`
`PTOVAIAION (05-12)
`
`Approved for use through 14/30/2020, OMB 0651-0032
`.
`U.5. Patent and Trademark Office; US, REPARTMENT OF COMMERCE
`Linder the Paperwork Reduction Act of 1998, no persons are reqJired te respond te a callection of information untess idi
`salid
`OMB canirol number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET(37 CFR 1.76)
`[CRYSTAL FORM OF OREXIN RECEPTOR ANTAGONIST, PREPARATION
`
`invention|METHOD THEREFOR AND USE THEREOF
`
`Tideor
`
`
`
`As the below named invertor, { hereby declare that:
`
`This declaration
`ig diracted10°
`
`|
`
`.
`
`arnfientic
`artharl
`‘
`The attached application, or
`«United States application or PCTinternational application number
`O7/3 1/2018
`fled on ="
`
`fe)
`
`PCTIGN2018/097797
`
`The above-identified application was made or authorized ta be made by me.
`
`|
`
`| believe that | amthe originalinventor or an originaljoint inventor of a claimed invention in the application.
`
`i} hereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C. 4
`i by fine or imprisonment of not more than five (5) years, or both.
`
`WARNING:
`
`Petifioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity ihefi. Personal information such as social security numbers, bank account numbers, or credit card numbers
`(other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by the USPTO
`to support a petition or an application.
`if this type of personal information is included in docurnents submitted to the USPTO,
`petitioners/applicanis should consider redacting such personal information fromthe docurnents before submitting them to the
`
`USPTO. Petitioner/applicant is advised that the record of a patent application is available to the public afier publication of the
`application (unless a non-publication request in compliance with 37 CFR 1.21 2a) is made in the application) or issuance of a
`patent. Furthermore, the record from an abandoned application may also be available to the public if the application is
`referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card authorization forms
`PTO-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`LEGAL NAME OF INVENTOR
`
`Inventor:
`
`Minhua Chen
`
`Date (Optional) :
`
`Note: An application data sheet (PTO/SB/14 or equivalent), inchiding naming the entire inventive entity, must accompany this form or must have
`heen previously filed. Use an additional PTO/AIA/O1 form jor each additional inventor.
`
`.63. The information 's required to obtain orretain a benefit by the public whichis io file fend
`§
`
`«the usSPTO to process} 2an application, Confidentiatityis governed by 38 U.S.C. 122 and 37 CFR 1.41 and 1.14. This collection is estimaied to take 1 minute to
`ceive including gathering, preparing, and submitting the completed application form ta the USPTO.Time will vary depending upon the individual case. Any
`comments on the arnount of time you require to complete this form and/or suggestions for reducing this burden, should be sent ta the Chief Information Officer, U.5.
`Patent and Trademark Office, U.S. Department of Commerce, P.0. Box 1450, Alexandria, VA 22243-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS, SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1466,
`ifyou need assistance in completing the form, call 1-800-PTO-3198 and select option 2.
`
`
`
`Page 1 of 383
`
`EISAI EXHIBIT 1004
`
`Page 1 of 383
`
`EISAI EXHIBIT 1004
`
`

