Claim Chart demonstrating that claims 24-30 and 33 are unpatentable under
`35 U.S.C. § 103(a) as obvious over Ichinose in view of Neonatal Group,
`Macrae, Loh, INOMAX label, Germann and Goyal.
`
`
`
`U.S. Pat. No.
`8,795,741
`CLAIM 24
`A method of treating
`patients who are
`candidates for inhaled
`nitric oxide treatment,
`which method
`reduces the risk of
`inducing an increase
`in PCWP leading to
`pulmonary edema in
`neonatal patients with
`hypoxic respiratory
`failure, the method
`comprising:
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`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
`
`
`
`
`
`
`
`
`
`
`
`
`35 U.S.C. § 103(a) as obvious over Ichinose in view of Neonatal Group,
`Macrae, Loh, INOMAX label, Germann and Goyal.
`
`
`
`U.S. Pat. No.
`8,795,741
`CLAIM 24
`A method of treating
`patients who are
`candidates for inhaled
`nitric oxide treatment,
`which method
`reduces the risk of
`inducing an increase
`in PCWP leading to
`pulmonary edema in
`neonatal patients with
`hypoxic respiratory
`failure, the method
`comprising:
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`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, INOMAX label,
`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, INOMAX label,
`Germann and Goyal
`
`Ex. 1006 at p. 2781.
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`3
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`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, INOMAX label,
`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.
`
`
`5
`
`(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, INOMAX label,
`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.
`
`6
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`(b) determining that a
`first patient of the
`plurality does not
`have pre-existing 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, INOMAX label,
`Germann and Goyal
`
`Ex. 1008 at 373-374.
`Ichinose teaches 20 ppm iNO is a known treatment.
`
`
`
`Ex. 1009 at 3106.
`
`
`
`
`
`
`
`Ex. 1009 at 3109.
`
`INOMAX label teaches treating neonates with hypoxic
`respiratory failure with 20 ppm iNO and that treatment should
`be maintained for up to 14 days or until the underlying oxygen
`desaturation has resolved and the neonate is ready to be
`weaned.
`
`Ex. 1014 at 6.
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient with
`LVD.
`
`8
`
`
`
`(c) administering a
`first treatment
`regimen to the first
`patient, wherein the
`first treatment
`regimen comprises
`administration of 20
`ppm inhaled nitric
`oxide for 14 days or
`until the first patient's
`hypoxia has resolved;
`
`(d) determining that a
`second patient of the
`plurality has pre-
`existing left
`ventricular
`dysfunction, so is at
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`particular risk of
`increased PCWP
`leading to pulmonary
`edema upon
`treatment with
`inhaled nitric oxide;
`and
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`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.
`
`
`
`
`
`
`
`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.
`
`9
`
`
`
`
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`Ex. 1006 at 2781.
`
`
`
`Ex. 1006 at 2781, Table 1.
`
`
`
`10
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`Ex. 1006 at 2782.
`
`Ex. 1006 at 2782, Table 2.
`11
`
`
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`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 pulmonary hypertension may be treated
`with aerosolized iloprost.
`
`
`
`Ex. 1010 at 1033.
`
`Neonatal Group teaches that hypoxic respiratory failure may be
`caused by pulmonary hypertension.
`
`
`
`12
`
`(e) administering a
`second treatment
`regimen to the second
`patient, wherein the
`second treatment
`regimen does not
`comprise either (i)
`administration of
`inhaled nitric oxide
`for 14 days or (ii)
`administration of
`inhaled nitric oxide
`until the second
`patient's hypoxia has
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`resolved.
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`
`
`Ex. 1011 at 598.
`
`
`
`CLAIM 25
`The method of claim
`24, wherein the
`second treatment
`regimen does not
`comprise
`administration of
`inhaled nitric oxide.
`
`CLAIM 26
`The method of claim
`24, wherein the
`second treatment
`regimen comprises
`beginning
`administration of
`inhaled nitric oxide
`but discontinuing the
`administration upon
`determination that
`
`
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`Germann teaches using aerosolized iloprost as a treatment
`regimen instead of iNO.
`
`
`
`Ex. 1010 at 1033.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`Ichinose teaches that there may be negative effects such as
`pulmonary edema upon administering iNO to a patient.
`
`Ex. 1006 at 3109.
`
`13
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`inhaling nitric oxide
`has increased the
`second patient's
`PCWP and/or
`induced pulmonary
`edema in the second
`patient.
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`Additionally, Loh teaches that wedge pressure increases upon
`treatment with iNO in patients with LVD.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at p. 2781, Table 1.
`
`
`
`
`
`14
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`Ex. 1006 at 2782.
`
`Ex. 1006 at 2782, Table 2.
`15
`
`
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`CLAIM 27
`The method of claim
`24, wherein the first
`patient has congenital
`heart disease.
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`Germann teaches that iNO treatment can be used on patients
`with congenital heart disease.
`
`CLAIM 28
`The method of claim
`24, wherein the pre-
`existing
`left
`ventricular
`dysfunction of
`second
`patient
`attributable
`congenital
`disease.
`
`the
`is
`to
`heart
`
`
`
`
`Ex. 1010 at 1033.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`Macrae teaches that LVD may be attributed to congenital heart
`disease.
`
`
`
`CLAIM 29
`The method of claim
`24, wherein
`the
`diagnostic
`process
`comprises
`echocardiography.
`
`Ex. 1008 at 374.
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`Macrae teaches that echocardiography can be used to identify
`patients with congenital heart disease, including LVD.
`
`
`
`
`
`16
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`
`
`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.
`
`
`
`CLAIM 30
`The method of claim
`24, wherein the
`second patient has a
`pulmonary capillary
`wedge pressure that is
`greater than or equal
`to 20 mm Hg
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`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.
`
`17
`
`
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at p. 2781, Table 1.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed above in Claim 24.
`
`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.
`
`18
`
`CLAIM 33
`The method of claim
`24,
`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
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,795,741
`comprises performing
`at least one diagnostic
`process.
`
`Ichinose, Neonatal Group, Macrae, Loh, INOMAX label,
`Germann and Goyal
`
`Ex. 1011 at Abstract.
`
`Ex. 1011 at 598.
`
`
`
`
`
`
`19
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