US Patent 10,722,667: Scope, Claim Construction, and US Landscape for Nasal Powder Sumatriptan Delivery via Bi-Directional Exhalation
US Patent 10,722,667 claims a device for delivering powdered sumatriptan to a subject’s nasal cavity using an oral exhalation-driven airflow that closes the oropharyngeal velum and produces a bi-directional exhalation flow between nasal passages. The independent claims define a coupled mouth/nose interface, a nosepiece that expands in the nasal valve, a trap between the powder reservoir and the nosepiece, and a specific powder particle size distribution.
The patent’s enforceable value is tied to three claim pillars that narrow the scope:
1) Airflow mechanism requiring oral exhalation to close the velum and route flow bidirectionally through both nasal passages.
2) Specific nasal valve-expanding nosepiece geometry/function.
3) Powder particle size distributions with multiple percentile cutoffs.
What do the claims protect? (Core independent claim scope)
Independent claim 1 (nosepiece-only version)
Claim 1 protects a nasal powder delivery device with the following mandatory elements:
A. Nasal interface
- A nosepiece configured to fit a nostril
- The nosepiece extends into the nostril
- The nosepiece expands at least a portion of a nasal valve
B. Powder reservoir
- A substance containing unit connected to the nosepiece
- The unit contains powdered sumatriptan to deliver to the nasal cavity
C. Powder PSD (particle size distribution)
Powder must meet all listed PSD constraints:
- At least 10% particles < about 20 μm
- At least 50% particles < about 50 μm
- At least 50% particles > about 30 μm
- At least 90% particles < about 150 μm
D. Trap
- A trap disposed between the substance containing unit and the nosepiece
E. Airflow/physiology mechanism
Device must be configured such that:
- When nosepiece is fitted to the nostril, oral exhalation through the substance containing unit and the nosepiece
- Acts to close the oropharyngeal velum
- Produces an exhalation flow passing into one nasal passage and out of the other nasal passage
- This yields a bi-directional exhalation flow for nasal delivery
Logical effect: the patent does not protect generic nasal insufflation of sumatriptan powder. It protects a specific hardware + powder spec + airflow routing scheme.
Independent claim 9 (mouthpiece + nosepiece version)
Claim 9 protects a broader “full mouth-to-nose” delivery geometry by adding a mouthpiece and explicitly requiring flow through the mouth.
Mandatory elements mirror claim 1 with these differences:
Additional elements
- Mouthpiece configured to fit an oral cavity
- The device is configured so that, with nosepiece fitted and mouthpiece fitted:
- Oral exhalation through the mouthpiece
- through the substance containing unit
- through the nosepiece
- closes the oropharyngeal velum
- produces the same bi-directional nasal passage flow
Element included
- Same nosepiece expanding the nasal valve
- Same trap between reservoir and nosepiece
- Same PSD constraints for the powdered sumatriptan
Additional functional limitation absent in claim 1: claim 9 requires explicit presence/use of the mouthpiece and that exhalation passes through mouthpiece and reservoir before reaching the nosepiece.
How do the dependent claims narrow scope? (Substantive claim-by-claim map)
Chemical identity constraints
- Claim 2: powdered sumatriptan comprises sumatriptan base or sumatriptan succinate
- Claim 10: same, applied to claim 9
- Claim 3: only sumatriptan succinate; no introduced excipients or adjuvants
- Claim 11: same, applied to claim 9
Impact:
- Claims 3/11 narrow to succinate-only, no added excipients.
- Claims 2/10 allow either base or succinate, keeping broader coverage.
Container/dosing form constraints
- Claim 4: powder disposed in a substance container
- Claim 12: same, applied to claim 9
- Claim 5: container is a capsule
- Claim 7: powder disposed in a capsule (even without explicitly reciting container in the claim preamble; still narrows)
- Claims 6 and 14: capsule contains a 10 mg dose
- Claims 13 and 15: capsule container applied to claim 9 and 9’s dependent hierarchy
Impact:
If competitors use cartridges/blisters instead of capsules, they may fall outside these dependents. Independent claims (1 and 9) do not require a capsule.
Alternative PSD “tightened” lower-end and upper-end
- Claim 8:
- at least 10% < about 10 μm
- at least 90% < about 90 μm
- Claim 16: same applied to claim 9
Impact:
Claims 8/16 further narrow particle distribution. A powder meeting claim 1 PSD is not necessarily meeting claim 8/16.
Additional flow-path structure
- Claim 17: further includes a labyrinthine structure disposed between the mouthpiece and the substance containing unit (dependent on claim 9)
Impact:
This is a hardware refinement targeting the mouth-to-reservoir path.
What is the enforceability “center of gravity”? (Where infringement arguments will focus)
In practice, infringement fights for device patents turn on mapping hardware and process conditions to claim elements. Here the center of gravity is the combination of:
1) Nosepiece that expands at least a portion of a nasal valve
- Literal mapping to a compliant insert/expandable structure at the nasal valve is likely central.
- “Expands” implies mechanical deformation or expansion during fitting/use, not just passive placement.
2) Trap between reservoir and nosepiece
- A “trap” is often where design-arounds occur (e.g., moving a filter farther upstream/downstream, changing capture function, eliminating catchment).
3) Bi-directional exhalation flow via velum closure
- This is the most process/functional limitation.
- Devices that deliver by inhalation suction rather than “oral exhalation” will likely avoid the airflow requirement.
- Devices that use an actuator that does not depend on velum closure are also at risk of non-infringement.
4) Powder PSD percentiles
- These are objective and measurable with particle sizing and distribution analysis.
