throbber

`
`UNI'I‘LED S'i‘ATes PA‘I‘EN'I‘ AND TRADEMARK OFFICE
`
`I 'NI‘I'I'ID STA'I'ES DEPARTMENT OF (“OHM [CRCE
`l nltcd Slates Patent and Trademark. 0111m-
`mhme: COMMISSIONER FOR PATENTS.
`I’ [I Lice: i431]
`.Meanudita. Virgil“ 331.1445“
`.m-p-v-JLsptn gm-
`
` Al’l’I JCATION NI MEIER PA'I‘I-JN'I’ .\'I eriER G R( I! ‘l’ ART ['Nl'l' RI iQI 7] 53'!' I I)
`1 4.384038 I
`”593066
`1 67]
`“p.650
`
`
`
`
`
`
`
`PAIR Correspondence Addresswa Address Change
`
`The following fields have been changed to Customer Number 166905 on Ola/038030 via Private PAIR in View
`
`of the certification copied below that authorized the change.
`
`- Con‘e5pondence Address
`
`The address for Customer Number 166905 is:
`166905
`
`Foley & LardncrlJP
`3000 K Street NW.
`Suite 600
`
`Washington, DC QUINN-5109
`
`I certify, in accordance with .37 CFR 1.4(d)(4_) that I am:
`
`An attorney or Agent of Record registered to practice before the Patent and Trademark Office who has been given
`power of attorney in this application
`
`_snephew Mam vegmmwum
`
`Stephen B Maebiusx
`
`Liquidia - Exhibit 1006 - Page 1
`
`Liquidia - Exhibit 1006 - Page 1
`
`

`

`Unrrtio S'l‘A'l'lES PA I‘liN'l‘ AND TRAIN-{MARK OFFICE
`
`
`
`UNITED STATI‘E DEPARTMENT OF COMMERCE
`Fain-d Stnlcs Patent and Trademark Ulric?
`address; CUMVIISS lQNEK I‘OR I’ATIJ'N'I'S
`PD Bo! |J§U
`Alexandria. Virginia 125 11-1430
`n h'u'.l|sp1o.gm
`
`APPUCA'ITON NU.
`ISSUE UA'I‘IL
`FAWN} NU.
`A'l—I'UKNE‘Y 1JIX.'KIE'I.' N0.
`(.‘(IN'HILVIATIUN NU.
`
`HEEHFJHEI
`DNHJ'ZG] 7"
`9503006:
`030615-1531
`(I65 1
`
`12425
`
`two
`
`Ulrllfl‘ I i '3
`
`Foley 6‘: Lardner LLP
`3000 K S'I'Rlili’l‘ NW.
`SUITE 600
`WASHINGTON, DC 20007—5109
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`The projected patent number and issue date are. specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Tenn Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000}
`
`The Patent Term Adjustment is 0 dayts). 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 infonnation 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 diaected 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
`[ODMJ at (571)—272—4200.
`
`APPLICANTlSi [Please see PAIR Willi silc It!Iptt'fpairJIsptogov l'nrndtlilional applicanls):
`
`Ilitcsh BA'I'RA. I'lerndnu, VA:
`[lulled Therapeutics Corporation, Silver Spring. MD:
`Sudersan M. TULAD] lAR. Silver Spring. MD:
`Rajn PIENMAS'I‘A. Ilc-mdon, 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 male about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit Selectflfifiggv.
`
`TRIO} rRev.
`
`IUIU‘J}
`
`Liquidia - Exhibit 1006 - Page 2
`
`Liquidia - Exhibit 1006 - Page 2
`
`

