Details for Patent: 7,717,889

Summary for Patent: 7,717,889

Title:	Disinfectant delivery system and method of providing alcohol free disinfection
Abstract:	A disinfectant delivery system and method of providing alcohol-free disinfection to a body to be disinfected, as well as a method of infection reduction by preparation of a patient before an invasive procedure. A blended cloth comprising first fibers and second fibers is provided with the first fibers generally being greater in quantity by weight than the second fibers. A disinfectant solution impregnates the blended cloth, with the disinfectant solution having chlorhexidine gluconate as an active ingredient and having no alcohol. In the method according to the invention, at least one impregnated blended cloth is used to disinfect at least a portion of a body. A plurality of blended cloths can be provided for disinfecting discrete portions of the body. When an invasive procedure is to be performed on a patient, a further method according to the invention of infection reduction comprises using a CHG-impregnated cloth to disinfect at least a portion of the patient at least one day prior to the invasive procedure proximate the location of the invasive procedure.
Inventor(s):	Thomas Keaty, Jr., Barbara T. Skiba, Paul H. Hanifi
Assignee:	Sage Products LLC
Application Number:	US11/426,611
Patent Claim Types: see list of patent claims	Use; Formulation;

Scope and claims of US Patent 7,717,889 and the US patent landscape for CHG-alcohol-free pre-procedure patient skin disinfection wipes

US 7,717,889 claims a narrowly defined infection-reduction workflow that combines (i) an alcohol-free cloth impregnated with chlorhexidine gluconate (CHG), (ii) a pre-procedure patient preparation window “at least one day prior to, and up to several days prior to” (and in related dependent language “up to several days prior”), (iii) an “all of the CHG” release requirement (or “substantially” in a dependent claim), and (iv) specific cloth architecture options (blended fibers and polyester-only mat) plus optional packaging and “further time” immediately pre-procedure. The core novelty is not just CHG antisepsis, but the combination of an alcohol-free CHG wipe, a defined pre-invasive timing, and an explicit CHG release completeness/degree requirement that ties product construction to the method outcome.

What is the claim scope of US 7,717,889 for infection reduction with alcohol-free CHG wipes?

Core independent claim themes: pre-procedure patient skin disinfection using an alcohol-free CHG impregnated blended cloth, with full CHG release into use, applied proximate the invasive site days before the procedure.

Independent claim 1 (representative operative elements)

Claim 1 recites a method comprising:

• Providing a blended cloth with a fibrous mat impregnated with:
  • CHG as the disinfecting active, and
  • no alcohol
• Using the impregnated cloth to disinfect at least a portion of the patient
  • proximate the location of the invasive procedure
  • up to several days prior to the invasive procedure
• Releasing all of the CHG from the fibrous mat during disinfection (step b)

Interpretation pressure points for enforcement

1. “Blended cloth”: constrains the product input to a cloth with at least two fiber constituents (reinforced by dependent claims that specify first/second fibers).
2. “No alcohol”: bars alcohol-containing CHG antiseptic wipe formulations from literal infringement of the method as drafted (unless alcohol is present but not counted as “alcohol” by claim construction, which is fact-specific).
3. “Releasing all of the CHG”: creates a construction and proof issue. The claim is tied to the method using the wipe such that the CHG is released from the fibrous mat during use. That links the method claim to wipe chemistry, loading, and release kinetics.
4. Timing (“up to several days prior”): limits the method window to days before the procedure rather than same-day or immediate pre-procedure only.
5. “Proximate” invasive location: narrows application to the surgical field area rather than whole-body disinfection.

Independent claim 6 (narrower product construction, slightly different timing wording)

Claim 6 recites a substantially similar method but specifies:

• The fibrous mat is composed of polyester fibers
• Disinfection occurs “at least one day prior to, and up to several days prior to” the invasive procedure
• Step b includes releasing substantially CHG in dependent claim 9 (but the independent claim 6 itself includes the broader CHG method elements)

Practical effect: claim 6 tightens the product composition (polyester-only) while also sharpening the minimum timing (“at least one day prior”).

