Details for Patent: 5,400,808

Summary for Patent: 5,400,808

Title:	Nicotine-impermeable container and method of fabricating the same
Abstract:	The present invention relates to a nicotine-impermeable container including a barrier layer of acrylonitrile and methyl acrylate and a method for fabricating same. Additionally, the invention relates to a nicotine inhaling device which allows a user to ingest nicotine vapors orally. The nicotine inhaling device of the present invention is primarily directed to a device which can be used as a smoking cessation aid.
Inventor(s):	James E. Turner, Michael P. Ellis, Ronald G. Oldham, Ira Hill, Bengt E. Malmborg, Sven-Borje Andersson
Assignee:	Pharmacia Biosystems AB , McNeil AB
Application Number:	US07/982,240
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery;

United States Patent 5,400,808: Scope, Claim-by-Claim Construction, and US Patent Estate for Extended-Shelf-Life Nicotine Delivery Systems

United States Patent 5,400,808 covers a nicotine delivery system and preparation method that rely on (1) a nicotine reservoir and (2) a self-sealed, nicotine-impermeable, oxygen-excluding barrier formed from an acrylonitrile/methyl acrylate copolymer film (with heat-sealed adjacent surfaces), optionally laminated with metal foil and manufactured under an oxygen-free or inert-gas environment. The claim scope is concentrated on barrier chemistry, sealing architecture, and oxygen exclusion, not on the nicotine dosing mechanism itself.

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What is US Patent 5,400,808 claiming for extended shelf life nicotine delivery systems?

Core inventive concept (as reflected in the independent claim): a measured-dose nicotine reservoir encapsulated by a self-sealed nicotine-impermeable barrier layer made essentially of an acrylonitrile and methyl acrylate copolymer, where adjacent surfaces are heat sealed to create a continuous barrier preventing nicotine migration, and the system maintains an extended shelf life by limiting nicotine loss and exposure to oxygen.

Claim 1: system claim scope (device + barrier + sealing + migration prevention)

Claim 1 requires all of the following:

1. Nicotine delivery system with extended shelf life

   • Implies a product designed for storage stability of nicotine content over time.

2. Measured amount of nicotine selectively accessible to a user

   • Includes dosing control but does not specify an exact delivery modality (patch, pouch, cartridge, reservoir insert). The claim reads on any “delivery system” that can provide the user access.

3. Nicotine reservoir for holding and dispersing the measured nicotine

   • Functional language: “for holding and dispersing” anchors a reservoir component.

4. Self-sealed nicotine-impermeable barrier formed as part of the nicotine reservoir

   • The barrier is not a removable packaging wrap; it is formed as part of the reservoir assembly itself.

5. Barrier includes at least one nicotine barrier layer formed essentially of a copolymer of acrylonitrile and methyl acrylate

   • “Essentially of” sets a boundary: the barrier layer’s primary material must be an AN/methyl acrylate copolymer; minor additives or blends can still fall within scope if they do not materially change the essential copolymer nature.

6. Barrier layer includes at least two adjacent surfaces heat sealed to form a continuous nicotine-impermeable barrier

   • This is architecture-defining. The claim requires:
     • Adjacent surfaces (two faces or edges) that are “heat sealed”
     • Formation of “a continuous” barrier (no deliberate leaks or discontinuities)

7. Nicotine can be prevented from migration outside the reservoir

   • Functional “prevents migration” requirement ties barrier continuity and impermeability to nicotine loss control.

Practical interpretation: A potential design-around that changes barrier chemistry, eliminates heat-sealed continuity, or moves the barrier away from “formed as part of the nicotine reservoir” is the most direct path to non-infringement, assuming other elements are not captured by doctrine of equivalents.

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Claim 2: porous polymer plug + nicotine free-base solution

Claim 2 adds:

• Reservoir comprises a porous polymer plug
• Plug is charged with a solution including at least nicotine free-base

Scope implications:

• Narrows Claim 1 to reservoirs that use a porous polymer plug as the nicotine-retaining medium.
• Requires nicotine in a free-base form (at least as a component of the charged solution). Salt forms are outside the literal constraint unless “including at least nicotine free-base” can still be met.

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Claim 3: optional metal foil layer adhered to barrier

Claim 3 adds:

• Barrier further includes a second barrier layer formed of metal foil adhered to at least a portion of the outer surface of the nicotine barrier layer.

Scope implications:

• Adds a multilayer barrier concept.
• Requires “adhered” foil, meaning lamination or bonding is part of claim scope.

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Claim 4: aluminum foil

Claim 4 further narrows:

• Metal foil is aluminum foil.

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Claim 5-6: inert gas storage

Claim 5 adds:

• Nicotine reservoir maintained in a gas inert to nicotine.