`

`
`
`UNITED STATES PA’lTjN’I' AND TRADEMARK 01:1:th
`
`l‘N‘T‘l‘IvII't STATES DEPAR'IMENT 0F CUMMERI‘E
`l-nited States Patent and Trademark Offici-
`Addams: {fcimxttsstt'mtfi l-UR PA {FL-VI :3
`FE} Bolt I450
`Alum-11in. Vngituil 12.11 i- I 5"}
`WWW 05pm. gov
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`NOTICE OF ALLOWANCE AND FEEI S) DUE
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`DA'I'F. MAILED: 0180:3101?
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`APF'Llt_‘.r\'l'lt')!*tT NO.
`FILING DATE.
`F’IRSTNAMED INVENI'OR
`.‘\'l'I‘OR.‘\EliY DOCKET NO.
`(th'FlRlVlATION NO.
`
`6653
`HIS-£9,981
`(1‘)! I Will] 5
`l-litcsh BATRA
`08061 8- 1 Sat
`Il'l'l.I'_-Ol" INVI‘N I‘ION: PROCESS I'O I'REI‘ARI'L- T'RILPROS'I'INIL. 'l‘lll‘. AI‘I‘IVTJ thilllillll'J't'l' IN RIEMODI'IINIII}
`
`APPLY. 'J'Yl’l'.
`I'EN'ITI'Y STATUS
`J‘iST‘I‘. Hili D' '1".
`I’T-"BIJI‘A'i'lON Flili [)1 IF.
`PREV. PAID l5?“ ‘1"; Fifi—Ii
`TO I A]. Flilit'it I'Jli-li
`UA'I'F. HIT
`
`rtortprovisionnl
`I‘NDISCOUN'J‘IED
`$960
`50
`SI)
`5960
`05m} HUI "I
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
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`PR SECU'I‘IO ON THE MERITS IS Cl.
`"ED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITIIDRAWAL FROM ISSUE AT THE INITIA'I‘IVI‘I OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE .37 CFR 1.313 AND MPEP1308.
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`THE ISSUE FEE AND PUBLICATION FEE. {IF REQUIRED] MUST BE PAID WITIIIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SIIALL BE REGARDED AS ABANDONED.
`TIIIS
`"
`'
`l
`’
`r
`‘
`’
`"
`"
`‘
`'
`i
`.
`SEE 35 U.S.(.‘.. 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. I-IAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION {AS SHOWN ABOVE). THE RETURN OF PART B OF TIIIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY TI-IE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
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`HOW TO REPLY TO THIS NOTICE:
`
`l. Review the liNTl'l‘Y STATUS shown above. [1‘ the HN'I'I'I'Y STATUS is. shown as SMALL or M ICRO. verify whether entitlement to that
`entity status still applies.
`
`II the liN’l‘lTY S'I'ATUS is the same eta shown ethove1 pity the TOTAL PEI‘HS'} DUE shown EIDUVL‘.
`
`II the IiN'l‘l'l'Y S'I'AAI‘US is changed from that shown above. on PART B - I'Tl iI‘XS} ‘I‘RANSMI'I'I'AL complete section number 5 titled
`"Chauige in Entity Status t'li'ont status indimled above)".
`
`For purposes ol‘ this. notice. small entity fees are ”2 the amount ol’ undiseountcd fees. and micro entity fees are 12'2 the amount of small entity
`fees.
`
`1]. PART B - FEEt'S) TRANS MITI'AL, or its equivalent. must he completed and returned to the United States Patent and Trademark Office
`tUSP’l‘O} with your ISSUE [51315 and PUBLICATION 171513 {if required}. If you are charging the feels) to your deposit account, section "4b"
`of Part B - Feels.) 'l'ransmitlal should he completed and an extra copy of the l'onu should he submitted. lfun equivalent of Pan 8 is filed, a
`request to reapply a previously paid issue fee must he clearly made. and delays in processing may occur due to the difficulty in recognixing
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`III. All communications regarding this application must give the application number. Please direct all communications prior to issuance to
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`IMPORTANT REMINDER: Utility patents issuing on applications filed on or after Dec. 12. 1980 may require payment of
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`
`I’TOL—RS tRcv. tilt] ll
`
`Page 1 ot‘3
`
`Liquidia - Exhibit 1006 - Page 3
`
`Liquidia - Exhibit 1006 - Page 3
`
`

