`Tel: 571.272.7822
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS, LLC d/b/a IKARIA, INC.
`Patent Owner
`
`_____________
`
`Case No. IPR2015-00891
`Patent 8,573,210
`_____________
`
`PETITIONER PRAXAIR DISTRIBUTION INC.’S OBJECTIONS TO
`PATENT OWNER INO THERAPEUTICS, LLC’S EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2015-00891
`Patent 8,573,210
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Praxair Distribution, Inc.
`
`(“Praxair”) hereby submits the following objections to the evidence Patent Owner
`
`INO Therapeutics, LLC (“Ikaria”) filed with its Patent Owner Response dated
`
`December 9, 2015.
`
`Exhibit 2019
`
`Exhibit 2019 purports to be a photograph of a device purportedly attributable
`
`to Praxair called the NOMIX Delivery System. Praxair objects to this Exhibit
`
`because it lacks foundation (FRE 602), relevance (FRE 402), and authentication
`
`(FRE 901) and constitutes inadmissible hearsay (FRE 802). Praxair also objects to
`
`Exhibit 2019 because it does not appear that Ikaria relies on this document in its
`
`Patent Owner Response, nor does it appear that Ikaria’s expert witness, Mr.
`
`Warren Heim, relies on this document in his declaration (Ex. 2021).
`
`Exhibit 2023
`
`Exhibit 2023 purports to be an article titled “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-
`
`introducesstate- of-the-art/272542. Praxair objects to Exhibit 2023 because it lacks
`
`foundation (FRE 602), relevance (FRE 402), and authentication (FRE 901) and
`
`constitutes inadmissible hearsay (FRE 802). Praxair also objects to Exhibit 2023
`
`because it does not appear that Ikaria relies on this document in its Patent Owner
`
`2
`
`
`
`Case No. IPR2015-00891
`Patent 8,573,210
`
`Response, nor does it appear that Ikaria’s expert witness, Mr. Warren Heim, relies
`
`on this document in his declaration (Ex. 2021).
`
`Exhibit 2024
`
`Exhibit 2024 purports to be a Technical Guide for the Bedfont NOxBox &
`
`NOxMixer devices. Praxair objects to this Exhibit because it lacks foundation
`
`(FRE 602), relevance (FRE 402), and authentication (FRE 901) and constitutes
`
`inadmissible hearsay (FRE 802).
`
`Exhibit 2025
`
`Exhibit 2025 purports to be letter from Praxair Technology, Inc. to Ikaria,
`
`Inc., dated November 25, 2009. Praxair objects to this Exhibit because it lacks
`
`foundation (FRE 602), relevance (FRE 402), and authentication (FRE 901) and
`
`constitutes inadmissible hearsay (FRE 802).
`
`Exhibit 2026
`
`Exhibit 2026 purports to be a certified English-language translation of a
`
`brochure for a product called NOMIX. Praxair objects to this Exhibit because it
`
`lacks foundation (FRE 602), relevance (FRE 402), and authentication (FRE 901)
`
`and constitutes inadmissible hearsay (FRE 802).
`
`Exhibit 2027
`
`Exhibit 2027 purports to be an operating manual for a device called
`
`CareFusion PrinterNOx. Praxair objects to this Exhibit because it lacks foundation
`
`3
`
`
`
`Case No. IPR2015-00891
`Patent 8,573,210
`
`(FRE 602), relevance (FRE 402), and authentication (FRE 901) and constitutes
`
`inadmissible hearsay (FRE 802).
`
`Exhibit 2036
`
`Exhibit 2036 purports to be a website printout for a product referred to as
`
`“Maxim Integrated iButton Products: 1-Wire Adapters.” Praxair objects to this
`
`Exhibit because it lacks foundation (FRE 602), relevance (FRE 402), and
`
`authentication (FRE 901) and constitutes inadmissible hearsay (FRE 802).
`
`Exhibit 2037
`
`Exhibit 2037 purports to be a website printout for a product referred to as
`
`“Maxim Integrated Memory Products: iButton 64Kb Memory (DS1996).” Praxair
`
`objects to this Exhibit because it lacks foundation (FRE 602), relevance (FRE
`
`402), and authentication (FRE 901) and constitutes inadmissible hearsay (FRE
`
`802).
`
`Exhibit 2039
`
`Exhibit 2039 purports to be a printout of a website showing the alleged
`
`content of the MAUDE database. Praxair objects to this Exhibit because it lacks
`
`foundation (FRE 602), relevance (FRE 402), and authentication (FRE 901) and
`
`constitutes inadmissible hearsay (FRE 802).
`
`Exhibit 2040
`
`Exhibit 2040 purports to be a document titled “The 510(k) Paradigm:
`
`4
`
`
`
`Case No. IPR2015-00891
`Patent 8,573,210
`
`Evaluating Substantial Equivalence in Premarket Notifications [510(k)], Guidance
`
`for Industry and Food and Drug Administration Staff,” and contains an alleged
`
`“Document issued” date of July 28, 2014. Praxair objects to this Exhibit because it
`
`lacks foundation (FRE 602), relevance (FRE 402), and authentication (FRE 901)
`
`and constitutes inadmissible hearsay (FRE 802).
`
`
`
`The Patent Trial and Appeal Board is hereby authorized to charge any fees
`
`owed by Petitioner and associated with this case to Deposit Account 02-1818.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted by
`
`
`
`
`
`K&L Gates LLP
`
`/Sanjay K. Murthy/
`Sanjay K. Murthy
`Reg. No. 45,976
`Customer No. 24573
`K&L Gates LLP
`e-mail: sanjay.murthy@klgates.com
`telephone number: 312-807-4416
`fax number: 312-827-8196
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602
`
`By:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`5
`
`
`
`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
`
`
`
`A copy of the foregoing has been served on counsel for Patent Owner on
`
`December 16, 2015 at the following email addresses:
`
`Robert Steinberg (bob.steinberg@lw.com)
`Daniel G. Brown (daniel.brown@lw.com)
`
`Date: December 16, 2015
`
`By:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Sanjay K. Murthy/
`Reg. No. 45,976
`Sanjay K. Murthy
`Customer No. 24573
`K&L Gates LLP
`e-mail: sanjay.murthy@klgates.com
`telephone number: 312-807-4416
`fax number: 312-827-8138
`70 W. Madison Street, Suite 3100
`Chicago, IL 60602