Patent: 8,277,830

Summary for Patent: 8,277,830

Title:	Posterior segment drug delivery
Abstract:	A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.
Inventor(s):	de Juan, Jr.; Eugene (Menlo Park, CA), Alster; Yair (Menlo Park, CA), Farinas; Kathleen Cogan (Menlo Park, CA), Gifford, III; Hanson S. (Menlo Park, CA), MacFarlane; K. Angela (Menlo Park, CA), Reich; Cary J. (Menlo Park, CA), Barrett; Michael (Menlo Park, CA), Campbell; Randolph E. (Menlo Park, CA), Sutton; Douglas (Menlo Park, CA)
Assignee:	ForSight Vision4, Inc. (Menlo Park, CA)
Application Number:	13/252,998
Patent Claims:	see list of patent claims

United States Patent 8,277,830 Claim Scope and US Patent Landscape for Implantable Ocular Refillable Reservoir Devices with Rigid Porous Tuned Release Structures

US 8,277,830 claims a refillable, implantable posterior-chamber ocular device with (i) a rigid, impermeable reservoir/wall that remains substantially fixed in volume during refill and use, and (ii) a distal rigid porous release structure (interconnected, irregular, tortuous channels) tuned to discharge therapeutic amounts over an extended time. Dependent claims narrow the porous-media structure (sintered, metallic/ceramic/glass) and the fluid-transport geometry (fixed tortuous channels, porosity/thickness/channel parameters, tortuosity proxy via effective length). The strongest claim-anchoring elements are the rigid refillable reservoir with substantially fixed volume plus a distal rigid porous structure configured and tuned for an extended release profile into the posterior chamber, with the device cross-section geometry and sclera-to-neck positioning defined for implantation.

Below is a claim-by-claim enforcement map, then a critical patent-landscape analysis in the US focused on likely overlap areas: ocular refillable reservoirs, rigid porous diffusion/flow restrictors, tuned release-profile tuning by channel geometry/thickness/porosity, and refill mechanics with a proximal cap and penetrable, non-permeable barrier.

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What is claimed in US Patent 8,277,830: refillable posterior-chamber implant with rigid porous release media?

Core independent claim 1: device architecture that stays rigid and fixed during refill

Claim 1 is a structural combination claim. It is not limited to a particular therapeutic agent in claim 1, and it covers the device itself rather than a specific indication.

Key elements:

1. Implant location and access geometry

   • Implantable therapeutic device for an eye “having a posterior chamber and a sclera.”
   • Implanted within the posterior chamber through a penetration in the sclera.
   • Reservoir neck positioned such that the sclera is positioned about the neck portion.

2. Rigid, hollow, refillable body with fixed volume

   • Rigid, hollow, refillable body formed of substantially rigid, impermeable wall of biocompatible material.
   • Proximal cap portion remains external to the posterior chamber.
   • Distal reservoir portion resides in posterior chamber.
   • Substantially fixed volume during implantation and use.
   • This is a major patentability and enforceability anchor: it excludes deformable reservoirs, collapsible chambers, and devices where refill pressure changes internal volume.

3. Distal rigid porous structure tuned to release

   • Rigid porous structure coupled to a discrete distal portion of the reservoir.
   • Porous structure has plurality of interconnecting, irregularly shaped channels.
   • Channels are “tuned” to release therapeutic amounts from reservoir through the channels into posterior chamber for extended time.

4. Refill mechanics

   • Cap portion adapted to receive injection of therapeutic agent into the reservoir and remain external.

Critical reading for infringement risk: To infringe claim 1, an accused device must satisfy the combination: rigid hollow refillable posterior-chamber reservoir + substantially fixed volume + rigid porous interconnecting channel media tuned for extended release into posterior chamber, with implantation geometry that positions sclera about a neck and keeps the cap outside.

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How do dependent claims narrow the release-media mechanism and structural limitations?

Interconnected fixed channels and non-changing channel geometry (claims 2–3)

• Claim 2: channels are “interconnected, substantially fixed channels.”
• Claim 3: volume of refillable reservoir remains substantially unchanged; porous structure remains rigid and channels remain substantially fixed when pressurized with injection.

Enforcement impact: This pushes the claim away from pressure-compensating or compliant porous membranes, and toward rigid sintered/ceramic/glass media or similar fixed-geometry structures. Many refillable ocular implants rely on compliant drug reservoirs or expandable membranes; those would be harder to map to claim 3.

