Details for Patent: 10,195,334

Which drugs does patent 10,195,334 protect, and when does it expire?

Patent 10,195,334 protects HEPZATO and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 10,195,334

Title:	Filter and frame apparatus and method of use
Abstract:	Provided is a filter apparatus, comprising two or more filter cartridges having a first end with an inlet and screen and a second end with an outlet and screen, and walls to contain a filter media held in a housing for holding the two or more filter cartridges in about the same orientation, and an attachment clamp connected to the housing. Also provided is a housing for holding two or more filter cartridges in about the same orientation and a method of using the filter apparatus and housing.
Inventor(s):	William M. Appling, Stephen N. Engelhard, Matthew G. Barton
Assignee:	Rosalind Master Fund Lp
Application Number:	US15/071,896
Patent Claim Types: see list of patent claims	Use; Device;

US Patent 10,195,334 Landscape: What Claims 1–13 Cover for Hemofiltration Filter Setup, Bubble Visibility, Priming, and Flushing

Executive summary. US 10,195,334 is directed to a method of setting up a hemofiltration filter apparatus on an IV pole, using a multi-cartridge housing whose upper and lower plates rotatably couple cartridges in the same orientation, so a user can rotate cartridges to observe lodged air bubbles in transparent cartridge walls/filter media. The claim set broadens from that core setup to specific installation mechanics (clamping; tubing to pump/saline bag/flow monitor; catheter connections), and to procedural steps (priming; flushing with saline including bottom loading; tapping to free bubbles). Dependent claims additionally narrow to housing construction (plates connected; plates parallel; clamp attachment), and to filter-media options (activated carbon; hydrogel-coated activated carbon). The claim themes cluster around (1) mechanically rotatable multi-cartridge positioning, (2) transparent cartridge tube for bubble inspection, and (3) setup/priming/flushing workflow for air management in hemofiltration.

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H1: US 10,195,334 Patent Scope and Claims: Rotatable Multi-Cartridge Hemofiltration Setup With Transparent Media

What is claimed in one sentence?

A method of attaching and preparing a hemofiltration filter apparatus that uses two or more cartridges in a transparent, filter-media-containing cartridge tube that is rotatably coupled to upper and lower plates, enabling users to rotate the cartridges to visually confirm lodged air bubbles in the filter media and then perform related priming/flushing/tapping steps.

Claim scope map (independent claim 1 as the backbone)

Independent claim 1 has five structural/procedural pillars:

1. Attachment on IV pole

   • “Attaching a filter apparatus to an IV pole.”

2. Multi-cartridge architecture with defined ends

   • “Two or more filter cartridges each having:
     • a first end with an inlet and a first screen
     • a second end with an outlet and a second screen”
   • Each cartridge includes “walls comprising a cartridge tube that is transparent and comprises a filter media.”

3. Housing that holds cartridges in substantially the same orientation

   • Housing has “upper plate” and “lower plate.”
   • Each plate defines “two or more openings” that rotatably couple the cartridges.
   • “Cartridges extend through openings of the upper plate and the lower plate.”
   • Orientation is controlled: “configured to hold the two or more filter cartridges in about the same orientation.”

4. Rotation as the enabling step for air-bubble inspection

   • “Rotating the two or more filter cartridges to observe if there are lodged air bubbles in the filter media.”

5. Functional relationship: transparency + rotation enables visual inspection

   • Transparent tube containing the media makes “observe” workable; rotatability makes “observe from different angles” workable; “same orientation” standardizes the inspection process across multiple cartridges.

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H2: How broad is Claim 1 of US 10,195,334 for hemofiltration filter setup on an IV pole?

Featured-snippet answer. Claim 1 is moderately broad on the setup concept and multi-cartridge housing/rotation/observation, but it is anchored to specific system features: transparent cartridge tube with filter media, rotatable coupling via upper and lower plates, and rotation to detect lodged air bubbles.

Key breadth levers in Claim 1

• “Two or more” cartridges: captures dual, tri, or larger multi-cartridge layouts.
• “Configured to hold … in about the same orientation”: gives tolerance for manufacturing variation while preserving the rotational symmetry and inspection consistency.
• “Transparent” tube: does not specify degree (optically transparent vs. translucent). But “observe … lodged air bubbles” implies visibility sufficient to identify bubbles.
• “Rotatably coupled”: covers a range of bearing/clamping/hinge-like coupling structures so long as cartridges rotate relative to the housing plates.
• “Observe if there are lodged air bubbles”: ties rotation to inspection rather than rotation for flow control or mixing.

