# US 10,369,215 B2 · Predilution sets for distributing antigens

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- Number: US 10,369,215 B2
- Document ID: US10369215B2
- Status: Granted
- Kind: B2
- Application number: 15/183,719
- Filed: 2016-06-15
- Published: 2016-12-22
- Granted: 2019-08-06
- Earliest claimed: 2015-06-02
- Assignees: Roca Medical Ltd.
- Applicants: Roca Medical Ltd.
- Inventors: James Strader; Jovan Hutton Pulitzer
- Web page: https://patentgrep.com/patent/US10369215B2

## CPC

- A61K 39/35: Allergens
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A method for delivering allergens to a pharmacist in a pre-diluted kit form, comprising providing a bulk container of base concentrate antigen containing at least one antigen at a predetermined concentrated level, creating a sequential and more diluted sequence of antigens, providing a plurality of end-use sealable containers that can receive a finite end amount of diluted antigens, dispensing from each of sequential bulk containers a finite end amount of diluted antigens into one of the plurality of end-use sealable containers, wherein the end-use seal containers filled from each of the sequential bulk containers comprises a group of end-use sealable containers associated with each of the sequential bulk containers, sealing each of the end-use containers after diluted antigens are disposed therein, and disposing a select number of the sealed end-use sealable containers from each of the groups of end-use sealable containers into a container comprising a kit.

## Claims

### Claim 1

A prediluted kit including a range of prediluted doses of allergens for dispensing to a pharmacy, comprising:
a container having a plurality of receiving pockets, each being associated with one of a plurality of sequential diluted allergen levels all based on a base concentrate antigen wherein the base concentrate antigen includes at least one specific antigen;
a plurality of end-use sealable containers of prediluted antigens,
wherein the plurality of end-use sealable containers are sterile,
wherein each one of the plurality of end-use sealable containers is at a defined level and disposed in one of the plurality of receiving pockets,
wherein each one of the plurality of end-use sealable containers is prepackaged as already including the base concentrate antigen at a sequential dilution level diluted in accordance with a predetermined sequential dilution process to provide sequentially lower dilution levels for use in an allergy desensitization regimen prescribed by a medical professional, and
wherein each one of the plurality of end-use sealable containers includes at least one insert operable to:
provide an elongated interior in the end-use sealable container, the elongated interior having a volume corresponding to at least a dose; and
fill space within the end-use sealable container to dispose a prediluted antigen at an elevated level in the end-use sealable container for extraction; and
an indicator disposed in association with each of the plurality of receiving pockets indicating the dilution level of the associated one of the end-use sealable containers included therein.

### Claim 2 (depends on 1)

The kit of claim 1, wherein each of the plurality of end-use sealable containers includes more than one diluted antigen.

### Claim 3 (depends on 1)

The kit of claim 1, wherein each of the plurality of end-use sealable containers includes only a single diluted antigen.

### Claim 4 (depends on 1)

The kit of claim 1, wherein a National Drug Code (NDC) of the base concentrate antigen is indicated on the container.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the indicator comprises a color code, there being a separate color code associated with each dilution level and wherein each of the end-use sealable containers associated with each of the dilution levels has a corresponding color code disposed there on.

### Claim 6 (depends on 1)

The kit of claim 1, wherein each of the end-use sealable containers contains only a single dose of diluted allergen, as defined by the medical professional.

### Claim 7 (depends on 2)

The kit of claim 2, wherein a plurality of National Drug Codes (NDC) is indicated on the container, wherein each of the plurality of NDCs is associated with a base concentrate antigen of each of the more than one diluted antigen.