Filed on behalf of: INO Therapeutics, LLC
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`Entered: December 31, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS LLC,
`Patent Owner
`_______________________
`
`Case IPR2015-00889
`U.S. Patent No. 8,573,209 B2
`_______________________
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, AND
`SCOTT A. DANIELS, Administrative Patent Judges.
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`PATENT OWNER’S UPDATED EXHIBIT LIST
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`Entered: December 31, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS LLC,
`Patent Owner
`_______________________
`
`Case IPR2015-00889
`U.S. Patent No. 8,573,209 B2
`_______________________
`
`Before KEN B. BARRETT, MICHAEL J. FITZPATRICK, AND
`SCOTT A. DANIELS, Administrative Patent Judges.
`
`
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`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
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`
`
`Case IPR2015-00889
`U.S. Patent No. 8,573,209
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner INO Therapeutics LLC
`
`(“Ikaria”) respectfully submits the following current exhibit list:
`
`2002
`
`2003
`2004
`
`EXHIBIT DESCRIPTION
`2001
`Drugs@FDA, Application No. NDA 020845, INOMAX – nitric
`oxide gas, Labeling Revision (Revised: 3/2013), available at
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0208
`45s014lbl.pdf
`INOmax DSIR® (Delivery System) Operation Manual (800 ppm
`INOMAX® (nitric oxide) for inhalation), Part No. 20010 Rev-
`05, 2012-03, available at
`http://inomax.com/wpcontent/uploads/2015/01/20010_rev_05_INO
`max_DSIR_Operation_Manual_with_Links.pdf
`Patent Owner’s Updated Power of Attorney
`Declaration of David K. Callahan in Support of Patent Owner INO
`Therapeutics LLC’s Motion for Pro Hac Vice Admission Under 37
`C.F.R. § 42.10(c)
`Declaration of Kenneth G. Schuler in Support of Patent Owner INO
`Therapeutics LLC’s Motion for Pro Hac Vice Admission Under 37
`C.F.R. § 42.10(c)
`Declaration of Marc N. Zubick in Support of Patent Owner INO
`Therapeutics LLC’s Motion for Pro Hac Vice Admission Under 37
`C.F.R. § 42.10(c)
`RESERVED
`RESERVED
`RESERVED
`RESERVED
`RESERVED
`RESERVED
`RESERVED
`RESERVED
`RESERVED
`U.S. Patent No. 5,913,309 to Sheehan et al.
`
`2005
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`2006
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`2007
`2008
`2009
`2010
`2011
`2012
`2013
`2014
`2015
`2016
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`1
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`2022
`2023
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`2024
`2025
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`2026
`2027
`2028
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`EXHIBIT DESCRIPTION
`2017
`Patent Owner’s Certified English Translation of Ex. 1011
`2018
`Enlarged Image of Air Liquide Santé Opti KINOX Station
`2019
`Photographs of Praxair NOMIX Delivery System
`2020
`Deposition Transcript of Robert T. Stone, dated December 2, 2015
`2021
`Declaration of Warren P. Heim in Support of Patent Owner’s
`Response to Petition for Inter Partes Review of U.S. Patent No.
`8,573,209
`Curriculum Vitae of Warren P. Heim
`Bedfont Scientific Introduces State of the Art Intelligent INO
`Delivery & Monitoring System, BIOSPACE (Sept. 10, 2012, 10:56
`AM), http://www.biospace.com/News/bedfont-scientific-introduces-
`state-of-the-art/272542
`Bedfont NOxBox & NOxMixer
`Letter from Praxair Technology, Inc. to Ikaria, Inc., dated November
`25, 2009
`Praxair NOmix Brochure [Certified English Translation]
`CareFusion PrinterNOx Operating Manual
`General Controls for Medical Devices, U.S. FOOD & DRUG ADMIN.,
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
`/Overview/GeneralandSpecialControls/ucm055910.htm
`Regulatory Controls, U.S. FOOD & DRUG ADMIN.,
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
`/Overview/GeneralandSpecialControls/ucm2005378.htm
`21 C.F.R. § 814.20
`21 C.F.R. § 814.82
`21 C.F.R. § 807.92
`Premarket Notification 510(k), U.S. FOOD & DRUG ADMIN.,
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
`/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotific
`ation510k/
`
`2030
`2031
`2032
`2033
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`2029
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`2
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`
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`EXHIBIT DESCRIPTION
`Medical Device Classification Product Codes – Guidance for
`2034
`Industry and Food and Drug Administration Staff, U.S. FOOD &
`DRUG ADMIN.,
`http://www.fda.gov/RegulatoryInformation/Guidances/ucm285317.h
`tm
`FDA MAUDE Database Example Results for Product Code MRN
`(Nitric Oxide Administration Apparatus) between 10/1/2009 and
`11/30/2011
`Maxim Integrated iButton Products: 1-Wire Adapters,
`https://www.maximintegrated.com/en/products/ibutton/products/1wi
`re_adapters.cfm
`Maxim Integrated Memory Products: iButton 64Kb Memory
`(DS1996),
`https://www.maximintegrated.com/en/products/digital/memory-
`products/DS1996.html
`The New 510(k) Paradigm – Alternative Approaches to
`Demonstrating Substantial Equivalence in Premarket Notifications,
`Final Guidance, dated March 20, 1998, U.S. FOOD & DRUG ADMIN.,
`http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
`/GuidanceDocuments/ucm080187.htm
`Medical Device Databases, U.S. FOOD & DRUG ADMIN.,
`http://www.fda.gov/medicaldevices/deviceregulationandguidance/da
`tabases/default.htm
`The 510(k) Paradigm: Evaluating Substantial Equivalence in
`Premarket Notifications [510(k)], Guidance for Industry and Food
`and Drug Administration Staff, issued July 28, 2014, U.S. FOOD &
`DRUG ADMIN.,
`http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf
`RESERVED
`Supplemental Declaration of Warren P. Heim in Support of Patent
`Owner’s Response to Petition for Inter Partes Review of U.S. Patent
`No. 8,573,209
`
`2035
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`2036
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`2037
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`2038
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`2039
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`2040
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`2041
`2042
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`Dated: December 31, 2015
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`Respectfully submitted,
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`By: /Robert Steinberg/
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`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)
`
`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
`
`Counsel for Patent Owner
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`4
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`Case IPR2015-00889
`U.S. Patent No. 8,573,209
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 31st day of
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`December, 2015, a true and correct copy of the foregoing Patent Owner’s
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`Updated Exhibit List was served by electronic mail on Petitioner’s lead and
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`backup counsel at the following email addresses:
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`sanjay.murthy@klgates.com
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`benjamin.weed@klgates.com
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`sara.kerrane@klgates.com
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`michael.abernathy@klgates.com
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`margaux.nair@klgates.com
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`maria.doukas@klgates.com
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`Praxair-Ikaria@klgates.com
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`By: /Robert Steinberg/
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`Robert Steinberg (Reg. No. 33,144)
`bob.steinberg@lw.com
`Latham & Watkins LLP
`355 South Grand Avenue
`Los Angeles, CA 90071-1560
`213.485.1234; 213.891.8763 (Fax)
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