Claims 1, 2, 4, 6, 7, 9, 11-13, 15, 18, 20, 21, 23, and 25 of the ʼ163 patent are
`unpatentable under 35 U.S.C. § 103(a) as Obvious Over Bernasconi in View of
`INOMAX label, Loh, and Goyal.
`
`
`
`U.S. Pat. No.
`8,431,163
`CLAIM 1
`A method of reducing
`the risk of occurrence
`of pulmonary edema
`associated with a
`medical treatment
`comprising inhalation
`of 20 ppm nitric
`oxide gas, said
`method comprising:
`(a) performing
`echocardiography to
`identify a term or
`near-term neonate
`patient in need of 20
`ppm inhaled nitric
`oxide treatment for
`hypoxic respiratory
`failure, wherein the
`patient is not
`dependent on right-
`to-left shunting of
`blood;
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`See Sections (a)-(c) of Claim 1 below.
`
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with inhaled nitric oxide (“iNO”).
`
`Ex. 1004 at 8.
`Bernasconi further teaches the FDA recommended dose for
`treating neonatal hypoxic respiratory failure is 20 ppm iNO.
`
`Ex. 1004 at 3.
`
`INOMAX label teaches identifying neonates with hypoxic
`respiratory failure associated with echocardiographic evidence
`
`
`
`1
`
`
`unpatentable under 35 U.S.C. § 103(a) as Obvious Over Bernasconi in View of
`INOMAX label, Loh, and Goyal.
`
`
`
`U.S. Pat. No.
`8,431,163
`CLAIM 1
`A method of reducing
`the risk of occurrence
`of pulmonary edema
`associated with a
`medical treatment
`comprising inhalation
`of 20 ppm nitric
`oxide gas, said
`method comprising:
`(a) performing
`echocardiography to
`identify a term or
`near-term neonate
`patient in need of 20
`ppm inhaled nitric
`oxide treatment for
`hypoxic respiratory
`failure, wherein the
`patient is not
`dependent on right-
`to-left shunting of
`blood;
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`See Sections (a)-(c) of Claim 1 below.
`
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with inhaled nitric oxide (“iNO”).
`
`Ex. 1004 at 8.
`Bernasconi further teaches the FDA recommended dose for
`treating neonatal hypoxic respiratory failure is 20 ppm iNO.
`
`Ex. 1004 at 3.
`
`INOMAX label teaches identifying neonates with hypoxic
`respiratory failure associated with echocardiographic evidence
`
`
`
`1
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`of pulmonary hypertension that may be treated with iNO.
`
`Ex. 1014 at 4.
`INOMAX label further teaches the FDA recommended dose for
`iNO treatment is 20 ppm.
`
`Ex. 1014 at 6.
`INOMAX label further teaches that iNO should not be used in
`patients dependent on right-to-left shunting of blood.
`
`Ex. 1014 at 4.
`Bernasconi teaches that there are negative effects of iNO in
`patients with left ventricular dysfunction (“LVD”) including a
`risk of causing pulmonary edema.
`
`Ex. 1004 at 8.
`
`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.
`
`(b) determining that
`the patient identified
`in (a) has left
`ventricular
`dysfunction
`consistent with a
`pulmonary capillary
`wedge pressure
`greater than or equal
`to 20 mm Hg, so is at
`particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide;
`and
`
`
`
`2
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at Table 1.
`Additionally, Goyal teaches measuring wedge pressure in
`infants.
`
`
`
`Ex. 1007 at 209.
`
`3
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`(c) excluding the
`patient from inhaled
`nitric oxide treatment,
`based on the
`determination that the
`patient has left
`ventricular
`dysfunction and so is
`at particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide.
`CLAIM 2
`The method of claim
`1, wherein the
`determination in (b)
`comprises performing
`echocardiography.
`
`Ex. 1007 at Table 1.
`Bernasconi teaches that patients with LVD treated with iNO
`are at risk of pulmonary edema.
`
`
`
`Ex. 1004 at 8.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 1.
`
`Bernasconi teaches that echocardiography may be used to
`confirm a diagnosis and conduct therapy with iNO, as well as
`to exclude a condition that may contraindicate the use of iNO.
`
`
`
`4
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`Ex. 1004 at 8.
`Bernasconi further teaches that patients with LVD treated with
`iNO are at risk of pulmonary edema.
`
`Ex. 1004 at 8.
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 1.
