`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`
`
`United States Patent and Trademark Office
`
`
`Address: COMMISSIONER FOR PATENTS
`
`P.O. Box 1450
`
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`161862 7590
`
`08/26/2019
`
`Compass Pathways I COOLEY LLP
`
`
`ATTN: IP Docketing Department
`
`
`1299 Pennsylvania Avenue, NW
`Suite 700
`
`Washington, DC 20004
`
`EXAMINER
`
`ANDERSON. REBECCA L
`
`ART UNIT
`
`PAPER NUMBER
`
`1626
`
`DA TE MAILED: 08/26/2019
`
`
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`
`
`
`
`ATTORNEY DOCKET NO. CONFIRMATION NO.
`
`16/155,386 10/09/2018
`
`Derek John Londesbrough
`
`
`
`
`
`
`USE
`
`COPA-001/00US 1524
`337248-2009
`
`TITLE OF INVENTION: PREPARATION OF PSILOCYBIN, DIFFERENT POLYMORPHIC FORMS, INTERMEDIATES, FORMULA TIO NS AND THEIR
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`APPLN. TYPE
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`ENTITY STATUS ISSUE FEE DUE
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`PUBLICATION FEE DUE PREY. PAID ISSUE FEE TOTAL FEE(S) DUE DATE DUE
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`
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`nonprovisional
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`SMALL $500
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`$0.00
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`$0.00
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`$500
`
`11/26/2019
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`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
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`THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`PROSECUTION ON THE MERITS IS CLOSED.
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`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
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`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
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`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE MAILING
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`DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED. THIS STATUTORY PERIOD
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`CANNOT BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES NOT REFLECT A CREDIT
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`FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION. IF AN ISSUE FEE HAS PREVIOUSLY BEEN PAID IN
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`I.Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
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`entity status still applies.
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
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`"Change in Entity Status (from status indicated above)".
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`fees.
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`If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled
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`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entity
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`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
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`of Part B - Fee(s) Transmittal should be completed and an extra copy of the form should be submitted. If an equivalent of Part B is filed, a
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`Page 1 of 3
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`PTOL-85 (Rev. 02/11)
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`PGR2020-00030
`Ex. 3001 p. 1 of 9
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`

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`Complete and sendthis form, together with applicable fee(s), by mail or fax, or via EFS-Web.
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`PARTB - FEE(S) TRANSMITTAL
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`
`By mail, sendto: By fax, send to:—(571)-273-2885Mail Stop ISSUE FEE
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`Commissioner for Patents
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`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATIONFEE(if required). Blocks 1 through 5 should be completed where appropriate. All
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`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
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`the USPTO via EFS-Weborby facsimile to (571) 273-2885, on the date below.
`(Typed orprinted name)
`(Signature)
`
`CURRENT CORRESPONDENCE ADDRESS(Note: Use Block 1 for any change of address)
`
`08/26/2019
`7590
`161862
`Compass Pathways | COOLEY LLP
`:
`ATTN: IP Docketing Department
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, DC 20004
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`16/155,386
`
`10/09/2018
`
`COPA-001/00US
`337248-2009
`TITLE OF INVENTION: PREPARATION OF PSILOCYBIN, DIFFERENT POLYMORPHIC FORMS, INTERMEDIATES, FORMULATIONS AND THEIR
`
`Derek John Londesbrough
`
`1524
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
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`
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`nonprovisional
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`SMALL
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`$500
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`$0.00
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`$0.00
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`$500
`
`11/26/2019
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`ANDERSON, REBECCA L
`
`1626
`
`514-077000
`
`1. Change of correspondenceaddressor indication of "Fee Address” (37
`CFR 1.363).
`
`(I Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`
`
`
`2. For printing on the patent front page,list
`(1) The namesof up to 3 registered patent attorneys
`or agents OR,alternatively,
`(2) The nameofa single firm (having as a member a
`registered attorney or agent) and the names of upto
`2 registered patent attorneys or agents. If no nameis
`listed, no namewillbe printed.
`
`
`
`
`
`1
`
`=—-_2
`
`
`
`
`
`[I "Fee Address" indication (or "Fee Address" Indication form PTO/
`SB/47; Rev 03-09 or more recent) attached. Use of a Customer
`Numberis required.
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(printor type)
`PLEASE NOTE: Unlessan assigneeis identified below, no assignee data will appear on the patent. If an assigneeis identified below, the document must have been previously
`recorded,orfiled for recordation, as set forth in 37 CFR 3.11 and 37 CFR 3.81(a). Completion of this form is NOTa substitute for filing an assignment.
`(A) NAMEOF ASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
`
`(LV individual LJ Corporation or other private group entity (_] Government
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`4a. Fees submitted:
`(Llissue Fee
`(Ipublication Fee (if required)
`(VAdvance Order- # of Copies
`4b. Method of Payment: (Please first reapply any previously paidfee shown above)
`(I Electronic Payment via EFS-Web
`(LI Enclosed check
`(LI Non-clectronic paymentby credit card (Attach form PTO-2038)
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` (I The Directoris hereby authorized to charge the required fee(s), any deficiency, or credit any overpaymentto Deposit Account No.
`
`5. Changein Entity Status (from status indicated above)
`(I Applicantcertifying micro entity status. See 37 CFR 1.29
`(I Applicantasserting small entity status. See 37 CFR 1.27
`(I Applicant changing to regular undiscounted fee status.
`
`
`
`NOTE:Absenta valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee paymentin the micro entity amountwill not be accepted at the risk of application abandonment.
`NOTE:If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
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`NOTE:Checking this box will be takento be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Date
`PGR2020-00030
`PGR2020-00030
`
`Ex. 3001 p. 2 of 9
`Ex. 3001 p. 2 of 9
`Registration No.
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`Authorized Signature
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`Typed orprinted name
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`PTOL-85 Part B (08-18) Approved for use through 01/31/2020
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`Page 2 of 3
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`USS. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`

