PRELIMINARY
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`Under CFR 1.115
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`Addressto:
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`Mail Stop Patent Application
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`Commissioner for Patents
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`P.O. Box 1450
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`Electronically Filed
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`Title:
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`Eye Disorders”
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`REGN-008CIPCON
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`To Be Assigned
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`YANCOPOULOS. GEORGED.
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`To Be Assigned
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`17 December 2015
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`To Be Assigned
`Group Art Unit
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`To Be Assigned
`“Use of a VEGF Antagonist to Treat Angiogenic
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`Sir:
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`Prior to the examination of the above-referenced application on the merits, please enter the
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`amendments below.
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`CELLTRION- EXHIBIT 1017
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`CELLTRION - EXHIBIT 1017
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`Atty Dkt. No.: REGN-O008CIPCON
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`USSN: To Be Assigned
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`AMENDMENTSTO THE CLAIMS
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`1.
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`(Currently Amended) A methodfor treating an angiogenic eye disorder in a patient,
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`said method comprising sequentially administering to the patient a single initial dose of a VEGF
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`antagonist, followed by one or more secondary doses of the VEGF antagonist, followed by one or more
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`tertiary doses of the VEGFantagonist;
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`wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose;
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`and
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`wherein each tertiary dose is administeredatteast-8-weeks-afterthe-tmmediateh_precedine
`dese on an as-needed/pro re nata (PRN) basis, based _on visual and/or anatomical outcomes as
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`assessed by a physician or other qualified medical professional;
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`wherein the VEGF antagonist is a receptor-based chimeric molecule comprising (1) a
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`(2) a VEGFR2
`ID NO:2;
`VEGFRI1 component comprising amino acids 27 to 129 of SEO
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`component comprising amino acids 130-231 of SEO ID NO:2; and (3) a multimerization
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`component comprising amino acids 232-457 of SEQ ID NO:2.
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`2.
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`(Original) The method of claim 1, whercin only a single secondary dose is administered
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`to the patient, and wherein the single secondary dose is administered 4 weeksafterthe initial dose of the
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`VEGFantagonist.
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`3.
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`(Original) The method of claim 1, wherein only two secondary doses are administered to
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`the patient, and wherein each secondary dose is administered 4 weeks after the immediately preceding
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`dose.
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`4.
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`5.
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`(Canceled)
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`(Canceled)
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`(Original) The method of claim 1, wherein the angiogenic eye disorderis selected from
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`the group consisting of: age related macular degeneration, diabetic retinopathy, diabetic macular edema,
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`central retinal vein occlusion, branchretinal vein occlusion, and corneal neovascularization.
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`7.
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`(Original) The method of claim 6, wherein the angiogenic eye disorderis age related
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`macular degeneration.
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`8.
`(Currently Amended) The method of claim 1, wherein all doses of the VEGF
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`antagonist Be RENEGEantibodorfragment watVEGEreceptorantbedyoFthereat
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`e are administered to the patient by
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`topical administration or by intraocular administration.
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`Atty Dkt. No.: REGN-O008CIPCON
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`USSN: To Be Assigned
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`9. - 12. (Canceled)
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`13
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`(Currently Amended) The method of claim 2 42, wherein all doses of the VEGF
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`antagonist are administered to the patient by intraocular administration.
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`14.
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`(Original) The method of claim 13, wherein the intraocular administration is intravitreal
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`administration.
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`15.-17.
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`(Canceled)
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`18.
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`(Currently Amended) The method of claim 13 47, wherein all doses of the VEGF
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`antagonist comprise from about 0.5 mg to about 2 mg of the VEGFantagonist.
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`19.
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`(Original) The method of claim 18, wherein all doses of the VEGF antagonist comprise
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`0.5 mg of the VEGFantagonist.
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`20.
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`(Original) The method of claim 18, wherein all doses of the VEGF antagonist comprise 2
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`mg of the VEGF antagonist.
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`21.
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`(New) The method of claim 1, wherein the VEGF antagonist is VEGFR1R2-FcAC1(a)
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`encoded by the nucleic acid sequence of SEQ ID NO:1.
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`0003
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`0003
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`REMARKS UNDER 37 CFR § 1.115
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`Atty Dkt. No.: REGN-O008CIPCON
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`USSN: To Be Assigned
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`Formal Matters
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`Claims 1-3, 6-8, 13, 14 and 18-21 are pending after entry of the amendments set forth herein.
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`Claims 4, 5, 9-12 and 15-17 are canceled without prejudice.
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`Claims | and 8 are amended.
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`Claim 21 is added.
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`For the convenience of the Examiner, support for the claim amendments is made in part with
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`reference to the allowed claims of the parent application.
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`The amendments to claim 1 with respect to defining the VEGFantagonists are identical to
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`allowed claim 1 of the parent application and supported within originally pending now cancelled claim
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`11.
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`The amendments to claim 1 with respect to the tertiary dose administration are supported in the
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`original application in paragraph [0062] Example 5, Table 2 and in paragraph [0065] Example 6.
