US Patent 12,161,767: Scope, Claim Coverage, and US Patent Landscape for Segmented Transdermal Patches with Sodium Bicarbonate and Donepezil

US Patent 12,161,767 claims a transdermal patch architecture built around a segmented intermediate layer with an active agent (optionally donepezil or donepezil HCl) in an adhesive active agent layer containing sodium bicarbonate, and a microporous membrane positioned to support controlled transport. Independent claim 1 is broad on patch structure and layering, while dependent claims narrow to specific materials (backing, occlusive laminate, adhesive chemistries, liner coatings), dimensional constraints, and patch positioning for extended wear (up to about 10 days, per method claim 15).

The claim set targets a design space that is mechanically modular (segmented intermediate layer) and chemically controlled (sodium bicarbonate in the adhesive active agent layer), with additional coverage for common patch components (elastic backing, acrylic adhesives, silicone/fluorinated liners) and for donepezil-specific implementations.

What is US Patent 12,161,767 claim 1 coverage for a segmented transdermal patch with sodium bicarbonate?

Claim 1 is the core infringement hook because it is written as a structural combination. For a US transdermal patch to fall within claim 1, it must contain each recited element in the claimed arrangement:

Claim 1 elements (patch structure)

Transdermal patch comprising:
- (a) Outermost backing layer
- (b) Interfacing adhesive layer (between backing layer and intermediate layer)
- (c) Segmented intermediate layer consisting of:
  - (i) Occlusive backing layer
  - (ii) Adhesive active agent layer comprising:
    - an active agent
    - sodium bicarbonate
  - (iii) Microporous membrane
  - (iv) Contact adhesive layer
- (d) Removable release liner in contact with the contact adhesive layer
Segmentation requirement
- The segmented intermediate layer comprises a plurality of segments that are at least partially separated.

How the architecture constrains designs

The claimed patch is not just “a donepezil patch” or “a microporous membrane patch.” It requires the particular layered stack inside the “segmented intermediate layer,” with:
- sodium bicarbonate in the adhesive active agent layer
- a microporous membrane located between the adhesive active agent layer and the contact adhesive layer
- a removable liner immediately associated with the contact adhesive
- a segmented intermediate layer, where segments are at least partially separated.

This segmentation limitation matters for design-arounds: a continuous, non-segmented intermediate layer can be a strong noninfringement posture for claim 1, even if all other materials are used.

Where claim 1 may read broadly

Claim 1 does not require:

specific adhesive polymer chemistry (those are deferred to dependent claims),
a specific backing polymer class (dependent claims do that),
a specific microporous membrane polymer (dependent claim 8 tightens to polypropylene),
any specific patch size limits (dependent claim 9),
any liner coating chemistry (dependent claim 11 tightens),
any specific dosing duration parameter (method claim 15 gives a functional range).

That means claim 1 can cover multiple donepezil transdermal product implementations as long as the stack and segmentation are met.

Does US 12,161,767 protect donepezil transdermal patches, or only sodium-bicarbonate microporous segmented stacks?

Direct active-agent limitation appears only in dependent claims

Claim 16: active agent is donepezil or a salt.
Claim 17: active agent is donepezil hydrochloride.

Because these are dependent claims, the scope of those claims is narrow to donepezil formulations with the claim 1 structural system.

Practical read-through

If an accused patch uses:

sodium bicarbonate + microporous membrane + segmented intermediate layer stack (claim 1 structure), then:
the composition is covered under claim 1 regardless of whether the active agent is donepezil, as long as claim 1’s “active agent” element is satisfied.
donepezil-specific embodiments (donepezil base or donepezil HCl) get additional dedicated narrowing coverage under claims 16–17.

So the protection is best characterized as platform-structure with optional donepezil targeting.

What materials are required by dependent claims on backing, adhesives, occlusive layers, microporous membrane, and release liner?

Dependent claims 2–14 define a material-specific ladder that can be used for:

licensing scope mapping (what formulations are clearly covered),
litigation claim charts (which components must match),
freedom-to-operate design-around (what to change).

Outermost backing layer (claims 2–4)

Claim 2: outermost backing layer can be elastic polymer film, polymer fabric, multi-directional elastic woven/nonwoven, stretchable film/woven/nonwoven.
Claim 3: outermost backing layer comprised of an elastic material.
Claim 4: outermost backing layer includes one or more polymers selected from:
- polyesters, polyethylenes, polypropylenes,
- polyvinylchloride,
- polyethylene vinyl acetate copolymers,
- polyurethanes.

Design-around note: Claim 1 does not require these specific polymer sets. An accused patch can avoid dependent-claim coverage while still potentially infringing claim 1 if the base structural recitations are met.

