`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`15/423,021
`
`02/02/2017
`
`Hitesh Batra
`
`080618-1718
`
`8815
`
`Foley & Lardner LLP
`3000 K STREET N.W.
`SUITE 600
`
`WASHINGTON,DISTRICT OF COLUMBIA 20007-5109
`
`VALENROD, YEVGENY
`
`ART UNIT
`1621
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/11/2018
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period forreply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`ipdocketing@foley.com
`
`PTOL-90A (Rev. 04/07}
`
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`Office Action Summary
`
`Application No.
`15/423,021
`Examiner
`YEVGENY VALENROD
`
`Applicant(s)
`Batra etal.
`Art Unit
`1621
`
`AIA Status
`No
`
`-- The MAILING DATEofthis communication appears on the coversheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply be timelyfiled
`after SIX (8) MONTHSfrom 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) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended peried 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 monthsafter the mailing date of this communication, evenif timely filed, may reduce any
`earnedpatent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)¥) Responsive to communication(s) filed on 9/29/17
`D A declaration(s/affidavit(s} under 37 CFR 1.130(b) was/werefiled on
`2a) This action is FINAL.
`2b) FJ This action is non-final.
`3)LJ An election was mace by the applicant in responseto a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
`4)0 Sincethis application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under £x parfe Quayle, 1935 C.D. 11, 453 0.G. 213.
`
`6)
`)
`7)
`
`** See the attached detailed Cffice action fora list of the certified copies not received. Attachment(s)
`
`Disposition of Claims*
`1,3-7 and 9-13 is/are pending in the application.
`5)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`(J Claim(s)
`is/are allowed.
`Claim(s) 1,3-7 and 9-13 is/are rejected.
`O Claim(s)
`is/are objected to.
`CO
`are subject to restriction and/or election requirement
`Claim(s)
`* If any claims have been determined allowable, you may beeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http:/Avww.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) )
`
`8 9
`
`Application Papers
`10}0J The specification is objected to by the Examiner.
`11} The drawing(s) filed on __ is/are: a)(] accepted or b)L) 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).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)() Acknowledgmentis made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d} or(f).
`Certified copies:
`c)L) None ofthe:
`bj) Some**
`aD All
`Certified copies of the priority documents have been received.
`1.0
`2.0 Certified copies of the priority documents have been received in Application No.
`3.1] Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`1) Oo Notice of References Cited (PTO-892)
`2.
`Inte
`tion
`Discl
`Stat
`t(s)
`(PTO/SB/08
`) oO nformation
`isc sure
`Statement(s)(
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`d/or PTO/SB/08b
`a and/or
`
`}
`
`3) OJ Interview Summary (PTO-413)
`Paper No(sy/Mail Date
`Other: 3rd party
`IDS.
`
`4)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20180105
`
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`Application/Control Number:15/423,021
`Art Unit:1621
`
`Page2
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`DETAILED CORRESPONDENCE
`
`Notice of Pre-AiA or AIA Status
`
`The present application is being examined underthe pre-AlAfirst to invent provisions.
`
`Withdrawn Rejections
`
`Rejection of claim 12 under 35USC 112(b)is withdrawn in view of applicants” amendmentto
`
`the claims.
`
`Rejection of claim 6 under 35 USC 102(b) over Phares et al is withdrawn in view of applicants’
`
`amendment to the claims. Claim 6 is now directed to a pharmaceutical product thatis obtained
`
`by acidification of the salt of claim 1. Since rejection over Phares was based on the art’s
`
`disclosure of the treprostinil salt, said rejection no longer applies to the amended claim6.
`
`Rejection of claims 1-3 under 35 USC 102(b) over Moriarty et al is withdrawn in view of
`
`amendments to the claims. Rejection over Moriarty was based ontheart's disclosure of
`
`treprostinil free acid. Since the amended claims are now dir3ectedto the salt of treprostinil the
`
`rejection of the free acid no longerapplies.
