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`Application/Control No.
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`Cancelled
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`Interference
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`Objected
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`0 T.D.
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`0 R.1.47
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`DATE
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`CLAIMS
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`(cid:143)
`
`Claims renumbered in the same order as presented by applicant
`CLAIM
`Fi naf
`Onginal
`1
`2
`3
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`5
`6
`7
`8
`9
`10
`11
`12
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`17
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`01/18/2019
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( t,lot for submission under 37 CFR 1.99)
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`First Named Inventor I ~e Palo, Francesco
`I 1629
`I PAT058197-US-CNT02
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`Examiner Name
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`U.S.PATENTS
`
`I Rernovej
`
`1
`
`5804157
`
`1998-09--08
`
`Mallinckrodt Medical, Inc.
`
`2
`
`5830431
`
`~ 998-11--03
`
`Mallinckrodt Medical, Inc.
`
`3
`
`5776894
`
`199B-07 --07
`
`Novartis AG
`
`4
`
`5753627
`
`h998-05-19
`
`Novartis AG
`
`5
`
`6183721
`
`81
`
`~001-02--06
`
`Novartis AG
`
`6
`
`6277356
`
`81
`
`~001-08-21
`
`Novartis AG
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`7
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`6123916
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`~000--09-26
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`Novartis AG
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`1629
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`Attorney Docket Number
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`where Relevant
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`Ts
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`A1
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`200S-01-24
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`~an Dulmen, A.
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`A1
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`2013-11-14
`
`Rigshospitalet
`
`A1
`
`2015-05-07
`
`The South African
`1-Juclear Energy
`Corporalion Lid.
`
`rrhe John Hopkins
`University et al.
`
`1
`
`t1Q08009444
`
`2
`
`~013167130
`
`3
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`~15063746
`
`WO
`
`WO
`
`WO
`
`4
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`~015171792
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`WO
`
`A1
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`2015-11-12
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`5
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`~01620TT32
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`6
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`~018074918
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`WO
`
`WO
`
`A1
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`2016-12-29
`
`~dvanced Accelerator
`~pplications
`
`A1
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`2018-04-26
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`rechnische Universiteit
`belft
`
`7
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`D515313
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`EP
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`81
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`2000-08-09
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`NoYarJis AG
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`1629
`
`Attorney Docket Number
`
`PAT058197-US-CNT02
`
`8
`
`00210192
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`A2
`
`2002-02-07
`
`ovartis AG et al.
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`9
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`99701579
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`A2
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`1997-01-16
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`andoz Lid et al.
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`T!i
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`at High
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
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`REEMAN etal., overview DevelOpmentand Formulation of177Lu--DOTA-TATE
`adiopharmaceuticals, (2016.
`. 8-18.
`
`AUS et al. , Aspects on radiolabeling of
`quired to maintain radiochemical purity, In
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`Lu-DOTA-TATE: After B purification re-addition of ascorbic acid is
`. Diagnostic lmagi
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`IU et al., Ascorbic Acid: Useful as a Buffer Agent
`ioconjugate Chem, (2003), 14, 1052- 1056.
`
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`, Radiochemistry, and Practical
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`eclaration for Grace Period filed in PCT/1B2018/057415, September 25, 2018
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`1629
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`Attorney Docket Number
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`PAT058197-US-CNT02
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`8
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`9
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`ciaration for Grace Period filed in PCT/182018/055575, July 25, 2018
`
`I., Lutetium-177 DOTATATE Producfion with and Automated Racfio-pharmaceutical Syn
`SLANI e
`sia Oceant oumal of Nuclear Medicine 8, Biology, (2015), 3, 107-115.
`
`10
`
`UTATHERA, Advance Accelerator Applications, Highlights of Prescribing Information, J uary 2018
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`UTATl4ERA. European Medicines Agency.
`dated April 11 , 2018
`
`AR Product lnfonn
`
`· n. Flrst Published January 17, 2018, last
`
`ration of 177Lu-Tyr3--octreolide and 177Lu-
`UNA-GUTIERREZ et al., Freeze-Dried mu · ose kits for lhe fast pr
`SMA(inhibitor) under GMP conditions. J adioanal Nucl Chem, (2017. 314, 2181-2188.
