United States Patent 10,765,640: What the Claims Cover and How to Map the Landscape
Scope summary. US Drug Patent 10,765,640 claims a non-aqueous lidocaine dissolving patch with a tightly bounded composition and mechanical performance envelope. The claims are built around (1) plaster formulation defined by lidocaine content, isostearic acid and dipropylene glycol concentration ranges, and (2) a specific support with a quantified stretch-strength limit and biaxially-oriented stretch cloth, plus (3) performance/adhesion/release constraints (adhesive power and 12-hour lidocaine release ratio). The sharpest claim fence is the support mechanical parameter and the acid + polyalcohol pair at specified levels.
1) What is claimed (independent claim 1)
Claim 1 is the core product claim. It defines a patch by structural, compositional, and material-performance parameters.
A. Patch type
- Non-aqueous patch containing:
- Lidocaine: 0.5 to 7 mass %
- Dissolving agent comprising:
- Organic acid: isostearic acid
- Polyalcohol: dipropylene glycol
- Lidocaine and dissolving agent are in a plaster.
- Plaster is held by a support.
B. Support mechanical performance limitation
- Support has stretch strength < 2,000 g/50 mm when stretched by 50% longitudinal extension.
- Support comprises biaxially-oriented stretch cloth.
This is the gating parameter most likely to separate design-arounds from literal infringement: both the biaxial stretch cloth requirement and the numerical stretch-strength threshold.
C. Dissolving agent quantitative boundaries inside plaster
- Isostearic acid: 0.9 to 2.5 mass %
- Dipropylene glycol: 0.2 to 1.5 mass %
D. Overall formulation boundaries within claim 1 context
Claim 1 does not list every ingredient, but it locks the patch to:
- Non-aqueous plaster,
- Lidocaine concentration (0.5 to 7 mass %),
- Acid and polyalcohol identity and concentration ranges,
- Support material defined by biaxial stretch cloth plus a quantified stretch-strength under 50% extension.
2) Dependent claims: performance and formulation narrowing
Claim 2 (adhesion window)
- Adhesive power: 0.4 N/width 25 mm to 5 N/width 25 mm
This is a quantitative performance limitation that can be used both for infringement and validity attack, depending on how tests were performed and whether prior art patches meet similar adhesion.
Claim 3 (release criterion)
- Release ratio of lidocaine: > 6% after 12 hours attachment to skin
This is a kinetic performance claim. It is test-dependent and often becomes the focus for disputes on conditions (skin type, temperature, load, sampling method).
Claim 4 (loading density)
- Lidocaine amount: 0.1 to 1 mg/cm² of plaster
This ties the mass-percent claim to an application-specific dosage density.
Claim 5 (closed formulation list)
Claim 5 narrows the plaster composition to a specific set of components:
- Plaster consists of
- lidocaine
- isostearic acid
- dipropylene glycol
- elastomer
- terpene resin
- butylated hydroxytoluene
- liquid paraffin
- light anhydrous silicic acid
Because Claim 5 uses “consists of,” it is closer to a closed list. Literal coverage likely depends on whether a product includes any additional components outside this list.
Claim 6 (elastomer sub-selection)
- Elastomer consists of a combination of:
- styrene isoprene
- polyisobutylene
This restricts the adhesive/elastomer system to that specific combination.
Claim 7 (mixing state)
- Lidocaine is dissolved in the dissolving agent
This is a processing/physical-state limitation. A product where lidocaine is dispersed or partially undissolved could avoid literal infringement even if overall component identity and amounts align.
Claim 8 (order of combining components)
- Lidocaine, polyalcohol, and organic acid are combined prior to addition of:
- elastomer
- terpene resin
- butylated hydroxytoluene
- liquid paraffin
- light anhydrous silicic acid
This is a process-order constraint. It can be a design-around if manufacturing sequence differs (or if the claim is interpreted narrowly to require that exact sequence).
3) Claim chart view: what must be present for infringement
Below is a “must-have” mapping that captures literal claim elements.
