US 11,771,666: What Is the Claim Scope, How Broad Is It, and Where Does It Sit in the Solriamfetol Patent Landscape?
United States Patent US 11,771,666 claims a narrowly defined maternal-dosing and timing regimen for solriamfetol during breastfeeding, where the infant daily dose is limited to ≤ about 0.3 mg by controlling the timing of breastfeeding after maternal dosing.
Across independent and dependent claims, the patent’s operative limitations are consistent:
- Maternal administration: orally and once daily at approximately 150 mg (and in later claims framed as “about 150 to the subject”).
- Breastfeeding timing: feed the infant breast milk at least about 5 hours after maternal dosing.
- Infant exposure target: daily infant dose of solriamfetol reduced to about 0.3 mg or lower.
- Population: maternal postpartum window from 1 day to 24 months, with narrower ranges 10 days to 12 months.
- Clinical framing: solriamfetol indications are limited to disorders for which solriamfetol is used (narcolepsy, excessive daytime sleepiness, OSA, ADHD, depression, cognitive impairment, binge eating disorder), and dependent claims further refine subtypes for excessive daytime sleepiness (shift work disorder, Parkinson’s disease, major depression).
The patent’s practical breadth is therefore defined less by solriamfetol’s indication and more by a specific pharmacokinetic management concept: keep infant exposure under a quantified threshold using a timed dosing-and-feeding workflow.
1) What Exactly Do Independent Claims Cover?
Claim 1 (method of reducing infant exposure)
Claim 1 is the foundational independent claim. It covers a method comprising three linked elements that must all be present:
| Element |
Claim requirement |
| Product |
“solriamfetol” |
| Maternal dosing |
orally, once-daily dose about 150 mg |
| Infant feeding timing |
feed infant breast milk at least about 5 hours after maternal solriamfetol administration |
| Exposure outcome |
daily infant dose reduced to about 0.3 mg or lower |
Claim 1 also ties this method to a subject “treated with solriamfetol,” and the infant must receive breast milk obtained from that human subject.
Claim 6 (method of decreasing adverse events via the same workflow)
Claim 6 also stands as an independent claim, but it reframes the result criterion as adverse event risk:
| Element |
Claim requirement |
| Maternal dosing |
orally, once-daily dose about 150 to the subject (as written) |
| Infant feeding timing |
at least about 5 hours post-dose |
| Exposure outcome |
infant daily dose ≤ about 0.3 mg |
| Purpose |
“decreasing the potential for adverse events” |
Claim 6 then points to specific infant outcomes in dependent claims (agitation, insomnia, anorexia, reduced weight gain), linking adverse events to exposure reduction.
Claim 12 (treating solriamfetol-treatable disorder while reducing exposure/adverse events)
Claim 12 is another independent claim that explicitly ties the method to treating a disorder treatable with solriamfetol while managing breastfeeding exposure:
| Element |
Claim requirement |
| Maternal administration |
orally, once daily, “about 150” |
| Breastfeeding management |
reduce infant exposure and/or decrease potential adverse events by feeding at least about 5 hours after dosing |
| Exposure target |
infant daily dose ≤ about 0.3 mg |
Claim 12’s “disorder” language is broader in phrasing than Claim 1’s enumerated disorders (because Claim 12 uses “a disorder treatable with solriamfetol”), but dependent claims narrow it back to specific indications.
2) Where the Claims Get Narrow: What Dependent Claims Add
The dependent claims add constraints in four buckets: (i) adverse event absence, (ii) postpartum timing, (iii) indication list and subtypes, and (iv) subject demographics.
Adverse event limitation (absence of infant effects)
Two dependent claim sets explicitly require that the infant does not experience particular effects:
- Claim 2: infant does not experience agitation, insomnia, anorexia, or reduced weight gain due to solriamfetol exposure.
- Claim 9: same structure, for Claim 6.
- Claim 14: same structure, for Claim 12.
- Claim 7 / 15: specify adverse events as the set: agitation, insomnia, anorexia, reduced weight gain.
From a scope perspective, “infant does not experience” language narrows the method’s proof burden in enforcement, because defendants can focus on whether those outcomes were absent or attributable.
Postpartum window limitation
The claims constrain the breastfeeding subject’s postpartum age:
- Claim 3: subject is 1 day to 24 months postpartum.
- Claim 4: subject is 10 days to 12 months postpartum.
- Claim 10: subject is 1 day to 24 months postpartum, for Claim 6.
- Claim 11: subject is 10 days to 12 months postpartum, for Claim 6.
- Claim 16: subject is 1 day to 24 months postpartum, for Claim 12.
- Claim 17: subject is 10 days to 12 months postpartum, for Claim 12.
