United States Patent RE44847: What the Claims Cover and Where the Patent Landscape Lands

United States Reissue Patent RE44847 claims methods for operating a needle-assisted jet-injection device that delivers a medicament via a movable needle guard concealing a needle with an axial opening, where the needle insertion depth is <5 mm, the fluid chamber holds 0.02 to 3 mL, and the jet ejects the chamber contents in <2.75 seconds. The independent claim set defines specific rate, pressure, and time thresholds (including ranges of 100 to 1000 psi, injection rate ≥0.40 mL/sec, and examples like ~1 mL in ~2 sec), plus multiple dependent claim paths covering needle-guard actuation, fluid communication, injection depth ranges, axial opening dimensions, and triggering mechanisms (stored mechanical energy and/or a push button).

1. Claim Scope: What the Patented Method Requires

What is the core system architecture in the claims?

The claims repeatedly require a needle-assisted jet injection device with these elements:

Proximal and distal ends
Needle concealed by a movable needle guard (needle guard has at least an “extended” and “retracted” position in the later claims)
Needle includes an axial opening through which medicament is ejected as a fluid jet
Medicinal fluid chamber with defined volume and pressurization
Force-providing mechanism that pressurizes the chamber to a specific pressure window
Jet penetration into tissue beyond the distal end of the needle, meaning the delivery is not limited to the needle tip alone

This architecture is present across method claims 1, 22, 23, 24, and 30, with dependent claims filling in specific mechanisms and structural measurements.

What are the hard numeric limitations?

The independent claims constrain performance in a way that narrows both dosing hardware and delivery kinetics.

Insertion depth and injection placement

Needle insertion depth is less than 5 mm (claims 1, 22, 23)
Subcutaneous use with insertion point depth 1 to 5 mm is called out (claim 7)
“Up to about 3 mm” is explicitly included (claim 8)
Needle insertion point is “more superficially than the injection site” (claim 23)

Fluid chamber volume

Fluid chamber holds 0.02 to 3 mL (claims 1, 22, 23)

Time-to-jet (delivery completion window)

Fluid chamber contents ejected through needle as a jet in less than about 2.75 seconds (claims 1, 22, 23)

Injection rates

Injection rate is at least 0.40 mL/sec (claims 9, 23)
A specific example is also claimed:
- ~1 mL in about 2 seconds (claims 5, 11, 23)
- That implies ~0.50 mL/sec (claim 5)

Pressure

Two overlapping pressure framings appear:

Claim 5: pressure between 100 to 500 psi, with rate around 0.50 mL/sec (and ~1 mL in ~2 sec)
Claims 22 and 23: pressurize to from around 100 up to no more than around 1000 psi
Claims 12 and 13 (dependent on claim 6’s structure pathway):
- No greater than ~500 psi (claim 12)
- Reaches 150 to 375 psi (claim 13)

Needle geometry and size ranges

Axial opening diameter: 0.004 to 0.012 inches (claim 14)
Needle gauge: 26 to 27 gage (claim 15)
Needle length and extension:
- Needle length approximately 1–5 mm (claim 18)
- Needle extended 1–5 mm from housing member (claim 19)
A specific internal geometric continuity limitation appears:
- proximal and injecting end portions have substantially common and continuous inner and outer diameters (claims 16–17)

These constraints are not “general jet injection” language. They are specific to a very short needle insertion depth paired with jet delivery beyond the needle tip.

2. How the Claims Differ: Independent Claim Threads

Thread A: “Gently urge needle guard proximally” + pressurize to meet jet kinetics (Claim 1)

Claim 1 is a method operating a needle-assisted jet device where:

applying the distal end “gently urge[s]” the needle guard to move proximally
inserting the needle into the injection site
causing a force-providing mechanism to pressurize the medicament chamber
meeting all kinetic constraints (depth <5 mm; 0.02–3 mL; jet ejects chamber contents in <2.75 seconds)
penetration beyond needle distal end is stated as the functional delivery endpoint

Thread B: Explicit fluid communication structure options (Claims 2–3, 6 and 23)

Claim 1 itself does not limit how needle and chamber communicate. Dependent claims add two mechanisms:

Twisting the needle guard to provide fluid communication (claim 2)
Distal stopper motion penetrates proximal needle end via pressurized fluid (claim 3)

A separate path in claim 6/22/23 requires that fluid communication between distal tip and fluid chamber exists prior to applying:

“providing fluid communication between the distal tip of the needle and the fluid chamber prior to the step of applying” (claim 6) This can be read as a structural precondition for activation.

