US Patent 9,433,630: What Is Claimed, What the Scope Covers, and Where the Landscape Closes In
US Patent 9,433,630 claims a sprayable, topical corticosteroid composition built around a specific formulation architecture: (i) steroid (multiple choices), (ii) non-polymeric emulsifier sorbitan stearate, (iii) a specified non-polymeric-type polymer family (cellulose/gum/alginate/phthalate), (iv) water + a water-immiscible oil/wax-type phase, while being substantially free of propellant and propylene glycol and substantially non-occlusive. Dependent claims add typical execution parameters (viscosity, non-foaming), optional penetration enhancers, and broad treatment method indications.
What is the independent claim architecture and how broad is the formulation scope?
Claim 1 core construct (composition)
Claim 1 defines the full formulation scope using a tight combination of constraints:
Sprayable topical pharmaceutical composition comprising:
- Active agent: at least one steroid
- Non-polymeric emulsifying agent: sorbitan stearate
- Polymer: selected from cellulose, gum, alginate, or phthalate (functional list downstream in claim 3)
- Water
- Water-immiscible substance (functional list downstream in claim 4)
- Substantially free of: propellant and propylene glycol
- Substantially non-occlusive to the skin
Claim 13 is a narrower cousin that locks the active to a betamethasone compound but keeps the same structural excipients and constraints.
Breadth summary
- Steroid identity is broad in claim 1: it lists a broad set of topical corticosteroids (multiple generations, esters, and salt forms). Claim 13 narrows to betamethasone compounds.
- Polymer identity is medium-broad: claim 1 allows an entire group (cellulose/gum/alginate/phthalates). Claim 3 enumerates specific polymers.
- Oil/water-immiscible phase is medium-broad: claim 4 lists multiple lipid and wax candidates.
- Critical exclusion constraints are narrow and likely outcome-determinative:
- No propellant (and therefore not a traditional propellant-driven aerosol)
- No propylene glycol (a common cosolvent/penetration promoter)
- Substantially non-occlusive (a performance property constraint, not just ingredients)
Net effect: The claims are wide across many ingredient permutations but are likely to have enforceability leverage based on the combination and the two “substantially free” exclusions plus the non-occlusive performance requirement.
Which steroid, polymer, and oil options actually fall inside?
Steroid set (claim 2, and repeated in claim 8; claim 13 uses betamethasone)
Claim 2 / claim 8 list includes:
- alclometasone dipropionate
- beclomethasone dipropionate
- betamethasone dipropionate
- betamethasone valerate
- fluocinolone acetonide
- halobetasol propionate
- hydrocortisone aceponate
- hydrocortisone acetate
- hydrocortisone valerate
- hydrocortisone butyrate
- mometasone furoate
- triamcinolone acetonide
- clocortolone pivalate
- clobetasol propionate
- desoximetasone
- fluticasone propionate
Claim 10 locks an example: betamethasone dipropionate.
Polymer set (claim 3, claim 16, and repeated in claim 8/20/21)
Claim 3 set includes:
- ethyl cellulose
- methyl cellulose
- hydroxyethyl cellulose
- hydroxypropylcellulose (spelled hydroxypropylcellulose)
- hydroxypropyl methylcellulose
- hydroxypropyl methylcellulose (also reflected elsewhere as hydroxypropyl methylcellulose)
- hydroxybutyl methyl cellulose
- xanthan gum
- tragacanth
- guar gum
- locust bean gum
- acacia
- alginate
- cellulose acetate phthalate
- cellulose acetate butyrate
- hydroxypropyl methylcellulose phthalate
Claim 9 narrows polymers to a subset (ethyl cellulose through hydroxybutyl methyl cellulose).
Water-immiscible substance set (claim 4; repeated in claim 17/20)
Claim 4 set includes:
- vegetable oil
- saturated paraffin oil
- mineral oil
- fatty acid
- fatty ester of a natural fatty acid
- triglyceride of animal or vegetable origin
- medium chain triglyceride
- mixture of mono-, di- and/or tri-glycerides
- wax
- hydrogenated vegetable oil
This is a classic topical oil/wax platform; the key is that it must coexist with water, sorbitan stearate, and be sprayable while remaining substantially non-occlusive.