`

`
`
`PTOMAIAIOT (06-12
`Aporavedfor use through 11/30/2020. OMB 0851-0032
`
`U.S, Palent and Trad mark Office, U.S.
`DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction actof 1995, no persons ave required te respond to a collecti
`j
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (87 CFR 1.76)
`Titeoy|CRYSTAL FORM OF OREXIN RECEPTOR ANTAGONIST, PREPARATION
`
`invention|METHOD THEREFOR AND USE THEREOF
`
`As the below named inventor, i hereby declare that:
`
`This declaration
`is directed to:
`
`
`_ The attached application, or
`
`i been previously filed. Use an ‘additional PTO/AIA/O1 formfor each additional inventor. This collection of information is required by 35 U.S.C. 145 and 37 CFR 1.83. The information is required to obtain or retain a benefit by the public whithis to file (and
`
`Petitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`contribute to identity theft. Personal inforrnation such as social security numbers, bank account numbers. or credit card numbers
`(other than a check or credit card authorization form PTO-2038 submitted for payrnent purposes) is never required by the USPTO
`to suppori.a petition or an application.
`tf this tyee of personalinformationis included in documents submitted to the USPTO,
`petitioners/applicants should consider redacting such personal information from the documents Gefore submitting them to the
`USPTO. Petifioner/applicant ic advised that the record of a patent application is available to the public after publicattion of the
`application (unless 3 non-publication request in compliance with 37 CFR 1.213{a) is made in the application) or issuance ofa
`patent. Furthermore, the record from an abandoned application may also be available fo the public if the applicati
`
`referenced in a published application or an issued patent (see 37 CFR 1.14}. Checks and credit card authorizat
`FTO-2038 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`United States application or PCT international application number
`O73 1/2018
`
`filed an
`
`PCTICN2018/087797
`
`The above-identified application was made or authorized fo be made by me.
`
`! believe that 1 am the original inventeror an original joint inventor of a claimed invention in the application.
`
`thereby acknowledge that any willful false statement made in this declaration is punishable under 18 U.S.C. 1001
`by fine or imprisonment of not more than five (5) years, or both.
`
`WARNING:
`
`LEGAL NAME OF INVENTOR
`
`inventor: Yanfeng éhang
`Signature:
`
`Date (Optional:
`
`Note: An apptication data sheet (PTO/SBHH14 of equivalent, including naming the entire inventive entity, must accompanythis form or must have
`
`py the USPTO ta process) an application. Confidentiality is governed by 35 U S.C. 122 and 47 CFR 1.11 and 1.14. This colfection is estimated to take 1 minute to
`campiate, inciuding gathering, sreparing, and submitting the compieted application form ta the USPTO. Time will vary depending upon the individual case, Any
`
`comments on the amaunt of time you require to complete this formand/or suggesiiens for recucing this burden, should be sent to the Chief information Officer, U.S.
`Patent and Trademark Office, U.S. Department of Commerce. P.O. Box 1480, Alexandtia, V4 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 2239301456.
`if you need assistance in completing the form,cali 1-800-PTO.9799 and select aption 2.
`
`Page 2 of 383
`
`Page 2 of 383
`
`

`

`
`
`PTOMALAIOT (06-12)
`Approved for use through 41/30/2020. OMB 6857-0532
`-
`U.S. Patent and Trademark Office, US. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1298, no persons are required ta respond to a collection of information unless it displays a valid OMBcontrol number.
`
`DECLARATION (37 CFR 1.63} FOR UTILITY OR DESIGN APPLICATION USING AN
`
`Tideof|CRYSTAL FORM OF OREXIN RECEPTOR ANTAGONIST, PREPARATION
`inventions|METHOD THEREFOR AND USE THEREOF
`
`APPLICATION DATA SHEET (37 CFR 1.78)
`
`i
`| Patitioner/applicant is cautioned to avoid submitting personal information in documents filed in a patent application that may
`j contribute to identity theft. Personal information such as social securily numbers, bank account numbers, or credit card numbers |
`| (other than a check or credit card authorization form PTO-2038 submitted for payment purposes)is never required by the USPTO}
`ito Support a petition or an application.
`if this type of personal information is included in documents submitied to the USPTO,
`i
`| Detitioners/applicants should consider redacting such personal information from the documents before subrnitting them to the
`USPTO, Petitioner/applicant is advised that the record of a patent application is available to the public after publication of the
`
`f application (unless a non-publication request in compliance with 37 CFR 1.242/a) is rnade in the application) orissuance of a
`jpatent, Furthermore, the record from an abandoned application may also be available to the public ifthe application is
`| referenced in a published application or an issued patent (see 37 CFR 1.14). Checks and credit card authorization forms
`1PTO-2036 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`As the below narnec inventor, i hereby declare that:
`
`This declaration
`is directed to:
`
`mati
`an
`The attached application, or
`United States application or PCT international appiication number
`7/34/2018
`
`fled on
`
`POTICN2018/097797
`
`The above-identified apolication was made or authorized to be mare by me.
`
`f belleve that | am the original inventor or an original joint inventor of a claimed inventionin the application,
`
`Hi hereby acknowledge that any willful false staternent made in this declaration is punishable under 18 U.S.C. 1004
`} by fine or imprisonment of not more than five (5) years, or both.
`
`WARNING:
`
`LEGAL NAME OF INVENTOR
`
`inventor:
`
`Chunxiang Huang
`
`Signature:
`
`Date (Optional) :
`
`i Note: An application data sheet (PTO/SB/14 or equivalent), including naming the entire inventive entity, must accompany this form or must have
`| been previously filed. Use an additional PTO/AIA/O1 farra for each additional inventor.
`a benefit by the public which is to Mle (and
`i
`Confidentiality is governec by 35 U.S.C. 122 and 37 CFR 1.11 and 4.74. This collection is estimated te take 1 minute to
`by the USPTO te process} an applica’
`corapiete, inciuding gathering, preparing, and subrniting the cornpieied application farm to the USPTO, Time will vary depending upon the individual case, Any
`comments an the amount of time yourequire to complete this form and/or suggestions for reducing this curden, should be sent ta the Chief Information Offteer, U.S.
`
`Patent and Trademark Office, U.S. Department of Commerce, 2.0, Box 1450, Alexandria, VA 22413-1480. OO NOT SEND FEES OR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1458, Alexandria, VA 22313-4458.
`lfyou need assistance in completing the form, cel! 1-800-PTO-2198 and select option 2.
`
`Page 3 of 383
`
`Page 3 of 383
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`

