Patent: 9,421,129

Summary for Patent: 9,421,129

Title:	Intraocular delivery devices and methods therefor
Abstract:	Injection devices for delivering pharmaceutical compositions into the eye are described. Some devices include a resistance component for controllably deploying an injection needle through the eye wall. The resistance component may be disposed on a removable injector attachment or on a portion of the injection device housing. Other devices may include a filter for the removal of air, infectious agents, and/or other particulate matter from the composition before the composition is injected into the eye. Related methods and systems comprising the devices are also described.
Inventor(s):	Lerner; Leonid E. (Newport Beach, CA)
Assignee:	OcuJect, LLC (Newport Beach, CA)
Application Number:	13/841,144
Patent Claims:	see list of patent claims

Executive summary
US Patent 9,421,129 is directed to an ophthalmic injection “injector attachment” that couples to a syringe and includes (i) a movable “dynamic sleeve” that shifts between a distal-exposed configuration for intraocular injection and a retracted, protected configuration, and (ii) an atraumatic ocular contact surface carrying a distance-measuring component using radially extending members to measure a “precise distance” from the injection port to an anatomical landmark. Independent system claims add an eye-injection delivery system with a housing and drug reservoir, and specify active-agent classes including anti-VEGF (ranibizumab/bevacizumab/aflibercept and modifications), and anti-complement agents.

Without bibliographic and prosecution history metadata (publication number, assignee, filing/priority dates, claim-set at grant, and the full specification), a complete validity and freedom-to-operate (FTO) assessment of claim scope, best-and-final equivalents, and expiration/exclusivity positioning cannot be produced from the claim text alone.

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US Patent 9,421,129 claims analysis: what the injector attachment covers and how the “dynamic sleeve + measuring component” limits scope

US 9,421,129 claim 1 is the core. It is a combination claim that binds together multiple structural features; most design-arounds will need to remove at least one required feature or move outside the “injection attachment” architecture.

1) Core structural elements that must all be present (claim 1)

Claim 1 requires, in one device:

1. Injector attachment with an input port configured to removably mate with the distal end of a syringe.
2. A conduit with proximal and distal ends fluidly connected to the input port.
3. A dynamic sleeve (concentrically disposed about the conduit) with a fixed axial length and a distal end.
4. An atraumatic ocular contact surface at the dynamic sleeve distal end.
5. A measuring component on the atraumatic ocular contact surface, where the measuring component has:
   • a plurality of radially extending members, each with substantially the same shape and length, configured to measure a precise distance between:
     • the distal end of the conduit and
     • an anatomical landmark of a patient's surface tissue.
6. A clip positioned between:
   • the distal end of the input port and
   • the proximal end of the dynamic sleeve.
7. The dynamic sleeve is movable between:
   • first configuration: conduit extends distally beyond the dynamic sleeve distal end (for intraocular injection), and
   • second configuration: conduit is retracted completely within the dynamic sleeve.

This is not a “measuring device” claim in isolation. The measuring structure is physically mounted to the ocular contact surface of the same sleeve that also shields/retracts the conduit.

2) The dynamic sleeve is the motion-control center

Claim 1 requires a sleeve that is movable and that changes the relative distal reach of the conduit. That creates at least two functional constraints that can be used in claim construction:

• The sleeve movement must be sufficient to switch from “conduit protrudes beyond sleeve end” to “conduit is retracted completely within sleeve.”
• The sleeve has a fixed axial length. That language can be asserted to exclude telescoping sleeve length changes as a substitute.

Implication for design-arounds: a device that uses a different shielding mechanism (e.g., a pivoting guard that never concentrically surrounds the conduit, or a retractable needle independent of an axial sleeve with fixed length) may avoid “dynamic sleeve concentrically disposed” plus “fixed axial length” limitations.

3) The measuring component is specific: radially extending members measuring a distance to a landmark

Claim 1’s measurement feature is tied to:

• location: on the atraumatic ocular contact surface, and
• geometry: plurality of radially extending members of substantially the same shape and length, and
• purpose: to measure a precise distance between the distal end of the conduit and a patient tissue landmark.

This reads like a mechanical distance gauging or scion-like contact geometry. It is not a “camera-based measurement” claim and not a “sensor-based measurement” claim on its face. Any system using optical tracking without the claimed radially extending members could be outside scope unless equivalents are found.

Implication for scope: the claim requires that the members are configured for measurement of the distance between the conduit end and a surface tissue landmark. If a competitor measures depth via a separate calibration/encoder not structurally integrated into radially extending members on the ocular contact surface, it can be argued as missing a required element.

4) The clip limitation is structural and positional

Claim 1 requires a clip positioned between the distal end of the input port and the proximal end of the dynamic sleeve. Dependent claim 2 further states the clip is removable.

A design-around that replaces the clip with a different coupling/retainer (e.g., threaded coupling, bayonet latch, adhesive bonding, snap features integrated into the sleeve body without a “clip positioned between” these elements) aims to remove literal compliance.