`
`Rejection of claim 12 under 35 USC 103(a) over Phares is withdrawn ion view of applicants’
`
`amendments. Claim 12 now dependsfrom claim 11.
`
`Rejection of claims 6 and 8 under 35 USC 103(a) over Moriarty et al is withdrawn in view of
`
`applicants’ amendments to the claims. Claim 8 has been canceled and claim 6 is now directed
`
`to a pharmaceutical product thatis obtained by acidificaton of the salt of claim 1.
`
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page3
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`Claim Rejections - 35 USC §102
`
`The following is a quotation of the appropriate paragraphsof pre-AlA 35 U.S.C. 102 that
`
`form the basis for the rejections underthis section madein this Office action:
`
`A person shall be entitled to a patent unless-
`
`(b) the invention was patented or described in a printed publication in this or a foreign
`
`country or in public use or on sale in this country, more than one year priorto the date of
`
`application for patent in the United States.
`
`Claim(s) 1,3, 4, 5 and 7 is/are rejected under pre-AlA 35 U.S.C. 102(b) as being
`
`anticipated by Phareset al (WO 2005/007081).
`
`Phares discloses crystal forms of treprostnil diethanolamine salt (pages 85-90). On
`
`page 87 polymorph of FormAis described as anhydrous.
`
`Claims 1, 3,4, 5 and 7 are treated as product by process claims. While Phares does
`
`not disclose the instantly claimed purity the product of Phares inherently meets the
`
`purity limitation becauseit is a crystalized form of the instantly clamed product. The product of
`
`Pharesis the sameasthe instantly claimed product. Since the product is the sameit inherently
`
`meets the limitation directed to product stability at an ambient temperature. A compound’s
`
`stability is the property of the product andis therefore inseparable from the productitself.
`
`“[E]ven though product-by-process claims are limited by and defined by the process,
`
`determination of patentability is based on the productitself. The patentability of a product does
`
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page4
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`not depend onits method of production. If the product in the product-by-process claim is the
`
`sameor obviousfrom the productofthe priorart, the claimis unpatentable even though the
`
`prior art product was madeby a different process.” In re Thorpe, 777 F.2d 695,698, 227 USPQ
`
`964, 966 (Fed. Cir. 1985) (MPEP§ 2113).
`
`Reply to applicants’remarks
`
`Applicants have argued that Paresfails to disclose the limitation directed to product’s stability at
`
`ambient temperature.
`
`Examiner has considered applicants’ remarks and found them to be not sufficient to overcome
`
`the rejection of record. The stability of the diethanol amine salt of treprostinil is an inherent
`
`property of the product. “Acompoundandits properties are inseparable’ in re Papesch, 315
`
`F.2d 381, 137 USPQ 43 (COPA 1963). Since the rejection of record stipulates that the product
`
`of Phares is the same asthe instantly claimed product, stability of the product disclosed by
`
`Pharesis the same asthatof the instantly claimed product.
`
`Claim Rejections - 35 USC §103
`
`The following is a quotation of pre-AlIA 35 U.S.C. 103(a) wnich formsthe basis forall
`
`obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained thoughtheinvention is not identically disclosed or
`
`described as set forth in section 102, if the differences between the subject matter sought to be
`
`patented and the prior art are such that the subject matter as a whole would have been obvious
`
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page5
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`at the time the invention was made to a person having ordinary skill in the art to which said
`
`subject matter pertains. Patentability shall not be negatived by the mannerin which the
`
`invention was made.
`
`This application currently namesjoint inventors. In considering patentability of the claims
`
`underpre-AlA 35 U.S.C. 103(a), the examiner presumesthat the subject matter of the various
`
`claims was commonly ownedatthe time any inventions covered therein were made absentany
`
`evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the
`
`inventor and invention dates of each claim that was not commonly owned at the time a later
`
`invention was madein order for the examiner to consider the applicability of pre-AIA 35 U.S.C.
