Trials@uspto.gov
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________
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`PRAXAIR DISTRIBUTION, INC. and PRAXAIR, INC.
`Petitioner
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`v.
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`INO THERAPEUTICS, LLC and IKARIA, INC.
`Patent Owner
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`_____________
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`Case IPR2015-00529
`Patent 8,846,112
`_____________
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`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE TO
`PETITION
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`Case IPR2015-00529
`Patent 8,846,112
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`
`TABLE OF CONTENTS
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`Page
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`I.
`II.
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`B.
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`B.
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`Introduction ...................................................................................................... 1
`The Board Correctly Found That The “Providing . . . Information” And
`“Providing . . . a Recommendation” Steps Should Not Be Given
`Patentable Weight ............................................................................................ 3
`A.
`The “Providing . . . Information” And “Providing . . . a
`Recommendation” Steps Are Printed Matter ........................................ 4
`No Functional Relationship Exists Between The Printed Matter
`Steps And Any Other Claim Element ................................................... 5
`i.
`The Board Properly Considered The Claims As A Whole ......... 5
`ii.
`The Printed Matter Steps Do Not Change The Claimed
`Methods ....................................................................................... 9
`The Information In The Printed Matter Steps Is An Inherent
`Property Of Nitric Oxide .......................................................... 11
`Expert Testimony Is Irrelevant To The Printed Matter
`Determination ............................................................................ 13
`III. The Board Correctly Found That The “Risk/Benefit” Steps Of Claims 3
`And 16-19 Should Be Given No Patentable Weight ..................................... 14
`IV. All The Claims Are Invalid In View Of The Prior Art ................................. 15
`A.
`The Board Is Correct That The INOmax Label Anticipates Or
`Renders Obvious The Independent Claims ......................................... 15
`i.
`The INOmax Label Discloses Every Element Of The
`Independent Claims .................................................................. 15
`The INOmax Label Alternatively Renders The Claims
`Obvious ..................................................................................... 16
`The Board Properly
`Instituted Review Based On
`Anticipation ............................................................................... 17
`Claims 1-19 Are Rendered Obvious By Bernasconi, INOmax
`Label, Loh And Goyal ......................................................................... 17
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`iii.
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`iv.
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`ii.
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`iii.
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`i
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`

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`ii.
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`V.
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`Case IPR2015-00529
`Patent 8,846,112
`i.
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`Patent Owner’s Arguments Are Based On Evidence That
`Should Be Given No Weight .................................................... 17
`Patent Owner’s Arguments Ignore The Plain Language Of
`The Claims ................................................................................ 19
`Patent Owner’s Evidence Of Secondary Considerations Is Unpersuasive ... 20
`A.
`The Proffered Results Are Legally Improper ...................................... 20
`B.
`No Nexus Exists Between The ‘112 Patent Claims And The
`INOT22 Study ..................................................................................... 21
`VI. Conclusion ..................................................................................................... 22
`
`ii
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`

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`Case IPR2015-00529
`Patent 8,846,112
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Apple, Inc. v. SightSound Techs. LLC,
`CBM2013-00020, Paper No. 105 at 25-27 (Oct. 7, 2014)................................... 18
`
`Application of Wiggins,
`488 F.2d 538 (C.C.P.A. 1973) ............................................................................. 22
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) .................................................................. passim
`
`Gen. Elec. Co. v. Jewel Incandescent Lamp Co.,
`326 U.S. 242 (1945) ............................................................................................. 13
`
`In re Cruciferous Sprout Litigation,
`301 F.3d 1343 (Fed. Cir. 2002) ............................................................................ 12
`
`In re Distefano,
`808 F.3d 845, 848 (Fed. Cir. 2015) ....................................................................4, 5
`
`In re Gulack,
`703 F.2d 1381 (Fed.Cir.1983) ................................................................................ 4
`
`In re Ngai,
`367 F.3d 1336 (Fed. Cir. 2004) ............................................................................ 10
`
`In re Omeprazole Patent Litigation,
`483 F.3d 1364 (Fed. Cir. 2007) ............................................................................ 12
`
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) ............................................................................ 22
`
`King Pharms., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) ....................................................................... 5, 11
`
`Mexichem Amanco Holdings v. Honeywell Int’l,
`IPR2013-00576, Paper 36 (September 5, 2014 ) ................................................. 19
`
`i
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`Case IPR2015-00529
`Patent 8,846,112
`Schering Corp. v. Geneva Pharms., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) review en banc denied, 348 F.3d 992 (Fed. Cir.
