`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 303
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 304
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 305
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 306
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 307
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Electronically Filed
`
`.
`INF ORMATION 7
`DISCLOSURE STATEMENT
`
`REGN-008CIPCON4
`8618
`George D. Yancopoulos
`16/159.282
`October 12, 2018
`1647
`
`Jon McClelland Lockard
`
`“Use ofa VEGF Antagonist to Treat Angiogenic
`
`Addressto:
`Commissionerfor Patents
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`a,
`
`re vel
`
`YE
`
`LSOFAETS
`
`Sir:
`
`Applicants submit herewith documents which may be material to the examination of this application
`
`and in respect of which there may be a duty to disclose in accordance with 37 C.F.R. § 1.56. This submission
`
`is not intended to constitute an admission that any documentreferred to therein is "prior art" for this invention
`
`unless specifically designated as such. A listing of the documents is shown on enclosed Form PTO/SB/O8A
`
`and copies of the foreign patents and non-patentliterature are also enclosed.
`
`The Examineris requested to make the documents listed on the enclosed PTO/SB/O8A ofrecord in this
`
`application. Applicants would appreciate the Examinerinitialing and returning the initialed copy of form
`
`PTO/SB/O8A,indicating the documents cited therein have been considered and made ofrecord herein.
`
`Statements
`
`XX]
`
` Nostatement
`
`L]
`
`PTA Statement under 37 CFR § 1.704(d)(1): Each item of information contained in
`
`the information disclosure statement filed herewith:
`
`(i) Wasfirst cited in any communication from a patent office in a counterpart foreign or
`
`international application or from the Office, and this communication was not received
`
`by any individual designated in § 1.56(c) more than thirty days priorto the filing of the
`
`information disclosure statement; or
`
`(ii) Is a communication that was issued by a patent office in a counterpart foreign or
`
`international application or by the Office, and this communication was not received by
`
`any individual designated in § 1.56(c) more than thirty days prior to the filing of the
`
`information disclosure statement.
`
`C]
`
`IDS Statement under 37 CFR § 1.97(e)(1): Each item of information contained in the
`
`information disclosure statement was first cited in any communication from a foreign
`
`Page 308
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 309
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`
`Application Number
`Filing Date
`
`16/159,282
`October 12, 2018
`George D. Yancopoulos
`
`Jon McClelland Lockard
`[Sheet[1[of]2__|Attorney Docket Number REGN-008CIPCON4
`
`
`U.S. PATENT DOCUMENTS
`
`
`
`
`Initial*
`No
`YYYY-MM-DD
`Applicant of Cited Document
`Relevant Passages or Relevant
`Figures Appear
`
`Examiner|Cite Patent Number Issue Date Nameof Patentee or Pages, Columns, Lines, Where
`
`Number-Kind Code(if known)
`
`U.S. PATENT APPLICATION PUBLICATIONS
`
`
`
`
`Examiner|Cite mentecntinesNumber Publication Date Nameof Patentee or Pages,Columns, Lines, Where
`
`
`Number-KindCode|neboKiadCoe(tino)—_|reAppear
`
`YYYY-MM-DD
`
`Applicant of Cited Document
`
`Relevant Passagesor Relevant
`
`Initial”
`
`No.
`
`
`
`
`“eensDocumentNumber
`YYYY-MM-DD
`ApplicantofCitedDocument
`Pages,Columns,Lines,
`coycatenanotneconCode-Number-KindCode(if or Relevant Figures
`
`ra|
`
`Cite
`
`known}
`
`Where Relevant Passages
`ea
`
`Publication Date
`
`Nameof Patentee or
`
`er
`Initials*
`
`'
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item (book,
`agazine,journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s), publisher, city and/or
`country where published.
