DocCode — SEQ. TXT
`
`SCORE Placeholder Sheetfor IFW Content
`
`Application Number: 17350958
`
`Document Date: 06/17/2021
`
`The presence ofthis form in the IFW record indicates that the following documenttype wasreceived
`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 physicalartifact 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 DAV or via the SCORE web page.
`e External customers may access SCORE content via PAIR using the Supplemental Content
`tab.
`
`Form Revision Date: March 1, 2019
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 001
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 001
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`

`

`Eye Disorders”
`
`Electronically Filed
`
`Attorney Docket No.
`Confirmation No.
`First Named Inventor
`Application Number
`June 17, 2021
`Filing Date
`To Be Assigned
`Group Art Unit
`To Be Assigned
`Examiner Name
`Title:
`“Use ofa VEGF Antagonist to Treat Angiogenic
`
`PRELIMINARY
`AMENDMENT
`Under CFR 1.115
`
`Addressto:
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Prior to the examination of the above-referenced application on the merits, please enter the
`
`amendments below.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 002
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 002
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`

`

`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`AMENDMENTSTO THE CLAIMS
`
`1. - 20. (Canceled)
`
`21.
`
`(New) A method for treating an angiogenic eye disorderin a patient in need thereof, said
`
`method comprising administering by intravitreal injection one or more maintenance doses of 2 mg of a
`
`VEGFantagonist comprising amino acids 27-457 of SEQ ID NO:2 at least about 8 weeksafter the
`
`immediately preceding dose;
`
`wherein said patient has previously received by intravitreal injection an initial dose of 2 mg of
`
`the VEGFantagonist followed by one or more secondary doses of 2 mg of the VEGFantagonist;
`
`wherein each secondary dose was administered about 2 to 4 weeksafter the immediately
`
`preceding dose; and
`
`wherein the patient achieves a gain in visual acuity at 24 weeks following the initial dose
`
`comparedto baseline.
`
`22.
`
`(New) The method of claim 21, wherein the angiogenic eye disorderis age related
`
`macular degeneration.
`
`23.
`
`(New) The method of claim 21, wherein the angiogenic eye disorderis diabetic
`
`retinopathy.
`
`24.
`
`(New) The method of claim 21, wherein the angiogenic eye disorderis diabetic macular
`
`edema.
`
`25.
`
`(New) The method of claim 21, wherein the angiogenic eye disorder is macular edema
`
`following retinal vein occlusion.
`
`26.
`
`(New) The method of claim 21, wherein the method comprises administering by
`
`intravitreal injection two or more maintenancedoses of 2 mg of the VEGFantagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 at least about 8 weeks after the immediately preceding dose.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 003
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 003
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`

`

`27.
`
`(New) The method of claim 26, wherein the patient experiences a gain in visual acuity of
`
`at least 7 letters on the ETDRSchart at 24 weeks following the initial dose compared to baseline.
`
`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`28.
`
`(New) The method of claim 21, wherein the method comprises administering by
`
`intravitreal injection five or more maintenance doses of 2 mg of the VEGF antagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 at least about 8 weeks after the immediately preceding dose.
`
`29.
`
`(New) The method of claim 28, wherein the patient achieves a gain in visual acuity at
`
`52 weeksfollowing the initial dose comparedto baseline.
`
`30.
`
`(New) The method of claim 29, wherein the patient achieves a gain in visual acuity of
`
`at least 8 letters on the ETDRSchart at 52 weeks following the initial dose comparedto baseline.
`
`31.
`
`(New) The method of claim 21, wherein said patient has previously received by
`
`intravitreal injection an initial dose of 2 mg of the VEGF antagonist followed by one or more secondary
`
`doses of 2 mg of the VEGF antagonist; followed by one or moretertiary doses of 2 mg of the VEGF
`
`antagonist;
`
`wherein each secondary dose was administered about 2 to 4 weeksafter the immediately
`
`preceding dose;
`
`wherein each tertiary dose was administered at least about 8 weeksafter the immediately
`
`preceding dose.
`
`32.
`
`(New) A method for treating an angiogenic eye disorderin a patient in need thereof, said
`
`method comprising administering by intravitreal injection one or more maintenance doses of 2 mg of a
`
`VEGFantagonist comprising amino acids 27-457 of SEQ ID NO:2 at least about 8 weeksafter the
`
`immediately preceding dose;
`
`wherein said patient has previously received by intravitreal injection an initial dose of 2 mg of
`
`the VEGFantagonist, followed by one or more secondary doses of 2 mg of the VEGFantagonist;
`
`wherein each secondary dose was administered about 2 to 4 weeksafter the immediately
`
`preceding dose; and
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 004
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 004
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`