`

`
`
`PTOVAIAION (66-412)
`Approved foruse through 11/20/2020. OMB 0651-Gaa2
`U.S. Patent and Tradernark Oifice; U.S. DEPARTMENT OF COMMERCE
`
`DECLARATION (37 CFR 1.83} FOR UTILITY OR DESIGN APPLICATION USING AN
`APPLICATION DATA SHEET (37 CFR 1.76)
`
`Tite of|CRYSTAL FORM OF OREXIN RECEPTOR ANTAGONIST, PREPARATION
`invention FMETHOD THEREFOR AND USE THEREOF
`
`As the below named inventor, | hereby declare that:
`
`
`This declaration=[~ inati
`is directed to:
`[|
`The atlached application, or
`ii|
`United States application ar PCT international application number PCTICNZ04 BOSTTOT
`07/34/2018
`filed on
`
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit displays a valid OMB control number.
`
`i
`| Petitioner/appticant is cautioned to avoid submitting personal information in documentsfiled in a patent application that may
`} contribute to identity theft. Personal information such as social security numbers, bank account numbers, or credit card numbers |
`| (other than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by the USPTO}
`j fo support a petition or an application.
`If his tyce of personal information is Included in documents submitted to the USPTO,
`|
`| petitioners/applicanis should consider redacting such personal information from the documents before subrnitting them te the
`FUSPTO. Petitisnerfapplicant is advised that the record of a patent application is available to the public after publication of the
`J applicalion (unless 2 non-publication request in compliance with 37 CFR 1.213(a) i¢ made in the application) or issuance of a
`ipatent. Furthermore, the record from an abandoned application mayalse be avaiable to the public if the application is
`i referenced in a published application or an issued patent (see 37 CFR 1.44}. Checks and cradit card authorization farms
`| PTO-2033 submitted for payment purposes are not retained in the application file and therefore are not publicly available.
`
`The above-identified application was made or authorized to be made by me.
`
`}
`
`| believe that | arn the original inventor or an originaljoint inventerof a claimed invention in the application.
`
`thereby acknowledge that any willful false statement madein this declaration is punishable under 18 U.S.C. 1007
`| by fine or imprisonment of not more than five (5) years, or bath.
`
`WARNING:
`
`LEGAL NAME OF INVENTOR
`
`Inventor: Xiaoyu ehang
`
`Date (Optional) :_
`
`: Note: An application data sheet (PTO/SB/14 or equivalent}, including naming the entire inventive entity, must accompany this form or must have
`i been previously filed. Use an additional PTC/ALA/O1 form for each additional inventor.
`i CFR 1.63. The information is required to obtain or retain a benefit by the public whichis te file (and
` “Thiscollectionofinformation is requiredby
`
`
`hy the USPTO ta process) an application, Cantiden
`y fs governed by 35 U.5.C. 122 and 37 CFR 4.17 and 1.74, This collection is estimated to take 1 minute to
`
`complete, including gathering, preparing, and submitting the completed application farmta the USPTO, Time will vary depending wean the individual case. Any
`
`comments on the amauniof time you require to complete
`this form and/or suggestions for reducing this burden, should be sent to the Chief Inforrnaiion Officer, U.S.
`Patent and Trademark Gifice, U.S. Department of Cormimerce, PG. dex 1450, Alexandria, VA 22312-7450. BO NOT SEND FEES GR COMPLETED FORMS TO
`THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22243-14458.
`ifyou need assistance in compfeting the form, call 1-800-PTO-3198 and select option 2.
`
`Page 4 of 383
`
`Page 4 of 383
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`