How do the dependent claims expand scope for cloth architecture, packaging, and dosing steps?

Dependent claims define alternative constructions and execution details that broaden or further cabin infringement risk depending on the accused product and procedure.

Dependent claims on fiber blending and absorbency (claims 2 and 7)

• Claim 2: step a comprises blended cloth with:
  • first fibers and second fibers
  • weight of first fibers generally greater than second fibers
  • absorbency by weight greater than the weight of the blended cloth
• Claim 7: same structure as claim 2, tied to the claim 6 formulation context (polyester mat independent base), in which the blended cloth has those absorbency and fiber-ratio constraints.

Scope implications

• These claims can narrow infringement for cloths that do not meet the stated absorbency-by-weight condition.
• Fiber-ratio constraints offer a route for design-arounds if a competitor’s wipe uses different fiber proportions or different material loading that fails the “generally greater” and absorbency criteria.

Dependent claims on packaged plural cloths and discrete site treatment (claims 3 and 8)

• Claim 3: a package of multiple blended cloths; using each cloth to disinfect a discrete portion of the patient.
• Claim 8: same structure but in the claim 6 polyester-based family.

Scope implications

• If a wipe is sold as a single unit or used as part of a protocol that does not treat “discrete portions” with separate cloths from a package, literal coverage may narrow.
• But clinics that cut protocol into separate cloth applications can still fall inside.

Dependent claims on additional immediate pre-procedure disinfection (claims 4 and 10)

• Claim 4: further step using the disinfecting solution immediately prior to the invasive procedure.
• Claim 10: same.

Scope implications

• These claims cover protocols that include both pre-window disinfection and an immediate pre-op wipe or re-application.
• If a competitor performs only pre-window disinfection and no immediate pre-procedure application, dependent claims 4 and 10 will not read, but independent claims may still be asserted.

Dependent claim on “consists of polyester fibers” (claim 5)

• Claim 5: fibrous mat consists of polyester fibers.

Scope implications

• “Consists of” is stricter than “comprises.” It narrows to polyester-only mats, excluding mixed fiber mats if any non-polyester fibers are present.

Dependent claim on releasing “substantially” the CHG (claim 9)

• Claim 9: releasing substantially of the CHG from the fibrous mat.

Scope implications

• Claim 1 demands “all of the CHG.” Claim 9 uses “substantially,” potentially covering wipes that do not achieve complete release.

What does “all of the CHG released” mean for infringement risk, and how could competitors design around it?

The claim text makes CHG release a functional requirement:

• A patentee can argue that a wipe protocol that saturates, wipes, and allows evaporation inherently releases the CHG from the fibrous mat during step b.
• A defendant can argue that some residual CHG remains bound in the mat or is not released during the asserted method steps.

Design-around levers (conceptual) consistent with the claim language

• Higher residual binding: altering polymer/fiber surface chemistry or CHG affinity so that the wipe does not release all CHG during standard use.
• Different release mechanism: using CHG in a form not readily released by the wiping action, such as more covalently bound actives or barrier layers.
• Change the “no alcohol” requirement: adding any alcohol ingredient to the formulation can move a product outside literal infringement of the “having no alcohol” requirement.

The presence of claim 9 (“substantially”) is important: even if a product avoids “all,” it may still fall in a “substantially” construction if it’s used in the polyester mat family context.

What patents protect CHG-alcohol-free pre-procedure skin disinfection wipes in the US?

Without the prosecution file wrapper and without the cited/related-family data for US 7,717,889, the only accurate landscape statement is the structural one implied by the claim language: this is a method-of-use and/or method-of-treatment claim family targeting procedural timing and cloth composition/release mechanics.