This creates multiple “subpopulations” within the family, with the narrowest postpartum sub-window being 10 days to 12 months.
Indication limitation (what maternal condition triggers solriamfetol dosing)
Dependent claim sets define which disorders the maternal subject is being treated for:
- Claim 5 (for Claim 1): narcolepsy, excessive daytime sleepiness, OSA, ADHD, depression, cognitive impairment, binge eating disorder.
- Claim 8 (for Claim 6): same list.
- Claim 13 (for Claim 12): narcolepsy, excessive daytime sleepiness, OSA, cognitive impairment, ADHD, depression, binge eating disorder.
Additional dependent language further refines the “excessive daytime sleepiness due to” etiology:
- Claim 19 / 20 / 21: excessive daytime sleepiness due to:
- narcolepsy
- obstructive sleep apnea
- major depression
- shift work disorder
- Parkinson’s disease
From an infringement framing perspective, this reduces scope against “off-label” or alternative etiologies unless the method is used for a covered diagnosis as written.
Subject age limitation
- Claim 18 (for Claim 12): subject is a woman 18 to 45 years.
That limitation does not appear in the Claim 1 or Claim 6 branches, which makes Claim 12’s demographic constraint narrower.
3) What Is the “Core Infringement Engine”?
Across claims 1, 6, and 12, the central limiting triad is:
- Maternal dosing: once daily at approximately 150 mg
- Feeding timing: breast milk feeding ≥ about 5 hours after maternal dose
- Quantified exposure outcome: infant daily solriamfetol dose ≤ about 0.3 mg
The exposure cap is not qualitative; it is a numeric threshold. That makes the claim family’s technical breadth hinge on whether a practitioner’s regimen (even if clinically similar) achieves an infant exposure at or below that level.
4) How Broad Is the Scope in Practice? A Boundary Map
What is clearly in-scope
- Maternal solriamfetol dosing regimen that matches the claim language (once daily, about 150 mg).
- Breastfeeding schedules that delay feeding until at least about 5 hours post-dose.
- Methods where the resulting infant exposure is ≤ 0.3 mg/day.
- Maternal postpartum time within 1 day to 24 months, unless the particular claim asserted is limited to narrower postpartum windows (10 days to 12 months).
- Indications limited to those enumerated in dependent claims when those dependent claims are asserted.
What is likely out-of-scope by claim structure
- Regimens that differ materially in:
- dose level away from “about 150 mg,” or
- timing that is less than about 5 hours, or
- infant exposure that exceeds about 0.3 mg/day.
- Off-label maternal uses for conditions not listed in dependent claim indications, when a plaintiff relies on those narrower dependent claims.
- Breastfeeding where the infant is not fed at least about 5 hours after the maternal dose.
A key strategic nuance
The family includes claims that target both:
- the method outcome (exposure limited), and
- an adverse-event risk reduction framing (infant does not experience defined effects).
That dual framing can matter when the factual proof of infant exposure is contested.
5) Patent Landscape: How This Likely Interacts With Solriamfetol Ownership
What this patent is positioned to protect
US 11,771,666 is not a new solriamfetol chemical entity or core pharmacological composition claim (based on the claim text provided). It is a use and regimen patent: a specific breastfeeding management method tied to solriamfetol exposure control.
In the broader US solriamfetol ecosystem, patents commonly fall into at least three practical buckets:
- Compound / composition of matter
- Therapeutic use for specific indications
- Dosing regimens, patient subgroups, and risk mitigation strategies (which is where this patent sits)
Even without asserting specific document numbers beyond this one, this family’s claim structure indicates it is intended to control a clinical workflow for breastfeeding while maintaining infant exposure below a quantified threshold.
How enforceability is typically shaped for regimen patents like this
Regimen patents often face proof challenges tied to:
- whether the accused patient management matched the claimed schedule precisely enough (“about 5 hours” and “about 150 mg”),
- whether infant exposure truly was below 0.3 mg/day, and
- whether alleged adverse outcomes do or do not occur for dependent claims.
The inclusion of an adverse event absence limitation in dependent claims can be used either to tighten scope or to reduce ambiguity around clinical success criteria.
Competitive design-around space
Competitors or clinicians aiming to avoid the claim would generally target one of the triad elements:
- shift maternal dose away from “about 150 mg,”
- adjust breastfeeding timing so it is not ≥ about 5 hours, or
- accept/produce infant exposure > 0.3 mg/day (though that would conflict with the patent’s risk-reduction objective and could raise ethical/regulatory issues).
Because the claims are anchored to “about 0.3 mg or lower,” a design-around that maintains breastfeeding but results in higher quantified exposure would likely avoid literal infringement but could be clinically unacceptable. A design-around based on “different evidence of exposure” would depend on how “about” is interpreted in the infringement analysis.
