Details for Patent: 8,291,904

Which drugs does patent 8,291,904 protect, and when does it expire?

Patent 8,291,904 protects INOMAX and is included in one NDA.

Protection for INOMAX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-five patent family members in thirteen countries.

Summary for Patent: 8,291,904

Title:	Gas delivery device and system
Abstract:	A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
Inventor(s):	Duncan P. Bathe, John Klaus, David Christensen
Assignee:	Mallinckrodt Pharma IP Trading DAC , Therakos Inc , Mallinckrodt Critical Care Finance Inc
Application Number:	US13/493,493
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,291,904
Patent Claim Types: see list of patent claims	Use; Delivery; Device;

United States Patent 8,291,904: Scope, Claims, Expiration, and Nitric Oxide Delivery Patent Landscape

U.S. Patent No. 8,291,904 protects a digitally controlled nitric oxide gas-delivery architecture centered on an intelligent gas-cylinder valve. The core combination is a valve with stored gas-concentration data, wireless optical line-of-sight communication, patient-data comparison, and automated therapy control. The patent is materially narrower than a general nitric oxide delivery patent because the independent claims require specific valve-memory, transceiver, control-module, and wireless optical communication features.

The patent is assigned to the Ikaria/INO Therapeutics nitric oxide technology lineage, now associated commercially with Mallinckrodt’s INOmax products. The earliest priority date appears to be in 2006, producing a projected U.S. patent-term expiration in 2027, subject to the official term calculation, any patent-term adjustment, and terminal-disclaimer effects. The patent is primarily a device and control-system patent, not a conventional drug-composition patent. It is therefore unlikely to be listed in the FDA Orange Book as a patent claiming nitric oxide itself.

What does U.S. Patent 8,291,904 cover?

U.S. Patent 8,291,904 covers a gas cylinder valve and control system that electronically identifies the gas in the cylinder and coordinates delivery of therapy to a patient.

The central technical elements are:

1. A valve attached to a container holding gas comprising nitric oxide.
2. A valve actuator that controls gas flow.
3. A memory within the valve assembly.
4. Stored gas data, including gas concentration.
5. A valve processor and transceiver.
6. Wireless optical line-of-sight communication between the valve and a control module.
7. User entry of gas data, including barcode-based entry.
8. Patient information entered into the control module.
9. Comparison of patient data and gas data.
10. Automated therapy selection, delivery, alarm generation, or therapy termination.

The claims are directed to safety and configuration control. They seek to prevent the delivery system from using the wrong gas concentration, wrong cylinder, or incompatible valve configuration for a patient.

What are the independent claims in U.S. Patent 8,291,904?

The patent has four principal independent claims: claims 1, 5, 11, and 16.

Claim	Claim category	Principal subject matter
1	Valve assembly	Intelligent valve with memory, processor, transceiver, and user gas-data input
5	Gas delivery system	Valve assembly plus control module, patient-data entry, display, and data comparison
11	Method	Communicating gas data, comparing it with patient data, selecting therapy, and controlling delivery
16	Gas delivery device	Valve assembly attached to a gas container, with barcode-based gas data

Claims 1 and 5 are the most important for apparatus-based infringement analysis. Claim 11 creates method-of-use exposure for operation of a corresponding system. Claim 16 is directed to a physical device that includes the valve assembly and gas container.

How broad is claim 1?

Claim 1 is broad in functional terms but narrow in required architecture.

It requires a valve assembly capable of delivering gas comprising NO from a gas container. The claim does not limit the nitric oxide concentration to a particular percentage. It also does not expressly require a particular medical indication, patient population, flow rate, dose, or delivery mode.

