US Patent 11,872,204 (Solriamfetol): Scope, Claim Construction, and US Patent Landscape
What does US 11,872,204 claim in operational terms?
US 11,872,204 claims a breastfeeding-related dosing method designed to prevent a reduction in the number of feedings and/or the volume of milk ingested by an infant when the infant is fed breast milk obtained from a subject treated with solriamfetol.
The independent claim(s) are method-of-use claims with a tight dosing-and-timing regime:
- Subject treatment: oral solriamfetol
- Maternal daily dose:
- Claim 1: about 150 mg/day
- Claim 9: about 75 mg/day
- Infant feeding window: feed infant at least about 5 hours after maternal solriamfetol administration
- Result constraint: the daily infant solriamfetol dose is about 0.3 mg/day (Claim 1) or about 0.15 mg/day (Claim 9) or lower
- Breastfeeding population linkage: subject is postpartum (dependent claims specify ranges)
- Underlying maternal indication linkage: EDS and a broad list of neurologic/psychiatric and sleep-related indications
This is a classic risk-mitigation dosing method: it conditions breastfeeding behavior (timing and dose) on limiting infant exposure while seeking to maintain feeding adequacy.
How are Claims 1 and 9 constructed (scope of the independent claims)?
Claim 1 (150 mg regimen)
Claim 1 requires all elements:
- Preventive outcome: prevents reduction in number of feedings and/or reduction in volume of milk ingested by the infant
- Maternal drug: oral solriamfetol
- Maternal dose: about 150 mg daily
- Timing: feed infant at least about 5 hours after dosing
- Exposure cap: daily infant dose of solriamfetol is about 0.3 mg/day or lower
- Breast milk source: infant is fed breast milk obtained from the solriamfetol-treated subject
Practical reading: If a clinician administers solriamfetol to a postpartum subject at ~150 mg/day, and then schedules breastfeeding such that infant exposure is predicted/achieved at ≤0.3 mg/day, the method is in scope if the outcome is achieved.
Claim 9 (75 mg regimen)
Claim 9 parallels Claim 1 with the following parameter changes:
- Maternal daily dose: about 75 mg/day
- Exposure cap: daily infant dose about 0.15 mg/day or lower
- Timing remains: feed infant at least about 5 hours after administration
Practical reading: lower maternal dose and lower infant exposure cap, with the same “at least 5 hours” feeding delay.
What do the dependent claims add (population, indication, and subgroup narrowing)?
Postpartum status narrowing
- Claim 2: subject is 1 day to 24 months postpartum
- Claim 3: subject is 10 days to 12 months postpartum
For a freedom-to-operate review, these postpartum ranges narrow the method class but still cover virtually the full biologically relevant breastfeeding window for many systems.
Indication linkage (maternal therapeutic use)
-
Claim 4: solriamfetol is used for at least one of:
- excessive daytime sleepiness
- narcolepsy
- obstructive sleep apnea
- shift work disorder
- attention deficit hyperactivity disorder
- depression
- binge eating disorder
- Parkinson's disease
- cognitive impairment
-
Claim 5: excessive daytime sleepiness is associated with:
- narcolepsy
- obstructive sleep apnea
- shift work
- major depression
- Parkinson's disease
-
Claim 6: cognitive impairment associated with:
- narcolepsy
- obstructive sleep apnea
- shift work
- Parkinson's disease
- attention deficit hyperactivity disorder
-
Claim 7: subject is treated “to improve wakefulness”
Demographic qualifier
- Claim 8: subject is a woman between 18 and 50 years
Claims 2-3 and 8 narrow who performs the method and where; Claims 4-6 broaden the medical rationale under which the dosing method is used.
Claim-by-claim scope map (what is required vs optional)
| Claim |
Added limitation type |
What must be satisfied |
| 1 |
Independent |
Outcome prevention + solriamfetol at ~150 mg/day + feed ≥5 hours post-dose + infant exposure ≤0.3 mg/day |
| 2 |
Dependent |
Postpartum: 1 day to 24 months |
| 3 |
Dependent |
Postpartum: 10 days to 12 months |
| 4 |
Dependent |
Indication list (EDS/narcolepsy/OSA/shift work/ADHD/depression/binge eating/Parkinson/cognitive impairment) |
| 5 |
Dependent |
EDS-associated condition narrowed to 5 items |
| 6 |
Dependent |
Cognitive impairment-associated condition narrowed to 5 items |
| 7 |
Dependent |
Solriamfetol “to improve wakefulness” |
| 8 |
Dependent |
Subject: woman, 18-50 |
| 9 |
Independent |
Outcome prevention + solriamfetol at ~75 mg/day + feed ≥5 hours post-dose + infant exposure ≤0.15 mg/day |
| 10 |
Dependent |
Postpartum: 1 day to 24 months |
| 11 |
Dependent |
Postpartum: “10 44 days to 12 months” (as provided; text appears to contain a formatting artifact) |
| 12 |
Dependent |
Indication list identical to Claim 4 |
| 13 |
Dependent |
EDS-associated condition narrowed identical to Claim 5 |
| 14 |
Dependent |
Cognitive impairment-associated condition narrowed identical to Claim 6 |
| 15 |
Dependent |
Solriamfetol “to improve wakefulness” |
| 16 |
Dependent |
Subject: woman, 18-50 |
How likely is this claim set to be enforced (typical infringement fit)?
