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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MURRAY & POOLE ENTERPRISES LTD.,
`Petitioner,
`v.
` INSTITUT DE CARDIOLOGIE DE MONTREAL,
`Patent Owner.
`______________________
`
`Case IPR2023-01064
`Patent No. 11,400,063
`______________________
`
`PETITIONER’S EXHIBIT LIST
`
`

`

`IPR2023-01064
`Patent No. 11,400,063
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner Murray & Poole Enterprises Ltd.
`
`hereby submits a current listing of Petitioner’s exhibits. Exhibits 1001-1049 are
`
`being filed today.
`
`Exhibit
`1001
`1002
`1003
`
`1004
`
`1005
`
`1007
`1008
`
`1009
`
`1010
`
`Description
`U.S. Patent No. 11,400,063 B2 to Tardif (“the ’063 patent”)
`Certified File History of the ’063 patent
`Provisional Application 63/093,988 (October 20, 2020, Provisional
`Application)
`Provisional Application 62/935,865 (November 15, 2019, Provisional
`Application)
`Nadia Bouabdallaoui et al., Time-to-treatment initiation of colchicine
`and cardiovascular outcomes after myocardial infarction in the
`Colchicine Cardiovascular Outcomes Trial (COLCOT), 41 Eur. Heart
`J. 4092-99 (2020)
`1006 WayBack Machine archive of Clinical Trials.gov identifier
`NCT02551094, Colchicine Cardiovascular Outcomes Trial (COLCOT)
`(COLCOT),
`https://web.archive.org/web/20171020004013/https:/clinicaltrials.gov/c
`t2/show/NCT02551094 (accessed Apr. 11, 2023)
`U.S. Patent No. 10,206,891 B2 to Nidorf (“the ’891 patent”)
`Ulf Stenestrand & Lars Wallentin, Early Statin Treatment Following
`Acute Myocardial Infarction and 1-Year Survival, 285 J. Am. Med.
`Ass’n 430-36 (2001)
`Borja Ibanez et al., 2017 ESC Guidelines for the management of acute
`myocardial infarction in patients presenting with ST-segment elevation,
`39 Eur. Heart J. 119-77 (2018)
`Gregg W. Stone, Angioplasty Strategies in ST-Segment-Elevation
`Myocardial Infarction: Part I: Primary Percutaneous Coronary
`Intervention, 118 Circulation 538-51 (2008)
`Hoang V. Tran et al., Trends in Length of Hospital Stay and the Impact
`on Prognosis of Early Discharge After a First Uncomplicated Acute
`Myocardial Infarction, 121 Am. J. Cardiology 397-402 (2018)
`
`1011
`
`1
`
`

`

`IPR2023-01064
`Patent No. 11,400,063
`
`Exhibit
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`Description
`Aernoud T. L. Fiolet et al., Colchinine in Acute Coronary Syndrome:
`When to Commence?, Am. Coll. Cardiology,
`https://www.acc.org/latest-in-
`cardiology/articles/2021/09/15/13/23/colchicine-in-acute-coronary-
`syndrome (accessed June 13, 2023)
`Harolyn Baker et al., Regional Hospital Collaboration and Outcomes
`in Medicare Heart Failure Patients: See You in 7, 3(10) JACC: Heart
`Failure 765-73 (2015)
`Cindy L. Grines et al., Safety and Cost-Effectiveness of Early
`Discharge After Primary Angioplasty in Low Risk Patients With Acute
`Myocardial Infarction, 31(5) J. Am. Coll. Cardiology 967-72 (1998)
`Aaron W. Aday & Paul M. Ridker, Antiinflammatory Therapy in
`Clinical Care: The CANTOS Trial and Beyond, 5(62) Frontiers in
`Cardiovascular Med. 1-6 (2018)
`COLCRYSTM [Package Insert] Philadelphia, PA: Mutual
`Pharmaceutical Company, Inc. (July 2009)
`Grant W. Reed et al., Acute myocardial infarction, 389 Lancet 197-210
`(2017)
`U.S. Patent No. 10,265,281 B2 to Nidorf (“the ’281 patent”)
`P.M. Ridker et al., Antiinflammatory Therapy with Canakinumab for
`Atherosclerotic Disease, 377(12) New Eng. J. Med. 1119-31 (2017)
`Stefan M. Nidorf et al., Low-Dose Colchicine for Secondary Prevention
`of Cardiovascular Disease, \61(4) J. Am. Coll. Cardiology 404-10
`(2013)
`Thomas J. Ryan et al., 1999 Update: ACC/AHA Guidelines for the
`Management of Patients With Acute Myocardial Infarction: Executive
`Summary and Recommendations: A Report of the American College of
`Cardiology/American Heart Association Task Force on Practice
`Guidelines (Committee on Management of Acute Myocardial
`Infarction), 100 Circulation 1016-30 (1999)
`Jean-Claude Tardif et al., Efficacy and Safety of Low-Dose Colchicine
`after Myocardial Infarction, 381(26) New Eng. J. Med. 2497-505
`(2019)
`Jacek Kubica et al., Treatment of patients with acute coronary
`syndrome: Recommendations for medical emergency teams: Focus on
`antiplatelet therapies. Updated experts’ standpoint, 25(3) Cardiology J.
`291-300 (2018)
`
`2
`
`

