United States Patent 9,119,932: Claim Scope, Expiration, Orange Book Position and Generic Entry Risk

United States Patent No. 9,119,932 protects a pressure-assisted nasal drug-delivery device that uses oral exhalation, a pressure-responsive flow resistor, and a sealed nasal interface to generate retrograde airflow through the nasal airway. The patent is directed primarily to device architecture and delivery mechanics, not to fluticasone propionate or another particular active ingredient.

The strongest claim themes are:

A mouthpiece and pressure-responsive exhalation valve.
A fluid-tight nasal seal.
Positive oral-to-nasal pressure differential causing indirect velum closure.
Delivery around the posterior margin of the nasal septum.
One-nostril and two-nostril configurations.
Nasal pressures of at least 50 or 100 cm H2O and flow rates of at least 20 L/min.
Aerosol generation and exhalation-responsive actuation.

The patent is closely associated with Optinose's Exhalation Delivery System used in XHANCE, fluticasone propionate exhalation delivery system. It is a device patent with potential Orange Book relevance when listed for an approved drug-device combination product.[1][2]

What does US Patent 9,119,932 protect?

US 9,119,932 protects a functional combination rather than an isolated nasal nozzle or aerosol generator. An accused product generally would need to practice each limitation of at least one asserted claim, either literally or under the doctrine of equivalents.

Core technical concept

The claimed system reverses the normal direction of nasal drug delivery. The patient exhales through a mouthpiece against a flow resistor. The resistor initially restricts exhalation and opens only after the exhalation flow or upstream pressure reaches a threshold. This increases pressure in the oral cavity relative to the nasal airway.

That pressure differential is claimed to indirectly close the oropharyngeal velum. With the velum closed, the exhaled gas carrying the substance enters one nostril, travels through the nasal cavity, passes around the posterior margin of the nasal septum, and may exit through the opposite nostril.

The claimed architecture is therefore more specific than conventional nasal sprays, nebulizers, powered nasal insufflation systems, or simple breath-actuated inhalers.

Claim architecture

Claim group	Independent claims	Principal subject matter
Single-nostril delivery with supply unit	1, 7, 15	Mouthpiece, pressure-responsive resistor, sealed nosepiece and substance supply
Bilateral delivery with outlet resistance	22	Delivery through one nostril and controlled resistance at the other nostril
Single-nostril delivery and pressure-responsive opening	30, 42	Exhalation-triggered flow resistor and sealed nasal delivery unit
Bilateral delivery with specified pressure/flow path	54	First resistor, first nosepiece, second nosepiece and outlet resistor
Combination claims	14, 21, 29, 41, 53, 62	Device combined with the substance to be delivered

The claims are drafted in multiple overlapping forms. That structure gives the patent owner several infringement theories against products using different combinations of pressure thresholds, nosepiece structures, aerosol generators, and bilateral flow paths.

How do the independent claims differ?

Claims 1, 7 and 15

Claim 1 requires a flow resistor with a movable element that opens only when exhalation exceeds a predetermined flow rate. It also requires a nosepiece with a sealing member enlarged toward its proximal end, which enlarges an anterior region of the nasal cavity.

Claim 7 focuses on a fluid-tight nasal seal and a positive nasal pressure of at least 50 cm H2O. Claim 9 raises that threshold to at least 100 cm H2O.

Claim 15 requires a supply unit containing the substance at a pressure sufficient to maintain a flow path beyond the posterior margin of the nasal septum. Claim 17 narrows the supply unit to an aerosol spray generator producing liquid droplets.

These claims create separate routes to infringement. A product may avoid the enlarged proximal sealing member of claim 1 but still implicate claim 7 or claim 15 if it uses the claimed pressure differential, sealed nosepiece and posterior nasal flow path.

Claims 22 and 54

Claims 22 and 54 cover a bilateral system. The delivery unit places the substance into one nostril, while an outlet unit places a second nosepiece and flow resistor in the opposite nostril.

