US Patent 10,959,946: What It Claims, the Claim Boundaries, and the Practical Patent Landscape
What is US 10,959,946’s invention scope?
US 10,959,946 claims a non-sterile, stable oral liquid formulation built around vancomycin hydrochloride with a tightly defined excipient composition and stability performance. The core structure is the same across claims 1 and 2, with claims 3-10 locking specific preferred concentration embodiments.
Independent claim architecture
Claim 1 (composition + compounding + stability + performance attributes)
- Non-sterile stable liquid formulation for oral administration
- Components and ranges (all w/v):
- Anhydrous citric acid: 0.1-0.4%
- Water: balance
- Sucralose: 0.1-0.3%
- Flavoring agent: 0.01-0.1%
- Sodium benzoate: 0.08-0.2%
- Vancomycin hydrochloride: present (amount not numerically stated in your excerpt, but vancomycin is an explicit functional ingredient)
- Stability requirement: “homogenous and stable for at least 30 days at ambient and refrigerated temperature”
- Performance attribute: “high solubility in water” and pH of 2.5-4.5
Claim 2 (composition + stability, no explicit “compounded solution” phrasing)
- Liquid solution for oral administration with the same excipient ranges and the same 30-day stability and homogeneity requirement at ambient and refrigerated conditions.
Claims 3-10 (specific concentration and flavor embodiment)
These claims specify narrower “point” formulations within the ranges in claim 2 and claim 1.
- Claim 3: anhydrous citric acid 0.12% w/v
- Claim 4: sucralose 0.2% w/v
- Claim 5: artificial grape flavor 0.05% w/v
- Claim 6: sodium benzoate 0.1% w/v
- Claims 7-10: the same numeric embodiments, tied back to claim 1’s formulation (non-sterile stable liquid formulation with pH/solubility/compounded-solution framing)
Composition map (ranges vs. locked embodiments)
| Ingredient |
Claim 1 / Claim 2 range (% w/v) |
Dependent claims lock-in (% w/v) |
| Anhydrous citric acid |
0.1 to 0.4 |
0.12 (Claims 3, 7) |
| Sucralose |
0.1 to 0.3 |
0.2 (Claims 4, 8) |
| Flavoring agent |
0.01 to 0.1 |
Artificial grape flavor 0.05 (Claims 5, 9) |
| Sodium benzoate |
0.08 to 0.2 |
0.1 (Claims 6, 10) |
| Water |
balance |
balance |
| Vancomycin hydrochloride |
present (level not specified in excerpt) |
present |
What are the legal/technical boundaries of infringement risk?
US 10,959,946’s practical boundary is defined by (i) formulation composition, (ii) pH window and solubility, and (iii) stability/homogeneity for 30 days under two temperature regimes.
1) Composition boundaries (excipient ranges)
A literal-reading infringement test typically keys off:
- Citric acid presence within 0.1-0.4%
- Sucralose presence within 0.1-0.3%
- Flavoring presence within 0.01-0.1%
- Sodium benzoate presence within 0.08-0.2%
- Vancomycin hydrochloride included
- Oral administration context
Any formulation missing one required component or shifting one component outside the stated range falls outside the strict literal wording of claims 1-2. Dependent claims 3-10 narrow further by locking specific values and specifying artificial grape flavor.
2) Claim 1 adds extra performance constraints vs. claim 2
Claim 1 requires more than claim 2:
- “compounded solution”
- pH 2.5-4.5
- “high solubility in water”
- non-sterile + stable for 30 days at ambient and refrigerated
Claim 2 still requires homogeneity and 30-day stability but does not explicitly state the pH window or “high solubility” language in the excerpt you provided.
3) Stability and homogeneity are functional claim elements
Both independent claims require:
- homogenous solution
- stable for at least 30 days
- stability under ambient and refrigerated temperature
This is a high-friction element for design-around and for enforcement. Even when excipients sit within ranges, failure to demonstrate or maintain the required stability window can defeat claim coverage (or at least weaken validity/enforcement posture).
Which claim elements likely drive enforceability?
The most enforceability-relevant parts tend to be the ones that are:
- specifically bounded (ranges, pH)
- measurable (pH, stability time points)
- directly tied to the active formulation
Key measurable elements embedded in the claims
- pH of 2.5-4.5 (claim 1)
- Stability at 30 days at ambient and refrigerated conditions (claims 1-2)
- Homogeneity (claims 1-2)
- Excipient range compliance for citric acid, sucralose, flavor, sodium benzoate (claims 1-2)
- Locked embodiments:
- citric acid 0.12%
- sucralose 0.2%
- artificial grape flavor 0.05%
- sodium benzoate 0.1%
(claims 3-10)
What does the dependent claim set practically signal about the preferred formulation?
Claims 3-6 and 7-10 create a tight “preferred center of mass” inside the broader ranges. The locked values align as follows:
- Citric acid: 0.12% (near lower-middle of 0.1-0.4)
- Sucralose: 0.2% (center-ish of 0.1-0.3)
- Flavor: 0.05% artificial grape (center-ish of 0.01-0.1)
- Sodium benzoate: 0.1% (near midpoint of 0.08-0.2)
This pattern suggests the patent owner expects:
- the acid/pH control to support vancomycin solubility and stability,
- sucralose + benzoate to support taste and preservation/chemical stability,
- and a specific flavor system to support patient acceptability without compromising stability.