`
`103(c) and potential pre-AlA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AlA 35 U.S.C. 103(a).
`
`
`Claim 9, 10 and 13 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable
`
`over Phareset al (WO 2005/007081).
`
`Scope ofprior art
`
`Phares et al teach preparation of treprostinil diethanolamine by dissolving treprostinil
`
`acid andtreating it with diethanolamine (page 22). Pharesfurther discloses two polymorphsof
`
`treprostinil diethanolamine (page 85) and discloses stability via their moisture
`
`sorption/desorption data (figure 22).
`
`Ascertaining the difference
`
`Pharesfails to exemplify storing of treprostinil product (claims 9 and 10).
`
`Pharesfails to disclose preparation of a batchthatis at least 2.9g.
`
`Obviousness
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page6
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`Pharesfurther describesstability of the described polymorphsvia their moisture
`
`sorption/desorption data. In view of the teaching of Phares oneskilled in the art at the time of
`
`the instant invention would have found it obviousto store treprostinil in an anhydrous
`
`environmentin order to avoid contact with water.
`
`Oneskilled in the art at the time the instant invention was made would havefound it
`
`obvious to prepare a large amountof treprostinil diethanolamine using the process described by
`
`Phares. Phares has shown that the claimed salt has the same safety profile as the on the
`
`marketform of treprostinil. One would have found it obvious to prepare large batchesof the salt
`
`in order to provide a pharmaceutical product.
`
`Reply to applicants’remarks
`
`Applicants’ arguments have been carefully considered and found to be not sufficient to
`
`overcometherejection of record.
`
`Applicants have argued thatthe salt of treprostinil is more stable than the free acid or
`
`othertreprostinil forms. Examiner agrees with applicants’ argument, however does notbelieve
`
`that said showing overcomestherejection of record.
`
`According to Pharestreprostinil diethanol amine can be prepared in a crystal form which
`
`will absorb moisture. According to Phares, treprostinil diethanolamine can be madeinto a
`
`pharmaceutical product (see page 83) and administered to patients. Since treprostinil is
`
`hydroscopic, one skilled in the art would have foundit obviousto store treprostinil
`
`diethanolaminein an anhydrous environmentin order to avoid contamination of the product.
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page7
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`Claims 11 and 12 are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable
`
`over Moriarty et al (Journal of Organic Chemistry, 2004, 69, 1890-1902) in viewof Pharesetal
`
`(WO 2005/007081 Az).
`
`Scope ofprior art
`
`Moriarty et al disclose a methodfor preparing treprostinil. Said method comprisesthe
`
`steps of: (a) alkylation of benzindenetrio! and (b) hydrolysis of the product of step (a) and
`
`acidification of the hydrolysis product to form a free acid (page 1895, Scheme 4,
`
`compounds34 to 35 to 7; page 1902 preparation of compounds 35 and 7). 441 g of treprostinil
`
`(compound 7) was prepared at 99.7% purity.
`
`Ascertaining the difference
`
`Moriarty fails to teach preparation of a diethanolaminesalt of treprostinil .
`
`Secondary reference
`
`Phareset al teach preparation of treprostinil diethanolamine by dissolving treprostinil
`
`acid andtreating it with diethanolamine (page 22). Pharesfurther discloses two polymorphsof
`
`treprostinil diethanolamine (page 85) and discloses stability via their moisture
`
`sorption/desorption data (figure 22).
`
`Obviousness
`
`Oneskilled in the art at the time of the instant invention practicing the invention of
`
`preparing treprostinil polymorphs as described by Phares would have foundit obviousto utilize
`
`the method of Moriarty to prepare the free acid of treprostinil. The free acid is required for
`
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page8
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`preparation of the diethanolamine salt and one would have ample expectation of successin
`
`carrying out the procedures based on the methodology described by Moriarty and Phares.
`
`Limitation directed to the stability of the resulting productis inherently met. The
`
`diethanol aminesalt of Pharesis the same as the productofthe instant claim1. Since the
`
`productis the sameit inherently possesses the instantly claimed characteristics.
