Patent: 6,899,699

Summary for Patent: 6,899,699

Title:	Automatic injection device with reset feature
Abstract:	The present invention relates to a dose setting and expelling device comprising a drive member and a dose setting mechanism which simultaneously sets a given dose and stores the energy necessary for a subsequently driving the drive member in order to expel a dose of medicine from an injection device. According to the invention the dose setting mechanism allows adjustment in both directions, such that a given set dose can be reduced or cancelled by reversing the input motion, typically by rotating a setting member backwardly, this in contrast to the known devices which either requires an additional release mechanism or which cannot be reversed at all.
Inventor(s):	Enggaard; Christian (Hiller.o slashed.d, DK)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	10/038,781
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,899,699
Patent Claims:	see list of patent claims

United States Patent 6,899,699: What the claims actually cover and where the landscape sits

US Patent 6,899,699 claims a spring-driven injection platform with a dose-setting mechanism that lets a user adjust dose without moving the drive member, while using a latch to hold the mechanism in the set position and then release to trigger spring-powered expulsion. The independent claim focus is not “dose accuracy” or “medical dosing systems” broadly; it is a specific mechanical control architecture: relative motion of a dose-setting element against spring bias, continuous engagement between dose-setting portions, non-locking threaded drive elements, and anti-counter-rotation coupling resistance that still allows user bidirectional dose changes.

The claim set then expands into more specific mechanical embodiments: rotational vs non-rotational couplings, frictional couplings, tooth/ramp jump-back geometries, and ratchet variants. The method claim maps the same mechanics to an infusion workflow.

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What is the core invention recited by the independent claims?

Claim 1: Spring-driven drive member + dose-setting assembly that does not move the drive member

Claim 1 recites a dose setting device for repetitive injection that includes:

• Housing
• Drive member to expel a dose from a fluid-filled reservoir
• Spring that drives the drive member
• Dose setting assembly mounted in the housing and connected to the spring:
  • A first portion moveable by user in a first direction to set a selected dose against bias of the spring
  • Movement of the first portion is accompanied by straining the spring
  • The first portion is moveable in the opposite direction to adjust the dose without moving the drive member
  • First portion has continuous engagement with a remaining portion of the dose setting assembly
• Latch means associated with the housing:
  • retains apparatus in set position against spring bias
  • is releasable to cause the drive member to expel the set dose
  • expelling force is provided by the spring

The claim’s “center of gravity” is the interaction between: 1) user dose adjustment motion, and
2) drive-member actuation, which only occurs after latch release.

That structural separation is reinforced by the phrase “without moving the drive member” during reverse-direction adjustments and by continuous engagement of dose-setting portions.

Claim 20: Rotatable dose setting assembly coupled to spring, with resistive anti-counter-rotation coupling

Claim 20 adds a more explicit coupling architecture:

• “rotatable dose setting assembly”
• coupling provides resistance sufficient to prevent the spring to counter rotate the dose setting member
• resistance is easily overcome by user setting in either direction (so user can both increase and decrease dose)
• dose-setting member moveable from initial to selected set position:
  • in first direction: accompanied by straining spring
  • in opposite direction: selectively adjust dose
• latch retains set position; release causes drive member expulsion
• optionally includes a second latch (claim 21)
• optionally torsional spring providing rotating force (claim 22)

In practice, claim 20 is a broader but more mechanism-specific “anti-backdrive” concept: spring energy must not rotate the dose setting element backward, but the user must be able to rotate it both directions.

Claim 23: Method claim tracks the same mechanical choreography

Claim 23 is a process claim that operationalizes the same mechanics:

• establish flow connection
• select dose by operating dose setting member
• release latch to allow spring to drive expulsion

The method does not introduce materially new mechanics beyond the mechanical claim.

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Claim-by-claim critical mapping: what breadth exists and what is functionally constrained

Claims 2 to 8: Coupling member and threaded non-locking pitch-based translation

Claim 2 introduces:

• a coupling member in displaceable engagement with the dose setting member
• spring acting on coupling member; coupling member acts on dose setting member

Claims 3 and 9:

• add threaded member(s) with non-locking threads
• use pitch angle so that axial movement of drive member is obtained by axial force applied by spring
• in claims 3 and 9 the threaded drive is non-locking but “pitch angle” drives translation under spring force

Claims 4, 7, 10:

• define “mutually cooperating surfaces” where dose setting motion strains spring
• define dose setting member rotational mounting leading to axial movement of dose setting member relative to drive member during setting

Claims 5, 6, 8:

• include a rotationally mounted dose setting member on drive member
• sliding, non-rotational engagement for the coupling member (to transmit force/strain spring without spinning where undesired)
• key “anti-counter rotation” coupling resistance:
  • sufficient to prevent spring counter-rotating the dose setting member
  • still easily overcome by user rotating in either direction

Critical point: Claims 6 and 8 do not require a particular anti-backdrive structure. They require resistance behavior with a user-overcoming threshold. That creates breadth over the coupling implementation.

