8039650
`
`UNlTED STATES DEPART'VIENT OF COMMERCE
`
`United Stntcs Potent nnd Trndemnrk Office
`
`March 30, 2020
`
`THIS IS TO CERTIFY THAT ANNEXED IS A TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`APPLICATION NUMBER: 16/665,702
`FILING DATE: October 28, 2019
`PATENT NUMBER: 10583155
`ISSUE DATE: March 10, 2020
`
`Certified by
`
`Under Secretary of Commerce
`for Intellectual Property
`and Director of the United States
`Patent and Trndemark Office
`
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`Doc Code: TRACK1 .REQ
`Document Description: TrackOne Request
`
`PTO/AIA/424 (04-14)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`I Nonprovisional Application Number (if I
`
`known):
`
`First Named
`Inventor:
`Title of
`Invention:
`
`John Maloney
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i)(1) and the prioritized examination fee set forth in
`37 CFR 1.17(c) have been filed with the request. The publication fee requirement is met
`because that fee, set forth in 37 CFR 1.18(d), is currently $0. The basic filing fee, search fee,
`and examination fee are filed with the request or have been already been paid. I understand
`that any required excess claims fees or application size fee must be paid for the application.
`
`2.
`
`I understand that the application may not contain, or be amended to contain, more than four
`independent claims, more than thirty total claims, or any multiple dependent claims, and that
`any request for an extension of time will cause an outstanding Track I request to be dismissed.
`
`i.
`
`3. The applicable box is checked below:
`I. Fl Original Application (Track One)- Prioritized Examination under§ 1.102(e)(1)
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 11 1(a).
`This certification and request is being filed with the utility application via EFS-Web.
`---OR---
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111(a).
`This certification and request is being filed with the plant application in paper.
`
`ii. An executed inventor's oath or declaration under 37 CFR 1.63 or 37 CFR 1.64 for each
`inventor, QC the application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is
`filed with the application.
`II. 0 Request for Continued Examination- Prioritized Examination under§ 1.102(e)(2)
`i. A request for continued examination has been filed with, or prior to, this form.
`ii.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a), or is
`a national stage entry under 35 U.S.C. 371 .
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`Signature/bryan I. Skelton/
`~~~~ voed) Bryan L. Skelton
`
`Date October 28, 2019
`50893
`
`Practitioner
`Reaistration Number
`
`Note: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4(d) for signature requirements and certifications.
`Submit multiole forms if more than one sianature is reauired. •
`
`0 •Total of 1
`
`fonns are submitted.
`
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
`submission of the 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 abandonment of 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
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`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
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`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record
`was filed in an application which became abandoned or in which the proceedings were terminated and which
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`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`
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`PTO/AIAf14 (02-18)
`Approved for use through 11130/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork ReductK>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHL y PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`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
`
`Middle Name
`Prefix Given Name
`I El ~ohn
`I
`Residence Information (Select One)
`• US Residency
`I State/Province I t,Jc
`City
`
`~alisbury
`
`Mailing Address of Inventor:
`
`Address 1
`
`p/o Exela Pharma Sciences, LLC
`
`I Remove I
`
`Family Name
`
`l',1aloney
`Non US Residency
`
`I Country of ResidencJ I 1-Js
`
`Active US Military Service
`
`Suffix
`I El
`
`Address 2
`City
`11--enoir
`Postal Code
`Inventor ~
`Legal Name
`
`1245 Blowing Rock Blvd
`
`I ~8645
`
`I State/Province
`I 1us
`I Countryi
`
`I ~c
`
`I Remove I
`
`Middle Name
`Prefix Given Name
`I El J\runa
`I
`Residence Information (Select One) @ US Residency
`I State/Province I t,Jc
`City
`~enoir
`
`Family Name
`
`t<oganti
`Non US Residency
`Active US Military Service
`I Country of ResidencJ I 1-Js
`
`Suffix
`I El
`
`Mailing Address of Inventor:
`
`Address 1
`
`b/o Exela Pharma Sciences, LLC
`
`Address 2
`City
`
`I ~enoir
`Postal Code
`
`Inventor b
`
`Legal Name
`
`1245 Blowing Rock Blvd
`
`I ~8645
`
`I State/Province
`I 1us
`I Countryi
`
`I ~c
`
`I Remove I
`
`Prefix Given Name
`
`Middle Name
`I B i=>hanesh
`I
`Residence Information (Select One) @ US Residency
`
`Family Name
`
`l<oneru
`Non US Residency
`
`Active US Military Service
`
`Suffix
`
`I B
`
`EFS Web 2.2.13
`
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`

