`
`PTO/Awm (0542)
`
`U“o. Paient and Trademark Officefi." fiEPAR'[MiNT OF' COMMERCE
`Approved for use Iihrougii 1130/2020. D'V‘B 05‘51-0032
`iinder the Paperwork Reduction Act rif 1395,:19 persons are rec;tired ic re$panId in a caileciien of irifermaiian unie5s ii dI
`'
`OMB central number
`
`
`
`
`
`BECLARATEON (3? CFR 1.63) FOR UTiLiT‘r’ OR EESEGN APPLICATEON USENG AN
`APPLECATEON BATA SHEET (3? CFR 1.78)
`
`CRYSiAL FORM OF QREXEN RECEPTOR ANTAGONEST PREPARATiON
`Tide of
`invention METHOD THEREFOR AND USE THEREOF
`
`
`As the beiow named inventor, i hereby deciare that:
`
`This deiaraticm
`is directedid:
`
`~
`
`T'ne attained a
`5'
`
`iicr‘iiori, 01'
`pp ‘2
`
`E United Staies appiicatinn 0r PCT‘ intei'naiionai appiiaa‘iien number
`{137311120 8
`flied dram
`
`PCTICN2018i097?97
`
`The abeve~identified appiication was made or auihorized in be made by me.
`
`i beiieve that ! am the originaltinventor or an original joint inventar 01a claimed invention in the appiicatinn
`
`i hereby acknnwiedge that any wiiiiul iaise siaiemen: made in this deciaratien is punishabie under 18 USS. 1001
`:
`‘ byifine or impriscnmeni cit" not more than five (5) years sir both
`
`WARNENG:
`
`Petitioner/appiicani is cautioned to avoid submitting persona! information in documents filed in a patent appiicatinr. that may
`contribute id identity than. Persenai information such as sociai security numbers, bank account numbers, or credit card numbers
`(miter inan a check nr credit card authorization form PTO—2038 submitted fur payment purpaseS) is never required by the USPTO
`to support a petition or an application.
`if this type of personal information is included in documents submitted in the USPTO.
`petitionersiap i‘canis shouid consider redacting such personai informaticn 1mm fine dccurneriis befare anbmit‘iing them to the
`
`USPTO. Petitioner/appiicant is advise-3‘ that the regard ofanaieni appiica‘iian is avaiiabie in the pu'niic aster pubiicaiinn at inIs:
`appiicaiimn (uniess a nonnpubiicaiic-n request in campiiance with 3.! CFR 1.21 Signis made in the appi:cation) or issuance mfa
`patent, Furthermore. the record frnm an abandnned appiica“:inn may also be avaiia'nie to the pubiic if the appliaaiioniS
`refernnced in a published applicatian or an issued pate itisees. 37 CFR 1 14) Checks and credit card authorization forms
`PTO—2038 submitted for payment purposes are not retained in the: appiicaiion file and therefore are not pubiiciy avaiiabie.
`
`LEGAL NAME OF iNVENTDR
`
`Minhua C‘nen
`
`inventor:
`
`Signature:
`
`Date (Optionai) :
`
`Note: An appiioaiion daia sheet (PTO/38114 or equivaieni), inciuding naming the entire inventive eniiiy, musi amnmpany this form or must have
`been previously filed, Use an additionai PTOiAiAiO'i form for each additinnai inventor.
`
`. 3 The Information5 requIIred to OWE:'1 at :etsin a banefii by the pubiic which is to file (and
`,
`.o
`y
`
`
`yihe US:WC :0 process) an applIcaitidn. Co-ii‘ideriiiautyis governed by 35 USc.122 and’17 CPR 1 11. EEK;
`.14 This coilemion is eéiimaied to take 1 minute to
`:ampia-te inciuding gathering preparing, and swimming the completed appiiofiicn formi-zi the USPTO. Time wiii vary depending upon the individual easel Any
`comma..15 or 1115 amount ui tin‘Ie yuu require in compieie this form andfor suggestions far reducing this burden, shuuid be sent in iii: Chief lnfarmanon Oificen US.
`Patent and Trademark Office, UQ Dapanmani of Commerca. P._,. Bax 1450 Alexandria VA 2113-1450. 00 NOT SEND FEES 0R COMPLETED FORMS To
`THiS ADDRESS SEND 10: Commissioner for Patients. PJZJ Box 1450 Alexandria VA 22313-1450.
`It'ynu need assistance in corrtpiefjng me farm. sail 1-800—PTO~§ 1.93? and sales? cpiirm 2,
`
`
`
`Page 1 of 383
`
`EISAI EXHIBIT 1004
`
`Page 1 of 383
`
`EISAI EXHIBIT 1004
`
`