The landscape to watch in parallel typically clusters into three buckets, because infringement of US 7,717,889 depends on meeting its exact elements:

1. CHG antiseptic wipe composition patents (claims to wipes, cloths, and formulations: CHG + no alcohol, carrier polymers, surfactants, preservatives, drying profile).
2. Pre-procedure skin disinfection method patents (claims to timing “days before” an invasive procedure, site targeting, and dual-phase protocols with immediate pre-op re-application).
3. Wipe performance and release patents (claims to CHG release profiles, absorbency, and carrier design).

Any competitor product that uses CHG wipes with an alcohol-free formulation and a days-before protocol may face overlapping method and composition estates. Conversely, if the competitor uses alcohol-containing CHG or shifts to same-day prep, the specific “no alcohol” and timing limitations reduce the relevance of this particular claim family.

When does US 7,717,889 lose exclusivity, and how do expiration dates affect generic/wipe-entry timing?

This analysis cannot be completed from the information provided because:

• US patent expiration depends on filing date, provisional/continuation chain, patent term adjustments, and any PTA/terminal disclaimer, none of which are included in the prompt.

Because the claim is method-based and tied to product construction (“no alcohol,” fiber architecture, CHG release), the practical exclusivity end determines when generic wipe makers can enter with similar products and when method claims become vulnerable to noninfringement rather than expiration. Those determinations require patent term computation from bibliographic data not supplied.

What is the Orange Book status of US 7,717,889?

US 7,717,889 is described as a patent for a method of infection reduction using a CHG impregnated cloth. Such patents can be:

• listed in FDA’s Orange Book if tied to an FDA-approved drug product with an NDC, or
• unlisted patents if not associated with a product application listing, or
• tied to medical devices and not Orange Book.

Orange Book listing status cannot be determined from the prompt alone, so no definitive status is provided.

What generic entry risks exist for CHG alcohol-free pre-op wipes under US 7,717,889?

Even if composition patents expire earlier, method claims can keep risk alive:

• If a generic wipe maker launches an alcohol-free CHG wipe that meets the claim’s cloth and release characteristics, they can still face method infringement exposure if clinicians follow a “days prior” protocol “proximate the invasive location” using the patented method steps.
• If clinicians follow protocols that are not within “up to several days prior” or include only immediate pre-op disinfection, the method claim risk changes.

Because claim 1 includes “all of the CHG” release, a product with partial release during standard wiping can reduce literal risk, though doctrine-of-equivalents analysis depends on claim construction and prosecution history.

How strong is the patent estate for US 7,717,889 based on claim drafting?

Strength is driven by how precisely the claims map to a real product and workflow:

• Strength factors

  • Clear limitations: alcohol-free, CHG-active, pre-procedure timing, site proximity, and CHG release completeness/degree.
  • Product-to-method linkage: “releasing all/substantially of the CHG” during use creates a factual infringement hook.
  • Additional narrowing features in dependents: fiber blend ratio/absorbency; polyester-only mat; packaged multiple cloths; immediate pre-op step.

• Vulnerability factors

  • Several claim elements are operational and product-material dependent. A defendant can attempt to avoid one limiting feature while maintaining similar clinical performance.
  • Overbreadth is not present; the claims are structured to be narrow. Narrow claims are easier to design around but harder to invalidate if the accused product fits.

What litigation typically targets claims like US 7,717,889, and where might enforcement focus?

Method claims in this space typically generate disputes around:

• whether the wipe is “having no alcohol”
• whether the wiping protocol qualifies as “up to several days prior” and is applied “proximate” to the invasive site
• whether CHG is released in the degree required (“all” vs “substantially”)
• whether the cloth mat is polyester-only or a blended fiber with sufficient absorbency by weight

Enforcement focus tends to follow commercial uptake: hospitals adopting a standardized pre-op CHG wipe protocol, and distributors selling alcohol-free CHG wipe SKUs aligned with such protocols.

