`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Ofiire
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.mptogov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`15/423,021
`
`02/02/2017
`
`Hitesh Batra
`
`ATTORNEY DOCKET NO.
`——
`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 for reply, 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)
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 1 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 1 of 14
`
`

`

`05709 A6170” Summaly
`
`Examiner
`YEVGENY VALENROD
`
`Art Unit
`1621
`
`AIA Status
`No
`
`Application No.
`15/423,021
`
`Applicant(s)
`Batra et al.
`
`- The MAILING DA TE ofthis communication appears on the covers/reef with the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`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).
`
`Status
`
`1)' Responsive to communication(s) filed on 9/29/17
`
`.
`
`CI A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a). This action is FINAL.
`2b) [I This action is non-final.
`3)|:| 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:l 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 Exparfe Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`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.
`
`)
`6
`7)
`
`
`
`is/areallowed.
`El Claim(s)
`Claim(s) 1,3-7 and 9-13 is/are rejected.
`[:l Claim(s)
`is/are objected to.
`El
`are subject to restriction and/or election requirement
`Claim(s)
`* 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
`http://www.usptogovlpatents/init events/pphlindexjsp or send an inquiry to PPeredback@uspto.gov.
`
`) )
`
`8 9
`
`Application Papers
`10)|:| The specification is objected to by the Examiner.
`11)|:| The drawing(s) filed on
`is/are: a)|:| accepted or b)|:| 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 ifthe drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)|:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or ( ).
`Certified copies:
`a)I:| All
`H]
`
`c)I:| None of the:
`b)I:I Some“
`Certified copies of the priority documents have been received.
`
`Certified copies of the priority documents have been received in Application No.
`2.I:l
`3.|:| 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)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) [3 Notice of References Cited (PTO—892)
`
`3) D Interview Summary (PTO—413)
`
`i
`D'
`t'
`r
`i
`2
`isc osure
`)|:| n orma ion
`Paper No(s)iMai| Date
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`St
`
`t
`t
`a emen (s)(
`.
`
`PTOISB/DB
`
`d/
`a an or
`
`PTO/SBIDBb
`
`)
`
`4)
`
`Office Action Summary
`
`Paper NOISI/Ma" Date
`Other: 3rd art
`IDS_
`—Ly—
`Part of Paper NoJMail Date 20180105
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 2 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 2 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`PageZ
`
`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 1 12(b) is withdrawn in view of applicants” amendment to
`
`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 ofthe treprostinil salt, said rejection no longerapplies to the amended claim 6.
`
`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 on the arts disclosure of
`
`treprostinil free acid. Since the amended claims are nowdir3ected to the salt oftreprostinil the
`
`rejection ofthe free acid no longer applies.
`
`Rejection of claim 12 under 35 USC 103(a) over Phares is withdrawn ion view ofapplicants'
`
`amendments. Claim 12 now depends from 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 that is obtained by acidification of the salt of claim 1.
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 3 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 3 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page3
`
`Claim Rejections - 35 USC §102
`
`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in 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.
`
`Claimis)1,3,4,5 and 7 is/are rejected under pre—AIA 35 U.S.C. 102(b) as being
`
`anticipated by Phares et al (WO 2005/007081).
`
`Pha res discloses crystal forms oftreprostinil diethanolamine salt (pages 85-90). On
`
`page 87 polymorph of FormA is 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 because it is a crystalized form of the instantly clamed product. The product of
`
`Phares isthe same as the instantly claimed product. Since the product is the same it inherently
`
`meets the limitation directed to product stability at an ambient temperature. Acompound's
`
`stability is the property of the product and is therefore inseparable from the product itself.
`
`“[E]ven though product-by—process claims are limited by and defined by the process,
`
`determination of patentability is based on the product itself. The patentability of a product does
`
`lPR2020-00769
`
`United Therapeutics EX2005
`Page 4 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 4 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page4
`
`not depend on its method of production. lfthe product in the product-by—proce$ claim is the
`
`same or obvious fromthe product ofthe prior art, the claim is unpatentable even thoughthe
`
`prior art product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ
`
`964, 966 (Fed. Cir. 1985) (MPEP § 2113).
`
`Reply to agglicants’remarks
`
`Applicants have argued that Pares fails 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 ofthe product. “A compound and its properties are inseparable” In re Papesch, 315
`
`F.2d 381, 137 USPQ 43 (CCPA 1963). Since the rejection of record stipulates that the product
`
`of Phares is the same as the instantly claimed product, stability ofthe product disclosed by
`
`Phares isthe same as that ofthe instantly claimed product.
`
`Claim Rejections - 35 USC §103
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or
`
`described as set forth in section 102, if the differences betweenthe subject matter sought to be
`
`patented and the prior art are such that the subject matter as a whole would have been obvious
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 5 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 5 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`PageS
`
`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 manner in which the
`
`invention was made.
