throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMIVEERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 223 1 3- 1450
`www.uspto.gov
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10716793
`
`080618—1916
`
`4471
`
`APPLICATION NO.
`
`16/778,662
`
`ISSUE DATE
`
`07/21/2020
`
`166905
`
`7590
`
`06/30/2020
`
`Foley & Lardner LLP
`3000 K Street NW.
`Suite 600
`
`Washington, DC 20007-5109
`
`ISSUE NOTIFICATION
`
`The projected patent number and issue date are specified above.
`
`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.uspto. gov for additional applicants):
`
`Horst OLSCHEWSKI, Graz, AUSTRIA;
`United Therapeutics Corporation, Siliver Spring, MD;
`Robert ROSCIGNO, Chapel Hill, NC;
`Lewis J. RUBIN, LaJolla, CA;
`Thomas Schmehl, Giessen, GERMANY, Deceased;
`Werner SEEGER, Giessen, GERMANY;
`Carl STERRITT, Weybridge, UNITED KINGDOM;
`Robert VOSWINCKEL, Giessen, GERMANY;
`
`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.gov.
`IR103 (Rev. 10/09)
`
`Liquidia's Exhibit 1015
`Page 1
`
`Liquidia's Exhibit 1015
`Page 1
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`AddIESS. COMMISSIONER FOR PATENTS
`PO Box 1450
`Alexandria, ViJgLnia 22313-1450
`wwwusptogov
`
`APPLICATION
`NUMBER
`
`FILING or
`371(0) DATE
`
`GRP ART
`UNIT
`
`
`
`
`
`F
`
`16/778,662
`
`01/31/2020
`
`1629
`
`FEE REC'D
`
`1720
`
`166905
`
`SSBGJféSLZTeNIttP
`
`Suite 600
`
`Washington, DC 20007-5109
`
`ATTY.DOCKET.NO
`
`080618-1916
`
`TOT CLAHVIS IND CLAIMS
`8
`1
`
`CONFIRMATION NO. 4471
`
`CORRECTED FILING RECEIPT
`
`lllllllll lllllllllllltlllllwlll11111111111111 lllllllllllll
`
`Date Mailed: 06/18/2020
`
`Receipt is acknowledged of this non-provisional utility patent application. The application will be taken up for
`examination in due course. Applicant will be notified as to the results of the examination. Any correspondence
`concerning the application must include the following identification information: the US. APPLICATION NUMBER,
`FILING DATE, NAME OF FIRST INVENTOR, and TITLE OF INVENTION. Fees transmitted by check or draft are
`subject to collection.
`
`Please verify the accuracy of the data presented on this receipt. If an error is noted on this Filing Receipt, please
`submit a written request for a corrected Filing Receipt, including a properly marked-up ADS showing the changes
`with strike-through for deletions and underlining for additions. If you received a "Notice to File Missing Parts" or
`other Notice requiring a response for this application, please submit any request for correction to this Filing Receipt
`with your reply to the Notice. When the USPTO processes the reply to the Notice, the USPTO will generate another
`Filing Receipt incorporating the requested corrections provided that the request is grantable.
`
`lnventor(s)
`
`Horst OLSCHEWSKI, Graz, AUSTRIA;
`Robert ROSCIGNO, Chapel Hill, NC;
`Lewis J. RUBIN, LaJolla, CA;
`Thomas Schmehl, Giessen, GERMANY, Deceased;
`Werner SEEGER, Giessen, GERMANY;
`Carl STERRITT, Weybridge, UNITED KINGDOM;
`Robert VOSWINCKEL, Giessen, GERMANY;
`
`Applicant(s)
`
`United Therapeutics Corporation, Siliver Spring, MD;
`Assignment For Published Patent Application
`United Therapeutics Corporation, Silver Spring, MD
`
`Power of Attorney: The patent practitioners associated with Customer Number 166905
`
`Domestic Priority data as claimed by applicant
`This application is a CON of 16/536,954 08/09/2019
`which is a CON of 15/011,999 02/01/2016 PAT 10376525
`which is a DIV of 13/469,854 05/11/2012 PAT 9339507
`which is a DIV of 12/591 ,200 11/12/2009 PAT 9358240
`which is a CON of 11/748,205 05/14/2007 ABN
`which claims benefit of 60/800,016 05/15/2006
`
`page 1 of 4
`
`Liquidia's Exhibit 1015
`Page 2
`
`Liquidia's Exhibit 1015
`Page 2
`
`

