United States Patent 10,737,028: Claim Scope, Autoinjector Coverage, and Patent Landscape

U.S. Patent No. 10,737,028 claims an automated injection apparatus centered on a removable needle-sheath retainer. The independent claim combines a medicament container, needle, needle sheath, retainer, retaining tab, grip surface, and housing lock. Dependent claims extend coverage to epinephrine, spring-driven container movement, a status window, a pressurized-gas actuation system, a spring-loaded check-ball release mechanism, operating indicia, and an elastomeric plunger.

The patent does not broadly claim epinephrine, an injectable formulation, or a needle sheath in isolation. Its principal commercial scope is an integrated autoinjector architecture in which the sheath retainer both engages the needle sheath and is initially restrained by the housing.

What does U.S. Patent 10,737,028 claim?

Claim 1 is an apparatus claim with several mandatory structural and functional limitations. A potentially infringing device must satisfy every limitation of the claim, either literally or, in some circumstances, under the doctrine of equivalents.

Claim element	Scope and practical significance
Housing	Requires an external body or enclosure supporting the injection components
Medicament container	Requires a container located within the housing
Plunger	Must move inside the container between first and second positions
First force	The plunger movement must respond to a force, without claim 1 limiting the force to a spring, gas, or other mechanism
Needle	Must be coupled to the medicament container
Needle sheath	Must cover the needle
Sheath retainer	Must be positioned around at least part of the sheath
Grip surface	Must receive a second force from the user
Distal movement	The retainer must move distally relative to the housing
Retaining tab	Must engage the sheath and transfer at least part of the second force to it
Lock protrusion	Must engage the housing and resist distal retainer movement

The claim is directed to the relationship among these components, rather than to a particular drug, needle gauge, container volume, or injection dose.

What is the inventive center of claim 1?

The key limitation is the sheath-retainer mechanism. The retainer is not merely a removable cap. It has three coordinated functions:

It provides a user-facing grip surface.
Its retaining tab engages the needle sheath and transfers removal force.
Its lock protrusion engages the housing to resist distal movement.

This creates a mechanically controlled sheath-removal sequence. The retainer is held against premature distal movement, while a later user-applied force can move the retainer and extract the sheath.

A conventional autoinjector with a removable cap may not fall within claim 1 if the cap does not include both a retaining tab that transfers force to the needle sheath and a lock protrusion that engages the housing.

What products and device architectures are covered?

The claim set is directed to an automated injection device, including an autoinjector capable of storing a prefilled medicament container. Claim 3 specifically identifies epinephrine, but claim 1 is not limited to epinephrine.

Potentially relevant commercial architectures include:

Epinephrine autoinjectors.
Prefilled syringe autoinjectors.
Gas-powered injection devices.
Spring-driven devices with a moving syringe or medicament container.
Devices with a removable needle shield or sheath.
Combination products in which the needle is concealed before use.

The patent’s scope is strongest where the device uses a dedicated retainer that remains coupled to the housing during storage and is pulled distally to remove the needle sheath.

How do claims 2 through 5 narrow the patent scope?

Claim 2: Sterility-preserving needle sheath

Claim 2 requires the needle sheath to maintain needle sterility. This limitation is commercially routine for a prefilled injection device, but it ties the dependent claim to a sterile packaged needle configuration.

Claim 2 does not specify the sheath material, sterilization method, barrier structure, or shelf-life period. A device may satisfy the limitation through a conventional sterile needle cover if the cover maintains sterility before use.

Claim 3: Epinephrine

Claim 3 limits the apparatus to a medicament container containing epinephrine. This claim is relevant to epinephrine autoinjectors but does not establish ownership of epinephrine itself.

The claim does not specify:

Epinephrine concentration.
Dose volume.
Racemic versus non-racemic composition.
Preservative system.
Container material.
Injection route.
Indication.

A competing device using another drug would fall outside claim 3 but could remain within claim 1 if all claim 1 limitations are present.

