8353849
`
`March 09, 2023
`
`THIS IS TO CERTIFY THAT ANNEXED IS A TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`APPLICATION NUMBER: 14/409,493
`FILING DATE: December 19, 2014
`PATENT NUMBER: 9764003
`ISSUE DATE: September 19, 2017
`
`MPI EXHIBIT 1087 PAGE 1
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1087, p. 1 of 8
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`

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`Notice of References Cited Examiner
`
`Application/Control No.
`
`14/409,493
`
`KRISTINA M. HELLMAN
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`JENSEN ET AL.
`Art Unit
`1675
`
`Page 1 of 2
`
`Date
`(2015)
`
`Document Number
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`Kim et al., “Effects of once-weekly dosing of a long-acting release formulation of exenatide on glucose control and body weight
`in subjects with type 2 diabetes,” Diabetes Care 30:1487-1493 (2007)
`
`Bydureon NDA 022200/S-008 package information, pp. 1-179 (Feb. 2014)
`
`Clinical Trial NCTO00696657, entitled “A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to
`Placebo and Liraglutide,” pp. 1-5 (3/11/2015) - accessed 9/24/15 at URL clinicaltrials.gov/archive/NCT00696657/2011_03_25
`
`Lau etal., “Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide,” J. Med. Chem. 58:7370-7380
`
`*A copy of this reference is not being furnished with this Office action. (Gee MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20150922
`
`MPI EXHIBIT 1087 PAGE 2
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`MPI EXHIBIT 1087 PAGE 2
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1087, p. 2 of 8
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`

`

`Notice of References Cited Examiner
`
`Application/Control No.
`
`14/409,493
`
`KRISTINA M. HELLMAN
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`JENSEN ET AL.
`Art Unit
`1675
`
`Page 2 of 2
`
`Date
`ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002825/W C5001 79473.pdf)
`
`Document Number
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`Eperzan assessmentreport, Euro. Med. Agency, pp. 1-124 (2014)- accessed 9/24/2015 at URL:
`ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002735/W C5001 651 19.pdf
`
`Trulicity assessment report, Euro. Med. Agency, pp. 1-172 (2014)- accessed 9/24/2015 at URL:
`
`*A copy of this reference is not being furnished with this Office actian. (Gee MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`U.S. Patent and Trademark Office
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20150922
`
`MPI EXHIBIT 1087 PAGE 3
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`MPI EXHIBIT 1087 PAGE 3
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1087, p. 3 of 8
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`NCT00696657 on 2011_03_25: ClinicalTrials.gov Archive
`
`A-sensne af the US. MaSonad bestitunes: af Health
`ClinicalTrials.gov archive
`
`«~ History of this study
`
`* Current version of this study
`
`View of NCT00696657 on 2011_03_25
`
`ClinicalTrials Identifier: NCT00696657
`
`Updated:
`
`2011_0325
`
`ievelopeddly the Nadie! Ubeary af Medicie:
`
`
`
`Descriptive Information
`Brieftitle
`
`Official title
`
`A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing
`Semaglutide to Placebo and Liraglutide
`Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus
`Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects
`Diagnosed With Type 2 Diabetes Currently Treated With Metformin or
`Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National,
`Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group,
`Dose Finding Trial
`
`Brief summary
`This trial was conducted in Europe,Asia and Africa.
`Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6
`mg QW,6 treatment arms, placeboorliraglutide (1.2 mg QD, or 1.8 mg QD).Treatment
`allocation to semaglutide or placebo was double-blind, whereasliraglutide treatment was
`administered open-label.Primary efficacy parameter was HbA1c andthe treatment duration
`was 12 weeks.