`
`AS et al., Preparation of DOTA- TE and DOT A-NOC freeze-dried kits for fo ulation of patient doses of 177Lu(cid:173)
`abeled agents and their comp son for peptide receptor radionuciide therapy ap · ation, J Radioanal Nucl Chem,
`2014)299, 1389-1398
`
`· eness of Quenchers to Reduce Radiolysis of 1111n- or 177-Lu-Lab ed Methionine-Containing
`e BLOIS et aL, Eff
`egulatory Peptide . Mainlainin!J Radiochemical Puoty as Measured by HPLC, Current Topi
`in Med Chem, (2012),
`2, 2677-2685 .
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`. , DOT A-NOC, a high-affinity ligand of somalostatin receptor subtypes 2, 3 and 5 for labelling
`Is. Eur J Nucl Med Mol Imaging. (2003), 30, 1338-1347.
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`EKKEBOOM et al., (177-Lu-DOTA0, Tyr3)octreotate: comparison with [111 ln-DTPA0]octreofide in patients. Eur
`ucl Med Mol Imaging. (,2001), 28, 1319-1325.
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`1629
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`Attorney Docket Number
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`PAT058197-US-CNT02
`
`AS et al., Preparation of Therapeutic Dose of 177Lu-DOT A-TA TE Using a Novel Single Vial Freeze-dried Kil: A
`omparison With 'In-situ' Preparation at Hospital Radiophatmacy, Current Radiopharmaceulicals, {201
`• 2-19_
`
`19
`
`20
`
`21
`
`22
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`ccelerator Applications Receives US FDA Approval for LUTATHERA® for Treatment of
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`APPLICATION
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`France co de Palo
`
`CONPfRMA TIO:-/ NO.
`
`1061
`
`Ill/ I 51:!0 19
`7590
`1095
`:\·ovARTIS PliARMACE TICALCORPORATION
`INTELLECTUAL PROPERTY DEPARTMENT
`O1\'E HEAL TH PLAZA 433/2
`EAST HA, 'OVER. i J 07936-1080
`
`PERREIRA. M0.ISSA Jr.A
`
`Alrl NIT
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`PAl:'ER • 1\JHllR
`
`lblK
`
`NOTLPICA TIO!', DATE
`
`OllU ERYM DE
`
`01Wf.!0l9
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time pc1iod for reply. if any, is ct in the attached communication.
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`Notice of the Office comrounjcation wa
`foJlowing e- mail add.re s(es):
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`phip.patents @novarti ,com
`
`ent electronically on above-indicated "Notification Date" to the
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`PTOL-90A (Rev, 04107\
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`UNITED STATES DEPARTME T OF COMMERCE
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`Address: COMMISSIONER FOR PAT ENTS
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`
`APPLICATION NO./
`CONTROL NO.
`16/175,239
`
`FILING DATE
`
`10/30/2018
`
`FIRST NAMED INVENTOR/
`PATENT IN REEXAMINATION
`de Palo et al.
`
`ATTORNEY DOCKET NO.
`
`PAT058197-US-CNT0
`
`NOVARTIS PHARMACEUTICAL CORPORATION INTELLECTUAL
`PROPERTY0EPAR:TMENT
`ONE HEALTH PLAZA.433/2
`EAST HANOVER, NJ 07936-1080
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`EXAMINER
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`MELISSA J PERREIRA
`ART UNIT
`PAPER
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`1618
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`20190214
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`DA TE /\1.A !LED:
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`Please find below and/or attached an Office communication concerning this application or
`proceeding.
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`The examiner has considered the I Os flied 11 /1 /18 after the applicants representative indicated that the references were
`provided in the parent application .
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`Commissioner for Patents
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`/Michael G. Hartley/
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`PTO-90C (Rev ,04 03)
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`Receipt date: 11/01/2018
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( t,lot for submission under 37 CFR 1.99)
`
`First Named Inventor I ~e Palo, Francesco
`I 1629
`I PAT058197-US-CNT02
`
`Art Unit
`
`Examiner Name
`
`I
`
`Attorney Docket NL1mber
`
`Examiner Cite
`No
`Initial*
`
`Patent Number
`
`Kind
`Code1
`
`Issue Date
`
`Name of Patentee or Applicant
`of cited Document
`
`Pages,Columns,Unes Where
`Relevant Passages or Relevant
`Figures Appear
`
`U.S.PATENTS
`
`I Rernovej
`
`1
`
`5804157
`
`1998-09--08
`
`Mallinckrodt Medical, Inc.
`
`2
`
`5830431
`
`~ 998-11--03
`
`Mallinckrodt Medical, Inc.
