PRELIMINARY
`AMENDMENT
`Under CFR 1.115
`
`Address to:
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Electronically Filed
`Attorney Docket No.
`REGN-008CIPCON5
`To Be Assigned
`Confirmation No.
`Y ANCOPOULOS, GEORGE D.
`First Named Inventor
`To Be Assigned
`Application Number
`Filing Date
`April 29, 2019
`To Be Assigned
`Group Art Unit
`To Be Assigned
`Examiner Name
`Title:
`"Use of a VEGF Antagonist to Treat Angiogenic
`Eve Disorders"
`
`Prior to the examination of the above-referenced application on the merits, please enter the
`amendments below.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 001
`
`

`

`Electronically Filed
`
`NOTIFICATION OF PRIOR
`SEQUENCE LISTING
`
`Attorney Docket
`
`REGN-008CIPCON4
`
`First Named Inventor
`
`Y ANCOPOULOS,
`GEORGED.
`
`Address to:
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Application Number
`
`To Be Assigned
`
`Filing Date
`
`April 29, 2019
`
`Confirmation Number
`
`To Be Assigned
`
`Group Art Unit
`
`To Be Assigned
`
`Examiner Name
`
`To Be Assigned
`
`Title:
`
`"USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS"
`
`The above-identified patent application contains sequences of nucleic acid and
`
`polypeptides. A sequence listing was prepared for parent application, 16/159,282, filed October
`
`12, 2018, in paper and computer-readable format. The sequence information in the paper or
`
`compact disk copy of the sequence listing (required by 1.82l(c)) of this application is identical to
`
`the sequence information in the computer-readable format (CRF) of the above-identified other
`
`application. No new matter has been added. Therefore, please transfer to this application, in
`
`accordance with 37 CFR § 1.82l(e), the fully compliant computer readable copy from applicants'
`
`other application. A paper (.txt) copy of this sequence listing is enclosed.
`
`Applicants respectfully submit that the present patent application is now in compliance
`
`with 37 CFR §§ 1.821 - 1.825. The Commissioner is hereby authorized to charge any
`
`underpayment of fees associated with this communication, including any necessary fees for
`
`extensions of time, or credit any overpayment to Deposit Account No. 50-0815, order number
`
`REGN-008CIPCON5.
`
`Respectfully submitted,
`
`BOZICEVIC, FIELD & FRANCIS LLP
`
`/Karl Bozicevic, Reg. No. 28,807/
`Karl Bozicevic
`Registration No. 28,807
`
`Dated:
`
`29 April 2019
`
`By:
`
`BOZICEVIC, FIELD & FRANCIS LLP
`201 Redwood Shores Parkway, Suite 201
`Redwood City, California 94065
`Telephone: (650) 327-3400
`Facsimile: (650) 327-3231
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 002
`
`