Interfacing adhesive layer (claim 5)

Claim 5 lists polymers including:
- acrylates and acrylate copolymers
- polyisobutylene
- silicone
- polystyrene butyl rubber
- polyethylene vinyl acetate and copolymers
- plasticized polymers

Again, claim 1 does not require this list. Dependent claim 5 provides narrower coverage.

Occlusive backing layer (claims 6–7)

Claim 6: occlusive backing layer is a laminate comprising a polyester layer.
Claim 7: occlusive backing layer material includes polymers selected from:
- polyesters, polyethylenes, polypropylenes, polystyrenes, polyvinylchloride
- PET/ethylene vinyl acetate laminate.

Microporous membrane (claim 8)

Claim 8: microporous membrane is a polypropylene microporous membrane.

This is a notable tightening. If an accused patch uses a non-polypropylene microporous membrane, it can argue it does not satisfy claim 8, though it might still meet claim 1 if claim 1’s microporous membrane element is satisfied.

Contact adhesive / adhesive active agent layer chemistry (claim 14)

Claim 14: adhesive active agent layer, contact adhesive layer, or both are acrylic adhesives.

This provides additional “component-specific” coverage, but not required by claim 1.

Release liner coatings (claim 11)

Claim 11: release liner is selected from silicone coated, fluorocarbon coated, or fluorosilicone coated materials.

Claim 1 only requires a removable release liner in contact with the contact adhesive layer.

What does claim 9 and claim 10 add about segment and patch geometry, and why does it matter?

Segment size constraint (claim 9)

Claim 9: each segment of the composite layer has a size of about 2–40 cm².

This is a direct quantitative limitation. If the accused patch’s segmentation yields segments outside this range, dependent claim 9 may not be met. Claim 1 still requires “plurality of segments at least partially separated,” but not the 2–40 cm² size.

Lateral extension of backing and liner (claim 10)

Claim 10: outermost backing layer and release liner extend about 0.5–1.0 cm beyond the perimeter of the composite layer.

This is a geometric configuration detail. It can be a litigation fulcrum for dependent-claim coverage and a design-around lever.

Which lamination configurations are covered (claims 12–13)?

Claim 12: outermost backing layer and interfacing adhesive layers are laminated.
Claim 13: occlusive backing layer and adhesive active agent layer are laminated.

These specify manufacturing and stack assembly relationships. An accused patch that uses different bonding/assembly could avoid dependent claims 12–13 while remaining exposed to claim 1 if the final layered structure is present and functionally equivalent under claim interpretation.

What method claim 15 covers for transdermal administration duration and steps?

Claim 15 recites a two-step method

Removing the release liner from the transdermal patch of claim 1.
Adhering the patch to skin for up to about 10 days to deliver the active agent.

This claim adds a timing/usage window but is still anchored to claim 1’s patch. Method claims often matter for:

authorized labeling and instructions,
inducement arguments,
distribution of devices intended for the claimed regimen.

The “up to about 10 days” language is functional and likely covers common extended-wear intervals.

How strong is the patent estate for claim 1 segmentation and sodium-bicarbonate microporous architecture?

Core “must-have” novelty anchors

Even without file history, the claim’s combination suggests two main differentiators:

segmented intermediate layer with segments at least partially separated
sodium bicarbonate in the adhesive active agent layer alongside a microporous membrane and contact adhesive / liner arrangement

In litigation terms, these elements create:

narrower claim interpretation pressure on segmentation,
clear claim-chart mapping for sodium bicarbonate inclusion and layer placement.

Most likely infringement dispute points

Segmentation
- Whether the accused patch has “plurality of segments” and whether they are “at least partially separated.”
Sodium bicarbonate placement
- Whether sodium bicarbonate is in the adhesive active agent layer (not elsewhere).
Microporous membrane presence
- Whether there is a “microporous membrane” in the claimed stack, as opposed to a non-porous barrier or different transport structure.
Layer interface order
- Whether the occlusive backing, adhesive active agent layer, microporous membrane, and contact adhesive layer correspond to the required configuration.

Dependent-claim breadth vs. practical coverage

Dependent claims narrow to material specifics, meaning:

overall claim 1 exposure is the highest,
dependent claims strengthen positional leverage when an accused product uses the listed materials and geometries.

What does a practical claim coverage matrix look like for US 12,161,767?

