Granted Patent
B2
US 12,416,630 · App. 18/120,329 · Granted Sep 16, 2025
Methods and devices for integrating analyte extraction, concentration and detection
Inventors:
Daniel Takashi Kamei (Monterey Park, CA); Yin To Chiu (Irvine, CA); Benjamin Ming Wu (San Marino, CA); Garrett L. Mosley (Newport Beach, CA)
View Patent ↗
Loading inventors, assignments & file history…
Abstract
Disclosed herein are devices and methods that use aqueous two phase systems and lateral flow assays to detect target analytes in a sample. These devices and methods may be used to diagnose a disease or condition in a biological sample, such as blood or serum. In addition, these devices and methods may be used to detect allergens in a food samples or contaminants, such as environmental toxins, in water samples. Device and kit components may be conveniently assembled in a portable container and are amenable to actuation in most settings. The devices are simple to use, requiring a non-trained operator to simply add the sample to the device. Conveniently, the time it takes to detect the target analyte is very short. Thus, the devices and methods disclosed herein provide novel and useful means for point-of-care.
Claims (31)
1. A device for the detection and/or quantification of a target analyte in a sample, the device comprising:
a lateral flow assay (LFA) comprising a porous matrix configured to contain an ATPS or components thereof;
an aqueous two-phase system (ATPS) or components thereof, wherein, in use, the ATPS comprises a mixed phase solution that separates into a first phase solution, a second phase solution, and an interface between said first phase solution and said second phase solution; and
a probe capable of binding said target analyte and forming a probe-analyte complex wherein, in use, said probe partitions preferentially into said interface of the ATPS.
2. The device of claim 1 , wherein the separation of the mixed phase into the first phase solution and the second phase solution occurs within the LFA.
3. The device of claim 1 , wherein a component of the first and/or a component of the second phase solution is dehydrated on and/or in said porous matrix.
4. The device of claim 3 , wherein the device is configured such that application of the sample to the device hydrates the ATPS or component thereof, thereby providing the ATPS or components thereof in the fluid phase.
5. The device of claim 1 , wherein, the probe comprises a material selected from the group consisting of a synthetic polymer, a metal, a mineral, a glass, a quartz, a ceramic, a biological polymer, a plastic, and combinations thereof.
6. The device of claim 5 , wherein the probe comprises a biological polymer selected from the group consisting of dextran, polypropylene glycol, polyethylene glycol, and combinations thereof.
7. The device of claim 5 , wherein the probe comprises a metal selected from the group consisting of gold, silver, platinum, and combinations thereof.
8. The device of claim 7 , wherein the probe comprises a nanoparticle.
9. The device of claim 8 , wherein the nanoparticle is a gold nanoparticle.
10. The device of claim 1 , wherein the probe comprises a coating that has an affinity for said interface.
11. The device of claim 10 , wherein said coating comprises a polymer that has an affinity for said interface.
12. The device of claim 11 , wherein the coating comprises polypropylene glycol or polyethylene glycol.
13. The device of claim 10 , wherein said coating comprises a hydrophilic protein.
14. The device of claim 13 , wherein the coating comprises serum albumin.
15. The device of claim 1 , wherein the aqueous two-phase system (ATPS) or components thereof comprise form a polymer-salt ATPS.
16. The device of claim 15 , wherein said polymer-salt ATPS comprises a polymer selected from the group consisting of Polyethylene glycol (PEG), Polypropylene glycol (PPG), Dextran, Ethylhydroxyethyl cellulose, Ficoll, Hydroxypropyl dextran, Hydroxypropyl starch, Maltodextrin, Methoxypolyethylene glycol, Methyl cellulose, Polyvinyl alcohol, and Polyvinyl pyrrolidone.
17. The device of claim 16 , wherein said polymer-salt ATPS comprises polyethylene glycol, polypropylene glycol, dextran, and combinations thereof.
18. The device of claim 17 , wherein said polymer-salt ATPS comprises polyethylene glycol (PEG).
19. The device of claim 15 , wherein said polymer-salt ATPS comprises a salt selected from the group consisting of potassium phosphate, sodium sulfate, magnesium sulfate, ammonium sulfate, and sodium citrate.
20. The device of claim 19 , wherein said polymer-salt ATPS comprises potassium phosphate.
21. The device of claim 15 , wherein said polymer-salt ATPS comprises polyethylene glycol (PEG) and potassium phosphate.
22. The device of claim 1 , wherein said porous matrix comprises a material selected from the group consisting of a sintered glass ceramic, a mineral, cellulose, a fiberglass, a nitrocellulose, polyvinylidene fluoride, a nylon, a charge modified nylon, a polyethersulfone, and combinations thereof.
