The broken line depiction of a point-of-care device is included for the purpose of illustrating environmental structure and forms no part of the claimed design.
The broken line depiction of a point-of-care device is included for the purpose of illustrating environmental structure and forms no part of the claimed design.
Number | Name | Date | Kind |
---|---|---|---|
5281395 | Markart et al. | Jan 1994 | A |
5413764 | Haar | May 1995 | A |
5567594 | Calenoff | Oct 1996 | A |
5885577 | Alvarez | Mar 1999 | A |
6146589 | Chandler | Nov 2000 | A |
6210901 | Seidel et al. | Apr 2001 | B1 |
7074888 | Miller et al. | Jul 2006 | B1 |
8193002 | Guo et al. | Jun 2012 | B2 |
8507216 | Kuroda et al. | Aug 2013 | B2 |
9250233 | Kipps et al. | Feb 2016 | B2 |
D774205 | Grace | Dec 2016 | S |
20030068664 | Albitar et al. | Apr 2003 | A1 |
20050084491 | Shealy et al. | Apr 2005 | A1 |
20050191620 | McDevitt et al. | Sep 2005 | A1 |
20050208587 | Cardoso et al. | Sep 2005 | A1 |
20050272106 | Moore et al. | Dec 2005 | A1 |
20060008920 | Wong et al. | Jan 2006 | A1 |
20060068501 | Li et al. | Mar 2006 | A1 |
20060286379 | Gao | Dec 2006 | A1 |
20100330585 | Kabri et al. | Dec 2010 | A1 |
20110117636 | Bae et al. | May 2011 | A1 |
20110136155 | Mehra et al. | Jun 2011 | A1 |
20110320130 | Valdes et al. | Dec 2011 | A1 |
20120220049 | Bunce et al. | Aug 2012 | A1 |
20120225423 | Schwoebel et al. | Sep 2012 | A1 |
20130040401 | Zin et al. | Feb 2013 | A1 |
20130085349 | Shaanan et al. | Apr 2013 | A1 |
20130130404 | Mehra et al. | May 2013 | A1 |
20130143246 | Nelson et al. | Jun 2013 | A1 |
20150293086 | Messmer et al. | Oct 2015 | A1 |
20150301031 | Zin et al. | Oct 2015 | A1 |
20160146829 | Kipps et al. | May 2016 | A1 |
Number | Date | Country |
---|---|---|
WO-2007022557 | Mar 2007 | WO |
WO-2009121024 | Oct 2009 | WO |
WO-2012023053 | Feb 2012 | WO |
WO-2015160834 | Oct 2015 | WO |
WO-2016123105 | Aug 2016 | WO |
Entry |
---|
Colman et al. Effects of amino acid sequence changes on antibody-antigen interactions. Research in Immunology 145(1):33-36 (1994). |
Dalakas et al. Effect of Alemtuzumab (Campath 1H) in patients with inclusion-body myositis. Brain 132:1536-1544 (2009). |
Harlow et al. Antibodies: A Laboratory Manual. Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY, pp. 23-26 (1988). |
Lederman et al. A single amino acid substitution in a common African allele of the CD4 molecule ablates binding of the monoclonal antibody, OKT4. Mol Immunol 28(11):1171-1181 (1991). |
U.S. Appl. No. 14/686,578 Office Action dated Oct. 14, 2016. |
U.S. Appl. No. 14/981,715 Office Action dated Jul. 12, 2016. |
McDade et al. What a Drop Can Do: Dried Blood Spots As a Minimally Invasive Method for Integrating Biomarkers into Population Based Research. Demography 44(4):899-925 (2007). |
PCT/US2015/025796 International Preliminary Report on Patentability dated Oct. 27, 2016. |
U.S. Serial No. 14/981,715 Office Action dated Jan. 19, 2017. |
U.S. Serial No. 15/185,549 Office Action dated Jan. 6, 2017. |
Adams et al. Monoclonal antibody therapy of cancer. Nat Biotechnol. 23:1147-1157 (2005). |
Barenholz et al. A peptide mimetic of the mycobacterial mannosylated lipoarabinomannan: characterization and potential applications. J Med Microbiol 56(pt 5):579-586 (2007). |
Barnett et al. In-Field Implementation of a Recombinant Factor C Assay for the Detection of Lipopolysaccharide as a Biomarker of Extant Life within Glacial Environments. Biosensors (Basel) 2(1):83-100 (2012). |
Bazin et al. Rapid visual tests: fast and reliable detection of ochratoxin A. Toxins (Basel) 2(9):2230-2241 (2010). |
Beum et al. Three new assays for rituximab based on its immunological activity or antigenic properties: analyses of sera and plasmas of RTX-treated patients with chronic lymphocytic leukemia and other B cell lymphomas. J Immunol Methods 289(1-2)97-109 (2004). |