The second resistor maintains positive dynamic pressure upstream of the outlet. Claim 27 and claim 60 require adjustability of that outlet resistance. Claims 24 and 56 cover a delivery channel, while claims 25 and 57 cover aerosol spray generation. Claims 26 and 58 cover exhalation-responsive actuation.

These claims are important because they extend beyond a single sealed nostril. A competing device using bilateral nasal components may face greater exposure even if its mouthpiece valve differs from the claimed valve.

Claims 30 and 42

Claims 30 and 42 are broader in some respects because they focus on a delivery unit and a flow resistor that opens only in response to exhalation pressure.

Claim 30 requires the resistor to open when upstream pressure reaches a predetermined pressure. Claim 42 requires maintenance of positive nasal pressure of at least 50 cm H2O, with claim 43 requiring at least 100 cm H2O.

The claim language does not require a specific drug. Claims 41 and 53 cover the device combined with the substance to be delivered, but the independent device claims can potentially reach products regardless of whether the delivered substance is fluticasone, another corticosteroid, a biologic, a vaccine, or a diagnostic agent.

What are the key limitations in US 9,119,932?

Pressure-responsive flow resistor

The resistor is not merely a fixed restriction. The claims require a closed and open condition, with opening triggered by exhalation flow or pressure reaching a threshold.

A product using a fixed orifice with no movable component may have a noninfringement position against claims expressly requiring a movable element. Claims 30 and 42 may present a different analysis because they focus on the resistor's pressure-responsive opening function rather than specifying the precise valve structure.

Relevant design-around variables include:

Fixed versus movable resistance element.
Pressure-triggered versus manually actuated opening.
Flow threshold versus pressure threshold.
Continuous leak path versus discrete open and closed positions.
Valve located at the mouthpiece versus elsewhere in the flow path.

Fluid-tight nasal seal

Several claims require a sealing member that creates or maintains a fluid-tight seal with the nostril during operation. The seal must withstand the claimed pressure and prevent escape around the nosepiece.

A loose nasal prong, open nostril mask, or interface that intentionally vents around the nostril may have a stronger noninfringement argument. That argument weakens if the device uses an elastomeric or resilient nosepiece that seals the nostril under operating pressure.

Indirect velum closure

The claims repeatedly require a positive pressure differential between the oral cavity and nasal airway that indirectly achieves closure of the oropharyngeal velum.

This limitation raises two issues. First, infringement may depend on the device's intended operating mode and pressure profile. Second, a product that produces nasal pressure without relying on oral exhalation may fall outside the literal scope of the principal claims.

The specification and prosecution history would be important in determining whether "indirectly achieving closure" is a structural result, an intended-use limitation, or a functional limitation requiring proof that the accused device actually produces the claimed physiological effect.

Posterior septal flow

Claims 15, 22, 30, 36, 48 and 54 refer to flow around the posterior margin of the nasal septum and, in several claims, out of the other nostril.

This is a significant technical limitation. Conventional nasal sprays usually deposit medication in the anterior nasal cavity. Products that rely on a continuous nasal airflow path from one nostril through the posterior nasal cavity to the other nostril are closer to the claimed mechanism.

Pressure and flow thresholds

The claims recite:

Limitation	Claims
At least 20 L/min nasal-airway flow	5, 12, 20, 28, 39, 51, 61
At least 50 cm H2O positive nasal pressure	7, 42
At least 100 cm H2O positive nasal pressure	9, 43
Flow resistor opens at a predetermined flow rate	1, 54
Flow resistor opens at a predetermined pressure	15, 30
Flow beyond posterior margin of nasal septum	15, 22, 30, 36, 48, 54

The 50 and 100 cm H2O limitations are commercially important. They may distinguish the claimed EDS approach from low-pressure sprays, but they also create potential evidentiary issues concerning how pressure is measured, where it is measured, and whether the accused product is configured to maintain the pressure throughout operation.

What formulations and delivery systems are protected?

US 9,119,932 does not claim a particular pharmaceutical formulation as its primary invention. It claims the interaction between the formulation or substance supply unit and the pressure-assisted nasal delivery device.

Aerosol spray generator

Claims 17, 25, 34, 46 and 57 cover an aerosol spray generator that produces liquid droplets containing the substance.

