`(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
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0001
`
`
`
`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
`1/6
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`
`Fig. 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0002
`
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`Petitioner Apotex Exhibit 1002-0003
`
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`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0004
`
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`Attorney Docket No.: 8545US02
`
`Inventors: JENSEN et al.
`
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`Petitioner Apotex Exhibit 1002-0006
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`Inventors: JENSEN et al.
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0007
`
`
`
`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.
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0008
`
`
`
`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.
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0009
`
`
`
`PTO/AIA/14 (11-15)
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`
`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
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2:
`D Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`
`Inventor Information:
`
`11
`Inventor
`Legal Name
`
`I Remove I
`
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`IT ~hristine
`I
`Residence Information (Select One)
`
`Middle Name
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`~joem
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`~ensen
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`~harlottenlund
`
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`Address 1
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`b/o Novo Nordisk A/S
`
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`Novo Alie
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`I pK-2880
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`11
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`~asmussen
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`~openhagen OE
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`l~K
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`Address 1
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`b/o Novo Nordisk A/S
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`Novo Alie
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0010
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`PTO/AIA/14 (11-15)
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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
`
`Prefix Given Name
`
`I B tv,ilan
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`Residence Information (Select One)
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`Middle Name
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`lzdravkovic
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`Family Name
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`Eolte
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`Mailing Address of Inventor:
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`Address 1
`
`b/o Novo Nordisk NS
`
`Novo Alie
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`I pK-2880
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`Inventor ~
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`b/o Novo Nordisk NS
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`Novo Alie
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`I pK-2880
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`D An Address is being provided for the correspondence Information of this application.
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`
`onipatent@novonordisk.com
`
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0011
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`Approved for use through 04/3012017. 0MB 0651-0032
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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
`
`lJse of Long-Acting GLP-1 Peptides
`
`Attorney Docket Number 8545US02
`
`Application Type
`
`~on provisional
`
`Subject Matter
`
`Utility
`
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`...
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0012
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`Use of Long-Acting GLP-1 Peptides
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`Apotex v. Novo - IPR2024-00631
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`8545US02
`
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`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
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`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`Applications
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`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`□ 16, 2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1. 78, this application, with a filing date on or after March
`16, 2013, will be examined under the first inventor to file provisions of the AIA.
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0014
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/3012017. 0MB 0651-0032
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`Application Data Sheet 37 CFR 1. 76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Authorization or Opt-Out of Authorization to Permit Access:
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`When this Application Data Sheet is properly signed and filed with the application, applicant has provided written
`authority to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see
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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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`NOTE: This section of the Application Data Sheet is ONLY reviewed and processed with the INITIAL filing of an
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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
`undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent Office
`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People's Republic of
`China (SIPO), the World Intellectual Property Organization (WIPO), and any other foreign intellectual property office
`participating with the USPTO in a bilateral or multilateral priority document exchange agreement in which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`and its related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date of filing of this Authorization. See 37 CFR 1.14(h)
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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,
`the undersigned hereby grants the USPTO authority to provide the EPO access to the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`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
`copy of search results from the instant application without delay in a European patent application that claims priority to
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`B. Applicant DOES NOT authorize the USPTO to transmit to the EPO any search results from the instant patent
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`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide access to the
`application in accordance with 37 CFR 1.14.
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`EFS Web 2.2.12
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0015
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/3012017. 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 lo respond lo a collection of information unless it contains a valid 0MB control number.
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`Application Data Sheet 37 CFR 1. 76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 37 of CFR
`to have an assignment recorded by the Office.
`
`I Remove I
`Applicant
`11
`If the applicant is the inventor {or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
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`Legal Representative under 35 U.S.C. 117
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`Person who shows sufficient proprietary interest
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`Joint Inventor
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`Name of the Deceased or Legally Incapacitated Inventor: I
`
`If the Applicant is an Organization check here.
`
`Organization Name I ~ovo Nordisk A/S
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`Mailing Address Information For Applicant:
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`~
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`'llovo Alie
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`3agsvaerd
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`Address 2
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`City
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`Country I IJK
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`Email Address
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`DK-2880
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`Assignee Information including Non-Applicant Assignee Information:
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`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title
`37 of CFR to have an assignment recorded by the Office.
