Details for Patent: 7,427,574

Which drugs does patent 7,427,574 protect, and when does it expire?

Patent 7,427,574 protects CHLORHEXIDINE GLUCONATE and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 7,427,574

Title:	Non-woven wash cloth
Abstract:	A non-woven washcloth formed from a blend of two different size polyester fibers, the majority of which have a length about half of that of the minority. The washcloth has good absorbing and holding properties for a solution containing chlorhexidine gluconate, while also releasing said chlorhexidine gluconate when wiped on skin.
Inventor(s):	Jennifer Allen
Assignee:	Sage Products LLC
Application Number:	US11/208,079
Patent Claim Types: see list of patent claims	Formulation;

United States Patent 7,427,574: Scope and Patent Landscape for Chlorhexidine Gluconate Non-Woven Wipes (Polyester Fiber Blend, Carding/Crosslapping, Needle-Punching)

Executive summary: US Patent 7,427,574 claims a non-woven fabric wipe used with a chlorhexidine gluconate (CHG) solution, defined by a two-component polyester fiber blend (distinct fiber lengths and deniers), a manufacturing process (carding, crosslapping, mechanical entanglement), and wipe performance characteristics (absorbing/holding and releasing CHG, or alternatively not binding CHG). Independent claim 1 is broad on the core “wipe system” concept (fabric + CHG solution + absorb/release behavior) while still locking onto specific fiber geometry and composition ranges. Dependent claims narrow to particular fiber dimensions, basis weight, thickness, and needle-punching.

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What does US Patent 7,427,574 claim for chlorhexidine gluconate wipes?

Direct answer: It claims a non-woven polyester fabric “in combination with” a solution containing chlorhexidine gluconate. The fabric is defined by:

1. Blend composition: 60–80 wt% first polyester fiber + 20–40 wt% second polyester fiber
2. First fiber specs: 1.0–3.0 in length; 1.2–2.0 denier
3. Second fiber specs: 3.0–4.0 in length; 4.0–5.0 denier
4. Fabric formation: carding, crosslapping, mechanical entanglement to create inter-engaged fibers
5. CHG interaction:
   • Claim 1: fabric absorbs/holds CHG and releases it when wiped on skin
   • Claim 11: fabric is not chemically or mechanically binding with CHG

Claim 1 structure: “system” claim with functional wipe behavior

Claim 1 is written as a combination of (i) a specific non-woven fabric and (ii) a CHG solution, with functional language tying the fabric to wipe transfer:

• Absorbing and holding CHG
• Releasing CHG when wiped on skin

This creates two enforceable elements for infringement:

• Product configuration (fiber blend + process + resulting inter-engaged structure)
• Functional performance (absorb/hold and release during wiping)

Claim 11 structure: alternative CHG interaction boundary

Claim 11 is parallel in structure to claim 1 but adds a limiting negative characteristic:

• fabric does not chemically or mechanically bind CHG

This can be important in litigation because it narrows the fabric’s CHG affinity/performance mechanism. A defendant fabric that “holds CHG” via physical entrapment but arguably “does not bind” may still map to claim 11, depending on how “bind” is construed.

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How broad is US 7,427,574’s independent claim 1 across fiber blend parameters?

Direct answer: Claim 1 is broad in the sense that it accepts ranges, but it is narrow because those ranges are tied to a two-fiber dual-denier/dual-length architecture.

Core claim “range locking”

Claim 1 requires these interdependent ranges:

• First fiber: 60–80 wt%, 1.0–3.0 in, 1.2–2.0 denier
• Second fiber: 20–40 wt%, 3.0–4.0 in, 4.0–5.0 denier
• Process: carding, crosslapping, mechanical entanglement
• Resulting structure: inter-engaged fibers
• Performance: absorb/hold and release CHG when wiped on skin

Why range-based claims still limit design-arounds

Even with ranges, a competitor can fall outside infringement if any of these are materially different:

• Use only one polyester denier/length class (no dual architecture)
• Use different polyester fiber denier windows (e.g., first fiber >2.0 denier or second fiber <4.0 denier)
• Use second fiber length outside 3.0–4.0 in
• Use a different manufacturing method (e.g., thermal bonding instead of mechanical entanglement)

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What manufacturing limitations (carding, crosslapping, mechanical entanglement) define infringement risk?