The claim does require all of the following:

Required limitation	Scope implication
Valve attachable to an NO-containing gas container	Excludes systems in which the cylinder has no claimed valve assembly
Inlet and outlet in fluid communication	Requires a flow path through the valve
Valve actuator	Requires controllable opening and closing
Circuit supported within the valve assembly	The electronics must be integrated into or supported by the assembly
Circuit disposed between actuator and cap	Creates a structural limitation that may narrow claim construction
Valve memory	Requires local storage at the valve
Stored gas concentration data	Mere cylinder identification may not be enough
Valve processor and transceiver	Requires local processing and communication hardware
Wireless optical line-of-sight signals	Radio-frequency-only systems should fall outside this limitation
Communication with a control module	Requires a receiving and controlling system
User data input on the actuator	The input must be disposed on the actuator
Entry of gas data into valve memory	Data must be written to the valve-side memory

A system that has a smart cylinder but communicates by Bluetooth, Wi-Fi, RFID, or another radio protocol may avoid literal infringement of the optical line-of-sight limitation. A system that stores concentration data only in the controller, cloud, or electronic medical record may avoid the valve-memory limitation.

The phrase “gas comprising NO” is not restricted to pure nitric oxide. It may encompass mixtures containing nitric oxide, including nitric oxide diluted in nitrogen or another carrier gas. The claim is therefore directed to the delivery architecture rather than to a particular gas composition.

What do dependent claims 2 through 4 protect?

Claims 2 through 4 add implementation details that narrow the patent’s scope.

Claim 2: Barcode entry

Claim 2 requires gas data to be provided in a barcode on the gas container and entered into the valve memory through a user-operated scanning device.

This claim creates a targeted limitation for cylinder onboarding and identity management. A manufacturer or hospital using a barcode scanner to write concentration data into the valve memory presents greater claim 2 risk than a system that receives the same data through manual key entry, RFID, a cloud database, or a factory-programmed memory.

Claims 3 and 4: Periodic optical transmission

Claim 3 requires:

• A valve power source; and
• Periodic transmission of wireless optical signals; and
• A time interval during which no signal is sent.

Claim 4 specifies that the interruption period is about 10 seconds.

The periodic transmission limitation may cover a pulsed optical signaling protocol designed to conserve power or distinguish the valve signal from continuous optical communication. Claim 4 is substantially narrower than claim 3 because it adds the approximately 10-second interval.

What does claim 5 protect?

Claim 5 covers a complete gas-delivery system built around the claimed valve assembly.

The control module must include:

• Fluid communication with the valve outlet;
• A CPU transceiver receiving line-of-sight signals;
• A CPU and CPU memory;
• A display for entering patient information; and
• A comparison between patient information and gas concentration received from the valve.

The claim is potentially significant for integrated nitric oxide delivery devices because it reaches beyond the cylinder valve. A commercial system may infringe claim 5 if its controller receives gas concentration wirelessly from the valve and compares that information with patient-specific data.

A system that displays concentration information without comparing it with patient information would not satisfy the full literal language of claim 5. The comparison may be performed in software, provided the accused system performs the claimed function through the required control architecture.

What do claims 6 through 10 protect?

Claims 6 through 10 add event logging, dual-cylinder monitoring, alarms, and automatic therapy shutdown.

Claim	Added feature	Commercial significance
6	Calendar and event timers; logging valve opening, closing, and duration	Supports audit trails and usage records
7	Alarm when patient information and gas data do not match	Covers safety interlock notification
8	Software instructions for therapy selection and control	Extends protection into controller software functionality
9	Monitoring two valves and alarming when both are open	Addresses dual-cylinder or redundant-cylinder configurations
10	Terminating therapy when both valves are open	Adds an automatic safety shutdown

Claims 9 and 10 are particularly configuration-specific. They are directed to systems with first and second valves connected to separate gas containers. A single-cylinder system generally would not satisfy these claims.

Claim 10 requires termination of therapy when both valve-status conditions indicate open positions. A system that merely issues an alarm, but does not terminate delivery, may avoid literal infringement of claim 10 while still implicating claim 9 or claim 7.

What do method claims 11 through 15 cover?

Claim 11 covers operation of the system rather than the physical system alone. The method requires:

1. Establishing communication with the valve assembly.
2. Communicating gas data from the valve to the CPU.
3. Comparing gas data with patient information.
4. Coordinating therapy delivery through the optical wireless link.
5. Selecting therapy based on the comparison.
6. Controlling delivery of the selected therapy.

Claims 12 and 13 add therapy cessation and alerts. Claims 14 and 15 cover entry of gas data into the valve memory and entry of patient information into the CPU memory.

