Trials@uspto.gov
`Tel: 571.272.7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________
`
`
`PATENT TRIAL AND APPEAL BOARD
`
`_____________
`
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`MALLINCKRODT HOSPITAL PRODUCTS IP LTD.,
`Patent Owner
`
`_____________
`
`
`Case: IPR2015-00891
`Patent: 8,573,210 B2
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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.
`
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`Case: IPR2015-00891
`U.S. Patent No. 8,573,210
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`The Problem Purportedly Solved by the ‘210 Patent Was Already
`Well-Known Prior To Its Filing ...................................................................... 1
`PO Misinterprets The Instituted Combinations ............................................... 4
`A.
`PO’s Complaints Regarding the Independent Claim ............................ 4
`B.
`PO’s Complaint Regarding Claim 10 ................................................... 7
`C.
`PO’s Complaint Regarding Claim 11 ................................................... 9
`IV. The Instituted Combinations are Proper Because PO’s Arguments
`About The References Lack Merit ................................................................ 11
`A.
`The ‘083 Patent ................................................................................... 12
`1. PO’s Nitric Oxide-Specific Arguments Are Inaccurate ................. 12
`2. The ‘083 Patent Obtains Concentration Data from Different
`Sources ...................................................................................... 14
`The ‘510 Patent ................................................................................... 14
`1. The ‘510 Patent Teaches Wireless Transmission ........................... 14
`2. The ‘510 Patent Suggests Using Stored Data For Control ............. 15
`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 ......................................................................................... 23
`VII. Conclusion ..................................................................................................... 25
`
`i
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`Case: IPR2015-00891
`U.S. Patent No. 8,573,210
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`
`PETITIONER’S UPDATED LIST OF EXHIBITS
`
`Ex. 1001 U.S. Patent No. 8,573,210 (“‘210 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
`
`French Publication No. 2 917 804 (“FR ‘804 Publication”), published
`
`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,
`
`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: IPR2015-00891
`U.S. Patent No. 8,573,210
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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_
`
`docs/nda/99/20845_inomax_prntlbl.pdf (August 9, 2000).
`
`Ex. 1015 Reserved
`
`Ex. 1016 Reserved
`
`Ex. 1017
`
`Prosecution History of U.S. Patent No. 8,573,210.
`
`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: IPR2015-00891
`U.S. Patent No. 8,573,210
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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
`
`December 18, 2009, published April 15, 2010.
`
`
`
`iv
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`Case: IPR2015-00891
`U.S. Patent No. 8,573,210
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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 ‘210 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 ‘210 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 ‘210 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
`
`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.
`
`1
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`U.S. Patent No. 8,573,210
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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
`
`fittings are the same ones used for different concentrations of NO. (Ex. 2021 at
`
`¶ 137 (“[t]hese connectors are unique to therapeutic nitric oxide mixtures.”).
`
`Where multiple concentrations of nitric oxide in nitrogen were available (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). Accordingly, the FDA itself had previously identified
`
`the problem PO avers was unrecognized until the ‘210 Patent.
`
`The FR ‘804 Publication, assigned to a well-known NO supplier in France
`
`(see Petition at 15) similarly identifies the problem PO asserts was “unknown.” It
`
`states “purely mechanical solutions which involve the use of connection
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`2
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`U.S. Patent No. 8,573,210
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`types…and connections, depending on different types of gas” were known, but that
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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).
`
`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 ‘210 Patent. (Ex. 2021 at ¶¶ 54, 111). 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 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
`
`
`2 In discussing pre-existing devices, PO does not even mention, let alone discuss
`
`the features of, its own prior art INOvent device. (PO Resp. at 59-60).
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`3
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`U.S. Patent No. 8,573,210
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`connectors. (Id. at 36, 142, 145, 166-167, 169).
