Details for Patent: 6,534,069

Summary for Patent: 6,534,069

Title:	Stable hydroalcoholic compositions
Abstract:	A hydroalcoholic lotion is disclosed which comprises (a) a lower alcohol and water in a weight ratio of about 35:65 to 100:0, and (b) between at least 0.5% and 8% by weight thickener system comprised of at least one emulsifier present in at least 0.05% by weight wherein the composition in a polymer free state has a viscosity of at least 4,000 centipoise at 23 degrees C. and wherein the emulsifier is comprised of at least one hydrophobic group and at least one hydrophilic group. The hydroalcoholic composition is useful as a hand preparation such as a lotion or as a presurgical scrub replacement.
Inventor(s):	Robert A. Asmus, Matthew T. Scholz, Jill R. Charpentier
Assignee:	3M Innovative Properties Co
Application Number:	US09/327,978
Patent Claim Types: see list of patent claims	Use; Composition;

Scope and US Patent Landscape Analysis for US Patent 6,534,069 (Hydroalcoholic Compositions with Emulsifier-Thickener Systems and Very Low Shear Viscosity Thresholds)

US 6,534,069 claims hydroalcoholic compositions and lotions built around (i) specific hydroalcoholic solvent windows, (ii) a defined “thickener system” present at 0.5% to 8% by weight, (iii) an emulsifier architecture with minimum hydrophobe chain lengths and alkylene-oxide or polyol/sorbitan hydrophiles, and (iv) measurable physical property thresholds tied to a “very low shear viscometer” and Brookfield heliopath/t-spindles. Claim scope is centered on viscosity at 23°C in the absence of an auxiliary thickener, paired with melt temperature (greater than defined °C thresholds), and is reinforced by explicit testing instrumentation language in multiple dependent claims.

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What does US 6,534,069 claim cover: hydroalcoholic solvent system plus defined emulsifier-thickener system?

Direct answer: The patent covers hydroalcoholic compositions and lotions containing a lower alcohol and water (with defined weight ratios), a thickener system at 0.5% to 8% by weight that includes specific emulsifier hydrophobe/hydrophile structures, and resulting compositions that meet melt temperature and very-low-shear viscosity thresholds at 23°C, measured using specified Brookfield heliopath/t-spindles, all “in the absence of an auxiliary thickener.”

Claim 1 anchors the core protected subject matter (composition)

Claim 1 (composition) requires all of the following:

1. Hydroalcoholic solvent composition

   • “Major amount” of a hydroalcoholic solvent comprising a lower alcohol and water in a weight ratio ~60:40 to ~75:25.

2. Thickener system amount

   • Thickener system present at ~0.5% to ~8% by weight (based on total composition).

3. Emulsifier presence inside the thickener system

   • At least one emulsifier in the thickener system at ≥ ~0.05% by weight (based on total composition).

4. Emulsifier structural constraints

   • Hydrophobic group:
     • alkyl ≥ C16 OR alkenyl ≥ C16 OR aralkyl/aralkenyl ≥ C20
   • Hydrophilic group selected from enumerated classes, including:
     • alkylene oxide (EO and/or PO) group bonded to hydrophobe through ether/ester, optionally terminated with specified esters
     • OR alcohol / polyhydric alcohol group
     • OR polyhydric alcohol ester/ether
     • OR sorbitan or polyalkoxylated derivative ester/ether having 2–150 moles alkylene oxide per mole of hydrophobe
     • OR combinations

5. Property thresholds (testing conditions matter)

   • Melt temperature > ~35°C when in the absence of an auxiliary thickener.
   • Viscosity ≥ ~4,000 cP at 23°C when in the absence of an auxiliary thickener.
   • Viscosity measured with a very low shear viscometer and T spindles with a heliopath adapter.

Functional takeaway: The claims are not just chemical-structure claims; they are also performance-anchored to viscosity and melt temperature, using a specific measurement setup.

Claim 2–5 expand formulation scope: emollients and antimicrobials

• Claim 2: add at least one emollient distinct from the thickener system.
• Claim 3: emollient can be wax or liquid.
• Claim 4–5: add antimicrobial distinct from the lower alcohol.
  • Claim 5 enumerates antimicrobial options including chlorhexidine salts, iodine/complexed iodine, parachlorometaxylenol (PCMX), triclosan, hexachlorophene, Lauricidin, phenols, long-chain quaternary surfactants, quaternary silanes, hydrogen peroxide, silver and silver salts/oxide/sulfadiazine.

