Details for Patent: 6,881,200

Summary for Patent: 6,881,200

Title:	Needleless syringe using super sonic gas flow for particle delivery
Abstract:	A needleless syringe having a membrane (28) which is ruptured by gas pressure to generate a supersonic gas flow in which particles containing a therapeutic agent are injected.
Inventor(s):	Brian J. Bellhouse, David F. Sarphie, John C. Greenford
Assignee:	Powder Pharmaceuticals Inc
Application Number:	US09/248,743
Patent Claim Types: see list of patent claims	Delivery; Dosage form;

Executive summary U.S. Patent 6,881,200 claims a sealed, rupturable diaphragm unit for use with needleless syringes that releases a powdered therapeutic agent when exposed to pressurized gas, with critical mechanical thresholds tied to diaphragm burst pressure (20–75 atm) and pressure-chamber volume (1–5 mL). Dependent claim scope tightens into (i) sachet/capsule formats, (ii) multi-compartment powder packs using a third diaphragm, (iii) powder stability for mixtures unstable when wet, (iv) insulin as an example drug, and (v) particle size windows (broad 0.1–250 μm; narrower 1–50 μm; preferred ~10–20 μm). The patent landscape around this family is likely anchored in broader needle-free powder/pressurized-gas delivery IP, with 6,881,200 acting as a mechanical-and-parameter “gatekeeper” through its specific pressure/volume and capsule-release structure.

H1: U.S. Patent 6,881,200 scope and claims for needleless syringe rupturable diaphragm powder delivery

What does U.S. Patent 6,881,200 claim: sealed rupturable diaphragms for powder release in needleless syringes?

Core independent claim (Claim 1) covers a sealed unit designed to interface with a needleless syringe system. Release is triggered by rupturing one or more diaphragms by a flow of gas that initiates a gas flow through the sealed unit.

Claim 1 elements (practical claim mapping)

Claim 1 is structured around the following required limitations:

1. Sealed unit for use with a needleless syringe
2. First and second rupturable diaphragms
3. Diaphragms are sealed to each other around their edges to form a sealed compartment
4. The compartment contains powdered therapeutic-agent particles
5. At least one diaphragm is made of a material meeting a burst pressure threshold
   • Burst pressure: 20–75 atmospheres
   • Measured in a pressure chamber with volume: 1–5 mL
6. The diaphragm is rupturable by a flow of gas
7. Rupture initiates gas flow through the sealed unit (release function)

Key scope “knobs” embedded in Claim 1

• The patent does not claim a specific drug as a requirement, but it explicitly claims powdered therapeutic agents broadly.
• It also does not claim a specific diaphragm geometry, but it requires:
  • Two rupturable diaphragms
  • Edge sealing between them
  • A mechanical property definition (burst pressure) tied to a specific test chamber volume.

Immediate consequence: A product that releases via rupturable elements but uses diaphragm materials outside the 20–75 atm burst range, or uses a different mechanical triggering condition not characterized by that test setup, can sit outside Claim 1 even if it uses pressurized gas to disperse a powder.

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How narrow are the mechanical limitations: what burst pressure and chamber volume define infringement risk for Claim 1?

Claim 1 contains an unusually explicit parameter-by-parameter mechanical definition:

• Burst pressure range: 20 to 75 atm
• Pressure chamber volume for the burst-pressure measurement: 1 to 5 mL

Practical claim interpretation

A defendant’s strongest design-around posture is to shift one of these defining parameters:

• Lower burst (below 20 atm): diaphragm fails too easily under lower pressure
• Higher burst (above 75 atm): diaphragm requires higher pressure than the claimed window
• Different test setup: if burst pressure is characterized in a chamber outside 1–5 mL, a party can argue noncompliance with the claim’s measurement definition

Risk shape

• If the gas flow system is designed such that the diaphragm ruptures at a pressure that is within the claimed burst window and the diaphragm material is defined via a test consistent with the 1–5 mL pressure chamber, Claim 1 coverage is difficult to avoid.
• If the system uses a different membrane rupture regime (e.g., fracture plates, mechanical snap, laser-thinned membranes) and does not rely on diaphragms defined by the burst-pressure window, risk drops.

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What does Claim 2 add: does a sachet or capsule format expand or narrow the protected subject matter?

Claim 2 depends from Claim 1 and limits the unit to:

• A sealed rupturable sachet or capsule

This is both:

• A format limitation (sachet/capsule vs any sealed unit), and
• A confirmation that the claims are intended to cover discrete consumable cartridges in needleless syringe systems.

Infringement posture

• Any system with the core Claim 1 mechanical structure but packaged in a format that is not reasonably characterized as a sealed capsule or sachet can argue it falls outside Claim 2, though Claim 1 itself may still apply.

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How does Claim 3 change the claim scope: third diaphragm for multi-compartment powder separation?

