Patent: 5,383,865

Summary for Patent: 5,383,865

Title:	Medication dispensing device
Abstract:	A medication dispensing device comprising a cartridge for containing an injectable product therein and an injector attached to the cartridge. The injector includes a drive mechanism comprising a dosage sleeve having a dosage knob at the proximal end thereof and a threaded rod coupled to the sleeve and axially advanceable into the cartridge upon clockwise rotation of the knob for dialing up a desired dosage to be injected. A ratchet mechanism is disposed in the injector housing and includes a rotatable piece secured to the dosage sleeve for rotation therewith and a locking seat in engagement with the rotatable piece. The ratchet mechanism permits rotational movement of the sleeve in the clockwise direction only. A disengaging mechanism is secured to the housing of the LCD assembly and includes a pin that extends into and engages the rotatable piece of the ratchet mechanism such that axial movement of the pin causes corresponding axial movement of the stationary piece. Upon depressing the outer surface of the disengaging mechanism, the pin and the rotatable piece are moved axially away from the seat sufficiently enough to permit a user to rotate the dosage knob in a counterclockwise direction to accurately dial back an accidental overdose measurement without removing the cartridge from the injector.
Inventor(s):	Peter Michel
Assignee:	Eli Lilly and Co
Application Number:	US08/031,595
Patent Claims:	see list of patent claims

US Patent 5,383,865: Claim-Scope, Validity Risks, and US Landscape Fit for Dial-Back Dosage Injection Clutches

What does US 5,383,865 claim in one line?

US 5,383,865 claims a manually operated, cartridge-based injectable dose-setting injector that lets a user (1) dial a set dosage by rotating a knob to axially advance a rod without advancing the plunger, and (2) dial the dosage back by selectively disengaging a one-way clutch/locking seat while the cartridge remains attached; delivery occurs only when axial force is applied to the knob to drive the cartridge plunger.

The core novelty cluster is the “dial-back” architecture: a rotational drive coupled to a rod for dose setting, a one-directional clutch that blocks reverse rotation during attachment, and a selective disengaging mechanism that re-enables reverse rotation to retract the rod (reducing the set dose) prior to injection. (Claims 1, 11, 15, 16)

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What are the enforceable claim pillars and where are the narrow chokepoints?

1) Hardware architecture: cartridge plunger + injector drive with staged actuation

Across independent claims (1, 11, 15), the device includes:

• A cartridge containing injectable product with an internal plunger. (Claims 1, 11, 15)
• An injector housing containing a drive mechanism with:
  • a dosage knob,
  • a rod coupled to a dosage sleeve or dosage device,
  • rotation in a first direction advances the rod a “first distance” to establish a set dosage without effecting delivery. (Claims 1, 11, 15)
• Axial force on the knob advances the rod further (a “second distance”) to engage and advance the plunger to effect delivery. (Claims 1, 11, 15)

Chokepoint: the staged separation between dose-setting rotation (rod advances to a first distance without delivery) and injection (axial force advances rod to a second distance and advances plunger). This limits scope to devices with a defined mechanical deadband or non-delivery state during dial setting.

2) One-direction restriction with a selective reverse-enabling disengager

Independent claims require a clutch mechanism configured to restrict reverse rotation:

• A rotatable piece is secured to the dosage sleeve for rotation.
• A locking seat restricts rotation of the rotatable piece, “and hence said dosage knob,” to a first direction only. (Claims 1, 15)
• A disengaging mechanism selectively disengages the locking seat from the rotatable piece, permitting rotation in a second and opposite direction while the cartridge remains attached, thereby reducing the first distance of axial advancement of the rod. (Claims 1, 15)
• The method claim (16) similarly requires engaging a “clutch-deactuating mechanism” to allow reverse rotation and then releasing it to prevent further reverse rotation while the cartridge is attached. (Claim 16)

Chokepoint: the disengaging mechanism must be selectively operative and must enable reverse rotation while the cartridge is attached, followed by a state that prevents continued reverse rotation when released (Claim 16). That combination is specific and may be difficult to read onto systems that only permit back-off by mechanical detents without a selective disengager.