Penetrable barrier location enabling refill without sclera/choroid needle penetration (claim 4)

• Reservoir extends along an axis through sclera and choroid.
• Penetrable barrier is at the proximal end so refill occurs by advancing injection needle through conjunctiva and penetrable barrier without needle penetrating sclera or choroid.

Enforcement impact: This limits refill workflow and barrier placement. Devices requiring trans-scleral needle placement would fall outside this specific claim.

Channel topology: intersections and tortuosity by effective length (claims 5, 10)

• Claim 5: channels intersect at multiple locations.
• Claim 10: tortuous channels with effective length greater than thickness, where thickness is the first-to-second side distance and effective length defines transport path.

Enforcement impact: Many porous media can be “sintered” but have mostly straight capillaries. Claim 10’s “effective length greater than thickness” is a functional geometry constraint that may be tested by imaging/porometry-like metrics in litigation.

Porous material type and structure (claims 6–8, 12)

• Claim 6: sintered material.
• Claim 7: sintered metallic disc.
• Claim 8: metal/ceramic/glass.

Enforcement impact: These are strong narrowing features but also provide multiple infringement routes. An accused design using a sintered metal, ceramic, or glass porous disk-like element can land within these dependent claims even if it differs in other details.

• Claim 12: rigid sintered grains; channels extend at least partially around grains to pass therapeutic agent.

Release tuning by thickness, surface area, porosity, and channel parameters (claims 9, 17–21, 24)

• Claim 9: thickness and surface area correspond to release rate.

• Claim 17: porosity, thickness, “channel parameter” and surface area configured for extended release.

• Claim 18: channel parameter corresponds to effective length.

• Claim 19: release rate corresponds to porosity/channel parameter ratio; ratio < about 0.5.

• Claim 20: release rate index no more than about 5.0 mm.

• Claim 21–22: half-life in reservoir corresponds to release rate and extended duration; “half-life within reservoir” substantially greater than half-life when directly injected into vitreous.

• Claim 24: first and second sides with first/second areas corresponding; thickness, porosity, and channel parameter configured for release.

Enforcement impact: These dependent claims create quantitative handles. In disputes, they reduce “vague tuning” arguments because accused products can be evaluated against porosity, thickness, surface area, and effective length metrics. Devices that use polymeric membranes, hydrogels, or loosely structured microchannels may struggle to map to rigid tortuous fixed channels with effective-length > thickness plus the specified ratio constraints.

Retention structure and penetrable barrier enabling sutureless retention (claim 13)

• Retention structure extends between sclera and conjunctiva to retain device without sutures.
• Claim 25 later repeats a variation.

Enforcement impact: This can be a major differentiator for design-around: a device with suture-based retention or different anchoring might avoid the retention-structure limitation, though claim 1 does not require it.

Treatment duration and reservoir half-life constraints (claims 14–16)

• Claim 14: reservoir half-life ≥ about 20 days; device treats for ≥ about 90 days.
• Claim 15: half-life ≥ about 30 days; device treats for ≥ about 120 days.
• Claim 16: half-life greater than the corresponding half-life injected directly into vitreous; reservoir half-life corresponds to release for ≥ about 120 days.

Enforcement impact: These claims turn biological performance into claim limitations. In litigation, they increase the evidentiary burden for plaintiffs to show that reservoir kinetics and in-eye duration meet thresholds, but they also provide more specificity than generic “extended release.”

Agent-agnostic broad scope with late claim 29 listing many modalities (claim 29)

• Claim 29 lists many therapeutic agents ranging from small molecules to biologics/antibodies and even “siRNAi molecule synthetic.”
• The claim is not limited to a single drug class.

Enforcement impact: The broad list can support broad coverage against many candidates, but it also invites validity challenges if prior art shows similar reservoir/porous diffusion devices loaded with different drugs. In practice, examiners and courts still focus on device structure, refillability, and porous tuning, not the particular payload.

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What is added in dependent claim 25: cross-sectional shape and retention/penetrable non-permeable barrier?

Independent claim 25: alternative framing of the same platform

Claim 25 is essentially another independent claim that reorganizes elements:

• Rigid-walled reservoir with defined volume, rigid porous structure in distal region with tuned predetermined rate profile.
• Proximal cap portion outside sclera.
• Cap portion includes retention structure and a penetrable, non-permeable barrier for agent introduction without explantation.
• Neck portion positioned between cap and reservoir; sclera about neck.
• Cap cross-sectional shape different than reservoir cross-sectional shape.

Critical delta vs claim 1: Claim 25 includes explicit “penetrable, non-permeable barrier” and cross-sectional shape difference. Devices with barriers that are permeable to the drug or that have equal cross-section shapes may avoid some dependent limitations while still potentially falling under claim 1.

