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Patent landscape, scope, and claims: |
Executive summary
US Patent 5,690,958 claims a specific chlorhexidine gluconate (CHG) “bactericidal agent dosage applicator” that uses (i) a manually crushable, hermetically sealed glass ampule with “extended shelf life,” and (ii) an optional protective/flexible cover carrying an applicator swab/sponge and directional release features. The claim set is largely packaging and process driven (ampule volume matching unit dose, specific heat-sealing/closure formation, optional flame closure, optional post-fill elevated temperature sterilization, protective cover and swab/sponge integration, and an accelerated stability testing workflow using a 40°C/3-month stress condition). The patent’s practical scope is narrow around the glass ampule closure mechanics and the hand-crush delivery architecture; it is unlikely to read on CHG in conventional plastic squeeze bottles/foil sachets unless the accused product uses an equivalent manually crushable, hermetically sealed glass ampule with similar volume and sealing parameters, plus (for some claims) a cover with a swab/sponge and directional release.
US Patent 5,690,958: What claims does it cover for chlorhexidine gluconate glass ampule applicators?
Plain-language scope of independent claims
Dependent claims that materially narrow coverage
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Claim 2: Heat-sealed extremity subjected to flame sufficient to melt the glass to provide the hermetic closure.
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Claim 3: Ampule is generally cylindrical with extremities at opposite ends.
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Claim 4: Elevated temperature sterilization after introduction of CHG into interior and hermetic sealing.
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Claim 5-8 (protective cover + delivery surface concepts):
- Claim 5: Flexible cover over ampule to protect user hand during crushing.
- Claim 6: Cover includes means to cause directional release upon manual crushing.
- Claim 7: Cover has an opening communicating with ampule exterior surface and a porous applicator swab carried by the cover extending through the opening.
- Claim 8: Elongated ampule; cover opening extends along longitudinal length; applicator sponge along opening to receive CHG released upon crushing.
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Claims 10-12 (process and sterilization parameterization):
- Claim 10: Adds elevated temperature sterilization prior to heat sealing.
- Claim 11: Sterilization temperature about 120°F to 140°F.
- Claim 12: Heat sealing effected by subjecting extremity to an open flame.
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Claim 13 (cover concept, method version): Placing flexible cover over hermetically sealed ampule to protect hand during crushing.
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Claim 14 (accelerated shelf-life verification method):
- Create hermetically sealed ampule as in Claim 9.
- Place ampule in 40°C for approx. three months.
- Break ampule, recover CHG, test degradation extent.
- This is a defined stability/stress testing procedure.
What the claims do not cover (high-level negative boundaries)
- No claim language targets:
- CHG concentration, antimicrobial spectrum, or specific clinical use instructions (method-of-use).
- Automated dispensing systems beyond manual crushing.
- Alternative container materials (plastic, metal collapsible ampules).
- Sealing by capping/crimping/epoxy/adhesives rather than heat-melting glass.
- Multi-dose reservoirs, metering pumps, or non-hermetic closure architectures.
How broad is the scope: Where is US 5,690,958 most likely to read and where does it narrow out?
Most important claim constraining elements
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Manually crushable glass ampule
- A key structural limitation. Even if a product uses glass ampules, if they are not crush-to-release or if release is via cap opening mechanisms, scope shifts away from the “manual crushing” architecture.
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Hermetic closure created by heat sealing/melting glass
- Claims 1, 2, 9, and 12 all require the closure be formed by heat melting of glass at the extremity (and specifically one extremity heat-sealed after filling in Claim 1).
- Products sealed with mechanical methods (e.g., pre-sealed ends with later caps), UV-cured polymer seals, adhesives, or non-thermal sealing are less likely to fall within literal scope.
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Ampule internal volume not significantly greater than unit dose volume
- This limits empty headspace. Many CHG products use oversized containers. If an accused design has materially more headspace volume relative to dose, it may avoid this limitation.
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Extended shelf life is not purely functional; it is tied to structure/process
- The claims do not just say “extended shelf life” as a free-standing property; they anchor the shelf-life concept to the ampule closure approach, volume matching, and optionally sterilization and testing. Still, “extended shelf life” can be litigated as a property tied to the claimed structure.
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Cover + directional release + swab/sponge (Claims 5-8, 13)
- These depend on an added delivery interface.
- A product using the same glass ampule but without a flexible cover and swab/sponge alignment likely avoids these dependent claims, while still potentially implicating Claim 1/9.
Infringement mapping: element-by-element approach
- If an accused product uses:
- glass ampules with one end sealed before filling,
- a filled ampule with the other end melted/heat sealed after filling,
- and a user crush releases a unit dose,
- it is closest to Claims 1 and 9.
- If it also includes:
- a flame/open-flame method for sealing,
- and/or defined cylindrical shape,
- it can move closer to Claims 2 and 3.
- If it includes:
- flexible cover with opening and porous swab,
- it can approach Claim 7.
- If it includes:
- flexible cover with longitudinal opening and sponge,
- it can approach Claim 8.
- If it includes:
- a protective hand cover plus directional release means,
- it can target Claims 5-6/13.
Patent strength implication (for enforcement strategy)
- The strongest enforcement posture is typically the independent claim coverage (Claim 1 system + Claim 9 process) because it targets the core packaging and sealing approach rather than peripheral usability features.
- Dependent claims can support a “fallback” ladder when accused products incorporate covers, swabs, sponges, or specific sterilization/sealing conditions.
What technical features define “manually crushable glass ampule” hermetic closure for CHG?
Claim-consistent technical interpretation
- Ampule: a glass container designed to be broken by manual force to release liquid.
- Extremity closed at filling: one end already sealed in manufacturing before CHG fill.
- Hermetic closure after fill: other end heat-sealed after CHG is inside.
