Details for Patent: 9,849,085

Summary for Patent: 9,849,085

Title:	Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof
Abstract:	A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled manner. The device includes an inner core or reservoir including the effective agent, an impermeable tube which encloses portions of the reservoir, and a permeable member at an end of the tube.
Inventor(s):	Hong Guo, Paul Ashton
Assignee:	Eyepoint Pharmaceuticals Inc
Application Number:	US14/919,962
Patent Claim Types: see list of patent claims	Use; Delivery;

Scope & Claims Analysis for U.S. Patent 9,849,085 (Drug Delivery Method Claims, Sustained-Release Reservoir with ≤3 mm Inner Tube and Vitreous Fluocinolone Acetonide Use)

U.S. Patent 9,849,085 is directed to a sustained-release drug delivery system and method of treating a mammal or human using that system, with the core claim architecture centered on (1) a drug reservoir, (2) a dimensionally stable “inner tube” with first and second open ends and diameter ≤3 mm (and in the human version length ≤7 mm), (3) an outer layer permeable to agent passage, and (4) agent release through at least one of the inner tube open ends. Dependent claims narrow the inner tube material class (polymer or metal; specific metals; extensive polymer lists), permeability characteristics, tube dimensions, corticosteroid agent identity, and ocular insertion (including injection) into vitreous/under-retina/sclera, with a principal dependent species: fluocinolone acetonide in the vitreous.

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Which claims define the protected subject matter in U.S. Patent 9,849,085? (Claim-by-claim scope and infringement touchpoints)

Claim 1: Broadest method claim structure (system features + sustained release + open-end release)

Claim 1 claims a method for treating a mammal using a sustained release drug delivery system comprising:

1. Drug reservoir with therapeutically effective amount of an agent.
2. Inner tube covering at least a portion of the reservoir:
   • First open end and second open end.
   • Diameter ≤ 3 mm.
   • Dimensionally stable and capable of supporting its own weight.
3. Outer layer covering a portion of the inner tube:
   • Permeable to passage of the agent.
4. Release mechanism: upon administering, the agent is released through at least one of the inner tube open ends.

Practical scope anchor: Claim 1 is not a general “drug-eluting device” claim. It is a specific layered architecture with open-ended inner tube geometry (≤3 mm diameter) and release through open ends (not merely diffusion through the outer layer). To infringe a method claim, the accused activity must be a method of treatment that includes administering a system meeting these structural predicates.

Claim 2–3: Inner tube permeability bifurcation

• Claim 2: inner tube impermeable to passage of the agent.
• Claim 3: inner tube permeable to passage of the agent.

These create two enforceable pathways depending on the accused design: the claims expressly cover either permeability state of the inner tube. In practice, this reduces design-around value because switching permeability alone does not evade the claim set; instead, one must attack other core elements (diameter, open ends, sustained-release reservoir with permeable outer layer, or release “through” open ends).

Claim 4–5: Inner tube materials (polymer or metal; specified metals)

• Claim 4: inner tube comprises a polymer or a metal.
• Claim 5: inner tube comprises gold, platinum, or stainless steel.

This narrows material identity for a dependent layer. Even if an accused inner tube is a polymer or non-specified metal, Claim 4 can still be in play via the “polymer or a metal” language. Claim 5 only adds specificity if the inner tube uses one of the enumerated metals.

Claim 6–7: Outer layer and inner/outer polymer exemplars

• Claim 6: recites a long polymer/material list that the inner tube or outer layer comprises (broad enumerated polymer class).
• Claim 7: outer layer comprises polyvinyl alcohol (PVA).

These material lists expand the claim footprint substantially for polymer selections. A design-around that replaces the polymer system must avoid not only the listed polymers but also potentially avoid the general “polymer” scope of Claim 4 and the permeable outer layer requirement of Claim 1. Claim 7 is the “PVA outer layer” carve-in.

Claim 8: Tube length ≤ 7 mm

• Claim 8: length of the tube not more than 7 mm.

Claim 8 is a further dimension narrowing. For the human-specific claim (Claim 17), length ≤7 mm is already built into the system definition, so Claim 8 mainly reinforces/extends dimension constraints for the mammal version.

Claim 9–10: Agent identity = corticosteroid; fluocinolone acetonide species

• Claim 9: agent is a corticosteroid.
• Claim 10: corticosteroid is fluocinolone acetonide.

