US Patent 5,140,993: Scope, Claims, Expiration, and Breath-Sample Device Patent Landscape

US Patent 5,140,993 covers a disposable breath-sample collection bag with two distinct interfaces: a patient inlet with a valve and a sealed outlet designed to puncture an external transfer container. The patent is directed to physical sample collection hardware, not a drug, active ingredient, diagnostic assay, or treatment method. Its enforceable US term has expired, eliminating current US infringement risk based on this patent alone.

What does US Patent 5,140,993 cover?

US Patent 5,140,993 covers a flexible, medical-grade, impervious plastic bag used to collect breath from a patient and transfer part of that sample into a separate container.

The core architecture has four required components:

A flexible breath-collection bag.
An inlet with a mouthpiece and valve.
An outlet at the opposite end of the bag.
A needle-based transfer mechanism enclosed within a sleeve.

The outlet is the patent’s principal technical limitation. The needle is mounted on an inner wall of the sleeve, extends into the sleeve bore, and is protected by a covering structure. The needle tip pierces both the covering and the wall of an associated external transfer device, such as a sealed vial or container. Once pierced, the needle bore provides a flow path from the breath bag into the external container.

The patent therefore protects a combination of:

Breath collection;
One-way or manually controlled patient-side flow;
A flexible bag;
A protected puncture needle;
Transfer into an external container through a pierceable wall.

It does not broadly claim every breath-sampling bag, every breath analyzer, or every container-transfer system.

What is the patent’s bibliographic and legal status?

Field	Information
Patent	US 5,140,993
Subject matter	Breath sample collection device
Technology category	Medical device, specimen collection, gas sampling
Patent type	Utility patent
Issue date	August 25, 1992
US term	Expired
Current enforceable US exclusivity	None
Orange Book listing	Not applicable
Paragraph IV relevance	None
Biosimilar relevance	None
Drug exclusivity relevance	None

The patent is a pre-URAA US patent. For patents subject to the pre-1995 term regime, the ordinary term was 17 years from grant, subject to applicable patent-term adjustments, terminal disclaimers, and other statutory modifications. On the face of the issue date, the ordinary 17-year term would have ended in August 2009. The patent is therefore no longer enforceable in the United States.[1][2]

The patent’s expiration does not invalidate technical teachings or prevent a company from relying on the disclosure for design development. It means that the claims no longer create a current US exclusionary right.

What is the scope of independent claim 1?

Claim 1 is the only independent claim in the supplied claim set. It requires the following elements.

Claim 1 element analysis

Element	Required limitation	Scope implication
A	A device for collecting a breath sample	The claim is limited to breath-sample collection
B	A flexible bag made of medical-grade, impervious plastic	Rigid containers and non-impervious structures are outside the literal wording
C	An inlet adjacent one end of the bag	The inlet must be positioned at or near one end
D	A mouthpiece providing an inlet passage	A patient-facing mouthpiece is required
E	Valve means for opening and closing the inlet passage	The inlet must include a flow-control structure
F	An outlet adjacent the opposite end of the bag	The outlet must be located separately from the inlet
G	A sleeve with a bore and inner end wall	The transfer outlet has a defined sleeve structure
H	A needle assembly mounted on the inner end wall	The needle is supported within the sleeve assembly
I	A hollow needle with a bore and tip	The needle must provide a fluid passage
J	The needle extends outward into the sleeve bore	The needle is positioned inside the sleeve rather than simply exposed
K	The tip is positioned within the sleeve bore	The sleeve protects or houses the tip
L	A covering structure covers the needle tip and closes the needle bore	The needle remains sealed before transfer
M	The tip pierces the covering and a wall of an external transfer device	Transfer depends on puncturing both protective and container walls
N	Piercing communicates the bag interior with the external container	The system must permit sample transfer after puncture

The claim is structurally narrow because it requires the combined inlet, bag, and protected-needle outlet arrangement. A product that has a breath bag but transfers gas through a luer fitting, septum port, stopcock, heat-sealed tube, or non-piercing connector would not literally satisfy all of the claim 1 limitations.

