`Doc code: IDS
`Approvedfor use through 11/30/2020. OMB 0651-0031
`.
`U.S. Patent and Trademark Office: U.S. DEPARTMENT OF COMMERCE
`Doc description: Information Disclosure Statement (IDS) Filed
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`16/672,267 ~ GAU: 1637
`
`Application Number
`
`
`
`
`
`
`| 6672267
`
`poo
`Filing Date
`
`
`INFORMATION DISCLOSURE|[55 Named Inventor
`
`
`
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`Attorney Docket Number
`| 42534-708.304
`
`Art Unit
`
`Examiner Name
`
`
`
`
`
`U.S.PATENTS [Remove|
`
`
`Examiner] Cite
`Initial*
`No
`
`Kind
`Code’
`
`Issue Date
`
`Nameof Patentee or Applicant
`of cited Document
`
`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`
`
`
`
`
`
`
`Add
`If you wish to add additional U.S. Patent citation information pleaseclick the Add button.
`
`U.S.PATENT APPLICATION PUBLICATIONS [Remove|
`
`
`
`Pages,Columns,Lines where
`Examiner Kind|PublicationPublication Name of Patentee or Applicant
`
`
`
`Initial*
`Cite No Number
`Code’) Date
`of cited Document
`Relevant Passages or Relevant
`Figures Appear
`
`
`
`If you wish to add additional U.S. Published Application citation information please click the Add button]Add|
`
`FOREIGN PATENT DOCUMENTS
`[Remove]
`
`
`Pages,Columns,Lines
`
`
`Name of Patentee or
`
` where RelevantKind|Publication
`Examiner] Cite|Foreign Document
`
`Ts
`
`Applicant of cited
`
`
`Initial* Code?4| DateNo|Number?
`
`
`Passages or Relevant
`Document
`
`
`Figures Appear
`
`
`If you wish to add additional Foreign Patent Documentcitation information please click the Add button
`
`[Remove]
`NON-PATENTLITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS),title of the article (when appropriate), title of the item
`Examiner) Cite
`TS
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
`Initials*|No
`publisher, city and/or country where published.
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`
`Filing Date
`2019-11-01
`
`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
`
`STATEMENT BY APPLICANT
`Art Unit
`|
`
`
`
`( Not for submission under 37 CFR 1.99)
`
` Attorney Docket Number
`
`
`
`
`16/672,267 - GRU: 1637
`
`Application Number
`16672267
`
`
` | 42534-708.304
`2012) 5, 887-900
`
`Examiner Name
`
`PINKEL, et al. Comparative Genomic Hybridization. Annual Review of Genomics and Human Genetics, 6: 331-354
`
`PLEASANCE,et al. A small-cell lung cancer genome with complex signatures of tobacco exposure. Nature. 2010 Jan
`4:463(7278):184-90. doi: 10.1038/nature08629. Epub 2009 Dec16.
`
`POLLACK,et al. Genome-wide analysis cof DNA copy-number changes using cDNA microarrays. Nat Genet. 1999
`Bep;23(1)-41-6.
`
`QIU, et al. DNA sequence-based "bar codes"for tracking the origins of expressed sequence tags from a maize cDNA
`ibrary constructed using multiple mRNA sources. Plant Physiol. 2003 Oct,133(2)-475-81.
`
`QUAIL, et al. A large genome center's improvementsto the Illumina sequencing system. Nat Methods. 2008 Dec;5
`12):1005-10. doi: 10.1038/nmeth.1270.
`
`QUINLAN, A.R.et al., “Pyrobayes: an improved basecaller for SNP discovery in pyrosequences,” Nat. Methods 2008
`b(?), 179-181
`
`C
`
`AFI,
`— meco
`
`|. et al. "Cell-free fetal DNA and non-invasive prenatal diagnosis,” Br. J. Gen. Pract. 2009 May 1; 59(562):e146—
`
`AND, et al. Headloop suppression PCRandits application to selective amplification of methylated DNA sequences.
`ucleic Acids Res. 2005 Aug 9:33(14):e127.
`
`REDON, R.et al., “Global variation in copy numberin the human genome,” Nature 2006 444(7118), 444-454
`
`eport and Recommendationin Civil Action No. 17-1623-LPS-CJB between Guardant Health, Inc. and Foundation
`edicine and between Guardant Health, Inc. and Personal GenomeDiagnostics, Inc., dated October 11, 2019
`
`RIZZO, J.M. et al. “Key Principles and Clinical Applications of ‘Next Generation’ DNA Sequencing,” Cancer Prev. Res.,
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`
`16/672,267 - GRU: 1637
`
`Application Number
`16672267
`
`
`Filing Date
`2019-11-01
`
`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
`
`STATEMENT BY APPLICANT
`Art Unit
`|
`
`
`
`( Not for submission under 37 CFR 1.99)
`
` Attorney Docket Number
`
`
` | 42534-708.304
`SEBAT, et al. Large-Scale Copy Number Polymorphism in the Human Genome. Science, 305: 525-528 (2004).