This language can encompass a spray generator integrated into the device or a generator fluidly connected to the nosepiece, depending on claim construction and the patent's specification. The claims do not require fluticasone propionate, a particular droplet-size distribution, a particular propellant, or a specific excipient system.

Exhalation-entrained substance

Claims 5, 12, 20, 28, 39 and 61 require substance entrainment in the exhalation flow at a specified nasal flow rate. The formulation must therefore be compatible with dispersion and transport through the nasal airway under the claimed operating conditions.

Potentially relevant formulation variables include:

Liquid spray versus dry powder.
Suspension versus solution.
Droplet size and aerodynamic behavior.
Viscosity and surface tension.
Dose volume.
Chemical stability under aerosolization.
Compatibility with the delivery channel and elastomeric nosepiece.

A formulation change alone may not avoid the device claims if the same pressure-responsive exhalation and sealed-nostril system is retained.

What is the FDA and Orange Book status?

XHANCE is an FDA-approved fluticasone propionate nasal spray delivered through Optinose's Exhalation Delivery System. FDA approved XHANCE under NDA 205434 for treatment of chronic rhinosinusitis with nasal polyps in adults.[2]

FDA milestones

Event	Date
FDA approval of XHANCE NDA 205434	June 27, 2017
Approved active ingredient	Fluticasone propionate
Dosage form	Nasal spray
Delivery technology	Exhalation Delivery System
Regulatory category	Drug-device combination product

The patent's regulatory importance comes from the device's integration with the approved drug product. A generic applicant seeking approval of an equivalent fluticasone product may need to address listed patents through an ANDA certification, a 505(b)(2) pathway, or a product design that does not rely on the patented device.

Orange Book listing status should be evaluated by product and NDA, not by patent number alone. The FDA's Orange Book identifies patents submitted by the NDA holder or approved manufacturer and does not independently determine patent validity or infringement.[1]

When does US 9,119,932 lose exclusivity?

The patent's nominal term is expected to run into 2028, subject to the official term calculation, patent-term adjustment, terminal disclaimers and any applicable legal event. Public patent-family records associate the patent with the Optinose nasal-delivery-device portfolio and an earliest priority period in the 2008 timeframe.[3]

Exclusivity element	Expected position
Patent type	Utility patent
Patent owner/commercial sponsor	Optinose-related entities
Nominal patent-term endpoint	2028 timeframe
FDA new chemical entity exclusivity	Not applicable to fluticasone propionate
FDA clinical-investigation exclusivity	Time-limited period associated with the 2017 approval
Biosimilar exclusivity	Not applicable
Small-molecule generic pathway	ANDA, subject to listed-patent certifications

The patent does not receive biologic or biosimilar exclusivity. Fluticasone propionate is a small-molecule active ingredient, and the main regulatory barrier is the combination of drug approval, device equivalence and listed-patent litigation.

Which companies are challenging the XHANCE patent estate?

The principal commercial risk comes from generic manufacturers pursuing fluticasone propionate nasal products or other nasal delivery systems that could substitute for XHANCE.

Potential challengers fall into three categories:

ANDA applicants seeking approval of a therapeutically equivalent product.
505(b)(2) applicants using a modified delivery device or delivery method.
Device companies developing non-EDS nasal systems that avoid the pressure-responsive and bilateral-flow limitations.

A Paragraph IV certification would create a patent dispute if an ANDA applicant asserts that US 9,119,932 is invalid, unenforceable or not infringed. The patent holder generally has 45 days after receiving the notice to file suit, which can trigger a 30-month stay of approval under the Hatch-Waxman framework, subject to statutory exceptions and court action.[4]

The supplied claim set does not identify a particular challenger, ANDA number, litigation docket or settlement. A patent-specific litigation conclusion cannot be stated accurately from the claims alone.

What patent litigation affects US 9,119,932?