The claim also appears to require a specific spatial relationship. The needle tip must be located within the sleeve bore, and the needle must be arranged to pierce the covering and an associated external transfer-device wall. A freely exposed needle, a needle located outside the sleeve, or a needle that connects through a conventional valve rather than piercing a container wall would create substantial literal-scope distinctions.

How do claims 2 through 8 narrow the patent?

Claims 2 through 8 are dependent claims. They add specific neck, clamping, valve, and adapter structures.

Claim	Added subject matter	Practical limitation
2	Flexible neck joined to the bag; sleeve received in neck; clamp prevents leakage	Requires a neck-and-clamp outlet construction
3	One-way check valve permitting flow only into the bag	Excludes outlet-capable or bidirectional inlet valves
4	Neck on the bag plus adapter coupling the neck to the valve	Requires a separate coupling arrangement
5	Adapter sleeve with outwardly tapering internal bore; valve body with external flange fitting tightly inside	Adds a particular interference or friction-fit geometry
6	Repeats the limitation recited in claim 5	Likely a duplicate or drafting error in the supplied claim set
7	Valve element manually movable between open and closed positions	Covers a manually controlled inlet variant
8	Neck on the bag plus adapter coupling the neck to the manually operated valve	Combines claim 7 with a neck-and-adapter structure

Claim 2: clamped neck construction

Claim 2 covers an outlet implementation in which a flexible neck is attached to the bag and receives an inner portion of the sleeve. A clamp secures the neck around the sleeve and prevents leakage.

This limitation narrows the claim to a mechanical attachment arrangement. A permanently welded sleeve, molded integral outlet, adhesive bond, or threaded connection might not satisfy the claim 2 language, depending on the precise construction and claim interpretation.

Claim 3: one-way inlet valve

Claim 3 requires a check valve that allows air to enter the bag but prevents reverse flow. The limitation is relevant to contamination control and prevents collected breath from flowing back toward the patient.

A conventional manually actuated valve does not necessarily meet claim 3. The valve must operate as a one-way check valve, not merely as a selectively opened and closed passage.

Claims 4 and 8: adapter structures

Claims 4 and 8 require a neck on the bag and a separate adapter that couples the neck to the valve. These claims target modular construction, in which the mouthpiece valve and bag are separate components joined through an adapter.

The adapter requirement creates additional noninfringement routes for products using:

An integral bag-to-valve weld;
A molded one-piece inlet;
A threaded connector;
A luer-lock interface;
A permanently bonded mouthpiece.

Claims 5 and 6: tapered sleeve and flanged valve body

Claims 5 and 6 recite substantially the same tapered-bore and flanged-body limitation. The internal bore of the adapter sleeve tapers outwardly, while the valve body has an external flange that slides into the sleeve and fits tightly within the tapered surface.

The repeated language in claims 5 and 6 raises a formal drafting issue. It does not expand the technical scope materially. If both claims were issued with identical limitations, they would generally be treated as duplicative unless a difference appears in the official patent text or dependency structure.

What are the strongest and weakest claim limitations?

The strongest practical limitation is the protected, hollow needle located inside a sleeve and configured to pierce an external transfer-container wall. That combination distinguishes the patent from generic breath bags and ordinary sample ports.

The most design-sensitive limitations are:

The sleeve bore and inner end wall;
The needle’s position inside the sleeve;
The covering that closes the needle bore;
Piercing of the external transfer device;
The opposite-end placement of inlet and outlet.

The bag and mouthpiece limitations are comparatively conventional. A competitor could often avoid the literal claim by changing the transfer architecture rather than the bag material or patient inlet.

Potential noninfringing alternatives include:

A sealed bag with a luer or screw connector.
A septum port accessed by a non-hollow puncture element.
A transfer tube with a valve rather than a puncture needle.
A rigid sample chamber.
A collection bag whose inlet and outlet are not located at opposite ends.
A system that transfers the entire bag assembly without piercing an external container.
A bag using a filter or sorbent cartridge in place of a punctured vial.

Because the patent has expired, these distinctions have no current US infringement consequence under Patent 5,140,993. They remain relevant for historical freedom-to-operate reviews and for identifying whether later patents may cover similar improvements.