`
`3
`
`5776894
`
`199B-07 --07
`
`Novartis AG
`
`4
`
`5753627
`
`h998-05-19
`
`Novartis AG
`
`5
`
`6183721
`
`81
`
`~001-02--06
`
`Novartis AG
`
`6
`
`6277356
`
`81
`
`~001-08-21
`
`Novartis AG
`
`7
`
`6123916
`
`~000--09-26
`
`Novartis AG
`
`If you wish to add additional U.S. Patent citation information please click the Add button.
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`U.S.PATENT APPLICATION PUBLICATIONS
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`IN FORMATION DISCLOSURE
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`Application Number
`
`Filing Date
`
`16175239
`
`2018-10-30
`
`First Named Inventor
`
`de Palo, Francesco
`
`Art Unit
`
`Examiner Name
`
`1629
`
`Attorney Docket Number
`
`PAT058197-US-CNT02
`
`Examiner
`Initial"
`
`Cite No
`
`Publication
`Number
`
`Kind Publication
`Code1 Date
`
`Name of Patentee or Applicant
`of cited Document
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`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
`
`1
`
`I
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`FOREIGN PATENT DOCUMENTS
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`Examiher Cite Foreign Document
`Initial*
`No Number3
`
`Country
`Code2j
`
`l<lnd Publication
`Code4 Date
`
`Name of Patentee or
`Applicant of cited
`Document
`
`Pages Co11Jh1hs,Lines
`where Relevant
`Passages or Relevant
`Figures Appear
`
`Ts
`
`A1
`
`200S-01-24
`
`~an Dulmen, A.
`
`A1
`
`2013-11-14
`
`Rigshospitalet
`
`A1
`
`2015-05-07
`
`The South African
`1-Juclear Energy
`Corporalion Lid.
`
`rrhe John Hopkins
`University et al.
`
`1
`
`t1Q08009444
`
`2
`
`~013167130
`
`3
`
`~15063746
`
`WO
`
`WO
`
`WO
`
`4
`
`~015171792
`
`WO
`
`A1
`
`2015-11-12
`
`5
`
`~01620TT32
`
`6
`
`~018074918
`
`WO
`
`WO
`
`A1
`
`2016-12-29
`
`~dvanced Accelerator
`~pplications
`
`A1
`
`2018-04-26
`
`rechnische Universiteit
`belft
`
`7
`
`D515313
`
`EP
`
`81
`
`2000-08-09
`
`NoYarJis AG
`
`EFSWeb2.U8
`
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`IN FORMATION DISCLOSURE
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`Application Number
`
`Filing Date
`
`16175239
`
`2018-10-30
`
`First Named Inventor
`
`de Palo, Francesco
`
`Art Unit
`
`Examiner Name
`
`1629
`
`Attorney Docket Number
`
`PAT058197-US-CNT02
`
`8
`
`1)00210192
`
`9
`
`~99701579
`
`WO
`
`WO
`
`A2
`
`2002-02-07
`
`lllovartis AG et al.
`
`A2
`
`1997-01-16
`
`$andoz Lid et al.
`
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`NON.PATENT LITERATURE DOCUMENTS
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`Examine, Cite
`Initials* No
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`Include 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, pages(s), volume-issue number(s),
`publisher, city and/or country where published .
`
`T !i
`
`1
`
`BREEMAN el al., Optimising Conditions for Radiolabelling of OOTA,-peplides with 90Y, 1111n and 177Lu at High
`ppecific Activities, Eur J Nucl Med Mol Imaging, (2003), 30 . 917-920.
`
`2
`
`3
`
`4
`
`5
`
`6
`
`BREEMAN el al., overview of Devetopment and Formulation of 177Lu-DOTA-TATE for PRRT, Current
`Radiopharmaceuticals, (2016), 9, 8-18.
`
`MAUS et al. , Aspects on radiolabeling of 177Lu--DOTA-TATE: After C1B purification re-addition of ascorbic acid is
`required to maintain radiochemical purity, lntJ" Diagnostic Imaging, (2014}. 1, 5-12_
`
`,JU et al., Ascorbic Acid: Useful as a Buffer Agent and Radiolytic Slabilizer for Melalloradiopharmaceutfcals,
`Bioconjugate Chem, (2003), 14, 1052-1056.
`
`,JU el al.. Stabilization of 90Y-Labeled DOTA-Biomolecule Conjugates Using Gentisic Acid and Ascorbic Acid.
`~ioconjugate Chem, (2001 ). 12. 554-558.
`
`~ANERJEE el al., Lutelium-177 Therapeutic Radiopharmaceulicals: Linkmg Chemistry, Radiochemistry, and Practical
`r\pplications, Chem Rev. (2015), 115, 2934-2974_
`
`7
`
`Declaration for Grace Period filed in PCT/1B2018/057415, September 25, 2018
`
`No references provided
`
`EFS Web 2.1.1 8
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LI NED THROOGH.
