Details for Patent: 8,025,635

Which drugs does patent 8,025,635 protect, and when does it expire?

Patent 8,025,635 protects SINUVA and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 8,025,635

Title:	Device and methods for treating paranasal sinus conditions
Abstract:	Described here are paranasal sinus devices for treating paranasal sinus conditions. The devices include a cavity member, ostial member, and nasal portion. One or more of the cavity member, ostial member, and nasal portion may deliver an active agent for sustained release to treat the paranasal sinus condition. Exemplary paranasal sinus conditions are sinus inflammation due to functional endoscopic sinus surgery (FESS) and rhinosinusitis.
Inventor(s):	Donald J. Eaton, Thomas R. Tice, David B. Downie, Patrick A. Arensdorf, Rodney Brenneman, Danielle L. Biggs
Assignee:	Intersect ENT Inc
Application Number:	US11/398,342
Patent Claim Types: see list of patent claims	Use; Device;

US Patent 8,025,635: Scope, Claims Deconstruction, and Patent Landscape

US Patent 8,025,635 covers a fully implantable, bioabsorbable paranasal sinus device delivered with an introducer into a sinus cavity. The device uses a first member with multiple prongs that are collapsed for delivery through a sinus ostium or surgically created fenestration and then expand into an implanted configuration to contact surrounding tissue, while an active agent is released from the bioabsorbable polymer structure. The claims span (1) system/device delivery and configuration change, and (2) method of fully implanting the pronged, bioabsorbable implant for treatment of paranasal sinus inflammation, including release-duration-dependent treatment windows.

Core claim architecture: “bioabsorbable polymer + prong architecture + collapsed-to-expanded deployment + drug release + sinus placement via introducer.”

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What exactly is claimed? (Claim set map and material limitations)

Independent claim 1: System for treating a paranasal sinus condition

Claim 1 is the broadest system claim and includes the following required structural and functional limitations:

1) System for treating a paranasal sinus condition
2) Introducer (delivery component) 3) Fully implantable paranasal sinus device comprising:

• First member
• Plurality of prongs, each prong with:
  • a proximal end extending from the distal end of the first member
  • a free distal end 4) Materials: the first member and prongs are made of a bioabsorbable polymer 5) Active agent configured to release therefrom 6) Bimodal configuration:
• First configuration: plurality of prongs collapsed to pass through a sinus ostium or surgically created fenestration
• Second expanded configuration: after placement into a sinus cavity

This claim defines the invention at the level of:

• a deployable prong scaffold (collapsed vs expanded),
• a bioabsorbable polymer carrier/drug reservoir,
• and an anatomy-specific delivery path (ostium/fenestration into sinus cavity).

Claim 2 and dependent delivery variants

Claim 2 narrows to an introducer architecture:

• Introducer has a conduit with lumen and distal portion
• The sinus device is either:
  • placed within the lumen, or
  • releasably secured to the distal portion of the introducer

Claims 3-5 build on this:

• Claim 3: system further comprises a sheath
• Claim 4: delivery by retracting the sheath to deploy first member and expand prongs
• Claim 5: introducer is preloaded with the sinus device

Claim 12 offers another mechanical delivery alternative:

• Claim 12: delivery by advancing a pusher through the conduit lumen

Claim 13 also broadens attachment logic:

• Claim 13: device is releasably secured to the introducer

Claim 14 adds an introducer characteristic:

• Claim 14: introducer is malleable

Claims for clinical indication and inflammatory target

Claim 6:

• Paranasal sinus condition is sinus inflammation due to FESS (functional endoscopic sinus surgery)

Claim 15:

• Paranasal sinus condition is sinus inflammation

These are separate dependent anchors that tie the technology to post-FESS inflammatory management.

Independent method claim 7: Fully implanting the prong device

Claim 7 recites the method analog of claim 1, with the key operational limitation:

• Fully implant a paranasal sinus device within the patient
• Device comprises:
  • first member + prongs with proximal ends from distal end of first member
  • bioabsorbable polymer first member and prongs
  • active agent release from the polymer
• Functional behavior: prongs expand to contact surrounding tissue in the paranasal sinus when fully implanted

Claim 7 is the method counterpart to the device’s collapsed-to-expanded deployment function (though it is framed as expansion upon full implantation).

Release-duration windows (claims 8-11)

Claims 8-11 specify different treatment-release durations:

• Claim 8: active agent releases to treat for about one week
• Claim 9: release duration about two weeks
• Claim 10: release duration about three weeks
• Claim 11: release duration about one month

These are important because they convert what might be “sustained release” into explicit dosing-time claim boundaries.

Drug formulation placement and anchoring

Claims 16 and 17 narrow how the active agent is carried and how prongs interface:

• Claim 16: active agent included in a coating on the device
• Claim 17: plurality of prongs comprises one or more anchoring elements

This links the scaffold to both drug-carrier positioning (coating) and tissue-engagement functionality beyond simple “contact.”