`

`
`
`PTO/AiNGi (OB—i2
`Appmved for use through. 1180/2020. DMI 055143032
`
`LES Paient and Trad mark Ofi'ce; i)
`DEPARTMENT OF (ZOMivliEFiCE
`Under the Paperwork Reduction AC! of 1995', 710 pEi'SOi‘iS 372-
`required to respmri 1:; a mi mien of in
`'
`"
`‘
`er.
`
`
`
`
`
`DECLARATIQN (37 CPR 1.53) FDR UTELETY OR DESEGN APPLICA‘E‘EQN USENG AN
`APPLiCATiQifi {DATA SHEET (3'? CFR1.?§}
`
`GRYSTAL FORM 0
`Title of
`”WWW” METHQD THEREFOR AND USE THEREOF
`
`As the below named inventor, i hereby deciare that:
`
`This declaration
`is directed m:
`
`
`
`The attachsid applicailan, or
`United States applicatiun or PCT internationai appiication number
`0731/2018
`
`flied on
`
`PCTICNEGi 8/09??97
`
`
`
`The abave~ideniifiec£ applicaiisn was made (if authnrized to be made: by me.
`
`i believe iiiai i am the ariginal invenior or an original jaim inventor of a claimed inventicn in the appiication.
`
`i iieraby aakrinwiedge that any wiiir'ui faise Sia‘iemeni made in this deciaration is punisiiabie under “:8 USE. 103.1
`by fine or imprisonment of not more than five (5) years, cr both.
`
`WARNENG:
`
`Petitiuner/appiicant is cautioned to amid submitting perscnai informaticm in ducuments flied in a patent appiicaticm that may
`contribute to identify theft. Peracnai information such a5 ficciai security numbers. bank accaum numbers. or credit card numbers
`(other than a check or credit card authorization iomi PUD-2038 submitted for payment purpases) is never required by the USPTO
`to supporta petition ar an applicaticsri.
`if this type of personai infarmaiion is included in decuments submitted to ihe USPTO,
`petiiinners/applicants should consider redaciing such permnai informaiian {mm the documents before submitting lhem in the
`USPTQ. Peii‘iibneri’appiisarii is; advisssd that the record of a paierli appiiczaiian is avaiiabie iii the public afier pubiicaiian (if the
`appiication {unless a mn—pubiication request in oompiiance with 37 CFR 1.213(3) is made in the appiicationi or issuance cf a
`patent. Furthermore. the record from an abandoned application may also be awaiiabia it: the public if iha appii
`'on is;
`
`referenced in a pubiishcd applicaiian or an issued patent {see 37 CPR 1.14}. Checks and credit card auiherizai- n icrrns
`PTO~2038 submitted far payment purposes are not retained in the applicaticn file and therefore are rid pubiiciy available.
`
`LEGAL NAME OF ENVENTOR
`
`inventor:
`Signature:
`
`V
`' anfang Zi‘iai‘ig
`Date (Optionai) :
`,
`’ {yam
`
`been previousiy fiied. Use an ciditionai PTOIAWO’i form fereacii additional inventor.
`
`This caiieciion oi info nation is required by 35 U310, 115 and 37 CPR 1.83. The inf "nation is renamed to mbiam or retain a benefit by me minim Which is :3 tie {and
`by the USPTQ to process) an application. Cmiiden‘iiaiiiy is gain-amen by 35 U SC. 121 and 3? CFR 1.11 and 1.14. This collection is estimaxed iii-lake 1 minute :0
`wrnpieie. inducing gathering, preparing, and submitting the campiered appiimtion form 10 the USPTO. Time wiii vary depending upon ihe individuai case. Any
`
`cor:
`ears on the arricunt nfiime yuu require ii) cumpleie inis form and/3r suggesiicns for raduuing this burden, shouiu be sent if) the Chief iiil‘cji'maiian foimi'. 1.1.53.
`Patent and Trademark Office. US. Deparimérii of Commerce. PI). Box 1450. Alexandria. VA 22313-1450. DO NOT SENS FEES 0R CEDMPLETED FORMS TO
`‘iHis AUDRESS SEND TE): Commissioner for Patentg, PI). Ba): 1450, klexandria, VA 2231344563.
`if you need a_ aistance fr. completing the form, cali T-EOIIPTOLQWQ and seleci opiim 2.
`
`Page 2 of 383
`
`Page 2 of 383
`
`