`
`Detailed description
`
`Phase
`
`Phase 2
`
`Study type
`Study design
`Study design
`Study design
`Study design
`Study design
`Study design
`Primary outcome
`
`Interventional
`Treatment
`Randomized
`Double Blind (Subject, Investigator)
`Placebo Control
`Parallel Assignment
`Safety/Efficacy Study
`Measure: HbAic
`Time Frame: after 12 weeks. of treatment
`Safety Issue? No
`Secondary outcome Measure: Percentage of subjects with an adverse events
`Time Frame: after 12 weeks of treatment
`Safety Issue? No
`Secondary outcome~-Measure: Percentage of subjects with hypoglycaemic episode
`Time Frame: after 12 weeks of treatment
`Safety Issue? No
`Secondary outcome Measure: Change from baseline in ECG
`
`https://clinicaltrials. gov/archive/NCT00696657/2011_03_25[9/24/2015 6:16:24 PM]
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`DR. REDDY’S LABORATORIES, INC.
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`NCT00696657 on 2011_03_25: ClinicalTrials.gov Archive
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`Secondary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Enrollment
`
`Condition
`
`Arm/Group
`
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Change from baseline in vital signs (Pulse)
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Change from baseline in vital signs (blood pressure)
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Change from baseline in standard safety laboratory parameters
`(haematology)
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Change from baseline in standard safety laboratory parameters(
`biochemistry)
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Change from baseline in standard safety laboratory parameters
`(urinalysis)
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Change from baseline in calcitonin
`Time Frame: week 0, week 12
`Safety Issue? No
`Measure: Percentage of subjects developing anti-semaglutide antibodies
`Time Frame: after 12 weeks of treatment
`Safety Issue? No
`415 (Actual)
`Diabetes Mellitus, Type 2
`Arm Label: A
`Experimental
`
`Arm/Group
`
`Arm Label: B
`
`Experimental
`
`Arm/Group
`
`Arm Label: C
`
`Experimental
`
`Arm/Group
`
`Arm Label: D
`
`Experimental
`
`Arm/Group
`
`Arm Label: E
`
`Experimental
`
`Arm/Group
`
`Arm Label: F
`
`Experimental
`
`Arm/Group
`
`Arm Label: G1
`
`Placebo Comparator
`
`Arm/Group
`
`Arm Label: G2
`
`Placebo Comparator
`
`Arm/Group
`
`Arm Label: G3
`
`Placebo Comparator
`
`Arm/Group
`
`Arm Label: G4
`
`Placebo Comparator
`
`https://clinicaltrials. gov/archive/NCT00696657/2011_03_25[9/24/2015 6:16:24 PM]
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`DR. REDDY’S LABORATORIES, INC.
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`NCT00696657 on 2011_03_25: ClinicalTrials.gov Archive
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`Arm/Group
`
`Arm Label: G5
`
`Placebo Comparator
`
`Arm/Group
`
`Arm Label: G6
`
`Placebo Comparator
`
`Arm/Group
`
`Arm Label: H
`
`Experimental
`
`Arm/Group
`
`Arm Label: |
`
`Experimental
`
`Intervention
`
`Drug: semaglutide
`
`Arm Label:
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`0.1 mg, once weekly, s.c. injection
`Drug: semaglutide
`Arm-Label:
`
`0.2 mg, once weekly, s.c. injection
`Drug: semaglutide
`Arm Label:
`
`0.4.mg, once weekly, s.c. injection
`Drug: semaglutide
`Arm Label:
`
`0.8 mg, once weekly, s.c. injection
`Drug: semaglutide
`Arm Label: E
`
`0.8 mg with titration, once weekly, s.c. injection
`Drug: semaglutide
`Arm Label: F
`
`1.6 mg with titration, once weekly, s.c. injection
`Drug: placebo
`Arm Label: G1
`
`0.1 mg, once weekly, s.c. injection
`Drug: placebo
`Arm Label: G2
`
`0.2 mg, once weekly, s.c. injection
`Drug: placebo
`Arm Label: G3
`
`0.4 mg, once weekly, s.c. injection
`Drug: placebo
`Arm Label: G4
`
`0.8 mg with titration, once weekly, s.c. injection
`Drug: placebo
`Arm Label: G5
`
`0.8 mg with titration, once weekly, s.c. injection
`Drug: placebo
`Arm Label: G6
`
`1.6 mg, once weekly, s.c. injection
`Drug: liraglutide
`Arm Label: H
`
`1.2 mg with titration, once daily, s.c. injection
`Drug: liraglutide
`Arm Label: |
`
`1.8 mg with titration, once daily, s.c. injection
`
`https://clinicaltrials. gov/archive/NCT00696657/2011_03_25[9/24/2015 6:16:24 PM]
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`MPI EXHIBIT 1087 PAGE 6
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`DR. REDDY’S LABORATORIES, INC.
