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
`
`_____________
`
`
`Case: IPR2015-00884
`Patent: 8,291,904 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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`
`
`
`

`
`III.
`
`B.
`
`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`The Problem Purportedly Solved by the ‘904 Patent Was Already
`Well-Known Prior To Its Filing ...................................................................... 1
`PO Misinterprets The Instituted Combinations ............................................... 4
`A.
`PO’s Complaints Regarding The Independent Claims ......................... 4
`B.
`PO’s Complaint Regarding Claim 9 ..................................................... 6
`C.
`PO’s Complaint Regarding Claim 10 ................................................... 9
`IV. The Instituted Combinations are Proper Because PO’s Arguments
`About The References Lack Merit ................................................................ 10
`A.
`The ‘083 Patent ................................................................................... 11
`1. PO’s Nitric Oxide-Specific Arguments Are Inaccurate ................. 12
`2. The ‘083 Patent Obtains Concentration Data from Different
`Sources ...................................................................................... 13
`The ‘510 Patent ................................................................................... 14
`1. The ‘510 Patent Teaches Wireless Transmission ........................... 14
`2. The ‘510 Patent Suggests Using Stored Data For Control ............. 14
`3. PO Misrepresented
`the ‘510 Patent
`in Arguing
`the
`Open/Close Data is Never Used for Real-Time Tasks ............. 15
`The FR ‘804 Publication ..................................................................... 16
`C.
`V. Mr. Heim’s Testimony Should Be Accorded No Weight ............................. 20
`VI. PO’s FDA Arguments Are Incorrect And Immaterial .................................. 22
`The FDA 510(k) Process is Merely a Path to Marketability .............. 22
`A.
`B.
`If Relevant,
`the FDA Records Support a Finding of
`Obviousness ......................................................................................... 24
`VII. Conclusion ..................................................................................................... 25
`
`i
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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
`
`
`PETITIONER’S UPDATED LIST OF EXHIBITS
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`Ex. 1001 U.S. Patent No. 8,291,904 (“‘904 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
`
`October 3, 2006
`
`Ex. 1005 U.S. Patent No. 5,558,083 (“‘083 Patent”), filed November 22, 1993,
`
`issued September 24, 1996
`
`Ex. 1006
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`French Publication No. 2 917 804 (“FR ‘804 Publication”), published
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`December 26, 2008
`
`Ex. 1007
`
`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 U.S. Patent No. 4,462,398 (“‘398 Patent”), filed December 3, 1982,
`
`issued July 31, 1984
`
`Ex. 1011 Air Liquide OptiKINOX Brochure, dated 2009
`
`Ex. 1012
`
`“Guidance Document for Premarket Notification Submissions for
`
`ii
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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`
`Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen
`
`Dioxide Analyzer,” (“FDA Guidance”) document issued January 24,
`
`2000 by the U.S. Department of Health and Human Services, Food
`
`and Drug Administration
`
`Ex. 1013 U.S. Patent No. 4,308,865 (“‘865 Patent”), filed October 19, 1979,
`
`issued January 5, 1982
`
`Ex. 1014 Center for Drug Evaluation and Research, Application Number: NDA
`
`20845, INOMAX®, Final Printed Labeling, (“INOMAX Label”)
`
`available
`
`at
`
`http://www.accessdata.fda.gov/drugsatfda_
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`docs/nda/99/20845_inomax_prntlbl.pdf (August 9, 2000)
`
`Ex. 1015
`
`Prosecution History of U.S. Patent No. 8,291,904
`
`Ex. 1016 Reserved
`
`Ex. 1017 Reserved
`
`Ex. 1018 Reserved
`
`Ex. 1019 Reserved
`
`Ex. 1020 Declaration of translator Claudine Joly-King under 28 U.S.C. § 1746
`
`regarding Ex. 1006
`
`Ex. 1021 Resume
`
`of Warren P. Heim, P.E.
`
`downloaded
`
`from
`
`http://www.teammedical.us/images/WP%20Heim-
`
`Medical%20Device%20and%20R&D%20Expert.pdf
`
`iii
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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`Ex. 1022
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`Transcript of February 2, 2016 Deposition of Warren P. Heim, P.E.