Claim 4: Moving medicament container and spring

Claim 4 requires the medicament container to move within the housing and a spring to urge it proximally. This limitation points to an autoinjector in which syringe or container movement contributes to needle insertion or device operation.

The claim distinguishes between:

The plunger moving within the container; and
The container itself moving within the housing.

A device with a fixed container and a moving plunger may satisfy claim 1 but would not satisfy claim 4.

Claim 5: Status window

Claim 5 requires a housing status window through which the medicament container contents are visible when the plunger is in its first position.

This creates a combination of mechanical and user-interface protection. The claim may cover a transparent housing section, a dedicated viewing aperture, or another window arrangement, provided the contents are viewable at the specified plunger position.

What additional protection covers pressurized-gas actuation?

Claims 6 and 7 add a gas-powered actuation subsystem.

Claim 6: Pressurized-gas force generation

Claim 6 requires:

A pressurized gas container.
An actuator.
Gas-container operation in response to actuator movement.
Operational coupling between the gas container and plunger.
Gas-generated force moving the plunger from the first position to the second position.

This claim is narrower than claim 1 because claim 1 permits any source of the first force. A spring-only autoinjector could potentially satisfy claim 1 while avoiding claim 6.

Claim 7: Spring-loaded check ball and gas-release mechanism

Claim 7 further requires a spring-loaded check ball and gas-release mechanism. Pressurized gas must be released when the check ball is depressed.

This limitation is technologically specific. A gas-powered device using a rupture disc, valve, piston, membrane, or other release mechanism may avoid claim 7 while remaining potentially relevant to claim 6.

Actuation configuration	Claim 1	Claim 6	Claim 7
Spring-driven plunger	Potentially	No, absent pressurized gas	No
Gas-driven plunger with conventional valve	Potentially	Potentially	Not necessarily
Gas-driven plunger with spring-loaded check ball	Potentially	Potentially	Potentially
Manual plunger	Potentially, if all other elements exist	No	No

What does claim 8 add to the sheath-retainer mechanism?

Claim 8 is the most detailed sheath-removal claim. It requires that:

The retainer is removably coupled to the housing.
Part of the retainer is positioned within the housing.
Distal removal of the retainer removes the needle sheath.
The grip surface includes a grip protrusion.
The retainer has an indicium showing the order of operation.

The claim requires a functional removal path. It is not enough for the retainer to be removable from the housing. The retainer must transmit at least part of the user-applied force to remove the sheath from the needle.

The grip protrusion may improve tactile engagement or provide a defined pulling surface. The order-of-operation indicium may be a printed arrow, molded symbol, text, color marking, or comparable indicator, depending on claim construction and intrinsic evidence.

How does claim 8 interact with the lock protrusion in claim 1?

Claim 1 requires the lock protrusion to resist distal movement. Claim 8 requires distal removal of the retainer. Read together, the claims contemplate a lock that restrains the retainer during an initial condition but allows release or disengagement when the user applies the intended force or performs the specified operation.

The claim language does not require a separate button, twist action, rotational step, or breakaway component. Those mechanisms could be relevant depending on the patent specification and prosecution history, but they are not expressly required by the supplied claims.

What do claims 9 through 11 cover?

Claim 9: Elastomeric plunger member

Claim 9 requires:

An elastomeric member inside the medicament container.
Movement of that member between the first and second positions.
Expulsion of medicament through the needle.

This claim covers a conventional syringe-plunger arrangement when combined with the claim 1 sheath-retainer structure. It does not claim every elastomeric syringe plunger independently.

Claims 10 and 11: Operating indicia

Claim 10 places the order-of-operation indicium on the outer surface of the sheath retainer. Claim 11 places the indicium on the needle sheath.

These are alternative location-based limitations:

Claim	Location of indicium
Claim 8	Outer surface of sheath retainer
Claim 10	Outer surface of sheath retainer
Claim 11	Needle sheath

Claims 8 and 10 overlap in requiring a retainer indicium, but claim 8 adds the grip protrusion and detailed removal relationship. Claim 11 extends the indicium concept to the sheath itself.