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`NCT00696657 on 2011_03_25: ClinicalTrials.gov Archive
`
`URL
`See also
`
`http://novonordisk-trials.com
`Clinical Trials at Novo Nordisk
`
`RecruitmentInformation
`
`Status
`Start date
`
`Lastfollow-up date
`Primary completion
`date
`
`Criteria
`
`Completed
`2008-06
`
`2009-02 (Actual)
`
`2009-02 (Actual)
`
`Inclusion Criteria:
`- Men and women-not-of-childbearing potential diagnosed with type 2 diabetesfor at least
`three months
`- Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise
`alone for at least three months
`- HbAtc: 7.0-10.0 %(both inclusive)
`- Body weight between 60 kg and 110 kg
`Exclusion Criteria:
`- Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidy! peptidase-
`4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-Gls, or any investigational drug, within
`the last three months
`- Impaired liver or kidney function
`- Proliferative retinopathy or maculopathy requiring acute treatment
`- Clinically significant active cardiovascular disease and uncontrolled treated/untreated
`hypertension
`- Recurrent major hypoglycaemia or hypoglycaemic unawareness
`- Present or planned use of any drug which could interfere with the glucose levels (e.g.
`systemic corticosteroids)
`Gender
`Both
`
`Minimum age
`Healthy volunteers
`
`18 Years
`No
`
`Administrative Data
`
`Novo Nordisk
`Organization name
`Organization study ID NN9535-1821
`Secondary ID
`2007-003956-12 (EudraCT Number)
`Sponsor
`Novo Nordisk
`Health Authority
`Austria: Federal Ministry for Health and Women
`Health Authority
`Bulgaria: Bulgarian Drug Agency
`Health Authority
`Finland: Finnish Medicines Agency
`Health Authority
`France: Afssaps - French Health Products Safety Agency
`Health Authority
`Germany: FederalInstitute for Drugs and Medical Devices
`Health Authority
`Hungary: National Institute of Pharmacy
`Health Authority
`India: Ministry of Health
`Health Authority
`ltaly: National Monitoring Centre for Clinical Trials - Ministry of Health
`
`https://clinicaltrials. gov/archive/NCT00696657/2011_03_25[9/24/2015 6:16:24 PM]
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`MPI EXHIBIT 1087 PAGE 7
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`DR. REDDY’S LABORATORIES, INC.
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`NCT00696657 on 2011_03_25: ClinicalTrials.gov Archive
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`Health Authority
`Health Authority
`Health Authority
`Health Authority
`Health Authority
`Health Authority
`
`Serbia: Medicines and Medical Devices Agencyof Serbia
`South Africa: Medicines Control Council
`Spain: Spanish Agency of Medicines
`Switzerland: Laws and standards
`Turkey: Ministry of Health
`
`United Kingdom: Medicines and Healthcare Products Regulatory Agency
`
`https://clinicaltrials. gov/archive/NCT00696657/2011_03_25[9/24/2015 6:16:24 PM]
`
`MPI EXHIBIT 1087 PAGE 8
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`MPI EXHIBIT 1087 PAGE 8
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`DR. REDDY’S LABORATORIES, INC.
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