United States Patent 7,713,255: Scope, Claims, Expiration, and Sinus Implant Patent Landscape

U.S. Patent No. 7,713,255 covers methods for delivering a biodegradable, drug-eluting implant into a paranasal sinus through a conduit under visualization. The patent is directed to procedure-and-device combinations rather than to a particular drug substance alone. Its strongest claim concept combines four elements: a biodegradable implant containing a therapeutic agent, a conduit used to access the sinus, delivery through a distal opening, and visualization during at least part of the procedure.

The patent issued on May 11, 2010. Its commercial significance was greatest for biodegradable sinus implants containing corticosteroids, including mometasone furoate, budesonide, fluticasone propionate, and triamcinolone acetonide. The patent term was tied to an early-2000s nonprovisional filing and would have reached its ordinary 20-year term around 2024, subject to patent-term adjustment. It is therefore unlikely to present a current blocking patent risk unless the USPTO record shows an unusually long term adjustment, a terminal disclaimer issue, or another enforceability event.

What does U.S. Patent 7,713,255 protect?

The patent protects a method of placing a biodegradable therapeutic implant in a paranasal sinus cavity. Independent claim 1 requires:

Loading one or more biodegradable implants into a conduit.
Creating access to a paranasal sinus with the loaded conduit.
Delivering the implant through an opening in the distal portion of the conduit.
Using visualization while creating access.
Using an implant containing a therapeutic amount of an active agent for treating sinusitis.

The claim is not limited to a named drug, a particular sinus, or a single implant geometry. Dependent claims narrow the scope through specific delivery routes, conduit structures, implant materials, active agents, and release periods. (U.S. Patent No. 7,713,255, claims 1-41.)

The patent does not claim every biodegradable implant or every sinus drug-delivery procedure. A potentially infringing method must satisfy the limitations of at least one claim. A product alone is not necessarily within the claims because the claims are drafted as methods of use.

What are the three independent claims?

Claims 1, 39, 40, and 41 are independent in substance, although the supplied claim set identifies claims 39-41 as separate method claims.

Claim	Core limitation	Distinguishing point
1	Sinus access is created with visualization; implant is delivered through a conduit	Visualization is tied to the access step
39	Implant is delivered while using visualization	Visualization is tied to delivery
40	Implant contains an active agent for reducing inflammation	Functional treatment is inflammation reduction
41	Implant is delivered while using visualization and reduces inflammation	Combines procedural and therapeutic limitations

Claims 39 and 40 provide alternative drafting positions. Claim 39 broadly covers treatment of sinusitis, while claim 40 focuses on reduction of inflammation. Claim 41 combines both concepts and repeats the visualization requirement.

How broad is the claim scope?

The broadest practical claim is claim 1. It does not require:

Mometasone furoate;
A specific implant shape;
A particular polymer;
A fixed sinus cavity;
A specific delivery angle;
A pusher;
Pressurized gas;
Computer image guidance;
A particular release duration; or
A specific commercial delivery system.

The claim does require a biodegradable implant containing a therapeutic amount of an active agent. A conduit used to access the sinus and deliver the implant is also mandatory. A procedure performed without a conduit, without delivery through a distal opening, or without the required visualization limitation may fall outside claim 1.

The claims cover multiple forms of implant, including rods, pellets, beads, strips, microparticles, gels, and semisolids. Claims 21-26 and 38 extend the material scope to biodegradable matrices, biodegradable polymer matrices, mucoadhesive polymers, PLGA, lactic acid, glycolic acid, and hyaluronic acid.

What implant characteristics are protected?

The patent claims a wide range of physical and chemical configurations:

Feature	Relevant claims
Biodegradable polymeric implant	7
Predetermined fracture lines	13
Biodegradable matrix	21
Biodegradable polymer matrix	22
Mucoadhesive polymer	23
PLGA copolymer	24
Lactic acid	25
Glycolic acid	26
Rod, pellet, bead, strip, or microparticle	32
Gel	33
Semisolid	34
Hyaluronic acid	38
Active-agent loading of 5% to 90% by weight	31

The 5%-90% loading range is broad. It may capture both relatively dilute polymer matrices and highly drug-loaded implants, subject to the ordinary rules of claim construction and written-description support.

What release periods are covered?

Claims 27-30 cover release periods from approximately one week to three months, with narrower alternatives covering two to four weeks and at least one or two weeks.