Claim 1 limits that reduce design-around freedom

• The method requires both:
  • transparent cartridge tube with filter media, and
  • rotatable coupling through openings in both upper and lower plates.
• If a competitor uses a fixed-orientation cartridge and instead uses sensors (pressure/ultrasound) rather than visual observation, Claim 1 may not be met because the claimed method specifically uses rotation to observe lodged air bubbles.

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H2: What do Claims 2–11 add to US 10,195,334 scope for housing construction and setup workflow?

Answer. Dependent claims 2–11 largely specify mechanical implementation (plate connection, clamping, tubing/catheter connections, parallel plate orientation, clamp attachment) and operational steps (priming, flushing, bottom filling, tapping to free bubbles).

Claim-by-claim incremental coverage

Claim 2. Upper plate and lower plate are connected to each other

• Narrows housing construction to integrated/connected plate geometry.
• If a competitor uses independent plate elements that are not “connected,” this claim avoids coverage.

Claim 3. Attaching is by clamping

• Narrows “attaching” method.
• If attachment is via straps, hooks, magnets, or bayonet locks instead of a clamp, Claim 3 is not triggered.

Claim 4. Connecting cartridges to pump/saline bag/flow rate monitor via tubing

• Expands the method’s system context beyond “attachment to IV pole” into an operational chain.
• Broadly covers tubing connections to common hemofiltration components.

Claim 5. Further comprising priming the filter cartridges

• Adds a specific procedural step.
• If a system does not prime cartridges (or primes upstream and bypasses the claimed method steps), Claim 5 is avoided.

Claim 6. Further comprising flushing the filter cartridge with saline

• Adds another procedural step.

Claim 7. Flushing includes filling the filter cartridge with saline from the bottom

• Narrows flushing mechanism to bottom loading.
• This is a strong design-around point: competitors using top loading, side injection, or circulation-based priming may not meet “from the bottom.”

Claim 8. Further comprising tapping the filter cartridge walls to free a lodged air bubble

• Adds manual agitation step.
• A competitor replacing tapping with vibration or automated agitation can avoid literal coverage, unless the new method still functionally “tapping” equivalents are argued.

Claim 9. Forming connections to supply catheter and venous return catheter

• Narrows method implementation to typical hemofiltration catheter routing.

Claim 10. Upper and lower plates oriented substantially parallel

• Limits to a parallel plate configuration.
• If housing plates are angled for ergonomic inspection, Claim 10 may not be met.

Claim 11. Filter apparatus further comprises an attachment clamp connected to the housing

• Narrows the presence and structural integration of a clamp attached to the housing (not merely clamping at the IV pole).

Practical consequence for infringement theory

Claim 1 is your primary hook for the rotatable multi-cartridge transparent inspection system. Claims 2–11 then create narrower fallback positions around how the system is mounted and prepared.

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H2: What do Claims 12–13 cover about filter media in US 10,195,334?

Answer. Claims 12–13 specify the filter media composition: activated carbon and then hydrogel-coated activated carbon.

Media-specific scope implications

• Claim 12: “filter media comprises activated carbon.”
  • Captures uncoated activated carbon in the transparent media-containing cartridge tube.
• Claim 13: “filter media is hydrogel coated activated carbon.”
  • Narrows to hydrogel-coated formulations.

Design-around opportunities within media selection

• Using a media type that is not activated carbon (e.g., polymer adsorbents, resins, membranes) can avoid claims 12 and 13.
• Even if activated carbon is present, changing coating type (or eliminating hydrogel coating) may avoid Claim 13 while still potentially falling under Claim 12.

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H2: How many patents cover rotatable multi-cartridge hemofiltration setups like US 10,195,334 in the US?

Answer. Not determinable from the information provided. The claim text alone does not identify the CPC classes, family members, continuations, or related patents needed to count “how many” covering the same concept across the US.

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H2: What patents protect the specific combination of transparent cartridge tube plus rotatable upper/lower plates to inspect air bubbles?

Answer. Not determinable from the information provided. A reliable protection map requires prosecution history, publication numbers, cited references, and the patent family (not supplied here).

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H2: When does US 10,195,334 lose exclusivity, and what is its patent term in practice?

Answer. Not determinable from the information provided. Term depends on priority date, filing dates, maintenance status, and any patent term adjustments or disclaimers, none of which are included in the prompt.

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H2: What is the Orange Book status of US 10,195,334, and does it relate to an FDA-approved drug?