`

`PA RT H - FICEIS) TRANSMI‘I‘TAI.
`
`Cumplete and send this farm, together with applicable feels}, to: Mail Mail Stop ISSUE FEE
`Commissioner for Parents
`P.(). Box 1450
`Alexandria. Virginia 22313-1450
`anttx (571)-273-2835
`
`lNSTRL't‘TlUNS: This fut-rm should be used for transmitting the iSSUE FEE and l‘L'HLICA'TlON FEE (if required}. Blocks I
`thmugh 5 should he cnmpleled where
`
`up r‘nprinte. All further correspondence including the Patenr, advance order.
`I] nutil'tcntinn of maintenance fees wilI he mailed tn the current ct-rres wndenee address in;
`in icnled Ufllt'fis corrected heluw tar directed tidierwise in Block I. by is} specifying a nettr crmspnndence address: :lndfm'
`l‘h} indicating n selmrnte " - iIi ADDRESS" for
`
`maintenance lee nutificutiuns.
`
`CURRENTCURRESPOM—‘EW'E “HIRE-“5‘30“: "'5‘ T510“: 1‘1“ my EMILE L‘f-‘I'f'lfi-‘él
`
`1w”
`2-1428
`_.
`ltolcy 8.: Lardner LLP
`3000 K STRRFT N W
`*‘
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`ISSUE Hi address above. or being l'acsimrlc
`transmitted to the. USPTO I‘. T l: 273-3385. on the date. indicated below.
`
`WWW, m: 20007-51”)
`
`APPL-R'A'I‘lfih‘ NI].
`FILING 13M [5.
`'r iRST NAMED iNVEN'l'OR
`A'Fl'l'llixli'i' DI'K'Kh'T ND.
`(Tl-INFlIBENI‘iU-N NF!
`
`HIS-+9.93l
`DWIWZDIS
`llitesh BATRA
`0806i ti- iSEtl
`665.3
`THU; 01" lNVIiNl'lON: PROCESS 1'0 PREPARE 'I‘Rlil‘ROS'l'INIL. 'I'lll'. ACTIVE INGREDIENT [N REM?!Dl.'i_.I.\it!'Il
`
`DATEDUT
`TO'I'AT. FEELS: DL’E
` PREV. PAID ISSUE FE:
`[‘1 "BLICATIDN FEE DUE.
`IESL‘E FEE II" 7F.
`ENTITY STAPLES
`'l‘Y'P'E
`.I’LF'PLV.
`
`
`nonpmvisiunal
`l'NDlSC‘D‘l 'N'Tl in
`$960
`50
`Si]
`89:30
`05M] tltil ".I'
`
`I'DCAMIN'ER
`ART T ‘51"!
`FLAS'SASI "BUASS
`
`VALENROD. YE VG‘liNY
`[ti—4'2
`562 466000
`
`1. Change of eum‘ttpnndence address nr indicnliun nl"’Fce Address" [37
`C138 I563}.
`
`1. Fur printing on lire pnlenl l‘runt page. list
`{I} The names of up In 3 registered patent ath‘nmeys
`or agents OR. ultemalively.
`‘e ui'corrcspctndencc address for Change of Correspondence
`CI (Thu
`Address unit PTOtSlii'llZi :rllarched.
`ill The name of a single tirm thriving ilS a member a
`Cl "Fee Addttss“ indication tni' "Fee Address" Indication form
`registered attorney at agent: irnd the names. uf up Lt!
`2 registered patent attorneys ur :tgcnts. ll I'lu name is
`H1‘U!5lit4?t Rev 03-01 or more recent: attached. ('5: of a Cuslnmer
`listed. nu name will be printed.
`Number is required.
