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`Application Number 17809544
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`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
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`STATEMENT BY APPLICANT
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`| 42534-708.313 iomarkers. 2010 Aug; 14{4):455-60. doi: 10.1089/gtmb.2010.0029.
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`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`STITZIEL, et al. Computational and statistical approaches to analyzing variants identified byexome sequencing.
`enomeBiol. 2011 Sep 14;12(9):227. doi: 10.1186/gb-2011-12-9-227.
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`Stroun, M, et al, "About the possible orgin and mechanism ofcirculating DNA apoptosis and active DNA release", Clin
`him Acta, vol. 313, No. 1-2, pp. 139-142, (2001).
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`STUMM, M. et al. "Noninvasive prenatal detection of chromosomal aneuploidies using different next generation
`Bequencing strategies and algorithms” Prenatal Diagnosis (2012) 32:569-577
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`SWANSON, A.et al. "Non-invasive prenatal testing for fetal aneuploidy by massively parallel DNA sequencing of
`atemal plasma : the future has arrived today” J Lab Med (2012) 36(5):269-275
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`ABACK,et al. Detection of tumor-specific genetic alterations in bone marrow from early-stage breast cancerpatients.
`ancer Res. 2003 Apr 15:63(8): 1884-7
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`AN, et al. Genome-wide comparison of DNA hydroxymethylation in mouse embryonic stem cells and neural
`progenitor cells by a new comparative hMeDIP-seq method. Nucleic Acids Res. 2013 Apr,41(7):e84. doi: 10.1093/nar/
`9kt091. Epub 2013 Feb 13.
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`AUDIEN, et al. Haplotyping and copy numberestimation of the highly polymorphic human beta-defensin locus on
`Bp23 by 454 amplicon sequencing. BMC Genomics. 2010 Apr 19:11:252. doi: 10.1186/1471-2164-11-252.
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`EER,J.K. et al. "Systematic comparison of three genomic enrichment methods for massively parallel DNA
`Bequencing” Genome Res (2010) 20(10): 1420-1431
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`hruPLEX{TM) DNA-seq Kit Instruction Manual, Rubicon Genomics (2014)
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`IE, J. et al., “Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with
`Blage Il colon cancer,”Sci. Transl. Med. 2016, 8(346):346ra92
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`OMAZ,et al. Differential methylation as a cause of allele dropout at the imprinted GNASlocus. Genet Test Mol
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`| 42534-708.313 'S Provisional Appl. No. 61/432119 filed 1/12/2011.
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`Filing Date 2022-06-28
`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
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`STATEMENT BY APPLICANT
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`OMLINSON, et al. A genome-wide association scan of tag SNPsidentifies a susceptibility variant for colorectal
`ancer at 8q?4 21. Nat Genet. 2007 Aug;39(8) 984-8. Epub 2007 Jul 8.
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`RAPNELL,C.et al. "How to mapbillions of short reads onto genomes" Nature Biotech (2009) 27(5):-455-457
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`SAI, et al. Discovery of rare mutations in populations: TILLING by sequencing. Plant Physiol. 2011 Jul;156
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`winstrand Biosciences, Inc. & The University of Washington v. Guardant Health, Inc. Complaint 1-21-cv-01126, dated
`August 3, 2071
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`.9. Provisional Application 61/613,413 (Schmitt '413 provisional”) (2012-03-20)
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`9. Provisional Application 61/625,319 (Schmitt '319 provisional”) (2012-04-17)
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`CSC GenomeBioinformatics. About the UCSC GenomeBioinformatics Site. http://genome.ucsc.edu/index.html.
`Accessed on 05/26/2015. 2 pgs.
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`METANI et al. Prediction of Breast Tumor Progression by Integrity of Free Circulating DNA in Serum. Journal of
`linical Oncology 24(26).4270-4276 (September 10, 2006).
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`S Provisional Appl. No. 61/384001 filed 9/17/2010.
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`Application Number 17809544
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`| 42534-708.313 ELCULESCU, et al. Serial Analysis of Gene Expression. Science, 270: 484-487 (1995).
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`INFORMATION DISCLOSURE
`First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`S Provisional Appl. No. 61/625,623filed 04/17/2012.
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`S Provisional Application No. 61/798,925 filed 03/15/2013. ("Diehn")
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`TTING, et al. Microsatellite analysis of free tumor DNA in urine, serum, and plasma of patients: a minimally invasive
`ethod for the detection of bladder cancer. Clin Cancer Res. 2002 Jan;8(1):35-40.
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`AN HOUTEN, et al. Mutated p53 as a molecular markerfor the diagnosis of head and neck cancer. J Pathol. 2002
`Nec; 198(4)-476-86.
