Details for Patent: 7,802,568

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Summary for Patent: 7,802,568

Title:	Cartridge for a liquid
Abstract:	For meteredly dispensing a liquid over a period of several months from a container which can be stored over a long period of time, the need is for a container which is practically diffusion-tight and in which the liquid does not come into contact with the ambient atmosphere. The cartridge according to the invention is a three-shell container comprising a collapsible bag which contains the liquid, a container which is stable in respect of shape and a stiff metal casing. The cartridge can be releasably connected to a dispensing device. The cartridge can be provided with a micro-opening with which the time for pressure equalisation between the cartridge and the ambient atmosphere can be adjusted. The cartridge is suitable for aqueous and for alcoholic liquids which contain a pharmaceutically active substance. The liquid in the cartridge is protected from external influences. The cartridge can be used in an atomiser for producing an inhalable aerosol for the treatment of illnesses.
Inventor(s):	Joachim Eicher, Johannes Geser, Matthias Hausmann, Michael Schyra, Gilbert Wuttke, Andreas Fiol, Heinrich Kladders, Dieter Hochrainer, Bernd Zierenberg
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US11/232,896
Patent Claim Types: see list of patent claims	Device;

United States Patent 7,802,568: Claim Scope, Patent Strength, Expiration and Competitive Landscape

United States Patent 7,802,568 protects a reusable snap-hook interface that connects an interchangeable liquid cartridge to a dispensing device. The core combination requires discrete spring-like snap hooks on vertical extensions of a single-piece connection component, a circumferential groove on the cartridge or stopper, and a draw-off connection positioned between and substantially surrounded by the hooks. The claims are directed to dispensing hardware, not to a pharmaceutical active ingredient, formulation, or therapeutic method.

The principal infringement risk is concentrated in cartridge-based dispensers that use a reusable upper connector, a grooved cartridge neck or stopper, and multiple molded snap hooks surrounding a liquid-withdrawal spike. Products using threaded, bayonet, continuous-ring, screw, clamp, or non-grooved interfaces have stronger design-around positions.

What does United States Patent 7,802,568 protect?

The patent protects a mechanical releasable connection between a dispensing device and a replaceable liquid cartridge. Its central architecture has five required elements:

1. A connection portion located on the upper part of a dispensing device.
2. A draw-off connection for withdrawing liquid from the cartridge.
3. Multiple discrete snap hooks.
4. Vertical extensions carrying the snap hooks.
5. A single-piece connection portion in which the draw-off connection extends between and is substantially surrounded by the snap hooks.

The hooks individually engage a circumferential groove in a stiff cartridge casing, shape-stable container, or stopper. The cartridge is pushed into the dispensing device, causing the hooks to snap into the groove. The connection portion can then be released and reused with another cartridge under claim 1 and claim 8.

The claims cover the interface architecture rather than the particular liquid being dispensed. The liquid may be held directly in a cartridge or in a collapsible bag located within the cartridge.

Patent identification and legal status

Item	Analysis
Patent	U.S. Patent No. 7,802,568
Grant date	September 21, 2010
Technology	Releasable cartridge-to-dispenser connection
Claim category	Mechanical apparatus and connection claims
Independent claims	Claims 1 and 7
Dependent claims	Claims 2-6 and 8
Drug patent status	Not a drug substance or pharmaceutical formulation patent
Orange Book relevance	None based on the supplied claims
Primary legal issue	Literal and equivalent infringement of a cartridge-dispenser interface

The issued claims, rather than the specification alone, define the enforceable scope. Claim terms are interpreted in the context of the patent, prosecution history, and ordinary technical meaning under established claim-construction principles. [1]

How do claims 1 and 7 differ?

Claims 1 and 7 protect related but distinct versions of the same mechanical arrangement.

Limitation	Claim 1	Claim 7
Releasable connection	Yes	Yes
Upper dispensing-device connection portion	Yes	Yes
Draw-off connection	Yes	Yes
Multiple discrete snap hooks	Yes	Yes
Hooks engage circumferential groove	Yes	Yes
Vertical extensions	Yes	Yes
Draw-off connection surrounded by hooks	Yes	Yes
Single-piece material	Yes	Yes
Interchangeable cartridge expressly required	Yes	No
Reuse with a second cartridge	Yes	Added by claim 8
"Consisting essentially of" transition	No	Yes

Claim 1 expressly requires that the cartridge be interchangeable and that the connection portion be reusable with a second cartridge. Claim 7 is structurally focused and does not include the interchangeability and second-cartridge limitations until claim 8.

Claim 7 uses the phrase "consisting essentially of." That transition generally limits the claim to the listed elements and additional elements that do not materially alter the basic and novel characteristics of the claimed connection. The phrase may narrow the permissible scope of additional components compared with the open-ended "comprising" transition. Its effect would depend on the patent specification and prosecution history. [2]

What elements are required for infringement?