Blasco et al. Evaluation of a peptide ELISA for the detection of rituximab in serum. J Immun Methods 325(1-2):127-139 (2007). |
Breidenbach et al. Substrate recognition strategy for botulinum neurotoxin serotype A. Nature 432(7019):925-929 (2004). |
Brissette et al. Identification of cancer targets and therapeutics using phage display. Curr Opin Drug Discov Devel 9:363-369 (2006). |
Carpino et al. 9-Fluorenylmethoxycarbonyl amino-protecting group. J Org Chem 37(22)3404-3409 (1972). |
Co-pending U.S. Appl. No. 15/185,549, filed Jun. 17, 2016. |
Co-pending U.S. Appl. No. 29/568,418, filed Jun. 17, 2016. |
Degardin et al. Understanding and fighting the medicine counterfeit market. J Pharm Biomed Anal 87:167-175 (2013). |
Delano et al. Convergent solutions to binding at a protein-protein interface. Science 287(5456):1279-1283 (2000). |
Ding et al. Endotoxin detection—from limulus amebocyte lysate to recombinant factor C. Subcell Biochem 53:187-208 (2010). |
FDA—definition of biological product. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm (Jul. 2015). |
Feltrup et al. Development of a fluorescence internal quenching correction factor to correct botulinum neurotoxin type a endopeptidase kinetics using SNAPtide. Anal Chem 84(24):10549-10553 (2012). |
Fernandez-Salas et al. Botulinum Neurotoxin Serotype a Specific Cell-Based Potency Assay to Replace the Mouse Bioassay. PLoS One 7(11):e49516 (2012). |
Golden et al. Extended result reading window in lateral flow tests detecting exposure to Onchocerca volvulus: a new technology to improve epidemiological surveillance tools. PLoS One 8(7):e69231 (2013). |
Hale et al. Blood concentrations of alemtuzumab and antiglobulin responses in patients with chronic lymphocytic leukemia following intravenous or subcutaneous routes of administration. Blood 104(4):948-955 (2004). |
Hale. Synthetic peptide mimotope of the CAMPATH-1 (CD52) antigen, a small glycosylphosphatidylinositol-anchored glycoprotein. Immunotechnology 1(3-4):175-187 (1995). |
Jiang et al. A novel peptide isolated from a phage display peptide library with trastuzumab can mimic antigen epitope of HER-2 J Biol Chem 280(6):4656-4662 (2004). |
Jilani et al. Alemtuzumab: validation of a sensitive and simple enzyme-linked immunosorbent assay. Leuk Res 28(12):1255-1262 (2004). |
Joiner et al. Comparison of Endotoxin Testing Methods for Pharmaceutical Products. Int J Pharm Compd 6:408-409 (2002). |
Jones et al. Development of improved SNAP25 endopeptidase immuno-assays for botulinum type A and E toxins. J Immunol Meth 329(1-2):92-101 (2008). |
Kosik et al. Studies of enzymatic cleavage of cellulose using polysaccharide analysis by carbohydrate gel electrophoresis (PACE). Methods Enzymol 510:51-67 (2012). |
Laderman et al. Rapid, sensitive, and specific lateral-flow immunochromatographic point-of-care device for detection of herpes simplex virus type 2-specific immunoglobulin G antibodies in serum and whole blood. Clin Vaccine Immunol. 15(1):159-163 (2007). |
Lee et al. Performance improvement of the one-dot lateral flow immunoassay for aflatoxin B1 by using a smartphone-based reading system. Sensors (Basel) 13(4):5109-5116 (2013). |
Lonza Limulus Amebocyte Lysate (LAL) QCL-1000. Available from: http://bio.lonza.com/uploads/txmwaxmarketingmaterial/Lonza ManualsProductInstructions CL-1000 Product Insert.pdf (2007). |
Maloney et al. IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 90(6):2188-2195 (1997). |
Manshouri et al. Circulating CD20 is detectable in the plasma of patients with chronic lymphocytic leukemia and is of prognostic significance. Blood 101(7):2507-2513 (2002). |
Merrifield. Solid Phase Peptide Synthesis I. J Am Chem Soc 85:2149-2154 (1963). |
Messmer et al. Specific blocking to improve biopanning in biological samples such as serum and hybridoma supernatants. Biotechniques 30(4):798-802 (2001). |
