IPR2015-00526, No. 1044 Exhibit - Claim chart claims 1 23, 31 32, 34 44 (P.T.A.B. Jan. 5, 2015)

Claim Chart demonstrating that claims 1–23, 31-32, and 34-44 of the ʼ741
`patent are unpatentable under 35 U.S.C. § 103(a) as obvious over Ichinose,
`Neonatal Group, Macrae, Loh, Germann and Goyal.
`
`
`U.S. Pat. No.
`8,795,741
`CLAIM 1
`A method of treating
`patients who are
`candidates for inhaled
`nitric oxide treatment,
`which method
`reduces the risk that
`inhalation of nitric
`oxide gas will induce
`an increase in
`pulmonary capillary
`wedge pressure
`(PCWP) leading to
`pulmonary edema in
`neonatal patients with
`hypoxic respiratory
`failure, the method
`comprising:
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`Ichinose teaches that inhaled nitric oxide (“iNO”) can be used
`to treat neonates with hypoxic respiratory failure.
`
`
`
`Ex. 1009 at 3108.
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with left
`ventricular dysfunction (“LVD”) and that 20 ppm iNO is a
`known treatment.
`
`Ex. 1009 at 3109.
`
`Ex. 1009 at 3106.
`
`Ex. 1009 at 3109.
`
`1
`
`
`
`
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`Additionally, Neonatal Group teaches term neonates with
`hypoxic respiratory failure are treated with 20 ppm iNO.
`
`Ex. 1011 at Abstract.
`
`
`
`
`
`Ex. 1011 at 598.
`
`Additionally, Loh teaches measuring a baseline wedge pressure
`prior to administering iNO. (Wedge pressure may also be
`called pulmonary capillary wedge pressure (“PCWP”),
`pulmonary arterial wedge pressure (“PAWP”), or merely
`“wedge.” All the terms refer to the same concept). Loh further
`teaches that patients with LVD have a baseline wedge pressure
`that is greater than 20 mm Hg and that the wedge pressure
`increases upon treatment with iNO.
`
`Ex. 1006 at 2780.
`
`2
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781.
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`
`
`3
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2782.
`
`Ex. 1006 at 2782, Table 2.
`4
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Goyal teaches that wedge pressure may be measured in infants
`and children.
`
`Ex. 1007 at 209.
`
`
`
`a
`identifying
`(a)
`plurality of term or
`near-term
`neonatal
`patients who have
`hypoxic
`respiratory
`failure
`and
`are
`candidates
`for 20
`ppm
`inhaled nitric
`oxide treatment;
`
`Ex. 1007 at Table 1.
`See also parts (a)-(e)
`Ichinose teaches 20 ppm iNO is a known treatment.
`
`
`
`Ex. 1009 at 3106
`
`
`
`
`
`
`
`Ex. 1009 at 3109
`Additionally, Neonatal Group teaches a diagnostic process for
`
`
`
`5
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`identifying term neonates in need of 20 ppm iNO for treatment
`of hypoxic respiratory failure. The diagnostic process
`comprises performing an echocardiography.
`
`Ex. 1011 at Abstract.
`
`
`
`Ex. 1011 at 597.
`
`
`
`
`
`6
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`(b) determining that a
`first patient of the
`plurality does not
`have left ventricular
`dysfunction;
`
`Ex. 1011 at 598.
`Ichinose teaches that there may be negative effects, such as
`pulmonary edema, upon administering iNO to a patient that has
`LVD.
`
`
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD.
`
`
`
`Ex. 1010 at 1033.
`
`Additionally, Macrae teaches that iNO can be harmful to
`babies with congenital heart disease, such as those with severe
`LVD. It teaches the use of echocardiography to exclude those
`patients prior to administering iNO.
`
`
`
`
`
`7
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`(c) determining that a
`second patient of the
`plurality has left
`ventricular
`dysfunction, so is at
`particular risk of
`increased PCWP
`leading to pulmonary
`edema upon
`treatment with
`inhaled nitric oxide;
`
`Ex. 1008 at 373-374.
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with
`LVD.
`
`
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD.
`
`
`
`Ex. 1010 at 1033.
`
`Additionally, Macrae teaches that iNO can be harmful to
`babies with congenital heart disease, such as those with severe
`LVD.
`
`
`
`
`
`8
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`Ex. 1008 at 373-374.
`Additionally, Loh teaches measuring a baseline wedge pressure
`prior to administering iNO. Loh further teaches that patients
`with LVD have a baseline wedge pressure that is greater than
`20 mm Hg and that the wedge pressure increases upon
`treatment with iNO.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`9
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`Ex. 1006 at 2782.
`
`
`
`
`
`10
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1007 at Table 1.
`Ichinose teaches that iNO can be used to treat patients and that
`20 ppm is a known effective dosage.
`
`
`
`(d) administering 20
`ppm inhaled nitric
`oxide treatment to the
`first patient; and
`
`Ex. 1009 at 3108.
`
`
`
`Ex. 1009 at 3106.
`
`Ex. 1009 at 3109.
`
`
`12
`
`
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Additionally, Neonatal Group teaches 20 ppm iNO treatment
`for patients with hypoxic respiratory failure that results in
`reduced use of extracorporeal membrane oxygenation.
`
`Ex. 1011 at Abstract.
`
`
`
`
`
`Ex. 1011 at 598.
`Ichinose teaches that there may be negative effects, such as
`pulmonary edema, upon administering iNO to a patient that has
`LVD.
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD.
`
`
`(e) excluding the
`second patient from
`treatment with
`inhaled nitric oxide,
`based on the
`determination that the
`second patient has
`left ventricular
`dysfunction, so is at
`particular risk of
`increased PCWP
`leading to pulmonary
`edema upon
`treatment with
`inhaled nitric oxide.
`
`
`
`13
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`Ex. 1010 at 1033.
`
`Additionally, Loh teaches that patients with LVD have a
`baseline wedge pressure that is greater than 20 mm Hg and that
`the wedge pressure increases upon treatment with iNO.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`
`
`14
`
`