3) Explicit coupling: reverse rotation retracts rod by reducing “set dosage”

Independent claims tie the mechanical motion to a dosing consequence:

• Reverse rotation reduces the rod’s axial advancement to reduce the “set dosage.” (Claims 1, 11, 15)

Chokepoint: some injectors allow “cancel” or “reset” via separate mechanisms that replace the drive state; those may avoid the claim if they do not retract the rod by re-enabling the same mechanism while attached.

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How broad are the independent claims in practice, and what variants can they still read on?

Claim 1 scope (dose sleeve + clutch piece + locking seat + disengager)

Claim 1 is the most structurally explicit:

• It uses “dosage sleeve having a knob at a proximal end” and a “rod coupled to said sleeve.”
• It includes a clutch mechanism with:
  • “rotatable piece” secured to sleeve,
  • “locking seat” engagement configured to restrict rotation to a first direction only,
  • a disengaging mechanism to disengage the seat so reverse rotation is permitted.
• It recites the rod advances a first distance to set dosage without delivery; and advances a second distance upon axial force to advance the cartridge plunger. (Claim 1)

Implication: Claim 1 will cover systems with the same staged mechanics and the same “selectively disengage locking seat” architecture. It is less comfortable with architectures where the dial-back is purely electronic (e.g., stepper motor position set) without a mechanical one-way clutch state change.

Claim 11 scope (injector means with knob and rod; clutch restriction; dial-back while attached)

Claim 11 re-states the concept in slightly different language:

• “injector means” including knob and rod advanced axially via rotation in first direction, rod restricted from opposite rotation by “clutch means,” and “clutch disengaging means” permits reverse rotation to reduce the first distance to reduce set dosage while cartridge remains attached.
• Delivery occurs upon axial force to knob to engage plunger and effect delivery. (Claim 11)

Implication: Claim 11 has slightly more flexibility in replacing the specific “locking seat” structure with “clutch means,” but it still requires a clutch restricting reverse rotation and a selective disengaging means that allows reverse rotation while attached.

Claim 15 scope (injector device; explicit “overdose measurement to be dialed back” functional statement)

Claim 15 parallels Claim 1:

• Clutch mechanism restricting rotation to a first direction only while injector is attached to cartridge.
• Disengaging mechanism permits rotation in second/opposite direction while attached, enabling “overdose measurement to be dialed back.”
• Staged axial advance remains required. (Claim 15)

Implication: Functional dosing statements do not broaden mechanical limitations; they clarify intended use. A design that can dial back but does not support “overdose measurement” conceptually still meets mechanical elements if the staged dose-setting and selective reverse enablement are present.

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Which dependent claims are likely to be easy to design around?

Dependent claims add specific structural implementations:

Dependent claim	Added limitation	Likely design-around vector
Claim 2	Rotatable piece has a grooved surface defining an adjacent lip; disengager comprises a pin in the grooved surface; axial movement of pin engages lip to axially move rotatable piece away from locking seat	Avoid grooved piece + pin-to-lip axial displacement; use other disengaging geometries (pivot, cam, magnet release)
Claim 3	Rotatable piece generally tubular and includes a spring biasing rotatable piece against locking seat	Use non-tubular clutch member; use different biasing method (e.g., detent geometry, elastomer)
Claim 4	LCD housing secured to injector housing; LCD assembly with integrated circuit, periodically input contact, and display window; contact engaged periodically by dosage knob to cause dosage indicia	Replace LCD with different user interface; or use continuous sensing rather than periodic contact engagement
Claim 5	Disengaging mechanism secured to LCD housing and includes a pin through an opening in injector housing engaging rotatable piece	Decouple disengager from display housing; remove through-opening pin coupling
Claim 6	Clutch mechanism is a ratchet device	Use different one-way mechanism than ratchet (e.g., pawl and ramp, friction clutch, one-way bearing)
Claim 7	Rod advanceable via threaded connection between rod and sleeve	Use non-threaded coupling (gear rack, spline, cam, belt)
Claim 8	Display increments and decrements as sleeve rotates in respective directions	Use display that updates based on measured position but does not increment/decrement tied to sleeve rotation direction
Claim 9	Disengaging mechanism includes user actuated element connected to clutch	Replace with automatic timing logic or tool-free release integrated to cartridge removal instead of user element
Claim 10	User actuated element slidable relative to housing	Non-slidable user actuator layout
Claim 12	Digital display means coupled to knob for visual dosage indication increments/decrements as knob rotates	Switch interface or decouple mechanical coupling
Claim 13	Rod is threadedly coupled to knob means	Again, avoid thread coupling
Claim 14	Means disengaging clutch means when cartridge removed from injector	Some systems disengage clutch only via insertion state or electronic reset rather than cartridge-removal mechanical link