This is the key species narrowing that aligns with ocular sustained corticosteroid delivery. If an accused system uses a different corticosteroid, Claims 9–10 would not be met, but Claim 1 may still be met if the accused agent is “an agent” meeting the system release mechanics.

Claim 11–15: Insertion mode and ocular locations

• Claim 11: administering comprises inserting the system.
• Claim 12: inserting comprises injecting at a desired location.
• Claim 13: location selected from: vitreous of the eye, under the retina, and onto the sclera.
• Claim 14: inserting comprises into the vitreous of the eye.
• Claim 15: injecting into the vitreous.

These are method-context limitations. The patent is enforceable in the context of injection/insertion for ocular depot-type delivery, not necessarily other routes (e.g., subcutaneous or intramuscular) unless the method fits the claim language.

Claim 16: Mammal is human

• Claim 16: mammal = human.

In combination with ocular insertion-dependent claims, this pushes enforcement into U.S. clinical use and label-consistent routes (if the accused method matches).

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How does Claim 17 change the scope for human vitreous delivery? (Key tightening vs Claim 1)

Claim 17: Human-specific ocular sustained-release claim (includes tube length and vitreous route)

Claim 17 is the human analog with built-in tightened features:

1. System elements track Claim 1, but with additional dimensional constraints:
   • inner tube diameter ≤ 3 mm
   • inner tube length ≤ 7 mm
   • inner tube must be dimensionally stable and support its own weight
   • outer layer permeable to passage
2. Administration method explicitly: inserting the system into the vitreous of the eye.
3. Release: agent released through at least one open end.

Claim 18–20: Human-specific corticosteroid species and injection

• Claim 18: agent is corticosteroid.
• Claim 19: corticosteroid is fluocinolone acetonide.
• Claim 20: inserting comprises injecting into the vitreous.

Scope delta vs Claim 1: Claim 17 adds two “hard” limitations simultaneously: human + vitreous route + tube length ≤7 mm. Any accused design targeting vitreous treatment with a different insertion route or longer/ differently dimensioned inner tube reduces likelihood of meeting Claim 17 while still potentially meeting Claim 1 depending on how the dependent chain is asserted.

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What are the core novelty levers in these claims? (Open-end release + ≤3 mm dimension stable inner tube + permeable outer layer)

Across the independent architecture, the strongest claim “hinges” are:

1. Inner tube with two open ends (release through open ends).
2. Inner tube diameter ≤ 3 mm (geometric limitation).
3. Dimensionally stable inner tube capable of supporting its own weight (structural/functional device property).
4. Outer layer permeable to passage of the agent (mass-transfer enabling shell).
5. Sustained release implied by “sustained release drug delivery system” and release language through open ends.

From an infringement analysis standpoint, these are the elements that typically drive claim-structure match. A competitor can often keep “sustained release” and “reservoir” in place while changing geometry, open-end architecture, or release pathway to attempt non-infringement. This claim set, however, is broad on agent identity (in Claim 1/17 “an agent” and later corticosteroid/fluocinolone species only in dependents) and broad on polymer/material lists (Claim 6).

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How many separate claim paths exist for enforcement? (Independent-to-dependent branching map)

A practical enforcement map:

System architecture path (device form features)

• Diameter constraint (≤3 mm) + dimensionally stable self-supporting inner tube with open ends + permeable outer layer and reservoir.

Permeability path

• Inner tube permeable (Claim 3) or impermeable (Claim 2). Both are covered as alternatives for claim 1’s “system” limitation via dependent claims.

Material path

• Inner tube polymer/metal (Claim 4) and enumerated metals (Claim 5).
• Polymer exemplars affecting inner tube or outer layer (Claim 6) and PVA outer layer (Claim 7).

Agent identity path

• Corticosteroid (Claim 9) and fluocinolone acetonide (Claim 10, 19).

Ocular route path

• Insert/inject (Claims 11–12) with target locations (Claim 13) and vitreous-specific subpath (Claims 14–15, 17, 20).

A claimant can typically assert multiple dependent layers to increase odds of matching an accused product by design feature, agent identity, and route.

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What formulation and delivery mechanism is protected beyond “drug + device”? (Release through tube open ends vs outer layer diffusion)

Claim 1 requires that, “upon administering,” the agent is released through at least one of the first open end and second open end. That requirement links release location to the internal geometry. The outer layer is permeable, but the claim does not merely say the agent diffuses through the outer layer; it ties release to the open ends.