23. The device of claim 1 , wherein the probe comprises a binding moiety that binds the target analyte.
24. The device of claim 23 , wherein the binding moiety is selected from the group consisting of an antibody, an antibody fragment, a lectin, a protein, a glycoprotein, a nucleic acid, a small molecule, a polymer, a lipid, and combinations thereof.
25. A method of detecting and/or quantifying a target analyte in a sample comprising:
applying the sample to a device of claim 1 ; and
detecting a presence or absence and/or quantifying the target analyte on the LFA.
26. The method of claim 25 , wherein the method comprises applying the sample to the LFA, wherein the LFA and the ATPS are integrated.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 18, 2025
From: KAMEI, DANIEL T.; CHIU, YIN TO; WU, BENJAMIN M.; MOSLEY, GARRETT L.
To: THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
Reel/Frame 070244/0509 →
Continuity (8)
Provisional Application
61953870
· Mar 16, 2014
Provisional Application
61949887
· Mar 7, 2014
References Cited (282)
US 5141850A
· Cole et al.
· 1992
[cited by applicant]
US 6194221B1
· Rehg et al.
· 2001
[cited by applicant]
US 6436722B1
· Clark et al.
· 2002
[cited by applicant]
US 6855561B2
· Jerome et al.
· 2005
[cited by applicant]
US 6924153B1
· Boehringer et al.
· 2005
[cited by applicant]
US 6979576B1
· Cheng et al.
· 2005
[cited by applicant]
US 7179657B2
· Jerome et al.
· 2007
[cited by applicant]
US 7226793B2
· Jerome et al.
· 2007
[cited by applicant]
US 7459314B2
· Guo et al.
· 2008
[cited by applicant]
US 7537937B2
· Jerome et al.
· 2009
[cited by applicant]
US 7553675B2
· Jerome et al.
· 2009
[cited by applicant]
US 7666614B2
· Cheng et al.
· 2010
[cited by applicant]
US 7794656B2
· Liang et al.
· 2010
[cited by applicant]
US 7867780B2
· Jones et al.
· 2011
[cited by applicant]
US 7932099B2
· Egan et al.
· 2011
[cited by applicant]
US 8003765B2
· Pentyala
· 2011
[cited by applicant]
US 8030091B2
· Jerome et al.
· 2011
[cited by applicant]
US 8193002B2
· Guo et al.
· 2012
[cited by applicant]
US 8377710B2
· Whitesides et al.
· 2013
[cited by applicant]
US 8445293B2
· Babu et al.
· 2013
[cited by applicant]
US 8603832B2
· Whitesides et al.
· 2013
[cited by applicant]
US 8628729B2
· Carrilho et al.
· 2014
[cited by applicant]
US 8828739B2
· Guo et al.
· 2014
[cited by applicant]
US 9193988B2
· Whitesides et al.
· 2015
[cited by applicant]
US 9207236B2
· Cary
· 2015
[cited by applicant]
US 9250236B2
· Babu et al.
· 2016
[cited by applicant]
US 9347955B2
· Pieribone
· 2016
[cited by applicant]
US 9823247B2
· Kamei et al.
· 2017
[cited by applicant]
US 20030215358A1
· Schulman et al.
· 2003
[cited by applicant]
US 20040002168A1
· Remington et al.
· 2004
[cited by applicant]
US 20040203079A1
· Pentyala
· 2004
[cited by applicant]
US 20060019406A1
· Wei et al.
· 2006
[cited by applicant]
US 20060025579A1
· Riedl et al.
· 2006
[cited by applicant]
US 20070003992A1
· Pentyala
· 2007
[cited by applicant]
US 20070140911A1
· Carney et al.
· 2007
[cited by applicant]
US 20070292902A1
· Cheng et al.
· 2007
[cited by applicant]
US 20080138842A1
· Boehringer et al.
· 2008
[cited by applicant]
US 20080227220A1
· Franse et al.
· 2008
[cited by applicant]
US 20080254440A1
· Uchida et al.
· 2008
[cited by applicant]
US 20090110601A1
· Levi et al.
· 2009
[cited by applicant]
US 20090191648A1
· Bohannon
· 2009
[cited by applicant]
US 20100227323A1
· Baeumner et al.
· 2010
[cited by applicant]
US 20110003310A1
· Ennis et al.
