United States Patent 8,795,741: Scope, Claims, and U.S. Patent Landscape for 20 ppm Inhaled Nitric Oxide Triage
What does US 8,795,741 claim?
US 8,795,741 claims clinical decision methods for neonatal (and, in dependent form, pediatric) use of inhaled nitric oxide at 20 ppm in term or near-term neonates with hypoxic respiratory failure, where therapy is withheld or stopped for patients with left ventricular dysfunction due to the risk of increased pulmonary capillary wedge pressure (PCWP) and pulmonary edema.
The core inventive concept is patient selection/stratification based on left ventricular dysfunction (and/or PCWP threshold), applied to candidate patients for 20 ppm inhaled nitric oxide, with exclusion of higher-risk patients and administration to lower-risk patients.
What is the independent claim set and what is the claim “center of mass”?
The patent includes multiple independent method claims that are substantially the same, with variations focused on:
- exclusion vs discontinuation after initiation
- diagnostic process specificity (at least one process; echocardiography)
- treatment regimen duration structure (14 days or until hypoxia resolves; in high-risk patients the regimen excludes those elements)
- risk focus expansion to “other serious adverse events”
- PCWP numeric criterion (PCWP ≥ 20 mm Hg)
- population expansion to “children” for parallel embodiments
Independent method claim families as provided in your claim list:
- Claim 1: identify term/near-term neonates for 20 ppm; determine first patient has no LV dysfunction; determine second has LV dysfunction; administer to first; exclude second.
- Claim 9: same but allows exclusion or discontinuation after initiation based on LV dysfunction determination.
- Claim 24: same but adds regimen structure: first patient gets 20 ppm for 14 days or until hypoxia resolves; second patient receives a second regimen that omits those 14-day and/or until-resolved NO administration elements.
- Claim 34: pediatric analogue (“children with a condition that makes them candidates for 20 ppm inhaled nitric oxide”), same LV dysfunction triage framework.
- Claim 37: neonatal variant for “children” wording, with exclusion or discontinuation.
What are the claim scope elements that matter for freedom-to-operate?
The claims repeatedly require the same minimum set of elements to read on infringement:
-
Population / indication
- Term or near-term neonatal patients with hypoxic respiratory failure (claims 1, 9, 24)
- “Children with a condition that makes them candidates for 20 ppm inhaled nitric oxide treatment” (claims 34, 37 and dependent variants)
-
Therapy threshold and dose
- Patients are “candidates” for 20 ppm inhaled nitric oxide
- Claims assume NO is used at 20 ppm, not a lower/higher ppm alternative.
-
Risk stratification criterion
- First patient: “does not have left ventricular dysfunction”
- Second patient: “has left ventricular dysfunction”
- Dependent claims add diagnostic and/or quantitative PCWP criteria.
-
Clinical action on stratified patients
- For first patient: administer 20 ppm inhaled nitric oxide (claims 1, 9, 24)
- For second patient: exclude from NO and/or discontinue after starting, based on LV dysfunction determination and optionally observed adverse event.
-
Risk endpoint
- The method is framed as reducing risk that NO inhalation increases PCWP leading to pulmonary edema.
Key dependent claims that tighten/expand scope
-
Diagnostic process
- Claim 6/22/31-33: determine LV dysfunction via at least one diagnostic process
- Claim 7/23/29: echocardiography
-
Congenital heart disease linkage
- Claim 2/14/27/36/41: first patient can have congenital heart disease
- Claim 3/5/15/16/28/41: second patient LV dysfunction attributable to congenital heart disease
-
PCWP numeric threshold
- Claim 8/13/30: second patient has PCWP ≥ 20 mm Hg
-
Exclusion vs discontinuation detail
- Claim 9 includes “excluding the second patient … or, despite … ongoing need … discontinuing … after it was begun.”
-
Adverse event specificity
- Claim 10-12: discontinuation based on determination and/or adverse event; adverse event examples include:
- pulmonary edema
- at least one of: increased PCWP, systemic hypotension, bradycardia, cardiac arrest
-
Treatment regimen structure (durational limitation)
- Claim 24: first regimen includes 20 ppm for 14 days or until hypoxia resolved
- Second regimen excludes either (i) 14-day NO administration or (ii) NO until hypoxia resolved (claim 24); dependent claims specify:
- claim 25: second regimen does not comprise NO
- claim 26: second regimen can start NO then stop upon observed PCWP increase and/or pulmonary edema
How do the claim variants map into practice?
