United States Patent 11,676,691: What the Claims Actually Cover and How the Landscape Stacks Up
What is US 11,676,691 Claiming, in Plain Technical Terms?
US 11,676,691 claims a hand-actuated delivery apparatus that contains a drug-containing tablet (with multiple claims specifying sufentanil and tablet dosing/size) and uses relative distal movement of a “delivery member” within a “housing” to deform a distal portion of the housing (or a housing tip) to create an opening through which the tablet is expelled.
Across the claim set, the core mechanical pattern is consistent:
- A housing defines an actuation pathway and has a distal end portion.
- A delivery member sits partly in that pathway.
- In an unactuated position, a volume is defined between distal surfaces of the housing and distal surfaces of the delivery member to contain a drug-containing tablet.
- When actuated, the delivery member moves distally to:
- expel the tablet from the volume, and
- deform a distal portion of the housing (or a deformable distal tip) to form an opening.
- The delivery member has protrusions and/or is supported by a channel/bridge/safety member to limit motion:
- Proximal direction retention (cannot be removed proximally through an opening).
- Distal direction stroke limiting (prevents overtravel).
The claims then layer on variants: recessed portions, sloped/concave geometries, bridge resistance with threshold deformation, deformable tips, and different housing multi-part architectures.
What does Claim 1 Establish as the Independent Core?
Claim 1 is the foundational independent claim. It establishes four enforceable pillars:
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Actuation architecture
- Housing defines an actuation pathway and has a distal end portion.
- Delivery member includes a portion disposed in the pathway.
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Tablet-holding volume
- Distal end portion of the delivery member and distal end portion of the housing define a volume configured to contain a drug-containing tablet.
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Distal actuation and housing deformation
- Distal movement of the delivery member expels the tablet.
- Distal end portion of the delivery member engages the distal end portion of the housing to deform the distal end portion and produce an opening through which the tablet is expelled.
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Bidirectional stroke control
- First protrusion limits proximal movement relative to the housing.
- Second protrusion limits distal movement relative to the housing.
This claim is broad on the drug payload (tablet generally), but it becomes narrower in dependent claims by specifying sufentanil and specific dose ranges.
Which Dependent Claim Features Create the Differentiating “Claim Ladders”?
Geometry and deformation mechanics
- Claim 2 (sloped surfaces): adds “sloped surface” engagement between distal end portions to deform the housing and produce the opening.
- Claim 8 (concave structure): the delivery member distal end has first and second sloped portions with a concave portion between them.
- Claim 13 (dual sloped engagement with flexing distal tip): introduces a recessed portion and a distal tip in the housing that is flexed by first and second sloped surfaces engaging opposite sides.
These add detail to how deformation is produced, potentially narrowing the claim scope to particular mechanical geometries.
Housing multi-part architecture and pre-formed volume
- Claim 4: housing includes first and second portions whose distal end portions overlap before actuation; the tablet-holding volume is at least partially defined between the overlapping distal portions even before the delivery member moves distally.
- Claim 6: at least one housing portion is flexibly deformable when the delivery member moves distally.
- Claim 21: specifies a deformable distal tip in the housing and explicitly states that the recessed portion of the distal delivery member and the deformable tip collectively define the volume in the unactuated state; actuation flexes the tip to create an opening.
These claims emphasize pre-formed containment rather than “tablet introduced later.”
Recessed distal end embodiment
- Claim 12: replaces the Claim 1 style distal engagement with a delivery member distal end having a recessed portion, while still requiring that the recessed delivery member portion and distal housing portion define the tablet volume before actuation and that flexible deformation produces the opening.
- Claim 13: further specifies sloped surfaces spaced apart by the recessed portion.
This recessed feature is likely intended to differentiate from designs that rely purely on a smooth distal face engagement.
Retention and safety mechanism options
- Claim 3: adds a removable safety member configured to contact the delivery member and limit distal movement in the distal direction.
- Claim 15: adds a safety member contacting a portion of the delivery member to limit distal movement.
