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`SCORE Placeholder Sheetfor IFW Content
`
`Application Number: 17072417
`
`Document Date: 10/16/2020
`
`The presence ofthis form in the IFW recordindicates that the following documenttype wasreceived
`in electronic format on the date identified above. This content is stored in the SCORE database.
`
`Since this was an electronic submission, there is no physical artifact folder, no artifact folder is
`recorded in PALM, and no paper documents or physical media exist. The TIFF images in the IFW
`record were created from the original documents that are stored in SCORE.
`
`SequenceListing
`
`At the time of documententry (noted above):
`e USPTO employees may access SCORE content via DAV or via the SCORE web page.
`e External customers may access SCORE content via PAIR using the Supplemental Content
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`
`Form Revision Date: March 1, 2019
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 001
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 001
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`Electronically Filed
`
`REGN-O08CIPCON6
`
`Eye Disorders”
`
`PRELIMINARY
`AMENDMENT
`Under CFR 1.115
`
`Address to
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Attorney Docket No.
`Confirmation No.
`First Named Inventor
`Application Number
`Filing Date
`Group Art Unit
`Examiner Name Po
`Title:
`“Use ofa VEGF Antagonist to Treat Angiogenic
`
`YANCOPOULOS, GEORGED.
`To Be Assigned
`
`Sir:
`
`Prior to the examination of the above-referenced application on the merits, please enter the
`
`amendments below.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 002
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 002
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`

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`Quantity
`
`eensTe=
`
`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`First Named Inventor/Applicant Name:
`
`George D. YANCOPOULOS
`
`Attorney Docket Number:
`
`REGN-O008CIPCON6
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC 111(a)
`
`Description
`
`Fee Code
`
`Sub-Total in
`
`USD(S)
`
`Claims:
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`CLAIMS IN EXCESS OF 20
`
`1202
`
`3200
`
`Miscellaneous-Filing:
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`REGENERON EXHIBIT 2010 PAGE 003
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`NT
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`202Z2Z-Ulb2e..—t~“Ct~‘C:t:*s
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 003
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`

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`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD(S)
`
`Patent-Appeals-and-Interference:
`
`Total in USD ($)
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time
`
`Miscellaneous:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 004
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 004
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`

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`Electronic AcknowledgementReceipt
`
`Application Number:
`
`17072417
`
`International Application Number:
`
`Confirmation Number:
`
`7325
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`ee
`
`a
`
`Paymentinformation:
`
`APOTEX V. REGENERON IPR2022-01524
`
`[pepotacon
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 005
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`

`

`File Listing:
`
`Pages
`Multi
`File Size(Bytes)/
`DocumentDescription
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`143341
`
`Application Data Sheet
`
`WebADS.pdf
`
`2923394182dacb29dea36a7a5aca461 8c6d
`e1442
`
`Information:
`
`159372
`
`REGN-O008CIPCON6_2020-10-16
`_Appln_as_fld.pdf
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`§a60e89dc83c584ba38225342c1 37aa4a20
`
`Multipart Description/PDF files in .zip description
`
`Information:
`
`mmfe
`
`Specification
`
`Information:
`
`Drawings-only black and whiteline
`.
`drawings
`
`REGN-008CIPCON6_Figure.pdf
`
`2d582f645d0c5d17d717e589b029a393319
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`105393
`
`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 mayaffect subsequent processing
`
`Information:
`
`Oath or Declaration filed
`
`REGN-OO8CIPCON6_declaration}
`.pdf
`
`6bda7272374e6af80c8c3d8cf30d012e465'
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`173097
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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 mayaffect subsequent processing
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 006
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`

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`Transmittal Letter
`
`REGN-O008CIPCON6_2020-10-16
`“IDS_Trans.pdf
`
`5d144817290af42b12711d58c36c67062ae
`79109
`
`Information Disclosure Statement (IDS)|REGN-OO8CIPCON6_2020-10-16
`936a86e4f82aa53a16efSef908b6f7fc573be
`Form (SB08)
`_IDS_SBO8A.pdf
`alb
`
`194906
`
`Information:
`
`This is not an USPTOsupplied IDSfillable form
`
`713a82d721e278305dd15219b3eb58af5fb}
`056c5
`
`REGN-O008CIPCON6_2020-10-16
`_pre_amend.pdf
`
`Information:
`
`Preliminary Amendment
`
`SequenceListing (TextFile)
`
`REGN-O008CIPCON6_SeqList.txt
`
`Information:
`
`Information:
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`8419c46bd61329de183aa14d84168d2205
`768afc
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 007
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 007
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`This AcknowledgementReceipt 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.
