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
`
`Celltrion Exhibit 1055
`Page 1
`
`

`

`DocCode — SEQ.TXT
`
`SCORE Placeholder Sheet for IFW Content
`
`Application Number: 15471506
`
`DocumentDate: 03/28/2017
`
`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 documents that are stored in SCORE.
`
`SequenceListing
`
`At the time of documententry (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
`
`Celltrion Exhibit 1055
`Page 2
`
`Celltrion Exhibit 1055
`Page 2
`
`

`

`Eye Disorders”
`
`PRELIMINARY
`AMENDMENT
`Under CFR 1.115
`
`Addressto:
`Mail Stop Patent Application
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Electronically Filed
`Attorney Docket No.
`
`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:
`
`Sit:
`
`Prior to the examination of the above-referenced application on the merits, please enter the
`amendments below.
`
`Celltrion Exhibit 1055
`Page 3
`
`Celltrion Exhibit 1055
`Page 3
`
`

`

`AMENDMENTSTO THE SPECIFICATION
`
`Atty Dkt. No.: REGN-OO8CIPCON2
`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 (now 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 whichis a
`
`continualion-in-part of International Patent Application No. PCT/US2012/020855, filed on January 11,
`
`2012, which claimsthe 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 reference in their entireties.
`
`Celltrion Exhibit 1055
`Page 4
`
`Celltrion Exhibit 1055
`Page 4
`
`

`

`Atty Dkt. No.: REGN-OO8CIPCON2
`USSN: To Be Assigned
`
`AMENDMENTS TO THE CLAIMS
`
`1. - 20. (Canceled)
`
`21.
`
`(New) A methodfor treating an angiogenic eye disorderin a patient, said method
`
`comprising sequentially administcring to the paticnt a single initial dose of a VEGFantagonist, followed
`
`by one or more secondary doses of the VEGF antagonist, 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 VEGF antagonist 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 includeallof:
`
`(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 of the
`
`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, whercin each tertiary dose is administered 8 wecksafter
`
`the immediately preceding dose.
`
`25.
`
`(New) The method of claim 21, wherein at least 5 tertiary doses of the VEGFantagonist
`
`are administered to the patient, and wherein thefirst four tertiary doses are administered 8 weeksafter
`
`3
`
`Celltrion Exhibit 1055
`Page 5
`
`Celltrion Exhibit 1055
`Page 5
`
`

`

`Atty Dkt. No.: REGN-OO8CIPCON2
`USSN: To Be Assigned
`
`the immediately preceding dose, and wherein each subsequenttertiary dose is administered 8 or 12
`
`weeksafter the immediately preceding dose.
`
`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 ncovascularization.
`
`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 VEGFantagonist 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 method for treating an angiogenic eye disorderin 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 VEGF antagonist, 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
`
`Celltrion Exhibit 1055
`Page 6
`
`Celltrion Exhibit 1055
`Page 6
`
`

`

`Atty Dkt. No.: REGN-OO8CIPCON2
`USSN: To Be Assigned
`
`wherein the VEGF antagonist is a VEGF receptor-based chimeric molecule comprising
`
`VEGFR1R2-FcAC 1(a) encoded by the nucleic acid sequence of SEQ ID NO:1;
`
`wherein exclusioncriteria for the patient includeallof:
`
`(1) active intraocular inflammation;
`
`(2) aclive ocular or periocular infection;
`
`(3) any ocular or periocular infection within the last 2 wecksprior 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, whercin cach tertiary dose is administered 8 wecksafter
`
`the immediately preceding dose.
`
`38.
`
`(New) The method of claim 37, wherein the angiogenic eye disorder is age related
`
`macular degeneration.
`
`39.
`
`(New) The method of claim 34, whereinat least 5 tertiary doses of the VEGF antagonist
`
`are administered to the patient, and wherein the first four tertiary doses are administered 8 weeksafter
`
`the immediately preceding dosc, and wherein cach subsequent tertiary dosc is administered 8 or 12
`
`weeks after 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, wherein all doses of the VEGF antagonist are
`
`administered to the patient by intraocular administration.
`
`Celltrion Exhibit 1055
`Page 7
`
`Celltrion Exhibit 1055
`Page 7
`
`

`

`Atty Dkt. No.: REGN-OO8CIPCON2
`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, whereinall 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, whercin all doses of the VEGFantagonist comprise 0.5
`
`mg of the VEGF antagonist.
`
`46.
`
`(New) The method of claim 44, wherein all doses of the VEGF antagonist comprise 2
`
`mg of the VEGF antagonist.
`
`Celltrion Exhibit 1055
`Page 8
`
`Celltrion Exhibit 1055
`Page 8
`
`

`

`Atty Dkt. No.: REGN-OO8CIPCON2
`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 exclusioncriteria for
`
`patients. These exclusioncriteria 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 UNDER 37 C.E.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 McKesson Info. Soln. Inc., v. Bridge Medical Inc., 487 F.3d 897; 82 USPQ2d 1865 (Fed.
`
`Cir. 2007).
`
`The Applicants wish to bring to the Examincr’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.
`
`Celltrion Exhibit 1055
`Page 9
`
`Celltrion Exhibit 1055
`Page 9
`
`

