PCT/US2018/046760 24.10.2018
`
`PATENT COOPERATION TREATY
`
`From the INTERNATIONAL SEARCHING AUTHORITY
`To: SIMREN DELANEY
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304
`
`PCT
`
`NOTIFICATION OF TRANSMITTAL OF
`THE INTERNATIONAL SEARCH REPORT AND
`THE WRITTEN OPINION OF THE INTERNATIONAL
`SEARCHING AUTHORITY, OR THE DECLARATION
`
`(PCT Rule 44.1)
`
`
`
`
`
`Date of mailing
`(day/month/year)
`2 4 0 C T 2018
`
`
`Applicant’s or agent’s file reference
`
`50535-709601 FOR FURTHER ACTION_Seeparagraphs | and 4 below
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`
`
`International application No.
`International filing date
`14 August 2018 (14.08.2018)
`
`PCT/US 18/46760
` (day/month/year)
`
`
`Applicant SPRUCE BIOSCIENCES, INC.
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`2. CL] The applicant is hereby notified that no international search report will be established and that the declaration under
`Article 17(2)(a) to that effect and the written opinion of the International Searching Authority are transmitted herewith.
`
`
`3. C] With regard to any protest against payment of(an) additional fee(s) under Rule 40.2, the applicantis notified that:
`the protest together with the decision thereon has been transmitted to the International Bureau together with any
`request to forward the texts of both the protest and the decision thereonto the designated Offices.
`
`no decision has been made yeton the protest;
`the applicant will be notified as soon as a decision is made.
`4, Reminders
`
`
`
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`The applicant may submit commentson an informal basis on the written opinionof the International Searching Authority
`to the International Bureau. These comments will be made available to the public after international publication. The
`International Bureau will send a copy of such comments to all designated Offices unless an international preliminary
`
`
`examination report has beenoris to be established.
`Shortly after the expiration of 18 months from the priority date, the international application will be published by the
`International Bureau.
`If the applicant wishes to avoid or postpone publication, a notice of withdrawal of the international
`application, or of the priority claim, must reach the International Bureau before the completion of the technical preparationsfor
`international publication (Rules 90b/s.1 and 905is.3).
`Within 19 months from the priority date, but only in respect of some designated Offices, a demand for international preliminary
`examination mustbefiled if the applicant wishes to postpone the entry into the national phase until 30 months from thepriority
`date (in some Offices even later); otherwise, the applicant must, within 20 months from the priority date, perform the
`prescribed acts for entry into the national phase before those designated Offices.
`In respect of other designated Offices, the
`time limit of 30 months (orlater) will apply even ifno demandis filed within 19 months. Fordetails about the applicable time
`limits, Office by Office, see www.wipo.int/pet/en/texts/time_limits.html and the PCT Applicant's Guide, National Chapters.
`
`
`Within 22 months from the priority date, the applicant may request that a supplementary international search be carried
`out by a different International Searching Authority that offers this service (Rule 45dis.1). The procedure for requesting
`
`
`supplementary international search is described in the PCT Applicant's Guide, International Phase, paragraphs 8.006-8.032.
`
`
`1. IX] The applicant is hereby notified that the international search report and the written opinion ofthe International Searching
`Authority have been established and are transmitted herewith.
`Filing of amendments and statement under Article 19:
`The applicantis entitled, if he so wishes, to amendthe claims of the international application (see Rule 46):
`When? The timelimit for filing such amendments is normally two months from the date oftransmittal of the international
`search report.
`How?_Dircctly to the Intemational Bureau of WIPO preferably through ePCTor on paperto, 34 chemin des Colombettes
`1211 Geneva 20, Switzerland, Facsimile No.: +41 22 338 82 70
`For moredetailed instructions, see PCT Applicant's Guide, International Phase, paragraphs 9.004 — 9.011.
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`PCT Helpdesk: 571-272-4300
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`Nameand mailing address of the ISA/US
`Mail Stop PCT,Attn: ISA/US
`Commissioner for Patents
`P.O. Box 1450, Alexandria, Virginia 22313-1450
`Facsimile No. 571-273-8300
`
`Authorized officer
`
`Lee W. Young
`
`Telephone No. per osp: 571-272-7774
`
`Form PCT/ISA/220 (July 2014)
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`1
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`NEUROCRINE 1003
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`1
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`NEUROCRINE 1003
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`