- Claim 11 and Claim 16: introduce a channel between the actuation pathway and exterior surface, with a protrusion slidably disposed in that channel, and an edge configured to limit distal movement.
Bridge / threshold deformation mechanics
- Claim 7: adds a bridge configured to engage the delivery member, with a portion separable from the housing when delivery member moves distally.
- Claim 17: adds a bridge member that resists distal movement and deforms when force exceeds a predetermined threshold.
This is a mechanical trigger concept: the bridge provides resistance until a force limit is reached, shaping the stroke and deformation profile.
Proximal opening retention, preventing removal
- Claim 18: specifies the proximal end portion of the housing defines a first opening and the proximal end portion of the delivery member extends through it in the unactuated state; a protrusion engages housing to limit proximal movement so the delivery member cannot be removed through the first opening.
This is an important safety and usability limitation: it turns the proximal opening into a structured retention constraint.
Sublingual delivery intention
- Claim 20: states the device is configured to enable delivery to a sub-lingual mucosal membrane.
- Claim 9 and Claim 19: tie drug content to sufentanil.
What is the Drug-Specified Scope: Sufentanil Dose and Tablet Size
Sufentanil in dependent claims
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Claim 9: tablet includes a dosage of sufentanil.
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Claim 10: specifies an amount selected from:
- 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 100 mcg
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Claim 10 also constrains physical properties:
- tablet volume < 30 microliters OR mass < 30 mg
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Claim 19 mirrors drug specification (sufentanil) in the claim set around Claim 12’s apparatus configuration.
Landscape implication of the tablet constraints
Dose and micro-scale volume/mass restrictions can narrow infringement to:
- sufentanil formulations meeting those ranges; and
- tablets designed for rapid mucosal delivery with tiny payload volumes.
From an enforcement standpoint, this suggests the broader mechanical claims may still cover devices using tablet-containing payloads, but the strongest pharmaceutical-specific hooks sit in these dependent claims.
Two Independent Apparatus Claim Families: Claim 1 vs Claim 12 and Related Variants
The claim text provided includes three distinct “apparatus” claim blocks:
- Claim 1 family: housing actuation pathway, distal engagement, deforming distal end portion, and bidirectional protrusion-based stroke limiting; dependent claims add slopes, safety member, multi-part housing, channels, concave geometry, and sufentanil tablet payload.
- Claim 12 family: includes a housing with first and second portion defining actuation pathway; delivery member distal end has a recessed portion; housing portions flexibly deform; dependent claims add deformable distal tip with dual sloped surfaces; safety member; channel and protrusion; bridge with threshold deformation; proximal opening retention; and sulfentanil payload and sublingual delivery.
- Claim 22: adds a proximal opening structure and a deformable distal tip concept in a more explicitly “mechanism locked in housing” form, including protrusions that limit proximal removal.
The practical effect: multiple routes to claim coverage exist, each tied to a specific housing/delivery member interface and motion/retention scheme.
How the Claims Likely Map to Product Design Variants (Infringement-Directed)
Likely “covered” design patterns
- A distal push mechanism that:
- contains a mini tablet in a defined internal volume; and
- creates an opening by deforming the distal housing tip.
- Stroke limitation via:
- at least two protrusions (or a protrusion plus channel sliding) to control proximal and distal motion.
- At least one of:
- sloped/concave engagement surfaces,
- multi-part housing overlap defining the volume in the unactuated state,
- a deformable distal tip flexed by opposed sloped surfaces,
- a bridge resisting force and deforming after a threshold.
Likely “design-around” pressure points (mechanical)
- If a competitor forms the tablet expelling opening by:
- opening a rigid latch,
- using a separate door that rotates or translates rather than deforming a tip,
- expelling the tablet with a plunger that does not deform the housing distal end to create the expelling opening,
- relying on chemical or thermal actuation instead of distal mechanical deformation,
- using a different containment/expulsion geometry that avoids the recessed/protrusion/channel/bridge features,
then these claims face reduced applicability.