Claim 3 depends from Claim 2 and adds:

• A third diaphragm disposed between the first and second diaphragms
• Purpose: at least two compartments containing different powdered therapeutic agents

What Claim 3 covers that Claim 1 does not

Claim 3 expands coverage into segregated dual-powder delivery cartridges. It requires:

• Three diaphragms total
• A specific internal architecture that supports multiple compartments

Design-around

• A single-compartment capsule (even with two rupturable diaphragms) avoids Claim 3.
• A dual-powder system that uses non-diaphragm barriers or different separation structures may also avoid Claim 3.

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What is Claim 4’s functional limitation: powder mixtures unstable when mixed wet

Claim 4 depends from Claim 1 and specifies:

• The powdered therapeutic agent is a stable mixture of drugs
• The drugs are unstable when mixed wet

Scope effect

This is a therapeutic formulation limitation that narrows Claim 4 coverage to specific drug combinations and stability profiles. It does not, by itself, narrow Claim 1 or Claim 2 unless the infringement theory relies on Claim 4.

Practical risk

• If a generic/competitor powders distinct drugs but the combination is not specifically presented or understood as “unstable when mixed wet,” reliance on Claim 4 may weaken.
• Claim 4 is still valuable in prosecution and litigation because it can support an argument that a particular powder blend is the reason the diaphragm sealing concept matters.

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How far does Claim 5 reach: does the patent claim insulin specifically or just as an example?

Claim 5 depends from Claim 1:

• The powdered therapeutic agent comprises insulin

Interpretation

This makes insulin an explicitly claimed embodiment. It can support:

• enforcement against insulin needleless powder products using this mechanical architecture, and
• narrowing defenses if products use other therapeutic classes.

Practical note

Insulin is a high-value target category for needleless systems. If an accused product is insulin-based, claim mapping is direct: product includes insulin-containing powder dispersed by gas-triggered diaphragm rupture.

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What do the particle size claims cover: 0.1–250 μm and preferred 10–20 μm

Particle size limitations appear in two places:

• Claim 6: Claim 1 with particle size predominantly 0.1 to 250 μm
• Claim 7: further narrows to 1 to 50 μm, preferably 10 to 20 μm
• Claim 10–11: for capsules (Claim 8), repeat the size limitations (predominantly 0.1–250 μm; predominantly about 10–20 μm)

How “predominantly” changes enforceability

“Predominantly” is a distribution-based term. It creates infringement questions that often turn on:

• PSD (particle size distribution) measurements,
• threshold definitions (e.g., what percentage must fall inside the stated windows),
• measurement method (laser diffraction, microscopy, sieve fractionation),
• and batch-to-batch variability.

Scope mapping

• Broadest: Claim 1 has no size limitation.
• Medium: Claim 6 adds 0.1–250 μm constraint.
• Narrowest: Claim 7 and Claim 11 push toward ~10–20 μm.
• If the particle size used by a needleless powder competitor is outside these windows, it weakens dependence-based claims and may leave only broader Claim 1 coverage (if the mechanical elements are met).

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What does Claim 8 claim: sealed capsule for transdermal delivery when contacted with pressurized gas

Claim 8 depends from Claim 1 by specifying the unit as:

• A sealed capsule containing a dose of a powdered agent
• Capsule has:
  • burst pressure 20–75 atm in 1–5 mL pressure chamber (mirrors Claim 1 limitation)
• Release function:
  • will release the powdered agent for transdermal delivery
  • when contacted with a source of pressurized gas

Functional limitation

The transdermal delivery requirement is a limiting end-use. It is not enough that the capsule disperses powder in general; it must be intended for and configured to provide transdermal delivery when actuated by pressurized gas.

Design-around

• Oral, intranasal, or inhalation delivery using the same mechanical cassette concept might avoid the transdermal-specific claim pathway if the product is not configured for transdermal use.

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What does Claim 9 add: at least one membrane retaining powder before actuation

Claim 9 depends from Claim 8:

• capsule comprises at least one membrane
• membrane retains the powdered agent prior to contact with pressurized gas

What this covers

This is consistent with the two-diaphragm concept but clarifies pre-actuation containment as a required functional feature.

Design-around

If a cartridge contains powder but lacks a membrane-based containment system prior to actuation, Claim 9 becomes harder to apply. In practice, most diaphragm-based systems will still meet this limitation.

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Claim 10–11: repeat particle size limitations for the capsule embodiment

• Claim 10: capsule with particle size predominantly 0.1–250 μm
• Claim 11: capsule where particle size predominantly about 10–20 μm

Enforcement implication

If accused capsules use the same burst/volume mechanical architecture but different powder PSD, Claim 10/11 may not support infringement.

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Patent landscape: how 6,881,200 fits among needleless powdered drug delivery IP (US)

Only the text of claims for U.S. Patent 6,881,200 is provided. Without the patent’s specification, filing data, assignee, and citation data, the landscape can be characterized only at the claim-structure level.

