Details for Patent: 7,294,342

Summary for Patent: 7,294,342

Title:	Ectoparasite asphyxiator compositions and methods for their application
Abstract:	Water-soluble or water-dispersible, substantially air-impermeable, pharmacologically acceptable, liquid barrier compositions for treating ectoparasite infestations on animal skin and hair, wherein the compositions contain at least one monohydric aralkyl alcohol to prevent the ectoparasites from closing their respiratory systems, and wherein the compositions are free from pesticides.
Inventor(s):	Michael J Precopio
Assignee:	Shionogi Inc
Application Number:	US10/336,457
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,294,342
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 7,294,342: Scope, Claims, and US Patent Landscape for Topical “Spiracle-Suffocation” Benzyl Alcohol Barrier Therapy

What is the core claim scope of US 7,294,342?

US Patent 7,294,342 is directed to a topical method for treating lice infestations on animal skin by applying a water-soluble or water-dispersible liquid barrier composition that is substantially air-impermeable, where the formulation relies on benzyl alcohol to prevent lice from closing their spiracles, causing suffocation within less than about 45 minutes, followed by rinsing/removal.

Claim 1 is the independent claim and sets the technical “fence”

Claim 1 requires all of the following elements in one method:

1) Treatment target and site

• “topical treatment of lice infestations on animal skin”
• “skin and hair containing lice”

2) Application composition

• “water-soluble or water-dispersible”
• “substantially air-impermeable”
• “pharmacologically acceptable, liquid barrier composition”
• contains benzyl alcohol at 1% to 50% by weight of the composition
• benzyl alcohol amount is “in amount sufficient to prevent the lice from closing their spiracles”
• composition is “free from pesticides other than any pesticidal activity provided by the benzyl alcohol”

3) Contact time

• leave in contact “at least until the lice have been killed by suffocation”
• suffocation occurs “within a period of time of less than about 45 minutes”

4) Removal

• “removing the composition and the dead lice … by rinsing with water or other water-based liquid”

This claim is structured to require both:

• a physical functional barrier (air-impermeable liquid barrier), and
• a chemical functional mechanism (benzyl alcohol sufficient to prevent spiracle closure), with a tight speed-to-kill window and non-pesticide composition purity constraint.

What does the dependent claim set add (claims 2–16)?

Dependent claims narrow Claim 1 through formulation form, time windows, benzyl alcohol ranges, air removal processing, and retreatment scheduling.

Form factor narrowing

• Claim 2: composition is “in the form of a gel.”
• Claims 13–14: composition is “substantially free from air,” and optionally ensures “substantially all of the air present … is removed prior to its use.”

These claims operationalize barrier performance: a gel and/or air-free composition can improve “substantially air-impermeable” behavior and reduce variability in suffocation.

Time suffocation narrowing

• Claim 3: leave in contact at least “about 10 minutes until the lice are suffocated.”
• Claim 4: suffocation time is “from about 10 minutes to about 45 minutes.”

Claim 1 already caps at <45 minutes; Claims 3–4 impose a lower bound and tighter range.

Removal step narrowing

• Claim 5: removal is “by rinsing with water.”

Claim 1 is broader (“water or other water-based liquid”); Claim 5 locks it to water.

Benzyl alcohol percentage narrowing

Claims 6–12 specify overlapping sub-ranges:

• Claim 6: 2% to 50%
• Claim 7: 3% to 50%
• Claim 8: 4% to 50%
• Claim 9: 5% to 50%
• Claim 10: 2% to 10%
• Claim 11: 3% to 10%
• Claim 12: 4% to 7%

These dependent claims provide multiple “ladder” fallback positions: a broad midrange (2–50) with narrower low-end cutoffs, and a particularly tight 4–7% window.

Retreatment for nits

• Claim 15: method repeated once or twice after an interval “to kill lice that have hatched from adherent nits.”
• Claim 16: each interval is “from about 7 to about 10 days.”

This adds a practical regimen for life-cycle coverage.

How does the claim language define the “essential invention” elements?

For infringement and validity mapping, Claim 1 can be decomposed into four essential elements plus optional narrowing limitations:

Essential elements in Claim 1

1) Topical on animal skin/hair infested with lice 2) Barrier composition

• water-soluble or water-dispersible
• liquid
• “substantially air-impermeable” 3) Benzyl alcohol mechanism and concentration
• 1–50 wt% benzyl alcohol
• “sufficient to prevent lice from closing their spiracles”
• no other pesticides except benzyl alcohol’s pesticidal activity 4) Rapid suffocation and removal
• killing via suffocation within <45 minutes
• rinse removal with water/water-based liquid

Optional narrowing features (dependent claims)

• gel form (Claim 2)
• contact time floor and range (Claims 3–4)
• rinse media specificity (Claim 5)
• specific benzyl alcohol sub-ranges (Claims 6–12)
• air-free processing (Claims 13–14)
• repeat dosing interval 7–10 days (Claims 15–16)

What is the scope in practical competitive terms? (What would likely read on this?)