The principal litigation questions would be:

Whether an accused device has a pressure-responsive resistor.
Whether the resistor opens only after the claimed threshold.
Whether the nasal interface creates a fluid-tight seal.
Whether the device creates the claimed oral-to-nasal pressure differential.
Whether the device causes or is configured to cause posterior septal flow.
Whether the product maintains 50 or 100 cm H2O pressure.
Whether a second-nostril outlet resistor is present and adjustable.
Whether the accused formulation is delivered in the exhalation flow.

Claim-construction pressure points

The following terms are likely to receive close scrutiny:

Term	Likely dispute
"Only able to transition"	Whether manual, passive or alternative opening mechanisms fall outside the claim
"Predetermined flow rate"	Whether the threshold must be fixed before use
"Positive pressure differential"	Measurement location and required magnitude
"Fluid tight seal"	Whether minor leakage defeats infringement
"Indirectly achieving closure"	Structural function versus physiological result
"Driving pressure sufficient"	Whether capability, intended operation or actual performance is required
"Around the posterior margin"	Required flow path and evidentiary proof
"At least 50 cm H2O"	Pressure measurement protocol and duration

The patent's functional language may support infringement allegations against products with different physical designs if they operate in substantially the same way. The same language can create validity risk if prior art discloses the claimed functions or if the claims are challenged for lack of written description, enablement, indefiniteness or obviousness.

How strong is the patent estate?

US 9,119,932 has meaningful commercial coverage because it combines several interdependent elements that are difficult to separate in an EDS-style product:

Patient-generated exhalation.
A threshold-opening oral resistor.
A sealed nasal interface.
Positive nasal pressure.
Retrograde or cross-nasal flow.
Optional aerosol generation.
Optional bilateral outlet resistance.

Its strength is highest against products that copy the EDS operating method. It is weaker against:

Conventional forward nasal sprays.
Powered devices that do not require oral exhalation.
Devices using an open-mouth or non-sealed nasal interface.
Systems that deliver medication into both nostrils without a posterior cross-flow path.
Products using fixed resistance rather than a pressure-responsive valve.
Low-pressure systems that do not meet the specified pressure thresholds.

The patent is less likely to block the broad field of nasal drug delivery than the narrower category of exhalation-assisted, high-pressure, sealed-interface delivery.

What generic launch risks exist?

Scenario 1: Direct EDS generic

A direct generic copies the mouthpiece, pressure-responsive resistor, sealed nosepiece and substance-delivery path. This presents the highest infringement risk. A Paragraph IV challenge would likely target validity, claim construction and noninfringement based on the precise valve and pressure profile.

Scenario 2: Modified EDS

A competitor changes the valve mechanism, uses a different pressure threshold, or replaces the nosepiece seal. This may avoid some claims but remains exposed to broader functional claims, particularly claims 30 and 42.

Scenario 3: Conventional nasal spray

A conventional pump spray generally has a stronger noninfringement position because it lacks oral exhalation, pressure-responsive resistance and the claimed velum-closure mechanism.

Scenario 4: Alternative powered nasal system

A powered bilateral insufflation device could avoid the oral-exhalation limitation. Risk would depend on whether it independently practices the claimed sealed nosepiece, posterior-flow and pressure limitations.

Scenario 5: 505(b)(2) product

A 505(b)(2) applicant could seek approval for a modified nasal delivery system while addressing listed patents through a Paragraph IV certification or a statement that the proposed product does not infringe. This pathway does not eliminate device-patent exposure.

How does US 9,119,932 compare with conventional nasal-delivery patents?

Technology	Oral exhalation required	Pressure-responsive valve	Fluid-tight nostril seal	Posterior cross-nasal flow	Risk under US 9,119,932
Conventional pump spray	No	No	Usually no	No	Low
Standard nebulizer	No	Usually no	Variable	Usually no	Low to moderate
Powered nasal insufflation	No	Not necessarily	Often	Possible	Moderate
EDS-style device	Yes	Yes	Yes	Yes	High
Bilateral EDS device	Yes	Yes	Yes	Yes	Highest
Dry-powder nasal device	Usually no	No	Variable	No	Low to moderate

What geographic coverage does the patent provide?