`2003).............................................................................................................. 13, 14
`
`
`
`ii
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`

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`Case IPR2015-00529
`Patent 8,846,112
`I.
`Introduction
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`INO Therapeutics, LLC. and Ikaria, Inc.’s (“Patent Owner”) Response fails
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`to demonstrate that the claims are valid over the prior art.1
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`First, Patent Owner challenges the Board’s conclusion that the limitations
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`reciting “providing . . . information” and “providing . . . a recommendation” were
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`directed to printed matter not functionally related to other limitations of the claim,
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`and therefore entitled to no patentable weight.2 Paper No. 22 at 18-33. Patent
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`Owner argues that the Board erred by failing to consider the claim’s preamble,
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`which recites providing a “pharmaceutically acceptable” nitric oxide gas. Id.
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`Even if Patent Owner were right that this preamble phrase is limiting, and even if it
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`has the meaning Patent Owner ascribes to it, the preamble would still have no
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`1 As a preliminary matter, Patent Owner provides no rebuttal to the Board’s
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`prima facie case that the cited prior art invalidates claims 12-19 of the U.S.
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`Patent No. 8,846,112 (“the ‘112 Patent”). Paper No. 22 at 1, n.1 (stating that
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`Patent Owner’s Response does not address claims 12-19 of the ‘112 Patent).
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`Thus, those claims should be deemed unpatentable.
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`2 The “printed matter steps” are the “providing . . . information” steps found in
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`independent claims 1, 12 and 14, the “providing . . . a recommendation” step of
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`independent claim 7, and the discontinuing . . . based on a recommendation”
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`step of dependent claim 9.
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`1
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`Patent 8,846,112
`impact on the Board’s printed matter analysis. The claims would still lack any act
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`of “administering” nitric oxide treatment or “excluding” a patient from treatment,
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`making the “providing…information” and “providing…recommendation” steps
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`just that: providing information and recommendations. They would remain
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`“printed matter” steps not functionally related to the rest of the method.
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`Moreover, as discussed in detail below, the Federal Circuit has already
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`rejected Patent Owner’s argument that labeling instructions are “functionally
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`related” to a drug product because they are required for safe and effective use of
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`the drug. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1048, 1065 (Fed.
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`Cir. 2010) (holding that label instructions, though “needed for the safe and
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`effective use of any drug,” do not “function with the drug to create a new,
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`unobvious product,” and are therefore merely printed matter). Tellingly, Patent
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`Owner fails to address AstraZeneca’s holding or rationale.
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`Next, Patent Owner argues that the Board exceeded its statutory authority by
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`instituting trial on anticipation grounds, and by construing the risk/benefit analysis
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`of certain dependent claims as being limited to a purely mental step. The Board’s
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`actions, however, were well within its authority and consistent with precedent.
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`Finally, Patent Owner attempts to rebut the obviousness rejections with
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`evidence of secondary considerations. But Patent Owner previously included the
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`same prosecution history and the secondary considerations evidence in its
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`2
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`Patent 8,846,112
`Preliminary Response and the Board has already found it to be “immaterial.”
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`Paper No. 12 at 14, 18. The Board also already ruled that the majority of Patent
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`Owner’s “secondary considerations” evidence should be given little or no weight,
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`because it is largely based on statements from declarants whom Patent Owner
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`refused to make available for cross-examination. See Ex. 1058. Moreover, while
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`Patent Owner touts the INOT22 study, it fails to acknowledge that the INOT22
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`study population did not include any neonates even though all the ‘112 Patent
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`claims are limited to “neonates.” As a result, Patent Owner cannot demonstrate the
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`necessary nexus tying any supposed unexpected results to the claims.
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`In sum, Patent Owner fails to demonstrate that claims 1-19 of the ‘112
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`Patent are novel and nonobvious. The Board should thus affirm its Institution
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`Decision (Paper No. 12) and invalidate the claims.
