Scope, Claims, and US Patent Landscape Analysis for U.S. Patent 11,903,941 (Varenicline for Nasal Treatment of Dry Eye)
U.S. Patent 11,903,941 claims a specific dosing and formulation envelope for using varenicline administered intranasally to treat dry eye, with dependent claim coverage narrowing to nasal spray delivery and absence of preservative. The practical scope centers on (i) dose range in micrograms/day, (ii) liquid concentration in mg/mL, and (iii) form-factor constraints (nasal spray) plus an excipient constraint (no preservative).
What do the independent claims cover?
Claim 1 (core independent claim)
Claim 1 is a method claim with three bounding elements:
-
Indication / patient population
- “treating dry eye in a human”
-
Route and daily dose window
- “nasally administering between 5 micrograms and 1000 micrograms of varenicline per day”
-
Formulation concentration window
- varenicline is in a liquid pharmaceutical formulation
- concentration of varenicline between about 0.1 mg/mL and about 10 mg/mL
Claim 1 scope in plain terms: Any intranasal dosing regimen for dry eye that stays within 5–1000 µg/day and uses a liquid containing varenicline at ~0.1–10 mg/mL falls within the claim, regardless of whether the formulation is a nasal spray unless further limitations are invoked by dependents.
Claim 13 (second independent claim)
Claim 13 is also a method claim and effectively carves a narrower dosing cadence:
- treating dry eye in a human
- nasally administering between 5 µg and 100 µg twice daily
- formulation concentration between about 0.1 mg/mL and about 10 mg/mL
Claim 13 scope in plain terms: Intranasal dry eye therapy with twice-daily administration where the per-dose amount is 5–100 µg (so a total daily amount of 10–200 µg/day) and formulation concentration is ~0.1–10 mg/mL.
How do dependent claims narrow the formulation and dosing space?
Concentration narrowing (claims 2, 3, 14, 15, 17, 18)
Across both independent frameworks, dependent claims tighten the concentration band:
| Claim set |
Dose cadence |
Concentration range (mg/mL) |
Claim numbers |
| Dependent to Claim 1 |
daily dosing (no cadence limitation beyond “per day”) |
about 0.2–1 |
2 |
| Dependent to Claim 1 |
daily dosing |
about 0.5–1 |
3 |
| Dependent to Claim 13 |
twice daily |
about 0.2–1 |
14 |
| Dependent to Claim 13 |
twice daily |
about 0.5–1 |
15 |
| Dependent to Claim 13 (via dose-specific claim 16) |
twice daily |
about 0.2–1 |
17 |
| Dependent to Claim 13 (via dose-specific claim 16) |
twice daily |
about 0.5–1 |
18 |
Implication for freedom-to-operate (FTO): If a competitor’s product lands anywhere inside 0.1–10 mg/mL, it can read on Claim 1 or 13. If it is instead engineered into 0.2–1 mg/mL or 0.5–1 mg/mL, it also risks being directly covered by multiple narrower dependents.
Dose narrowing (claims 4, 16, 5–6, 17–18 etc.)
Key dependent dose constraints are:
- Claim 4: Claim 1 where daily dose is between 5 µg and 600 µg per day
- Claim 16: Claim 13 where total twice-daily amount is between 25 µg and 100 µg twice daily
Those create two notable dosing sub-areas:
| Claim |
Frame |
Dose boundary |
Related dependents |
| 4 |
dependent to Claim 1 |
5–600 µg/day |
5 and 6 add concentration sub-ranges |
| 16 |
dependent to Claim 13 |
25–100 µg twice daily |
17 and 18 add concentration sub-ranges |
Cadence effect: Claim 13 already limits to twice-daily dosing with per-dose 5–100 µg. Claim 16 further moves that per-dose band to 25–100 µg. Any formulation that uses twice-daily with per-dose below 25 µg avoids Claim 16 but can still fall within Claim 13.
Delivery device constraint (nasal spray) (claims 7, 9, 11, 19, 21, 23)
Several dependent claims require nasal spray delivery:
| Dependent claim |
Triggering parent |
Spray requirement |
| 7 |
Claim 6 |
“administered as a nasal spray” |
| 9 |
Claim 8? (as written: dependent to Claim 7/8 family) |
“administered as a nasal spray” |
| 11 |
dependent to Claim 4/10 family |
“administered as a nasal spray” |
| 19 |
dependent to Claim 18 |
“administered as a nasal spray” |
| 21 |
dependent to Claim 9 |
“administered as a nasal spray” |
| 23 |
dependent to Claim 16 |
“administered as a nasal spray” |
Implication: If a competitor avoids nasal spray and uses another intranasal device (drops, atomizer, gel, nebulized formulations), it can attempt to design outside those “nasal spray” dependents. However, it still faces risk under the broader independent claims that do not require spray unless a dependent is asserted.
Preservative exclusion (claims 8, 10, 12, 20, 22, 24)
Multiple dependents exclude preservatives:
| Dependent claim |
Triggering parent |
Excipient limitation |
| 8 |
Claim 7 |
“does not include a preservative” |
| 10 |
Claim 9 |
“does not include a preservative” |
| 12 |
Claim 11 |
“does not include a preservative” |
| 20 |
Claim 19 |
“does not include a preservative” |
| 22 |
Claim 21 |
“does not include a preservative” |
| 24 |
Claim 23 / Claim 9 family |
“does not include a preservative” |
Implication: A preservative-containing version can avoid these “no preservative” dependents but still remains exposed to the base coverage (Claims 1 and 13, and concentration/dose dependents that do not recite preservative).
What is the effective “claim matrix” for product design around the patent?
The patent’s claim architecture creates a matrix across three axes: (A) daily dose, (B) concentration, and (C) cadence / administration + device + preservative.
