Patent Trial and Appeal Board
`
`A, petition has beenfited in Patent Number 9,593,066, Application Number 14/849,981 on March 30,
`2020.
`
`The AIA Review Number is IPR2020-00769.
`
`To view the documentsfiled in this petition, go to httos://ptab.uspto.gov and Search for the AIA Review
`Number.
`
`e Enter your search criteria on the “Search PTAB” page
`¢
`Type in the AIA Review Numberor Patent Number
`« You will need to answer the CAPTCHAto prove that you are not a robot.
`e Click on the “Search” button
`
`e The searchresults will appear identifying the AIA Review Number
`e Click on the “View Documents”button
`
`« A pop up window will appearwith a list of documents
`¢ Click on the “Download” button to download the document.
`
`Questions regarding this notice should be directed to the Patent Trial and Appeal Board at
`571-272-7822.
`
`IPR2020-00769
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`

`*
`
` BRR UNITED S1ATES 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.Uuspto.Z0V
`
` APPLICATION NUMBER
`
`1672
`
`REQUESTID
`
`102656
`
`14/849,981
`
`9593066
`
`PATEN' NUMBER
`
`GROUP ARTUNIT
`
`PAIR Correspondence Address/Fee Address Change
`
`The following fields have been changed to Customer Number 166905 on 01/03/2020 via Private PAIR in view
`of the certification copied below that authorized the change.
`
`* Correspondence Address
`
`The address for Customer Number 166905 is:
`166905
`
`Foley & Lardner LLP
`3000 K Street N.W.
`Suite 600
`
`Washington, DC 20007-5109
`
`I certify, in accordance with 37 CFR 1.4(d)(4) that Iam:
`
`Anattorney or Agent of Record registered to practice before the Patent and Trademark Office who has been given
`powerof attorney in this application
`
` Registration Number:
`
`35264
`
`IPR2020-00769
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`

`To:
`From:
`Ce:
`Subject:
`
`ipdocketing@foley.com,,
`PAIR_eOfficeAction@uspto.gov
`PAIR_eOfficeAction@uspto.gov
`Private PAIR CorrespondenceNotification for Customer Number 22428
`
`Feb 23, 2017 03:34:48 AM
`
`Dear PAIR Customer:
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`SUITE 600
`WASHINGTON, DC 20007-5109
`UNITED STATES
`
`The following USPTO patent application(s) associated with your Customer Number, 22428 , have
`new outgoing correspondence. This correspondenceis now available for viewing in Private PAIR.
`
`The official date of notification of the outgoing correspondencewill be indicated on the form PTOL-90
`accompanying the correspondence.
`
`Disclaimer:
`The list of documents shown below is provided as a courtesy andis notpart of the official file
`wrapper. The content of the images shown in PAIR is the official record.
`
`Application
`14849981
`
`Document
`ISSUE.NTF
`
`Mailroom Date
`02/22/2017
`
`Attorney Docket No.
`0806 18-1581
`
`To view your correspondenceonline or update your email addresses, please visit us anytime at
`https://sportal.uspto.gov/secure/myportal/privatepair.
`
`If you have any questions, please email the Electronic Business Center (EBC) at EBC@uspto.gov
`with 'e-Office Action’ on the subjectline or call 1-866-217-9197 during the following hours:
`
`Monday- Friday 6:00 a.m. to 12:00 a.m.
`
`Thank you for promptattention to this notice,
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT APPLICATION INFORMATION RETRIEVAL SYSTEM
`
`IPR2020-00769
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`