`

`PCT/US2018/046760 24.10.2018
`
`PATENT COOPERATION TREATY
`
`PCT
`INTERNATIONAL SEARCH REPORT
`
`(PCTArticle 18 and Rules 43 and 44)
`
`Applicant’s or agent's file reference
`50535-709601
`
`FOR FURTHER
`ACTION
`
`see Form PCT/ISA/220
`as well as, where applicable, item 5 below.
`
`International application No.
`PCT/US 18/46760
`
`Applicant
`SPRUCE BIOSCIENCES, INC.
`
`Internationalfiling date (day/month/year)
`14 August 2018 (14.08.2018)
`
`(Earliest) Priority Date (day/month/year)
`14 August 2017 (14.08.2017)
`
`This international search report has been prepared by this International Searching Authority and is transmitted to the applicant
`according to Article 18. A copy is being transmitted to the International Bureau.
`
`sheets.
`This international search report consists of a total of
`C] It is also accompanied by a copy ofeach ppfor art documentcited in this report.
`
`Basis of the report
`a. With regard to the language, the international search wascarried out on the basis of:
`bs the international application in the language in whichit wasfiled.
`whichis the language of
`CJ a translation of the international application into
`a translation furnished for the purposes of international search (Rules 12.3(a) and 23.1(b)).
`b. C] This international search report has been established taking into account the rectification of an obvious mistake
`authorized by or notified to this Authority under Rule 91 (Rule 43.65is(a)).
`&. C]} With regard to any nucleotide and/or aminoacid sequence disclosed in the international application, see Box No.I.
`
`Certain claims were found unsearchable (see Box No.II).
`
`C Unity of invention is lacking (see Box No.III).
`
`. With regard to the title,
`(X]
`the text is approved as submitted by the applicant.
`CL]
`the text has been established by this Authority to read as follows:
`
`b. CL) none ofthe figures is to be published with the abstract.
`
`5. With regard to the abstract,
`the text is approved as submitted by the applicant.
`C] the text has been established, according to Rule 38.2, by this Authority as it appears in Box No. [V. The applicant
`may, within one month from the date of mailing of this international search report, submit comments to this Authority.
`
`6. With regard to the drawings,
`a.
`the figure of the drawings to be published with the abstract is Figure No. 2
`‘yi
`as suggested by the applicant.
`as selected by this Authority, because the applicant failed to suggest a figure.
`as selected by this Authority, because this figure better characterizes the invention.
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`Form PCT/ISA/210 (first sheet) (January 2015)
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`2
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`PCT/US2018/046760 24.10.2018
`
`INTERNATIONAL SEARCH REPORT
`
`
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`International application No.
`PCT/US 18/46760
`
`Box No.II
`
`Observations where certain claims were found unsearchable (Continuation of item 2 offirst sheet)
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`because they relate to parts of the international application that do not comply with the prescribed requirements to such an
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`This international search report has not beenestablished in respect of certain claims under Article 17(2)(a) for the following reasons:
`1, C] Claims Nos.:
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`
`
`
` 2. [] Claims Nos.:
`extent that no meaningful international search can be carried out, specifically:
`
`
`7
`
`ai
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`Claims Nos.: 4-79, 88-93 and 96-174
`
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
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`
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`Box No. 1Il
`Observations where unity of invention is lacking (Continuation of item 3 offirst sheet)
`
` This International Searching Authority found multiple inventionsin this international application, as follows:
`
`claims.
` As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`
`
`As all searchable claims could be searched withouteffort justifying additional fees, this Authority did not invite payment of
`additional fees.
`
` As only someof the required additional search fees were timely paid by the applicant, this international search report covers
`only those claims for which fees were paid, specifically claims Nos.:
`
