Scope and claims analysis for U.S. Patent 10,265,334: anhydrous NO-releasing composition using hydroxypropyl cellulose, ethanol/isopropanol, cyclomethicone, and hexylene glycol

United States Patent 10,265,334 is tightly focused on a specific vehicle and solvent system for an anhydrous topical composition that includes (i) hydroxypropyl cellulose (HPC) as a matrix/rheology component, (ii) a defined high-percentage ethanol or isopropyl alcohol (IPA) cosolvent, (iii) hexylene glycol as a skin-conditioning co-solute, (iv) cyclomethicone as a volatility-controlled silicone component, and (v) an NO-releasing compound at very broad loading. The claims define an “anhydrous composition consisting essentially of” those ingredients, with explicit numerical ranges for HPC, alcohol, and cyclomethicone, and broad ranges for NO-releasing compound. Dependent claims lock down whether ethanol vs IPA is used and provide narrower NO-releasing concentration bands, plus one specific NO-releasing-compound embodiment: diazeniumdiolated co-condensed silica particles.

What does U.S. Patent 10,265,334 claim in plain terms?

Core claimed product (independent claim 1):
A composition that is (a) anhydrous and (b) “consisting essentially of” five ingredient categories plus NO donor:

Hydroxypropyl cellulose (HPC): 0.5% to about 2% by weight
Ethanol or isopropyl alcohol (IPA): 45% to 90% by weight
Hexylene glycol: about 10% by weight
Cyclomethicone: about 2.5% by weight
NO-releasing compound: 0.01% to 40% by weight
No other ingredients may be present in amounts that would materially change the claimed composition’s basic and novel characteristics, given the “consisting essentially of” transition.

Key structural feature: the alcohol system is unusually dominant (45–90%), while the supporting excipients are narrowly framed (hexylene glycol fixed at ~10%, cyclomethicone fixed at ~2.5%, HPC capped at ~2%). That combination constrains the formulation space and supports a clear infringement posture against products built around the same anhydrous vehicle ratios.

What is the “consisting essentially of” boundary and how does it affect claim scope?

Legal-claim consequence: “Anhydrous composition consisting essentially of” means the composition may include minor additional components that do not materially affect the basic and novel characteristics. If additional excipients are added in material quantities that change performance-relevant attributes (for example, water content, solubilization regime, film-forming behavior, NO release kinetics), they can fall outside the claim.

Practical scope impact for competitors:

High-risk infringement region: products that match the defined vehicle ratios and include an NO-releasing compound as the pharmacologically active donor.
Lower-risk zone: formulations that change the vehicle structure materially, for example by:
- replacing cyclomethicone with a different silicone of substantially different volatility/skin feel profile,
- using a different polymer thickener instead of HPC,
- using an alcohol system outside 45–90% ethanol/IPA,
- formulating with water or moisture levels that make the composition not “anhydrous,”
- using NO donors but at loadings outside 0.01–40% (or outside narrower dependent-claim bands).

How broad is the NO-releasing-compound coverage from claim 1 through claim 18?

Independent claim 1: NO loading range is extremely wide

0.01% to 40% by weight of the NO-releasing compound.

This breadth makes the independent claim hard to design around by dosage/loading alone. A generic “NO donor in anhydrous alcohol/silicone vehicle with HPC and glycol” approach can still land within claim 1 if it meets the other excipient constraints.

Dependent claims: staging bands that map to specific formulation variants

Dependent claims 4–16 carve the NO donor range into multiple bands:

Claim 4: 0.01% to 30%
Claim 5: 0.01% to 2%
Claims 8–17: “about” stepped concentrations at ~1%, 2%, 4%, 8%, 12%, 16%, 20%, 24%, 30%, and 32%

These suggest the patent owner pursued multiple candidate strengths, likely aligned to different product formats or dose-titration strategies.

Claim 18: specific NO donor identity

Claim 18: NO-releasing compound comprises diazeniumdiolated co-condensed silica particles.

That is a direct species claim on donor chemistry and carrier. If a product uses a different NO donor platform (e.g., S-nitrosothiols, NONOates, other silica/diazeniumdiolate architectures), claim 18 may not read, but claim 1 still can if the “NO-releasing compound” is broadly defined.

How do claim 2 and claim 3 narrow the alcohol component?

Ethanol vs isopropyl alcohol are mutually exclusive dependent embodiments

Claim 2: composition comprises ethanol
Claim 3: composition comprises isopropyl alcohol

Because claim 1 allows “ethanol or isopropyl alcohol,” claim 2 and 3 function as alternative dependent claim hooks to support infringement theories depending on which alcohol is actually used.