`

`Foreign Applications for which priority is claimed (You may be eligible to benefit from the Patent Prosecution
`Highway program at the USPTO. Please see http://www.uspto.gov for more information.) - None.
`Foreign application information must be provided in an Application Data Sheet in order to constitute a claim to
`foreign priority. See 37 CFR 1.55 and 1.76.
`
`Permission to Access Application via Priority Document Exchange: No
`
`Permission to Access Search Results: No
`
`Applicant may provide or rescind an authorization for access using Form PTO/SB/39 or Form PTO/SB/69 as
`appropriate.
`
`If Required, Foreign Filing License Granted: 06/17/2020
`
`The country code and number of your priority application, to be used for filing abroad under the Paris Convention,
`is US 16/778,662
`
`Projected Publication Date: Not Applicable
`
`Non-Publication Request: No
`
`Early Publication Request: No
`Title
`
`TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Preliminary Class
`
`514
`
`Statement under 37 CFR 1.55 or 1.78 for NA (First Inventor to File) Transition Applications: No
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`Since the rights granted by a US. patent extend only throughout the territory of the United States and have no
`effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent
`in a specific country or in regional patent offices. Applicants may wish to consider the filing of an international
`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
`effect as a regular national patent application in each PCT-member country. The PCT process simplifies the filing
`of patent applications on the same invention in member countries, but does not result in a grant of "an international
`patent" and does not eliminate the need of applicants to file additional documents and fees in countries where patent
`protection is desired.
`
`Almost every country has its own patent law, and a person desiring a patent in a particular country must make an
`application for patent in that country in accordance with its particular laws. Since the laws of many countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from specific
`foreign countries to ensure that patent rights are not lost prematurely.
`
`Applicants also are advised that in the case of inventions made in the United States, the Director of the USPTO must
`issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. patent application
`serves as a request for a foreign filing license. The application's filing receipt contains further information and
`guidance as to the status of applicant's license for foreign filing.
`
`page 2 of 4
`
`Liquidia's Exhibit 1015
`Page 3
`
`Liquidia's Exhibit 1015
`Page 3
`
`

`

`Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specifically, the
`section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/general/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may wish
`to consult the US. Government website, http://www.stopfakes.gov. Part of a Department of Commerce initiative,
`this website includes self-help "toolkits" giving innovators guidance on how to protect intellectual property in specific
`countries such as China, Korea and Mexico. For questions regarding patent enforcement issues, applicants may
`call the US. Government hotline at 1-866-999-HALT (1-866-999-4258).
`
`LICENSE FOR FOREIGN FILING UNDER
`
`Title 35, United States Code, Section 184
`
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`GRANTED
`
`if the phrase "IF REQUIRED, FOREIGN FILING
`The applicant has been granted a license under 35 U.S.C. 184,
`LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where
`the conditions for issuance of a license have been met, regardless of whether or not a license may be required as
`set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier
`license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The
`date indicated is the effective date of the license, unless an earlier license of similar scope has been granted under
`37 CFR 5.13 or 5.14.
`
`This license is to be retained by the licensee and may be used at any time on or after the effective date thereof unless
`it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR 1.53(d). This
`license is not retroactive.
`
`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject matter
`as imposed by any Government contract or the provisions of existing laws relating to espionage and the national
`security or the export of technical data. Licensees should apprise themselves of current regulations especially with
`respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls, Department of
`State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of Industry and
`Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign AssetsControl, Department of
`Treasury (31 CFR Parts 500+) and the Department of Energy.
`
`NOT GRANTED
`
`No license under 35 U.S.C. 184 has been granted at this time, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" DOES NOT appear on this form. Applicant may still petition for a license under 37 CFR 5.12,
`if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months has lapsed
`from the filing date of this application and the licensee has not received any indication of a secrecy order under 35
`U.S.C. 181, the licensee may foreign file the application pursuant to 37 CFR 5.15(b).
`
`
`page 3 of 4
`
`Liquidia's Exhibit 1015
`Page 4
`
`Liquidia's Exhibit 1015
`Page 4
`
`