`No required additional search fees were timely paid by the applicant. Consequently, this international search report is
`restricted to the invention first mentioned in the claims;
`
`
`it is covered by claims Nos.:
`Remarkon Protest
`[] The additional search fees were accompanied bythe applicant's protest and, where applicable, the
`
`
`
`
`paymentofa protestfee.
`| The additional search fees were accompanied by the applicant’s protest but the applicable protest
`
`
`fee was not paid within the time limit specified in the invitation.
`Noprotest accompanied the payment of additional search fees.
`
`Form PCT/ISA/210 (continuation offirst sheet (2)) (January 2015)
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`3
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`PCT/US2018/046760 24.10.2018
`
`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/US 18/46760
`
`CLASSIFICATION OF SUBJECT MATTER
`A.
`IPC(8) - A61K 31/415; 31/425; 31/519; CO7D 487/04; A61P 5/24 (2018.01)
`CPC - A61K 31/41; A61K 31/519; CO7D 487/04; CO7D 401/04
`
`ing to International Patent Classification (IPC) or to both national classification and IPC
`FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`See Search History Document
`Documentation searched other than minimum documentationto the extent that such documents are included in the fields searched
`See Search History Document
`Electronic data base consulted during the intermational search (name of data base and, where practicable, search terms used)
`See Search History Document
`
`Cc. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category*
`
`Citation of document, with indication, where appropriate, of the relevant passages
`US 8,030,304 B2 (CHENet al.) 04 October 2011 (04.10.2011) Col 1, Im 10-15; Col 2, In 51-
`56;Col 3, In 8-12; Col 5, In 63 to Col 6, In 4; Col 6, In 11-13; Col 32, Example 16
`
`Relevantto claim No.
`1-3, 80-87, 94-95; 175-
`180
`
`TURCU atal. 'Single-Dose Study of a Corticotropin-Releasing Factor Receptor-1 Antagonist in
`Women With 21-Hydroxylase Deficiency’, J. Clin. Endocrinol. Metab. 2016, Vol. 101(3), pp.
`1174-1180. Abstract; pg. 1177, Table 2; pg. 1179, Table 3; pg 1179, Col 2, para 2 to pg. 1180,
`Col 1, para 2
`
`4-3, 80-87, 94-95; 175-
`180
`
`US 2017/0020877 A1 (NEUROCRINE BIOSCIENCES, INC.) 26 January 2017 (26.01.2017)
`ENTIRE DOCUMENT
`
`1-3, 80-87, 94-95; 175-
`180
`
`US 2010/0155595 A1 (GHOSHALetal.) 24 June 2010 (24.06.2010) ENTIRE DOCUMENT
`
`1-3, 80-87, 94-95; 175-
`180
`
`ee et al. ‘Attenuated Forms of Congenital Adrenal Hyperplasia due to 21-hydroxylase
`Deficiency’, Journalof Clin Endocrin Metab 1982, Vol. 55, pp. 866-871. ENTIRE DOCUMENT
`
`1-3, 80-87, 94-95; 175-
`180
`
`“T"
`
`
`
`C] See patent family annex.
`C] Further documents are listed in the continuation of Box C,
` jater documentpublished after the internationalfiling date orpriority
`Special categories of cited documents:
`date and not in conflict with the application but cited to understand
`documentdefining the generalstate of the art which is not considered
`the principle or theory underlying the invention
`to be of particular relevance
`“xXdocumentof particular relevance; the claimed invention cannot be
`earlier application or patent but published on orafter the intemational
`considered novel or cannot be considered to involve an inventive
`filing date
`step when the documentis taken alone
`document which may throw doubts on priority claim(s) or which is
`cited ° establish the puciente date of another citation or other aye gocument of particular relevance;the claimed invention cannot be
`special reason (as specified)
`a
`considered to involve an inventive step when the document
`is
`document referring to an oral disclosure, use, exhibition or other
`combined with one or more other such documents, such combination
`means
`being obvious to a person skilled in the art
`document publishedprior to the internationalfiling date butlaterthan «2» gocument member of the same patent family
`the priority date claimed
`Date ofthe actual completion of the international search
`25 SEPTEMBER 2018
`Name and mailing address of the ISA/US
`Mail Stop PCT,Attn: ISA/US, Commissionerfor Patents
`P.O. Box 1450, Alexandria, Virginia 22313-1450
`Facsimile No,
`571-273-8300
`
`Date of mailing of the international search report
`Z A 0 c A, 2018
`Authorized officer:
`
`Lee W. Young
`
`PCT Helpdesk: $74-272-4200
`PCT OSP: 571-272-7774
`
`Form PCT/ISA/210 (second sheet) (January 2015)
`
`4
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`

