`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`USCETED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademart(ifice
`Adtes: COMMISSIONER FOR PATENTS
`PO. Bow 145)
`Alexamthia, Virginia 22314-1450
`(ew USpi pov
`
`
`
`1672
`
`REQUESTID
`
`102656
`
`APPLICATION NUMBER
`
`PATENT NUMBER
`
`GROUP ART UNIT
`
`14/849,98]
`
`9593006
`
`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 166905is:
`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 I am:
`
`An attorney or Agent of Record registered to practice before the Patent and Trademark Office who has been given
`powerof attorney in this application
`
`Registration Number:
`aepenB.Mashin
`
`Liquidia - Exhibit 1006 - Page 1
`
`Liquidia - Exhibit 1006 - Page 1
`
`

`

`
`
`Unrrep STATES PATENT AND TRADEMARK OPFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address COMMISSIONER FOR PATENTS.
`P.O Bex J450)
`Alewandria, Vinginta 22313-1450
`rtESptcry
`
`APPLICATION NO.
`ISSUE DATT.
`PATENT NO.
`ATTORNEY DOCKET NO,
`CONFIRMATION NO.
`
`14/349.981
`03/14/2017
`9593066
`OROG18-1581
`6653
`
`22428
`
`7590)
`
`OR?
`
`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 Adjustmentis 0 day(s). Any patent to issue from the above-identified application will include
`an indication of the adjustment onthe front page.
`
`If a Continued Prosecution Application (CPA) wasfiled in the above-identified application, the filing datethat
`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://pairuspto.goy lor additional applicants):
`
`Hitesh BATRA, Hemdon, VA;
`United Therapeutics Corporation, Silver Spring, MD;
`Sudersan M, TULADITAR, Silver Spring, MD;
`Raju PENMASTA, [lemdon, 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 yourbusiness, visit SelectUSA. gov.
`
`TR103 (Rev. LOO)
`
`Liquidia - Exhibit 1006 - Page 2
`
`Liquidia - Exhibit 1006 - Page 2
`
`

`

`
`
`UNrrepD STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENTOF COMMERCE
`United States Patent and Trademark Office
`Addins: COMMISSIONER FOR PATENTS
`PO Bom i450
`Alexandria, Virginia 22315-1450
`wwwluEplo. gov
`
`NOTICE OF ALLOWANCEAND FEE(S) DUE
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`
`WASHINGTON, DC 20007-5109
`
`EXAMINER
`
`VALENROD, YEVGENY
`
`1672
`
`DATE MAILED: 01/30/2017
`
` APPLICATION NO.
`
`Hitesh BATRA
`OO/LO/2015
`14/849,981
`TITLE OF INVENTION; PROCESS TO PREPARE TREPROSTINIL. THE ACTIVE INGREDIENT [IN REMODULING
`
`O80618-1581
`
`6653
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`
`
`
`
`
`
` APPLN. TYPE PUBLICATION FEE DUE|PREV, PAID ISSUR FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`nonprovisional
`UNDISCOUNTED
`$960
`50
`80
`$960
`OS5/01/2017
`
`
`
`
`
`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 GRANTOF PATENTRIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROMISSUE AT THI INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITLUN THREE MONTOS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATU
`(PE
`"
`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 THE ISSUE FEE NOW
`DUE.
`
`1tOW TO REPLYTO THIS NOTICE:
`
`L Review the ENTITY STATUS shown above. Ifthe ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`Ifthe ENTITY STATUS is the same as shown above, pay the TOTAL PEER(S) DUE shown above.
`Ifthe ENTITY STATUS ts changed from that shown aboye, on PART B - FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (fromstatus indicated above)".
`For purposesofthis notice, small entity fees are 1/2 the amount of undiscounted fees, and micro entity fees are 1/2 the amount of small entily
`lees.
`
`IL. PART B - FEE(S) TRANSMITTAL, or its equivalent, must be completed and returned to the United States Patent and Trademark Office
`
`of Part B - Pee(s) Transmittal should be completed and an extra copy of the form should be submitted. [fan 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.
`
`UL, All communications regarding this application must give the application number. Please direci 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
`maintenance fees. It is patentee's responsibility to ensure timely payment of maintenancefees when due,
`
`PTOL-85 (Rev. (2/11)
`
`Page 1 of 3
`
`Liquidia - Exhibit 1006 - Page 3
`
`Liquidia - Exhibit 1006 - Page 3
`
`

