Last Updated: June 25, 2026

Details for Patent: 7,947,017


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Summary for Patent: 7,947,017
Title:Devices, systems and methods for medicament delivery
Abstract:An apparatus includes a movable member and a valve coupled to the movable member. The movable member is configured to be disposed within a housing of a medical device and has a first end portion and second end portion. A portion of the first end portion is configured to define a portion of a boundary of a gas chamber. The first end portion defines an opening configured to be in fluid communication between the gas chamber and an area outside the gas chamber. The second end portion is configured to be coupled to a needle configured to deliver a medicament into a body. The valve is configured to selectively allow fluid communication between the gas chamber and the area outside the gas chamber through the opening defined by the first end portion of the movable member.
Inventor(s):Evan Thomas Edwards, Eric Shawn Edwards, Mark J. Licata
Assignee: kaleo Inc
Application Number:US11/566,422
Patent Claim Types:
see list of patent claims
Composition; Device; Dosage form;
Patent landscape, scope, and claims:

Executive summary
US Patent 7,947,017 is directed to a gas-chamber venting and valving architecture inside a movable medicament injector/pen/autoinjector. The claims concentrate on a movable member that defines at least part of a gas chamber boundary, an opening that can place the gas chamber in communication with atmosphere/ambient, and a valve (often actuated by injector movement) that transitions between fluid isolation and vented communication. The patent includes multiple dependent claim variations covering sealing structures (seals, O-rings, flexible members) and valve closure/opening mechanisms (biasing member, frangible seal), with epinephrine called out as a medicament example.

Because the entire claim set you provided is already internally coherent and appears to track a single claim taxonomy (gas chamber isolation/venting tied to medicament expulsion), the scope is best characterized as a mechanical and fluidic control patent for controlled venting during/after expulsion rather than a formulation or purely use-method patent.


What is US Patent 7,947,017 about and what are the core claim elements?

Short answer: It claims an apparatus for a medical device (injector) that uses a gas chamber with selective venting controlled by a valve actuated by movement of a medicament-moving structure (carrier/movable member), often using sealing elements to isolate the gas chamber until venting is desired.

Gas chamber venting architecture: the repeating mechanical motif

Across independent-style claim language (your Claim 1, Claim 8, Claim 16, Claim 24, Claim 32), the same functional elements recur:

  1. Housing defining a gas chamber
  2. Movable member with a first portion that defines part of the boundary of the gas chamber (and often an opening in that boundary)
  3. Gas chamber isolation vs communication
    • In isolation mode: valve/seal arrangement blocks communication between gas chamber and area outside.
    • In communication mode: valve is opened or displaced so the gas chamber connects to outside.
  4. Actuation is coupled to injector motion
    • Valve actuator is part of the carrier (Claim 1/32 family).
    • Gas release member transitions when injector reaches a position (Claim 16 family).
    • Valve configuration changes as movable member moves and expels medicament (Claim 24 family).
  5. Mediating fluidic closure components
    • Sealing portion, O-ring, flexible member, frangible seal, movable sealing member, biasing member.

Independent claim claim-set coverage map (from your text)

Your provided claims fall into a small number of structural “families”:

  • Family A (carrier + valve actuator + movable member defines opening)

    • Core: Claim 1 and (near-identical) Claim 32.
    • Key: carrier disposed in housing, medicament container coupled, valve actuator on carrier, movable member defines gas boundary and an opening; valve allows venting when actuated.
  • Family B (medicament injector with movable injector positions and first/second valve configurations)

    • Core: Claim 8.
    • Key: injector moves between first (retracted) and second (extended) positions; valve transitions when movable member reaches second position; opening/flow path integrated into movable member.
  • Family C (needle delivery + gas release member with persistent opened configuration behavior)

    • Core: Claim 16.
    • Key: gas release member has two configurations; transitions with movable member position; can be maintained in opened configuration even when the movable member returns.
  • Family D (plunger expulsion plumbed to valve that remains opened after partial expulsion)

    • Core: Claim 24 (and dependents).
    • Key: valve is coupled to movable member; opened configuration occurs after at least a portion of medicament has been expelled; multiple dependents cover valve deformation and post-expulsion actuator/bias/retraction patterns.

What patents protect gas-chamber venting in autoinjectors like US 7,947,017?

Short answer: US 7,947,017 is protection on the mechanics of venting a gas chamber via a valve/seal that is actuated by injector movement. The patent’s scope is a niche within autoinjector IP: systems that need a controlled gas release/venting path for consistent actuation and pressure management.

