C. §§ 321–329 applies only to patents subject to the first-inventor-to-file regime — i.e., effective filing dates on or after 2013-03-16. This patent was filed 1989-02-22 and issued 1991-05-07. No PGR could ever have been filed against it.
3. CBM was categorically unavailable. Covered business method review required a patent claiming a method or apparatus for a financial product or service (AIA § 18(d)(1)). A catheter/backflow-valve assembly in A61M25/06 is a technological invention, not a covered business method. (CBM also sunset on 2020-09-20.)

So the only trial type theoretically available at any point was IPR — and only during the 1991–1995 in-force window would such a challenge have had practical purpose, since IPR did not exist then and the patent was expired by the time it did. I note explicitly, as an accuracy caveat, that an IPR petition can be filed against an already-expired patent (challengers do this to clear past-damages exposure under 35 U.S.C. § 286), so expiration alone does not legally foreclose an IPR. The point is that no one filed one. I found no such petition.

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False positives I discarded (flagged per instruction)

The web searches for "5013304" and "'5,013,304'" return substantial noise because several unrelated patents end in the digits 304. None of these involve US 5,013,304:

• IPR2017-01588 (Inter Partes Review of U.S. Pat. 8,460,247) — the docket file for this proceeding contains an exhibit (Exhibit 2005-60, the file history of US 9,370,641) in which US-5013304 appears only as a string inside an examiner's EAST search query, alongside ~40 other patent numbers in a .did. boolean string. Being listed in a search string in someone else's file history is not a proceeding against this patent. Source: https://www.docketalarm.com/cases/PTAB/IPR2017-01588/
• IPR2025-00883 (Hisense v. VideoLabs) — challenged U.S. Pat. 8,667,304; the "'304 patent" language refers to that patent, not 5,013,304.
• IPR2025-01249 / IPR2025-01251 (Samsung et al. v. Omni MedSci) — challenged U.S. Pat. 10,874,304 ("the '304 patent"). Again a different patent; the "the '304 is available for IPR" certification language in the search snippet is from that Omni MedSci petition, and this is the single most misleading hit of the set.
• US-5013304 as a citation — the patent appears in the "Cited By" / reference lists of later patents (Google Patents shows 86 cited-by entries in the truncated list, 157 in the fuller list), including Justia's page for U.S. Pat. 7,715,918. Being cited as prior art against someone else's patent is not PTAB activity.

I want to be plain that these searches produced zero genuine PTAB hits. I did not invent a proceeding number, and I am not going to fill the template with a proceeding that does not exist.

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Strategic summary

Claim status — CANCELED / SUSTAINED / UNTESTED: All five claims (1–5) are UNTESTED. Not one of them has ever been the subject of an AIA trial. Claims 1 and 3 are the independents (claim 1 covering the fin-shaped handle line; claim 3 the tab-shaped handle line), with claims 2, 4, and 5 depending. Their validity as issued is untouched by the Board — but note the previously generated claim analysis, which independently flags real internal problems: claim 4's preamble purports to claim "The catheter needle safety sheath housing of claim 3" even though claim 3 is an assembly claim, and the Summary of the Invention recites a "needle hub support member" that claim 1 replaces with a differently-named "needle hub end member." Those are § 112-style vulnerabilities a challenger would have probed. No one did, because the patent had already lapsed.

Estoppel landscape: With no institution, there is no § 315(e)(2) estoppel, and no § 325(e) estoppel. Every ground — § 102, § 103, and § 112 — remains available to any defendant. The usual reason to care about this (salvaging a defense after an earlier petitioner burned the art) does not apply, because no one burned anything. The only reason it matters here is academic.

Pattern signals: None of the usual patterns are present. There is no repeat petitioner, no Unified Patents–style defensive aggregator, no PTAB appeal activity by the patent owner, and no Federal Circuit appeal — for the simple reason that there is no trial record to appeal. The recorded post-issuance events in this patent's file are financial rather than adversarial: a security interest to The CIT Group/Credit Finance, Inc. (recorded 1995-07-24, Reel/Frame 007570/0260, assignor named as "Alpha Pro Tech, Ltd., formerly known as BFD Industries, Inc.") and its release (recorded 2000-10-10, Reel/Frame 011164/0394). My prior section already flagged the chain-of-title ambiguity as between BFD Inc. and Alpha Pro Tech, and I cannot resolve it here. One further item I want to flag rather than smooth over: the record contains a 2018-01-29 STCH entry reading "PATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362," which sits in tension with the 1995 lapse events. The 1995 lapse (effective 1995-05-10) is the operative termination; the 2009-02-22 "anticipated expiration" is the 20-year statutory maximum. I would not treat the 2018 entry as evidence of the patent having been alive after 1995 without a direct Patent Center status pull.

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Recommended next steps

If you are a defendant being asserted against — lead with expiration, not with IPR. The decisive fact is that US 5,013,304 lapsed effective 1995-05-10 for nonpayment of maintenance fees and has been in the public domain for over three decades. An expired patent cannot be infringed prospectively. Any monetary exposure would be governed by the damages look-back in 35 U.S.C. § 286 (six years), and here even that window closed in the 1990s. There is also a false-marking/standing dimension if anyone is asserting it today: a lapsed patent cannot support an infringement claim, and the assertion itself is worth scrutinizing for Rule 11 / § 285 purposes. I am reporting this as a documentary finding from the legal-events record, not as a legal opinion — get a Patent Center status confirmation (maintenance-fee receipts or their absence) before resting anything dispositive on it.