· 2011
[cited by applicant]
US 20110151479A1
· Stevens et al.
· 2011
[cited by applicant]
US 20110312074A1
· Azimi et al.
· 2011
[cited by applicant]
US 20120107956A1
· Boehringer et al.
· 2012
[cited by applicant]
US 20120238008A1
· Henry et al.
· 2012
[cited by applicant]
US 20130102063A1
· Levi et al.
· 2013
[cited by applicant]
US 20140004539A1
· Simon et al.
· 2014
[cited by applicant]
US 20140228549A1
· Schembecker et al.
· 2014
[cited by applicant]
US 20150017656A1
· Wang
· 2015
[cited by applicant]
US 20150198592A1
· Wang
· 2015
[cited by applicant]
US 20150323534A1
· Egan et al.
· 2015
[cited by applicant]
US 20160282343A1
· Jeyendran et al.
· 2016
[cited by applicant]
US 20160313307A1
· Titmus et al.
· 2016
[cited by applicant]
US 20160334397A1
· Yan et al.
· 2016
[cited by applicant]
US 20170323441A1
· Shah et al.
· 2017
[cited by applicant]
US 20180188256A1
· Wong
· 2018
[cited by applicant]
US 20200150116A1
· Kamei et al.
· 2020
[cited by applicant]
CN 102224160A
· 2011
[cited by applicant]
CN 102584933A
· 2012
[cited by applicant]
CN 103008038A
· 2013
[cited by applicant]
CN 106662582A
· 2017
[cited by applicant]
EP 1064553A1
· 2001
[cited by applicant]
EP 1340085A1
· 2003
[cited by applicant]
EP 1436592A1
· 2004
[cited by applicant]
EP 1733233A2
· 2006
[cited by applicant]
EP 1771734A1
· 2007
[cited by applicant]
EP 0941468B1
· 2007
[cited by applicant]
EP 2076775A2
· 2009
[cited by applicant]
EP 2126569A2
· 2009
[cited by applicant]
EP 2245135A2
· 2010
[cited by applicant]
EP 2426498A1
· 2012
[cited by applicant]
ES 2382381T3
· 2012
[cited by applicant]
JP H03130663A
· 1991
[cited by applicant]
JP 2003250575A
· 2003
[cited by applicant]
JP 2007500363A
· 2007
[cited by applicant]
JP 2008537119A
· 2008
[cited by applicant]
JP 2011075366A
· 2011
[cited by applicant]
JP 2013531259A
· 2013
[cited by applicant]
JP 2013181870A
· 2013
[cited by applicant]
KR 20080103200A
· 2008
[cited by applicant]
WO WO9818964A1
· 1998
[cited by applicant]
WO WO2004081528A2
· 2004
[cited by applicant]
WO WO2005042579A1
· 2005
[cited by applicant]
WO WO2005074609A2
· 2005
[cited by applicant]
WO WO2005098439A2
· 2005
[cited by applicant]
WO WO2007092302A2
· 2007
[cited by applicant]
WO WO2008043040A2
· 2008
[cited by applicant]
WO WO2011116256A2
· 2011
[cited by applicant]
WO WO2011159537A2
· 2011
[cited by applicant]
WO WO2012010666A1
· 2012
[cited by applicant]
WO WO2013105090A1
· 2013
[cited by applicant]
WO WO2015134938A1
· 2015
[cited by applicant]
WO WO2017041030A1
· 2017
[cited by applicant]
WO WO2017214315A1
· 2017
[cited by applicant]
WO WO2018039139A1
· 2018
[cited by applicant]
WO WO2018183211A1
· 2018
[cited by applicant]
WO WO2018222765A1
· 2018
[cited by applicant]
Ahmed (2015) “Hydrogel: Preparation, characterization, and applications: A review” J. Adv. Res., 6:105-121.
[cited by applicant]
Arrer et al. (2002) “β-Trace Protein as a Marker for Cerebrospinal Fluid Rhinorrhea” Clin. Chem. 48(6): 939-941.
[cited by applicant]
AU Examination report No. 1 dated May 24, 2021 issued in AU 2020201579.
[cited by applicant]
AU Examination report No. 1 dated Oct. 8, 2019 issued in AU 2015226930.
[cited by applicant]
AU Office Action dated Aug. 8, 2023, in application No. AU2017277631.
[cited by applicant]
AU Office Action dated Nov. 4, 2021 issued in AU 2016318103.
[cited by applicant]
AU Office Action dated Oct. 10, 2022, in Application No. AU2016318103.