The claim scope is not limited to a particular base polymer or excipient system beyond the functional requirements. It targets formulations that meet these functional constraints:

Formulation must meet all of these functional tests

• water-soluble or water-dispersible
• substantially air-impermeable as a barrier when applied
• contains benzyl alcohol in specified concentration ranges
• kills by suffocation (with suffocation time <45 minutes)
• composition is free from other pesticides

Product types that sit closest to the claim

• Benzyl alcohol-based topical lice treatments using a viscosity/gel/barrier matrix designed to restrict air movement to spiracles
• Two-stage schedules (initial application plus one or two reapplications at 7–10 days) for hatched lice

Products that are more distant

• Permethrin, pyrethrum, malathion, spinosad, ivermectin-based topical lice treatments: these likely fail the “free from pesticides other than any pesticidal activity provided by benzyl alcohol” limitation.
• Pure benzyl alcohol without a substantially air-impermeable barrier structure: risk failing the barrier requirement.
• Methods that rely on neurotoxicity rather than suffocation kinetics: risk failing the “killed by suffocation” within the specified time.

What claim-to-mechanism “pressure points” matter for enforcement?

The strongest infringement hooks are usually the ones that are both specific and measurable:

1) “Substantially air-impermeable” barrier behavior

• This can be supported by device tests (air permeability, oxygen transmission, or practical suffocation performance).

2) “Prevent the lice from closing their spiracles”

• This is mechanism language. It can be contested on whether benzyl alcohol causes the claimed spiracle effect.

3) Suffocation time <45 minutes

• This is a kinetic limitation. Time-to-death testing becomes central.

4) “Free from pesticides other than” benzyl alcohol

• Ingredient lists become central for validity/infringement.

How do claims 6–12 create a multi-tier competitive fence around benzyl alcohol content?

The dependent claims provide multiple “exact corridor” fallback ranges. For competitive portfolio design:

• If you exceed 1–50 but cannot demonstrate suffocation <45 minutes, you miss Claim 1 anyway.
• If your benzyl alcohol formulation sits in a “narrow band,” Claims 10–12 (2–10 and especially 4–7) can still capture it, even if broader claims are avoided.

Notably, Claim 12’s 4–7% is the narrowest benzyl alcohol limitation in the set, and it functions as a high-confidence fallback.

What is the expected US patent landscape shape around this technology class?

Even without reproducing other patents’ claim text here, the landscape around benzyl alcohol, suffocation/physical barrier lice treatment, and air-blocking formulations typically clusters into:

1) Benzyl alcohol composition claims (concentration and formulation class) 2) Application methods and contact-time claims (time-to-suffocation windows) 3) Regimen claims (reapplication intervals to catch hatched lice from nits) 4) Mechanism language claims (spiracles closure, suffocation rather than neurotoxicity) 5) Form factor claims (gel vs liquid vs emulsions; air content control)

In litigation or licensing, the practical map is usually:

• direct competitors try to keep benzyl alcohol but vary barrier/air/permeability and contact time, or
• they move to other actives (and then face the “no other pesticides” limitation), or
• they adjust formulation to fail “substantially air-impermeable” while keeping viscosity.

Key takeaways for business decisions

• US 7,294,342 is a method-of-treatment patent with a specific mechanistic and kinetic thesis: benzyl alcohol in a substantially air-impermeable water-dispersible barrier kills lice by suffocation, within <45 minutes, followed by rinsing.
• The claim has multiple dependent “rails”:
  • gel form (Claim 2)
  • contact time between about 10 and 45 minutes (Claims 3–4)
  • benzyl alcohol ranges, including a tight 4–7% corridor (Claims 6–12)
  • air-free or substantially air-free composition (Claims 13–14)
  • repeat dosing at 7–10 day intervals (Claims 15–16)
• Enforcement and clearance risk will center on measurable variables: air permeability/air-impermeability, time-to-death (suffocation), ingredient exclusivity (no other pesticides), and benzyl alcohol concentration.

FAQs

1) What is the single most important limitation in claim 1 beyond benzyl alcohol?

“Substantially air-impermeable” barrier composition combined with killing “by suffocation” within “less than about 45 minutes.”

2) Does the patent cover any benzyl alcohol lice treatment regardless of formulation?

No. Claim 1 requires a “water-soluble or water-dispersible” and “substantially air-impermeable” liquid barrier composition, plus suffocation kinetics.

3) What benzyl alcohol ranges are explicitly claimed in dependent claims?

2–50%, 3–50%, 4–50%, 5–50%, 2–10%, 3–10%, and 4–7% (Claims 6–12).

4) How is suffocation time handled across the claims?

Claim 1 sets an upper bound “less than about 45 minutes,” while Claims 3–4 require “at least about 10 minutes” and define a “about 10 minutes to about 45 minutes” range.

5) Does the patent address nits and re-treatment?

Yes. Claims 15–16 cover repeating once or twice after “7 to 10 days” to kill lice hatched from adherent nits.

Cited Sources (APA)

[1] United States Patent 7,294,342.

Drugs Protected by US Patent 7,294,342

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