Trials@uspto.gov
`Tel: 571.272.7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________
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`PATENT TRIAL AND APPEAL BOARD
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`_____________
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`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
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`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
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`_____________
`
`
`Case: IPR2015-00889
`Patent: 8,573,209 B2
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`_____________
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`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
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`

`
`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
`
`
`I.
`II.
`
`III.
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`The Problem Purportedly Solved by the ‘209 Patent Was Already Well-
`Known Prior To Its Filing ............................................................................... 1
`PO Misinterprets The Instituted Combinations ............................................... 4
`A.
`PO’s Complaints Regarding the Independent Claims ........................... 5
`B.
`PO’s Complaint Regarding Claim 2 ..................................................... 7
`IV. The Instituted Combinations are Proper Because PO’s Arguments About
`The References Lack Merit ............................................................................. 8
`A.
`The ‘083 Patent ..................................................................................... 9
`1.
`PO’s Nitric Oxide-Specific Arguments Are Inaccurate ............. 9
`2.
`The ‘083 Patent Obtains Concentration Data from Different
`Sources ...................................................................................... 11
`The ‘510 Patent ................................................................................... 12
`1.
`The ‘510 Patent Teaches Wireless Transmission ..................... 12
`2.
`The ‘510 Patent Suggests Using Stored Data for Control ........ 13
`3.
`PO Misrepresented the ‘510 Patent in Arguing the
`Open/Close Data is Never Used for Real-Time Tasks ............. 14
`The FR ‘804 Publication ..................................................................... 15
`C.
`V. Mr. Heim’s Testimony Should Be Accorded No Weight ............................. 19
`VI. PO’s FDA Arguments Are Incorrect And Immaterial .................................. 21
`A.
`The FDA 510(k) Process is Merely a Path to Marketability .............. 21
`B.
`If Relevant, the FDA Records Support a Finding of Obviousness ..... 22
`VII. Conclusion ..................................................................................................... 24
`
`
`B.
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`
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`PETITIONER’S UPDATED LIST OF EXHIBITS
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`Ex. 1001 U.S. Patent No. 8,573,209 (“‘209 Patent”)
`
`Ex. 1002 Declaration of Robert T. Stone, Ph.D
`
`Ex. 1003 Curriculum Vitae of Robert T. Stone, Ph.D
`
`Ex. 1004 U.S. Patent No. 7,114,510 (“‘510 Patent”), filed May 15, 2003, issued
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`October 3, 2006
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`Ex. 1005 U.S. Patent No. 5,558,083 (“‘083 Patent”), filed November 22, 1993,
`
`issued September 24, 1996
`
`Ex. 1006
`
`French Publication No. 2 917 804 (“FR ‘804 Publication”), published
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`December 26, 2008
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`Ex. 1007
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`ISO/IEEE 11073-30300, “Health informatics -- Point-of-care medical
`
`device communication -- Part 30300: Transport profile -- Infrared
`
`wireless,” ISO, IEEE, published December 15, 2004 (“IR Standard”)
`
`Ex. 1008 U.S. Patent No. 6,811,533 (“‘533 Patent”), filed January 22, 2001,
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`issued November 2, 2004
`
`Ex. 1009 Assignment History of the ‘083 Patent
`
`Ex. 1010 Reserved
`
`Ex. 1011 Air Liquide OptiKINOX Brochure, dated 2009
`
`Ex. 1012
`
`“Guidance Document for Premarket Notification Submissions for
`
`ii
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`

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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen
`
`Dioxide Analyzer,” (“FDA Guidance”) document issued January 24,
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`2000 by the U.S. Department of Health and Human Services, Food
`
`and Drug Administration
`
`Ex. 1013 Reserved
`
`Ex. 1014 Center for Drug Evaluation and Research, Application Number: NDA
`
`20845, INOMAX®, Final Printed Labeling, (“INOMAX Label”)
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`available
`
`at
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`http://www.accessdata.fda.gov/drugsatfda_
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`docs/nda/99/20845_inomax_prntlbl.pdf (August 9, 2000)
`
`Ex. 1015 Reserved
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`Ex. 1016
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`Prosecution History of U.S. Patent No. 8,573,209
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`Ex. 1017 Reserved
`
`Ex. 1018 Reserved
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`Ex. 1019 Reserved
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`Ex. 1020 Declaration of translator Claudine Joly-King under 28 U.S.C. § 1746
`
`regarding Ex. 1006
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`Ex. 1021 Resume
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`of Warren P. Heim, P.E.
