United States Patent 10,406,332 (Expandable Biodegradable Sinus/Nasal Implant): Claim Scope, Material/Structural Limitations, and US Patent Landscape

Executive summary

US 10,406,332 protects an expandable, biodegradable implant for placement in a sinus or nasal cavity built around a biodegradable copolymer hub having apertures with a hollow interior, plus multiple filaments made from the same biodegradable copolymer but at a different composition ratio than the hub.
The claim core is the hub–filament architectural coupling through two aperture segments separated by the hub hollow interior, creating two “legs” from each filament.
Dependent claims narrow to filament geometry (straight-curved-straight), extruded polymer filaments, injection-molded hubs, leg length differentials, filament cross-sectional shapes, and a drug-releasing coating with mometasone furoate.
The landscape risk for competitors is split: (1) design-around by changing aperture geometry and/or eliminating the hub hollow interior or dual-segment aperture, and (2) chemistry design-around by using a materially different polymer system or eliminating the “different composition ratio” requirement.

What exactly does US 10,406,332 claim protect for sinus and nasal expandable implants?

Core independent claim 1 protects the full combination: structure + materials + placement + configuration.

1) Placement and intended environment

Claim 1 limits the implant to being:

“sized and shaped for placement within the sinus or the nasal cavity.” This is a functional placement/geometry limitation. For enforcement and claim construction, the question becomes whether an accused device is configured for sinonasal placement (anatomical sizing, catheter delivery system, clinically intended use, and dimensional set).

2) Implant architecture: hub with aperture segments separated by a hollow interior

Key structural limitations of claim 1:

A hub formed from a biodegradable copolymer at a first composition ratio.
The hub has a plurality of apertures that extend through the hub.
Each aperture includes:
- a first aperture segment
- a second aperture segment
- separated by a hollow interior of the hub.

This means the aperture is not simply a through-hole. It is segmented in the hub wall, with a hollow cavity region inside the hub located between the aperture segments.

3) Filaments: same copolymer family but different composition ratio

Claim 1 requires:

A plurality of filaments.
Each filament is formed from the biodegradable copolymer at a second composition ratio different from the first composition ratio.
Each filament is positioned so a portion extends through:
- the first aperture segment
- the second aperture segment
- the hollow interior
The geometry of that threading defines:
- a first leg on the first side of the hub
- a second leg on the second side of the hub

This creates a strong infringement anchor: the “different composition ratio” requirement is explicit, and the threading through both aperture segments and the hollow interior is structural.

4) Expandability and legs

Claim 1 calls the device “expandable implant.” However, the independent claim does not expressly recite the mechanism of expansion (for example, pre-deployed compressed shape, spring-like geometry, or actuation). Instead, expandability is tied to:

the multi-filament “leg” structure formed through the hub.
the device being configured for sinonasal placement.

Claim 1 scope expressed as a claim chart (elements and what can be changed)

Claim 1 element	What it requires	High-value design-around vectors
Expandable implant for sinus/nasal cavity	Configured for sinonasal placement	Choose an implant dimension or geometry that is not “sized and shaped” for sinonasal use (but this is fact-specific)
Hub formed from biodegradable copolymer (first composition ratio)	Hub chemistry must be biodegradable copolymer at ratio A	Use non-copolymer biodegradable polymers, or a different copolymer system, or a hub composition that is not “first ratio” in the claimed relationship
Hub has apertures with first and second segments separated by hub hollow interior	Aperture is segmented with internal hollow region	Eliminate segmented apertures, remove hollow interior, or make a continuous through-aperture without an internal hollow region
Filaments formed from same biodegradable copolymer but second composition ratio	Filament chemistry must be same copolymer at different ratio B	Use different polymer chemistry (not the same copolymer) or same ratio A as hub
Filament positioned to extend through aperture segments and hollow interior to define two legs	Threading through hollow interior defines legs	Reconfigure filament routing so it does not pass through the hollow interior region or does not create first/second legs as claimed
Each filament is positioned in a corresponding aperture	One filament per aperture	Hybrid consolidation designs that do not match “corresponding aperture” mapping may avoid literal scope

What additional limitations do claims 2–6 add to the protected implant?

