Details for Patent: 6,342,482

Summary for Patent: 6,342,482

Title:	Formulations for controlling human lice
Abstract:	Safer pediculicidal formulations comprising a spinosyn, or a physiologically acceptable derivative or salt thereof, and a physiologically acceptable carrier, and methods of controlling lice infestations in a human with these formulations are provided.
Inventor(s):	Daniel Earl Snyder
Assignee:	Elanco US Inc
Application Number:	US09/543,441
Patent Claim Types: see list of patent claims	Formulation; Compound;

US Patent 6,342,482: What Is Claimed and How It Sits in the US Pediculicide Landscape

US Patent 6,342,482 is directed to pediculicidal hair conditioning formulations and lotions that combine a spinosyn active (or physiologically acceptable derivative/salt) with a conditioner and a liquid vehicle (water or other vehicle, depending on claim scope). The claims are written to capture both (i) conditioner-based topicals and (ii) anti-lice lotions, with dependent claim structure that narrows to particular formulation classes: long-chain quaternary ammonium conditioners, lipid loadings, and optional surfactants.

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What Is the Core Claim Scope (Independent Claims)

How broadly does Claim 1 cover formulations?

Claim 1 defines a “pediculicidal hair conditioner formulation” with four essential limitations:

1. Active ingredient: a spinosyn (or physiologically acceptable derivative or salt)
2. Concentration range: about 0.1% to about 30% spinosyn
3. Carrier system: a conditioner and water
4. Dosage form concept: hair conditioner with pediculicidal activity

Practical scope implications

• The active range (0.1% to 30%) is wide enough to include low-dose cosmetic-on-treatment use and higher-dose actives.
• The “conditioner and water” wording means the product must contain both components as part of the formulation, but it does not require a specific conditioner chemistry at Claim 1 level.

How broadly does Claim 7 cover lotions?

Claim 7 defines an “anti-lice lotion comprising”:

1. Spinosyn (or derivative/salt)
2. Conditioner
3. A liquid vehicle

It sets no explicit base requirement that the liquid vehicle is water in Claim 7 itself.

Does Claim 7 add flexibility vs Claim 1?

Yes. Claim 1 hard-anchors “water” as the liquid phase (“conditioner and water”). Claim 7 uses “liquid vehicle,” then provides vehicle specifics in dependents (Claims 10-11).

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What Dependent Claims Add: Conditioner Chemistry, Lipids, Surfactants, and Vehicles

How does Claim 3 narrow conditioner type?

Claim 3 requires the conditioner to be:

• a long chain quaternary ammonium compound combined with
• a lipid material

This is a meaningful narrowing because it selects specific conditioner chemistry:

• Long-chain quaternary ammonium compound conditioning agents (a common hair conditioner class)
• A lipid co-component that is explicitly tied to the conditioner system

How does Claim 4 quantify lipid content?

Claim 4 narrows the lipid material level to:

• about 0.5% to about 3% of the formulation

This numeric window tightens infringement analysis for products that otherwise match the “long chain quaternary ammonium + lipid” architecture but use different lipid loadings.

How does Claim 5 expand composition options with surfactant?

Claim 5 adds a surfactant as an additional component.

How does Claim 6 constrain surfactant amount?

Claim 6 requires surfactant at:

• 0.1% to about 5% of the formulation

This constrains claims 5-6 to a numeric surfactant window, while leaving Claim 5 (without the amount limitation) logically enforceable only within Claim 5’s own framing (but the dependent adds the specific range).

How do vehicle-specific dependents expand product formats?

Claim 10: liquid vehicle is water
Claim 11: liquid vehicle is a monohydric alcohol

This indicates the patent anticipates multiple liquid vehicle formulations that still retain:

• spinosyn active
• conditioner component
• anti-lice lotion dosage form

How does Claim 12 define conditioner chemistry further?

Claim 12 states:

• conditioning agent is a quaternary ammonium salt

This aligns with Claim 3’s “long chain quaternary ammonium compound,” but Claim 12 is less specific (it does not explicitly require “lipid material,” which is added in Claim 3-4).

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Numeric Claim Coverage: Spinosyn Concentrations and Formulation Windows

Where are the spinosyn concentration windows?

