Details for Patent: 8,267,903

Summary for Patent: 8,267,903

Title:	Casing
Abstract:	A casing for an injection device of the type having a safety device which prevents operation of the device, incorporating an actuator means by which the safety means of the device can be actuated to allow operation of the device. Also a casing for a medicament container having an opening closed prior to use by a break-off tip, having relatively moveable first and second casing parts, which on relative movement apply a breaking force to the break-off tip. A preferred embodiment includes both such features.
Inventor(s):	Gregor John McLennan Anderson, John Mitchell
Assignee:	Zogenix Inc
Application Number:	US13/011,240
Patent Claim Types: see list of patent claims	Use; Device; Dosage form;

United States Patent 8,267,903: Scope, Claim Architecture, and US Landscape for Needle-Free Injectors

United States Patent 8,267,903 claims a needle-free injector architecture that combines (i) a cartridge-to-skin injection path, (ii) a trigger and drive release system, and (iii) a two-part casing with a removable end cap that functions as an interlock to prevent actuation until the injector is properly prepared for use. The claim set emphasizes safety-by-mechanical obstruction and procedural correctness via a specific sequencing constraint: the drive mechanism cannot operate before removal of the removable end cap.

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What does Claim 1 actually require (core scope)?

Claim 1 is the independent claim and sets the infringement “gate”

A product must meet every limitation below to fall within Claim 1:

A. Injection system and functional path

1. Needle-free injector
2. A cartridge containing a medicament
3. The cartridge has an orifice at one end
4. A drive mechanism that drives the medicament out of the cartridge via an exit orifice and through skin of the patient
5. A trigger mechanism that releases the drive mechanism upon actuation

B. Safety mechanism with two configurations

6. A safety mechanism with a first configuration that prevents drive actuation and a second configuration that allows it
7. The safety mechanism operates by obstructing movement of a movable trigger component

C. Two-part casing architecture with a removable end cap interlock

8. The injector has a first casing part
9. The injector has a second casing part
10. The second casing part comprises a removable end cap
11. The removable end cap closes a nozzle orifice prior to removal of the removable end cap
12. Crucially, the injector is configured such that the drive mechanism cannot be operated before the second casing part has been removed from the end opening of the first casing part

This last element is the most legally distinctive: it creates a precondition to actuation tied to removal of the end cap.

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How dependent claims narrow mechanics and user interaction

Claims 2 to 18 constrain the independent concept through specific actuation mechanics, casing coupling, safety mechanisms, and user indication. These dependent claims create narrower “design lanes” where a variant product can be captured even if it diverges from some Claim 1 specifics.

2–7: Trigger motion, casing structure, and coupling method

• Claim 2: the moveable trigger component moves by urging the orifice against the patient’s skin.
• Claim 3: the first casing part forms a cover around the injector.
• Claim 4: the first casing part has an end opening positioned so the injection orifice can be brought adjacent to skin.
• Claim 5: the second casing part has a removable cover for the first casing end opening.
• Claim 6: the first casing part holds the injector non-rotatably; the second casing part is rotatable relative to the first.
• Claim 7: the casing parts are initially connected by (a) screw thread or (b) bayonet connection; moving the second casing part in rotary motion separates the casing parts and exposes the end opening.

Practical meaning: the claims are not limited to one removal style. But they are limited to a design where the “end cap removal” is achieved via rotation-based separation (or an equivalent that still matches the claimed connection types).

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8–12: Safety interlock function during end cap removal

• Claim 8: the safety mechanism prevents inadvertent trigger actuation while removing the second casing part.
• Claim 9: the safety mechanism is a locking mechanism incorporated in the second casing part.
• Claim 10: the second casing part includes an actuator mechanism; relative movement causes safety mechanism change from configuration 1 to configuration 2.
• Claim 11: the second casing part includes at least one obstructer part that blocks movement of a part essential for operation.
• Claim 12: safety mechanism comprises an actuator with an obstructor part:
  • configuration 1: obstructs
  • configuration 2: allows movement of the moveable trigger part.

Practical meaning: these claims tie the interlock function to the second casing part, not the injector body alone. If safety logic is implemented elsewhere, or the removal does not drive safety configuration change, the dependent claims may not map cleanly.

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13–18: Actuator form, lever geometry, retention, and indication

• Claim 13: actuator form is one of: button, tongue, or lever.
• Claim 14: the end cap covers part of actuator; unscrewing exposes actuator.
• Claim 15: actuator is a lever.
• Claim 16: lever movement moves the obstructer part in a direction perpendicular to the trigger movement direction (trigger moves when orifice is urged to skin).
• Claim 17: actuator is retained in its second configuration after safety mechanism actuation.
• Claim 18: retained actuator is accompanied by an indication selected from visible or audible.

Practical meaning: these claims are very specific about lever-based geometry and post-actuation retention, plus an optional feedback feature.

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Scope boundaries: what the claims do NOT read on

The claim set is tightly limited by the interlock sequencing and by the obstruction-based safety mechanism tied to a specific movable trigger component and the two-part casing/end cap relationship. Infringement risk will drop where:

1. Drive actuation is possible without removing the end cap/casing component (breaks the Claim 1 precondition).
2. Safety interlock is electronic or pneumatic without “obstructing movement of a movable trigger component” (may not satisfy the operating principle).
3. The user procedure does not involve the claimed end-opening exposure and casing removal sequence tied to rotary separation (relevant to Claim 6–7, 14).
4. The lever geometry, perpendicular movement, or retention with indication is missing (relevant to Claims 15–18).