`

`wherein the patient maintains visual acuity at 24 weeks followingthe initial dose
`
`comparedto baseline.
`
`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`33.
`
`(New) The method of claim 32, wherein the angiogenic eye disorderis age related
`
`macular degeneration.
`
`34.
`
`(New) The method of claim 32, wherein the angiogenic eye disorderis diabetic
`
`retinopathy.
`
`35.
`
`(New) The method of claim 32, wherein the angiogenic eye disorderis diabetic macular
`
`edema.
`
`36.
`
`(New) The method of claim 32, wherein the angiogenic eye disorder is macular edema
`
`following retinal vein occlusion.
`
`37.
`
`(New) The method of claim 32, wherein the method comprises administering by
`
`intravitreal injection two or more maintenancedoses of 2 mg of the VEGFantagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 at least about 8 weeks after the immediately preceding dose.
`
`38.
`
`(New) The method of claim 32, wherein the method comprises administering by
`
`intravitreal injection five or more maintenance doses of 2 mg of the VEGF antagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 at least about 8 weeks after the immediately preceding dose.
`
`39.
`
`(New) The method of claim 32, wherein said patient has previously received by
`
`intravitreal injection an initial dose of 2 mg of the VEGF antagonist followed by one or more secondary
`
`doses of 2 mg of the VEGF antagonist; followed by one or moretertiary doses of 2 mg of the VEGF
`
`antagonist;
`
`wherein each secondary dose was administered about 2 to 4 weeksafter the immediately
`
`preceding dose;
`
`wherein each tertiary dose was administered at least about 8 weeksafter the immediately
`
`preceding dose.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 005
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 005
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`

`

`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`AO.
`
`(New) The method of claim 38, wherein the patient maintains visual acuity at 52
`
`weeks following the initial dose compared to baseline.
`
`Al.
`
`(New) A method for treating an angiogenic eye disorderin a patient in need thereof, said
`
`method comprising administering by intravitreal injection one or more maintenance doses of 2 mg of a
`
`first VEGF antagonist comprising amino acids 27-457 of SEQ ID NO:2 at least about 8 weeks after
`
`the immediately preceding dose;
`
`wherein the patient has previously received by intravitreal injection an initial dose of a second
`
`VEGFantagonist, followed by one or more secondary doses of the second VEGFantagonist;
`
`wherein each secondary dose was administered about 2 to 4 weeksafter the immediately
`
`preceding dose; and
`
`wherein the treatment with the first VEGF antagonist results in the patient maintaining
`
`visual acuity at 24 weeks following the initial dose comparedto baseline.
`
`42.
`
`(New) The method of claim 41, wherein the angiogenic eye disorderis age related
`
`macular degeneration.
`
`43.
`
`(New) The method of claim 41, wherein the angiogenic eye disorderis diabetic
`
`retinopathy.
`
`44.
`
`(New) The method of claim 41, wherein the angiogenic eye disorderis diabetic macular
`
`edema.
`
`45.
`
`(New) The method of claim 41, wherein the angiogenic eye disorder is macular edema
`
`following retinal vein occlusion.
`
`46.
`
`(New) The method of claim 41, wherein the method comprises administering by
`
`intravitreal injection two or more maintenancedoses of 2 mg of a VEGF antagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 at least about 8 weeks after the immediately preceding dose.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 006
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 006
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`