`_—_=_=~oa
`
`Examiner Name
`
`RYAN, et al. A prospective study of circulating mutant KRAS2 in the serum of patients with colorectal neoplasia: strong
`prognostic indicator in postoperative follow up. Gut. 2003 Jan:52(1}:101-8.
`
`RYGAARD, et al. Abnormalities in structure and expression of the retinoblastoma gene in small cell lung cancercell
`ines and xenografts in nude mice. Cancer Res. 1990 Sep 1:50(17):5312-7.
`
`SANGER,F. et al. "DNA sequencing with chain-terminating inhibitors" PNAS (1977) 74(12):5463-5467
`
`—_-wNo
`
`—_
`
`hoNoSo
`
`NoNo
`
`SAUSEN, M. et al. "Integrated genomic analyses identify ARID1A and ARID1B alterations in the childhood cancer
`euroblastoma", Nature Genetics 2013, 45(1), 12-17
`
`SCHMITTet al. Supplemental Information http/Avww.pnas.org/content/suppl/20 12/08/01/1208715109.
`DCSupplemental
`
`SCHMITT,et al. Detection of ultra-rare mutations by next-generation sequencing. Proc Natl Acad Sci US A. 2012 Sep
`H-109(36):14508-13. doi: 10.1073/pnas.1208715109. Epub 2012 Aug 1.
`
`SCHWARZENBACH, etal. A critical evaluation of loss of heterozygosity detected in tumortissues, blood serum and
`bone marrow plasma from patients with breast cancer. Breast Cancer Res. 2007;9(5)-R66.
`
`5 CHWARZENBACH, etal. Cell-free tumor DNAin blocd plasma as a markerforcirculating tumorcells in prostate
`ancer. Clin Cancer Res. 2009 Feb 1;15(3):1032-8. doi: 10.1158/1078-0432 CCR-08-1910.
`
`SCHWARZENBACK,H. etal. "Cell-free nucleic acids as biomarkers in cancer patients" Nature Reviews Cancer
`2011) 11:426-437
`
`SCHWEIGER etal., “Genome-wide massively parallel sequencing of formaldehyde fixed-paraffin embedded (FFPE}
`umortissues for copy-number- and mutation-analysis,” PLoS One 2009, 4(5), e5548
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`
`
`16/672,267 - GAU: 1637
`
`Application Number 16672267
`
`
`
`Filing Date 2019-11-01
`
`INFORMATION DISCLOSURE
`First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Art Unit |
`
`Examiner Name
`
` | 42534-708.304
`
`
`
` Attorney Docket Number
`
`
`
`pbiochemotherapy. Clin Cancer Res. 2007 Apr 1:13(7):2068-74.
`pidemiol Biomarkers Prev. 1994 Jan-Feb;3(1):6/-71.
`
`SEHNERT, A.J. et al. "Optimal Detection of Fetal Chromosomal Abnormalities by Massively Parallel DNA Sequencing
`bf Cell-Free Fetal DNA from Maternal Blood" Clin Chem (2011) 57(7):1042-1049
`
`SHAW et al. Genomic analysis of circulating cell-free DNAinfers breast cancer dormancy. Genome Research 22
`2):220-231 (February 2012).
`
`SHAW,et al. Microsatellite alterations plasma DNAof primary breast cancer patients. Clin Cancer Res. 2000 Mar;6
`
`SHENDURE,J. et al. “Next-generation DNA sequencing,” Nat. Biotechnol. 2008 26(10), 1135-1145
`
`BHINOZAKI, et al. Utility of circulating B-RAF DNA mutation in serum for monitoring melanoma patients receiving
`
`
`
`SHIROGUCHI, et al. Digital RNA sequencing minimizes sequence-dependentbias and amplification noise with
`Dptimized single-molecule barcodes. Proc Natl Acad Sci US A. 2012 Jan 24;109(4):1347-52. doi: 10.1073/
`bnas.1118018109. Epub 2012 Jan 9.
`
`
`
`
`
`SHOEMAKER,et al. Quantitative phenctypic analysis of yeast deletion mutants using a highly parallel molecular bar-
`oding strategy. Nature Genetics, 14: 450-456 (1996).
`
`SIMPSON, et al. Copy numbervariant detection in inbred strains from short read sequence data. Bioinformatics. 2010
`eb 15;26(4):565-7. doi: 10.1093/bioinformatics/btp693. Epub 2009 Dec18.
`
`SMITH, et al. Highly-multiplexed barcode sequencing: an efficient methodfor parallel analysis of pooled samples.
`ucleic Acids Research, 38(13): e142 (2010).