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What is the real commercial scope? (Practice coverage by sub-feature)

A) Deployment geometry: collapsed passage then expanded implantation

The device is defined by a two-state deployment:

• Collapsed to pass through:
  • sinus ostium, or
  • surgically created fenestration
• Expanded after placement into sinus cavity

Practically, this reads on any implant that:

• transforms from a delivery state constrained to the ostium/fenestration pathway
• to a deployed state contacting tissue inside the sinus cavity.

B) Scaffold material: bioabsorbable polymer

The first member and prongs must be bioabsorbable polymer. This limits the scope away from permanent-metal implants and toward resorbable polymer architectures (or polymer composites that qualify as bioabsorbable polymer for the prongs and member).

C) Drug-release requirement

The system requires an active agent configured to release therefrom. Combined with “bioabsorbable polymer,” this implies drug is either:

• loaded within polymer matrix,
• released from polymer bulk,
• and/or delivered via a polymer coating (explicitly claimed in claim 16).

D) Delivery train coverage

The system claims cover multiple delivery mechanics:

• device within lumen or secured at distal portion
• sheath retraction deployment
• pusher advancement deployment
• preloaded introducer
• malleable introducer

This is a broad set of “ways of getting it there,” suggesting the patent is intended to cover multiple delivery system embodiments.

E) Indication anchoring

Claim 6 and claim 15 tie treatment to sinus inflammation and specifically FESS-related inflammation in claim 6. The presence of both indicates the applicant expects commercial use in post-procedural inflammatory management.

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How broad are these claims? (Element-by-element infringement pressure points)

Key “must-have” elements

Any asserted system or method in the scope must satisfy all of the following:

• Fully implantable paranasal sinus device
• First member + plurality of prongs with specified proximal/distal relationships
• Bioabsorbable polymer used for both member and prongs
• Active agent releasing from the device
• Collapsed-to-expanded deployment, with collapsed state allowing passage through sinus ostium or fenestration
• Expanded state contacts surrounding tissue (method claim explicitly requires contact; system claim implies contact via expanded configuration in the sinus cavity)

Key “tighteners” in dependent claims

For system claims, dependent nodes add:

• sheath-based delivery (claim 4)
• preloading (claim 5)
• pusher delivery (claim 12)
• malleable introducer (claim 14)
• releasable securing to introducer (claims 2 and 13)

For method claims, dependent nodes add:

• explicit release durations (claims 8-11)
• coating-based active agent placement (claim 16)
• prong anchoring elements (claim 17)

Most vulnerable to design-around

• If a competitor uses a non-bioabsorbable scaffold (metal or non-resorbable polymer) for prongs/member, it breaks a core structural requirement.
• If deployment does not involve collapsed passage through ostium/fenestration (for example, a different access route or different transformation logic), it pressures claim 1’s delivery configuration element.
• If the scaffold is drug-free and drug is delivered separately, the “active agent configured to release therefrom” requirement becomes a key gap.
• If release duration is outside the claimed “about” windows, claims 8-11 may not map, but claim 7 still requires release without a specific duration.

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Claim-by-claim scope summary table

Claim	Claim type	Tight scope elements	What it covers in practice
1	System	Bioabsorbable prong device + active agent release + collapsed delivery through ostium/fenestration + expanded sinus cavity	Core deployable drug-eluting resorbable implant system
2	System (dep. 1)	Conduit lumen + device in lumen or releasably secured to distal portion	Basic introducer form factor
3	System (dep. 2)	Adds sheath	Delivery train with controlled deployment
4	System (dep. 3)	Sheath retraction deploys first member and expands prongs	Specific sheath deployment mechanism
5	System (dep. 2)	Preloaded introducer	Packaging/procedure workflow variant
6	System (dep. 1)	Indication: sinus inflammation due to FESS	Clinical use tied to post-FESS inflammation
7	Method	Full implantation of prong device; prongs expand to contact tissue	Procedure steps for implanting and achieving contact
8-11	Method (dep. 7)	Active agent release duration: about 1 week, 2 weeks, 3 weeks, or 1 month	Time-bounded sustained release profiles
12	System (dep. 2)	Pusher advances through lumen to deliver	Alternative mechanical deployment vs sheath retraction
13	System (dep. 1)	Device releasably secured to introducer	Attachment variant
14	System (dep. 1)	Introducer malleable	Manipulation/steering variant
15	System (dep. 1)	Indication: sinus inflammation	Indication anchor for broad deployment systems
16	Method (dep. 7)	Active agent in a coating	Drug placement formulation design
17	Method (dep. 16)	Prongs include anchoring elements	Tissue retention design layer

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Patent landscape: where US 8,025,635 sits vs likely competitor clusters

A precise “landscape” normally depends on citation lists, assignee, family members, and prosecution history. None of that is provided here, and this analysis therefore frames the landscape only in terms of claim-category competition that typically clusters around deployable, drug-eluting, resorbable nasal/sinus implants.

Cluster 1: Resorbable sinus spacers and stents

Potential overlap drivers:

• bioabsorbable polymer scaffolds placed in sinus cavities
• tissue-contacting expanded structures
• drug-eluting coatings or matrices

Key differentiator in US 8,025,635:

• “first member + plurality of prongs” with a collapsed-to-expanded configuration specifically to pass through sinus ostium/fenestration.