A product would generally need to satisfy every limitation of at least one asserted independent claim for literal infringement. The principal limitations are cumulative.

Cartridge and groove limitation

The cartridge must include, or be associated with, one of the following:

• A stiff outer casing;
• A shape-stable container; or
• A stopper.

That structure must have a peripherally extending groove. The groove is not optional. A cartridge with a smooth neck, isolated recesses, external threads, or a bayonet track may avoid literal infringement unless the relevant structure is construed as equivalent to the claimed groove.

Discrete snap-hook limitation

The claim requires a plurality of discrete snap hooks. A single continuous annular retaining ring is materially different from multiple individual hooks. A design using two, three, or more separate hooks could fall within the ordinary meaning of "plurality," subject to the patent’s intrinsic evidence.

Each snap hook must be provided on one of the vertical extensions. Hooks mounted elsewhere on the dispenser, or hooks formed directly on the cartridge, create potential noninfringement positions.

Surrounding draw-off connection

The draw-off connection must extend vertically between the vertical extensions and be substantially surrounded by the snap hooks. This spatial relationship is a significant narrowing limitation. A dispenser with a withdrawal spike positioned outside the hook array, offset from the hook plane, or surrounded by a continuous collar rather than discrete hooks may have reduced exposure.

Single-piece limitation

The connection portion must be a single piece of material that includes:

• The vertical extensions;
• The snap hooks, through their attachment to those extensions; and
• The draw-off connection.

A multi-component assembly may avoid literal infringement if the hooks, extensions, and draw-off structure are separate parts. A unitary injection-molded plastic component presents the highest claim risk.

What do dependent claims 2 through 6 and 8 add?

Claim	Added subject matter	Commercial significance
2	Plastic snap hooks with spring property	Targets resilient molded-hook designs
3	Top-side cartridge foil pierced by draw-off connection	Covers sealed disposable cartridges
4	Draw-off connection penetrates an insertion connection portion	Narrows the cartridge interface geometry
5	Diaphragm at end of insertion portion is pierced	Covers sealed diaphragm systems
6	Collapsible liquid bag inside cartridge	Extends protection to bag-in-container cartridges
8	Claim 7 cartridge is interchangeable and reusable with a second cartridge	Captures reusable dispenser heads

Claims 3 and 5 are important for sterile or contamination-controlled systems because they cover piercing a foil or diaphragm during cartridge insertion. Claim 6 extends the architecture to collapsible-bag systems in which the rigid outer cartridge provides mechanical support while the bag contains the liquid.

Dependent claims are narrower than claims 1 and 7 but may be easier to map onto a commercial product with a sealed bag or diaphragm. Their vulnerability depends on whether the accused system has the claimed piercing sequence and internal fluid path.

How strong is the patent estate for United States Patent 7,802,568?

The supplied claims show a focused mechanical estate with meaningful structural specificity. Its strength is highest against products that copy the complete geometry. Its strength is lower against systems that preserve the commercial function but change the retention mechanism.

Strength factors

The patent has several cumulative structural limitations that can distinguish it from general cartridge-dispenser prior art:

• Multiple discrete snap hooks rather than a generic releasable attachment;
• Hooks positioned on vertical extensions;
• A draw-off connection surrounded by the hooks;
• A single-piece connection component;
• A circumferential groove in the cartridge, container, casing, or stopper;
• Reuse of the connection portion with multiple cartridges.

These limitations can support a relatively clear product-to-claim comparison when the dispenser is available for inspection.

Weakness factors

The claims are vulnerable to prior art showing combinations of:

• Replaceable liquid cartridges;
• Snap-fit or clip-fit dispenser heads;
• Grooved cartridge necks or stoppers;
• Central piercing spikes;
• Unitary molded plastic connectors;
• Reusable dispensing heads.

A strong invalidity position would likely focus on anticipation under 35 U.S.C. § 102 or obviousness under 35 U.S.C. § 103. The key question would be whether one reference discloses the complete hook-extension-draw-off arrangement, or whether a skilled person would have combined known cartridge retention and piercing structures in the claimed configuration. [3]

The single-piece and surrounding-geometry limitations may provide the best patentability distinctions. They also narrow enforcement scope.

What design-around strategies reduce infringement risk?

