Last Updated: May 10, 2026

Details for Patent: 6,488,027


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Summary for Patent: 6,488,027
Title:Powder inhaler
Abstract:This invention relates to single dose dry powder inhalers in which medicament is stored in a capsule and is released by piercing the capsule wall with polymer-coated steel pins. Methods of preparation of polymer-coated piercing means and their use in releasing the medicament from the capsule are described.
Inventor(s):Claude Moulin
Assignee: Novartis AG
Application Number:US09/657,967
Patent Claim Types:
see list of patent claims
Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and US Patent Landscape for US Patent 6,488,027

US Patent 6,488,027 covers an inhaler device with a steel capsule-piercing element that is surface-engineered with a two-part coating system. The coating is designed so the piercing element both pierces a capsule and resists degradation at the capsule interface, using (1) a metal-alloy “alloy layer” and (2) an “alloy matrix layer” that disperses inert polymer particles in a metal-alloy matrix.

What is protected in US 6,488,027?

What is the core claimed structure?

Claim 1 defines an inhaler device comprising:

  • A steel capsule-piercing means for piercing a capsule
  • Where at least the portion that contacts and pierces the capsule is coated with: 1) An alloy layer comprising at least one metal selected from:
    • chromium
    • a Group VIII metal
    • a noble metal 2) An alloy matrix layer comprising:
    • inert polymer particles
    • an alloy comprising at least one metal selected from:
      • chromium
      • a Group VIII metal
      • a noble metal

This is the claim’s essential combination: steel piercing element + two-layer coating architecture + specific metals + dispersed inert polymer particles.

What elements narrow claim scope beyond claim 1?

Claims 2 to 11 narrow by specifying the metal set, the polymer family, the inclusion of phosphorus, the alloy composition ranges, the PTFE selection, and coating thickness/volume fraction.

Claim-by-claim scope map (from the text provided)

Claim Added limitation vs. claim 1 Functional impact on scope
1 Two-layer coating: alloy layer (Cr/Group VIII/noble) + alloy matrix layer (alloy + inert polymer particles) Broadest boundary of infringement
2 Metal selected from: iron, cobalt, nickel, ruthenium, rhodium, palladium, and combinations Narrows the “Group VIII/noble” implementation
3 Metal is nickel Further narrows within claim 2
4 Alloy matrix additionally comprises phosphorus Introduces P as a required alloying element in matrix
5 Alloy comprises nickel and phosphorus Locks in Ni + P combination in matrix
6 Alloy composition for the alloy: 90-93 wt% nickel; 7-10 wt% phosphorus Requires tight compositional window
7 Polymer is a fluorocarbon polymer Restricts “inert polymer particles” to fluorocarbons
8 Polymer is polytetrafluoroethylene (PTFE) Restricts “inert polymer particles” to PTFE
9 Coating specifics: alloy layer = Ni-P; alloy matrix = Ni + P + PTFE particles Defines exact chemistry of both layers
10 Thickness ranges: alloy layer 5-15 microns; alloy matrix layer 3-10 microns Adds process/structure dimensional limits
11 PTFE content in matrix: 20-30% by volume PTFE Requires a polymer volume fraction window

What metals and polymer families fall inside the claim set?

What metals qualify for the alloy layer and the alloy matrix layer?

Claim 1 uses three metal buckets: chromium, Group VIII metal, noble metal.

Claim 2 explicitly enumerates a narrower set for “the metal,” listing:

  • iron, cobalt, nickel
  • ruthenium, rhodium, palladium
  • combinations thereof

Claim 3 selects nickel.

Claim 4 adds phosphorus to the alloy matrix.

Claim 9 specifies both coating layers using nickel-phosphorus chemistry plus PTFE particles in the matrix.

In practice, the protected chemistries collapse to nickel-phosphorus alloy with PTFE dispersion when the narrower dependent claims are invoked (claims 3, 5, 6, 8, 9, 11, with thickness limits in claim 10).

What polymers qualify?