`
`U.S. Pat. No.
`8,795,741
`
`
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`Ex. 1006 at 2782.
`
`15
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2782, Table 2.
`Goyal teaches that wedge pressure may be measured in infants
`and children.
`
`
`
`
`
`CLAIM 2
`The method of claim
`1, wherein the first
`patient has congenital
`heart disease.
`
`Ex. 1007 at 209.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`
`Germann teaches that iNO treatment can be used on patients
`with congenital heart disease.
`
`
`
`16
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`
`Ex. 1010 at 1033.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`
`Macrae teaches that LVD may be attributed to congenital heart
`disease.
`
`
`
`Ex. 1008 at 374.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD, as it can lead to increased left ventricular
`preload.
`
`
`
`Ex. 1010 at 1033.
`
`
`17
`
`CLAIM 3
`The method of claim
`1, wherein the left
`ventricular
`dysfunction of
`second
`patient
`attributable
`congenital
`disease.
`
`the
`is
`to
`heart
`
`CLAIM 4
`The method of claim
`1, wherein the second
`patient is determined
`to be at particular risk
`not only of increased
`PCWP
`leading
`to
`pulmonary
`edema,
`but also of other
`serious
`adverse
`events,
`upon
`treatment
`with
`inhaled nitric oxide,
`and
`the
`second
`patient
`is excluded
`from
`inhaled nitric
`oxide treatment based
`on the determination
`that
`the
`second
`patient
`has
`left
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`ventricular
`dysfunction and so is
`at particular risk not
`only of
`increased
`PCWP
`leading
`to
`pulmonary
`edema,
`but also other serious
`adverse events, upon
`treatment
`with
`inhaled nitric oxide.
`CLAIM 5
`The method of claim
`4, wherein the left
`ventricular
`dysfunction of
`second
`patient
`attributable
`congenital
`disease.
`
`the
`is
`to
`heart
`
`CLAIM 6
`The method of claim
`1,
`wherein
`determining that the
`first patient does not
`have pre-existing left
`ventricular
`dysfunction and the
`second patient does
`have pre-existing left
`ventricular
`dysfunction
`comprises performing
`at least one diagnostic
`process on each of
`
`
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 4.
`
`Macrae teaches that LVD may be attributed to congenital heart
`disease.
`
`
`
`Ex. 1008 at 374.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`
`Macrae teaches that echocardiography can be used to identify
`patients with congenital heart disease, including LVD.
`
`
`
`
`
`18
`
`

