`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`22428
`
`7590
`
`04/27/2016
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`5mm
`
`WASHINGTON, DC 20007-5109
`
`TOWNSLEY, SARA ELIZABETH
`
`1629
`
`DATE MAILED: 04/27/2016
`
`12/591,200
`
`11/12/2009
`
`Horst Olschewski
`
`080618—0716
`
`4093
`
`TITLE OF INVENTION: Treprostinil administration using a metered dose inhaler
`
`
`
`
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`$480
`
`$0
`
`$0
`
`$480
`
`07/27/2016
`
`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:
`
`I. 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.
`
`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—85 (Rev. 02/11)
`
`Page 1 of3
`
`Liquidia's Exhibit 1044
`Page 1
`
`Liquidia's Exhibit 1044
`Page 1
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`PO. Box 1450
`Alexandria, Virginia 22313-1450
`or m (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required). Blocks 1
`péJropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`n icated 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.
`
`a i
`
`CURRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 for any change ofaddFESS)
`
`7590
`22428
`Foley & Lardner LLP
`3000 K STREET N W
`'
`'
`
`04/27/2016
`
`SUITE 600
`WASHINGTON, DC 20007-5109
`
`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
`gave its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273—2885, on the date indicated below.
`,
`.
`(”WW“)
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
` F {ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/591,200
`
`11/12/2009
`
`Horst Olschewski
`
`080618—0716
`
`4093
`
`TITLE OF INVENTION: Treprostinil administration using a metered dose inhaler
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE
`
`PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`SMALL
`
`$480
`
`$0
`
`$0
`
`$480
`
`07/27/2016
`
`EXAMINER
`
`ART UNIT
`
`CLASS-SUB CLASS
`
`TOWNSLEY, SARA ELIZABETH
`
`1629
`
`514— 183000
`
`1. Change of correspondence address or indication of "Fee Address" (37
`CFR 1.363).
`
`3 Chan e of correspondence address (or Change of Correspondence
`Address orm PTO/SB/ 122) attached.
`
`
`
`
`
`2
`
`3
`
`3 "Fee Address" indication (or "Fee Address" Indication form
`PTO/SB/47; Rev 03—02 or more recent) attached. Use of a Customer
`Vumber 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)
`
`2. For printing on the patent front page, list
`(1) The names of up to 3 registered patent attorneys
`1
`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.
`
`
`
`Please check the appropriate assignee category or categories (will not be printed on the patent) :
`
`'3 Individual
`
`'3 Corporation or other private group entity '3 Government
`
`4a. The following fee(s) are submitted:
`3 Issue Fee
`
`
`
`3 Publication Fee (No small entity discount permitted)
`3 Advance Order — # of Copies
`
`4b. Payment of Fee(s): (Please first reapply any previously paid issue fee shown above)
`3 A check is enclosed.
`
`3 Payment by credit card. Form PTO—2038 is attached.
`3 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)
`
` 3 Applicant certifying micro entity status. See 37 CFR 1.29
`
`3 Applicant asserting small entity status. See 37 CFR 1.27
`
`3 Applicant changing to regular undiscounted fee status.
`
`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.
`
`Authorized Signature
`
`Typed or printed name
`
`
`Date
`
`Registration No.
`
`PTOL—85 Part B (10—13) Approved for use through 10/31/2013.
`
`Page20f3
`OMB 0651—0033
`
`Liquidia's Exhibit 1044
`US. Patent and Trademark Office; US. DEPARTMENT OFIDQEEEZCE
`
`Liquidia's Exhibit 1044
`Page 2
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`F {ST NAMED INVENTOR
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/591,200
`
`11/12/2009
`
`Horst Olschewski
`
`080618—0716
`
`4093
`
`22428
`
`7590
`
`04/27/2016
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`5mm
`
`WASHINGTON, DC 20007-5109
`
`TOWNSLEY, SARA ELIZABETH
`
`1629
`
`DATE MAILED: 04/27/2016
`
`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 1—(888)—786—0101 or (571)—272—4200.
`
`PTOL—85 (Rev. 02/11)
`
`Page 3 0f 3
`
`Liquidia's Exhibit 1044
`Page 3
`
`Liquidia's Exhibit 1044
`Page 3
`
`