[cited by applicant]
Bachmann et al. (2002) “Predictive values of beta-trace protein (prostaglandin D synthase) by use of laser-nephelometry assay for the identification of cerebrospinal fluid.” Neurosurgery, 50(3): 571-577.
[cited by applicant]
Bernasconi, L., et al., “Retrospective Validation of a Beta-trace Protein Interpretation Algorithm for the Diagnosis of Cerebrospinal Fluid Leakage”, Clinical Chemistry and Laboratory Medicine, published online Sep. 22,…
[cited by applicant]
CA Office Action dated Jan. 28, 2023, in Application No. CA3002020.
[cited by applicant]
CA Office Action dated May 19, 2022, in Application No. CA3002020.
[cited by applicant]
Carter and Cary (2007) “Lateral flow microarrays: a novel platform for rapid nucleic acid detection based on miniaturized lateral flow chromatography,” Nucleic Acids Research 35(10): e74 (11 pages).
[cited by applicant]
Center for Disease Control and Prevention. Diagnostic Tests for Zika Virus. “Updated Guidance for US Laboratories Testing for Zika Virus Infection Jul. 24, 2017”; Availabe at: https://www.cdc.gov/zika/transmission/index…
[cited by applicant]
Chiu, et al. (2010) “Generation of Porous Poly(Ethylene Glycol) Hydrogels by Salt Leaching.” Tissue Engineering Part C: Methods 16: 905-912.
[cited by applicant]
Chiu et al. (2014) “Biomarker concentration and detection directly on paper,” abstract, MicroTAS Annual Meeting, San Antonio, Texas, 3 pages.
[cited by applicant]
Chiu et al. (2014) “Dextran-coated gold nanoprobes for the concentration and detection of protein biomarkers,” Annals of Biomedical Engineering 42(11): 2322-2332.
[cited by applicant]
Chiu et al. (2014) “Simultaneous concentration and detection of biomarkers on paper,” poster presentation, MicroTAS Annual Meeting, San Antonio, Texas, 1 page.
[cited by applicant]
Chiu et al. (2014) “Simultaneously concentrating and detecting biomarkers on paper,” abstract of podium presentation, The Biomedical Engineering Society Annual Meeting, San Antonio, Texas, 1 page.
[cited by applicant]
Chiu et al. (2014) “Simultaneously concentrating and detecting biomarkers on paper,” slides from podium presentation, The Biomedical Engineering Society Annual Meeting, San Antonio, Texas, 52 slides.
[cited by applicant]
Chiu et al. (2014) “Manipulating gold nanoparticles to achieve effective and rapid detection of protein biomarkers for resource-poor settings,” slides from presentation, not published/distributed. The Annual UC System w…
[cited by applicant]
Chiu et al. (2014) “Polymer-coated gold nanoprobes for the concentration and detection of protein biomarkers for resource-poor settings,” The Biomedical Engineering Society Annual Meeting, San Antonio, Texas, poster, 1 …
[cited by applicant]
Chiu et al. (2014) “Polymer-coated gold nanoprobes for the concentration and detection of protein biomarkers for resource-poor settings,” The Biomedical Engineering Society Annual Meeting, San Antonio, Texas, published …
[cited by applicant]
Chiu et al., (2015) “An aqueous two-phase system for the concentration and extraction of proteins from the interface for detection using the lateral-flow immunoassay,” PLoS One 10: e0142654 (14 pages).
[cited by applicant]
Chiu et al. (2015) “Creating the gold standard point-of-care test for sexually transmitted infections,” 20 slide deck, not published, not distributed, for judging only, OneStart Competition, 20 pages.
[cited by applicant]
Chiu et al. (2015) “Creating the gold standard point-of-care test for sexually transmitted infections,” 3 minute/3 slide deck, OneStart Competition, 3 pages.
[cited by applicant]
Chiu, R.Y.T., et al., “Simultaneous concentration and detection of biomarkers on paper,” Lab Chip, 2014, vol. 14(16), pp. 3021-3028.
[cited by applicant]
Cho, et al. (2013) “Lateral-flow enzyme immunoconcentration for rapid detection of Listeria monocytogenes.” Anal Bioanal Chem 405:3313-3319.
[cited by applicant]
CN First Office Action dated Jan. 22, 2018 issued in CN 201580023439.9.
[cited by applicant]
CN First Office Action dated Mar. 27, 2020 issued in CN 201680059385.6.
[cited by applicant]
CN Fourth Office Action dated Mar. 24, 2022 issued in CN 201680059385.6 with English translation.