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`II. The Board Correctly Found That The “Providing . . . Information” And
`“Providing . . . a Recommendation” Steps Should Not Be Given
`Patentable Weight
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`To determine whether terms that appear to be printed matter should be given
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`patentable weight, the Federal Circuit has established a two-part test: (1)
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`determine if the claim element is printed matter, and (2) if so, is there “any new
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`and unobvious functional relationship between the printed matter and the
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`substrate?” King Pharms. Inc., v. Eon Labs. Inc., 616 F.3d 1267, 1279 (Fed. Cir.
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`2010) citing In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983)); In re DiStefano,
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`3
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`Patent 8,846,112
`808 F.3d 845, 848 (Fed. Cir. 2015) (citation omitted) (“we have long held that if a
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`limitation claims (a) printed matter that (b) is not functionally or structurally
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`related to the physical substrate holding the printed matter, it does not lend any
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`patentable weight to the patentability analysis.”). In method cases, the second
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`question is modified to ask whether a new and unobvious functional relationship
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`exists between the printed matter and the known method. King Pharms., 616 F.3d
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`at 1279.
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`A. The “Providing . . . Information” And “Providing . . . a
`Recommendation” Steps Are Printed Matter
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`The Board’s construction of the “providing . . . information” steps of
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`independent claims 1, 12 and 14; the “providing . . . a recommendation” step of
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`independent claim 7; and the “discontinuing . . . based on a recommendation” step
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`of dependent claim 9 is correct: these steps are “tantamount to printed matter” and
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`thus have no patentable weight. Paper No. 12 at 9; see also King Pharms., 616
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`F.3d at 1278. These elements are not claim limitations and “may not be a basis for
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`distinguishing prior art.” In re Distefano, 808 F.3d at 848.
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`The Federal Circuit recently instructed that the “first step of the printed
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`matter analysis is the determination that the limitation in question is in fact directed
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`toward printed matter. Our past cases establish a necessary condition for falling
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`into the category of printed matter: a limitation is printed matter only if it claims
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`the content of information.” Id. at 849 (citation omitted).
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`4
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`Case IPR2015-00529
`Patent 8,846,112
`As shown by Patent Owner’s discussion of the content of the printed matter
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`steps throughout the Response, the printed matter steps are specifically directed to
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`the content of the information and recommendation provided. See, e.g., Paper No.
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`22 at 5 (“information sufficient to cause a medical provider considering iNO
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`treatment to avoid treating neonates with pre-existing LVD [left ventricular
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`dysfunction]”); see also Paper No. 12 at 8-12. In fact, Patent Owner does not
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`dispute that the steps are printed matter.
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`Accordingly, the parties agree that the printed matter steps are directed to the
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`content of the information provided. Thus, the only dispute is whether the claims
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`disclose a new and unobvious functional relationship between the printed matter
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`and the known method. Paper No. 22 at 18. As explained by the Board in its
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`Institution Decision, and discussed below, they do not.
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`B. No Functional Relationship Exists Between The Printed Matter
`Steps And Any Other Claim Element
`i.
`Patent Owner suggests that the Board did not consider “pharmaceutically
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`The Board Properly Considered The Claims As A Whole
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`acceptable nitric oxide gas,” a term in the preamble, in determining that the printed
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`matter steps should not be afforded patentable weight. Paper No. 22 at 18-24. Yet,
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`regardless of how the term is defined, or whether the preamble is limiting, it fails
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`5
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`Case IPR2015-00529
`Patent 8,846,112
`to create a functional relationship.3
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`Patent Owner argues that the printed matter steps are functionally related
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`because the preamble phrase “pharmaceutically acceptable” requires that the nitric
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`oxide be FDA-approved and suitably safe for pharmaceutical use.4 Paper No. 22 at
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`3 Petitioner asserts the preamble is not limiting, and, to the extent it is considered
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`to be limiting, is disclosed by the cited art. See Paper No. 1 at 10, 46; Ex. 1014.
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`Moreover, even if the Board accepts the term as limiting, Patent Owner’s
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`definition of the term as “pharmaceutically acceptable” gas in compliance with
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`FDA labeling, renders the term, in itself, additional printed matter.