`
`the application.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary componentsfora 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 shownonthis
`AcknowledgementReceiptwill 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/EO/903indicating acceptanceof the application asa
`national stage submission under35 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 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this AcknowledgementReceiptwill establish the international filing date of
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 008
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 008
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`PTO/AIA/14
`U.S, Patent and TrademarkOffice; U.S. DEPARTMENT OF COMMERCE
`
`
`
`Suffix
`
`
`
`
`
`
`
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`Attorney Docket Number REGN-008CIPCONG
`
`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 arrangedin a format specified by the United States Patent and TrademarkOffice 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 includedin a paperfiled application.
`
`Secrecy Order 37 CFR 5.2:
`
`Portionsorall of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to 37
`
`L CFR 5.2 (Paperfilers only. Applications thatfall under Secrecy Order may notbefiled electronically.)
`
`Inventor Information:
`
`Ta caaleele
`
`1
`
`Legal Name
`Prefix |GivenName Middle Name
`
`Family Name
`
`Residence Information (Select One)
`City
`Yorktown Heights
`
`(@) US Residency
`State/Province
`
`©)
`
`©) Active US Military Service
`NonUSResidency
`Country of Residence i
`US
`
`Mailing Addressof Inventor:
`
`Address 1
`
`Address 2
`
`c/o Regeneron Pharmaceuticals, Inc.
`
`777 Old Saw Mill River Road
`
`All Inventors Must Be Listed - Additional Inventor Information blocks may be generated
`within this form by selecting the Add button.
`
`CorrespondenceInformation:
`
`Enter either Customer Numberor complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`[_] An Addressis being provided for the correspondence Informationofthis application.
`Customer Number
`96387
`
`
`
`Email Address
`
`docket@bozpat.com
`
`Add Email
`
`Remove Email
`
`Application Information:
`
`Title of the Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Attorney Docket Number|REGN-OO8CIPCONG Small Entity Status Claimed [|
`
`
`
`1 A
`
`Subject Maier
`
`Total Numberof Drawing Sheets(if any)
`
`1
`
`Suggested Figure for Publication (if any)
`
`WEB ADS1.0
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`POTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 009
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 009
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`

`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`REGN-OO8CIPCON6
`oo.
`Attorney Docket Number
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`
`
`
`
`Title of Invention
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`Filing By Reference:
`
`Only complete this section whenfiling an application by reference under 35 U.S.C. 111(c) and 37 CFR 1.57{a). Do not complete this section if
`application papersincluding a specification and any drawings are beingfiled. 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 purposesofa filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previouslyfiled application, subject to conditions and requirements of 37 CFR 1.57(a).
`
`i
`
`Application numberof the previously
`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country
`
`Publication Information:
`
`[_] Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`CO
`
`35 U.S.C.
`Request Not to Publish. | hereby request that the attached application not be published under
`122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of an
`application filed in another country, or under a multilateral international agreement, that requires publication at eighteen
`monthsafterfiling.
`
`
`
`
`
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorneyin the application (see 37 CFR 1.32).
`Either enter Customer Numberor complete the Representative Name section below.If both sections are completed the customer Number
`will be used for the Representative Information during processing.
`
`
`Please Select One:
`Customer Number
`
`(@) Customer Number
`93726
`
`C) USPatent Practitioner
`
`C) Limited Recognition (37 CFR 11.9)
`
`Prefix|GivenName|Middle Name|FamilyName=||FamilyName=||Suffix
`aeeeones
`Registration Number
`Prefix|GivenName|Middle Name|FamilyName=|Name|Suffix
`—Te
`Registration Number
`
`Additional Representative Information blocks may be generated within this form by
`selecting the Add button.