Claims 11 to 14: Second embodiment variant using cooperating surfaces + resistance anti-backdrive

Claims 11–14 largely restate the same architecture but in the alternative “piston drive member” framing. They preserve the core functional requirement:

• rotation of dose setting to set dose strains spring
• anti-counter rotation by coupling resistance that can be overcome by user

Claims 15 to 18: Specific mechanical coupling implementations

This is where the claim set narrows into identifiable coupling technologies:

Claim 15: sector-shaped teeth with ramp shaped edges

• teeth slide with ramp shaped parts over each other
• “jump back each time a top of the teeth is reached”
• pitch chosen so jump back occurs per dose unit increment

Claim 16: frictional coupling between cooperating surfaces

• compression force provided by spring acting on coupling member

Claim 17: coupling can be selectively engaged/disengaged

• allows dose-setting member rotation in either direction

Claim 18: one-way ratchet mechanism

• first and second ratchet members
• can be disengaged by relative axial movement between ratchet members

Critical point: Claims 15–18 convert a functional “resistance sufficient to prevent counter rotation” into specific structures. These claims are likely the easiest to read against prior art because they contain concrete geometric/structural features (teeth/ramp/jump-back) and classic mechanism families (ratchet, friction coupling).

Claims 19 and 21: Latch placement and additional latch

Claim 19: latch means acts on the drive member.

Claim 21: second latch retains dose setting member in coupled position; releasable to allow dose setting member disengagement.

Critical point: The latch architecture is an interaction-control element. Some prior art may have one latch (drive lock) but not the “dose setting member in its coupled position” latch. Claim 21 forces additional structure if asserted.

Claim 22: torsional spring providing rotating force on dose setting member

This inserts a torsional spring framing, which can differentiate from linear spring embodiments.

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The patent’s likely claim “pressure points” in enforcement

A practical infringement analysis would typically stress whether an accused product has:

1) A latch-hold-and-release architecture where setting stores energy and expulsion happens after release. 2) A dose setting element that adjusts dose in either direction while avoiding back-driving the drive member. 3) An anti-counter rotation coupling meeting the behavioral requirement:

• prevents spring from counter-rotating the dose setting member
• yet allows user bidirectional adjustment 4) Non-locking threaded pitch mechanics (if the accused design maps to claims 3/9 and dependent structures) 5) A specific coupling implementation if asserted against claims 15–18 (teeth ramp jump-back; friction coupling; selective engagement/disengagement; ratchet with axial disengagement).

Because the claims span from broad functional behavior (claims 1, 2, 6, 14, 20) to narrow structural couplings (15–18), the patent likely has:

• broader coverage if the device uses a coupling resistance mechanism meeting the function,
• less coverage against prior art that uses a different energy-storage architecture or backdrive management (for example, pawl indexing that locks the dose setter during spring load, or geartrains that backdrive and instead rely on anti-backdrive brakes).

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Patent landscape: what parts of the claim set are most likely to overlap with earlier injection/dose-setting systems

Even without reproducing the full prior-art set for 6,899,699 in this record, the claim language points to standard mechanical families in drug delivery devices:

1) Spring-powered dose delivery with latch release

Many historical injection systems use a spring to store energy and a latch to release upon triggering. That means claim novelty is unlikely to be the mere presence of a latch and spring.

Where novelty concentrates in this patent: the dose-setting choreography that allows dose increase and decrease without moving the drive member, plus the anti-counter-rotation coupling that manages spring torque during user adjustment.

2) Threaded non-locking drive with pitch-based axial movement

Non-locking threads with pitch angle enabling axial movement is a common mechanical approach to convert rotational input into axial displacement under load. The patent’s claim differentiation is the integration with:

• dose setter rotational motion,
• coupling resistance against spring counter-rotation,
• and “without moving the drive member” during opposite-direction adjustment.