`

`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 |
`
`appropriate. All further correspondence including the Patent, advance orders
`and notification of maintenance fees will be mailed to the current correspondence address us
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a newcorrespondence address; and/or (b) indicating a separate "PEE ADDRESS" for
`maintenance fee notifications.
`
`CURRENT CORRESPONDENCE ADDRESS (Note; Use Block 1 for any change of address!
`
`Tn
`> ee
`Foley &Lardner LLP
`3000 K STREETN.W.
`2
`SUITE 600
`
`BiBAeD
`
`Note: A certificale of mailing ean only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any olher accompanying
`aipers. Each additional paper, such as an ussigament or formal drawing, must
`fave its own ecrtificate of mailing or transmission,
`Certificate of Mailing or Transmission
`L hereby certily that this Pee(s) Transmittal is being deposited. with the United
`States Postal Service with sufficientpostage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimule
`transmitted to the USPTO (371) 273-2885, on the date indicated below.
`
`SPAS HINGCTON, 1 200k 4109
`
` APPLICATION NO;
`
`Hitesh BATRA
`OO/ 102015
`14/849,98 |
`TITLE OF INVENTION: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE INGREDIENT IN REMODULIN®
`
`080618-1581
`
`6653
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO:
`
`CONFIRMATION NO
`
`
`
`
`
`
`
`
`
`
`
`AFPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTALFEES) DUE DATE DUE
`
`
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`50
`
`50
`
`5960
`
`OS/AL/2017
`
` EXAMINER
`
`ART UNIT
`
`1672
`
`CLASS-SUBCLASS
`
`562166000
`
`VALENROD, YEVGENY
`
`2. Por printing on the patent front page, list
`fahaeeot correspondence address or indication of "Pee Address” (37
`CFR
`1.363).
`(1) The names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`LY Change of correspondence address (or Change of Correspondence
`Address form PTO/SE/122) attached,
`(2) The name ofa single firm (having as a member a
`(1 "Fee Address” indication (or "Fee Address” Indication form
`registered attorney or agent) and the names of up to
`2 registered patent altorneys or agents. Lf no name is
`PPO/SBAT, Rev 03-02 ar nore recent) attached. Use ofa Customer
`listed, no name will be printed.
`Number is required.
`_ ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT(print or type)
`If an assignee is identihed below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below. oo assignee data will appear on the patent.
`recordation a§ set forth in 37 CPR 3.11, Completion of this form ig NOT a substitute for filing an assignment,
`(A) NAMEOF ASSIGNEE
`(6) RESIDENCE: (CITYand STATE OR COUNTRY)
`
`
`
`=
`
`l
`
`3
`:
`
`Le
`
`(individual Corporation or other private group entity L) Government
`Please check the appropriate assignee categoryor categories (will not be printed onthe patent):
`du. The following fee(s) are submitted:
`4b. Payment of Pee(s): (Please first reapply any previously paid issue fee shown above)
`Issue Fee
`LIA check is enclosed.
`C) Publication Fee (Nosmall entity discount permitted)
`O Payment by credit card. Porm PTO-2038 ts attached.
`Qj Advance Order - # ofCopies
`ithe directoris hereby authorized tocharge the required fee(s), any defieiency. or credils any
`overpayment, to Deposit Account Number _ fenclose an extea copy of this form),
`
`
`5. Change in Entity Status (from status indicated above)
`Applicant certifying micro entity status. See 37 CPR 129
`
`NOTE: Absent u valid certification of Micro Entity Status (see forms PTO/SB/15A and 153), issue
`fee payment in the micro entity amount will not be accepted al the risk ofapplication abandonment
`NOTE: If the application was previously under microentity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this bos will be taken (tobe a notification ofloss of entitlement to small or micro
`entity status. as applicable.
`NOTE: This form must be signed in accordance with 37 CPR LAL and 1.33. See 37 CPR LA forsignature requirements and certifications.
`
`
`Q Applicant asserting small entily status. See 37 CPR 1.27
`
`J Applicant changing to regular undiscounted fee status.
`
`
`
`Authorized Signature
`
`Date
`
`Typed or printed name
`Registration No.
`
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013,
`
`OMB 0651-0033
`
`U.S. Patent and ‘Trademark Office; U.S, DEPARTMENT OF COMMERCE
`
`Page 2 of 3
`
`Liquidia - Exhibit 1006 - Page 4
`
`Liquidia - Exhibit 1006 - Page 4
`
`

