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`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`
`Attorney Docket No.
`
`42534-708.303
`First Named Inventor Helmy EL TOUKHY
`Title
`
`METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`"\
`
`\...
`
`(Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`1.0 Fee Transmittal Form
`(PTO/SB/17 or equivalent)
`
`2.0 Applicant asserts small entity status.
`See 37 CFR 1.27
`3.o Applicant certifies micro entity status. See 37 CFR 1.29.
`Applicant must attach form PTO/SB/15A or B or equivalent.
`
`Priority Mail Express®
`Label No.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`ACCOMPANYING APPLICATION PAPERS
`10. D Assignment Papers
`(cover sheet & document(s))
`Name of Assignee
`
`l
`
`11. 0
`
`0
`
`Power of Attorney
`
`5. 0
`
`37 CFR 3.73(c) Statement
`4.0 Specification
`[Total Pages
`(when there is an assignee)
`Both the claims and abstract must start on a new page.
`(See MPEP § 608.0l{a)for information on the preferred arrangement) 12.D English Translation Document
`[Total Sheets 11
`(if applicable)
`l
`Drawing(s) (35 U.S.C. 113)
`[Total Pages 2
`l 13.o Information Disclosure Statement
`6. Inventor's Oath or Declaration
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`7.0 Application Data Sheet
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`See 37 CFR 1.76 (PTO/AIA/14 or equivalent)
`
`8.
`
`CD-ROM or CD-R
`in duplicate, large table, or Computer Program (Appendix)
`
`Landscape Table on CD
`
`D
`9. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. - c. are required)
`
`a. D Computer Readable Form (CRF)
`
`b. D
`
`Specification Sequence Listing on:
`
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`
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`
`c. D Statements verifying identity of above copies
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`14.o Preliminary Amendment
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`
`17. 0
`
`16.o Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
`Nonpublication Request
`Under 35 U.S.C. 122(b)(2)(B)(i). Applicant must attach form PTO/SB/35
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`18.0 Other: Certification and Request for Prioritized Examination
`
`*Note: (1) Benefit claims under 37 CFR 1.78 and foreign priority claims under 1.55 must be included in an Application Data Sheet (ADS).
`(2) For applications filed under 35 U.S.C. 111, the application must contain an ADS specifying the applicant if the applicant is an
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`19. CORRESPONDENCE ADDRESS
`0 The address associated with Customer Number: 115823
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`ORD Correspondence address below
`
`Name
`
`Address
`
`City
`
`Country
`
`Signature
`
`Name
`(Print/Type)
`
`State I
`I
`I Telephone I
`
`/Timothy A. Hott/
`Timothy A. Hott
`
`I Zip Code
`I
`
`
`Date
`
`( Atta rn ey /Agent)
`
`2019-10-14
`Registration No. 67740
`
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`TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, ca/11-800-PTO-9199 and select option 2.
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`EX1084
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`
`00002
`
`
`
`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`42534-708.303
`
`Application Number
`
`Title of Invention METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2:
`D Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`Inventor Information:
`
`Inventor
`11
`Legal Name
`
`Prefix Given Name
`
`I El ~elmy
`
`Middle Name
`I
`Residence Information (Select One)
`• US Residency
`I State/Province
`City
`J'l.therton
`
`I Remove I
`
`Family Name
`
`f=LTOUKHY
`Non US Residency
`Active US Military Service
`I Country of ResidencJ
`I f.Js
`
`Suffix
`
`I El
`
`I ~A
`
`Mailing Address of Inventor:
`
`Address 1
`
`505 Penobscot Drive
`
`Address 2
`I ~edwood City
`City
`I ~o63
`Postal Code
`
`Inventor b
`
`Legal Name
`
`I State/Province
`I 1us
`I Countryi
`
`I FA
`
`I Remove I
`
`Prefix Given Name
`
`Middle Name
`I El J'l.mirAli
`I
`Residence Information (Select One) @ US Residency
`I State/Province I ~A
`City
`J'l.therton
`
`Family Name
`
`jrALASAZ
`Non US Residency
`Active US Military Service
`I Country of ResidencJ I 1-Js
`
`Suffix
`
`I El
`
`Mailing Address of Inventor:
`
`Address 1
`
`505 Penobscot Drive
`
`Address 2
`I State/Province
`I ~edwood City
`City
`I ~o63
`I 1us
`I Countryi
`Postal Code
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`I FA
`
`I
`
`Add
`
`I
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`EFSWeb2.2.13
`
`00003
`
`
`
`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`42534-708.303
`
`Application Number
`
`Title of Invention METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`D An Address is being provided for the correspondence Information of this application.
`Customer Number
`15823
`
`Email Address
`
`Email Address
`
`oatents@guardanthealth.com
`
`patentdocket@wsgr.com
`
`Application Information:
`
`I Add Email I
`I Add Email I
`
`I Remove Email I
`
`I Remove Email I
`
`Title of the Invention
`
`Attorney Docket Number
`
`METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`I Small Entity Status Claimed D
`
`ft2534-708.303
`
`Application Type
`
`Non provisional
`
`Subject Matter
`
`Utility
`
`.
`.
`
`Total Number of Drawing Sheets (if any)
`Filing By Reference:
`Only complete this section when filing an application by reference under 35 U.S.C. 111 (c) and 37 CFR 1.57(a). Do not complete this section if
`application papers including a specification and any drawings are being filed. Any domestic benefit or foreign priority information must be
`provided in the appropriate section(s) below (i.e., "Domestic Benefit/National Stage Information" and "Foreign Priority Information").