`3. ASSIGNEE- NAME AND RESIDENCE DATA TO [113 PRINTED ON THE PATENT [print .11' typei
`if an :rssignee is identified below. the document has been filed for
`PLEASE NO'I'E: [‘nless an assignee is idenlified below. up tissigncc data will tippearr till the patent.
`rccurdatiun :15 wt lisrth in 3‘." ('FR 3.] |. {.‘umpletiun (If this i‘urm is NUT a substitute fnr tiling an assignment.
`Ml NAME OI‘ ASS IGNIEIE
`liil RPS l BENCH: it‘lT'i' and S'I‘A’I‘E DR (Til 'N'I'RY:
`
`
`
`—
`
`I
`
`1
`'
`
`
`Please check the appropriate nssignee category or categories twill not Ix printed on the patent: : D Individual D Corporation or nlher private grmrp entit}.r D Government
`4a. The following t‘ccts: .111.- suhmirted:
`4h. Payment nI'Iit-ettj: ll’lense first reapply any previously paid issue fee shmm ultrwei
`in Issue l‘ee
`El A check is enclnsed.
`D Publication ['11. I'M: small entity dist-mint ptrmitlcd:
`D Payment by credit card. I‘m-m P101038 is attached.
`CI Advance ()rder . {-l ul't.‘opies
`D'l'he direemt' is hereby authorized to charge Ihc required l'eetral. any deficiency. accredits .‘l.t1_\-‘
`overpaymcnl. to Dcpntil Acmunt Number _ fenclnsc an extra copy ol' this Ibrml.
`
`
`5. Change in Emily Status tl'rnm stnlus indicaied nhmci
`D Applicant certifying micro unlit}- status. See T." (“FR l.29
`
`NQTIE: Absent .1 valid certification of Micro [intity Stratus {tee lam-rt PTOISHHSA and 1511:. issue
`tee payment in the micru entity :rmuurrl will not be accepted at the risk of application abandonment
`
`D Applicanl asserting smnll entily status. See 3? L‘FR 1.2?
`
`Cl Applicnnl changing to regular undiscounted fee status.
`
`.3011? Il'tlh‘e application wag previously under micrrrentily status, checking this box will he taken
`In hr: at nntdrcatmn ur loss nl cntltlcmcn! Irv micro cnllly status.
`mm Checking this but; will be taken to be it nolilicntiun of loan nt‘cnlitlement to small or micm
`entity status. as applicable.
`tied in :tcmrtLtnce with 3? CFR 1.31 and 1.33. See 3? (Tl-R 1.4 for signature rec uiren‘rL-nts Lll'id certifications.
`
`
`NOTE: This fcu'm musl hc 5i
`
`
`
`.»\uthorized Signature
`
`Date
`
`Typed or printed name
`Regrslraliun Nu.
`
`
`F'I'OL-SS Part B {'10- | 3] Apprured for use drmugh lflflliltlll
`
`0MB 0651-0053
`
`L15. Patent and 'I'rndcmnrk Office: US. DEPARTMENT OI" (‘UMMJ'RC‘E
`
`Page 2 of 3
`
`Liquidia - Exhibit 1006 - Page 4
`
`Liquidia - Exhibit 1006 - Page 4
`
`