`
`Reply to applicants’remarks
`
`Applicants’ have argued that the art fails to meetthe limitation of claim 1 directed the stability of
`
`the product at ambient temperature. This has already been addressed in 102(b) rejection over
`
`Phares above and in the second paragraphof the obviousness section of the instant rejection.
`
`
`Claim6is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over
`
`Moriarty et al (Journal of Organic Chemistry, 2004, 69, 1890-1902) in viewof Phareset al (WO
`
`2005/007081 A2) and Kawakamietal (JP 56-122328A).
`
`Scopeofprior art
`
`Moriarty et al disclose a method for preparing treprostinil. Said method comprises the
`
`stepsof: (a) alkylation of benzindenetrio! and (b)hydrolysis of the product of step (a) and
`
`acidification of the hydrolysis product to form a free acid (page 1895, Scheme 4,
`
`compounds34 to 35 to 7; page 1902 preparation of compounds 35 and 7). 441 g of treprostinil
`
`(compound 7) was prepared at 99.7% purity.
`
`Ascertaining the difference
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page9
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`Moriarty differs from the instant claim 6 in that he fails to teach formation of a salt of
`
`treprostinil and subsequent conversionofsaid salt backinto free acid.
`
`secondary references
`
`Phares teachespreparation of treprostinil diethanolamine andcrystallization of the said product.
`
`Kawakami teachesthat “[t]he dicyclohexylamine salt of the methanoprostacyclin derivative [I]
`
`thus obtained generally hasfairly high purity, and the purity can be further improved by
`
`recrystallization using appropriate solvent” and also “[t]he dicycloxehylaminesalt obtained by
`
`the present invention can be easily reverted to a free methanoprostacydin derivative [I] by
`
`conventional methods, and the resulting methanoprostacyclin derivative exhibits excellent
`
`crystallinity compared with the substances not purified according to the present invention” In
`
`summary Kawakami teachespurification of a prostacydin compound (same type of compound
`
`at treprostinil) by converting to a salt, crystalizing and converting backto the free acid.
`
`Obviousness
`
`Oneskilled in the art would have foundit obviousto purify the treprostinil free acid disclosed by
`
`Moriarty by preparing a salt as disclosed by Phares,crystalizing the salt and converting it back
`
`to the free acid. As demonstrated by Kawakami this would represent a known method of
`
`purifying a prostacyclin compound and the expected result would be an improvementin purity
`
`comparedto the product of Moriarty.
`
`Double Patenting
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page10
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`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`groundedin public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`impropertimewise extension of the “right to exclude” granted by a patent and to prevent
`
`possible harassment by multiple assignees. A nonstatutory double patenting rejection is
`
`appropriate where the conflicting claims are not identical, but at least one examined application
`
`claim is not patentably distinct from the reference claim(s) because the examined application
`
`claim is either anticipated by, or would have been obviousover, the reference claim(s). See,
`
`e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d
`
`1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`
`1985); In re Van Ornum,686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d
`
`438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA
`
`1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d) may
`
`be used to overcomean actual or provisional rejection based on nonstatutory double patenting
`
`provided the reference application or patent eitheris shown to be commonly owned with the
`
`examined application, or claims an invention made as a result of activities undertaken within the
`
`scopeofa joint research agreement. See MPEP § 717.02 for applications subject to
`
`examination underthe first inventorto file provisions of the AIA as explained in MPEP § 2159.
`
`See MPEP §§ 706.02(I){1)-706.02(1)(3) for applications not subjectto examination under the
`
`first inventorto file provisions of the AIA. A terminal disclaimer must be signed in compliance
`
`with 37 CFR 1.321(b).
`
`The USPTO Internet website contains terminal disclaimer forms which may be used.