`
`Ex. 1023
`
`INOvent Delivery System – Operation and Maintenance Manual
`
`(CGA Variant), Dated 02/08/00
`
`Ex. 1024
`
`510(k) Summary for INOmax DS (Delivery System), submitted
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`December 18, 2009, published April 15, 2010
`
`
`
`iv
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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
`
`I.
`
`INTRODUCTION
`
`The Petition for Inter Partes Review (“Petition”) (Paper 1) explained why
`
`the prior art combinations supporting the instituted Grounds render the ‘904 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 ‘904 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 ‘904 Patent Claims.” (PO Resp. at 39-42; see also
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`id. at 55-57). 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
`
`by using CGA 626 connections, and thus no requirement remained that would have
`
`led to including the teachings of FR ‘804.” (Ex. 2021 at ¶ 153; see also PO Resp.
`
`at 48-49). It follows, PO argues, that a person of skill would not have been
`
`motivated to provide additional safety mechanisms, such as those in the FR ‘804
`
`Publication, when designing a NO delivery system. (PO Resp. at 49-50).
`
`PO’s argument is based on selective quotation of the FDA Guidance. (PO
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`
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`1 All emphasis herein added unless otherwise indicated.
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`1
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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`Resp. at 48). The PO Response omitted the following text:
`
`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
`
`¶ 137). Where multiple concentrations of nitric oxide in nitrogen were available
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`(as PO’s original labeling for iNO indicated was true by August, 2000, see Ex.
`
`1014 at 6-7), the FDA Guidance indicates the use of a CGA standardized
`
`connector would be inadequate. (Ex. 1012 at 8).
`
`The FR ‘804 Publication, assigned to a NO supplier in France (see Petition
`
`at 15) also identifies the problem PO states was unknown: “purely mechanical
`
`solutions which involve the use of connection types…depending on different types
`
`of gas” were known, but “there are no such foolproofing mechanical systems for a
`
`certain number of compatible gases.” (Ex. 1006 at 17-18).
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`2
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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
`
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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 ‘904 Patent. (Ex. 2021 at ¶¶ 54, 112). 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
`
`operator “[c]heck the therapy gas cylinders for the correct product identity labels
`
`and NO concentrations. The NO concentration must match that shown in the
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`Setup menu for Cylinder Concentration.” (Id. at 36; see also id. at 42, 106, 156,
`
`157). It identifies and warns against this risk despite the system’s use of the CGA
`
`626 connectors. (Id. at 36, 142, 145, 166-167, 169).
`
`Accordingly, PO is incorrect that the problem it avers was solved by the
`
`‘904 Patent was unknown to those of skill in the art in the prior art time frame.
`
`
`2 In discussing pre-existing devices, PO does not even mention, much less describe
`
`the features of, its own prior art INOvent device. (PO Resp. at 59-60).
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`3
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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
`
`III. PO MISINTERPRETS THE INSTITUTED COMBINATIONS
`
`The instituted combinations rely on four primary references: the ‘083
`
`Patent, the ‘510 Patent, the FR ‘804 Publication, and the IR Standard. (Petition at
`
`19-25).3 The Petition explains the resulting system. (See, e.g., Petition at 22-23).
`
`The Petition also explains why the combinations disclose each limitation of the
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`challenged claims. (See, e.g., id.at 25-46).
`
`A.
`
`PO’s Complaints Regarding The Independent Claims
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`PO argues that the Petition does not acknowledge the “gas concentration
`
`data” included in the “a valve memory to store gas data comprising gas
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`concentration in the gas container” limitation.” (PO Resp. at 30). It further argues
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`the Petition does not explain how the data can be used, stored in a valve memory,
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`or communicated to the control module. (Id.)
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`However, the Petition does acknowledge, “gas concentration data” and
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`further describes how “gas concentration data” is stored, used, and transmitted:
`
`[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 actual
`concentration of the gas in the cylinder can be used to “verify that the
`
`
`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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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
`
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`proper supply is being utilized.” (Ex. 1005 at 6:5-8.)
