Details for Patent: 5,772,346

Summary for Patent: 5,772,346

Title:	Liquid applicator with structural insert
Abstract:	A liquid applicator for applying a desired liquid to a surface includes a closed ampule formed of a fracturable material containing the desired liquid, a body having a pocket with an open side and a shape adapted to receive the ampule, and a porous element sealed to the body and closing off the open side of the pocket so that liquid flows through the element when the ampule is fractured. The body includes a pair of side walls that are spaced from one another in a first direction to define the pocket, and a pair of gripping members, are provided, which can be pivoted to fracture the ampule during use. The porous element is laminated with a material that does not stretch in the first direction, and the laminate material is secured between the side walls of the body to define a structural insert that prevents the side walls from pulling apart from one another when the gripping members are pivoted.
Inventor(s):	William R. Edwards
Assignee:	FIRST SOURCE FINANCIAL Inc , CareFusion 2200 Inc
Application Number:	US08/837,653
Patent Claim Types: see list of patent claims	Use; Delivery;

United States Patent 5,772,346 Landscape: Scope, Claim-Depth, and Freedom-to-Operate for Liquid Applicators Using Fracturable Ampules and Porous Laminates

United States Drug Patent 5,772,346 is a mechanical delivery device patent focused on a liquid applicator that dispenses a drug-containing fracturable ampule using a lever/tappet fracture mechanism. Claim scope is anchored on (i) an applicator body with a pocket holding a closed, fracturable ampule, (ii) a lever that fractures the ampule via an intermediate tappet, and (iii) a porous element covering the pocket, with the porous element laminated to side walls using a laminate that resists pulling apart in a specified direction (and additional dependent features on stretching direction, fabric type, puncture resistance to glass fragments, dual levers, and melt-bonding).

The patent landscape is likely concentrated in: topical liquid applicators, unit-dose ampule fracture dispensers, and compression/lever actuated fracture and capture structures, with design-around routes centered on changing the fracture trigger, breaking the “porous element laminated directly to side walls” limitation, or shifting the mechanics of securing the porous layer.

What is the core invention in US Patent 5,772,346 and what does it cover?

Core claim concept (independent claim 1): a liquid applicator with:

• Body: pair of side walls spaced in a “first direction” defining a pocket.
• Closed ampule: placed in the pocket, formed of fracturable material, containing liquid to dispense.
• Actuation: a lever with:
  • first end secured to a side wall,
  • free second end,
  • intermediate tappet bearing against the body and fracturing the ampule when lever pivots.
• Dispense interface:
  • porous element covering the pocket so liquid flows through it after ampule fracture.
  • porous element is laminated with material that does not stretch in the first direction.
  • laminate is secured directly to the side walls to prevent side walls from pulling apart when the lever pivots.

H3: Key claim anchors that define claim scope

Claim 1 is not a generic “ampule applicator.” It requires a specific structural combination:

1. Porous element covering pocket
2. Laminate that resists stretch in the “first direction”
3. Direct attachment of laminate to side walls to stop side-wall separation under lever actuation
4. Lever-mediated tappet fracture of a closed, fracturable ampule contained in the pocket

Each of these anchors can be used as an infringement gate in analytics, because they function as mutually reinforcing constraints: fracture, capture/transport through porous element, and laminate/side-wall structural stabilization in a directional manner.

How broad are claim 1 limitations in US Patent 5,772,346?

H3: “First direction” and directional stretch resistance

Claim 1 uses a directional limitation: laminate material “does not stretch in the first direction.” Breadth hinges on claim construction:

• If “first direction” is interpreted broadly as the direction of side-wall spacing, then the laminate must resist deformation specifically in that spacing direction.
• If interpreted narrowly as a defined orientation in the specification drawings, infringement depends on whether accused devices position side walls and lamination so that stretching occurs in an analogous “first direction.”

This is a high-value limitation for design-around because a competitor can:

• reduce or eliminate the relevance of directional non-stretch by using materials/structures that behave differently under load,
• decouple the porous element attachment from the side walls, or
• change the load path such that side-wall pulling apart is not constrained by a non-stretch laminate directly secured to both side walls.

H3: “Laminate secured directly to the side walls”

This is likely the most litigated-style limitation in similar device patents. Claim 1 requires:

• laminate material of the porous element is secured directly to the side walls of the body.

Design-around targets often include:

• securing the porous layer to a frame or cross-member rather than directly to side walls,
• using a separate bonding element that places a non-laminated intermediate layer between laminate and side wall,
• relocating structural reinforcement away from the side walls.

Even small structural differences in attachment scheme can matter if “directly” is construed strictly.

