throbber
Patent Trial and Appeal Board
`
`A, petition has been filed in Patent Number 9,593,066, Application Number 14/849,981 on March 30,
`2020.
`
`The AlA Review Number is IPR2020-00769.
`
`To view the documents filed in this petition, go to httQSII/ptabusptogov and Search for the AIA Review
`Number.
`
`. Enter your search criteria on the ”Search PTAB" page
`0
`Type in the AIA Review Number or Patent Number
`0 You will need to answer the CAPTCHA to prove that you are not a robot.
`- Click on the “Search” button
`
`0 The search results will appear identifying the AIA Review Number
`o Click on the "View Documents" button
`
`0 A pop up window will appear with a list of documents
`0 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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`W‘mm‘,
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTIVTENT 0F COMNIERW
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
` APPLICATION N LMBER PATENT N UMBER GROUP ART UN IT REQUEST ID
`14/849,981
`9593066
`1672
`102656
`
`
`
`
`
`
`
`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.
`
`0 Correspondence Address
`
`The address for Customer Number 166905 is:
`166905
`
`Foley & Lardner LLP
`3000 K Slreet NW.
`Suite 600
`
`Washington, DC 20007—5109
`
`I certify, in accordance with 37 CFR 1.4(d)(4) that I am:
`
`An attorney or Agent of Record registered to practice before the Patent and Trademark Office Who has been given
`power of attorney in this application
`
`35264
`
`I' egistration Number:
`
`IPR2020-00769
`
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`

`

`To:
`From:
`Cc:
`Subject:
`
`ipdocketing@foley.com,,
`PAIR_eOfficeAction@uspto.gov
`PAIR_eOfficeAction@uspto.gov
`Private PAIR Correspondence Notification 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 correspondence is now available for viewing in Private PAIR.
`
`The official date of notification of the outgoing correspondence will be indicated on the form PTOL—90
`accompanying the correspondence.
`
`Disclaimer:
`The list of documents shown below is provided as a courtesy and is not part of the official file
`wrapper. The content of the images shown in PAIR is the official record.
`
`Application
`14849981
`
`Document
`ISSU E.NTF
`
`Mailroom Date
`02/22/2017
`
`Attorney Docket No.
`080618—1581
`
`To view your correspondence online or update your email addresses, please visit us anytime at
`https://sporta|.uspto.gov/secure/myportaI/privatepair.
`
`If you have any questions, please email the Electronic Business Center (EBC) at EBC@uspto.gov
`with 'e-Office Action‘ on the subject line or call 1-866-217—9197 during the following hours:
`
`Monday - Friday 6:00 am. to 12:00 am.
`
`Thank you for prompt attention to this notice,
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT APPLICATION INFORMATION RETRIEVAL SYSTEM
`
`IPR2020-00769
`
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`