5) Dependent claim stack: material and auxiliary features

Dependent claims 3 and 4 narrow sleeve properties:

• Claim 3: dynamic sleeve is rigid
• Claim 4: dynamic sleeve is non-deformable

Those are narrowing limitations that may help enforceability against “deformable compliant guard” designs, but they are optional unless the asserted claim is those dependents.

Claims 5-10 add optional sub-systems:

• Claim 5: needle stabilization mechanism
• Claim 6: one or more filters
• Claim 7-8: hydrophilic filter and hydrophobic filter
• Claim 9: needle deployment indicator
• Claim 10: needle deployment indicator comprises high visibility dye

These are typical for ophthalmic injection disposables, but the patent makes them “add-ons” to the claimed injector attachment.

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How broad are the claims on drug composition: do they cover anti-VEGF and anti-complement biologics?

The patent’s system claim (claim 11) builds on the injector attachment and adds an eye-injection system with:

• housing,
• drug reservoir, and
• actuation mechanism (with a plunger and a plunger actuation lever) for delivering an active agent into an eye (claims 11-15).

Active-agent coverage in dependent system claims

Claims 17-19 specify anti-VEGF categories:

• Claim 17: anti-VEGF agent selected from ranibizumab, bevacizumab, aflibercept, and modifications/derivatives/analogs and combinations.
• Claim 18: ranibizumab or bevacizumab.
• Claim 19: aflibercept, ocriplasmin, steroid, and additional growth factor options (including placenta-derived and platelet-derived growth factors) and combinations.

Claim 20 adds:

• Claim 20: an anti-complement agent.

Key analytic point: these are dependent limitations. To infringe the “drug-specific” claims (17-20), an accused product must not only implement the injector attachment architecture but also use the specified active agent(s). A generic of ranibizumab is not generally “generic” in the conventional small-molecule sense, but any biosimilar or off-label compound packaged in the claimed system could still fall into these classes depending on wording coverage and whether “modifications, derivatives, and analogs” are construed broadly.

Practical enforcement angle: Many litigation postures proceed on the device claim independent of formulation. Here, the architecture claim is the backbone. Drug claims may be asserted when the defendant’s product uses the specified actives.

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What is the patent claim focus: device architecture vs method of use?

The provided claims are apparatus/system oriented:

• Claim 1: injector attachment (device)
• Claim 11: system for delivering into an eye (device/system)
• Claims 17-20: active-agent selections (device/system with formulation-specific dependency)

There is no explicit method-of-use claim in the text provided. That matters for enforceability against products where the device is sold for “injection” even if instructions focus elsewhere.

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What patent estate risks exist for competitors: how easy is it to design around the dynamic sleeve + radially extending measuring members?

Given the combination nature of claim 1, infringement risk is concentrated on products that replicate the same multi-feature structure.

High-risk design targets for a manufacturer

A high-risk product design includes all of the following:

• syringe-mating input port
• conduit concentrically surrounded by a sleeve that has a fixed axial length
• atraumatic ocular contact surface at sleeve distal end
• a distance-measuring component on that ocular contact surface made of multiple radially extending members of same shape and length
• clip between input port distal end and sleeve proximal end
• sleeve travel that retracts the conduit within the sleeve for a protected second configuration

Low-risk design features that may avoid claim 1

Potential design-around routes based on omission of required limitations:

• Remove “radially extending members”: use a different measurement approach (e.g., a non-radial geometry, or measurement not performed by such members).
• Decouple measurement from the ocular contact surface: put measurement elsewhere in the device. Claim 1 anchors measurement “on the atraumatic ocular contact surface.”
• Change sleeve architecture: use a non-concentric guard, or a sleeve with adjustable axial length, or a shielding mechanism that does not produce full conduit retraction within a fixed-length concentrically disposed sleeve.
• Replace “clip positioned between” with a different coupling structure not falling within “clip positioned between” these elements.
• Avoid the two configuration requirements: if the conduit is not retracted completely within the sleeve, or if the sleeve motion does not correspond to the claimed first/second configuration.

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Where do formulation and delivery-mechanism claims change the litigation profile?

The system claim adds a plunger actuation mechanism and in some dependents a plunger actuation lever fixed to the plunger and extending through the housing side wall, plus a back plunger.

Device-only vs device+drug assertions

• A defendant selling a similar injector attachment but with different actuation could still face claim 1 exposure.
• A defendant selling a similar system but with different actuation lever/back plunger details might avoid dependents 13-15, but claim 11 still requires the system structure plus the injector attachment architecture.

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Comparison to common ophthalmic injection disposables: what elements are likely “standard,” and which are likely “differentiators”?

Based on the claim language alone, the likely differentiators are:

• dynamic sleeve with fixed axial length moving between exposed and retracted configurations, and
• mechanical distance measurement using radially extending members on an ocular contact surface to measure distance to a surface tissue landmark.

Likely conventional elements (typical across many delivery systems) include:

• syringe/housing mating interface
• filters (hydrophilic/hydrophobic)
• deployment indicators
• plunger-based actuation

This split matters for both validity and infringement analysis in litigation: conventional elements often limit the portion of the claim that is truly distinctive.