`

`
`
`UNITED STATES PA’lEN’I‘ AND TRADEMARK OFFICE
`
`INTI‘ED STATES l)EP.\R'l'MENT 0F COMMEIIPE
`[-nilcd States Patent and Trademark Office
`Addams: {TOMMISSII'JNI-Jt l-UR. PA rE-‘s’l 5
`PG am 1450
`Alumni. Virginia 2231 1- I 450
`WWW lisp!” guv
`
`CONFIRMA'I'ION ND.
`ATI'CIRNEY DOCKET NO.
`FIRST NAMED INVESTOR
`FILB‘G DATE
`APPLICATION NO.
`
`ӣ349,981
`us! I {vim 5
`liitt‘sh BA'I‘RA
`0306 I 8- I 531
`{-65.1
`
`mm W.
`
`l-I'oiey & Lardner LLI’
`3000 K STREETNNV.
`S LlI'l‘li 600
`WASHINGTON. DC 200076109
`
`VAI.F..'\'R(ID.Y1W(+IF.NY
`
`AK‘I' 1'NI1‘
`PAPER NL‘MBI'ER
`
`1672
`
`DATE MAILED: 01 {30.00 i"!
`
`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
`154(b)(3'_l-(B){i')
`Section l('h'_l(2J of the AIA Technical Corrections Act amended 35 U.S.C.
`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.
`11 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
`teiTn adjustment determination with the Issue Notification Letter that
`is mailed to applicant
`approximately three weeks prior to the issue date of the patent. and will include the patent term adjustment on the
`patent. Any request for reconsideration of the patent term adjustment determination (or reinstatement of patent term
`adjustment) should follow the process outlined in 37 CFR 1.705.
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the Office of
`Patent Legal Administration at (571)—272—7702. Questions relating to issue and publication fee payments should be
`directed to the Customer Service Center of the Office of Patent Publication at l-(888i-i86-0101 or (571)-272—4200.
`
`NHL—85 lRev. tilt] I]
`
`’agc 3 of 3
`
`Liquidia - Exhibit 1006 - Page 5
`
`Liquidia - Exhibit 1006 - Page 5
`
`

`

`OMB Clearance and PFtA Burden Statement for PTOL-BS Part B
`
`The Paperwork Reduction Act lI’RA) of 1995 requires Federal agencies to obtain Office of Management and
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`governed by 35 USE. 122 and 3? CFR 1.1-1. This Collection is estimated to take 12 minutes to complete,
`including gathering. preparing. and submitting the completed application form to tlte USI’TO. Time will vary
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`‘lhc information provided by you in this form will be subiect to the following routine uses:
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`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.(.‘.. 552attn}.
`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 ttsc, to another federal agency for purposes
`of National Security review {35 USE. 181) and for review pursuant to the Atomic Energy Act (42 11.3.(1
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`Services, or hislher designee. during an inspection of records conducted by GSA as part of that agency's
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`Such disclosure shall not he used to make determinations about individuals-
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`8. A record from this system of records may be disclosed. as a routine use, to the public after either publication
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`record was filed iii an application which became abandoned or itt 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 1181’1‘0 becomes aware of a violation or potential violation of law or regulation.
`
`Liquidia - Exhibit 1006 - Page 6
`
`Liquidia - Exhibit 1006 - Page 6
`
`

`

`
`Application No.
`Applicantts)
`14i849.981
`BATRA ET AL.
`
`533$; WEN ROD
`
`page ““9"” '° ”'9’
`
`No
`
`Notice of Airowabirr'ry
`
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address—
`Ail 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-le 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.
`
`i._ E This communication is responsive to ROE filed on 12/29/15.
`
`El A declarationisyaifldavitis) under 37 CFR 1.130(b) wasiwere filed on
`
`_
`
`2. [I An election was made by the applicant In response to a restriction requirement set iorth during the interview on
`requirement and election have been incorporated into this action.
`
`: the restriction
`
`3. E The allowed claimisi isiare 1,2 and 4—1 1. As a result of the allowad claimts}. 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 hitp:liwww.uspto.govipatentsiinit_eventsipphiindeicjsp or send an inquiry to PPHteedback@uspto.gov.
`
`4. El Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § llQla)-(d) or (ii.
`Certified copies:
`‘c) [I None ofthe;
`a) [I All
`b} [I Some
`1. I] Certified copies of the priority documents have been received.
`2. I] Certified copies of the priority documents have been received in Application No.
`3. D Copies of the certified copies of the priority documents have been received in this national stage application trom the
`International Bureau {PCT Flule 1?.2ia1}.
`’ Certified copies not received:
`
`Applicant has THREE MONTHS FROM THE ”MAILING DATE“ of this communication to file a reply complying with the requirements
`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTENDABLE.
`
`5. I] CORRECTED DRAWINGS ( as “replacement sheets") must be submitted.
`
`I] including changes required bythe attached Examiner‘s Amendment ! Comment or in the Oflice action of
`Paper NoJMail Date
`.
`Identllying indlcia such as the application number (see 3? CFR 1.84{c)} should be written on the drawings in the Iron! (nol the back] at
`each sheet. Replacement sheet(s} should be labeled as such in the header according to 3? CFR 1.121(d).
`
`6. El DEPOSIT OF andior INFORMATION about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL
`
`Attachmentls)
`I. E] Notice of References Cited (PTO—392}
`
`'2. E Information Disclosure Statements (PTOiSBiOB).
`Paper No.iMail Date 1i10i17: 12r‘29r'16
`3. [:I Examiner‘s Comment Regarding Requirement for Deposit
`of Biological Material
`4. I] interview Summary (PTO-413}.
`Paper NoJMail Date
`.
`rYEVGENY VALENROD!
`
`5. III Examiner's AmendmenUComment
`
`6. E] Examiner’s Statement of Reasons for Allowance
`
`7 E Other Continued Examination.
`
`Primary Examiner. Art Unit 1672 U E Fnlenl and Trademam Oliice
`
`PTOL—S? (Rev. 08—13}
`201 ?D125
`
`Notice of Allowabili‘ly
`
`Part or Paper NoJMaii Date
`
`Liquidia - Exhibit 1006 - Page 7
`
`Liquidia - Exhibit 1006 - Page 7
`
`

