Details for Patent: 8,066,975

Summary for Patent: 8,066,975

Title:	Foaming composition for washing and treating hair and/or scalp based on an active principle
Abstract:	The invention concerns a foaming composition for washing and treating hair and/or scalp essentially characterized in that it contains in an aqueous medium: at least an active principle selected among corticoids and retinoids; at least an anionic surfactant; at least an amphoteric surfactant; and a pro-penetrating agent.
Inventor(s):	Isabelle Preuilh, Anne-Emmanuelle Guise, Nathalie Willcox
Assignee:	Galderma SA
Application Number:	US11/984,018
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 8,066,975: Scope, Claim Construction, and US Patent Landscape for Clobetasol Propionate Stable Shampoo

What does US 8,066,975 claim, in product terms?

US 8,066,975 claims a “stable shampoo” for washing and treating hair and/or scalp that is defined by (i) an anti-inflammatory corticosteroid active, (ii) a specific surfactant system built around sodium lauryl ether sulphate (SLES) and cocoyl betaine, (iii) a polymeric conditioning/thickening component, (iv) a high ethanol level, and (v) a tight pH band.

Core formula constraints shared across the independent claim set

Across claims 1-3, the composition is locked to these ranges/specs:

Element	Claim language scope
Active	clobetasol propionate at 0.05 wt % (claims 1-2) or 0.05% (claim 3)
Primary anionic surfactant	SLES at 2 to 25 wt %
Amphoteric surfactant	cocoyl betaine at 1 to 15 wt %
Polymer/conditioning	polyquaternium 10 at 2 wt % (claim 1) or polyquaternium 10 at 2 wt % OR cationic guar gum at 0.5 wt % (claim 2), or cationic guar gum at 0.01 to 3 wt % OR polyquaternium 10 at 0.01 to 3 wt % (claim 3)
Solvent/alcohol	ethanol (95%-96%) at 2 wt % (claim 1) or 10 wt % (claim 2-3)
pH	citric acid and sodium citrate in an amount required to adjust pH to 5.5 to 6.5
Vehicle	q.s. for 100% water
Stability	“stable shampoo” is the product limitation, tied to the combination above

What is the claim architecture and how broad is it?

Independent claims (1-3)

These are formula claims with multiple tiered options. The breadth comes from allowing multiple polymer choices and specifying ranges for surfactants and polymer concentration. The constraining features are the fixed active level (0.05 wt %) and the fixed pH window (5.5 to 6.5), plus the presence of ethanol at a specified level (claims 2-3) and defined ethanol strength.

Claim 1 (SLES/cocoyl betaine + polyquaternium 10 + 2 wt% ethanol)

• Active: 0.05 wt % clobetasol propionate
• Surfactants:
  • SLES: 2 to 25 wt %
  • cocoyl betaine: 1 to 15 wt %
• Conditioning/polymers:
  • polyquaternium 10: 2 wt %
  • (no alternative polymer in claim 1 as written)
• Alcohol:
  • ethanol (95%-96%): 10 wt % (your excerpt shows “2 wt % of polyquaternium 10, 10 wt % of ethanol (95%-96%)”)
• Buffer:
  • citric acid + sodium citrate amount to pH 5.5-6.5
• Water to 100%

Claim 2 (polyquaternium 10 OR cationic guar gum + 10 wt% ethanol)

• Same active and surfactant ranges as claim 1
• Conditioning options:
  • polyquaternium 10 at 2 wt %, OR
  • cationic guar gum at 0.5 wt %
• Ethanol:
  • 10 wt % ethanol (95%-96%)
• Buffer:
  • citric acid/sodium citrate to pH 5.5-6.5

Claim 3 (broad polymer range + “cosmetically acceptable basifying or acidifying agents” to pH)

• Same active and surfactant ranges
• Polymer range widened:
  • cationic guar gum at 0.01 to 3 wt %, OR
  • polyquaternium 10 at 0.01 to 3 wt %
• Ethanol:
  • 10 wt % ethanol (95%-96%)
• pH:
  • “cosmetically acceptable basifying or acidifying agents” to pH 5.5-6.5
  • (claim 3 no longer limits to citric acid/sodium citrate specifically; it uses basifying/acidifying agents generally)

Practical breadth read: Claim 3 is the broadest on pH-control reagents and conditioning polymer concentration. Claims 1-2 are narrower because they tie pH to citric acid/sodium citrate (1-2) and (1-2) fix polymer to 2 wt % (polyquaternium 10) or a specific alternative level (0.5 wt % cationic guar gum in claim 2).

Dependent claims (4-6): ratios as “secondary constraints”

These tighten the surfactant system internal balance.

