throbber
8319732
`
`November 29, 2022
`
`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: 15/471,506
`FILING DATE: March 28, 2017
`PATENT NUMBER: 10130681
`ISSUE DATE: November 20, 2018
`
`Samsung Bioepis Exhibit 1055
`Page 1
`
`

`

`DocCode — SEQ.TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 15471506
`
`DocumentDate: 93/28/2017
`
`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 eDAN using the Supplemental Content
`tab, or via the SCORE web page.
`e External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: August 26, 2013
`
`Samsung Bioepis Exhibit 1055
`Page 2
`
`Samsung Bioepis Exhibit 1055
`Page 2
`
`

`

`Eye Disorders”
`
`PRELIMINARY
`AMENDMENT
`Under CFR 1.115
`
`Addressto:
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Electronically Filed
`
`REGN-008CIPCON2
`To Be Assigned
`YANCOPOULOS, GEORGED.
`To Be Assigned
`March 28, 2017
`To Be Assigned
`To Be Assigned
`“Use ofa VEGF Antagonist to Treat Angiogenic
`
`Title:
`
`Sir:
`
`Prior to the examination of the above-referenced application on the merits, please enter the
`amendments below.
`
`Samsung Bioepis Exhibit 1055
`Page 3
`
`Samsung Bioepis Exhibit 1055
`Page 3
`
`

`

`AMENDMENTS TO THE SPECIFICATION
`
`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`Please amend paragraph [0001] on pagel of the specification to read as follows:
`
`[0001] This application is a continuation of U.S. Patent Application Serial No. 14/972,560,filed
`
`December 17, 2015 (mow allowed) which is a continuation of U.S. Patent Application Serial No.
`
`13/940,370 filed July 12, 2013, now U.S. Patent No. 9,254,338 issued February 9, 2016 which is a
`
`continuation-in-part of International Patent Application No. PCT/US2012/020855, filed on January 11,
`
`2012, which claims the benefit of US Provisional Application Nos. 61/432,245, filed on January 13,
`
`2011, 61/434,836, filed on January 21, 2011, and 61/561,957, filed on November 21, 2011, the contents
`
`of which are hereby incorporated by referencein their entireties.
`
`Samsung Bioepis Exhibit 1055
`Page 4
`
`Samsung Bioepis Exhibit 1055
`Page 4
`
`

`

`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`AMENDMENTSTO THE CLAIMS
`
`1. - 20. (Canceled)
`
`21.
`
`(New) A method for treating an angiogenic eye disorder in a patient, said method
`
`comprising sequentially administering to the patient a single initial dose of a VEGFantagonist, followed
`
`by one or more secondary doses of the VEGFantagonist, followed by one or moretertiary doses of the
`
`VEGFantagonist;
`
`wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose;
`
`and
`
`wherein each tertiary dose is administered at least 8 weeks after the immediately preceding dose;
`
`wherein the VEGFantagonist is a VEGF receptor-based chimeric molecule comprising (1) a
`
`VEGFR1 component comprising amino acids 27 to 129 of SEQ ID NO:2; (2) a VEGFR2 component
`
`comprising amino acids 130-231 of SEQ ID NO:2; and (3) a multimerization component comprising
`
`amino acids 232-457 of SEQ ID NO:2;
`
`wherein exclusion criteria for the patient include allof:
`
`(1) active intraocular inflammation;
`
`(2) active ocular or periocular infection;
`
`(3) any ocular or periocular infection within the last 2 wecks prior to treatment.
`
`22.
`
`(New) The method of claim 21, wherein only a single secondary dose is administered to
`
`the patient, and wherein the single secondary dose is administered 4 weeksafter the initial dose ofthe
`
`VEGFantagonist.
`
`23.
`
`(New) The method of claim 21, wherein only two secondary doses are administered to the
`
`patient, and wherein each secondary dose is administered 4 weeks after the immediately preceding dose.
`
`24.
`
`(New) The method of claim 23, wherein each tertiary dose is administered 8 weeks after
`
`the immediately preceding dose.
`
`25.
`
`(New) The method of claim 21, wherein at least 5 tertiary doses of the VEGF antagonist
`
`are administered to the patient, and wherein thefirst four tertiary doses are administered 8 weeks after
`
`3
`
`Samsung Bioepis Exhibit 1055
`Page 5
`
`Samsung Bioepis Exhibit 1055
`Page 5
`
`