Extended release after second dosing (claim 26)

• Porous structure and reservoir chamber tuned to release an additional quantity over a second extended period after additional agent introduction after first extended period.

Enforcement impact: This is a design discriminator for single-dose reservoirs versus true multi-cycle dosing.

Molecular-weight dependent release mapping (claim 28)

• Agent molecular weight between 100 Da and 1,000,000 Da and corresponding predetermined release-rate profile.

Enforcement impact: This creates another quantitative axis that can become disputed in claim construction: “corresponds” is ambiguous without a defined mapping methodology, but the claim language indicates intended coupling between agent size and release profile.

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What patentability vulnerabilities exist in US 8,277,830 based on claim construction and novelty pressure?

1) Device-structure claims are vulnerable to prior ocular implant platforms

The claim set is designed to combine known building blocks:

• Implantable ocular reservoirs
• Refilling methods via injection through external ports/caps
• Controlled release via porous media or membranes
• Sintered rigid porous structures with interconnecting channels

Any single pre-8,277,830 US patent that teaches a refillable posterior-chamber reservoir coupled to a rigid porous rate-controlling element with fixed geometry and extended release could undercut novelty or at least constrain inventiveness arguments.

2) Quantified “tuning” parameters increase both enforceability and validity attack surface

Parameters like:

• porosity/channel parameter ratio < 0.5
• effective length greater than thickness
• release rate index ≤ 5.0 mm
• reservoir half-life thresholds

are helpful for claim matching but also create obviousness leverage. If prior art teaches how to tune porous sintered disks (by thickness, porosity, and tortuosity/length) to achieve extended half-life windows, then adding threshold numbers can be framed as routine optimization.

3) Broad agent payload lists invite lack-of-enablement or predictability arguments

Even though claims are device-focused, the payload-agnostic list (claim 29) can support enablement challenges if the patent does not teach how release is tuned for wildly different classes (e.g., antibodies vs small molecules) under the same rigid porous geometry without additional guidance. In practice, courts typically assess whether the specification provides a reasonable basis, but the broad list gives defendants ammunition.

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US patent landscape: what other IP families likely overlap (and why)

Without pulling live patent-family/Orange Book datasets, the landscape can only be mapped at the level of claim-category collision points. The most probable overlap themes in the US for an ocular implant with refillable reservoir and rigid porous tuned release are:

1. Refillable ocular implants with external refill ports

   • Competition is usually in the “port-cap-barrier-neck” mechanics, including how to refill through conjunctiva and sclera and how to prevent leakage.

2. Controlled release using rigid porous media

   • Sintered metallic/ceramic/glass porous structures and diffusion channels are classic rate-control components.
   • The “interconnecting, irregularly shaped channels” and “tortuous channels with effective length > thickness” language is designed to distinguish from straight-channel capillaries and from polymer membranes.

3. Extended release reservoir kinetics

   • The “reservoir half-life” constraints align with prior art that measures intrachamber half-life or cumulative release time.

4. Sutureless retention structures

   • Retention between sclera and conjunctiva is a known engineering constraint for scleral implants.

5. Posterior chamber targeting

   • Many devices are intravitreal; claim language targets posterior chamber with scleral penetration. That distinction matters for infringement mapping.

Business consequence: If an accused product uses a compliant drug reservoir, a polymeric rate-limiting membrane instead of rigid sintered porous structures, or refill geometry that differs (needle traverses sclera/choroid rather than conjunctiva + proximal barrier), the defense has multiple non-infringement paths against specific dependent claims even if claim 1 remains broad.

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How strong is the patent estate coverage for competitors? Key claim “hooks”

Based on the claim text, the strongest coverage hooks are:

1. Substantially fixed volume refillability under pressurization

   • Claim 1 + claim 3.
   • Design-around: use compliant reservoirs, elastomer diaphragms, or pressure-absorbing structures.

2. Rigid porous structure with interconnecting irregular/tortuous fixed channels

   • Claim 1 + claim 2 + claim 3 + claim 10.
   • Design-around: replace with a deformable porous polymer, hydrogel, or a non-porous micro-orifice approach.

3. Quantitative tuning parameters

   • Claim 17–21 and claim 24.
   • Design-around: avoid meeting the specified ranges or avoid “release rate index” defined as in the patent.

4. Refill without sclera/choroid needle penetration

   • Claim 4.
   • Design-around: different barrier placement or refill access path requiring trans-scleral penetration.

5. Sintered material porous media

   • Claim 6–8 and claim 12.
   • Design-around: use non-sintered porous media.

