United States Patent 10,973,811 Scope and Claims: Method-of-Use Claims for Nasal Cocaine Local Anesthesia in Renally Impaired Patients
Executive summary: US Drug Patent 10,973,811 claims a method of administering nasal local anesthesia using soaked pledgets containing a ready-to-use cocaine hydrochloride composition (about 3.6% to 4.4% w/w cocaine HCl, plus preservative and acidulant, optionally colorant), applied to nasal mucosa for up to about 20 minutes, then removed prior to a diagnostic or surgical procedure in renally impaired subjects. Dependent claims narrow the patient renal function range (eGFR 15 to <60, and 15 to <29), and further limit the procedure to specific nasal endoscopic/laryngoscopic contexts. The independent claim is structured as a dosage and workflow method (soak volume, concentration, contact duration, and pledget removal) coupled to an indication constraint (“renally impaired subject”). Separate dependent claims add quantitative performance ranges via an absorptivity factor for cocaine.
What does US 10,973,811 claim cover: method scope for nasal cocaine pledgets in renally impaired patients?
Core claim coverage (Claim 1). The patent is directed to a pre-procedure local anesthesia method for diagnostic or surgical procedures on renally impaired subjects, using nasal pledgets prepared with a ready-to-use composition of cocaine hydrochloride.
Essential elements of Claim 1 (practically, infringement hinges on all of these):
- Population/indication constraint: “a renally impaired subject.”
- Timing/workflow: administering the anesthetic prior to performing the procedure.
- Dosage form and delivery device: “one or more pledgets.”
- Composition preparation: pledgets are soaked in up to about 4 mL of a ready-to-use composition.
- Active concentration: composition comprises about 3.6% to about 4.4% cocaine hydrochloride by weight.
- Excipients: includes a preservative and an acidulant; optionally includes coloring additive.
- Route/anatomic contact: each pledget contacts a nasal mucous membrane.
- Contact duration: “up to about 20 minutes.”
- Termination step: removing each pledget from contact with the mucous membrane.
Structural implication for scope: Because Claim 1 is a single chained method claim, design-arounds typically target one or more “hard stops”:
- change cocaine concentration outside 3.6% to 4.4% w/w
- change pledget soaking volume outside “up to about 4 mL”
- extend contact duration beyond “up to about 20 minutes”
- use a different nasal-local delivery concept (e.g., spray/gel not “pledgets,” or contact route not “nasal mucous membrane”)
- remove pledgets without the same removal step (less likely, because removal is inherent)
- dispute whether the subject qualifies as “renally impaired” (since dependent claims define eGFR bands)
How do the dependent claims narrow the renally impaired eGFR subgroup in US 10,973,811?
Claim 2 (eGFR medium CKD band).
- Renally impaired subject has eGFR about 15 to <60 mL/min/1.73 m².
Claim 3 (more restrictive CKD band).
- Renally impaired subject has eGFR about 15 to <29 mL/min/1.73 m².
Scope effect:
- Claim 1 already requires “renally impaired,” but Claims 2 and 3 add objective renal-function ranges.
- In litigation, these ranges help define the patient set and can affect both infringement and validity arguments (e.g., whether the method is nonobvious for a defined CKD severity range).
Practical infringement framing:
- If a clinician uses the claimed method in a CKD patient with eGFR ≥60, it would fall outside Claims 2 and 3. It still could fall within Claim 1 if “renally impaired” is interpreted more broadly than Claims 2 and 3, but the dependent claims will pressure narrower construction arguments around CKD thresholds.
What procedures are covered: nasal endoscopy and laryngoscopy variations in US 10,973,811?
Claim 4 to Claim 8 list procedure types. Each is a further limitation on Claim 1’s method.
Claim 4: procedure comprises nasal endoscopy.
Claim 5: procedure comprises nasal laryngoscopy.
Claim 6: procedure comprises nasal debridement.
Claim 7: procedure comprises nasopharyngeal laryngoscopy.
Claim 8: procedure comprises laryngoscopy.
Scope implication:
- Coverage is not limited to a single CPT-like procedure. It spans endoscopic and laryngoscopic nasal airway contexts and even debridement, which can be clinically diverse.
- “Laryngoscopy” in Claim 8 is broad enough that it could capture a wider anatomic procedure category, but it still sits behind the “prior to performing” method and the “nasal mucous membrane pledget contact” structure.
What performance/kinetic limitation is claimed: absorptivity factor ranges for cocaine in US 10,973,811?
Claim 9 and Claim 10 introduce quantitative “absorptivity factor” ranges. These claims add measurable pharmacokinetic or modeling parameters.
Claim 9: method achieves an absorptivity factor for cocaine in the range 0.640 h−1 to 0.687 h−1.
Claim 10: method achieves an absorptivity factor in the range 0.483 h−1 to 0.789 h−1.