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`4 Further, since Patent Owner’s construction varies over time (in that what is
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`“substantially safe” is approved by the FDA, and that differs from the prior art
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`to the present), Patent Owner’s own statements undermine the connection
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`between the information in the printed matter steps and the “pharmaceutically
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`acceptable gas” term. Based on Dr. Rosenthal’s testimony, the gas would have
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`been considered “substantially safe” at the time of approval, when the
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`information in the printed matter steps was still allegedly unknown. See, e.g.
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`Ex. 1057 at 68:11-69:6 (“What is pharmaceutically acceptable today is based
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`upon the information that is available today. What is pharmaceutically
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`acceptable at some point in the future would require incorporation of existing
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`and subsequent information. So it’s possible that there is an agent that is
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`6
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`Case IPR2015-00529
`Patent 8,846,112
`21-22. According to Patent Owner, the printed matter steps (1) include
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`information related to the risks of administering nitric oxide, (2) which creates a
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`functional relationship since the nitric oxide must be suitably safe, (3) which
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`means “that safety determination is fundamentally coupled to the way in which the
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`drug is meant to be used, per FDA-approved dosage information and safety
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`warnings.” Id. at 28.
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`The Federal Circuit, however, has explicitly rejected this exact argument. In
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`AstraZeneca, the district court invalidated claims that included a drug element and
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`a label element containing information regarding dosage and safety for that drug.
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`633 F.3d at 1063. The Federal Circuit affirmed, holding that the claim elements
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`involving the label information regarding the drug’s administration were printed
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`matter entitled to no patentable weight. Id.
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`Like the AstraZeneca claims, the ‘112 patent claims are directed to a drug
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`element (the cylinder containing compressed nitric oxide gas) in conjunction with
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`claim elements providing dosage and safety information. Compare Ex. 1001 at
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`claims 1, 7 with AstraZeneca, 633 F.3d at 1048 (listing representative claims of the
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`asserted patents in that case).
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`Indeed, the patentee in AstraZeneca made precisely the same argument as
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`pharmaceutically acceptable today, but we learn something that would make it
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`not considered pharmaceutically acceptable in the future”).
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`7
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`Patent Owner makes here, contending that the FDA-required labeling mandates
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`that a functional relationship exists between the information in the claims and the
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`drug. 633 F.3d at 1064 (“FDA regulations require the label for a drug to include
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`information needed for proper use of the drug and argues that without the label a
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`physician would be unable to safely and effectively treat patients. In light of this,
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`AstraZeneca contends that a drug label is essential to physicians when prescribing
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`a drug and, therefore, is functionally related to the drug.”).
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`The Federal Circuit held otherwise. According to the court, merely because
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`information related to safety and usage appears on a drug label does not render that
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`information functionally related to the drug claims:
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`The instructions in no way function with the drug to create a new,
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`unobvious product. Removing the instructions from the claimed kit
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`does not change the ability of the drug to treat respiratory diseases.
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`Although AstraZeneca is correct that FDA regulations require a label
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`containing information needed for the safe and effective use of any
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`drug, this is a requirement for FDA approval, not patentability.
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`AstraZeneca, 633 F.3d at 1065.
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`Similarly, here, Patent Owner’s revised instructions for use do not create a
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`new or unobvious drug or change the drug’s ability to treat hypoxic respiratory
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`failure. While the revised label may assist in the safe and effective use of the drug,
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`8
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`Patent 8,846,112
`it does not affect the patentability of the claims. No evidence exists, therefore, of
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`any functional relationship between the printed matter steps and any other aspect
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`of the claims.
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`Thus, the Board has not improperly excised the printed matter limitations
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`from the claims. Rather, it has properly considered the claims as a whole and
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`determined that no patentable weight should be given to the printed matter
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`limitations. Paper No. 12 at 8-12. The Board’s actions comport with Federal
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`Circuit precedent and comply with the rationale behind the printed matter cases,
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`which “foreclose[] the argument that simply adding new instructions to a known
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`product creates the functional relationship necessary to distinguish the product
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`from the prior art . . . if this court concluded otherwise ‘anyone could continue
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`patenting a product indefinitely provided that they add a new instruction sheet to
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`the product.’ ” AstraZeneca, 633 F.3d at 1065 quoting In re Ngai, 367 F.3d 1336,
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`1339 (Fed. Cir. 2004).