The patent uses two explicit spinosyn windows in dependents:

• Claim 2: about 1% to about 10% spinosyn (for the conditioner formulation of Claim 1)
• Claim 8: about 0.1% to about 30% spinosyn (for the lotion of Claim 7)
• Claim 9: about 1% to about 10% spinosyn (for the lotion of Claim 8)

So the system repeats the same concentration windows:

• broad (0.1%-30%) and narrower (1%-10%)

Where do the remaining numeric limitations appear?

• Lipid material: about 0.5% to about 3% (Claim 4)
• Surfactant: 0.1% to about 5% (Claim 6)

The claims do not specify:

• exact conditioner base chemistry beyond quaternary ammonium and long-chain selection in Claim 3
• exact spinosyn type (but “spinosyn” encompasses the active family and its derivatives/salts as written)

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Claim-to-Formulation Mapping: What Must a Product Contain to Fall Within Each Claim

Claim 1 (hair conditioner + water + spinosyn)

To infringe Claim 1 (as written), a product must:

• include a spinosyn active (or derivative/salt)
• be a pediculicidal hair conditioner
• contain a conditioner component plus water
• have spinosyn at about 0.1% to about 30%

Claim 2 (adds preferred spinosyn concentration)

• Claim 1 elements plus spinosyn at about 1% to about 10%

Claim 3 (adds conditioner chemistry)

• Claim 1 elements plus conditioner is “long chain quaternary ammonium compound + lipid”

Claim 4 (adds lipid quantitative window)

• Claim 3 elements plus lipid at about 0.5% to about 3%

Claim 5 (adds surfactant)

• Claim 1 elements plus includes a surfactant

Claim 6 (adds surfactant numeric window)

• Claim 5 elements plus surfactant at 0.1% to about 5%

Claim 7 (anti-lice lotion with vehicle concept)

• spinosyn active (or derivative/salt)
• conditioner component
• liquid vehicle

Claim 8 (spinosyn numeric window for lotion)

• Claim 7 elements plus spinosyn at about 0.1% to about 30%

Claim 9 (preferred lotion spinosyn window)

• Claim 8 elements plus spinosyn at about 1% to about 10%

Claim 10 (water vehicle)

• Claim 7 elements plus liquid vehicle is water

Claim 11 (alcohol vehicle)

• Claim 7 elements plus liquid vehicle is a monohydric alcohol

Claim 12 (quaternary ammonium salt conditioning agent)

• Claim 7 elements plus conditioning agent is quaternary ammonium salt

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How the Claims Interlock: Coverage Breadth vs Enforcement Leverage

What gives the patent strong coverage?

1. Spinosyn concentration is broadly defined in Claim 1 and Claim 7 (0.1% to 30%).
2. Conditioner and vehicle concepts are flexible at the independent level:
   • Claim 1 requires water; Claim 7 permits alternative liquid vehicles.
3. Conditioner class is specific in dependents (quaternary ammonium, long-chain, lipid combination), letting the patent enforce at multiple levels:
   • a broad “spinosyn + conditioner + water” theory (Claim 1)
   • narrower “spinosyn + quaternary ammonium conditioner + lipid” theory (Claims 3-4)

Where the patent narrows into measurable “formulation design-around” parameters

• Lipids at 0.5%-3% (Claim 4)
• Surfactant at 0.1%-5% (Claim 6)
• Long-chain quaternary ammonium plus lipid structure (Claim 3)
• Vehicle types explicitly listed:
  • water (Claim 10)
  • monohydric alcohol (Claim 11)

A competitor product that keeps spinosyn within 0.1%-30% but changes conditioning chemistry or lipid/surfactant loadings can reduce exposure to the dependent claims, but Claim 1/7 may still remain in play unless it also removes the required conditioner + water (Claim 1) or conditioner + liquid vehicle with the right architecture (Claim 7).

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US Patent Landscape: Where This Patent Sits and What It Competes Against

Immediate landscape anchor: US approvals using spinosyn actives for lice

This patent is part of the broader spinosyn-driven pediculicide formulation space. The claims are “formulation” claims, built around use of spinosyn as the pediculicidal active in conditioner/lotion systems.