Weakness in enforcement: If prior art already discloses rigid refillable posterior-chamber reservoirs with fixed porous rate-control media, then the patent’s scope may be narrowed by claim construction or invalidated if the numbers/wording are deemed obvious parameter optimization.

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Litigation and challenges: what to look for in US practice

Given only the claims, the most actionable litigation focus areas are:

• Claim construction disputes likely centered on

  • “substantially fixed volume”
  • “rigid porous structure,” “substantially fixed channels,” and “when the reservoir is pressurized”
  • “tuned” and whether tuning is structural limitation or performance limitation
  • “effective length greater than thickness”
  • numeric thresholds like “ratio < 0.5” and “release rate index ≤ 5.0 mm”

• Evidence strategy likely centers on

  • micro-CT or microscopy-based channel geometry measurement
  • porosity/thickness/surface-area characterization
  • reservoir deformation testing during simulated refill pressurization
  • in vivo/in vitro release profiling to match reservoir half-life constraints

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Commercial entry risk analysis: what generic or competitor “launch” scenarios would be blocked?

This patent is a device patent. “Generic launch” in the small-molecule sense is not the model; instead, the risk is for:

• Competitor devices that implement the same refillable rigid reservoir + rigid porous tuned release platform.
• Reformulation or payload switching within that device architecture, since claim 29 lists many agent types.

High infringement-risk scenario

• A posterior chamber implant with an external refill cap using an injection needle that fills a rigid impermeable reservoir connected to a distal rigid sintered porous disk with tortuous interconnecting channels tuned for extended release, maintaining substantially fixed reservoir volume under pressurization.

Lower risk scenarios

• Devices using a drug reservoir that visibly changes volume with refill pressure.
• Devices using polymeric membranes or hydrogels as the rate limiting element rather than rigid porous structures with fixed channels.
• Devices where refill requires needle penetration into sclera/choroid rather than conjunctiva + proximal barrier placement.

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Key Takeaways

• US 8,277,830 is a platform device patent focused on a rigid, refillable ocular reservoir with substantially fixed volume and a distal rigid porous porous-channel release structure tuned for extended release into the posterior chamber.
• The strongest differentiators are the fixed-volume refillability under pressurization and the rigid, sintered-type porous media with defined channel geometry (interconnecting irregular/tortuous, effective length > thickness).
• Dependent claims add quantitative and performance thresholds (porosity/channel ratio, release rate index, reservoir half-life and treatment duration), which can improve infringement mapping but increase validity and evidentiary complexity.
• Design-around is most plausible via reservoir compliance (volume change on refill), replacing rigid sintered porous media with non-rigid or different rate-control architectures, or changing refill-barrier geometry so the needle path differs from claim 4/25.

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FAQs

1) What part of US 8,277,830 most directly blocks refillable posterior-chamber ocular implants?
The combination of a rigid impermeable refillable reservoir with substantially fixed volume during pressurization plus a distal rigid porous release structure with interconnecting, irregular/tortuous fixed channels tuned for extended release into the posterior chamber.

2) Do the claims require the therapeutic agent to be a specific drug?
Claim 1 is broad and agent-agnostic. Claim 29 lists many possible therapeutic agents, but infringement of claim 1 does not depend on a single named drug if the device features are met.

3) How can a competitor lower risk against claims 17–21?
By avoiding the defined tuning relationships that map porosity, thickness, effective length/channel parameter, surface area, and release rate index into the claimed numeric thresholds and ratios.

4) Is “tuned to release” a performance requirement or a structural requirement?
It functions as a claim element that ties porous structure geometry to extended release into the posterior chamber. Courts typically construe “tuned” as limiting, with both structural configuration and evidence of the achieved release profile relevant to infringement.

5) What refill mechanism differences are most likely to avoid the sclerally constrained refill limitations?
Refill designs that require the injection needle to penetrate sclera/choroid (rather than conjunctiva plus a proximal penetrable barrier) or that use a different barrier placement that does not match the claim-defined proximal barrier location.

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References

No source documents were provided in the prompt (e.g., USPTO record, file wrapper, cited references, prosecution history, or related patents). Therefore, no external citations can be generated from the provided information.

Details for Patent 8,277,830

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	August 22, 1975	8,277,830	2031-10-04
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	May 20, 1985	8,277,830	2031-10-04
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	June 23, 1987	8,277,830	2031-10-04
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	October 16, 1986	8,277,830	2031-10-04
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	February 04, 1999	8,277,830	2031-10-04
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	October 08, 1996	8,277,830	2031-10-04