Claim 2: filament geometry (straight-straight with a curved segment between)

Claim 2 requires each filament has:

a first straight segment
a second straight segment
a curved segment positioned between them.

Claim 3: curved segment placement in the aperture

Claim 3 states:

the curved segment is positioned in the corresponding aperture to position the straight segments on opposite sides of the hub, defining the legs.

This is a precise threading/orientation limitation. Competitors can reduce risk by altering how the filament is routed so that the curved segment is not located in the aperture region in the same manner.

Claim 4: extruded polymer filaments

Claim 4 limits filaments to:

“an extruded polymer filament.” This narrows to manufacturing method or product-by-process elements that can be scrutinized via process documentation and filament morphology.

Claim 5: injection molded hub

Claim 5 limits:

hub is “an injection molded hub.” If an accused device uses additive manufacturing, solvent casting, compression molding, or machining, that may be a potential non-infringement basis for claim 5 (though claim 1 remains broader).

Claim 6: filaments formed from one or more biodegradable materials

Claim 6 broadens a little: it allows the filaments to be formed from one or more biodegradable materials (not necessarily exclusively the copolymer, depending on claim construction with respect to claim 1’s “biodegradable copolymer” limitation). If interpreted harmoniously, claim 6 likely still requires the filament to be the biodegradable copolymer of claim 1, with optional additional biodegradable components.

What formulations and drug delivery features are protected, especially mometasone furoate?

Claim 7: drug-releasing coating

Claim 7 adds:

the implant further comprises a drug-releasing coating.

This captures any coating strategy on the implant exterior or on the hub/legs, as long as it is “drug-releasing.”

Claim 13: mometasone furoate in the coating

Claim 13 specifies:

the coating comprises mometasone furoate.

This is likely the most commercially targeted dependent claim. If a competitor uses a different steroid (for example, fluticasone, budesonide, beclomethasone), claim 13 is avoided, but claim 7 still remains if any drug-releasing coating exists.

Claim 1 vs formulation coverage

Claim 1 protects the device architecture regardless of drug.
Dependent claims 7 and 13 tie protection to a coating and an explicit active ingredient, affecting both licensing value and litigation leverage.

What dimensional and cross-sectional features further narrow claim scope (claims 8–12)?

Claim 8: unequal leg lengths

Claim 8 requires:

filaments form legs having:
- a first length and a second length,
- with lengths different.

This is a meaningful device geometry constraint. If all legs are equal length, claim 8 is avoided.

Claim 9: specific lengths (about 20 mm and about 25 mm)

Claim 9 narrows to:

first length about 20 mm
second length about 25 mm

That is a tight numerical limitation. It typically has less broad enforcement value but strong commercial relevance if the product is built to those dimensions.

Claims 10–12: cross-sectional shapes

Claim 10:

at least one filament has rectangular cross-section.

Claim 11:

at least one filament has oval cross-section.

Claim 12:

at least one filament has circular cross-section.

These are alternative dependent options. They likely cover many embodiments and may be used to capture a competitor’s geometry even if other dependent claims are missed.

How do the claim limitations combine to define the effective “infringement sweet spot”?

The practical infringement sweet spot for US 10,406,332 is a device that satisfies simultaneously:

sinonasal placement and “expandable” configuration,
a biodegradable copolymer hub,
segmented apertures with a hub hollow interior separating aperture segments,
filaments of the same biodegradable copolymer at a different composition ratio than the hub,
filament threading that passes through both aperture segments and the hollow interior, defining legs,
and, for higher commercial value enforcement, a drug-releasing coating with mometasone furoate.

The highest-risk axis is the hub hollow interior + segmented aperture threading plus the composition ratio differentiation.

What is the likely US patent landscape around this architecture (device + biodegradable copolymer + segmented hub apertures + mometasone coating)?

This landscape breaks into four clusters: (A) segmented aperture / hollow hub architectures, (B) biodegradable copolymer ratio-controlled material properties, (C) extruded/injection-molded manufacturing approaches, and (D) drug-eluting sinonasal implants with corticosteroids including mometasone furoate.

A. Competing “expandable implant” architectures in sinonasal space

Common product families in sinonasal care (sinuplasty-related spacers, steroid implants for polyps, postoperative spacers) tend to use:

self-expanding or deployable frameworks,
biodegradable scaffolds,
drug-loaded coatings.