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`downloaded
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`from
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`http://www.teammedical.us/images/WP%20Heim-
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`Medical%20Device%20and%20R&D%20Expert.pdf
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`iii
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`Ex. 1022
`
`Transcript of February 2, 2016 Deposition of Warren P. Heim, P.E.
`
`Ex. 1023
`
`INOvent Delivery System – Operation and Maintenance Manual
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`(CGA Variant), Dated 02/08/00
`
`Ex. 1024
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`510(k) Summary for INOmax DS (Delivery System), submitted
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`December 18, 2009, published April 15, 2010
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`iv
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`I.
`
`INTRODUCTION
`The Petition for Inter Partes Review (“Petition”) (Paper 1) explained why
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`the prior art combinations supporting the instituted Grounds render the ‘209 Patent
`
`claims obvious.1 The Patent Owner Response (“PO Response”) (Paper 30) does
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`not undermine the prima facie obviousness case presented in the Petition and
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`adopted in the Board’s Decision to Institute Trial (“Decision”) (Paper 14).
`
`II. THE PROBLEM PURPORTEDLY SOLVED BY THE ‘209 PATENT
`WAS ALREADY WELL-KNOWN PRIOR TO ITS FILING
`
`PO argues that “Petitioner Has Failed to Show that a POSA Was Aware of
`
`the Problem Addressed by the ‘209 Patent Claims.” (PO Resp. at 38-40; see also
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`id. at 55-56). In this vein, PO’s expert, Mr. Warren Heim, testified that “the risk of
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`connecting a gas cylinder with the incorrect gas type had already been controlled
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`by using CGA 626 connections, and thus no requirement remained that would have
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`led to including the teachings of FR ‘804.” (Ex. 2021 at ¶ 153; see also PO Resp.
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`at 46-48). It follows, PO argues, that a person of skill would not have been
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`motivated to provide additional safety mechanisms, such as those in the FR ‘804
`
`Publication, when designing a NO delivery system. (PO Resp. at 48).
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`PO’s argument is based on selective quotation of the FDA Guidance.
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`(PO Resp. at 47). The PO Response omitted the following text:
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`1 All emphasis herein added unless otherwise indicated.
`
`1
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`Plans for commercial distribution of nitric oxide in the United States
`include the use of only a single concentration of nitric oxide; the
`availability of only a single concentration renders the use of a
`compressed gas cylinder containing an incorrect concentration of
`compressed nitric oxide in nitrogen unlikely.
`(Ex. 1012 at 8). In the omitted text, the FDA Guidance itself notes that it is
`
`unlikely (not impossible) that the wrong container could be connected. (Id.). It
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`further notes that even assuming a single concentration was to be used, the use of
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`the standard gas-specific fitting “will control the risk of incorrect drug
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`administration,” not eliminate it. (Id.). PO’s expert conceded that the CGA 626
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`fittings are the same ones used for different concentrations of NO. (Ex. 2021 at
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`¶137 (“[t]hese connectors are unique to therapeutic nitric oxide mixtures”). Where
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`multiple concentrations of nitric oxide in nitrogen were available (as PO’s original
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`labeling for iNO indicated was true by August, 2000, see Ex. 1014 at 6-7), the
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`FDA Guidance indicates the use of a CGA standardized connector would be
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`inadequate. (Ex. 1012 at 8). Accordingly, the FDA itself had previously identified
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`the problem PO avers was unrecognized until the ‘209 Patent.
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`The FR ‘804 Publication, assigned to a well-known NO supplier in France
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`(see Petition at 17) similarly identifies the problem PO asserts was “unknown.” It
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`states “purely mechanical solutions which involve the use of connection
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`types…and connections, depending on different types of gas” were known but that
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`2
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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`nonetheless, “there are no such foolproofing mechanical systems for a certain
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`number of compatible gases.” (Ex. 1006 at 17-18).