`

`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 12 minutes to complete,
`including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary
`depending upon the individual case. Any comments on the amount of time you require to complete this form
`and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
`Trademark Office, U.S. Department of Commerce, PO. Box 1450, Alexandria, Virginia 22313-1450. DO NOT
`SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, PO. Box
`1450, Alexandria, Virginia 22313-1450. Under the Paperwork Reduction Act of 1995, no persons are required to
`respond to a collection of information unless it displays a valid OMB control number.
`
`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 Freedom of Information Act.
`2. A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence
`to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of
`settlement negotiations.
`3. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
`request involving an individual, to whom the record pertains, when the individual has requested assistance
`from the Member with respect to the subject matter of the record.
`4. A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having
`need for the information in order to perform a contract. Recipients of information shall be required to
`comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
`5. A record related to an International Application filed under the Patent Cooperation Treaty in this system of
`records may be disclosed, as a routine use, to the International Bureau of the World Intellectual Property
`Organization, pursuant to the Patent Cooperation Treaty.
`6. A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes
`of National Security review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C.
`218(c)).
`7. A record from this system of records may be disclosed, as a routine use, to the Administrator, General
`Services, or his/her designee, during an inspection of records conducted by GSA as part of that agency's
`responsibility to recommend improvements in records 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.
`Liquidia's Exhibit 1044
`Page 4
`
`Liquidia's Exhibit 1044
`Page 4
`
`

`

` Application No.
`
` .
`
`.
`.
`Notice of Allowability
`
`12/591,200
`'
`EXETEFLOWNSLEY
`
`Applicant(s)
`OLSCHEWSKI ET AL.
`'
`AIA (First Inventor to File)
`f‘gggn“
`Status
`No
`
`-- 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 A licant’s re lies filed 11/9/2015' 2/2/2016' 3/3/2016' 3/4/2016' and 3/28/2016.
`
`I] 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 _; the restriction
`requirement and election have been incorporated into this action.
`
`3. [Z The allowed claim(s) is/are 58-66. 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
`
`htt
`:/‘/www.usbto.‘ov/ atentsx‘iri it events/r) h/indexjsb or send an inquiry to PPeredback ‘ us;
`to. ‘ov .
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`Certified copies:
`
`a) [I A”
`
`b) D Some
`
`*c) I] None of the:
`
`1. I] Certified copies of the priority documents have been received.
`
`2. I: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. El CORRECTED DRAWINGS (as “replacement sheets”) must be submitted.
`
`El
`
`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. El DEPOSIT OF and/or INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner’s comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
`
`Attachment(s)
`1. I] Notice of References Cited (PTO-892)
`
`5. El Examiner‘s Amendment/Comment
`
`6. El Examiner‘s Statement of Reasons for Allowance
`
`2. IX Information Disclosure Statements (PTO/SB/08),
`Paper No./Mai| Date See Continuation Sheet
`3. I:I Examiner‘s Comment Regarding Requirement for Deposit
`of Biological Material
`4. X Interview Summary (PTO-413),
`Paper No./Mai| Date 20160402.
`
`
`7. I] Other
`
`.
`
`/SARA E. TOWNSLEY/
`
`Examiner, Art Unit 1629
`
`/JEFFREY S. LUNDGREN/
`
`Supervisory Patent Examiner, Art Unit 1629
`
`US. Patent and Trademark Office
`
`PTOL-37 (Rev. 08-13)
`20160402
`
`Notice of Allowability
`
`Part of Paper No./Mai| Date
`
`Liquidia's Exhibit 1044
`Page 5
`
`Liquidia's Exhibit 1044
`Page 5
`
`

`

`Continuation Sheet (PTOL-37)
`
`Application No. 12/591,200
`
`Continuation of Attachment(s) 2. Information Disclosure Statements (PTO/SB/08), Paper No./Mai| Date: 3/9/2015 and 11/9/2015.
`
`2
`
`Liquidia's Exhibit 1044
`Page 6
`
`Liquidia's Exhibit 1044
`Page 6
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`12/591,200
`
`11/12/2009
`
`Horst Olschewski
`
`080618—0716
`
`4093
`
`03/19/2014
`7590
`22428
`FOLEY AND LARDNER LLP
`SUITE 500
`3000 K STREET NW
`WASHINGTON, DC 20007
`
`EXAMINER
`
`TOWNSLEY, SARA ELIZABETH
`
`ART UNIT
`
`1629
`
`MAIL DATE
`
`03/19/2014
`
`PAPER NUMBER
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`Liquidia's Exhibit 1044
`Page 7
`
`Liquidia's Exhibit 1044
`Page 7
`
`