`

`PCT/US2018/046760 24.10.2018
`
`SEARCH HISTORY
`
`
`
`Application Number|PCT/US 18/46760
`
`
`Search Conducted By|JAP
`
`CPC: A61K 31/41; A61K 31/519; CO7D 487/04; CO7D
`CPC/IPC Classifications|401/04
`Searched|IPC(8): A61K 31/415; 31/425; 31/519; CO7D 487/04; A61P
`5/24 (2018.01)
`
`
`Date Conducted|24 September 2018 (24.09.2018)
`
`
`
`
`
`Documentation Searched|Patent & Non-patent Documents
`
`Search Terms Used
`
`level 17-OHP ACTH testosterone androstenedione
`normal
`congenital adrenal hyperplasis CRF1 morpholin-4-y!l chloro
`thiazol-5-yl 2,5-dimethylpyrazolo(1,5-a)-pyrimidine
`1-ethylpropyl chloro infertility metabolic syndrome
`
`Date Conducted:
`
`05 September 2018 (05.09.2018)
`
`Electronic Database Searched|PATBASE
`
`Files Searched|Full-text = AU BE BR CA CH CN DE DK EP ES FI FR GB IN JP
`KR SE TH TW US WO
`
`Date Conducted|05 September 2018 (05.09.2018)
`
`Search Logic:
`
`Search 1:
`
`Search 2:
`
`Search 3:
`Search 4:
`Search 5:
`Search 6:
`Search 7:
`
`CPC=(A61K31/41 or A61K31/519 or CO7D487/04 or CO7D401/04) (Results
`30191)
`IC=(A61K31/415 or 31/425or 31/519 or CO7D487/04 or A61P5/24) (Results
`41382)
`1 or 2 (Results 56037)
`3 and CRF1 (Results 64)
`4 andinfertility or CAH or hyperandrogenic or acne or metabolic (Results 24)
`5 and pyrazolo*pyrimidine (Results 3)
`4 and congenital near hyperplasia (Results 3)
`
`5
`
`

`

`PCT/US2018/046760 24.10.2018
`
`Search 8:
`
`3 and CAHandtestosterone and 17-ohp and ACTHand androstenedione (Results
`0)
`4 and testosterone and 17-ohp and ACTH and androstenedione (Results 0)
`Search 9:
`3 and pyrazolo*pyrimidine (Results 378)
`Search 10:
`10 and CRFI1 (Results 5)
`Search 11:
`10 and morpholin-4-yl (Results 12)
`Search 12:
`12 and thiazol-5-yl (Results 2)
`Search 13:
`Search 14: pyrazolo*pyrimidine (Results 593)
`Search 15:
`14 and thiazol-5-y] (Results 14)
`Search 16:
`15 and morpholin-4-yl (Results 2)
`Search 17:
`14 and CRF1 (Results 5)
`Search 18:
`14 and Congenital and hyperplasia (Results 2)
`Search 19:
`14 and testosterone and 17-ohp and ACTHand androstenedione (Results 0)
`Search 20:
`14 and infertility and acne (Results 0)
`Search 21:
`14 and infertility (Results 5)
`Search 22:
`14 and CAH (Results 3)
`Search 23: 22 and metabolic (Results 0)
`
`Date Conducted|05 September 2018 (05.09.2018)
`
`
`
`Search Logic:
`
`
`
`
`
`
`
`
`
`
`
`Results 1-10 of 655 for normal level 17-OHP ACTHtestosterone andostenedione ng/dl (0.04 sec)
`Results 1-5 of 5 for normal level 17-OHP ACTHtestosterone androstenedione congenital adrenal
`hyperplasis CRF1 treatment (0.10 sec)
`;
`Results 1-1 of 1 for morpholin-4-yl chloro thiazol-5-yl 2,5-dimethylpyrazolo(1,5-a)-pyrimidine 1-
`ethylpropyl chloro (0.23 sec) .
`Results 1-10 of 31 for infertility metabolic syndrome pyrazolo(1,5-a)-pyrimidine CRF1 acne (0. 24
`sec)
`
`
`
`
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`Date Conducted|05 September 2018 (05.09.2018)
`
`
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`Search Logic:
`
`6
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`