Scope signal: what it is covering vs not covering

From the claim language you provided, protection is aimed at:

  • Fluid communication control between a gas chamber and outside area
  • Valve closure and vent opening via:
    • valve actuated by carrier movement (Claim 1/32)
    • valve actuator configured to change valve configuration at a certain position (Claim 8)
    • gas release member transitioning and potentially staying open after return (Claim 16)
    • flexible/flexible-deforming members and frangible seal concepts (Claims 5, 12, 17-20, 25-26)

It is not, based on these claims, primarily targeted to:

  • Specific formulation or method-of-treatment (other than epinephrine as an example medicament in dependents)
  • Electrical controls, electronic valves, or purely software-controlled venting
  • Actuation chemistry (the claims are about fluid communication and vent control in a housing)

Frequent claim terms that define the “protected concept”

  • “gas chamber”
  • “fluidically isolate”
  • “area outside the gas chamber”
  • “opening configured to be in fluid communication”
  • “valve…allow fluid communication…through the opening”
  • “valve…first position/second position”
  • “frangible seal”
  • “sealing portion / O-ring / flexible member / sealing member”
  • “movable member…defines a portion of a boundary of the gas chamber”
  • “actuated by the valve actuator” / “configured to engage”

These terms identify the likely literal infringement trigger set: a device that reproduces the same structural relationship between gas chamber boundary, vent opening, sealing, valve state transition, and actuation timing.


How broad is the scope of US 7,947,017 claims (literal coverage and likely equivalents)?

Short answer: The claim scope is broad at the level of functional relationships (gas chamber isolation vs communication via valve through an opening defined by a movable boundary member) and mechanism categories (seals, O-rings, frangible seal, flexible deformable members). It narrows on particular configurations when dependent claims specify the exact valve/seal mechanism.

Claim 1/32: strongest “anchor” for broad coverage

Claim 1 (and Claim 32) are broad because they do not require:

  • frangible seal specifically (that is dependent)
  • epinephrine specifically (dependent)
  • needle vs nozzle specifically (not required in Claim 1/32)
  • a specific gas release member persistence after return

Instead, they require the coupling:

  • movable member defines boundary and opening
  • valve coupled to movable member
  • valve actuated by valve actuator on carrier
  • venting allowed when valve actuated through opening

A product would likely land in this independent claim if it has:

  • an internal chamber used to drive/operate an injector (gas chamber)
  • a boundary member that creates/uses an opening aligned with gas release path
  • a valve that transitions isolation to vented state at an injection event

Dependent claims: narrowing sub-scope that maps to design options

Key narrowing elements from dependents:

  • Sealing portion or O-ring (Claims 2-3)
    Requires a sealing element that engages the housing to isolate gas chamber.

  • Valve has a biasing member and moves between first/second positions (Claim 4)
    Requires a biased, movable valve body with discrete positions, not just a one-time frangible release.

  • Frangible seal valve (Claim 5)
    Requires frangible closure, a common design variant where the vent path is opened by breaking a seal.

  • Movable sealing member disposed about the opening (Claim 6)
    Requires a sealing element movable relative to the opening.

  • Epinephrine container (Claim 7)
    Adds a medicament-specific limitation; it is not needed to practice the broad vent architecture but narrows to epinephrine autoinjectors for enforceability.

Claim 8: broader in “positioning” but includes injection member and lumen

Claim 8 ties venting transitions to a medicament injector moving between first and second positions, including explicit injection member functionality (needle or nozzle dependents). It adds:

  • medicament injector movably disposed in housing
  • injection member lumen in fluid communication with medicament container
  • valve actuator engagement when the movable member is in the second position

This adds a structural context for vent timing (vent activation correlated with injector position).

Claim 16: “stays opened when movable member returns” increases design specificity

Claim 16 includes an explicit behavioral limitation: the gas release member is maintained in its second configuration when the movable member moves back. That can be used to distinguish devices where the vent path automatically recloses upon retraction.

Claim 24: “opened configuration after at least a portion of medicament has been expelled”

Claim 24 introduces a time/sequence coupling:

  • valve opened configuration occurs after at least a portion of medicament is expelled

Designs that open venting only at the onset or only at the end of expulsion may avoid this precise sequence requirement depending on how “after at least a portion” is interpreted.


When does US 7,947,017 gas venting become active and how does that timing limit design-arounds?

Short answer: The claims tie valve opening to a particular injector state, commonly the second position (extended/actuated) and, in some variants, to post-expulsion persistence or opened after at least a portion of expulsion.

Timing features by claim family

  • Claim 1/32 timing
    Valve is allowed to vent “when the valve is actuated by the valve actuator of the carrier.”
    Design implication: vent opening must occur due to the carrier’s actuator engagement with valve.