Scope effect: The patent is positioned for antiseptic/antimicrobial alcoholic lotions where emulsifier-thickener architecture yields high melt temperature and viscosity at low shear.

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How broadly are emulsifiers defined: what hydrophobic/hydrophilic structures create coverage?

Direct answer: Coverage requires emulsifiers built from (i) long-chain hydrophobes (C16/C20 minimums depending on subtype) and (ii) one of several hydrophilic motifs, especially EO/PO-containing groups bonded to the hydrophobe via ether/ester, or polyol/sorbitan-derived hydrophiles.

Hydrophobic group ranges

• Alkyl ≥ C16
• Alkenyl ≥ C16
• Aralkyl/aralkenyl ≥ C20

Hydrophilic group motifs (examples embedded in claim text)

• EO/PO-based hydrophiles bonded to the hydrophobe via ether/ester and optionally terminated with C1–C36 alkyl ester, C2–C36 alkenyl ester, or C6–C36 alkaryl ester.
• Alcohol group / polyhydric alcohol group
• Polyhydric alcohol ester or ether (including polyalkoxylated derivatives)
• Sorbitan or polyalkoxylated sorbitan ester/ether with 2–150 mol alkylene oxide per mole hydrophobic group
• Combinations

Minimum emulsifier concentration inside thickener system

• ≥ 0.05% by weight emulsifier (based on total composition).

Scope implication: An accused product using an emulsifier outside these hydrophobe length thresholds, or relying on a substantially different hydrophile class (not covered by enumerated options), is exposed to non-infringement arguments. Conversely, the broad listing of hydrophile types supports reading across multiple nonionic surfactant families that have EO/PO or sorbitan/polyol functionality.

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What is protected about viscosity: how “very low shear” and Brookfield heliopath testing shapes infringement risk?

Direct answer: The patent limits covered compositions to those that hit specific viscosity thresholds under specified low-shear measurement conditions, in the absence of an auxiliary thickener.

Claim 1 and related claims: viscosity threshold

• ≥ 4,000 cP at 23°C (very low shear viscometer, T spindles, heliopath adapter).
• Viscosity is required “in the absence of an auxiliary thickener.”

Claim 19 expands viscosity floor substantially

• A different composition window (lower alcohol:water ~40:60 to ~95:5) and viscosity ≥ 20,000 cP at 23°C (still “in the absence of an auxiliary thickener” and using the same instrument family).

Claim 7 and 13: explicit instrument recitation

• Brookfield LVDV-I+ equipped with model D Brookfield heliopath and T spindles B–F.

Practical infringement lever: If a product’s viscosity is measured by a different rheometer configuration, or if it relies on an “auxiliary thickener” component that takes viscosity above threshold, the claim language provides potential avenues to avoid meeting the “in the absence of auxiliary thickener” requirement. If, instead, an accused product meets both property thresholds under the same or functionally equivalent measurement setup, structural differences in emulsifier may still be decisive.

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When does melt temperature matter: what melt temperature thresholds do claims require?

Direct answer: Melt temperature is a gating feature tied to “absence of auxiliary thickener,” with different thresholds by claim family.

Melt temperature thresholds by claim set

• Claim 1 / 2 / 4 etc.: melt temperature > ~35°C
• Claim 11: melt temperature > ~40°C (no auxiliary thickener)
• Claim 14: lotion with melt temperature > ~25°C and viscosity ≥ 4,000 cP at 23°C
• Claim 18: lotion melt temperature > ~35°C with viscosity ≥ 4,000 cP at 23°C
• Other dependent formulations preserve the measurement framework and viscosity floor while shifting solvent ratios and antimicrobial/emulsifier constraints.

Scope implication: Melt temperature ties the protected compositions to a gel-like or thickened behavior that manifests as a higher melting/phase transition property, not just viscosity alone.

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What formulations are covered: lotion vs hydroalcoholic composition, and what antimicrobial roles exist?

Direct answer: The patent covers both a composition format (Claim 1 and related) and lotion formats (Claims 12–15, 18), including antimicrobial versions (Claim 4 for composition; Claims 12 and 14 for lotions).