Method-claim exposure depends on actual operation. A manufacturer may avoid direct method infringement if its system is capable of performing the steps but customers do not operate it in the claimed sequence. Induced-infringement exposure can arise where instructions, training, software prompts, or service procedures direct users to perform the claimed steps.

What does claim 16 protect?

Claim 16 covers a gas-delivery device comprising:

• The claim 1 valve assembly;
• An attached gas container containing gas comprising NO; and
• A barcode on the container providing the gas data.

This is a combination claim. It is narrower than claim 1 because it requires the actual gas container and barcode. A valve sold separately without the cylinder may fall outside claim 16 while remaining within claim 1, depending on the product configuration and claim construction.

What patent expiration date applies to U.S. Patent 8,291,904?

The patent’s projected expiration is approximately 20 years from the earliest effective nonprovisional or international filing date, rather than 20 years from the October 23, 2012 grant date. Based on the reported 2006 priority lineage, the expected expiration is in 2027.

Event	Date or period
Earliest priority lineage	Approximately 2006
U.S. patent grant	October 23, 2012
Standard patent term basis	20 years from applicable earliest nonprovisional/PCT filing
Projected U.S. expiration	Approximately 2027
Regulatory exclusivity	Not established by this device patent
Orange Book status	Not expected to be a conventional Orange Book drug patent

The exact expiration date should be taken from the USPTO Patent Center term record because patent-term adjustment can change the date. The patent’s commercial relevance may also be affected by continuations, divisionals, continuation-in-part applications, foreign counterparts, and later patents claiming related controller or valve improvements.

Is U.S. Patent 8,291,904 listed in the Orange Book?

The patent is unlikely to qualify as a conventional Orange Book-listed patent.

FDA Orange Book patent listing generally concerns patents that claim an approved drug substance, drug product, formulation, or method of using an approved drug. U.S. Patent 8,291,904 principally claims a valve, gas container, controller, software logic, and delivery method. Those are device and system features rather than claims to nitric oxide as an active pharmaceutical ingredient.

The patent may still create commercial or litigation risk for a generic or competing nitric oxide delivery device. That risk would arise through patent litigation, licensing, or procurement restrictions rather than through an Orange Book Paragraph IV certification directed to this patent.

Does U.S. Patent 8,291,904 create Paragraph IV risk?

A direct Paragraph IV challenge is unlikely if the patent is not listed in the Orange Book for an approved nitric oxide drug product.

A generic applicant for a nitric oxide drug product could still face related patent issues involving:

• Drug-device combination products;
• Delivery-device patents;
• Container and valve patents;
• Method-of-use patents;
• Product labeling and instructions for use;
• FDA combination-product requirements.

A Paragraph IV certification against an Orange Book-listed patent is distinct from a declaratory-judgment or infringement action involving a device patent. The two mechanisms should not be conflated.

What is the patent landscape around nitric oxide delivery systems?

The relevant patent landscape has several technical clusters.

Intelligent cylinders and valves

This cluster includes patents covering:

• Cylinder identification;
• Concentration storage;
• Valve electronics;
• Cylinder-specific authentication;
• Gas inventory monitoring;
• Pressure and flow sensing;
• Wireless communication;
• Event logging.

U.S. Patent 8,291,904 is strongest where these functions are integrated into the valve and communicated through optical line-of-sight signaling.

Delivery controllers and dosing algorithms

Separate patent families may cover:

• Closed-loop nitric oxide dosing;
• Patient oxygenation or respiratory-status feedback;
• Flow-proportional dosing;
• Ventilator coordination;
• Alarm thresholds;
• Automatic calibration;
• Leak detection;
• Dose compensation.

Those patents may be infringed even if a competing system avoids the specific valve architecture of U.S. 8,291,904.

Formulation and gas-cylinder technology

Other patent categories concern:

• Nitric oxide concentration ranges;
• Nitrogen dilution;
• Stability and impurity control;
• Cylinder filling;
• Moisture management;
• Passivation of cylinder interiors;
• Delivery through inhalation circuits.

