Docket No.: 8545US02
`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of: Christine Bjoem Jensen et al.
`
`Application No.: Not Yet Assigned
`
`Confirmation No.: NIA
`
`Filed: Concurrently Herewith
`
`Art Unit: NIA
`
`For: Use ofLogn-Acting GLP-1 Peptides
`
`Examiner: Not Yet Assigned
`
`UTILITY PATENT APPLICATION TRANSMITTAL
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
`
`This is a request for filing a Continuation application under 37 C.F.R. l.53(b).
`
`Applicant: Novo Nordisk A/S
`
`Title: Use of Long-Acting GLP-1 Peptides
`
`Applicants enclose a duly filled in Application Data Sheet with all relevant priority information.
`
`Direct all future correspondence to Customer Number 23650.
`
`Please charge the required fee associated with this application and credit any overpayments to
`
`Novo Nordisk, Inc., Deposit Account No. 14-1447, under Order No. 8545US02 from which the undersigned
`
`is authorized to draw. Please charge any additional fees, should they be required, to Deposit Account No.
`
`14-1447.
`
`Dated: July 20, 2017
`
`Respectfully submitted,
`
`Electronic signature: /Leon Y. Lum/
`Leon Y. Lum
`Registration No.: 62,124
`NOVO NORDISK INC
`800 Scudders Mill Road
`Plainsboro, New Jersey 08536
`(609) 987-5800
`Attorney For Applicant
`
`8545US02 - Application Transmittal.doc
`
`MPI EXHIBIT 1002 PAGE 1
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 1 of 369
`
`

`

`Attorney Docket No.: 8545US02
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN etal.
`Inventors: JENSEN et al.
`
`1/6
`
`Lirag I utide
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`Data are LS means.
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`
`Fig. 1
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`
`MPI EXHIBIT 1002 PAGE 2
`
`MPI EXHIBIT 1002 PAGE 2
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 2 of 369
`
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`MPI EXHIBIT 1002 PAGE 3
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 3 of 369
`
`

`

`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`3/6
`
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`
`MPI EXHIBIT 1002 PAGE 4
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 4 of 369
`
`

`

`Attorney Docket No.: 8545US02
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN etal.
`Inventors: JENSEN et al.
`
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`MPI EXHIBIT 1002 PAGE 5
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 5 of 369
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 6 of 369
`
`

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`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`6/6
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`MPI EXHIBIT 1002 PAGE 7
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 7 of 369
`
`

`

`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`38/40
`
`Claims
`
`1. A method for
`
`a) reduction of HbA1c;
`
`b) treatment of type 2 diabetes, hyperglycemia, impaired glucose tolerance, or non-insulin
`
`dependent diabetes; or
`
`c) treatment of obesity, reducing body weight and/or food intake, or inducing satiety;
`
`wherein said method comprises administration of a GLP-1 agonist to a subject in need thereof,
`
`wherein said GLP-1 agonist
`
`i) has a half-life of at least 72 hours;
`
`ii) is administered in an amount of at least 0.7 mg per week, such an amount equivalent to at
`
`least 0. 7 mg semaglutide per week; and
`
`iii) is administered once weekly or less often.
`
`2. The method according to claim 1, wherein said GLP-1 agonist has a half-life of at least 96
`
`hours.
`
`3. The method according to claim 1, wherein the GLP-1 agonist has an EC50 at or below
`3000pM.
`
`4. The method according to claim 1, wherein said GLP-1 agonist is administered in an amount
`
`of
`
`i) at least 0.8 mg per week; or
`
`ii) in an amount equivalent to at least 0.8 mg semaglutide per week.
`
`MPI EXHIBIT 1002 PAGE 8
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 8 of 369
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`

`

`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`39/40
`
`5. The method according to claim 1, wherein the GLP-1 agonist is a GLP-1 peptide.
`
`6. The method according to claim 5, wherein said GLP-1 peptide comprises no more than 6
`
`amino acid residues which have been substituted, inserted or deleted as compared to GLP-1 (7-
`
`37).
`
`7. The method according to claim 1, wherein said GLP-1 agonist is selected from the group
`
`consisting of semaglutide, exenatide, albiglutide, and dulaglutide.
`
`8. The method according to claim 1, wherein said GLP-1 agonist is administered by parenteral
`
`administration.
`
`9. The method according to claim 1, wherein said GLP-1 agonist is administered simultaneously
`
`or sequentially with another therapeutic agent.
`
`10. The method according to claim 1, wherein the method comprises treatment, reduction or
`
`induction in one or more diseases or conditions selected from a) and b), a) and c), b) and c), or
`
`a), b) and c) as defined in claim 1.
`
`MPI EXHIBIT 1002 PAGE 9
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 9 of 369
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`

`

`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. 0MB 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 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`The application data sheet is 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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`Inventor
`11
`Legal Name
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`I Remove
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`I El J:hristine
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`Residence Information (Select One)
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`~harlottenlund
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`~joern
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`Active US Military Service
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`Address 1
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`~o Novo Nordisk A/S
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`I l3agsvaerd
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`PTO/AIN14 (11-15)
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`8545US02
`
`Application Number
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`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Application Information:
`
`Title of the Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Attorney Docket Number
`
`'3545US02
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 12 of 369
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`PTO/AIN14 (11-15)
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`Application Data Sheet 37 CFR 1.76
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`8545US02
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`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
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`DR. REDDY’S LABORATORIES, INC.
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
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`MPI EXHIBIT 1002 PAGE 15
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 15 of 369
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`Title of Invention
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`Use of Long-Acting GLP-1 Peptides
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`I ~ova Nordisk A/S
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`DK-2880
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 16 of 369
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`8545US02
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`Use of Long-Acting GLP-1 Peptides
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`liLeon Y. Lum/
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`Date (YYYY-MM-DD) 12017-07-20
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`~eon Y.
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`I Last Name I ~um
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`Registration Number
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`~2,124
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`MPI EXHIBIT 1002 PAGE 17
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 17 of 369
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`8545US02
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`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`This collection of information is required by 37 CFR 1. 76. The information is required to obtain or retain a benefit by the public which
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1002, p. 18 of 369
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`2017-07-21
`I J:;hristine Bjoem Jensen
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`U.S.PATENTS
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`1
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`as36122
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`A1
`
`R013-09-17
`
`caU et al.
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`2
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`a129343
`
`A1
`
`Ro12-03-06
`
`au et al.
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`20110301080
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`Ro11-12-oa
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`Bush et al.
`
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`3
`
`20100292133
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`Ro10-11-1a
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`Spetzler et al.
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`20100047762
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`Button et al.
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