`

`GEST ANDFey
`
`
`SA ‘ 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
`WW W.USpLO.goV
`
`CONFIRMATION NO.
`
`ATTORNEY DOCKET NO.
`
`080618-1581
`
`6053
`
`APPLICATION NO.
`
`14/849,981
`
`ISSUF DATE
`
`03/14/2017
`
`PATENT NO.
`
`9593066
`
`22428
`
`7590
`
`02/22/2017
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`SUITE 600
`WASHINGTON, DC 20007-5109
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustmentis the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEBsite (http://pair.uspto. gov).
`
`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 Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEBsite http://pair.uspto.govfor additional applicants):
`
`Hitesh BATRA, Herndon, VA;
`United Therapcutics Corporation, Silver Spring, MD;
`Sudersan M. TULADIIAR,Silver Spring, MD;
`Raju PENMASTA,Herndon, VA;
`David A. WALSH,Palmyra, VA;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage and facilitate business investment. To learn more about why the USAis the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA. gov.
`
`IR103 (Rev. 10/09)
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OLTICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`WWww.usplo.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`Foley & [ardner IP
`3000 K STREET N.W.
`Stir oon
`WASITINGTON, DC 20007-5109
`
`VALENROD, YEVGENY
`
`1672
`DATE MAILED: 01/30/2017
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATIONNO.
`
`ILlitesh BATRA
`09/10/2015
`14/849,981
`TITLE OF INVENTION: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN®
`
`080618-1581
`
`6653
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV.PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`$0
`$0
`
`
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$960
`
`05/01/2017
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROMISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY TILE APPLICANT. SEE 37 CER 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (UF REQUIRED) MUST BE PAID WITITIN THREE MONTHS FROM TITE
`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.
`LF 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 REAPPLYTILE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`1. Review the ENTITY S'TATUS shown above.If the ENTITY STATUS is shown as SMALL or MICRO,verify whether entitlementto that
`entitystatusstill applies.
`
`If the ENTITY STATUSis the same as shownabove, pay the TOTAL FEE(S) DUE shownabove.
`If the ENTITY STATUSis changed from that shown above, on PART B - FEE(S) TRANSMITTAL,complete section number5 titled
`"Changein I/ntity Status (from status indicated above)".
`For purposes ofthis 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,orits 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 issue fee must be clearly made, and delays in processing mayoccur dueto the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`If. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEEunless advised to the contrary.
`
`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)
`
`Page 1 of 3
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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
`Commissionerfor 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 "FEE ADDRESS"for
`maintenancefee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS(Note: Use Block1 for any changeof address)
`
`7390
`22428
`.
`Foley & VardnerI.1.P
`3000 K STREET N.W
`‘
`.
`wv
`SUITE 600
`WASITINGTON, DC 20007-5109
`
`01/30/2017
`
`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
`apers. Each additional paper, such as an assignment or formal drawing, must
`have its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE BEE address above, or being facsimile
`(ransmilled lo the USPTO (571) 273-2885, on the dale indicated below.
`"
`———(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATIONNO.
`
`Hitesh BATRA
`09/10/2015
`14/849,981
`TITLE OF INVENTION: PROCESS TO PREPARE TREPROSTINIL, TIE ACTIVE INGREDIENT IN REMODULIN®
`
`080618-1581
`
`6653
`
`
`
`
`
`APPLN. ‘TYPL PUBLICATION LLL DUL|PREV. PAID ISSUL FLEELNITILTY STATUS ISSUE LLE DUL TOTAL FELIS) DUL DATE DUE
`
`
`$0
`nonprovisional
`UNDISCOUNTED
`S960
`S960
`05/01/2017
`
`ART UNIT
`
`CLASS-SUBCLASS
`
` EXAMINER
`
`VALENROD, YEVGENY
`
`1672
`
`562-466000
`
`2. For printing on the patent front page, list
`1. Change of correspondence addressor indication of "Fee Address" (37
`CFR 1.363).
`(1) The names of 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 allomey or agent) and the names of up lo
`Lj "Tee Address" indication (or "'ee Address" Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`2 registered patent attorneys or agents. If no nameis
`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 beenfiled for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as sct forth in 37 CFR 3.11. Completion of this form is NOT a substitute forfiling an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
`
`No
`
`3,
`
`
`
`Ld tadividuat LJ Corporation or other private group entity LJ Government
`Please check the appropriate assignee category or categories (will not be printed on the patent):
`da. The following fee(s) are submitted:
`4b. Paymentof Fee(s): (Please first reapply any previously paid issue fee shown above)
`(J Issue Fee
`(A check is enclosed.
`(J Publication Fee (No small entity discount permitted)
`LI Paymentby credit card. Form PTO-2038 is attached.
`(LJ Advance Order- # of Copies
`(_] The director is hereby authorized to charge the required fee(s), anydeficiency, or credits any
`overpayment, to Deposit Account Number
`(enclose an extra copy of this form).
`
`5. Changein Entity Status (from status indicated above)
`LI Applicant certifying micro entity status. See 37 CFR 1.29
`
`LJ) Applicant asserting small enlily slatus. 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 amountwill not be acceptedat the risk of application abandonment.
`NOE: Il the application was previously under micro enlily slalus, checking Lhis box will be taken
`lo be a notification ofloss of entidement to microentily status.
`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. Sec 37 CFR 1.4 for signature requirements and certifications.
`
`Authorized Signature
`
`‘lyped or printed name
`
`
`Date
`
`Registration No.
`
`PTOL-8S5Part B (10-13) Approved for use through 10/31/2013.
`
`Page 2 of 3
`OMB0651-0033
`
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`IPR2020-00769
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`