`

`| hereby certify that this paper (along with any paperreferred to as being attached or enclosed)is
`being transmitted via the Office electronic filing system in accordance with 37 C.F.R. § 1.6(a)(4).
`
`/Xiaoyuan Ding/
`
`Dated: January 30, 2020
`Electronic Signature for Xiaoyuan Ding:
`
`Docket No.: 134070-01602
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARKOFFICE
`
`In re Utility Application of:
`Minhua Chenetal.
`
`Application No.: Not Yet Assigned
`Continuation of PCT/CN2018/097797
`
`Confirmation No.: N/A
`
`Filed: Concurrently Herewith
`Int’! Filing Date: July 31, 2018
`
`Art Unit: N/A
`
`For: CRYSTALLINE FORM OF OREXIN
`RECEPTOR ANTAGONIST, PROCESSES FOR
`PREPARATION THEREOF AND USE
`THEREOF
`
`Examiner: Not Yet Assigned
`
`MS Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`INFORMATION DISCLOSURE STATEMENT (DS)
`
`Dear Sir:
`
`Pursuant to 37 C.F.R. §§ 1.56, 1.97, and 1.98, the attention of the United States Patent and
`
`Trademark Office is hereby directed to the referenceslisted on the attached PTO/SB/08. It is
`
`respectfully requested that the information be expressly considered during the prosecution of the
`
`above-identified application, and that the references be made ofrecord therein and appear among
`
`the “References Cited” on any patent to issue therefrom.
`
`This Information Disclosure Statement is filed together with a continuation application filing
`
`as set forth in 37 C.F.R. § 1.491 (37 C.E.R. § 1.97(b)(1)).
`
`ME1 32457729v.1
`
`Page 5 of 383
`
`Page 5 of 383
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`

`

`Application No.: Continuation of PCT/CN2018/097797
`
`Docket No.: 134070-01602
`
`In accordance with 37 C.F.R. § 1.98(a)(2)(Gi), Applicant has not submitted copies of U.S.
`
`patents and U.S. patent applications. Applicant submits herewith copies of foreign patents and non-
`
`patent literature in accordance with 37 C.F.R. § 1.98(a)(2).
`
`In accordance with 37 C.F.R. § 1.97(g), the filing of this Information Disclosure Statement
`
`shall not be construed as a representation that a search has been made.
`
`In accordance with
`
`37 C.E.R. § 1.97(h), the filing of this Information Disclosure Statement shall not be construed to be
`
`an admission that the information cited in this Information Disclosure Statementis, or 1s considered
`
`to be, material to patentability as defined in 37 C.F.R. § 1.56(b).
`
`It is submitted that the Information Disclosure Statement is in compliance with
`
`37 C.F.R. § 1.98, and the Examineris respectfully requested to considerthe listed references.
`
`Applicant believes no fee is due with this response.
`
`Dated: January 30, 2020
`
`Respectfully submitted,
`
`/Xiaoyuan Ding/
`
`Electronic signature:
`Xiaoyuan Ding
`Registration No.: 75,354
`MCCARTER & ENGLISH, LLP
`265 Franklin Street
`Boston, Massachusetts 02110
`(617) 449-6500
`(617) 607-9200 (Fax)
`Attorney/Agent For Applicant
`
`ME1 32457729v.1
`
`Page 6 of 383
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`Page 6 of 383
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`

