`
`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 ALLOWANCEANDFEE(S) DUE
`
`|
`05/17/2017
`7590
`118262
`LOWENSTEIN SANDLER LLP / Purduc
`Patent Docket Administrator
`65 Livingston Avene
`Roseland, NJ 07068
`
`SINGI, RANDEEP
`
`1615
`DATE MAILED: 05/17/2017
`
` APPLICATION NO.
`
`Curtis Wright
`02/04/2016
`15/015,722
`TITLE OF INVENTION: PHARMACEUTICAL FORMULATION CONTAINING GELLING AGENT
`
`21076-548
`
`9971
`
`FILING DA'TE
`
`FIRS’! NAMED INVEN'TOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`
`
`
`
`
`
`ENTITY STATUS PUBLICATION FEE DUEJ]PREV. PAID ISSUE FEEISSUE FEE DUE ‘TOTAL FEER(S) DUE DATE DUE
`
`
`
` APPLN. ‘TYPE
`
`nonprovisional
`
`UNDISCOUNTED
`
`S960
`
`$960
`
`08/17/2017
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. TITS NOTICE OF ALLOWANCEIS NOT A GRANT OF PATENT RIGITTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROMISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (UF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED.
`SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION,
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THEISSUE FEE NOW
`DUE.
`
`TOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shownabove.If the ENTITY STATUSis shown as SMALL or MICRO,verily whether entitlementto that
`entity status still applics.
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`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shownabove.
`If the ENTITY STATUS is changed fromthat shown above, on PART B - FEE(S) TRANSMITTAL, complete section number5 titled
`"Change in Entity Status (fromstatus indicated above)".
`Yor purposesof this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amountof small entity
`fees.
`
`II. PART B - FEE(S) TRANSMITTAL,or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`(USPTO) with your ISSUE FEE and PUBLICATION FEE (if required). If you are charging the fee(s) to your deposit account, section "4b"
`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
`request to reapply a previously paid issuc fee must be clearly madc, and delays in processing may occur duc to thedifficulty in recognizing
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`I. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenancefees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-85 (Rev. 02/11)
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`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax (571)-273-2885
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE(if required). Blocks 1
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "[EEZ ADDRESS"for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block | for ay change ofaddress)
`
`05/17/2017
`.
`7590
`saa
`118262
`LOWENSTEIN SANDILER LIP / Purdue
`we
`\
`Patent Docket Administrator
`65 Livingston Avenue
`Roseland, NJ 07068
`
`can only be used for domestic mailings of the
`Note: A certificate of mailing
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`ave its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I herebycertify that this Fee(s) Transmittal is being deposited with the United
`States Fostal Service with sufficient postage for first class mailin ao Bavelope
`addressed
`to the Mail Stop ISSUR FEE address above, or
`being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated helow.
`(Depositor's name)
`(Signature)
`
`(ate)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Curtis Wright
`02/04/2016
`15/015,722
`TITLE OF INVENTION: PHARMACEUTICAL. FORMULATION CONTAINING GELLING AGENT
`
`21076-548
`
`9971
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`$0
`$0
`nonprovisional
`UNDISCOUNTED
`S960
`$960
`08/17/2017
`
`EXAMINER
`
`SINGH, RANDEEP
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`1615
`
`514-165000
`
`2. For printing on the patent front page.list
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`(1) The namesof up to 3 registered patent attorneys
`or agents OR,alternatively,
`() Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122)attached.
`(2) ‘The nameofa single firm (having as a member a
`registered attorney or agent) and the namesof up to
`LJ "Fee Address"indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`2 registered patentattorneys or agents. If no name is
`listed. no namewill be printed.
`Numberis required.
`
`3.ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(printor type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as sel forth in 37 CFR 3.11. Completion ofthis form is NO'Ta substitute Lor filing an assignment.
`(A) NAMEOFASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
`
`2
`3
`
`
`
`Ld Individual LJ Corporation or other private group entity LL} Government
`Please check the appropriate assignee categoryor categories (will not be printed on the patent) :
`4a. The following fee(s) are submitted:
`4b. PaymentofFee(s): (Please first reapply any previously paid issue fee shown above)
`(I Issue Fee
`Ld A checkis enclosed.
`(J Publication Fee (No smal] entity discount permitted)
`LI Payment by credit card. Form PTO-2038 is attached.