• Claim 4: SLES:cocoyl betaine ratio between 1-20
• Claim 5: SLES:cocoyl betaine ratio between 2-10
• Claim 6: SLES:ethanol ratio between 1-2 (ethanol at the claim’s stated level in claims 1-3)

What this means for scope: The ratios limit which embodiments in claims 1-3 are captured even if they are otherwise within the component ranges. They function as additional “numerical guardrails” that can be used both to market-proof a competitor and to assess non-infringing design targets.

Which elements most likely control infringement risk?

In formula claims like these, infringement usually turns on whether a product contains the claimed ingredients at (or within) the claimed amounts, and whether the pH is within the claimed band.

Highest-impact limitations (hard constraints)

1. Clobetasol propionate level: fixed at 0.05 wt % in claims 1-2 (and 0.05% in claim 3 as excerpted).
2. pH band: 5.5 to 6.5 for the shampoo composition.
3. Surfactant system presence and ranges:
   • SLES at 2 to 25 wt %
   • cocoyl betaine at 1 to 15 wt %
4. Ethanol at specified level and concentration range:
   • ethanol (95%-96%) at 10 wt % in claims 2-3 (per excerpt)
   • claim 1 contains ethanol at 10 wt % as well (per excerpt)
5. Polymer selection and amount:
   • polyquaternium 10 at 2 wt % (claim 1-2, in the polyquaternium branch)
   • cationic guar gum at 0.5 wt % (claim 2 branch) or 0.01-3 wt % (claim 3 branch)

Medium-impact limitations (help narrow, but can be designed around)

• SLES:cocoyl betaine ratio (claims 4-5)
• SLES:ethanol ratio (claim 6)
• Citric acid/sodium citrate specific requirement in claims 1-2 (claim 3 loosens this to other basifiers/acidifiers)

“Stable shampoo” limitation

“Stable” is a product property phrase. In practice, it can be used to argue that the claimed combination achieves stability. For infringement, stability is often less determinative than whether the composition literally falls within the numeric ingredient/pH ranges. For validity, it can support a “technical effect” argument tied to the combination.

How can a competitor design around these claims (US practice framing)?

Even without prosecution history, the numeric structure indicates the main design-around levers:

Design-around levers

• Active level: change clobetasol propionate away from 0.05 wt %.
  • Risk note: even minor deviations can land outside the literal claim. If a competitor uses a closely adjacent dose, doctrine-of-equivalents risk rises, depending on how the patent ties “stability” to the exact level.
• pH control: move pH outside 5.5-6.5.
• Remove or replace one surfactant:
  • If SLES is removed or reduced below 2 wt %, claim entry narrows sharply.
  • If cocoyl betaine is removed or reduced below 1 wt %, same.
• Ethanol constraint: if ethanol is not present at 10 wt % (as stated), claims 2-3 are harder to reach.
• Polymer swap:
  • If using no polyquaternium 10 and no cationic guar gum within the stated ranges, claim 1 and the polyquaternium-guar branches shrink.
• pH adjuster chemistry:
  • Using citric acid/sodium citrate is not required in claim 3, but it is required in claims 1-2 (as excerpted).

Ratios (claims 4-6) as targeted carve-outs

• If a formulation is otherwise within claims 1-3, a competitor can attempt to push the SLES:cocoyl betaine ratio outside 1-20 (claim 4) or outside 2-10 (claim 5) or push SLES:ethanol outside 1-2 (claim 6).
• Because claims 4-6 are dependent on 1-3, the competitor must first fall outside the core independent limitations or rely on ratio shifts.

Claim chart style mapping (representative embodiment)

Below is a mechanical check against claims 1-3 using a hypothetical “in-range” target. This is not a statement about any real product; it shows where a product would land relative to the claim constraints.

Component	Claim requirement	“In-range” example	Pass/Fail basis
Clobetasol propionate	0.05 wt %	0.05 wt %	Pass
SLES	2-25 wt %	15 wt %	Pass
Cocoyl betaine	1-15 wt %	5 wt %	Pass
Polyquaternium 10	claim 1: 2 wt %; claim 3: 0.01-3 wt %	2 wt %	Pass for claim 1 and claim 3 polyquaternium branch
Cationic guar gum	claim 2: 0.5 wt %; claim 3: 0.01-3 wt %	0.5 wt %	Pass for claim 2 branch and claim 3 guar branch
Ethanol (95%-96%)	claims 2-3: 10 wt %	10 wt %	Pass
pH	5.5-6.5	5.9	Pass
pH adjuster	claims 1-2: citric acid + sodium citrate; claim 3: basifying/acidifying agents	citric + sodium citrate	Pass for claims 1-2; still pass for claim 3

The moment any of the hard constraints breaks (active level, pH, SLES/cocoyl betaine ranges, ethanol level, polymer presence), literal infringement risk drops.

What is the likely patent landscape around this formulation?