`
`(Petition at 28). In the combination, this data is stored in the ‘510 Patent’s valve
`
`memory. (Ex. 1002 ¶¶ 111, 120.) PO’s argument is thus incorrect 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.
`
`Second, PO argues that the Petition does not identify why the prior art
`
`teaches communicating gas data to a “control module that controls gas delivery to
`
`a subject” where the gas data must be “gas concentration.” (PO Resp. at 31).
`
`Contrary to PO’s argument, the Petition explained why this limitation is met
`
`when the CPU of the ‘083 Patent (part of the control module) performs the safety
`
`check of the FR ‘804 Publication using gas concentration data prior to the ‘083
`
`Patent’s control module delivering gas received from the ‘510 Patent’s valve:
`
`[T]he NO 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
`in the ‘083 Patent, is an example of the claimed control module. (Ex.
`1005 at 5:60-6:19.)
`
`(Petition at 27; see also id. at 27-32). The Petition identifies a valve (from the ‘510
`
`Patent) that flows gas to a control module (from the ‘083 Patent), which the ‘904
`
`Patent relies on as enabling disclosure of the claimed “control module.” (Id. at 29).
`
`“When the valve of the ‘510 Patent and the FR ‘804 Publication are incorporated
`
`5
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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`into in the ‘083 Patent, the combination discloses storing gas concentration data in
`
`the valve memory for subsequent communication to the CPU of the ‘083 Patent’s
`
`control module. (Ex. 1004 at 5:43-6:2; Ex. 1002 ¶ 107.)” (Id. at 29).
`
`Finally, PO argues that Petitioner’s claim 2 analysis suggest that the control
`
`module 300 of the FR ‘804 Publication is located at the valve of the ‘510 Patent.
`
`(PO Resp. at 32). This is untrue. Petitioner relied on the FR ‘804 Publication
`
`regarding claim 2 for reading data from a bar code on the cylinder; a separate
`
`citation is provided to the ‘510 Patent’s discussion of storing gas data (e.g., data
`
`read from the cylinder in the FR ‘804 Publication) in the valve memory. (Petition
`
`at 31). It did not assert that the control module would be included in the valve.
`
`B.
`
`PO’s Complaint Regarding Claim 9
`
`PO argues that the combination does not teach claim 9’s requirement that the
`
`CPU “emit an alarm.” (PO Resp. at 33). PO’s position is a claim construction
`
`argument that the broadest reasonable construction of “alarm” must be limited to
`
`be “an indication of danger.” (PO Resp. at 33-34 (emphasis in original)). Yet PO
`
`does not offer any construction (see id. at 7), instead arguing that when applying
`
`the ‘398 Patent, a person of skill in the art would not understand those teachings to
`
`disclose an alarm because the relied-on LED 92 “is an indicator light, not an alarm,
`
`intended to indicate that the system is properly supplying gas.” (Id. at 33).
`
`It is unsurprising that PO does not present a formal claim construction. The
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`6
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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`‘904 Patent itself does not support the notion that an alarm must indicate danger,
`
`for example stating that “the memory may include instructions to cause the
`
`processor to emit an alarm when a desired dose has been delivered through a
`
`valve.” (Ex. 1001 at 4:30-32). Thus, at least one embodiment of the ‘904 Patent
`
`uses the term “alarm” to indicate a desired dose, not an indication of “danger.”
`
`Moreover, PO’s only evidence to support its definition is from “dictionary.com.”
`
`(PO Resp. at 33-34; Ex. 2041). Even this undercuts PO’s position, as it
`
`alternatively defines “alarm” as “a warning sound; signal for attention.” (Ex. 2041
`
`at 1).