- The PSD requirements are uncommon and will drive whether a formulation meets the claim.
Net: a competitor’s product must satisfy a multi-element nexus: specific airflow routing, nasal valve expansion, trap placement, and PSD.
How broad are claims 1 vs 9? (Relative scope)
Claim 1 requires:
- nosepiece fitted to nostril
- oral exhalation through substance unit and nosepiece
- velum closure and bi-directional flow
It does not require a mouthpiece.
Claim 9 requires:
- both mouthpiece and nosepiece fitted
- oral exhalation through mouthpiece, then reservoir, then nosepiece
- same velum closure and bi-directional flow
Practical conclusion: Claim 1 is broader on the interface set (no explicit mouthpiece), but both claims preserve the airflow mechanism and PSD. Claim 9 adds an additional structural limitation that can reduce coverage if a competing product does not use a mouthpiece.
Claim terms most likely to become dispute points
Below are terms that will matter in claim construction and infringement mapping.
| Claim Term |
What it requires (as written) |
Why it matters |
| “Nosepiece configured to… expand at least a portion of a nasal valve” |
Mechanical expansion at/near nasal valve |
Direct hardware limitation and easy design-around candidate |
| “Trap disposed between the substance containing unit and the nosepiece” |
Capture device located between reservoir and nose |
Competitors can relocate/replace capture mechanism |
| “Oral exhalation … acts to close the oropharyngeal velum” |
Exhalation through the device closes velum |
Functional/physiology limitation that controls process |
| “Bi-directional exhalation flow” |
Flow into one nasal passage and out the other |
Requires specific airflow pattern, not just nasal delivery |
| Particle size distribution with multiple percentile constraints |
Meets all listed PSD percentiles |
Formulation-based limitation with testability |
What is the likely US patent landscape around this invention?
Landscape segmentation
The US landscape for nasal sumatriptan delivery typically clusters into:
1) Intranasal sumatriptan formulations (sprays, powders, different polymorphs/salts)
2) Devices for intranasal powder delivery (insufflation mechanisms, airflow generation)
3) Airflow-path devices with oral/nasal coupling (nasal drug delivery using controlled breathing/exhalation)
4) Particle engineering claims (PSD targets for deposition/performance)
US Patent 10,722,667 sits at the intersection of (2) powder delivery devices, (3) breathing-driven velum/bi-directional airflow concepts, and (4) explicit PSD percentile targets.
Why this matters for freedom-to-operate
-
If a competitor pursues a nasal powder sumatriptan device but changes:
- the delivery mechanism (e.g., inhalation suction, breath-actuated without oral exhalation),
- removes the trap or shifts its location,
- uses a non-expanding nasal insert,
- or uses a powder outside the PSD percentiles,
then independent claim coverage can break.
-
If a competitor uses a different salt (sumatriptan base) the independent claims still can read (claims 2/10). But dependents 3/11 (succinate-only, no excipients) would not cover those formulations.
Practical claim-scoped “design-around” map (what to avoid to stay clear)
Avoiding airflow/velum limitations
- Avoid a design that requires oral exhalation through the reservoir and nosepiece to close the velum and route airflow to both nasal passages.
- Avoid claims that depend on bi-directional flow for delivery; switching to a unidirectional deposition model can reduce risk.
Avoiding nasal valve expansion
- Use a nosepiece that does not expand nasal valve tissue during fitting (for example, a rigid tube without expansion).
Avoiding a trap positioned between reservoir and nosepiece
- Use an alternative powder management approach that does not place a trap in that location.
Avoiding PSD targets
- Use a PSD that does not meet any of these constraints simultaneously:
- ≥10% <20 μm
- ≥50% <50 μm
- ≥50% >30 μm
- ≥90% <150 μm
- If targeting narrower dependents, avoid:
- ≥10% <10 μm and ≥90% <90 μm
Key Takeaways
- US Patent 10,722,667 is a device claim anchored by: nasal valve-expanding nosepiece, trap between reservoir and nosepiece, oral exhalation that closes the oropharyngeal velum, and bi-directional nasal passage airflow.
- Coverage also depends on powder PSD percentiles, making formulation and particle engineering integral to infringement.
- Claim 9 adds a mouthpiece requirement; Claim 1 does not.
- Dependent claims narrow to sumatriptan identity (succinate-only in claims 3/11), capsule packaging and 10 mg dose (claims 5/6/7 and 12-15), and tighter PSD (claims 8/16), plus labyrinthine structure (claim 17).
FAQs
1) Does the patent cover sumatriptan base as well as succinate?
Yes. Claims 2 and 10 cover sumatriptan base or sumatriptan succinate. Claims 3 and 11 restrict to sumatriptan succinate only with no introduced excipients or adjuvants.
2) Is a capsule required to infringe independent claims?
No. Capsules are in dependent claims (e.g., claims 5, 7, 12-15). Independent claims 1 and 9 require a “substance containing unit,” not a capsule.
3) Are the particle size distribution limits optional?
No. The independent claims require the powder meet the full set of PSD percentile constraints. Dependent claims 8/16 add tighter constraints.
4) What is the practical meaning of “bi-directional exhalation flow”?
The device is configured so oral exhalation produces flow into one nasal passage and out the other, using velum closure.
5) What is the most likely design-around area?
The combination of (i) nasal valve expansion mechanism, (ii) trap location/function, and (iii) velum-closure bi-directional exhalation airflow routing, plus (iv) powder PSD.
References
[1] United States Patent 10,722,667. (n.d.). Device for delivering powdered sumatriptan to a nasal cavity using bi-directional exhalation flow. Google Patents. https://patents.google.com/patent/US10722667B2