`
`I Suggested Figure for Publication (if any) 11
`
`1111
`
`For the purposes of a filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previously filed application, subject to conditions and requirements of 37 CFR 1.57(a).
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`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country
`
`,_
`
`I
`
`Publication Information:
`D
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. I hereby request that the attached application not be published under
`35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`D
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
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`
`Please Select One:
`
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`
`I
`
`US Patent Practitioner lo Limited Recognition (37 CFR 11.9)
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`
`~15823
`
`EFS Web 2.2.13
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`00004
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`
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`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`42534-708.303
`
`Application Number
`
`Title of Invention METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`Domestic Benefit/National Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) or indicate
`National Stage entry from a PCT application. Providing benefit claim information in the Application Data Sheet constitutes
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`When referring to the current application, please leave the "Application Number" field blank.
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`Prior Application Status
`
`!='ending
`
`Application Number
`
`Continuity Type
`
`I
`
`~ontinuation of
`
`Prior Application Status Patented
`Application
`Number
`
`Continuity Type
`
`115892178
`
`pontinuation of
`
`Prior Application
`Number
`IT 114861989
`
`T
`
`T
`
`T
`
`Prior Application Number
`
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
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`15892178
`
`Filing Date
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`
`~018-02-08
`I Remove I
`Issue Date
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`
`Patent Number
`
`Prior Application Status
`
`t=xpired
`
`T
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`~015-09-22
`
`~920366
`
`~018-03-20
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`~4861989
`
`~ontinuation of
`
`T PCTUS2014072383
`
`Prior Application Status
`
`l=xpired
`
`Application Number
`
`Continuity Type
`
`~4861989
`
`~laims benefit of provisional
`
`Prior Application Status
`
`l=xpired
`
`T
`
`T
`
`T
`
`Prior Application Number
`
`61948509
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`~014-12-24
`I Remove I
`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`~014-03-05
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`Filing or 371 (c) Date
`(YYYY-MM-DD)
`
`t4861989
`
`~laims benefit of provisional
`
`T
`
`61921456
`
`~013-12-28
`
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`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55. When priority is claimed to a foreign application
`that is eligible for retrieval under the priority document exchange program (PDXi the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(i)(1) and (2). Under the POX program, applicant bears the ultimate
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`property office, or a certified copy of the foreign priority application is filed, within the time period specified in 37 CFR 1.55(g)(1 ).
`
`EFS Web 2.2.13
`
`00005
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`
`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`42534-708.303
`
`Application Number
`
`Title of Invention METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`Application Number
`
`Filing Date (YYYY-MM-DD)
`I
`I
`I
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`Countryi
`
`I Remove I
`Access Codei (if applicable)
`
`I Add
`
`I
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`D 16,2013_
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2013, will be examined under the first inventor to file provisions of the AIA.
`
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`00006
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`
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`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`42534-708.303
`
`Application Number
`
`Title of Invention METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`When this Application Data Sheet is properly signed and filed with the application, applicant has provided written
`authority to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see
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`
`Should applicant choose not to provide an authorization identified in subsection 1 below, applicant must opt-out of the
`authorization by checking the corresponding box A or B or both in subsection 2 below.
`
`NOTE: This section of the Application Data Sheet is ONLY reviewed and processed with the INITIAL filing of an
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`authorization for access by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Priority Document Exchange (PDXl - Unless box A in subsection 2 (opt-out of authorization) is checked, the
`undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People's Republic of
`China (SIPO), the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
`participating with the USPTO in a bilateral or multilateral priority document exchange agreement in which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`and its related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date of filing of this Authorization. See 37 CFR 1.14(h)
`(1 ).
`
`B. Search Results from U.S. Application to EPO - Unless box Bin subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authority to provide the EPO access to the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`application is filed. See 37 CFR 1.14(h)(2).
`
`The applicant is reminded that the EPO's Rule 141(1) EPC (European Patent Convention) requires applicants to submit a
`copy of search results from the instant application without delay in a European patent application that claims priority to
`the instant application.
`
`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s)
`
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`D application-as-filed. If this box is checked, the USPTO will not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`B. Applicant DOES NOT authorize the USPTO to transmit to the EPO any search results from the instant patent
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`application.
`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide access to the
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`
`EFS Web 2.2.13
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`00007
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`
`
`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`42534-708.303
`
`Application Number
`
`Title of Invention METHODS AND SYSTEMS FOR DETECTING GENETIC VARIANTS
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Tille 37 of CFR
`to have an assignment recorded by the Office.
`
`I Remove I
`Applicant
`11
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`I Clear
`
`I
`
`• Assignee
`
`I
`Person to whom the inventor is obligated to assign.
`
`Legal Representative under 35 U.S.C. 117
`
`Joint Inventor
`
`I
`Person who shows sufficient proprietary interest
`
`I
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`1~1
`
`Name of the Deceased or Legally Incapacitated Inventor: I
`
`If the Applicant is an Organization check here.
`
`~
`
`Organization Name
`
`I 13UARDANT HEAL TH, INC.
`
`Mailing Address Information For Applicant:
`
`Address 1
`
`Address 2
`
`City
`Country I 1-Js
`Phone Number
`
`Email Address
`
`505 Penobscot Drive
`
`Redwood City
`
`State/Province
`
`CA
`
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