`
`This application currently namesjoint inventors. In considering patentability of the claims
`
`under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various
`
`claims was commonly owned atthe time any inventions covered therein were made absent any
`
`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 made in order for the examiner to considerthe applicability of pre-AIA 35 U.S.C.
`
`103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (9) prior art under pre-AlA 35 U.S.C.103(a).
`
`
`Claim 9 10 and 13 are rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable
`
`over Phares et al (WO 2005/007081).
`
`Scope of prior art
`
`Pha res et al teach preparation of treprostinil diethanolamine by dissolving treprostinil
`
`acid and treating it with diethanolamine (page 22). Phares further discloses two polymorphs of
`
`treprostinil diethanolamine (page 85) and discloses stability via their moisture
`
`sorption/desorption data (figure 22).
`
`Ascertaining the difference
`
`Phares fails to exemplify storing oftreprostinil product(claims 9 and 10).
`
`Pha res fails to disclose preparation of a batch that is at least 2.9g.
`
`Obviousness
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 6 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 6 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page6
`
`Phares further describes stability of the described polymorphs via their moisture
`
`sorption/desorption data. In view of the teaching of Phares one skilled in the art at the time of
`
`the instant invention would have found it obvious to store treprostinil in an anhydrous
`
`environment in order to avoid contad with water.
`
`One skilled in the art at the time the instant invention was made would have found it
`
`obvious to prepare a large amount of treprostinil diethanolamine using the process described by
`
`Phares. Phares has shown that the claimed salt has the same safety profile as the on the
`
`market form oftreprostinil. One would have found it obvious to prepare large batches ofthe salt
`
`in order to provide a pharmaceutical product.
`
`Reply to agglicants’remarks
`
`Applicants' arguments have been carefully considered and foundto be not sufficient to
`
`overcome the rejection of record.
`
`Applicants have argued thatthe salt of treprostinil is more stable than the free acid or
`
`other treprostinil forms. Examiner agrees with applicants' argument, however does not believe
`
`that said showing overcomes the rejection of record.
`
`According to Phares treprostinil diethanol amine can be prepared in a crystal form which
`
`will absorb moisture. According to Phares, treprostinil diethanolamine can be made into a
`
`pharmaceutical product (see page 83) and administered to patients. Since treprostinil is
`
`hydroscopic, one skilled in the art would have found it obvious to store treprostinil
`
`diethanolamine in an anhydrous environment in order to avoid contamination ofthe product.
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 7 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 7 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page7
`
`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 Phares et al
`
`(WO 2005/007081 A2).
`
`Scope of prior art
`
`Moriarty et al disclose a method for preparing treprostinil. Said method comprises the
`
`steps of: (a) alkylation of benz'ndene triol and (b) hydrolysis ofth e product of step (a) and
`
`acidification of the hydrolysis product to form a free acid (page 1895, Scheme 4,
`
`compounds 34 to 35 to 7; page 1902 preparation of compounds 35 and 7). 441 g oftreprostinil
`
`(compound 7) was prepared at 99.7% purity.
`
`Ascertaining the difference
`
`Moriarty fails to teach preparation of a diethanolamine salt of treprostinil.
`
`Se con dary referen ce
`
`Phares et al teach preparation of treprostinil diethanolamine by dissolving treprostinil
`
`acid and treating it with diethanolamine (page 22). Phares further discloses two polymorphs of
`
`treprostinil diethanolamine (page 85) and discloses stability via their moisture
`
`sorption/desorption data (figure 22).
`
`Obviousness
`
`One skilled in the art at the time ofthe instant invention practicing the invention of
`
`preparing treprostinil polymorphs as described by Phares would have found it obvious to utilize
`
`the method of Moriarty to prepare the free acid oftreprostinil. The free acid is required for
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 8 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 8 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Pages
`
`preparation ofthe diethanolamine salt and one would have ample expectation ofsuccess in
`
`carrying out the procedures based on the methodology described by Moriarty and Phares.
`
`Limitation directed to the stability of the resulting product is inherently met. The
`
`diethanol amine salt of Phares is the same as the product of the instant claim 1. Since the
`
`product is the same it inherently possesses the instantly claimed characteristics.
`
`Reply to agglicants’remarks
`
`Applicants” have argued that the art fails to meet the 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 paragraph of the obviousness section ofthe instant rejection.
`
`Claim 6 is/are rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over
`
`Moriarty et al (Journal ofOrganic Chemistry, 2004, 69, 1890-1902) in viewof Phares et al (WO
`
`2005/007081 A2) and Kawakami et al (JP 56-122328A).
`
`Scope of prior art
`
`Moriarty et al disclose a method for preparing treprosfinil. Said method comprisesthe
`
`steps of: (a) alkylation of benz'ndene triol and (b) hydrolysis of th e product of step (a) and
`
`acidification of the hydrolysis product to form a free acid (page 1895, Scheme 4,
`
`compounds 34 to 35 to 7; page 1902 preparation of compounds 35 and 7). 441 g oftreprostinil
`
`(compound 7) was prepared at 99.7% purity.