`
`PO’s argument also ignores the Petition’s statement that “[a] person of skill
`
`would also have understood that the L3 signal, which indicates that multiple valves
`
`are open simultaneously, can be provided as an input to the CPU of the ‘083 Patent
`
`to trigger action appropriate for such a condition.” (Petition at 55). The Petition
`
`relied on LED 92 as a visual indicator, and noted that “a person of skill in the art
`
`would have understood that the L3 signal could be generated using the valve
`
`sensors disclosed in the ‘510 Patent. (Ex. 1004 at 3:16-29.)” (Id.). And
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`Petitioner’s expert, Dr. Robert Stone, testified that “part of the knowledge of a
`
`person of skill in the art designing improved gas delivery systems would have been
`
`that if it is harmful for two sources of gas to be delivered at the same time, that
`
`situation should be at least indicated to a user and avoided or prevented if
`
`7
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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`possible.” (Ex. 1002 at ¶ 147; see also Petition at 55-56).4 PO’s expert fails to
`
`challenge this testimony, (Ex. 2021 at ¶¶ 185-86), and instead admitted that the
`
`‘083 Patent and the FR ‘804 Publication each disclose emitting an alarm if a
`
`dangerous condition exists. (Ex. 2021 at ¶ 61 (‘083 Patent), ¶ 91 (FR ‘804
`
`Publication)). PO’s argument also ignores the fact that the combination relied on
`
`in the Petition deals with delivery of NO, meaning that in a two-cylinder system,
`
`the condition indicated by the LED 92 would be potentially harmful, and thus
`
`would be an alarm even under PO’s narrow construction. (Petition at 54-56).
`
`
`4 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 17-29). This is
`
`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).
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`8
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`

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`Case: IPR2015-00884
`U.S. Patent No. 8,573,904
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`Those of skill understand that if it is harmful to have two cylinders open
`
`simultaneously, that harm should be indicated to the user.
`
`C.
`
` PO’s Complaint Regarding Claim 10
`
`PO argues that the combination on which trial was instituted for claim 10 is
`
`deficient because it does not disclose “terminat[ing] delivery of therapy” if two
`
`valves are determined to be open. (PO Resp. at 34-38). As described with regard
`
`to claim 9, the combination teaches that signal L3 indicates whether both valves
`
`are open simultaneously. (Petition at 59-60). It explains the combination:
`
`Incorporating the ‘398 Patent’s teachings with the teachings of the
`‘083 Patent results in a system where the L3 signal of the ‘398 Patent,
`which indicates whether two valves in a dual-valve configuration are
`open, can drive the shutoff valve 14 of the ’083 Patent.
`
`(Petition at 60). Contrary to PO’s first argument (PO Resp. at 35-36), the Petition
`
`did not discuss how the references could be combined; instead, it explained what a
`
`person of skill in the art would have understood, citing the factual testimony of Dr.
`
`Stone. (Petition at 54-57, 59-60; see also Ex. 1002 at ¶¶ 138-150). The teachings
`
`of the ‘083 Patent regarding a shutoff valve to take “more drastic steps”
`
`affirmatively teaches that the CPU can control gas delivery by shutting off delivery
`
`according to an appropriate algorithm based on an appropriate input. (Petition at
`
`59-60; see also Ex. 1005 at 2:52-57). Indeed, the ‘083 Patent itself specifically
`
`notes that “the CPU takes over the manual setting of any valves…” (Ex. 1005 at
`9
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`U.S. Patent No. 8,573,904
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`2:64-65).
`
`further
`
`teaches “various controls, alarms, and
`
`safety
`
`
`
`It
`
`devices…including means to shut down the NO system or to reduce the NO
`
`concentration to the patient to a safer level.” (Id. at 3:14-18). Thus, the ‘083
`
`Patent itself teaches that it was known to “the entire system may be controlled to
`
`alleviate the unsafe condition sensed.” (Id. at 3:23-25). PO next argues that there
`
`is no reason to modify the ‘083 Patent or the ‘398 Patent to account for a situation
`
`where it is dangerous for both valves to be open simultaneously. (PO Resp. at 36).
`
`To the contrary, the ‘083 Patent teaches using a CPU to control valves to alleviate
`
`unsafe conditions. (Ex. 1005 at 8:14-25). Dr. Stone testified that based on the
`
`FDA Guidance, a person of skill would understand that delivering gas from two
`
`cylinders of NO is potentially harmful, and would thus have been motivated to
`
`prevent such a situation. (Ex. 1002 at ¶ 141; see also Petition at 60). And
`
`evidence PO itself introduced and now relies on shows that prior art NO systems
`
`(specifically, the OptiKINOX system) used two cylinders of NO. (Ex. 2017 at 2).
