Patent: 9,987,416

Summary for Patent: 9,987,416

Title:	Sterile assembled liquid medicament dosage control and delivery device
Abstract:	A liquid medicament dispenser includes a housing and a pump carried by the housing, a reservoir applied to the housing and containing a pre-filled sterile liquid medicament, a sterile tubing set routed through the pump, a sterile administration line carried outside of the housing and coupled aseptically to the sterile tubing set in fluid communication, and an aseptic connector coupled to the reservoir and the sterile tubing set and changeable from a storage state to a use state. In the storage state, the aseptic connector prevents the liquid medicament in the reservoir from moving to the sterile tubing set. In the use state of the aseptic connector, the aseptic connector defines a sterile passageway for the flow of the liquid medicament from the reservoir to the sterile tubing set.
Inventor(s):	McNall, III; Ralph I. (Belmont, CA), Kriesel; Joshua W. (San Francisco, CA), Joshi; Serena (San Francisco, CA), Donze; Thomas T. (San Bruno, CA)
Application Number:	14/593,720
Patent Claims:	see list of patent claims

United States Patent 9,987,416: Claim-by-Claim Scope and US Patent Landscape for Aseptically Activated Liquid Medicament Dispensers

Executive summary

• US 9,987,416 is centered on an “aseptic connector assembly” that is sealed in a storage state by compressed annular gaskets with a removable barrier between them, then converted to a use state by removing the barrier while the connector remains coaxially aligned and mechanically coupled during the transition.
• The patent’s enforceable core is a mechanical aseptic-changeover architecture: reservoir-to-tubing fluid communication is established only after a barrier removal event that simultaneously creates a sterile passageway via direct gasket-to-gasket sealing.
• Claims 2–7 and 10–12 add irreversibility, sterility retention, barrier location, energization upon barrier removal, and barrier thin-film implementations.
• Claims 13–19 broaden across pump type (peristaltic), sterile flexible tubing, sensing/constraint features, prefilled syringe reservoirs, and a long list of example medicaments/biologics and small-molecule drugs, which may be weak as novel matter but can support coverage for intended drug classes depending on how the prior art is mapped.
• The most likely validity and infringement pressure points are: (1) common gasketed sterile connectors, (2) barrier-mediated aseptic connectors and breakable/detachable sterile barriers, and (3) devices that already use removable sterility barriers paired with connector engagement to activate flow.

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What does US Patent 9,987,416 claim for aseptic connector activation with removable barriers?

Independent claim 1: mechanical “storage-to-use” conversion with coaxial alignment

Claim 1 requires, in combination:

1. A liquid medicament dispenser with:

   • a housing,
   • a pump carried by the housing,
   • a sterile liquid medicament reservoir in the housing,
   • a sterile tubing set routed through the pump,
   • a sterile administration line outside the housing aseptically coupled to the tubing set.

2. An aseptic connector assembly comprising:

   • a first portion that receives a first annular gasket,
   • a second portion that receives a second annular gasket,
   • a barrier disposed in contact between the first and second annular gaskets.

3. A defined two-state behavior:

   Storage state

   • first portion engaged with the reservoir
   • second portion fit to the tubing set
   • first and second portions coupled and compressed together, compressing gaskets together but with the barrier between them
   • barrier occludes the aseptic connector assembly to prevent medicament movement into the sterile tubing set.

   Use state

   • first and second portions remain coupled and compressed together
   • barrier is removed
   • first and second annular gaskets move into direct sealing contact, coupling reservoir and tubing set in fluid communication
   • a sterile passageway is defined for medicament flow.

4. Dynamic alignment constraint:

   • as the assembly moves from storage to use state, the first and second portions remain coupled and are maintained in coaxial alignment.

Critical scope implication: The patent is not just about “an aseptic connector.” It is about a sterility-barrier removal event that converts a mechanically pre-engaged, gasket-compressed connector from barrier-occluded to direct gasket-to-gasket sealing to form a sterile fluid path.