[cited by applicant]
CN Office Action dated Aug. 29, 2022 in Application No. CN201780046652 with English translation.
[cited by applicant]
CN Office Action dated Dec. 15, 2022 in Application No. 201880042214.1 with English translation.
[cited by applicant]
CN Office Action dated Feb. 24, 2022, in Application No. CN201780046652 with English translation.
[cited by applicant]
CN Office Action dated Oct. 25, 2022, in application No. CN201911106057.9 with English translation.
[cited by applicant]
CN Second Office Action dated Feb. 20, 2021 issued in CN 201680059385.6.
[cited by applicant]
CN Second Office Action dated Nov. 29, 2018 issued in CN 201580023439.9.
[cited by applicant]
CN Third Office Action dated Jun. 22, 2021 issued in CN 201680059385.6.
[cited by applicant]
EP 2nd Office Action dated Jul. 27, 2021 issued in EP 17810966.6.
[cited by applicant]
EP Extended European Search report dated Apr. 21, 2023, in Application No. EP22211678.2.
[cited by applicant]
EP Extended Search Report dated Mar. 23, 2021 issued in EP 20200335.6.
[cited by applicant]
EP Extended Search Report dated Oct. 26, 2017 issued in EP 15758881.5.
[cited by applicant]
EP Extended Supplementary Search Report dated Dec. 6, 2019 issued in EP 17810966.6.
[cited by applicant]
EP Extended Supplementary Search Report dated Jan. 27, 2021 issued in EP 18809609.3.
[cited by applicant]
EP Extended Supplementary Search Report dated Jun. 14, 2019 issued in EP 16843134.4.
[cited by applicant]
EP Office Action dated Oct. 6, 2020 issued in EP 17810966.6.
[cited by applicant]
EP Partial Supplementary Search Report dated Feb. 4, 2019 issued in EP 16843134.4.
[cited by applicant]
European Office Action dated Mar. 9, 2023 in Application No. EP18809609.3.
[cited by applicant]
Fang et al. (2011) “Barcode lateral flow immunochromatographic strip for prostate acid phosphatase determination,” J. Pharmaceut. Biomed. Anal., 56(5): 1035-1040.
[cited by applicant]
Fu et al. (2011) “Enhanced sensitivity of lateral flow tests using a two-dimensional paper network format,” Anal. Chem. 83(20): 7941-7946 (NIH Public Access—Author Manuscript—12 pages).
[cited by applicant]
Fung et al. (2009) “Development of a creatinine enzyme-based bar-code-style lateral-flow assay,” Analytical and Bioanalytical Chemistry, 393(4): 1281-1287.
[cited by applicant]
Fung et al. (2009) “Development of enzyme-based bar code-style lateral-flow assay for hydrogen peroxide determination,” Anal Chim Acta. 634(1): 89-95.
[cited by applicant]
GCA Saliva-Check Mutans product sheet. 2011. http://www.gcamerica.com/storage/dps_c/GCA_SALIVA-CHECK_MUTANS-iPad.pdf retrieved Sep. 21, 2019.
[cited by applicant]
International Preliminary Report on Patentability dated Mar. 2, 2023, in PCT Application No. PCT/US2021/046166.
[cited by applicant]
International Search Report and Written Opinion dated Nov. 30, 2021, in PCT Application No. PCT/US2021/046166.
[cited by applicant]
JP 2nd Office Action dated Aug. 30, 2021 issued in JP 2018-511707.
[cited by applicant]
JP 2nd Office Action dated Feb. 3, 2020 issued in JP 2016-573716.
[cited by applicant]
JP Office Action dated Apr. 3, 2023 in Application No. JP2022-28070 with English translation.
[cited by applicant]
JP Office Action dated Aug. 8, 2022, in Application No. JP2021-15690 with English translation.
[cited by applicant]
JP Office Action dated Dec. 12, 2022, in Application No. 2018-564267 with English translation.
[cited by applicant]
JP Office Action dated Feb. 14, 2022, in Application No. JP2021-15690 with English translation.
[cited by applicant]
JP Office Action dated Feb. 8, 2019 issued in JP 2016-573716.
[cited by applicant]
JP Office Action dated Mar. 7, 2022, in Application No. JP2018-564267 with English translation.
[cited by applicant]
JP Office Action dated May 17, 2021 issued in JP 2018-564267.
[cited by applicant]
JP Office Action dated Sep. 7, 2020 issued in JP 2018-511707.