Design-around pressure:

• Use of a continuous sleeve-like spacer rather than discrete prongs may avoid “plurality of prongs” mapping.
• A different deployment path not constrained by ostium/fenestration may also avoid the configuration limitation.

Cluster 2: Delivery systems for endonasal deployable implants

Potential overlap drivers:

• introducer systems with lumen + distal portion
• sheath-based deployment vs pusher-based deployment
• preloaded delivery workflow
• malleable introducers for navigation

Key differentiator in US 8,025,635:

• delivery system is linked directly to the prong device’s collapsed passage through sinus ostium or fenestration and its expanded contact upon deployment.

Design-around pressure:

• If a competitor uses a different delivery transformation (for example, rotational deployment or balloon expansion) and avoids prong-based expansion, it reduces mapping to claim 1’s device architecture.

Cluster 3: Drug-eluting anti-inflammatory sinus devices

Potential overlap drivers:

• sustained release of anti-inflammatory or anti-fibrotic agents
• coatings for elution
• multi-week duration targeting

Key differentiator in US 8,025,635:

• drug release is required and is structurally tied to a bioabsorbable polymer prong scaffold
• claim 8-11 define release duration windows: ~1 week, ~2 weeks, ~3 weeks, ~1 month.

Design-around pressure:

• Use of different time-release profiles may avoid dependent claims 8-11 while still potentially infringing claim 7 if release occurs at all and the device matches structurally.

Cluster 4: Post-FESS inflammation management

Potential overlap drivers:

• sinus inflammation therapy after functional endoscopic sinus surgery
• local anti-inflammatory implantation

Key differentiator in US 8,025,635:

• explicit indication language in claims 6 and 15.

Design-around pressure:

• If a competitor targets other sinus indications, it may evade claims that require “FESS” (claim 6) but could still face claim 1/7/15 if those claims are asserted.

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Landscape implications for freedom-to-operate (FTO) strategy

Given the claim set, FTO should treat infringement risk as a matrix across three axes:

1) Architecture: prong-based, first-member-and-prongs geometry
2) Deployment state change: collapsed-to-expanded passage through ostium/fenestration
3) Local therapy: bioabsorbable polymer with active-agent release, with possible coating and anchoring variants
4) Delivery hardware: sheath and/or pusher delivery within conduit lumen and preloaded/malleable introducer variations

For business decisions, US 8,025,635 is most likely to block competitors whose sinus implants are:

• prong-structured resorbable scaffolds,
• collapsible for ostium/fenestration passage,
• and drug-eluting for multi-week anti-inflammatory treatment.

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Key Takeaways

• US 8,025,635 claims a deployable, bioabsorbable, drug-releasing prong implant for paranasal sinus placement, with collapsed passage through sinus ostium or fenestration and expanded tissue contact in the sinus cavity.
• The patent covers both system delivery (introducer with conduit and optionally sheath/pusher, plus preloading and malleability variants) and a method of full implantation.
• Dependent claims add indication anchoring (sinus inflammation, including FESS-related inflammation) and release-duration windows (about 1, 2, 3 weeks, or 1 month) and formulation/interaction features (coating and prong anchoring elements).
• In the patent landscape, the most direct competitive threat comes from other resorbable, drug-eluting sinus implants that use an endonasal deployable scaffolding mechanism aligned with collapsed-to-expanded prongs.

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FAQs

1) What is the single most important novelty element in US 8,025,635?

The device’s prong-based architecture combined with a collapsed-to-expanded deployment that enables passage through a sinus ostium or surgically created fenestration, followed by expanded contact in the sinus cavity, while releasing an active agent from a bioabsorbable polymer.

2) Does claim 7 require sheath-based delivery?

No. Claim 7 is a method claim focused on fully implanting a device that expands to contact surrounding tissue and releases an active agent from bioabsorbable prongs. Sheath mechanics belong to system claims (e.g., claim 4), not claim 7.

3) How do claims 8 to 11 narrow the technology?

They tie the method to specific active-agent release duration windows: about 1 week, 2 weeks, 3 weeks, or 1 month. These are dependent on claim 7’s full-implantation framework.

4) Can a competitor avoid infringement by changing the introducer hardware?

Changing the introducer alone can avoid specific dependent system claims (sheath retraction, pusher advancement, preloading, malleability). But claim 1 still requires an introducer and delivery that enables the prong device’s collapsed passage and expanded placement.

5) Is the indication limited to FESS-related inflammation?

No. Claim 6 narrows to sinus inflammation due to FESS, but claim 15 covers sinus inflammation more generally. Independent claim 1 covers a “paranasal sinus condition” and depends on the device/system features rather than a strict FESS limitation.

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References

[1] United States Patent 8,025,635 (claims provided in prompt).

Drugs Protected by US Patent 8,025,635

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			Y			TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT

International Family Members for US Patent 8,025,635

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006231506
Canada	2603081
China	101189016
European Patent Office	1871383
European Patent Office	2298317
European Patent Office	2298318