`
`WEB ADS 1.0
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 010
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 010
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`

`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76 Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Domestic Benefit/National Stage Information:
`This section allowsfor the applicantto either claim benefit under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) or indicate National
`Stage entry from a PCT application. Providing benefit claim information in the Application Data Sheet constitutes the specific
`reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`Whenreferring to the current application, please leave the “Application Number”field blank.
`
` l
`
`Application Number
`
`Continuity Type
`
`|
`
`
`
`2018-08-06
`16055847
`Continuation of
`
`
`
`Remove
`Prior Application Status
`
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Continuation of
`
`16397267
`
`
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`2019-04-29
`
`
` Remove
` Prior Application Status|Pending
`
`Filing or 371(c) Date
`Application Number
`Continuity Type
`Prior Application Number
`(YYYY-MM-DD}
`
`16397267
`
`Continuation of
`
`16159282
`
`2018-10-12
`
`Issue Date
`Filing Date
`Prior Application
`4
`Application
`(YYYY-MM-DD)
`Patent Number
`(YYYY-MM-DD)
`Number
`Continuity Type
`Number
`
`16159282
`Continuation of
`15471506
`2017-03-28
`10130681
`2018-11-20
`
`
`
`
`Application
`Number
`15471506
`
`4
`Continuity Type
`
`Prior Application
`Number
`14972560
`
`Filing Date
`(YYYY-MM-DD)
`2015-12-17
`
`Patent Number
`9669069
`
`Issue Date
`(YYYY-MM-DD)
`2017-06-06
`
`Application
`Number
`14972560
`
`a
`Continuity Type
`
`Prior Application
`Number
`13940370
`
`Filing Date
`(YYYY-MM-DD)
`2013-07-12
`
`Patent Number
`9254338
`
`Issue Date
`(YYYY-MM-DD)
`2016-02-09
`
`Prior Application Status|Expired
`
`Filing or 371(c) Date
`(YYYY-MM-DD}
`
`Continuity Type
`
`Prior Application Number
`
`Application Number
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`13940370
`WEBADS1.0
`
`Continuation in part of
`
`2012-01-11
`PCT/US2012/020855
`APOTEX V. REGENERON IPR2022-01524
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`G
`°
`peers
`REGENERON EXHIBIT 2010 PAGE 011
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`Prior Application Number
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`Filing or 371(c) Date
`(YYYY-MM-DD)
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 011
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`

`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`REGN-OO8CIPCON6
`oo.
`Attorney Docket Number
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`
`
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`Title of Invention
`
`
` Remove
`
`
`Prior Application Status|Expired
`
`Filing or 3/1(c) Date
`
`
`Continuity Type
`Prior Application Number
`(YYYY-MM-DD)
`
`
`
`61432245
`2011-01-13
` PCT/US2012/020855
`Claims benefit of provisional
`
`
`
`
`Application Number
`
`
`Prior Application Status
`
`Remove
`
`
`Filing or 3/1(c) Date
`(YYYY-MM-DD)
`
`
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`
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`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`PCT/US2012/020855
`Claims benefit of provisional
`61434836
`2011-01-21
`
`Prior Application Status Remove
`
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing or 3/1(c} Date
`(YYYY-MM-DD)
`
`2011-11-21
`61561957
`Claims benefit of provisional
`PCT/US2012/020855
`
`Additional Domestic Benefit/National Stage Data may be generated within this form by
`selecting the Add button.
`
`Foreign Priority Information:
`
`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55. When priority is claimed to a foreign application thatis eligible
`for retrieval underthe priority document exchange program (PDX) the information Will be used by the Office to automatically attempt retrieval
`pursuant to 37 CFR 1.55(i)(1) and (2). Under the PDX program,applicant bears the ultimate responsibility for ensuring that a copy of the foreign
`
`application is received by the Office from the participating foreign intellectual property office, or a certified copy of the foreign priority
`
`application is filed, within the time period specified in 37 CFR 1.55{g){1).
`
`
`
`Application Number
`
`Additional Foreign Priority Data may be generated within this form by selecting the Add
`button.
`
`Access Code if applicable)
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventorto File) Transition
`Applications
`
`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effectivefiling date on or after March
`[] 16, 2013.
`NOTE:By providing this statement under 37 CFR 1.55 or 1.78, this application, withafiling date on or after March
`
`16, 2013, will be examined underthefirst inventorto file provisions of the AIA.