A) Dose axis
| Axis segment |
Covered by |
| 5–1000 µg/day |
Claim 1 |
| 5–600 µg/day |
Claim 4 (subset of Claim 1) |
| 5–100 µg twice daily |
Claim 13 (subset framing by twice-daily cadence) |
| 25–100 µg twice daily |
Claim 16 (subset of Claim 13 framing) |
B) Concentration axis
| Axis segment |
Covered by |
| ~0.1–10 mg/mL |
Claims 1 and 13 |
| ~0.2–1 mg/mL |
Claims 2 and 14 and 17 |
| ~0.5–1 mg/mL |
Claims 3 and 15 and 18 |
C) Additional limitations axis
| Limitation |
Covered by |
| Nasal spray |
Claims 7, 9, 11, 19, 21, 23 |
| No preservative |
Claims 8, 10, 12, 20, 22, 24 |
Practical scope: Claims 1 and 13 are the broad anchors. The nasal spray and no-preservative language is layered through dependents.
What is the patent landscape risk profile?
1) Landscape structure most relevant to FTO
Given the claims are framed as methods of treating dry eye with intranasal varenicline dosing and liquid concentration windows, infringement risk concentrates on:
- Dry eye indication (method-of-use claims are sensitive to the labeled/claimed therapeutic intent)
- Intranasal route (systemic or ocular routes are not covered by these claims)
- Dose and concentration compliance (microgram/day and mg/mL bands)
- Device and preservative (only for certain dependents)
2) Common competitor “avoidance” routes and how the claim set responds
| Design choice |
Does it likely avoid Claim 1/13? |
Does it still trigger dependents? |
| Change from nasal to ocular or systemic route |
Yes for route (independent claims require “nasally administering”) |
No for these dependent spray/preservative claims |
| Use intranasal but dosing outside 5–1000 µg/day or outside twice-daily per-dose limits |
Likely yes |
Depends on where you land; could still hit concentration-only dependents if dose is inside |
| Keep dose in-range but shift concentration outside ~0.1–10 mg/mL |
Likely yes |
Might avoid all dependents reciting narrower concentration windows |
| Keep dose and concentration in-range but use nasal drops/atomizer not “nasal spray” |
Avoids nasal-spray dependents |
Does not avoid Claims 1/13 (no spray limitation there) |
| Formulate with preservative |
Avoids “no preservative” dependents |
Does not avoid Claims 1/13 (no preservative limitation there) |
What do the claim definitions imply about enforcement leverage?
Dose and concentration windows are the core leverage
Because the claims tie infringement to numerical formulation parameters, enforcement can pivot on:
- dosing device and regimen calculations (micrograms delivered per day and twice-daily schedule)
- assayed or specified concentration mg/mL in the liquid
- whether administration is “nasally” and, if dependents are asserted, whether it is “nasal spray”
- whether the product includes a “preservative” (dependents 8/10/12/20/22/24)
The patent can reach multiple product variants without requiring device parity
Even if a competitor changes the intranasal device, Claims 1 and 13 can still be asserted if the competitor lands within the dosing and concentration bands and uses the method for treating dry eye.
Which embodiments are covered by dependent claims as written?
Below are “covered embodiment” examples derived only from your claim text.
Coverage that is explicitly narrowed
-
Claim 1 + Claim 2 + Claim 7 + Claim 8
- intranasal dry eye method
- 5–1000 µg/day
- 0.2–1 mg/mL
- nasal spray
- formulation does not include preservative
-
Claim 13 + Claim 15 + Claim 19 + Claim 20
- intranasal dry eye method
- 5–100 µg twice daily
- 0.5–1 mg/mL
- nasal spray
- no preservative
-
Claim 13 + Claim 17 + Claim 23 + Claim 24 (with Claim 16 dose subset)
- per-dose 25–100 µg twice daily
- concentration 0.2–1 mg/mL
- nasal spray
- no preservative
Coverage that remains broader if device/preservative differs
- Any intranasal dry eye method meeting Claim 1 or Claim 13 dosing and concentration bands stays in scope even if it is not a nasal spray and contains a preservative.
Key Takeaways
- Claims 1 and 13 are the broad anchors: intranasal treatment of dry eye using liquid varenicline at ~0.1–10 mg/mL with daily dose 5–1000 µg/day (Claim 1) or 5–100 µg twice daily (Claim 13).
- Dependent claims narrow to concentration bands (0.2–1 mg/mL, 0.5–1 mg/mL) and dose subsets (5–600 µg/day, 25–100 µg twice daily).
- Nasal spray and “does not include a preservative” are not in the independent claims; they appear in dependent claims (spray: 7/9/11/19/21/23; no preservative: 8/10/12/20/22/24).
- For competitive R&D, the highest-risk design space is staying within (dose in-range) AND (concentration in-range) for intranasal dry eye, since those constraints are present in the independent claims.
FAQs
-
Is nasal spray required to infringe U.S. 11,903,941?
Not for the independent claims. Nasal spray appears only in dependent claims (e.g., 7, 9, 11, 19, 21, 23).
-
What concentration range is protected at the broadest level?
The independent claims cover a liquid formulation with varenicline at about 0.1 mg/mL to about 10 mg/mL.
-
What is the highest daily dose window in Claim 1?
Claim 1 covers 5 micrograms to 1000 micrograms per day.
-
Does Claim 13 require twice-daily dosing?
Yes. Claim 13 specifies “between 5 micrograms and 100 micrograms twice daily.”
-
How can a formulation with preservative affect infringement risk?
It can avoid dependent claims that require the formulation “does not include a preservative” (8/10/12/20/22/24), but Claims 1 and 13 still apply if dose and concentration windows are met.
References
[1] U.S. Patent 11,903,941.