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`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`16175239
`
`2018-10-30
`
`First Named Inventor
`
`de Palo, Francesco
`
`Art Unit
`
`Examiner Name
`
`1629
`
`Attorney Docket Number
`
`PAT058197-US-CNT02
`
`8
`
`Deciaration for Grace Period filed in PCT/182018/055575, July 25, 2018
`
`9
`
`MLANI et al., Lutetium--177 DOTATATE Producfion with and Automated Racfio--pharmaceutical Synthesfs System,
`~sia Oceania Journal of Nuclear Medicine 8, Biology, (2015), 3, 107-115.
`
`10
`
`~UTATHERA, Advanced Accelerator Applications, Highlights of Prescribing lnfomiation. January 2018
`
`11
`
`UTATHERA, European Medicines Agency, EPAR Public Assessment Report, First Published January 17, 2018
`
`12
`
`UTATHERA, European Medicines Agency, EPAR Product Information, Flrst Published January 17, 2018. last
`µpdated April 11 , 2018
`
`13
`
`,_UTATHERA, European Medicines Agency, CHMP Summary Positive Opinion, Rrst Published July 21 , 2017
`
`14
`
`._UNA-GUTIERREZ et al., Freeze-Dried rnultl-dose kits for the fast preparation of 177Lu-Tyr3--octreolide and 177Lu-
`~SMA(inhibitor) under GMP conditions. J Radioanal Nucl Chem, (2017), 314, 2181-2188.
`
`15
`
`16
`
`DAS et al., Preparation of DOTA-TATE and DOTA-NOC freeze-dried kits for formulation of patient doses of 177Lu-
`abeled agents and their comparison for peptide receptor radionuclide therapy application, J Radioanal Nucl Chem,
`2014)299, 1389--1398
`
`~e BLOIS et aL, Effectiveness of Quenchers to Reduce Radiolysis of 1111n- or 177-Lu-Labelled Methionine-Containing
`Regulatory Peptides. Maintaining Radiochemical Puoty as Measured by HPLC, Current Topics in Med Chem. (2012),
`~2. 2677-2685.
`
`17 WILD et al., DOT A-NOC, a high-affinity ligand of somalostatin receptor subtypes 2, 3 and 5 for labelling with various
`radiometals. Eur J Nucl Med Mol Imaging. (2003), 30, 1338-1347.
`
`18
`
`i<WEKKEBOOM et al., (177-Lu-DOTA0, Tyr3)octreotate: comparison with [111 ln-DTPA0]octreofide in patients, Eur J
`Nucl Med Mal Imaging. (.2001), 28, 1319-1325.
`
`EFS Web 2.1.18
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROOGH.
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`/ M.J .P/
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`oo refezence.s provide d
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`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Application Number
`
`Filing Date
`
`16175239
`
`2018-10-30
`
`First Named Inventor
`
`de Palo, Francesco
`
`Art Unit
`
`1629
`
`Examiner Name
`
`Attorney Docket Number
`
`PAT058197-US-CNT02
`
`19
`
`PAS et al., Preparation of Therapeutic Dose of 177Lu-DOT A-TA TE Using a Novel Single Vial Freeze-dried Kil: A
`bomparison With 'ln--situ' Preparation at Hospital Radiophatmacy, Current Radiopharmaceuticals, {2014) 7, 12-19_
`
`20
`
`MATHUR et al., Bulk Seate Formulation ofTherapeulic Dosed of Clinical Grade Ready-to-Use 177Lu-OOTA-TATE:
`lrhe Intricate Radiochemistry Aspects, Cancer Biotherapy and Radiopharmaceuticals, (2017), 32, 7, 266-273 .
`
`21
`
`f\dvanced Accelerator Applications Announces European Approval of Lutetium (177Lu) Oxodotreotide (Lutalhera®) for
`~aslroenteropancrealic Neuroendocrine (GEP-NET) Tumors. PRESS RELEASE September 29. 2017
`
`22
`
`~dvanced Accelerator Applications Receives US FDA Approval for LUTA TH ERA® for Treatment of
`~astroenteropancreatic Neuroendocrine Tumors, PRESS RELEASE January 26, 2018
`
`I
`
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`16175239
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`2018-10-30
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`de Palo, Francesco
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`Examiner Name
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`1629
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`PAT058197-US-CNT02
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`2018-11-01
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