`
`WEB ADS1.0
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`REGENERON EXHIBIT 2010 PAGE 012
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2010 PAGE 012
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`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Application Data Sheet 37 CFR 1.76 Title of Invention
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`Whenthis Application Data Sheet is properly signed andfiled with the application, applicant has provided written authority to
`permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see paragraph A in
`subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant application {see
`paragraph B in subsection 1 below).
`
`Should applicant choose notto provide an authorization identified in subsection 1 below, applicant must opt-out of the
`authorization by checking the corresponding box A or B or both in subsection 2 below.
`
`NOTE:This section of the Application Data Sheet is ONLY reviewed and processed with the INITIALfiling of an application.
`After theinitial filing of an application, an Application Data Sheet cannot be used to provide or rescind authorization for access
`by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
`
`
`A. Priority Document Exchange {PDX} - Unless box Ain subsection 2 (opt-out of autharization) is checked, the undersigned
`hereby grants the USPTO authority to provide the European Patent Office {EPO}, the Japan Patent Office (JPO), the Korean
`Intellectual Property Office (KIPO), the State Intellectual Property Office of the People’s Republic of China (SIPO), the World
`Intellectual Property Organization (WIPO), and any otherforeign intellectual property office participating with the USPTO ina
`bilateral or multilateral priority document exchange agreementin whicha foreign application claiming priority to the instant
`patent application is filed, access to: (1} the instant patent application-as-filed and its related bibliographic data, (2) any foreign
`or domestic application to which priority or benefit is claimed by the instant application and its related bibliographic data, and
`(3) the date offiling of this Authorization. See 37 CFR 1.14(h}(1).
`
`
`B. Search Results from U.S. Application to EPO - Unless box B in subsection 2 (opt-out of authorization) is checked, the
`undersigned hereby grants the USPTO authority to provide the EPO accessto the bibliographic data and search results from
`the instant patent application when a European patent application claiming priority to the instant patent applicationis filed. See
`37 CFR 1.14(h)(2).
`
`The applicant is reminded that the EPO’s Rule 141(1) EPC (European Patent Convention) requires applicants to submit a copy of
`search results from the instant application without delay in a European patent application that claims priority to the instant
`application.
`
`
`
`
`
`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s)
`
`[_]
`
`A. Applicant DOES NOT authorize the USPTOto permit a participating foreign IP office access to the instant
`application-as-filed. If this box is checked, the USPTOwill not be providing a participating foreign IP office with any
`documents and information identified in subsection 1A above.
`
`Oo
`
`B. Applicant DOES NOT authorize the USPTOto transmit to the EPO anysearch results from the instant patent
`application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant application.
`
`NOTE: Oncethe application has published oris otherwise publicly available, the USPTO may provide access to the application in
`accordance with 37 CFR 1.14.
`
`WEB ADS1.0
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`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Application Data Sheet 37 CFR 1.76 Title of Invention
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirementof part 3 of Title 37 of CFR to have
`an assignment recorded by the Office.
`
`Ye)e1is: 11 ae
`If the applicantis the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed. The
`information to be providedin this section is the name and addressof the legal representative whois the applicant under 37 CFR 1.43; or the
`name and address of the assignee, person to whomthe inventoris under an obligation to assign the invention, or person who otherwise shows
`sufficient proprietary interest in the matter whois the applicant under 37 CFR 1.46. If the applicantis an applicant under 37 CFR 1.46 (assignee,
`person to whom the inventor is obligated to assign, or person who otherwise showssufficient proprietary interest) together with one or more
`joint inventors, then the joint inventor or inventors who are also the applicant should be identified in this section.
`
`©) Assignee
`
`
`
`©) Legal Representative under 35 U.S.C. 117
`
`QC)
`
`Joint Inventor
`
`Clear
`
`
`
`Person who showssufficient proprietary interest
`QO
`(@) Person to whom theinventoris obligated to assign.
`
`If applicant is the legal representative, indicate the authority to file the patent application, the inventoris:
`
`
`
`
`
`Nameofthe Deceased or Legally Incapacitated Inventor: Po
`If the Applicantis an Organization check here.
`x]
`Organization Name
`REGENERON PHARMACEUTICALS,INC.
`
`Mailing Address Information For Applicant:
`
`Address1
`
`Address 2
`
`777 Old Saw Mill River Road
`
`Email Address
`
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`WEB ADS1.0
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`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76 Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Assignee Information including Non-Applicant Assignee Information:
`
`Providing assignmentinformationin this section does not substitute for compliance with any requirementofpart 3 ofTitle 37 of
`
`CFR to have an assignmentrecorded by the Office.
`
`1
`Assignee
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent application
`publication. An assignee-applicant identified in the "Applicant Information" section will appear on the patent application publication as an
`applicant. For an assignee-applicant, complete this section onlyif identification as an assigneeis also desired on the patent application
`publication.
`
`If the Assignee or Non-Applicant Assignee is an Organization check here.
`Organization Name
`REGENERON PHARMACEUTICALS,INC.
`
`Mailing Address Information For Assignee including Non-Applicant Assignee:
`
`x]
`
`
`
`
`
`777 Old Saw Mill River Road
`
`Address 1
`
`Address 2
`
`Email Address
`
`Additional Assignee or Non-Applicant Assignee Data may be generated within this form by
`selecting the Add button.
`
`WEB ADS1.0
`
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`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Signature:
`NOTE:This Application Data Sheet must be signed in accordance with 37 CFR 1.33(b). However,if this Application Data Sheet
`is submitted with the INITIALfiling of the application and either box A or B is not checked in subsection 2 of the
`“Authorization or Opt-Out of Authorization to Permit Access” section, then this form must also be signed in accordance
`with 37 CFR 1.14(c).
`This Application Data Sheet must be signed by a patent practitioner if one or more of the applicants is ajuristic entity (e.
`g., corporation or association).If the applicant is two or more joint inventors, this form must be signed by a patentpractitioner,
`all joint inventors who are the applicant, cr one or morejoint inventor-applicants who have been given powerofattorney(e.g.,
`see USPTO Form PTO/AIA/81) on behalf ofall joint inventor-applicants.
`See 37 CFR 1.4(d) for the manner of making signatures and certifications.
`
`Application Data Sheet 37 CFR 1.76 Title of Invention
`
`
`Additional Signature may be generated within this form by selecting the Add button.
`
`/Karl Bozicevic/
`
`Date (YYYY-MM-DD)
`
`WEB ADS1.0
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`Atty Dkt.. No. REGN-008CIPCON6
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`ABSTRACT
`
`The present invention provides methods for treating angiogenic eye disorders by sequentially
`
`administering multiple doses of a VEGF antagonist to a patient. The methodsof the present
`
`invention include the administration of multiple doses of a VEGF antagonist to a patient at a
`
`frequency of once every 8 or more weeks. The methods of the present invention are useful for the
`
`treatment of angiogenic eye disorders such as age related macular degeneration, diabetic
`
`retinopathy, diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion,
`
`and corneal neovascularization.
`
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`Whatis claimedis:
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`Atty Dkt.. No. REGN-008CIPCON6
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`1.
`
`A method for treating an angiogenic eye disorder in a patient, said method comprising
`
`sequentially administering to the patient a single initial dose of a VEGF antagonist, followed by one
`
`or more secondary dosesof the VEGF antagonist, followed by one or moretertiary doses of the
`
`VEGF antagonist;
`
`wherein each secondary dose is administered 2 to 4 weeksafter the immediately preceding
`
`dose; and
`
`wherein eachtertiary dose is administered at least 8 weeks after the immediately preceding
`
`dose.
`
`2.
`
`The method of claim 1, wherein only a single secondary dose is administered to the
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`patient, and wherein the single secondary dose is administered 4 weeksafter the initial dose of the
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`VEGF antagonist.
`
`3.
`
`The method of claim 1, wherein only two secondary doses are administered to the
`
`patient, and wherein each secondary doseis administered 4 weeksafter the immediately preceding
`
`dose.
`
`4.
`
`The method of claim 3, wherein each tertiary dose is administered 8 weeksafter the
`
`immediately preceding dose.
`
`5.
`
`The method of claim 1, wherein at least 5 tertiary doses of the VEGF antagonist are
`
`administered to the patient, and wherein the first four tertiary doses are administered 8 weeksafter
`
`the immediately preceding dose, and wherein each subsequenttertiary dose is administered 8 or
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`12 weeks after the immediately preceding dose.
`
`6.
`
`The method of claim 1, wherein the angiogenic eye disorder is selected from the
`
`group consisting of: age related macular degeneration, diabetic retinopathy, diabetic macular
`
`edema, central retinal vein occlusion, branch retinal vein occlusion, and corneal neovascularization.
`
`7.
`
`The method of claim 6, wherein the angiogenic eye disorderis age related macular
`
`degeneration.
`
`8.
`
`The method of claim 1, wherein the VEGF antagonist is an anti-VEGF antibody or
`
`fragmentthereof, an anti-VEGF receptor antibody or fragment thereof, or a VEGF receptor-based
`
`chimeric molecule.
`
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`9.
`
`The method of claim 8, wherein the VEGF antagonist is a VEGF receptor-based
`
`chimeric molecule.
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`Atty Dkt.. No. REGN-008CIPCON6
`
`10.
`
`The method of claim 9, wherein the VEGF receptor-based chimeric molecule
`
`comprises VEGFR1R2-FcAC1(a) encoded by the nucleic acid sequence of SEQ ID NO:1.
`
`11.
`
`The method of claim 9, wherein the VEGF receptor-based chimeric molecule
`
`comprises (1) a VEGFR1 component comprising amino acids 27 to 129 of SEQ ID NO:2; (2) a
`
`VEGFR2 component comprising amino acids 130-231 of SEQ ID NO:2; and (3) a multimerization
`
`component comprising amino acids 232-457 of SEQ ID NO:2.
`
`12.
`
`The method of claim 1, wherein all doses of the VEGF antagonist are administered to
`
`the patient by topical administration or by intraocular administration.
`
`13.
`
`The method of claim 12, wherein all doses of the VEGF antagonist are administered
`
`to the patient by intraocular administration.
`
`14.
`
`The method of claim 13, wherein the intraocular administration is intravitreal
`
`administration.
`
`15.
`
`The method of claim 11, wherein all doses of the VEGF antagonist are administered
`
`to the patient by topical administration or by intraocular administration.
`
`16.
`
`The method of claim 15, wherein all doses of the VEGF antagonist are administered
`
`to the patient by intraocular administration.
`
`17.
`
`The method of claim 16, wherein the intraocular administration is intravitreal
`
`administration.
`
`18.
`
`The method of claim 17, wherein all doses of the VEGF antagonist comprise from
`
`about 0.5 mg to about 2 mg of the VEGF antagonist.
`
`19.
`
`The method of claim 18, wherein all doses of the VEGF antagonist comprise 0.5 mg
`
`of the VEGF antagonist.
`
`20.
`
`The method of claim 18, wherein all doses of the VEGF antagonist comprise 2 mg of
`
`the VEGF antagonist.
`
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`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Atty Dkt.. No. REGN-008CIPCON6
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`This application is a continuation of 16/055,847 filed August 6, 2018 and is a continuation
`
`of 16/397,267filed April 29, 2019 which is a continuation 16/159,282 filed October 12, 2018, which
`
`is a continuation of 15/471 ,506 filed March 28, 2017, now U.S. Patent No. 10,130,681 issued
`
`November20, 2018, which is a continuation of 14/972,560 filed December 17, 2015, now U.S.
`
`Patent No. 9,669,069 issued June 6, 2017, which is a continuation of 13/940,370filed July 12,
`
`2013, now U.S. Patent No. 9,254,338 issued February 9, 2016, which is a continuation-in-partof
`
`International Patent Application No. PCT/US2012/020855, filed on January 11, 2012, which claims
`
`the benefit of US Provisional Application Nos. 61/432,245, filed on January 13, 2011, 61/434,836,
`
`filed on January 21, 2011, and 61/561 ,957, filed on November 21, 2011, the contents of which are
`
`hereby incorporated by referencein their entireties.
`
`FIELD OF THE INVENTION
`
`[0002]
`
`The present invention relates to the field of therapeutic treatments of eye disorders. More
`
`specifically, the invention relates to the administration of VEGF antagonists to treat eye disorders
`
`caused byor associated with angiogenesis.
`
`BACKGROUND
`
`[0003]
`
`Several eye diso