Common competitor formulation classes in pediculicide topicals

Even without assuming specific product identities, US pediculicide formulation portfolios typically include actives such as:

• pyrethrins/pyrethroids,
• organophosphates (historically in some markets),
• and other pediculicidal drugs.

US formulation patents for those actives usually focus on:

• vehicle (alcohols, aqueous gels, emulsion bases),
• surfactant/co-solvent systems,
• conditioner-like deposition agents (to improve spread, adherence, and hair feel),
• and stability.

In that context, US 6,342,482 differentiates by tying pediculicidal efficacy to a spinosyn + conditioner system with quaternary ammonium conditioning agents in dependents.

How to interpret “scope” in landscape terms

• If a product uses a spinosyn active at 0.1%-30% and delivers it as a “hair conditioner” with water, it maps tightly to Claim 1.
• If it positions as a lotion with alternative vehicles and includes conditioner plus liquid vehicle, it maps to Claim 7 and its concentration dependents.
• If it adopts the “long-chain quaternary ammonium + lipid” conditioner architecture, it moves into Claims 3-4.
• If it uses a quaternary ammonium salt conditioner broadly in a lotion format, it maps to Claim 12.

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Freedom-to-Operate (FTO) Framing for US 6,342,482 Claims

Most sensitive infringement path

A spinosyn-containing pediculicidal product that is explicitly formulated as:

• hair conditioner with water (Claim 1) and
• includes long-chain quaternary ammonium conditioner + lipid (Claims 3-4),
• or includes surfactant within 0.1%-5% (Claims 5-6), would face the tightest claim-to-ingredient correspondence.

Design-around pressure points

• Avoiding the conditioner type limitation in Claim 3 (long-chain quaternary ammonium + lipid) can reduce dependent claim exposure.
• Moving lipid level outside 0.5%-3% reduces Claim 4.
• Moving surfactant level outside 0.1%-5% reduces Claim 6.
• Choosing vehicles outside the explicitly described dependents (water vs monohydric alcohol) can reduce reliance on Claims 10-11, while not affecting Claim 7 if the vehicle still qualifies as a “liquid vehicle.”

Why Claim 1 and 7 remain central

Even if lipid and surfactant are altered, Claim 1 and Claim 7 still hinge on:

• having spinosyn in the stated ranges,
• and including a conditioner component plus water (Claim 1) or conditioner plus liquid vehicle (Claim 7).

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Key Takeaways

• US 6,342,482 claims spinosyn-based pediculicidal hair conditioner and anti-lice lotion formulations with broad spinosyn concentration coverage (about 0.1% to about 30%) and narrower dependent bands (about 1% to about 10%).
• The strongest formulation-specific narrowing targets quaternary ammonium conditioner systems, especially long-chain quaternary ammonium + lipid with lipid at about 0.5% to about 3% (Claims 3-4).
• The claim set also targets add-on formulation architecture through optional surfactants at 0.1%-5% (Claims 5-6) and vehicle specificity (water or monohydric alcohol as dependent embodiments).
• In the US landscape, the patent aligns with the spinosyn pediculicide formulation class and creates enforcement leverage around conditioner/lotion delivery rather than only active chemistry.

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FAQs

1) What is the broadest claim in US 6,342,482?

Claim 1 is broadest for “hair conditioner” format: spinosyn (or derivative/salt) at about 0.1%-30% in a formulation with conditioner and water.

2) What is the broadest spinosyn range covered?

Across the independent and concentration dependents, the broadest explicit range is about 0.1% to about 30%.

3) Which claims require a specific conditioner chemistry?

Claims 3 and 12. Claim 3 requires “long chain quaternary ammonium compound combined with a lipid material,” while Claim 12 requires a “quaternary ammonium salt” as the conditioning agent.

4) Which claim sets a quantified lipid range?

Claim 4 requires lipid at about 0.5% to about 3%.

5) Which claim sets a quantified surfactant range?

Claim 6 requires surfactant at 0.1% to about 5%.

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References (APA)

[1] United States Patent 6,342,482.

Drugs Protected by US Patent 6,342,482

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 6,342,482

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	326212
Australia	4700499
Australia	750046
Brazil	9911795
Canada	2337789