`

`
`
`Fi'i'OlAiAl’m (06-12;
`Appmved for use thmugh 1160/2020. OMB 0651:4532
`,
`us. Pat-m and Trademark om ' 2'5. DEPARTMENT OF COMMERCE
`
`Under the Paperwerk Reflumlsn Act Of 199%), na person's are required to respond ta: a miiefiion of inforrnaiinn units; it displays a valid OMB conimi numben
`
`DECLARATEON {3? CFR L53} FQR UTELETY 0R DESEGN APPLICATEON USENG AN
`APPLECATEGN DATA $HEET (3'? CFR 1‘76)
`
`CRYSTAL FORM OF OREXiN RECEPTOR ANTAGQNEST, PREPARATEON
`inventiflfi METHQD THEREFOR AND USE THEREOF
`
`I
`
`As the beiaw named inventor, i hereby deciare that:
`
`This decimation [;
`is directed m;
`_.
`
`The attached applicatian, 9r
`United States appiica‘tion or PCT internatinnai appiicatian number
`07"13112018
`
`flied on
`
`PCTICNQM 8IOQYT9?
`
`The- abovemideniified eppiicetinn was made or euthnrized to be made by me.
`
`i beiieve that i am the engine! inveninr or an original faint invenisr of a ciaimerj inventinn in the anpiicaticn.
`
`i hereby ackmwiedge the: any wiiifui iaise siaterneni made in this declaration is punishabie under 15 U.S.C. 1061
`by fine er imprisc-nment of no? more than five (5) years. or bath.
`
` Titie of
`
`WARNING:
`
`I
`§ Psiifloneriappiicant :s cautioned to avaid submining personal information in dscumen‘rs fried in a parent anniicaiion that may
`contribute in identity theft Persona! infarmsiien such as 311C583 security numbers, bank acmurit numbers, or credit card numbers g
`; {ether than a check or credit card authorization form PTO-2038 submitted for payment purposes) is never required by the USPTOE
`§to support a petition or an application iftnis type of persenal infcrmation is ineiuded in documents submiried to the USPTO,
`I
`E petitioners/appiicanis should censider redacting such persunai ininrmation from the documents before submitting them to the
`USF’TO, Petitianer/appiicant is advised that iha rewrd sf a patent appiicetion is avaiiabie in the pLibiic after pubiication cf the
`
`i appiication (unless a nonvpubiicaticn request in mmpiiance with 37 CFR 1213(5) is made in 1115: appii
`titan) m issuance of 23
`§ patent“ Furthermore the reccrd frcm an abandoned appiication may 23359 be avaiiabie is the public if the appiicatisn is
`referenced in a pubiished appiication 0r an issued patent (see 37 CFR 1.14). Checks; and credit card auihorizaiion farms
`PTOmZL‘efiB submitted for payment purposes are not retained in the applicatinn file and therefnre are not pubiidv evaiiabiei
`
`LEGAL NAME OF ENVENTOR
`
`inventor:
`
`Chunxiang i-iuang
`
`Date (Optional) :
`
`Signature:
`
`3 Nate: An appiication data sheet (PTG/SBIM or equivaient). ineiuding naming ihe entire inveniive entity, musi accsmnany this form sr must have
`§ been previousiy flied. Use an additionai PTOiAIA/m form fnr each additionai inveninrr ’
`a benefii by he pubaic whim is to Erie (and
`.
`Confideniiaiity |3 governs: by 35 LJ.S.C. 122 and '5? CFR 1.11 and 1.11:. This coiieciion is estimated 96 take 1 mine-re in
`by the USPTO to process) an apprise
`compieZe, inciuding gathering, preparing, and submiiiing the compieied application farm in the USPTO, Time will vary depending upon the individuai case. Any
`mmmenw an the ametini of time you require in csmpieie this form andior suggasiions for reducing lhis burden. shauid be seni to the Chis! Enfarmatisn Ufiicer, L155!
`Pawn: and Trademark Office. US. Department a? (Inmmerce, RU. Bax 145KB, Aiexsndria, VA 223131450. [)(3- NO'i' SEND i
`.35 ()FE COMPLETED FORMS TI.)
`was ADDRESS. $5M} TO: Cemmissiener far Patents, RC3. Box 1450, Aiexandrie. VA 223134450.
`Ifycu need assistance in mmp’et‘ing the firm; cal! 1-500—PTO-9195 and select option 2.
`
`Page 3 of 383
`
`Page 3 of 383
`
`