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`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`16/155,386
`
`10/09/2018
`
`Derek John Londesbrough
`
`COPA-001/00US
`243-2009
`
`1524
`
`161862
`7590
`08/26/2019
`Compass Pathways | COOLEY LLP
`ATTN: IP Docketing Department
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, DC 20004
`
`ANDERSON,REBECCA L
`
`1626
`DATE MAILED:08/26/2019
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applications filed on or after May 29, 2000)
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`The Office has discontinued providing a Patent Term Adjustment (PTA)calculation with the Notice of Allowance.
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`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the requirement
`that the Office provide a patent term adjustment determination with the notice of allowance. See Revisions to Patent
`Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer providing an initial
`patent term adjustment determination with the notice of allowance. The Office will continue to provide a patent term
`adjustment determination with the Issue Notification Letter that is mailed to applicant approximately three weeks prior
`to the issue date of the patent, and will include the patent term adjustmenton the patent. Any request for reconsideration
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`PTOL-85 (Rev. 02/11)
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`Page 3 of 3
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`PGR2020-00030
`PGR2020-00030
`Ex. 3001 p. 3 of 9
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`

`

`.
`
`wos
`
`Application No.
`16/155,386
`
`A pplicant(s)
`Derek John Londesbrough
`
`Notice Requiring Inventor’s Oath or Declaration
`
`Examiner
`ANDERSON, REBECCA L
`
`Art Unit
`1626
`
`This notice is an attachment to the Notice of Allowability (PTOL-37), or the Notice of Allowability For A Design
`Application (PTOL-37D).
`
`An inventor’s oath or declaration in compliance with 37 CFR 1.63 or 1.64 executed by or with respect to each
`inventor has not yet been submitted.
`
`An oath or declaration in compliance with 37 CFR 1.63, or a substitute statement in compliance with 37 CFR 1.64,
`executed by or with respect to each inventor (for any inventor for which a compliant oath, declaration, or substitute
`
`statement has not yet been submitted) MUSTbefiled _no later than the date on which the issue fee is paid. See 35
`U.S.C. 115). Failure to timely comply will result in ABANDONMENTofthis application.
`
`A properly executed inventor’s oath to declaration has not been received for the following inventor(s):
`
`If applicant previously filed one or more oaths, declarations, or substitute statements, applicant may have received
`an informational notice regarding deficiencies therein.
`
`The following deficiencies are noted:
`
`INFORMAL ACTION PROBLEMS
`* A properly executed inventor's oath or declaration has not been received for the following inventor(s): Derek
`John Londesbrough, Christopher Brown, Julian Scott Northen, Gillian Moore, and Hemant Kashinath
`Patil.
`Applicant may submit the inventor's oath or declaration at any time before the Notice of Allowance and Fee(s)
`Due, PTOL-85, is mailed.
`
`Questions relating to this Notice should be directed to the Application Assistance Unit at 571-272-4200.
`
`U:S. Patent and Trademark Office
`
`PTO-2306 (01-13)
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`Notice Requiring Inventor’s Oath or Declaration
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`PGR2020-00030
`PGR2020-00030
`Ex. 3001 p. 4 of 9
`Ex. 3001 p. 4 of 9
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`