What patent landscape surrounds breath-sample collection devices?

The relevant patent landscape is broader than this single patent. It includes several technical clusters.

Breath bags and specimen containers

These patents generally address:

Impermeable polymer films;
Low-background or low-adsorption materials;
Disposable mouthpieces;
Bag welding and sealing;
Evacuated or preconditioned containers;
Gas retention during storage and transport.

The claims may cover material composition, multilayer films, sterilization, or manufacturing methods rather than the puncture-transfer system in Patent 5,140,993.

Transfer connectors and puncture systems

This cluster includes:

Needle-and-septum assemblies;
Piercing cannulas;
Self-sealing membranes;
Luer fittings;
Needleless transfer ports;
Valved sampling containers;
Closed-system gas transfer devices.

Patent 5,140,993 is most closely associated with this category.

Breath-analysis systems

Separate patent families may cover the analytical instrument rather than the collection bag. Examples include systems for measuring:

Hydrogen;
Methane;
Carbon dioxide;
Volatile organic compounds;
Isotopically labeled carbon dioxide;
Nitric oxide;
Alcohol.

A patent on a breath analyzer does not automatically cover the disposable bag or transfer connector. Conversely, a bag patent does not generally cover the analytical method or instrument.

Diagnostic and medical-use patents

Patents may also claim the use of breath measurements to diagnose or monitor:

Carbohydrate malabsorption;
Small-intestinal bacterial overgrowth;
Helicobacter pylori infection;
Pulmonary disease;
Metabolic disorders;
Drug metabolism.

Those method-of-use claims are distinct from the mechanical device claims in Patent 5,140,993.

Does US Patent 5,140,993 have Orange Book or FDA exclusivity?

No. The patent is not an Orange Book patent.

The FDA Orange Book identifies approved drug products, therapeutic-equivalence information, and certain patents and exclusivity periods associated with approved drugs. A breath-sample collection bag is a medical device component, not a drug product. Patent 5,140,993 therefore has no Orange Book listing, no Hatch-Waxman patent certification, and no FDA drug exclusivity period.[3][4]

FDA status may still matter for a commercial product using the patented technology. Depending on intended use, a breath-collection device could be regulated as a medical device, specimen-collection accessory, or component of a diagnostic system. That regulatory classification is separate from patent status. Patent expiration does not establish FDA clearance, approval, or compliance.

Are there Paragraph IV challenges or biosimilar risks?

No meaningful Paragraph IV or biosimilar issue applies.

Paragraph IV certifications concern an abbreviated new drug application that challenges patents listed for an approved drug. Patent 5,140,993 is directed to a physical collection device, not an active pharmaceutical ingredient or drug formulation.

Biosimilar pathways also do not apply. Biosimilar litigation concerns biological products and reference biologics. A breath bag or transfer assembly is neither a biologic nor a biosimilar product.

Any current regulatory or commercial dispute would more likely involve:

Medical-device clearance;
Diagnostic-system labeling;
Sample integrity;
Sterility;
Gas permeability;
Reimbursement;
Product liability;
Trade dress or design rights;
Later patents covering connectors or analyzer systems.

What litigation, licensing, or settlement issues affect the patent?

There is no current enforceable US patent right under Patent 5,140,993. The patent’s expiration removes the basis for a new US infringement action based solely on its claims.

The supplied information does not establish an issued litigation history, license agreement, or settlement involving this patent. Patent assignment records and litigation dockets should be distinguished from the patent’s technical disclosure. An assignment would identify ownership at a particular time, but it would not extend the expired patent term.

The absence of current enforceability also means that a historic license for the patent would generally have limited value unless it included:

Know-how;
Trade secrets;
Product designs;
Manufacturing tooling;
Regulatory files;
Improvements;
Trademark rights;
Other unexpired patent families.

How strong is the patent estate for a competing breath-sample product?

Patent strength depends on the broader family, not Patent 5,140,993 alone.