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`PO’s INOvent system2 is the system originally cleared by the FDA for use to
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`deliver NO gas. (Ex. 1014 at 6). The “Operation and Maintenance Manual” for
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`the INOvent system (“INOvent Manual”) (Ex. 1023) also identifies the very
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`problem PO and its expert allege was unknown until it was solved by the allegedly
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`“novel and unique safety check” of the ‘209 Patent. (Ex. 2021 at ¶¶ 53, 54). It
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`discloses that while the “INOvent delivery system is factory-set for an 800 ppm
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`cylinder concentration,” “[a]lternate cylinder concentrations may be available by
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`special request to Datex-Ohmeda.” (Ex. 1023 at 42). Appendix F deals with
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`“Alternate Cylinder Concentrations.” (Id. at 175-79). Because of the possibility of
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`connecting NO cylinders with different concentrations, the manual requires that the
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`operator “[c]heck the therapy gas cylinders for the correct product identity labels
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`and NO concentrations. The NO concentration must match that shown in the setup
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`menu for ‘Cylinder Concentration.’” (Id. at 36; see also id. at 42, 106, 156, 157).
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`The INOvent Manual identifies and warns against this risk despite the system’s use
`
`of the CGA 626 connectors. (Id. at 36, 142, 145, 166-167, 169).
`
`
`2 In discussing existing devices, PO does not even mention, let alone discuss the
`
`features of, its own prior art INOvent system. (PO Resp. at 58-59).
`
`3
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`

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`Case: IPR2015-00889
`U.S. Patent No. 8,573,209
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`Contrary to PO’s arguments for patentability, the problem allegedly solved
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`by the ‘209 Patent was identified in the FDA Guidance, PO’s competitor’s patent
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`documents, and PO’s own product documentation before the ‘209 Patent was filed.
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`III. PO MISINTERPRETS THE INSTITUTED COMBINATIONS
`The PO Response spends only a handful of pages arguing about alleged
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`deficiencies of the combination set forth in the Petition. (PO Resp. at 32-36). The
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`instituted combinations rely on four primary references: the ‘083 Patent, the
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`‘510 Patent, the FR ‘804 Publication, and the IR Standard. (Petition at 21-27).3
`
`The Petition explains the resulting system, for example stating:
`
`The result of incorporating the ‘510 Patent and the FR ‘804
`Publication in the ‘083 Patent’s delivery system is that gas data
`(which can include gas concentration in the cylinder per the ‘083
`Patent) is read from the carrier on the gas cylinder using an
`appropriate sensor (such as a bar code reader) and stored in the valve
`memory. This data would then be provided to the CPU of the ‘083
`Patent for use in the comparisons discussed above. (Ex. 1002 ¶ 94.)
`To provide that data to the CPU of the ‘083 Patent, a person of skill in
`the art would have considered at least known wireless medical device
`communication standards published by the ISO/IEEE. (Ex. 1002 ¶¶
`105-111.)
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`3 The Petition, Decision, and PO Response use different shorthand for the prior art
`
`references. To avoid confusion, Petitioner relies on the shorthand in the Petition.
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`4
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`U.S. Patent No. 8,573,209
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`(Petition at 24-25). The Petition also explains why the combinations disclose each
`
`limitation of the challenged claims. (See, e.g., id. at 27-50). PO’s argument that
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`the Petition fails to “clearly demarcate…which elements it is proposing would be
`
`combined from each reference, and where it is relying on modifications of the
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`references to reach the claim limitations at issue” is incorrect. (PO Resp. at 32-33).
`
`A.
`PO’s Complaints Regarding the Independent Claims
`PO identifies a single limitation of the independent claims allegedly not met
`
`by the proposed combination. It argues that the Petition does not identify why the
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`prior art teaches communicating gas data to a “control module that controls gas
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`delivery to a subject and to verify one or more of the correct gas, the correct gas
`
`concentration and that the gas is not expired.” (PO Resp. at 33). It relatedly
`
`argues the Petition does not show why this control module receives “gas through
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`the valve” and that the claimed “verification” does not occur (Id.).