`

`REGN-008CIPCON2_SeqList.txt
`
`SEQUENCE LISTING
`
`<110> George D. Yancopoulos
`
`<120> use of a VEGF Antagonist to Treat Angiogenic Eye Disorders
`
`<130> 725Al
`
`<140> To be assigned
`<141> Filed herewith
`
`<150> PCT/US2012/020855
`<151> 2012-01-11
`
`<150> 61/432,245
`<151> 2011-01-13
`
`<150> 61/434,836
`<151> 2011-01-21
`
`<150> 61/561,957
`<151> 2011-11-21
`
`<160> 2
`
`<170> FastSEQ for windows version 4.0
`
`<210> 1
`<211> 1377
`<212> DNA
`<213> Artificial sequence
`
`<220>
`<223> synthetic
`
`<400> 1
`atggtcagct actgggacac cggggtcctg ctgtgcgcgc tgctcagctg
`acaggatcta gttccggaag tgataccggt agacctttcg tagagatgta
`cccgaaatta tacacatgac tgaaggaagg gagctcgtca ttccctgccg
`cctaacatca ctgttacttt aaaaaagttt ccacttgaca ctttgatccc
`cgcataatct gggacagtag aaagggcttc atcatatcaa atgcaacgta
`gggcttctga cctgtgaagc aacagtcaat gggcatttgt ataagacaaa
`catcgacaaa ccaatacaat catagatgtg gttctgagtc cgtctcatgg
`tctgttggag aaaagcttgt cttaaattgt acagcaagaa ctgaactaaa
`gacttcaact gggaataccc ttcttcgaag catcagcata agaaacttgt
`ctaaaaaccc agtctgggag tgagatgaag aaatttttga gcaccttaac
`gtaacccgga gtgaccaagg attgtacacc tgtgcagcat ccagtgggct
`aagaacagca catttgtcag ggtccatgaa aaggacaaaa ctcacacatg
`ccagcacctg aactcctggg gggaccgtca gtcttcctct tccccccaaa
`accctcatga tctcccggac ccctgaggtc acatgcgtgg tggtggacgt
`gaccctgagg tcaagttcaa ctggtacgtg gacggcgtgg aggtgcataa
`aagccgcggg aggagcagta caacagcacg taccgtgtgg tcagcgtcct
`caccaggact ggctgaatgg caaggagtac aagtgcaagg tctccaacaa
`gcccccatcg agaaaaccat ctccaaagcc aaagggcagc cccgagaacc
`accctgcccc catcccggga tgagctgacc aagaaccagg tcagcctgac
`aaaggcttct atcccagcga catcgccgtg gagtgggaga gcaatgggca
`aactacaaga ccacgcctcc cgtgctggac tccgacggct ccttcttcct
`ctcaccgtgg acaagagcag gtggcagcag gggaacgtct tctcatgctc
`gaggctctgc acaaccacta cacgcagaag agcctctccc tgtctccggg
`
`tctgcttctc 60
`cagtgaaatc 120
`ggttacgtca 180
`tgatggaaaa 240
`caaagaaata 300
`ctatctcaca 360
`aattgaacta 420
`tgtggggatt 480
`aaaccgagac 540
`tatagatggt 600
`gatgaccaag 660
`cccaccgtgc 720
`acccaaggac 780
`gagccacgaa 840
`tgccaagaca 900
`caccgtcctg 960
`agccctccca 1020
`acaggtgtac 1080
`ctgcctggtc 1140
`gccggagaac 1200
`ctacagcaag 1260
`cgtgatgcat 1320
`taaatga
`1377
`
`<210> 2
`<211> 458
`
`Page 1
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 003
`
`

`

`REGN-008CIPCON2_SeqList.txt
`
`<212> PRT
`<213> Artificial sequence
`
`<220>
`<223> synthetic
`
`<400> 2
`Met val Ser Tyr Trp Asp Thr Gly val Leu Leu cys Ala Leu Leu Ser
`1
`15
`5
`10
`cys Leu Leu Leu Thr Gly Ser Ser Ser Gly Ser Asp Thr Gly Arg Pro
`20
`25
`30
`Phe val Gl u Met Tyr Ser Gl u Ile Pro Gl u Ile Ile His Met Thr Gl u
`40
`45
`35
`Gly Arg Gl u Leu val Ile Pro cys Arg val Thr Ser Pro Asn Ile Thr
`50
`55
`60
`val Thr Leu Lys Lys Phe Pro Leu Asp Thr Leu Ile Pro Asp Gly Lys
`70
`75
`65
`80
`Arg Ile Ile Trp Asp Ser Arg Lys Gly Phe Ile Ile Ser Asn Ala Thr
`85
`90
`95
`Tyr Lys Gl u Ile Gly Leu Leu Thr cys Gl u Ala Thr val Asn Gly His
`110
`100
`105
`Leu Tyr Lys Thr Asn Tyr Leu Thr His Arg Gl n Thr Asn Thr Ile Ile
`115
`120
`125
`Asp val val Leu Ser Pro Ser His Gly Ile Gl u Leu Ser val Gly Gl u
`140
`130
`135
`Lys Leu val Leu Asn cys Thr Ala Arg Thr Gl u Leu Asn val Gly Ile
`145
`150
`155
`160
`Asp Phe Asn Trp Gl u Tyr Pro Ser Ser Lys His Gl n His Lys Lys Leu
`165
`170
`175
`val Asn Arg Asp Leu Lys Thr Gl n Ser Gly Ser Gl u Met Lys Lys Phe
`180
`185
`190
`Leu Ser Thr Leu Thr Ile Asp Gly val Thr Arg Ser Asp Gl n Gly Leu
`195
`200
`205
`Tyr Thr cys Ala Ala Ser Ser Gly Leu Met Thr Lys Lys Asn Ser Thr
`210
`215
`220
`Phe val Arg val His Gl u Lys Asp Lys Thr His Thr cys Pro Pro cys
`225
`230
`235
`240
`Pro Ala Pro Gl u Leu Leu Gly Gly Pro Ser val Phe Leu Phe Pro Pro
`245
`250
`255
`Lys Pro Lys Asp Thr Leu Met Ile Ser Arg Thr Pro Gl u val Thr cys
`260
`265
`270
`val val val Asp val Ser His Gl u Asp Pro Gl u val Lys Phe Asn Trp
`275
`280
`285
`Tyr val Asp Gly val Gl u val His Asn Ala Lys Thr Lys Pro Arg Gl u
`290
`295
`300
`Gl u Gl n Tyr Asn Ser Thr Tyr Arg val val Ser val Leu Thr val Leu
`315
`320
`305
`310
`His Gl n Asp Trp Leu Asn Gly Lys Glu Tyr Lys cys Lys val Ser Asn
`325
`330
`335
`Lys Ala Leu Pro Ala Pro Ile Gl u Lys Thr Ile Ser Lys Ala Lys Gly
`340
`345
`350
`Gl n Pro Arg Gl u Pro Gl n val Tyr Thr Leu Pro Pro Ser Arg Asp Gl u
`355
`360
`365
`Leu Thr Lys Asn Gl n val Ser Leu Thr cys Leu val Lys Gly Phe Tyr
`370
`375
`380
`Pro Ser Asp Ile Al a val Gl u Trp Glu Ser Asn Gly Gl n Pro Gl u Asn
`400
`385
`390
`395
`Asn Tyr Lys Thr Thr Pro Pro val Leu Asp Ser Asp Gly Ser Phe Phe
`405
`410
`415
`Leu Tyr Ser Lys Leu Thr val Asp Lys Ser Arg Trp Gl n Gl n Gly Asn
`420
`425
`430
`val Phe Ser cys Ser val Met His Glu Ala Leu His Asn His Tyr Thr
`435
`440
`445
`
`Page 2
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 004
`
`