`

`47.
`
`(New) The method of claim 46, wherein the method comprises administering by
`
`intravitreal injection five or more maintenance doses of 2 mg of a VEGFantagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 at least about 8 weeks after the immediately preceding dose.
`
`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`A8.
`
`(New) The method of claim 47, wherein the patient maintains visual acuity at 52
`
`weeks following the initial dose compared to baseline.
`
`49,
`
`(New) The method of claim 41, wherein said patient has previously received by
`
`intravitreal injection an initial dose of 2 mg of the second VEGFantagonist followed by one or more
`
`secondary doses of 2 mg of the second VEGFantagonist; followed by one or moretertiary doses of 2
`
`mg of the second VEGFantagonist;
`
`wherein each secondary dose was administered about 2 to 4 weeksafter the immediately
`
`preceding dose;
`
`wherein each tertiary dose was administered at least about 8 weeksafter the immediately
`
`preceding dose.
`
`50.
`
`(New) A method for treating an angiogenic eye disorderin a patient in need thereof, said
`
`method comprising administering by intravitreal injection three or more maintenance doses of 2 mg of a
`
`VEGFantagonist comprising amino acids 27-457 of SEQ ID NO:2 about once every 8 or more weeks;
`
`wherein said patient has previously received by intravitreal injection two or more doses of 2
`
`mg of the VEGF antagonist about once every 4 weeks; and
`
`wherein the method results in the patient achieving a gain in visual acuity at 24 weeksafter the
`
`first maintenance dose.
`
`51.
`
`(New) The method of claim 50, wherein the method comprises administering by
`
`intravitreal injection four or more maintenance doses of 2 mg of the VEGF antagonist comprising amino
`
`acids 27-457 of SEQ ID NO:2 about once every 8 or more weeks.
`
`52.
`
`(New) The method of claim 50, wherein the angiogenic eye disorderis age related
`
`macular degeneration.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 007
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 007
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`

`

`53.
`
`(New) The method of claim 50, wherein the angiogenic eye disorderis diabetic
`
`retinopathy.
`
`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`54.
`
`(New) The method of claim 50, wherein the angiogenic eye disorderis diabetic macular
`
`edema.
`
`55.
`
`(New) The method of claim 50, wherein the angiogenic eye disorder is macular edema
`
`following retinal vein occlusion.
`
`56.
`
`(New) The method of claim 50, wherein visual acuity is measured using the Early
`
`Treatment Diabetic Retinopathy Study (ETDRS) letter score.
`
`57.
`
`(New) A method for treating an angiogenic eye disorderin a patient in need thereof, said
`
`method comprising administering by intravitreal injection three or more maintenance doses of 2 mg of a
`
`VEGFantagonist comprising amino acids 27-457 of SEQ ID NO:2 about once every 8 or more weeks;
`
`wherein said patient has previously received by intravitreal injection one or more dosesof 2
`
`mg of the VEGF antagonist about once every 4 weeks; and
`
`wherein the method results in the patient maintaining visual acuity at 24 weeksafter the first
`
`maintenance dose.
`
`58.
`
`(New) The method of claim 57, wherein the angiogenic eye disorderis age related
`
`macular degeneration.
`
`59.
`
`(New) The method of claim 57, wherein the angiogenic eye disorderis diabetic
`
`retinopathy.
`
`60.
`
`(New) The method of claim 57, wherein the angiogenic eye disorderis diabetic macular
`
`edema.
`
`61.
`
`(New) The method of claim 57, wherein the angiogenic eye disorder is macular edema
`
`following retinal vein occlusion.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 008
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 008
`
`

`

`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`62.
`
`(New) The method of claim 57, wherein visual acuity is measured using the Early
`
`Treatment Diabetic Retinopathy Study (ETDRS) letter score.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 009
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 009
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`

`

`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`REMARKS UNDER 37 CFR § 1.115
`
`Formal Matters
`
`Claims 21-62 are pending after entry of the amendmentsset forth herein.
`
`Original claims 1-20 are canceled without prejudice.
`
`Claims 21-62 are addedhere.
`
`Support for new claims 21-62 can be found in originally pending now canceled claims 1-20, and
`
`throughoutthe specification.
`
`No new matter has been added.
`
`SEQUENCE LISTING
`
`Applicants submit herewith the attached SequenceListing in .txt format. As set out in MPEP
`
`§2422.03(a), the Office has advised that if the sequencelisting text file submitted via EFS-Web complies
`
`with the requirements of 37 CFR 1.824(a)(2)-(6) and (b)(1.e., is a compliant sequencelisting ASCII text
`
`file), the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the computer
`
`readable form (CRF) required by 37 CFR 1.821(e). Further, per MPEP §2422.03(a), neither (1) a second
`
`copy of the sequencelisting in a PDF file; nor (2) a statement under 37 CFR 1.821(f) (indicating that the
`
`paper copy and CREcopy of the sequencelisting are identical) should be submitted.
`
`The Sequence Listing was prepared with the software FASTSEQ for Windows version 4.0, and
`
`conformsto the Patent Office guidelines. Applicant respectfully submits that the subject application is
`
`in adherence to 37 CFR §§ 1.821-1.825. [hereby certify that the enclosed submission includes no new
`
`matter.
`
`Applicants respectfully submit that the present patent application is now in compliance with 37
`
`CFR §§ 1.821-1.825.
`
`
`
`STATEMENT UNDER 37 C.E.R. §§1.56 AND 1.2
`
`Applicants hereby advise the Examinerofthe status of a co-pending application in compliance
`
`with the Applicant’s duty to disclose under 37 C.F.R. §§1.56 and 1.2 ( see also MPEP §2001.06(b)) as
`
`discussed in McKesson Info. Soln. Inc., v. Bridge Medical Inc., 487 F.3d 897; 82 USPQ2d 1865 (Fed.
`
`Cir. 2007).
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 010
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 010
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`