If you want a court-grade confirmation that no PTAB proceeding exists, the checks are:

• PTAB E2E / PTAB Center patent-number search: https://ptacts.uspto.gov/ptacts/ (this is the same system whose P-TACTS petition documents appear in the search results above).
• USPTO PTAB Decisions page for any Final Written Decision: https://www.uspto.gov/patents/ptab/decisions
• USPTO Open Data Portal AIA trial proceedings endpoint — which, per the canonical structured block supplied for this analysis, already returns nothing for this patent.
• CourtListener as a Federal Circuit backstop: https://www.courtlistener.com/?q=%225013304%22 (note the collision with an unrelated CourtListener investment-disclosure record ID 5013304, flagged in my prior section).

The absence is the signal, and it points the same direction as everything else. The heuristic "well-asserted patents eventually attract IPRs" is sound, but the converse here is not "an untested, hence strong, patent." It is: this patent was never asserted in a way that provoked a trial, because it was off the books by 1995. For a defendant today, that means do not invest in preparing an IPR petition. There is no live patent to challenge at the Board, and filing one against a long-expired patent would be a waste of resources that a court may view unfavorably. Spend the effort on the expiration and standing analysis instead.

I'll reconstruct the assignment record and probe the entities and correspondents involved.

Good leads — BFD Industries, Inc. merged into Alpha Pro Tech, Ltd., and Justia names a prosecuting attorney. Let me dig further.

Assignment Record Reconstruction — US 5,013,304 (Intravascular catheter assembly)

Sources used: Google Patents legal-events record for the patent (https://patents.google.com/patent/US5013304/en), the USPTO assignment data mirrored there, Justia Patents assignee/agent pages, and SEC filings of Alpha Pro Tech, Ltd. (10-K exhibit indexes, FY1994–FY2025) retrieved during this analysis.

One correction to the earlier summary, up front: the prior section flagged a tension between Google's "Current Assignee: BFD Inc" field and the Alpha Pro Tech naming in the assignment record and said it could not be resolved. It can now be largely resolved. The 1995-07-24 security-interest record itself recites the assignor as "ALPHA PRO TECH, LTD., FORMERLY KNOWN AS BFD INDUSTRIES, INC.," and Alpha Pro Tech's own SEC filings list a "Certificate of Ownership and Merger (BFD Industries, Inc. into Alpha Pro Tech, Ltd.)" as Exhibit 3(l) to its FY1994 Form 10-K (filed 1995-03-31). BFD therefore did not survive as an independent owner; Google's "BFD Inc" assignee field is a stale bibliographic artifact of the original 1989-04-14 recording.

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Inventors

All three inventors conveyed to the same assignee by a single instrument, which is the ordinary employee-inventor/contractor pattern and not by itself evidence of anything unusual.

Unusual-pattern check (departures within 12 months): Not determinable. I found no employment, termination, or departure records for Russell, Carroll, or Miller. Nothing in the record suggests a fire-sale dynamic — the assignment post-dates the 1989-02-22 filing by about two weeks (executed 1989-03-08), which is the routine "file first, paper the assignment" sequence, not a distress signal.

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Original assignee

Entity on the issued patent: BFD, Inc. (Alabama), recorded at Reel 005064/0316. The same inventor group's patent family is indexed by Justia under "Patents Assigned to BFD, Inc." with this patent listed as the sole relevant grant (filed 1989-02-22, issued 1991-05-07).

• Primary line of business / product: BFD was a small medical-device concern in the vascular-access space in Foley/ Birmingham, Alabama. I could not corroborate that BFD ever shipped a commercial product embodying claims 1–5 (a retractable-needle safety sheath plus resealable-diaphragm backflow adapter). The patent lapsed before any evidence of commercialization surfaced in the records I can reach.
• Current status: Dissolved by merger. BFD, Inc. → BFD Industries, Inc. → merged into Alpha Pro Tech, Ltd. (Certificate of Ownership and Merger, Exhibit 3(l) to Alpha Pro Tech's FY1994 10-K). Alpha Pro Tech is today a publicly traded operating company — NYSE American ticker APT, CIK 0000884269, incorporated in Delaware, principal executive office Aurora, Ontario — whose business is disposable protective apparel (face masks, shields, shoecovers, gowns, coveralls), per its FY2025 10-K (filed 2026-03-11). It is not in bankruptcy and never was, on any filing I found.
• Related-party note (low confidence, flagged): Alpha Pro Tech's exhibit index also references an "Asset Purchase Agreement between the Company and the BFD Industries Limited Partnership dated May 17, 1990" and a "Purchase Agreement … with Bernard Charles Sherman and Apotex, Inc." I cannot confirm that the 1990 BFD Industries L.P. asset purchase touches this patent, and I would not assert it does.

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Assignment timeline

Three post-filing recordings exist. Critical caveat on correspondents: Google Patents' legal-events view reproduces reel/frame, dates, conveyance type, and parties — but it does not expose the "correspondent of record" field. I therefore cannot give you the recording attorney/firm for any of these three entries from the sources I can reach, and I will not guess. Each correspondent field must be pulled directly from the Assignment Center abstract for the reel/frame cited (links at the end).

1. 1989-03-08 executed / recorded 1989-04-14 — Reel 005064/0316

   • Conveyance: Assignment
   • Assignor: Russell, John P.; Carroll, Terry; Miller, Sam
   • Assignee: BFD, INC. (Alabama)
   • Correspondent: not retrievable from available sources — verify directly by reel/frame. (For reference, the attorney of record on the face of the patent was George A. Bode — see Justia's "Patents Represented by Attorney George Bode" listing, which indexes this patent under BFD, Inc. That is a prosecution field, not an assignment-correspondent field, and the two must not be conflated.)
   • Context: Initial inventor→company assignment; standard wage/contract vesting into the operating company.