`
`Regarding PO’s third argument, the Petition provides rationale to combine the
`
`references applied to claim 10 (Petition at 54-57); it is Mr. Heim who provides
`
`conclusory, unpersuasive testimony on the lack of motivation (Ex. 1021 at ¶ 184).
`
`IV. THE INSTITUTED COMBINATIONS ARE PROPER BECAUSE
`PO’S ARGUMENTS ABOUT THE REFERENCES LACK MERIT
`
`PO argues the alleged impropriety of the Petition’s combinations. (PO Resp.
`
`10
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`U.S. Patent No. 8,573,904
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`at 42-55). Since the FR ‘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 19-25; 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 42-46). Because the FR ‘804 Publication teaches the very “pre-use
`
`safety check” PO uses as a shorthand to describe the allegedly patentable feature of
`
`the claims of the ‘904 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. 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 Patent5
`
`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 12-14). PO’s teaching away
`
`
`5 According to PO, the ‘083 Patent describes “Patent Owner’s NO delivery
`
`systems.” (PO Resp. at 8; see also Ex. 2002 at 3 (marked with ‘083 Patent)).
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`11
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`U.S. Patent No. 8,573,904
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`argument is contrary to common sense and the express teaching of the ‘083 Patent.
`
`1.
`
`PO’s Nitric Oxide-Specific Arguments Are Inaccurate
`
`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
`
`inspiration is used as feedback to the control system. (PO Resp. at 42-46).
`
`According to the FDA, “[n]itrogen dioxide is a toxic gas formed by reaction
`
`of nitric oxide with oxygen.” (Ex. 1012 at 9).6 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).7 To control this risk,
`
`“[t]he administration device should include provision for nitrogen dioxide gas
`
`analysis with alarms. The breathing circuit location for sampling should sample
`
`
`6 PO’s argument about “rebound pulmonary hypertension” is irrelevant. (PO Resp.
`
`at 46). The “sudden cessation” PO cites could only occur if NO was being
`
`delivered to the patient and thereafter stopped (id.); here, the data on the cylinder
`
`carrier is far less useful than the sensed NO/NO2 concentration inspiration.
`
`7 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).
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`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
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`therapeutic and toxic gases are delivered to the patient.
`
`The record does not provide any support for the idea that using data on the
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`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 14-15). 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 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 the Petition’s
`
`basis for combinability: “[s]uch alternative gas data sources are disclosed 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 ¶ 126.).” (Petition at 22). While Dr. Stone stressed the
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`importance of this teaching in his deposition (Ex. 2020 at 92:11-93:13, 95:22-
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`96:16), Mr. Heim did not address it at all (see, e.g., Ex. 2021 at ¶ 56-66).
`
`B.
`
`The ‘510 Patent
`
`1.
`
`The ‘510 Patent Teaches Wireless Transmission
`
`Mr. Heim opined about the wired protocol disclosed in the ‘510 Patent.
`
`(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 4-5, 29-31, 33-34). Accordingly, there is no dispute that the ‘510
`
`Patent 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 28-31).
`
`2.
`
`The ‘510 Patent Suggests Using Stored Data For Control
`
`The Abstract of the ‘510 Patent discloses that that data stored in its valve
`
`memory can be used “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 the valve handle memory can serve a role in controlling
`
`therapy. (Ex. 2020 at 124:16-125:6; see also id. at 128:23-129:1).8 Neither Mr.
`
`
`
`8 PO argues that the data stored in the ‘510 Patent valve memory is not the claimed
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`Heim nor the PO Response addresses this testimony (or the clear disclosure of
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`“control” in the ‘510 Patent’s Abstract). Instead, Mr. Heim testified about column
`
`7 of the ‘510 Patent (Ex. 2021 at ¶69) and implied that “control” in the ‘510 Patent
`
`deals with “inventory control.” The Abstract distinguishes “inventory control”
`
`from “other record-keeping and control functions.” (Ex. 1004 at Abstract).
`
`3.