`

`REGN-008CIPCON2_SeqList.txt
`Gln Lys Ser Leu Ser Leu Ser Pro Gly Lys
`450
`455
`
`Page 3
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 005
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`First Named Inventor/Applicant Name:
`
`George D. YANCOPOULOS
`
`Filer:
`
`Karl Bozicevic/Kimberly Zuehlke
`
`Attorney Docket Number:
`
`REGN-008CIPCON5
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC 111 (a)
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`UTILITY APPLICATION FILING
`
`UTILITY SEARCH FEE
`
`UTILITY EXAMINATION FEE
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`CLAIMS IN EXCESS OF 20
`
`INDEPENDENT CLAIMS IN EXCESS OF 3
`
`Miscellaneous-Filing:
`
`1011
`
`1111
`
`1311
`
`1202
`
`1201
`
`1
`
`1
`
`1
`
`9
`
`1
`
`300
`
`660
`
`760
`
`100
`
`460
`
`300
`
`660
`
`760
`
`900
`
`460
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 006
`
`

`

`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`PUBL. FEE- EARLY, VOLUNTARY, OR NORMAL
`
`1504
`
`1
`
`0
`
`0
`
`Petition:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`Miscellaneous:
`
`Total in USO($)
`
`3080
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 007
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`35858839
`
`16397267
`
`International Application Number:
`
`Confirmation Number:
`
`8135
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`First Named Inventor/Applicant Name:
`
`George D. YANCOPOULOS
`
`Customer Number:
`
`96387
`
`Filer:
`
`Karl Bozicevic/Kimberly Zuehlke
`
`Filer Authorized By:
`
`Karl Bozicevic
`
`Attorney Docket Number:
`
`REGN-008CIPCON5
`
`Receipt Date:
`
`29-APR-2019
`
`Filing Date:
`
`Time Stamp:
`
`14:51:44
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully received in RAM
`
`yes
`
`CARD
`
`$3080
`
`RAM confirmation Number
`
`0430191NTEFSW14522800
`
`Deposit Account
`
`Authorized User
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 008
`
`