Below is a “claim-to-implementation” matrix that shows exactly where real-world protocols can land, given the claim wording you supplied.
| Protocol design choice |
Does it fit the independent claim architecture? |
Which dependent hooks are most likely triggered |
| Use echocardiography to identify LV dysfunction before starting 20 ppm NO |
Yes |
Claims 7/23/29; also 6/22/31-33 if non-echocardiographic diagnostics used |
| Start 20 ppm NO only in neonates with no LV dysfunction; withhold in those with LV dysfunction |
Yes |
Claims 1/9/24 (exclusion portion) |
| Start NO, then discontinue when LV dysfunction is found or PCWP/pulmonary edema develops |
Yes |
Claims 9-12; claims 24-26 (discontinue after observed increase/adverse event) |
| Use a PCWP cutoff (PCWP ≥ 20 mm Hg) to identify the “second patient” |
Yes |
Claims 8/13/30 |
| Restrict the duration of NO in low-risk patients to “14 days or until hypoxia resolved” |
Yes |
Claim 24 |
| For high-risk patients, entirely avoid NO |
Yes |
Claims 25, 9 (exclusion), 24 (second regimen omits NO elements) |
| High-risk patients receive some NO but shorter than 14 days and not “until hypoxia resolved” |
Potentially yes |
Claim 24 (depends on whether NO administration still falls within either excluded duration element) |
| High-risk patients receive NO but apply a different threshold than LV dysfunction (e.g., only based on oxygenation parameters) |
Likely not |
Claims require “left ventricular dysfunction” determination; PCWP alone might still read if tied to LV dysfunction per claim language |
What is the likely claim coverage logic against 20 ppm inhaled NO protocols?
Given the repeated “two-patient” structure (first: no LV dysfunction; second: LV dysfunction), the patent’s coverage most directly attacks protocols that:
- treat all candidates uniformly with 20 ppm NO, including those with LV dysfunction; or
- start NO without measuring/diagnosing LV dysfunction, such that a subset with LV dysfunction is inadvertently treated.
The “risk-reduction” framing is tied to the claimed action (exclude/discontinue), and the claim language is operational rather than purely explanatory: it requires a clinician/health system to perform determinations and make a specific treatment decision outcome.
Where does this sit in the inhaled nitric oxide patent landscape?
Without an enumerated list of co-cited references, family members, or the patent’s prosecution history in your input, the only landscape assessment that can be grounded is a mechanistic positioning based on claim subject matter:
- Existing NO therapy patents/clinical literature commonly cover the use of inhaled nitric oxide for hypoxic respiratory failure (including neonatal PPHN contexts) and dosing regimens generally.
- This patent distinguishes itself by adding a cardiac risk stratification step using left ventricular dysfunction and optionally PCWP ≥ 20 mm Hg to determine who gets 20 ppm NO.
In practical landscape terms, US 8,795,741 targets a narrower “process” space: peri-treatment triage that prevents pulmonary edema risk by identifying patients predisposed to elevated left-sided filling pressures after NO-mediated pulmonary vascular effects.
What would be non-infringing alternatives under these claim terms?
Based purely on claim language provided, pathways that tend to avoid literal coverage include:
- Using a nitric oxide dose other than 20 ppm (claims repeatedly anchor to “20 ppm inhaled nitric oxide treatment”)
- Not determining or using left ventricular dysfunction as the decision gate (substituting a different criterion not recited)
- Administering NO uniformly regardless of LV dysfunction (this would more often increase risk and more likely read on the claims if LV dysfunction is later determined, but if no determination is made and no exclusion/discontinuation occurs, literal method steps may not be satisfied)
- If “PCWP ≥ 20 mm Hg” is required by a dependent claim: a protocol that never meets that numeric cutoff and never makes a determination consistent with it may avoid that dependent layer, though independent claims do not always require the numeric threshold.
Claim-by-claim scope map (condensed)
Below is a direct read-through of your claim list into the scope “axes” that define reach.
| Claim |
Core action |
Added limitations that constrain scope |
| 1 |
Administer NO to first; exclude second |
Neonatal candidates for 20 ppm; second has LV dysfunction; goal is preventing PCWP increase/pulmonary edema |
| 2 |
As in 1 |
First has congenital heart disease |
| 3 |
As in 1 |
Second LV dysfunction attributable to congenital heart disease |
| 4 |
As in 1 |
Exclude based on LV dysfunction because of PCWP/pulmonary edema plus other serious adverse events |
| 5 |
As in 4 |
Second LV dysfunction attributable to congenital heart disease |
| 6 |
As in 1 |
Determinations use at least one diagnostic process |
| 7 |
As in 1 |
Determinations use echocardiography |
| 8 |
As in 1 |
Second has PCWP ≥ 20 mm Hg |
| 9 |
Administer to first; exclude or discontinue second |
Adds discontinuation option despite ongoing need |
| 10 |
As in 9 |
Discontinuation in view of LV determination and adverse event |
| 11 |
As in 10 |
Adverse event = pulmonary edema |
| 12 |
As in 10 |
Adverse event includes increased PCWP and/or systemic hypotension/bradycardia/cardiac arrest |
| 13 |
As in 9 |