`Bayer Investor News, “VEGF Trap-Eye: New Data Confirm Successesin the Treatment of
`Age-related Macular Deg
`ion” (September 28, 2008
`Regeneron Press Release “Positive Interim Phase 2 Data Reported For VEGF Trap-Eye
`In Age-Related Macular Degeneration” (March 27, 2007
`Regeneron Press Release “VEGF TRAP-Eye Phase 2 Wet AMD Results Reported At
`Arvo Annual Meeting” (May 9, 2007
`Regeneron Press Release “Regeneron Reports Second Quarter Financial And Operating
`Results” (August 1, 2007
`Regeneron Pharmaceuticals, Inc., “Regeneron and Bayer Healthcare Initiate Phase 3
`Global Development Program for VEGF Trap-Eye In Wet Age-Related Macular
`Degeneration (AMD)” (August 2, 2007
`Regeneron Press Release “Regeneron AnnouncesPositive Primary Endpoint Results
`From A Phase 2 Study Of VEGF Trap-Eye In Age-Related Macular Degeneration”
`October 1, 2007
`Regeneron Press Release “Regeneron Reports Fourth Quarter And Full Year 2007
`Financial And Operating Results” (February 27, 2008
`Regeneron Pharmaceuticals, Inc., "Regeneron and Bayer HealthCare Announce
`Encouraging 32-WeekFollow-up Results from a Phase 2 Study of VEGF Trap-Eyein
`A
`.
`:
`
`Regeneron Pharmaceuticals, Inc., “Regeneron and Bayer HealthCare Announce VEGF
`Trap-Eye Achieved Durable Improvementin Vision over 52 Weeksin a Phase 2 Studyin
`
`Seeeee
`
`Considered
`
`Signature
`
`“EXAMINER: Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Drawline throughcitation if not in conformance and not
`considered.
`Include copy of this form with next communication to applicant.
`
`Page 310
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`16/159 ,282
`October 12, 2018
`Cctober 12,2018
`1647
`Jon McClelland Lockard
`
`|of|==2|Attorney Docket Number REGN-008CIPCON4
`NON PATENT LITERATURE DOCUMENTS
`
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`
`Application Number
`Filing Date
`
`Examin
`er
`Initials*
`
`‘
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item (book,
`agazine,journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s), publisher,city and/or
`country where published.
`
`Regeneron Pharmaceuticals, Inc. “Regeneron Reports Full Year and Fourth Quarter 2008
`Financial and Operating
`Regeneron Pharmaceuticals, Inc. “Bayer and Regeneron Extend Development Program
`for VEGF Trap-Eye to Include Central Retinal Vein Occlusion” (April 30, 2009
`
`December 5, 2011
`
`pfae Regeneron Press Release “First Patient Enrolled In Regeneron And Bayer Healthcare
`ae Regeneron Press Release “Regeneron Schedules November22, 2010Teleconference
`
`VEGF Trap-Eye Phase 3 Program In Central Retinal Vein Occlusion” (July 23, 2009
`
`And Webcast To Discuss Results Of Two Phase 3 Studies With VEGF Trap-Eye In Wet
`
`Regeneron Press Release “Regeneron And Bayer Start Phase 3 Trial To Extend
`Ophthalmology Research & Development Program For VEGF Trap-EyeIn Asia” (January
`18, 2011
`Regeneron Press Release “Regeneron To WebcastInvestor Briefing On VEGF Trap-Eye
`Clinical Program On Sunday, February 13th At 9 Am Et” (February 9, 2011
`Regeneron Press Release “Regeneron Submits Biologics License Application To FDA For
`VEGF Trap-Eye For Treatment Of Wet Age-Related Macular Degeneration” (February 22,
`
`Regeneron Pharmaceuticals, Inc., “FDA Grants Priority Review for VEGF Trap-Eyefor the
`Treatment of Wet Age-Related Macular Degeneration”
`
`Regeneron Pharmaceuticals, Inc., “Regeneron Announces EYLEA™ (aflibercept
`ophthalmic solution) Receives Unanimous Recommendation for Approval for Treatmentof
`Wet AMD from FDA Advisory Committee” (June 17, 2011
`Regeneron Press Release “Regeneron AnnouncesClinical Presentations at ASRS 2011
`Annual Meeting” (August 17, 2011
`Regeneron Pharmaceuticals, Inc., “Regeneron Announces FDA Approval of
`EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular
`Degeneration: CORRECTED (November 18, 2011
`Regeneron Pharmaceuticals, Inc., “Regeneron and Bayer Initiate Phase 3 Clinical
`Program for the Treatment of Wet Age-Related Macular Degeneration in China”
`November 28, 2011
`Regeneron Pharmaceuticals, Inc., “Two Year Results of Phase 3 Studies with EYLEA™
`(aflibercept) Injection in wet AMD Show Sustained Improvement in Visual Acuity”
`
`Seeeee
`
`Considered
`
`Signature
`
`“EXAMINER: Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Drawline throughcitation if not in conformance and not
`considered.