`
`Please visitwww.uspto.gov/patent/patents-forms. Thefiling date of the application in which the
`
`form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26)
`
`should be used. Aweb-based eTerminal Disclaimer maybefilled out completely online using
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`Application/Control Number:15/423,021
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`Pagel1
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`web-screens. An eTerminal Disclaimerthat meets all requirements is auto-processed and
`
`approved immediately upon submission. For more information about eTerminal Disclaimers,
`
`refer to www.uspto.gov/patents/process/file/efs/guidance/eT D-info-l.jsp.
`
`
`Claims 1, 3-7 and 9-13 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable overclaims 1-10 of U.S. Patent No. 9,593,066. Although the claimsat issue
`
`are notidentical, they are not patentably distinct from each other because:
`
`The pharmaceutical batch and productis recitedin claims 1 -7 and 9 of ‘066. Amethod
`
`of preparing a pharmaceutical product comprising the steps of alkylation and hydrolysis is
`
`recited in claims 8 and 10 of ‘066.
`
`
`Claims 1, 3-7 and 13 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable overclaiml-22 of U.S. Patent No. 8,497,393. Although the claimsat
`
`issue are notidentical, they are not patentably distinct from each other because:
`
`Claims 1 -22 of ‘393 are directed to a product prepared by process which comprises the
`
`steps of alkylation, hydrolysis and base formation. The purity of the said productis at least
`
`99.5% (claim 10). While ‘393 does not recite a “pharmaceutical batch” the product of ‘393
`
`inherently meets said limitation becauseit recites preparation of pharmaceutically acceptable
`
`salts. Furthermoresince treprastinil is a well-known pharmaceutical agent one would have
`
`foundit obvious to formulate it in to a pharmaceutical product.
`
`Claims 11 and 12 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable overclaims 1-26 of U.S. Patent No. 8,242,305. Although the claims at issue are
`
`not identical, they are not patentably distinct from each other because:
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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page12
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`Claimsof ‘305 are directed to a process for preparing treprostinil comprising the steps of
`
`alkylation, hydrolysis and contacting with a baseto forma salt.
`
`Conclusion
`
`Claims 1, 3-7, 9-13 are pending
`
`Claims 1, 3-7, 9-13 are rejected
`
`THIS ACTION IS MADEFINAL. Applicant is reminded of the extension oftime policy as
`
`set forth in 37 CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHSfrom the mailing date of this action.
`
`In the event a first reply is filed within TWO
`
`MONTHSof the mailing date ofthis final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR 1.136(a) will be calculated from the mailing date of the advisory action.
`
`In no event,
`
`however,will the statutory period for reply expire later than SX MONTHS from the mailing date
`
`ofthis final action.
`
`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to YEVGENY VALENROD whosetelephone numberis (571)272-9049. The
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`examiner can normally be reached on Mon-Fri 9am-5pm.
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`Examinerinterviews are available via telephone, in-person, and video conferencing
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`using a USPTO supplied web-basedcollaboration tool. To schedule an interview, applicantis
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`http:/Avwww.uspto.gov/interviewpractice.
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`IPR2020-00769
`United Therapeutics EX2005
`Page 13 of 14
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`IPR2020-00769
`United Therapeutics EX2005
`Page 13 of 14
`
`

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`Application/Control Number:15/423,021
`Art Unit:1621
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`Page13
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`If attempts to reach the examinerby telephone are unsuccessful, the examiner’s
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`supervisor, Winston Wu-Cheng can be reached on 571-272-3157. The fax phone numberfor
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`the organization wherethis application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applicationsis available through Private PAIR only. For more information about the PAIR
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`system, seehttp://pair-direct.uspto.gov. Should you have questions on accessto the Private
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`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197(toll-free). If you
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`would like assistance from a USPTO Customer Service Representative or accessto the
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`automated information system,call 800-786-9199 (INUSA OR CANADA)or 571-272-1000.
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`YEVGENY VALENROD/
`Primary Examiner, Art Unit 1621
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`IPR2020-00769
`United Therapeutics EX2005
`Page 14 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 14 of 14
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