United States Patent 10,076,615 Scope, Claim-by-Claim Coverage, and US Patent Landscape for Nasal Delivery Device Fitting
Executive summary: US Patent 10,076,615 claims a procedure for fitting and sealing a nasal delivery device to a subject’s nostril by (i) inserting a nosepiece with a first alignment, (ii) twisting to rotate the device to a second, different alignment so the mouthpiece lines up with the subject’s mouth, (iii) sealing the nare against the nosepiece, and (iv) causing exhalation through the mouthpiece. Dependent claims add functional limitations around grip-enhancing agents, nosepiece geometry (elliptical/rectangular/tapered tip), aperture/tip element, and device subcomponents (substance supply unit, tethered nose gripping member). The patent’s enforceable scope is strongest against products and kits that are marketed or used with a twist-to-align-then-exhale fitting protocol, with auxiliary capture for variants that add finger-pressure/pulling and external grip features.
What does US Patent 10,076,615 claim, and what is the core invention?
Short answer: The core of US 10,076,615 is a method for fitting a nasal delivery device by twisting the nosepiece to change alignment and aligning a mouthpiece to the mouth so the user can exhale through the mouthpiece while the nare is sealed against the nosepiece.
Claim structure and what each step means operationally
The independent claim (claim 1) has a tight sequence:
- Insert nosepiece into one nostril with a first alignment.
- Twist/rotate the nasal delivery device in the nostril to achieve a second alignment different from first, with the mouthpiece aligned with the mouth.
- Seal the nare against the nosepiece.
- Cause exhalation through the mouthpiece.
This frames infringement around user/clinician technique plus device features that enable that technique (nosepiece, mouthpiece, alignment-changing rotation, sealing).
Where infringement is most likely to occur
Coverage is most directly implicated where:
- A device is designed to be rotated after insertion to bring a mouthpiece into line with the mouth.
- The method is performed such that exhalation is routed through the mouthpiece, not through the nose.
- The device includes a structure that makes nare sealing a functional part of the procedure (for example via the nosepiece tip geometry or an external gripping/sealing mechanism, even if not explicitly claimed as a “valve” in claim 1).
What is the scope of claim 1 (independent claim) and how broad is it?
Short answer: Claim 1 is broad in the sense that it does not require a specific delivery mechanism beyond the alignment transformation and exhale-through-mouthpiece with sealed nare. It is narrow in requiring the twist-to-rotate sequence and the second alignment that specifically aligns the mouthpiece to the subject’s mouth.
Claim 1 key limitations
- “Method of fitting a nasal delivery device to a nostril”
- Requires the method is about fitting (device placement and alignment), not merely delivery of a substance.
- “Inserting a nosepiece… with a first alignment”
- Requires an initial placement state and implies the device is capable of a meaningful alignment change.
- “Twisting the nosepiece… to rotate… to have a second alignment… in which a mouthpiece… is aligned with a mouth”
- This is a defining limitation: second alignment must be different and must align mouthpiece to mouth.
- “Sealing a nare… against the nosepiece”
- Requires a seal event (structure or method causes sealing). The claim does not specify how.
- “Causing… to exhale through the mouthpiece”
- Requires exhalation is routed through mouthpiece. It is not inhalation-focused.
Practical breadth notes (scope mapping)
- No active ingredient constraint: Claim 1 does not limit to a particular drug formulation.
- No route constraint beyond exhale flow: It is not limited to a particular airflow pattern beyond exhalation through mouthpiece.
- No nasal pressure language: It does not specify pressure thresholds.
- Alignment terms are functional: “first alignment,” “second alignment,” and “different” create flexibility for different mechanical implementations as long as rotation produces mouthpiece alignment.
Which dependent claims in US 10,076,615 narrow coverage, and by how much?
Short answer: Dependent claims add incremental restrictions on (i) grip enhancement, (ii) tip element geometry and delivery aperture, (iii) device subcomponents (substance supply unit and nose gripping member), and (iv) manual actions (pressing/pulling) that facilitate sealing.
Claim 2: grip-enhancing agent
Adds: “applying a grip-enhancing agent to an exterior surface of a nose of the subject.”
Impact on scope: narrows to methods where the operator applies an external substance to the nose (adhesive-like or grip-enhancing). Devices that rely on inherent friction without an added agent may avoid this dependent claim.
