`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/
`
`
`
`16/672,267 - GAU: 1637
`16672267
`Application Number
`2019-11-01
`Filing Date
`AmirAli TALASAZ
`First Named Inventor
`
` Attorney Docket Number
`
`Art Unit
`
`Examiner Name
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`
` | 42534-708.304
`otice of allowance dated 08/04/2017 for US Application No.15/467,570
`
`AWROZ,et al. Microsatellite alterations in serum DNA of head and neck cancer patients. Nat Med. 1996 Sep;2
`9):1035-7.
`
`EWMAN, etal. An ultrasensitive method for quantitating circulating tumor DNA with broad patient coverage. Nat Med
`P014 May;20(5):548-54. dor: 10.1038/nm.3519. Epub 2014 Apr6.
`
`G, §.B., et al., “Targeted capture and massively parallel sequencing of 12 human exomes,” Nature 2009, 461(7261),
`
`IELSEN, R.et al. "Genotype and SNP calling from next-generation sequencing data" Nature Reviews Genetics
`2011) 12(6):443-451
`
`ORD, et al. Accurate and exact CNV identification from targeted high-throughput sequence data. BMC Genomics.
`P0O11 Apr 12;12°184.
`
`otice of Allowance dated 01/31/2017 for U.S. Patent Application No. 14/712,754.
`
`otice of allowance dated 03/21/2014 for US Application No. 12/969,581.
`
`otice of allowance dated 06/15/2017 for US Application No.15/076,565.
`
`otice of allowance dated 06/19/2014 for US Application No. 12/969,581.
`
`otice of allowance dated 08/01/2017 for US Application No. 15/492,659
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`16/672,267 - GAU: 1637
`16672267
`Application Number
`
`2019-11-01
`Filing Date
`
`
`
`First Named Inventor AmirAli TALASAZ
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
` | 42534-708.304
`Office action dated 06/01/2017 for US Application No. 15/467,570
`_—_=_=~oa
`
` Attorney Docket Number
`
`Art Unit
`
`Examiner Name
`
`
`
`otice of allowance dated 08/22/2014 for US Application No
`
`. 12/969,581.
`
`otice of allowance dated 08/29/2017 for US Application No
`
`. 15/492,659
`
`otice of allowance dated 09/11/2017 for US Application No
`
`. 15/076,565
`
`otice of allowance dated 10/03/2017 for US Application No
`
`. 15/076,565.
`
`otice of allowance dated 10/25/2017 for US Application No
`
`. 14/861,989
`
`otice of allowance dated 12/28/2017 for US Application No
`
`. 14/861,989.
`
`—_-wNo
`
`—_
`
`hoNoSo
`
`NoNo
`
`Office Action dated 02/09/2017 for U.S. Patent Application No. 15/076,565.
`
`Office action dated 05/13/2019 for US Application No. 15/669,779.
`
`Office action dated 05/20/2016 for US Application No. 14/855,301.
`
`Office action dated 05/31/2016 for US Application No. 14/712,754.
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`INFORMATION DISCLOSURE
`First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`
`
`Art Unit |
`
`Examiner Name
`
` Attorney Docket Number
`
`
`
`16/672,267 - GAU: 1637
`
`Application Number 16672267
`
`
`
`Filing Date 2019-11-01
`
`
` | 42534-708.304
`Office action dated 12/07/2017 for US Application No. 14/855,301
`
`Office action dated 06/03/2016 for US Application No. 14/861,989.
`
`Office action dated 06/12/2017 for US Application No. 15/492,659.
`
`Office action dated 07/18/2017 for US Application No. 14/861,989
`
`Office Action dated 07/30/2019 for U.S. Application No. 16/283,635.
`
`Office action dated 08/06/2019 for US Application No. 14/855,301.
`
`Office action dated 10/03/2013 for US Application No. 12/969,581.
`
`Office Action dated 10/12/2016 for U.S. Patent Application No. 14/712,754.
`
`Office action dated 10/20/2017 for US Application No. 14/425,189.
`
`Office Action dated 11/21/2016 for U.S. Patent Application No. 14/855,301.
`
`Office action dated 12/04/2015 for US Application No. 14/712,754.
`
`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
`ebsite http-/Avww_pacificbiosciences_com/support/pubmap/documentation.html.
`
`Examiner Name
`
`wwwa
`
`wao
`
`pppfwwwaN=oooo~
`
`Office Action dated 12/09/2016 for U.S. Patent Application No. 14/861,989.
`
`Office action dated 12/21/2018 for US Application No. 15/978,848.
`
`OGINC, et al. Quantification of PCR bias caused by a single nucleotide polymorphism in SMN gene dosageanalysis.
`ol Diagn. 2002 Nov;4(4):185-90.
`
`Opposition Brief dated August 7, 2018 for Japanese Opposition No. 2018-700659 to JP Patent 6275145
`
`Opposition Decision dated January 15, 2019 for Japanese Opposition No. 2018-700659 to JP Patent 6275145
`
`Opposition Form and Statement to EP2893040 filed October 2, 2019 by Foundation MedicineInc.
`
`Opposition Form and Statement to EP2893040 filed October 2, 2019 by Grunecker Patent-und Rechtsanwalte PartG
`
`Opposition Form and Statement to EP2893040 filed October 2, 2019 by Personal Genome Diagnostics,Inc.
`
`Opposition Form and Statement to EP2893040 filed October 2, 2019 by Strawman Limited
`
`Opposition Form and Statement to EP3087204 filed November 14, 2018
`
`ihBK
`
`Pacific Biosciences. Template Preparation and Sequencing Guide. Publication date: 2014-10-14. Pacific Biosciences
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/K.R.H/
`
`
`
`
`
`PIHLAK,et al. Rapid genome sequencing with short universaltiling probes. Nature Biotechnology, 26: 676-684 (2008).
`
`
`INFORMATION DISCLOSURE
`First Named Inventor|AmirAli TALASAZ
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`| 42534-708.304
`
`PAN, et al. Loss of heterozygosity patterns provide fingerprints for genetic heterogeneity in multistep cancer
`progression of tobacco smoke-induced non-small cell lung cancer. Cancer Res. 2005 Mar 1:65(5): 1664-9.
`
`PARK, et al. Discovery of common Asian copy numbervariants using integrated high-resolution array CGH and
`assively parallel DNA sequencing. Nat Genet. 2010 May;42(5):400-5. doi: 10.1038/ng.555. Epub 2010 Apr4.
`
`PARKINSON, N.J. et al., “Preparation of high-quality next-generation sequencing libraries from picogram quantities of
`arget DNA,” Genome Res. 2012, 22(1), 125-133
`
`PEL, J. et al. "Duplex proximity sequencing (pro-seq): A method to improve DNA sequencing accuracy without the cost
`of molecular barcoding redundancy” bioRxiv (2017) https://doi_org/10.1101/163444
`
`PERAKIS, S. et al. "Advancesin Circulating Tumor DNA Analysis" Adv Clin Chem (2017) pp 1-81
`
`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/
`
` Attorney Docket Number
`
`| E
`
`Art Unit
`
`xaminer Name
`
`16/672,267 ~ GAU: 1637
`
`Application Number
`16672267
`
`
`Filing Date
`2019-11-01
`
`
`
`
`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/
`
`