- Heat sealing mechanics: melting the glass extremity and forming the closure on cooling.
Why these features matter in claim construction
- “Hermetic closure” plus “heat-sealed” plus “melt the glass” are tightly coupled. If accused closure does not involve melting the glass extremity, the literal match breaks.
- “Not significantly greater” volume is a second technical trigger. Many ampules are sized for manufacturing tolerances and could have materially greater volume headspace than the unit dose; the claim aims to constrain that.
What patents protect the same chlorhexidine gluconate dosing applicator concept in the US? How many claims overlap across the packaging/process space?
Scope relationship within 5,690,958 itself
- The patent covers a family of related embodiments:
- Structure: Claims 1, 3, 5-8.
- Manufacturing: Claims 9-12.
- Validation: Claim 14.
- This creates a coherent landscape around CHG in crushable hermetically sealed glass units with protective delivery interface.
Cross-patent landscape (US)
The prompt requests “patent landscape,” but the only hard input provided is the claim text for US 5,690,958. No dataset of related patents, citations, re-exam filings, continuations, or the prosecution history is provided. Without those, a complete and accurate comparison across the US patent estate cannot be generated.
When does US 5,690,958 expire for chlorhexidine applicators? What is the exclusivity timeline risk?
US patent term generally runs from earliest non-provisional filing date, with potential adjustments. The prompt does not provide:
- filing date,
- application number,
- any patent term adjustment (PTA),
- and whether the patent had additional period under 35 USC 154(b).
Without those facts, an accurate expiration date or exclusivity timeline cannot be produced.
What is the Orange Book status of US 5,690,958? Does it map to an FDA-listed CHG product?
Orange Book status requires:
- drug product listing (active ingredient, dosage form, route),
- listed patent numbers,
- and expiration terms.
The prompt provides no FDA listing linkage for US 5,690,958. An accurate Orange Book mapping cannot be produced from the claim text alone.
What generic entry risks exist for chlorhexidine gluconate crushable ampule applicators under this patent?
Launch risk drivers
- A generic entrant would need to design around:
- glass ampule crush architecture,
- hermetic heat-sealed glass extremities,
- volume matching,
- and if included in product, swab/sponge cover features and sealing/sterilization steps.
Most likely design-arounds
- Use a different container form:
- resealable squeezable plastic ampules or blister systems that do not require manual crushing of a glass ampule.
- Use a different sealing mechanism:
- pre-formed sealed ends with capping or polymer sealing rather than melting the glass extremity.
- Increase headspace volume:
- “not significantly greater than” limitation can be targeted if volumetrics are redesigned.
- Omit the cover/swab/sponge:
- if only Claim 1/9 remain, infringement burden changes, and the cover-specific claims may be avoided.
Most litigation-relevant target
- Products that look operationally identical:
- user crushes a small glass ampule,
- hermetic seal holds CHG for shelf life,
- release transfers onto a swab/sponge.
Those designs map most directly to Claims 1/5/7/8 and 9/13/14.
How does US 5,690,958 compare with competing CHG delivery devices: crush ampule vs bottle vs blister?
Claim coverage differentiators vs common commercial packaging patterns
- Crush glass ampule: required for the claimed architecture; many CHG products instead use:
- liquids in bottles,
- pre-moistened pads,
- swabs with separate applicator fluids,
- or blister-packed wipes.
- Heat-melted glass hermetic seal: distinguishes from:
- crimped or capped closures,
- thermal-sealed polymer sachets,
- and non-thermal adhesive seals.
Practical consequence
- Even if the active ingredient is CHG and the intended antiseptic use is similar, the patent’s claim structure centers on container and preparation steps, not antimicrobial efficacy or clinical protocol.
What patent litigation affects US 5,690,958? Have there been Paragraph IV challenges?
No litigation docket information, settlements, or Paragraph IV filings are provided. A specific litigation timeline cannot be generated from the claim text alone.
Key Takeaways
- US 5,690,958 protects a specific CHG unit-dose delivery platform: a manually crushable glass ampule with hermetic heat-melted glass sealing and tight volume matching to the dose.
- Independent claim coverage is anchored in the sealing and ampule architecture (Claims 1 and 9). Dependent claims add narrow features: flame sealing, post-fill sterilization, and flexible cover with directional release plus swab or sponge.
- The most defensible enforcement target is likely the core crush-to-release hermetic heat-sealed ampule concept; cover/swab/sponge features are additive scope only if present in the accused device.
- Accurate determination of expiration, Orange Book status, Paragraph IV risk, and litigation posture requires prosecution and FDA/patent linkage facts not included in the input.
FAQs
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Does US 5,690,958 cover pre-cracked glass ampules that open without crushing?
The claims require “manually crushable” glass ampule operation; an alternative opening mechanism may not satisfy the crushing limitation.
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Can a product using CHG in a plastic ampule avoid US 5,690,958?
Literal scope is tied to a “glass ampule,” so substituting container material typically impacts infringement risk, especially for Claims 1 and 9.
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If an accused product uses heat-sealing but not open flame, does it still implicate the patent?
Claims 2 and 12 require flame/open flame. Claims 1 and 9 require heat sealing by melting glass but do not explicitly require open-flame in the independent versions.
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How does the “internal volume not significantly greater than the volume of said unit dose” limit design-around?
It is a volumetric constraint that can be targeted by changing ampule geometry and headspace relative to unit dose.
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Does US 5,690,958 protect accelerated stability testing methods beyond the 40°C/3-month protocol?
Claim 14 is specific to an elevated temperature environment of about 40°C for approximately three months and subsequent degradation testing after recovery.
References (APA)
- United States Patent 5,690,958. (n.d.). Bactericidal agent dosage applicator having extended shelf life; method of preparation and accelerated test.
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