8360351
`
`March 28, 2023
`
`THIS IS TO CERTIFY THAT ANNEXED IS A TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`APPLICATION NUMBER: 17/352,892
`FILING DATE: June 21, 2021
`PATENT NUMBER: 11253572
`ISSUE DATE: February 22, 2022
`
`Samsung Bioepis Exhibit 1014
`Page 1
`
`

`

`DocCode — SEQ.TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 17352892
`
`DocumentDate: 06/21/2021
`
`The presenceof 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 documentsthat are stored in SCORE.
`
`SequenceListing
`
`At the time of document entry (noted above):
`e USPTO employees may access SCORE content via DAV or via the SCORE webpage.
`e External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: March 1, 2019
`
`Samsung Bioepis Exhibit 1014
`Page 2
`
`Samsung Bioepis Exhibit 1014
`Page 2
`
`

`

`Alexandria, VA 22313-1450 Eye Disorders”
`
`Electronically Filed
`
`REGN-008CIPCON10
`To Be Assigned
`YANCOPOULOS, GEORGE D
`To Be Assigned
`June 21, 2021
`To Be Assigned
`To Be Assigned
`“Use ofa VEGF Antagonist to Treat Angiogenic
`
`PRELIMINARY
`AMENDMENT
`Under CFR 1.115
`
`Addressto:
`Mail Stop Patent Application
`Commissionerfor Patents
`P.O. Box 1450
`
`:
`Filing Date
`Group Art Unit
`
`Title:
`
`Sir:
`
`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.
`
`Samsung Bioepis Exhibit 1014
`Page 3
`
`Samsung Bioepis Exhibit 1014
`Page 3
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`AMENDMENTS TO THE CLAIMS
`
`1. - 20. (Canceled)
`
`21.
`
`(New) A method oftreating an angiogenic eye disorderin a patient in need
`
`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 ofaflibercept, followed by one
`
`or more tertiary doses of 2 mg ofaflibercept;
`
`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.
`
`22.
`
`(New) The method of claim 21 wherein the patient achieves a gain in Best
`
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`
`letter score.
`
`23.
`
`(New) The method of claim 22 wherein the patient gains at least 7 letters Best
`
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabetic Retinopathy Study (ETDRS)
`
`letter score.
`
`24.
`
`(New) The method of claim 23 wherein the paticnt achicves the gain in visual
`
`acuity within 24 weeks following the initial dosc.
`
`25.
`
`(New) The method of claim 23 wherein only two secondary doses are
`
`administered to the patient.
`
`Samsung Bioepis Exhibit 1014
`Page 4
`
`Samsung Bioepis Exhibit 1014
`Page 4
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`20.
`
`(New) The method of claim 23 wherein the aflibercept is formulated as an
`
`isotonic solution.
`
`27.
`
`(New) The method of claim 23 wherein the aflibercept is formulated with a non-
`
`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 achicves the gain in visual
`
`acuity within 24 wecks following the initial dosc.
`
`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.
`
`31.
`
`(New) The method of claim 30 wherein only two secondary doses are
`
`administered to the patient.
`
`32.
`
`(New) The method of claim 30 wherein the aflibercept is formulated as an
`
`isotonic solution.
`
`33.
`
`(New) The method of claim 30 whercin the afliberecpt is formulated with a non-
`
`ionic surfactant.
`
`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.
`
`Samsung Bioepis Exhibit 1014
`Page 5
`
`Samsung Bioepis Exhibit 1014
`Page 5
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`35.
`
`(New) A method oftreating diabetic macular edemain a patient in need 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.
`
`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 Diabctic Retinopathy Study (ETDRS)
`
`letter score.
`
`38.
`
`(New) The method of claim 37 wherein the aflibercept is formulated as an
`
`isotonic solution.
`
`39.
`
`(New) The method of claim 37 wherein the aflibercept is formulated with a non-
`
`ionic surfactant.
`
`40.
`
`(New) The method of claim 37 wherein the patient achieves a gain in visual
`
`acuity within 24 weeks followingthe initial dose.
`
`A].
`
`(New) The method of claim 36 wherein the patient gains at least 8 letters Best
`
`Corrected Visual Acuity (BCVA) according to Early Treatment Diabctic Retinopathy Study (ETDRS)
`
`Ictter score.
`
`Samsung Bioepis Exhibit 1014
