Case 1:20-cv-01580-LPS Document 1-3 Filed 11/23/20 Page 1 of 62 PageID #: 147
`Case 1:20-cv-01580-LPS Document 1-3 Filed 11/23/20 Page 1 of 62 PageID #: 147
`
`
`
`
`
`EXHIBIT 3
`
`EXHIBIT 3
`
`

`

`( 12 ) United States Patent
`Talasaz et al .
`
`( 10 ) Patent No .: US 10,704,086 B2
`( 45 ) Date of Patent :
`* Jul . 7 , 2020
`
`US010704086B2
`
`( 54 ) SYSTEMS AND METHODS TO DETECT
`RARE MUTATIONS AND COPY NUMBER
`VARIATION
`( 71 ) Applicant : GUARDANT HEALTH , INC . ,
`Redwood City , CA ( US )
`( 72 ) Inventors : Amir Ali Talasaz , Atherton , CA ( US ) ;
`Stefanie Ann Ward Mortimer , Morgan
`Hill , CA ( US )
`( 73 ) Assignee : GUARDANT HEALTH , INC . ,
`Redwood City , CA ( US )
`Subject to any disclaimer , the term of this
`patent is extended or adjusted under 35
`U.S.C. 154 ( b ) by 0 days .
`This patent is subject to a terminal dis
`claimer .
`( 21 ) Appl . No .: 16 / 593,653
`( 22 )
`Filed :
`Oct. 4 , 2019
`( 65 )
`
`Prior Publication Data
`US 2020/0115739 A1 Apr. 16 , 2020
`
`( * ) Notice :
`
`( 63 )
`
`( 51 )
`
`Related U.S. Application Data
`Continuation of application No. 15 / 669,779 , filed on
`Aug. 4 , 2017 , which is a continuation of application
`No. 15 / 076,565 , filed on Mar. 21 , 2016 , now Pat . No.
`9,902,992 , which is a continuation of application No.
`14 / 855,301 , filed on Sep. 15 , 2015 , now abandoned ,
`which is
`continuation of application No.
`a
`PCT / US2014 / 000048 , filed on Mar. 15 , 2014 .
`( 60 ) Provisional application No. 61 / 948,530 , filed on Mar.
`5 , 2014 .
`Int . Ci .
`( 2006.01 )
`C12P 19/34
`( 2018.01 )
`C12Q 1/6827
`( 2018.01 )
`C12Q 1/6806
`G16B 30/00
`( 2019.01 )
`( 2018.01 )
`C12Q 1/6869
`( 52 ) U.S. CI .
`CPC
`C12Q 1/6827 ( 2013.01 ) ; C12Q 1/6806
`( 2013.01 ) ; G16B 30/00 ( 2019.02 ) ; C12Q
`1/6869 ( 2013.01 )
`( 58 ) Field of Classification Search
`None
`See application file for complete search history .
`References Cited
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`Case 1:20-cv-01580-LPS Document 1-3 Filed 11/23/20 Page 2 of 62 PageID #: 148
`
`( 56 )
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`( Continued )
`Primary Examiner Kenneth R Horlick
`( 74 ) Attorney , Agent , or Firm — Timothy A. Hott
`( 57 )
`ABSTRACT
`The present disclosure provides a system and method for the
`detection of rare mutations and copy number variations in
`cell free polynucleotides . Generally , the systems and meth
`ods comprise sample preparation , or the extraction and
`isolation of cell free polynucleotide sequences from a bodily
`fluid ; subsequent sequencing of cell free polynucleotides by
`techniques known in the art ; and application of bioinfor
`matics tools to detect rare mutations and copy number
`variations as compared to a reference . The systems and
`methods also may contain a database or collection of dif
`ferent rare mutations or copy number variation profiles of
`different diseases , to be used as additional references in
`aiding detection of rare mutations , copy number variation
`profiling or general genetic profiling of a disease .
`30 Claims , 17 Drawing Sheets
`
`

`

`US 10,704,086 B2
`Page 2
`
`( 56 )
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