2. 1995-03-30 executed / recorded 1995-07-24 — Reel 007570/0260

   • Conveyance: Security Interest (Security Agreement — collateral, not a title transfer)
   • Assignor: ALPHA PRO TECH, LTD., formerly known as BFD INDUSTRIES, INC.
   • Assignee: THE CIT GROUP/CREDIT FINANCE, INC. (Illinois)
   • Correspondent: not retrievable from available sources — verify directly by reel/frame.
   • Context: Securitization / secured financing. A commercial finance lender taking a blanket lien over the patent as collateral. This is the key classification point: the chain has only one true title transfer (entry 1) and zero transfers to a licensing entity.

3. 2000-05-31 executed / recorded 2000-10-10 — Reel 011164/0394

   • Conveyance: Release of Security Agreement (release of the agreement recorded at Reel 007570/0260)
   • Assignor: THE CIT GROUP/CREDIT FINANCE, INC. (Illinois)
   • Assignee: ALPHA PRO TECH, LTD. (Canada)
   • Correspondent: not retrievable from available sources — verify directly by reel/frame.
   • Context: Release of collateral / internal re-consolidation. Titles never left the Alpha Pro Tech side; the release cleared the CIT lien.

4. (Non-assignment event, for completeness) — the BFD Industries, Inc. → Alpha Pro Tech, Ltd. merger is documented via SEC Exhibit 3(l), not via a standalone USPTO merger reel that I retrieved. It is recited in the 1995-07-24 record itself. It is a change of name / reorg only.

Also note: a maintenance fee was never paid — reminder mailed 1994-12-13, lapse 1995-05-07, formally expired effective 1995-05-10, with a 2018-01-29 STCH entry citing 37 CFR 1.362. The patent was abandoned roughly four years after issue, entirely within the Alpha Pro Tech holding period.

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Timeline diagram

timeline
    title Ownership of US 5013304
    1989 : Inventors assign to BFD Inc
         : Reel 005064 frame 0316
    1991 : Patent issues May 7
    1994 : BFD merged into Alpha Pro Tech Ltd
    1995 : Alpha Pro Tech grants security interest to CIT Group
         : Reel 007570 frame 0260
         : Patent lapses for unpaid maintenance fee
    2000 : CIT Group releases security interest
         : Reel 011164 frame 0394

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NPE / troll-pattern signals

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Verdict

Defensive / non-asserting — chain terminates in non-asserting hands.

Of the five permitted categories this is the closest fit, and I am picking it deliberately rather than defaulting to "NPE." Every NPE signal is negative: the only true title transfer is the 1989 inventor→BFD assignment (Reel 005064/0316), the 1995 CIT Group entry (Reel 007570/0260) is a security interest later released in 2000 (Reel 011164/0394), and the surviving holder is Alpha Pro Tech, Ltd., a listed operating company (NYSE American: APT) — not a licensing vehicle. The patent was abandoned for nonpayment of maintenance fees effective 1995-05-10 and was never litigated, so there is no assertion to characterize. Caveat on the label: the categories define "Defensive / non-asserting" as termination at a defensive aggregator; here it terminated in an operating company that simply abandoned it, so read this as a non-NPE, non-asserting verdict rather than a literal defensive-aggregator finding. The one genuinely open item is signal #3 — the assignment correspondents of record, which I could not retrieve and which must be pulled from the reel/frame abstracts directly.

Verification links:

• USPTO Assignment Center (current): https://assignmentcenter.uspto.gov/
• USPTO Assignment Search (legacy, search by patent number 5013304): https://assignment.uspto.gov/patent/index.html
• Google Patents legal events: https://patents.google.com/patent/US5013304/en

I'll verify each of the 14 cited references and the background-art references against live sources before assessing § 102 relevance.

Prior-Art Analysis — US 5,013,304 ("Intravascular catheter assembly")

Patent reviewed: US 5,013,304 A (application US 07/313,465; filed/priority 1989‑02‑22; issued 1991‑05‑07; BFD Inc.). Source: https://patents.google.com/patent/US5013304/en (fetched 2026‑09‑30).

Identifier handling: The number was interpreted literally as 5,013,304. I did not substitute or return look‑alikes. The patent is governed by pre‑AIA 35 U.S.C. § 102 (application filed 1989, well before 2013‑03‑16), so the operative subsections are 102(a), (b), and (e).

Note on a date discrepancy (flagged, not resolved): the task header states "Current Date: April 26, 2026," while the system context and the earlier-generated sections use 2026‑09‑30. Nothing in this analysis turns on the difference; I flag it only because you asked that contradictions be surfaced.

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1. What "cited art" means here — and what I could and could not verify

The 14 references below are the front‑page "Patent Citations (14)" listed on the face of US 5,013,304 (Google Patents / USPTO record). I do not have the prosecution history, so I cannot state which of these the examiner applied as § 102 references versus as § 103 support, nor which (if any) were applicant‑submitted IDS items. The listing is unmarked as to category.

Of the 14, I was able to directly verify the text/claims of four in this session: US 4,747,831 (Kulli), US 4,762,516 (Luther), US 4,935,010 (Cox/Pharmacia), and US 4,772,265 (Walter) (the last only as to bibliographic existence/dates). For the remaining ten I rely on the patent's own authoritative citation table (number, dates, assignee, title) plus general knowledge for the one‑line descriptions; those descriptions should be treated as lower confidence and are individually marked below.