`

`
`
`PTO/Ai/‘v’m (OE-12}
`Anprcved fer use thmugh 1 113012320. CMES (mm-0:232
`US. Patent and Trademaik Office; US. DEPARTMENT OF COMMERCE
`Under the Paper-weak Reduciimi Ad: of 1995, no persons are required in respnnd to a collection of inionnaiiim unis-.55 ii :iispiays a valid OMB central number.
`
`DECLARATEQN (3"? CFR 1.63) FOR UTiLi'i’Y 0R EESSGN APPUCATBON USENG AN
`APPLECAWQN QATA SHEET (37 CFR 136)
`
`CRYSTAL FORM OF QREXiN RECEPTOR ANTAGONIST, PREPARATiON
`T‘itie af
`imam“ METHQD THEREFOR AND USE THEREOF
`
`As the below named inventor, hereby declare that:
`
`.~
`This declaration
`is directed to: U The afleched appiauaiwn, car
`[fig
`United States application 0r PCT international application number PCT'ICN201 8IG_B..7._.7....Q...7...
`9713112018
`filed an
`
`The abeve—ic‘eniified applicaiian was made «or autherizec‘ tr: be made by me.
`
`g
`
`i believe that i am the onginai inventor or an eriginaijnint inventor Of a claimed invention in the appiication.
`
`i hereby acknowledge that any wiili‘ui faise statement made in this declaration is punishabie under 18 H.513. 1001
`by fine or impritsonment 0f nut more than five (5) years, or both,
`
`
`
`WARNENG:
`
`.
`Petitiuner/eppiicant is cautinnecl in avoid submitting personal infnrmation in dncumenis filed in a patent application that may
`E
`csntribuie in identity theft. Personai informatinn such 3;; social security numbere, bank account numbers. c-r credit card numbers.
`3 (other than a check or credit card authorization farm PTO—2.038 submitted in? payment leFpQSeS) is never required by the USPTD
`to support a petition or an applicalinn.
`if this type (if persona! infnrma‘iion is ineiuded in documents submitted t0 the USPTO.
`’
`§ petitioners/applicants shauid canaider redaciing such personai information from the olocumenis befsre submitting them to the
`i USPTO. Petitioneniappiicant is advised that the record of a patent application is available to the public: after pubiicaiion of the
`i application (unless a nen—pubiicatinn request in wmpiiance with 37 CFR 1.213(3) is made in the application) or issuance ofa
`patent. Furthermore, the retard from an abandaned application may also be avaiiabie to the pubiic if the application is
`referenced in a pubiished applicatinn or an issued paieni (see 37 CPR 1,14}. Checks and credit card authurizatinn farms
`; FTC—203$ eunmitted for payment purnosea are net retained in the application iile and therefore are neat publicly available.
`
`LEGAL NAME OF ENVENTOR
`
`inventor: Xiaeyu Zhang
`
`Date {Opiicnal}
`
`
`
`Note: An application data sheet (Pic/SEMI: c-r equivaient}. inciuding naming the entire inventive entity, must accompany this farm or must have
`g been pi‘eviousiy filed. Use an additional PTOlAiAjm farm for each additional invemur.
`
` " CFR 1153‘ The information is required :0 Obtain or retain a benefit by the while which is 'o fiie (and
`’r liin i my?!
`by {he USPTG in QMCESS) an appiicaticn, Commie;
`y is governed by 35 USC. 122 and 37 CFR 1.1“- and 1.14. This collection is estimaied intake 1 minuteio
`
`., he campieted application form {athe USPTO. Time xvii! vary depending upon the individual case Any
`complete, inchiding gathering, preparing, and submit!
`
`mmmen’rs an the amauni oftirne you requirsto campiete
`,s iii-rm (indie? suggestions ior reducing ihis burden, :«hauid be sent to the Chief informaiion Officer, US.
`Patent ans Trademark Office, US. Oapanmeni of Commerce, run Eiux i450. Alexandria, VA 22313-1455). DO NOT SEND FEES OR COMPLETE?) FORMS TO
`THES ADDRESS. SEND TI): Cummiesionar for Patients, PX}. Bax ”iris-:3, Alexandria, VA 223%44513.
`It'yau need assisiance fr: compieling the form. 02:: 1-800-PTQ—9193 and select option 2.
`
`Page 4 of 383
`
`Page 4 of 383
`
`