`Page 6
`
`Samsung Bioepis Exhibit 1014
`Page 6
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`42.
`
`(New) The method of claim 41 wherein the aflibercept is formulated as an
`
`isotonic solution.
`
`43.
`
`(New) The method of claim 41 wherein the aflibercept is formulated with a non-
`
`ionic surfactant.
`
`44,
`
`(New) The method of claim 35 wherein only two secondary doses are
`
`administered to the patient.
`
`45.
`
`(New) The method of claim 35 wherein four secondary doses are administered to
`
`the patient.
`
`46.
`
`(New) A method of treating age related macular degeneration in a patient in need
`
`thereof comprising sequentially administering to the patient a single initial dose of 2 mg ofaflibercept,
`
`followed by one or more secondary doses of 2 mg of aflibercept, followed by one or moretertiary doses
`
`of 2 mgofaflibercept;
`
`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 ranibizumabby intravitreal injection in human subjects with
`
`age-related macular degeneration at 52 weeks following the initial dose.
`
`47,
`
`(New) The method of claim 46 wherein only two secondary dosesare
`
`administered to the patient.
`
`48.
`
`(New) The method of claim 46 wherein the gain in visual acuity is measured
`
`using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
`
`Samsung Bioepis Exhibit 1014
`Page 7
`
`Samsung Bioepis Exhibit 1014
`Page 7
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`49,
`
`(New) A method of treating age-related macular degeneration in a patient in need
`
`thereof comprising sequentially administering to the patient a single initial dose of 2 mg ofaflibercept,
`
`followed by one or more secondary doses of 2 mg of aflibercept, followed by one or more tertiary doses
`
`of 2 mgofaflibercept;
`
`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 methodis as effective in maintaining visual acuity as monthly
`
`administration of 0.5 mg of ranibizumabby 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.
`
`Samsung Bioepis Exhibit 1014
`Page 8
`
`Samsung Bioepis Exhibit 1014
`Page 8
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`REMARKS UNDER 37 CFR § 1.115
`
`Formal Matters
`
`Claims 21-50 are pending after entry of the amendmentsset 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
`
`throughoutthe 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 sequencelisting textfile submitted via EFS-Web
`
`complies with the requirements of 37 CFR 1.824(a)(2)-(6) and (b) (-e., is a compliant sequencelisting
`
`ASCIItext 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) asecond copy of the sequencelisting in a PDFfile; nor (2) a statement under 37 CFR 1.821 (f)
`
`(indicating that the paper copy and CRFcopy of the sequencelisting are identical) should be submitted.
`
`The Sequence Listing was prepared with the software FASTSEQ for Windows version 4.0, and
`
`conformsto 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.F.R. §81.56 AND 1.2
`
`Applicants hereby advise the Examinerofthe 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).
`
`Samsung Bioepis Exhibit 1014
`Page 9
`
`Samsung Bioepis Exhibit 1014
`Page 9
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`The Applicant wishes to bring to the Examiner’s attention U.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 wasfiled 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 December8, 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 December4, 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.
`
`Samsung Bioepis Exhibit 1014
`Page 10
`
`Samsung Bioepis Exhibit 1014
`Page 10
`
`

`

`Atty Dkt. No.: REGN-O08CIPCON10
`USSN:To Be Assigned
`
`CONCLUSION
`Applicant submits that all of the claims are in condition for allowance, which action is requested.
`
`If the Examinerfinds that a telephone conference would expedite the prosecution of this application,
`
`please telephone the undersigned at the numberprovided.
`
`The Commissioneris hereby authorized to charge any underpaymentoffees 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-O008CIPCON10.
`
`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
`
`Samsung Bioepis Exhibit 1014
`Page 11
`
`Samsung Bioepis Exhibit 1014
`Page 11
`
`