`
`
`UNITED STATES PATENT AND TRADEMARK OLTICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`WWww.usplo.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATIONNO.
`
`14/849,981
`
`22428
`
`|
`7590
`
`09/10/2015
`
`01/30/2017
`
`Foley & [ardner IP
`3000 K STREET N.W.
`Stir oon
`WASITINGTON, DC 20007-5109
`
`Hitesh BATRA
`
`080618-1581
`
`6653
`
`VALENROD, YEVGENY
`
`1672
`DATE MAILED: 01/30/2017
`
`Determination of Patent Term Adjustment under35 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 AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)@)
`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-Q101 or (57 1)-272-4200.
`
`PTOL-85 (Rev. 02/11)
`
`Page 3 of 3
`
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`

`OMB Clearance and PRA Burden Statement for PTOL-85 Part B
`
`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 (1) provides a valid OMB Control Number and expiration
`date for the agency to display on the instrument that will be used to collect the information and (11) requires the
`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CIR
`1320.5(b).
`
`The information collected by PTOL-85 Part B is required by 37 CFR 1.311. The information is required to obtain
`or retain a benefit by the public which is to file (and by the USPTO to process) an application. Confidentialityis
`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 submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`‘Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO TITTS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
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`
`Privacy Act Statement
`
`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 information is
`35 U.S.C. 2(b)(2); (2) furnishing of the 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 of the patcnt.
`
`The information provided by you in this form will be subject to the following routine uses:
`1. The information on this form will be treated confidentially to the extent allowed under the Freedom of
`Information Act (5 U.S.C. 552) and the Privacy Act (5 U.S.C 552a). Records from this system of records
`may be disclosed to the Department ofJustice to determine whether disclosure of these records is required
`by the Freedomof Information Act.
`2. Arccord fromthis system of records may be discloscd, as a routine usc, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`3. A record in this system of records may be disclosed, as a routine use, toa Memberof Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance
`from the Member withrespect to the subject matter of the record.
`4. A record in this system of records may be 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
`comply with 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 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 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 as part 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.
`Such disclosure shall not be used to make determinations about individuals.
`8. A record fromthis system of records may be disclosed, as a routine use, to the public after either publication
`ofthe application pursuant to 35 U.S.C. 122(b) or issuance of a 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
`and which application is referenced by either a published application, an application open to public
`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 USPTO becomesawareof a violation or potential violation of law or regulation.
`
`IPR2020-00769
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`