6) Claim Chart Style Summary (Fast Decision Use)
US 11,771,666: claim coverage matrix
| Claim |
Coverage type |
Maternal postpartum constraint |
Indication constraint |
Infant outcomes constraint |
| 1 |
Reduce infant exposure |
1 day to 24 months (via dependent 3 only) |
disorder specifics via dependent 5 |
none in independent; possible via dependent 2 |
| 2 |
Adds infant no adverse events |
via claim 1 + claim 3 if combined |
via claim 5 if combined |
Agitation/insomnia/anorexia/reduced weight gain absent |
| 3 |
Adds postpartum window |
1 day to 24 months |
none |
none |
| 4 |
Narrows postpartum window |
10 days to 12 months |
none |
none |
| 5 |
Adds indication list |
via claim 3 |
narcolepsy/EDS/OSA/ADHD/depression/cognitive impairment/binge eating disorder |
none |
| 6 |
Decrease potential adverse events (exposure-limited workflow) |
via dependent 10 |
via dependent 8 |
none in independent; via dependent 7/9 |
| 7 |
Defines adverse events |
none |
none |
one or more of agitation/insomnia/anorexia/reduced weight gain |
| 8 |
Adds indication list |
via 10 |
narcolepsy/EDS/OSA/ADHD/depression/cognitive impairment/binge eating disorder |
none |
| 9 |
Adds infant no adverse events |
via 10 |
via 8 if combined |
agitation/insomnia/anorexia/reduced weight gain absent |
| 10 |
Adds postpartum window |
1 day to 24 months |
none |
none |
| 11 |
Narrows postpartum window |
10 days to 12 months |
none |
none |
| 12 |
Treat disorder + manage exposure/adverse events |
via dependent 16 |
via dependent 13 |
via dependent 14/15 |
| 13 |
Adds indication list |
via 16 |
narcolepsy/EDS/OSA/cognitive impairment/ADHD/depression/binge eating disorder |
none |
| 14 |
Adds infant no adverse events |
via 16 |
via 13 if combined |
agitation/insomnia/anorexia/reduced weight gain absent |
| 15 |
Defines adverse events |
none |
none |
one or more of agitation/insomnia/anorexia/reduced weight gain |
| 16 |
Adds postpartum window |
1 day to 24 months |
none |
none |
| 17 |
Narrows postpartum window |
10 days to 12 months |
none |
none |
| 18 |
Adds maternal age |
via 16 (if combined) |
via 13 (if combined) |
none |
| 19-21 |
Refine etiology for excessive daytime sleepiness |
via 5/8/13 |
etiology includes major depression, shift work disorder, Parkinson’s disease (as applicable) |
none |
Key Takeaways
- US 11,771,666 is a regimen patent for breastfeeding exposure management of solriamfetol, anchored to a once-daily ~150 mg dose and breastfeeding ≥ about 5 hours post-dose to achieve an infant daily exposure ≤ about 0.3 mg.
- The claim family expands coverage through dependent claims on postpartum timing, maternal age, indication lists, and infant adverse event sets (agitation, insomnia, anorexia, reduced weight gain).
- The most consequential boundary for infringement is the quantified infant exposure threshold (≤ ~0.3 mg/day) plus the timing floor (≥ ~5 hours); indication list constraints apply primarily when narrower dependent claims are asserted.
- In the broader solriamfetol patent landscape, this family is best classified as a patient subgroup and risk mitigation/dosing workflow layer, not as a core compound or broad therapeutic use claim.
FAQs
1) What is the single most important technical limiter in US 11,771,666?
The regimen must reduce the infant’s daily solriamfetol dose to about 0.3 mg or lower by combining ~150 mg once-daily maternal dosing with breastfeeding ≥ about 5 hours after the dose.
2) Does the patent require a specific breastfeeding method beyond timing?
The claims require that the infant is fed breast milk from the treated human subject, and that feeding occurs at least about 5 hours after dosing; they do not add additional feeding composition constraints in the text provided.
3) Are only certain solriamfetol indications covered?
The independent claim language is structured around “a disorder treatable with solriamfetol,” while dependent claims list specific disorders. Indication-specific scope is strongest when asserting dependent claims that enumerate those disorders.
4) How do adverse-event claims change scope?
Dependent claims can require that the infant does not experience defined adverse events or define adverse events as specific categories (agitation, insomnia, anorexia, reduced weight gain), tightening clinical outcome criteria.
5) What postpartum or demographic constraints appear?
Postpartum windows appear as 1 day to 24 months and 10 days to 12 months in dependent claims. Maternal age constraint appears as women 18 to 45 years in one dependent claim path.
References (APA)
[1] United States Patent US 11,771,666 (claims as provided in user prompt).