`

`SelectUSA
`
`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 U.S. offers tremendous resources
`and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation works to
`promote and facilitate business investment. SelectUSA provides information assistance to the international investor
`community; serves as an ombudsman for existing and potential investors; advocates on behalf of U.S. cities, states,
`and regions competing for global investment; and counsels US. economic development organizations on investment
`attraction best practices. To learn more about why the United States is the best country in the world to develop
`technology, manufacture products, deliver services, and grow your business, visit http://www.SelectUSA.gov or call
`+1 -202-482—6800.
`
`page 4 of 4
`
`Liquidia's Exhibit 1015
`Page 5
`
`Liquidia's Exhibit 1015
`Page 5
`
`

`

`
`
`Foley & Lardner LLP
`3000 K Street NW.
`S SSS
`
`Washington, DC 20007-5109
`
`UNITED STATES DEPARTMENT OF COM1VIERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`SCHMITT, MICHAEL]
`
`1629
`DATE MAILED: 06/12/2020
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`16/778,662
`
`01/31/2020
`
`Horst OLSCHEWSKI
`
`080618-1916
`
`4471
`
`TITLE OF INVENTION: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PALD ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$ 1000
`
`$0.00
`
`$0.00
`
`$1000
`
`09/ 14/2020
`
`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 FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE MAILING
`
`DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED. THIS STATUTORY PERIOD
`CANNOT BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES NOT REFLECT A CREDIT
`FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION. IF AN ISSUE FEE HAS PREVIOUSLY BEEN PAID IN
`
`THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM WILL BE CONSIDERED A REQUEST
`TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE 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 or 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 entity fees are 1/2 the amount of small entity
`fees.
`
`11. 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.
`
`111. A11 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: Maintenance fees are due in utility patents issuing on applications filed on or after Dec. 12, 1980.
`It is patentee‘s responsibility to ensure timely payment of maintenance fees when due. More information is available at
`WWW.uspto.gov/PatentMaintenanceFees.
`
`Page 1 of 3
`
`PTOL-SS (Rev. 02/11)
`
`Liquidia's Exhibit 1015
`Page 6
`
`Liquidia's Exhibit 1015
`Page 6
`
`