Claim	Release limitation
27	About one week to about three months
28	About two weeks to about four weeks
29	At least about one week
30	At least about two weeks

These claims are relevant to drug-eluting sinus implants designed to maintain local corticosteroid exposure after sinus surgery or in a chronically inflamed sinus cavity.

Which delivery routes and conduit structures are protected?

Claims 2 and 3 cover two principal access routes:

Delivery through a sinus ostium.
Delivery through a sinus wall.

The sinus-ostium limitation is particularly relevant to endoscopic placement into an existing anatomical opening. The sinus-wall limitation is broader in procedural concept because it includes access created through the wall of the sinus cavity.

The conduit claims cover both procedural access and delivery geometry:

Conduit or delivery feature	Relevant claims
Pusher	5
Pressurized gas	6
Sharp-tipped conduit	8
Angulated distal portion	9-10
Angulation from about 0° to about 135°	10
Distal opening at the tip	11
Distal opening in the side wall	12
Endoscopy	19
Computer image guidance	20

The combination of a sharp tip, angulated distal section, and side-wall opening is directed to controlled placement in anatomically difficult sinus locations. A product using a flexible catheter, preloaded implant, and pusher could potentially satisfy these elements, but the outcome would depend on the actual method steps and claim construction.

Does the patent cover Propel or Sinuva sinus implants?

The patent is technically relevant to products such as PROPEL and SINUVA because both are biodegradable corticosteroid-eluting sinus implants delivered through specialized systems. Technical relevance does not establish infringement.

PROPEL

PROPEL is a bioabsorbable sinus implant containing mometasone furoate and is associated with Intersect ENT, later acquired by Medtronic. FDA materials describe PROPEL as a drug-device combination product intended to maintain sinus patency and deliver mometasone furoate locally after sinus surgery. (FDA, 2011.)

A PROPEL procedure may implicate the general subject matter of the patent because it involves:

A biodegradable implant;
A corticosteroid;
Sinus placement;
A delivery system; and
Endoscopic surgical use.

The claim analysis would turn on whether the commercial procedure satisfies each limitation, including the specific definition of a conduit, the manner in which access is created, and whether visualization is used during the claimed step.

SINUVA

SINUVA is a bioabsorbable mometasone furoate sinus implant approved for adults with recurrent nasal polyps who previously had ethmoid sinus surgery. Its labeled release period is approximately 90 days. The product is placed in the ethmoid sinus through an implant delivery system. (FDA, 2017.)

SINUVA is especially close to claims 14-18 and 27 because:

Mometasone furoate is expressly claimed in claim 15.
The implant is biodegradable.
The product delivers an anti-inflammatory corticosteroid.
The release period is approximately three months.
Delivery occurs into a paranasal sinus cavity.

The patent’s claims, however, are methods claims. Patent coverage cannot be determined from the product label alone. The relevant question is whether a specific physician-performed procedure, including access, visualization, conduit loading, and implant delivery, practices every limitation of an asserted claim.

What is the Orange Book status of U.S. Patent 7,713,255?

U.S. Patent 7,713,255 is not, by its claim format, a conventional drug-substance patent. It claims methods for delivering an implant. The patent is therefore distinct from patents claiming:

Mometasone furoate as a chemical entity;
A nasal corticosteroid formulation;
A specific approved drug product;
A drug-device combination product as a whole; or
A manufacturing process.

The FDA Orange Book primarily identifies patents submitted for approved drug products under the applicable NDA framework. A delivery-method patent may appear in an Orange Book listing if properly submitted and accepted for a specific approved product, but the patent number alone does not establish an Orange Book listing. (FDA, 2024a; 21 C.F.R. § 314.53.)

For commercial diligence, the patent should be checked separately against:

The FDA Orange Book patent listing for the relevant NDA.
FDA approval letters and product labeling.
USPTO Patent Center.
The patent owner’s assignment history.
Any terminal disclaimer or patent-term-adjustment record.

A patent covering sinus implant delivery is more likely to operate as a procedural or device-related patent than as a traditional Orange Book drug patent.

When did U.S. Patent 7,713,255 lose exclusivity?

The patent’s ordinary term was approximately 20 years from the earliest effective nonprovisional filing date. The patent issued in 2010, but issuance date does not control expiration. A patent granted from an early-2000s application generally expired around 2024, subject to patent-term adjustment under 35 U.S.C. § 154.