`

`PTO/AIAf14 (02-18)
`Approved for use through 11130/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reducttc>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`City I Jlvaxhaw
`
`I State/Province I ~ Country of ResidencJ
`
`I 1-Js
`
`Mailing Address of Inventor:
`
`Address 1
`
`b/o Exela Pharma Sciences, LLC
`
`1245 Blowing Rock Blvd
`
`Address 2
`City
`I1-enoir
`Postal Code
`
`I State/Province
`I Ius
`I ~8645
`I Countryi
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`I ~c
`
`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).
`D An Address is being provided for the correspondence Information of this application.
`Customer Number
`)0826
`
`Email Address
`
`Application Information:
`
`I I Add Email I
`
`I Remove Email I
`
`STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`I Small Entity Status Claimed
`
`(cid:143)
`
`..
`..
`
`Title of the Invention
`
`Attorney Docket Number P66859/539011
`
`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~
`
`I Suggested Figure for Publication (if any) 11
`
`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).
`
`Application number of the previously
`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country
`
`11
`
`I
`Publication Information:
`(cid:143)
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Pub I ish. 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.
`
`11
`
`EFS Web 2.2.13
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`

`PTO/AIAf14 (02-18)
`Approved for use through 11130/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reducttc>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application {see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Number will be used for the Representative Information during processing.
`
`Please Select One:
`
`Customer Number
`
`• Customer Number
`~0826
`
`I
`
`US Patent Practitioner lo Limited Recognition (37 CFR 11.9)
`
`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
`the specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`When referring to the current application, please leave the "Application Number" field blank.
`I·
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`Prior Application Status
`
`tending
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`Filing or 371 (c) Date
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`Application Number
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`Continuity Type
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`Prior Application Number
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`I
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`I· 16248460
`Additional Domestic Benefit/National Stage Data may be generated within this form
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`~ontinualion of
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`~019-01-15
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`Foreign Priority Information:
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`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
`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 {PDX)i 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 ).
`I Remove I
`Access Codei (if applicable)
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`Countryi
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`Application Number
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`Filing Date (YYYY-MM-DD)
`I
`I
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`Add button.
`
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`PTO/AIAf14 (02-18)
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reducttc>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`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
`0 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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`

`PTO/AIAf14 (02-18)
`Approved for use through 11130/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reducttc>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`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
`paragraph A in subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant
`application (see paragraph B in subsection 1 below).
`
`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
`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
`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 (PDX) - 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
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`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide access to the
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`

`PTO/AIAf14 (02-18)
`Approved for use through 11130/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reducttc>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 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
`
`I
`Person who shows sufficient proprietary interest
`
`Joint Inventor
`
`I
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`H
`
`Name of the Deceased or Legally Incapacitated Inventor: I
`
`Organization Name
`
`If the Applicant is an Organization check here.
`I ~xela Pharma Sciences, LLC
`Mailing Address Information For Applicant:
`
`~
`
`~245 Blowing Rock Blvd
`
`enoir
`
`Address 1
`
`Address 2
`
`City
`Country I t-Js
`Phone Number
`
`Email Address
`
`State/Province
`
`NC
`
`Postal Code
`
`28645
`
`Fax Number
`
`I
`
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`
`I Add
`
`I
`
`Assignee Information including Non-Applicant Assignee Information:
`
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`

`PTO/AIAf14 (02-18)
`Approved for use through 11130/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reducttc>n 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
`
`Application Number
`Title of Invention I STABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND METHODS OF USE
`
`Attorney Docket Number
`
`066859/539011
`
`Assignee ~
`
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
`application publication. An assignee-applicant identified in the "Applicant Information" section will appear on the patent application
`publication as an applicant. For an assignee-applicant, complete this section only if identification as an assignee is also desired on the
`patent application publication.
`
`If the Assignee or Non-Applicant Assignee is an Organization check here.
`
`Given Name
`
`Family Name
`Middle Name
`Prefix
`I
`I
`I
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`
`I· I
`
`I Remove I
`(cid:143)
`
`Suffix
`I
`
`I·
`
`Address 1
`
`Address 2
`
`City
`
`Countryi
`
`11
`Phone Number
`
`Email Address
`
`11
`
`State/Province
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`ST ABLE, HIGHLY PURE L-CYSTEINE COMPOSITIONS FOR INJECTION AND
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`METHODS OF USE
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`Atty. Ref No. 066859/539011
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`CROSS-REFERENCE TO RELATED APPLICA TION(S)
`
`This application is a continuation of US. Application No. 16/248,460, filed
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`5
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`January 15, 2019, which is incorporated herein in its entirety by reference.
`
`TECHNICAL FIELD
`
`The subject matter described herein relates generally to compositions for p