`
`Application No.
`Applicant(s)
`14/849,981
`BATRAET AL.
`
`xa VALENROD
`aom
`State.at inventor to Fite)
`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 RCE filed on 12/29/16.
`Cla declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`:
`
`2. 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 incorporatedinto this action.
`
`3. KJ The allowed claim(s) is/are 1,2 and 4-11. As a result of the allowed claim(s), you maybe 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. DJ Acknowledgmentis made ofa claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) [J None ofthe:
`a)CJ All
`=b)L) Some
`1. Certified copies of the priority documents have been received.
`2. F Certified copies of the priority documents have been received in Application No.
`3. FJ Copiesofthe certified copies of the priority documents have been receivedin this national stage application from the
`International Bureau (PCT Rule 17.2(a)).
`* Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE “MAILING DATE?” of this communicationto file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT ofthis application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. 1) 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 (not the back) of
`each sheet. Replacement sheet(s) should be labeled as such in 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. [1 Notice of References Cited (PTO-892)
`2. [XJ Information Disclosure Statements (PTO/SB/08),
`
`Paper No./Mail Date 1/10/17; 12/29/16
`3. 1] Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`4. [J Interview Summary (PTO-413),
`Paper No./Mail Date
`.
`/YEVGENY VALENROD/
`
`5. 1 Examiner's Amendment/Comment
`6. LJ Examiner's Statement of Reasonsfor Allowance
`
`7. &] Other Continued Examination.
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`20170125
`
`Notice of Allowability
`
`Part of Paper No./Mail Date
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 9 of 7113
`
`Primary Examiner, Art Unit 1672
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 9 of 7113
`
`

`

`Application/Control Number: 14/849,981
`Art Unit: 1672
`
`Page 2
`
`The presentapplication is being examined underthe pre-AlA first to invent
`
`provisions.
`
`Continued Examination Under 37 CFR 1.114
`
`A request for continued examination under 37 CFR 1.114, including the fee set
`
`forth in 37 CFR 1.17(e), wasfiled in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`12/29/16 has been entered.
`
`Withdrawn rejections
`
`Rejection of claims 1-2 and 4-11 over US patent 8,242,305 and application
`
`14/754,932 is withdrawn in view of the terminal disclaimerfiled on 12/29/16.
`
`Conclusion
`
`Claims 1-2 and 4-11 are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to YEVGENY VALENROD whosetelephone number is
`
`(571)272-9049. The examiner can normally be reached on mon-fri 8-4:30.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Fereydoun G. Sajjadi can be reached on 571-572-3311. The fax phone
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 10 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 10 of 7113
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`

`

`Application/Control Number: 14/849,981
`Art Unit: 1672
`
`Page 3
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`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
`
`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 automatedinformation
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/YEVGENY VALENROD/
`Primary Examiner, Art Unit 1672
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 11 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 11 of 7113
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`