`

`
`
`UnNrreD STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENTOF COMMERCE
`United States Patent and Trademark Office
`Address: unORE FOR PATENTS
`Alexandria, Virginia 22315-1450
`wwusplo. coy
`
`
`
`FILING DATE ATTORNEY DOCKET NO.|CONFIRMATION NO.FIRST NAMED INVENTOR
`
`
`
` APPLICATION NO.
`
`14/849,98 1
`
`OOLO/2015
`
`Hitesh BATRA
`
`O8001 8-158]
`
`6653
`
`(a0)
`
`7590
`20498
`Foley & Lardner LLP
`3000 K STREETN.W.
`SUITE: 600
`WASHINGTON, DC 20007-5109
`
`EARNER
`VALENROD, YEVGENY
`
`1672
`
`DATE MAILED: 01/30/2017
`
`Determination of Patent Term Adjustment under 35 U,S.C. 154 (b)
`(Applicationsfiled 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 CustomerService Centerof the Office of Patent Publication at 1-(888)-786-0101 or (571)-272-4200.
`
`PTOL-85 (Rev. (2/11)
`
`Page 3 of 3
`
`Liquidia - Exhibit 1006 - Page 5
`
`Liquidia - Exhibit 1006 - Page 5
`
`

`

`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
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`The information collected by PTOL-85 Part B is required by 37 CPR 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
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`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
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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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`The information provided by you in this form wall be subject to the following routine uses:
`L. The information on this form will be treated confidentially to the extent allowed under the Freedomof
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`2. Arecord fromthis system of records may be disclosed, as a routine use, in the course of presenting evidence
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`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
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`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
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`responsibility to recommend improvements in records management practices and programs, under authority
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`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
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`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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`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 oflaw or regulation.
`
`Liquidia - Exhibit 1006 - Page 6
`
`Liquidia - Exhibit 1006 - Page 6
`
`

`

` Application No.
`Notice of Allowability
`aed sekcenaes
`Seones VOI TEA)
`
`Applicant(s)
`BATRA ET AL.
`
`14/849,981
`
` No
`
`«- 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 PATENT RIGHTS. This application is subject to withdrawal ftom issue at theinitiative
`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`
`|, & This communication is responsive to ACEfiled on 12/29/16.
`(-] A declaration(s)/affidavit(s) under 87 CFR 1.130(b) was/werefiled on
`
`_
`
`; the restriction
`2. (J An election was made by the applicant in responsetoarestriction requirement set forth during the interview on
`requirement and election have been incorporated into this action.
`
`3. EJ The allowed claim(s)is/are 1,2 and 4-11. As a result of the allowed claim(s), you may beeligible to benefit from the Patent
`Prosecution Highway program at a participatingintellectual property office for the corresponding application. For more information,
`please see hitp://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto,gov,
`
`4, 1 Acknowledgmentis madeof a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or(f),
`Certified copies:
`*c) (1) Noneofthe:
`a)C All
`=b)[])Some_
`1. 0 Certified copies of the priority documents have been received.
`2. (] Certified copies of the priority documents have been received in Application No.
`3. C1 Copies ofthe certified copies of the priority documents have been received jn 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 ABANDONMENTofthis application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5, [] CORRECTED DRAWINGS( as “replacement sheets”) must be submitted,
`(1 including changes required by the attached Examiner's Amendment / Commentorin the Office action of
`Paper No,/Mail Date
`;
`Identifying indicia such as ihe 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 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 commentregarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL
`
`Attachment(s)
`1. DJ Notice of References Cited (PTO-892)
`2. BX Information Disclosure Statements (PTO/SB/08),
`Paper No./Mail Date 1/10/17; 12/29/16
`3. (1) Examiner's Comment Regarding Requirementfor Deposit
`of Biological Material
`4. 1] interview Summary (PTO-413),
`Paper No./Mail Date
`:
`/YEVGENY VALENROD/
`
`5. Examiner's Amendment/Comment
`6. (J Examiner's Statement of Reasons for Allowance
`
`7. 4 Other Continued Examination.
`
`Primary Examiner, Art Unit 1672 US Patent and Trademark Office
`
`PTOL-37 (Rey. 08-13)
`20170125
`
`Notice of Allowability
`
`Part of Paper No./Mail Date
`
`Liquidia - Exhibit 1006 - Page 7
`
`Liquidia - Exhibit 1006 - Page 7
`
`