Lotion claims are more specific on solvent ratios and emulsifier counts

• Claim 12 (lotion) requires:

  • lower alcohol:water ~60:40 to ~100:0
  • thickener 0.5%–8%
  • thickener system includes at least two emulsifiers, each ≥ 0.05%
  • at least one emulsifier has hydrophobe as in Claim 1 and hydrophile selected from a slightly modified list (includes polyalkoxylated polyhydric alcohol ester/ether and sorbitan/polyalkoxylated sorbitan with alkylene oxide 2–150)
  • at least one other emulsifier has hydrophobe as in the same size constraints and hydrophile as “alcohol or polyhydroalcoholic hydrophilic group”
  • antimicrobial distinct from lower alcohol
  • melt temp > ~35°C (no auxiliary thickener)
  • viscosity ≥ 4,000 cP under specified low-shear setup

• Claim 14 (lotion) requires:

  • lower alcohol:water ~60:40 to ~100:0
  • hydrophobe size tightened to ≥ C20 minimums for alkyl/alkenyl/aralkyl/aralkenyl
  • hydrophile includes EO/PO-based and polyhydric/sorbitan groups but in a form that is narrower on hydrophobe carbon count
  • specific antimicrobial: chlorhexidine salt
  • melt temp > ~25°C and viscosity ≥ 4,000 cP
  • measured under the very-low-shear viscometer system

• Claim 18 (hydroalcoholic lotion):

  • lower alcohol:water ~60:40 to ~75:25
  • emulsifier and thickener architecture aligns with Claim 1
  • melt temp > ~35°C
  • viscosity ≥ 4,000 cP

Scope implication: A generic formulation that changes emulsifier count (single vs dual emulsifier systems), antimicrobial identity, or hydrophobe carbon thresholds can fall outside.

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How does the method claim expand protection: does 6,534,069 cover manufacturing steps?

Direct answer: Yes. The patent includes methods of preparing stable hydroalcoholic compositions and lotions by melting the thickener system, heating water above melt temperature, combining, then adding lower alcohol.

Claim 16: method for stable hydroalcoholic composition

Key steps:

1. Heat thickener system sufficient to melt it.
   • thickener system includes emulsifier in ≥ 0.05% by weight
   • emulsifier has hydrophobe/hydrophile structures per Claim 1
2. Heat water above melt temperature of thickener system.
3. Combine thickener system and water.
4. Add lower alcohol to reach solvent ratio ~60:40 to ~75:25
5. End composition has:
   • melt temp > ~35°C and viscosity ≥ 4,000 cP at 23°C, “in absence of auxiliary thickener,” measured via very low shear/Brookfield heliopath/t spindles.

Claim 17: method for lotion with dual emulsifiers

Similar logic but:

• thickener system includes at least two emulsifiers each ≥ 0.05% (with specified hydrophobe/hydrophile variations)
• antimicrobial included as part of alcoholic solvent system (antimicrobial distinct from lower alcohol)
• solvent ratio ~60:40 to ~100:0
• end product meets melt temp > ~35°C and viscosity ≥ 4,000 cP at 23°C in absence of auxiliary thickener.

Manufacturing implication: Even if a formulation is compositionally similar, process variations that avoid one or more steps (or avoid achieving the final viscosity/melt requirements) can be a path to non-infringement on method claims.

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What is the likely patent scope “center of gravity” for enforcement and design-around?

Direct answer: Enforcement leverage is strongest where the accused product is an alcoholic antimicrobial lotion with (i) long-chain emulsifier architecture matching the hydrophobe/hydrophile classes, (ii) thickener content in the 0.5%–8% range, and (iii) viscosity and melt temperature meeting the specified low-shear thresholds without auxiliary thickener.

Claim “gates” that narrow infringement

• Solvent ratio windows
  • most claims sit in ~60:40 to ~75:25 or ~60:40 to ~100:0 depending on claim family
• Thickener system concentration
  • 0.5%–8% by weight
• Emulsifier presence
  • ≥ 0.05% by weight of emulsifier in thickener system
• Hydrophobe carbon number minimums
  • C16 (some claims) vs C20 (Claim 14)
• Hydrophile selection
  • specific structural families and sorbitan alkylene oxide mole range 2–150
• Performance
  • melt temp and viscosity thresholds
• Measurement method
  • “very low shear” and heliopath/t spindles, with dependent claims naming Brookfield LVDV-I+ and model D heliopath.

Design-around surfaces

• Use a different viscosity build that relies on an auxiliary thickener so the “absence of auxiliary thickener” condition is not satisfied.
• Shift emulsifier hydrophobe chain lengths below the minimums for the specific claim(s) asserted (notably Claim 14’s C20 minimum).
• Change antimicrobial selection to avoid chlorhexidine salt where Claim 14 is in play.
• Change rheological performance such that the product does not reach the specified cP thresholds at 23°C under the same low-shear setup.

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How many distinct claim “families” exist within US 6,534,069 based on the provided text?

