Notice of Refund | Jun 18, 2020 | PAPER | BOARD |
Petitioner's Request for Refund | Jun 10, 2020 | PAPER | PETITIONER |
Trial Instituted Document | Nov 13, 2019 | PAPER | BOARD |
Ex. 3001 | Nov 13, 2019 | EXHIBIT | BOARD |
Patent Owner's Response to Petitioner's Explanation of Multiple Petitions Challenging Patent No. 9,422,345 and Ranking Petitions | Oct 4, 2019 | PAPER | PATENT OWNER |
Petitioner's Explanation of Multiple Petitions Challenging Patent No. 9,422,345 and Ranking of Petitions | Oct 2, 2019 | PAPER | PETITIONER |
Galen Declaration | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Madigan 2000, Part 2 of 2 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Patent Owner Preliminary Response | Aug 16, 2019 | PAPER | PATENT OWNER |
Patent Owner Exhibit List | Aug 16, 2019 | PAPER | PATENT OWNER |
Madigan 2000, Part 1 of 2 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
van Wely 2001 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Hegde 2006 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Orr 1999 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Terpe 2006 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Natale 2008 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Papanikou 2007 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Hemila 1989 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Bishai II 1987 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Cabiaux 1988 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Choi 2004 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Mergulhao 2004 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Pappenheimer 1977 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Perentesis 1988 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Bashai I 1987 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Zettlmeissl 1986 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Mogensen 2005 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Uchida 1971 | Aug 16, 2019 | EXHIBIT | PATENT OWNER |
Petitioner Power of Attorney | Jul 31, 2019 | PAPER | PETITIONER |
Petitioner's Mandatory Change-of-Information Notices | Jul 31, 2019 | PAPER | PETITIONER |
Patent Owner's Mandatory Notices | May 28, 2019 | PAPER | PATENT OWNER |
Patent Owner's Power of Attorney | May 28, 2019 | PAPER | PATENT OWNER |
Notice of Accord Filing Date | May 16, 2019 | PAPER | BOARD |
U.S. Patent No.: 9,422,345, N. Blais et al., Issued: August 23, 2016 | May 6, 2019 | EXHIBIT | PETITIONER |
File History of U.S. Patent No.: 9,422,345 | May 6, 2019 | EXHIBIT | PETITIONER |
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Patent Owner Preliminary Response in IPR2019-00230, filed February 14, 2019. | May 6, 2019 | EXHIBIT | PETITIONER |
Patent Owner Preliminary Response in IPR2019-00241, filed February 14, 2019. | May 6, 2019 | EXHIBIT | PETITIONER |
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Curriculum Vitae of George Georgiou, Ph.D. | May 6, 2019 | EXHIBIT | PETITIONER |
pET System Tutorial (https://web.archive.org/web/20030408091617/http://novagen.com/SharedImages/TechnicalLiterature/7_pETExp.pdf) (accessed April 15, 2019) | May 6, 2019 | EXHIBIT | PETITIONER |
pET-22b(+) Vector Map (https://web.archive.org/web/20030819085202/http://www.novagen.com/docs/NDIS/69744-000.pdf) [with higher resolution image appended from https://plasmid.med.harvard.edu/PlasmidRepository/file/map/pET22b(+).pdf] | May 6, 2019 | EXHIBIT | PETITIONER |
pET-25b(+) Vector Map (https://web.archive.org/web/20030516011318/http://novagen.com/SharedImages/TechnicalLiterature/7_TB065.pdf) [with higher resolution image appended from www.synthesisgene.com/vector/pET-25b.pdf] | May 6, 2019 | EXHIBIT | PETITIONER |
pET-26b(+) Vector Map (https://web.archive.org/web/20030620093207/http://www.novagen.com/SharedImages/TechnicalLiterature/7_TB071.pdf) [with higher resolution image appended from www.synthesisgene.com/vector/pet-26b.pdf] | May 6, 2019 | EXHIBIT | PETITIONER |
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pET-27b(+) Vector Map (https://web.archive.org/web/20030622190457/http://www.novagen.com/SharedImages/TechnicalLiterature/7_TB073.pdf) [with higher resolution image appended from http://www.emdmillipore.com/US/en/product... | May 6, 2019 | EXHIBIT | PETITIONER |
PCT Publication No.: WO 2006/137398, E. Mekada et al., Published: December 28, 2006, with sequence listing retrieved from ¿¿¿Published International Application¿¿¿ section at https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2006137398... | May 6, 2019 | EXHIBIT | PETITIONER |
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Parathyroid Hormone entry in the DrugBank database at https://www.drugbank.ca/drugs/DB05829, creation date November 18, 2007 (accessed May 3, 2019) | May 6, 2019 | EXHIBIT | PETITIONER |
Declaration of George Georgiou, Ph.D. in Support of Petition for Inter Partes Review of U.S. Patent No. 9,422,345 | May 6, 2019 | EXHIBIT | PETITIONER |
Petitioner's Power of Attorney | May 6, 2019 | PAPER | PETITIONER |
Petition for Inter Partes Review | May 6, 2019 | PAPER | PETITIONER |