`

`IPR2023-01064
`Patent No. 11,400,063
`
`Exhibit
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`Description
`Yukio Ozaki et al., CVIT expert consensus document on primary
`percutaneous coronary intervention (PCI) for acute myocardial
`infarction (AMI) in 2018, 33 Cardiovascular Intervention &
`Therapeutics 178-203 (2018)
`EUR. SOC’Y OF CARDIOLOGY, ESC CONGRESS 2020: THE DIGITAL
`EXPERIENCE: 29 AUGUST TO 1 SEPTEMBER: POST-CONGRESS REPORT
`(2020)
`Peter L. Thompson & S. Mark Nidorf, Colchicine: an affordable anti-
`inflammatory agent for atherosclerosis, 29(6) Current Op. Lipidology
`467-73 (2018)
`ISIS-2 (Second International Study of Infarct Survival) Collaborative
`Group, Randomised Trial of Intravenous Streptokinase, Oral Aspirin,
`Both, or Neither Among 17 187 Cases of Suspected Acute Myocardial
`Infarction: ISIS-2, 2(8670) Lancet 349-60 (1988)
`Thomas Hennessy et al., The Low Dose Colchicine after Myocardial
`Infarction (LoDoCo-MI) study: A Pilot randomized placebo controlled
`trial of colchicine following acute myocardial infarction, Am. Heart J.
`215:62-69 (2019)
`Kaivan Vaidya et al., Colchicine Therapy and Plaque Stabilization in
`Patients With Acute Coronary Syndrome: A CT Coronary Angiography
`Study, 11(2) JACC: Cardiovascular Imaging 305-16 (2018)
`Subodh Verma et al., Colchicine in cardiac disease: a systematic
`review and meta-analysis of randomized controlled trials, 15 BMC
`Cardiovascular Disorders 96 (2015)
`Clinical Trials.gov identifier NCT02551094, History of Changes for
`Study: NCT02551094: Colchicine Cardiovascular Outcomes Trial
`(COLCOT) (COLCOT),
`https://clinicaltrials.gov/ct2/history/NCT02551094?A=1&B=3&C=Sid
`e-by-Side#StudyPageTop (accessed Apr. 23, 2023)
`Borja Ibañez & Valentin Fuster, CANTOS: A Gigantic Proof-of-
`Concept Trial, 121 Circulation Rsch. 1320-22 (2017)
`Richard A. Baylis et al., The CANTOS Trial: One Important Step for
`Clinical Cariology but a Giant Leap for Vascular Biology, 37(11)
`Arteriosclerosis, Thrombosis, & Vascular Biology e174-e177 (2017)
`Subodh Verma et al., CANTOS Ushers in a New Calculus of
`Inflammasome Targeting for Vascular Protection – and Maybe More,
`26 Cell Metabolism 703-05 (2017)
`
`3
`
`