`
`U.S. Pat. No.
`8,795,741
`the first and second
`patients.
`CLAIM 7
`The method of claim
`1,
`wherein
`determining that the
`first patient does not
`have pre-existing left
`ventricular
`dysfunction and the
`second patient does
`have pre-existing left
`ventricular
`dysfunction
`comprises performing
`echocardiography on
`the first and second
`patients.
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1008 at 373-374.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`
`Macrae teaches that echocardiography can be used to identify
`patients with congenital heart disease, including LVD.
`
`
`
`
`
`Ex. 1008 at 373-374.
`
`Additionally, Neonatal Group teaches a diagnostic process for
`identifying term neonates in need of iNO for treatment of
`hypoxic respiratory failure. The diagnostic process comprises
`performing an echocardiography.
`
`
`
`Ex. 1011 at 598.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`19
`
`CLAIM 8
`The method of claim
`1, wherein the second
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`patient has a PCWP
`that is greater than or
`equal to 20 mm Hg.
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Loh teaches measuring the wedge pressure prior to
`administering iNO to determine baseline conditions. Loh
`further teaches that patients with LVD have a baseline wedge
`pressure greater than 20 mm Hg.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to patients and that
`20 ppm iNO is a known treatment.
`20
`
`CLAIM 9
`A method of treating
`patients who
`are
`candidates for inhaled
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`nitric oxide treatment,
`which
`method
`reduces the risk that
`inhalation
`of
`the
`nitric oxide gas will
`induce an increase in
`PCWP
`leading
`to
`pulmonary edema in
`neonatal patients with
`hypoxic
`respiratory
`failure, said method
`comprising:
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1009 at 3109.
`
`Ex. 1009 at 3106.
`
`
`
`
`
`
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Neonatal Group teaches term neonates with
`hypoxic respiratory failure are treated with 20 ppm iNO.
`
`Ex. 1011 at Abstract.
`
`Ex. 1011 at 598.
`
`21
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Loh teaches measuring a baseline wedge pressure prior to
`administering iNO by having patients inhale room air and then
`performing measurements. Loh further teaches that patients
`with LVD have a baseline wedge pressure that is greater than
`20 mm Hg and that the wedge pressure increases upon
`treatment with iNO.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`
`
`22
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2782.
`
`Ex. 1006 at 2782, Table 2.
`23
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Goyal teaches that wedge pressure may be measured in infants
`and children.
`
`Ex. 1007 at 209.
`
`
`
`Ex. 1007 at Table 1.
`See also parts (a)-(e)
`Ichinose teaches 20 ppm iNO is a known treatment.
`
`
`
`
`
`
`
`
`
`Ex. 1009 at 3106.
`
`Ex. 1009 at 3109.
`
`
`24
`
`a
`identifying
`(a)
`plurality of term or
`near-term
`neonatal
`patients who have
`hypoxic
`respiratory
`failure
`and
`are
`candidates
`for 20
`ppm
`inhaled nitric
`oxide treatment;
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Additionally, Neonatal Group teaches a diagnostic process for
`identifying term neonates in need of 20 ppm iNO for treatment
`of hypoxic respiratory failure. The diagnostic process
`comprises performing an echocardiography.
`
`Ex. 1011 at Abstract.
`
`
`
`Ex. 1011 at 597.
`
`
`
`
`
`25
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`(b) determining that a
`first patient of
`the
`plurality does not
`have left ventricular
`dysfunction;
`
`Ex. 1011 at 598.
`Ichinose teaches that there may be negative effects, such as
`pulmonary edema, upon administering iNO to a patient that has
`LVD.
`
`
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD.
`
`
`
`Ex. 1010 at 1033.
`
`Additionally, Macrae teaches that iNO can be harmful to
`babies with congenital heart disease, such as those with severe
`LVD. It teaches the use of echocardiography to exclude those
`patients prior to administering iNO.
`
`
`
`
`
`26
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`(c) determining that a
`second patient of the
`plurality
`has
`left
`ventricular
`dysfunction, so is at
`particular
`risk
`of
`increased
`PCWP
`leading to pulmonary
`edema
`upon
`treatment
`with
`inhaled nitric oxide;
`
`Ex. 1008 at 373-374.
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with
`LVD.
`
`
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD.
`
`Ex. 1010 at 1033.
`Additionally, Macrae teaches that iNO can be harmful to
`babies with congenital heart disease, such as those with severe
`LVD.
`
`
`
`
`
`
`
`27
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`Ex. 1008 at 373-374.
`Additionally, Loh teaches measuring a baseline wedge pressure
`prior to administering iNO by having patients inhale room air
`and then performing measurements. Loh further teaches that
`patients with LVD have a baseline wedge pressure that is
`greater than 20 mm Hg and that the wedge pressure increases
`upon treatment with iNO.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`28
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`Ex. 1006 at 2782.
`
`
`
`
`
`29
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1007 at Table 1.
`Ichinose teaches that iNO can be used to treat patients and that
`20 ppm is a known effective dosage.
`
`
`
`(d) administering 20
`ppm
`inhaled nitric
`oxide treatment to the
`first patient; and
`
`Ex. 1009 at 3108.
`
`
`
`Ex. 1009 at 3106.
`
`Ex. 1009 at 3109.
`
`
`31
`
`
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Additionally, Neonatal Group teaches 20 ppm iNO treatment
`for patients with hypoxic respiratory failure that results in
`reduced use of extracorporeal membrane oxygenation.
`
`Ex. 1011 at Abstract.
`
`
`
`
`
`the
`excluding
`(e)
`second patient from
`treatment
`with
`inhaled nitric oxide
`based
`on
`the
`determination in (c),
`or, despite the second
`patient's
`ongoing
`need for inhaled nitric
`oxide
`treatment for
`hypoxic
`respiratory
`failure, discontinuing
`the second patient's
`treatment
`with
`inhaled nitric oxide
`after it was begun, the
`discontinuation being
`
`
`
`Ex. 1011 at 598.
`Ichinose teaches that there may be negative effects, such as
`pulmonary edema, upon administering iNO to a patient that has
`LVD.
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD.
`
`
`32
`
`