`9611 “111%
`
`
`5%: 2% UNITED STATES PATENT AND TRADEMARK OFFICE
`E' V.
`
`a.
`
`
`UNITED STATES DEPARTMENT OF COMLIERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P 0. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPUCATIOV V0.
`ISSUE DATE
`PATE \l V0.
`ATTORNEY DOCKET N0.
`COVEIRVIATION V0.
` 14/849,981 03/14/2017 9593066 080018-1581 0053
`22428
`7590
`02/22/2017
`
`
`
`
`
`
`
`
`
`Foley & Lardner LLP
`3000 K S'I'REE'I' N.W.
`SUITE 600
`WASHINGTON, DC 20007—5 109
`
`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 Adjustment is 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) WEB site (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 WEB site http://pair.uspt0.gov for additional applicants):
`
`Hitesh BATRA, Herndon, VA;
`United Therapeutics Corporation, Silver Spring, MD;
`Sudersan M. TI ILADIIAR, Silver Spring, MD;
`Rajn 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 USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.Oov.
`
`IR103 (Rev. 10/09)
`
`IPR2020-00769
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COlVEMERCE
`Unith States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P 0. Box 1450
`Alexandria, Virginia 22313-1450
`W“’W.llSpT.O.gOV
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`sumoo
`WASIIINGTON. DC 20007-5109
`
`VALENRoD. YEVGENY
`
`1573,
`DATE MAILED: 01/30/2017
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`IIitesh BATRA
`09/10/2015
`14/849,981
`TITLE OF INVENTION: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN®
`
`080618-1581
`
`6653
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`nonprovisional
`
`UNDISCOLNTED
`
`5960
`
`PUBLICATION FEE DUE
`$0
`
`PREV. PAID ISSUE FEE
`$0
`
`TOTAL FEE(S) DUE
`
`5960
`
`DATE DUE
`
`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 VVITHDRAVVAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY TIIE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`TIIE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID VVITIIIN THREE MONTIIS FROM TIIE
`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 TEHS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY TIIE PREVIOUSLY PAID ISSUE FEE TOWARD TIIE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`1. Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL 0r MICRO, verify whether entitlement to that
`entity status still applies.
`
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(_S) DUE shown above.
`If the ENTITY STATUS is changed from that shown above, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`For purposes of this notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entily fees are 1/2 the amount of small entity
`fccs.
`
`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 issue fee must be clearly made, and delays in processing may occur due to the difficulty in recognizing
`the paper as an equivalent of Part B.
`
`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
`Mail Stop ISSUE FEE unless advised to the contrary.
`
`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12, 1980 may require payment of
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenance fees when due.
`
`PTOL-SS (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: Mil Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (571)-273-2885
`throughSshould be completed where
`INSTRUCTIONS. This form should be used for transmitting the ISSIE FEE and PUBLICATIO\ FEE (if required). Blocks 1
`ap ropriate All further correspondence including the Patent advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`nicated 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
`i‘naintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any Change ofaddIESS‘:
`
`[390
`22428
`‘
`l‘Ole & Lardner III 1P
`3000 K STREETN W
`‘
`V
`'
`'
`SUITE 600
`WASHINGTON, DC 20007—5109
`
`01/30/2017
`
`Note: A certificate of mailin can only be used for domestic mailings of the
`Fee(s) Transmittal. This certi icate 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 Vlailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Sen/ice with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USP'I'O (571) 2732885 on the date indicated below
`
`(Signature) (Date)
`
`(Dam‘mmm’
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`Hitesh BATRA
`09/10/2015
`I4/849,981
`TITLE OF INVENTION: PROCESS TO PREPARE TREPROSTINIL. TIIE ACTIVE INGREDIENT IN REMODULIN®
`
`080618-1581
`
`(653
`
`APPLN. IYPE
`ENWIIIY SIAI US
`SISUE 1EE DUE
`1"”UBLICAIION I EE DUE
`PREV PAID ISSUE IEL
`'I'O'IAL I‘EEIS) DUE
`DA'I‘E DLE
`
`nonprov1sional
`
`
`
`S960 3960UNDISCOLNTED 05/01/2017
`
`
`EXAMENER
`ART UNIT
`CLASS-SUBCLASS
`
`VALENROD. YEVGENY
`1672
`562-466000
`
`1. Change of correspondence address or indication oI "Fee Address" (37
`CFR 1.363).
`
`2. For printing on the patent front page, list
`( 1) The names of up to 3 registered patent attorneys
`or agents OR. alternatively.
`D Change of correspondence address (or Change of Correspondence
`Address orm PTO/SB/IZZ) attached.
`(2) Ihe name of a single firm (having as a membet a
`registered attorney or agent) and the names 01 up to
`D "Fee Address" indication (or "Fee 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 name is
`listed no name will be printed.
`Number is required.
`
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or 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 set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`
`
`I
`N
`
`3
`
`'3 Corporation or other private group entity '3 Government
`'3 Individual
`Please check the appropriate assignee categ01y 0r categories (will not be printed on the patent) :
`4a. The following fee(s) are submitted:
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`D Issue Fee
`D A check is enclosed.
`D Publication Fee (No small entity discount permitted)
`D Payment by credit card. Form PTO-2038 is attached.
`D Advance Order - # of Copies
`D The director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`overpayment. to Deposit Account Number
`(enclose an extra copy of this form).
`
`5. Change in Entity Status (from status indicated above)
`D Applicant certifying micro entity status. See 37 CFR 1.29
`
`D Applicant asserting small entity status. See 37 CFR 1.27
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ISA and ISB), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`N_OIE: II the application was previously under micro entity status checking this box will be taken
`tob—ea notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`D Applicant changing to regular undiscounted fee status.
`entity status. as applicable.
`
`NOTE: This form must be si ned in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for si nature re uiremcnts and certifications.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`PTOL785 Part B (1013) Approved for use through 10/31/2013.
`
`Page 2 of 3
`OMB 065170033
`
`
`US Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
`
`IPR2020-00769
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`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF CONEMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P 0. Box 1450
`Alexandria, Virginia 22313-1450
`W“’W.llSpT.O.gOV
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/849,981
`
`22428
`
`—
`7390
`
`09/10/2015
`
`01/30/2017
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`surrEeoo
`WASIIINGTON, DC 20007-5109
`
`Hitesh BATRA
`
`080618-1581
`
`6653
`
`VALENROD, YEVGENY
`
`1573,
`DATE MAILEL): 01/30/2017
`
`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 AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i)
`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 l-(888)-786-0101 or (571)-272-4200.
`
`PTOL-SS (Rev. 02/11)
`
`Page 3 of 3
`
`IPR2020-00769
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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 ()MB approves an agency
`request to collect information from the public, OMB (i) 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 (ii) requires the
`agency to inform the public about the OMB Control Number’s legal significance in accordance with 5 CFR
`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. 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 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, US Patent and
`Trademark Office, US. Department of Commerce, PO. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO TIIIS ADDRESS. SEND TO: Commissioner for Patents, PO. Box
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`Privacy Act Statement
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`The Privacy Act of 1974 (PL. 93-579) requires that you be given certain information in connection with your
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`the information is used by the US. Patent and Trademark Office is to process and/or examine your submission
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`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 of Justice to determine whether disclosure of these records is required
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`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence
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`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(0)).
`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 management practices 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 from this 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 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 becomes aware of a violation or potential violation of law or regulation.
`
`lPR2020-00769
`
`United Therapeutics EX2006
`Page 8 of 7113
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`

