Merck Sharp & Dohme LLC v. Pogona, LLC - IPR2026-00221

Director Discretionary Decision: Deny

Patent Owner's Preliminary Response

Ex Parte Smith

Ex Parte Smith Appeal

Ex Parte Eckhardt

Ex Parte Eckhardt Appeal

US11400162

US8192746

Patent Owner's Updated Exhibit List

Motion to Seal

Petitioner’s Opposition to Patent Owner’s Discretionary Denial Brief [Under Seal]

Petitioner’s Opposition to Patent Owner’s Discretionary Denial Brief [Redacted]

Platt Declaration ISO Petitioner's Opposition to Patent Owner's Discretionary Denial Brief [Under Seal]

Platt Declaration ISO Petitioner's Opposition to Patent Owner's Discretionary Denial Brief [Redacted]

Heather Platt Curriculum Vitae

Merck Internal PowerPoint Presentation (Excerpt) [Under Seal]

’435 Application File History Update

’757 Patent Claim Comparison to ’435 Application

Stay Order

Federal Courts Management Statistics

FDA Approves CAPVAXIVE for Adult Pneumococcal Disease Prevention

U.S. Patent No. 9,399,060

Patent Owner's Discretionary Denial Brief

Declaration of Bruce D. Forrest in Support of Patent Owner's Discretionary Denial Brief

Email Correspondence

Email Correspondence

U.S. Patent No. 11,395,849

Information Disclosure Statement

District Court's Order

A. Matanock et al.

C. Whitney, Pneumococcal Vaccines for Older Adults

A. Matanock, Invasive Pneumococcal Disease in the U.S. - 2008-2016

Petitioner's Updated List of Exhibits

Sotera Stipulation Letter Regarding IPR Invalidity Grounds

Petitioner's Updated Mandatory Notices

Notice: Mandatory Notice

Notice: Power of Attorney

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

Notice: Power of Attorney

Petition: as filed

U.S. Patent No. 11,058,757 (“the ’757 Patent”)

Declaration of Dr. Dennis Kasper

Curriculum Vitae of Dr. Dennis Kasper

Prosecution History of the ’757 Patent (Part 1 of 3)

Prosecution History of the ’757 Patent (Part 2 of 3)

Prosecution History of the ’757 Patent (Part 3 of 3)

International Publication No. WO 2014/118201 (“Porro”)

International Publication No. WO 2017/011338 (“Mekalanos”)

U.S. Patent No. 8,808,707 (“Siber”)

International Publication No. WO 2016/149771 (“Babb”)

International Publication No. WO 2016/207905 (“Matur”)

International Publication No. WO 2015/121783 (“Gu”)

Plotkin, Vaccines (6th ed. 2013)

Nahm, Pneumococcal Capsules, 28 Clin. Microbiol. Rev. 871 (2015)

Mekalanos Provisional Application No. 62/191,028

Mekalanos Redline with Provisional

Prosecution History of U.S. Application No. 17/347,435 (Part 1 of 4)

Prosecution History of U.S. Application No. 17/347,435 (Part 2 of 4)

Prosecution History of U.S. Application No. 17/347,435 (Part 3 of 4)

Prosecution History of U.S. Application No. 17/347,435 (Part 4 of 4)

PDR 2011 Prevnar 13, Physicians' Desk Reference (65th ed. 2011)

Wagenvoort, Risk of Invasive Pneumococcal Disease, 34 Vaccine (2016)

Dransfield, Pneumococcal Vaccine Response, 180 Am. J. Respir. (2009)

Domenech, Emerging Non-PCV13 Serotypes, 10 PLoS One (2015)

Richter, Pneumococcal Serotypes After PCV13, 58 Antimicrob. Agents (2014)

International Publication No. WO 2007/034280 (“Blay”)

International Publication No. WO 2006/065137 (“Nierop”)

Imöhl, Pneumococcal Meningitis in Germany, 15 BMC Infect. Dis. (2015)

Flasche, Pneumococcal Vaccination in England, 8 PLoS Med. (2011)

Mazmanian & Kasper, Bacterial Polysaccharides, 6 Nat. Rev. Immunol. (2006)

Bentley, Capsular Biosynthetic Locus, 2 PLoS Genet. (2006)

CDC, Explaining How Vaccines Work

Obaro, New Pneumococcal Vaccine, 8 Clin. Microbiol. Infect. (2002)

Mäkelä, Capsular Polysaccharide Vaccines, 12 Infection (1984)

Rappuoli, Mechanisms of Conjugate Vaccines, 116 PNAS (2019)

Avery & Goebel, Conjugated Carbohydrate-Proteins, 50 J. Exp. Med. (1929)

Anderson, HIB Capsular Antibodies in Infancy, 111 J. Pediatr. (1987)

Kniskern, Haemophilus influenzae Type b Vaccines, Vaccine Design (1995)

U.S. Patent No. 9,492,559 (“Emini”)

International Publication No. WO 2011/100151 A1 (“Caulfield”)

U.S. Patent No. 5,360,897 (“Anderson 1994”)

Payton, Lyophilized Vaccine Development, Practical Aspects (2022)

Lesinski, Novel Vaccine Strategies, 47 J. Microbiol. Methods (2001)

Mekalanos Claim Comparison with Provisional

Finn, Polysaccharide-Protein Conjugates, 70 Br. Med. Bull. (2004)

Kasper, GBS Polysaccharide-Tetanus Conjugate, 98 J. Clin. Invest. (1996)

Shinefield, S. aureus Vaccine, 346 N. Engl. J. Med. (2002)

Lin, Salmonella typhi Vi Conjugate Vaccine, 344 N. Engl. J. Med. (2001)

Morais, Glycoconjugate Vaccine Methods, 9 Bioengineering (2022)

Paoletti, GBS Tetravalent Conjugate Vaccine, 62 Infect. Immun. (1994)

Johnson, Pneumococcal Opsonophagocytosis, 180 J. Infect. Dis. (1999)

Burton, MOPA4 for Pneumococcal Antibodies, 13 Clin. Vaccine Immunol. (2006)

Malley, Serotype-Independent Pneumococcal Vaccines, 109 PNAS (2012)

International Publication No. WO 2017/067962 (“Bertaud”)

PDR 1979 Pneumovax, Physicians' Desk Reference (33d ed. 1979)

PDR 1990 Pneumovax 23, Physicians' Desk Reference (44th ed. 1990)

Mantis, B Cells & Antibodies, Encyclopedia of Microbiology (2019)

Sigurdardottir, 9vPnC-MnCC Vaccine Safety, 26 Vaccine (2008)

Satzke, Pneumococcal Serotypes 6C & 6D, 48 J. Clin. Microbiol. (2010)

Richter, Antimicrobial-Resistant S. pneumoniae in U.S. (2009)

Yao, Serogroup 6 S. pneumoniae in China, 70 Diag. Microbiol. (2011)

Calix, Pneumococcal Serotypes 11A, 11B, 11C, 11F, 193 J. Bacteriol. (2011)

ISDA Abstract, Emerging Pneumococcal Serotypes 6C & 23A (2011)