Thread C: Delivery mechanism variants and post-delivery safety position (Claims 4, 24, 30)

The claims also capture device behavior after delivery:

retract the needle into needle guard after delivery (claim 4)
remove the device and guard transitions from retracted to extended (claims 24, 30)

Claim 24 and 30 further define trigger mechanics:

applying device urges needle guard movement to “retracted” and activates a stored energy generating mechanical member (claim 24)
alternatively includes a push button at the proximal end that pressurizes the chamber (claim 30)

Thread D: Pressure ceiling variants and rate floor variants

Claims 5 and 12 limit pressure (100–500 psi or no greater than 500 psi). Claims 22 and 23 allow up to 1000 psi. The presence of rate floors (≥0.40 mL/sec) makes it possible for designs with higher pressure but slower jetting to avoid infringement on method steps.

3. Dependent Claim Coverage: What Additional “Design Facts” Are Locked In

Below is a structured breakdown of the dependent claim limitations mapped to infringement-relevant product design decisions.

Fluid communication and activation mechanics

Twisting needle guard creates fluid communication (claim 2)
Distal stopper penetrates needle proximal end and is driven by pressurized fluid (claim 3)
Stored energy mechanical member pressurizes upon needle guard reaching retracted position (claim 24)
Push button pressurizes to eject medicament (claim 30)

Injection setting and needle depth

Subcutaneous injection with needle insertion point depth 1–5 mm (claim 7)
Needle insertion point depth up to ~3 mm (claim 8)
“Needle insertion point located more superficially than injection site” (claim 23)

Dose delivery kinetics

At least 0.40 mL/sec (claims 9, 23)
Injection in <2.75 sec (claims 10, 7/6-dependent set)
Example dosing: ~1 mL in ~2 sec (claims 5, 11, 23)

Pressure windows

Example: 100–500 psi (claim 5)
Pressure ceiling: ≤500 psi (claim 12)
Pressure window: 150–375 psi (claim 13)
Main window: ~100 to ≤1000 psi (claims 22, 23, and claim-structure leading)

Needle axial opening and gauge

Axial opening diameter 0.004–0.012 in (claim 14)
Needle is 26–27 gauge (claim 15)

Needle and extension geometry

Needle portions:
- injecting end portion and proximal portion with common axial cross-sectional dimensions
- proximal portion longer than injecting end (claim 16)
Common continuous inner/outer diameters between portions (claim 17)
Needle length ~1–5 mm (claim 18)
Needle extended ~1–5 mm from housing (claim 19)

Chamber construction

Fluid chamber made of glass (claim 20)

Additional operational steps

Apply injection pressure such that injection site is deeper than needle insertion point (claim 21)
Viewing medicament within fluid chamber to determine status (claim 27, 33)
Remove safety cap before applying (claim 28, 34)
Depress push button after applying distal end (claim 29)

4. Practical Scope Boundary: Where Nonconformance Likely Avoids the Method Claims

The claims are method claims, but the limiting parameters create clear “nonconformance corridors” for design-around:

Needle insertion depth: Any method that delivers jet penetration without inserting a needle to <5 mm likely falls outside core limitations (claims 1, 22, 23, and subcutaneous depth dependent claims).
Time-to-eject: Delivery that does not eject the fluid chamber contents through the needle in <2.75 seconds is outside the core requirement (claims 1, 22, 23, and claim 24’s “rate of at least 0.02 ml in 2.75 seconds”).
Rate floor: Designs that inject below 0.40 mL/sec risk noninfringement on claims that demand that threshold (claims 9 and 23).
Pressure range: If a design cannot reach the required pressure windows (especially the “from ~100 up to ≤1000 psi” window), it will likely fail method limitation matching in independent claims 22 and 23.
Axial opening/needle size: Where dependent claims require 26–27 gauge and axial opening diameter 0.004–0.012 inches, product designs that deviate could avoid those dependent claim pathways (claims 14–15), though independent claims may still be broader depending on the device specifics.

5. Patent Landscape for RE44847: What It Likely Covers in the Competitive Space

A rigorous “landscape” normally requires citation to the underlying patent family, prosecution history, and forward/backward citations. The prompt provided includes only the RE44847 claim text and not the patent’s assignee, filing dates, reissue basis, family members, or citations. Without those bibliographic anchors, a complete, accurate US landscape mapping (including other live patents covering similar needle-assisted jet injection) cannot be produced to a defensible standard.

What can be stated from the claims alone is the type of competitive activity RE44847 targets:

Needle-assisted jet injection with very short needles (1–5 mm) and needle insertion depth <5 mm
Movable needle guard that is proximally urged during application and transitions positions before/after dosing
Pressurized medicament chamber delivering a fast jet (completion time <2.75 sec) with high injection rate (≥0.40 mL/sec)
Device activation via stored mechanical energy or a push button
Structural constraints likely used to distinguish from conventional needle-based injection and from needle-free jet injection

In portfolio terms, RE44847 is positioned as a claims set focused on delivery mechanics and operating steps rather than medicament formulations.

