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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`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:
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`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`Inventor Information:
`
`Inventor
`11
`Legal Name
`
`I Remove
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`I
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`Prefix Given Name
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`Middle Name
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`Family Name
`
`I El t'Jaoki
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`Residence Information (Select One)
`
`City
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`[sukuba-shi, lbaraki
`
`I
`US Residency
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`JlvATANABE
`• Non US Residency
`Active US Military Service
`l1country of Residence i
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`If P
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`Suffix
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`I El
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`I
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`Mailing Address of Inventor:
`
`Address 1
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`Address 2
`
`Room 402, Ruvio II, 21-3, Sakura 1-chome
`
`City
`
`I tsukuba-shi, lbaraki
`I ro5-ooo3
`Postal Code
`Inventor ~
`Legal Name
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`I State/Province
`I ~p
`I Countryi
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`11
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`I Remove
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`I
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`Prefix Given Name
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`Middle Name
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`Family Name
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`I El fr'ouhei
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`Residence Information (Select One)
`
`t,ATOU
`I
`US Residency @ Non US Residency
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`City
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`[sukuba-shi, lbaraki
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`IICountry of Residence i
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`Active US Military Service
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`If P
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`Suffix
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`I El
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`I
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`Mailing Address of Inventor:
`
`Address 1
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`Address 2
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`Room 401, Ruvio II, 21-3, Sakura 1-chome
`
`City
`
`I If sukuba-shi, lbaraki
`I ~05-0003
`Postal Code
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`Inventor b
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`Legal Name
`
`EFSWeb2.2.13
`
`I State/Province
`I µp
`I Countryi
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`11
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`I Remove
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`I
`
`
`
`PTO/AIN14 (02-18)
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`I El Jshin'ichi
`
`Residence Information (Select One)
`
`lfAKEDA
`I
`US Residency @ Non US Residency
`
`Active US Military Service
`
`City
`
`rodaira-shi, Tokyo
`
`IICountry of Residence i
`
`l~P
`
`Suffix
`
`I El
`
`I
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o National Center of Neurology and Psychiatry
`
`Address 2
`1-1, Ogawahigashicho 4-chome
`I f<odaira-shi, Tokyo
`City
`I 1181-8551
`Postal Code
`Inventor ~
`Legal Name
`
`I State/Province
`I ~p
`I Countryi
`
`11
`
`I Remove I
`
`Prefix Given Name
`
`Middle Name
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`Family Name
`
`I El lfetsuya
`
`Residence Information (Select One)
`
`f'JAGATA
`I
`US Residency @ Non US Residency
`
`Active US Military Service
`
`City
`
`rodaira-shi, Tokyo
`
`IICountry of Residence i
`
`l~P
`
`Suffix
`
`I El
`
`I
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o National Center of Neurology and Psychiatry
`
`Address 2
`1-1, Ogawahigashicho 4-chome
`I f<odaira-shi, Tokyo
`City
`Postal Code
`1 1181-8551
`
`I State/Province
`I ~p
`I Countryi
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
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`11
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`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
`)55694
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`DBRIPDocket@dbr.com
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`Application Information:
`
`Title of the Invention
`
`I\NTISENSE NUCLEIC ACIDS
`
`Attorney Docket Number 1209658-0001-08-US-590121
`
`Application Type
`
`Non provisional
`
`Subject Matter
`
`Utility
`
`I Small Entity Status Claimed □
`
`.
`.
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`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
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`1119
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`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.
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`Please Select One:
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`US Patent Practitioner lo Limited Recognition (37 CFR 11.9)
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`Customer Number
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`~55694
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`EFS Web 2.2.13
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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
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`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`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
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`Application Number
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`110329319
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`~019-06-25
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`. 16449537
`.
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`Continuity Type
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`116449537
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`pontinuation of
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`Prior Application Status
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`!='atented
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`Application
`Number
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`Continuity Type
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`115619996
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`pontinuation of
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`Prior Application Status
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`!='atented
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`Application
`Number
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`Continuity Type
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`114615504
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`pontinuation of
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`Prior Application Status
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`t=xpired
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`Prior Application
`Number
`I· 115619996
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`.