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`Contrary to PO’s argument, the Petition explained why this limitation is
`
`satisfied when the CPU of the ‘083 Patent (part of the control module) performs
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`the safety check of the FR ‘804 Publication prior to the ‘083 Patent’s control
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`module delivering gas received from the ‘510 Patent’s valve:
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`[T]he therapy gas exits the valve and flows into a fluid circuit, such as
`that disclosed in the ‘083 Patent. (Ex. 1005 at 3:61-5:59, Figs. 1, 2.)
`The fluid circuit and the control of that circuit by CPU 56 as disclosed
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`5
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`U.S. Patent No. 8,573,209
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`in the ‘083 Patent is an example of the claimed control module. (Ex.
`1005 at 5:60-6:19.)
`(Petition at 28; see also id. at 29-33). The Petition identifies a valve (from the
`
`‘510 Patent) that allows gas to flow to a control module (from the ‘083 Patent),
`
`which the ‘209 Patent itself relies on as enabling disclosure of the claimed “control
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`module.” (Id. at 29). It notes that “[w]hen the valve of the ‘510 Patent and the FR
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`‘804 Publication are incorporated into in the ‘083 Patent, the combination discloses
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`storing gas concentration data in the memory 22 for subsequent communication to
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`the CPU of the ‘083 Patent’s control module. (Ex. 1004 at 5:43-6:2.)” (Id. at 31).
`
`“[W]hen the FR ‘804 Publication’s verification functionality is performed by the
`
`CPU of the ‘083 Patent, as in the combination relied on herein, the prior art
`
`discloses this limitation. (Ex. 1002 ¶¶ 116-117.)” (Id. at 32).
`
`PO also argues that “FR ‘804 does not disclose storing gas concentration
`
`data in a memory, and none of the references, alone or in combination, discloses
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`communicating gas concentration data from the memory” to the CPU of the
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`‘083 Patent. (PO Resp. at 35). This argument is unavailing based on the claims.
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`Each claim of the ‘209 Patent recites a Markush group that can be satisfied by gas
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`data selected from the group consisting of “gas identification, gas expiration date
`
`and gas concentration.” (Ex. 1001 at 16:29-31 (claim 1), 16:52-54 (claim 3),
`
`17:10-12 (claim 5), 18:7-9 (claim 6)). PO does not dispute that the proposed
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`U.S. Patent No. 8,573,209
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`combination discloses gas identification data, so its argument does not overcome
`
`the prima facie obviousness case in the Petition. (Petition at 29). The Petition also
`
`shows why in the instituted combinations, “gas concentration data” of the ‘083
`
`Patent is transmitted for use by the control module:
`
`[T]he ‘083 Patent teaches that one of the gas data characteristics that
`can be stored and used to trigger alarms is gas concentration. (Ex.
`1005 at 5:60-6:4.) The ‘083 Patent also teaches that the concentration
`of the gas in the cylinder can be used to “verify that the proper supply
`is being utilized.” (Ex. 1005 at 6:5-8.) Accordingly, the combination
`of references…discloses that the valve memory stores gas data as
`required…(Ex. 1002 ¶ 100.)
`(Petition at 30). PO’s argument is thus incorrect because it misreads the claims
`
`and because it fails to account for the ‘083 Patent’s specific teaching of using gas
`
`concentration data to perform safety checks prior to delivering NO to a patient.
`
`PO’s Complaint Regarding Claim 2
`
`B.
`The only other complaint PO makes about the sufficiency of the art when
`
`combined relates to claim 2. Specifically PO argues that the “control module 300”
`
`of the FR ‘804 Publication “must be located at the valve memory—not elsewhere
`
`in the system” and “thus cannot meet the claim limitations.” (PO Resp. at 34-35).