`
`SMITH, T.F. et al. "Comparison of Biosequences" Adv App Math (1981) 2:482-489
`
`SORENSON, et al. Soluble normal and mutated DNA sequencesfrom single-copy genes in human blood. Cancer
`
`NoNo>w
`
`Nooa
`
`wNoNoNoNo=Sowoco~ao
`
`wwwNo
`
`ww
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`16/672,267 - GAU: 1637
`
`Application Number 16672267
`
`
`
`Filing Date 2019-11-01
`
`INFORMATION DISCLOSURE
`First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Art Unit |
`
` Attorney Docket Number
`
`
` | 42534-708.304
`Blage Il colon cancer,”Sci. Transl. Med. 2016, 8(346):346ra92
`
`Examiner Name
`
`wwwa
`
`wao
`
`>awwwwoS©co~
`>>WwNo=
`
`SPARKS, et al. Selective analysis of cell-free DNA in maternal blood for evaluation of fetal trisomy. Prenat Diagn. 2012
`an;32(1):3-9. doi: 10.1002/pd.2922. Epub 2012 Jan 6
`
`STEIN, et al. "The case for cloud computing in genome informatics", GenomeBiol. 2010; 11 (5):207. Epub 2010 May 5
`
`STEINMAN. Free DNAin serum and plasma from normal adults. J Clin Invest. 1975 Aug;56(2):512-5.
`
`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.
`
`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).
`
`STUMM, M. et al. "Noninvasive prenatal detection of chromosomal aneuploidies using different next generation
`Bequencing strategies and algorithms” Prenatal Diagnosis (2012) 32:569-577
`
`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
`
`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.
`
`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.
`
`EER,J.K. et al. "Systematic comparison of three genomic enrichment methods for massively parallel DNA
`Bequencing” Genome Res (2010) 20(10): 1420-1431
`
`ihBK
`
`IE, J. et al., “Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`
`
`16/672,267 ~ GAU: 1637
`
`Application Number 16672267
`
`
`Filing Date 2019-11-01
`
`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
`
`STATEMENT BY APPLICANT
`|...
`
`( Not for submission under 37 CFR 1.99)
`
`Examiner Name
`
`
`
`
`
`
`
` Attorney Docket Number
`
`| 42534-708.304
`
`
`
`OMAZ,et al. Differential methylation as a cause of allele dropout at the imprinted GNASlocus. Genet Test Mol
`iomarkers. 2010 Aug; 14{4):455-60. doi: 10.1089/gtmb.2010.0029.
`
`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.
`
`SAI, et al. Discovery of rare mutations in populations: TILLING by sequencing. Plant Physiol. 2011 Jul;156
`3):1257-68. doi: 10.1104/pp.110.169748. Epub 2011 Apr 29.
`
`S. Appn. No. 14/102,285, filed 12/10/2013
`
`.9. Provisional Application 61/613,413 (Schmitt '413 provisional”) (2012-03-20)
`
`9. Provisional Application 61/625,319 (Schmitt '319 provisional”) (2012-04-17)
`
`If you wish to add additional non-patentliterature documentcitation information please click the Add button
`
`EXAMINER SIGNATURE
`
`*EXAMINER:Initial if reference considered, whetheror not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
`
`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP $01.04. 2 Enter office that issued the document, by the two-letter code (WIPO
`Standard ST.3). > For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial numberof the patent document.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. * Applicantis to place a check mark here if
`English language translation is attached.
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`16/672,267 ~ GAU: 1637
`
`
`Application Number 16672267
`
`Filing Date 2019-11-01
`
`INFORMATION DISCLOSURE First Named Inventor|AmirAli TALASAZ
`
`STATEMENT BY APPLICANT
`|...
`
` Attorney Docket Number
`
`
`Examiner Name
`
`| 42534-708.304
`
`
`
`
`
`( Not for submission under 37 CFR 1.99)
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection{s):
`
`CERTIFICATION STATEMENT
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`[-]
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three monthsprior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`See attachedcertification statement.
`
`The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`* Acertification statement is not submitted herewith.
`
`SIGNATURE
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
`
`Signature
`
` Name/Print
`
`2019-12-06
`
`
`
`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`public whichis to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissionerfor Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`Privacy Act Statement
`
`16/672,267 ~ GAU: 1637
`
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
`that:
`(1) the general authority for the collection of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited
`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
`process and/or examine your submission related to a patent application or patent.
`If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonmentof the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Departmentof Justice to determine whether the Freedom ofInformation Act requires disclosure of these record s.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence toa
`court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement
`negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`requestinvolving an individual, to whom the record pertains, when the individual has requested assistance from the
`Memberwith respect to the subject matter of the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
`the information in order to perform a contract. Recipients of information shall be required to comply with the
`requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
`may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant
`to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
`his/her designee, during an inspection of records conducted by GSAaspart of that agency's responsibility to
`recommend improvements in records management practices and programs, underauthority of 44 U.S.C. 2904 and
`2906. Such disclosure shall be made in accordance with the GSA regulations governing inspection of records for this
`purpose, and any other relevant(i.e., GSA or Commerce)directive. Such disclosure shall not be used to make
`determinations about individuals.
`
` The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`
`
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
`the application pursuant to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record
`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record wasfiled in
`an application which became abandonedor in which the proceedings were terminated and which application is
`referenced by either a published application, an application open to public inspections or an issued patent.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency,if the USPTO becomes aware ofa violation or potential violation of law or regulation.
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`