`

`Application/Control Number; 14/849.981
`Art Unit: 1672
`
`Page 2
`
`The present application 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, thefinality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissionfiled 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.
`
`Anyinquiry concerning this communication or earlier communications from the
`
`examiner should be directed to YEVGENY VALENROD whosetelephone numberis
`
`(571)272-9049. The examiner can normally be reached on mon-fri 8-4:30.
`
`lf 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
`
`Liquidia - Exhibit 1006 - Page 8
`
`Liquidia - Exhibit 1006 - Page 8
`
`

`

`Application/Control Number: 14/849.981
`Art Unit: 1672
`
`Page 3
`
`numberfor 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
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`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.
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`For more information about the PAIR system, see hitp://pair-direct.uspto.gov. Should
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`you have questions on accessto the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/YEVGENY VALENROD/
`Primary Examiner, Art Unit 1672
`
`Liquidia - Exhibit 1006 - Page 9
`
`Liquidia - Exhibit 1006 - Page 9
`
`

`

`PTO/SB/08 (modified Substitute for form 1449/PTO
`
`
`b
`
`ite
`
`U.S. PATENT DOCUMENTS
`Pages, Columns, Lines,
`Where Relevant
`Name of Patentee or Applicant of
`ee Publication Date
`Examiner
`Passagesor Relevant
`Cited Document
`Number-Kind Code(it
`MM-DD-YY¥Y
`.
`Initials*
`Figures Appear
`known)
`
`
`
`
`
`Receipt date: 12/29/2016
`
`14849981 ~— GAD: 1672
`
`Complete if Known
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`Hitesh BATRA
`Piste Bibiinied
`
`use as many sheets as necessary)
`Examiner Name
`Yevgeny Valenrod
`Attorney Docket Number
`080618-1581
`
`number(s), publisher, city and/or country where published.
`
`
`
`
`
`
`
` FOREIGN PATENT DOCUMENTS
`|
`}
`.
`|
`Pages, Columns, Lines,
`Examiner|Cite | Foreign PatentDocument_|Publication Date Nameof Patentee or Where Relevant
`
`
`| No.’
`|
`Country Code*Number™
`Passagesor Relevant
`initiatis*
`MM-DD-YYYY¥
`Applicant of Cited Documents
`|
`|
`Kind Code? (if known
`|
`Figures Appea
`
`
`Examiner
`Initials*
`
`| Cite
`No.’
`
`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
`
`NON PATENT LITERATURE DOCUMENTS
`
`D1
`
`D2
`
`Redacted Petitioner's Reply to Patent Owner's Responseto Petition filed on September 27,
`2016 in Steadymed Ltd. (Petitioner), v. United Therapeutics Corporation (Patent Owner),
`| Case IPR2016-00006, US Patent6,497,393, with Exhibits 1022-1028.
`Petitioner's Demonstratives filed November 28, 2016, in Steadymed Lid. (Petitioner), v.
`United Therapeutics Corporation (Patent Owner), Case IPR2016-00006, US Patent
`
`||} 8497393
`—_
`-
`D3
`Patent Owner Responseto Petition filed November 23, 2016, in Steadymed Ltd. (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,
`2016, 1151 pages.
`Patent 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 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.
`te5,
`nl
`a:
`Service copy of Third Party Submission dated October 16, 2016,filed but not entered in US
`[
`14/849,981 on October 16, 2016, with 6 indicated attachments, 822 pages.
`
`D4
`
`D5
`
`D6
`
`oO=
`
`D8
`
`7
`
`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 NewJersey, 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), |n The United States District Court for the District of
`_New Jersey, Civil Action No. 3:14-cv-5499(PGH)(LHG), 189 pages.
`
`Examiner
`Signature
`
`4823-8067-7182.1
`
`| Date
`| Considered
`
`|
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/Y.V/
`
`Liquidia - Exhibit 1006 - Page 10
`
`Liquidia - Exhibit 1006 - Page 10
`
`