`

`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 YANCOPOULOS
`
`Attorney Docket Number:
`
`REGN-008CIPCON10
`
`Filed as Large Entity
`
`Description
`
`Fee Code
`
`Basic Filing:
`
`UTILITY SEARCH FEE
`
`UTILITY EXAMINATION FEE
`
`REQUEST FOR PRIORITIZED EXAMINATION
`
`1311
`
`1817
`
`
`
`UTILITY APPLICATION FILING
`
`
`Miscellaneous-Filing:
`
`Filing Fees for Track! Prioritized Examination - Nonprovisional Application under 35 USC 111(a}
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($}
`
`4200
`
`4200
`
`
`
`CLAIMS IN EXCESS OF 20
`
`
`Samsung Bioepis Exhibit 1014
`Page 12
`
`Samsung Bioepis Exhibit 1014
`Page 12
`
`

`

`-
`
`oe
`
`Desenpwren
`PUBL.FEE-EARLY,VOLUNTARY,ORNORMAL
`
`PROCESSING FEE, EXCEPT PROV. APPLS.
`
`UsD(s)
`sven jAmaun
`1504 fiefs
`
`Total in USD (S$)
`
`.
`
`Sub-Total in
`
`1830
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`Samsung Bioepis Exhibit 1014
`Page 13
`
`Samsung Bioepis Exhibit 1014
`Page 13
`
`

`

`Electronic AcknowledgementReceipt
`
`43040441
`EFS ID:
`
`
`Application Number:
`
`17352892
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`ee
`
`
`
`Attorney Docket Number: REGN-008CIPCON10
`
`Receipt Date:
`
`21-JUN-2021
`
`Utility under 35 USC 111(a
`Application Type:
`
`
`Paymentinformation:
`
`he Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`a T
`
`Samsung Bioepis Exhibit 1014
`Page 14
`
`Samsung Bioepis Exhibit 1014
`Page 14
`
`

`

`Document
`sigs
`.
`File Size(Bytes)/
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`
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`
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`Information:
`
`
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`The page size in the PDF is too large. The pages should be 8.5 x 11 or Ad.If this PDF is submitted, the pages will be resized upon entry into the
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`Information:
`
`Information:
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`TrackOne Request
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`REGN-008CIPCON10_2021-06-
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`DocumentDescription
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`Claims
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`Drawings-only black and white line
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`Samsung Bioepis Exhibit 1014
`Page 15
`
`Samsung Bioepis Exhibit 1014
`Page 15
`
`

`

`Oath or Declaration filed
`
`REGN-O08CIPCON10_declaratiof
`n.pdf
`
`6bda7272374e6af80c8c3d8c130d01 26465:
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`173097
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`REGN-008CIPCON10_2021-06-
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`3617dd33068/ a0efcS3f68ece70170549590
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`1_IDS_SBO8A.pdf
`
`Information:
`
`This is not an USPTO supplied IDSfillable form
`
`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
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`
`
`
`
`Information:
`
`REGN-O08CIPCON10_2021-06-
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`
`Samsung Bioepis Exhibit 1014
`Page 16
`
`Samsung Bioepis Exhibit 1014
`Page 16
`
`

`

`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`cea833dt2cffe6106b85cd3221 5d976d8b89)
`313
`
`
`
`
`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
`Acknowledgement Receiptwill establish thefiling 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/903 indicating acceptanceof 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.
`NewInternational 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
`andof 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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`
`Information:
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTOof 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.
`
`Samsung Bioepis Exhibit 1014
`Page 17
`
`Samsung Bioepis Exhibit 1014
`Page 17
`
`