Messmer et al. Two human neonatal IgM antibodies encoded by different variable-region genes bind the same linear peptide: evidence for a stereotyped repertoire of epitope recognition. J Immun 162(4):2184-2192 (1999). |
Montagna et al. A new sensitive enzyme-linked immunosorbent assay (ELISA) for Alemtuzumab determination: development, validation and application. Int J Immunopathol Pharmacol 20(2):363-371 (2007). |
Mulvaney et al. Incorporating fluorescent dyes and quantum dots into magnetic microbeads for immunoassays. Biotechniques. 36(4):602-609 (2004). |
Nakamura et al. Lipopolysaccharide-sensitive serine-protease zymogen (factor C) found in Limulus hemocytes. Isolation and characterization. Eur J Biochem 154:511-521 (1986). |
Nakano et al. ELISAs for free human immunoglobulin light chains in serum: improvement of assay specificity by using two specific antibodies in a sandwich detection method. J Immunol Methods 293:183-189 (2004). |
Ouimet et al. Comparison of Fluorigenic Peptide Substrates PL50, SNAPtide, and BoTest A/E for BoNT/A Detection and Quantification: Exosite Binding Confers High-Assay Sensitivity. Journal of Biomolecular Screening 18(6):726-735 (2013). |
PCT/US2009/038674 International Preliminary Report on Patentability dated Sep. 28, 2010. |
PCT/US2009/038674 International Search Report and Written Opinion dated Dec. 24, 2009. |
PCT/US2015/025796 International Search Report and Written Opinion dated Aug. 21, 2015. |
PCT/US2016/14924 International Search Report and Written Opinion dated Apr. 8, 2016. |
Perosa et al. Identification of an antigenic and immunogenic motif expressed by two 7-merrituximab-specific cyclic peptide mimotopes: implication for peptide-based active immunotherapy. J Immunol 179(11):7967-7974 (2007). |
Pierce® LAL Chromogenic Endotoxin Quantitation Kit. Available from: https://www.piercenet.com/instructions/2162445.pdf (2013). |
Poras et al. Detection and Quantification of Botulinum Neurotoxin Type A by a Novel Rapid In Vitro Fluorimetric Assay. Applied and Environmental Microbiology 75(13):4382-4390 (2009). |
Rebello et al. Pharmacokinetics of CAMPATH-1H: assay development and validation. J Immunol Methods 260(1-2):285-302 (2002). |
Rohr et al. Immunoassay employing surface-enhanced Raman spectroscopy. Anal Biochem 182(2):388-398 (1989). |
Sanchez et al. A general process for the development of peptide-based immunoassays for monoclonal antibodies. Cancer Chemother Pharmacol 66(5):919-925 (2010). |
Shin et al. Combinatorial solid phase peptide synthesis and bioassays. J Biochem Mol Biol 38(5):517-525 (2005). |
Sosnick et al. Distances between the antigen-binding sites of three murine antibody subclasses measured using neutron and X-ray scattering. Biochemistry 31:1779-1786 (1992). |
Tan et al. Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors. Clin Cancer Res. 12(21):6517-6522 (2006). |
Tian et al. Antigen peptide-based immunosensors for rapid detection of antibodies and antigens. Anal Chem 81(13):5218-5225 (2009). |
Titov et al. Development and optimization of immunoassays for the detection of botulinum toxins. Prikl Biokhim Mikrobiol 48(2):249-256 (2012). |
Tokunaga et al. Further studies on lipopolysaccharide-sensitive serine protease zymogen (factor C): its isolation from Limulus polyphemus hemocytes and identification as an intracellular zymogen activated by alpha-chymotrypsin, not by trypsin. J Biochem 109:150-157 (1991). |
U.S. Serial No. 12/934,624 Office Action dated Aug. 22, 2014. |
U.S. Serial No. 12/934,624 Office Action dated Jan. 8, 2014. |
U.S. Serial No. 12/934,624 Office Action dated Mar. 27, 2015. |
Wang et al. Acute intraocular inflammation caused by endotoxin after intravitreal injection of counterfeit bevacizumab in Shanghai, China. Ophthalmology 120(2):355-361 (2013). |
Williams et al. Thrice-weekly low-dose rituximab decreases CD20 loss via shaving and promotes enhanced targeting in chronic lymphocytic leukemia. J Immunol 177:7435-7443 (2006). |