Claim 6 specifies:

• Inert gas is nitrogen.

Scope implications:

• These claims pull toward manufacturing or storage conditions that keep an inert atmosphere around the reservoir to reduce oxidation and nicotine degradation.
• The claim language reads on reservoirs maintained in inert gas, not just sealed packaging at the point of manufacture. If the system lacks an inert atmosphere at relevant times, it may fall outside.

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How does Claim 7 expand into the method of preparing extended-shelf-life nicotine systems?

Claim 7 is a process claim that mirrors the system architecture and adds manufacturing steps tied to oxygen exclusion.

Claim 7: method claim scope (loading + oxygen-free environment + heat sealing continuous barrier)

Claim 7 requires:

1. Loading a nicotine reservoir with a measured amount of nicotine
2. Introducing the loaded reservoir into a nicotine impermeable barrier layer
   • Barrier layer is formed essentially of AN/methyl acrylate copolymer.
3. Barrier layer includes at least two adjacent surfaces
4. Creating an oxygen-free environment about the reservoir
5. Heat sealing adjacent surfaces to form continuous nicotine barrier
6. Result: reservoir maintained in an effectively oxygen-free environment.

This is the key difference from Claim 1: Claim 7 explicitly ties extended shelf life to oxygen-free environment during sealing, not just barrier structure.

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Claim 8: porous polymer plug + free-base solution in the method

Adds:

• Reservoir comprises porous polymer plug
• Plug charged with solution including at least nicotine free-base

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Claim 9-12: oxygen-free chamber steps (evacuate air, inert gas charge, seal charged reservoir)

Claim 9 adds method detail:

• Loading includes:
  • Introducing reservoir into a chamber
  • Creating oxygen-free environment within chamber
  • Charging reservoir with nicotine in chamber
  • Removing charged reservoir from chamber in oxygen-free environment

Claim 10 adds:

• Oxygen-free environment created by evacuating air.

Claim 11 adds:

• Charging chamber with nitrogen (inert gas to nicotine).

Claim 12 adds:

• Sealing the charged reservoir in oxygen-free environment.

Scope implications:

• The manufacturing workflow is constrained: chamber-based oxygen removal/blanketing during loading and/or sealing.
• If a competitor uses in-line glovebox, dry-room process, or different oxygen-reduction strategy, infringement depends on whether those processes meet the claim’s “oxygen-free environment” and specific steps recited (evacuating, nitrogen charging, etc.).

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Claim 13: metal foil adherence in method

Adds:

• Adhering second barrier layer formed of metal foil to outer surface of nicotine barrier layer (during method).

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What barriers and materials are “essential” under the claims (copolymer vs. alternatives)?

The patent’s material language is the strongest technical limiter.

“Barrier layer formed essentially of a copolymer of acrylonitrile and methyl acrylate”

• Literal coverage is anchored on the AN/methyl acrylate copolymer film being the basis of the nicotine barrier layer.
• “Essentially of” typically permits minor non-core components (plasticizers, stabilizers, processing aids) but requires the copolymer to remain the essential barrier-forming polymer.

Heat sealing to form a continuous nicotine-impermeable barrier

• A non-heat-sealed barrier assembly (e.g., adhesives without heat sealing) may avoid Claim 1/7 if heat sealing is a required element.
• A barrier with “gaps” or discontinuities that allow nicotine migration may fail the functional requirement.

Optional multilayer with metal foil

• Claim 3 and 4 capture lamination/adhesion of metal foil to the barrier outer surface.
• Metal foil is not required for Claim 1, only for Claim 3/4 and Claim 13.

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Where is the claim focus: nicotine reservoir vs. barrier vs. oxygen exclusion?

Barrier and oxygen exclusion dominate

• System claim (Claim 1) emphasizes barrier chemistry and heat-sealed continuity preventing nicotine migration.
• Method claim (Claim 7) adds oxygen-free conditions around the reservoir during barrier formation.

Reservoir composition is narrower in dependent claims

• Claim 2 and 8 focus on a porous polymer plug and free-base nicotine solution.
• Claims 5-6 introduce inert gas maintenance, reinforcing an oxygen/oxidation control narrative.

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What competing product designs are most at risk under the literal claim language?

Most at risk:

• Products using an AN/methyl acrylate copolymer film as the nicotine impermeable barrier.
• Assemblies where adjacent barrier surfaces are heat sealed to create a continuous nicotine barrier.
• Reservoirs maintained in inert gas (nitrogen) during relevant storage or processing stages (for Claim 5-6).
• Manufacturing methods that charge nicotine into a reservoir within an oxygen-free chamber and then heat seal to create the oxygen-free sealed structure (Claim 7 and 9-12).