`

`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`
`13/940,370, filed July 12, 2013 which issued on February 9, 2016 as U.S. Patent 9,254,338.
`
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`
`14/972,560, filed December 17, 2015 which issued on June 6, 2017 as U.S. Patent No. 9,669,069.
`
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`
`15/471,506, filed March 28, 2017 which issued on November 20, 2018 as U.S. Patent No. 10,130,681.
`
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`
`16/055,847, filed August 6, 2018 which issued on December8, 2020 as U.S. Patent No. 10,857,205.
`
`The Applicant wishes to bring to the Examiner’s attention U.S. Patent Application No.
`
`16/159,282, filed October 12, 2018 which issued on November 10, 2020 as U.S. Patent No. 10,828,345.
`
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`
`No. 16/397,267, filed April 29, 2019 which issued on January 12, 2021 as U.S. Patent No. 10,888,601.
`
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`
`No. 17/072,417, filed October 16, 2020 for which no actions have been mailed.
`
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`
`No. 17/117,404, filed December 4, 2020 for which no actions have been mailed.
`
`The Applicant wishes to bring to the Examiner’s attention co-pending U.S. Patent Application
`
`No. 17/112,063, filed December 4, 2020 which wasfiled concurrently with the above-referenced patent
`
`application. No actions have been mailed.
`
`These documents are available on PAIR,and thus are not provided with this
`
`communication. Please inform the undersigned if there is any difficulty in obtaining the documents
`
`from PAIR.
`
`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.
`
`10
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 011
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 011
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`

`

`Atty Dkt. No.: REGN-008CIPCON9
`USSN: To Be Assigned
`
`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-008CIPCONS9.
`
`Respectfully submitted,
`BOZICEVIC, FIELD & FRANCIS LLP
`
`
`
`Date: By:__/Karl Bozicevic, Reg. No. 28,807/17 June 2021
`Karl Bozicevic, Reg. 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
`
`11
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 012
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 012
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`

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`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`Quantity
`
`areneTe=
`
`First Named Inventor/Applicant Name:
`
`George YANCOPOULOS
`
`Attorney Docket Number:
`
`REGN-O08CIPCON9
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC 111(a)
`
`Description
`
`Fee Code
`
`Sub-Total in
`
`USD(S)
`
`CLAIMSINEXCESSOF20
`
`INDEPENDENT CLAIMS IN EXCESS OF 3
`
`1202 pa{2 2200
`
`1201
`
`Miscellaneous-Filing:
`
`REGENERON EXHIBIT 2012 PAGE 013
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 013
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`

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`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`
`USD(S)
`
`Patent-Appeals-and-Interference:
`
`Total in USD ($)
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time
`
`Miscellaneous:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 014
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 014
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`

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`Electronic AcknowledgementReceipt
`
`Application Number:
`
`17350958
`
`International Application Number:
`
`Confirmation Number:
`
`4833
`
`Title of Invention:
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`ee
`
`ee
`
`Paymentinformation:
`
`APOTEX V. REGENERON IPR2022-01524
`
`[Depotacon
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 015
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`