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Invalidity and claim-strength analysis: which claim limitations are most vulnerable and which are most defensible

Without the patent specification, priority dates, prosecution record, and the full list of asserted claims at grant, a rigorous novelty/obviousness mapping to specific prior art cannot be completed. However, the claim’s own internal structure indicates where arguments will likely concentrate:

Potential vulnerability points

• Broad system framing + enumerated actives: claims 17-20 cover large classes of biologics (ranibizumab/bevacizumab/aflibercept and modifications/analogs; anti-complement agents generally). Broad active-agent categories can invite arguments that the incremental value lies only in device architecture, leaving drug-dependent limits weak to establish meaningful novelty unless the device is functionally tied to those actives.
• “Precisely measure a distance” language: if prior art discloses depth/positioning measurement in ophthalmic injection contexts, a challenge may target whether “precise distance” is a functional label rather than a specific structural measurement mechanism beyond the radially extending members.

Potentially strong differentiators

• The mechanical coupling of measurement (radially extending members) and contact surface (atraumatic ocular contact surface) with a dynamic, retracting concentrically disposed sleeve and a clip positioned between the input port and sleeve proximal end.

If that combination is not shown in a single reference, obviousness must be built by combination, which can be contested via teaching-away, lack of reasonable expectation, or incompatibility of features.

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Orange Book, FDA exclusivity, and biosimilar/Paragraph IV context: what can be concluded from the claim text

The patent is a device/system patent tied to intraocular injection delivery. It does not, from the claim text provided, map to a specific small-molecule NDA/BLA and thus cannot be tied here to Orange Book listings or patent-to-product associations.

Also, the claim text does not indicate whether any FDA exclusivity (3-year/5-year) or biologics reference product exclusivity would be implicated. Biosimilar “risk” in practice depends on:

• whether the device is used with a reference biologic subject to BLA exclusivity, and
• whether patent enforceability is through the biologic sponsor or a device manufacturer.

No reliable mapping to an FDA listing can be made from the provided information alone.

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What can be concluded about the competitive landscape

From the claim’s subject matter, the relevant competitive set is not limited to a single brand of anti-VEGF. The system claims cover:

• ranibizumab, bevacizumab, aflibercept, and “modifications, derivatives, and analogs”
• additional actives including ocriplasmin, steroids, and growth factors
• anti-complement agents

This breadth implies that competitors developing injection systems for a portfolio of ophthalmic actives could intersect. Enforcement posture is therefore likely device-focused rather than molecule-focused, with drug-dependent claims serving as supplemental hooks when the accused product’s reservoir contains one of the specified actives.

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Key Takeaways

• Claim 1 is a combination claim requiring a syringe-coupling injector attachment with a movable concentrically disposed fixed-length dynamic sleeve, an atraumatic ocular contact surface, and a distance-measuring component formed by multiple radially extending members configured to measure distance between the conduit tip and a patient tissue landmark.
• Infringement risk is concentrated in products that replicate the two configuration sleeve behavior (conduit exposed for injection, then fully retracted within the sleeve) plus the specific mechanical measuring geometry on the ocular contact surface.
• Dependent system claims broaden relevance across injection-system architectures using plunger/lever/back-plunger structures and across ophthalmic active agents, including anti-VEGF biologics and anti-complement agents.
• Design-around opportunities center on omitting or altering at least one required structural element, most notably the radially extending distance-measuring members on the ocular contact surface, the fixed-length concentric dynamic sleeve with full conduit retraction, or the clip positioned between the input port and sleeve.

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FAQs

1. What parts of US 9,421,129 are most likely to be targeted in infringement?
Claim 1 limitations: dynamic sleeve structure and movement between exposed and fully retracted configurations, and the measuring component’s radially extending members mounted on the atraumatic ocular contact surface.

2. Can a product avoid infringement by using a different measurement technology?
If the measurement is not performed by the claimed plurality of radially extending members configured to measure the conduit tip-to-landmark distance on the ocular contact surface, the device may fall outside literal scope.

3. Does the anti-VEGF language expand the patent beyond device architecture?
Only through dependent system claims (17-19). To reach those dependents, the accused system must use one of the specified anti-VEGF selections (including stated modifications/analogs categories).

4. Is the sleeve material limitation important for enforcement?
Only if the asserted claims are the dependents requiring a rigid and/or non-deformable dynamic sleeve. Claim 1 does not, on the provided text, require rigidity.

5. Are filters and deployment indicators central to the patent’s novelty?
They appear as optional dependent features (claims 5-10). The core likely remains the sleeve/measurement architecture in claim 1.

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References (APA)

1. US Patent 9,421,129. (n.d.). Injector attachment for ophthalmic injection with dynamic sleeve and distance measuring component.

Details for Patent 9,421,129

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2033-03-15
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	June 30, 2006		2033-03-15
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	August 10, 2012		2033-03-15
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	October 13, 2016		2033-03-15
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	March 20, 2018		2033-03-15
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	November 18, 2011		2033-03-15