`
`Ascertaining the difference
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 9 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 9 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page9
`
`Moriarty differs from the instant claim 6 in that he fails to teach formation of a salt of
`
`treprostinil and subsequent conversion of said salt back into free acid.
`
`Secondary references
`
`Phares teaches preparation of treprostinil diethanolamine and crystallization of the said product.
`
`Kawakami teaches that “[t]he dicyclohexylamine salt of the methanoprostacyclin derivative [I]
`
`thus obtained generally has fairly high purity, and the purity can be further improved by
`
`recrystallization using appropriate solvent” and also “[t]he dicycloxehylamine salt obtained by
`
`the present invention can be easily reverted to a free methanoprostacydin derivative [I] by
`
`conventional methods, andthe resulting methanoprostacyclin derivative exhibits excellent
`
`crystallinity compared with the substances not purified according to the present invention” In
`
`summary Kawakami teaches purification of a prostacydin compound (same type of compound
`
`at treprostinil) by converting to a salt, crystalizing and converting backto the free acid.
`
`Obviousness
`
`One skilled in the art would have found it obvious to 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 improvement in purity
`
`compared to the product of Moriarty.
`
`Double Pa tenting
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 10 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 10 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page 10
`
`The nonstatutory double patenting rejection is based on ajudicially created doctrine
`
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`
`improper timevvise extension ofthe “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 fromthe reference claim(s) because the examined application
`
`claim is either anticipated by, or would have been obvious over, 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 overcome an 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
`
`scope of a joint research agreement. See MPEP § 717.02 for applications subject to
`
`examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159.
`
`See MPEP §§ 706.02(I)(1 ) -706.02(I)(3) for applications not subjectto examination under the
`
`first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance
`
`with 37 CFR1.321(b).
`
`The USPTO Internet website contains terminal disclaimer forms which may be used.
`
`Please visitwww.uspto.gov/patent/patents-fonns. The filing 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 may be filled out completely online using
`
`IPR2020-00769
`
`United Therapeutics EX2005
`Page 11 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 11 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Pagell
`
`web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and
`
`approved immediately upon submission. For more information about eTerminal Disclaimers,
`
`refer to www.uspto.gov/patents/processffile/efs/g uidance/eTD-info—l.jsp.
`
`
`Claims 1 3-7 and 9-13 are rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claims 1 -10 of US. Patent No. 9,593,066. Althoughthe claims at issue
`
`are not identical, they are not patentably distinct from each other because:
`
`The pharmaceutical batch and product is recited in claims 1 -7 and 9 of ‘066. A method
`
`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 over claiml-22 of US. Patent No. 8,497,393. Although the claims at
`
`issue are not identical, 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 product is at least
`
`99.5% (claim 10). While ‘393 does not recite a “pharmaceutical batch"the product of ‘393
`
`inherently meets said limitation because it recites preparation of pharmaceutically acceptable
`
`salts. Furthermore since treprostinil is a well-known pharmaceutical agent one would have
`
`found it obvious to formulate it in to a pharmaceutical product.
`
`Claims 11 and 12 are rejected on the ground ofnonstatutory double patenting as being
`
`unpatentable over claims 1-26 of US. Patent No. 8,242,305. Although the claims at issue are
`
`not identical, they are not patentably distinct from each other because:
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 12 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 12 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page 12
`
`Claims of ‘305 are directed to a process for preparing treproslinil comprising the steps of
`
`alkylation, hydrolysis and contacting with a base to form a salt.
`
`Conclusion
`
`Claims 1, 3-7, 9-13 are pending
`
`Claims 1, 3-7, 9-13 are rejected
`
`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as
`
`set forth in 37 CFR1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date ofthis action.
`
`In the event a first reply is filed within TWO
`
`MONTHS of the mailing date ofthis final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTH shortened 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 ofthe advisory action.
`
`In no event,
`
`however, will the statutory period for reply expire later than SIX 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 whose telephone number is (571 )272-9049. The
`
`examiner can normally be reached on Mon-Fri 9am-5pm.
`
`Examiner interviews are available via telephone, in-person, and video conferencing
`
`using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is
`
`encouraged to use the USPTO Automated Interview Request (AIR) at
`
`http://www.uspto.gov/interviewpradice.
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 13 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 13 of 14
`
`

`

`Application/Control Num ber: 15/423,021
`Art Unit: 1621
`
`Page 13
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Winston Wu-Cheng can be reached on 571-272—3157. The fax phone numberfor
`
`the organization where this application or proceeding is assigned is 571-273—8300.
`
`Information regarding the status ofan 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://pair-direct.uspto.gov. Should you have questions on access to the Private
`
`PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (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 OR CANADA) or 571 -272—1000.
`
`lYEVGENY VALENROD/
`
`Primary Examiner, Art Unit 1621
`
`|PR2020-00769
`
`United Therapeutics EX2005
`Page 14 of 14
`
`IPR2020-00769
`United Therapeutics EX2005
`Page 14 of 14
`
`