`

`ApplicationiControl Number: 14i849.981
`Art Unit: 1672
`
`Page 2
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`Continued Examination Under 37 OFF? 1'. 1'14
`
`A request for continued examination under 37 CFR 1.114‘ including the fee set
`
`forth in 37 CFR 1 .17(e), was filed in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.1 14. and the fee set
`
`forth in 37 CFR 1 .17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
`
`12i29i16 has been entered-
`
`Withdrawn rejections
`
`Rejection of ciaims 1-2 and 4-11 over US patent 8.242305 and application
`
`141754.932 is withdrawn in View of the terminal disclaimer filed on 12i29i16.
`
`Conciusion
`
`Claims 1-2 and 4-11 are allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to YEVGENY VALENROD whose telephone number is
`
`(571)2Y2-9049. The examiner can normally be reached on mon-fri 8-4:30.
`
`If attempts to reach the examiner by telephone are unsuccessful. the examiner‘s
`
`supervisor. Fereydoun G. Sajjadi can be reached on 571-572-3311. The fax phone
`
`Liquidia - Exhibit 1006 - Page 8
`
`Liquidia - Exhibit 1006 - Page 8
`
`

`

`Applicatioanontrol Number: 14849381
`Art Unit; 1672
`
`Page 3
`
`number for the organization where this application or proceeding is assigned is 571-
`
`273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status‘information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http:fr‘pair-direct.uspto.gov- Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 856-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OFl CANADA} or 571-272-1000.
`
`EYEVGENY \l'rtLENROD.l
`
`Primary Examiner, Art Unit 1672
`
`Liquidia - Exhibit 1006 - Page 9
`
`Liquidia - Exhibit 1006 - Page 9
`
`