`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 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 unlessit contains a valid OMB control number.
`
`Title of Invention|TuEREOF AND USE THEREOF
`
`ati
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`
`The application data sheetis part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arrangedin 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 maybe printed and included in a paperfiled application.
`
`Secrecy Order 37 CFR5.2:
`
`Oo Portionsorall of the application associated with this Application Data Sheet mayfall under a Secrecy Order pursuantto
`
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may notbefiled electronically.)
`
`Inventor Information:
`
`
`
`ResidenceInformation (Select One)
`
`US Residency
`
`@ Non US Residency
`
`Active US Military Service
`
`Middle Name
`
`
`
`
`
`Mailing Addressof Inventor:
`Address 1
`| 4-301, Biobay, 218 Xinghu Street
`Address 2
`| uzhou Industrial Park
`
`city[uznoutanosu—S—_~* State/Province
`
`Postal Code
`Countryi
`Inventor
`b
`PeSearsPeeTenens
`THfevers
`bes|‘Gf
`Residence Information (Select One)
`US Residency
`@) Non US Residency
`Active US Military Service
`City[BuoyYCountry of Residence! g_
`
`Legal Name
`
`
`
`
`
`City[BeenYCountry of Residence! x
`
`
`
`
`
`Mailing Addressof Inventor:
`
`Address 1
`
`B4-301, Biobay, 218 Xinghu Street
`
`
`
`Address 2
`uzhou Industrial Park
`
`roity|Buxtouvenssu________] StaterProvince ||
`
`
`
`Postal Code|215123 Country i
`Inventor
`Legal Name
`
`EFS Web 2.2.13
`
`Page 7 of 383
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`Page 7 of 383
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`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|134070-01602
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`Title of Invention
`
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`THEREOF AND USE THEREOF
`
`
`
`retSeenaneaneTames
`
`EfPeme a
`Residence Information (Select One)
`US Residency
`(@) Non US Residency
`Active US Military Service
`city
`Country of Residence
`B______]
`
`
`
`
`Mailing Addressof Inventor:
`
`Address 1
`
`B4-301, Biobay, 218 Xinghu Street
`
`
`
`
`
`Address 2
`Feiy|Beene] Sterne
`
`
`Legal Name
`
`[Pref]GivenName|WiddleName_——_——(FamilyName(|Sui
`THkee
`bes|
`ResidenceInformation (Select One) Active US Military Service US Residency (@) Non US Residency
`
`
`
`
`Country of Residence i
`
`Mailing Addressof Inventor:
`Address|Pa04Boban0MngheStest
`
`(Address?|BurounausnalPak——SSSSOSOSOSOSSCSCCC~*S
`rciy[Fumo SSC—~*dsStateProvinceJTSCSCSC~C~S~*S
`[PostalGode[pew—————~ieomiyiTENSSSCSCS~S~*S
`All
`Inventors Must Be Listed - Additional
`Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`Correspondence Information:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`| Hlocket@mecarter.com
`
`[_] An Addressis being provided for the correspondenceInformation of this application.
`Customer Number
`| 5738
`Email Address
`
`EFS Web 2.2.13
`
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`Page 8 of 383
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`