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`The amendments to claim 8 are supported in originally pending now cancelled claim 12.
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`Formal amendments are made to claims 13 and 18 in view of the cancellation of claims 12 and
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`17.
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`Newly added claim 21 is supported in the original specification in original paragraph [0034].
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`No new matter has been added.
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`PARENT APPLICATION
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`The parent application has been allowed. Further, as indicated above, correspondence and
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`support for the current claims relative to those of the parent application can be reviewed and confirmed.
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`In the event the Examiner has any questions with respect to claim support or other issues in connection
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`with the application, the Examiner is respectfully requested to contact the undersigned attorney at the
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`indicated telephone numberto arrange for an interview to expedite this position of this application.
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`STATEMENT UNDER 37 C.F.R.
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`881.56 AND 1,2
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`Applicants hercby advise the Examinerof the status of a co-pending application in compliance
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`with the Applicant’s duty to disclose under 37 C.F.R. §§1.56 and 1.2 ( see also MPEP §2001.06(b)) as
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`0004
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`0004
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`Atty Dkt. No.: REGN-O008CIPCON
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`USSN: To Be Assigned
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`discussed in McKesson Info. Soin. Inc., v. Bridge Medical Inc., 487 F.3d 897; 82 USPQ2d 1865 (Fed.
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`Cir. 2007).
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`The Applicants wish to bring to the Examiner’s attention that a Notice of Allowance was mailed
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`on October 19, 2015 in co-pending U.S. Patent Application No. 13/940,370,filed July 12, 2013.
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`This document is (These documents are) available on PAIR,andthus is (are) not provided with
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`this communication. Please inform the undersigned if there is any difficulty in obtaining the
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`document(s) from PAIR.
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`CONCLUSION
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`Applicant submits that all of the claims are in condition for allowance, which action is requested.
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`If the Examiner finds that a telephone conference would expedite the prosecution of this application,
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`please telephone the undersigned at the numberprovided.
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`The Commissioneris hereby authorized to charge any underpaymentof fees up to a strict limit of
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`$3,000.00 beyondthat authorized on the credit card, but not more than $3,000.00 in additional fees due
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`with any communication for the above referenced patent application, including but not limited to any
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`necessary fees for extensions of time, or credit any overpayment of any amountto Deposit Account No.
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`50-0815, order number REGN-OO8CIPCON.
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`Respectfully submitted,
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`BOZICEVIC, FIELD & FRANCIS LLP
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`Date: By:__/Karl Bozicevic, Reg. No. 28,807/17 December 2015
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`Karl Bozicevic
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`Registration No. 28,807
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`Bozicevic, Field & Francis LLP
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`Telephone: (650) 327-3400
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`Facsimile: (650) 327-3231
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`0005
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`0005
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`Electronic Patent Application Fee Transmittal
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`Application Number:
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`Filing Date:
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`Title of Invention:
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`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
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`First Named Inventor/Applicant Name:
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`GEORGE D. YANCOPOULOS
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`restice
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`Attorney Docket Number:
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`REGN-O008CIPCON
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`Filed as Large Entity
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`Filing Fees for Utility under 35 USC 111(a)
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`Basic Filing:
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`Utility application filing
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`Utility Search Fee
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`Utility Examination Fee
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`1311
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`Miscellaneous-Filing:
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`Patent-Appeals-and-Interference:
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`0006
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`0006
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`Sub-Total in
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`Post-Allowance-and-Post-Issuance:
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`Miscellaneous:
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`0007
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`0007
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`he Director of the USPTOis hereby authorized to charge indicated fees and credit any overpayment as follows:
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`0008
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`Electronic AcknowledgementReceipt
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`24386727
`EFS ID:
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`Application Number:
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`14972560
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`Title of Invention:
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`USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
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`ttorney Docket Number: REGN-008CIPCON
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`Receipt Date:
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`17-DEC-2015
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`Application Type:
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`Utility under 35 USC 111{a)
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`Paymentinformation:
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`0008
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`Application Data Sheet
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`Assignee showing of ownership per 37
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`PTO/AIA/14 (11-15)
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`Approved for use through 04/30/2017. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unless it contains a valid OMB control number.
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`Attorney Docket Number|REGN-OO8CIPCON
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`Application Data Sheet 37 CFR 1.76
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`The application data sheetis part of the provisional or nonprovisional application for whichit is being submitted. The following form contains the
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`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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`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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`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not befiled electronically.)
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`City State/Province [RY|Country of Residencdorktown Heights
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`Mailing Address of Inventor:
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`i 'o Regeneron Pharmaceuticals,Inc.
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`| 77 Old Saw Mill River Road
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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 Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
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`[_] An Addressis being provided for the correspondence Information of this application.
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`Customer Number
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`N6387
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`Application Information:
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`Rowers’—SCSCSCSCSCSCSCSCSCSSSSSTTCC“*déS
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`PTO/AIA/14 (11-15)
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`Approved for use through 04/30/2017. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unlessit contains a valid OMB control number.