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`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
`National Security review (35 U.S.C. 181) and for review pursuantto the Atomic Energy Act (42 U.S.C. 218(c)).
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`or his/her designee, during an inspection of records conducted by GSAaspart of that agency's responsibility
`to recommend improvements in records managementpractices and programs, under authority of 44 U.S.C.
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`8. Arecord from this system of records may be disclosed, as a routine use, to the public after either publication of
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`in an application which became abandonedorin which the proceedings were terminated and which application
`is referenced byeither a published application, an application open to public inspectionor an issued patent.
`peRr929-00030
`PGR2020-00030
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law kx. 3001p. 5 of 9
`Ex. 3001 p. 5 of 9
`enforcement agency, if the USPTO becomesawareof a violation or potential violation of law or regulation.
`
`

`

`Notice of Allowability
`
`Application No.
`
`16/155,386
`Examiner
`REBECCA L ANDERSON
`
`Applicant(s)
`
`Londesbrough et al.
`AIA (FITF) Status
`1626 Yes
`
`Art Unit I
`
`--The MAILING DA TE of this communication appears on the cover sheet with the correspondence address-­
`
`
`
`
`
`
`
`
`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
`
`
`
`
`
`
`
`
`
`
`
`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
`
`
`
`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
`
`
`
`
`
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`1.0 This communication is responsive to the amendment filed 3 June 2019.
`
`
`
`
`
`
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`
`2.0 An election was made by the applicant in response to a restriction requirement set forth during the interview on __ ; the
`
`
`
`
`
`
`
`
`
`
`restriction requirement and election have been incorporated into this action.
`
`3.0 The allowed claim(s) is/are 22 and 31-40. As a result of the allowed claim(s), you may be eligible to benefit from the Patent
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Prosecution Highway program at a participating intellectual property office for the corresponding application. For more information
`
`
`
`, please see http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`
`
`4.0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`
`
`
`
`
`
`
`
`
`Certified copies:
`a)□All b)0 Some*c) 0 None of the:
`
`
`
`1. 0 Certified copies of the priority documents have been received.
`2. D Certified
`copies of the priority documents have been received in Application No. __ .
`
`
`
`
`3. D Copies of the certified
`
`
`
`
`
`International Bureau (PCT Rule 17.2(a)).
`
`
`*Certified copies not received: __ .
`
`
`
`copies of the priority documents have been received in this national stage application from the
`
`
`
`Applicant has THREE MONTHS FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
`
`
`
`
`
`
`
`
`
`
`
`
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`
`5.0 CORRECTED DRAWINGS (as "replacement sheets") must be submitted.
`
`
`
`
`
`
`Paper No./Mail Date __ .
`
`
`
`
`
`
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`
`
`
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`sheet. Replacement sheet{s) should be labeled as such in the header according to 37 CFR 1.121{d).
`
`Office action of Examiner's Amendment/ Comment or in the by the attached D including changes required
`
`Identifying indicia such as the application number {see 37 CFR 1.84{c)) should be written on the drawings in the front {not the back) of each
`
`6.0 DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`
`
`
`
`
`
`
`
`
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`5.0 Examiner's Amendment/Comment
`
`1. D Notice of References Cited (PT0-892)
`
`
`6.0 Examiner's Statement of Reasons for Allowance
`
`
`
`
`2.0 Information Disclosure Statements (PTO/SB/08),
`
`
`
`
`
`Paper No./Mail Date 5/23/19, 6/3/19, 6/20/19, 7/26/19, 8/14/19.
`7.□Other __
`
`
`
`for Deposit3. D Examiner's Comment Regarding Requirement
`.
`of Biological Material
`
`4.0 Interview Summary (PT0-413),
`
`Paper No./Mail Date. 20190814A.
`/REBECCA L ANDERSON/
`
`
`Primary Examiner, Art Unit 1626
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`
`
`Allowability Part of Paper No./Mail Date 20190814A Notice of
`
`
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`PGR2020-00030
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`Application/Control Number: 16/155,386
`Art Unit: 1626
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`Page 2
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`DETAILED ACTION
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`Claims 22 and 31-40 are currently pending in the instant application, appear allowable
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`over the prior art of record, and have been renumberedas claims 1-11.
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`Notice of Pre-AlA or AIA Status
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`The presentapplication, filed on or after March 16, 2013, is being examined under the
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`first inventor to file provisions of the AIA.
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`Response to Amendment and arguments
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`Applicant's amendment and argumentsfiled 3 June 2019 have been fully considered
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`and enteredinto the instant application.
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`Applicant’s amendment has overcomethe 35 USC 112(a) rejection of claim 19 as claim
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`19 has been cancelled. The 35 USC 112(b) rejection of claims 11 and 28 has been overcome
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`as Claims 11 and 28 have been cancelled. The amendment to claim 22 has overcomethe 35
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`USC 112(b) rejection of claim 22 as the claim has been amendedto recite identifying
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`characteristics of the recited Polymorph A. The cancellation of claims 21, 23, and 24-30 has
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`overcome the 35 USC 112(b) rejection of theseclaims. The amendmentto claim 22 has