`
`in Arguing the
`PO Misrepresented the ‘510 Patent
`Open/Close Data is Never Used for Real-Time Tasks
`
`PO argues that, “[a]ll of the logging and tracking functions supported by the
`
`valve [of the ‘510 Patent] are contemplated for later analysis (e.g., preparing
`
`invoices) as opposed to any real-time application, such as a safety check or
`
`verification of operating parameters, when the device delivers gas to a patient.”
`
`(PO Resp. at 14 (citing Ex. 2021 at ¶85)). Mr. Heim testified that this is
`
`
`
`“gas data” because it is not “gas type, gas concentration, or gas expiration date.”
`
`(PO Resp. at 15). The Petition explained why this is incorrect (Petition at 28) and
`
`even Mr. Heim conceded that inventory control requires knowledge of the gas type
`
`(Ex. 1022 at 78:20-24). Regardless, storing certain gas data is at least a motivation
`
`to look to storing other kinds of gas data, such as IDb of the FR ‘804 Publication
`
`(which PO concedes is the claimed “gas data”, see PO Resp. at 16-17) or gas
`
`concentration of the ‘083 Patent, in the valve memory. (Petition at 29-30).
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`inaccurate—at least displaying the open/closed status of the valve is a “real-time
`
`application.” (Ex. 1022 at 142:10-17). The operator can use the real-time display
`
`to assess the ongoing therapy, including the therapeutic impact on the patient. (Ex.
`
`1004 at 3:65-4:4, 5:31-42).9 Thus, the ‘510 Patent suggests that open/close data is
`
`stored and used in real-time, and thus at least suggests that this data is amenable to
`
`use as the comparison data in the FR ‘804 Publication.
`
`C. The FR ‘804 Publication
`
`PO’s only real complaint regarding FR ‘804 Publication concerns
`
`combinability (PO Resp. at 46-54).10
`
`PO argues that the FR ‘804 Publication would not be combined as suggested
`
`in the Petition because it is not directed to medical gas delivery devices. (PO Resp.
`
`at 16-17). Mr. Heim admitted that the disclosed system “can be used for other
`
`
`9 The Petition relied on the FR ‘804 Publication as disclosing controlling gas
`
`delivery upon verifying that the gas is the expected gas. The aspects of the ‘510
`
`Patent addressed here relate to the combinability with the FR ‘804 Publication.
`
`10 PO’s argument about Air Liquide allegedly not including the features of the FR
`
`‘804 Publication are both tenuous from an evidentiary perspective (they are based
`
`on a single marketing brochure for a single product, see Ex. 2017) and irrelevant,
`
`as the combination involves the FR ‘804 Publication, not a prior art device.
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`operating circuit purposes besides filling bottles.” (Ex. 1022 at 144:13-14). One
`
`such use is in a “health facility.” (Ex. 2021 at ¶ 97; Ex. 1006 at 19). PO cannot
`
`dispute that Air Liquide (the assignee of the FR ‘804 Publication) was a company
`
`those of skill understood was in the business of providing inhaled NO in the prior
`
`art timeframe. Indeed, PO relies on this fact to make its secondary consideration
`
`arguments. (PO Resp. at 7-9, 59-60; Petition at 15-17; Ex. 1002 at ¶¶ 61-69).11
`
`PO also argues the FR ‘804 Publication is “inherently incompatible” with
`
`the ‘510 Patent because its “mechanism of operation relies on an automatic valve
`
`that defaults to a closed position and only opens when the controller signals a
`
`match in gas type,” while “[b]y contrast, [the ‘510 Patent] discloses a valve that is
`
`
`11 PO’s secondary considerations argument (PO Resp. at 59-60) fails to establish
`
`what features the prior art products and the INOmax DSIR had and did not have,
`
`and certainly does not perform a claim-by-claim analysis of these products. (PO
`
`Resp. at 7-9; Ex. 2021 at ¶¶ 111-13). Finally, PO fails to explain whether the lack
`
`of claimed features was due to failure of others to conceive or implement these
`
`features or some other regulatory, commercial, or logistical considerations. See
`
`AstraZeneca LP v. Breath Ltd., 88 F.S