`Include copy of this form with next communication to applicant.
`
`Page 311
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 312
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 313
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`section
`
`
`
`First Named Inventor/Applicant Name:
`
`George D. Yancopoulos
`
`ec
`
`Paymentinformation:
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`[pepestaccount
`
`Page 314
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 315
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 316
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 317
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 318
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 319
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virgima 22313-1450
`WWW. USpto.gov
`
` APPLICATION NO.
`
`16/159,282
`
`FILING DATE
`
`10/12/2018
`
`FIRST NAMED INVENTOR
`
`ATTORNEYDOCKET NO.
`
`CONFIRMATION NO.
`
`George D. Yancopoulos
`
`REGN-008CIPCON4
`
`8618
`
`Regeneron- Bozicevic, Field & Francis
`201 REDWOOD SHORES PARKWAY
`SUITE 200
`REDWOOD CITY, CA 94065
`
`LOCKARD, JON MCCLELLAND
`
`
`
`1647
`
`07/01/2020
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`
`docket@ bozpat.com
`
`PTOL-90A (Rev. 04/07)
`
`Page 320
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 321
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 322
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regeneron Pharmaceuticals, Inc. Exhibit 2053 Page 323
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc. IPR2023-00884
`
`

`

`Receipt date: 03/31/2020
`
`INFORMATION DISCLOSURE
`STATEMENTBY APPLICANT
`
`Application Number
`Filing Date
`First Named Inventor
`
`16/159.282
`October 12, 2018
`George D. Yancopoulos
`
`Jon M. Lockard
`fShet[St~———Sdof~—S2~—_| Attorney Docket Number REGN-008CIPCON4
`
`
`U.S. PATENT DOCUMENTS
`Issue Date
`Nameof Patentee or
`YYYY-MM-DD
`Applicant of Cited Document
`
`Initial*
`
`No
`
`Patent Number
`
`
`
`
`
`Pages, Columns, Lines, Where
`Relevant Passages or Relevant
`Figures Appear
`Number-Kind Code(if known)
`|=|=‘ 7070959 2006-07-04 Papadopoulos Pid
`
`
`
`|si|2_*| 8092803 2012-01-10 Furfine et al. Pd
`
`
`|sit3|10406226 Dixet al.PpCtC—‘CSCs‘i*dC2019-09-10
`
`
`|4|10464992 2019-11-05 Furfine et al. PE
`
`
`U.S. PATENT APPLICATION PUBLICATIONS
`
`Examiner|Cite Publication Number Publication Date Nameof Patentee or Pages, Columns, Lines, Where
`
`
`
`
`
`
`Initial* No|Number‘KindGods(ino)—_|YYYY-MM-DD Applicant of Cited Document Relevant Passages or Relevant
`
`
`Number-Kind Code (if known)
`Figures Appear
`
`||4__| 2019/0388539 2019-12-26 Dix etal. po
`
`
`|2|2020/0017572 2020-01-16 Furfineet al. PC
`
`
`Foreign Document Number
`
`Examiner
`Initial”
`
`Country Code-Number-Kind Code (if
`known}
`
`FOREIGN PATENT DOCUMENTS
`Publication Date
`Name of Patentee or
`_MM_
`‘i
`YYYY-MM-DD
`Applicant of Cited Document
`
`.