`LY Advance Order - # of Copies
`(J Thedirectoris herebyauthorized to charge the required fee(s), any deficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copyof this form).
`
`
`
` I Applicantcertifying micro entity status. See 37 CFR 1.29
`
`5. Change in Entity Status (from status indicated above)
`
`LI Applicantasserting small entity status. See 37 CFR 1.27
`
`NOTE:Absenta valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee payment in the micro entity amount will 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 entitystatus.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`LI Applicant changing to regular undiscounted fee status.
`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.
`
`Authorized Signature
`
`
`Date
`
`Typed or printed name
`
`Registration No.
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`Page 2 of 3
`OMB 0651-0033
`
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`GERD
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`SY
`
`
` 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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`15/015,722
`
`02/04/2016
`
`Curtis Wright
`
`21076-5348
`
`9971
`
`05/17/2017
`7590
`118262
`LOWENSTEIN SANDLER LLP / Purduc
`Patent Docket Administrator
`65 Livingston Avene
`Roseland, NJ 07068
`
`SINGH, RANDEEP
`
`1615
`DATE MAILED: 05/17/2017
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(Applications filed on or after May 29, 2000)
`
`The Office has discontinued providing a Patent Term Adjustment (PTA) calculation with the Notice of Allowance.
`
`to eliminate the
`Section 1(h)(2) of the ATA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)G)
`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 adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-85 (Rev. 02/11)
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`Page 3 of 3
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`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
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`The Paperwork Reduction Act (PRA) of 1995 requires Federal agencies to obtain Office of Management and
`Budget approval before requesting most types of information from the public. When OMB approves an agency
`request to collect information from the public, OMB (i) provides a valid OMB Control Number and expiration
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`1320.5(b).
`
`The information collected by PTOI.-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public whichis to file (and by the USPTO to process) an application. Confidentiality is
`governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete,
`including gathering, preparing, and submilung the completed application form to the USPTO. Time will vary
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`Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMSTO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your
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`requirements of the Act, please be advised that: (1) the general authority for the collection of this informationis
`35 U.S.C. 2(b)(2); (2) furnishing ofthe information solicited is voluntary; and (3) the principal purpose for which
`the information is used by the U.S. Patent and Trademark Office is to process and/or examine your submission
`related to a patent application or patent. If you do not furnish the requested information, the U.S. Patent and
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`proceedings or abandonmentof the application or expiration ofthe patent.
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`The information provided by youin this form will be subject to the following routine uses:
`1. ‘he information on this form will be treated confidentially to the extent allowed under the Kreedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records
`maybe disclosed to the Department of Justice to determine whcther disclosure of these records is required
`by the Freedomof Information Act.
`2. A record fromthis system of records may be disclosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
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`4. A record in this system of records maybe disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to
`complywith the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records maybe 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 pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA aspart of that agency's
`responsibility to recommend improvements in records managementpractices and programs, under authority
`of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the GSA regulations
`governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive.
`Suchdisclosure shall not be used to make determinations aboutindividuals.
`8. Arecord fromthis system of records may be disclosed, as a routine use, to the public after either publication
`of the application pursuant to 35 U.S.C. 122(b) or issuance ofa patent pursuant to 35 U.S.C. 151. Further, a
`record may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the
`record was filed in an application which became abandoned or in which the proceedings were terminated
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`inspection or an issued patent.
`9. A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
`enforcement agency,if the USP'L'O becomes aware of a violation or potential violation of law or regulation.
`
`PCLG00246975
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`Application No.
`Applicant(s)
`
`15/015,722
`WRIGHTETAL.
`BaerSINGH
`anit
`States vemtor to File)
`No
`
`Notice of Allowability
`
`
`
`-- The MAILING DATEof 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 PATENTRIGHTS.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. J This communication is responsive to Applicants' Amendment/Response dated 02/02/2017.
`(J A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`:
`
`2. CJ An election was madeby the applicant in response to a restriction requirementsetforth during the interview on
`requirement and election have been incorporatedinto this action.
`
`; the restriction
`
`3. XJ The allowed claim(s) is/are 41-43,46-53 and 57-62. As a result of the allowed claim(s), you may be eligible to benefit from the Patent
`Prosecution Highwayprogram ata 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. [J Acknowledgmentis made ofa claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) [1] None ofthe:
`a) All
`b)—1Some
`1. [J Certified copies of the priority documents have been received.
