Patent 10,376,661 Landscape: Scope and Claim-by-Claim Coverage for Ampoule Opening and Wettability-Controlled Aerosol Device Components
United States Patent 10,376,661 claims a specific ampoule opening element and an aerosol generation device architecture in which a second member positioned in or on a conduit partitions the conduit into multiple axial sections and, critically, has higher wettability (lower contact angle) than the conduit-defining surface so fluid is guided into an aerosol generation pathway by gravitational force. The claims are drafted to cover both component-level infringement (opening element) and system-level infringement (opening element integrated with a vibrating membrane aerosol generating element, including perforated membranes, plus patient interface features).
What does US patent 10,376,661 claim cover in plain terms?
Core claim theme. The patent covers an opening element used to open an ampoule within an aerosol generation device. The opening element has:
- A first member defining a conduit that guides fluid out of the ampoule.
- A second member arranged inside or on the conduit that:
- partitions the conduit into at least two sections aligned in the axial direction (fluid flow direction),
- guides the fluid into the device by gravitational force, and
- has greater wettability than the conduit-defining surface, defined by contact angle differences.
Litigation-relevant consequence. Infringement analysis will center on whether an accused device uses a conduit with an insert or internal element that (a) partitions the conduit into axial sections and (b) changes fluid handling through a measurable wettability differential (lower contact angle by at least specified thresholds in dependent claims).
Claim dependencies that narrow coverage
- Independent claim 1 covers the opening element including the wettability differential, partitioning geometry, and gravitational guidance.
- Dependent claims 2–7 narrow the second member’s geometry, extent, contact, and mechanical state.
- Dependent claims 8–10 narrow shapes and where openings for ampoule opening occur.
- Dependent claims 12–15 narrow material selection and material pairing.
- Dependent claims 16–17 narrow contact angle delta thresholds.
- Claims 18–20 move from the opening element to an aerosol device system with a vibrating membrane aerosol generator and patient-facing delivery parts.
What is the scope of independent claim 1 (opening element)?
Claim 1 structure
Claim 1 is composed of coupled limitations that must all be met:
A. Structural system
- “An opening element for opening an ampoule in an aerosol generation device”
- First member has:
- “a conduit extending therethrough”
- “for guiding a fluid contained in the ampoule through the first member”
- Second member:
- “arranged at least partly inside or on the conduit”
- “guides the fluid into the aerosol generation device by gravitational force”
- has a wettability condition relative to the conduit surface:
- “entire surface of the second member has a higher degree of wettability … than a surface of the first member defining the conduit”
- “wettability … defined by a contact angle”
- “entire surface of the second member has a smaller contact angle than the surface of the first member defining the conduit”
- “partitions the conduit into at least two sections”
- each section extends in an axial direction of the conduit
- and the sections are “arranged next to each other in a direction perpendicular to the axial direction.”
B. Geometric meaning of “axial direction” + partition layout
- Axial direction = direction of fluid flow through conduit.
- “Next to each other” perpendicular to axial direction indicates lateral side-by-side partitioning, not simply a single divider wall upstream.
C. Wettability limitation is “entire surface”
- The claim requires the wettability differential for the entire surface of the second member, not a partial region.
- That drafting supports enforcement by focusing on surface chemistry/coatings/material selection over only part of the interface.
Practical enforcement posture
A court or ITC fact pattern will likely hinge on:
- Whether the “second member” is actually inside/on the conduit in a way that partitions into two or more axial sections.
- Whether gravitational guidance is a functional requirement tied to structure rather than a separate, purely descriptive feature.
- Whether contact angle evidence can be obtained (device materials and manufacturing controls).
How do dependent claims 2–7 further define the second member’s geometry and function?
Claim 2: Second member extends across conduit width
- “At least a portion of the second member extends across the width of the conduit”
- “a plane of the second member is parallel to the axis of the conduit”
Impact: Captures “crosswise” partitions where a planar element spans the conduit width while aligning lengthwise with fluid flow axis.
Claim 3: Second member extends along entire conduit length
- “at least a portion of the second member extends along the entire length of the conduit”
Impact: Covers inserts running through the axial length rather than short plugs.