`
`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
`
`11-25). The Petition explains the resulting system (id. at 24-25) and why the
`
`combinations disclose each limitation. (See, e.g., id. at 26-46). PO’s argument
`
`that 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
`
`references to reach the claim limitations at issue” is incorrect. (PO Resp. at 30).
`
`A.
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`PO’s Complaints Regarding the Independent Claim
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`PO identifies a single limitation of independent claim 1 allegedly not met by
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`the proposed combination. Specifically, it argues that the Petition does not identify
`
`why the prior art teaches communicating gas data to a “control module and to
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`verify one or more of the gas identification, the gas concentration and that the gas
`
`is not expired.” (PO Resp. at 31). It relatedly argues the Petition does not show
`
`why the control module receives “gas comprising NO through the valve” and that
`
`as a result, the claimed “verification” does not occur. (Id.).
`
`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
`
`the safety check of the FR ‘804 Publication prior to the ‘083 Patent’s control
`
`4
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`U.S. Patent No. 8,573,210
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`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 28; see also id. at 27-32). The Petition identifies a valve (from the ‘510
`
`Patent) that allows gas to flow to a control module (from the ‘083 Patent), which
`
`the ‘210 Patent relies on as enabling disclosure of the claimed “control module.”
`
`(Id. at 27-29). It notes that “[w]hen the valve of the ‘510 Patent and the FR ‘804
`
`Publication are incorporated 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.)” (Id. at
`
`30). “[W]hen the FR ‘804 Publication’s verification function is performed by the
`
`CPU of the ‘083 Patent to achieve the precise monitoring mandated by the
`
`INOMAX label [] the prior art discloses the one limitation the examiner did not
`
`find in the ‘510 Patent alone. (Ex. 1002 ¶¶ 129-132; Ex. 1017 at 150.)” (Id. at 32).
`
`PO argues that “FR ‘804 does not disclose storing gas concentration data in
`
`a memory, and none of the references, alone or in combination, discloses
`
`communicating gas concentration data from the memory” to the CPU of the ‘083
`
`Patent. (PO Resp. at 33). This argument is unavailing based on the claims. The
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`5
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`Case: IPR2015-00891
`U.S. Patent No. 8,573,210
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`sole independent claim recites a Markush group that can be satisfied by gas data
`
`selected from the group consisting of “gas identification, gas expiration date and
`
`gas concentration.” (Ex. 1001 at 17:25-27). PO does not dispute that the proposed
`
`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 actual
`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.)
`
`(Petition at 29). This data is stored in the ‘510 Patent’s valve memory. (Ex. 1002
`
`¶¶ 111, 116.) 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.
`
`
`
`Finally, PO argues that Petitioner’s claim 3 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 3 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
`
`6
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`Case: IPR2015-00891
`U.S. Patent No. 8,573,210
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`read from the cylinder in the FR ‘804 Publication) in the valve memory. (Petition
`
`at 32-33). Petitioner did not assert that the control module would be included in
`
`the valve.
`
`B.
`
`PO’s Complaint Regarding Claim 10
`
`PO also complains that the combination in the Petition does not meet claim
`
`10’s requirement that the CPU “emit an alarm.” (PO Resp. at 33). PO’s position
`
`is, in reality, a claim construction argument that the broadest reasonable
`
`construction of “alarm” must be limited to be “an indication of danger.” (Id. 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.” (Id. at 33).
`
`It is unsurprising that PO does not present a formal claim construction
`
`argument. The ‘210 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
`
`‘210 Patent uses the term “alarm” to indicate a desired dose, not an indication of
`
`“danger.” PO’s only evidence to support its definition is from “dictionary.com.”
`
`(PO Resp. at 34; Ex. 2041). Even this undercuts PO’s position, as it alternatively
`
`7
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`U.S. Patent No. 8,573,210
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`defines “alarm” as “a warning sound; signal for attention.” (Ex. 2041 at 1).