Risk factor	Assessment for Patent 5,140,993
Current US patent term	None
Claim breadth	Moderate to narrow
Central inventive concept	Protected puncture-needle transfer outlet
Dependence on exact structure	High
Generic breath bag coverage	Low
Analyzer coverage	None shown
Diagnostic method coverage	None shown
Manufacturing-process coverage	None shown
Orange Book leverage	None
Paragraph IV leverage	None
Biosimilar leverage	None
Current US blocking value	None

For a current product, the meaningful review should focus on later patents covering the complete commercial system. Relevant searches would include patents assigned to manufacturers of breath-hydrogen systems, methane analyzers, urea breath-test systems, carbon-isotope analyzers, specimen bags, septum vials, and closed-transfer assemblies.

Geographic coverage must also be reviewed separately. Expiration in the United States does not establish expiration in Canada, Europe, Japan, China, or other jurisdictions. Foreign counterparts may have expired earlier, lapsed for nonpayment, or differed in claim scope. The US patent number alone does not prove the status of any foreign family member.

What generic or competing launch scenarios exist?

Because Patent 5,140,993 is expired, a company can launch a US breath-sample collection device without obtaining permission under this patent. The principal launch scenarios are:

Like-for-like reproduction

A company may reproduce the disclosed bag, mouthpiece, check valve, sleeve, and needle-transfer architecture. Patent 5,140,993 does not block that activity in the United States.

Modified transfer system

A company may use the same general collection concept with a luer fitting, septum, stopcock, or valve-based transfer port. This may reduce exposure to later patents directed to needle-transfer assemblies.

Integrated diagnostic kit

A company may combine a collection bag with an analyzer or diagnostic test. The bag patent does not grant freedom to operate for the analyzer, assay, software, calibration system, or diagnostic method.

International launch

A foreign launch requires country-by-country review. The US expiration cannot be used as a proxy for foreign patent status.

Key Takeaways

US Patent 5,140,993 covers a breath-collection bag with a patient inlet and a protected hollow needle for transferring breath into an external container.
Claim 1 is limited by the sleeve, internal needle position, covering structure, and puncture-based transfer mechanism.
Claims 2 through 8 add neck, clamp, check-valve, adapter, tapered-bore, flange, and manual-valve limitations.
Claims 5 and 6 appear duplicative on the supplied language.
The patent issued on August 25, 1992, and its ordinary US term expired in August 2009.
The patent has no current US enforceable exclusivity.
It is not an Orange Book patent and has no Paragraph IV or biosimilar relevance.
FDA regulation of a commercial breath-collection product is separate from the expired patent.
Current freedom-to-operate analysis should focus on later patents covering transfer connectors, bag materials, analyzers, diagnostic methods, and manufacturing processes.
Foreign patent status must be assessed independently from US Patent 5,140,993.

FAQs

Can a company manufacture the claimed breath bag in the United States today?

Yes. The US patent has expired, so Patent 5,140,993 does not currently prevent manufacture, sale, or use of the claimed device in the United States.

Does the patent cover breath hydrogen testing?

No. The claims cover a physical breath-sample collection and transfer device. They do not claim hydrogen measurement, methane measurement, an analyzer, or a diagnostic method.

Does a luer-lock breath-sample bag infringe claim 1?

Not necessarily. A luer-lock system may avoid the claim’s required sleeve-mounted hollow needle and puncture-transfer arrangement. Later patents must still be reviewed independently.

Is the patent relevant to a urea breath-test kit?

Only as a historical device patent. Urea breath-test kits may involve separate patents on labeled substrates, assay chemistry, analyzer systems, and diagnostic methods.

Can the expired patent be used as prior art against a later patent?

Yes. The patent’s disclosure and claims may be relevant prior art in assessing novelty or obviousness of later patent claims, subject to the applicable statutory framework and the particular later patent’s priority dates.

References

United States Patent and Trademark Office. (1992). US Patent No. 5,140,993, Breath sample collection device. U.S. Department of Commerce.
United States Code, 35 U.S.C. § 154. Patent term and adjustment.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
United States Code, 21 U.S.C. § 355(j). Abbreviated new drug applications and patent certifications.

Details for Patent: 5,140,993

Summary for Patent: 5,140,993