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2. The 14 cited references — master table

Timing point worth noting: only four of the fourteen (US 3,572,334; 4,193,399; 4,224,943; 4,610,665) issued more than one year before the 1989‑02‑22 filing date and therefore qualify under § 102(b). The other ten issued after 1988‑02‑22 but were all filed before 1989‑02‑22, so they are available only as § 102(e) art (U.S. patents granted on applications filed before the applicant's invention date) — a materially weaker and more contestable posture, since it can be antedated by a sworn prior‑invention showing under Rule 131. US 4,917,669 (Safetyject) is the razor's edge of the group: filed 1989‑02‑08, only 14 days before the 5013304 filing date.

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3. Detailed assessments of the four most relevant references

(A) US 4,935,010 — Cox et al. / Pharmacia Limited — § 102(e) (most relevant to claims 1(b) and 3(b))

• Full citation: US 4,935,010, "Devices for sampling, drainage or infusion of liquids from or to the human or animal body," Pharmacia Limited; filed 1986‑11‑20; issued 1990‑06‑19.
• Disclosure (verified from the reference's own text): a device with first connecting means for a cannula and second connecting means for a fluid source/drain, with valve means comprising an elastomeric membrane that "is penetrable by a co‑operating ducted member to provide an open condition of the valve means and which membrane is self sealing on withdrawal of the member." Each chamber has venting means (a hydrophobic, e.g. PTFE 0.2‑micron, filter) that passes air but not liquid; the membrane may have a zone of weakness or a preformed central puncture; and the chamber serves as a flashback chamber (transparent plastic) during cannulation with an introducing needle passed through the membrane.
• § 102 assessment: This is the single best piece of art against the "self‑closing valve member" element of claims 1 and 3. It discloses, in one reference: a housing, an adapter body interposed between a cannula and a rear connection, an elastomeric, self‑sealing membrane valve, and a vented chamber. It therefore reads on much of element (b).
  • However, anticipation of claim 1 or 3 fails because US 4,935,010 discloses no retractable needle safety sheath — i.e., nothing corresponding to claim elements 1(c) or 3(c).
  • There is also a genuine, arguable distinction on the re‑sealing mechanism. The 5013304 claims require the diaphragm to re‑seal "by a return of the diaphragm material to its original position so as to fill a puncture opening," and the specification expressly states the diaphragm "does not necessarily rely upon structural confinement for re‑sealing." Cox discloses that "the membrane is radially compressed to assist self sealing" — i.e., confinement‑assisted sealing. That is the same distinction the applicant drew against US 3,853,127 / 4,177,814 / 4,626,245 (see § 5 below). Whether that is a patentable distinction or a mere characterization is a claim‑construction question I cannot resolve from the face of the documents.
• Bottom line: strong § 103 art; not a clean § 102 anticipation of any claim.

(B) US 4,762,516 — Luther / Luther Medical Products — § 102(a)/(e) (most relevant to claims 1(c), 3(c), 4, and 5)

• Full citation: US 4,762,516, "Assembly of needle catheter protector," Luther Medical Products, Inc.; inventors Ronald B. Luther and Pradip V. Choksi; application 07/022,132, filed 1987‑03‑05; issued 1988‑08‑09.
• Disclosure (verified from the reference's own claim 1 and description): an elongate housing providing sidewalls and detent means, a rearwardly closed end and an open end; a needle mounted inside the housing projecting through the open end; a needle guard slidably mounted within the housing, having a pull tab at its forward end and outwardly biased ears in contact with the housing sidewalls, and a hub support defining a bore; a luer‑type locking hub and catheter mounted on the hub support; and, after venipuncture, retraction of the housing so the guard slides forward until the biased ears snap into the housing detent slots and permanently lock, with the guard sized to completely enclose the needle.
• § 102 assessment: This is the closest structural analogue in the cited art to the claimed sheath, and it is the reference I would expect an examiner to have applied most heavily:
  • It discloses the elongate hollow housing + internal slot/detent + slidably engaged member + permanent lock‑up on retraction architecture that underlies claim 1(c) and claim 4's retraction/locking concept.
  • It does not, however, disclose a fin‑shaped (or tab‑shaped) handle mounted on a needle hub and projecting through a slot, nor a needle hub end member slidably disposed in a rear sheath portion. In Luther the needle is fixed to the housing and the guard moves; in 5013304 the housing is held and the needle/handle moves backward. The kinematic inversion is real, not semantic.
  • It discloses no elastomeric self‑sealing diaphragm at all, so it cannot touch element (b) of claims 1 or 3.
• Bottom line: does not anticipate claim 1, 3, 4, or 5; it is the primary § 103 reference against the sheath sub‑combination.
• Related‑art observation (flagged as unverified): Luther Medical Products' portfolio includes a separate patent whose abstract describes an assembly "for connecting needles and catheters in I.V. applications… a leak proof, sterile, self‑sealing septum from which the needle is inserted [and which] will reseal [on retraction]… The septum is positioned between the distal end and the proximal end to provide a self‑sealing seal between the needle and the catheter." That is conceptually very close to 5013304's element (b). I have not verified its patent number or filing date, so I cannot say whether it qualifies as § 102(e) art; it appears in a third‑party reference list as US 4,874,373 (Luther et al., Oct. 1989) — if that identification is correct, its issue date postdates the 1989‑02‑22 filing date, so it would matter only under § 102(e), which I have not confirmed. Treat this lead as a to‑do, not a finding.