[cited by applicant]
Jue et al. (2014) “Simultaneous Concentration and Detection of Biomarkers on Paper,” published document for the Capstone Design team, MicroTAS Annual Meeting, San Antonio, Texas, 7 pages.
[cited by applicant]
Jue et al. (2014) “Using an aqueous two-phase polymer-salt system to rapidly concentrate viruses for improving the detection limit of the lateral-flow immunoassay,” Biotechnology and Bioengineering 111(12): 2499-2507.
[cited by applicant]
Jue et al. “Simultaneous Concentration and Detection of Biomarkers on Paper,” document submitted but not published, UCLA, 23 pages.
[cited by applicant]
Kim, et al. (2013) “Image Analysis of a Lateral Flow Strip Sensor for the Detection of Escherichia coli 0157:H7.” J. of Biosystems Eng. 38(4):335-340.
[cited by applicant]
Koczula, et al. (2016) “Lateral flow assays.” Essays in Biochemistry 60: 111-120.
[cited by applicant]
KR Office Action dated Apr. 26, 2023, in Application No. KR10-2019-7000413 with English translation.
[cited by applicant]
KR Office Action dated Aug. 10, 2023, in Application No. KR10-2019-7000413 with English translation.
[cited by applicant]
KR Office Action dated Aug. 23, 2021 issued in KR 10-2019-7000413.
[cited by applicant]
KR Office Action dated Dec. 12, 2022 in Application No. KR10-2022-7013951 with English translation.
[cited by applicant]
KR Office Action dated Jan. 25, 2022, in Application No. KR1020167027705 with English translation.
[cited by applicant]
KR Office Action dated Jan. 26, 2023, in Application No. KR10-2018-7009424 with English translation.
[cited by applicant]
KR Office Action dated Jun. 21, 2022, in Application No. KR10-2019-7000413 with English translation.
[cited by applicant]
KR Office Action dated Mar. 22, 2021 issued in KR 10-2016-7027705.
[cited by applicant]
Le, A.M., et aL, “Improving the Lateral-Flow Immunoassay Using Aqueous Two-Phase Systems”, 2012, pp. 78 pages.
[cited by applicant]
Leung, W., et al. “InfectCheck CRP Barcode-style Lateral Flow Assay for Semi-quantitative Detection of C-reactive Protein in Distinguishing between Bacterial and Viral Infections,” Journal of Immunological Methods, 2008…
[cited by applicant]
Luo, et al. (2005) “PDMS microfludic device for optical detection of protein immunoassay using gold nanoparticles.” Lab on a Chip 5:726-729.
[cited by applicant]
Mashayekhi et al. (2009) “Concentration of mammalian genomic DNA using two-phase aqueous micellar systems,” Biotechnology and Bioengineering 102(6): 1613-1623, publ online Nov. 3, 2008, publ in journal Apr. 15, 2009.
[cited by applicant]
Mashayekhi, F. et al., “Enhancing the Lateral-flow Immunoassay for Detection of Proteins Using an Aqueous Two-phase Micellar System,” Analytical and Bioanalytical Chemistry, Jul. 31, 2012, vol. 404, pp. 2057-2066.
[cited by applicant]
Mashayekhi, F. et al., “Enhancing the Lateral-flow Immunoassay for Viral Detection Using an Aqueous Two-phase Micellar System”, Analytical and Bioanalytical Chemistry, Sep. 24, 2010, vol. 398, No. 7, pp. 2955-2961.
[cited by applicant]
McCudden et al. (2012) “Evaluation of high resolution gel beta 2-transferrin for detection of cerebrospinal fluid leak,” Clinical Chemistry and Laboratory Medicine 6 pages [Abastract].
[cited by applicant]
McCudden et al. (2013) “Evaluation of high resolution gel β2-transferrin for detection of cerebrospinal fluid leak.” Clin. Chem. Lab. Med., 51(2): 311-315, CCLM / FESCC. 0. 1-5. 10.1515/cclm-2012-0408.
[cited by applicant]
Mosley G. et al. (2017) “Improved lateral-flow immunoassays for chlamydia and immunoglobulin M by sequential rehydration of two-phase system components within a paper-based diagnostic” Mikrochimica Acta 184(10): 4055-40…
[cited by applicant]
MY Office Action dated Dec. 2, 2019 issued in My PI2016001615.
[cited by applicant]
NIH Small Business Technology Transfer Grant Application, Proposal to improve healthcare of tooth decay by developing a point-of-care (POC) diagnostic device, 6 pages, submitted Nov. 19, 2014.