Independent coverage threshold (Claim 1)
A product falls within claim 1 if it meets all of:
- Non-aqueous lidocaine patch
- Plaster contains:
- lidocaine 0.5 to 7 mass %
- isostearic acid 0.9 to 2.5 mass %
- dipropylene glycol 0.2 to 1.5 mass %
- Support:
- biaxially-oriented stretch cloth
- stretch strength < 2,000 g/50 mm at 50% longitudinal extension
Additional dependent constraints
- Claim 2: adhesive power in 0.4 to 5 N/25 mm
- Claim 3: lidocaine release ratio > 6% after 12 hours on skin
- Claim 4: lidocaine loading 0.1 to 1 mg/cm²
- Claim 5: plaster is exactly the listed component set
- Claim 6: elastomer limited to styrene isoprene + polyisobutylene
- Claim 7: lidocaine dissolved in dissolving agent
- Claim 8: specific pre-combination sequence before elastomer/resin/etc.
4) Practical scope boundaries and likely claim construction pressure points
A. Mechanical support parameter is the key structural fence
The claim is not only “stretch cloth” but specifies a quantitative test:
- stretch strength < 2,000 g/50 mm at 50% extension
- plus biaxially-oriented stretch cloth
That suggests a product with:
- a different cloth orientation (unidirectional or non-biaxial) and/or
- a different fabric that fails the stretch-strength threshold
could avoid claim 1 without changing the drug formulation.
B. Dissolving agent specificity narrows chemical space
The claim requires:
- isostearic acid (not generic fatty acid)
- dipropylene glycol (not generic polyol)
- defined concentration windows inside plaster
This is a high-value “both identity and quantity” restriction.
C. “Non-aqueous” plus “plaster consists of” limits formulation latitude
If a competitor uses:
- an aqueous microdomain,
- water-bearing components,
- different fillers,
- alternative antioxidants,
- alternative silicic acids or silicas with different grades,
they risk stepping outside Claim 5’s “consists of.”
D. Performance limitations can be both evidentiary and vulnerability points
Adhesion (N/25 mm) and release ratio (>6% at 12 hours) are:
- test-condition sensitive,
- potentially variable across skin models and handling,
- and often litigated around measurement methodology.
They still expand scope for Claim 2 and Claim 3 but do not necessarily broaden beyond Claim 1’s core chemical/mechanical constraints.
E. Processing claims (Claims 7 and 8) increase manufacturing-specific coverage
If a competitor:
- does not dissolve lidocaine in the dissolving agent,
- or uses a different mixing order,
they can reduce literal infringement risk on Claims 7/8 while still possibly infringing Claim 1/5/6 depending on how courts interpret the role of processing limitations.
5) Design-around map (where competitors can move without touching the hard fences)
This section translates the claim boundaries into levers.
Levers that can avoid Claim 1 literal coverage
- Support route
- Use non-biaxial stretch cloth, or a cloth that does not meet the <2,000 g/50 mm threshold at 50% extension.
- Acid route
- Replace isostearic acid with a different organic acid.
- Or shift isostearic acid outside 0.9 to 2.5 mass %.
- Polyalcohol route
- Replace dipropylene glycol with another polyalcohol.
- Or shift dipropylene glycol outside 0.2 to 1.5 mass %.
- Lidocaine concentration route
- Shift lidocaine outside 0.5 to 7 mass % in plaster (or outside the implied 0.1 to 1 mg/cm² dosing range to avoid Claim 4).
Levers that can avoid dependent claims while retaining core coverage
- Claim 5 (“plaster consists of”): introduce or substitute any component outside the listed set (this is the most direct route, if substantiated and not read as interchangeable under claim interpretation).
- Claim 6 (elastomer composition): use an elastomer system not limited to styrene isoprene + polyisobutylene.
- Claim 7 (lidocaine state): ensure lidocaine is not dissolved in the dissolving agent (e.g., present as a dispersion or bound state), assuming proof and claim construction allow that distinction.
- Claim 8 (order): adopt a different mixing sequence that removes the “combined prior to addition” requirement.
6) Patent landscape approach: how this patent likely sits
Claim architecture suggests a product-patent strategy aimed at formulation engineering and support mechanics for drug release and adhesion.
Given only the claims text, the landscape can be mapped at the “technical feature” level:
Technology clusters likely relevant to the same competitive set
- Topical/transdermal lidocaine patches
- Typical focus in prior art: lidocaine loading, pressure-sensitive adhesive systems, and release control polymers/plasticizers.