6. Scope Map: Claim-to-Design Feature Matrix

Claim(s)	Must-do operating step(s)	Must-hit performance metrics	Structural constraints explicitly claimed
1	Apply distal end to urge needle guard proximally; needle inserts; force mechanism pressurizes chamber	Needle depth <5 mm; 0.02–3 mL; eject in <2.75 sec; penetrates beyond needle tip	Needle with axial opening under guard; fluid chamber pressurization; jet injection beyond distal needle
2	Twisting needle guard provides fluid communication	Same as claim 1	Fluid communication method tied to twist
3	Distal stopper motion provides fluid communication	Same as claim 1	Stopper penetrates proximal needle end driven by pressurized fluid
5	Pressurize to 100–500 psi; rate ~0.50 mL/sec for ~1 mL in ~2 sec	Example kinetics and pressure	Same architecture as claim 1
6–8	Provide fluid communication prior to applying; subcutaneous injection depths	Depth 1–5 mm (claim 7); up to ~3 mm (claim 8)	Dependent needle/chamber integration prerequisites
9–13	Inject at ≥0.40 mL/sec; pressure ceilings/windows	Rate floor and pressure range; time <2.75 sec (in those dependent paths)	Builds on claim 6 structure pathway
14–20	Needle axial opening diameter; gauge; needle length; chamber material	Rate/pressure/time as required by independent framework	Axial opening 0.004–0.012 in; 26–27 gage; needle length 1–5 mm; glass chamber (claim 20)
22	Provide fluid communication; apply device to urge guard; pressurize chamber to ≤1000 psi; eject <2.75 sec	Needle depth <5 mm; 0.02–3 mL; jet in <2.75 sec	Pressure range defined higher ceiling than claim 1’s dependent variants
23	Extend needle ~1–5 mm to insertion point <5 mm depth; pressurize 100–1000 psi; eject up to 3 mL in <2.75 sec; ≥0.40 mL/sec	Needle/superficial insertion point vs deeper injection site; high-speed jet beyond needle tip	Requires needle extension and penetration beyond insertion point
24	Apply distal end to urge guard to retracted; activates stored mechanical pressurization; remove device; guard returns extended	Eject at least 0.02 mL in 2.75 sec	Stored-energy activation; extended vs retracted guard position
30	Apply to urge guard to retracted; depress push button to pressurize and eject; remove device	Eject rate at least 0.02 mL in 2.75 sec	Push button activation and guard motion

Key Takeaways

RE44847 is anchored on needle-assisted jet injection with sub-5 mm needle insertion depth, a small fluid chamber (0.02 to 3 mL), and fast delivery where the jet ejects in under 2.75 seconds.
The claims lock in delivery kinetics (not just dose) through rate floors (≥0.40 mL/sec in key paths) and pressure windows (around 100 to ≤1000 psi; with narrower examples at 100–500 psi).
The movable needle guard and activation mechanics matter: claim coverage includes twist-to-connect, stopper-driven fluid communication, and activation by stored mechanical energy or push button.
Dependent claims narrow to specific needle dimensions (axial opening diameter 0.004–0.012 in, 26–27 gauge, needle length/extension 1–5 mm) and chamber material (glass).

FAQs

1) Does RE44847 cover needle-free jet injectors?

No. The claims require a movable needle guard concealing a needle with an axial opening and insertion into the injection site with depth <5 mm.

2) What is the fastest delivery constraint in the claims?

The fluid jet must eject the fluid chamber contents through the needle in less than about 2.75 seconds (claims 1, 22, 23).

3) What injection rate threshold appears in the key method claims?

At least 0.40 mL/sec (claims 9 and 23).

4) Are pressure limits central to infringement risk?

Yes. Independent claims (especially 22 and 23) require pressurization from around 100 psi up to no more than around 1000 psi, with dependent examples at 100–500 psi and windows like 150–375 psi.

5) Which additional features narrow the claims the most?

The most narrowing dependent features include needle gauge (26–27 gage), axial opening diameter (0.004–0.012 in), needle length/extension (1–5 mm), and glass fluid chamber (claim 20).

References

[1] RE44847 claim set provided by user (claims 1–34).

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	240756	⤷ Start Trial
Austria	281195	⤷ Start Trial
Australia	5470499	⤷ Start Trial
China	1212867	⤷ Start Trial
China	1323230	⤷ Start Trial
Germany	69908140	⤷ Start Trial
Germany	69921704	⤷ Start Trial
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Details for Patent: RE44847

Summary for Patent: RE44847