`

`Atty Dkt. No.: REGN-OO8CIPCON2
`USSN: To Be Assigned
`
`These documents are available on PAIR,and thusare 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 number provided.
`
`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-008CIPCON2.
`
`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
`
`Celltrion Exhibit 1055
`Page 10
`
`Celltrion Exhibit 1055
`Page 10
`
`

`

`Electronically Filed
`
`REGN-008CIPCON2
`Attorney Docket
`NOTIFICATION OF PRIOR
`SEQUENCELISTING ta.|YANCOPOULOS,
`
`First Named Inventor
`GEORGED.
`
`Application Number
`
`To Be Assigned
`
`ANGIOGENIC EYE DISORDERS”
`
`28 March 2017
`Filing Date
`Address to:
`Confirmation Number|To Be Assigned
`Mail Stop Patent Application
`
`Commissioner for Patents
`Group Art Unit
`To Be Assigned
`P.O. Box 1450
`,
`,
`:
`
`Alexandria, VA 22313-1450
`Examiner Name
`To Be Assigned
`Title:
`“USEOF A VEGF ANTAGONIST TO TREAT
`
`Sir:
`
`The above-identified 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 sequence listing (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
`
`from applicants’ 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-O008CIPCON2.
`
`Respectfully submitted,
`
`BOZICEVIC, 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
`
`Celltrion Exhibit 1055
`Page 11
`
`Celltrion Exhibit 1055
`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 D. YANCOPOULOS
`
`
`
`Filer: Karl Bozicevic/Kimberly Zuehlke
`
`Attorney Docket Number:
`
`REGN-OO8CIPCON2
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC 111(a)
`
`
`
`
`
`
`
`
`
`Miscellaneous-Filing:
`
`Sub-Total in
`Fee Code Quantity AmountDescription USD($)
`
`
`
`
`
`Basic Filing:
`
`UTILITY APPLICATION FILING
`
`
`UTILITY SEARCH FEE
`
`
`UTILITY EXAMINATION FEE
`
`Claims:
`
`
`
`
`
`Celltrion Exhibit 1055
`Page 12
`
`Celltrion Exhibit 1055
`Page 12
`
`

`

`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Miscellaneous:
`
`Extension-of-Time:
`
`
`
`Total in USD ($)
`
`2080
`
`Celltrion Exhibit 1055
`Page 13
`
`Celltrion Exhibit 1055
`Page 13
`
`

`

` a T
`
`he Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`Electronic AcknowledgementReceipt
`
`28758182
`EFS ID:
`
`
`Application Number:
`
`15471506
`
`Confirmation Number:
`
`8014
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`First Named Inventor/Applicant Name: GEORGE D. YANCOPOULOS
`
`Customer Number:
`
`96387
`
`aa
`
`Filing Date:
`
`Time Stamp:
`
`15:02:24
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`Application Type:
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`Utility under 35 USC 11 1{a)
`
`Paymentinformation:
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`Celltrion Exhibit 1055
`Page 14
`
`Celltrion Exhibit 1055
`Page 14
`
`

`

`
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`File Listing:
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`DocumentDescription
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`Number Message Digest|Part/.zip) (ifappl.)
`1823602
`
`Application Data Sheet
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`REGN-O008CIPCON2_2017-03-2§ 2834e41e9193695ad5U6080d920b4006ce
`dco46c
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`529155
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`REGN-008CIPCON2_Specificati
`on.pdf
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`66488¢5363714.0771 Sffe32f0b6596663f6e0)
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`Specification
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`105393
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`REGN-O008CIPCON?2.declaration
`.pdf
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`6hda?7272374e6ath0c8-3dicf30d01 2e465,
`
`173097
`
`Celltrion Exhibit 1055
`Page 15
`
`Celltrion Exhibit 1055
`Page 15
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`

`

`dalc454ce99§210936f1 s0bcu0Sfe671224
`82d93
`
`
`REGN-008CIPCON2_2017-03-28
`_pre_amend_asfld.pdf
`
`Multipart Description/PDF files in .zip description
`
`SequenceListing
`
`REGN-O008CIPCON2_seq_list_t
`rans.pdf
`
`15712f98903ec6052e7e5f716b4a6.9701 69]
`01474
`
`Information:
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`SequenceListing (Text File)
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`REGN-O008CIPCON2_SeqList.txt
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`Information:
`
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`
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`fee-info.pdf
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`66a646fa2e7f56edc76cb7306d608.90aede
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`2766815
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`Celltrion Exhibit 1055
`Page 16
`
`Celltrion Exhibit 1055
`Page 16
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`

`

`New Applications Under 35 U.S.C. 111
`If a new applicationis 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 shownon this
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
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`
`NewInternational Application Filed with the USPTO as a Receiving Office
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`Celltrion Exhibit 1055
`Page 17
`
`Celltrion Exhibit 1055
`Page 17
`
`

`

`PTO/AIA/14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unlessit contains a valid OMB control number.
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`. Attorney Docket Number|REGN-008CIPCON2.
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`
`Application Data Sheet 37 CFR 1.76
`Application Number
`
`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 whichit is being submitted. The following form contains the
`bibliographic data arrangedin a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
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`Inventor Information:
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`
`Inventor [1[Remove|
`
`Legal Name
`
`
`Prefix; Given Name
`Middle Name
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`
`D.
`‘ANCOPOULOS
`[+]
`
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`PTO/AIA/14 (11-15)
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`PTO/AIA/14 (11-15)
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`PTO/AIA/14 (11-15)
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