  • Claim 8 timing
    Valve actuator engages valve when movable member is in second movable member position; gas chamber transitions in second configuration when injector is in second position.
    Design implication: vent opening should correlate with the injector reaching that second configuration.

  • Claim 16 timing and persistence
    Gas release member moved to second configuration when movable member is in its second position, and remains there when movable member returns.
    Design implication: if vent is only momentary and closes on return, Claim 16’s “maintained” limitation may not be met.

  • Claim 24 timing
    Valve opened configuration is when gas chamber becomes in fluid communication “after at least a portion of the medicament has been expelled.”
    Design implication: if venting does not begin until after substantially complete expulsion, it could still meet “after at least a portion,” but if venting is entirely before expulsion or only during a small fraction at the very start, construction becomes critical.


What formulations or medicaments are covered (epinephrine limitation)?

Short answer: Epinephrine appears as a dependent limitation in multiple claims (Claims 7, 15, 23, 30). The independent apparatus concepts are not limited to epinephrine, but epinephrine-specific embodiments are explicitly claimed.

Practical enforcement angle

  • If asserting against a non-epinephrine injector with the same venting architecture, the epinephrine-dependent claims would not read.
  • If asserting against epinephrine autoinjectors (notably competing products in emergency use), epinephrine-dependent claims can provide narrower, higher-specificity infringement anchors.

What specific valve and seal mechanisms does US 7,947,017 claim (frangible vs flexible vs biased valves)?

Short answer: The patent explicitly claims multiple closure mechanism categories that can be implemented in alternative designs while still meeting claim elements.

Mechanism categories and which claims capture them

  • Biased movable valve body between positions (Claim 4)
  • Frangible seal valve (Claim 5)
  • Movable sealing member around opening (Claim 6)
  • Sealing portion / O-ring (Claims 2-3)
  • Flexible member deforms with movable member movement (Claims 25-26)
  • Gas release member including frangible seal (Claims 17-18)
  • Puncturer punctures frangible member (Claim 18)
  • Actuator contacts gas release member to place in second configuration (Claim 19)
  • Housing passageway + seal moved by movable member actuator (Claim 20)

Design-around implications (mechanism swapping)

If a competitor uses:

  • only a purely electronic or pressure-only vent that does not rely on a valve coupled to the movable member boundary opening
  • or a valve state change that is not tied to the recited actuator engagement timing then it may avoid the specific mechanical “coupling and state-transition” claim elements.

If a competitor uses:

  • a different closure actuator, but still uses a valve and opening defined by a movable boundary member to go from isolated to vented state then the broad apparatus claim language is more likely to capture it.

How many embodiments of the “gas isolation then vent” concept are claimed?

Short answer: Your claim set spans at least four structural embodiment routes plus multiple closure mechanisms, implying a relatively high internal coverage density.

Countable embodiment types from the provided claims

  1. Carrier with valve actuator on second end portion coupled to movable member valve (Claim 1/32)
  2. Medicament injector with injection member and movable injector positions controlling valve config (Claim 8)
  3. Gas release member with maintained open configuration on return (Claim 16)
  4. Movable member coupled plunger action plus valve opened after at least partial expulsion (Claim 24)

Each route includes dependent modifications adding:

  • O-ring/sealing portion
  • biasing member
  • frangible seal
  • flexible members
  • puncture actuators
  • actuator contact positioning
  • housing passageway and moved seals

This structure indicates the patent is trying to capture variations in how the vent pathway is opened and closed.


What is the likely Orange Book / FDA regulatory linkage for US 7,947,017?

Short answer: Based on the provided claim language alone, the patent reads like a device/injector patent paired with an injectable medicament that can be epinephrine. Orange Book listings are typically for approved drug products with patents that claim the drug substance, formulation, or use. Device patents like this often appear in other IP registries or as listed patents only when they have been submitted for listing in connection with an approved drug.

No Orange Book status can be determined from the claims text you provided.


What generic entry risks exist under this patent for epinephrine autoinjectors?

Short answer: Generics typically replicate drug substance and approved dosage form, not the device mechanics. The practical risk comes from the fact that an ANDA pathway would not automatically waive infringement of a device-claim patent if the generic manufacturer makes a device that falls within the claim scope.

Risk profile by claim scope type

  • If claims are enforced as device/injector architecture patents:
    Generic “entry” of the medicament does not necessarily avoid infringement if the generic includes a similar venting injector mechanism.

  • If only the drug is generic but the device differs:
    Risk hinges on the venting architecture: opening/valve coupled to movable boundary member and state transitions.