`
`Bernasconi teaches that negative effects of iNO treatment in
`patients with LVD can include not only pulmonary edema, but
`also rapid left heart failure.
`
`5
`
`Ex. 1004 at 8.
`
`
`
`CLAIM 4
`The method of claim
`1, wherein the patient
`is determined to be at
`particular
`risk not
`only of pulmonary
`edema, but also of
`other serious adverse
`events,
`upon
`treatment
`with
`inhaled nitric oxide,
`and
`the patient
`is
`excluded
`from
`inhaled nitric oxide
`treatment based on
`the determination that
`the patient has left
`ventricular
`dysfunction and so is
`at particular risk not
`only of pulmonary
`edema, but also of
`other serious adverse
`events,
`upon
`treatment
`with
`inhaled nitric oxide.
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`CLAIM 6
`A method of
`treatment comprising:
`(a) performing
`echocardiography to
`identify a plurality of
`term or near-term
`neonate patients who
`are in need of 20 ppm
`inhaled nitric oxide
`treatment for hypoxic
`respiratory failure,
`wherein the patients
`are not dependent on
`right-to-left shunting
`of blood;
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`See Sections (a)-(e) of Claim 6 below.
`
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with iNO.
`
`Ex. 1004 at 8.
`Bernasconi further teaches the FDA recommended dose for
`treating neonatal hypoxic respiratory failure is 20 ppm iNO.
`
`Ex. 1004 at 3.
`
`INOMAX label teaches identifying neonates with hypoxic
`respiratory failure associated with echocardiographic evidence
`of pulmonary hypertension that may be treated with iNO.
`
`Ex. 1014 at 4.
`INOMAX label further teaches the FDA recommended dose for
`iNO treatment is 20 ppm.
`
`Ex. 1014 at 6.
`INOMAX label further teaches that iNO should not be used in
`patients dependent on right-to-left shunting of blood.
`
`
`
`6
`
`
`
`U.S. Pat. No.
`8,431,163
`
`(b) determining that a
`first patient of the
`plurality has left
`ventricular
`dysfunction
`consistent with a
`pulmonary capillary
`wedge pressure
`greater than or equal
`to 20 mm Hg, so is at
`particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide;
`
`Bernasconi, INOMAX label, Loh, and Goyal
`Ex. 1014 at 4.
`Bernasconi teaches that there are negative effects of iNO in
`patients with LVD including a risk of causing pulmonary
`edema.
`
`Ex. 1004 at 8.
`
`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.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`
`
`7
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1006 at Table 1.
`Additionally, Goyal teaches measuring wedge pressure in
`infants.
`
`
`
`Ex. 1007 at 209.
`
`
`
`
`
`8
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1007 at Table 1.
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with iNO and identifying conditions that may
`contraindicate iNO.
`
`
`
`(c) determining that a
`second patient of the
`plurality does not
`have left ventricular
`dysfunction;
`
`Ex. 1004 at 8.
`
`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.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`9
`
`
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`
`Ex. 1006 at Table 1.
`
`Additionally, Goyal teaches measuring wedge pressure in
`infants.
`
`Ex. 1007 at 209.
`Bernasconi teaches a treatment comprising administering 20
`ppm nitric oxide gas to treat neonates.
`
`
`
`(d) administering the
`20 ppm inhaled nitric
`oxide treatment to the
`second patient; and
`
`Ex. 1004 at 3.
`
`
`10
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`INOMAX label teaches the FDA recommended dose for iNO
`treatment is 20 ppm.
`
`(e) excluding the first
`patient from
`treatment with
`inhaled nitric oxide,
`based on the
`determination that the
`first patient has left
`ventricular
`dysfunction, so is at
`particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide.
`CLAIM 7
`The method of claim
`6, wherein the second
`patient has congenital
`heart disease.
`
`Ex. 1014 at 6.
`Bernasconi teaches that patients with LVD treated with iNO
`are at risk of pulmonary edema.
`
`Ex. 1004 at 8.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 6.
`
`Bernasconi teaches that 20 ppm iNO treatment is effective in
`selectively lowering pulmonary vascular resistance in children
`with pulmonary hypertension and congenital heart disease.
`
`CLAIM 9
`The method of claim
`6, wherein the first
`patient is determined
`to be at particular risk
`
`Ex. 1004 at 12.
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 6.
`
`
`
`
`11
`
`
`
`U.S. Pat. No.