Competitor design-around note: substituting ethanol for IPA (or vice versa) does not avoid claim 1; it only affects which dependent claim is satisfied.

What do claims 6–7 do to the polymer (HPC) space?

Claim 6: HPC 0.5% to about 1%
Claim 7: HPC about 1%

These narrow embodiments help capture formulations at a midrange polymer loading, likely optimized for viscosity, spreadability, and film formation.

Design-around effect: if a competitor moves HPC outside the 0.5–2% window in claim 1, it can potentially exit the independent claim. But altering HPC often forces changes to the rest of the formulation to keep performance consistent, which can reintroduce risk.

What does cyclomethicone at about 2.5% mean for infringement risk?

Claim 1 sets cyclomethicone to about 2.5% by weight, while hexylene glycol is about 10% and HPC/alcohol are banded.

This “about” language typically allows small tolerances. Still, the fixed nature of these two components (hexylene glycol and cyclomethicone) means a formulation that materially deviates in silicone content or glycol level is a more viable design-around lever than changing the NO donor loading alone.

What is the formulation “geometry” created by claim 1?

Claim 1 effectively defines a constrained composition matrix:

Alcohol: 45–90%
HPC: 0.5–2%
Hexylene glycol: ~10%
Cyclomethicone: ~2.5%
NO donor: 0.01–40%

That geometry is compatible with an anhydrous topical or transdermal delivery vehicle where alcohol is the primary solvent phase and cyclomethicone is the silicone component to modulate skin feel/spread and possibly affect NO release.

What patents protect the underlying NO-releasing concept and the specific excipient vehicle, based on this claim structure?

This patent’s claim drafting suggests two IP layers:

Donor technology layer: “NO-releasing compound” broadly, plus a species claim for diazeniumdiolated co-condensed silica particles (claim 18). That indicates prior art existed for NO donors and silica diazeniumdiolate systems; the owner then integrated them into a specific anhydrous vehicle.
Vehicle architecture layer: a high-alcohol anhydrous formulation with HPC, hexylene glycol, and cyclomethicone plus a defined NO donor loading.

However, without the actual publication history, specification description, assignee, continuation chain, or cited documents, a complete mapping of other US patents in the family and across competitors cannot be produced from the claim text alone.

Therefore, the enforceable “protected space” that can be asserted from the claims you provided is limited to the composition and dependent claim structures above.

How strong is the patent estate likely to be from the claim structure alone?

Strength indicators from claim architecture:

Direct product claims on a defined formulation, not just methods or single-use conditions.
Wide NO donor loading range in claim 1 (0.01–40%) reduces easy design-around by lowering or increasing donor concentration.
Fixed excipient anchors (hexylene glycol ~10%, cyclomethicone ~2.5%) provide clear matching criteria.
An “anhydrous” requirement introduces a binary switch for many formulation routes (aqueous gels are excluded).
“Consisting essentially of” allows enforcement against near-miss formulations that add minor excipients while still capturing materially similar vehicles.

Potential weakness indicators (from claim-only view):

No explicit claim elements for droplet size, film thickness, delivery rate, or site of action in your excerpt. If the NO donor identity and vehicle drive novelty, the claims should still be enforceable against formulation copies.
If competitors use a different polymer thickener system or change silicone/glycol levels substantially, they may step outside the independent claim.

What generic entry risks exist for an NO-donor topical product using similar ingredients?

Highest risk scenario:

Anhydrous product with ethanol or IPA, HPC 0.5–2%, hexylene glycol ~10%, cyclomethicone ~2.5%, and an NO donor within 0.01–40%, including diazeniumdiolated silica particles, would likely read on claim 1 (and potentially claim 18 and several concentration-dependent claims).

Lower risk scenario:

Any strategy that changes at least one of the following materially:
- polymer identity (replace HPC with a different thickener),
- remove or replace hexylene glycol and/or cyclomethicone,
- move out of ethanol/IPA 45–90% band,
- formulate with water such that it is no longer “anhydrous,”
- use a non-silica diazeniumdiolate donor if specifically targeting claim 18 (but claim 1 may remain).

What does the claims set imply about the intended dosage forms and use?

The vehicle reads like a topical, alcohol-rich, anhydrous formulation with a silicone component and polymer thickener. Your excerpt does not include method-of-use or patient-treatment claims, so the enforceable scope is primarily formulation-based.

If the NO donor is diazeniumdiolated co-condensed silica, the product likely relies on controlled NO release from a stable solid-state donor dispersed in anhydrous matrix. The claims do not tie to a therapeutic indication, but they strongly imply a localized NO delivery role.