(C) US 4,747,831 — Kulli / Phase Medical — § 102(a)/(e) (most relevant to claim 1(c) and claim 4)

• Full citation: US 4,747,831, "Cannula insertion set with safety retracting needle," Phase Medical, Inc.; inventor John C. Kulli; filed 1987‑04‑29; issued 1988‑05‑31. (Confirmed via Google Patents and via its citation in EP 0 922 466 A3 / DE 694 33217 T2, which describe the reference in detail.)
• Disclosure: a hollow needle projects from the forward end of a hollow handle; the needle rides in a carrier block that slides inside the handle; a manually releasable latch (mutually interfering stop elements on the block exterior and handle interior) holds the block forward and, when squeezed/rotated, releases it so the sharp end is retracted into the handle beyond reach; the handle has an aperture large enough for the needle but too small for fingertips.
• § 102 assessment: Discloses the retract‑the‑needle‑into‑a‑protective‑handle concept with a forward‑position latch — relevant to claim 1(c) generally and to claim 4(a)'s forward‑lock feature (though claim 4 recites a wedge member frictionally engaging a tapered slot portion, which Kulli does not disclose). It discloses no handle projecting through an elongated slot, no fin‑ or tab‑shaped handle, no needle hub end member in a rear sheath portion, and no elastomeric diaphragm.
• Bottom line: supportive § 103 art; no anticipation of any claim.

(D) US 4,772,265 — Walter, Gregory W. — § 102(a)/(e)

• Full citation: US 4,772,265, "Safety catheter," Walter, Gregory W.; filed 1987‑03‑16; issued 1988‑09‑20.
• Confidence caveat: I confirmed the bibliographic record and its repeated citation by later art, but not the disclosure text. Based on the title and its recurrence in safety‑catheter reference lists, it is a needle‑safety catheter device relevant to claims 1(a) and 1(c). I do not assert any § 102 anticipation for this reference without reading it.

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4. The remaining ten, treated briefly

These are, on their titles and the patent's own characterization, background/§ 103‑support references going to individual elements, not § 102 anticipations of the claims as a whole. All descriptions below are derived from the citation table's titles and my general knowledge; each is flagged as unverified.

• US 3,572,334 (J&J, 1968/1971, § 102(b)) — claims 1(a)/3(a). Foundational over‑the‑needle IV catheter placement unit: needle within the catheter bore for venipuncture. Relevant only to the catheter‑member element; the claimed adapter/valve and retractable sheath are absent.
• US 4,193,399 (Travenol, 1977/1980, § 102(b)). A self‑venting plug for a venous entry unit — relevant to the flash‑chamber/venting teaching in the specification (elements 17/18), which is described but not claimed. Note that the self‑closing valve in the claims is distinct from a venting plug.
• US 4,224,943 (Sorenson, 1979/1980, § 102(b)). Cannula and method for bidirectional blood flow — background to the claimed fluid‑communication objective.
• US 4,610,665 (Terumo, 1983/1986, § 102(b)). A "medical instrument" in the catheter/needle‑hub field; background to elements 1(a)/(b).
• US 4,781,692 (University of Virginia Alumni Patents Foundation, 1985/1988, § 102(a)/(e)). Retractable safety needles — relevant to the retraction concept of 1(c).
• US 4,834,718 (Michael McDonald, 1987/1989, § 102(e)). Safety needle apparatus — relevant to 1(c).
• US 4,846,805 (ICU Medical, 1987/1989, § 102(e)). Catheter insert device. Notably, US 4,762,516's own specification identifies an ICU Medical device on the market that "almost completely enclose[s] the needle subsequent to use" but "does not provide a housing or protective cover for the needle tip." That is a useful corroborating datum: the ICU Medical device was known to enclose the needle but not to guard the tip.
• US 4,850,961 (Wanderer, 1987/1989, § 102(e)). Indwelling placement device with guard — relevant to 1(c).
• US 4,917,669 (Safetyject, 1989‑02‑08/1990‑04‑17, § 102(e)). Catheter inserter — the closest in time to the 5013304 filing date (14 days earlier). Its § 102(e) status is the most vulnerable to a Rule 131 antedating showing.
• US 4,944,728 (Safe Medical Devices, 1988‑10‑17/1990‑07‑31, § 102(e)). Intravenous catheter placement device — relevant to 1(a)/3(a).

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5. Background art cited in the specification body but not on the front page (flagged separately)

The specification's "Description of Related Art" cites seven further U.S. patents that do not appear in the front‑page citation table. Quoted literally from the patent text:

• For elastomeric/self‑sealing fluid‑control members: "U.S. Pat. Nos. 3,853,127; 4,177,814; and 4,626,245" — described by the applicant as "sealing members made of elastomeric material having a perforation formed therein which re‑seals because of the structural confinement of the elastic material."
• For needle shielding: "U.S. Pat. Nos. 3,595,230; 4,676,783; 4,747,831; and 4,643,199."

Analytical significance: the applicant's own characterization of the 3,853,127 / 4,177,814 / 4,626,245 group is the express basis on which the claimed diaphragm is distinguished — the claims require re‑sealing by "return of the diaphragm material to its original position," and the specification says the diaphragm "does not necessarily rely upon structural confinement for re‑sealing." This is the key § 102 battleground for claims 1(b)/3(b), and US 4,935,010 sits awkwardly close to it because Cox also describes confinement‑assisted (radially compressed) sealing.

Uncertainty: I did not verify the identities, dates, or disclosures of US 3,853,127, US 4,177,814, US 4,626,245, US 3,595,230, US 4,676,783, or US 4,643,199 in this session, and I do not assert anything about them beyond the literal text of the 5013304 specification. Note also that "4,747,831" appears both in the background text and on the front page (as US 4,747,831 / Kulli) — interpreted literally, these are the same number.

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6. Overall § 102 conclusion

1. No single reference among the 14 cited on the face of US 5,013,304 discloses the full combination of claim 1 or claim 3. Both independent claims require all three of: (a) a catheter member with rearwardly opening hub; (b) an adapter/backflow device containing a self‑closing elastomeric diaphragm that re‑seals by material return; and (c) a catheter needle safety sheath with a handle projecting through a slot (fin‑shaped in claim 1; roughened tab‑shaped in claim 3). The cited art splits cleanly along that line: the valve teaching is in US 4,935,010; the retractable‑needle protective housing teaching is in US 4,762,516 and US 4,747,831. Nothing cited bridges the two.