`Pages, Columns,Lines,
`Where Relevant Passages
`or Relevant Figures
`Appear
`
`NON PATENT LITERATURE DOCUMENTS
`
`Examin
`er
`Initials*
`
`.
`
`'
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item (book,
`agazine,journal, serial, symposium, catalog, etc.), date. page(s), volume-issue number(s), publisher, city and/or
`where published.
`
`ANONYMOUS “Anti-VEGF 2019: The State of the Art” Review of Ophthalmology
`
`CHATZIRALLIet al. “Intravitreal aflibercept for neovascular age-related macular
`degeneration in patients aged 90 yearsor older: 2-year visual acuity outcomes” Eye
`2018) 32:1523-1529
`CHUNGetal. “Ziv-aflibercept: A novel angiogenesisinhibitor for the treatment of
`metastatic colorectal cancer” Am J Heath-Syst Pharm (November1, 2013) 70:1887-1896
`COOPER etal., “Increased Renal Expression of Vascular Endothelial Growth Factor
`(VEGF) and Its Receptor VEGFR-2 in Experimental Diabetes” Diabetes (1999) 48:2229-
`2239
`
`CROLLetal., “VEGF-mediated inflammation precedes angiogenesis in adult brain”
`Experimental Neurology
`(2004) 187:388-402
`DeVRIESEet al., “Antibodies against Vascular Endothelial Growth Factor Improve Early
`Renal Dysfunction in Experimental Diabetes” J. Am. Soc. Nephrol
`(2001) 12:993-1000
`EREMINA etal., “Glomerular-specific alterations of VEGF-A expression lead to distinct
`congenital and acquired renal diseases” Journal ofClinical Investigation (March 2003)
`111(5):707-716
`ERIKSSON etal., “Structure, Expression and Receptor-Binding Properties of Novel
`Vascular Endothelial Growth Factors” Vascular Growth Factors and Angiogenesis,
`Springer
`(1999) pp. 41-57
`
`Seeeee
`
`Considered
`
`Signature
`
`“EXAMINER: Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Drawline throughcitation if not in conformance and not
`considered.
`Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.4L/
`
`Page 324
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`Receipt date: 03/31/2020
`
`INFORMATION DISCLOSURE
`
`STATEMENT BY APPLICANT=arurms > arco
`Jon Mi Lockard
`
`|of|==2|Attorney Docket Number REGN-008CIPCON4
`NON PATENT LITERATURE DOCUMENTS
`
`1, 2003) 102(1):161-168
`
`agazine,journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s), publisher,city and/or
`count
`i
`
`FERRARA, N. “Vascular Endothelial Growth Factor: Molecular and Biological Aspects”
`Advancesin Organ Biolog
`FERRARAet al., “Clinical applications of angiogenic growth factors andtheir inhibitors”
`Nature Medicine (December 1999) 5(12):1359-1364
`FLYVBJERGet al., “Amelioration of Long-Term Renal Changesin Obese Type 2 Diabetic
`Mice by a Neutralizing Vascular Endothelial Growth Factor Antibody” Diabetes (October
`2002) 51:3090-3094
`HOLASH etal., “Vessel Cooption, Regression, and Growth in Tumors Mediated by
`Angiopoietins and VEGF” Science (June 18, 1999) 284(5422):1994-1998
`KOROBELNIK etal., “Intravitreal Aflibercept Injection for Macular Edema Resulting from
`Central Retinal Vein Occlusion” American Academy of Ophthalmology (2014) 121(1):202-
`
`MITCHELL, Edith P. “Targeted Therapy for Metastatic Colorectal Cancer: Role of
`pt” Clinical Colorectal Cancer (2013) 12(2):73-85
`NOGUERA-TROISE etal., “Blockade of D114 inhibits tumour growth by promoting non-
`productive angiogenesis” Nature (December 2006) 444:1032-1037
`
`RUDGE et al., “VEGF Trap complex formation measures production rates of VEGF,
`providing a biomarkerfor predicting efficacious angiogenic blockade” PNAS (November
`20, 2007) 104(47):18363-18370
`SCHMIDT-ERFURTHetal., “Intravitreal Aflibercept Injection for Neovascular Age-related
`Macular Degeneration” Ophthalmology
`(2014) 121:193-201
`
`SEMERAROetal., “Aflibercept in wet AMD: specific role and optimal use” Drug Design,
`Development and Therapy
`(August 2, 2013) 7:711-722
`TANNOCK etal., “Aflibercept versus placebo in combination with docetaxel and
`prednisone for treatment of men with metastatic castration-resistant prostate cancer
`VENICE): a phase 3, double-blind randomizedtrial” Lancet Oncol
`(2013) 14:760-768
`THURSTON, Gavin “Complementary actions of VEGF and Angiopoietin-1 on blood vessel
`growth and leakage” J. Anat.
