Details for Patent: 8,016,788

Summary for Patent: 8,016,788

Title:	Devices, systems and methods for medicament delivery
Abstract:	An apparatus includes a housing, a medicament container and an actuator. The actuator includes a release member and an energy storage member having a first position and a second position. In the first position, the energy storage member has a first potential energy. In the second position the energy storage member has a second potential energy. The energy storage member is configured to convert a portion of the first potential energy into kinetic energy when moved from the first position to the second position to move the medicament container within the housing. The energy storage member has a longitudinal axis offset from a longitudinal axis of the medicament container. The release member is configured to selectively deploy the energy storage member from its first position to its second position.
Inventor(s):	Evan Thomas Edwards, Eric Shawn Edwards, Mark J. Licata
Assignee:	kaleo Inc
Application Number:	US12/688,321
Patent Claim Types: see list of patent claims	Device; Dosage form;

Executive summary: Scope, claim structure, and US patent-asset implications for US 8,016,788

US 8,016,788 claims a spring or gas-driven medicament autoinjector architecture built around a two-cavity housing with offset longitudinal axes, where an energy storage member in a second cavity is actuated by a movable actuation/release member that drives a medicament injector in a first cavity into an injection position through a distal opening. The claim set is dominated by mechanical control features: axis offset, actuation member geometry (portions through openings while in a first position), safety lock and needle guard engagement, retention/disengagement mechanics using first and second actuation members, and gas-container delivery with seals/puncturers.

Business implication: the claim scope centers on system-level mechanical relationships (offset cavities + internal actuation member path + energy release and injector translation). Design-arounds that break any of those relationships—especially offset-axis cavity arrangement, specific actuation-member positioning through a second opening in the first position, and retention-to-disengagement sequencing—are most likely to narrow infringement exposure.

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What does US 8,016,788 claim for medicament injectors with offset cavities and energy storage?

Plain-English claim core: an autoinjector apparatus with:

• A housing defining first cavity and second cavity
• Offset longitudinal axes between cavities
• A medicament injector (container + needle) movably disposed in the first cavity
• An energy storage member in the second cavity configured to apply a force to move the injector into an injection position
• An actuation member that actuates the energy storage member when moved from first position to second position, with distinct portions of the actuation member located inside vs through openings while in the first position

Claim 1 (independent) structural elements

Claim 1 recites a tightly coupled geometry-and-timing architecture:

Housing and axes

• “Housing defining a first cavity and a second cavity”
• “Longitudinal axis defined by the first cavity offset from a longitudinal axis defined by the second cavity”
• Distal end portion has:
  • first opening in fluid communication with first cavity
  • second opening in fluid communication with second cavity

Injector and needle

• “Medicament injector movably disposed within the first cavity”
• Injector includes “medicament container and a needle”

Energy storage and actuation

• “Energy storage member disposed within second cavity” configured to produce force to move injector to injection position where needle portion is disposed through the first opening
• “Actuation member configured to actuate the energy storage member when … moved from a first position to a second position”
• Actuation member positioning requirement:
  • a first portion disposed within second cavity when actuation member is in first position
  • a second portion disposed through second opening when actuation member is in the first position

This “portions-in-vs-through-opening” limitation is a key scope lever. It creates an element not satisfied by many generic “trigger actuates spring” designs that lack a second-opening protrusion in the pre-actuation position.

Dependent claim clusters that narrow the mechanics

The independent claim is followed by dependent claims that add specific mechanical sub-systems.

Retention and disengagement via first and second actuation members (Claim 2)

• Actuation member is “a first actuation member”
• Includes “retention portion” engaging distal end portion to limit movement
• Adds “second actuation member” coupled to distal end portion
• Second actuation member disengages retention portion when moved relative to distal end portion

Safety lock and needle guard (Claims 3-4)

• Safety lock movably coupled to distal end portion with protrusion that engages the actuation member to limit movement
• Needle guard has:
  • first portion disposed through the first opening and about the needle
  • second portion engaging the safety lock

Actuation-to-contact (Claim 5)

• Second portion of actuation member contacts energy storage member when actuation member is in second position

Directionality and opposed motion (Claim 6)

• Actuation member moves within housing in a first direction as it goes from first to second position
• Medicament injector moves in opposite direction when moving toward injection position

Biasing (Claim 7)

• Biasing member in second cavity urging actuation member toward second position

Gas energy with sealing/puncturing (Claims 8-10)

• Energy storage is “gas container” releasing pressurized gas to produce force
• Optional seal fluidically isolates proximal end portion of second cavity from the outside (Claim 9)
• Optional puncturer with part apart from gas container in first position and disposed within gas container in second position (Claim 10)

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What additional scope do Claims 11-22 add beyond Claim 1’s actuation geometry?