`

`PCT/US2018/046760 24.10.2018
`
`Results 1-2 of 2 for normal level 17-OHP ACTHtestosterone androstenedione congenital adrenal
`hyperplasis CRF1 treatment (44 sec)
`Results 1-10 of 128 for normal level 17-OHP ACTHtestosterone androstenedione ng/dl(0.35 sec)
`Results 1-10 of 420 for morpholin-4-yl chloro thiazol-5-yl 2,5-dimethylpyrazolo(1,5-a)-pyrimidine
`l-ethylpropy! chloro (0.40 sec)
`Results 1-10 of 25 for CRF1 morpholin-4-yl chloro thiazol-5-yl 2,5-dimethylpyrazolo(1,5-a)-
`pyrimidine 1-ethylpropyl chloro (0. 43 sec)
`Results 1-5 of 5 for congenital adrenal hyperplasia CRF1 dose mg/kg morpholin-4-yl chloro thiazol-
`5-yl 2,5-dimethylpyrazolo(1,5-a)-pyrimidine 1-ethylpropyl chloro (0.33 sec)
`Results 1-4 of 4 for
`(0.34 sec)
`
`dimethylpyrazolo(1,5-a)-pyrimidine 1-ethylpropyl chloro (0.33 sec)
`
`Results 1-10 of 23 for
`
`infertility metabolic syndrome morpholin-4-yl chloro thiazol-S-yl 2,5-
`
`SUPPLEMENTAL SEARCH: MSS
`
`PubWEST
`
`Files Searched
`
`PGPB,USPT,USOC,EPAB,JPAB
`
`Date Conducted|27 September 2018 (27.09.2018)
`
` Electronic Database Searched
`
`
`
`
`
`
`
`
`Hide? Set Name Query Hit Count
`
`Search Logic:
`
`
`DB=PGPB,USPT,USOC,EPAB,JPAB; PLUR=YES; OP=ADJ
`L12L11 and L102
`L11 L9 and (metabolic with (syndromeor disease or disorder)) 6
`L10 L9 and "congenital adrenal hyperplasia" 2
`L9 L8 and ((CRFor"corticotropin releasing factor") with (inhibit$ or antagonist)) 17
`L8 "pyrazolo[1,5-a]pyrimidine".ti,ab,clm. 351
`L7 L6 and L5 4
`L6 L4 and (metabolic with (syndromeordisease or disorder)) 16
`L5 L4 and “congenital adrenal hyperplasia" 4
`L4L3 and ((CRF or “corticotropin releasing factor") with antagonist) 54
`L3 L2 and pyrazolo$pyrimidine.ti,ab,clm. 785
`L2 L1 or A61P005/24.ipc. 74346
`L1 A61K031/415.ipc. or A61K031/425.ipc. or CO7D487/04.ipc. or A61K31/41.cpc. or
`A61K31/519.cpc. or CO7D487/04.cpc. or CO7D401/04.cpc. 73934
`END OF SEARCH HISTORY
`
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`
`7
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`PCT/US18/46760 0
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`
`100
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`-100
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`QUI|eSeGWO}abuey9%
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`
`PCT/US18/46760 03-10-2018
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`10
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`
`

`

`U.S. PATENT & TRADEMARK OFFICE
`PCT RECEIVING OFFICE
`
`FILED VIA: EFS-WEB
`
`International Application No.
`
`PCT/US2018/046760
`
`International Filing Date:
`
`14 August 2018 (14.08.2018)
`
`Applicant:
`
`SPRUCE BIOSCIENCES,INC.
`
`Attorney Docket No.:
`
`50535-709.601
`
`Mail Stop PCT
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`RESPONSE TO FORMPCT/RO/106
`
`INVITATION TO CORRECT DEFECTS
`
`Dear Authorized Officer:
`
`In response to Form PCT/RO/106 Invitation to Correct Defects mailed 27 August 2018,
`
`Applicants submit the following:
`
`Annex Cl
`
`« Replacement pages 1/3-3/3 of the Drawings.
`
`The replacement drawings are now compliant with Rule 11.13.
`
`Please do not hesitate to contact us should you have any questions.
`
`
`
`Date: October 3, 2018 Respectfully submitted,
`
`/Simren Delaney/
`
`Simren Delaney
`Agent of Record, Reg. No. L-1151
`
`Wilson Sonsini Goodrich & Rosati
`650 Page Mill Road
`Palo Alto, California 94304-1050
`650.493.9300
`
`11
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`6oalqng
`
`0}y8lqns
`
`
`
`
`
`suljasegwoud)abueu9
`
`%
`
`|yalgng
`
`Zyoalqng
`
`€yoalqng
`
`9yalqns©gpelqns(5pyoelangLL
`
`1yalgns
`
`gyoalqng
`
`6Joalqng
`
`01yalgns
`
`13
`
`
`
`
`

`

`3/3
`
`Androstenedione
`
`suljasegwodjabueuy%
`
`N«L0}Walang
`Zyalqns
`€yoalqns
`yyoalqns
`Gyelqns
`9joalqns
`1yoalqns
`gjoalqns
`6yoalgns
`
`|oelgns
`
`FIG. 4
`
`14
`
`
`

`

`Electronic AcknowledgementReceipt
`
`33907901
`EFS ID:
`
`
`Application Number:
`
`International Application Number:
`
`PCT/US18/46760
`
`Title of Invention:
`
`CORTICOTROPIN RELEASING FACTOR RECEPTOR ANTAGONISTS
`
`
`
`First Named Inventor/Applicant Name:
`
`SPRUCE BIOSCIENCES,INC.
`
`94304-1050
`
`WILSON, SONSINI, GOODRICH & ROSATI
`
`650 PAGE MILL ROAD
`
`- P
`
`ALO ALTO
`
`US
`
`650-493-9300
`
`patentdocket@wsgr.com
`
`Correspondence Address:
`
`
`
`Filing Date: 14-AUG-2018
`
`Time Stamp:
`
`15:13:00
`
`Application Type:
`
`International Application (PCT) for filing in the US receiving office
`
`Paymentinformation:
`
`15
`
`15
`
`