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`File Listing:
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`Pages
`Multi
`File Size(Bytes)/
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`Document
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`Number Message Digest|Part/.zip|P (if appl.)
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`Application Data Sheet
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`WebADS.pdf
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`159371
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`REGN-OO08CIPCON9_2021-06-1
`_Appln_as_fld.pdf
`
`Information:
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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 pages will be resized upon entry into the
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`Image File Wrapper and mayaffect subsequent processing
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`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 016
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`REGN-OO08CIPCON9_2021-06-1
`_Prelim_Amend.pdf
`
`f1b60097f4a68dc8d039ae3eae1ddd3 162}
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`ee
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`Information:
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`Information:
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`Information:
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`SequenceListing (TextFile)
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`REGN-O008CIPCON9_SegqList.txt
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`Fee Worksheet (SB06)
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`fee-info.pdf
`
`ec7f79c25fa1a922c3cl Sc2e60acaea46246a
`b5c
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`the application.
`
`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 shown onthis
`AcknowledgementReceiptwill establish thefiling date of the application.
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903indicating acceptanceof the application asa
`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shownon this AcknowledgementReceiptwill establish the international filing date of
`
`This AcknowledgementReceipt evidences receipt on the noted date by the USPTO ofthe 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.
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 017
`
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`REGENERON EXHIBIT 2012 PAGE 017
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`

`

`
`
`PTO/AIA/14
`U.S, Patent and TrademarkOffice; U.S. DEPARTMENT OF COMMERCE
`
`
`
`Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`The application data sheet is part of the provisional or nonprovisional application for whichit is being submitted. The following form contains the
`biblicgraphic data arrangedin a format specified by the United States Patent and TrademarkOffice as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the document
`may be printed and includedin a paperfiled application.
`
`Secrecy Order 37 CFR 5.2:
`
`Portionsorall of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to 37
`
`L CFR 5.2 (Paperfilers only. Applications thatfall under Secrecy Order may notbefiled electronically.)
`
`Inventor Information:
`
`Ta caaleele
`
`1
`
`Legal Name
`
`
`Prefix |GivenNamesiMiddle Name Family Name
`
`Residence Information (Select One)
`City
`Yorktown Heights
`
`(@) US Residency
`State/Province
`
`©) Active US Military Service
`©) Non USResidency
`Country of Residence i
`US
`
`Mailing Addressof Inventor:
`
`Address 1
`
`Address 2
`
`c/o Regeneron Pharmaceuticals, Inc.
`
`777 Old Saw Mill River Road
`
`All Inventors Must Be Listed - Additional Inventor Information blocks may be generated
`within this form by selecting the Add button.
`
`CorrespondenceInformation:
`
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`[_] An Addressis being provided for the correspondence Informationof this application.
`Customer Number
`96387
`
`
`
`Email Address
`
`docket@bozpat.com
`
`Add Email
`
`Remove Email
`
`Application Information:
`
`Title of the Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Attorney Docket Number|REGN-OO8CIPCON9 Small Entity Status Claimed [|
`
`
`
`1 A
`
`Total Numberof Drawing Sheets(if any)
`
`1
`
`Suggested Figure for Publication (if any)
`
`WEB ADS1.0
`
`POTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 018
`
`Application Data Sheet 37 CFR 1.76
`
`
`
`Attorney Docket Number REGN-008CIPCONS
`
`Application Number
`
`
`
`Suffix
`
`
`
`
`
`
`
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 018
`
`

`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S.Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`REGN-O08CIPCONS
`oo.
`Attorney Docket Number
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`
`
`
`
`Title of Invention
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`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 section if
`application papers including a specification and any drawings are beingfiled. Any domestic benefit or foreign priority information must be
`provided in the appropriate section(s) below(i.e, "Domestic Benefit/National Stage Information” and “Foreign Priority Information’).
`
`For the purposesofa filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
`reference to the previouslyfiled application, subject to conditions and requirements of 37 CFR 1.57(a).
`
`i
`
`Application numberof the previously
`filed application
`
`Filing date (YYYY-MM-DD)
`
`Intellectual Property Authority or Country
`
`Publication Information:
`
`[_] Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`CO
`
`35 U.S.C.
`Request Not to Publish. | hereby request that the attached application not be published under
`122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of an
`application filed in another country, or under a multilateral international agreement, that requires publication at eighteen
`pp
`ry
`g
`q
`p
`g
`monthsafterfiling.
`
`
`
`
`
`
`Representative Information:
`
`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorneyin the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer Number
`will be used for the Representative Information during processing.
`
`
`Please Select One:
`Customer Number
`
`(@) Customer Number
`96387
`
`© USPatentPractitioner
`
`C) Limited Recognition (37 CFR 11.9)
`
`Prefix|GivenName|Middle Name|FamilyName||FamilyName||Suffix
`eeeenoes
`Registration Number
`Prefix|GivenName|Middle Name|FamilyName=|Name|Suffix
`eeeS
`Registration Number
`
`Additional Representative Information blocks may be generated within this form by
`selecting the Add button.
`
`WEB ADS1.0
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 019
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 019
`
`