US 9,119,932 provides protection in the United States only. Related patent-family members may provide corresponding protection in Europe, Canada, Australia and other jurisdictions, but foreign claims, expiration dates, prosecution amendments and enforceability must be analyzed separately.

A US freedom-to-operate conclusion cannot be extended automatically to:

European Patent Office rights.
United Kingdom national rights.
Canadian rights.
Japanese rights.
Australian rights.
Chinese rights.

Foreign equivalents may differ materially because of added-matter standards, claim amendments, opposition proceedings and local patent-term rules.

What manufacturing and IP barriers does the patent create?

The patent creates manufacturing barriers around the integrated system rather than around a single component. A competing manufacturer would need to design around the interaction of:

The pressure-triggered resistor.
The mouthpiece and tubular section.
The resilient or frusto-conical nosepiece.
The sealing member.
The aerosol generator.
The delivery channel.
The bilateral outlet resistor.
The actuation mechanism.

The most practical design-around strategy is to eliminate oral exhalation as the pressure source. The next strategy is to avoid a fluid-tight nostril seal or use a fixed resistance architecture. Both approaches may reduce performance equivalence and regulatory comparability to XHANCE.

Key Takeaways

US 9,119,932 is a device patent centered on exhalation-assisted nasal delivery.
The patent does not primarily claim fluticasone propionate or a specific formulation.
Its central limitations are a pressure-responsive flow resistor, sealed nasal interface, positive oral-to-nasal pressure differential and indirect velum closure.
Claims 22 and 54 add bilateral delivery and a resistive outlet at the opposite nostril.
Claims 7, 9, 42 and 43 create specific exposure at 50 and 100 cm H2O.
Claims 5, 12, 20, 28, 39, 51 and 61 add a 20 L/min nasal-flow limitation.
The patent is most relevant to XHANCE-style EDS products and less relevant to conventional nasal sprays.
The patent's expected term extends into the 2028 timeframe, subject to the official USPTO term calculation and legal events.
Generic risk is highest for a product that copies the EDS operating method and lowest for a conventional forward nasal spray.
The patent is one element of a broader Optinose device and product patent estate. Orange Book status must be checked against the approved NDA and current FDA listings.

FAQs About US Patent 9,119,932

Does US 9,119,932 claim XHANCE specifically?

No. The claims are technology-focused and do not require the active ingredient to be fluticasone propionate. XHANCE is a principal commercial product associated with the claimed EDS technology.

Can a nasal spray avoid US 9,119,932 by using a different drug?

Changing the drug alone may not avoid infringement. A product using the same claimed pressure-responsive exhalation system and sealed nasal interface could remain exposed regardless of the active ingredient.

Does the patent cover a device that delivers medication through both nostrils?

Yes, claims 22 and 54 specifically address delivery through one nostril with a second nosepiece and flow resistor at the other nostril.

Are biologics subject to this patent's biosimilar provisions?

No. The patent does not create biosimilar exclusivity. A biologic delivered through a device practicing the claims could still raise infringement issues, but the regulatory pathway would be different from the fluticasone ANDA pathway.

Is US 9,119,932 alone sufficient to block a generic XHANCE launch?

Not necessarily. Launch exposure depends on the complete Orange Book-listed patent set, the generic's device design, certification strategy, litigation outcome, settlement terms and any remaining regulatory exclusivity.

References

U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
U.S. Food and Drug Administration. (2017). XHANCE: Fluticasone propionate nasal spray, NDA 205434, prescribing information. FDA.
United States Patent and Trademark Office. (2015). U.S. Patent No. 9,119,932, nasal delivery device. USPTO Patent Center.
U.S. Food and Drug Administration. (2024). ANDA submissions: Patent certifications and 30-month stays under the Hatch-Waxman Amendments. FDA.
Optinose, Inc. (2024). Annual report on Form 10-K. U.S. Securities and Exchange Commission.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9904906.6	Mar 3, 1999
United Kingdom	9911686.5	May 19, 1999

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	285810	⤷ Start Trial
Austria	422923	⤷ Start Trial
Austria	427130	⤷ Start Trial
Austria	487506	⤷ Start Trial
Austria	506983	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 9,119,932