A complete landscape requires bibliographic and citation data (family members, citing/cited patents, examiner citations, and prosecution history). Your excerpt provides only claim text and does not provide document metadata (assignee, priority, filing date), nor does it list related patents, INPADOC family members, or forward citations.

Under the constraints here, the landscape can only be characterized at a structural level based on what this patent claims: it sits in the intersection of (i) topical corticosteroid (clobetasol propionate) delivery in a shampoo format, (ii) “stable” formulations with specific surfactant systems, and (iii) ethanol and pH-controlled surfactant polymer blends.

Landscape inference from claim scope (what to expect around it)

The competitive US IP set around this claim typically clusters into three categories:

1. Clobetasol propionate in non-vehicle topical dosage forms
   • Covered by separate drug delivery patents, often with generic formulation and vehicle-specific claims.
2. Shampoo formulations using clobetasol propionate
   • Covered by formulation-specific claims that differ on surfactants, solvent system, and pH control.
3. Stability improvements in surfactant/alcohol systems
   • Covered by claims that target stability through choice of amphoteric surfactants, anionics, polymers (polyquaternium/cationic guar), and buffering systems.

This patent’s novelty posture, based on the tight numeric combination, is likely the specific stabilization of a clobetasol propionate shampoo using the SLES/cocoyl betaine surfactant system with polymer plus ethanol and a defined pH band.

What is the scope of protection compared to claim 1 vs claim 3?

Claim 3 likely covers more variations because:

• it expands polymer concentration range (0.01 to 3 wt % vs fixed 2 wt % or 0.5 wt % in other branches)
• it loosens pH adjuster chemistry (any cosmetically acceptable basifying/acidifying agents vs citric acid/sodium citrate)

That shifts protection from “exact ingredient set” toward “functional parameter set” (same active level, same surfactants ranges, same ethanol, same pH band, polymer within a broad range).

Claims 1-2 are narrower on pH adjusters and on polymer level branches.

Key Takeaways

• US 8,066,975 claims a clobetasol propionate shampoo with a tightly specified surfactant system (SLES 2-25 wt % + cocoyl betaine 1-15 wt %), ethanol (95%-96%) at 10 wt %, and pH controlled to 5.5-6.5.
• The most enforceable “hard limits” are the fixed clobetasol propionate level (0.05 wt %), the pH band, and the ethanol presence at the stated level; the SLES and cocoyl betaine ranges are also high-impact.
• Claim 3 is the broadest due to its wider polymer concentration range and general basifying/acidifying agents for pH control; claims 1-2 are narrower because they require citric acid/sodium citrate and tighter polymer dosing.
• Dependent claims 4-6 add ratio constraints (SLES:cocoyl betaine and SLES:ethanol) that can further narrow coverage within the independent-claim parameter space.
• A true “US patent landscape” map (families, continuations, forward citations, and close alternatives) cannot be completed from the provided excerpt alone; what can be stated is that the protection sits in clobetasol shampoo stability and formulation-specific surfactant/alcohol/pH stabilization space.

FAQs

1) Does the patent require citric acid/sodium citrate?

Claims 1-2 (as excerpted) require citric acid and sodium citrate to set pH to 5.5-6.5. Claim 3 instead uses “cosmetically acceptable basifying or acidifying agents” to reach the same pH band.

2) What ingredients are mandatory to fall within independent claims 1-3?

Based on the excerpted claim language: clobetasol propionate at 0.05 wt %, SLES at 2-25 wt %, cocoyl betaine at 1-15 wt %, ethanol (95%-96%) at the stated level (10 wt % per claims 2-3), and pH at 5.5-6.5 with the specified pH adjuster regime per claim. A qualifying polymer (polyquaternium 10 and/or cationic guar gum within the ranges/levels) is also required.

3) Which claim is most protective for competitors?

Claim 3 is broader on polymer concentration and pH adjuster chemistry, so it typically covers more variants that keep the same active, surfactant ranges, ethanol level, and pH band.

4) Are the ratio limits optional?

They are additional limitations in dependent claims 4-6. If a product does not meet those ratios, it may still potentially fall within claims 1-3 unless it also misses another independent limitation.

5) How do you most efficiently design around this patent?

The most direct routes are changing at least one high-impact hard constraint: clobetasol propionate level (0.05 wt %), pH (outside 5.5-6.5), ethanol level/presence or strength, or dropping SLES/cocoyl betaine outside the stated ranges. Ratio shifts help only for formulations that otherwise remain inside claims 1-3.

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References

[1] US Patent 8,066,975 (claim text as provided by user).

Drugs Protected by US Patent 8,066,975

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: 8,066,975

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	98 07802	Jun 19, 1998

International Family Members for US Patent 8,066,975

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	019321
Austria	308960
Austria	444054
Australia	4151499
Australia	753735
Brazil	9911849
Canada	2333427