`

`PTO/AIA/14
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`maybeprinted and includedin a paperfiled application.
`
`The application data sheetis part of the provisional or nonprovisional application for whichit 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
`
`Secrecy Order 37 CFR 5.2:
`Portionsor all of the application associated with this Application Data Sheet mayfall under a Secrecy Order pursuant to 37
`LI CFR 5.2 (Paperfilers only. Applications thatfall under Secrecy Order maynotbe filed electronically.)
`
`
`
`Inventor Information:
`
`
`
`Inventor 1
`
`Legal Name
`
`
`Prefix| Given Name
`
`Middle Name
`
`Family Name
`
`Suffix
`
`
`George
`YANCOPOULOS
`
`Residence Information (Select One)
`(#) US Residency
`C) Non US Residency
`©) Active US Military Service
`
`
`
`City|Yorktown Heights State/Province NY Country of Residence i US
`
`
`
`
`
`Mailing Address of Inventor:
`
`
`Address 1
`c/o Regeneron Pharmaceuticals,Inc.
`
`Address 2
`777 Old Saw Mill River Road
`
`
`
`City
`Tarrytown
`State/Province
`NY
`
`Postal Code
`10591
`Country i
`US
`
`All Inventors Must Be Listed - Additional Inventor Information blocks may be generated
`within this form by selecting the Add button.
`
`Enter either Customer Numberor complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`CorrespondenceInformation:
`
` [_] An Address is being provided for the correspondence Information of this application.
`
`96387
`Customer Number
`
`
`
`
`Email Address
`
`docket@bozpat.com
`
`|
`
`Add Email
`
`
`
`
`
`Title of the Invention
`
`Attorney Docket Number
`
`REGN-008CIPCON 10
`
`Nonprovisional
`
`C
`
`Application Information:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Small Entity Status Claimed
`Application Type
`
`
`
`Subject Matter
` Total Numberof Drawing Sheets(if any)
`
`
`Suggested Figure for Publication (if any)
`
`WEBADS 1.0
`
`Samsung Bioepis Exhibit 1014
`Page 18
`
`Samsung Bioepis Exhibit 1014
`Page 18
`
`

`

`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 respondto a collection of information unless it contains a valid OMB control number.
`
`
`.
`oo.
`
`Application Data Sheet 37 CFR 1.76
`
`
`Application Number
`
` Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Attorney Docket Number
`
`REGN-008CIPCON10
`
`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 sectionif
`application papers including a specification and any drawingsare 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
`
`
`
`Intellectual Property Authority or Country
`Filing date (YYYY-MM-DD)
`Application numberofthe previously
`filed application
`
`
`
`
`Publication Information:
`
`[_] Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`
`
`Request Notto 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.
`
`35 U.S.C.
`
`
`
`
`
`
`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 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
`will be used for the Representative Information during processing.
`
`
`
`
`Please Select One: | ©) Limited Recognition (37 CFR 11.9) (@) Customer Number | ©) USPatentPractitioner
`
`
`
`Customer Number 96387
`
`
`
`Given Name
`Middle Name
`Family Name
`
`
`Registration Number
` Middle Name
`
`Family Name
`
`Remove
`
`
`
`Remove
`
`
`
`Registration Number
`
`Additional Representative Information blocks may be generated within this form by
`selecting the Add button.
`
`
`
`WEB ADS1.0
`
`Samsung Bioepis Exhibit 1014
`Page 19
`
`Samsung Bioepis Exhibit 1014
`Page 19
`
`