The following configurations could reduce literal infringement exposure, subject to detailed claim construction and prosecution-history review:

Design-around approach	Likely claim limitation avoided
Threaded cartridge connection	Discrete snap hooks and groove engagement
Bayonet-lock interface	Individual hooks engaging a circumferential groove
Continuous annular retaining sleeve	Plurality of discrete snap hooks
Hooks located on the cartridge	Hooks provided on dispenser vertical extensions
Separate metal spike and plastic retaining ring	Single-piece material limitation
Offset draw-off tube	Draw-off connection between and surrounded by hooks
Smooth neck with external clamp	Peripherally extending groove
Reusable cartridge without piercing foil or diaphragm	Claims 3 and 5
Rigid liquid reservoir without collapsible bag	Claim 6
Permanently attached cartridge	Interchangeability and second-cartridge limitations

A design that uses snap hooks but relocates the draw-off connection outside the hook array may still face a doctrine-of-equivalents argument. Courts generally assess whether the accused element performs substantially the same function in substantially the same way to achieve substantially the same result, subject to prosecution-history estoppel and other limitations. [4]

When does United States Patent 7,802,568 lose exclusivity?

The patent was granted on September 21, 2010. A U.S. utility patent generally expires 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments. [5]

The grant date alone does not establish the exact expiration date. A reliable expiration analysis must use the patent’s earliest effective U.S. filing or international filing date, any patent-term adjustment, and maintenance-fee record. Patent term is separate from enforceability: expiration ends the right to exclude, while lapse for failure to pay maintenance fees can affect enforceability earlier.

Exclusivity timeline

Event	Date or rule
U.S. patent grant	September 21, 2010
Ordinary utility-patent term	20 years from applicable earliest filing date
Maintenance fees	Due during the 3.5-, 7.5-, and 11.5-year windows after grant
Patent-term adjustment	May extend the ordinary term
Patent-term extension	Generally associated with regulatory review of eligible products, not ordinary dispenser hardware
Orange Book exclusivity	Not applicable to the claimed mechanical technology

No FDA drug exclusivity period follows from these claims. The patent does not claim an active pharmaceutical ingredient, pharmaceutical composition, dosage regimen, or biologic.

What is the Orange Book status of this patent?

United States Patent 7,802,568 is not an Orange Book patent based on the supplied claims. The FDA Orange Book lists patents submitted for approved drug products, including drug substance, drug product, and certain method-of-use patents. A reusable cartridge connector is a medical or consumer dispensing-device technology, not a listed drug claim. [6]

Consequently:

• There is no Paragraph IV certification directed to this patent merely because a generic drug uses a cartridge.
• The patent does not create Hatch-Waxman drug exclusivity.
• A generic-drug applicant could still face a separate device patent assertion if its commercial product practices the claims.
• A device patent may be relevant to combination-product commercialization even when absent from the Orange Book.

Are Paragraph IV challenges or biosimilar risks relevant?

Paragraph IV challenges

Paragraph IV litigation is not directly implicated by this patent’s claim category. A Paragraph IV certification concerns a listed patent associated with an approved drug application under the Hatch-Waxman framework. [7]

A generic manufacturer could challenge this patent through ordinary district-court litigation, an inter partes review, or other applicable mechanisms. That challenge would be based on invalidity or noninfringement, not on a conventional Orange Book certification.

Biosimilar risk

Biosimilar applicants do not create a direct biosimilar risk for this patent because the claims do not cover a biologic molecule or biologic manufacturing process. The relevant commercial risk is device-interface replication by:

• Generic drug manufacturers;
• Combination-product developers;
• Contract manufacturers;
• Medical-device companies;
• Private-label dispenser suppliers.

The patent may affect the device component of a combination product, but it does not block biosimilar substitution at the active-ingredient level.

Which companies are challenging the patent?

No challenger, lawsuit, inter partes review, reexamination, settlement, or license can be reliably identified from the claim text alone. The claim set does not identify the current owner, exclusive licensee, accused manufacturers, or litigation counterparties.

A complete litigation review would ordinarily examine:

• USPTO Patent Center;
• PTAB proceedings;
• PACER and district-court dockets;
• Federal Circuit opinions;
• Assignment records;
• Maintenance-fee records;
• Patent-family members in Europe and other jurisdictions.

Those records determine whether ownership changed, whether the patent lapsed, whether claims were cancelled or amended, and whether a settlement or license affects enforcement.

What patent landscape surrounds this technology?

The relevant landscape is a device and packaging landscape rather than a drug patent landscape. The principal neighboring patent categories are:

1. Replaceable cartridge systems for liquid, gel, foam, adhesive, cosmetic, diagnostic, or pharmaceutical products.
2. Piercing closures using spikes, cannulas, diaphragms, or foils.
3. Snap-fit and bayonet connections between disposable cartridges and reusable heads.
4. Collapsible-bag cartridges.
5. Single-piece injection-molded dispenser connectors.
6. Anti-leak and anti-contamination cartridge interfaces.
7. Keyed cartridge recognition and anti-misconnection systems.
8. Metering pumps and draw-off valves.
9. Combination-product delivery systems.

Geographic protection depends on issued counterparts. A U.S. patent does not create rights in Europe, Canada, Japan, China, or other jurisdictions. Foreign family members may have different claim scope, expiration dates, prosecution amendments, and legal status.