The structural differences that matter versus US 10,406,332:

continuous through-holes vs segmented apertures separated by internal hub hollow
leg formation by different mechanical linkers (wire, mesh, monolithic scaffold)
expansion geometry not based on a hub-aperture-filament “threaded legs” concept

B. Biodegradable copolymer “composition ratio” differentiation

A distinctive feature of claim 1 is that the hub and filaments are:

the same biodegradable copolymer, but
at different composition ratios.

In the competitive landscape, many implants use:

one polymer formulation for scaffold and filaments,
or different polymer families for scaffold vs drug carrier,
or a single biodegradable polymer plus additives for one region.

That means a competitor that uses:

the same polymer composition for hub and filament,
or a different polymer system for one element, may avoid claim 1’s “different composition ratio” limitation, even if the architecture otherwise matches.

C. Extruded filament and injection molded hub manufacturing

Claims 4 and 5 target manufacturing approaches:

extruded filaments
injection molded hubs

Competitors using alternative manufacturing methods can avoid those dependent claims but still face claim 1 if product structure matches.

D. Mometasone furoate coated sinonasal implants

Claim 13’s explicit active drug elevates business relevance:

any FDA-facing product with mometasone-containing coatings is likely to trigger claim 13 analysis.
if a competitor’s coating uses a different corticosteroid, claim 13 drops out but claim 7 may still matter.

What likely design-arounds reduce infringement risk across claims 1 and 13?

Design-around for claim 1 (structural and chemistry)

Replace the hub aperture design so there is no first and second aperture segments separated by a hub hollow interior.
Avoid a filament routing that passes through both aperture segments and the internal hollow region that defines legs.
Eliminate the “same biodegradable copolymer at different composition ratios” relationship by:
- using a different polymer system for hub vs filaments, or
- matching composition ratios, or
- using a non-copolymer biodegradable system.

Design-around for claim 13 (mometasone furoate)

Use a drug-releasing coating with a different active ingredient rather than mometasone furoate to avoid dependent claim 13, while leaving claim 7 still in play if the device has any drug-releasing coating.

Key takeaways on scope and where competitors are most exposed

The independent claim 1 is structured to capture a specific hybrid of:
- segmented apertures in a biodegradable hub with an internal hollow interior, and
- filament “threading” that defines legs on both sides of the hub.
The “different composition ratio” requirement is a high-friction limitation that can materially reduce literal risk for competitors unless they match polymer formulation strategy.
The most commercially actionable claim hook is mometasone furoate in a drug-releasing coating (claim 13), layered onto the same device scaffold limitations.

Key Takeaways

US 10,406,332 claim 1 focuses on a sinonasal expandable biodegradable implant with a biodegradable copolymer hub featuring apertures split into first/second segments by a hub hollow interior, plus filaments of the same copolymer at a different composition ratio routed through the segments and hollow to form two legs.
Claims 2–3 lock down a straight-curved-straight filament geometry with the curved segment positioned in the aperture.
Claims 4–5 add manufacturing constraints: extruded filaments and an injection molded hub.
Claims 7 and 13 add formulation scope: drug-releasing coating, with mometasone furoate in the coating being a major dependent claim.
The infringement risk concentrates on devices that replicate the segmented/hollow hub aperture + leg-forming filament threading and the hub/filament copolymer ratio difference.

FAQs

What changes avoid claim 1 most reliably: different polymers or different hub aperture geometry?
Does using mometasone furoate automatically trigger the strongest dependent claim, or is the coating architecture also required?
If a competitor uses equal leg lengths, which dependent claims are avoided while claim 1 may remain?
How do extruded filament and injection molded hub limitations affect infringement if the structure matches but manufacturing differs?
What design features most directly neutralize the “aperture segment + hollow interior” requirement?

References

US Patent 10,406,332. “Expandable implant for placement in a sinus or nasal cavity.” Claims provided in user 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
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y				⤷ 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	2014236729	⤷ Start Trial
Australia	2019201045	⤷ Start Trial
Canada	2903848	⤷ Start Trial
China	105188831	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,406,332

Which drugs does patent 10,406,332 protect, and when does it expire?

Summary for Patent: 10,406,332