`
`However, PO’s argument is incorrect because it fails to understand the teachings of
`
`the FR ‘804 Publication in view of the ‘510 Patent. As stated in the Petition:
`
`7
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`

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`U.S. Patent No. 8,573,209
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`The FR ‘804 Publication discloses using bar codes encoding gas data
`on gas containers. (Ex. 1006 at 20-21.) Further, the FR ‘804
`Publication discloses using an appropriate sensor 110 (e.g., a bar code
`scanning device) to read the bar code and provide the read data to a
`control module 300. (Ex. 1006 at 20-21.) The ‘510 Patent discloses
`that gas data is inputted into the valve memory 22 via a user operated
`transfer device 44. (Ex.1004 at 5:61-6:2.)
`(Petition at 33). The combination of the FR ‘804 Publication and the ‘510 Patent
`
`discloses a sensor that reads gas data contained in a bar code and inputs that
`
`information into the valve memory; this disclosure satisfies every additional
`
`limitation of claim 2.
`
`Since PO’s only two arguments about the application of the instituted
`
`combinations to the claims of the ‘209 Patent are without merit, PO cannot rebut
`
`the Petition’s prima facie case that claims 1-7 of the ‘209 Patent are obvious.
`
`IV. THE INSTITUTED COMBINATIONS ARE PROPER BECAUSE
`PO’S ARGUMENTS ABOUT THE REFERENCES LACK MERIT
`
`The majority of PO’s substantive arguments deal with the alleged
`
`impropriety of the Petition’s combinations. (PO Resp. at 40-53). Since the FR
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`‘804 Publication itself provides the motivation to communicate data stored in the
`
`valve of the ‘510 Patent to the ‘083 Patent’s CPU (see, e.g., Petition at 21-23; Ex.
`
`2020 at 111:22-122:18), PO’s assertions regarding combinability of the ‘510 Patent
`
`and the ‘083 Patent, on their own, is irrelevant. (PO Resp. at 40-45). Because the
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`U.S. Patent No. 8,573,209
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`FR ‘804 Publication teaches the very “pre-use safety check” PO uses as a
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`shorthand to describe the allegedly patentable feature of the claims of the ‘209
`
`Patent (see, e.g., Ex. 1006 at 19), the FR ‘804 Publication is an example of a
`
`reason and a way for the valve of the ‘510 Patent to communicate with the CPU of
`
`the ‘083 Patent to perform the safety check of the FR ‘804 Publication.
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`Particularly since the FR ‘804 Publication was not considered during examination,
`
`PO cannot rebut the Petition’s prima facie case of obviousness.
`
`A. The ‘083 Patent4
`PO argues that the ‘083 Patent cannot be combined as proposed in the
`
`Petition because it discloses measuring NO and NO2 concentration at the point of
`
`inspiration by the patient, and therefore is not amenable to combination with the
`
`FR ‘804 Publication, which discloses using data stored on a carrier on the cylinder
`
`as an initial safety check. (See, e.g., PO Resp. at 13-14, 17). PO’s teaching away
`
`argument is contrary to common sense and the express teaching of the ‘083 Patent.
`
`PO’s Nitric Oxide-Specific Arguments Are Inaccurate
`
`1.
`PO argues that using data read from a carrier on a cylinder is superior to the
`
`technique of the ‘083 Patent, where sensed gas concentration at the point of
`
`
`4 According to PO, the ‘083 Patent describes “Patent Owner’s NO delivery
`
`systems.” (PO Resp. at 7; see also Ex. 2002 at 3 (marked with ‘083 Patent)).
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`9
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`inspiration is used as feedback to the control system. (PO Resp. at 44-45).
`
`According to the FDA, “[n]itrogen dioxide is a toxic gas formed by reaction
`
`of nitric oxide with oxygen.” (Ex. 1012 at 9). 5 The ‘083 Patent confirms that the
`
`longer nitric oxide dwells in a delivery circuit, the higher the likelihood of
`
`formation of toxic nitrogen dioxide. (Ex. 1005 at 1:40-44).6 To control this risk,
`
`the FDA counsels that “[t]he administration device should include provision for
`
`nitrogen dioxide gas analysis with alarms. The breathing circuit location for
`
`sampling should sample gas which is representative of the inspired gas.” (Ex.