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`ii.
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`The Printed Matter Steps Do Not Change The Claimed
`Methods
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`Providing information or a recommendation does not change the claimed
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`method of providing a pharmaceutically acceptable nitric oxide gas, specifically, a
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`“cylinder containing compressed nitric oxide gas in the form of a gaseous blend of
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`nitric oxide and nitrogen.” Ex. 1001 at claims 1, 7.
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`Patent Owner argues that King Pharmaceuticals is inapposite because
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`9
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`Case IPR2015-00529
`Patent 8,846,112
`informing a patient about the benefits of a drug differs from informing a doctor
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`about “the safe use of iNO.” Paper No. 22 at 25. According to Patent Owner,
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`printed information “changes the information provided to a physician regarding
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`the safe administration of iNO.” Id. (emphasis in original). But Patent Owner
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`ignores a crucial fact: the methods of the claims are directed to obtaining and
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`supplying a cylinder of pharmaceutically acceptable nitric oxide gas. Information
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`regarding how to administer that gas does not change the method of obtaining and
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`supplying that gas.
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`As the Board previously noted, none of the independent claims of the ‘112
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`Patent have an administrative step.5 Paper No. 12 at 11, n.5. Thus, information
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`regarding whether or not to treat any particular patient at any particular dosage
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`5 Certain dependent claims include administration steps, such as in claim 4,
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`which recites “treating [at least one patient determined to have pre-existing
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`LVD] with 20ppm inhaled nitric oxide.” This method of treatment is also
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`unrelated to the printed matter steps. A doctor may choose to treat or not treat a
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`patient based on her own skill and experience. See, e.g., Ex. 1002 at ¶¶ 24-29.
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`Moreover, the “administration step” is contrary to the printed matter steps
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`which require that the doctor provided with the information in the steps “elect
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`to avoid treating” a patient with pre-existing LVD. See, e.g. Ex. 1001 at claim
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`1.
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`10
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`Case IPR2015-00529
`Patent 8,846,112
`level is irrelevant and cannot provide any functional relationship to the claimed
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`methods.
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`iii. The Information In The Printed Matter Steps Is An
`Inherent Property Of Nitric Oxide
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`Moreover, the information in printed matter limitations cannot just have a
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`functional relationship to the rest of the method in order to be limiting; rather, it
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`must be a “novel and unobvious” relationship. King Pharms., 616 F.3d at 1279;
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`see also Paper No. 12 at 10.
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`The method step of recognizing
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`that providing nitric oxide, even
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`“pharmaceutically acceptable” nitric oxide,6 can harm neonatal patients with
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`certain physiological conditions, such as pre-existing left ventricular dysfunction,
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`merely acknowledges an inherent property of nitric oxide.7 And the Federal
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`6 As Dr. Rosenthal testified, “pharmaceutically acceptable” nitric oxide changes
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`over time. Ex. 1057 at 68:11-69:6. Thus, the prior art INOmax label discloses
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`“pharmaceutically acceptable” nitric oxide based on the information available
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`as of the date of the prior art label. Ex. 1014; see also Paper No. 1 at 12.
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`7 Patent Owner asserts that the finding that treatment with inhaled nitric oxide
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`may place certain patients at risk is an inherent problem of administration of
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`nitric oxide, and that the method steps of the invention are an inventive solution
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`to the inherent problem. Paper No. 22 at 38. But these steps (obtaining and
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`11
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`Case IPR2015-00529
`Patent 8,846,112
`Circuit has long held that recognizing previously unknown qualities of a product is
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`not inventive. See, e.g., In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373
`
`(Fed. Cir. 2007) quoting In re Cruciferous Sprout Litigation, 301 F.3d 1343, 1349
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`(Fed. Cir. 2002) (“Artisans of ordinary skill may not recognize the inherent
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`characteristics or functioning of the prior art.”); see also Gen. Elec. Co. v. Jewel
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`Incandescent Lamp Co., 326 U.S. 242, 249 (1945) (“It is not invention to perceive
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`that the product which others had discovered had qualities they failed to detect.”);
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`Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377-80 (Fed. Cir. 2003),
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`review en banc denied, 348 F.3d 992 (Fed. Cir. 2003) (holding that production of
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`descarboethoxyloratadine was inherent, despite the prior art having no disclosure
`
`of any part of the claimed subject matter).