`

`Receipt date: 12/29/2016
`
`14849981 - GAU:
`
`1672
`
`PTO/SB/08 (modified
`
`Substitute for form 1449/PTO
`
`
`14/849,981
`9/10/2015
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Application Number
`
` Complete if Known
`
`Date Submitted:
`
`DEI 2 9 POI
`
`12~——sdfof13~—S—SsS@ Attorney Docket Number|080618-1581
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials’
`
`| No,’
`
`| 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
`| Laboratores 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|particularlypages 18-20, 42-62 and 269-280). 2 |
`
`| D
`
`
`
`
`Exhibit G, Invalidity Claim Chartforthe ‘393 patent, January 12, 2015, 66 pages.
`
`D10
`
`
`
`efendant Teva Pharmaceuticals USA, Inc.'s Amended Non-Infringement and Invalidity Contentions,
`dated April 24, 2015, United Therapeutics Corporation (Plaintiff) v. Teva Pharmaceuticals USA,Inc.
`(Defendant), In The United States District Court for the District of New Jersey, Civil Action No, 3:14-
`
`cv-05498(PGS)(LHG), 94 pages, (see particularly pages 22-54).
`D12)|Arumugan et al., “A New Purification Process for Pharmaceutical and Chemical (ndustries," Organic
`|
`Process Research & Development, 2005, 9:319-320.
`
`| D13|Burk et al., “An Enantioselective Synthesis of(S)-(+)-3-Aminomethyl-5-methyihexanoic Acid via
`Asymmetric Hydrogenation,” J, Org. Chem,, 2003, 68:5731-5734.
`
`'D14|Eliel et al., Stereochemistry of Organic Compounds, 1904, 322-325. .°~—~*#
`
`
`
`| D15|Harwoodet al., Experimental organic chemistry: Principles and Practice, 1989, 127-134.
`
`Di6é|Jones, Maitland Jr.,OrganicChemistry, 2 Ed,, 2000, 153-155. |
`
`
`
`| '
`
`| D17|Lin etal., “Benzindene Prostaglandins. Synthesis of Optically Pure 15-Deoxy-U-68,215 and Its
`Enantiomervia a Modified Intramolecular Wadsworth-Emmons-Wittig Reaction," J. Org. Chem.,
`
`|
`_ 1987, 52:5594-5601.
`D1i8|McManus et al., “Tetrazole Analogs of Plant Auxins,” J. Org. Chem., 1959, 24:1464-1467.
`
`D139|Monson,Richard S., Advanced Organic Synthesis, Methods and Techniques, 1971, 178-188.
`
`
`
`
`D20|Ohno et al., "Development of Dual-Acting Benzofurans for Thromboxane A2 Receptor Antagonist and
`Prostacyclin Receptor Agonist: Synthesis, Structure-Activity Relationship, and Evaluation of
`
`| Benzofuran Derivatives,” J. Med.Chem,, 2005, 48:5279-5294.0 -
`D21
`| Olmsted Ill et al., Chemistry, The Molecular Science, Mosby-Year Book, Inc., Chapter 10 “Effects of
`Intermolecular Forces,” 1994, 428-486,
`
`bi D22|Pavia et al., Introduction to Organic Laboratory Techniques,First Edition, 1998, 648.
`
`
`“2
`al
`=
`—
`—_——
`bn
`D23|Physicians’ Desk Reference, 59 Edition, 2005, for Bicillin® L-A (penicillin G benzathine suspension),
`5 pages.
`
`phenylpropyl)piperazine (GBR 12909): High Affinity Ligands for the Dopamine Transporter," J. Med.
`Chem., 2002, 45:4371-4374.
`
`l D24|Priscinzano et al., “Piperidine Analoguesof 1-[2-[Bis(4-fluoropheny!)methoxy]ethyl]-4-(3- j
`
`|
`
`Examiner
`Signature
`4823-8067-7 182.1
`
`
`
`| Date
`| Considered
`
`|
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/Y.V/
`
`Liquidia - Exhibit 1006 - Page 11
`
`Liquidia - Exhibit 1006 - Page 11
`
`

`

`Receipt date: 12/29/2016
`
`14849981 ~ GAU: 1672
`PTO/SB/08 (modified
`
`Complete if Known
`Substitute for form 1449/PTO
`
`14/849 987
`Application Number
`INFORMATION DISCLOSURE
`
`FilingDate
`9/10/2015
`STATEMENT BY APPLICANT
`First Named Inventor
`Hitesh BATRA
`itted:
`9
`t
`aia
`caer
`Date Submitted
`9 2016
`
`_(use as many sheets as necessary) Examiner Name Yevgeny Valenrod
`
`Sheet
`Attorney Docket Number
`080618-1581
`
`| Wiberg, Laboratory Technique in Organic Chemistry, 1960, 112.
`
`
`
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`Initials*
`
`|
`
`Include name ofthe author (in CAPITAL LETTERS), title of the article (wnen 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 publish