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`Prior Application
`Number
`I· 114615504
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`.
`
`Prior Application
`Number
`I· 113819520
`
`.
`
`~015-02-06
`
`~708361
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`~013-04-10
`
`~079934
`
`~017-07-18
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`Issue Date
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`
`~015-07-14
`I Remove I
`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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`~3819520
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`► 371 of international
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`. PCT/JP2011/070318
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`~011-08-31
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`
`Application Number
`
`Countryi
`
`Filing Date (YYYY-MM-DD)
`
`J/010-196032
`
`EFS Web 2.2.13
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`~p
`
`J/010-09-01
`
`I Remove I
`Access Codei (if applicable)
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`PTO/AIN14 (02-18)
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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
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`Add
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`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
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`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`Authorization or Opt-Out of Authorization to Permit Access:
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`When this Application Data Sheet is properly signed and filed with the application, applicant has provided written
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`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
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`A. Priority Document Exchange (PDXl - Unless box A in subsection 2 (opt-out of authorization) is checked, the
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`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
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`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)
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`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
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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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`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`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:
`
`Name of the Deceased or Legally Incapacitated Inventor: I
`
`1~1
`
`If the Applicant is an Organization check here.
`
`~
`I ~IPPON SHINYAKU CO., LTD.
`
`Organization Name
`
`Mailing Address Information For Applicant:
`
`Address 1
`
`Address 2
`
`City
`Country I ~P
`
`Phone Number
`
`Email Address
`
`14, Kisshoin Nishinosho Monguchicho, Minami-ku
`
`Kyoto-shi, Kyoto
`
`State/Province
`
`Postal Code
`
`Fax Number
`
`601-8550
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
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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
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`Applicant b
`
`I Remove I
`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.
`
`I
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`ITI
`
`Legal Representative under 35 U.S.C. 117
`
`I
`Person who shows sufficient proprietary interest
`
`Joint Inventor
`
`Name of the Deceased or Legally Incapacitated Inventor: I
`
`If the Applicant is an Organization check here.
`
`[81
`
`Organization Name
`
`I ~ATIONAL CENTER OF NEUROLOGY AND PSYCHIATRY
`
`Mailing Address Information For Applicant:
`
`Address 1
`
`Address 2
`
`City
`Country I ~P
`Phone Number
`
`Email Address
`
`1-1, Ogawahigashicho 4-chome
`
`Kodaira-shi, Tokyo
`
`State/Province
`
`Postal Code
`
`187-8551
`
`Fax Number
`
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`
`I Add
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`Assignee Information including Non-Applicant Assignee Information:
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`
`Assignee
`
`11
`
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
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`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.
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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
`
`209658-0001-08-US-590121
`
`Application Number
`
`Title of Invention
`
`ANTISENSE NUCLEIC ACIDS
`
`Organization Name
`
`I ~IPPON SHINYAKU CO., LTD.
`
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`n4, Kisshoin Nishinosho Monguchicho, Minami-ku
`
`Address 1
`
`Address 2
`
`City
`
`Countryi
`
`I ~p
`Phone Number
`
`Email Address
`
`I I
`l<yoto-shi, Kyoto
`
`State/Province
`
`Postal Code
`
`601-8550
`
`Fax Number
`
`Additional Assignee or Non-Applicant Assignee Data may be generated within this form by
`selecting the Add button.
`
`Add
`
`I
`
`I
`
`Assignee ~
`
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`patent application publication.
`
`I Remove I
`~
`
`If the Assignee or Non-Applicant Assignee is an Organization check here.