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`Patent Owner never claims to have caused nitric oxide to have a negative
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`physiological reaction in neonates with left ventricular dysfunction. Nitric oxide is
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`inherently dangerous under these circumstances. At best, Patent Owner claims to
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`have discovered that dangerous property of nitric oxide during the INOT22 study.
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`supplying nitric oxide gas) are clearly disclosed in the prior art. It is only a
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`characteristic of nitric oxide, i.e., its risk to neonates with left ventricular
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`dysfunction, which is allegedly not explicitly found in the art.
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`12
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`Case IPR2015-00529
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`See Paper No. 22 at 5-11.8
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`As the Federal Circuit recognized in Schering, discovering inherent
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`properties of a drug, even in studies that post-date the priority date of the patent,
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`does not confer patentability. Schering, 339 F.3d at 1377. Because the
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`information provided in the printed matter limitations is merely an inherent
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`property of nitric oxide, it cannot be used to show a novel and unobvious
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`functional relationship between the printed matter limitations and the claimed
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`methods.
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`iv. Expert Testimony Is Irrelevant To The Printed Matter
`Determination
`
`Dr. Rosenthal’s testimony concerning “functionally related” is irrelevant,
`
`since functional relationship is a legal conclusion. Dr. Rosenthal admitted that
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`“functional relationship” is a legal term and that he used “a meaning in the
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`common vernacular” for his analysis. Ex.1057, 59:19-25; see also 61:5-12; 63:12-
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`8 Patent Owner also argues that the printed matter steps disclose “inherent risks
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`of the prior art method” rather than an inherent property of the claimed
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`method. Paper No. 22 at 26 (emphasis in original). Even if that is true, and the
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`information is inherent to the prior art, the Federal Circuit has confirmed that
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`recognizing any inherent limitation, even when previously unrecognized, is not
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`a novel act. Schering, 339 F.3d at 1377-80.
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`13
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`Case IPR2015-00529
`Patent 8,846,112
`20.
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`Similarly, Patent Owner argues that Dr. Beghetti admitted that “the
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`information that patients with pre-existing left ventricular dysfunction, inhaled
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`nitric oxide may increase pulmonary capillary wedge pressure leading to
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`pulmonary edema is functionally related to providing a pharmaceutically
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`acceptable nitric oxide gas in an FDA-approved cylinder.” Paper No. 22 at 32.
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`But Patent Owner fails to acknowledge that Dr. Beghetti, for whom English is not
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`his first language, elsewhere testified that the claim elements were not related. Ex.
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`2022 at 86:10-25. Regardless, as noted supra, whether a functional relationship
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`exists is a legal conclusion. As a result, Dr. Beghetti was never asked to, nor did
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`he provide, testimony in his declaration on the functional relationship or lack
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`thereof between claim elements. See Ex. 2022 at 81:25-82:11.
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`In sum, Dr. Rosenthal’s and Dr. Beghetti’s statements are irrelevant to
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`whether the printed matter steps are functionally related to the rest of the claimed
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`methods.
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`III. The Board Correctly Found That The “Risk/Benefit” Steps Of Claims 3
`And 16-19 Should Be Given No Patentable Weight
`
`The Board correctly found that “dependent [c]laims 3 and 16-19 relate to
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`performing a risk/benefit analysis . . .” should also be afforded no patentable
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`weight. Paper No. 12 at 12-13. Patent Owner argues that the Board’s construction
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`of these claim terms was improper because 35 U.S.C. § 101 is not a statutory
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`ground for institution in inter partes reviews. Paper No. 22 at 33-34. Yet the
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`Board did not institute review based on whether the claims were directed to
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`patent-eligible subject matter under § 101; rather, the Board merely construed
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`these limitations as covering a purely mental step—and therefore afforded them no
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`weight—as part of its invalidity analysis under §§ 102 and 103. Nothing in 37
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`C.F.R. § 42.100(b) precludes the Board from construing claim terms and affording
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`them their proper weight under the patent code and the case law.
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`Moreover, none of
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`these dependent claims contain any
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`limitation
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`demonstrating a functional relationship between the printed matter steps and the
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`claimed methods. Indeed, Patent Owner nowhere argues that the claim elements
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`provide the necessary functional relationship that is lacking in the independent
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`claims.