`

`IPR2023-01064
`Patent No. 11,400,063
`
`Exhibit
`1035
`
`1036
`
`1037
`
`1040
`
`1038
`1039
`
`Description
`Christian Weber & Philipp von Hundelshausen, CANTOS Trial
`Validates the Inflammatory Pathogenesis of Atherosclerosis: Setting
`the Stage for a New Chapter in Therapeutic Targeting, 121(10)
`Circulation Rsch. 1119-21 (2017)
`UNITED STATES PHARMACOPEIAL CONVENTION, THE UNITED STATES
`PHARMACOPEIA, “Colchicine” 38 USP 2934-36 (2015)
`European Patent Office File History of Application Number
`EP19209545.3
`Declaration of Raymond Cruitt, M.S.
`Paul M Ridker et al., Antiinflammatory therapy with canakinumab for
`atherosclerotic disease, Protocol, 377 New Eng. J. Med. 1119-31
`(2017)
`Spyridon Deftereos et al., Anti-Inflammatory Treatment With
`Colchicine in Acute Myocardial Infarction: A Pilot Study, 132
`Circulation 1395-1403 (2015)
`Gonzalo J. Martínez et al., Colchicine Acutely Suppresses Local
`Cardiac Production of Inflammatory Cytokines in Patients With an
`Acute Coronary Syndrome, 4(8) J. Am. Heart Ass’n e002128 (2015)
`Stefano Toldo & Antonio Abbate, The NLRP3 inflammasome in acute
`myocardial infarction, 15(4) Cardiology 203-14 (2018)
`Stefan M. Nidorf & Subodh Verma, Is There a Role for Colchicine in
`Acute Coronary Syndromes?, 4(8) J. Am. Heart Ass’n e002372 (2015)
`Georgios Tsivgoulis et al., The Role of Colchicine in the Prevention of
`Cerebrovascular Ischemia, 24 Current Pharm. Design 668-74 (2018)
`1045 WayBack Machine archive of Clinical Trials.gov identifier
`NCT02898610, Colchicine for Prevention of Vascular Inflammation in
`Non-cardio Embolic Stroke (CONVINCE),
`https://web.archive.org/web/20191214125501/https:/clinicaltrials.gov/c
`t2/show/NCT02898610 (accessed June 1, 2023)
`1046 WayBack Machine archive of Clinical Trials.gov identifier
`NCT03048825, Colchicine and Spironolactone in Patients With
`STEMI/SYNERGY Stent Registry (CLEAR-SYNERGY),
`https://web.archive.org/web/20190507114813/https:/clinicaltrials.gov/c
`t2/show/NCT03048825 (accessed June 1, 2023)
`Stefan Mark Nidorf & Peter Lindsay Thompson, Why Colchicine
`Should Be Considered for Secondary Prevention of Atherosclerosis: An
`Overview, 41(1) Clinical Therapeutics 41-48 (2019)
`
`1041
`
`1042
`
`1043
`
`1044
`
`1047
`
`4
`
`

`

`Exhibit
`1048
`
`1049
`
`
`
`Date: June 16, 2023
`
`IPR2023-01064
`Patent No. 11,400,063
`
`Description
`Australian New Zealand Clinical Trials Registry, The effect of
`Colchicine on Cardiovascular Outcomes in Acute Coronary Syndrome
`Study (TheCOLCARDIO-ACS Study),
`https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370
`284&isReview=true (accessed June 1, 2023)
`Declaration of Paul Ridker, M.D.
`
`Respectfully submitted,
`
`By: /Mark J. Feldstein/
`Mark J. Feldstein, Reg. No. 46,693
`Lead Counsel for Petitioner
`Murray & Poole Enterprises Ltd.
`
`
`
`5
`
`

`

`IPR2023-01064
`Patent No. 11,400,063
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(a), the undersigned certifies
`
`that on June 16, 2023, a copy of the foregoing Petitioner’s Exhibit List and
`
`Exhibits 1001-1049 were served by FedEx Priority Overnight on
`
`the
`
`correspondence address of record indicated in the Patent Office’s Patent Center
`
`website for U.S. Patent No. 11,400,063:
`
`Jan N. Tittel
`Clark & Elbing LLP
`101 Federal Street
`Boston, MA 02110
`
`
`
`
`Date: June 16, 2023
`
`By: /William Esper/
`William Esper
`Case Manager and PTAB Coordinator
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
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