IP Library Granted Patent US 9,759,716
Granted Patent B2
US 9,759,716 · App. 15/157,362 · Granted Sep 12, 2017

Compositions, apparatus and methods for monitoring biomarkers

Inventors: Natalie Green (Sacramento, CA); Juliana Green (Sacramento, CA)
Assignee: Berkeley NOX Limited
G01N33/526G01N33/84G01N2800/32G01N2800/708Y10T436/177692
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Quick Facts
Patent No.
US 9,759,716
App. No.
15/157,362
Granted
Sep 12, 2017
Kind
B2
Abstract

A single device to collect, transfer, and measure salivary nitric oxide analyte and metabolite, nitrite, a biomarker for nitric oxide, as well as, a method to assess the effects of diet and exercise on changing an individual's nitric oxide status and health.

Claims (17)

1. A method for increasing dietary intake of nitrate rich foods comprising the use of a device for the detection of the presence of nitric oxide in saliva,

wherein the device comprises a single unit for collecting the saliva and analyzing the contents of the saliva,

wherein the single unit comprises an elongated strip, wherein the strip contains a scored mark at the midpoint of the strip and wherein the strip contains a first absorbent pad at one end and a second absorbent pad at the opposite end,

wherein the first absorbent pad comprises a fluid collection pad, and wherein the second absorbent pad comprises a test pad,

wherein the test pad enables dry reagent detection chemistry comprising components modified from the Griess diazotization reaction, comprising mixture of N-naphthylenediamine-dihydrochloride and sulphanilamide, or N-(naphthyl)ethylenediammonium-dihydrochloride and sulphanilamide, or para-arsanilic acid N-ethylenediamine tetrahydroquinoline, or para-arsanilic acid N-(1-naphthyl)ethylenediamine dihydrochoride;

wherein the fluid collection pad is inserted into the mouth for a first predetermined period of time to absorb saliva, wherein the device is then folded so that the fluid collection pad and test pad make contact for a second predetermined period of time, wherein the contact between the fluid collection pad and test pad results in a color change on the test pad following a third predetermined period,

wherein the color change is compared to a color scale and wherever the color falls within the scale, a representative physiological nitric oxide content is evaluated; and

wherein the test pad provides a concentration range of the nitric oxide analyte, nitrite, ranging from 12 to >400 μmol /L with visibly distinct color ranges corresponding to 0 to 25, 25 to 100, 100 to 200, 200 to 350, or greater than 400 μmol /L.

2. The method of claim 1 , wherein the nitrate rich foods contain high levels of cardioprotective and cardio-enhancing factors.

3. The method of claim 2 , wherein the nitrate rich foods comprise leafy greens, spinach and arugula.

4. The method of claim 2 , wherein the nitrate rich food comprises beetroots, beetroot juice, and beetroot powder.

5. The method of claim 1 , wherein the increased dietary intake of nitrate rich foods results in improved cardiovascular health.

6. The method of claim 1 , wherein the fluid collection pad comprises a wicking pad, membrane, paper, resin, sponge, immunoabsorbent pad, ionic, or other suitable platform that absorbs saliva analytes to be transferred to the test reagent pad.

7. The method of claim 1 , wherein the representative physiological nitric oxide content is utilized to enable the assessment of vascular wellness and fitness.

8. The method of claim 7 , wherein vascular wellness and fitness comprises the ability to maintain a normal blood pressure range, lower blood pressure, extend time-to-exhaustion, reduce the need for oxygen consumption, improve cellular respiration, or mitochondrial efficiency.

9. The method of claim 1 , wherein the representative physiological nitric oxide content is utilized to enable modification of nitric oxide levels comprising daily physical exercise, anaerobic training, aerobic training, consuming a diet consisting of leafy green vegetables and other nitrate-rich vegetables, fruit, whole foods supplement intended to increase nitric oxide levels, consuming a Mediterranean diet, or consuming a DASH diet.

10. The method of claim 1 , wherein the first and second predetermined period of time are about 10 seconds; and wherein the third predetermined period of time is about 10-45 seconds.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 28, 2021
From: BERKELEY NOX LIMITED
To: RHA INVESTMENT LIMITED
Reel/Frame 056379/0778 →
CORRECTIVE ASSIGNMENT TO CORRECT THE EXECUTION DATES INSIDE THE ASSIGNMENT DOCUMENT PREVIOUSLY RECORDED AT REEL: 042001 FRAME: 0640. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 4, 2017
From: GREEN, NATALIE; GREEN, JULIANA
To: BERKELEY TEST, LLC
Reel/Frame 043528/0774 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2017
From: GREEN, NATALIE; GREEN, JULIANA
To: BERKELEY TEST, LLC
Reel/Frame 042001/0640 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2017
From: BERKELEY TEST, LLC
To: BERKELEY NOX LIMITED
Reel/Frame 042001/0721 →
Continuity (3)
Continuation 14020065 · Sep 6, 2013
Provisional Application 61697462 · Sep 6, 2012
Related Publication 20170074866A1 · Mar 16, 2017