2. The most probable statutory posture is § 103, not § 102. The natural examiner rationale is a combination of US 4,935,010 (Cox/Pharmacia) for element (b) with US 4,762,516 (Luther) or US 4,747,831 (Kulli) for element (c), with the catheter member (a) being old and admitted (US 3,572,334 and the like). Whichever side of the § 102/§ 103 line these references were applied on, I cannot determine without the file wrapper.

3. For the dependent claims, § 102 is more plausible than for the independents — but only for claim 4/5's narrow structure, and only if a reference discloses the specific wedge member frictionally engaging the tapered slot portion, the retraction hole that prevents re‑projection, and the two slide slots. On the verified text, US 4,762,516 discloses the analogous "biased ears → detent slot" permanent lock and US 4,747,831 discloses a manually releasable forward latch, but neither discloses the claimed wedge/tapered‑slot friction lock or the two‑slide‑slot handle. So even for claims 4 and 5, I would not call the anticipation clean.

4. Claim‑drafting caveat carried forward from the earlier sections (relevant to any § 102 mapping): claim 4's preamble reads "The catheter needle safety sheath housing of claim 3," even though claim 3 is an assembly claim. Any anticipation analysis of claim 4 must therefore first resolve what "claim 3" is being referenced, which affects which elements must be disclosed in a single reference.

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7. Explicit uncertainty disclosure

• High confidence: the 14 front‑page citations, their numbers, dates, assignees, and titles (taken from the patent's own authoritative record); the full claim text of US 4,762,516 and the disclosures of US 4,935,010 and US 4,747,831 (read directly from those references this session); the pre‑AIA § 102(b) vs. § 102(e) breakdown by date.
• Medium confidence: the one‑line descriptions of US 3,572,334, US 4,193,399, US 4,224,943, US 4,610,665, US 4,781,692, US 4,834,718, US 4,846,805, US 4,850,961, US 4,917,669, and US 4,944,728 — these are derived from titles and general knowledge, not from reading the references.
• Low / not established: the identities and relevance of the seven specification‑cited background numbers in § 5; the possible Luther family member identified as US 4,874,373; and which references the examiner actually applied, and under which subsection — that requires the prosecution history (USPTO Patent Center / Public PAIR file wrapper for application 07/313,465), which I did not retrieve.
• Not done, and required for a court‑grade § 102 opinion: a full‑text pull of each of the ten unverified references, and a file‑wrapper review to see the examiner's citations, rejections, and any Rule 131/132 submissions.

I'll pull the prior-art references cited on the patent page so I can anchor the § 103 analysis to actual disclosure content.

Let me verify the remaining cited references.

Obviousness Analysis — U.S. Pat. 5,013,304 under 35 U.S.C. § 103

Bottom line

On the record of this patent's own Prior Art section (the 14 references in the front-page "References Cited" list, plus the two families the specification itself identifies in its "Description of Related Art"), all five claims are vulnerable to a § 103 rejection. Claims 2, 3, 4 and 5 are weak — they add only material, shape/ergonomic, locking-means and guide-slot features that were individually known. Claim 1 is the only genuinely contestable claim, and the contest turns on one limitation: whether the recited elastomeric diaphragm "re-seals by a return of the diaphragm material to its original position" is patentably distinct from the elastomeric sealing members of US 3,853,127 / 4,177,814 / 4,626,245 — which the applicant's own specification concedes were known but characterizes as re-sealing "because of the structural confinement of the elastic material."

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1. Framework and thresholds

This is a pre-AIA § 103(a) case (application filed 1989‑02‑22; priority 1989‑02‑22). The factual inquiries are the Graham v. John Deere four: scope/content of the prior art, differences from the claims, PHOSITA level, and secondary considerations. The motivation inquiry is governed by KSR Int'l v. Teleflex — a combination of known elements is obvious where each performs its known function and the combination yields no more than predictable results.

Critical timing caveats (flagged, as required):

• Only references with a pre‑1989‑02‑22 date can be used. Three of the cited references issued after the filing date and therefore can only be prior art under pre-AIA § 102(e) (i.e., if their U.S. filing predates the inventors' invention date): US 4,917,669 (filed 1989‑02‑08 — only 14 days before the filing date), US 4,944,728 (filed 1988‑10‑17), US 4,933,010 (filed 1986‑11‑20). Their § 102(e) status is date-sensitive and would need an invention-date record to nail down.
• Every reference in the "Cited By" list is unusable as prior art — the earliest of them (USD326154, 1989‑07‑04; US5167635, 1989‑09‑22) post-dates the 1989‑02‑22 filing. They are evidence of later art, not of obviousness.
• The patent expired for non-payment of maintenance fees (lapse effective 1995‑05‑10), so this is a retrospective/hypothetical validity analysis, not a live dispute.

PHOSITA (my proposed definition, stated explicitly since it drives everything below): a person with a bachelor's degree in mechanical or biomedical engineering, or equivalent, and 2–4 years' experience designing over-the-needle intravascular (I.V.) catheter placement devices, including familiarity with needle-retraction safety housings, flash chambers, and luer-hub fluid couplings. This is not a "genius" level of skill — the art at the 1989 critical date was crowded with incremental safety designs, as the 86-member Cited By list itself demonstrates.

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2. The prior art, in three families

The 14 cited references cluster into three functionally distinct groups. That clustering is itself the answer to "why combine?" — each group supplies one of the three claimed subassemblies, and the applicant's specification lists them together as the state of the art it was improving on.