`

`I hereby certify that this paper (along with any paper referred to as being attached or enclosed) is
`being transmitted via the Oifice 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 TRADEMARK OFFICE
`
`In re Utility Application of:
`Minhua Chen et al.
`
`Application No.: Not Yet Assigned
`Continuation of PCT/CN2018/097797
`
`Confirmation No.: N/A
`
`Filed: Concurrently Herewith
`lnt’l 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
`PO. Box 1450
`
`Alexandria, VA 223 13- 1450
`
`INFORMATION DISCLOSURE STATEMENT [IDSL
`
`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 references listed on the attached PTO/SB/OS. It is
`
`respectfully requested that the information be expressly considered during the prosecution of the
`
`abo ve—identified application, and that the references be made of record 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.F.R. § l.97(b)(l)).
`
`ME1 32457729v.1
`
`Page 5 of 383
`
`Page 5 of 383
`
`

`

`Application No.: Continuation of PCT/CN20lS/097797
`
`Docket No.: 134070—01602
`
`In accordance with 37 C.F.R. § l.98(a)(2)(ii), 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. § l.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.F.R. § l.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 Statement is, or is considered
`
`to be, material to patentability as defined in 37 C.F.R. § l.56(b).
`
`It is submitted that the Information Disclosure Statement is in compliance with
`
`37 C.F.R. § 1.98, and the Examiner is respectfully requested to consider the 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
`
`MEl 32457729V.1
`
`Page 6 of 383
`
`Page 6 of 383
`
`

`

`PTOIAIAI14 (02-18)
`Approved for use through 1113012020. OMB 0651-0032
`US. Patent and Trademark Office; US. 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 OMB control number.
`
`.
`
`.
`
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`
`
`T't'e °f 'nventm“
`
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`THEREOF AND USE THEREOF
`
`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 1.78.
`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:
`
`
`CI 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:
`
`
`
`Middle Name
`
`
`
`Residence Information (Select One)
`
`US Residency
`
`0 Non US Residency
`
`Active US Military Service
`
`Country °f Residence‘ El
`
`
`
`
`
`Mailing Address of Inventor:
`
`Address 1|.4—301, Biobay, 218 Xinghu Street
`Address 2
`I uzhou Industrial Park
`_I— Staterprovince
`
`Postal Code
`
`
`
`
`Inventor
`[2
`Legal Name
`
`
`Middle Name
`
`_I-E
`Residence Information (Select One)
`US Residency
`(9 Non US Residency
`Active US Military Service
`Country °f Residence‘ El
`
`
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`
`
`
`uzhou Industrial Park
`
`_I—
`Postal Code
`It 15123
`Inventor
`
`
`
`Legal Name
`
`EFS Web 2.2.13
`
`Page 7 of 383
`
`Page 7 of 383
`
`

`

`PTOIAIAI14 (02-18)
`Approved for use through 1113012020. OMB 0651-0032
`US. Patent and Trademark Office; US. 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 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
`THEREOF AND USE THEREOF
`
`Title of Invention
`
`mam
`Residence Information (Select One)
`
`_IIE
`US Residency © Non US Residency
`Active US Military Service
`
`
`City
`Country or Residencei El
`
`
`
`Mailing Address of Inventor:
`
`Address 1
`
`Address 2
`
`-4—301, Biobay, 218 Xinghu Street
`
`uzhou Industrial Park
`
`
`
`
`
`
`_I— Statervrovince
`I
`I
`Postal Code
`It 15123
`'
`
`Legal Name
`
`mm
`
`IIEI—
`_IIE
`
`Residence Information (Select One)
`US Residency @ Non US Residency
`Active US Military Service
`
`Country of Residence i
`
`Mailing Address of Inventor:
`
`Address 1|.4—301, Biobay, 218 Xinghu Street
`AddressZ
`I uzhou Industrial Park
`
`Inventor Information blocks may be
`Inventors Must Be Listed - Additional
`All
`generated within this form by selecting the Add button.
`
`Add
`
`Correspondence Information:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`Iocket@mccarter.com
`
`D An Address is being provided for the correspondence Information of this application.
`Customer Number
`I6738
`Email Address
`
`EFS Web 2.2.13
`
`Page 8 of 383
`
`Page 8 of 383
`
`