Key claim-element coverage matrix for product/protocol mapping

Claim element	Claim 1	Claim 6	Claims 2/7 (fiber blend + absorbency)	Claim 3/8 (plural cloths + discrete portions)	Claim 4/10 (immediate pre-op re-use)	Claims 5 (polyester-only) / 9 (“substantially” release)
Active ingredient	CHG	CHG	CHG unchanged	CHG unchanged	CHG unchanged	CHG unchanged
Alcohol content	“having no alcohol”	“having no alcohol”	same	same	same	same
Cloth	blended cloth, fibrous mat	polyester fiber mat	defines first/second fibers + weight ratio + absorbency-by-weight	defines packaged multiple cloths	same	5 restricts to polyester-only; 9 adjusts release standard
Timing window	up to several days prior	at least 1 day prior to up to several days prior	same	same	adds immediate pre-op	same
Application location	proximate invasive location	proximate invasive location	same	discrete portion via each cloth	adds immediate pre-op	same
CHG release standard	releases all of CHG	releases CHG (release degree handled in dependents)	same	same	same	5 polyester-only; 9 “substantially” release

How does US 7,717,889 compare to adjacent CHG wipe patent strategies?

US 7,717,889 is best viewed as a method claim with product limitations embedded. Adjacent strategies in CHG wipe patenting commonly fall into:

• composition claims that cover alcohol-free CHG formulations and carrier systems (hard to avoid if you need alcohol-free CHG)
• method-of-treatment claims that cover “days prior” pre-op protocols (hard to avoid if hospitals use that timing)
• device-like claims focusing on wipe configuration, absorbency, and retention/release

Compared with pure formulation patents, US 7,717,889 ties enforcement to both product formulation constraints and a specific clinical timing workflow. Compared with pure method patents, it increases infringement certainty where the accused wipe matches the “no alcohol,” fiber architecture, and CHG release elements.

Key Takeaways

• US 7,717,889 claims a CHG antisepsis workflow that requires an alcohol-free CHG impregnated cloth used days before an invasive procedure, applied proximate the invasive site, with a functional requirement that CHG is released to the degree claimed (“all” in claim 1; “substantially” in claim 9).
• Dependent claims further constrain cloth construction (fiber blending with weight ratio and absorbency-by-weight; polyester-only mats), distribution format (multi-cloth package and discrete portion treatment), and protocol design (option for immediate pre-procedure re-use).
• The main enforceability lever is matching the product’s “no alcohol” and wipe release characteristics to the method timing and site-targeted disinfection steps.
• The main design-around lever is avoiding one or more limiting claim elements, especially alcohol-free status, timing window, fiber mat composition, or CHG release completeness.

FAQs

1. What elements of US 7,717,889 create the highest infringement burden for an accused CHG wipe?
The “having no alcohol,” the pre-procedure “up to several days prior” (or “at least one day prior to”) timing, “proximate” invasive site application, and the CHG release requirement (“all of the CHG” or “substantially”) are the highest-burden elements because they require both product proof and protocol adherence.

2. Can an alcohol-containing CHG wipe practice the US 7,717,889 method?
Not as written, because the claims require “having no alcohol,” which is a literal limitation of the cloth/disinfecting solution used in the method steps.

3. Do hospitals that apply CHG wipe disinfection only immediately before surgery risk infringement?
US 7,717,889 requires disinfection “up to several days prior” (and in the polyester-based independent claim “at least one day prior”). Immediate-only protocols fall outside the claimed pre-procedure window for the core method elements.

4. Does the patent cover single-use wipes, or only multi-cloth packages?
The core independent claims do not require multiple cloths in a package. The multi-cloth package and “discrete portion” treatment is limited to dependent claims (claims 3 and 8).

5. How does “polyester fibers” affect coverage?
Claim 5 requires a mat “consists of polyester fibers,” and claim 6 uses a polyester-fiber mat construction in the independent claim. Mixed-fiber mats with non-polyester content can fall outside those specific claim paths.

---

References

1. US Patent 7,717,889. (Claims reproduced from the prompt).

Drugs Protected by US Patent 7,717,889

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

International Family Members for US Patent 7,717,889

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2467150
Canada	2467155