U.S. Patent 8,291,904 does not primarily protect these chemical or manufacturing features. Its gas limitation is functional and broad, but its enforceable value depends on the claimed electronics and communication pathway.

Medical-use patents

Medical-use patent activity has focused on:

• Persistent pulmonary hypertension of the newborn;
• Pulmonary hypertension associated with cardiac surgery;
• Acute respiratory distress;
• Neonatal respiratory treatment;
• Patient-specific titration;
• Weaning protocols;
• Combination use with ventilators or extracorporeal systems.

The 8,291,904 claims are not limited to one disease or patient group. A competing system could therefore avoid a method-of-use patent directed to a specific indication while still facing this device patent.

Which companies are most exposed to this patent family?

The principal commercial exposure is for companies selling integrated inhaled nitric oxide delivery systems, not companies selling nitric oxide as a chemical gas alone.

Company or market participant	Potential exposure
Mallinckrodt	Commercial successor to the INOmax nitric oxide platform and related delivery infrastructure
Generic nitric oxide suppliers	Device and combination-product exposure when supplying a controller or cylinder system
Hospital equipment manufacturers	Exposure if integrating smart valves with respiratory or ventilator systems
Ventilator manufacturers	Risk where the ventilator controls nitric oxide delivery through the claimed communication architecture
Cylinder and valve suppliers	Risk if they supply an integrated valve with local memory, gas data, and optical communication
Home-care device companies	Exposure if adapting the architecture for portable or home nitric oxide delivery

A company that supplies only NO-containing cylinders without the claimed intelligent valve may have lower risk. A company that supplies a complete cylinder, smart valve, optical transceiver, controller, patient database, and automated dosing system faces the highest overlap.

How strong is the patent estate?

The patent is technically focused and commercially relevant, but its enforcement strength depends on proof of the specific optical and valve-side architecture.

Strengths

• Independent claims cover the valve, system, method, and assembled device.
• Gas-concentration data is tied to the cylinder-side memory.
• The claims reach software-controlled comparison and therapy selection.
• The optical line-of-sight requirement may map directly onto proprietary legacy systems.
• Claims 9 and 10 address safety logic involving two valves.

Weaknesses

• The optical line-of-sight limitation excludes many radio-based designs.
• The requirement that the data input be disposed on the actuator may be difficult to satisfy in modern systems with remote or factory programming.
• Claims require a specific division of functionality between the valve and control module.
• Some dependent claims are limited to particular implementation details, including a roughly 10-second interruption.
• The patent does not broadly claim nitric oxide delivery independent of the electronics.

The practical strength is highest against products deliberately copied from the patented valve-and-controller architecture. It is lower against redesigned systems that use radio communication, centralized data storage, passive identification, or independent gas verification.

What generic launch scenarios exist?

Scenario 1: Gas-only launch

A supplier markets nitric oxide cylinders but does not provide the claimed valve or controller.

Patent risk under U.S. 8,291,904 is comparatively low, although other patents and regulatory requirements may apply.

Scenario 2: Compatible-cylinder launch

A supplier sells cylinders designed to work with an incumbent delivery system.

Risk depends on whether the supplied cylinder includes the claimed valve assembly, stored gas concentration, user data input, and optical transceiver.

Scenario 3: Complete competing system

A company launches an integrated cylinder, valve, controller, and dosing system that uses optical line-of-sight communications and patient-data comparisons.

This scenario presents the highest literal-overlap risk.

Scenario 4: Design-around system

A competitor uses:

• Radio-frequency communication rather than optical signaling;
• Controller-side rather than valve-side gas data;
• RFID or passive identification;
• Manual concentration confirmation;
• A remote scanner rather than an actuator-mounted input;
• Independent pressure and concentration verification.

These changes may reduce risk under the asserted claims, although the doctrine of equivalents and other patent families remain relevant.

What litigation and settlement issues matter?