`

`Receipt date: 12/29/2016
`
`14849981 - GAU: 1672
`PTO/SB/08 (modified
`
`Complete if Known
`Substitute for form 1449/PTO
`14/849,981
`INFORMATION DISCLOSURE
`9/10/2015
`STATEMENT BY APPLICANT
`
`Hitesh BATRA
`First Named Inventor
`ittad:
`
`Art Unit
`1679
`Date Submitted:
`
`use as many sheets as necessary)
`Examiner Name
`|_Yevgeny Valenrod
`Attorney Docket Number|080618-1581
`
`Application Number
`
`U.S. PATENT DOCUMENTS
`Document Number
`Examiner [pg Publication Date
`Nameof Patentee or Applicantof
`Number-Kind Code* (if
`MM-DD-YYYY
`Cited Document
`Initials*
`.
`
`known)
`
`~Pages, Columns, Lines,
`Where Relevant
`Passagesor Relevant
`Figures Appear
`
`
`
`
`
`
`FOREIGN PATENT DOCUMENTS
`; ee
`:
`Pages, Columns, Lines,
`|
`.
`
`
`Examiner|Foreign Patent Document Publication Date Name of Patentee or Where Relevant
`
`Initials*
`.
`Country Code Number
`MM-DD-YYYY
`| Applicant of Cited Documents
`Passagesor Relevant
`Kind Code? (if known)
`:
`Figures Appear
`
`
`
`
`
`
`
`
`
`
` NON PATENT LITERATURE DOCUMENTS
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`Examiner
`Initials*
`item (book, magazine, journal, serial, symposium, catalog, etc.) date, page(s), volume-issue
`number(s), publisher, city and/or country where published.
`Redacted Petitioner's Reply to Patent Owner's Responseto Petition filed on September 27,
`2016 in SteadymedLtd. (Petitioner), v. United Therapeutics Corporation (Patent Owner),
`____| CaseIPR2016-00006, US Patent 8,497,393, with Exhibits 1022-1028.
`D2
`Petitioner's Demonstratives filed November 28, 2016, in SteadymedLid. (Petitioner), v.
`United Therapeutics Corporation (Patent Owner), Case IPR2016-00006, US Patent
`
`8,497,393
`Patent Owner Responseto Petition filed November 23, 2016, in SteadymedLid. (Petitioner),
`v. United Therapeutics Corporation (Patent Owner), Case IPR2016-00006, US Patent
`8,497,393, with Redacted Exhibits 2006, 2020, 2022, 2058 and 2059 filed November 23,
`
`6, 1151 pages.
`ent Owner Demonstratives filed November 23, 2016, in Steadymed Lfd. (Petitioner), v.
`United Therapeutics Corporation (Patent Owner), Case IPR2016-00006, US Patent
`
`8,497,393, 62 pages.
`Decision Redacted Institute of inter Partes Review dated November 23, 2016, in Steadymed
`Ltd. (Petitioner), v. United Therapeutics Corporation (Patent Owner), Case IPR2016-00006,
`US Patent 8,497,393, 53 pages.
`ee
`Service copy of Third Party Submission dated October 16, 2016, filed but not entered in US
`D6
`14/849,981 on October 16, 2016, with 6 indicated attachments, 822 pages.
`
`
`D1
`
`D3
`
`D5
`
`D7
`
`D8
`
`Redacted Defendant SandozInc.'s Invalidity Contentions dated February 5, 2015, United
`Therapeutics Corporation (Plaintiff) v. Sandoz Inc. (Defendant), In The United States District Court for
`the District of New Jersey, Civil Action No. 3:14-cv-5499(PGH)(LHG),90 pages.
`Defendant Sandoz Inc.'s Invalidity Contention Chartss dated February 5, 2015, United Therapeutics
`Corporation (Plaintiff) v. Sandoz Inc. (Defendant), in The United States District Court for the District of
`New Jersey, Civil ActionNo.3:14-cv-5499(PGH)(LHG),189pages.
`
`
`
`Examiner
`Signature
`4823-8067-7182.1
`
`Date
`Considered
`
`
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/Y.V/
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 12 of 7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 12 of 7113
`
`

`

`Receipt date: 12/29/2016
`
`14849981 - GAU: 1672
`
`
`Complete if Known
`
`14/849,98 1
`Application Number
`INFORMATION DISCLOSURE
`
`
`STATEMENT BY APPLICANT _49/10/2015
`
`:
`.
`First Named Inventor
`Hitesh BATRA
`Date Submitted:
`DEY 9 9 ZONE
`Art Unit
`1672
`
`use as many sheets as necessary)
`Examiner Name
`Yevgeny Valenrod
`Attorney Docket Number
`080618-1581
`
`NON PATENT LITERATURE DOCUMENTS
`
`Initials*
`
`Examiner
`
`:
`
`Dg
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the
`item (book, magazine, journal, serial, symposium, catalog, etc.) date, page(s), volume-issue
`number(s), publisher, city and/or country where published.
`Defendant Actavis Laboratories FL, Inc. Preliminary Invalidity Contentions, dated August 30, 2016,
`United Therapeutics Corporation, and Supemus Pharmaceuticals, Inc., (Plaintiff) v. Actavis
`Laboratories FL, Inc,, (Defendant), In The United States District Court for the Distritc of New Jersey,
`Civil Action No. 3:16-cv-01816-PGS-LHG, Civil Action No. 3:16-cv-03642-PGS-LHG, 330 pages, (see |
`
`particularly pages 18-20, 42-62 and 269-280).
`D10|Exhibit G, Invalidity Claim Chart