Claim 4: Substantially planar second member
Impact: Narrows to planar structures (e.g., blade-like or plate-like parts), not fully cylindrical or complex 3D geometries.
Claim 5: Circumferential extension
- “at least partly extends along the circumference of the conduit”
Impact: Adds a radial coverage dimension; second member may wrap partially around the conduit interior.
Claim 6: Second member contacts conduit-defining surface
- “at least partly in contact with a surface of the first member defining the conduit”
Impact: Useful where the second member is seated, bonded, or physically joined to the conduit surface.
Claim 7: Resilient second member in compressed or locked state
- “resilient”
- arranged inside/on conduit in “at least partly compressed state or locked”
Impact: Captures clip-spring style inserts, interference-fit elements, or mechanically retained partitions.
What shape constraints exist for the first member and ampoule opening features?
Claim 8: First member substantially cylindrical
- “first member has a substantially cylindrical shape”
Impact: Likely targets typical conduit housing geometry and supports manufacturing feasibility arguments.
Claims 10–11: Opening portions for ampoule opening
- Claim 10: first member has an “opening portion for opening the ampoule”
- Claim 11: second member also has an “opening portion for opening the ampoule”
Impact: Two alternative embodiments: ampoule puncture/opening can be on either member.
Key scope consequence: Devices that open ampoules via a separate upstream piercer element may fall outside unless the opening “portion” is on the recited member(s) within the claimed opening element structure.
How do material and wettability delta dependent claims narrow infringement risk?
Claim 12–15: Material selection
- Claim 12: second member is “made of a metal.”
- Claim 13: first member is “made of a polymer.”
- Claim 14: first member material differs from second member material.
- Claim 15: second material has “higher degree of wettability” than first material.
Enforcement utility: These claims support a “materials pairing” narrative for thermoplastic conduit housings with metallic wetting-enhancing inserts, but dependent claims also provide fallback coverage if a higher-level assertion focuses on general structure rather than material identity.
Claims 16–17: Contact angle threshold deltas
- Claim 16: entire second member contact angle is 5° or more smaller than conduit surface.
- Claim 17: entire second member contact angle is 20° or more smaller.
Why these matter commercially and in litigation:
They create measurable thresholds useful for expert testing and for distinguishing close substitutes. They also support summary adjudication strategies where measured contact angles are available.
What does independent claim 18 add: aerosol generation device with vibrating membrane and fluid communication?
Claim 18 is the system claim that incorporates the opening element limitations of claim 1 and adds an aerosol generator setup:
Added limitations in claim 18
- Includes “aerosol generation device”
- Includes opening element with:
- first member conduit,
- second member gravitational guidance and wettability differential,
- partitioning into at least two axial sections laterally arranged.
- Adds “aerosol generating element” comprising:
- Adds “fluid communication” so fluid flows:
- ampoule → opening element → onto vibrating membrane
Claim 19: Perforated vibrating membrane
- “vibrating membrane is a perforated vibrating membrane”
Impact: A narrower version targeting common membrane designs with through-holes.
Claim 20: Mouthpiece/mask/nosepiece
- adds patient delivery interface elements.
How broad is the wettability requirement: does it force specific coating chemistry?
The claims do not require a particular coating mechanism, but they do require that:
- “an entire surface of the second member” has higher wettability than “a surface of the first member defining the conduit,”
- defined by contact angle, and
- “entire surface” of the second member has a “smaller contact angle.”
So the claim scope covers any approach that yields the contact-angle differential, including:
- inherent material surface energy differences (e.g., metal vs polymer),
- surface treatments,
- surface roughness changes,
as long as the measured contact angle condition is satisfied under the claim’s definition.
Practical consequence: Infringement can turn into a materials science fight (testing method, wetting conditions, aging effects), especially because the claim language is tied to contact angle at which a fluid interface meets the surface.
How does the partitioning limitation constrain design-arounds?
Claim 1 requires:
- “second member partitions the conduit into at least two sections”
- sections extend in axial direction
- positioned next to each other perpendicular to axial direction
Design-around options (at least in claim language terms) include:
- removing the axial-section partitioning feature (e.g., using a non-partitioning insert),
- using a second member that partitions in a non-axial way (e.g., partitions across the flow axis rather than axially aligned sections),
- using a structure that routes fluid without gravitational guidance tied to the second member’s presence.