`

`
`Application No.
`Applicant(s)
`12/591,200
`OLSCHEWSKI ET AL.
`
`Office Action Summary
`Examiner
`Art Unit
`AIA (First Inventorto File)
`
`
`1629SARA E. TOWNSLEY first“
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 7/2/2013.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lX| This action is non-final.
`2a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)|XI Claim(s) 18 25 27-30 and 32-40 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`
`18 25 27-30 and 32-40 is/are rejected.
`
`is/are objected to.
`
`
`
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, 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
`htt ://\va.usoto. ov/ atentS/init events) .h/index.‘
`
`
`
`3 , or send an inquiry to PRI1feedback©uspto.qov.
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`Application Papers
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`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
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`b)I:I Some” c)I:I None of the:
`a)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`
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`3) I] Interview Summary (PTO-413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/Osb)
`Paper No(s)/Mai| Date 7/2/2013.
`4) D Other: —-
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`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`01 0 1
`Part of aper NolMaiI D
`Ln I Ias Eex 161? fi044
`Page 8
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`Liquidia's Exhibit 1044
`Page 8
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`

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`Application/Control Number: 12/591 ,200
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`Page 2
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`Art Unit: 1629
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`NON-FINAL REJECTION
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`Receipt is acknowledged of Applicants' Amendments and Remarks, filed Jul. 2,
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`2013.
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`Claim 18 has been amended.
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`Claims 1-17, 19-24, 26, and 31 have been canceled.
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`New claims 35-40 have been added.
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`Thus, claims 18, 25, 27-30, and 32-40 now represent all claims currently pending
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`and under consideration.
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`Rejections and/or objections not reiterated from previous Office Actions are
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`hereby withdrawn. The rejections and/or objections set forth below are either
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`maintained or newly applied, and constitute the complete set presently applied to the
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`instant claims.
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`REQUEST FOR CONTINUED EXAMINA TION
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`A request for continued examination under 37 CFR 1.114, including the fee set
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`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
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`application is eligible for continued examination under 37 CFR 1.114, and the fee set
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`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
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`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Jul. 2,
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`2013 has been entered.
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`Liquidia's Exhibit 1044
`Page 9
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`Liquidia's Exhibit 1044
`Page 9
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`