Lower direct risk (based on structural/method deviations):

• Barrier materials not based on AN/methyl acrylate copolymer (even if they are nicotine-impermeable).
• Barrier assemblies using non-heat sealing closure methods where “heat sealed” and “continuous” formation are not met.
• Loading/sealing performed under “low oxygen” but not “oxygen-free” environments, and without evacuated air or nitrogen steps as recited in narrower dependent method claims.

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US patent estate: what other patents likely surround 5,400,808 on nicotine barrier packaging and oxygen exclusion?

Only the claims you provided are in-scope here. A complete estate map requires bibliographic and citation data (family members, forward citations, and related assignee filings). Without those inputs, this analysis cannot produce a defensible list of other US patents, expiration dates, or priority chain coverage.

What can be said from claim text alone:

• The estate is likely to be concentrated around:
  • Nicotine barrier film compositions (AN/methyl acrylate copolymer formulations)
  • Heat-sealed self-encapsulating barrier architectures
  • Oxygen-exclusion inert gas and chamber manufacturing workflows
  • Multilayer barrier constructs (e.g., metal foil lamination)
  • Porous polymer plugs loaded with free-base nicotine

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When does 5,400,808 lose exclusivity?

A defensible exclusivity and expiration timeline requires:

• application filing date, priority date, grant date, and any patent term adjustment/extension. Those data are not provided in the prompt, so a precise calendar-driven timeline cannot be produced from the claim text alone.

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Orange Book status and generic entry risk: is 5,400,808 tied to an FDA-approved nicotine product?

A litigation- and entry-relevant answer requires:

• the Orange Book listing(s) and the NDA/ANDA/BLA that 5,400,808 is listed against. No drug product identity, application number, or Orange Book entry is supplied, so this cannot be mapped.

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How strong are the claims for enforcement given the specific language?

Strength drivers (high specificity)

• Polymer chemistry is specified (AN/methyl acrylate copolymer, “essentially of”).
• Closure method is specified (heat sealing of adjacent surfaces to form continuous barrier).
• Oxygen exclusion is specified in the method claim (“oxygen-free environment about the reservoir”).
• Dependent claims specify concrete reservoir structure (porous polymer plug) and nicotine form (free-base), plus optional aluminum foil and nitrogen atmosphere.

Strength risks (specificity creates design-around space)

• Competitors can potentially route around by:
  • using different barrier polymer systems not meeting AN/methyl acrylate copolymer language
  • using non-heat sealing methods
  • meeting oxygen exclusion via approaches that do not qualify as “oxygen-free environment” or do not match recited chamber steps in dependent method claims
• Dependent claims add further narrowing constraints, lowering reach for those sub-formats.

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Key Takeaways

1. US 5,400,808 centers on a nicotine reservoir encapsulated by a self-sealed nicotine-impermeable barrier formed from an acrylonitrile/methyl acrylate copolymer film, with heat-sealed adjacent surfaces forming a continuous barrier that prevents nicotine migration.
2. Dependent claim coverage tightens reservoir composition (porous polymer plug, free-base nicotine) and adds optional multilayer protection (adhesive metal foil, aluminum foil).
3. The method claims (Claim 7 and dependents) tie extended shelf life to manufacturing under an oxygen-free environment, including chamber-based oxygen removal and inert gas (nitrogen) options.
4. The most enforceable hooks are barrier chemistry plus heat-sealed continuous barrier architecture and oxygen-free processing during sealing; those elements are the most direct infringement targets and the most direct design-around levers.

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FAQs

1. Can a nicotine barrier using a different copolymer avoid Claim 1?

Claim 1 requires a barrier layer “formed essentially of” an acrylonitrile and methyl acrylate copolymer, so different barrier polymer chemistry creates a primary non-infringement pathway.

2. Does Claim 1 require aluminum foil?

No. Aluminum foil is only in dependent Claim 4 (and metal foil in Claim 3). Claim 1 covers the copolymer barrier without requiring metal foil.

3. Is “oxygen-free environment” limited to manufacturing time?

Claim 7 requires creating an oxygen-free environment about the reservoir and maintaining the reservoir in an “effectively oxygen-free environment.” The method steps strongly anchor oxygen exclusion during loading/sealing.

4. Is the porous polymer plug and free-base nicotine required for all claims?

No. Porous plug and free-base nicotine appear only in dependent Claims 2 and 8 (system and method, respectively).

5. Does Claim 5 require nitrogen specifically?

Claim 5 requires an inert gas to nicotine; Claim 6 narrows inert gas specifically to nitrogen.

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References

1. User-provided text of US Patent 5,400,808 claim set (Claims 1-13).

Drugs Protected by US Patent 5,400,808

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 5,400,808

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	174805
Australia	642506
Australia	8002791
Brazil	9106537
Canada	2084771
China	1059649