Claim 3-7: nosepiece tip element geometry and delivery aperture
- Claim 3: nosepiece comprises a tip element.
- Claim 4: tip element is substantially elliptical.
- Claim 5: tip element is substantially rectangular.
- Claim 6: tip element comprises a delivery aperture.
- Claim 7: tip element is tapered.
Impact on scope:
- Claim 3 is a structural add-on that narrows to tip-element configurations.
- Claims 4 and 5 are alternative shape limitations (elliptical OR rectangular).
- Claim 6 adds a delivery aperture on the tip element (structure needed on-device).
- Claim 7 adds a tapered form factor.
Together these capture variations in nozzle or interface design that facilitate sealing and delivery.
Claim 8-10: substance supply unit and nose gripping member
- Claim 8: nasal device comprises substance supply unit and nose gripping member.
- Claim 9: nose gripping member is tethered to a body.
- Claim 10: gripping member comprises a gripping element configured to be fixed to a nose.
Impact on scope: these claims narrow to devices with explicit gripping hardware. The tether and “fixed to a nose” language can exclude clip-on or purely contact-friction-only devices.
Claim 11: pressing finger to press nare against nosepiece
Adds operator action: pressing a finger against skin to press nare against nosepiece.
Impact on scope: captures hand-assisted sealing techniques.
Claim 12-13: pulling nare over the nosepiece (finger-driven)
- Claim 12: pulling nare over nosepiece.
- Claim 13: pulling done by a finger.
Impact on scope: narrows to active nare repositioning rather than just sealing by passive contact.
What does this claim set cover that typical nasal delivery patents do not?
Short answer: Many nasal delivery device patents focus on drug formulation, spray mechanics, or general nasal application. This one is distinct because it is anchored to a fitting-and-alignment procedure that uses twist rotation to bring a mouthpiece into alignment, followed by exhalation through the mouthpiece while the nare is sealed. That procedural choreography is the differentiator.
Key “non-obvious from typical nasal spray” features
- Mouthpiece alignment with the subject’s mouth (integration across mouth and nose).
- Twist-to-change alignment after insertion.
- Exhale-through-mouthpiece (exhalation routing as part of device use).
How “method-of-use” structure can broaden enforcement
Because this is a method claim, infringement can attach to:
- Direct performance by a user or clinician.
- Induced performance scenarios where instructions tie use to the claimed twist-seal-exhale protocol.
- Licensing and settlement leverage around training materials, labeling, and workflow.
Which product designs could fall within or outside the claim boundaries?
Likely within coverage (claim 1)
Designs that include:
- A nosepiece that can be inserted in one alignment and then rotated inside the nostril.
- A mouthpiece that ends up aligned to the mouth after the rotation.
- A manner of sealing the nare against the nosepiece.
- A use protocol where the patient exhales through the mouthpiece.
Likely outside coverage (at least for claim 1)
- Designs where the mouthpiece alignment happens by sliding or pivoting without “twisting” of the nosepiece in the nostril (or where twist does not result in mouthpiece alignment).
- Designs where exhalation is not routed through a mouthpiece.
- Designs where sealing is not achieved against the nosepiece during exhalation through a mouthpiece.
Likely within dependent claims
- Claim 2: if the device kit instructs applying a grip-enhancing agent to the nose.
- Claims 4-7: if the nosepiece interface is designed as elliptical/rectangular/tapered and includes a delivery aperture.
- Claims 9-10: if the kit includes tethered nose gripping structure that fixes to the nose.
- Claims 11-13: if training instructs finger pressing or pulling the nare over the nosepiece.
How many US patents are likely to cover related “nosepiece/twist/alignment/mouthpiece/exhale” concepts?
Executive answer: Without the complete bibliographic record and full specification for US 10,076,615, and without an identifier-backed prior-art query set (assignees, filing family, publication numbers, CPC classes, cited references), a defensible “how many patents” count cannot be produced from the claim text alone.
Accordingly: no quantitative “count” is provided here.
What is the US patent landscape around nasal delivery devices that route airflow via a mouthpiece?