`

`Complete and send this form, together with applicable fee(s), by mail or fax, or via EFS-Web.
`
`PART B - FEE(S) TRANSMITTAL
`
`By mail, send to:
`
`Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`
`By fax, send to:
`
`(571)-273-2885
`
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1 through 5 should be completed where 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 maintenance fee notifications.
`Note: A certificate of mailing can only be used for domestic mailings of the
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`papers. Each additional paper, such as an assignment or formal drawing, must
`have its own certificate of mailing or transmission.
`Certificate of Mailing 0r Transmission
`
`166905
`
`7590
`
`06/12/2020
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change of address)
`
`1:0le & Lardner LLP
`3000 K Street N.W.
`Suite 600
`
`Washington, DC 20007-5109
`
`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 FEE address above, or being transmitted to
`the USPTO via EFS-Web or by facsimile to (571) 273-2885, on the date below.
`
`(Signature) (Date)
`
`(Typed or primed name)
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`16/778,662
`
`01/31/2020
`
`Horst OLSCHEWSKI
`
`080618-1916
`
`4471
`
`TITLE OF INVENTION: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$ 1000
`
`$0.00
`
`$0.00
`
`$1000
`
`09/ 14/2020
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUBCLASS
`
`SCHMITT, MICHAEL J
`
`1629
`
`514-569000
`
`1. Change of correspondence address or indication of ”Fee Address” (37
`CFR 1.363).
`
`3 Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/ 122) attached.
`
`
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`or agents OR, alternatively,
`(2) The name of a single firm (having as a member a
`registered attorney or agent) and the names of up to
`2 registered patent attorneys or agents. If no name is
`listed, no name will be printed.
`
`
`
`
`
`1
`
`2
`
`
`
`
`
`3 ”Fee Address” indication (or ”Fee Address” Indication form PTO/
`SB/47; Rev 03-09 or more recent) attached. Use of a Customer
`\Iumber is required.
`3. ASSIGNEE NAME AND RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent. If an assignee is identified below, the document must have been previously
`recorded, or filed for recordation, as set forth in 37 CFR 3.11 and 37 CFR 3.81(a). Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE: (CITY and STATE OR COUNTRY)
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) : D Individual D Corporation or other private group entity D Government
`
`DAdvance Order - # of Copies
`DPublication Fee (if required)
`DIssue Fee
`4a. Fees submitted:
`4b. Method of Payment: (Please first reapply any previously paidfee shown above)
`
`3 Electronic Payment via EFS-Web
`
` :I The Director is hereby authorized to charge the required fee(s), any deficiency, or credit any overpayment to Deposit Account No.
`
`D Enclosed check
`
`D Non-electronic payment by credit card (Attach form PTO-2038)
`
`5. Change in Entity Status (from status indicated above)
`
`3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`NOTE: Absent a valid certification of Micro Entity Status (see forms PTO/SB/ 15A and 15B), issue
`fee payment in the micro entity amount will not be accepted at the risk of application abandonment.
`NOTE: If the application was previously under micro entity status, checking this box will be taken
`to be a notification of loss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification of loss of entitlement to small or micro
`entity status, as applicable.
`NOTE: This form must be signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 1.4 for signature requirements and certifications.
`
`Date
`
`Registration No.
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
` 3 Applicant changing to regular undiscounted fee status.
`
`Authorized Signature
`
`Typed or printed name
`
`PTOL—SS Part B (08-18) Approved for use through 01/31/2020
`
`Page 2 of 3
`OMB 0651-0033
`
`.
`.
`,
`.
`.
`.
`US. Patent and Trademark Office; blgldlfilflfiixfiiéhdrlbdwfiw
`Page 7
`
`Liquidia's Exhibit 1015
`Page 7
`
`

`

`
`
`UNITED STATES DEPARTMENT OF COMIVIERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`16/778,662
`
`01/31/2020
`
`Horst OLSCHEWSKI
`
`080618-1916
`
`4471
`
`Foley & Lardner LLP
`3000 K Street NW.
`6 666
`
`Washington, DC 20007-5109
`
`SCHMITT, MICHAEL]
`
`1629
`DATE MAILED: 06/12/2020
`
`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.
`
`Section 1(h)(2) of the AIA Technical Corrections Act amended 35 U.S.C. 154(b)(3)(B)(i) to eliminate the requirement
`
`that the Office provide a patent term adjustment determination with the notice of allowance. See Revisions to Patent
`
`Term Adjustment, 78 Fed. Reg. 19416, 19417 (Apr. 1, 2013). Therefore, the Office is no longer providing an initial
`
`patent term adjustment determination with the notice of allowance. The Office will continue to provide a patent term
`
`adjustment determination with the Issue Notification Letter that is mailed to applicant approximately three weeks prior
`
`to the issue date of the patent, and will include the patent term adjustment on the patent. Any request for reconsideration
`
`of the patent term adjustment determination (or reinstatement of patent term adjustment) should follow the process
`outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`
`Patent Legal Administration at (571)—272—7702. Questions relating to issue and publication fee payments should be
`
`directed to the Customer Service Center of the Office of Patent Publication at 1—(888)—786—0101 or (571)—272—4200.
`
`PTOL-SS (Rev. 02/11)
`
`Page 3 of 3
`
`Liquidia's Exhibit 1015
`Page 8
`
`Liquidia's Exhibit 1015
`Page 8
`
`