`
`PO’s argument also ignores the Petition’s statement that “[w]hen the ’398
`
`Patent is incorporated in the Ground 1 combination, the CPU of the ‘083 Patent
`
`receives L3 and L3’ of the ‘398 Patent from the valves of the ‘510 Patent and
`
`compares those signals”; this comparison causes an alarm if both valves are open.
`
`(Petition at 58, see also id. at 54-57). And 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 possible.” (Ex. 1002 at ¶ 157; see
`
`also Petition at 57-58).3 PO’s expert fails to challenge this testimony, (Ex. 2021 at
`
`
`3 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 19-30). 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
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`8
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`Case: IPR2015-00891
`U.S. Patent No. 8,573,210
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`¶¶ 187-88), 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 54-58). 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 11
`
`PO argues that the combination on which trial was instituted for claim 11 is
`
`deficient because it does not disclose “terminat[ing] delivery of therapy” if two
`
`valves are determined to be open. (PO Resp. at 35-37). As described with regard
`
`to claim 10, the combination teaches that signal L3 indicates whether both valves
`
`are open simultaneously. (Petition at 59-60). It explains the combination as
`
`follows:
`
`
`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. Petitioner presents expert testimony here; it properly addresses
`
`technical issues regarding the references themselves.
`
`9
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`U.S. Patent No. 8,573,210
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`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 60; see Ex. 1002 at ¶¶ 147-160). 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 60; see also Ex.
`
`1005 at 2:52-56). Indeed, the ‘083 Patent itself specifically notes that “the CPU
`
`takes over the manual setting of any valves…” (Ex. 1005 at 2:64-65). It further
`
`teaches “various controls, alarms, and safety 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 that
`
`“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). Again, the evidence refutes this argument.
`
`The ‘083 Patent specifically teaches using a CPU to control valves to alleviate
`10
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`U.S. Patent No. 8,573,210
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`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 from occurring. (Ex. 1002 at ¶ 150; see also Petition at
`
`60). PO’s own INOMAX label reiterates this. (Ex. 1002 at ¶ 151). 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 a rationale to combine the
`
`references applied to claim 11 (Petition at 53-57); it is Mr. Heim who provides
`
`conclusory, unpersuasive testimony on the lack of motivation (Ex. 2021 at ¶ 188).
`
`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 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 21-25; Ex.
`
`2020 at 111:22-122:18), PO’s assertions regarding combinability of the ‘510 Patent
`
`and the ‘083 Patent, on their own, are irrelevant. (PO Resp. at 42-47). 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 ‘210
`
`11
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`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.
`
`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). PO’s teaching away
`
`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 44-46).
`
`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
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`
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`4 According to PO, the ‘083 Patent describes “Patent Owner’s NO delivery
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`systems.” (PO Resp. at 8; see also Ex. 2002 at 3 (marked with ‘083 Patent)).
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`5 PO’s argument about “rebound pulmonary hypertension” is irrelevant. (PO Resp.
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`longer nitric oxide dwells in a delivery circuit, the higher the likelihood of
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`formation of toxic nitrogen dioxide. (Ex. 1005 at 1:40-44).6 To control this risk,
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`the FDA counsels that “[t]he administration device should include provision for
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`nitrogen dioxide gas analysis with alarms. The breathing circuit location for
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`sampling should sample gas which is representative of the inspired gas.” (Ex.
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`1012 at 10). Thus, according to the FDA’s own guidance regarding nitric oxide
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`delivery, sensors (akin to those disclosed in the ‘083 Patent) should be used to
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`ensure appropriate levels of therapeutic and toxic gases are delivered to the patient.
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`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.
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`Incorporating the safety check of the FR ‘804 Publication is therefore an additional
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`check, and not an alternative check, to those provided in the ‘083 Patent.
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`at 46). The “sudden cessation” could only occur if NO was being delivered to the
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`patient and thereafter stopped (id.); in this scenario, the data on the cylinder carrier
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`is far less useful than the sensed NO/NO2 concentration at the inspiration point.