[cited by applicant]
PCT International Preliminary Report on Patentability dated Dec. 20, 2018 issued in PCT/US2017/036418.
[cited by applicant]
PCT International Preliminary Report on Patentability dated Dec. 3, 2019 issued in PCT/US2018/035204.
[cited by applicant]
PCT International Preliminary Report on Patentability dated Feb. 26, 2019 issued in PCT/US2017/047849.
[cited by applicant]
PCT International Preliminary Report on Patentability dated Mar. 15, 2018 issued in PCT/US2016/050257.
[cited by applicant]
PCT International Preliminary Report on Patentability dated Oct. 1, 2019 issued in PCT/US2018/024392.
[cited by applicant]
PCT International Preliminary Report on Patentability dated Sep. 13, 2016 issued in PCT/US2015/019297.
[cited by applicant]
PCT International Search Report and Written Opinion dated Aug. 3, 2018 issued in PCT/US2018/035204.
[cited by applicant]
PCT International Search Report and Written Opinion dated Dec. 1, 2017 issued in PCT/US2017/047849.
[cited by applicant]
PCT International Search Report and Written Opinion dated Dec. 22, 2016 issued in PCT/US2016/050257.
[cited by applicant]
PCT International Search Report and Written Opinion dated Jun. 15, 2018 issued in PCT/US2018/024392.
[cited by applicant]
PCT International Search Report and Written Opinion dated Jun. 3, 2015 issued in PCT/US2015/019297.
[cited by applicant]
PCT International Search Report and Written Opinion dated Sep. 20, 2017 issued in PCT/US2017/036418.
[cited by applicant]
Pereira et al. (2014) “Enhancing the phase separation behavior of a micellar aqueous two- phase system in a paper-based diagnostic,” The Annual UC System wide Bioengineering Symposium, Irvine, California, poster, 1 page.
[cited by applicant]
Pereira et al. (2014) “Enhancing the phase separation behavior of a micellar aqueous two- phase system in a paper-based diagnostic,” UC Bioengineering Symposium 2014, Abstract, 2 pages.
[cited by applicant]
Pereira et al. (2014) “Paper-based diagnostic accelerates phase separation of a micellar aqueous two-phase system,” The Biomedical Engineering Society Annual Meeting, San Antonio, Texas, poster, 1 page.
[cited by applicant]
Pereira et al. (2015) “Improving malaria biomarker detection and accelerating micellar two- phase separation with a paper-based diagnostic,” Department of Engineering, UCLA 90095, UCLA Tech Forum, abstract, 1 page.
[cited by applicant]
Pereira et al. (2015) “Improving malaria biomarker detection and accelerating micellar two-phase separation with a paper-based diagnostic,” The UCLA Engineering Tech Forum, Los Angeles, California, poster, 1 page.
[cited by applicant]
Pereira et al. (2015) “Single-step, paper-based concentration and detection of a malaria biomarker,” Analytica Chimica Acta 882: 83-89.
[cited by applicant]
Pereira et al. “Paper-based diagnostic accelerates phase separation of a micellar aqueous two-phase system,” Department of Engineering, University of California, Los Angeles, abstract, 2 pages.
[cited by applicant]
Phase Diagnostics, Business Plan, OneStart Competition 2015, May 2015, 12 pages.
[cited by applicant]
Raja, S. et al., “Aqueous Two Phase Systems for the Recovery of Biomolecules—A Review”, Science and Technology, 2011, vol. 1, No. 1, pp. 7-16.
[cited by applicant]
Ribeiro S.C., et al., “Isolation of Plasmid Dna From Cell Lysates by Aqueous Two-phase Systems,” Biotechnology and Bioengineering, May 2002, vol. 78(4), pp. 376-384.
[cited by applicant]
Risch, et al. (2005) “Rapid, accurate and non-invasive detection of cerebrospinal fluid leakage using combined determination of B-trace protein in secretion and serum” Clinica Chimica Acta 351: 169-176.
[cited by applicant]
Sampaio et al. (2009) “Predictability of quantification of beta-trace protein for diagnosis of cerebrospinal fluid leak: Cutoff determination in nasal fluids with two control groups.” Am. J. Rhinol. Allerg. 23(6): 585-5…
[cited by applicant]
Sarangi, B.K. et al., “Purification of Alkaline Protease from Chicken Intestine by Aqueous Two Phase System of Polyethylene Glycol and Sodium Citrate”, Journal of Food Science and Technology, Nov. 1, 2010, vol. 48, No. …
[cited by applicant]
SG Examination Report dated May 14, 2019 issued in Sg 11201607582R.