`8,431,163
`not only of
`pulmonary edema,
`but also of other
`serious adverse
`events, upon
`treatment with
`inhaled nitric oxide,
`and the first patient is
`excluded from
`inhaled nitric oxide
`treatment based on
`the determination that
`the first patient has
`left ventricular
`dysfunction and so is
`at particular risk not
`only of pulmonary
`edema, but also other
`serious adverse
`events, upon
`treatment with
`inhaled nitric oxide.
`CLAIM 11
`The method of claim
`6, wherein
`determining that the
`first patient of the
`plurality has pre-
`existing left
`ventricular
`dysfunction and the
`second patient of the
`plurality does not
`have pre-existing left
`ventricular
`dysfunction
`comprises performing
`
`
`
`Bernasconi, INOMAX label, Loh, and Goyal
`Bernasconi teaches that negative effects of iNO treatment in
`patients with LVD can include not only pulmonary edema, but
`also rapid left heart failure.
`
`Ex. 1004 at 8.
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 6.
`
`Bernasconi teaches that echocardiography may be used to
`confirm a diagnosis and conduct therapy with iNO, as well as
`to exclude a condition that may contraindicate the use of iNO.
`
`Ex. 1004 at 8.
`
`Bernasconi further teaches that patients with LVD treated with
`iNO are at risk of pulmonary edema.
`12
`
`
`
`U.S. Pat. No.
`8,431,163
`echocardiography on
`the first and second
`patients.
`
`CLAIM 12
`A method of reducing
`the risk of occurrence
`of pulmonary edema
`associated with a
`medical treatment
`comprising inhalation
`of 20 ppm nitric
`oxide gas, said
`method comprising:
`(a) performing
`echocardiography to
`identify a term or
`near-term neonate
`patient in need of 20
`ppm inhaled nitric
`oxide treatment for
`hypoxic respiratory
`failure, wherein the
`patient is not
`dependent on right-
`to-left shunting of
`blood;
`
`
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1004 at 8.
`
`See Sections (a)-(c) of Claim 12 below.
`
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with iNO.
`
`Ex. 1004 at 8.
`Bernasconi further teaches the FDA recommended dose for
`treating neonatal hypoxic respiratory failure is 20 ppm iNO.
`
`Ex. 1004 at 3.
`
`INOMAX label teaches identifying neonates with hypoxic
`respiratory failure associated with echocardiographic evidence
`of pulmonary hypertension that may be treated with iNO.
`13
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1014 at 4.
`INOMAX label further teaches the FDA recommended dose for
`iNO treatment is 20 ppm.
`
`Ex. 1014 at 6.
`INOMAX label further teaches that iNO should not be used in
`patients dependent on right-to-left shunting of blood.
`
`Ex. 1014 at 4.
`Bernasconi teaches that there are negative effects of iNO in
`patients with LVD including a risk of causing pulmonary
`edema.
`
`Ex. 1004 at 8.
`
`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.
`
`(b) determining that
`the patient identified
`in (a) has left
`ventricular
`dysfunction
`consistent with a
`pulmonary capillary
`wedge pressure
`greater than or equal
`to 20 mm Hg, so is at
`particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide;
`and
`
`Ex. 1006 at 2780.
`
`14
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1006 at 2781.
`
`
`
`Ex. 1006 at Table 1.
`Additionally, Goyal teaches measuring wedge pressure in
`infants.
`
`
`
`Ex. 1007 at 209.
`
`
`
`
`
`15
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1007 at Table 1.
`Bernasconi teaches that patients with LVD treated with iNO
`are at risk of pulmonary edema.
`
`
`
`Ex. 1004 at 8.
`
`
`
`(c) excluding the
`patient from inhaled
`nitric oxide treatment,
`or, despite the
`patient's ongoing
`need for treatment for
`hypoxic respiratory
`failure, discontinuing
`the treatment after it
`has begun, the
`exclusion or
`discontinuation being
`based on the
`determination that the
`patient has left
`ventricular
`dysfunction and so is
`at particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide.
`
`
`
`16
`
`
`
`U.S. Pat. No.
`8,431,163
`CLAIM 13
`The method of claim
`12, wherein
`the
`determination in (b)
`comprises performing
`echocardiography.
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 12.
`
`Bernasconi teaches that echocardiography may be used to
`confirm a diagnosis and conduct therapy with iNO, as well as
`to exclude a condition that may contraindicate the use of iNO.