`
`Organization Name
`
`I ~ATIONAL CENTER OF NEUROLOGY AND PSYCHIATRY
`
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`
`Address 1
`
`Address 2
`
`City
`
`Countryi
`
`I ~p
`Phone Number
`
`Email Address
`
`n-1, Ogawahigashicho 4-chome
`
`11 l<odaira-shi, Tokyo
`
`State/Province
`
`Postal Code
`
`187-8551
`
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`Application Data Sheet 37 CFR 1.76
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`209658-0001-08-US-590121
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`ANTISENSE NUCLEIC ACIDS
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`I,zhengyu Feng/
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Docket No.: 209658-0001-08-US-590121
`(PATENT)
`
`In re Patent Application of:
`Naoki WATANABE et al.
`
`Continuation Application of
`Prior Application No.: 16/449,537
`Prior Application Filed: June 24, 2019
`
`Continuation Filed: Concurrently Herewith
`
`For: ANTISENSE NUCLEIC ACIDS
`
`Confirmation No.: Unassigned
`
`Group Art United: 1635
`(Prior Application)
`
`Examiner: Sean McGarry
`(Prior Application)
`
`FIRST PRELIMINARY AMENDMENT
`
`MS NEW
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Sir:
`
`Prior to examination on the merits, please amend the above-identified U.S. patent
`
`application as follows:
`
`Amendments to the Specification begin on page 2.
`
`Amendments to the Claims begin on page 3.
`
`Remarks begin on page 5.
`
`121471652.1
`
`
`
`Application No. Not Yet Assigned
`Amendment dated December 12, 2019
`First Preliminary Amendment
`
`Docket No.: 209658-0001-08-US-590121
`Page2
`
`AMENDMENTS TO THE SPECIFICATION
`
`Please insert the following paragraph on page 1 of the specification before the section
`
`entitled "TECHNICAL FIELD":
`
`CROSS REFERENCE TO RELATED APPLICATIONS
`
`This application is a Continuation of copending Application No. 16/449,537 (allowed),
`
`filed June 24, 2019, which is a Continuation of Application No. 15/619,996, filed June 12, 2017
`
`(now U.S. Patent No. 10,329,319 issued June 25, 2019), which is a Continuation of Application
`
`No. 14/615,504, filed February 6, 2015 (now U.S. Patent No. 9,708,361 issued July 18, 2017),
`
`which is a Continuation of Application No. 13/819,520, filed April 10, 2013 (now U.S. Patent
`
`9,079,934 issued July 14, 2015), which is a PCT National Stage of PCT/JP2011/070318 filed
`
`August 31, 2011, which claims priority to JP Application No. 2010-196032 filed September 1,
`
`2010, all of which are incorporated by reference in their entireties.
`
`SEQUENCE LISTING
`
`The instant application contains a Sequence Listing which has been submitted in ASCII
`
`format via EFS-Web and is hereby incorporated by reference in its entirety. Said ASCII copy,
`
`created on December 9, 2019 is named 209658_0001_08_US_590121_ST25.txt and is 24,765
`
`bytes in size.
`
`121471652.1
`
`
`
`Application No. Not Yet Assigned
`Amendment dated December 12, 2019
`First Preliminary Amendment
`
`Docket No.: 209658-0001-08-US-590121
`Page 3
`
`AMENDMENTS TO THE CLAIMS
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`This listing of claims will replace all prior versions, and listings, of the claims in the
`
`application:
`
`LISTING OF CLAIMS
`
`Claim 1. (Previously Amended): An antisense oligomer which causes skipping of the
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`53rd exon in the human dystrophin gene, consisting of a nucleotide sequence complementary to
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`any one of the sequences consisting of the 32nd to the 56th or the 36th to the 56th nucleotides
`
`from the 5' end of the 53rd exon in the human dystrophin gene.
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`Claim 2. (Original): The antisense oligomer according to claim 1, which is an
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`oligonucleotide.
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`Claim 3. (Original): The antisense oligomer according to claim 2, wherein the sugar
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`moiety and/or the phosphate-binding region of at least one nucleotide constituting the
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`oligonucleotide is modified.
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`Claim 4. (Original): The antisense oligomer according to claim 3, wherein the sugar
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`moiety of at least one nucleotide constituting the oligonucleotide is a ribose in which the 2'-OH
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`group is replaced by any one selected from t