`(2002) 200:575-580
`XIA et al., “Transgenic delivery of VEGF to mouseskin leads to an inflammatory condition
`resembling human psoriasis” Blood (July
`
`Examiner
`Saute
`
`Date
`
`06/24/2020
`
`“EXAMINER: Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Drawline throughcitation if not in conformance and not
`considered.
`Include copy of this form with next communication to applicant.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
`
`/J.4L/
`
`Page 325
`Exhibit2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Application Number
`Filing Date
`First Named Inventor
`
`16/159,282
`October 12, 2018
`George D. Yancopoulos
`
`Jon McClelland Lockard
`fSheet[tCFT5_|Attorney Docket Number|REGN-008CIPCON4
`U.S. PATENT DOCUMENTS
`
`
`
`
`Initial*
`No
`YYYY-MM-DD
`Applicant of Cited Document
`Relevant Passages or Relevant
`Figures Appear
`
`Examiner|Cite Patent Number Issue Date Nameof Patentee or Pages, Columns, Lines, Where
`
`Number-Kind Code(if known)
`
`U.S. PATENT APPLICATION PUBLICATIONS
`Examiner
`Cite
`Publication Number
`Publication Date
`Nameof Patentee or
`Pages, Columns,Lines, Where
`
`
`
`Initial* No.|MumnberKindGade(view——_|YYYY-MM-DD Applicant of Cited Document Relevant Passages or Relevant
`
`
`Number-Kind Code (if known)
`Figures Appear
`
`|1|2019/0290725 2019-09-26 Vitti et al. pe
`
`
`FOREIGN PATENT DOCUMENTS
`
`Pages.Columns,Lines,or Relevant Figures
`NameofPatenteeor
`ee PublicationDateExaminer|Cite counGatenansrtnecae(|Gode-Number-KindCode(if
`Foreign Document Number
`YYYY-MM-DD
`Applicant of Cited Document
`Where Relevant Passages
`
`
`
`known}
`Appear
`C No.
`Pt © 2005/000895
`005-01-05
`Pharmaceuticals,Inc.
`
`Regeneron|1|wo2008/106878a2Pharmaceuticals, Inc.
`
`
`
`Regeneron
`
`
`
`
`WO 2005/ 95 A2|2005-01- .
`
`NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item (book,
`agazine,journal, serial, symposium, catalog, etc.). date. page(s), volume-issue number(s), publisher,city and/or
`where published.