Direct answer: The claim ties infringement to a specific non-woven manufacturing route: carding + crosslapping + mechanical entanglement with inter-engaged fibers.

Key elements

• Carding: opening/aligning fibers into a web
• Crosslapping: building layered web architecture
• Mechanical entanglement: producing inter-fiber locking (claim 8 specifies needle punching)
• Result: inter-engaged fibers

Design-around leverage

Competitors can reduce risk by shifting:

• From mechanical entanglement to chemical bonding (binders) or thermal bonding
• From needle punching to another mechanical entanglement method (if claim 8 matters)
• To a web structure lacking “inter-engaged” fiber architecture as construed

The exact legal impact depends on whether “mechanical entanglement” is read broadly to include different entangling methods, or narrowly to needle punching-type processes when claim 8 is asserted.

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What do dependent claims 2–10 and 12–20 narrow (fiber specs, basis weight, thickness, needle punching)?

Dependent claims tied to specific fiber dimensional points

• Claim 2: first fiber length ~1.5 in
• Claim 3: first fiber denier ~1.2
• Claim 4: second fiber length ~3.0 in
• Claim 5: second fiber denier ~4.75
• Claim 12–15 mirror these for claim 11 (same fiber-point constraints)

Basis weight limitations

• Claim 6: basis weight 3.8–5.8 oz/yd²
• Claim 7: basis weight ~4.8 oz/yd²
• Claim 16–17 mirror these for claim 11

Thickness limitations

• Claim 9: thickness 0.055–0.125 in
• Claim 10: thickness ~0.090 in
• Claim 19–20 mirror these for claim 11

Needle punching

• Claim 8: mechanical entanglement is needle punching
• Claim 18: same for claim 11

Practical reading: If a competitor matches the independent claim ranges but deviates from basis weight or thickness, it can still land in claim 1/11 territory. If it deviates from the dual fiber architecture, it can fall outside the independent claims entirely.

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How does claim 1’s “release when wiped” language compare to claim 11’s “not binding” limitation?

Direct answer: Claim 1 focuses on functional transfer (release during wiping). Claim 11 focuses on binding behavior (no chemical or mechanical binding with CHG). Both can be asserted as alternative theories depending on how the product is characterized.

Infringement mapping scenarios

• A wipe that absorbs CHG and releases during wiping tends to fit claim 1 even if the mechanism is physical entrapment.
• A wipe whose fiber matrix is engineered so that CHG is primarily held as unbound liquid (less entrapment, no functional binding) can be positioned to fit claim 11.

Litigation significance

The two provisions give a patentee two potential routes:

• functional performance evidence (release on skin)
• materials characterization evidence (lack of binding chemistry/mechanics)

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What is the practical scope: is US 7,427,574 limited to pre-moistened wipes?

Direct answer: The claim is written as a fabric in combination with a solution containing CHG. It does not explicitly require “pre-moistened packaging,” but infringement proof typically aligns with wipe formats where a CHG-containing solution contacts the non-woven fabric.

Scope anchors:

• A fabric that performs when used with a CHG solution
• Performance judged by wiping on skin (for claim 1)

Non-scoped surfaces: The claim is oriented toward “wiped on skin,” which is typical of antiseptic wipe uses. It does not read like a “substrate for any CHG delivery” claim, based on the functional limitation tied to skin use.

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What patent landscape items matter around this claim family (materials + antiseptic delivery)?

Direct answer: US 7,427,574 is a materials-architecture claim for a CHG antiseptic delivery wipe. The enforceability and value depend on how many neighboring patents exist for:

• non-woven polyester fiber architecture for aqueous antiseptic delivery
• manufacturing routes for entangled non-wovens used as wipe substrates
• CHG-specific transfer/release requirements or reduced binding performance

Closest competitive clusters likely to collide

Even without naming specific patent numbers from the provided record, the patent landscape for this subject tends to cluster into:

1. Non-woven wipe substrates: fiber blend, denier/length distribution, basis weight, thickness, and entangling method
2. CHG delivery performance: release, retention, drying, transfer efficiency
3. Formulation interactions: how the substrate binds or holds antiseptics
4. Pre-moistened wipe systems: combination claims of substrate + antiseptic solution

Risk for entrants: If a rival uses a different antiseptic but the claim is limited to CHG, CHG-specific scope matters. Conversely, if a rival uses CHG but a distinct non-woven architecture (fiber geometry and bonding method), that may be the more important design-around route.