`

`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`1
`
`Application Data Sheet
`
`REGN-008CIPCON5_2019-04-2
`_ADS.pdf
`
`File Size(Bytes}/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`1256704
`
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`
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`
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`REGN-008CIPCON5_2019-04-2L
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`
`85 2 7 3a4 9 52 96621 a979ffed 2ccd ec65 02c79
`9c0c
`
`yes
`
`24
`
`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Abstract
`
`Claims
`
`Specification
`
`24
`
`23
`
`21
`
`24
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`
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`
`REGN-008CIPCONS_Figure.pdf
`
`no
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`1
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`91bdb
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`Warnings:
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`The page size in the PDF is too large. The pages should be 8.5 x 11 or A4. If this PDF is submitted, the pages will be resized upon entry into the
`Image File Wrapper and may affect subsequent processing
`
`Information:
`
`4
`
`Oath or Declaration filed
`
`REGN-008CIPCONS_declaration
`.pdf
`
`173097
`
`6bda7272374e6af80c8c3d8cf30d012e465
`b588
`
`no
`
`2
`
`Warnings:
`
`The page size in the PDF is too large. The pages should be 8.5 x 11 or A4. If this PDF is submitted, the pages will be resized upon entry into the
`Image File Wrapper and may affect subsequent processing
`
`Information:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 009
`
`

`

`5
`
`46449
`
`REGN-008CIPCON5_2019-04-2L
`_pre_amend_asfld.pdf
`
`ddb00b729b9b8Sf23f25609bea2b88928ef
`dfd95
`
`yes
`
`7
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`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
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`Applicant Arguments/Remarks Made in an Amendment
`
`Claims
`
`Preliminary Amendment
`
`Warnings:
`
`Information:
`
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`
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`
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`
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`
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`
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`
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`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 010
`
`

`

`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT /DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 011
`
`

`

`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`REGN-008CIPCON5
`
`Application Number
`
`Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2:
`D Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`Inventor Information:
`
`Inventor
`11
`Legal Name
`
`Prefix Given Name
`
`I El l3eorge
`
`Residence Information (Select One)
`• US Residency
`I State/Province
`City
`frorktown Heights
`
`I t'JY
`
`Middle Name
`p.
`
`I Remove
`
`I
`
`Family Name
`
`fl'ANCOPOULOS
`Non US Residency
`Active US Military Service
`I Country of ResidencJ
`I f.Js
`
`Suffix
`
`I El
`
`Mailing Address of Inventor:
`
`Address 1
`
`~o Regeneron Pharmaceuticals, Inc.
`
`lf77 Old Saw Mill River Road
`
`Address 2
`I lfarrytown
`City
`Postal Code
`
`I State/Province
`I 110591
`I Countryi
`11us
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`I ~y
`
`I Add
`
`I
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`D An Address is being provided for the correspondence Information of this application.
`Customer Number
`36387
`
`Email Address
`
`docket@bozpal.com
`
`Application Information:
`
`I Add Email I
`
`I
`
`I Remove Email I
`
`Title of the Invention
`
`Attorney Docket Number REGN-008CIPCON5
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`I Small Entity Status Claimed D
`
`Application Type
`
`Non provisional
`
`Subject Matter
`
`Utility
`
`T
`
`T
`
`Total Number of Drawing Sheets (if any)
`
`1
`11
`
`I Suggested Figure for Publication (if any) 111
`
`EFSWeb2.2.13
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2009 PAGE 012
`
`

`

`PTO/AIN14 (02-18)
`Approved for use through 11/30/2020. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number REGN-008CIPCON5
`
`Application Number
`
`Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Filing By Reference:
`Only complete this section when filing an application by reference under 35 U.S.C. 111 (c) and 37 CFR 1.57(a). Do not complete this section if
`application papers including a specification and any drawings are being filed. Any domestic benefit or foreign priority information must be
`provided in the appropriate section(s) below (i.e., "Domestic Benefit/National Stage Information" and "Foreign Priority Information").
`
`For the purposes of a filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
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`115471506
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`114972560
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`ponlinuation of
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`t=xpired
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`Claims benefit of provisional
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`tcT /US2012/020855
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`Claims benefit of provisional
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`1~1
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`~
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`Address 2
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`City
`Country I 1-Js
`Phone Number
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`'77 Old Saw Mill River Road
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`Tarrytown
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`NY
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`10591
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`I ~EGENERON PHARMACEUTICALS, INC.
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`Mailing Address Information For Assignee including Non-Applicant Assignee:
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`r,77 Old Saw Mill River Road
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`I I
`lrarrytown
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`Address 1
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`Address 2
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`City
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`Countryi
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`I f.Js
`Phone Number
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`10591
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