Second has PCWP ≥ 20 mm Hg |
| 14 |
As in 9 |
First has congenital heart disease |
| 15 |
As in 9 |
Second LV dysfunction attributable to congenital heart disease |
| 16 |
As in 9 |
Second LV dysfunction attributable to congenital heart disease (duplicate slot in your list) |
| 17 |
As in 9 |
Other serious adverse events risk drives exclusion/discontinuation |
| 18 |
As in 17 |
Defines other serious adverse events list (PCWP increase, hypotension, bradycardia, cardiac arrest) |
| 19 |
As in 17 |
Discontinuation in view of LV determination + other-risk determination + experienced adverse event |
| 20 |
As in 19 |
Adverse event = pulmonary edema |
| 21 |
As in 19 |
Adverse event includes increased PCWP/hypotension/bradycardia/cardiac arrest |
| 22 |
As in 9 |
Determinations use at least one diagnostic process |
| 23 |
As in 9 |
Determinations use echocardiography |
| 24 |
Administer regimen 1 to low-risk; regimen 2 to high-risk |
Introduces 14-day or until hypoxia resolved structure for first; second regimen omits those NO elements |
| 25 |
As in 24 |
Second regimen does not comprise NO |
| 26 |
As in 24 |
Second regimen may begin NO then discontinue upon PCWP increase/pulmonary edema |
| 27 |
As in 24 |
First has congenital heart disease |
| 28 |
As in 24 |
Second LV dysfunction attributable to congenital heart disease |
| 29 |
As in 24 |
Diagnostic process = echocardiography |
| 30 |
As in 24 |
Second has PCWP ≥ 20 mm Hg |
| 31-33 |
As in 1/9/24 |
Identifying plurality uses at least one diagnostic process |
| 34 |
Pediatric version of exclusion decision process |
“Children” with condition making them candidates for 20 ppm; then exclude high-risk based on LV dysfunction |
| 35 |
As in 34 |
Other serious adverse events also factor into exclusion |
| 36 |
As in 34 |
Second LV dysfunction attributable to congenital heart disease |
| 37 |
Pediatric wording of exclusion or discontinuation variant |
Adds discontinuation option; same LV decision gating |
| 38-40 |
As in 37 |
Discontinuation tied to adverse event; defines adverse event forms list |
| 41 |
As in 37 |
LV dysfunction attributable to congenital heart disease |
| 42-44 |
As in 37 |
Other serious adverse events risk governs exclusion/discontinuation; discontinuation tied to experienced adverse event |
What is the practical “patent coverage” conclusion?
The patent’s actionable coverage is narrow but specific: it claims a clinical method that (1) identifies neonatal candidates for 20 ppm inhaled NO, (2) uses diagnosis to determine left ventricular dysfunction status (optionally echocardiography and/or PCWP ≥ 20 mm Hg), and (3) directs clinicians to exclude or discontinue NO in the LV dysfunction cohort to mitigate PCWP-driven pulmonary edema.
For commercialization and R&D, this matters because it implies that any new NO protocol, clinical decision support tool, or dosing algorithm that uses left ventricular dysfunction as an inclusion/exclusion gate for 20 ppm inhaled NO in hypoxic respiratory failure neonates can land inside the method claim set, at least at the level of the independent claims.
Key Takeaways
- US 8,795,741 claims triage methods for 20 ppm inhaled nitric oxide in term/near-term neonates with hypoxic respiratory failure, using left ventricular dysfunction (and optionally PCWP ≥ 20 mm Hg and echocardiography) to decide who gets NO versus who is excluded or discontinued.
- The independent claim backbone is consistent across variants: administer to “no LV dysfunction” patients; exclude or discontinue “LV dysfunction” patients to reduce PCWP increase leading to pulmonary edema.
- Dependent claims narrow into specific implementation details: echocardiography, congenital heart disease attribution, PCWP threshold, discontinuation after adverse event, and a 14-day or until hypoxia resolves regimen structure.
- Landscape positioning: the patent is best viewed as a process add-on to baseline neonatal inhaled NO therapy, centered on cardiac filling pressure risk management.
FAQs
-
Is this a new nitric oxide formulation patent?
No. The claims are method claims tied to clinical decision-making around using 20 ppm inhaled nitric oxide, not a chemical composition or device.
-
Does the patent require PCWP ≥ 20 mm Hg to be infringed?
Not for all claims. The PCWP threshold appears in dependent claims (e.g., claims 8, 13, 30). The independent claim concept centers on left ventricular dysfunction determination.
-
Can the method apply if clinicians discontinue nitric oxide after starting?
Yes. Claim 9 (and pediatric variants like claim 37) explicitly includes exclusion or discontinuation based on LV dysfunction determination and optionally adverse events.
-
Does echocardiography have to be used?
Not for all claims. Echocardiography is a dependent limitation (e.g., claims 7, 23, 29). Independent claim language allows at least one diagnostic process in some embodiments.
-
What patient subgroup is central to the risk logic?
The “second patient” subgroup with left ventricular dysfunction, including cases where LV dysfunction is attributable to congenital heart disease, which is repeatedly recited in dependent claims.
References
[1] United States Patent US 8,795,741, “Method of treating patients using inhaled nitric oxide with risk reduction for pulmonary edema in neonatal patients with hypoxic respiratory failure,” claims text as provided.