Net: dependent claims tighten to specific subassemblies. A competitor will target independent claims by altering the mechanism such that the selective locking-seat disengagement enabling reverse rotation while attached is not met (or the staged rod/plunger distances are restructured). Dependent claims mostly narrow to specific embodiments.

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What is the key claim interpretation: does “selectively disengaging” require an explicit user action?

Only Claim 9/10 explicitly recite a user actuated element. Independent claims 1, 11, 15 and method claim 16 recite:

• A disengaging mechanism that selectively disengages the locking seat while the cartridge is attached. (Claims 1, 15)
• Method steps that include engaging a clutch-deactuating mechanism, rotating knob back, and then releasing to prevent further reverse rotation while attached. (Claim 16)

This supports a requirement for a switchable state that enables reverse rotation and then returns to a blocking state. Whether the switch is user-driven, automated on a time schedule, or triggered by another mechanical event is not constrained in the independent claims. The “while attached” and “release to prevent continued reverse rotation” aspects are the critical functional and state requirements.

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How does the method claim (16) impact infringement theories?

Claim 16 is a “reduce excess dosage” method:

1. Attach cartridge to injector.
2. Rotate knob in first direction to advance rod into cartridge by a first distance to set dosage without effecting delivery.
3. Engage a clutch-deactuating mechanism.
4. Rotate knob in second/opposite direction until rod retracts by a sufficient distance to reduce dosage.
5. Release the clutch-deactuating mechanism thereby preventing rotation in the second direction while cartridge attached. (Claim 16)

Infringement leverage: method claims can capture service, labeling, and training impacts if the product’s normal use sequence includes those steps and the “clutch-deactuating mechanism” is engaged and released during a dial-back event. For a design-around to matter, it must remove at least one step equivalence: staged non-delivery dial setting, the “clutch-deactuating mechanism” function enabling reverse rotation, or the blocking after release while cartridge attached.

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What is the likely prior-art pressure point?

The claim’s likely novelty lies in the combination:

• staged actuation (dial setting without injection, then axial trigger delivery), and
• mechanical one-direction clutch preventing reverse dial-back by default, with a selective disengager enabling reversal while cartridge remains connected, and
• the dosing adjustment being achieved by retracting the rod (reducing a measured axial distance).

Prior art risk concentrates around:

• dial-setting injectors with one-way dose mechanisms,
• retractable or cancelable dose dial designs,
• user-controlled “back-off” or “set reduction” mechanisms, and
• cartridge-injector couplings where cartridge removal changes state.

However, dependent claims also embed specific UI (LCD with periodic contact engagement) and specific mechanical geometries (grooved lip pin; ratchet; threaded rod), which are easier to invalidate by finding closer UI and clutch designs.

Because the landscape details and specific references are not provided here, no definitive claim-by-claim anticipation mapping can be executed without external search results.

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How to think about freedom-to-operate (FTO): which design choices matter most?

1) Keep or break the “one-way clutch + selective disengage while attached” chain

The decisive architectural decision is whether a reverse rotation during attachment is enabled via a selective disengagement of a locking seat or equivalent one-way restriction system.

Design-around targets:

• eliminate a default reverse-blocking clutch that can be “selectively disengaged,” or
• permit reverse rotation without a clutch-seat disengagement state change, or
• change the adjustment mechanism so it does not retract the same rod/set distance used for initial set dosage.

2) Reframe staged delivery distances

Claim scope ties injection to axial force that drives the rod a second distance to engage the cartridge plunger. If a product uses an alternative delivery mechanism (e.g., direct plunger actuation during dial setting, or a separate delivery actuator that is electrically or mechanically decoupled from the dial-back rod travel), independent claim capture becomes less likely.