`
`Ex. 1004 at 8.
`Bernasconi further teaches that patients with LVD treated with
`iNO are at risk of pulmonary edema.
`
`CLAIM 15
`The method of claim
`12, wherein the
`patient is determined
`to be at particular risk
`not only of
`pulmonary edema,
`but also of other
`serious adverse
`events, upon
`treatment with
`inhaled nitric oxide,
`and the patient is
`excluded from
`inhaled nitric oxide
`treatment, or, despite
`
`
`
`Ex. 1004 at 8.
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 12.
`
`Bernasconi teaches that negative effects of iNO treatment in
`patients with LVD can include not only pulmonary edema, but
`also rapid left heart failure.
`
`Ex. 1004 at 8.
`
`17
`
`
`
`U.S. Pat. No.
`8,431,163
`the patient's ongoing
`need for treatment for
`hypoxic respiratory
`failure, the patient's
`treatment with
`inhaled nitric oxide is
`discontinued after it
`was begun, the
`exclusion or
`discontinuation being
`based on the
`determination that the
`patient has left
`ventricular
`dysfunction and so is
`at particular risk not
`only of pulmonary
`edema, but also other
`serious adverse
`events, upon
`treatment with
`inhaled nitric oxide.
`CLAIM 18
`The method of claim
`13, wherein the
`patient is determined
`to be at particular risk
`not only of
`pulmonary edema,
`but also of other
`serious adverse
`events, upon
`treatment with
`inhaled nitric oxide,
`and the patient is
`excluded from
`inhaled nitric oxide
`
`
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 13.
`
`Bernasconi teaches that negative effects of iNO treatment in
`patients with LVD can include not only pulmonary edema, but
`also rapid left heart failure.
`
`18
`
`
`
`U.S. Pat. No.
`8,431,163
`treatment, or, despite
`the patient's ongoing
`need for treatment for
`hypoxic respiratory
`failure, the patient's
`treatment with
`inhaled nitric oxide is
`discontinued after it
`was begun, the
`exclusion or
`discontinuation being
`based on the
`determination that the
`patient has pre-
`existing left
`ventricular
`dysfunction and so is
`at particular risk not
`only of pulmonary
`edema, but also other
`serious adverse
`events, upon
`treatment with
`inhaled nitric oxide.
`CLAIM 20
`A method of
`treatment comprising:
`(a) performing
`echocardiography to
`identify a plurality of
`term or near-term
`neonate patients who
`are in need of 20 ppm
`inhaled nitric oxide
`treatment for hypoxic
`respiratory failure,
`wherein the patients
`
`
`
`Bernasconi, INOMAX label, Loh, and Goyal
`Ex. 1004 at 8.
`
`
`See Sections (a)-(e) of Claim 20 below.
`
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with iNO.
`
`Ex. 1004 at 8.
`Bernasconi further teaches the FDA recommended dose for
`treating neonatal hypoxic respiratory failure is 20 ppm iNO.
`
`19
`
`
`
`U.S. Pat. No.
`8,431,163
`are not dependent on
`right-to-left shunting
`of blood;
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1004 at 3.
`
`INOMAX label teaches identifying neonates with hypoxic
`respiratory failure associated with echocardiographic evidence
`of pulmonary hypertension that may be treated with iNO.
`
`Ex. 1014 at 4.
`INOMAX label further teaches the FDA recommended dose for
`iNO treatment is 20 ppm.
`
`Ex. 1014 at 6.
`INOMAX label further teaches that iNO should not be used in
`patients dependent on right-to-left shunting of blood.
`
`Ex. 1014 at 4.
`Bernasconi teaches that there are negative effects of iNO in
`patients with LVD including a risk of causing pulmonary
`edema.
`
`Ex. 1004 at 8.
`
`
`20
`
`(b) determining that a
`first patient of the
`plurality has left
`ventricular
`dysfunction
`consistent with a
`pulmonary capillary
`wedge pressure
`greater than or equal
`to 20 mm Hg, so is at
`particular risk of
`pulmonary edema
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`upon treatment with
`inhaled nitric oxide;
`
`Bernasconi, INOMAX label, Loh, and Goyal
`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.
`
`Ex. 1006 at 2780.
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at Table 1.
`Additionally, Goyal teaches measuring wedge pressure in
`infants.
`
`
`
`
`
`21
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1007 at 209.