`

`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 respondto 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 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.
`Whenreferring to the current application, please leave the “Application Number’field blank.
`
` |
`
`Application Number
`
`Continuity Type
`
`|
`
`Prior Application Number
`
`Continuation of
`
`17350958
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`2021-06-17
`
`
`
`
`
`
`
`
`
`
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`17350958
`Continuation of
`17112404
`2020-12-04
`
`
`
`
`Filing or 371(c) Date
`
`
`
`Application Number
`Continuity Type
`Prior Application Number
`(YYYY-MM-DD)
`
`17072417
`17112404
`Continuation of
`2020-10-16
`
`Prior Application Status
`
`Remove
`
`Issue Date
`Filing Date
`Prior Application |
`.
`Application
`Patent Number
`(YYYY-MM-DD)
`(YYYY-MM-DD)
`Number
`Continuity Type
`Number
`
`17072417
`Continuation of
`16055847
`2018-08-06
`10857205
`2020-12-08
`
`
`
`Prior Application Status[Remove|
`Application
`PriorApplication
`owe Date
`Issue Date
`Patent Number
`Continuity Type
`Number
`YYYY-MM-DD)
`(YYYY-MM-DD)
`
`
`
`
`17072417|Continuationofof 16397267 2019-04-29 10888601 2021-01-12
`
`
`Prior Application Status[Remove|
`Application
`PriorApplication | wns Date
`Issue Date
`Patent Number
`Continuity Type
`Number
`YYYY-MM-DD)
`(YYYY-MM-DD)
`
`
`
`
`16397267|Continuationofof 16159282 2018-10-12 10828345 2020-11-10
`
`
`Prior Application Status[Remove|
`Application
`PriorApplication
`own Date
`Issue Date
`Patent Number
`Continuity Type
`Number
`YYYY-MM-DD)
`(YYYY-MM-DD)
`
`16159282|Continuationof=of 15471506 2017-03-28 10130681 2018-11-20
`
`
`
`
`WEB ADS1.0
`
`Samsung Bioepis Exhibit 1014
`Page 20
`
`
`
`Samsung Bioepis Exhibit 1014
`Page 20
`
`

`

`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 respondto a collection of information unless it contains a valid OMB control number.
` Application Data Sheet 37 CFR 1.76
`
`REGN-O008CIPCON10
`
`
`
`
`
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`Title of Invention
`
`
`Attorney Docket Number
`
`Application Number
`
`Application
`Number
`15471506
`
`.
`Continuity Type
`Continuation of
`
`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
`
`.
`Continuity Type
`Continuation of
`
`Prior Application
`Number
`13940370
`
`Filing Date
`(YYYY-MM-DD)
`2013-07-12
`
`Patent Number
`9254338
`
`ssue Date
`(YYYY-MM-DD)
`2016-02-09
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`Prior Application Number
`Continuity Type
`Application Number
`
`13940370
`Continuation in part of
`PCT/US2012/020855
`2012-01-11
`
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`
`
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`
`
`
`
`
`
`
`
`
`Prior Application Status
`
`Prior Application Status
`
`
`
`Filing or 371(c) Date
`Prior Application Number
`(YYYY-MM-DD)
`Continuity Type
`Application Number
`
`PCT/US2012/020855
`Claims benefit of provisional
`61432245
`2011-01-13
`
`
`
`
`
`Filing or 3/1(c) Date
`Prior Application Number
`(YYYY-MM-DD)
`Continuity Type
`Application Number
`
`PCT/US2012/020855
`Claims benefit of provisional
`61434836
`2011-01-21
`
`
`Filing or 3/1(c) Date
`Application Number
`Continuity Type
`Prior Application Number
`(YYYY-MM-DD)
`
`PCT/US$2012/020855
`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 applicationthatis eligible
`for retrieval underthe priority document exchange program (PDX) the information Will be used by the Office to automatically attemptretrieval
`pursuantto 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 ADS1.0
`
`Samsung Bioepis Exhibit 1014
`Page 21
`
`Samsung Bioepis Exhibit 1014
`Page 21
`
`

`

`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 respondto a collection of information unless it contains a valid OMB control number.
`
` 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
`
`
`
`
`
`
`Application Number
`Access Codekif applicable)
`
`
`Additional Foreign Priority Data may be generated within this form by selecting the Add
`button.
`
`
`
`
`REGN-O008CIPCON10
`
`
`
`
`
`Statement under 37 CFR 1.55 or 1.78 forAIA (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 effective filing date on or after March
`J 16, 2013.
`NOTE:By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2013, will be examined underthe first inventor to file provisions of the AIA.
`
`WEB ADS1.0
`
`Samsung Bioepis Exhibit 1014
`Page 22
`
`Samsung Bioepis Exhibit 1014
`Page 22
`
`

`

`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 respondto 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 and filed 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.
`Afterthe initial filing of an application, an Application Data Sheet cannot be used to p