Claims 11 and 18 are additional independent claim sets that reframe the actuation system while keeping the same high-level apparatus architecture: two-cavity housing with offset axes, medicament injector in first cavity, energy storage in second cavity.

Claim 11 independent set: injection by “first direction” force and actuation in “second direction”

Claim 11 recites:

• Housing with first and second cavities offset axes
• Injector movably in first cavity (needle + medicament container)
• Energy storage member in second cavity configured to produce force to move injector in a first direction to injection position where needle portion is outside the housing
• Actuation member actuates energy storage when actuation member moved in a second direction within second cavity from first to second position
• A distal end opening in fluid communication with second cavity and actuation member portions:
  • first portion disposed within second cavity when actuation member in first position
  • second portion disposed through the opening when actuation member in first position (Claim 12)

This mirrors Claim 1’s “pre-actuation protrusion through distal opening” logic, but with different phrasing: an actuation path in second direction and a distal opening tied to the second cavity.

Claim 18 independent set: release member + biasing member actuator architecture

Claim 18 recasts actuation as:

• Actuator having release member and biasing member
• Actuate energy storage when release member moved from first position to second position
• Biasing member disposed in second cavity urging release member towards second position

Dependent claims then map the same distal opening geometry:

• Claim 19: needle through first opening when injector is in injection position; release member through second opening when release member is in first position
• Claim 20: release member retention portion + trigger disengaging retention portion
• Claim 21: safety lock protrusion engaging retention portion + safety lock-limited movement
• Claim 22: directionality between release member movement and injector movement

Scope takeaway: US 8,016,788 contains multiple independent claims aimed at the same product concept but with variant actuator implementations:

• actuation member that actuates energy storage by movement from first to second position (Claims 1-7, 11-17)
• release member plus biasing member within second cavity (Claims 18-22)

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How do the offset-axis and two-opening limitations shape claim coverage and design-around risk?

Offset longitudinal axes: a major claim differentiator

All independent sets recite the longitudinal axes of first and second cavities are offset. This is not a trivial aesthetic limitation; it defines internal packaging geometry that affects:

• where force-transmission elements must run
• how the injector translation aligns to the needle path
• whether actuation members and energy-storage elements can be co-axially arranged

Design-around leverage:

• Reconfiguring to co-axial cavities (aligned axes) is a direct attack on this limitation. If the accused product’s cavity axes are not offset, literal infringement weakens.
• If offset exists but is marginal, claim construction can turn on how the axes are measured and whether the claim requires a non-zero offset in a way that can be quantified.

Distal first and second openings and “actuation member protrusion”

Claim 1’s “second portion disposed through the second opening when actuation member is in the first position” is the most litigation-relevant subfeature because it encodes a pre-actuation structural condition.

Design-around leverage:

• If the accused injector hides the trigger/release element entirely within the housing until actuation (no portion protruding through a distal opening in the first position), the limitation may be avoided.
• If the distal opening is present but the actuation member does not protrude through it in the first position, the pre-actuation protrusion condition is not met.

Coupling sequence and retention/disengagement mechanics

Claims 2 and 20 emphasize retention portions that limit movement and a second actuation member or trigger that disengages retention when moved relative to distal housing structure.

Design-around leverage:

• Replacing a retention/disengagement coupling with a different safety/lock mechanism (different limiting structure or different disengagement timing) can reduce correspondence to these dependent limitations.
• Still, note: these are dependent claims. If the accused device practices the independent claim elements, dependent claim differences affect infringement only if asserted.

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What is the strongest claim scope for litigation: independent claims 1, 11, or 18?

Best target for infringement arguments is the independent claim set that most closely matches commercial architecture.

• Claim 1: most detailed “actuation member portions through openings in first position,” plus directionality and safety lock/needle guard dependent options.
• Claim 11: focuses on injector movement direction (force in a first direction) and actuation member movement direction (second direction) inside the second cavity, while retaining the distal second opening protrusion requirement in Claim 12.
• Claim 18: strongest if the product uses a release member and a biasing member that urges it toward the second position.

Scope logic for plaintiff framing

• If accused device uses a second-cavity energy source (gas or spring) actuated by a movable release/actuation component that protrudes through a distal second opening before actuation, Claim 1/11/18 theories all have plausible mapping.
• The retention/safety/guard language likely drives the strongest secondary claim coverage, especially if products incorporate a needle guard locked by a safety protrusion.

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How many patents cover offset-cavity gas/ejection autoinjector architectures, and who typically owns them?

Not enough information was provided to enumerate the global patent estate around US 8,016,788. You provided only the claim text, not:

• the publication numbers,
• the title/assignees,
• file history,
• cited references,
• or the family members.

Per the operating constraints, no complete and accurate landscape can be produced without those bibliographic anchors.

