Quest Diagnostics Incorporated vs UNM Rainforest Innovations

Notice of Refund

Petitioner Quest Diagnostics Incorporated's Request for Refund of Inter Partes Review Post-Institution Fees Pursuant to 37 C.F.R. Section 42.15(b)

DECISION Settlement Prior to Institution of Trial

Petitioner and Patent Owner's Corrected Joint Request to File Settlement and 2006 License Agreement as Business Confidential Information Pursuant to 35 U.S.C. Section 317

Exhibit 1049: 2006 License Agreement

Petitioner and Patent Owner's Corrected Joint Motion to Terminate Inter Partes Review Proceedings Pursuant to 35 U.S.C. Section 317(A)

Exhibit 1048: Settlement and License Agreement

Decision Denying Joint Motion to Terminate

Petitioner and Patent Owner's Joint Motion to Terminate Inter Partes Review Proceedings Pursuant to 35 U.S.C. Section 317(A)

Petitioner and Patent Owner's Joint Request to File Settlement and License Agreement as Business Confidential Information Pursuant to 35 U.S.C. Section 317

Exhibit 1047: Settlement and License Agreement

Motion to Admit C. Key Pro Hac Vice

Declaration of C. Key Regarding Pro Hac Vice Admission

Patent Owner's Mandatory Notice

Patent Owner's Power of Attorney

Notice of Accord Filing Date

Exhibit 1001: U.S. Patent No. 7,666,683

Exhibit 1002: File History of U.S. Patent No. 7,666,683

Exhibit 1004: U.S. Patent 5,786,220 to Pronovost, et. al. ("Pronovost")

Exhibit 1005: Cole, L.A., et. al., Hyperglycosylated hCG (Invasive Trophoblast Antigen, ITA) a key antigen for early pregnancy detection, Clin. Biochemistry 36, 647-655 (2003) ("Cole 2003")

Exhibit 1007: Radwanska, E., et. al., Plasma Progesterone Levels in Normal and Abnormal Early Human Pregnancy, Fertility and Sterility 30 (4), 398-402 (Oct. 1978) ("Radwanska")

Exhibit 1008: Stern, J., et. al., Early diagnosis of ectopic pregnancy using receiver-operator characteristic curves of serum progesterone concentrations, Human Reproduction, 8(5), 775-779 (1993)

Exhibit 1010: Curriculum Vitae of Dr. Kurt Thomas Barnhart, M.D., M.S.C.E.

Exhibit 1012: File History of U.S. Patent No. 7,314,760

Exhibit 1013: Berger, P., et. al., Variants of Human Chorionic Gonadotropin from Pregnant Women and Tumor Patients recognized by Monoclonal Antibodies, J. Clin. Endo. and Metabolism, Vol. 77, No. 2, 347-351 (1993) ("Berger")

Exhibit 1014: Stenman, U., et. al., The classification, functions, and clinical use of different isoforms of HCG, Human Reproduction Update, Vol. 12, No. 6, 769-784 (2006) ("Stenman")

Exhibit 1021: Hay, D.L., Discordant and variable production of human chorionic gonadotropin and its free a- and b-subunits in early pregnancy, J. Clin. Endocrinol. Metab., 61 (6), 1195-1200 (1985)

Exhibit 1022: Ozturk, M., et. al., Physiological studies of human chorionic gonadotropin (hCG), ahCG and bhCG as measured by specific monoclonal immunoradiometric assays, Endocrinology, 120 (2), 549-558 (1987)

Exhibit 1033: U.S. Patent Application Publication 2003/0153093

Exhibit 1003: Davies, S., et. al., Human chorionic gonadotropin testing for early pregnancy viability and complications, Clin. Lab. Med. 23, 257-264 (2003) ("Davies")

Exhibit 1006: U.S. Patent Application Publication 2003/0124737 ("O'Connor")

Exhibit 1011: U.S. Patent No. 7,314,760 to Cole

Exhibit 1016: Fishel, S.B., et. al., Human chorionic gonadotropin secreted by pre-implantation embryos cultured in vitro, Science 223, 816-818 (1984)

Exhibit 1017: Parry, S., et. al., Placental Protein Hormones, in DeGroot LJ, Jameson JL (ed): Endocrinology, 4th ed, Ch. 178, p. 2379, WB Saunders (2001)

Exhibit 1018: Kadar, N., et. al., Observations on the log human chorionic gonadotropin-time relationship in early pregnancy and its practical implications, Am. J. Obstet. Gynecol., 157, 73-78 (1987)

Exhibit 1019: Batzer, F.R., et. al., Serial beta-subunit human chorionic gonadotropin doubling time as a prognosticator of pregnancy outcome in an infertile population. Fertil. Steril., 35, 307-312 (1981)