Answer. Not determinable from the information provided. Orange Book status is specific to FDA product listings (NDC, drug substance, dosage form) and does not follow automatically from a method patent that is tied to a device/procedure rather than a listed drug product.

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H2: What generic entry risks exist for US 10,195,334 via Paragraph IV challenges?

Answer. Not determinable from the information provided. Paragraph IV is an ANDA mechanism for small-molecule drug product exclusivity, and a hemofiltration setup patent typically implicates device and procedure claims rather than a listed drug patent. A meaningful risk assessment requires linkage between the patent and an FDA-listed drug product and the presence of Orange Book listings.

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H2: What patent litigation or PTAB challenges affect US 10,195,334?

Answer. Not determinable from the information provided. Litigation/PTAB status requires docket-level lookup or known case identifiers.

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H2: How strong is the patent estate around US 10,195,334 for hemofiltration air-bubble prevention and priming workflows?

Claim strength indicators (based on claim language only)

• Specific physical features: transparent cartridge walls containing filter media + rotatable coupling via upper and lower plates.
• Clear user-action step: rotating to observe lodged air bubbles.
• Operational specificity: priming, saline flushing, bottom filling, and tapping.

These attributes support enforceability against systems that replicate the same method steps and mechanical inspection logic.

Weakness indicators (based on claim language only)

• The claim is a method claim. Enforcement depends on proving performance of the steps by a user (hospital staff, vendor, or service provider). That can be more complex than device-claim enforcement.
• Coverage may be narrower than broad “air removal” patents because the claimed mechanism is rotation for visual inspection and (in dependents) tapping and bottom flushing.

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H2: How does US 10,195,334 compare with typical hemofiltration cartridge and priming designs that use fixed orientations?

Answer. Not determinable against named competitor patents without a comparative dataset. But conceptually:

• Fixed-orientation cartridges can avoid the core requirement of rotatably coupled cartridges in upper and lower plates for inspection.
• Systems relying on non-visual air detection (pressure sensors, bubble sensors) rather than “observe … lodged air bubbles” can avoid Claim 1 method performance, depending on claim construction for “observe.”
• Systems that do not use a transparent tube containing the media can avoid the observation capability required by claim phrasing.

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H2: What jurisdictions and claim types are most likely to be in the same family as US 10,195,334?

Answer. Not determinable from the information provided. Jurisdictional spread requires publication family data and continuation tracking.

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H2: What formulations are protected by US 10,195,334, and are the media claims limited to carbon sorbents?

Answer. The claims presented protect filter media compositions in the cartridges:

• Activated carbon (Claim 12)
• Hydrogel-coated activated carbon (Claim 13)

The claim text does not cover pharmaceutical formulations; it targets the cartridge media used in the hemofiltration setup.

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H2: Which companies are likely implementing rotatable multi-cartridge hemofiltration housings with transparent media tubes?

Answer. Not determinable from the information provided. Company identification requires mapping from product catalogs, device manuals, and patent citations.

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Key Takeaways

• Core protection: Claim 1 targets a method combining (i) IV-pole attachment, (ii) transparent cartridge tube with filter media, and (iii) a housing with upper and lower plates that rotatably couple multiple cartridges, enabling rotation to visually observe lodged air bubbles.
• Fallback scope: Claims 2–11 narrow housing structure and operational steps, especially clamping, priming, saline flushing, bottom filling, and tapping to free bubbles.
• Media narrowing: Claims 12–13 are limited to activated carbon and hydrogel-coated activated carbon.
• Enforcement angle: Method claims depend on step performance, with enforcement typically focusing on the installation and preparation workflow plus the rotatable transparent cartridge housing.

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FAQs

1. Does rotating a cartridge for inspection need to be done after priming to meet Claim 1?
2. If only one cartridge is rotated while others remain stationary, does Claim 1’s “two or more” rotation requirement apply?
3. Can a design with transparent windows (instead of a transparent cartridge tube) avoid the “transparent” limitation?
4. If saline flushing is done by top injection rather than “from the bottom,” does Claim 7 avoid coverage?
5. If hydrogel-coated activated carbon is present but cartridges are not rotatably coupled through both upper and lower plate openings, which claims remain at risk?

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References (APA)

1. US Patent 10,195,334 (claim text provided in prompt).

Drugs Protected by US Patent 10,195,334

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes	10,195,334		Y

International Family Members for US Patent 10,195,334

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Denmark	3603693
European Patent Office	2797644
European Patent Office	3238762