`

`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`the immediately preceding dose, and wherein each subsequenttertiary dose is administered 8 or 12
`
`wecksafter the immediately preceding dosc.
`
`26.
`
`(New) The method of claim 21, wherein the angiogenic eye disorderis selected from the
`
`group consisting of: age related macular degeneration, diabetic retinopathy, diabetic macular edema,
`
`central retinal vein occlusion, branch retinal vein occlusion, and corneal neovascularization.
`
`27.
`
`(New) The method of claim 26, wherein the angiogenic eye disorderis age related
`
`macular degeneration.
`
`28.
`
`(New) The method of claim 21, wherein all doses of the VEGF antagonist are
`
`administered to the patient by topical administration or by intraocular administration.
`
`29.
`
`(New) The method of claim 28, wherein all doses of the VEGF antagonist are
`
`administered to the patient by intraocular administration.
`
`30.
`
`(New) The method of claim 29, whercin the intraocular administration is intravitreal
`
`administration.
`
`31.
`
`(New) The method of claim 30, wherein all doses of the VEGF antagonist comprise from
`
`about 0.5 mg to about 2 mg of the VEGF antagonist.
`
`32.
`
`(New) The method of claim 31, wherein all doses of the VEGF antagonist comprise 0.5
`
`mg of the VEGFantagonist.
`
`33.
`
`(New) The method of claim 31, wherein all doses of the VEGF antagonist comprise 2 mg
`
`of the VEGFantagonist.
`
`34.
`
`(New) A methodfor treating an angiogenic eye disorder in a patient, said method
`
`comprising sequentially administering to the patient a single initial dose of a VEGF antagonist, followed
`
`by one or more secondary doses of the VEGFantagonist, followed by one or moretertiary doses of the
`
`VEGFantagonist;
`
`wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose;
`
`and
`
`wherein each tertiary dose is administered at least 8 weeks after the immediately preceding dose;
`4
`
`Samsung Bioepis Exhibit 1055
`Page 6
`
`Samsung Bioepis Exhibit 1055
`Page 6
`
`

`

`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`wherein the VEGFantagonist is a VEGF receptor-based chimeric molecule comprising
`
`VEGFR1R2-FcAC l(a) encoded by the nucleic acid sequence of SEQ ID NO:1;
`
`wherein exclusion criteria for the patient includeallof:
`
`(1) active intraocular inflammation;
`
`(2) active ocular or periocular infection;
`
`(3) any ocular or periocular infection within the last 2 weeks prior to treatment.
`
`35.
`
`(New) The method of claim 34, wherein only a single secondary dose is administered to
`
`the patient, and wherein the single secondary dose is administered 4 weeksafter the initial dose of the
`
`VEGFantagonist.
`
`36.
`
`(New) The method of claim 34, wherein only two secondary doses are administered to the
`
`patient, and wherein each secondary dose is administered 4 weeks after the immediately preceding dose.
`
`37.
`
`(New) The method of claim 36, wherein each tertiary dose is administered 8 weeksafter
`
`the immediately preceding dose.
`
`38.
`
`(New) The method of claim 37, whercin the angiogenic cyc disorderis age related
`
`macular degeneration.
`
`39.
`
`(New) The methodof claim 34, wherein at least 5 tertiary doses of the VEGFantagonist
`
`are administered to the patient, and whereinthe first four tertiary doses are administered 8 weeksafter
`
`the immediately preceding dose, and wherein each subsequenttertiary dose is administered 8 or 12
`
`weeksafter the immediately preceding dose.
`
`40.
`
`(New) The method of claim 34, wherein the angiogenic eye disorderis selected from the
`
`group consisting of: age related macular degeneration, diabetic retinopathy, diabetic macular edema,
`
`central retinal vein occlusion, branch retinal vein occlusion, and corneal neovascularization.
`
`41.
`
`(New) The method of claim 34, wherein all doses of the VEGF antagonist are
`
`administered to the patient by topical administration or by intraocular administration.
`
`42.
`
`(New) The method of claim 41, whercin all doses of the VEGF antagonist are
`
`administered to the patient by intraocular administration.
`
`Samsung Bioepis Exhibit 1055
`Page 7
`
`Samsung Bioepis Exhibit 1055
`Page 7
`
`