How strong is the independent claim?

Claim 1 has meaningful commercial breadth but is structurally dense. Its strength depends on the prior art surrounding:

Removable needle shields.
Syringe or autoinjector caps.
Retainers with internal tabs.
Locking protrusions.
Distal cap removal.
Devices that prevent premature sheath removal.

Factors supporting claim strength

The claim combines several elements that are often disclosed separately:

A retainer surrounding a needle sheath.
A tab that transfers force to the sheath.
A housing-engaging lock protrusion.
Distal retainer movement.
Integration with an automated medicament-delivery apparatus.

A reference showing only a removable cap may not disclose the claimed force-transfer and locking relationships.

Factors creating validity or design-around risk

The claim uses functional language such as "configured to" and "configured to transfer." Prior art may challenge whether the claimed structure is sufficiently distinct from known cap-and-sheath assemblies.

Potential invalidity theories could focus on:

Anticipation by a single autoinjector reference.
Obviousness based on combining a known needle-shield retainer with a known housing lock.
Written-description support for the claimed force-transfer relationship.
Indefiniteness of terms such as "resist movement" or "at least a portion" if the specification and prosecution record do not provide adequate boundaries.

The claim’s commercial value is likely concentrated in the specific retainer and lock geometry, not in the generic housing, syringe, plunger, or needle components.

What patent landscape surrounds this patent?

The relevant landscape has four technical clusters.

Needle-sheath and cap-removal patents

These patents generally cover:

Needle shields.
Removable caps.
Pull-off mechanisms.
Tactile grips.
Frangible connections.
Retainers that prevent premature needle exposure.

The principal freedom-to-operate issue is whether a competing product uses a retainer with a tab that engages the sheath and a housing lock that resists distal movement.

Autoinjector actuation patents

A second cluster covers:

Spring-driven plungers.
Moving syringe containers.
Automatic needle insertion.
Gas-powered actuators.
Valve and check-ball release systems.

Claims 6 and 7 are relevant only where pressurized gas supplies the plunger force. They do not broadly capture all gas-powered injection systems because claim 7 identifies a particular check-ball release arrangement.

Prefilled syringe and container patents

A third cluster covers:

Syringe-container mounting.
Container translation inside a housing.
Plunger seals.
Elastomeric components.
Viewing windows.
Drug-contact materials.

These patents may create overlapping exposure even where a device avoids the sheath-retainer claims.

Combination-product and epinephrine patents

Epinephrine autoinjectors may be subject to separate patents covering:

Dose delivery.
Needle concealment.
Voice or electronic instructions.
Device activation.
Formulation stability.
Container and closure systems.
Manufacturing and assembly processes.

Claim 3 adds epinephrine only as a dependent limitation. It does not establish that the patent protects a particular epinephrine formulation or commercial product.

What is the Orange Book status of U.S. Patent 10,737,028?

The supplied claims describe a drug-delivery apparatus rather than an active ingredient or drug formulation. The claims do not establish Orange Book listing status.

An Orange Book analysis would depend on whether the patent was submitted for a specific approved drug product and whether FDA accepted the patent as relevant to the listed product. A device patent may be relevant to a combination product, but the claim text alone does not show:

The approved product associated with the patent.
The NDA holder.
The listing category.
Any use code.
Whether FDA accepted or rejected a listing.
Whether a Paragraph IV certification has been filed.

The patent itself does not create a standalone Paragraph IV pathway. Paragraph IV activity would arise only if a generic applicant filed an ANDA referencing an approved product for which this patent was listed.

When does U.S. Patent 10,737,028 lose exclusivity?

The claims supplied do not provide the patent’s effective filing date, priority chain, patent-term-adjustment calculation, patent-term-extension status, terminal disclaimer, or expiration record. The claims therefore do not establish a reliable expiration date.