Executive answer: US 10,076,615 sits at the intersection of:
- nasal interface mechanics (sealing at nare/nosepiece tip),
- patient workflow and instruction (twist alignment, exhale behavior),
- and device integration across anatomical sites (mouthpiece to mouth).
That combination narrows the plausible comparative landscape more than it would for generic nasal spray patents. The most relevant landscape tends to come from prior art and neighboring families in:
- inhalation/exhalation assisted delivery,
- nasal interfaces with specialized sealing and patient handling,
- multi-component devices requiring rotation or staged alignment.
This section is therefore best used for licensing and design-around discussions: treat the patent as a claim set about procedural steps and device choreography, not just nasal nozzle geometry.
Which patent claim elements matter most for design-around and litigation risk?
Short answer: The highest litigation risk elements are:
- Twisting/rotating after insertion to reach a second alignment.
- Mouthpiece aligned with the mouth in the second alignment.
- Exhaling through the mouthpiece while sealing the nare.
“Design-around” pressure points
- Replace rotation mechanics: use a different alignment mechanism that does not require “twisting the nosepiece” in the nostril.
- Eliminate mouthpiece alignment to the mouth at the moment of exhalation.
- Change airflow routing: exhale through a different channel or require inhalation rather than exhalation through a mouthpiece.
- Alter sealing method: avoid nare sealing “against the nosepiece” during the exhale-through-mouthpiece step.
Dependent claim pressure points
- Avoid adding grip-enhancing agents to the nose (claim 2).
- Use alternative tip geometry not matching the enumerated structures.
- Omit tethered/fixed nose gripping member (claims 8-10).
- Avoid training protocols that require finger pressing/pulling (claims 11-13).
How strong is US 10,076,615 as a patent estate for licensing leverage?
Executive answer: Strength depends on two drivers: (i) how directly commercial users perform the exact twist-seal-exhale protocol, and (ii) how narrowly or broadly the term “twisting” and the “different first/second alignment” are construed in light of the specification and prosecution history. Based only on the claim set provided, the patent has clear leverage where the product and IFU (instructions for use) are aligned with the choreography of claim 1, with additional leverage for “kit” features captured in dependent claims (grip agents, nose gripping members, specific tip geometry, and finger-based sealing/pulling).
What is the likely FDA / Orange Book relevance for this kind of method claim?
Executive answer: For a method claim like this, Orange Book listing typically matters if the patent is listed for a marketed drug product (NDA/ANDA/BLA) and the claim is deemed applicable to the product’s approved use. If the underlying device is used with a drug product, the method-of-use may be listed against the drug. Without the NDA/ANDA number tied to US 10,076,615, a precise Orange Book status cannot be stated from the claim text alone.
Key Takeaways
- US 10,076,615 is anchored to a device-fitting method: insert nosepiece, twist to rotate alignment so a mouthpiece aligns with the mouth, seal the nare, then have the subject exhale through the mouthpiece.
- Claim 1’s enforceable scope is driven by the procedural choreography: twist-to-align plus exhale-through-mouthpiece with nare sealing.
- Dependent claims add licensing leverage around grip-enhancing agents, nosepiece tip geometry (elliptical/rectangular/tapered) and aperture, substance supply unit plus tethered/fixed nose gripping member, and finger pressing or pulling to achieve sealing.
- Design-around risk concentrates on any product that can be used (or instructed) to perform the exact twist-seal-exhale sequence.
FAQs
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Does US 10,076,615 require a specific drug formulation or active ingredient?
No. Claim 1 is device-fitting and workflow based, not formulation based.
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Is infringement tied to exhaling through the nose or the mouthpiece?
The claim requires exhalation through the mouthpiece.
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Can a device avoid claim 1 by aligning the mouthpiece without twisting?
Potentially, if alignment is achieved without the claimed “twisting the nosepiece… in the nostril” to reach the second alignment.
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Do claims 4 and 5 create mutually exclusive coverage?
They are alternative dependent limitations on the tip being substantially elliptical versus substantially rectangular.
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How do dependent claims 11-13 affect the practical risk for consumer use?
They increase risk where the IFU or user behavior includes finger pressing (claim 11) or pulling the nare over the nosepiece (claims 12-13).
References (APA)
No citable sources are provided in the prompt, and no bibliographic/record identifiers for US Patent 10,076,615 were supplied beyond the claim text.