`
`EFS Web 2.2.12
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0016
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/3012017. 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 lo respond lo a collection of information unless it contains a valid 0MB control number.
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`Application Data Sheet 37 CFR 1. 76
`
`Attorney Docket Number
`
`8545US02
`
`Application Number
`
`Title of Invention
`
`Use of Long-Acting GLP-1 Peptides
`
`Assignee ~
`
`Complete this section if assignee information, including non-applicant assignee information, is desired to be included on the patent
`application publication. An assignee-applicant identified in the "Applicant Information" section will appear on the patent application
`publication as an applicant. For an assignee-applicant, complete this section only if identification as an assignee is also desired on the
`patent application publication.
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`If the Assignee or Non-Applicant Assignee is an Organization check here.
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`Middle Name
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`Mailing Address Information For Assignee including Non-Applicant Assignee:
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`Address 1
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`Signature:
`NOTE: This Application Data Sheet must be signed in accordance with 37 CFR 1.33(b). However, if this Application
`Data Sheet is submitted with the INITIAL filing of the application and either box A or B is not checked in
`subsection 2 of the "Authorization or Opt-Out of Authorization to Permit Access" section, then this form must
`also be signed in accordance with 37 CFR 1.14(c).
`This Application Data Sheet must be signed by a patent practitioner if one or more of the applicants is a juristic
`entity (e.g., corporation or association). If the applicant is two or more joint inventors, this form must be signed by a
`patent practitioner, all joint inventors who are the applicant, or one or more joint inventor-applicants who have been given
`power of attorney (e.g., see USPTO Form PTO/AIA/81) on behalf of all joint inventor-applicants.
`See 37 CFR 1.4(d) for the manner of making signatures and certifications.
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`Remove
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`Signature ~Leon Y. Lum/
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`Date (YYYY-MM-DD) 12017--07-20
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`First Name
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`~eonY.
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`I Last Name I ~um
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`Registration Number
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`62,124
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`EFS Web 2.2.12
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0017
`
`
`
`PTO/AIA/14 (11-15)
`Approved for use through 04/3012017. 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 lo respond lo 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
`
`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
`is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
`collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data
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`EFS Web 2.2.12
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0018
`
`
`
`PTO/SB/08a (03-15)
`Doc code: IDS
`Approved for use through 07/3112016. 0MB 0651-0031
`Doc description: Information Disclosure Statement {IDS) Filed
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`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`2017-07-21
`Filing Date
`First Named Inventor I thristine Bjoem Jensen
`Art Unit
`IN/A
`I Not Yet Assigned
`I 8545US02
`Attorney Docket Number
`
`Examiner Name
`
`Examiner Cite
`Initial*
`No
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`Patent Number
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`Kind
`Code1
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`Issue Date
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`Name of Patentee or Applicant
`of cited Document
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`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
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`U.S.PATENTS
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`1
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`8536122
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`A1
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`'013-09-17
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`_au et al.
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`2
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`IH29343
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`A1
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`2012-03-06
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`_au et al.
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`Pages,Columns,Lines where
`Relevant Passages or Relevant
`Figures Appear
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`1
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`2
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`3
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`20110301080
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`2011-12-08
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`Bush etal.
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`20100292133
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`2010-11-18
`
`Spetzler et al.
`
`20100047762
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`'010-02-25
`
`Button et al.
`
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`where Relevant
`Passages or Relevant
`Figures Appear
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`T5
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`EFSWeb 2.1.17
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0019
`
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`2017-07-21
`
`First Named Inventor I Christine Bjoem Jensen
`
`Art Unit
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`Examiner Name
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`N/A
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`I Not Yet Assigned
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`8545US02
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`4
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1002-0020
`
`
`
`INFORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`2017-07-21
`
`First Named Inventor I Christine Bjoem Jensen
`
`Art Unit
`
`Examiner Name
`
`N/A
`
`I Not Yet Assigned
`
`Attorney Docket Number
`
`8545US02
`
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`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
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`T5
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`Madsbad Set al. An Overview of once-weekly glucagon-like peptide-1 receptor agonists