What extra limitations narrow practice beyond the ingredient lists?
Optional penetration enhancer (claims 5-7 and 18-19)
- Claim 5/18: composition further comprising a penetration enhancer
- Claim 6/19: enhancer in about 0.001% to about 15% by weight
- Claim 7: enhancer selected from:
- polyol and esters
- ethers
- sulfoxides
- fatty acids
- fatty acid esters
- or any combination
This is a broad penetration-enhancer category with a wide numeric band; enforcement is likely to pivot on whether the penetration enhancer is within that “selected from” list and present within the weight range.
Viscosity and physical performance (claims 11 and 22)
- Claim 11 / claim 22: viscosity in about 10 to about 15,000 centipoise
This is a large operational range that likely supports multiple sprayable viscosities.
Non-foaming (claims 12 and 23)
- Claim 12 / claim 23: composition is substantially non-foaming
This can matter in spray performance, but it is also another “substantially” performance term.
Substantially non-occlusive and substantially free constraints (claim 1/13)
The strongest gating language is in the independent claims:
- “Substantially free of a propellant”
- “Substantially free of propylene glycol”
- “substantially non-occlusive to the skin”
From a landscape perspective, these constraints are the most likely to distinguish the invention from:
- conventional aerosol corticosteroids (propellant-driven)
- cosolvent-heavy formulations containing propylene glycol
- occlusive ointments/creams where occlusion is intentional
How does claim 13 compare to claim 1 (and why it matters)?
Claim 1: steroid can be any listed steroid.
Claim 13: active is a betamethasone compound.
Everything else stays structurally aligned:
- sorbitan stearate emulsifier
- polymer in the same family (cellulose/gum/alginate/phthalate)
- water + water-immiscible substance
- substantially free of propellant and propylene glycol
- substantially non-occlusive to skin
Practical implication: claim 13 creates a direct betamethasone-specific lane, which matters because betamethasone ester brands are among the most competitive topical steroid categories.
What does the method claim cover (claim 24 and 25)?
Claim 24
Method: treating a skin condition by administering a pharmaceutically effective amount of the claim 1 composition.
Condition list includes:
- atopic dermatitis
- seborrhoeic dermatitis
- eczema
- plaque psoriasis
- erythroderma psoriasis
- psoriasis of the scalp
- steroid responsive dermatoses
- erythema
- contact sensitivity reactions
- and other associated diseases or disorders
Claim 25
Same method construct using claim 13 composition (betamethasone-specific).
Scope character: broad disease labeling categories, typical for topical steroid method claims, with no additional administration regimen parameters (dose frequency, duration, formulation form factor beyond “composition”).
Where are the likely design-arounds and infringement pressure points?
Design-around pressure points
The claims are broad on ingredient permutations, but there are three design-around “tripwires”:
- Propellant exclusion: formulations using propellants may avoid the “substantially free of propellant” requirement (depending on how close to zero is “substantially”).
- Propylene glycol exclusion: any formulation using propylene glycol at meaningful levels increases the risk of not meeting “substantially free of propylene glycol.”
- Non-occlusive performance: changing the formulation to become more occlusive can shift outside the performance constraint even if other ingredient lists remain similar.
Potential internal narrowing by dependent claims
Enforcement is often strongest when a competitor’s product matches:
- the exact emulsifier (sorbitan stearate) plus
- the polymer family selection and
- the sprayable/cosolvent constraints plus
- viscosity and non-foaming (if those are met in product specs)
- with optional penetration enhancers falling within the claimed categories and concentration range
Patent landscape: how US 9,433,630 is likely positioned against sprayable topical steroid IP
Because the request is for an “analysis of scope and claims and patent landscape,” the landscape must be framed around claimable subject matter themes present in this patent:
Theme 1: Sprayable, propellant-free topical steroid formulations
This patent’s independent-claim structure is built to distinguish from propellant aerosol systems by requiring:
- substantially free of propellant
Competitive implication: landscape clusters that claim aerosolized steroids with propellants may not overlap on this axis. Conversely, formulation companies targeting “spray without propellant” face more direct overlap risk with this patent, especially if they also avoid propylene glycol and use sorbitan stearate plus the specified polymer family.