Caveat on verification: I fully retrieved and read the disclosure of only four references (3,853,127; 4,177,814; 4,747,831; 4,762,516) plus secondary characterization of 4,626,245. For the remainder I have title, assignee and date only and do not assert their disclosure content. The combination arguments below are built on the four verified references, which is sufficient to reach every claim.

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3. Element mapping — claim 1

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4. The combinations

Combination 1 → claim 1: Kulli (4,747,831) or Luther (4,762,516) + Spademan (3,853,127)

(a) Why a PHOSITA would combine. The motivation is not inferred — it is printed in the references themselves, which is the strongest form of the KSR "design incentive" showing:

• Kulli's own continuation (US 5,575,777, describing the '831 disclosure) states the invention "is for helping protect people from contracting diseases (particularly fatal diseases such as AIDS and hepatitis) through accidental puncture by needles."
• Luther states: "there is always a small possibility that the discarded needle points may inadvertently stick or scratch medical health personnel… reducing accidental infection from patients who have HTLV III (AIDS) virus, hepatitis, and other infectious diseases."
• Spademan states the exact problem the '304 patent claims to solve: "leakage of IV fluids and blood through aperture 7 may occur" when the perforation fails to close.

Both references are in the same field of endeavor (intravascular access devices) and the '304 specification itself groups them ("[v]arious attempts have been made to incorporate fluid control devices into catheters… disclosed, for example, in U.S. Pat. Nos. 3,853,127; 4,177,814; and 4,626,245… Attempts have also been made at providing a means for shielding a needle… U.S. Pat. Nos. … 4,747,831…"). When a reference's own background identifies the same two failure modes the applicant addresses — blood leakage at the hub and needlestick injury — the "motivation to combine" element is satisfied almost as a matter of course.

(b) Predictable result, no new interaction. The septum goes in the adapter lumen (where Spademan puts it in the hub); the retractable-needle sheath plugs into the adapter's rear hub (where Luther mounts its hub/catheter on a hub support). Neither element changes how the other works: the septum seals when the needle leaves, the sheath retracts the needle into the housing. This is the paradigm KSR case — "a combination of familiar elements according to known methods… when it does no more than yield predictable results."

(c) The one real gap. Element (b)'s "re-seals by a return of the diaphragm material to its original position" versus the applicant's characterization of 3,853,127 / 4,177,814 / 4,626,245 as sealing "because of the structural confinement of the elastic material." My assessment: this distinction is weaker than it looks, and probably insufficient.

• Spademan's base disclosure (its Figs. 1–3, describing the prior-known unit of US 3,313,299) is precisely a catheter hub containing a plain penetrable elastic sealing member that is expected to close on withdrawal by material recovery; Spademan's stated problem is that the perforation "may take a set" and not close. Spademan therefore teaches the same mechanism the '304 claim recites, plus a reliability improvement. Reading claim 1 on Spademan + Kulli does not require the accused device to lack structural confinement.
• 4,177,814's valve is a silicone elastomer whose slot "is sealed due to this compressive force" only in the sense that compression closes the pre-existing slit; the wall of the disc that a needle punctures still closes by material recovery.
• The claim language is functional and mechanism-agnostic on its face — "re-seals by a return of the diaphragm material to its original position so as to fill a puncture opening." Any soft elastomeric septum that does not leak after needle withdrawal satisfies it. There is no claim limitation requiring the diaphragm to be free of surrounding confinement, and no limitation specifying durometer, geometry, or a pre-formed slit versus a needle-made puncture.

Combination 2 → claim 2: any of the above + Luther (4,762,516), or + KLI (4,177,814)

Claim 2 adds only "cylindrical… lightweight transparent plastic material suitable for prolonged contact with human tissues and blood."

• Luther expressly discloses a clear-plastic (injection-molded polycarbonate or polystyrene) housing "enabl[ing] flashback to be readily observed," with a magnification portion — i.e., transparency for the same reason.
• KLI discloses a body of "acetal, polysulfone, any high temperature thermoplastic, or stainless steel… as long as it may be sterilized," and a "bio-compatible elastomer, preferably silicone."
• Selecting a transparent, blood-compatible, injection-moldable polymer is an obvious material selection with a predictable benefit (flashback viewing + disposability). MPEP 2144.04 (In re Kuhle-type design/material choices).

Combination 3 → claim 3: claim 1's combination, but the handle is tab-shaped with a roughened upper surface

• Luther discloses a pull tab 24 at the forward end of the needle guard — a flat, finger-actuated tab, structurally what claim 3 recites.
• Kulli discloses a projection 42 from the handle "adapted for manual actuation by a user" and handle grip ridges.
• Substituting a tab for a fin, and roughening a finger-engagement surface for friction, are design expedients (In re Kuhle: "the particular shape… is a matter of design choice"; roughened grip surfaces are ubiquitous). No functional change is asserted in the specification — the '304 text itself says the tab handle "serves generally the same functions as the fin-shaped handle member 12."

Combination 4 → claim 4: + Kulli or Luther

Claim 4 adds (a) a wedge on the front of the handle frictionally engaging the tapered slot front to lock the needle forward, and (b) a retraction hole at the sheath housing's front inner surface allowing retraction through it but preventing re-projection.

• Kulli claims "securing means for securing the shaft to the handle with the sharp end projecting" plus "releasing means… for substantially permanently retracting the sharp end." Permanent retention of the retracted needle is the same function claim 4(b) recites.
• Luther discloses outwardly biased locking ears 25 that permanently lock into detent slots 18 — a one-way, non-reversible trap. That is the same function as the convex retraction hole (permit one-way passage, prevent return), and the specification's own description ("the needle tends to remain in the peripheral portion of the convex-shaped retraction hole") is an arrangement-of-parts/geometry choice relative to Luther's detent-and-ear lock.
• A wedge friction lock is a classical mechanical expedient for holding a slider in a forward position; combined with a tapered slot front it is a predictable, non-inventive locking design.
• Motivation is again supplied by the references: both Kulli and Luther expressly aim at preventing reuse and post-disposal sticks, which is exactly the purpose of a permanent, non-reversible needle lock.