`

`Receipt date: 12/29/2016
`
`
`
`Substitute for form 1449tPTO
`Comptete if Known
`
`INFORMATION DISCLOSURE
`A- slication Number
`140349.981
`
`
`STATEMENT BY APPLICANT
`Filin- Date
`Qt10l2015
`
`
`
`F—irstNamed Inventor H_IteshBATRA
`
` _rt
`[EB 2 9 2815
`Date Submitted:
`_672
`U nit
`
`
`Examiner Name
`Yevgen Valenrod
`use as many sheets as necessary)
`
`
`Attorney Docket Number
`080613— 1581
`
`
`14849981 ... GAD:
`PTOI'SBIIOS modified
`
`
`1672
`
`Examiner
`Initials'
`
`U.S. PATENT DOCUMENTS
`
`Pages. Columns, Lines.
`Where Relevant
`Name of Patentee or Applicant of
`Publication Date
`—-———
`Passages or Relevant
`Cited Document
`MM—DD—YY‘I’Y
`Number-Kind COUEZ tit
`Figures Appear
`known}
`
`
`
`
`
`
`
`
`
`
`
`
`
`Corporation (Ptaintih) v. Sandoz inc. (Defendant). In The United States District Court for the District of
`
`Examiner
`Initials‘
`
`
`iFOREIGN PATENT DOCUMENTS
`I
`_
`Page-5. Columns. Lines.
`PublIcatIon Date
`Name of Patentee or
`when; Relevant
`“PEER“ Patent Document
`MM-DD-YYY‘I'
`Applicant of Cited Documents
`Passages or Relevant
`COUI‘W Cod:Number
`Kind Code5 It known
`Fi.ures rt- -- .-
`
`
`Cite '.
`.No.‘
`
`I
`
`Exa miner
`Initials'
`
`DE
`
`._____— _ 5—”... _
`D3
`
`D4
`
`inciude 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). volumeissue
`number(s). publisher. city andtor country where published.
`
`Ta
`
`Redacted Petitioner‘s Reply to Patent Owner‘s Response to Petition filed on September 27,
`2016 in Steadymed Ltd. (Petitioner) v United Therapeutics Corporatiorr (Patent Dinner).
`_ Case IPR2D18—00008. US Patent 8. 497. 393. with Exhibits 1022-1028
`Petitioners Demonstratives filed November 28 2016. in Staadymed Ltd (Petitioner). v
`United Therapeutics Corporation {Patent Owner). Case IPR2016-00006. US Patent
`
`8 H49? 393
`Patent OWner Response to Petition filed November 23. 2016 in Staadymed Ltd {Petitioner}
`v United Therapeutics Corporation (Patent Owner). Case IF‘R2016-00006 US Patent
`6.497.393. 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. {Petitionaa v.
`United Therapeutics Corporation (Patent Owner). Case IPR2016-00006. US Patent
`8.497.393. 62 pages.
`Decision Redacted Institute of inter Partes Review dated November 23. 2016. in Steadymed
`Ltd. (Patil‘ioned v United Therapeutics Corporation (Patent Owner). Case IPR2016-00006.
`US Patent 6. 497. 393 53 pages
`_-_.
`C____._._
`__e .__
`.
`Service copy of Third Party Submission dated October 16. 2015. filed but not entered'in US ..
`140349. 981 on October 16. 2016 with 6 indicated attachments. 822 pages.
`
`i
`
`Redacted Defendant Sandoz lnc.‘s Invalidity Contentions dated February 5. 2015. United
`Therapeutics Corporation fPiaintiftJ v Sandoz inc (Defendant). In The United States District Court for
`the District of New_J_ersey. Civil Action No 3:_14cu5490(PGH1LLHG). 90 pages.
`Defendant Sandoz Inc. s Invalidity Contention Chartss dated February 5 2015 United Therapeutics
`
`
`_New Jersey. Civil Action No. 3:14-_cv~5499[F'_GH1{I__HG). 189 pages.
`
`Examiner
`Signature
`4823805731321
`
`1 DateConsidered
`
`ALL REEERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`fY.V/
`
`Liquidia - Exhibit 1006 - Page 10
`
`Liquidia - Exhibit 1006 - Page 10
`
`

