`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of: Christine Bjoem Jensen et al.
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`Application No.: Not Yet Assigned
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`Confirmation No.: NIA
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`Filed: Concurrently Herewith
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`Art Unit: NIA
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`For: Use ofLogn-Acting GLP-1 Peptides
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`Examiner: Not Yet Assigned
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`UTILITY PATENT APPLICATION TRANSMITTAL
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`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Dear Commissioner:
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`This is a request for filing a Continuation application under 37 C.F.R. l.53(b).
`
`Applicant: Novo Nordisk A/S
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`Title: Use of Long-Acting GLP-1 Peptides
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`Applicants enclose a duly filled in Application Data Sheet with all relevant priority information.
`
`Direct all future correspondence to Customer Number 23650.
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`Please charge the required fee associated with this application and credit any overpayments to
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`Novo Nordisk, Inc., Deposit Account No. 14-1447, under Order No. 8545US02 from which the undersigned
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`is authorized to draw. Please charge any additional fees, should they be required, to Deposit Account No.
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`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
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`MPI EXHIBIT 1002 PAGE 1
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`Attorney Docket No.: 8545US02
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`Inventors: JENSEN et al.
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`3/6
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`Fig. 3A
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`MPI EXHIBIT 1002 PAGE 4
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`Attorney Docket No.: 8545US02
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`Inventors: JENSEN et al.
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`6/6
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`MPI EXHIBIT 1002 PAGE 7
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`
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`Attorney Docket No.: 8545US02
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`Inventors: JENSEN et al.
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`38/40
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`Claims
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`1. A method for
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`a) reduction of HbA1c;
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`b) treatment of type 2 diabetes, hyperglycemia, impaired glucose tolerance, or non-insulin
`
`dependent diabetes; or
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`c) treatment of obesity, reducing body weight and/or food intake, or inducing satiety;
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`wherein said method comprises administration of a GLP-1 agonist to a subject in need thereof,
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`wherein said GLP-1 agonist
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`i) has a half-life of at least 72 hours;
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`ii) is administered in an amount of at least 0.7 mg per week, such an amount equivalent to at
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`least 0. 7 mg semaglutide per week; and
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`iii) is administered once weekly or less often.
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`2. The method according to claim 1, wherein said GLP-1 agonist has a half-life of at least 96
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`hours.
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`3. The method according to claim 1, wherein the GLP-1 agonist has an EC50 at or below
`3000pM.
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`4. The method according to claim 1, wherein said GLP-1 agonist is administered in an amount
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`of
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`i) at least 0.8 mg per week; or
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`ii) in an amount equivalent to at least 0.8 mg semaglutide per week.
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`MPI EXHIBIT 1002 PAGE 8
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`Attorney Docket No.: 8545US02
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`Inventors: JENSEN et al.
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`39/40
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`5. The method according to claim 1, wherein the GLP-1 agonist is a GLP-1 peptide.
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`6. The method according to claim 5, wherein said GLP-1 peptide comprises no more than 6
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`amino acid residues which have been substituted, inserted or deleted as compared to GLP-1 (7-
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`37).
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`7. The method according to claim 1, wherein said GLP-1 agonist is selected from the group
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`consisting of semaglutide, exenatide, albiglutide, and dulaglutide.
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`8. The method according to claim 1, wherein said GLP-1 agonist is administered by parenteral
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`administration.
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`9. The method according to claim 1, wherein said GLP-1 agonist is administered simultaneously
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`or sequentially with another therapeutic agent.
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`10. The method according to claim 1, wherein the method comprises treatment, reduction or
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`induction in one or more diseases or conditions selected from a) and b), a) and c), b) and c), or
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`a), b) and c) as defined in claim 1.
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`MPI EXHIBIT 1002 PAGE 9
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`
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`8545US02
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`Application Number
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`Title of Invention
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`Use of Long-Acting GLP-1 Peptides
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`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
`document may be printed and included in a paper filed application.
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`Secrecy Order 37 CFR 5.2:
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`Inventor Information:
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`Inventor
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`~harlottenlund
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`~joern
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`Address 1
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`~o Novo Nordisk A/S
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`Address 1
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`8545US02
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`Application Number
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`Title of Invention
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`Use of Long-Acting GLP-1 Peptides
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`Prefix Given Name
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`Middle Name
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`Family Name
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`I El IVlilan
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`Residence Information (Select One)
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`~o Novo Nordisk A/S
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`Novo Alie
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`Email Address
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`nnipatent@novonordisk.com
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`8545US02
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`Application Number
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`Title of Invention
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`Use of Long-Acting GLP-1 Peptides
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`Application Information:
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`Title of the Invention
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`Use of Long-Acting GLP-1 Peptides
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`Attorney Docket Number
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`'3545US02
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`Application Type
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`For the purposes of a filing date under 37 CFR 1.53(b), the description and any drawings of the present application are replaced by this
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`Use of Long-Acting GLP-1 Peptides
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`Title of Invention
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`Use of Long-Acting GLP-1 Peptides
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`8545US02
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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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`8545US02
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`Title of Invention
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`Use of Long-Acting GLP-1 Peptides
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`PTO/AIN14 (11-15)
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`Application Data Sheet 37 CFR 1.76
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`Use of Long-Acting GLP-1 Peptides
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`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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`R013-09-17
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`caU et al.