3) Coupling resistance: friction coupling, ratchet, and indexed ramp-tooth designs

Claims 15–18 map to recognizable mechanism families:

• friction couplings under spring compression
• ratchets with disengagement by axial motion
• tooth/ramp systems that provide discrete “jump-back” dose units

These features create the most direct prior-art overlap risk.

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Claim strength assessment (critical read): breadth vs defensibility

Where the patent is most defensible

• Functional mechanical architecture tying together:
  • energy stored in a spring by dose-setting motion,
  • latch hold in set position,
  • drive-member expulsion on release,
  • dose adjustment in opposite direction without moving the drive member,
  • and continuous engagement between dose-setting portions (claim 1).

These are specific enough that simple “spring latch injection” prior art may not capture the bidirectional dose-setting behavior and the “no drive member movement” limitation.

Where the patent is vulnerable

• The “coupling resistance” concept in claims 6, 8, 14, 20 can be broad. Prior art could use many different anti-backdrive methods and argue they meet or avoid the functional resistance.
• Dependent claims 15–18, while narrower, may collide with earlier mechanisms that already use:
  • indexed ramps or teeth with audible/visible “click” dose increments,
  • friction couplings,
  • or ratchet-based dose increments with disengagement.
• Claims 3 and 9 include non-locking thread and pitch-angle axial movement. If earlier injection pens used standard non-self-locking screw drives with pitch-based translation, these portions may not distinguish well.

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Commercial relevance: which product design choices map to the independent claims

Independent claim coverage is most likely to fit devices that implement:

• A user-rotated dose knob that stores energy (spring straining) while dose is adjusted
• A mechanical coupler that prevents spring torque from back-driving the dose knob
• A trigger release that then allows the drive member to move and expel drug

The design must also maintain:

• bidirectional dose adjustment capability (increase and decrease) without moving the drive member during adjustment.

Devices that only allow dose increase (one-way ratchet without easy reversal) would likely avoid the “move in opposite direction to selectively adjust” limitations unless they include an equivalent reversible mechanism.

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Key Takeaways

• US 6,899,699 is a mechanical-method patent centered on spring energy storage during dose setting, latch hold, and release-driven expulsion, with a differentiating requirement that users can adjust dose in both directions while not moving the drive member during reverse adjustment (claim 1) and with anti-counter-rotation coupling resistance that still allows user-driven bidirectional dose change (claims 6 and 20).
• The broadest protection likely lives in the coupling resistance functional requirement and the choreography separation between dose setting motion and drive-member actuation.
• The highest collision risk comes from the narrower dependent claims that recite friction coupling, ratchet mechanisms, and sector-shaped tooth ramp jump-back dose indexing (claims 15–18).
• Enforcement leverage is strongest against accused injection systems that have an analogous spring-powered drive with latch release, plus a dose setter that is held against back-driving yet remains user-reversible.

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FAQs

1. What is the single most limiting feature in claim 1?
   The dose setting first portion must move in opposite directions to adjust dose without moving the drive member, while remaining in continuous engagement with the remaining dose-setting portion.

2. Does the patent claim cover any spring-and-latch injector?
   No. It requires the specific dose-setting mechanics: spring straining during dose selection, latch holding the set position, release driving the expulsion, and anti-backdrive/coupling behavior that allows user dose adjustment in both directions.

3. Which claims are most likely to narrow coverage against prior art?
   Claims 15–18 because they recite specific coupling structures: ramp-tooth jump-back indexing, friction coupling, selective engagement/disengagement, and one-way ratchet with axial disengagement.

4. Is the “non-locking thread pitch” essential to the concept?
   It is essential only to dependent claims 3 and 9 (and related dependent structure). The independent claims do not necessarily require threaded non-locking pitch.

5. Does claim 23 add more than the apparatus claims?
   It maps the same mechanics into a method flow: establish connection, operate dose setting, release latch to drive spring expulsion.

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References

[1] US Patent 6,899,699. “Dose setting device and method of infusing a flowable drug.” United States Patent and Trademark Office.

Details for Patent 6,899,699

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	June 07, 2000	6,899,699	2022-01-02
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	January 19, 2001	6,899,699	2022-01-02
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	April 23, 2004	6,899,699	2022-01-02
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986	October 31, 2013	6,899,699	2022-01-02

International Patent Family for US Patent 6,899,699

Country	Patent Number	Estimated Expiration
Austria	E296650
China	1313168
China	1509193
Germany	60204422