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What generic entry risks exist for chlorhexidine gluconate wipe products relative to US 7,427,574?

Direct answer: This is not a typical “small-molecule composition” patent. It is a device-like materials claim tied to a substrate architecture and performance with CHG solution. For “generic” wipe products, the risk comes from substrate equivalence rather than active ingredient patent cliffs.

Where risk concentrates

• Pre-moistened or re-moistenable wipes delivering CHG
• Non-woven substrates constructed via carding + crosslapping + mechanical entanglement
• Dual polyester blend matching the defined length/denier windows and wt% ranges
• Product specifications matching basis weight and thickness (if those dependent claims are asserted)

How low-risk designs typically avoid the claims

• Using different fiber denier/length combinations outside the stated ranges
• Changing from mechanical entanglement to a different web bonding route
• Changing web thickness/basis weight enough to miss dependent limitations (though independent claims still matter)
• Avoiding the “absorb/hold and release” characteristics for claim 1 or “no binding” for claim 11 through engineered substrate interactions

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How strong is US 7,427,574’s enforceability likely to be based on claim drafting structure?

Direct answer: Strength is driven by claim specificity and the number of concurrent limitations. The upside is that the claim maps clearly to a manufacturing-and-structure recipe. The downside is that enforcement requires proving all key elements, including the fiber architecture and the CHG interaction/performance behavior.

Strength factors

• Specific, measurable fiber parameters (length in inches, denier ranges)
• Defined process steps (carding, crosslapping, mechanical entanglement)
• Quantified physical properties (basis weight, thickness) in dependents
• Functional limits relating to CHG release/binding

Enforcement burden

To prevail, a claimant likely needs:

• compositional evidence (fiber wt% and types)
• production evidence (web formation steps and method)
• physical measurements (basis weight/thickness if asserted)
• performance evidence (release on wiping and/or lack of binding)

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Key Takeaways

• US 7,427,574 is a chlorhexidine gluconate wipe substrate patent defined by a two-polyester-fiber architecture (specific wt%, length, denier ranges) plus a mechanical entanglement non-woven manufacturing route.
• Independent claim 1 requires a fabric that absorbs/holds CHG and releases it on wiping; independent claim 11 requires a fabric that does not bind CHG chemically or mechanically.
• Dependent claims narrow to specific fiber point values, basis weight (3.8–5.8 oz/yd²), thickness (0.055–0.125 in), and needle punching.
• For “generic” CHG wipes, the main infringement exposure is substrate architecture and manufacturing method, not the CHG active ingredient itself.

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FAQs

1) Does US 7,427,574 require the fabric to be needle-punched?

No. Needle punching is in dependent claim 8 (and claim 18). Independent claims 1 and 11 require mechanical entanglement generally.

2) Can a CHG wipe infringe if it has the same polyester fibers but different basis weight?

It depends on which claims are asserted. Independent claim 1 does not require the specific basis weight range in claim 6, but dependent claim 6 (and 16) would not be met.

3) What aspect most easily enables design-around: fiber length, fiber denier, or bonding method?

The bonding method and the dual-fiber geometry are typically the highest-leverage because independent claims require mechanical entanglement and specific length/denier windows for two different polyester fiber classes.

4) Is claim 11 a narrower “no binding” version of claim 1?

Yes. Claim 11 keeps the same core substrate recipe but changes the CHG interaction from “absorbs/holds and releases” toward no chemical or mechanical binding.

5) Is the patent limited to pre-moistened commercial products?

The claims require “fabric in combination with a solution containing chlorhexidine gluconate” and, for claim 1, release during wiping on skin. This aligns strongly with wipe products, without expressly requiring a specific packaging format.

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References

1. United States Patent 7,427,574 (claims provided in prompt).

Drugs Protected by US Patent 7,427,574

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005		OTC	Yes	Yes	7,427,574		Y

International Family Members for US Patent 7,427,574

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2551688