Direct answer: From the claim text provided, the scope clusters into at least six functional families:

1. Core hydroalcoholic composition with solvent ratio ~60:40 to ~75:25, thickener 0.5%–8%, emulsifier structural constraints, melt > 35°C, viscosity ≥ 4,000 cP (Claim 1).
2. Core composition add-ons: emollient (wax/liquid) and antimicrobial list (Claims 2–5).
3. Dual emulsifier lotion with antimicrobial: solvent ~60:40 to 100:0, at least two emulsifiers each ≥ 0.05%, melt > 35°C, viscosity ≥ 4,000 cP (Claim 12).
4. Chlorhexidine lotion with tighter hydrophobe minimum: solvent ~60:40 to 100:0, hydrophobe ≥ C20, melt > 25°C, viscosity ≥ 4,000 cP (Claims 14–15).
5. Hydroalcoholic lotion with solvent ~60:40 to ~75:25 and melt > 35°C (Claim 18).
6. Alternative composition window with higher viscosity floor: solvent ~40:60 to ~95:5, viscosity ≥ 20,000 cP, melt > 35°C (Claim 19).

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What does the patent landscape likely look like around this specific claim structure (based on claim content, not outside record)?

Direct answer: The estate is positioned in a crowded formulation field where infringement turns on a narrow set of shared rheology requirements: long-chain, EO/PO or sorbitan-polyalkoxylate emulsifiers used as “thickener systems” in hydroalcoholic media, producing high viscosity under very low shear measurement and elevated melt temperatures.

Competitive product design constraints signaled by the claims

• Many commercial alcoholic antiseptic gels and lotions rely on polymer thickeners. This patent emphasizes thickening via an emulsifier-thickener system and excludes “auxiliary thickener” from the viscosity threshold.
• The presence of explicit instrumentation suggests that low-shear viscosity discrimination is central to novelty and to later claim construction.

Litigation posture likely implied by claim drafting

• Claims are written to support both:
  • composition and lotion infringement, and
  • method infringement for preparation using controlled heating and order of addition.

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Key takeaways

• US 6,534,069 protects hydroalcoholic compositions and lotions built from a defined emulsifier-thickener system at 0.5%–8% and containing ≥ 0.05% emulsifier.
• Infringement hinges on performance gates: melt temperature above defined thresholds and very low shear viscosity above specified cP levels at 23°C, measured with heliopath/T-spindle methodology, without auxiliary thickener.
• The emulsifier definition is structural and size constrained: hydrophobe length minimums (C16 or C20 depending on claim) plus EO/PO or polyol/sorbitan-derived hydrophiles, including sorbitan alkylene oxide 2–150 mol ranges.
• Lotion claims further narrow scope using emulsifier count (dual emulsifier requirement in Claim 12), antimicrobial identity (chlorhexidine salt in Claim 14), and solvent ratio ranges.
• Method claims cover a specific process sequence: melt thickener system, heat water above thickener melt temperature, combine, then add lower alcohol to achieve the claimed solvent ratio and final rheology.

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FAQs

1) Does US 6,534,069 protect generic “alcohol and water lotions” without the specified emulsifier structures?
No. Claims require a thickener system with emulsifiers defined by hydrophobe length and hydrophile class, plus viscosity and melt temperature thresholds under the specified low-shear measurement and “absence of auxiliary thickener” condition.

2) Can a formulation avoid infringement by adding a polymer thickener as an “auxiliary thickener”?
The claims key the viscosity requirement to “in the absence of an auxiliary thickener.” A product whose viscosity above threshold depends on an auxiliary thickener can be positioned to argue that it does not meet the claim conditions.

3) Are method-of-use or therapeutic claims involved?
Not from the provided claim text. The method claims focus on formulation preparation steps and achieving the specified physical properties.

4) Which claim is most restrictive on emulsifier hydrophobe carbon length?
Claim 14 is notably tighter, requiring hydrophobic groups of at least C20 for alkyl/alkenyl/aralkyl/aralkenyl.

5) If an accused product measures viscosity with a different rheometer setup, does that matter?
The patent repeatedly ties viscosity to “very low shear viscometer” with T spindles and heliopath adapter, with dependent claims explicitly naming Brookfield LVDV-I+, model D heliopath, and T spindles B–F. Different testing setup can be a central infringement issue.

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References

1. United States Patent No. 6,534,069. (Claims text provided).

Drugs Protected by US Patent 6,534,069

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 6,534,069

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	6103496
Australia	715468
Canada	2224702
Germany	69630221
European Patent Office	0833606
European Patent Office	1407761