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What formulations or uses are claimed here: drug product vs device mechanics?

US 8,016,788 is a device/apparatus claim set. It does not claim:

• a specific drug molecule
• a specific formulation composition
• dosing regimens by therapeutic indication
• method-of-use steps

The claimed subject matter is the mechanical autoinjector system with needle and medicament container, along with actuation and safety components.

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What is Orange Book status or FDA regulatory status for US 8,016,788?

No product association (listed drug name, NDA/BLA/ANDA, reference product) is included with US 8,016,788 in the provided information.

Given the device-only claim structure and lack of FDA linkage details, the Orange Book status cannot be determined from the provided record.

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What generic or biosimilar risks exist from this patent?

This patent claims an apparatus for delivering medicament, not a drug substance or biologic.

For risk framing:

• “Generic entry” in the conventional Hatch-Waxman sense (ANDA for a small-molecule drug) generally concerns active ingredient, formulation, and use claims tied to an NDA/BLA.
• If a device patent like this is asserted, risk depends on whether the generic challenger uses a practically identical autoinjector structure or whether the litigation focuses on replacement parts and device-specific infringement.

No accused product or licensing/authorization context is provided, so a case-specific “entry scenario” cannot be derived.

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Timeline: when would US 8,016,788 expire, and when could exclusivity end?

No filing date, priority date, or patent term adjustment data is provided in the input. Without those dates, any exclusivity/expiration computation would be incomplete or inaccurate.

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Claim chart ready: limitations checklist for freedom-to-operate review

Use this as a structured mapping checklist against an accused device:

Core independent limitations (Claim 1 as template)

1. Housing with first cavity and second cavity
2. Offset longitudinal axes between cavities
3. Distal end portion defines:
   • first opening in fluid communication with first cavity
   • second opening in fluid communication with second cavity
4. Medicament injector movably disposed in first cavity
   • includes medicament container and needle
5. Energy storage member in second cavity producing force to move injector into injection position
6. Injection position includes needle portion disposed through first opening
7. Actuation member actuates energy storage member when moved first position to second position
8. Actuation member positioning in first position:
   • first portion disposed within second cavity
   • second portion disposed through second opening while in first position

High-probability dependent add-ons (depending on asserted claims)

• Actuation retention portion engages distal end portion to limit movement (Claim 2)
• Second actuation member disengages retention (Claim 2)
• Safety lock protrusion engages second portion (Claims 3-4)
• Needle guard first portion disposed through first opening about needle; second portion engages safety lock (Claim 4)
• Second portion contacts energy storage member at second position (Claim 5)
• Opposed motion direction between actuation member and injector (Claim 6)
• Biasing member urging actuation/release toward second position (Claim 7)
• Gas container energy storage with optional:
  • seal fluidically isolating second cavity proximal end from outside (Claim 9)
  • puncturer entering gas container in second position (Claim 10)

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Key Takeaways

• US 8,016,788 claims an autoinjector apparatus defined by two offset cavities, a distal first/second opening pair, and an energy storage member in the second cavity actuated by a movable actuation/release member.
• The most distinctive claim feature is the pre-actuation structural condition: the actuation member has a portion that is disposed through the distal second opening when the actuation member is in the first position.
• Dependent claims further target retention/disengagement mechanics, safety lock engagement, needle guard geometry, and gas-container actuation with seals and puncturing.
• The provided information is insufficient to build a complete US/FTO landscape (other patents, expiration computations, Orange Book linkage, or litigation timelines).

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FAQs

1) Does US 8,016,788 claim the drug formulation or only the injector mechanism?
It claims the injector apparatus and internal mechanical relationships, not specific drug formulations or therapeutic methods.

2) What feature most strongly supports infringement if a product uses a gas-driven autoinjector?
Claim coverage tightens when the product uses a second-cavity energy storage member actuated by an actuation/release member that has a portion through the distal second opening while in the first position, with offset cavity axes.

3) Can a design that changes cavity geometry avoid infringement?
Shifting from offset longitudinal axes to aligned axes is the most direct way to break a core independent limitation.

4) Are safety locks and needle guards essential to infringement of independent claims?
They appear in dependent claims. They matter if those dependent claims are asserted, but the independent claims already require the offset-cavity and actuation/energy/injection-position architecture.

5) Does this patent affect “generic entry” in the same way as a drug substance patent?
The patent is a device/apparatus claim set, so the practical impact depends on whether competitors use an apparatus that maps onto the claimed mechanical architecture.

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References

1. United States Patent No. 8,016,788. Claims provided in prompt text.

Drugs Protected by US Patent 8,016,788

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

International Family Members for US Patent 8,016,788

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004325202
Australia	2006210865
Australia	2007245139