Because the second member must also have higher wettability and guide by gravitational force, an insert that partitions mechanically but does not change wettability (or fails the contact angle requirement) is a likely non-infringing candidate for a worst-case assertion of claim 1.
What product architectures are most at risk under US 10,376,661?
The claim set is most directly aligned with:
- breath-actuated or device-borne ampoule-to-membrane nebulization systems,
- devices where an ampoule is opened inside a nozzle/conduit assembly,
- systems with a membrane-type aerosol generator where liquid is delivered onto a vibrating membrane,
- designs using an internal or inserted member positioned in the outlet conduit that improves wetting to promote gravity-driven flow.
If the accused product uses:
- vibrating membrane,
- conduit partitioning by an insert,
- and a wettability differential between insert and conduit surface measured as contact angle,
the scope is strong.
Timeline and exclusivity exposure: what matters for filing and expiration analysis?
This prompt provides claim text only. It does not provide:
- filing date, priority date, or publication number for US 10,376,661,
- prosecution history,
- prosecution disclaimer excerpts,
- any terminal disclaimer terms,
- PTA calculations,
- maintenance fee status, or
- related continuations/divisionals that expand or narrow scope.
Because those elements determine enforceable expiration windows and any family-based “claim set stacking,” a complete and accurate exclusivity timeline cannot be produced from the supplied information alone.
How many patents cover the same technology space? (US patent estate mapping)
A full “landscape” requires at least:
- application publication numbers for the family,
- INPADOC family members,
- assignees and cited references,
- parallel filings (EP, WO),
- and whether there are continuations that keep the same concept alive in related claim sets.
The supplied information is limited to the claims of US 10,376,661. Without the patent bibliographic record and cited-family map, a complete patent estate count and jurisdiction-by-jurisdiction coverage cannot be produced accurately.
What is the strongest claim anchor for enforcement: claim 1 vs claim 18?
- Claim 1 is the strongest “component” hook because it is not tied to the vibrating membrane. It requires only the opening element architecture and wettability/partitioning/gravity-guided flow.
- Claim 18 is the strongest “system” hook because it adds the vibrating membrane device and fluid pathway from ampoule through the opening element onto the membrane.
In litigation strategy, claim 18 typically benefits from clearer end-user evidence (the assembled aerosol device) and can narrow the factual disputes to device operation plus structural correspondence. Claim 1 can be asserted against suppliers or component-level makers if they provide the opening element as an accused product.
Key takeaways
- US 10,376,661 claims a wettability-differentiated conduit partitioning opening element where a second member creates at least two axially extending conduit sections and improves liquid delivery by gravitational force using a contact-angle-defined wetting differential.
- The independent system claim (18) locks the architecture to an aerosol generation device with a vibrating membrane (and dependent 19 targets perforated membranes).
- Dependent claims tighten infringement risk using measurable thresholds (contact angle differences of ≥5° and ≥20°), and specific materials (metal insert + polymer conduit).
- The claim drafting emphasizes “entire surface” contact angle and axial partition geometry, two points that can be decisive in both infringement and design-around evaluation.
FAQs
What surface wettability metric does US 10,376,661 require to prove infringement?
It defines wettability by contact angle and requires the second member’s entire surface to have a smaller contact angle than the conduit-defining surface.
Does US 10,376,661 require a perforated vibrating membrane?
No. Perforation is only in dependent claim 19. Independent claim 18 only requires a vibrating membrane.
Can a design that partitions the conduit in a non-axial direction avoid claim 1?
If it does not “partition the conduit into at least two sections” that “each extend in an axial direction” and are “next to each other” perpendicular to axial direction, it can fall outside claim 1’s geometry.
Is gravitational force a standalone functional limitation or tied to structure?
Claim 1 requires that the second member “guides the fluid … by gravitational force,” tying liquid delivery behavior to the claimed second-member arrangement.
Which dependent claims provide the clearest numerical infringement thresholds?
Claims 16 and 17 specify contact angle differentials: ≥5° and ≥20° (second member smaller than conduit surface).
References
- United States Patent 10,376,661. Claims as provided in prompt.