`2. C1] Certified copies of the priority documents have been receivedin Application No.
`3. [J Copiesof the certified copies of the priority documents have been receivedin this national stage application from the
`International Bureau (PGT Rule 17.2(a)).
`* Certified copies not received:
`
`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 ofthis application.
`THIS THREE-MONTHPERIOD IS NOT EXTENDABLE.
`
`5. [] CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`(including changes required by the attached Examiner's Amendment / Commentor in the Office action of
`Paper No./Mail Date
`.
`Identifying indicia such as the application number (see 37 CFR 1.84{c)) should be written on the drawingsin the front (nat the back) of
`each sheet. Replacement sheet(s) should be labeled as suchin the header according to 37 CFR 1.121(d).
`
`6. [] 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)
`1. [] Notice of References Cited (PTO-892)
`2. & Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date See Continuation Sheet
`3. 1] Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [] Interview Summary (PTO-413),
`Paper No./Mail Date
`.
`
`/Randeep Singh/
`
`5. FJ Examiner's Amendment/Comment
`6. J] Examiner's Statement of Reasons for Allowance
`
`7. C] Other
`
`.
`
`Examiner, Art Unit 1615
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`20170514
`
`Notice of Allowability
`
`Part of Paper No./Mail Date
`
`PCLG00246976
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`Continuation Sheet (PTOL-37)
`
`Application No. 15/015,722
`
`Continuation of Attachment(s) 2. Information Disclosure Statements (PTC/SB/08), Paper No./Mail Date: 11/23/16,2/15/17,2/24/17.
`
`PCLG00246977
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`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 2
`
`DETAILED ACTION
`
`Status of the Application
`
`Receipt of Applicants' Amendment/Responsefiled 02/02/2017 is acknowledged.
`
`Applicants have overcome all rejections by virtue of the amendmentsto the claims
`
`and/or persuasive remarks.
`
`In Applicants’ Amendment/Response dated 02/02/2017, claims 41, 53, and 60
`
`were amended. Claims 44, 45, and 54-56 were cancelled. Claims 41-43, 46-53, and
`
`57-62 are pending in this action and have been allowed.
`
`Information Disclosure Statement
`
`The information disclosure statements submitted on 11/23/2016, 02/15/2017, and
`
`02/24/2017 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the
`
`information disclosure statements have been considered by the Examiner. Please see
`
`attachedinitialed PTO-1449 forms.
`
`Reasonsfor Allowance
`
`The following is the Examiner's statement of reasonsfor allowance:
`
`the prior art
`
`of record doesnotteachor fairly suggest the claimed invention. For example, the
`
`closestprior art of record, Kaiko, teaches dosage forms comprising oxycodone or a salt
`
`thereof and an antagonist to the oxycodone or salt thereof. As such, the oxycodone or
`
`salt thereof in the dosage forms of Kaiko is not the sole active agent in the composition.
`
`Furthermore, the closest prior art of record does not teach or fairly suggest preparing an
`
`PCLG00246978
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`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 3
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`abuse deterrent dosage form comprising particles prepared from a homogenous mixture
`
`of polyglycolyzed glycerides, a C12 to Cao fatty acid, carnauba wax, and beeswax, such
`
`that the dosage form is abuse deterrent when subjected to tampering comprising
`
`heating at a temperature greater than about 45 degreesC.
`
`Any comments considered necessary by Applicants must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompanythe issue fee. Such submissions should be clearly labeled "Comments on
`
`Statement of Reasons for Allowance".
`
`Conclusion
`
`Claims 41-43, 46-53, and 57-62 are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to RANDEEP SINGH whosetelephone number is
`
`(571)270-3881. The examiner can normally be reached on Monday-Friday 10:00-6:30
`
`PM.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Robert A. Wax can be reached on (571)272-0623. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`PCLG00246979
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`Application/Control Number: 15/015,722
`Art Unit: 1615
`
`Page 4
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
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`you have questions on accessto the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Randeep Singh/
`Examiner, Art Unit 1615
`
`/Robert A. Wax/
`Supervisory Patent Examiner
`Art Unit 1615
`
`PCLG00246980
`
`Purdue 2006
`Collegium v. Purdue, PGR2018-00048
`9 of 9
`
`Purdue 2006
`Collegium v. Purdue, PGR2018-00048
`9 of 9
`
`