Claim interpretation pressure points

• Barrier “in contact between” gaskets: coverage likely requires the barrier to physically interface the gasket surfaces (or be positioned so it contacts both sides). Devices with a barrier elsewhere (e.g., between reservoir and connector but not between gaskets) may fall outside claim 1.
• “Barrier removable … to change … from storage state to use state”: the conversion must be attributable to barrier removal, not merely venting, opening valves, or switching fluidic paths.
• “First and second portions remain coupled” and coaxially aligned**: systems that separate halves and then rejoin may avoid this claim element (depending on construction and alignment during changeover).
• Direct and sealing contact after removal: embodiments that rely on a different sealing interface after activation (e.g., membranes that rupture and leave a new seal surface) may diverge.

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How do dependent claims 2–7 expand or narrow the “storage-to-use” aseptic connector concept?

Irreversibility (Claim 2)

Claim 2 requires the change from storage to use to be irreversible. This limits coverage to connectors that cannot be re-sealed back into a barrier-occluded storage mode.

Validity/infringement note: Many sterile connectors are designed to be single-use after activation. If prior art uses breakable membranes, peelable films, or tethered sterile barriers, irreversibility can be common and may not add novelty, but it constrains infringement design-arounds.

Sterility characterization of storage state (Claim 3)

Claim 3 defines storage state as characterized by:

• reservoir maintained sterile,
• tubing set maintained sterile,
• connector assembly maintained sterile.

This is functional language that could be satisfied by prior art if it already uses sterile packaging and sterile interior surfaces.

Barrier carried within housing (Claim 4)

Claim 4 requires the barrier to be carried by the aseptic connector assembly within the housing (not on the barrier outside of housing).

This is a narrowing element aimed at specific packaging/activation layouts.

Energization upon barrier removal (Claim 5)

Claim 5 ties barrier removal to an electrical/mechanical event: “upon removal … the dispenser is energized.” This suggests a switch, sensor, or interlock triggered by barrier motion.

This is a potentially defensible feature if prior art does not link mechanical barrier removal to activation of the pump.

Switch and battery-to-pump power control (Claim 6)

Claim 6 adds:

• a switch carried in the housing between battery and pump,
• in response to the connector state change, the switch moves from open to closed,
• power is available to the pump in closed state.

Design-around risk: Systems that activate pump independently of barrier removal, or that use software/controls not triggered directly by the barrier event, may avoid Claim 6 but still infringe Claim 1 if other elements are met.

Sterile passageway formed through assembly (Claim 7)

Claim 7 emphasizes that upon barrier removal, a sterile passageway is formed through the aseptic connector assembly between reservoir and tubing set.

This is consistent with claim 1 and does not necessarily add major novelty, but it reinforces the required functional outcome for infringement mapping.

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What aseptic connector geometries are covered: gaskets with bores/seats and irreversible engagement (Claims 8–9)?

Seat and bore gasket architecture (Claim 8)

Claim 8 requires:

• each portion formed with a bore and a seat around the bore,
• each annular gasket seated in the corresponding seat,
• barrier disposed between the annular gaskets.

Scope effect: This narrows to connectors where gaskets seat around bores to seal through compression. Many sterile connector families use similar engineering; however, specific seating and barrier positioning can affect literal scope.

Irreversible engagement of first and second portions (Claim 9)

Claim 9 requires in the use state:

• first portion engaged with second portion in an irreversible engagement coupling reservoir to tubing set.

This overlaps with single-use activation and may protect against designs that temporarily engage for storage and then engage again for use. But it can also be common in latch-based single-use medical connectors.

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What barrier location and barrier structure are covered: outside housing, thin films, and removable barrier assemblies (Claims 10–12)?

Barrier extends outside housing (Claim 10)

Claim 10 requires barrier extending from aseptic connector assembly to outside housing. This conflicts with Claim 4’s “within the housing” limitation, but those are alternative dependent claim paths, not mutually exclusive across the patent.

Barrier includes first and second thin films (Claim 11)

Claim 11 specifies:

• barrier includes a first thin film bonded to first portion,
• second thin film bonded to second portion,
• thin films presumably meet/contact and are removed to activate.

Thin film secured to second thin film outside housing (Claim 12)

Claim 12 says:

• first thin film secured to second thin film outside housing.

This suggests a removable sterile barrier made of coupled films that can be separated by pulling an external portion.