How does this formulation constrain design-around strategies?
Based strictly on claim text, there are limited straightforward routes to avoid literal coverage:
A. Shift one required excipient outside its numeric range
- Move citric acid below 0.1% or above 0.4%
- Move sucralose below 0.1% or above 0.3%
- Move sodium benzoate below 0.08% or above 0.2%
- Move flavor concentration outside 0.01-0.1%
This is the cleanest literal design-around, but it can be hard to maintain stability if formulation function depends on being inside the window.
B. Replace a required excipient
- Remove sucralose or replace it with another sweetener
- Replace sodium benzoate with another preservative
- Replace citric acid with a different acid system
This avoids the “consisting of” structure in claim 1/2 only if the replacement is not still within the same required component list.
C. For dependent claim exposure: change the locked embodiment
Even if you stay within claim 2 ranges, dependent claims 3-10 would be avoided by:
- using a different citric acid level than 0.12%
- using a different sweetener than achieving exactly 0.2% sucralose
- using a different flavor (not “artificial grape”) or different flavor level than 0.05%
- using a different sodium benzoate concentration than 0.1%
Note: avoiding dependent claims does not necessarily avoid independent claim 2 unless excipient ranges also miss.
What is the likely patent landscape structure around US 10,959,946?
Based on the claim language and formulation theme, the landscape typically clusters into three adjacent buckets:
-
Vancomycin oral liquid formulation patents
- Focus on taste masking, stabilizers, and solubility for oral dosing.
- Often combine acidulants (for pH control), preservatives, and sweeteners.
-
Stability and compounding-related patents
- Emphasize chemical stability time points at ambient and refrigerated conditions.
- Often include “homogeneous” and “shelf life” language.
-
Preservation and acceptability packages
- Typical preservative families include benzoates.
- Sweeteners often include sucralose or alternatives.
- Flavors often specify patient-acceptable flavor types and concentrations.
Where US 10,959,946 likely sits
US 10,959,946 is a “composition + stability package” rather than a manufacturing process patent. Its claims tie:
- multiple excipient components with narrow ranges,
- to a stability and pH profile (claim 1),
- in a non-sterile oral dosing solution format.
That positioning tends to create enforceable coverage against “same recipe, same stability performance” formulations, but it leaves more room for:
- different acid systems,
- different preservative systems,
- different sweetener systems,
- or major reformulation outside one or more numeric ranges.
What commercialization and litigation leverage does the claim set support?
A strong enforcement posture generally comes from:
- Clear excipient ranges that map to formulation recipes,
- A measurable stability standard (30 days at two temperature regimes),
- and, for claim 1, an explicit pH window.
If a competitor’s product (or proposed product) uses the same excipients within those ranges and achieves similar stability, the patent’s claim set targets that overlap. If a competitor uses alternative excipients, it can reduce literal overlap, but stability and homogeneity requirements can still create factual pressure, especially if the competitor’s data shows the same performance.
Key Takeaways
- US 10,959,946 is a narrow recipe-stability patent for a non-sterile oral liquid vancomycin hydrochloride formulation.
- Claims 1-2 require 30-day stability and homogeneity at ambient and refrigerated conditions.
- Claim 1 adds performance limits: pH 2.5-4.5 and “high solubility in water,” plus “compounded solution” framing.
- Excipient coverage is numerically bounded (citric acid 0.1-0.4%, sucralose 0.1-0.3%, flavor 0.01-0.1%, sodium benzoate 0.08-0.2%).
- Dependent claims 3-10 lock a preferred embodiment: citric acid 0.12%, sucralose 0.2%, artificial grape flavor 0.05%, sodium benzoate 0.1%.
- Design-around is feasible but constrained: staying outside a single excipient range or replacing a required component can avoid literal coverage, but stability risk remains.
FAQs
1) Does US 10,959,946 claim a process or a product?
It claims a product formulation (non-sterile oral liquid solution) with compositional and stability requirements.
2) What stability standard is required in claims 1 and 2?
The formulation must be homogenous and “stable for at least 30 days” at ambient and refrigerated temperature.
3) Is the pH limit only in claim 1?
Yes. In the provided claim text, pH 2.5-4.5 is explicitly stated in claim 1 and not in claim 2.
4) Can a formulation that matches excipient ranges but fails stability still infringe?
The claims require stability for at least 30 days at ambient and refrigerated conditions, so failure to meet that functional requirement undermines literal compliance.
5) Which claim elements most directly narrow the patent’s protected recipe?
The excipient numeric ranges (citric acid, sucralose, flavor, sodium benzoate) and the dependent-claim fixed embodiment (citric acid 0.12%, sucralose 0.2%, artificial grape 0.05%, sodium benzoate 0.1%) provide the tightest recipe boundaries.
References
- United States Patent No. 10,959,946. (Claims 1-10 as provided by user text).