- Dissolving agent systems using fatty acids and glycols
- The specific pairing of isostearic acid + dipropylene glycol is a narrow chemical combination that can be used to separate the patent from broader fatty-acid plasticizer prior art.
- Stretchable backing/support mechanics
- The “biaxially-oriented stretch cloth” plus quantified stretch strength at set extension suggests a design target around conformability and mechanical integrity under body motion.
- Adhesion and release performance envelopes
- Quantitative windows (adhesion in N/25 mm; release ratio >6% at 12 hours) suggest the patent expects competitors to be comparable on performance but different on composition/support.
Who is most likely to have overlapping claim risk
- Incumbent patch manufacturers using lidocaine plus non-aqueous adhesives,
- Firms specializing in stretch cloth backings and flexible supports,
- Companies that use fatty acids and glycol plasticizers in adhesive systems.
Where overlap is most defensible
- Products that also use isostearic acid and dipropylene glycol within the claimed plaster concentration ranges.
- Products that also use biaxially-oriented stretch cloth and have mechanical stretch strength within the specified threshold.
7) What this means for freedom-to-operate (FTO) planning
High-risk overlap (literal coverage likelihood)
- Any non-aqueous lidocaine patch with:
- isostearic acid (0.9 to 2.5 mass %) and dipropylene glycol (0.2 to 1.5 mass %) in plaster,
- biaxially oriented stretch cloth support,
- and stretch strength <2,000 g/50 mm at 50% extension,
- with lidocaine also within 0.5 to 7 mass %.
If those are met, Claim 1 is triggered; dependent claims then add numerical adhesion/release and formulation closure constraints.
Medium-risk overlap (dependent claim sensitivity)
If the product avoids at least one Claim 1 element but still matches others:
- It may still face dependent-claim arguments only if claim construction reads the omitted element as not required for that dependent claim (courts typically require all elements of the independent claim for dependent claims).
Low-risk overlap (clear design-around positions)
- Swapping support mechanics or removing the acid/polyalcohol pair is the clearest route, because it breaks Claim 1’s required combination rather than adjusting a marginal parameter.
Key Takeaways
- Claim 1 locks a non-aqueous lidocaine patch to a specific acid + polyalcohol pair (isostearic acid and dipropylene glycol) at defined plaster mass-% ranges and to a biaxially-oriented stretch cloth support with a quantified stretch-strength limit under 50% extension.
- Dependent claims then narrow further using adhesion power, 12-hour lidocaine release ratio, lidocaine loading (mg/cm²), and in some cases a closed “plaster consists of” ingredient list and elastomer sub-composition.
- The strongest design-around levers are (1) support fabric/strength compliance and (2) replacing or shifting the isostearic acid and dipropylene glycol combination outside the stated windows.
- Process limitations in Claims 7 and 8 add manufacturing-specific coverage, but they function as additional constraints rather than the core novelty anchor compared with Claim 1’s material and mechanical parameters.
FAQs
1) What is the single most important element in Claim 1 for infringement analysis?
The support requirement: biaxially-oriented stretch cloth plus stretch strength <2,000 g/50 mm at 50% longitudinal extension.
2) Can a competitor infringe if they use different acids but match the rest of the patch?
No literal infringement of Claim 1 if the acid is not isostearic acid at 0.9 to 2.5 mass % in the plaster, given Claim 1’s identity and range requirements.
3) What do Claims 2 and 3 add beyond Claim 1?
They add quantified performance limits: adhesive power (0.4 to 5 N/25 mm) and lidocaine release ratio (>6% after 12 hours on skin).
4) Does Claim 5 significantly narrow coverage?
Yes. It uses “plaster consists of” a listed set of components, including elastomer, terpene resin, butylated hydroxytoluene, liquid paraffin, and light anhydrous silicic acid alongside lidocaine, isostearic acid, and dipropylene glycol.
5) Are mixing order constraints legally meaningful here?
Yes. Claims 7 and 8 require lidocaine to be dissolved in the dissolving agent and require a specific combination sequence before adding elastomer/resin/other components.
References
[1] United States Patent No. 10,765,640 (claims as provided in prompt).