The claims’ repeated emphasis on distal engagement deforming the housing and opening formation means that the mechanical deformation trigger is a key distinguishing attribute.
Claim Scope: What is Broad vs What is Narrow
Broad elements (available in Claim 1 and not necessarily limited by drug specifics)
- Apparatus housing defining actuation pathway.
- Delivery member moves distally to expel tablet.
- Distal engagement deforms housing to create an opening.
- Protrusions limit proximal and distal movement.
Narrow elements introduced mainly by dependent claims
- Sloped surfaces, concave features.
- Recessed portion in the delivery member distal end.
- Deformable distal tip and dual-sided sloped flexing.
- Specific multi-part housing overlap defining volume before actuation.
- Removable safety member.
- Channel and slidably disposed protrusion in that channel.
- Bridge member with predetermined threshold for deformation.
- Proximal opening with retention to prevent removal.
- Drug constraints: sufentanil dose list and tablet volume/mass limits.
- Sublingual configuration.
Patent Landscape Read: Competitive and Portfolio Considerations
What the claims indicate about the inventive focus
This family is positioned as a mechanical delivery system for ultra-small dosage tablets, aimed at controlled expulsion to the sublingual mucosa, with a deformable distal tip approach rather than a purely rigid gate. The presence of bridge threshold language and channel/protrusion retention suggests engineering emphasis on:
- repeatable stroke,
- retention safety,
- predictable opening creation,
- and packaging usability.
How this shapes the competitive field
Likely crowded zones include:
- devices that expel orally/sublingually using a mechanical plunger,
- dosage forms for sufentanil and other potent opioids,
- mini-tablet or micro-dose formats,
- and safety-actuated dispensing mechanisms.
The differentiator for US 11,676,691 is the specific mechanical requirement: the distal end engagement deforms the housing distal portion to produce an opening through which the tablet is expelled, combined with bidirectional motion limiting structures.
Portfolio risk posture for adjacent tech
For any competitor device:
- If it relies on deformation of a housing distal tip caused by distal motion of an internal delivery element, risk increases.
- If it uses alternate expulsion mechanics that do not deform the housing distal end to create the expelling opening, the risk may drop even if the user experience is similar.
Key Takeaways
- US 11,676,691 claims a distal-actuated, deformation-based tablet expulsion device where a delivery member moves distally in a housing, deforming the housing distal portion to create an opening that expels a contained tablet.
- Claim 1 anchors the core infringement hook: housing actuation pathway + distal engagement to deform the housing and produce an opening + first and second protrusions limiting proximal and distal movement.
- A second apparatus family (Claim 12 and dependent claims) adds a recessed distal portion and flexibly deformable housing features, including specific embodiments with deformable distal tips and sloped engagement surfaces.
- Several dependent claims narrow to sufentanil payloads with explicit dosage levels (5 to 100 mcg) and tablet physical constraints (volume < 30 µL or mass < 30 mg).
- Device design-around most effectively targets the mechanism requiring distal engagement that deforms the housing distal portion to form the expelling opening, or substitutes different motion retention and opening formation structures.
FAQs
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Does US 11,676,691 require sufentanil in all claims?
No. Sufentanil appears in dependent claims (e.g., Claims 9 and 19), while Claim 1 and Claim 12 cover drug-containing tablets more generally.
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What is the key mechanical limitation that defines the expulsion opening?
The delivery member’s distal engagement deforms the housing distal portion to produce an opening through which the tablet is expelled.
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What do the first and second protrusions accomplish?
They limit relative movement of the delivery member versus the housing in proximal and distal directions, respectively.
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Where does the recessed portion matter?
In the Claim 12 family, the delivery member distal end includes a recessed portion that, with the distal housing portion, defines the tablet-containing volume before actuation.
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What additional constraints appear when the device is drug-and-dose specific?
Dependent claims specify sufentanil dosage options and tablet size metrics (volume < 30 microliters or mass < 30 mg).
References
[1] US Patent No. 11,676,691. Claims provided in prompt text.