`
`
`
`Ex. 1007 at Table 1.
`Bernasconi teaches that echocardiography is essential to
`identify and treat pediatric patients with conditions that may be
`treated with iNO and identifying conditions that may
`contraindicate iNO.
`
`
`
`(c) determining that a
`second patient of the
`plurality does not
`have left ventricular
`dysfunction;
`
`Ex. 1004 at 8.
`
`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.
`
`Ex. 1006 at 2780.
`
`22
`
`
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1006 at 2781.
`
`
`
`
`
`Ex. 1006 at Table 1.
`
`Additionally, Goyal teaches measuring wedge pressure in
`infants.
`
`Ex. 1007 at 209.
`Bernasconi teaches a treatment comprising administering 20
`ppm nitric oxide gas to treat neonates.
`
`
`
`23
`
`(d) administering the
`20 ppm inhaled nitric
`oxide treatment to the
`second patient; and
`
`
`
`
`
`U.S. Pat. No.
`8,431,163
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`Ex. 1004 at 3.
`
`INOMAX label teaches the FDA recommended dose for iNO
`treatment is 20 ppm.
`
`Ex. 1014 at 6.
`Bernasconi teaches that patients with LVD treated with iNO
`are at risk of pulmonary edema.
`
`Ex. 1004 at 8.
`
`
`
`(e) excluding the first
`patient from
`treatment with
`inhaled nitric oxide,
`or, despite the first
`patient's ongoing
`need for treatment for
`hypoxic respiratory
`failure, discontinuing
`the first patient's
`treatment with
`inhaled nitric oxide
`after it was begun, the
`exclusion or
`discontinuation being
`based on the
`determination that the
`first patient has left
`ventricular
`dysfunction, so is at
`particular risk of
`pulmonary edema
`upon treatment with
`inhaled nitric oxide.
`
`
`
`24
`
`
`
`U.S. Pat. No.
`8,431,163
`CLAIM 21
`The method of claim
`20, wherein the
`second patient has
`congenital heart
`disease.
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 20.
`
`Bernasconi teaches that 20 ppm iNO treatment is effective in
`selectively lowering pulmonary vascular resistance in children
`with pulmonary hypertension and congenital heart disease.
`
`CLAIM 23
`The method of claim
`20, wherein the first
`patient is determined
`to be at particular risk
`not
`only
`of
`pulmonary
`edema,
`but also of other
`serious
`adverse
`events,
`upon
`treatment
`with
`inhaled nitric oxide,
`and the first patient is
`excluded
`from
`inhaled nitric oxide
`treatment, or, despite
`the
`first
`patient's
`ongoing
`need
`for
`treatment for hypoxic
`respiratory
`failure,
`the
`first
`patient's
`treatment
`with
`inhaled nitric oxide is
`discontinued after it
`was
`begun,
`the
`
`
`
`Ex. 1004 at 12.
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 20.
`
`Bernasconi teaches that negative effects of iNO treatment in
`patients with LVD can include not only pulmonary edema, but
`also rapid left heart failure.
`
`Ex. 1004 at 8.
`
`25
`
`
`
`Bernasconi, INOMAX label, Loh, and Goyal
`
`
`All the elements of the independent claim from which this
`claim depends are disclosed in Bernasconi, INOMAX label,
`Loh, and Goyal as outlined above in Claim 20.
`
`Bernasconi teaches that echocardiography may be used to
`confirm a diagnosis and conduct therapy with iNO, as well as
`to exclude a condition that may contraindicate the use of iNO.
`
`Ex. 1004 at 8.
`Bernasconi further teaches that patients with LVD treated with
`iNO are at risk of pulmonary edema.
`
`U.S. Pat. No.
`8,431,163
`or
`exclusion
`discontinuation being
`based
`on
`the
`determination that the
`first patient has left
`ventricular
`dysfunction and so is
`at particular risk not
`only of pulmonary
`edema, but also other
`serious
`adverse
`events,
`upon
`treatment
`with
`inhaled nitric oxide.
`CLAIM 25
`The method of claim
`20,
`wherein
`determining that the
`first patient of
`the
`plurality
`has
`pre-
`existing
`left
`ventricular
`dysfunction and the
`second patient of the
`plurality does not
`have pre-existing left
`ventricular
`dysfunction
`comprises performing
`echocardiography on
`the first and second
`patients.
`
`
`
`
`
`Ex. 1004 at 8.
`
`26
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