`

`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`43.
`
`(New) The method of claim 41, wherein the intraocular administration is intravitreal
`
`administration.
`
`44.
`
`(New) The method of claim 43, wherein all doses of the VEGF antagonist comprise from
`
`about 0.5 mg to about 2 mg of the VEGF antagonist.
`
`45.
`
`(New) The method of claim 44, wherein all doses of the VEGF antagonist comprise 0.5
`
`mg of the VEGFantagonist.
`
`46.
`
`(New) The method of claim 44, wherein all doses of the VEGF antagonist comprise 2
`
`mg of the VEGFantagonist.
`
`Samsung Bioepis Exhibit 1055
`Page 8
`
`Samsung Bioepis Exhibit 1055
`Page 8
`
`

`

`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`REMARKS UNDER 37 CFR § 1.115
`
`Formal Matters
`
`Claims 21-46 are pending after entry of the amendmentsset forth herein.
`
`Claims 1-20 are canceled without prejudice.
`
`Claims 21-46 are added.
`
`Claims 21-46 are identical to claims 1-26 of issued U.S. Patent 9,254,338 with two exceptions.
`
`Specifically, the independent claims 21 and 34 include limitations with respect to exclusion criteria for
`
`patients. These exclusion criteria are disclosed within the original application in paragraph [0050].
`
`Specifically, they are the exclusion criteria 18, 19 and 20 of paragraph [0050].
`
`The specification has been amendedto update the cross-reference to related application section.
`
`No new matter has been added.
`
`PARENT APPLICATION
`
`The parent application has been allowed. Further, as indicated above, correspondence and
`
`support for the current claims relative to those of the parent application can be reviewed and confirmed.
`
`In the event the Examiner has any questions with respect to claim support or other issues in connection
`
`with the application, the Examiner is respectfully requested to contact the undersigned attorney at the
`
`indicated telephone numberto arrange for an interview to expedite this position of this application.
`
`
`
`STATEMENT UNDER37 C.F.R. §§$1.56 AND 1.2
`
`Applicants hereby advise the Examinerof 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 McKessonInfo. Soln. Inc., v. Bridge Medical Inc., 487 F.3d 897; 82 USPQ2d 1865 (Fed.
`
`Cir. 2007).
`
`The Applicants wish 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.
`
`The Applicants wish to bring to the Examiner’s attention that a Notice of Allowance was mailed
`
`on March 6, 2017 and the issue fee was paid on March 28, 2017 in co-pending U.S. Patent Application
`
`No. 14/972,560, filed December 17, 2015.
`
`Samsung Bioepis Exhibit 1055
`Page 9
`
`Samsung Bioepis Exhibit 1055
`Page 9
`
`

`

`Atty Dkt. No.: REGN-008CIPCON2
`USSN: To Be Assigned
`
`These documents are available on PAIR, and thus arc not provided with this
`
`communication. Please inform the undersignedif there is any difficulty in obtaining the documents
`
`from PAIR.
`
`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 numberprovided.
`
`The Commissioneris hereby authorized to charge any underpaymentof fees up toastrict 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-O08CIPCON2.
`
`Respectfully submitted,
`BOZICEVIC, FIELD & FRANCIS LLP
`
`
`
`Date: By:__/Karl Bozicevic, Reg. No. 28,807/28 March 2017
`Karl Bozicevic
`Registration No. 28,807
`
`
`
`Bozicevic, Field & Francis LLP
`201 Redwood Shores Parkway, Suite 200
`RedwoodCity, California 94065
`Telephone: (650) 327-3400
`Direct: (650) 833-7735
`Facsimile:
`(650) 327-3231
`
`Samsung Bioepis Exhibit 1055
`Page 10
`
`Samsung Bioepis Exhibit 1055
`Page 10
`
`