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`overcomethe 35 USC 112(b) rejection of claim 22 as the term “(12A)” has been removed. The
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`cancellation of claims 7 and 8 has overcome the 35 USC 112(b) rejection of these claims. The
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`cancellation of claim 30 has overcome the 35 USC 112(b) rejection of this claim.
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`EXAMINER’S AMENDMENT
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`An examiners amendmentto the record appears below. Should the changes and/or
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`additions be unacceptable to applicant, an amendment maybefiled as provided by 37 CFR
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`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
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`payment of the issue fee.
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`Authorization for this examiner's amendment was given in an interview wth Sandhya
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`Deo on 14 August 2019.
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`The application has been amended asfollows:
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`PGR2020-00030
`PGR2020-00030
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`Ex. 3001 p. 7 of 9
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`Application/Control Number: 16/155,386
`Art Unit: 1626
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`Page 3
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`19.7”
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`1.
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`2.
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`Amend claim 22 by deleting “, and 17.5” and inserting inits place “, 17.5, and
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`Amend claim 40 by deleting from a) the phrase “as measured by European
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`Pharmacopoeia 2.2.32”
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`By deleting from b) the phrase “as measured by US Pharmacopoeia <281>”
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`And by deleting from h) the phrase “, as measured by US Pharmacopoeia
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`<233>”.
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`Reasons for Allowance
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`The following is an examiner's statementof reasons for allowance. This invention relates
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`to methods of treating drug resistant depression by orally administering crystalline psilocybin in
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`the form Polymorph A combined with silicified microcrystalline cellulose. The novel and
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`nonobvious aspectof this invention involves the combination of PolymorphA withsilicified
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`microcrystalline cellulose. The closest prior art of record, Folen, fails to teach or suggest
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`Applicant’s instantly claimed invention as the psilocybin provided in Folen differs by having
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`peaksat 17.7 instead of 17.5 +/- 0.1 and by having a peakat 19.4 instead of 19.7 +/- 0.1, see
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`page 366, Table Il and Bragg’s law. Additionally, see Table 1, page 350, pattern No. 62
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`(combined with Bragg’s law) which provides relative intensities for peaks at 14.5 (100), 19.4 (43)
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`and 11.9 (43), comparedto the relative intensities of the peaks of instant polymorphA, page 5
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`of specification, 14.5 (100), 19.7 (37.29), and 12.0 (26.45
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`Any comments considered necessary by applicant must be submitted no later than the
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`payment of the issue fee and, to avoid processing delays, should preferably accompany the
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`issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons
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`for Allowance.”
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`PGR2020-00030
`PGR2020-00030
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`Application/Control Number: 16/155,386
`Art Unit: 1626
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`Page 4
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`examiner should be directed to Rebecca L. Anderson whose telephone number is
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`(571)-272-0696. The examiner can normally be reached Monday-Friday from 6:30am-
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`2:30pm.
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`Examiner interviews are available via telephone, in-person, and video
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`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
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`interview, applicant is encouraged to use the USPTO Automated Interview Request
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`(AIR) at http:/Awww.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Joseph McKane, can be reached at (571) 272-0699. The fax phone number
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`for the organization wherethis application or proceeding is assignedis 571-273-8300.
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, seehttp://pair-direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll-free).
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`If you would like assistance from a
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`USPTO CustomerService Representative or accessto the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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`/REBECCA L ANDERSON’
`Primary Examiner, Art Unit 1626
`14 August 2019
`Rebecca Anderson
`Primary Examiner
`Art Unit 1626, Group 1620
`Technology Center 1600
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`PGR2020-00030
`PGR2020-00030
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`Ex. 3001 p. 9 of 9
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