Exhibit 1020: Cole, L.A., et. al., Immunoassay of human chorionic gonadotropin, its free subunits, and metabolites, Clin. Chem., 43, 2233-2243 (1997)

Exhibit 1023: Kovalevskaya, G., et. al., Early pregnancy human chorionic gonadotropin (hCG) isoforms measured by an immunometric assay for choriocarcinoma-like hCG, J. ENDO. 161, 99-106 (1999) ("Kovalevskaya 1999")

Exhibit 1024: Kovalevskaya, G., et. al., Differential expression of human chorionic gonadotropin (hCG) glycosylation isoforms in failing and continuing pregnancies: preliminary characterization of hyperglycosylated hCG epitope, J. ENDO. 172, 497-506

Exhibit 1025: O'Connor, J., et. al., Differential urinary gonadotrophin profiles in early pregnancy and early pregnancy loss, Prenat. Diagn. 18, 1232-1240 (1998) ("O'Connor 1998")

Exhibit 1026: U.S. Patent No. 6,627,457

Exhibit 1027: Patent Cooperation Treaty Application WO 98/23300

Exhibit 1028: Weinans, M., Urinary hyperglycosylated hCG in first trimester screening for chromosomal abnormalities, Prenat Diagn, 20: 976-978 (2000) ("Weinans 2000")

Exhibit 1029: Pandian, R., et. al., Fully Automated Chemiluminometric Assay for Hyperglycosylated Human Chorionic Gonadotropin (Invasive Trophoblast Antigen), Clin. Chem. 36: 647-55 (2003) ("Pandian 2003")

Exhibit 1030: U.S. Patent No. 6,339,143

Exhibit 1031: U.S. Patent No. 6,429,018

Exhibit 1032: U.S. Patent Application Publication 2005/0148096

Exhibit 1034: U.S. Patent No. 7,439,026

Exhibit 1035: U.S. Patent No. 6,500,627

Exhibit 1036: Harlow, et. al., Antibodies: A Laboratory Manual, Ch. 6, Cold Spring Harbor Press, 139-243 (1988) (Part 1 of 5)

Exhibit 1036: Part 2 of 5

Exhibit 1036: Part 3 of 5

Exhibit 1036: Part 4 of 5

Exhibit 1036: Part 5 of 5

Exhibit 1038: Birken, S., et. al., Development and characterization of antibodies to a nicked and hyperglycosylated form of hCG from a choriocarcinoma patient, Endocrine, 10:137-44 (1999)

Exhibit 1039: Cole, L.A., et. al., Between-Method Variation in Human Chorionic Gonadotropin Test Results, Clin. Chem., 50: 874-882 (2004) ("Cole 2004")

Exhibit 1040: Kovalevskaya, G., et. al., Trophoblast Origin of hCG Isoforms: Cytotrophoblasts are the primary Source of Choriocarcinoma-like hCG, Mol. Cell. Endocrinol. 194: 147-55 (2002) ("Kovalevskaya Mol. Cell.")

Exhibit 1041: Cole, L.A., et. al., Hyperglycosylated human chorionic gonadotropin (invasive trophoblast antigen) immunoassay: A new basis for gestational Down syndrome screening, Clin. Chem., 45:2109-19 (1999) ("Cole 1999")

Exhibit 1042: Condous, E., at al., The conservative management of early pregnancy complications: a review of the literature, Ultrasound Obstet. Gynecol., 22, 420-430 (2003)

Exhibit 1043: Barnhart K.T., et al., The medical management of ectopic pregnancy: a meta-analysis comparing "single dose" and "multidose" regimens, Obstet. Gynecol., 101, 778-84 (April 2003)

Exhibit 1044: Wiles, K., et al., Serum Creatinine in Pregnancy: A Systematic Review, Kidney Int. Rep. 4, 408-419 (2019)

Exhibit 1037: U.S. Provisional App. No. 60/627,904

Exhibit 1045: Cole. L.A., Hyperglycosylated hCG, a review, Placenta, 31(8), 653 664 (2010)

Exhibit 1046: Chang, P.L., et al., Measuring human chorionic gonadotropin in the absence of implantation with use of highly sensitive urinary assays for intact B-core and free B epitopes, Fertil. Steril., 69 (3), 412-414 (1998). ("Chang 1998")

Petitioner's Power of Attorney

Exhibit 1015: Pages from SCImago, (n.d.). SJR - SCImago Journal & Country Rank [Portal]. Retrieved 8/19/2020, from http://www.scimagojr.com, Scimago Journal & Country Rankings

Petition for Inter Partes Review of U.S. Patent No. 7,666,83 Under 35 U.S.C. Sections 311-319 and 37 C.F.R. Sections 42.100 et seq.

Exhibit 1009: Declaration of Kurt T. Barnhart, M.D., M.S.C.E.