`

`NOTIFICATION OF PRIOR
`SEQUENCE LISTING
`
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Electronically Filed
`
`Attorney Docket
`
`First Named Inventor
`
`REGN-008CIPCON2
`YANCOPOULOS,
`GEORGED.
`
`Application Number
`
`To Be Assigned
`
`Filing Date
`
`28 March 2017
`
`,
`
`:
`
`Title:
`
`“USEOFA VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS”
`
`stsyapa
`
`Sir:
`
`The above-identificd patent application contains
`
`sequences of nucleic acid and
`
`polypeptides. A sequence listing was prepared for parent application, 14/927,560,
`
`filed
`
`December 17, 2015, in paper and computer-readable format. The sequence information in the
`
`paper or compact disk copy of the sequencelisting (required by 1.821(c)) of this application is
`
`identical to the sequence information in the computer-readable format (CRF) of the above-
`
`identified other application. No new matter has been added. Therefore, please transfer to this
`
`application, in accordance with 37 CFR § 1.821(e), the fully compliant computer readable copy
`
`fromapplicants’ other application. A paper(.txt) copy of this sequencelisting is enclosed.
`
`Applicants respectfully submit that the present patent application is now in compliance
`
`with 37 CFR §§ 1.821 - 1.825.
`
`The Commissioner is hereby authorized to charge any
`
`underpayment of fees associated with this communication, including any necessary fees for
`
`extensions of time, or credit any overpayment to Deposit Account No. 50-0815, order number
`
`REGN-008CIPCON2.
`
`Respectfully submitted,
`
`BO7ZICEVIC, FIELD & FRANCIS LLP
`
`
`
`Dated: By:_/Karl Bozicevic, Reg. No. 28.807/28 March 2017
`Karl Bozicevic
`Registration No. 28,807
`
`
`
`BOZICEVIC, FIELD & FRANCIS LLP
`201 Redwood Shores Parkway, Suite 201
`RedwoodCity, California 94065
`Telephone: (650) 327-3400
`Facsimile: (650) 327-3231
`
`Samsung Bioepis Exhibit 1055
`Page 11
`
`Samsung Bioepis Exhibit 1055
`Page 11
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`First Named Inventor/Applicant Name:
`
`GEORGE D. YANCOPOULOS
`
`UTILITY APPLICATION FILING
`
`
`Attorney Docket Number:
`
`REGN-008CIPCON2
`
`Filed as Large Entity
`
`Description
`
`Fee Code
`
`Basic Filing:
`
`UTILITY SEARCH FEE
`
`UTILITY EXAMINATION FEE
`
`1311
`
`Miscellaneous-Filing:
`
`
`
`
`
`Filing Fees for Utility under 35 USC 111(a)
`
`Quantity
`
`Amount
`
`Sub-Total in
`USD($}
`
`
`
`Samsung Bioepis Exhibit 1055
`Page 12
`
`Samsung Bioepis Exhibit 1055
`Page 12
`
`

`

`sas
`
`.
`
`Sub-Total in
`
`Miscellaneous:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`
`
`Total in USD (S$)
`
`2080
`
`Samsung Bioepis Exhibit 1055
`Page 13
`
`Samsung Bioepis Exhibit 1055
`Page 13
`
`

`

`
`
`a A
`
`Electronic AcknowledgementReceipt
`
`28758182
`EFS ID:
`
`
`Application Number:
`
`15471506
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`ee
`
`
`
`ttorney Docket Number: REGN-008CIPCON2
`
`Receipt Date:
`
`28-MAR-2017
`
`Utility under 35 USC 111(a
`Application Type:
`
`
`Paymentinformation:
`
`
`
`[Pevotacone——SSSSCSCSC*idSSSSSSSS
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`Samsung Bioepis Exhibit 1055
`Page 14
`
`Samsung Bioepis Exhibit 1055
`Page 14
`
`

`

`Pages
`Multi
`File Size(Bytes)/
`File Name
`DocumentDescription
`Document
`
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`Number Message Digest|Part/.zip| (ifappl.)
`1823602
`
`Information:
`
`529155
`
`Application Data Sheet
`
`REGN-008CIPCON2_201 7-03-28
`_ADS.pdf
`
`2834c41¢9193695ad5d6080d920b4006cc
`dce46c
`
`REGN-008CIPCON2_Specificati
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`
`661885363717715ffe32f0b659666316e0
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`Multipart Description/PDF files in .zip description
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`DocumentDescription
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`Specification
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`Information:
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`Warnings:
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`105393
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`Claims
`
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`Abstract
`
`Drawings-only black and whiteline
`.
`drawings
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`REGN-OO8CIPCON2_Figure.pdf
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`2d5821645d0c5d 17d717e589b029a393319
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`The page size in the PDF is too large. The pages should be 8.5 x 11 or A4.If this PDF is submitted, the pageswill be resized upon entry into the
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`REGN-OO8CIPCON2_declaration
`.pdf
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`6bda7272374e6af80c8c3d8cf30d01 2e465:
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`173097
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`Image File Wrapper and mayaffect subsequent processing
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`Samsung Bioepis Exhibit 1055
`Page 15
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`Samsung Bioepis Exhibit 1055
`Page 15
`
`