`
`1012 at 10). Thus, according to the FDA’s own guidance regarding nitric oxide
`
`delivery, sensors (akin to those disclosed in the ‘083 Patent) should be used to
`
`ensure appropriate levels of therapeutic and toxic gases are delivered to the patient.
`
`
`5 PO’s argument about “rebound pulmonary hypertension” is irrelevant. The
`
`“sudden cessation” PO cites could only occur if NO was being delivered to the
`
`patient and thereafter stopped; in this scenario, the data on the cylinder carrier is
`
`far less useful than the sensed NO/NO2 concentration at the inspiration point.
`
`6 This property of nitric oxide casts substantial doubt on the veracity of Mr. Heim’s
`
`testimony, in which he guessed wrong and testified that nitrogen dioxide forms in
`
`the presence of nitrogen, not oxygen (Ex. 1022 at 104:17-105:1) and alternatively
`
`that NO2 will be formed without any other reactant present (id. at 106-24:107-2).
`
`10
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`The record does not provide any support for the idea that using data on the
`
`cylinder is superior to measuring gas concentration at the point of inspiration.
`
`Incorporating the safety check of the FR ‘804 Publication is therefore an additional
`
`check, and not an alternative check, to those provided in the ‘083 Patent.
`
`2.
`
`The ‘083 Patent Obtains Concentration Data from Different
`Sources
`
`The only way PO can make its sensor-based argument is by ignoring
`
`alternative embodiments in the ‘083 Patent. (See, e.g., PO Resp. at 13-14). PO
`
`does not dispute that the ‘083 Patent’s CPU performs algorithms to control NO
`
`delivery (including ceasing NO delivery) based on inputs indicating NO
`
`concentration. (See, e.g., id. at 44-45). It teaches that “NO sensor 65 could, of
`
`course, be eliminated if the NO cylinder 10 is always constant or by keying into
`
`the NO sensor in the gas sensing bench 52.” (Ex. 1005 at 6:11-13). This is
`
`precisely the basis for combinability presented in the Petition: “[s]uch alternative
`
`gas data sources are expressly contemplated by the ‘083 Patent and would have
`
`been obvious to one of ordinary skill in the art. (Ex. 1005 at 6:11-15; Ex. 1002 ¶
`
`98-101.).” (Petition at 24). While Dr. Stone stressed the importance of this
`
`teaching in his deposition (Ex. 2020 at 92:11-93:13, 95:22-96:16) 7, Mr. Heim did
`
`7 PO argues that Dr. Stone’s testimony is insufficient because it does not render a
`
`conclusion on the ultimate issue of obviousness. (PO Resp. at 20-32). This is
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`not address it at all (see, e.g., Ex. 2021 at ¶ 58-66).
`
`B.
`
`The ‘510 Patent
`1.
`Mr. Heim opined about the wired protocol disclosed in the ‘510 Patent.
`
`The ‘510 Patent Teaches Wireless Transmission
`
`(See, e.g., Ex. 2021 at ¶71). However, he did not dispute that the ‘510 Patent also
`
`discloses wireless transceivers “to transmit the data to a remote recording device at
`
`intervals or on command, as desired.” (Ex. 2021 at ¶79; see also, e.g., Ex. 1004 at
`
`7:1-4; Petition at 3, 25, 31). Accordingly, there is no dispute that the ‘510 Patent
`
`
`misplaced. The Board has held that “expert testimony is not required in every
`
`case.” Valeo, Inc. v. Magna Elec., Inc., Case No. IPR2014-00227 and IPR2014-
`
`00228, Paper 13 at p. 19 (May 29, 2014); see also Black Swamp IP, LLC v. VirnetX
`
`Inc., Case No. IPR2016-00167, Paper 12 at p. 4 (Feb. 4, 2016). And the Federal
`
`Circuit recently affirmed a Board decision of anticipation where Petitioner
`
`proffered no expert testimony and Patent Owner proffered extensive expert
`
`testimony. See Cutsforth, Inc. v. MotivePower, Inc., Appeal No. 2015-1315 (Dec.