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Patent landscape for this claim family concept (US needles-free + safety interlocks)

Without additional bibliographic data (publication number, assignee, related continuations, and cited references), the only reliable landscape claims are structural: the field where US needle-free injectors cluster around (i) cartridge-based high-force delivery and (ii) safety mechanisms that prevent premature firing.

Landscape segmentation by claim feature

This is the fastest way to position competitors and design-arounds:

1. Two-stage use preparation + firing interlock

   • Claim-defining element: drive mechanism cannot operate before removal of the second casing part / end cap.
   • Look for competitors with procedural safeguards that require removal of a protective element or exposure of a nozzle prior to firing.
   • Key differentiator: whether the interlock is mechanically integrated into the removable part (as claimed) or implemented by an independent lock.

2. Safety-by-obstruction of a movable trigger component

   • Look for designs where a safety element physically blocks the trigger path.
   • Key differentiator: whether the obstruction is achieved by a movable trigger component being blocked and then unblocked through relative movement of the second casing part.

3. User input is driven by urging the orifice against skin

   • Many needle-free injectors use a “press-to-fire” paradigm.
   • Differentiator: whether the press motion triggers a moveable trigger component whose movement is mechanically obstructed by the interlock mechanism.

4. End cap / nozzle sealing for pre-use and exposure

   • Claim 1 requires the end cap closes a nozzle orifice prior to removal.
   • Differentiator: whether removal of the protective/nozzle seal is explicitly coupled to the firing lock-out.

5. Actuator form factors (button/tongue/lever), indication, and post-actuation retention

   • Claims 13–18 create a narrow “mechanism of actuation” lane.
   • Competitors may use different UI geometry and still capture core Claim 1 if the interlock sequencing and obstruction principle are met.

How to read Claim 1 in competitive freedom-to-operate terms

• If a competitor’s injector has a removable protective/nozzle element that must be removed before firing, it is an immediate screening target.
• If safety is also implemented via a mechanical blocker that prevents trigger movement, the closer it is to a “blocking the movable trigger component” model, the higher the risk.
• If safety logic is a separate interlock that still permits trigger movement but prevents drive energy release, the mapping may miss the “operating by obstructing movement of a movable trigger component” limitation, depending on claim construction.

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Actionable claim-chart style mapping (what to verify on candidate products)

For any injector you evaluate

Check whether each of these six items can be confirmed from product images, manuals, or teardown:

1. Two-part casing: first casing part + second casing part with removable end cap.
2. Nozzle/orifice closure: end cap closes nozzle orifice before removal.
3. Precondition to firing: drive mechanism cannot operate before second casing part removal.
4. Trigger component: there is a movable trigger component whose movement is needed to actuate.
5. Safety principle: safety mechanism operates by obstructing the movement of that movable trigger component.
6. Safety change driven by relative movement of casing parts: removal/rotation changes safety configuration.

If all six are present, the candidate is within Claim 1’s factual perimeter.

If you want to test dependent-claim risk

• Does the system require pressing or urging the orifice against skin to move the trigger?
• Is the second casing part removed by screw thread or bayonet connection and rotation?
• Is there a lever actuator under the end cap, exposed by unscrewing, that moves an obstructer perpendicularly?
• Is the lever retained after safety activation, with visible or audible indication?

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Key Takeaways

1. Claim 1 is built around a sequencing interlock: drive actuation is locked out until a second casing part with a removable end cap is removed from an end opening of the first casing part.
2. The safety mechanism is not generic. It must operate by obstructing movement of a movable trigger component, using a two-configuration safety model.
3. Dependent claims narrow toward a specific user workflow and mechanical implementation: press-to-fire via urging the orifice against skin, rotary separation (screw thread or bayonet), lever-based obstructor geometry, and post-actuation retention with indication.
4. For landscape screening, prioritize competitors whose devices use: (a) removable nozzle-seal/end cap, (b) mechanical lock preventing trigger movement, and (c) firing prevented until the protective component is removed.

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FAQs

1. What is the single most infringement-sensitive element in 8,267,903 Claim 1?
The requirement that the drive mechanism cannot be operated before the second casing part (with removable end cap) has been removed from the end opening of the first casing part.

2. Do these claims require that the safety mechanism be located in the second casing part?
Claim 9 says the safety mechanism is a locking mechanism incorporated in the second casing part. Claim 1 does not explicitly limit location, but dependent claims do.

3. Does the patent claim a particular type of injection force source?
The claim requires a drive mechanism that drives medicament through skin, but it does not specify a named energy source in the provided claim text.

4. Can a competitor avoid the patent by using an electronic safety lock?
If the design does not operate by obstructing movement of a movable trigger component, it may avoid the key safety operating principle required in Claim 1.

5. Which dependent claims create the tightest mechanical constraints?
Claims 15–18: lever actuator, perpendicular obstructer movement, retention in second configuration, and visible/audible indication.

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References

[1] United States Patent No. 8,267,903 (claims 1-18 as provided in prompt).

Drugs Protected by US Patent 8,267,903

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: 8,267,903

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0206560.5	Mar 20, 2002

International Family Members for US Patent 8,267,903

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003219086
Canada	2479316
Germany	60315429
European Patent Office	1487517