`

`REGN-O008CIPCON2_201 7-03-28
`_pre_amend_asfld.pdf
`
`dai1c454ceb9521 e936f1 bObea0Ste671224
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`Multipart Description/PDF files in .zip description
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`DocumentDescription
`
`Start
`
`
`
`Information:
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`
`Information: Total Files Size (in bytes)
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`Preliminary Amendment
`
`Specification
`
`Claims
`
`Applicant Arguments/Remarks Made in an Amendment
`
`Information:
`
`SequenceListing
`
`REGN-O008CIPCON2_seq_list_t
`rans.pdf
`
`157 12f98903ec6052e7e5f7| 6b4a670169
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`Information:
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`SequenceListing (Text File)
`
`REGN-OO8CIPCON2_SegList.txt
`
`
`
`Warnings:
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`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`660646la2e7[S6edc76cb7306d608b0aede
`Z
`
`
`Warnings:
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`2766815
`
`Samsung Bioepis Exhibit 1055
`Page 16
`
`Samsung Bioepis Exhibit 1055
`Page 16
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`

`

`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.
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`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.
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`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.
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`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 componentsfor
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`national security, and the date shownon this AcknowledgementReceiptwill establish the international filing date of
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`Samsung Bioepis Exhibit 1055
`Page 17
`
`Samsung Bioepis Exhibit 1055
`Page 17
`
`

`

`PTOVAIA/14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OME control number.
`
`Application Data Sheet 37 CFR 1.76
`
`—
`
`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`The application data sheetis 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
`
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`
`Secrecy Order 37 CFR 5.2:
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`0 Portions or all of the application associated with this Application Data Sheet mayfall under a Secrecy Order pursuantto
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`Remove
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`Inventor Information:
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`Inventor
`,
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`Legal Name
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`iGivenName(|MiddleName=FamilyName|
`~TlBeoeid.—«*cormsSid
`Residence Information (Select One)
`e US Residency
`Non US Residency
`Active US Military Service
`
`
`
`
`
`Mailing Addressof Inventor:
`
`
`i ‘io Regeneron Pharmaceuticals, Inc.
`Address 1
`|777 Old Saw Mill River Road
`
`Address 2
`
`
`Faso SSSSSS—~S& Statesrovince|RY
`
`Postal Code
`10591
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`Inventors Must Be Listed - Additional
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`
`CorrespondenceInformation:
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`Enter either Customer Number or complete the CorrespondenceInformation section below.
`
`For further information see 37 CFR 1.33(a).
`
`[|An Addressis being provided for the correspondenceInformation of this application.
`| p6387
`|Hocket@bozpat.com
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`Suggested Figure for Publication (if any)
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`EFS Web 2.2.12
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`Samsung Bioepis Exhibit 1055
`Page 18
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`Samsung Bioepis Exhibit 1055
`Page 18
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`

`

`PTOVAIA/14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
` Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number|REGN-O08CIPCON2
`
`Application Number
`
`
`
`
`
`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
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`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’).
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`
`
`
`For the purposesof a filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previously filed application, subject to conditions and requirements of 37 CFR 1.57(a).
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`filed application
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`Intellectual Property Authority or Country
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`po
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`Publication Information:
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`[_] Request Early Publication (Fee required at time of Request 37 CFR 1.219)
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`
`Request Not to Publish. | hereby requestthat 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 andwill not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months afterfiling.
`
`Representative Information:
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`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 powerof attorney in the application (see 37 CFR 1.32).
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`If both sections are completed the customer
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`Domestic Benefit/National Stage Information:
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`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.
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`EFS Web 2.2.12
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`Samsung Bioepis Exhibit 1055
`Page 19
`
`Samsung Bioepis Exhibit 1055
`Page 19
`
`