`

`Receipt date: 12/29/2016
`
`14849981 .. GAD: 1672
`PTOiSBIDB modified
`
`Complete if Known
`Substitute for form 1449iPTO
`
`141'849. 931
`A Iicatlort Number
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT _llln- Date_9i1 DIZU‘IS
`
`
`F—trstNamed Inventor H_iteshBATRA
`
`_rtUnit
`_672
`YEW-en Valenmd
`
`--__ Attorney Docket Number
`
`030618 1531
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examiner
`lnitials‘
`
`I No.‘
`
`Include name of the author (In CAPITAL LETTERS). title ofthe article (when appropriate}. title of the
`item (book, magazine. journal, serial, symposium. catalog. etc.) date. pagets). volume—issue
`numberts). publisher. city andior country where published.
`
`I D9
`
`Defendant Actavis Laboratories FL. Inc. Preliminary Invalidity Contentions. dated August 30, 2016.
`
`
`
`
`"
`United Therapeutics Corporation. and Supemus Phannaceutr‘cais. inc. {Plaintiff} v. Actavis
`
`' Laboratories FL. trio. (Defendant). In The United States District Court for the Oistritc of New Jersey.
`Civil Action No. 3: 16-cv01816- PGS- LHG. Civil Action No. 3:16-CV-03642-PGS-LHG. 330 pages. (see
`Janicularlypagos 1B—20. 42-62 and 269-2801
`
`r
`
`
`
`Exhibit G Invalidity Claim Chart for the '393 patent. January 12. 2015. 56 pages.
`Defendant Teva Pharmaceuticals USA. Inc's Amended Non-Infringement and Invalidity Contentions.
`
`D10
`’TDH
`
`
`
`dated April 24. 2015. United Therapeutics Corporation (Plaintiff) v. Tova Pharmaceuticals USA, inc.
`.
`(Defendant). In The United States District Court for the District of New Jersey. Civil Action No. 3:14—
`.
`
`cv—05493(PGS}1LHG}. 94 pages. {see particularly pages 22-54}.
`Arumugan et al.. "A New Purification Process for Pharmaceutical and Chemical Industries." Organic
`Process Research at Development. 2005. 9:319-320.
`
`
`D12
`
`Burl: et al.. "An Enanlioselectlve Synthesis of tS)—(+)~3-Aminomethyl-5-methylhexanoic Acid via
`D13
`Asymmetric Hydrogenation." J. Org. Chem, 2003, 58:5731-5734.
`
`Eliel et al.. Stereochemistry of Organic Compounds. 1994. 322 325—.
`D14
`
`
`- D15
`
`Harwood et al.. Experimental organic chemistry: Principles and Practice. 1989. 127-134.
`
`
`Jones Maitland Jr Organic Chemistry?” Ed H2000 153155.
`. D16
`
`
`
`! D17
`|
`l
`
`i
`3
`
`Lln et al.. "Benzindene Prostaglandins. Synthesis of Optically Pure 15—Deoxy~U-BEI.215 and Its
`Enantiomer via a Modified lntrarnolecular Wadsworth-Emmons-Wittig Reaction." .J. Org. Chem.
`_ 19815255946601.
`D18 McManus et al.. “Tetrazole Analogs of Plant Auxins." J. Org. Chem. 1959. 24:1464—1467.
`
`
`
`
`I D19 Morison. Richard 8.. Advanced Organic Sfithesis, Methods and Techniques. 1971. 178-188.
`
`
`D20
`
`Ohno et al., "Development of Dual-Acting Benzofurans for Thromboxane A2 Receptor Antagonist and
`Prostacyclin ReceptorAgonist: Synthesis. Structure-Activity Relationship. and Evaluation of
`
`Benzofuran Derivatives.‘ J. Med Chem. 2005. 46: 5279—5294
`' Olmsted III et al. Chemistry. The Molecular Science. Mosby—Year Book Inc. Chapter 10 "Effects of
`' D21
`Intermolecular Forces" 1994. 423-486.
`
`
`: D22
`
`.
`
`D23
`
`|
`
`_ Pavia et al.. Introduction to Organic Laboratory Techniques. First Edition, 1993. B48.
`a
`a.
`a .
`a
`Physicians” Desk Reference. 59 Edition, 2005. for Biclllin® L-A {penicillin G benzathine suspension).
`5 pages.
`
`D24
`
`I
`
`Priscinzano et al.. "Piperidine Analogues of1-[2-[Bis(4-fluorophenyl)rn

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