What patent litigation affects US 7,947,017?

Short answer: No litigation docket, venue, or case caption is provided in the input. A litigation landscape cannot be constructed from the claim text alone.


How does US 7,947,017 compare with competing venting/valve autoinjector concepts?

Short answer: The comparative benchmark for design competition is whether the competitor uses:

  • an internal gas chamber boundary member with a vent opening
  • a valve that transitions from isolation to communication
  • actuation tied to injector movement state

The patent is not limited to one closure method because it includes frangible and flexible-member variants, but it is still structurally specific to the vent opening and valve-coupled architecture.

Comparison dimensions for freedom-to-operate (FTO)

  1. Is the vent opening defined by a movable member that forms part of the gas chamber boundary?
  2. Is there a valve (or valve-equivalent structure) coupled to that movable member enabling isolated vs vented configurations?
  3. Is valve actuation tied to carrier/movable member positions corresponding to medicament expulsion?
  4. Does venting persist after return or occur only after partial expulsion, depending on which dependent claim theory is asserted?

Key claim-scope “grab list” for infringement mapping (what to check in a product)

  1. A housing with a gas chamber internal to the injector
  2. A movable member that:
    • is within the housing
    • defines a portion of a boundary of the gas chamber
    • has an opening that can connect the gas chamber to outside
  3. A valve that:
    • blocks fluid communication in one state
    • allows fluid communication through the opening in another state
  4. A mechanism for switching valve state:
    • valve actuator on carrier engaging the valve at an extended/injected position
    • or gas release member moved into second configuration
  5. The presence of sealing and closure options:
    • seal/O-ring/flexible member or frangible seal with puncture or actuator

Key Takeaways

  • US 7,947,017 is an injector gas-chamber venting/valving patent.
  • It claims an architecture where a movable boundary member defines a gas-chamber opening, and a valve transitions between isolation and vented communication, with actuation coupled to injector position and medicament expulsion sequence.
  • Dependent claims materially expand coverage across sealing forms (O-ring, seal, sealing portion, flexible member) and opening mechanisms (biased valve body, frangible seal, puncturer).
  • Epinephrine is present as a dependent medicament limitation, supporting enforceability for epinephrine injector embodiments without restricting the broader venting concept.
  • Design-around opportunities typically depend on breaking one of the structural couplings: boundary member/opening relationship, valve isolation-to-vent transition, or timing/persistence behavior (especially where claims require maintaining open state after return or opening after at least partial expulsion).

FAQs

  1. Does US 7,947,017 require epinephrine to infringe?
    Epinephrine appears in dependent claims in your text. The core apparatus concepts in the broader claims are not restricted to epinephrine unless the asserted claim includes those dependent limitations.

  2. Can a device avoid infringement by using a different venting actuator that is not tied to injector position?
    If the product does not achieve the claimed valve state transition via the recited carrier/movable member valve actuation tied to the injector’s movable positions, it may fall outside key elements.

  3. What is the significance of the “frangible seal” dependents in US 7,947,017?
    They capture venting implementations where a closure is broken to open communication, but they are not required for the broadest independent gas-chamber valve concept unless asserted through a dependent claim path.

  4. How do the “maintained in second configuration when movable member returns” elements limit design-around space?
    That limitation narrows to architectures with post-actuation persistence. A design that recloses upon return may better avoid those dependent claim constraints.

  5. What design changes most directly impact claim element mapping for this patent?
    Changes to the gas chamber boundary definition, vent opening formation, and the isolation-to-vent transition mechanism (including timing and persistence) are the most direct levers for avoiding the claim’s structural-functional relationships.


References

  1. US Patent 7,947,017 (claim set provided in prompt).

More… ↓

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Drugs Protected by US Patent 7,947,017

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-003 Nov 17, 2017 RX Yes No 7,947,017 ⤷  Start Trial Y ⤷  Start Trial
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-002 Aug 10, 2012 BX RX Yes Yes 7,947,017 ⤷  Start Trial Y ⤷  Start Trial
Kaleo Inc AUVI-Q epinephrine SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 201739-001 Aug 10, 2012 BX RX Yes No 7,947,017 ⤷  Start Trial Y ⤷  Start Trial
Kaleo Inc EVZIO naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 205787-001 Apr 3, 2014 DISCN Yes No 7,947,017 ⤷  Start Trial Y ⤷  Start Trial
Kaleo Inc EVZIO (AUTOINJECTOR) naloxone hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 209862-001 Oct 19, 2016 DISCN Yes No 7,947,017 ⤷  Start Trial Y ⤷  Start Trial
>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 7,947,017

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

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