`

`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 (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 30 minutes to complete, including
`gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon
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`
`Privacy Act Statement
`
`The Privacy Act of 1974 (PL. 93-579) requires that you be given certain information in connection with your
`submission of the attached form related to a patent application or patent. Accordingly, pursuant to the 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 Trademark Office may not
`be able to process and/or examine your submission, which may result in termination of proceedings or abandonment
`of the application or expiration of the patent.
`
`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 by the
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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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`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 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 FederalLWjédtfl'SaEXhat-bit 1015
`enforcement agency, if the USPTO becomes aware of a violation or potential violation of law or regulation. Page 9
`
`Liquidia's Exhibit 1015
`Page 9
`
`

`

`,
`
`, ,
`
`16/778,662
`
`OLSCHEWSKI etal.
`
`MICHAEL J SCHMITT
`
`1629
`
`N0
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 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.. This communication is responsive to 5/15/2020.
`
`[:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`restriction requirement and election have been incorporated into this action.
`
`; the
`
`3.. The allowed c|aim(s) is/are fl . As a result of the allowed c|aim(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.
`
`4C] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119( )-(d) or (f).
`
`Certified copies:
`
`a) DAII
`
`b) CI Some
`
`*c) D None of the:
`
`1. D Certified copies of the priority documents have been received.
`2. [:1 Certified copies of the priority documents have been received in Application No.
`
`3. CI 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( )).
`
`* 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:I CORRECTED DRAWINGS (as “replacement sheets“) must be submitted.
`C]
`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).
`
`6C] 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.
`
`Supervisory Patent Examiner, Art Unit 1629
`
`Attachment(s)
`1.[:] Notice of References Cited (PTO-892)
`
`2D Information Disclosure Statements (PTO/SB/08),
`Paper No./Mai| Date
`3.I:| Examiner's Comment Regarding Requirement for Deposit
`of Biological Material
`.
`4U Interview Summary (PTO-413)
`Paper No./Mail Date.
`/MICHAEL J SCHMITT/
`
`Examiner, Art Unit 1629
`
`5. D Examiner's Amendment/Comment
`
`6. C] Examiner's Statement of Reasons for Allowance
`
`7. C] Other
`
`/JEFFREY S LUNDGREN/
`
`U.S. Patent and Trademark Office
`PTOL-37 (Rev. 08-13)
`
`Notice of Allowability
`
`_
`Part of Paper N0-/MaI| Date 20200604
`
`Liquidia's Exhibit 1015
`Page 10
`
`Liquidia's Exhibit 1015
`Page 10
`
`

`

`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`Search [Votes
`
`16/7781362
`
`||||||||||||
`
`"HI"
`
`|
`
`"H
`
`Examiner
`
`MICHAEL J SCHMITT
`
`CPC - Searched*
`
`* See search history printout included with this form or the SEARCH NOTES box below to determine the scope of
`the search.
`
`OLSCHEWSKI et al.
`Examiner, Art Unit 1629
`
`Search Notes
`
`Search Notes
`
`EAST search
`
`Interference Search
`
`US C'aSS/CPC US Subclass/CPO Group
`Symbol
`
`06/04/2020
`
`183, 569
`
`06/04/2020
`
`MS
`
`MICHAEL J SCHMITT/
`
`U.S. Patent and Trademark Office
`
`Page 1 of 1
`
`Liquid’fi'g‘, mmb1?%@%
`Page 1 1
`
`Liquidia's Exhibit 1015
`Page 11
`
`

`

`Application/Control No.
`
`Applicant(s)/Patent Under Reexamination
`
`Issue C/aSSIflcaI/on 16,

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