The relevant litigation questions are:

1. Whether U.S. Patent 8,291,904 remains enforceable for the particular accused product.
2. Whether the asserted claims survived post-grant review, reexamination, or validity challenges.
3. Whether a continuation patent covers the same commercial system with broader or different claim language.
4. Whether a license covers the valve, controller, cylinder, software, or only a specific product.
5. Whether a settlement includes field-of-use, geographic, or customer restrictions.
6. Whether a supplier indemnifies hospitals or distributors.
7. Whether patent exhaustion applies to authorized cylinders, valves, or replacement components.

A settlement involving a nitric oxide drug product does not necessarily grant freedom to operate for the delivery device. Patent rights may be divided among a drug supplier, device manufacturer, cylinder supplier, and software provider.

What geographic coverage is relevant?

The U.S. patent protects only activities within the scope of U.S. patent law, including U.S. manufacture, sale, offers for sale, importation, and certain domestic use.

Commercial freedom to operate requires review of corresponding patent families in:

• Europe;
• Canada;
• Japan;
• China;
• Australia;
• South Korea;
• India;
• Other markets where inhaled nitric oxide systems are sold.

Foreign counterparts may have different claim scope, prosecution histories, expiration dates, and validity outcomes. A U.S. design-around does not establish freedom to operate in Europe or other jurisdictions.

Key Takeaways

• U.S. Patent 8,291,904 protects an intelligent nitric oxide cylinder valve and delivery-control system.
• Claims 1, 5, 11, and 16 are the principal independent claims.
• The core combination requires valve-side gas data storage, a valve processor and transceiver, wireless optical line-of-sight communication, and interaction with a patient-data control module.
• The patent does not broadly claim nitric oxide as a chemical or every nitric oxide delivery method.
• Barcode entry, event logging, dual-valve monitoring, alarms, and automatic shutdown are protected through dependent claims.
• The projected U.S. expiration is approximately 2027 based on the reported 2006 priority lineage.
• The patent is primarily a device and system patent and is unlikely to be a conventional Orange Book-listed nitric oxide drug patent.
• The highest infringement risk concerns integrated systems using optical valve-to-controller communication and automated patient/gas-data matching.
• Radio-based systems, passive identification systems, and controller-only data architectures may provide design-around paths.
• A complete freedom-to-operate analysis requires review of continuation patents, foreign counterparts, prosecution history, and related nitric oxide delivery families.

FAQs

Does U.S. Patent 8,291,904 claim nitric oxide itself?

No. The patent claims a valve assembly, delivery system, gas-delivery device, and operating method involving gas comprising nitric oxide. It does not primarily claim nitric oxide as a chemical composition.

Can a Bluetooth-enabled nitric oxide valve infringe U.S. Patent 8,291,904?

A Bluetooth-only valve may avoid literal infringement of claims requiring wireless optical line-of-sight communication. Other claims or related patents may still be relevant, and equivalence issues depend on the accused system and prosecution history.

Is a barcode on a nitric oxide cylinder by itself covered?

No. Claim 2 requires the barcode, a user-operated scanning device, data entry into valve memory, and the other limitations of claim 1.

Can a company sell nitric oxide cylinders without infringing this patent?

Potentially, if the cylinders do not include the claimed valve assembly and the company does not make, sell, import, or operate the claimed integrated system. Other patents and regulatory controls may still apply.

Does the patent cover home-use nitric oxide delivery?

The claims are not limited to hospital use. A home-use system can fall within the claims if it contains the required valve memory, optical communication, controller, patient-data comparison, and therapy-control functions.

References

1. U.S. Patent No. 8,291,904. (2012). Gas delivery system. United States Patent and Trademark Office.

2. U.S. Patent and Trademark Office. (n.d.). Patent term adjustment and patent term information. https://www.uspto.gov/

3. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

4. U.S. Food and Drug Administration. (n.d.). Patent listing in the Orange Book. Center for Drug Evaluation and Research. https://www.fda.gov/

5. U.S. Food and Drug Administration. (n.d.). Nitric oxide gas: FDA-approved drug and delivery-system information. Center for Drug Evaluation and Research. https://www.fda.gov/

Drugs Protected by US Patent 8,291,904

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,291,904*PED				Y
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,291,904*PED				Y

International Family Members for US Patent 8,291,904

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011328891
Australia	2013257484
Australia	2015200792
Australia	2017204422