`

`Submitted with Payment
`
`File Listing:
`Document
`sae
`.
`File Size(Bytes)/
`
`
`
`
`
`Number Message Digest|Part/.zip|Document HescHiprioa File Nae (if appl.)
`
`Misc. incomingletter from Applicant - IA
`
`50535_709_601_PCT_RESPON
`E.pdf
`
`Ibed Tbh5R0abdbfte06s999606[e1eT
`a070R
`
`
`
`Warnings:
`Information:
`
`the application.
`
`New Applications Under 35 U.S.C.111
`Ifa new applicationis being filed and the application includes the necessary componentsfora filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`AcknowledgementReceiptwill establish thefiling date of the application.
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903 indicating acceptanceof the application asa
`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`NewInternational Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary componentsfor
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and ofthe International Filing Date (Form PCT/RO/105) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this AcknowledgementReceiptwill establish the international filing date of
`
`Drawings-other than black and white|50535_709_601_REPLACEMEN
`93a8b28963S004Bbccha?$451 Mae
`line drawings
`T_FIGURES.pdf
`Sdid
`
`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO ofthe indicated documents,
`characterized by the applicant, and including page counts, where applicable.It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`16
`
`16
`
`

`

`DocCode — SCORE
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: PCT/US18/46760
`
`Document Date: 10/03/2018
`
`The presenceof this form in the IFW record indicates that the following documenttype was received
`in electronic format on the date identified above. This content is stored in the SCORE database.
`
`Since this was an electronic submission, there is no physicalartifact folder, no artifact folderis
`recorded in PALM, and no paper documents or physical media exist. The TIFF imagesin the IFW
`record were created from the original documentsthat are stored in SCORE.
`
`Drawing
`
`At the time of document entry (noted above):
`e USPTO employees may access SCORE content via eDAN using the Supplemental Content
`tab, or via the SCORE webpage.
`e External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: August 26, 2013
`
`17
`
`

`

`PATENT COOPERATION TREATY
`
`Prom the INTERNATIONAL SEARCHING AUTHORITY
`te
`SIMREN DELANEY
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CALIFORNIA 94304
`
`PCT
`
`Poa oe
`NOTPIFIC A TON OP RECEIPT
`OF SEARCH COPY
`
`(PCT Rule 28.1) Confirmation No: 1262
`
`Telephone No, 571-272-0400
`
`27 Aug 2018
`Date ok eailine
`felayfmonth/year)
`
`Applicant's or agent's file reference
`50535-709601
`
`IMPORTANT NOTIFICATION
`
`International application No.
`
`international filing date (dav/month*ear)
`
`Priority date (daymonrh/vear)
`
`PCT/US2018/046760
`
`14 Aug 2018
`
`14 Aug 2017
`
`Applicant
`
`SPRUCE BIOSCIENCES,
`
`INC.
`
`Where the International Searching Authority and the receiving Office are not the same Office:
`The applicant is hereby notified that the search copyof the international application was received by this International Searching
`Authority on the date indicated below.
`
`Where the International Searching Authority and the receiving Office are the same Office:
`The applicant is hereby notified that the search copy of the international application was received on the date indicated below.
`
`27 Aug 2018
`
`(date ofreceipt
`
`fj ‘the search copy was accompanied by a nucleotide and/or amino acid sequence listing in the form of an Annex C/ST.25
`text file under PCT Rule ]3rer.1(a) for the purposes of international search only.
`
`The search copy contained a nucleotide and/or amino acid sequence listing in the form of an Annex C/S'T.25 text file
`forming part ofthe international application as filed,
`
`Time timit for establishment of international search report and written opinion of the International Searching Authority
`
`The applicant is informed that the time limit for establishing the international search report and the written opinion of the
`International Searching Authority is three months fromthe date of receipt indicated above or nine months from the priority date,
`whichever time limit expires later (Rules 42.1 and 434is.1(a)).
`
`A copy ofthis Notification has been sent to the International Burean and, where the first sentence of paragraph | applies, to the
`receiving Office.
`
`Name and mailing address of the [SA/US
`Mail Stop PCT, Commissioner for Patents
`P.O. Box 1450, Alexandria, VA 22313-1450
`Facsimile No. 571-273-8300
`
`Authorizedofficer
`
`.
`Darlene Proctor
`
`Porm PCTASA/202 Ganuary 2015)
`
`18
`
`18
`
`