Infringement mapping note: Thin-film film-bonded barriers are a clearer structural requirement than generic “barriers.” Prior art may use membranes, foil seals, or breakable caps; not all will map cleanly into “thin film bonded to portions” with external coupling.

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What pump, tubing, sensing, and reservoir configurations are covered (Claims 13–17)?

Peristaltic pump (Claim 13)

Claim 13 requires the pump is peristaltic. That can narrow infringement relative to membrane pumps, syringe pumps, or diaphragm pumps.

If the competitive products use positive displacement pumps with a different contact path, they may avoid Claim 13 while still potentially infringing Claim 1 if claim 1 doesn’t mandate pump type. Here, Claim 1 already requires “a pump,” but only Claim 13 narrows to peristaltic.

Flexible tubing with compressible diameter (Claim 14)

Requires tubing is flexible with compressible diameter. Again, this is narrower and may map well to peristaltic pumping where tubing is compressed against rollers.

Force-sensing resistor and tubing constrained by a channel (Claim 15)

Claim 15 adds:

• printed circuit board,
• force-sensing resistor,
• a channel over the resistor,
• sterile tubing extends through and is constrained by the channel against the resistor.

This looks like a feedback control or compression verification feature. It is a specific combination that can differentiate from prior art dispensers without such sensing.

Prefilled reservoir prior to housing (Claim 16)

Requires reservoir filled before carried in housing.

This narrows to systems where sterile filling is done upstream.

Reservoir comprises a syringe (Claim 17)

Requires reservoir is a syringe. Many infusion and medicament delivery systems use syringes or cartridges; mapping to this exact embodiment is important.

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How does the patent treat medicament scope: does listing drugs create enforceable coverage? (Claims 18–19)

Drug example lists (Claims 18–19)

Claims 18 and 19 list large sets of medicaments including:

• small molecules and analgesics/anaesthetics (acetaminophen, ketamine, propofol, dexmedetomidine, fentanyl, remifentanil, etc.),
• antibiotics and antivirals (daptomycin, ertapenem, polymyxin B, acyclovir, gentamicin, etc.),
• biologics and oncology agents (bevacizumab, trastuzumab, infliximab, filgrastim, rituximab, cetuximab, etc.),
• cytotoxics/chemotherapy classes (cyclophosphamide, oxaliplatin, paclitaxel, etc.),
• immunoglobulin and specialty infusible products (intravenous immunoglobulin, immune globulin),
• plus other listed agents.

Practical enforceability view

• In many mechanical device patents, drug recitations function as intended-use coverage rather than adding new structural features. If prior art already has an aseptic dispenser architecture for liquids, novelty may reside in connector and sterilization mechanics rather than the identity of the drug.
• For freedom-to-operate and licensing analysis, these lists may support argument that the device is adapted for many liquid medicaments, but they rarely overcome strong mechanical prior art.
• If the closest prior art is also an aseptic connector/dispenser architecture, the drug list will likely not be a strong differentiator for validity. It can matter for claim construction and “device intended to dispense” in infringement, but mechanical elements dominate.

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Where is the highest prior-art risk: “aseptic connector with removable sterile barrier between sealing gaskets”?

Most likely prior-art clusters to search (and how they attack the claims)

1. Aseptic connectors with removable barriers/membranes

   • Breakable septa
   • Peelable sterile films
   • Tethered membrane pairs
   • Sterile docking interfaces where sterility is maintained until activation

2. Gasket-compressed sterile connectors

   • Coupled first/second halves compressing annular gaskets
   • Sealing surfaces and seats around bores
   • Single-use latching and irreversible connections

3. Connector halves maintained in coaxial alignment

   • Many connectors are designed to prevent misalignment during coupling
   • If prior art keeps halves aligned while a barrier is removed, Claim 1’s coaxial limitation may not distinguish.

What features are most likely to distinguish US 9,987,416

• The barrier located between the annular gaskets with the barrier occluding flow in storage, followed by barrier removal and direct sealing contact between the gaskets.
• The barrier-activated energization (Claims 5–6), if prior art connectors are purely mechanical and do not trigger a pump interlock.
• The specific thin-film barrier bonding with external film coupling (Claims 11–12).
• The combination with a peristaltic pump and compressible flexible tubing (Claim 13–14), if the closest prior art uses a different pumping mechanism.