`
`U.S. Pat. No.
`8,795,741
`the
`view
`of
`in
`determination in (c).
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`Ex. 1010 at 1033.
`
`Additionally, Loh teaches that patients with LVD have a
`baseline wedge pressure that is greater than 20 mm Hg and that
`the wedge pressure increases upon treatment with iNO.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`
`
`33
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`Ex. 1006 at 2782.
`
`
`
`
`
`34
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2782, Table 2.
`
`Goyal teaches that wedge pressure may be measured in infants
`and children.
`
`
`
`Ex. 1007 at 209.
`
`
`
`
`
`35
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`CLAIM 10
`The method of claim
`9,
`wherein
`the
`discontinuation is in
`view of both
`the
`determination in (c)
`and
`the
`second
`patient's experiencing
`an
`adverse
`event
`upon treatment with
`inhaled nitric oxide.
`
`
`
`Ex. 1007 at Table 1.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with
`LVD.
`
`Ex. 1009 at 3109.
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD and cause left ventricular
`preload.
`
`
`
`
`
`36
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1010 at 1033.
`
`CLAIM 11
`The method of claim
`10, wherein
`the
`adverse
`event
`comprises pulmonary
`edema.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 10.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with
`LVD.
`
`
`
`Ex. 1009 at 3109.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 10.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD and cause left ventricular preload.
`
`CLAIM 12
`The method of claim
`10, wherein the
`adverse event
`comprises at least one
`of increased PCWP,
`systemic
`hypotension,
`bradycardia, or
`cardiac arrest.
`
`
`
`Ex. 1010 at 1033.
`Loh teaches that patients with LVD have a baseline wedge
`pressure greater than 20 mm Hg and that the wedge pressure
`increases upon treatment with iNO, which is also an adverse
`event.
`
`
`
`37
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`
`
`38
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2782.
`
`Ex. 1006 at 2782, Table 2.
`39
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Goyal teaches that wedge pressure may be measured in infants
`and children.
`
`Ex. 1007 at 209.
`
`
`
`Ex. 1007 at Table 1.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD and cause left ventricular preload.
`
`
`
`
`
`Ex. 1010 at 1033.
`
`
`
`
`
`40
`
`

`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Loh teaches measuring the wedge pressure prior to
`administering iNO to determine baseline conditions. Loh
`further teaches that patients with LVD have a baseline wedge
`pressure greater than 20 mm Hg and that the wedge pressure
`increases upon iNO treatment.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`CLAIM 13
`The method of claim
`9, wherein (c)
`comprises
`determining that the
`second patient has a
`pulmonary capillary
`wedge pressure that is
`greater than or equal
`to 20 mm Hg.
`
`
`
`
`
`41
`
`