`

`PATENT COOPERATION TREATY
`
`From the RECEIVING OFFICE
`To:
`SIMREN DELANEY
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CALIFORNIA 94304
`
`|
`
`PCT
`
`|
`
`NOTIFICATION CONCERNING PAYMENT
`OF PRESCRIBED FEES
`
`27 Aug 2018
`
`Telephone No, 571-272-0400
`
`(PCTRules i2bis.i(c), 14, 15 and 16
`and Administrative Instructions,
`Sections 304, 323(b) and 707}
`
`Date of mailing
`(dayémonth/year)
`
`PAYMENT DUE
`
`tJ
`i
`International filing date/Date of receipt
`|mer",
`4g ng D018
`
`see item 3 for time limits
`
`Priority date (day/menth/vear)
`14 Aug 2017
`
`Applicant's or agent's file reference
`50535-709601
`
`International application No,
`PCT/US2018/046760
`Applicant
`SPRUCE BIOSCIENCES, INC.
`
`The applicant is hereby notified that this receiving Office has received:
`the payment ofall the prescribed fees, and
`LJ] an overpayment, which will be refunded in due course.
`LJ no or insufficient payment ofthe prescribed fees and the applicant is hereby
`invited to pay the balance due, as
`summarized under item 2, within the time limit(s) indicated underitem 3.
`
`Fees and payment calculation:
`
`4,231.00
`4,231.00
`“Amountpaid
`~Fotalfeespayable
`[] The details ofthe calculation are given in the Annex.
`
`w
`
`0.00
`“Balance
`
`Time limit(s) for payrnent and amouni(s} payable (Rules 14.1, 15.3 and 16.1(f}}:
`[| within ONE MONTE from the date ofreceipt ofthe international application Gor the transmittal fee (ifany), the search
`fee and the international filing fee). The amount payable for cach fee is the amount applicable on the date of receipt of the
`intemational application.
`
`within 16 MONTHS fromthe priority date fonly for the fee for priority document}. The applicant’s attention is drawn to the
`fact that the request made by the applicant under Rule 17.1(b) will be considered not to have been made unless the fee is paid
`within that time limit.
`
`4. Additional observations (if mecessary):
`The search copy will not be transmitted to the International Searching Authority until the search fee is paid (therefore the
`start of the infernational search will be delayed) (Rule 23. 1{a)} and(b)}).
`
`Name and mailing address of the receiving Office
`Mail Stop PCT, Commissioner for Patents
`P.O. Box 1450, Alexandria, VA 22313-1450
`
`Authorized officer
`Darlene Proctor
`
`Facsimile No. 571-273-8300
`Form PCT/RO/EO2 (haily 2015)
`
`19
`
`19
`
`

`

`ANNEX PO FORM PCT/RO/TO02
`CALCULATION OF THE PRESCRIBED FEES
`
`(ifa reducedfe
`
`e has been applied, the reduced amount is indicated. }
`
`e Transmitial Pee
`Prescribed amount:
`
`Amount paid:
`Balance: .
`
`Search Fee
`
`Prescribed arount:
`
`Aqmount paid:
`Balance: .
`
`
`
`International application No.
`PCT/US2018/046760
`
`correct amount |
`Cy overpayment
`ry balance due
`
`2,080.00 fs}
`2.080.00
`0.00
`
`[ix correct amoun. |
`Cj overpayment
`Ci balance due
`
`ied
`
`International Filing Fee
`Prescribed amount:
`
`Fixed amount for first 30 sheets:
`
`50 x
`Numberofsheets
`in excess of 30
`excluding pages referred
`to in Section FO7ta-bis})
`
`15.00 =
`Fee per sheet
`
`1,161.00 fq
`£90.003]
`
`Reduction where the international application is filed
`(See PCT Pee tables http -/Avwwivipa.iavpoi/ensAees,pal}:
`in electronic form, the request not being in
`character coded format .
`OF
`
`inelectronic form, the request being ip character
`coded format,
`fy bas eh a eR wT
`or
`
`in electronic form, the request, description,
`claims and absiract being m character coded
`format .
`
`Sub-total:
`
`0.00 [r]
`
`0.00 fr}
`
`0.00 fF]
`
`1,911.00 fiii2-]
`
`Applicants from certain States are entitled to a reduction of 9% ofthe
`ternationalfiling fee, Where the applicant is (or ali applicaris are) so
`entitied, the total ta be entered at 7 is 1006 ef the sub-tetal entered at
`(iF +i2-1);
`{see Notes to the Fee Calculation Sheet as annexed to the
`Request Form, PCU/ROAQL, for details):
`
`=
`
`senescentOEE
`1,911.00
`
`Asnount paid:
`Balance: .
`
`Fee for Priority Document
`Prescribed amount:
`.
`
`Amant paid:
`Balance:
`
`.
`
`Fee for Earlier Search Documents
`
`Prescribed amount:
`
`.
`
`Aaount paid:
`Balance:
`
`.
`
`Form PCT/RO/LO2 (Annex) (fuly 2017)
`
`0.00 [Fr]
`0.00
`
`0.00
`
`0.00 fF
`0.00
`
`0.00
`
`20
`
`Rj correct amount
`C] overpayment
`C] balance due
`
`correct amount|
`c} overpayment
`cr} balance due
`
`| correct amount |
`["] overpayment
`Ci balance due
`ms
`
`20
`
`