  • Claim 1: “inert polymer particles” (broad)
  • Claim 7: “fluorocarbon polymer” (intermediate)
  • Claim 8: polytetrafluoroethylene (PTFE) (narrow)
  • Claim 9 and claim 11: PTFE particles in the alloy matrix with defined chemistry and volume fraction

How strong is the claim architecture for enforcement?

What gives the patent a distinct scope advantage?

The combination is specific in three independent dimensions:

1) Device interface element: the steel capsule-piercing means that contacts and pierces the capsule
2) Coating architecture: two layers (alloy layer + alloy matrix layer)
3) Coating composition: constrained metal sets (Cr/Group VIII/noble) and inert polymer particles in a metal-alloy matrix; with optional but narrowing Ni-P/PTFE windows and dimensional limits

That structure helps distinguish from:

  • coatings that are single-layer
  • coatings that use polymer binders but not as dispersed particles in an alloy matrix
  • coatings that do not involve a steel capsule-piercing interface

Which claims create “high-confidence” infringement zones?

The dependent claims create the tightest, most easily measurable infringement boundaries:

  • Ni-P alloy matrix composition (90-93 wt% Ni; 7-10 wt% P) in claim 6
  • PTFE as the inert polymer in claim 8
  • PTFE volume fraction 20-30% by volume in claim 11
  • Coating layer thicknesses 5-15 microns (alloy layer) and 3-10 microns (alloy matrix) in claim 10
  • Exact coating chemistries in claim 9 (alloy layer Ni-P; alloy matrix Ni, P, PTFE particles)

These parameters are testable in forensic claim construction and technical diligence.

Claim scope outcomes: what design-arounds likely sit outside?

What substitutions likely avoid claim 1 while staying “close”?

Claim 1 is broad on metal buckets and polymer category, but it is strict on architecture: a two-layer coating with an alloy layer and an alloy matrix layer where polymer particles are dispersed in an alloy matrix.

Potential outside-the-claim approaches (conceptual, based on the claim language you provided):

  • use a single-layer coating rather than the required two-layer structure
  • use inert polymer as a separate topcoat without forming an “alloy matrix layer” that includes polymer particles dispersed in an alloy
  • change polymer family away from fluorocarbons if targeting claims 7-11
  • change the metal implementation so it does not fall into chromium, Group VIII metal, or noble metal categories as used in claim 1

What substitutions likely avoid claims 2-11 specifically?

To avoid the narrower dependents:

  • Avoid nickel as the selected “metal” if relying on claim 2/3 narrowing (though claim 1 still exists)
  • Avoid phosphorus in the alloy matrix if trying to stay outside claim 4-6
  • Avoid PTFE specifically if trying to avoid claim 8/9/11
  • Avoid the PTFE volume fraction window (20-30% by volume) and the layer thickness ranges (claim 10)
  • Avoid the specific Ni-P alloy weight window (90-93 wt% Ni; 7-10 wt% P)

Landscape analysis: where does this sit in the broader inhaler surface-coating field?

What is the likely “technical neighborhood” of US 6,488,027?

Even without the specification text or citation list, the claims point to a narrow niche:

  • Inhaler capsule systems requiring mechanical piercing
  • Wear/corrosion management at a metal-capsule interface
  • Use of nickel-phosphorus alloy systems and PTFE particulate dispersion to reduce friction and wear
  • Two-layer coating stacks with controlled thickness

In the patent landscape, this is typically adjacent to:

  • metal plating and alloy coating patents
  • PTFE composite coatings and tribology-focused surface engineering
  • medical device coatings where the device contacts consumable elements (capsules, vials, cartridges)

What does the claim set imply about novelty strategy?

The claim structure suggests the “novelty” sits in combining:

  • a specific alloy coating metal selection framework (chromium/Group VIII/noble)
  • a nickel-phosphorus alloy implementation (in the narrower claims)
  • a PTFE particulate dispersion in an alloy matrix
  • dimensional control over coating thicknesses and PTFE volume fraction
  • application to the capsule-piercing steel interface of an inhaler device

That combination is the enforceable hook. A buyer or licensee evaluates freedom-to-operate around whether the piercing interface is steel and whether it uses the defined two-layer composite coating architecture.