`
`U.S. Pat. No.
`8,795,741
`
`
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`CLAIM 14
`The method of claim
`9, wherein the first
`patient has congenital
`heart disease.
`
`Ex. 1006 at 2781, Table 1.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Germann teaches that iNO treatment can be used on patients
`with congenital heart disease.
`
`
`
`
`Ex. 1010 at 1033.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Macrae teaches that LVD may be attributed to congenital heart
`
`42
`
`CLAIM 15
`The method of claim
`9, wherein the left
`ventricular
`dysfunction of
`
`the
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`second
`patient
`attributable
`congenital
`disease.
`
`is
`to
`heart
`
`CLAIM 16
`The method of claim
`14, wherein the left
`ventricular
`dysfunction of
`second
`patient
`attributable
`congenital
`disease.
`
`the
`is
`to
`heart
`
`CLAIM 17
`The method of claim
`9, wherein
`the second patient is
`determined to be at
`particular
`risk not
`only of
`increased
`PCWP
`leading
`to
`pulmonary
`edema,
`but also of other
`serious
`adverse
`events,
`upon
`treatment
`with
`inhaled nitric oxide;
`and
`
`
`either (i) the second
`patient is excluded
`
`
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`disease.
`
`
`
`Ex. 1008 at 374.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 14.
`
`Macrae teaches that LVD can be attributed to congenital heart
`disease.
`
`
`
`Ex. 1008 at 374.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD, as it can lead to increased left ventricular
`preload.
`
`
`
`Ex. 1010 at 1033.
`
`
`43
`
`

`
`U.S. Pat. No.
`8,795,741
`from inhaled nitric
`oxide treatment based
`on both the
`determination in (c)
`and the determination
`that the second
`patient is also at risk
`of other serious
`adverse events upon
`treatment with
`inhaled nitric oxide;
`or (ii) despite the
`second patient's
`ongoing need for
`inhaled nitric oxide
`treatment for hypoxic
`respiratory failure,
`the second patient's
`treatment with
`inhaled nitric oxide is
`discontinued after it
`was begun, the
`discontinuation being
`in view of both the
`determination in (c)
`and the determination
`that the second
`patient is also at risk
`of other serious
`adverse events upon
`treatment with
`inhaled nitric oxide.
`CLAIM 18
`The method of claim
`17, wherein the other
`serious adverse
`events comprise one
`
`
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 17.
`
`Germann teaches that treatment with iNO can be dangerous in
`
`44
`
`

`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`patients with LVD and cause left ventricular preload.
`
`U.S. Pat. No.
`8,795,741
`or more of increased
`PCWP, systemic
`hypotension,
`bradycardia, or
`cardiac arrest.
`
`
`
`Ex. 1010 at 1033.
`
`Loh teaches that patients with LVD have a baseline wedge
`pressure greater than 20 mm Hg and that the wedge pressure
`increases upon treatment with iNO, which is also an adverse
`event.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`45
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`Ex. 1006 at 2782.
`
`
`
`
`
`46
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1007 at Table 1.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD and cause left ventricular preload.
`
`
`
`
`
`Ex. 1010 at 1033.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 17.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient.
`
`Ex. 1009 at 3109.
`
`48
`
`
`
`CLAIM 19
`The method of claim
`17, wherein the
`discontinuation is in
`view of: the
`determination in (c),
`the determination that
`the second patient is
`also at risk of other
`serious adverse
`events, and the
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`second patient's
`experiencing an
`adverse event upon
`treatment with
`inhaled nitric oxide.
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Additionally, Germann teaches that treatment with iNO can be
`dangerous in patients with LVD and cause left ventricular
`preload.
`
`CLAIM 20
`The method of claim
`19, wherein
`the
`adverse
`event
`experienced by
`the
`second
`patient
`comprises pulmonary
`edema.
`
`CLAIM 21
`The method of claim
`19, wherein the
`adverse event
`experienced by the
`second patient
`comprises at least one
`of increased PCWP,
`systemic
`hypotension,
`bradycardia, or
`cardiac arrest.
`
`
`
`Ex. 1010 at 1033.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 19.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient.
`
`
`
`Ex. 1009 at 3109.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 19.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD and cause left ventricular preload.
`
`
`
`Ex. 1010 at 1033.
`
`49
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Loh teaches that patients with LVD have a baseline wedge
`pressure greater than 20 mm Hg and that the wedge pressure
`increases upon treatment with iNO, which is also an adverse
`event.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`
`
`50
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2782.
`
`Ex. 1006 at 2782, Table 2.
`51
`
`
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`Goyal teaches that wedge pressure may be measured in infants
`and children.
`
`Ex. 1007 at 209.
`
`
`
`Ex. 1007 at Table 1.
`
`Germann teaches that treatment with iNO can be dangerous in
`patients with LVD and cause left ventricular preload.
`
`
`
`
`
`52
`
`Ex. 1010 at 1033.
`
`
`
`
`
`