Claim interpretation pressure point: For non-infringement, a competitor design would target a release mechanism that does not release through tube open ends. If release occurs only by permeation through the outer layer into surrounding tissue without expression through open ends, the claim language is harder to satisfy.

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How does the claim cover ocular locations beyond vitreous? (vitreous vs under retina vs sclera)

Claim 13 enumerates:

• vitreous of the eye
• under the retina
• onto the sclera

Claims 14–15 narrow to vitreous. Claim 17 is restricted to vitreous. So enforcement in under-retina or onto-sclera contexts is largely through the mammal claims (Claim 1 + Claim 13) rather than the human-vitreous-only claim 17.

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What patents or entities would typically be implicated by this claim style? (Inference constrained to the claim text only)

The provided claim text alone does not identify patent family members, assignees, or priority. Without the published patent record (assignee, specification details, prosecution history, cited references, or related patents), a complete “patent landscape” across the estate cannot be generated in a way that is legally actionable.

Given the constraints, the most defensible scope conclusion from the claim text is that U.S. 9,849,085 likely targets a narrow class of ocular sustained-release steroid depot concepts combining:

• a tube-in-reservoir layered geometry,
• capped/handled via injection/insertion,
• and sustained release with open-end release.

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When does exclusivity expire? (No data available from the claim text)

No priority date, filing date, or patent term adjustment data is provided. Patent expiration and regulatory exclusivity timelines cannot be computed accurately from the claims alone.

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What FDA regulatory status issues would matter for this claim? (Not determinable from claim text)

The claim language references vitreous injection of fluocinolone acetonide (a drug associated with intraocular sustained-release steroid delivery), but the FDA product name, NDA/ANDA/BLA number, listed indications, and Orange Book entries are not contained in the provided material. A complete Orange Book status and paragraph IV challenge analysis cannot be produced from claim text alone.

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Which generic entry risks exist if a competitor makes a similar sustained-release tube system? (Risk matrix driven only by the claim elements provided)

High infringement risk designs

• Devices with:
  • inner tube diameter ≤3 mm
  • dimensionally stable/self-supporting tube with first and second open ends
  • permeable outer layer covering the tube
  • release of steroid through the tube open ends
  • ocular injection/insertion into vitreous (or other enumerated locations for the mammal claim)
  • if the agent is fluocinolone acetonide, the dependent claims add further specificity

Lower infringement risk design levers

• Change inner tube diameter beyond 3 mm (attacks core Claim 1/17 dimensional predicate).
• Avoid a tube architecture that has two open ends used as the release pathway (attacks the “released through at least one of the first open end and second open end” predicate).
• Use a non-ocular route not covered by the insertion/location language.
• Use a different agent (not corticosteroid) to avoid dependent corticosteroid claims, though Claim 1 still covers “an agent” generally.

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Key Takeaways

• U.S. 9,849,085 claims a sustained-release method using a layered tube-in-reservoir system with a self-supporting inner tube (diameter ≤3 mm) that has open ends through which the agent is released.
• Dependent claims broaden enforcement across inner tube permeability (permeable or impermeable), material classes (polymer/metal and extensive listed polymers; PVA outer layer), and ocular insertion routes (vitreous, under retina, sclera; vitreous injection emphasized).
• The strongest product-specific hook is the combination of fluocinolone acetonide with vitreous injection and the human limitation including inner tube length ≤7 mm.

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FAQs

1. Does U.S. 9,849,085 require the outer layer to be the release pathway?
   No. The claims require release through at least one of the inner tube open ends; the outer layer is permeable but the release pathway is tied to the open ends.

2. Can a design evade infringement by making the inner tube permeable instead of impermeable?
   No. The patent includes dependent claims for both permeable and impermeable inner tube embodiments.

3. If a competitor uses an agent that is not a corticosteroid, is the patent still relevant?
   Yes for Claim 1 and Claim 17, because agent identity is not limited in the independent claims; corticosteroid and fluocinolone acetonide are dependent.

4. Is vitreous injection required for all claims in the patent?
   No. Vitreous is built into Claim 14/15/17/20, but other ocular locations are covered via Claim 13.

5. What is the main dimensional parameter for infringement risk?
   The inner tube diameter ≤3 mm is central to the independent claim system definition; in the human claim (Claim 17) tube length ≤7 mm is also required.

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References

No external sources were provided or cited.

Drugs Protected by US Patent 9,849,085

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 9,849,085

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2233112		122014000063	Germany
European Patent Office	2233112		132014902285293	Italy
Argentina	028372