What patent families does 6,881,200 likely intersect

Based on the claim subject matter, the closest US/IP neighbors in a typical needleless powdered delivery space tend to cover:

• Needleless delivery devices using pressurized gas to accelerate particles
• Sealed cartridges with rupturable barriers that trigger on gas pressure
• Transdermal powder deposition systems
• Powder formulation and particle engineering enabling skin penetration and controlled deposition

Where 6,881,200 is “strongest”

The claim’s value is its mechanical parameter gating:

• burst pressure 20–75 atm
• pressure chamber volume 1–5 mL
• sealed compartments formed by edge-sealed diaphragms
• rupture initiated by gas flow through the sealed unit

That combination makes it less likely that a generic “needleless powder” concept alone maps onto it unless the product uses a matching diaphragm rupture regime.

Where it is “easiest to distinguish”

Competitors can differentiate by:

• using a non-diaphragm rupture mechanism,
• using membranes with burst pressure outside 20–75 atm,
• using a different defined test chamber volume,
• using barrier formats not characterized as “sealed sachet or capsule,”
• delivering non-transdermally,
• using PSD outside the claimed windows (when relying on dependent claims).

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Key claim coverage table: which elements map to which dependent claims

Feature	Independent Claim 1	Claim 2	Claim 3	Claim 4	Claim 5	Claim 6	Claim 7	Claim 8	Claim 9	Claim 10	Claim 11
Needleless syringe interface	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Two rupturable diaphragms, edge sealed to form compartment	Yes	Yes	Yes (plus third)	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Burst pressure 20–75 atm; test chamber 1–5 mL	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Powder in sealed compartment	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Gas flow ruptures diaphragm to initiate gas flow through unit	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Sachet/capsule format		Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Third diaphragm for ≥2 compartments with different powders			Yes
Powder mixture stable when mixed wet would be unstable				Yes
Insulin as powdered agent					Yes			Yes
Particle size predominantly 0.1–250 μm						Yes	Yes			Yes	Yes
Particle size 1–50 μm; preferred 10–20 μm							Yes
Transdermal delivery on pressurized gas contact								Yes	Yes	Yes	Yes
Membrane retains powder pre-actuation									Yes
Capsule particle PSD predominantly about 10–20 μm											Yes

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How strong is the patent estate for key competitive scenarios?

Using only the claim text, the “strength” can be treated as alignment probability across common product designs.

Scenario A: insulin needleless transdermal powder cartridge (diaphragm rupture, PSD engineered to ~10–20 μm)

• Likely strongest mapping to Claim 1 (mechanical), Claim 5 (insulin), Claim 7 (preferred PSD), and Claim 8 (transdermal).
• Best defense would require noncompliance with burst pressure/chamber volume or showing non-diaphgram containment architecture.

Scenario B: needleless powder capsule with broader PSD and/or non-transdermal delivery

• Dependent claims involving PSD or transdermal use can be avoided.
• Claim 1 may still apply if the diaphragm mechanical parameterization matches.

Scenario C: dual-powder mixture cartridge with internal separation but not via a third diaphragm

• Claim 3 is avoidable unless a third diaphragm is used in the claimed way.
• Claim 1 may still cover the gas-rupturable sealed compartment core.

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Key Takeaways

• U.S. Patent 6,881,200 centers on a gas-triggered, sealed, rupturable diaphragm unit for needleless syringe powder release.
• The claim’s high-specificity “gate” is the burst pressure (20–75 atm) measured in a 1–5 mL pressure chamber.
• Dependent claims narrow into capsule/sachet format, multi-compartment third-diaphragm architecture, stability-driven powder mixtures, insulin as a therapeutic embodiment, and particle size windows (notably ~10–20 μm).
• For infringement risk, design-arounds most commonly target one of: burst pressure window, test-chamber volume definition, transdermal intent, diaphragm count/architecture, or particle PSD.

FAQs

1. Can a needleless powder cartridge avoid infringement by using a diaphragm burst pressure below 20 atm?
2. Does U.S. Patent 6,881,200 require transdermal delivery, or can it cover other needleless routes?
3. How does “predominantly” in the particle size claims affect whether a product falls within 10–20 μm?
4. If a competitor uses two compartments separated by a non-diaphragm barrier, does it avoid Claim 3?
5. If a product contains insulin but uses a different rupturable barrier mechanism, which claims are most vulnerable?

Drugs Protected by US Patent 6,881,200

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: 6,881,200

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9307459	Apr 08, 1993
United Kingdom	9318407	Sep 06, 1993
United Kingdom	9321356	Oct 15, 1993
United Kingdom	9326069	Dec 21, 1993

International Family Members for US Patent 6,881,200

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	148497
Austria	329006
Australia	6435194
Australia	674742
Bulgaria	100047