`
`U.S. Pat. No.
`8,795,741
`CLAIM 22
`The method of claim
`9,
`wherein
`determining that the
`first patient does not
`have pre-existing left
`ventricular
`dysfunction and the
`second patient does
`have pre-existing left
`ventricular
`dysfunction
`comprises performing
`at least one diagnostic
`process on each of
`the first and second
`patients.
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Macrae teaches that echocardiography can be used to identify
`patients with congenital heart disease, including LVD.
`
`
`
`
`
`Ex. 1008 at 373-374.
`
`Additionally, Neonatal Group teaches a diagnostic process for
`identifying term neonates in need of iNO for treatment of
`hypoxic respiratory failure. The diagnostic process comprises
`performing an echocardiography.
`
`CLAIM 23
`The method of claim
`9,
`wherein
`determining that the
`first patient does not
`
`Ex. 1011 at 598.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Macrae teaches that echocardiography can be used to identify
`
`
`
`
`
`53
`
`

`
`U.S. Pat. No.
`8,795,741
`have pre-existing left
`ventricular
`dysfunction and the
`second patient does
`have pre-existing left
`ventricular
`dysfunction
`comprises performing
`echocardiography on
`each of the first and
`second patients.
`
`CLAIM 31
`The method of claim
`1, wherein identifying
`the plurality of term
`or near-term neonatal
`patients who have
`hypoxic
`respiratory
`failure
`and
`are
`candidates
`for 20
`ppm
`inhaled nitric
`oxide
`treatment
`comprises performing
`at least one diagnostic
`process.
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`patients with congenital heart disease, including LVD.
`
`
`
`
`
`Ex. 1008 at 373-374.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 1.
`
`Neonatal Group teaches a diagnostic process for identifying
`term infants in need of 20 ppm iNO for treatment of hypoxic
`respiratory failure that could be caused by persistent pulmonary
`hypertension of the newborn (“PPHN”). The diagnostic
`process comprises performing an echocardiography.
`
`Ex. 1011 at Abstract.
`
`
`
`
`
`54
`
`

`
`U.S. Pat. No.
`8,795,741
`
`CLAIM 32
`The method of claim
`9, wherein identifying
`the plurality of term
`or near-term neonatal
`patients who have
`hypoxic
`respiratory
`failure
`and
`are
`candidates
`for 20
`ppm
`inhaled nitric
`oxide
`treatment
`comprises performing
`at least one diagnostic
`process.
`
`CLAIM 34
`A method of treating
`patients who
`are
`candidates for inhaled
`nitric oxide treatment,
`which
`method
`reduces the risk that
`inhalation of nitric
`oxide gas will induce
`an
`increase
`in
`
`
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1011 at 598.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 9.
`
`Neonatal Group teaches a diagnostic process for identifying
`term infants in need of 20 ppm iNO for treatment of hypoxic
`respiratory failure that could be caused by PPHN. The
`diagnostic process comprises performing an echocardiography.
`
`Ex. 1011 at Abstract.
`
`
`
`
`
`Ex. 1011 at 598.
`
`Ichinose teaches that iNO can be used to treat patients.
`
`
`
`55
`
`

`
`U.S. Pat. No.
`8,795,741
`pulmonary capillary
`wedge
`pressure
`(PCWP)
`leading
`to
`pulmonary
`edema,
`the
`method
`comprising:
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1009 at 3108.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with
`LVD and that 20 ppm iNO is a known treatment.
`
`Ex. 1009 at 3109.
`
`Ex. 1009 at 3106.
`
`
`
`
`
`
`
`
`
`Ex. 1009 at 3109.
`
`Additionally, Neonatal Group teaches term neonates with
`hypoxic respiratory failure are treated with 20 ppm iNO.
`
`Ex. 1011 at Abstract.
`
`
`
`
`
`56
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`
`
`Ex. 1011 at 598.
`
`Additionally, Loh teaches measuring a baseline wedge pressure
`prior to administering iNO. Loh further teaches that patients
`with LVD have a baseline wedge pressure that is greater than
`20 mm Hg and that the wedge pressure increases upon
`treatment with iNO.
`
`Ex. 1006 at2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`57
`
`

`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, Germann, and
`Goyal
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`Ex. 1006 at 2782.
`
`
`
`
`
`5

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