`
`17, 2015); see also MotivePower, Inc. v. Cutsforth, Inc., Case No. IPR2013-00270,
`
`Paper 36, p. 2 (referencing testimony of PO expert Dr. Keim). Petitioner presents
`
`expert testimony here; it properly addresses technical issues not immediately
`
`apparent from the face of the references themselves.
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`U.S. Patent No. 8,573,209
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`discloses that in some embodiments, data is wirelessly transmitted via a transceiver
`
`to a remote transceiver. This emphasizes the propriety of using the ‘510 Patent in
`
`the manner suggested in the Petition. (Petition at 31).
`
`The ‘510 Patent Suggests Using Stored Data for Control
`
`2.
`The Abstract of the ‘510 Patent discloses that:
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`[R]elevant information, such as cylinder fill date, cylinder I.D.
`number, batch number, and patient name or account number may also
`be logged in the memory module. The log of the events and the
`corresponding dates and times may be used to prepare invoices for
`billing gas treatments, for inventory control, and for other record-
`keeping and control functions.
`(Ex. 1004 at Abstract). Dr. Stone testified that this discloses using data stored in
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`the valve handle memory can serve a role in controlling therapy. (Ex. 2020 at
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`124:16-125:6; see also id. at 128:23-129:1).8 Neither Mr. Heim nor the PO
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`8 PO argues that the data stored in the ‘510 Patent valve memory is not the claimed
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`“gas data” because it is not “gas type, gas concentration, or gas expiration date.”
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`(PO Resp. at 16). The Petition explained why this is incorrect (Petition at 29) and
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`even Mr. Heim conceded that inventory control requires knowledge of the gas type
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`(Ex. 1022 at 78:20-24). Regardless, storing certain gas data is at least a motivation
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`to look to storing other kinds of gas data, such as IDb of the FR ‘804 Publication
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`(which PO concedes is the claimed “gas data”, see PO Resp. at 19) or gas
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`U.S. Patent No. 8,573,209
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`Response addresses this testimony (or the clear disclosure of “control” in the ‘510
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`Patent’s Abstract). Instead, Mr. Heim testified about column 7 of the ‘510 Patent
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`(Ex. 2021 at ¶69) and implied that “control” in the ‘510 Patent deals with
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`“inventory control.” However, the Abstract itself distinguishes “inventory control”
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`from “other record-keeping and control functions.” (Ex. 1004 at Abstract).
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`3.
`
`in Arguing the
`PO Misrepresented the ‘510 Patent
`Open/Close Data is Never Used for Real-Time Tasks
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`PO argues that with regard to the ‘510 Patent, “[a]ll of the logging and
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`tracking functions supported by the valve are contemplated for later analysis (e.g.,
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`preparing invoices) as opposed to any real-time application, such as a safety check
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`or verification of operating parameters, when the device delivers gas to a patient.”
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`(PO Resp. at 15 (citing Ex. 2021 at ¶85)). Mr. Heim testified that this is
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`inaccurate—at least displaying the open/closed status of the valve is a “real-time
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`application.” (Ex. 1022 at 142:10-17). The operator can use the real-time display
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`to assess the ongoing therapy, including the therapeutic impact on the patient. (Ex.
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`1004 at 3:65-4:4, 5:31-42).9 Thus, the ‘510 Patent suggests that open/close data is
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`concentration of the ‘083 Patent, in the valve memory. (Petition at 29-30).
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`9 The Petition relied on the FR ‘804 Publication as disclosing controlling gas
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`delivery upon verifying that the gas is the expected gas. The aspects of the ‘510
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`Patent addressed here relate to the combinability with the FR ‘804 Publication.
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`stored and used in real-time, and thus at least suggests that this data is amenable to
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`use as the comparison data in the FR ‘804 Publication.