H3: “Porous element covering the pocket”

Claim 1 requires porous coverage over the pocket that permits liquid flow when the ampule is fractured.

• If an accused applicator uses a porous element that does not “cover” the pocket, or uses discrete flow channels not described as a porous element covering the pocket, infringement may be avoided.
• If the accused design uses a non-porous wicking material, the question becomes whether it qualifies as “porous element” and covers the pocket as claimed.

What do dependent claims 2–7 add and how do they narrow scope?

H3: Claim 2: stretchability along longitudinal axis

Claim 2 adds that:

• body is elongated, defining a longitudinal axis transverse to the first direction.
• laminate material is stretchable along the longitudinal axis.

This is a directional dual-property requirement:

• non-stretch in the first direction (Claim 1)
• stretchable along longitudinal axis (Claim 2)

This can narrow the claim set for infringement, because a competitor that uses a laminate that resists stretching in both axes may not meet the “stretchable along longitudinal axis” feature. Conversely, broad material classes could still satisfy it if their mechanical behavior supports anisotropic stretch.

H3: Claim 3–4: fabric and polyester fabric

Claim 3 limits laminate material to a fabric. Claim 4 further narrows to polyester fabric.

If an accused device uses non-fabric laminate (film, nonwoven polymer sheet without textile characteristics, woven-free reinforcement, or a composite with no fabric classification), it can avoid dependent-claim coverage. Independent claim 1 would still potentially be in play unless the laminate in practice is a “laminate material that does not stretch in the first direction” with direct side-wall attachment.

H3: Claim 5: puncture resistance to glass fragments; glass ampule

Claim 5 requires:

• ampule is glass, and
• laminate of porous element resists puncture by fragments of glass from fractured ampule.

This is an additional materials-functional limitation that can be used defensively:

• switching ampule material away from glass (e.g., polymeric fracturable ampule)
• using a porous element laminate that does not claim or functionally resist puncture in the relevant way

This claim narrows significantly; it is not needed to read onto all implementations under claim 1.

H3: Claim 6: levers on both side walls

Claim 6 requires levers secured to both side walls, each with tappet fracture action. This is a narrower mechanical configuration than claim 1 (single lever).

H3: Claim 7: melt-melt bonding of laminate to body

Claim 7 requires:

• laminate material and body material are melted together to secure porous element to body.

This narrows construction to a specific bonding method. A device using ultrasonic welding, adhesive lamination, mechanical anchoring, or thermal lamination without “melted together” might avoid this dependent claim.

What parts of the claim drive infringement risk most in US Patent 5,772,346?

H3: High-friction limitations (most design-dependent)

1. Lever + intermediate tappet that fractures the ampule when pivoted
2. Porous element covering pocket
3. Laminate material that does not stretch in first direction
4. Laminate secured directly to side walls to prevent side-wall pulling apart when lever pivots
5. (Conditional) glass ampule + puncture-resistant laminate (Claim 5)
6. (Conditional) anisotropic stretch in both axes (Claim 2)
7. (Conditional) dual-side levers (Claim 6)
8. (Conditional) melt bonding (Claim 7)

H3: Low-friction vs high-friction for design-around

• If a competitor keeps the same fracture mechanism and porous covering but changes lamination attachment or directional stretch behavior, claim 1 risk can be reduced.
• If a competitor changes actuation from lever/tappet to a different fracture trigger (springs, plungers, tear-open, shear, thermal), the “intermediate tappet” lever mechanism can break the core claim.

How does claim construction likely treat “porous element,” “laminate,” and “fracturable ampule”?

H3: “Fracturable material” and “closed ampule”

The claim does not require the ampule to be glass in claim 1. It is “fracturable material” containing liquid to be dispensed.

• That broadens potential coverage under independent claim 1 to polymer, composite, or other fractureable ampule materials, subject to the porous laminate handling and fracture geometry.

H3: “Porous element”

Claim 1 needs porous coverage so liquid flows through after fracture.

• If an accused design uses a non-porous membrane with multiple perforations or capillary wicking only in localized regions, courts may fight over whether it is a “porous element” in the ordinary meaning and as supported by the specification drawings.

H3: “Laminate”

A laminate implies layered construction. Claim 1 requires laminate material of the porous element that has directional mechanical behavior and is secured directly to side walls.

• Using a single-layer material without lamination could avoid “laminated with material” limitations under claim 1 if construed strictly.

What is the likely patent estate structure around US 5,772,346?

Without prosecution history, family, or citation data, a complete cross-family mapping cannot be produced. What can be stated from the claims alone is the likely “adjacent” neighborhood:

• device patents for fracturable ampule dispensers,
• topical applicators with porous release surfaces,
• reinforcement structures preventing side-wall deformation under actuation,
• anisotropic laminate reinforcement.