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`20110301080
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`Bush et al.
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`20100292133
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`Ro10-11-1a
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`Spetzler et al.
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`INFORMATION DISCLOSURE
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`Application Number
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`I Christine Bjoern Jensen
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`8545US02
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`1
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`12136790
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`2
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`12130136
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`3
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`12016419
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`WO
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`wo
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`WO
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`A1
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`2012-10-11
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`Glaxo Group Lid
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`A1
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`2012-10-04
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`Tianjin Inst Phann
`Research
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`A1
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`2012-02-09
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`Zhejiang Beta Pharma Inc
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`4
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`102229668
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`~N
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`A
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`2011-11-02
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`Zhejiang Beta Pharma
`Co.,ltd
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`JO 10/092163
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`)011138421
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`)012177929
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`)012107476
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`JO 11/080103
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`)012080471
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`WO
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`wo
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`WO
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`wo
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`WO
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`wo
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`WO
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`2010-08-19
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`Boehringer lngelheim Int
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`A1
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`2011-11-10
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`Boehringer lngelheim Int
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`A2
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`2012-12-27
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`l\mylin Pharmaceuticals,
`nc
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`A1
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`2012-08-16
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`Boehringer lngelheim Int
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`A1
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`2011-07-07
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`Novo Nordisk As
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`2006-09-21
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`Novo Nordisk As
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`2012-06-21
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`MPI EXHIBIT 1002 PAGE 20
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`INFORMATION DISCLOSURE
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`Application Number
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`I Christine Bjoern Jensen
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`8545US02
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`T5
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`1
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`2
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`3
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`Madsbad S et al. An Overview of once-weekly glucagon-like peplide-1 receptor agonists available efficacy and safety
`:!ala and perspectives for the future, 'Diabetes, Obesity and Metabolism" Year 2011, Vol 13, No 5, Pages 394-407
`
`BUSE B. J_ et al., Exenalide once weekly versus liraglulide once daily in patients with type 2 diabetes {DURATION-6):
`~ randomised, open-label study, Lancet, 2013, Vol. 381, pages 117-124
`
`Kim et al. "Effects of Once-Weekly Dosing of a Long-Acting Release Formulation of Exenlide on Glucose Control and
`Body Weight in Subjects with Type 2 Diabetes." Diabetes care (2007) Vol 30 pgs 1487-1493.
`
`4
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`Bydureon NOA 022200/S-008 Package Information pages 1-179 {February 2014).
`
`:;Iinical Trial NCT00696657 entitled "A Randomized Controlled Clinical Trial in Type 2 Diabetes Comparing
`Semaglulide to Placebo and Liraglulide." pages 1-5 March 2015. Accessed September 24, 2015 at clinicaltrials.gov/
`~rchive/NCT00696657/2011 _ 03 _ 25.
`
`cau et al. "Discovery of the Once-WEekly Glucagon-Like Peplide-1 {GLP-1) Analogue Semaglulide." J_ Med. Chem.
`2015) Vol 58 pgs 7370-7380
`
`Eperzan Assessment Report. Euro. Med. Agency. pages 1-124 (2014) accessed September 24, 2015 at URL ema.
`~uropa.ed/docs/en _ GB/document_library/EPAR _ -_Public_ assessment_report/human/002735/WC500165119 .pdf
`
`~rulicity Assessment Report. Euro. Med. Agency. pages 1-172 (2014) accessed September 24, 2015 at URL ema.
`~uropa.ed/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002825/WC500179473.pdf
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`Mizuta et al. "The Role for GLP-1 in Regulation of Body Weight." Progress in Medicine 2008 Vol 28 No 8 pgs
`1909-1912
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
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`Application Number
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`Filing Date
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`First Named Inventor
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`2017-07-21
`I Christine Bjoern Jensen
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`Art Unit
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`Examiner Name
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`N/A
`I Not Yet Assigned
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`Attorney Docket Number
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`8545US02
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`10
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`:;oc, "National Health and Nutrition Examination Survey: Healthy Weight, Overweight and Obesity among U.S. adults"
`J3-0260 pp 1-2 {July 2003), accessed 5/10/2016 at URL cdc.gov/nchs/data/nhanes/databriefs/adultweighl.pdf
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`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO
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`INFORMATION DISCLOSURE
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