Strong infringement “hooks”
This patent is strongest where a program:
- Writes or operationalizes a breastfeeding protocol for solriamfetol that includes:
- maternal dose level(s) (~150 mg/day or ~75 mg/day),
- a ≥5 hour feeding delay, and
- a stated infant daily exposure target consistent with the caps.
- Uses postpartum patients and labels the dosing protocol under relevant indications or wakefulness improvement.
Evidence burden in practice
Method patents often require evidence linking:
- maternal dosing at the claimed regimen,
- breastfeeding timing consistent with “at least about 5 hours,”
- infant dose calculation/estimation that reaches the 0.3 mg/day or 0.15 mg/day cap, and
- feeding outcome (no reduction in feedings or milk volume ingested).
That said, the claims are drafted with quantitative dosing constraints (maternal and estimated infant exposure), which tends to make enforcement more targetable than purely qualitative claims.
What is the effective subject-matter scope (what’s inside vs outside)?
Inside the scope
- Solriamfetol given orally to postpartum women (broad age range via Claim 8 if invoked) in the claimed dose ranges, with breastfeeding delayed ≥5 hours and designed to keep infant exposure at or below the specified daily infant dose caps.
- The breastfeeding milk can be used to feed the infant at least 5 hours post-dose.
Likely outside
- Maternal regimens that do not meet the specific daily dose targets (or achieve infant exposure higher than the caps).
- Feeding schedules that do not consistently comply with ≥5 hours after administration.
- Scenarios where the “prevention” outcome is not achieved (depending on proof standards, this can reduce enforceability in some cases).
- Uses that are not anchored to solriamfetol treatment in postpartum subjects (no method trigger without that structural connection).
What is the patent landscape around US 11,872,204?
Landscape constraints
The prompt includes only the claims, not:
- assignee,
- priority date,
- filing/publication numbers,
- prosecution history,
- related family members,
- or any citing documents.
Under the operating constraint, the response cannot assert family scope, expiration dates, or related US filings without reliable bibliographic data tied to US 11,872,204.
What can be said from the claims alone
- The patent is a formulation-independent method-of-use (no explicit new chemical entity is claimed here).
- It likely sits in a breastfeeding safety/dosing optimization layer over an existing solriamfetol product and its approved indications.
- The claim structure suggests it is meant to be read alongside clinical or PK work that supports:
- timing delay (“at least about 5 hours”),
- infant exposure estimate, and
- feeding outcome.
Competitive and R&D implications for solriamfetol breastfeeding programs
Even without the full bibliographic record, the claim set informs what product teams must navigate:
Protocol parameters that are directly “claim-shaped”
- Maternal dose levels: ~75 mg/day and ~150 mg/day
- Dosing-to-feeding delay: ≥5 hours
- Infant exposure caps: ≤0.15 mg/day or ≤0.3 mg/day
- Applicable postpartum windows: from early postpartum through at least 12 months (and up to 24 months in Claim 2/10)
Design-around pressure points
Any alternative protocol that:
- uses different timing than ≥5 hours,
- targets maternal doses outside the specified amounts,
- or yields infant exposure above the stated caps,
is structurally positioned to avoid the literal dosing/exposure limitations.
Key takeaways
- US 11,872,204 claims a specific breastfeeding method tied to solriamfetol dosing in postpartum subjects and uses a ≥5 hour feeding delay plus infant daily exposure caps (≤0.3 mg/day or ≤0.15 mg/day) to prevent reduced feeding or reduced milk intake volume.
- Independent claims are anchored to two maternal daily dose regimes: ~150 mg/day (Claim 1) and ~75 mg/day (Claim 9), with matched infant exposure thresholds.
- Dependent claims narrow the postpartum window and define solriamfetol indication linkage (EDS and related disorders, cognitive impairment, wakefulness improvement) and include a female age qualifier (18-50) in a dedicated dependency.
- The patent appears positioned as a risk-mitigation method-of-use rather than a new drug entity, making enforcement and licensing more likely to focus on clinic protocol language and operational dosing guidance that matches the quantitative parameters.
FAQs
1) Is US 11,872,204 about preventing infant exposure to solriamfetol in general?
No. It is about preventing a reduction in infant feeding metrics (number of feedings and/or volume of milk ingested) when the infant is fed breast milk from a mother treated with solriamfetol, under specific dosing, timing, and infant exposure caps.
2) Do the claims require a specific solriamfetol dosing schedule beyond “daily dose” and “≥5 hours” feeding delay?
The claim language specifies a daily dose and that feeding occurs at least about 5 hours after administration; it does not add more schedule detail in the claim text provided.
3) Are the indication and wakefulness-related limitations mandatory?
They are mandatory only where invoked through the dependent claims (e.g., Claims 4-7). The independent claims (1 and 9) do not require the specific indication wording.
4) Does the patent cover all postpartum women?
It covers postpartum subjects broadly in the independent claims, with dependent claims narrowing postpartum timing (Claims 2-3 and 10-11). Claim 8/16 further narrows subject to women aged 18-50 for those dependent paths.
5) What are the two critical numeric elements that define infringement risk?
Maternal daily dose (about 150 mg or about 75 mg) and the matched infant daily solriamfetol exposure cap (about 0.3 mg/day or 0.15 mg/day) alongside the ≥5 hour feeding delay.
References
[No external sources were provided in the prompt; therefore no citations are included.]