Theme 2: Propylene glycol avoidance
Many topical steroid formulations historically used propylene glycol for solubilization, humectancy, or penetration enhancement. This patent excludes it at the independent level:
- substantially free of propylene glycol
Competitive implication: products that rely on propylene glycol for stability or skin feel may not satisfy this limitation even if other ingredients are close.
Theme 3: Non-occlusive skin feel / performance
“Substantially non-occlusive to the skin” adds a performance constraint that can differentiate from classic occlusive vehicles.
Competitive implication: products marketed as non-greasy, breathable, or non-occlusive could more readily fall into this lane if they match the emulsifier/polymer/oil architecture.
Claim chart style mapping (fast diligence view)
Claim 1 scope checklist
A product likely falls within claim 1 if it matches all items below:
| Element |
Claim requirement |
Product must do/show |
| Dosage form |
Sprayable topical pharmaceutical composition |
Metered-dose, sprayable solution/suspension/dispersion |
| Active |
At least one steroid |
Steroid selection within claim 2 list (or equivalent steroid within “at least one steroid” if not restricted) |
| Emulsifier |
Non-polymeric emulsifying agent comprising sorbitan stearate |
Contains sorbitan stearate as emulsifier; not just any emulsifier |
| Polymer family |
Polymer selected from cellulose/gum/alginate/phthalate |
Polymer must fall in the enumerated families (claim 3 set) or functionally equivalent within the claim scope |
| Vehicle |
Water + water-immiscible substance |
Two-phase or microemulsion/dispersion with immiscible oil/wax phase |
| Exclusions |
Substantially free of propellant and propylene glycol |
No meaningful propellant and no meaningful propylene glycol |
| Skin performance |
Substantially non-occlusive |
Demonstrates non-occlusive behavior (likely by in-use TEWL/occlusion testing) |
Claim 13 checklist (betamethasone lane)
Replace “at least one steroid” with “betamethasone compound” from claim 15/20 lists:
- betamethasone benzoate
- betamethasone dipropionate
- betamethasone sodium phosphate
- betamethasone valerate
Key takeaways
1) The claim set is formulation-mechanism driven
US 9,433,630 is not primarily about the therapeutic indication. It is about a specific topical sprayable vehicle system:
- sorbitan stearate emulsifier
- defined polymer family
- water + immiscible lipid phase
- performance exclusions: no propellant, no propylene glycol
- performance property: substantially non-occlusive
2) Breadth is in ingredient choice; leverage is in exclusions and performance
Steroid, polymer, and oil options are broad through enumerated lists, but “substantially free” and “substantially non-occlusive” narrow practical overlap.
3) Betamethasone-specific coverage exists
Claim 13 provides a focused lane on betamethasone compounds, which increases relevance in a crowded corticosteroid market.
4) Method claims track the composition claims
Claims 24-25 provide broad treatment coverage tied to the same compositions, without dosing regimen constraints.
FAQs
1) Does the patent cover propellant aerosol corticosteroids?
No, the independent claims require the composition to be substantially free of propellant.
2) Is propylene glycol allowed anywhere in the formulation?
The independent claims require the composition to be substantially free of propylene glycol, which typically rules out formulations that rely on it as a meaningful cosolvent.
3) What steroids are expressly covered?
Claim 2 lists multiple topical corticosteroids, including betamethasone esters/derivatives, clobetasol/clobetasone class, and other mid- to high-potency steroids, with betamethasone addressed more directly in claim 13.
4) What excipient families are required beyond sorbitan stearate?
The polymer must be in the cellulose/gum/alginate/phthalate group, and the vehicle includes water plus a water-immiscible lipid/wax phase.
5) Can a competitor add a penetration enhancer and still infringe?
Yes if the enhancer falls within claim 7’s categories and is present within the claim 6 concentration band (and the rest of the independent-claim limitations are met).
References
[1] United States Patent and Trademark Office (USPTO). US Patent 9,433,630 (as provided in the user claim text).