`

`PTOVAIA/14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`
`
`Attorney Docket Number|REGN-O08CIPCON2
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`
`
`
`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Prior Application StatusPatented= Remove
`Application
`Prior Application
`Filing Date
`Issue Date
`Number
`Continuity Type
`Number
`(YYYY-MM-DD)
`Patent Number
`(YYYY-MM-DD)
`
`14972560
`ontinuation of
`+ 13940370
`2013-07-12
`9254338
`2016-02-09
`Prior Application Status Expired
`Remove
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`Prior Application Number
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`-| PCT/US2012/020855
`2012-01-11
`
`
`
`
`
`Application Number
`3940370
`
`Continuity Type
`| ontinuation in part of
`
`
`Prior Application Status
`
`Application Number
`PCT/US2012/020855
`Prior Application Status
`
`Continuity Type
`| laims. benefit of provisional
`
`Prior Application Number
`-| 61432245
`
`
`
`
`
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`
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`Remove
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`2011-01-13
`Remove
`Filing or 371(c) Date
`(YYYY-MM-DD)
`Prior Application Number
`
`
`~ 61434836
`2011-01-21
`
`Application Number
`PCT/US2012/020855
`
`Prior Application Status
`
`Continuity Type
`| laims benefit of provisional
`
`Prior Application Number
`Continuity Type
`Application Number
`-| 61561957
`| laims benefit of provisional
`PCT/US2012/020855
`Additional Domestic Benefit/National Stage Data may be generated within this form
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`Filing or 371(c) Date
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`2011-11-21
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`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 forpriority as required by 35 U.S.C. 119(b) and 37 CFR 1.55. When priority is claimed to a foreign application
`thatis eligible for retrieval under the priority document exchange program (PDX)! the information will be used by the Office to
`automatically attempt retrieval pursuant to 37 CFR 1.55{i)(1) and (2). Under the PDX program, applicant bears the ultimate
`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
`property office, or a certified copy of the foreign priority applicationis filed, within the time period specified in 37 CFR 1.55(g)(1).
`
`
`Application Number
`Country!
`Filing Date (YYYY-MM-DD)
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`Add
`
`Access Code (if applicable)
`
`
`EFS Web 2.2.12
`
`Samsung Bioepis Exhibit 1055
`Page 20
`
`
`
`Samsung Bioepis Exhibit 1055
`Page 20
`
`

`

`PTOVAIA/14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`atl
`Application Data Sheet 37 CFR 1.76
`
`
`
`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to 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
`
`[-] 16, 2013.
`NOTE: Byproviding this statement under 37 CFR 1.55 or 1.78, this application, withafiling date on or after March
`16, 2013, will be examined underthe first inventorto file provisions of the AIA.
`
`EFS Web 2.2.12
`
`Samsung Bioepis Exhibit 1055
`Page 21
`
`Samsung Bioepis Exhibit 1055
`Page 21
`
`

`

`PTOVAIA/14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Underthe Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
`atl
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Authorization or Opt-Out of Authorization to Permit Access:
`
`When this 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
`paragraphA 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 not to 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 INITIAL filing of an
`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
`authorization for access by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`
`
`
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s}
`
`
`A. Priority Document Exchange (PDX) - Unless box A in subsection 2 (opt-out of authorization) is checked, the
`undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People’s Republic of
`China (SIPO), the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
`participating with the USPTOin a bilateral or multilateral priority document exchange agreementin which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`andits related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date offiling of this Authorization. See 37 CFR 1.14(h)
`(1).
`
`
`B. Search Results from U.S. Application to EPO - Unless box B in subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authority to provide the EPO access to the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`application is filed. See 37 CFR 1.14(h)(2).
`
`The applicant is reminded that the EPO’s Rule 141(1}) EPC (European Patent Convention) requires applicants to submit a
`copy of search results from the instant application without delay in a European patent application that claimspriority to
`the instant application.
`
`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s}
`
`[|]
`
`A. Applicant DOES NOTauthorize the USPTOto permit a participating foreign IP office access to the instant
`application-as-filed.
`If this box is checked, the USPTOwill not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
`
`[_]
`
`B. Applicant DOES NOT authorize the USPTO to transmit to the EPO any search results from the instant patent
`application. If this box is checked, the USPTO will not be providing the EPO with search results from the instant
`application.
`NOTE: Oncethe application has published oris otherwis

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