3) Decouple dispense display from dosage sleeve rotation if LCD claims are asserted

If a system uses LCD with periodic contact engagement by the dosage knob, or increments/decrements strictly based on sleeve rotation direction, dependent claims 4, 5, 8, 12 are vulnerable. Avoiding these UI couplings limits dependent-claim reach but may not avoid independent claims.

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What is the patent landscape posture?

US 5,383,865 is a late-1990s mechanical injector claim set with:

• mechanical state control,
• dial-back dose reduction,
• staged dose setting and injection actuation, and
• optional display integration.

From a business perspective, the primary landscape question for competitors is not “does the product show a dial-back?” It is whether the product uses a mechanical state machine equivalent to:

• “restrict reverse rotation with a clutch/locking seat”,
• “selectively disengage that restriction while cartridge is attached,” and
• “deliver only after axial force advances the rod further to drive the cartridge plunger.”

Any modern product that uses motor control or electromechanical position sensing still may map onto the staged “rod/plunger” structure if it includes a mechanical equivalent one-way restriction and selective disengage enabling reverse rotation while attached.

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Key Takeaways

• US 5,383,865 is built around a mechanical dose-setting workflow: knob rotation sets dosage by axially advancing a rod without delivering; axial knob force delivers by advancing the cartridge plunger.
• Independent claims hinge on a one-direction clutch restricting reverse rotation and a selective disengaging mechanism that re-enables reverse rotation while the cartridge remains attached, reducing the rod’s axial advancement and therefore the set dosage.
• Dependent claims are implementation-specific (pin/lip, tubular spring clutch, LCD periodic contact, ratchet, threaded rod, slidable actuator) and are generally easier to design around than the independent claim architecture.
• The method claim (16) strengthens normal-use infringement theories because it recites a dial-back sequence with engaging and releasing a clutch-deactuating mechanism to allow and then block reverse rotation while attached.
• The most practical FTO gate is mechanical equivalence to the “locking seat + selective disengage + reverse dial-back while attached + staged delivery distances” state machine.

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FAQs

1) Does the patent require a specific type of clutch (ratchet) in the independent claims?

No. Ratchet is only in dependent claim 6. Independent claims require a clutch mechanism with a rotatable piece and locking seat restricting reverse rotation in one direction only, plus a selective disengaging mechanism to enable reverse rotation while the cartridge is attached.

2) Can a design still infringe if it uses a different display than an LCD?

It can. LCD is only required in dependent claims 4 and 5. Independent claims do not require a display. A competitor can avoid dependent LCD limitations while still potentially meeting independent mechanical elements.

3) What is the critical difference between dial-back and cancel?

For this patent, dial-back is achieved by permitting reverse rotation while the cartridge is attached through a selective clutch disengagement that reduces the axial advancement distance of the rod used to set dosage. Cancel/reset mechanisms that do not retract the dose-setting rod distance via that selective clutch state may avoid the “dial-back” mechanical equivalence.

4) Is user actuation required to disengage the clutch?

Not in the independent claims. Claim 1 and 15 require a disengaging mechanism that selectively disengages the locking seat while attached. Claim 9 requires a user actuated element, but that is dependent. The method claim (16) requires engaging and releasing the clutch-deactuating mechanism during use.

5) Does cartridge removal affect infringement risk?

Cartridge removal is addressed in dependent claim 14 (“disengaging… when the cartridge is removed”). Independent claims are tied to the state “while the cartridge is attached,” so the key risk is the in-use dial-back capability and associated clutch disengagement, not what happens after removal.

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References

[1] United States Patent 5,383,865, “Medication dispensing device,” claims 1-16 (as provided in the prompt).

Details for Patent 5,383,865

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	June 23, 1987		2013-03-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	October 16, 1986		2013-03-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	February 04, 1999		2013-03-15

International Patent Family for US Patent 5,383,865

Country	Patent Number	Estimated Expiration
South Africa	941579
Yugoslavia	11294
Ukraine	26866
Taiwan	267945
Slovenia	0615762
Russian Federation	94007352
Russian Federation	2132704