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`Application/Control Number: 12/591 ,200
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`Page 3
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`Art Unit: 1629
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`INFORMA TION DISCLOSURE STA TEMENT
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`The information disclosure statement (IDS) submitted on Jul. 2, 2013 is in
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`compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
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`statement has been considered by the examiner.
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`MAINTAINED REJECTIONS
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`The following rejection is maintained from the previous Office Action dated Oct.
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`17, 2012, on the ground that the references cited therein continue to read on the
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`limitations of the amended claims.
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`Double Patenting
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`Claims 18, 25, 27-30, and 32-34 stand provisionally rejected on the ground of
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`nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-
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`13, 15-18, and 52-59 of copending Application No. 11/748,205 in view of Chaudry
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`(US Pub. 2004/0265238), Byron (Proc. Am. Thorac. Soc. (1), pp. 321-328, 2004) and
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`Cloutier et al (USPN 6,521,212).
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`In addition, this rejection is extended to new claims 35-40.
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`Reference claims 1, 4-13, 15-18, and 52-59 are drawn to methods for treating
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`pulmonary hypertension, comprising administering to a subject in need thereof
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`treprostinil or treprostinil derivative, or a pharmaceutically acceptable salt thereof by a
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`metered dose inhaler, wherein said treprostinil derivative is selected from C1-4 alkyl
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`esters of treprostinil and C1-4 alkyl amides of treprostinil,
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`Liquidia's Exhibit 1044
`Page 10
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`Liquidia's Exhibit 1044
`Page 10
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`Application/Control Number: 12/591 ,200
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`Page 4
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`Art Unit: 1629
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`wherein the metered dose inhaler is a soft mist inhaler,
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`wherein said treprostinil is formulated as a solution, wherein a solvent of the
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`solution comprises water, ethanol or a mixture thereof,
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`wherein a concentration of the treprostinil ranges from about 500 ug/ml to about
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`2500 ug/ml, or from about 1000 ug/ml to about 2000 ug/ml,
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`wherein a dose of the treprostinil administered during a single event ranges from
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`about 15 ug to about 100 ug, or from about 30 ug to about 90 ug, or from about 30 ug to
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`about 60 ug,
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`wherein said administering does not have a systemic side effect on said subject,
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`wherein the systemic side effect is selected from the group consisting of headache,
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`flush, nausea, and dizziness,
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`wherein said administering does not disrupt gas exchange in said subject,
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`wherein said administering does not change heart rate of said subject,
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`wherein said administering does not affect systemic arterial pressure and
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`systemic arterial resistance,
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`wherein said administering is carried out in 20 breaths or less breaths in a single
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`event, or 10 or less breaths in a single event, or in 5 or less breaths in a single event,
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`wherein said administering lasts less than 5 minutes, or less than 1 minute,
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`wherein said subject is a human being,
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`wherein said administering comprises administering aerosol particles containing
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`the treprostinil and said particles have a diameter of less than 10 microns, or a diameter
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`of less than 5 microns.
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`Liquidia's Exhibit 1044
`Page 11
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`Liquidia's Exhibit 1044
`Page 11
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`Application/Control Number: 12/591 ,200
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`Page 5
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`Art Unit: 1629
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`The reference claims do not recite administration with an ultrasonic nebulizer, as
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`recited by examined claims 18 and 27.
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`Chaudry discloses methods of treating pulmonary hypertension by
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`administering inhalable formulations of treprostinil by way of a metered dose inhaler, a
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`dry powder inhaler, a pressurized aerosol (para. 0052), Le, a pressurized metered dose
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`inhaler, or via nebulization (para. 0040). Chaudry teaches that any nebulizer is suitable,
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`including ultrasonic nebulizers (para. 0057).
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`Byron discloses drug delivery devices for inhalation such as metered dose
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`inhalers (MDls), specifically soft mist MDls, as recited by the reference claims, as well
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`as ultrasonic nebulizers, as recited by the examined claims, e.g., computer-controlled
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`ultrasonic (piezoelectric) nebulizers that monitor each patient's breathing pattern and
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`administer nebulizer output phased with inspiration (p. 323, left col.).
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`Because Chaudry teaches that any conventionally known method of
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`administering inhalable medicaments may be used in methods of administering
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`inhalable treprostinil to treat pulmonary hypertension (para. 0052), it would have been
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`predictable to a skilled artisan to administer inhalable treprostinil formulations with either
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`a soft-mist inhaler, as recited by the reference claims, or with an ultrasonic nebulizer, as
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`recited by the examined claims, with a reasonable expectation of success.
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`In addition, as recognized by MPEP §2144.06, it is prima facie obvious to
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`substitute art-recognized equivalents, and an express suggestion to substitute one
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`equivalent component or process for another is not necessary to render such
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`substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
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`Liquidia's Exhibit 1044
`Page 12
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`Liquidia's Exhibit 1044
`Page 12
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`Application/Control Number: 12/591 ,200
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`Page 6
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`Art Unit: 1629
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`This is a provisional obviousness-type double patenting rejection.
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`RESPONSE TO ARGUMENTS AND EVIDENCE
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`The Declaration filed on Jul. 2, 2013 under 37 CFR § 1.131 (a) is sufficient to
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`overcome the Sandifer reference. Therefore, the rejection under 35 U.S.C. § 103 over
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`Chaudry, Sandifer et al., and Cloutier et al. is withdrawn.
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`Applicant's arguments filed Jul. 2, 2013 have been fully considered but they are
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`not persuasive.
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`Specifically, Applicant contends that the references do not disclose a single
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`event dose of 15 to 90 mcg treprostinil which is inhaled in 18 or less breaths, as recited
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`by amended claim 18 (Remarks, pp. 5-6).
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`These limitations are addressed in the new rejection set forth below.
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`Applicant further contends that the PTO improperly disregards Applicants'
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`surprising/unexpected results, relying on Sandifer, specifically the claimed method’s
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`significant improvement in quality of life for pulmonary hypertension patients due to its
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`substantially greater convenience compared to the only other available inhaled
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`prostacyclin on the market, as shown in the previously filed Rule 132 Declarations of
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`Drs. Rubin and Gotzkowsky (filed on May 23, 2012 and August 10, 2012 respectively)
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`(Remarks, pp. 6-7).
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`To the extent Applicant’s arguments with respect to Sandifer are applicable to the
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`currently cited references, they are addressed in the new rejection set forth below.
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`Liquidia's Exhibit 1044
`Page 13
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`Liquidia's Exhibit 1044
`Page 13
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`Application/Control Number: 12/591 ,200
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`Page 7
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`Art Unit: 1629
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`Applicant contends that one of ordinary skill in the art would not be able to arrive
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`at the surprising/unexpected result of improved quality of life, nor predict the surprisingly
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`robust patient benefits shown in the previously submitted Rule 132 Declarations by
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`making the changes in the inhalation method that are recited in claim 18, at least
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`because