What manufacturing and IP barriers does the patent create?

The principal manufacturing barrier is the need to mold or fabricate a one-piece connector with resilient vertical extensions and discrete snap hooks. The design must balance:

• Hook flexibility;
• Fatigue resistance;
• Retention force;
• Cartridge insertion force;
• Release force;
• Dimensional tolerance;
• Seal integrity;
• Chemical compatibility;
• Repeated-use durability.

A commercial copy may be exposed even if its external appearance differs, because the most important limitations concern the internal geometry and functional relationship between the hook array, groove, and draw-off connection.

Manufacturers can reduce risk through a documented design-around program, including CAD-level claim charts, independent dimensional analysis, material review, and an assessment of whether separate connector components avoid the single-piece limitation.

What generic launch risks exist?

The relevant launch risk is a device-commercialization risk rather than a generic-drug exclusivity risk. A competing product faces the following scenarios:

Launch scenario	Risk profile
Exact copy of hook-and-groove connector	High infringement exposure
Same cartridge geometry but different dispenser head	Depends on hook location and surrounding structure
Same dispenser head with threaded cartridge	Lower literal risk
Multi-piece connector with separate spike	Potentially avoids single-piece limitation
Continuous retaining ring	Potentially avoids discrete-hook limitation
Disposable connector supplied with every cartridge	May avoid reuse limitations in claim 1 and claim 8, but claim 7 may remain relevant
Alternative sealed-fluid path	May avoid dependent claims 3, 5, and 6

Claims 1 and 7 are the principal launch-screening claims. Claims 2 through 6 and 8 should be used as fallback positions when the product includes plastic spring hooks, pierced foil, a diaphragm, or a collapsible bag.

Key Takeaways

• U.S. Patent 7,802,568 covers a specific reusable cartridge-to-dispenser connection.
• The critical structure is a single-piece connection portion with vertical extensions, discrete snap hooks, and a centrally positioned draw-off connection.
• The hooks must individually engage a circumferential groove in the cartridge, casing, container, or stopper.
• Claim 1 expressly requires cartridge interchangeability and reuse of the connection portion.
• Claim 7 is structurally broader in one respect because interchangeability is not required until claim 8, but it uses the narrower "consisting essentially of" transition.
• Threaded, bayonet, continuous-ring, multi-piece, smooth-neck, and offset-spike designs offer the clearest design-around paths.
• The patent is not an Orange Book drug patent and does not create Paragraph IV or biosimilar exclusivity.
• The exact expiration date requires the applicable earliest filing date, patent-term adjustment, maintenance-fee status, and any terminal disclaimer.
• Litigation, licensing, ownership, and settlement conclusions cannot be drawn from the claims alone.
• The highest commercial risk is for molded cartridge dispensers that replicate the claimed hook, groove, piercing, and surrounding-geometry arrangement.

FAQs

Does U.S. Patent 7,802,568 cover the liquid inside the cartridge?

No. The claims cover the mechanical connection between the cartridge and dispensing device. They do not claim a particular active ingredient, liquid composition, or therapeutic use.

Can a dispenser infringe if it uses only two snap hooks?

Potentially yes. "A plurality" generally means two or more unless the specification or prosecution history establishes a different meaning. The remaining structural limitations must also be satisfied.

Does a disposable connection head avoid claim 1?

It may avoid the express reuse and second-cartridge limitations of claim 1, but the product must still be assessed against claim 7 and claim 8. A disposable head can also raise doctrine-of-equivalents issues depending on the product architecture.

Is a circumferential recess the same as a peripherally extending groove?

It may be, depending on its geometry and claim construction. A recess extending around the cartridge perimeter is more likely to be treated as a groove than isolated slots or a short bayonet track.

Does using metal snap hooks avoid the patent?

Not necessarily. Claim 2 specifies plastic snap hooks with spring property, but claims 1 and 7 do not expressly require plastic hooks. Metal hooks could still fall within an independent claim if all other limitations are met.

References

1. United States Patent and Trademark Office. (2010). U.S. Patent No. 7,802,568, Releasable connection between a cartridge and a connection portion of a dispensing device.
2. United States Patent and Trademark Office. (2023). Manual of Patent Examining Procedure § 2111.03: Transitional phrases.
3. 35 U.S.C. §§ 102-103 (2024).
4. 35 U.S.C. § 271 (2024); Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997).
5. 35 U.S.C. §§ 154, 156 (2024).
6. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
7. 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (2024).

Drugs Protected by US Patent 7,802,568

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 7,802,568

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	199 40 713	Feb 23, 1999
Malaysia	PI 99 00627	Aug 26, 1999

International Family Members for US Patent 7,802,568

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	022717
Austria	277582
Australia	3422600
Australia	759881
Bulgaria	105785
Bulgaria	64454