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`an Kets, V. et al. "Kapa Hyper Prep: A Next-Generation Kit for Fast and Efficient Library Construction from
`hallenging DNA Samples” Poster (2014)
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`AN LOO, P. et al. "Allele-specific copy number analysis of tumors" PNAS (2010) 107(39}:16910-16915
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`AN NIEUWERBURGH, F. et al. "Quantitative Bias in Illumina TruSeq and a Novel Post Amplification Barcoding
`Strategy for Multiplexed DNA and Small RNA Deep Sequencing” PLoS One (2011) with Supporting Information
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`an Orsouw, N. et al. "Complexity Reduction of Polymorphic Sequences (CRoPSTM): A Novel Approach for Large-
`Scale Polymorphism Discovery in Complex Genomes" PLoS One (2007) 11(61172):1-10
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`ASYUKHIN, V. et al., "K-Ras Point Mutations in the Blood Plasma DNAof Patients with Colorectal Tumors"
`hallenges of Modern Medicine, 141-150 (Verna and Shamoo eds, 1994)
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`ELCULESCU, et al. Characterization of the Yeast Transcriptome. Cell, 88: 243-251 (1997).
`
`Now
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`Nooa
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`EFS Web 2.1.18
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`Application Number 17809544
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`Filing Date 2022-06-28
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`| 42534-708.313 squamous cell carcinomas,” Sci. Transl. Med. 2015, 7(293):293ra104
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`INFORMATION DISCLOSURE
`First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Examiner Name
`
`wwwa
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`wao
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`>awwwwoS©co~
`>>WwNo=
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`ENNISON, S.J. "Chapter 5: Restriction Digestion and Ligation of DNA" in Laboratory Manual for Genetic Engineering
`2009) Easter Economy Edition, PHI Learning Private Limited” pp. 32-35
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`OGELSTEIN, etal. Digital PCR. Proc. Natl. Acad. Sci., 96(16): 9236-924 1(1999).
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`'AGLE,N. et al., “High-throughput Detection of actionable Genomicalterationsin clinical tumor samples by targeted,
`assively Parallel sequencing,” Cancer Discov. 2012, (2)1:82-93
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`ALKER,et al. Isothermalin vitro amplification of DNA by a restriction enzyme/DNA polymerase system. Proc Natl
`Acad Sci US A. 1992 Jan 1;89(1):392-6.
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`ALSH, et al. Detection of inherited mutations for breast and ovarian cancer using genomic capture and massively
`parallel sequencing. Proc Natl Acad Sci U $ A. 2010 Jul 13;107(28)-12629-33. doi: 10.1073/pnas.1007983107. Epub
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`ANG, et al. iCLIP predicts the dual splicing effects of TIA-RNA interactions, 2010 Oct, PLoS Bicol, 8(10):e1000530.
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`ANG, et al. Molecular detection of APC, K- ras, and p53 mutationsin the serum of colorectal cancer patients as
`irculating biomarkers. World J Surg. 2004 Jul;28(7)}: 721-6. Epub 2004 Jun 8
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`ANG, et al. RNA-Seq: a revolutionary tool for transcriptomics. Nature Reviews Genetics, 10: 57-63 (2009).
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`ANG, T.L. et al. "Digital Karyotyping” PNAS (2002) 99(25):16156-16161
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`ANG, T.T. et al. "High efficiency error suppression for accurate detection of low-frequency variants" NAR (2019) 47
`15):
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`ihBK
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`ANG, Y. et al., “Detection of somatic mutations and HPVin the saliva and plasmaofpatients with head and neck
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`EFS Web 2.1.18
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`Application Number 17809544
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`Filing Date 2022-06-28
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`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Examiner Name
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`Attorney Docket Number
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`| 42534-708.313
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`ANG, Y. et al., “Detection of tumor-derived DNAin cerebrospinalfluid of patients with primary tumors of the brain
`And spinal cord,” Proc. Natl. Acad. Sci. USA 2015, 112(31), 9704-9709
`
`ANG, Y. et al., “Diagnostic potential of tumor DNA from ovarian cystfluid,” eLife 2016, 5:e15175
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`EBER, et al.A real-time polymerase chain reaction assay for quantification of allele ratios and correction of
`Amplification bias. Anal Biochem. 2003 Sep 15:320(2}):252-8.
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`HEELER,D.A.et al., “The complete genomeof an individual by massively parallel DNA sequencing,” Nature 2008,
`H52(7 189), 872-876
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`ILLIFORD, A.et al., “Gene Fusion,” eLS 2013, 1-8
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`ITTES, et al. Searching for Evidence of Altered Gene Expression: a CommentonStatistical Analysis of Microarray
`Data. Journal of the National CancerInstitute, 91(5): 400-401 (1999).
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