`

`PATENT COOPERATION TREATY
`
`PCT
`
`From the RECEIVING OFFICE
`
`To:
`
`SIMREN DELANEY
`WIESON SC NaI GOOERIGH G: BOSAT!
`650 PAGE MILL ROAD
`PALO ALTO, CALIFORNIA 94304
`
`Confirmation No: 1262
`
`NOTIFICATION OF THE INTERNATIONAL
`:
`APPLICATION NUMBER AND OF THE
`INTERNATIONAL FILING DATE
`
`(PCT Rule 20.2(c))
`
`Date ofmailing
`(day/month/year)
`
`27 Aug 2018
`
`
`
`Applicant’s or agent’s file reference
`IMPORTANT NOTIFICATION
`50535-709601
`
`International application No.
`International filing date (day/month/vear)
`Priority date (day/month/vear)
`PCT/US2018/046760
`14 Aug 2018
`14 Aug 2017
`
`Applicant
`SPRUCE BIOSCIENCES, INC.
`Title ofthe invention
`CORTICOTROPIN RELEASING FACTOR RECEPTOR ANTAGONISTS
`
`The applicant is herebynotified that the international application has been accordedthe international application numberand the
`internationalfiling date indicated above.
`
`2.
`
`Theapplicant is further notified that the record copy ofthe international application:
`:
`i
`BJ was transmitted to the International Bureau on
`has not yet beentransmitted to the International Bureau forthe reasonindicated below and acopyofthis notification
`has beensent to the International Bureau*:
`
`27 Aug 2018
`
`[] because the necessarynational security clearance has not yet been obtained.
`[| because (reasontobespecified):
`
`* The International Bureau monitorsthe transmittal ofthe record copyby the receiving Office and will notify the applicant (with
`Form PCT/IB/301) ofits receipt. Should the record copynot have been received by the expiration of 14 months fromthe priority
`date, the International Bureau will notify the applicant (Rule 22.1(c)).
`Completed by: OP
`FOREIGN TRANSMITTAL LICENSE INFORMATION
`Additional license for foreign transmittal not required. This subject matter is covered bya license already granted or
`the equivalent U.S. national application. Refer to that license for information concerning its scope.
`
`C] License for foreign transmittal not required. 37 CFR. 5.11(e)(1) or 37 CFR 5.11(e)(2). However, a license may be
`required for additional subject matter. See 37 CFR 5.15(b).
`oe
`:
`:
`=
`—
`=
`24 Aug 2018
`hx] Foreign transmittal license granted. 35 U.S.C. 184; 37 CFR 5.11 on
`[1 37.ceR 5.15(a)
`BX]
`37 cr 5.1506)
`
`(date)
`
`Name and mailing address ofthe receiving Office
`Mail Stop PCT, Commissioner for Patents
`P.O, Box 1450, Alexandria, VA 22313-1450
`
`Authorized officer
`Darlene Proctor
`
`Facsimile No. 574-273-8300
`Form PCT/RO/105 (July 2008)
`
`Telephone No. 571-272-0400
`
`21
`
`21
`
`

`

`PATENT COOPERATION TREATY
`
`From the RECEPVING OFFICE
`To:
`SIMREN DELANEY
`WILSON SONSINI GOODRICH & ROSATI
`650 PAGE MILL ROAD
`PALO ALTO, CALIFORNIA 94304
`
`|
`
`PCT
`
`ii
`nA er
`;
`INVITATION TO CORRECT DEFECTS IN
`THE INTERNATIONAL APPLICATION
`
`(PCT Articles 3(4)G) and 14(1} and Rul