What is the likely infringement map by ingredient substitution?

Substitution variable	If changed materially, does claim 1 likely avoid?	Notes keyed to claim text
Remove “anhydrous” condition (add water)	Yes	Claim 1 requires an anhydrous composition
Replace HPC with different polymer	Yes	Claim 1 requires hydroxypropyl cellulose in 0.5–2%
Change ethanol/IPA below 45% or above 90%	Yes	Claim 1 requires 45–90% ethanol or IPA
Change hexylene glycol off ~10%	Yes	Claim 1 fixes about 10%
Change cyclomethicone off ~2.5%	Yes	Claim 1 fixes about 2.5%
Use NO donor outside 0.01–40%	Yes	Claim 1 requires 0.01–40%
Use a different NO donor chemotype	No for claim 1; Yes for claim 18	Claim 18 requires diazeniumdiolated co-condensed silica particles
Swap ethanol for IPA	No	Claim 1 covers both; claim 2 vs 3 depends on which is used

How does claim 18 narrow the donor identity beyond claim 1?

Claim 18 converts a broad platform claim into a specific species:

“NO-releasing compound comprises diazeniumdiolated co-condensed silica particles.”

That gives the patent owner at least two enforcement modes:

Broad mode: claim 1 captures any NO-releasing compound meeting the formulation constraints.
Specific mode: claim 18 captures a particular donor carrier and chemotype.

For an IP challenge, claim 18 can be used to differentiate competitors using the silica diazeniumdiolate platform, even if their donor loading remains within claim 1.

Patent landscape limitations based on provided information

A complete US landscape for 10,265,334 normally requires:

assignee and inventors,
the patent’s publication number chain (continuations),
specification definitions for “NO-releasing compound,”
prosecution history and claim amendments,
any related patents and continuations in the same family,
Orange Book listings and FDA product linkage (if the patent is listed to an approved drug),
and any litigation dockets referencing this patent number.

None of that is contained in your excerpt. The analysis above is therefore constrained to claim scope and formulation design constraints that can be derived directly from the provided claim language.

Key Takeaways

Claim 1 is the core enforcement hook: an anhydrous composition with HPC (0.5–2%), ethanol or IPA (45–90%), hexylene glycol (~10%), cyclomethicone (~2.5%), and NO-releasing compound (0.01–40%), using “consisting essentially of” to tolerate only immaterial extras.
NO donor breadth is large in claim 1 and segmented in dependent concentration claims; claim 18 specifically targets diazeniumdiolated co-condensed silica particles.
Best design-around levers are formulation-geometry changes: avoid the anhydrous condition, move polymer identity off HPC, exit alcohol band, or deviate materially from hexylene glycol and cyclomethicone anchors.
Swapping ethanol vs IPA does not avoid claim 1.
Using a different NO donor chemotype may avoid claim 18 while still risking claim 1 if the product otherwise matches the vehicle and loading constraints.

FAQs

1) Does using diazeniumdiolated co-condensed silica particles automatically infringe?
No. Infringement requires matching the full anhydrous formulation constraints of claim 1, including HPC, ethanol/IPA band, hexylene glycol, cyclomethicone, and NO donor loading.

2) Can a competitor avoid infringement by lowering the NO donor below 0.01%?
Yes for claim 1, because claim 1 requires 0.01–40% by weight. Dependent claims also depend on their narrower bands.

3) If a product uses isopropyl alcohol instead of ethanol, does it avoid the patent?
No. Claim 1 covers ethanol or IPA. It only changes which dependent claim (2 vs 3) is implicated.

4) Are water-based formulations captured by the claims?
The claims require an anhydrous composition, so formulations with meaningful water content would not fall within claim 1’s anhydrous limitation.

5) Is claim 18 necessary for infringement?
No. Claim 18 is a narrower embodiment specifying a particular NO donor composition. Claim 1 can still be infringed by other NO-releasing compounds if the formulation constraints are met.

References (APA)

United States Patent 10,265,334 (claims provided by user).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lnhc	ZELSUVMI	berdazimer sodium	GEL;TOPICAL	217424-001	Jan 5, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	112014000178	⤷ Start Trial
European Patent Office	2729131	⤷ Start Trial
Spain	2804263	⤷ Start Trial
Japan	2014518282	⤷ Start Trial
Japan	2017149766	⤷ Start Trial
Japan	6277124	⤷ Start Trial
Japan	6505772	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,265,334

Which drugs does patent 10,265,334 protect, and when does it expire?

Summary for Patent: 10,265,334