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`IV. All The Claims Are Invalid In View Of The Prior Art
`A. The Board Is Correct That The INOmax Label Anticipates Or
`Renders Obvious The Independent Claims
`i.
`
`The INOmax Label Discloses Every Element Of The
`Independent Claims
`Patent Owner provides no evidence or argument to overcome the prima facie
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`case of invalidity established by the cited art under the Board’s claim construction.
`
`For example, Patent Owner’s expert, Dr. Rosenthal, assumes that all the claim
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`steps have patentable weight and fails to provide any opinion that takes into
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`account the Board’s claim construction. See, e.g. Ex. 2020 at ¶15.
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`As the Board recognized, the INOmax Label discloses every element of the
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`independent claims. Paper No. 12 at 15-18. Patent Owner agrees that the INOmax
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`Label discloses compressed nitric oxide supplied to medical providers in cylinders
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`along with an approved label, and that the compressed nitric oxide is used to treat
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`neonates with hypoxic respiratory failure. Paper No. 22 at 36; see also Ex. 1057,
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`98:13-99:9 (confirming that according to Dr. Rosenthal, INOmax was, in 1999
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`when it was first approved, and still is today, (a) a gaseous blend of NO and N, (b)
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`supplied to medical providers in cylinders with compressed gas, (c) provided along
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`with an approved label, and (d) was in 1999 and still is used to treat neonates with
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`hypoxic respiratory failure); see also Ex. 1014 (disclosing the label for the FDA-
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`approved INOmax product over nine years prior to the filing of the application
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`leading to the ‘112 patent). Patent Owner disputes whether the printed matter steps
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`are disclosed by the INOmax Label. But, as described above, the printed matter
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`steps do not confer any patentable weight.
`
`ii.
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`The INOmax Label Alternatively Renders The Claims
`Obvious
`
`Additionally, as described by Dr. Beghetti, doctors use their professional
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`judgment to take in information and make treatment decisions. See, e.g. Ex. 1002
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`at ¶¶22-29. Accordingly, a skilled artisan, looking at the INOmax Label in
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`conjunction with the information known to them from their professional
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`experience and knowledge of the relevant art, would be able to ascertain the
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`information in the printed matter steps, rendering those steps obvious.
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`iii. The Board Properly Instituted Review Based On
`Anticipation
`
`Contrary to Patent Owner’s assertion on pages 36-37 of its Response, the
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`Board properly instituted review based on grounds other than those presented by
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`the Petitioner in the original Petition. See Apple, Inc. v. SightSound Techs. LLC,
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`CBM2013-00020, Paper No. 105 at 25-27 (Oct. 7, 2014) (finding that the Board
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`had the right to institute on any ground supported by the evidence provided in the
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`Petition, even where the Ground was not specifically enumerated by the Petitioner
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`and ,that due process was not violated as Patent Owner had the opportunity to
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`reply); see also SightSound Techs., LLC v. Apple Inc., No. 2015-1159, 2015 WL
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`8770164, at *4 (Fed. Cir. Dec. 15, 2015); see generally Garmin International Inc.
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`et al v. Cuozzo Speed Technologies LLC, IPR2012-000001, Paper No. 59 (PTAB
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`Nov. 15, 2013); In re Cuozzo Speed Technologies, LLC, 793 F. 3d 1268, 1272-73
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`(Fed. Cir. 2015). Patent Owner does not even address this precedent.
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`B. Claims 1-19 Are Rendered Obvious By Bernasconi, INOmax
`Label, Loh And Goyal
`i.
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`Patent Owner’s Arguments Are Based On Evidence That
`Should Be Given No Weight
`
`The Board noted that the Petition presented arguments that Bernasconi, Loh,
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`Goyal, and the INOmax Label disclose every element of the claims, and that the
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`skilled artisan would understand to combine the teachings of the references. Paper
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`No. 12 at 18. Patent Owner attempted to rebut these arguments in its preliminary
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`response by “rel[ying] primarily on expert declarations submitted during the
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`prosecution of the ’112 Patent.” Id. It now uses the same declarations to support
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`its positions in its Patent Owner Response.