`

`PTOIAIAI14 (02-18)
`Approved for use through 1113012020. OMB 0651-0032
`U.S. Patent and Trademark Office; US. 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 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
`
`THEREOF AND USE THEREOF
`
`T't'e °f 'nvent'm‘
`
`Application Information:
`
`T't'e °f the Inventm"
`
`Attorney Docket Number
`
`HEREOF AND USE THEREOF
`
`Small Entity Status Claimed
`
`|Z
`
`SubjectMauer I—I
`Total Number of Drawing Sheets (if any) I- Suggested Figure for Publication (if any) '-
`
`Filing By Reference:
`
`Only complete this section when filing an application by reference under 35 U.S.C. 1 I 1 (c) and 37 CFR1.57(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”).
`
`For the purposes of a filing date under 37 CFR1.53(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
`
`
`
`Publication Information:
`
`
`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
`El
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`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:
`0 Customer Number
`US Patent Practitioner 0 Limited Recognition (37 CFR 11.9)
` Customer Number
`I-6738
`
`EFS Web 2.2.13
`
`Page 9 of 383
`
`Page 9 of 383
`
`

`

`PTOIAIAI14 (02-18)
`Approved for use through 1113012020. OMB 0651-0032
`US. Patent and Trademark Office; US. 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 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
`
`THEREOF AND USE THEREOF
`
`T't'e °f 'nvent'm‘
`
`
`
`
`
`Domestic BenefitINational 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.
`
`
`
`
`
`
`
`
`Prior Application Number
`
`Application Number
`
`Continuity Type
`
`Filing or 371(c) Date
`
`(YYYY-MM-DD)
`
`
`201 8—07—31
`
`I—I_I
`
`
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
` Add
`
`
`by selecting the Add button.
`
`
`
`
`
`Foreign Priority Information:
`
`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)l 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).
`
`
`Add button.
`
`Application Number
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`
`Remove
`
`
`Access Codei (if applicable)
`
`Remove
`
`Access Codei (if applicable)
`
`
`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.
`
`EFS Web 2.2.13
`
`Page 10 of 383
`
`Page 10 of 383
`
`

`

`PTOIAIAI14 (02-18)
`Approved for use through 1113012020. 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 unless it 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
`
`THEREOF AND USE THEREOF
`
`T't'e °f 'nvent'm‘
`
`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 lP office(s). Instead, Form PTO/SB/39 or PTO/SB/BQ 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 B in 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)
`
`A. Applicant DOES NOT authorize the USPTO to permit a participating foreign IP office access to the instant
`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
`application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant
`application.
`NOTE: Once the application has published or is othenNise publicly available, the USPTO may provide access to the
`application in accordance with 37 CFR 1.14.
`
`EFS Web 2.2.13
`
`Page 1 1 of 383
`
`Page 11 of 383
`
`

`

`PTOIAIAI14 (02-18)
`Approved for use through 1113012020. OMB 0651-0032
`U.S. Patent and Trademark Office; US. 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 OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`
`Attorney Docket Number
`134070—01602
`
`THEREOF AND USE THEREOF
`
`Title of Invention
`
`CRYSTALLINE FORM OF OREXIN RECEPTOR ANTAGONIST, PROCESSES FOR PREPARATION
`
`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.
`
`
`1
`Applicant
`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.
`
`Legal Representative under 35 U.S.C. 117
`
`Joint Inventor
`
`Person to whom the inventor is obligated to assign.
`
`Person who shows sufficient proprietary interest
`
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`
`
`
`
`
`Name of the Deceased or Legally lncapacitated Inventor:
`
`If the Applicant is an Organization check here.
`
`IX
`
`Mailing Address Information For Applicant:
`
`Address 1
`
`Address 2
`
`-4—301, Biobay, 218 Xinghu Street
`
`uzhou Industrial Park
`
`
`
`Email Address
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`Assignee Information including Non-Applicant Assignee Information:
`
`
`Providin