Feature	Claim 1 (base)	Dependent claims adding certainty
Segmented intermediate layer; segments at least partially separated	Required	Claim 9 adds segment size (2–40 cm²)
Occlusive backing layer	Required	Claims 6–7 restrict to polyester laminate / specific polymer list
Adhesive active agent layer containing active agent + sodium bicarbonate	Required	Claims 16–17 narrow active agent to donepezil / donepezil HCl; Claim 14 adds acrylic adhesive option
Microporous membrane	Required	Claim 8 restricts to polypropylene microporous membrane
Contact adhesive layer	Required	Claim 14 may cover if acrylic
Removable release liner in contact with contact adhesive	Required	Claim 11 restricts liner coatings
Outermost backing elastic + specific polymer list	Not required by claim 1	Claims 2–4 cover elasticity and specific polymers
Adhesive interfacing polymer list	Not required by claim 1	Claim 5 lists allowed polymers/chemistries
Lamination configuration	Not required by claim 1	Claims 12–13 require specific laminated layer pairings
Patch geometry extension	Not required by claim 1	Claim 10 requires 0.5–1.0 cm extension
Wear duration in method	Not required by claim 1	Claim 15: up to about 10 days
Step of removing liner then adhering	Method-only	Claim 15

US regulatory and Orange Book status: what can be inferred from the claim text provided?

The claim text identifies a donepezil active agent, implying a potential nexus to US FDA approval pathways for transdermal donepezil products. However, no Orange Book listing, NDA/BLA number, listing dates, patent type (US patent “listed” vs “unlisted”), or exclusivity identifiers were provided, so a precise Orange Book mapping cannot be produced from the information supplied here.

What generic entry risks exist for design-arounds to US 12,161,767?

Most effective design-around vectors (structural)

Because claim 1 is structural and includes segmentation and sodium bicarbonate, the principal noninfringement strategies are:

Eliminate or change segmentation
- Use a continuous intermediate layer (no “plurality of segments at least partially separated”).
Remove sodium bicarbonate from the adhesive active agent layer
- Use a different buffer system or place sodium bicarbonate elsewhere (though “elsewhere” risks will depend on claim construction).
Replace microporous membrane
- Substitute a non-microporous transport layer or different membrane type that cannot be credibly characterized as “microporous membrane.”
Reconfigure layer stack ordering
- Ensure the occlusive backing layer / adhesive active agent layer / microporous membrane / contact adhesive layer do not map to the claim’s configuration.

Dependent-claim avoidances are usually secondary

Switching backing polymer families, using different liner coatings, or using non-acrylic adhesives can reduce exposure to dependent claims, but claim 1 can still capture those changes if the segmentation + sodium bicarbonate + microporous membrane architecture is preserved.

Key Takeaways

US 12,161,767 claim 1 protects a transdermal patch with a segmented intermediate layer (segments at least partially separated) and a microporous membrane, where the adhesive active agent layer contains sodium bicarbonate.
Donepezil coverage is explicit in dependent claims 16–17 (donepezil or donepezil HCl), meaning the patent is a platform-structure claim with optional active-agent narrowing.
Dependent claims add material and geometry constraints (elastic backing polymers, polyester occlusive laminate, polypropylene microporous membrane, silicone/fluorinated liner coatings, segment size 2–40 cm², 0.5–1.0 cm extension).
The strongest litigation leverage and infringement mapping will focus on: segmentation, sodium bicarbonate inclusion and location, and microporous membrane presence and placement.

FAQs

How does “at least partially separated” segmentation limit US 12,161,767 coverage?
It requires discrete segment separation in the intermediate layer, not a fully continuous composite; the more continuous the structure, the weaker the fit to the claim language.
If sodium bicarbonate is used as a formulation buffer but not in the adhesive active agent layer, does it avoid infringement?
Claim 1 requires sodium bicarbonate in the adhesive active agent layer. Shifting location or chemistry can undermine that specific element.
Would using a non-polypropylene microporous membrane avoid claim 8 but still infringe claim 1?
Likely yes. Claim 8 is specific to polypropylene; claim 1 only requires a microporous membrane.
Can a patch meet claim 15 method protection if it is worn for fewer than 10 days?
Claim 15 covers adhesion for “up to about 10 days,” which includes shorter durations within that range.
Are donepezil transdermal products automatically covered by claim 16–17?
No. Donepezil must be delivered via a patch that satisfies claim 1’s full segmented sodium bicarbonate microporous architecture; claim 16–17 add only the active-agent limitation.

References

United States Patent 12,161,767 (claims provided in prompt).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		DISCN	Yes	No	12,161,767	⤷ Start Trial	Y	Y		A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	⤷ Start Trial
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		DISCN	Yes	No	12,161,767	⤷ Start Trial	Y	Y		A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016381351	⤷ Start Trial
Australia	2022235539	⤷ Start Trial
Canada	3010183	⤷ Start Trial
China	108697655	⤷ Start Trial
European Patent Office	3397250	⤷ Start Trial
Israel	260290	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,161,767

Which drugs does patent 12,161,767 protect, and when does it expire?

Summary for Patent: 12,161,767