IP Library › Granted Patent US 12,623,227
Granted Patent B2
US 12,623,227 · App. 17/910,149 · Granted May 12, 2026

Apparatus and methods for molecular diagnostics

Inventors: Richard Crockett (Austin, TX); Alan Blake (Austin, TX); Michael Karberg (Austin, TX); John Lupher (Austin, TX); Chris Clever Nee (Austin, TX); Matthew Flint Kepler (Austin, TX)
Assignee: NUCLEIN, LLC
B01L7/52B01L2200/16B01L2300/0832B01L2400/043B01L2400/0478B01L2400/0683
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Quick Facts
Patent No.
US 12,623,227
App. No.
17/910,149
Granted
May 12, 2026
Kind
B2
Abstract

This disclosure relates to apparatus and methods for molecular diagnostics. Certain embodiments include a piston cycled from a first position proximal to a first end of a housing, to a second position proximal to a second end of the housing, and back to the first position proximal to the first end of the housing. In some embodiments, the present disclosure relates to devices, methods, and systems for molecular diagnostics that do not comprise a piston.

Claims (43)

1 . An apparatus for performing molecular diagnostics, the apparatus comprising:

a chamber comprising:

a piston; and

a fluid configured to amplify a nucleic acid via thermal cycling;

a plurality of reservoirs;

a plurality of reaction components, wherein each reaction component is contained in a reservoir of the plurality of reservoirs; and

a control circuit configured to receive a first signal from a user interface and transmit a second signal to the array of reaction component, wherein the second signal causes the release of a reaction component from a reservoir into the chamber.

2 . An apparatus according to claim 1 wherein the plurality of reservoirs is arranged in an array.

3 . An apparatus according to claim 1 , wherein the user interface is incorporated into a separate device that transmits the first signal to the control circuit, and wherein the separate device is a smart phone, tablet or computer.

4 . An apparatus according to claim 1 , wherein the reaction component from the array of reaction components is a primer set is configured to replicate a nucleic acid and identify a particular analyte.

5 . An apparatus according to claim 1 , wherein the piston is configured to reciprocate in the chamber, and wherein the apparatus further comprises a light source configured to illuminate the reaction components chamber.

6 . An apparatus according to claim 1 , wherein:

the chamber comprises a first end and a second;

the apparatus comprises a first heat source proximal to the first end of the chamber.

7 . An apparatus according to claim 6 , further comprising an actuator configured to move the piston in a cycle from a first position proximal to the first end of the chamber, to a second position proximal to the second end of the chamber, and back to the first position proximal to the first end of the chamber.

8 . An apparatus as in claim 7 wherein:

the piston is configured to direct the fluid to the second end of the chamber when the piston is in the first position; and

the piston is configured to direct the fluid to the first end of the chamber when the piston is in the second position.

9 . An apparatus according to claim 7 , further comprising a controller configured to control the actuator.

10 . An apparatus of claim 9 wherein:

the apparatus further comprises a second heat source proximal to a second end of the chamber;

the controller is configured to control the first heat source and the second heat source;

the controller is configured to control the first heat source to heat the fluid proximal to the first end of the chamber to a temperature between about 92 and 98 degrees Celsius;

the controller is configured to control the second heat source to heat the fluid proximal to the second end of the chamber to a temperature between about 60 and 65 degrees Celsius; and

the controller is configured to cycle the piston from the first position to the second position and back to the first position between about 30 and 50 cycles.

11 . An apparatus according to claim 10 , wherein:

the nucleic acid is DNA or RNA; and

the fluid comprises polymerase chain reaction (PCR) reagents or reverse transcriptase polymerase chain reaction (RT-PCR) reagents.

12 . An apparatus according to claim 1 , further comprising an illumination module configured to illuminate an analyte contained in the fluid and a detection module configured to detect a response from the analyte contained in the fluid.

13 . An apparatus according to claim 12 , wherein the detection module detects a response from the analyte in real time during amplification.

14 . An apparatus according to claim 12 , wherein the detection module detects a response from the analyte within an amplification cycle.

15 . An apparatus according to claim 1 , wherein the apparatus weighs less than two pounds.

16 . An apparatus according to claim 1 , wherein the apparatus has two or fewer moving parts.

17 . An apparatus according to claim 1 , wherein the apparatus is powered by a battery having a capacity not greater than 3,000 mAh.

18 . An apparatus according to claim 1 , wherein the apparatus has an operating noise level of less than 10 decibels.

19 . An apparatus according to claim 1 , wherein chamber has a volume of less than 50 microliters.

20 . A method of analyzing a biological sample, the method comprising:

obtaining an apparatus for performing molecular diagnostics, where the apparatus comprises:

a chamber comprising a piston and a fluid, wherein the fluid is configured to amplify a nucleic acid via thermal cycling;

a plurality of reservoirs;

a plurality of reaction components, wherein each reaction component is sealed in a reservoir of the plurality of reservoirs; and

a control circuit configured to receive a first signal from a user interface and transmit a second signal, wherein the second signal causes the release of a desired reaction component of the plurality of reaction components from a reservoir into the chamber; and

selecting the desired reaction component of the plurality of reaction components via the user interface.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 21, 2023
From: CROCKETT, RICHARD; BLAKE, ALAN; KARBERG, MICHAEL; LUPHER, JOHN; NEE, CHRIS CLEVER; KEPLER, MATTHEW FLINT
To: NUCLEIN, LLC
Reel/Frame 062758/0924 →
Continuity (2)
Provisional Application 62987185 · Mar 9, 2020
Related Publication 20230105360A1 · Apr 6, 2023
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