`
`BENZetal. “CLEAR-IT-2: Interim Results Of The PhaseII, Randomized, Controlled Dose-
`and Interval-ranging Study Of Repeated Intravitreal VEGF Trap
`Administration In Patients With Neovascular Age-related Macular Degeneration (AMD)”
`ARVO Annual Meeting
`DO etal. “Results of a Phase 1 Study of Intravitreal VEGF Trap in Subjects with Diabetic
`Macular Edema: The CLEAR-IT DME Study” ARVO Annual Meeting
`DO et al. “VEGF Trap-Eye Vision-specific Quality of Life through 52 Weeksin Patients
`with Neovascular AMD in CLEAR-IT 2: A Phase 2 Clinical Trial” ARVO Annual Meeting
`
`HALLER etal., “VEGF Trap-Eye In CRVO: Primary Endpoint Results of the Phase 3
`COPERNICUS Study” ARVO Annual Meeting Abstract
`(April 2011
`HEIER etal., “CLEAR-IT 2: Phase 2, Randomized Controlled Dose andInterval-Ranging
`Study of Intravitreal VEFG Trap Eye in Patients with Neovascular Age-Related Macular
`Degeneration: Predictive Factors for Visual Acuity” ARVO Annual Meeting Abstract (April
`
`HEIER etal., “The 1-year Results of CLEAR-IT 2, a Phase 2 Study of Vascular
`Endothelial Growth Factor Trap-Eye Dosed As-neededAfter 12-week Fixed Dosing”
`Ophthalmology 2011 ;118:1098—1106 (June 2011
`HEIER etal., “The 1-year Results of CLEAR-IT 2, a Phase 2 Study of Vascular
`Endothelial Growth Factor Trap-Eye Dosed As-neededAfter 12-week Fixed Dosing:
`Erratum” Ophthalmology 2011;118:1700 (September 2011
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT00320775
`“Safety and Tolerability of Intravitreal Administration of VEGF Trap in Patients With
`Neovascular Age-Related Macular Degeneration” 70 pages, Latest version submitted
`June 8, 2011 on ClinicalTrials.gov (NCT00320775 2006-2011
`
`Seeeee
`
`Considered
`
`Signature
`
`“EXAMINER: Initial if reference considered, whether ornot citation is in conformance with MPEP 609. Drawline throughcitation if not in conformance and not
`considered.
`Include copy of this form with next communication to applicant.
`
`Page 326
`Exhibit 2053
`Regeneron Pharmaceuticals, Inc.
`Samsung Bioepis Co., Ltd. v. Regeneron Pharmaceuticals, Inc.
`IPR2023-00884
`
`

`

`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`
`Application Number
`Filing Date
`First Named Inventor
`
`16/159,282
`October 12, 2018
`George D. Yancopoulos
`
`Jon McClelland Lockard
`
`[Sheet[2CdFT5__|Attorney Docket Number|REGN-008CIPCON4
`NON PATENT LITERATURE DOCUMENTS
`
`version submitted November 28, 2014 on ClinicalTrials.gov (NCT00637377_ 2012-2014
`
`agazine,journal, serial, symposium, catalog, etc.), date, page(s), volume-issue number(s), publisher,city and/or
`count
`i
`
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT00320775
`“Safety and Tolerability of Intravitreal Administration of VEGF Trap in Patients With
`Neovascular Age-Related Macular Degeneration” 10 pages, Latest version submitted
`March 16, 2015 on ClinicalTrials.gov (NCT00320775 2015
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT00320788
`“Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial
`Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration
`(AMD)” 71 pages, Latest version submitted December1, 2011 on ClinicalTrials.gov
`NCT00320788_2006-201 1
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT00320788
`“Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial
`Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration
`(AMD)” 31 pages, Latest version submitted January 27, 2012 on ClinicalTrials.gov
`NCT00320788_ 2012
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT0032081 4
`“Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema” 30 pages, Latest
`version submitted June 8, 2011 on ClinicalTrials.gov (NCT00320814 2006-2011
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT00509795
`“Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eyein Subjects With
`Wet AMD (VIEW 1)” 318 pages, Latest version submitted December 1, 2011 on
`ClinicalTrials.gov (NCT00509795 2007-2011
`Information from ClinicalTrials.gov archive History of Changes for Study: NCT00509795
`“Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With
`Wet AMD (VIEW 1)” 200 pages, Latest version submitted December 20, 2012 on
`ClinicalTrials.