Patent-term-extension rules under 35 U.S.C. § 156 are generally associated with regulatory review of drug products and do not automatically apply to a broad procedural patent. No regulatory extension should be assumed without a specific USPTO and FDA record.

Event	Date or timing
U.S. patent grant	May 11, 2010
Ordinary term basis	20 years from applicable nonprovisional filing date
Expected ordinary expiration window	Approximately 2024
Possible adjustment	USPTO patent-term adjustment
Current diligence issue	Confirm the USPTO term-adjustment calculation and status

If the patent has expired, a current commercial launch would not ordinarily face prospective infringement liability for post-expiration practice. Accrued damages for pre-expiration conduct remain a separate legal issue and depend on notice, claim validity, infringement, and applicable limitation periods.

How strong is the patent estate for sinus implant delivery?

The patent has strong conceptual breadth but limited present-day blocking value if its term has ended. Its technical strength rests on the combination of a broad implant definition and a broad conduit-delivery framework.

Strengths

Claims cover both sinusitis treatment and inflammation reduction.
Mometasone furoate is expressly identified.
The claims cover ostial and sinus-wall delivery.
The implant may be a rod, pellet, bead, strip, microparticle, gel, or semisolid.
PLGA and other biodegradable materials are specifically claimed.
Release periods extend from one week to three months.
Endoscopic and computer-assisted visualization are included.
The claims cover both tip and side-wall conduit openings.

Weaknesses and validity pressure points

The claims combine many procedural and product limitations, creating multiple noninfringement positions.
Terms such as "therapeutic amount," "about," "creating access," and "visualization technique" may require construction.
Broad implant and polymer disclosures can create written-description and enablement issues depending on the prosecution record.
Earlier sinus surgery, drug-delivery, catheter, and biodegradable-polymer references may be relevant to anticipation or obviousness.
Claims 39-41 repeat much of the core method and may face similar prior-art challenges.
Commercial products may avoid literal infringement through implant geometry, access technique, delivery timing, or a different interpretation of "conduit."

The patent’s legal strength must be separated from its commercial relevance. A broad expired patent can remain historically important without creating a current exclusionary right.

Which companies challenged or licensed this patent?

The supplied claim text does not identify a Paragraph IV certification, inter partes review, district-court case, or settlement involving U.S. Patent 7,713,255. Paragraph IV litigation is also less likely for this patent than for a conventional Orange Book drug patent because the claims are directed to a method of delivering a sinus implant.

The principal commercial entities in the relevant market have included:

Company	Relevant role
Acclarent, Inc.	Original sinus-device platform and patent holder associated with the patent family
Johnson & Johnson	Acquired Acclarent
Intersect ENT	Developer of PROPEL and SINUVA
Medtronic	Acquired Intersect ENT and commercialized its sinus implant portfolio

No license should be inferred solely from overlapping products, corporate acquisitions, or patent-family citations. An acquisition transfers rights through corporate ownership but is not the same as a third-party license.

What patent landscape surrounds biodegradable sinus implants?

The surrounding landscape includes four overlapping patent groups.

Drug-eluting implant patents

These patents claim an implant containing a corticosteroid or other anti-inflammatory agent. They may focus on drug loading, polymer composition, geometry, release kinetics, or implant placement.

Delivery-system patents

These patents cover catheters, conduits, pushers, deployment mechanisms, angulated tips, side openings, and systems for positioning implants in the frontal, maxillary, sphenoid, or ethmoid sinuses.

Method-of-use patents

These patents claim treatment of sinusitis, nasal polyps, postoperative inflammation, or sinus obstruction by positioning a drug-eluting implant in a specified sinus or ostium.

Manufacturing and formulation patents

These patents may cover:

PLGA molecular weight and copolymer ratio;
Solvent-based or extrusion manufacturing;
Drug-polymer dispersion;
Implant porosity;
Degradation rates;
Mucoadhesive coatings;
Fracture-line designs; and
Sterilization and packaging.

A freedom-to-operate review must examine live continuation, divisional, and continuation-in-part patents. The expiration of U.S. Patent 7,713,255 does not eliminate later patents claiming narrower products or delivery systems.

What generic entry risks exist for sinus implant products?

Traditional generic substitution is less direct for PROPEL and SINUVA than for a conventional tablet or nasal spray. These products combine:

A drug substance;
A biodegradable implant;
A delivery system; and
A procedural method of use.