`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S.Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Title of Invention
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`
`
`
`Domestic Benefit/National Stage Information:
`This section allowsfor the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) or indicate National
`Stage entry from a PCT application. Providing benefit claim information in the Application Data Sheet constitutes the specific
`reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`Whenreferring to the current application, please leave the “Application Number”field blank.
`
`
`
`2020-12-04
`17112404
`Continuation of
`
`
`
`
`Prior Application Status|Patented
`
`Application
`a
`Prior Application
`Filing Date
`Issue Date
`Number
`Continuity Type
`(YYYY_MM-DD)
`{YYYY-MM-DD)
`Patent Number
`17072417
`2018-08-06
`10857205
`2020-12-08
`
`16055847
`
`
`
`Application
`Number
`17072417
`
`4
`-
`Continuity Type
`Continuation of
`
`Prior Application
`Number
`16397267
`
`Filing Date
`(YYYY-MM-DD)
`2019-04-29
`
`Patent Number
`10888601
`
`Issue Date
`(YYYY-MM_DD)
`2021-01-12
`
`
`Application
`.
`Prior Application
`Filing Date
`Issue Date
`Number
`Continuity Type
`Number
`(YYYY-MM-DD)
`(YYYY-MM-DD)
`Patent Number
`
`16397267
`Continuation of
`16159282
`2018-10-12
`10828345
`2020-11-10
`
`Application
`Number
`16159282
`
`.
`Continuity Type
`
`Prior Application
`
`15471506
`
`Filing Date
`(YYYY-MM-DD)
`201 7-03-28
`
`Patent Number
`10130681
`
`Issue Date
`(YYYY-MM-DD)
`2018-11-20
`
`Application
`Number
`15471506
`
`.
`Continuity Type
`Continuation of
`
`Prior Application
`
`14972560
`
`Filing Date
`(YYYY-MM-DD)
`2015-12-17
`
`Patent Number
`9669069
`
`Issue Date
`(YYYY-MM-DD)
`2017-06-06
`
`WEB ADS1.0
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 020
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`
`
`
`
`Continuity Type
`
`Continuation of
`
`Prior Application Number
`
`17072417
`
`Prior Application Status
`Application Number
`
`17112404
`
`
`
`
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`2020-10-16
`
`
`
`APOTEX V. REGENERON IPR2022-01524
`REGENERON EXHIBIT 2012 PAGE 020
`
`

`

`PTO/AIA/14 (08-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S.Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`REGN-O08CIPCONS
`
`Attorney Docket Number
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`
`
`
`
`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
`Title of Invention
`
`
`Prior Application Status|Patented
`Application
`_
`Prior Application
`Filing Date
`Issue Date
`Number
`Continuity Type
`Number
`(YYYY-MM-DD)
`(YYYY-MM-DD)
`14972560
`13940370
`2013-07-12
`2016-02-09
`
`Patent Number
`9254338
`
`Prior Application Status|Expired
`
`Filing or 3/1(c) Date
`(YYYY-MM-DD}
`
`Continuity Type
`
`Prior Application Number
`
`Application Number
`
`13940370
`
`PCT/US2012/020855
`
`2012-01-11
`
`Application Number
`
`l
`
`Continuity Type
`
`.
`
`Prior Application Number
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`PCT/US2012/020855
`
`Claims benefit of provisional
`
`61432245
`
`2011-01-13
`
`
`
`
`
`
`
`
`
`
`
`
`
`Prior Application Status
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`2011-01-21
`61434836
`Claims benefit of provisional
`PCT/US2012/020855
`
`
`
`Filing or 371(c) Date
`(YYYY-MM-DD)
`
`
`
`2011-11-21
`
`
`
`l
`
`
`Prior Application Status
`
`Application Number
`
`Continuity Type
`
`.
`
`Prior Application Number
`
`
`
`PCT/US2012/020855
`
`Claims benefit of provisional
`
`61561957
`
`
`Additional Domestic Benefit/National Stage Data may be generated within this form by
`selecting the Add button.
`
`Foreign Priority Information:
`
`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55. Whenpriority is claimedto a foreign applicationthatis 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