`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 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 unlessit contains a valid OMB control number.
`
`
`Attorney Docket Number|134070-01602
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`
`Title of Invention|TyeRFOF AND USE THEREOF
`
`Application Information:
`
`Title of the Invention
`
`
`Attorney Docket Number
`
`Small Entity Status Claimed
`
`[xX]
`
`
`
`Subject Matter =o
`Total Numberof Drawing Sheets {if any) a Suggested Figure for Publication (if any) ||
`Filing By Reference:
`
`
`Only completethis section whenfiling an application by reference under 35 U.S.C. 111(c) and 37 CFR 1.57(a). Do not complete this sectionif
`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”).
`
`For the purposesofa 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 numberof the previously
`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country
`
`Publication Information:
`
`
`
`
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`Request Not to Publish. | hereby requestthat 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
`Ol
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months afterfiling.
`
`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 powerof 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
`
`Numberwill be used for the Representative Information during processing.
`
`
`
`Please Select One:
`
`@ Customer Number
`
`US Patent Practitioner
`
`C) Limited Recognition (37 CFR 11.9)
`
`Customer Number
`
`EFS Web 2.2.13
`
`Page 9 of 383
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`Page 9 of 383
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`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|134070-01602
`
`Application Data Sheet 37 CFR 1.76
`Application Number
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
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`Title of Invention|TyeRFOF AND USE THEREOF
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`
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`Domestic Benefit/National Stage Information:
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`
`
`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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`the specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
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`When referring to the current application, please leave the “Application Number”field blank.
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`
`
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`Filing or 371(c) Date
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`Application Number
`Continuity Type
`Prior Application Number
`(YYYY-MM-DD)
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`[FerranoeFy reece
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`2018-07-31
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`Additional Domestic Benefit/National Stage Data may be generated within this form
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` Add
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`by selecting the Add button.
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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 underthe priority document exchange program (PDX)! the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55(i)(1) and (2). Under the PDX 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).
`
`Remove
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`Access Code (if applicable)
`
`Remove
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`Application Number
`
`Add button.
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`Additional Foreign Priority Data may be generated within this form by selecting the
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`Access Code (if applicable)
`
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`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
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`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 effectivefiling date on or after March
`[] 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 underthefirst inventorto file provisions of the AIA.
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`EFS Web 2.2.13
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`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 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 unlessit contains a valid OMB control number.
`
`Attorney Docket Number|134070-01602
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`
`Title of Invention|TyeRFOF AND USE THEREOF
`
`application in accordance with 37 CFR 1.14.
`
`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 Ain 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 USPTOin a bilateral or multilateral priority document exchange agreementin which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`andits 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 offiling of this Authorization. See 37 CFR 1.14(h)
`(1).
`
`B. Search Results from U.S. Application to EPO - Unless box B in subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authority to provide the EPO accessto 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}
`
`A. Applicant DOES NOT authorize the USPTOto permit a participating foreign IP office access to the instant
`|] application-as-filed.
`If this box is checked, the USPTOwill not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`[_]
`
`B. Applicant DOES NOT authorize the USPTOto transmit to the EPO any search results from the instant patent
`application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant
`application.
`NOTE: Oncethe 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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`Page 11 of 383
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`Page 11 of 383
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`

`

`PTO/AIA/14 (02-18)
`Approved for use through 11/30/2020. OMB 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 unlessit contains a valid OMB control number.
`
`
`Attorney Docket Number|134070-01602
`Application Data Sheet 37 CFR 1.76
`Application Number
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`
`Title of Invention|TyeRFOF AND USE THEREOF
`
`Applicant Information:
`
`
`Providing assignmentinformation 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.
`
`
`4
`Applicant
`If the applicantis the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`Theinformation to be provided in this section is the name and addressof the legal representative whois the applicant under 37 CFR
`1.43; or the name and addressof the assignee, person to whom the inventoris under an obligation to assign the invention, or person
`who otherwise showssufficient 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 inventoris obligated to assign, or person who otherwise showssufficient
`proprietary interest) together with one or morejoint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
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`Legal Representative under 35 U.S.C. 117
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`Joint Inventor
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`Person to whom the inventoris obligated to assign.
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`Person who showssufficient proprietary interest
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`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`
`
`
`
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`Nameof the Deceased or Legally Incapacitated Inventor:
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`If the Applicant is an Organization check here.
`
`x
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`Organization Name
`
`: rystal Pharmaceutical (Suzhou) Co., Ltd.
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`Mailing Address Information For A