Practical enforcement and diligence checklist (based on claim language)

What technical facts must be verified in an accused product?

For claim 1 (and especially for claims 7-11), diligence should establish:

  • The presence of a steel capsule-piercing element used to pierce the capsule
  • Whether the piercing portion is coated
  • Whether the coating is two-layer:
    • an “alloy layer”
    • an “alloy matrix layer”
  • Whether the “alloy layer” includes chromium, a Group VIII metal, and/or a noble metal
  • Whether the “alloy matrix layer” includes:
    • an alloy including chromium/Group VIII/noble metals
    • inert polymer particles dispersed in that alloy matrix
  • If evaluating narrower claims:
    • fluorocarbon polymer vs. PTFE specifically
    • presence of phosphorus in the alloy matrix
    • Ni-P composition window (90-93 wt% Ni and 7-10 wt% P)
    • alloy composition and coating chemistry in claim 9 (alloy layer Ni-P; matrix Ni-P + PTFE)
    • thickness ranges for both layers
    • PTFE volume fraction range 20-30%

What measurement methods map to the claims?

  • Coating thickness: cross-section microscopy with micron-scale measurement
  • Alloy composition: EDS/EPMA or other compositional analysis to confirm Ni and P wt%
  • PTFE identification: spectroscopy and particle morphology
  • PTFE volume fraction: image analysis or other quantification methods
  • Layer distinction: metallographic cross-sections demonstrating discrete alloy layer and alloy matrix layer

Key takeaways

  • US 6,488,027 protects a coated steel capsule-piercing element in an inhaler, using a two-layer coating architecture. Claim 1 requires an alloy layer plus an alloy matrix layer with inert polymer particles dispersed in the alloy matrix.
  • The enforceable “tight scope” is driven by the dependent claims: nickel-phosphorus alloy chemistry, PTFE particulate dispersion, specified PTFE volume fraction (20-30% by volume), and coating thickness windows (alloy layer 5-15 microns; matrix 3-10 microns).
  • Freedom-to-operate hinges on whether the accused device matches the coating architecture and measurable composition/thickness/PTFE-volume windows, not just on whether it uses any coating or any PTFE-containing surface.
  • Design-around is most plausible by breaking the claim’s structural requirements (single-layer coatings, polymer not dispersed in an alloy matrix, or piercing elements not using the defined metal buckets/coating structure).

FAQs

Does claim 1 require PTFE specifically?

No. Claim 1 requires “inert polymer particles” in an alloy matrix layer, and PTFE is only required by dependent claims 7-9 and 11.

Is phosphorus required for claim 1?

No. Phosphorus is added in claim 4 and subsequent dependent claims; claim 1 does not require phosphorus.

What is the narrowest independent boundary in the provided claim set?

Claim 9 plus claim 10 plus claim 11 create the tightest implementation: Ni-P alloy in the alloy layer, Ni-P alloy matrix with PTFE particles, defined layer thicknesses, and PTFE volume fraction 20-30%.

How strict are the composition and thickness windows?

They are explicit ranges:

  • Alloy composition in claim 6: 90-93 wt% nickel; 7-10 wt% phosphorus
  • Thickness in claim 10: alloy layer 5-15 microns; matrix layer 3-10 microns
  • PTFE volume fraction in claim 11: 20-30% by volume

Can a device infringe even if only part of the piercing element is coated?

Claim 1 requires “at least a portion” of the capsule-piercing means that contacts and pierces the capsule be coated with the two-layer system.


References

  1. US Patent 6,488,027 (claims as provided in prompt).

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Drugs Protected by US Patent 6,488,027

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

Foreign Priority and PCT Information for Patent: 6,488,027

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom9805102Mar 10, 1998

International Family Members for US Patent 6,488,027

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 283083 ⤷  Start Trial
Australia 3032399 ⤷  Start Trial
Australia 750844 ⤷  Start Trial
Brazil 9908587 ⤷  Start Trial
Brazil 9908626 ⤷  Start Trial
Canada 2322575 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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