`

`
`
`
`Application No.
`Applicant(s)
`14/849,981
`BATRA ET AL.
`532$; VALENROD
`fgggn"
`2:313?“ '"Ve"t°”° F“)
`No
`
`Notice of Allowability
`
`
`
`
`-- 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. IX This communication is responsive to ROE filed on 12/29/16.
`
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2. I] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`; the restriction
`
`3. IX The allowed claim(s) is/are 12 and 4-11. 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 PPeredback@uspto.gov.
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`*c) E] None of the:
`a) [I All
`b) [I Some
`1. I] Certified copies of the priority documents have been received.
`2. I] Certified copies of the priority documents have been received in Application No. _
`3. El Copies of the certified copies of the priority documents have been received in 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 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. I] CORRECTED DRAWINGS ( as “replacement sheets”) must be submitted.
`
`III
`
`including changes required by the attached Examiner’s Amendment / Comment or in the Office action of
`Paper No./Mai| Date
`.
`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 sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`
`6. I] 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.
`
`5. El Examiner‘s Amendment/Comment
`6. El Examiner‘s Statement of Reasons for Allowance
`
`7. X Other Continued Examination.
`
`Attachment(s)
`1. I] Notice of References Cited (PTO-892)
`2. IZI Information Disclosure Statements (PTO/SB/OB),
`
`Paper No./Mai| Date 1/10/17' 12/29/16
`3. El Examiner‘s Comment Regarding Requirement for Deposit
`of Biological Material
`4. II] Interview Summary (PTO—413),
`Paper No./Mai| Date
`/YEVGENY VALENROD/
`Primary Examiner, Art Unit 1672
`
` U 8 Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`20170125
`
`Notice of Allowability
`
`Part of Paper No./Mai| Date
`
`IPR2020-00769
`
`United Therapeutics EX2006
`Page 9 of 7113
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`
`
`
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 9 of 7113
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`

`

`Application/Control Number: 14/849,981
`Art Unit: 1672
`
`Page 2
`
`The present application is being examined under the pre-AIA 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), was filed 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 disclaimer filed 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 whose telephone 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 -572-331 1. The fax phone
`
`lPR2020-00769
`
`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 access to 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.
`
`/YEVGENY VALENROD/
`
`Primary Examiner, Art Unit 1672
`
`lPR2020-00769
`
`United Therapeutics EX2006
`Page 11 of7113
`
`IPR2020-00769
`United Therapeutics EX2006
`Page 11 of 7113
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`