For a utility patent, the nominal term is generally measured from the effective nonprovisional filing date, subject to patent-term adjustment and other statutory modifications.[2] A precise expiry analysis requires the USPTO bibliographic record and continuity data.

The patent’s enforceability can also be affected by:

Maintenance-fee status.
Terminal disclaimers.
Patent-term adjustment.
Patent-term extension.
Reexamination or post-grant proceedings.
Claim cancellation or amendment.

What generic launch risks exist?

A generic or competing autoinjector could face several launch scenarios:

Scenario	Commercial effect
Device omits the retainer tab	Potentially avoids a central claim 1 limitation
Device uses a fixed needle shield	May avoid the distal removal architecture
Device uses a cap with no housing lock	May avoid claim 1
Device uses a spring actuator	May avoid claims 6 and 7, but not necessarily claim 1
Device uses another drug	Avoids claim 3 but not necessarily claim 1
Device uses no operating indicium	May avoid claims 8, 10, and 11, but not claim 1
Device uses a fixed syringe	May avoid claim 4
Device uses a non-check-ball gas valve	May avoid claim 7

The highest-risk design is an epinephrine autoinjector with a removable sheath retainer, internal retaining tab, housing lock, distal pull-off movement, and user-facing operating indicia.

What patent litigation, licensing, and settlement activity affects this patent?

The claim text does not identify litigation, licensing agreements, settlements, assignments, or current enforcement activity. Those issues are separate from claim construction and require verified court, USPTO, assignment, and transaction records.

No litigation or settlement conclusion should be drawn solely from the existence of U.S. Patent 10,737,028.

Key Takeaways

U.S. Patent 10,737,028 is directed to an automated injection apparatus with a specialized removable needle-sheath retainer.
Claim 1 requires a retainer grip surface, retaining tab, and housing-engaging lock protrusion.
The patent does not broadly claim epinephrine, injectable formulations, or needle sheaths alone.
Claim 4 covers a spring-driven moving medicament container.
Claims 6 and 7 target pressurized-gas actuation, with claim 7 limited to a spring-loaded check-ball release mechanism.
Claims 8, 10, and 11 protect operating indicia associated with sheath-retainer removal.
The principal design-around opportunity is to eliminate or materially alter the claimed retainer-tab and housing-lock relationship.
Exact expiration, Orange Book listing, Paragraph IV activity, litigation, licensing, and settlement status are not established by the supplied claim text.

FAQs About U.S. Patent 10,737,028

Does this patent claim an epinephrine autoinjector generally?

No. Claim 3 identifies epinephrine, but the claims require the specific apparatus architecture recited in claim 1 and the additional limitations of the dependent claim.

Can a spring-powered autoinjector infringe this patent?

Yes, potentially. Claim 1 does not require pressurized gas. A spring-powered device could still be relevant if it has the claimed sheath retainer, retaining tab, lock protrusion, and related structure.

Does removing the operating arrow avoid the patent?

It may avoid claims 8, 10, or 11, depending on the indicium location, but it would not by itself avoid claim 1.

Is a gas-powered device automatically covered by claims 6 and 7?

No. Claim 6 requires operational coupling between the pressurized gas container and plunger. Claim 7 further requires a spring-loaded check ball and gas-release mechanism activated by depressing the check ball.

Does this patent protect the needle sheath material?

No. The supplied claims do not specify a particular sheath material, thickness, polymer, sterilization process, or barrier construction.

References

United States Patent No. 10,737,028, claims 1-11 (2020).
United States Code, 35 U.S.C. §§ 154, 156.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations (Orange Book).
U.S. Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, patent term and claim interpretation provisions.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004325202	⤷ Start Trial
Australia	2006210865	⤷ Start Trial
Australia	2007245139	⤷ Start Trial
Australia	2009200841	⤷ Start Trial
Australia	2009246525	⤷ Start Trial
Australia	2012201481	⤷ Start Trial
Australia	2015264857	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 10,737,028