Drafting defect to note (not a § 103 point but relevant to claim scope): claim 4's preamble reads "The catheter needle safety sheath housing of claim 3," even though claim 3 is an "intravascular catheter assembly" claim. That is a § 112(b) indefiniteness problem that would complicate, but not defeat, a § 103 rejection, since claim 4's body plainly adds structure to the claim 3 handle.

Combination 5 → claim 5: + Luther (4,762,516) / Kulli (4,747,831)

Claim 5 requires only that the handle have "two slide slots for slidably engaging said sheath housing."

• Luther's needle guard is slidably mounted within the housing with biased flexible members engaging the housing walls.
• Kulli's carrier block is slidably disposed in the hollow handle with a slot (e.g., slot 167 in one embodiment) and housing side openings.
• Providing two opposed slots to guide a slider within a cylindrical housing is a known mechanical equivalent for a linear guide/anti-rotation feature (In re Kuhle; MPEP 2144.04). The specification attributes no unexpected result to the two side slots 53.

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5. Anticipated counterarguments

Counterargument 1 — "The references re-seal by structural confinement; my diaphragm does not." This is the applicant's strongest § 103 argument, and the only one grounded in the specification. Its weaknesses:

1. The claim does not recite non-confinement. Unclaimed features cannot be relied on for patentability (In re Self, 671 F.2d 1344 (CCPA 1982); MPEP 2145; In re Hiniker Co. — "the name of the game is the claim"). The '304 specification's extended discussion of the diaphragm's non-reliance on confinement is description, not claim scope.
2. Spademan's base disclosure shows re-sealing by material return in a catheter hub and treats confinement (unequal stress) as a reliability enhancement to that same mechanism — not a teaching away, but an improvement upon it.
3. Under KSR, "the proper question [is] whether the improvement is more than the predictable use of prior art elements according to their established functions." A soft latex/silicone/Neoprene diaphragm is a classic burst/pressure-tight resalable septum; the specification lists only pre-existing materials (Latex, silicone, rubber, soft plastic, Neoprene, paper filter material).

Counterargument 2 — "The claims solve a problem others had not solved, at low cost." The '304 specification concedes that the prior devices "have not solved all of the problems described above and often are expensive and cumbersome to manufacture." That is a cost/manufacturing convenience argument, which KSR squarely discounts: "the mere duplication of parts" and "smaller, cheaper" are not the stuff of non-obviousness absent unexpected results.

Counterargument 3 — Secondary considerations. There is no evidence in the record of commercial success with a nexus to the claims, licensing of the claimed invention, copying, or industry praise. The device appears to have been commercialized (the assignment chain runs to Alpha Pro Tech, Ltd., f/k/a BFD Industries, Inc.), but commercial success at the product level without a demonstrated nexus to the claimed features carries little weight, and I have no evidence of either. I flag this as an open, potentially claim-1-saving issue only if a rights-holder could adduce nexus evidence.

Which claim survives? My assessment: claim 1 is the only claim with a plausible (not strong) non-obviousness argument, and only on the diaphragm mechanism — and that argument depends on reading a non-confinement limitation into the claim, which the claim text does not support. Claims 2–5 would, in my view, fall to the combinations above.

A teaching-away point worth checking: 4,177,814's valve is compressed by a nut and its slot is sealed by that compression; a PHOSITA could argue that the reference steers toward a pre-slitted, compressed septum rather than the unslit, needle-punctured diaphragm of claim 1. My read is that this is not a true teaching away, because 4,177,814 does not criticize or foreclose needle-punctured elastomers, and because 3,853,127 (a needle-punctured elastomer in a catheter hub) points the other way. But it is the strongest available "teaching away" framing and would be the natural place to attack Combination 1.

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6. Verification status and uncertainties (per operating rules)

• High confidence: the disclosure content quoted from US 3,853,127, US 4,177,814, US 4,747,831 (including the Kulli continuation's AIDS/hepatitis statement) and US 4,762,516 (including the pull tab 24, hub support 26, locking ears 25, detent slots 18, and the clear-plastic flashback housing), all retrieved during this analysis from Google Patents / Espacenet / uspto.report.
• Moderate confidence: that US 4,626,245 (Cordis) is a slit elastomeric hemostasis-valve partition — based on the assignee/title listing in third-party reference tables, not a full-text read.
• Low confidence / not asserted: the specific disclosures of US 3,572,334, US 4,224,943, US 4,193,399, US 4,610,665, US 4,781,692, US 4,832,696, US 4,834,718, US 4,846,805, US 4,850,961, US 4,772,265, US 4,917,669, US 4,933,010 and US 4,944,728. I used these by title, assignee and date only. I did not confirm the content of US 4,933,010, US 4,917,669 or US 4,944,728, which are the three references whose very status as prior art is date-sensitive.
• Cannot resolve: the exact invention date of record (which controls whether US 4,917,669 is pre-AIA § 102(e) art), and whether any secondary-considerations evidence exists.
• Date discrepancy flagged: the task header states the current date as April 26, 2026, while the patent-page fetch and the previously generated sections are dated 2026‑09‑30. I have not treated either date as affecting the analysis — the critical date for § 103 here is the 1989‑02‑22 filing date, not the present — but I note the inconsistency as instructed.