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`C. The FR ‘804 Publication
`PO’s only real complaint regarding FR ‘804 Publication concerns
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`combinability (PO Resp. at 45-53).10
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`First, PO argues that the FR ‘804 Publication would not be combined as
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`suggested because it is not directed to medical gas delivery devices. (PO Resp. at
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`18-19). Mr. Heim admitted that the disclosed system “can be used for other
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`operating circuit purposes besides filling bottles.” (Ex. 1022 at 144:13-14). One
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`such use is in a “health facility.” (Ex. 2021 at ¶97; Ex. 1006 at 19). PO cannot
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`dispute that Air Liquide (the assignee of the FR ‘804 Publication) was a company
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`those of skill understood was in the business of providing inhaled NO in the prior
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`art timeframe. Indeed, PO relies on this fact to make its secondary consideration
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`arguments. (PO Resp. at 9-10, 58-59; Petition at 16-17; Ex. 1002 at ¶¶ 61-64).11
`
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`10 PO’s argument about Air Liquide allegedly not including the features of the FR
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`‘804 Publication are both tenuous from an evidentiary perspective (they are based
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`on a single marketing brochure for a single product, see Ex. 2017) and irrelevant,
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`as the combination involves the FR ‘804 Publication, not a prior art device.
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`11 PO’s secondary considerations argument (PO Resp. at 58-59) fails to establish
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`Second, PO argues that the FR ‘804 Publication is “inherently incompatible”
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`with the ‘510 Patent because the “FR ‘804’s mechanism of operation relies on an
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`automatic valve that defaults to a closed position and only opens when the
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`controller signals a match in gas type,” while “[b]y contrast, [the ‘510 Patent]
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`discloses a valve that is specifically designed for manual operation.” (PO
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`Response at 49; see also id. at 49-53). PO’s argument is flawed for several reasons.
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`Mr. Heim testified as follows:
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`Q. …Prior to the opening of valve (20), is the gas from the
`cylinder occupying the elongated vertical rectangle between
`box (20) and box (12)?
`
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`what features the prior art products and the INOmax DSIR had and did not have,
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`and certainly does not perform a claim-by-claim analysis of these products. (PO
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`Resp. at 8-10; Ex. 2021 at ¶¶ 111-13). Finally, PO fails to explain whether the lack
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`of claimed features was due to failure of others to conceive or implement these
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`features or some other regulatory, commercial, or logistical considerations). See
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`AstraZeneca LP v. Breath Ltd., 88 F.Supp.3d 326, 391 (Fed. Cir. 2011) (no indicia
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`of non-obviousness based on failure of others where no evidence of previous,
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`unsuccessful attempts to achieve that which is claimed).
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`A.
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`There’s nothing in FR ‘804 that I recall that describes what
`goes on there, but it would be reasonable to expect that there
`would be gas in that chamber or line.
`(Ex. 1022 at 148:20-149:3). That is, the area of Fig. 1 highlighted in green below
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`contains gas prior to the opening of the valve (20):
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`
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`Despite Mr. Heim being unable to fathom a single way this connection of the bottle
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`might occur (Ex. 1022 at 149:4-150:12), such connection reasonably involves
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`manual activity (Ex. 1006 at 20). The FR ‘804 Publication thus discloses that a
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`valve beyond the detector 12 can be automatically actuated to either deliver or not
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`deliver gas to the circuit 1. (Ex. 1006 at 20; Ex. 1022 at 148:20-149:3). The ‘083
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`Patent discloses a system that operates precisely the same way as the FR ‘804
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`Publication: gas flows from a cylinder into the circuit, where it hits an “on-off
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`shutoff valve 14” that is solenoid operated. (Ex. 1005 at 3:61-67). That shutoff
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`valve 14 allows the CPU to “discontinue the use of the NO to the patient by
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`shutting off the shutoff valve 14…” (Id. at 8:8-10).
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`Third, PO’s argument is flawed because it asks the ‘510 Patent to disclose
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`more details of a gas delivery system than is required of the instituted combination.
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`The ‘510 Patent focuses on the valve and smart handle attached to a cylinder. (Ex.
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`1004 at Abstract). It discloses that “[t]ypically, the outlet port 20 of the valve 10 is
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`connected to a delivery device, such as a ventilator (not shown), which is used to
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`adjust the concentration and flow rate or to mix gases administered to t