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`6 This property of nitric oxide casts substantial doubt on the veracity of Mr. Heim’s
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`testimony, in which he guessed wrong and testified that nitrogen dioxide forms in
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`the presence of nitrogen, not oxygen (Ex. 1022 at 104:17-105:1) and alternatively
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`that NO2 will be formed without any other reactant present (id. at 106-24:107-2).
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`2.
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`The ‘083 Patent Obtains Concentration Data from Different
`Sources
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`The only way PO can make its sensor-based argument is by ignoring
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`alternative embodiments in the ‘083 Patent. (See, e.g., PO Resp. at 14). PO does
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`not dispute that the ‘083 Patent’s CPU performs algorithms to control NO delivery
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`(including ceasing delivery) based on inputs indicating concentration. (See, e.g.,
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`id. at 45). It teaches that “NO sensor 65 could, of course, be eliminated if the NO
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`cylinder 10 is always constant or by keying into the NO sensor in the gas sensing
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`bench 52.” (Ex. 1005 at 6:11-13). This is the basis for combinability presented in
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`the Petition: “[s]uch alternative gas data sources are expressly contemplated by the
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`‘083 Patent. (Ex. 1005 at 6:11-15; Ex. 1002 ¶126.).” (Petition at 23). While Dr.
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`Stone stressed the importance of this teaching (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 ¶¶ 58-66).
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`B.
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`The ‘510 Patent
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`1.
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`The ‘510 Patent Teaches Wireless Transmission
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`Mr. Heim opined about the wired protocol disclosed in the ‘510 Patent.
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`(See, e.g., Ex. 2021 at ¶ 71). However, he did not dispute that the ‘510 Patent also
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`discloses wireless transceivers “to transmit the data to a remote recording device at
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`intervals or on command, as desired.” (Id. at ¶ 79; see also, e.g., Ex. 1004 at 7:1-4;
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`Petition at 4-5, 29-31, 33-34). Accordingly, there is no dispute that the ‘510 Patent
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`discloses that in some embodiments, data is wirelessly transmitted via a transceiver
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`to a remote transceiver. This emphasizes the propriety of using the ‘510 Patent in
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`the manner suggested in the Petition. (Petition at 29-31).
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`2.
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`The ‘510 Patent Suggests Using Stored Data For Control
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`The Abstract of the ‘510 Patent discloses the stored data can be used for
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`various purposes, including “inventory control [] and for other record-keeping
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`and control functions.” (Ex. 1004 at Abstract). Dr. Stone testified that this
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`discloses using data stored in the valve handle memory can serve a role in
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`controlling therapy. (Ex. 2020 at 124:16-125:6; see also id. at 128:23-129:1).
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`Neither Mr. Heim nor the PO Response addresses this testimony (or the clear
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`disclosure of “control” in the ‘510 Patent’s Abstract). Instead, Mr. Heim testified
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`about column 7 of the ‘510 Patent (Ex. 2021 at ¶ 69) and implied that “control” in
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`the ‘510 Patent deals with “inventory control.” However, the Abstract itself
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`distinguishes “inventory control” from “other record-keeping and control
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`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).7 Thus, the ‘510 Patent suggests that open/close data
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`are stored and used in real-time, and therefore at least suggests that this data is
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`amenable to use as the comparison data in the FR ‘804 Publication.
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`C. The FR ‘804 Publication
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`PO’s only real complaint regarding FR ‘804 Publication concerns
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`combinability (PO Resp. at 46-54).8
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`PO argues that the FR ‘804 Publication would not be combined as suggested
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`7 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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`8 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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`in the Petition because it is not directed to medical gas delivery devices. (PO Resp.
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`at 18). 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, 59-60; Petition at 15; Ex. 1002 at ¶¶ 67-70).9
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`PO also 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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`9 PO’s secondary considerations argument (PO Resp. at 59-60) fails to establish
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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 claime