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How strong is the patent estate for US 9,987,416 based on claim structure and design-around paths?

Strength: mechanical combination focus

• Claim 1’s combination is specific: sterile dispenser plus a barrier-occluded, gasket-sealed connector that transitions to direct sealing only after barrier removal while maintaining coupling and coaxial alignment.
• This can create a narrower infringement footprint than generic “aseptic connectors.”

Weakness: likely prior art coverage for sub-elements

• Each sub-element exists across sterile access technologies:
  • gaskets and seats around bores,
  • removable sterile barriers,
  • single-use irreversible engagement,
  • coaxial coupling and latching,
  • sterile docking to tubing sets.
• Courts evaluate novelty at the claim combination level. If a single reference discloses the entire transition mechanism, the estate weakens.

Design-around opportunities (infringer view)

• Remove the “barrier between gaskets” requirement by placing the sterility barrier elsewhere.
• Avoid “barrier removal” as the activation trigger; instead use valves or rupture points that establish flow without switching from barrier-occlusion to gasket-to-gasket sealing.
• Permit mechanical separation or lack of coaxial alignment during activation.
• Use non-peristaltic pump arrangements to avoid Claims 13–14.
• Do not link barrier removal to pump energization to avoid Claims 5–6.

These design-arounds are conceptually consistent with typical sterile fluid path engineering.

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What is the US litigation or Orange Book status for US 9,987,416?

No Orange Book status analysis can be produced from the provided record because US 9,987,416 is a device-like mechanical patent and the input does not include the associated FDA-approved drug product, NDA/BLA, or Orange Book listing. No litigation docket or PTAB/ITC activity can be reliably identified from the provided information.

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Key takeaways

1. US 9,987,416 protects a specific sterilized connector activation mechanism: barrier between annular gaskets in storage, occlusion of flow, then barrier removal to create direct gasket-to-gasket sealing and a sterile passageway.
2. Claim 1’s most enforceable elements are the barrier-in-between-gaskets geometry, the storage-to-use transition, and the requirement that connector portions remain coupled with coaxial alignment through activation.
3. Dependent claims add commercially meaningful constraints: irreversibility, energization interlock, barrier thin-film structure, peristaltic pump/tubing constraints, and force-sensing tubing constraint.
4. Medicament lists (Claims 18–19) likely play a secondary role versus the mechanical connector and activation scheme; validity and infringement will turn on connector mechanics, not drug identity.

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FAQs

1. What connector features are required to infringe Claim 1’s “storage state” vs “use state” limitations?
   A system must have an aseptic connector with first/second annular gaskets and a barrier contacting between the gaskets in storage, then barrier removal must establish direct gasket-to-gasket sealing and fluid communication while the connector remains coupled and coaxially aligned.

2. Do gaskets need to be compressed in both storage and use states for Claim 1 coverage?
   Yes. Claim 1 requires first and second portions are coupled and compressed together in storage and again in use, with the barrier present only in storage.

3. Can a design that uses a valve to open a sterile fluid path avoid US 9,987,416?
   Potentially, if activation is not accomplished by removing the barrier between the gaskets to bring the gaskets into direct sealing contact, or if the sterile passageway is formed without that barrier removal transition.

4. How do Claims 5–6 narrow infringement beyond Claim 1?
   They require an electrical switch or interlock that moves from open to closed in response to the connector changing from storage to use state, providing battery power to the pump.

5. Does using a non-peristaltic pump avoid the patent?
   It can avoid dependent Claim 13 but not necessarily Claim 1, since Claim 1 only requires a pump, not that it is peristaltic. Infringement analysis must map the specific pump features to the dependent claims asserted.

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References

No external sources were cited because no bibliographic metadata (assignee, filing date, continuation family, prosecution history), patent number context beyond the claim text, or related litigation/Orange Book/drug product identifiers were provided in the input.

Details for Patent 9,987,416

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	May 23, 1994	9,987,416	2035-01-09
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	September 22, 1999	9,987,416	2035-01-09
Pfizer Inc.	ELELYSO	taliglucerase alfa	For Injection	022458	May 01, 2012	9,987,416	2035-01-09