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`Attorney Docket Number|REGN-008CIPCON
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`Application Data Sheet 37 CFR 1.76 Application Number
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`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
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`Filing By Reference:
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`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 drawings are beingfiled. Any domestic benefit or foreign priority information must be
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`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 bythis
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`reference to the previously filed application, subject to conditions and requirements of 37 CFR 1.57(a).
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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 request that the attached application not be published under
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`35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
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`subject of an application filed in another country, or under a multilateral international agreement, that requires
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`publication at eighteen months afterfiling.
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`Representative Information:
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`Representative information should be provided for all practitioners having a power of attorney in the application. Providing
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`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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`Either enter Customer Number or complete the Representative Name section below.If both sections are completed the customer
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`Numberwill be used for the Representative Information during processing.
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`C) Limited Recognition (37 CFR 11.9)
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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
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`the specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
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`PTO/AIA/14 (11-15)
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`Approved for use through 04/30/2017. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unlessit contains a valid OMB control number.
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`Application Number
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`. Attorney Docket Number|REGN-008CIPCON.
`Application Data Sheet 37 CFR 1.76
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`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
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`Filing or 371(c) Date
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`2012-01-11
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`2011-01-13
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`PCT/US2012/020855
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`| laims benefit of provisional
`PCT/US2012/020855
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`Additional Domestic Benefit/National Stage Data may be generated within this form
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`by selecting the Add button.
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`PCT/US2012/020855
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`Foreign Priority Information:
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`This section allows for the applicant to claim priority to a foreign application. Providing this information in the application data sheet
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`constitutes the claim for priority as required by 35 U.S.C. 119(b) and 37 CFR 1.55. Whenpriority 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
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`automatically attempt retrieval pursuant to 37 CFR 1.55(1)(1) and (2). Under the PDX program, applicant bears the ultimate
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`responsibility for ensuring that a copy of the foreign application is received by the Office from the participating foreign intellectual
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`property office, or a certified copy of the foreign priority applicationis filed, within the time period specified in 37 CFR 1.55(g){1).
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`Additional Foreign Priority Data may be generated within this form by selecting the
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`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
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`Applications
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`EFS Web 2.2.12
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`0014
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`0014
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`PTO/AIA/14 (11-15)
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`Approved for use through 04/30/2017. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unlessit contains a valid OMB control number.
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`. Attorney Docket Number|REGN-008CIPCON.
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`Application Data Sheet 37 CFR 1.76
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`Application Number
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`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
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`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
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`contains, or contained at any time, a claim to a claimed invention that has an effectivefiling date on or after March
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`NOTE: Byproviding this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
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`16, 2013, will be examined underthe first inventorto file provisions of the AIA.
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`EFS Web 2.2.12
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`0015
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`0015
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`PTO/AIA/14 (11-15)
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`Approved for use through 04/30/2017. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unlessit contains a valid OMB control number.
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`Attorney Docket Number|REGN-008CIPCON
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`Title of Invention|USE OF A VEGF ANTAGONIST TO TREAT ANGIOGENIC EYE DISORDERS
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`Application Data Sheet 37 CFR 1.76 Application Number
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`Authorization or Opt-Out of Authorization to Permit Access:
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`Whenthis Application Data Sheet is properly signed and filed with the application, applicant has provided written
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`authority to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see
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`paragraph A in subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant
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`application (see paragraph B in subsection 1 below).
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`Should applicant choose not to provide an authorization identified in subsection 1 below, applicant must opt-out of the
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`authorization by checking the corresponding box A or B or both in subsection 2 below.
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`NOTE: This section of the Application Data Sheet is ONLY reviewed and processedwith the INITIAL filing of an
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`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
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`authorization for access by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
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`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
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`A. Priority Document Exchange (PDX)- Unless box A in subsection 2 (opt-out of authorization) is checked, the
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`undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
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`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People’s Republic of
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`China (SIPO), the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
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`participating with the USPTOin a bilateral or multilateral priority document exchange agreementin which a foreign
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`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
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`andits related bibliographic data, (2} any foreign or domestic application to which priority or benefit is claimed by the
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`instant application and its related bibliographic data, and (3) the date offiling of this Authorization. See 37 CFR 1.14(h)
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`(1).
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`B. Search Results from U.S. Application to EPO - Unless box B in subsection 2 (opt-out of authorization) is checked,
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`the undersigned hereby grants the USPTO authority to provide the EPO accessto the bibliographic data and search
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`results from the instant patent application when a European patent application claiming priority to the instant patent
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`application is filed. See 37 CFR 1.14(h)(2).
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`The applicant is reminded that the EPO’s Rule 141(1) EPC (European Patent Convention} requires applicants to submit a
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`copy of search results from the instant application without delay in a European patent application that claimspriority to
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`the instant application.
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`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s}
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