`

`Receipt date: 12/29/2016
`
`Substitute for form 1449/PTO
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`14849981 w GAD: 1672
`PTO/SB/O8 modified
`
`Complete if Known
`14/849,981
`A nlication Number
`9/10/2015
`'
`'
`
`First Named Inventor
`Hitesh BATRA
`
`Art Unit
`1672
`BEE 2 9 2315
`Date Submitted:
`
`use as many sheets as necessgg)
`Examiner Name
`I Yevgeny Valenrod
`Attorney Docket Number
`080618-1581
`
`U.S. PATENT DOCUMENTS
`
`Examiner
`Initials'
`
`Document Number
`' WT Publication Date
`Name of Patentee or Applicant of
`Number—Kind Code (if
`MM-DD-YYYY
`Cited Document
`I
`
`known)
`
`Pages, Columns, Lines,
`Where Relevant
`Passages or Relevant
`1 11__f Figures Appear
`
`
`
`
`
`Examiner
`Initials“
`
`,
`
`,
`
`ForeIgn Patent Documem
`COUNTY Code Number
`Kind Code5 (If known)
`
`I
`
`>
`PublicatIon Date
`MM~DD~YYYY
`
`:
`Name of Patentee or
`:
`i Applicant of Cited Documents
`,
`
`V AirnPuangyeEColumnsLines,
`Where Relevant
`Passages or Relevant
`
`FOREIGN PATENT DOCUMENTS
`
`NON PATENT LITERATURE DOCUMENTS
`
`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.
`
`
`
`D1
`
`1
`
`D2
`
`
`
`
`
`
`
`
`Redacted Petitioner's Reply to Patent Owner‘s Response to Petition filed on September 27,
`2016 in Steadymed Ltd (Petitioner), v United Therapeutics Corporation (Patent Owner),
`”Case IPR201600006, US Patent 8,497,393, with Exhibits 1022- 1028
`Petitioners Demonstratives filed November 28 2016, in Steadymed Ltd (Petitioner), v.
`United Therapeutics Corporation (Patent Owner) Case |PR201600006 US Patent
`
`8,497,393
`Patent Owner Response to Petition filed November 23, 2016, in Steadymed Ltd. (Petitioner),
`v. United Therapeutics Corporation (Patent Owner), Case |PR2016~00006, US Patent
`8,497,393, with Redacted Exhibits 2006, 2020, 2022, 2058 and 2059 filed November 23,
`
`6 1161 pages “Mm
`
`ent OWner Demonstratives filed November 23, 2016, in Steadymed Ltd (Petitioner) v.
`United Therapeutics Corporation (Patent Owner), Case |PR2016—00006, US Patent
`
`8,497,393, 62 Haes.
`Decision Redacted Institute of Inter Paites Review dated November 23, 2016, in Steadymed
`Ltd (Petitioner), v. United Therapeutics Corporation (Patent Owner), Case IPR2016—00006,
`US Patent8, 497, 393, 53 wees
`_
`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
` A-.............. r. m, ,
`D7
`Redacted Defendant Sandoz Inc.’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 Jerse, Civil Action No 3: 14-01-5499 PGHMLHG),_96pages.
`Defendant Sandoz Inc.’ 5 invalidity Contention Chanss dated February 5, 2015 United Therapeutics
`Corporation (Plaintiff) v Sandoz Inc (Defendant) In The United States District Court for the District of
`New Jerse, Civil Action No 3: 14-cv-5499(PGH)(LHG)189paces.
`
`D3
`
`D5
`
`D8
`
`Examiner
`Signature
`4823-8067-71821
`
`
`
`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
`
`PTO/SB/OB modified
`
`
`Substitute for form 1449/PTO
`Complete if Known
`
`INFORMATION DISCLOSURE
`14/849,981
`A -Iication Number
`
`STATEMENT BY APPLICANT
`W, 9/10/2015
`
`-
`.
`Hitesh BATRA
`First Named Inventor
`“El 2 9 2MB
`Art Unit
`1672
`Date Submitted.
`
`use as many sheets as necessary)
`Examiner Name
`Attorney Docket Number
`
`080618-1581
`
`_
`E
`ln’i‘gflge'
`
`’
`
`D9
`
`D10
`
`Include name of the author (in CAPITAL LE'I'I'ERS), 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, 33

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