FDA approval may therefore involve an NDA, a combination-product review, or another product-specific pathway rather than a simple ANDA substitution model. The principal competitive risks include:

A competing corticosteroid implant approved through a separate regulatory pathway.
A device using the same or similar polymer and release profile.
A physician-administered local therapy that avoids the patented delivery steps.
A later patent covering a commercial implant formulation.
A biosimilar-style risk analysis for biologic products, which is generally inapplicable because mometasone furoate is a small molecule, not a biologic.

The relevant regulatory risk is generic or follow-on drug-device competition, not biosimilar substitution.

How does U.S. Patent 7,713,255 compare with competing patent strategies?

Strategy	Primary protection	Typical enforcement target
Patent 7,713,255	Method of delivering biodegradable therapeutic implants into sinuses	Surgical procedure and delivery method
Formulation patent	Drug-polymer composition and release profile	Implant manufacturer
Device patent	Conduit, catheter, pusher, or deployment structure	Delivery-system manufacturer
Method-of-use patent	Treatment of sinusitis or nasal polyps	Product label and clinical use
Manufacturing patent	Polymer processing and drug loading	Contract manufacturer or product developer

Patent 7,713,255 is broad at the procedural-concept level but less specific than a narrow commercial formulation patent. A competitor may avoid it by changing the delivery sequence while still needing to address separate composition, device, or method-of-use patents.

Key Takeaways

U.S. Patent 7,713,255 claims methods for placing biodegradable, drug-eluting implants in paranasal sinus cavities.
The broadest claim requires a biodegradable therapeutic implant, a conduit, sinus access, delivery through a distal opening, and visualization.
Mometasone furoate, budesonide, fluticasone propionate, and triamcinolone acetonide are expressly claimed.
PLGA, mucoadhesive polymers, hyaluronic acid, gels, semisolids, pellets, beads, strips, and microparticles are covered by dependent claims.
PROPEL and SINUVA are technically relevant commercial comparators, but product relevance does not establish infringement.
The patent is a method patent, not a conventional active-ingredient patent.
Its ordinary patent term appears to have ended around 2024, subject to USPTO patent-term adjustment.
Current freedom-to-operate analysis must include later continuation patents, formulation patents, device patents, and manufacturing patents.
Paragraph IV and biosimilar risks are less central than product-specific combination-product, device, and follow-on formulation risks.
No license, settlement, or litigation should be inferred without a specific assignment, court, USPTO, or FDA record.

FAQs About U.S. Patent 7,713,255

Does U.S. Patent 7,713,255 claim mometasone furoate itself?

No. Claim 15 identifies mometasone furoate as an active agent in a biodegradable implant. The patent claims the delivery method and implant use, not mometasone furoate as a chemical compound.

Does the patent cover delivery through the ethmoid sinus?

The claims refer generally to a paranasal sinus cavity and do not limit the independent claims to one named sinus. Ethmoid delivery may fall within the claims if every required procedural and implant limitation is met.

Is a biodegradable sinus implant without a drug covered?

Generally, no. The independent claims require a therapeutic amount of an active agent for sinusitis treatment or inflammation reduction.

Can a physician infringe the patent by using a commercial sinus implant?

Potentially, if the patent was enforceable during the relevant procedure and the procedure practiced every limitation of an asserted method claim. Liability cannot be determined from the implant alone.

Are PLGA-based sinus implants specifically covered?

Yes. Claim 24 expressly identifies a poly(lactic-co-glycolic acid) copolymer as the biodegradable polymer matrix. The implant must also satisfy the broader method limitations in claim 1 or another applicable independent claim.

References

U.S. Patent No. 7,713,255. (2010). Methods and devices for delivering therapeutic agents to paranasal sinuses. United States Patent and Trademark Office.
U.S. Food and Drug Administration. (2011). PROPEL sinus implant: Premarket approval and labeling materials. FDA.
U.S. Food and Drug Administration. (2017). SINUVA sinus implant: Approval order and prescribing information. FDA.
U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations. FDA.
U.S. Patent and Trademark Office. (2024). Patent term adjustment and patent term extension guidance. USPTO.
21 C.F.R. § 314.53. Submission of patent information with certain applications and approved applications.
35 U.S.C. § 154. Contents and term of patent; provisional rights.
35 U.S.C. § 156. Extension of patent term.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004222340	⤷ Start Trial
Canada	2518960	⤷ Start Trial
European Patent Office	1605863	⤷ Start Trial
European Patent Office	3103422	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,713,255

Summary for Patent: 7,713,255