[cited by applicant]
SG Office Action [Search Report and Written Opinion] dated Jan. 24, 2018 issued in SG 11201607582R.
[cited by applicant]
Song, et al. (2016) “Instrument-Free Point-of-Care Molecular Detection of Zika Virus.” Analytical Chemistry 88: 7289-7294.
[cited by applicant]
US Final Office Action dated Jun. 1, 2021 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
U.S. Final office Action dated Jun. 23, 2022 in U.S. Appl. No. 16/307,125.
[cited by applicant]
US Final Office Action dated Jun. 4, 2020 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
U.S. Final Office Action dated Mar. 10, 2023 in U.S. Appl. No. 16/616,923.
[cited by applicant]
US Final Office Action dated May 17, 2021 issued in U.S. Appl. No. 16/498,312.
[cited by applicant]
U.S. Non-Final office Action dated Apr. 17, 2023 in U.S. Appl. No. 17/530,336.
[cited by applicant]
U.S. Non-Final Office Action dated Jun. 24, 2022, in U.S. Appl. No. 16/616,923.
[cited by applicant]
U.S. Non-Final Office Action dated Mar. 29, 2023 in U.S. Appl. No. 17/673,530.
[cited by applicant]
U.S. Non-Final Office Action dated May 25, 2022, in U.S. Appl. No. 16/751,114.
[cited by applicant]
US Notice of Allowance dated Apr. 3, 2019 issued in U.S. Appl. No. 15/990,398.
[cited by applicant]
US Notice of Allowance dated Aug. 23, 2021 issued in U.S. Appl. No. 16/498,312.
[cited by applicant]
U.S. Notice of Allowance dated Aug. 23, 2023 in U.S. Appl. No. 17/530,336.
[cited by applicant]
US Notice of Allowance dated Aug. 8, 2017 issued in U.S. Appl. No. 14/641,022.
[cited by applicant]
U.S. Notice of Allowance dated Dec. 13, 2022 in U.S. Appl. No. 16/751,114.
[cited by applicant]
US Notice of Allowance dated Feb. 28, 2018 issued in U.S. Appl. No. 15/787,638.
[cited by applicant]
U.S. Notice of Allowance dated Jan. 12, 2022, in U.S. Appl. No. 16/326,687.
[cited by applicant]
U.S. Notice of Allowance dated Jul. 19, 2023, in U.S. Appl. No. 16/307,125.
[cited by applicant]
US Notice of Allowance dated Jul. 20, 2017 issued in U.S. Appl. No. 14/641,022.
[cited by applicant]
US Notice of Allowance dated Nov. 16, 2021 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
U.S. Notice of Allowance dated Sep. 18, 2023 in U.S. Appl. No. 17/673,530.
[cited by applicant]
US Office Action Advisory Action dated Aug. 20, 2021 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
US Office Action Advisory Action (second) dated Sep. 17, 2021 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
US Office Action dated Jan. 21, 2021 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
US Office Action dated Jan. 6, 2017 issued in U.S. Appl. No. 14/641,022.
[cited by applicant]
US Office Action dated Jun. 4, 2021 issued in U.S. Appl. No. 16/326,687.
[cited by applicant]
US Office Action dated Jun. 9, 2021 issued in U.S. Appl. No. 16/307,125.
[cited by applicant]
US Office Action dated Nov. 2, 2018 issued in U.S. Appl. No. 15/990,398.
[cited by applicant]
US Office Action dated Oct. 27, 2020 issued in U.S. Appl. No. 16/498,312.
[cited by applicant]
US Office Action dated Sep. 26, 2019 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
US Office Action [Restriction Requirement] dated May 14, 2019 issued in U.S. Appl. No. 15/756,542.
[cited by applicant]
U.S. Restriction Requirement dated Jan. 25, 2022, in U.S. Appl. No. 16/616,923.
[cited by applicant]
Wong et al. (2015) “Direct Reading of Bona Fide Barcode Assays for Diagnostics with Smartphone Apps,” Scientific Reports 5, Article No. 11727 (11 pages).
[cited by applicant]
Wu et al. (Jul. 21, 2014) “Research highlights: increasing paper possibilities” Lab on a Chip, 14(17) 3258-3261.
[cited by applicant]
Yu, et al. (2009) “Flow-through functionalized PDMS microfluidic channels with dextran derivative for ELISAs.” Lab on a Chip 9:1243-1247.
[cited by applicant]