The most probable competitors and litigants in this niche are companies that build:

• self-contained unit-dose dispensing systems,
• controlled-activation topical delivery,
• applicators where ampule fracture drives immediate liquid release.

What generic entry risks exist for drug products if US 5,772,346 is a device patent?

This patent is directed to a liquid applicator device mechanism, not a small-molecule composition per se. Entry risk depends on whether the drug product is supplied with this device as part of the FDA-labeled combination and whether the device is integral to dispensing the drug.

• If the drug is an NDA/505(b)(2) product marketed with a specific applicator, device patents can affect Paragraph IV signaling only insofar as the generic must be marketed with “same” or functionally equivalent delivery hardware.
• If the generic can market the drug with a different device, the device patent can become a licensing or injunction risk rather than a straightforward composition/IP block.

Because the question asked for “drug patent,” the compliance posture should treat 5,772,346 as a combination and device delivery barrier rather than a conventional API monopoly.

How would a litigation strategy likely attack or defend US 5,772,346 claim scope?

H3: Plausible infringement arguments (what plaintiffs would emphasize)

• The accused product uses a pocket with a closed, fracturable ampule
• Actuation uses a lever that pivots and includes an intermediate tappet that fractures the ampule against a body feature
• The fractured liquid is carried by a porous element over the pocket
• The porous element is reinforced with a laminate that is mechanically anisotropic (non-stretch in the side-wall spacing direction)
• The laminate is secured directly to side walls and performs the function of preventing side-wall separation under lever actuation

H3: Plausible defenses (design-around and non-infringement)

• Not “directly secured” laminate to side walls (use intermediary frame, different attachment path)
• Different actuation: not a lever with intermediate tappet fracture
• No porous element covering pocket (use separate wicking area, different liquid transfer path)
• Laminate stretch behavior does not meet “does not stretch in first direction” or does not include “stretchable along longitudinal axis” where relevant
• Not laminated fabric (for dependent claims)
• Ampule not glass (for Claim 5)
• No melt-bonding (for Claim 7)
• Single-sided vs dual lever (for Claim 6)

What formulation patents and method-of-use patents could be relevant even if US 5,772,346 is about a device?

H3: Pairing risk in “combination product” marketing

In many topical liquid delivery systems, device patents coexist with:

• formulation patents protecting viscosity range, stabilizers, permeation enhancers, and solvent system,
• method-of-use patents tied to dosing regimens, patient populations, or treatment protocols.

Even if 5,772,346 covers the applicator, investors and litigators typically run a portfolio view that includes formulation and method patents for the same product labeling.

A full combined landscape requires Orange Book listings, FDA application identifiers, and related device listings, which are not provided here.

How many patents cover similar concepts as US 5,772,346?

A quantified “how many” count cannot be produced from the claim text alone without an actual database search across:

• USPTO device classification areas,
• IPC/CPC families around “fracturable ampule dispenser,”
• litigation clusters,
• continuations and divisionals related to 5,772,346.

Accordingly, no count is provided.

Key takeaways

• US 5,772,346 claim 1 is a tightly coupled mechanical delivery invention: lever/tappet fracture of a closed fracturable ampule inside a pocket, followed by liquid discharge through a porous element that is laminated and directly secured to side walls using non-stretch directional reinforcement to prevent side-wall pulling apart during actuation.
• The highest-value infringement levers are: (i) lever with tappet fracture mechanics and (ii) porous laminate directly secured to side walls with anisotropic stretch behavior.
• Dependent claims narrow further to anisotropic longitudinal stretch, fabric/polyester, glass/puncture-resistant laminate, dual levers, and melt bonding.
• Design-around likely focuses on changing attachment scheme (not “directly secured”), changing fracture mechanism (no intermediate tappet lever fracture), changing the discharge interface (porous element coverage), or changing ampule material from glass for the dependent claim features.

FAQs

1. Can an applicator avoid US 5,772,346 by using a different fracture trigger than a pivoting lever with an intermediate tappet?
2. If a porous layer is reinforced, but not laminated or not directly secured to the side walls, does it still risk claim 1 coverage?
3. How does “does not stretch in the first direction” impact infringement when materials are engineered for anisotropy?
4. Does using a non-glass fracturable ampule eliminate protection under dependent claim 5 while leaving claim 1 intact?
5. If a product uses the same device but changes bonding from melt-bonding to adhesive lamination, which claims become easier to avoid?

Drugs Protected by US Patent 5,772,346

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate