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`9306€40
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`TO4Mm,TOWS(N[tlEESilEl EWSFiIIUSJ gmlqE' gP!@13
`UMTED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`
`October 20,2AZZ
`THIS IS TO CERTIFY TIIAT ANNEXED IS A TRUE COPY FROM TIIE
`REC0RDSoFTHIS0FFICEoFTIIEFILEWRAPPERANDCONTENTS
`OF:
`
`APPLICATION NUMBER: 17/3 52,892
`FILING DATE: June 21,2021
`PATENT NUMBER; I 1,253'572
`ISSUE DATE: February 22,2022
`
`By AuthoritY of the
`Under SecretarY of Commerce for Intellectual ProPe*Y
`and
`and Director of the United States Patent
`
`0ffice
`
`Certiffing Officer
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`
`ft
`
`h
`
`October 20,2022
`
`THIS IS TO CERTIFY THAT ANNEXED IS A TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`-■4
`
`APPLICATION NUMBER: 17/352,892
`FILING DATE: June 21, 2021
`PATENT NUMBER: 11,253,572
`ISSUE DATE: February 22, 2022
`
`By Authority of the
`Under Secretary of Commerce for Intellectual Property
`and Director of the United States Patent and Trademark Office
`
`Curtis Goffe
`Certifying Officer
`
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 001
`
`

`

`DocCode - SEQ.TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 17352892
`
`Document Date: 06/21/2021
`
`The presence of this form in the IFW record indicates that the following document type was received
`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.
`
`* Sequence Listing
`
`At the time of document entry (noted above):
`• USPTO employees may access SCORE content via DAV or via the SCORE web page.
`• External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: March 1,2019
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 002
`
`

`

`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-008CIPCON10
`To Be Assigned
`Confirmation No.
`First Named Inventor
`YANCQPQULQS, GEORGE D.
`To Be Assigned
`Application Number
`June 21, 2021
`Filing Date
`To Be Assigned
`Group Art Unit
`Examiner Name
`To Be Assigned
`Title: “Use of a VEGF Antagonist to Treat Angiogenic
`_______ Eye Disorders ”____________________________
`
`Prior to the examination of the above-referenced application on the merits, please enter the
`amendments below.
`
`Amendments to the claims begin on page 2.
`Remarks begin on page 7.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 003
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`AMENDMENTS TO THE CLAIMS
`
`1.-20. (Canceled)
`
`(New) A method of treating an angiogenic eye disorder in a patient in need
`21.
`thereof comprising sequentially administering to the patient by intravitreal injection a single initial dose
`of 2 mg of aflibercept, followed by one or more secondary doses of 2 mg of aflibercept, followed by one
`or more tertiary doses of 2 mg of aflibercept;
`wherein each secondary dose is administered approximately 4 weeks following
`the immediately preceding dose; and
`wherein each tertiary dose is administered approximately 8 weeks following the
`immediately preceding dose;
`wherein the patient achieves a gain in visual acuity within 52 weeks following
`
`the initial dose.
`
`(New) The method of claim 21 wherein the patient achieves a gain in Best
`22.
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`letter score.
`
`(New) The method of claim 22 wherein the patient gains at least 7 letters Best
`23.
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`letter score.
`
`(New) The method of claim 23 wherein the patient achieves the gain in visual
`24.
`acuity within 24 weeks following the initial dose.
`
`(New) The method of claim 23 wherein only two secondary doses are
`25.
`administered to the patient.
`
`2
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 004
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`(New) The method of claim 23 wherein the aflibercept is formulated as an
`
`(New) The method of claim 23 wherein the aflibercept is formulated with a non­
`
`26.
`isotonic solution.
`
`27.
`ionic surfactant.
`
`28. (New) The method of claim 22 wherein the patient gains at least 8 letters Best
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`letter score.
`
`29. (New) The method of claim 28 wherein the patient achieves the gain in visual
`acuity within 24 weeks following the initial dose.
`
`30. (New) The method of claim 22 wherein the patient gains at least 9 letters Best
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`letter score.
`
`(New) The method of claim 30 wherein only two secondary doses are
`31.
`administered to the patient.
`
`32.
`isotonic solution.
`
`33.
`ionic surfactant.
`
`(New) The method of claim 30 wherein the aflibercept is formulated as an
`
`(New) The method of claim 30 wherein the aflibercept is formulated with a non­
`
`34.
`
`(New) The method of claim 21 wherein exclusion criteria for the patient include
`
`both of:
`
`(1) active ocular inflammation; and
`(2) active ocular or periocular infection.
`
`3
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 005
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`(New) A method of treating diabetic macular edema in a patient in need thereof
`35.
`comprising sequentially administering to the patient a single initial dose of 2 mg of aflibercept, followed
`by one or more secondary doses of 2 mg of aflibercept, followed by one or more tertiary doses of 2 mg
`of aflibercept;
`
`wherein each secondary dose is administered to the patient by intravitreal
`injection approximately 4 weeks following the immediately preceding dose; and
`wherein each tertiary dose is administered to the patient by intravitreal injection
`approximately 8 weeks following the immediately preceding dose.
`
`36. (New) The method of claim 35 wherein the patient achieves a gain in visual
`acuity within 52 weeks following the initial dose.
`
`37. (New) The method of claim 36 wherein the patient gains at least 9 letters Best
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`letter score.
`
`38.
`isotonic solution.
`
`39.
`ionic surfactant.
`
`(New) The method of claim 37 wherein the aflibercept is formulated as an
`
`(New) The method of claim 37 wherein the aflibercept is formulated with a non­
`
`40. (New) The method of claim 37 wherein the patient achieves a gain in visual
`acuity within 24 weeks following the initial dose.
`
`41. (New) The method of claim 36 wherein the patient gains at least 8 letters Best
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`letter score.
`
`4
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 006
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`(New) The method of claim 41 wherein the aflibercept is formulated as an
`
`(New) The method of claim 41 wherein the aflibercept is formulated with a non­
`
`42.
`isotonic solution.
`
`43.
`ionic surfactant.
`
`(New) The method of claim 35 wherein only two secondary doses are
`44.
`administered to the patient.
`
`45.
`
`(New) The method of claim 35 wherein four secondary doses are administered to
`
`the patient.
`
`(New) A method of treating age related macular degeneration in a patient in need
`46.
`thereof comprising sequentially administering to the patient a single initial dose of 2 mg of aflibercept,
`followed by one or more secondary doses of 2 mg of aflibercept, followed by one or more tertiary doses
`of 2 mg of aflibercept;
`
`wherein each secondary dose is administered to the patient by intravitreal
`injection approximately 4 weeks following the immediately preceding dose; and
`wherein each tertiary dose is administered to the patient by intravitreal
`injection approximately 8 weeks following the immediately preceding dose;
`wherein the method is as effective in achieving a gain in visual acuity as
`monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with
`age-related macular degeneration at 52 weeks following the initial dose.
`
`(New) The method of claim 46 wherein only two secondary doses are
`47.
`administered to the patient.
`
`(New) The method of claim 46 wherein the gain in visual acuity is measured
`48.
`using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
`
`5
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 007
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`(New) A method of treating age-related macular degeneration in a patient in need
`49.
`thereof comprising sequentially administering to the patient a single initial dose of 2 mg of aflibercept,
`followed by one or more secondary doses of 2 mg of aflibercept, followed by one or more tertiary doses
`of 2 mg of aflibercept;
`
`wherein each secondary dose is administered to the patient by intravitreal
`injection approximately 4 weeks following the immediately preceding dose; and
`wherein each tertiary dose is administered to the patient by intravitreal
`injection approximately 8 weeks following the immediately preceding dose;
`wherein the method is as effective in maintaining visual acuity as monthly
`administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-
`related macular degeneration at 52 weeks following the initial dose.
`
`50. (New) The method of claim 49 wherein maintenance of visual acuity means loss
`of less than 15 letters Best Corrected Visual Acuity (BCVA) as measured by using the Early Treatment
`Diabetic Retinopathy Study (ETDRS) letter score.
`
`6
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 008
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`Remarks Under 37 CFR § 1.115
`
`Formal Matters
`Claims 21-50 are pending after entry of the amendments set forth herein.
`Original claims 1-20 are canceled without prejudice.
`Claims 21-50 are added here.
`Support for new claims 21-50 can be found in originally pending now canceled claims 1-20, and
`throughout the specification.
`No new matter has been added.
`
`Sequence Listing
`Applicants submit herewith the attached Sequence Listing in .txt format. As set out in MPEP
`§2422.03(a), the Office has advised that if the sequence listing text file submitted via EFS-Web
`complies with the requirements of 37 CFR 1.824(a)(2)-(6) and (b) (i.e., is a compliant sequence listing
`ASCII text file), the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the
`computer readable form (CRF) required by 37 CFR 1.821(e). Further, per MPEP §2422.03(a), neither
`(1) a second copy of the sequence listing in a PDF file; nor (2) a statement under 37 CFR 1.821(f)
`(indicating that the paper copy and CRF copy of the sequence listing are identical) should be submitted.
`The Sequence Listing was prepared with the software FASTSEQ for Windows version 4.0, and
`conforms to the Patent Office guidelines. Applicant respectfully submits that the subject application is
`in adherence to 37 CFR §§ 1.821-1.825. I hereby certify that the enclosed submission includes no new
`matter.
`
`Applicants respectfully submit that the present patent application is now in compliance with 37
`CFR §§ 1.821-1.825.
`
`Statement under 37 C.I .R. §§1.56 and 1.2
`Applicants hereby advise the Examiner of the status of a co-pending application in compliance
`with the Applicant’s duty to disclose under 37 C.F.R. §§1.56 and 1.2 ( see also MPEP §2001.06(b)) as
`discussed in McKesson Info. Soln. Inc., v. Bridge Medical Inc., 487 F.3d 897; 82 USPQ2d 1865 (Fed.
`Cir. 2007).
`
`7
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 009
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`The Applicant wishes to bring to the Examiner’s attention ET.S. Patent Application No.
`13/940,370, filed July 12, 2013 which issued on February 9, 2016 as U.S. Patent 9,254,338, for
`which Inter Partes Review No. IPR2021-00881 was filed on May 5, 2021.
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`14/972,560, filed December 17, 2015 which issued on June 6, 2017 as U.S. Patent No. 9,669,069,
`for which Inter Partes Review No. IPR2021-00880 was filed on May 5, 2021.
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`15/471,506, filed March 28, 2017 which issued on November 20, 2018 as U.S. Patent No. 10,130,681.
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`16/055,847, filed August 6, 2018 which will issue on December 8, 2020 as U.S. Patent No. 10,857,205.
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`16/159,282, filed October 12, 2018 which issued on November 10, 2020 as U.S. Patent No. 10,828,345,
`for which Post-Grant Review No. PGR2021-00035 was filed on January 7, 2021.
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`No. 16/397,267, filed April 29, 2019, which issued on January 12, 2021 as U.S. Patent No.
`10,888,601.
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`No. 17/072,417, filed October 16, 2020 for which no actions have been mailed.
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`17/112,063, filed December 4, 2020 for which no actions have been mailed.
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`No. 17/112,404 filed December 4, 2020 for which no actions have been mailed.
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`No. 17/350,958 filed June 17, 2021 for which no actions have been mailed.
`These documents are available on PAIR, and thus are not provided with this
`communication. Please inform the undersigned if there is any difficulty in obtaining the documents
`from PAIR.
`
`8
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 010
`
`

`

`Atty Dkt. No.: REGN-008CIPCON10
`USSN: To Be Assigned
`
`Conclusion
`Applicant submits that all of the claims are in condition for allowance, which action is requested.
`If the Examiner finds that a telephone conference would expedite the prosecution of this application,
`please telephone the undersigned at the number provided.
`The Commissioner is hereby authorized to charge any underpayment of fees up to a strict limit of
`$3,000.00 beyond that authorized on the credit card, but not more than $3,000.00 in additional fees due
`with any communication for the above referenced patent application, including but not limited to any
`necessary fees for extensions of time, or credit any overpayment of any amount to Deposit Account No.
`50-0815, order number REGN-008CIPCON10.
`
`Respectfully submitted,
`BOZICEVIC, FIELD & FRANCIS LLP
`
`Date:
`
`June 21. 2021
`
`By: /Karl Bozicevic, Reg. No. 28,807/
`Karl Bozicevic, Reg. No. 28,807
`
`Bozicevic, Field & Francis LLP
`201 Redwood Shores Parkway, Suite 200
`Redwood City, California 94065
`Telephone: (650) 327-3400
`Direct: (650) 833-7735
`Facsimile: (650) 327-3231
`
`9
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 011
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONISTTO TREAT ANGIOGENIC EYE DISORDERS
`
`First Named Inventor/Applicant Name:
`
`George YANCOPOU LOS
`
`Filer:
`
`Karl Bozicevic/Kimberly Zuehlke
`
`Attorney Docket Number:
`
`REGN-008CIPCON10
`
`Filed as Large Entity
`
`Filing Fees for Track I Prioritized Examination - Nonprovisional Application under 35 USC 111 (a)
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($)
`
`Basic Filing:
`
`UTILITY APPLICATION FILING
`
`UTILITY SEARCH FEE
`
`UTILITY EXAMINATION FEE
`
`REQUEST FOR PRIORITIZED EXAMINATION
`
`1011
`
`1111
`
`1311
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`1817
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`1
`
`1
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`1
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`1
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`320
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`700
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`800
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`320
`
`700
`
`800
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`4200
`
`4200
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`Pages:
`
`Claims:
`
`CLAIMS IN EXCESS OF 20
`
`1202
`
`10
`
`100
`
`1000
`
`Miscellaneous-Filing:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 012
`
`

`

`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`PUBL. FEE- EARLY, VOLUNTARY, OR NORMAL
`
`PROCESSING FEE, EXCEPT PROV. APPLS.
`
`1504
`
`1830
`
`1
`
`1
`
`0
`
`140
`
`Sub-Total in
`USD($)
`
`0
`
`140
`
`Petition:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-lssuance:
`
`Extension-of-Time:
`
`Miscellaneous:
`
`Total in USD ($)
`
`7160
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 013
`
`

`

`Electronic Acknowledgement Receipt
`
`EFS ID:
`
`Application Number:
`
`43040441
`
`17352892
`
`International Application Number:
`
`Confirmation Number:
`
`5070
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONISTTO TREAT ANGIOGENIC EYE DISORDERS
`
`First Named Inventor/Applicant Name:
`
`George YANCOPOU LOS
`
`Customer Number:
`
`96387
`
`Filer:
`
`Karl Bozicevic/Kimberly Zuehlke
`
`Filer Authorized By:
`
`Karl Bozicevic
`
`Attorney Docket Number:
`
`REGN-008CI PCON 10
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`21-J UN-2021
`
`15:17:13
`
`Application Type:
`
`Utility under 35 USC 111(a)
`
`Payment information:
`
`Submitted with Payment
`Payment Type
`Payment was successfully received in RAM
`RAM confirmation Number
`
`yes
`
`CARD
`
`$7160
`
`E20216KF17320356
`
`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 2013 PAGE 014
`
`

`

`File Listing:
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`Number
`
`Document Description
`
`File Name
`
`File Size(Bytes)/
`Message Digest
`
`Multi
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`
`Pages
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`1
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`
`WebADS.pdf
`
`Warnings:
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`
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`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 015
`
`

`

`5
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`Form (SB08)
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`Warnings:
`Information:
`
`This is not an USPTO supplied IDS fillable form
`
`8
`
`REGN-008CI PCON 10_2021 -06-2
`1_Track-
`One_Preliminary_Amendment.
`pdf
`
`58360
`
`2939ef005bd2ff14fa87d73f738ca32cf058a
`099
`
`yes
`
`9
`
`Multipart Description/PDF files in .zip description
`
`Document Description
`
`Start
`
`End
`
`Preliminary Amendment
`
`Claims
`
`Applicant Arguments/Remarks Made in an Amendment
`
`Warnings:
`Information:
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`1
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`6
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`9
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`1
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`2
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`7
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`6473
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`9
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`Sequence Listing (Text File)
`
`REGN-008CIPCON10_SeqList.
`txt
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`no
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`Warnings:
`Information:
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`APOTEX V. REGENERON IPR2022-01524
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`10
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`Fee Worksheet (SB06)
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`fee-info.pdf
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`no
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`2
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`cea833df2cffe6106b85cd32215d976d8b89
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`Warnings:
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`Total Files Size (in bytes):
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`1077067
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`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. Ill
`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
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`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 1810), a Notification of the International Application Number
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 017
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`

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`PTO/AIA/14
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`Application Number
`
`REGN-008CIPCON10
`
`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:
`n
`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:
`
`1
`
`Inventor
`Legal Name
`Prefix
`Given Name
`
`Middle Name
`
`George
`Residence Information (Select One)
`City
`Yorktown Heights
`
`(•) US Residency
`State/Province
`
`Mailing Address of Inventor:
`
`Family Name
`
`YANCOPOULOS
`
`Suffix
`
`Q Non US Residency Q Active US Military Service
`Country of Residence
`
`US
`
`NY
`
`c/o Regeneron Pharmaceuticals, Inc.
`
`777 Old Saw Mill River Road
`
`Address 1
`Address 2
`State/Province
`City
`Country i
`Postal Code
`10591
`US
`All Inventors Must Be Listed - Additional Inventor Information blocks may be generated
`within this form by selecting the Add button.
`
`Tarrytown
`
`NY
`
`Add
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`| | An Address is being provided for the correspondence Information of this application.
`
`Customer Number
`Email Address
`
`96387
`
`docket@bozpat.com
`
`Add Email
`
`Remove Email
`
`Application Information:
`Title of the Invention
`Attorney Docket Number
`Application Type
`Subject Matter
`Total Number of Drawing Sheets (if any)
`
`Nonprovisional
`
`Utility
`
`WEB ADS 1.0
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`Small Entity Status Claimed
`
`REGN-008CIPCON10
`
`□
`
`1
`
`Suggested Figure for Publication (if any)
`
`1
`
`APOTEX V. REGENERON IPR2022-01524
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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
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`Attorney Docket Number
`Application Number
`
`REGN-008CIPCON10
`
`Application Data Sheet 37 CFR 1.76
`
`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").
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`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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`•i-
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`| | Request Early Publication {Fee required at time of Request 37 CFR 1.219)
`RGC|UGSt Not to Publish. I hereby request that the attached application not be published under 35 U.S.C.
`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
`months after filing.
`
`n R
`
`epresentative 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 attorney in the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer Number
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`
`Please Select One:
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`96387
`Given Name
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`Given Name
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`Prefix
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`Registration Number
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`Middle Name
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`
`Suffix
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`Middle Name
`
`Family Name
`
`Suffix
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`Remove
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`Remove
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`Additional Representative Information blocks may be generated within this form by
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`WEB ADS 1.0
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 019
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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
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`Attorney Docket Number
`Application Number
`
`REGN-008CIPCON10
`
`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 allows for the applicant to 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.
`When referring to the current application, please leave the "Application Number" field blank.
`
`Prior Application Status Pending
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`Continuation of
`
`17350958
`
`2021-06-17
`
`Prior Application Status Pending
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`17350958
`
`Continuation of
`
`17112404
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`2020-12-04
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`Prior Application Status Pending
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`Application Number
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`Continuity Type
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`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`17112404
`
`Continuation of
`
`17072417
`
`2020-10-16
`
`Prior Application Status
`Application
`Number
`
`Continuity Type
`
`Patented
`
`Remove
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`17072417
`
`Continuation of
`
`16055847
`
`2018-08-06
`
`10857205
`
`2020-12-08
`
`Prior Application Status
`Application
`Number
`
`Continuity Type
`
`Patented
`
`Remove
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`17072417
`
`Continuation of
`
`16397267
`
`2019-04-29
`
`10888601
`
`Prior Application Status
`Application
`Number
`
`Continuity Type
`
`Patented
`
`Remove
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`16397267
`
`Continuation of
`
`16159282
`
`2018-10-12
`
`10828345
`
`Issue Date
`(YYYY-MM-DD)
`
`2021-01-12
`
`Issue Date
`(YYYY-MM-DD)
`
`2020-11-10
`
`Prior Application Status
`Application
`Number
`
`Continuity Type
`
`Patented
`
`Remove
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`16159282
`
`Continuation of
`
`15471506
`
`2017-03-28
`
`10130681
`
`2018-11-20
`
`WEB ADS 1.0
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2013 PAGE 020
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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
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`Attorney Docket Number
`Application Number
`
`REGN-008CIPCON10
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Prior Application Status
`Application
`Number
`
`Continuity Type
`
`Patented
`
`Remove
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`15471506
`
`Continuation of
`
`14972560
`
`2015-12-17
`
`9669069
`
`2017-06-06
`
`Prior Application Status
`Application
`Number
`
`Continuity Type
`
`Patented
`
`Remove
`
`Prior Application
`Number
`
`Filing Date
`(YYYY-MM-DD)
`
`Patent Number
`
`Issue Date
`(YYYY-MM-DD)
`
`14972560
`
`Continuation of
`
`13940370
`
`2013-07-12
`
`9254338
`
`2016-02-09
`
`Prior Application Status Expired
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`13940370
`
`Continuation in part of
`
`PCT/US2012/020855
`
`2012-01-11
`
`Prior Application Status Expired
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`PCT/US2012/020855
`
`Claims benefit of provisional
`
`61432245
`
`2011-01-13
`
`Prior Application Status Expired
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`PCT/US2012/020855
`
`Claims benefit of provisional
`
`61434836
`
`2011-01-21
`
`Prior Application Status Expired
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`PCT/US2012/020855
`
`Claims benefit of provisional
`
`61561957
`
`2011-11-21
`
`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 that is eligible
`for retrieval under the priority document exchange program (PDX) the information viill 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).
`
`WEB ADS 1.0
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EX