Scope effect and litigation dynamics:
- These dependent claims can narrow the infringement universe to methods producing a particular absorptive kinetic outcome.
- In enforcement, plaintiffs typically tie absorptivity factor to a specific measurement protocol (study design, sampling schedule, modeling method). If the patent’s specification defines a formula, assay, or model, those become pivotal for infringement and validity.
- If multiple clinical protocols exist that still meet the workflow concentration/contact-time limits in Claim 1, these absorptivity claims may be harder to prove without protocol alignment.
What is the practical claim “center of gravity” for infringement in US 10,973,811?
Most enforceable anchor points (high likelihood):
- Ready-to-use cocaine HCl composition at ~3.6% to ~4.4% w/w
- Soaking pledgets in up to ~4 mL
- Nasal mucous membrane contact up to ~20 minutes
- Renally impaired subject
Most likely contested elements:
- Whether the subject is “renally impaired” (especially outside Claim 2/3 eGFR bands)
- Whether the delivered form truly meets “pledgets” and “soaking” (as opposed to different application modalities)
- Whether contact duration is “up to about 20 minutes” (how “about” is construed and measured)
- Proof of absorptivity factor in Claims 9/10
How would a competitor design around US 10,973,811 if the goal is to avoid literal infringement?
Common design-around levers tied to claim language:
- Move cocaine concentration outside 3.6% to 4.4% w/w
- Change application method so it is not “soaking pledgets” (for example, different device/formulation and workflow)
- Change volume so it exceeds “up to about 4 mL” of composition soaked into pledgets (or is insufficient such that it is not “up to”)
- Change contact time beyond “up to about 20 minutes”
- Treat non-CKD patients or deploy the anesthetic in patients without meeting the “renally impaired” criteria (though that may be commercially constrained)
- Alter formulation architecture (e.g., omit one required category such as the preservative or acidulant, though omission may conflict with product quality/safety requirements)
Doctrinal note: Even when a competitor avoids literal infringement, equivalents may be asserted, especially for “about” ranges and duration/concentration substitutions. But the claim’s numerical windows and workflow steps reduce ambiguity compared with broader qualitative claims.
What is the patent landscape context for US 10,973,811: is it a formulation patent or a method patent?
Claim character: This is primarily a method-of-use claim for a specific clinical workflow and specific composition concentration range used on nasal mucosa. It is not drafted as a standalone chemical composition claim; it is a procedural administration method with composition limitations.
Landscape implication: In the US market, competitive freedom typically turns on:
- Whether other patents exist covering the same composition range and vehicle/excipients
- Whether there are additional patents covering renal impairment-specific dosing or pharmacokinetic performance for cocaine
- Whether any product is covered by Orange Book listings as an approved drug with method-use patents attached (method patents are often tied to approved dosage forms and labeling claims)
What this means for freedom-to-operate (FTO):
- Even if a competitor has a different formulation, it can still infringe if it meets Claim 1’s concentration and excipient categories and performs the same pledget soak/contact/removal procedure in renally impaired subjects.
- Conversely, if a competitor develops a different cocaine concentration or delivery method but is still used in renally impaired patients, it may avoid Claim 1 but could still face other IP (not stated here).
What does “ready-to-use composition” imply for scope and licensing leverage?
Claim 1 requires “a ready-to-use composition.” That phrase can be read to target:
- commercially prepared dosing with preservative/acidulant already incorporated, rather than extemporaneous mixing at the site
- packaging and workflow that do not require on-the-spot formulation adjustments
For licensing and manufacturing, this supports an argument for control over:
- the composition as administered
- the clinical workflow associated with that composition
Where does the estate’s strength sit: breadth vs. provability of dependent claims
Broad coverage (Claim 1)
- Broad procedural set (diagnostic or surgical, with multiple dependent procedure options)
- Broad renally impaired concept (though constrained by dependent eGFR claims)
Narrow coverage (Claims 2, 3)
- Defined eGFR ranges: 15 to <60 and 15 to <29
Narrowest coverage (Claims 9, 10)
- Quantified absorptivity factor windows, which are typically harder to show in routine practice unless tied to an assay/model and clinical sampling protocol that matches the patent’s teaching.
Commercial takeaway: In enforcement, Claim 1 often sets the posture; dependent claims support narrower infringement narratives or help in pleading fallback theories.
Key claim chart for US 10,973,811 (elements and infringement-critical parameters)
| Claim element |
What the claim requires |
Design-around pressure point |
| Patient |
Renally impaired subject |
Use eGFR outside qualifying range; dispute classification |
| Timing |
Administer prior to diagnostic/surgical procedure |
Change when dosing occurs |
| Device |
One or more pledgets |
Use non-pledget delivery |
| Soak amount |
Soak pledgets in up to ~4 mL |
Change volume/workflow |
| Drug concentration |
Cocaine HCl about 3.6% to 4.4% w/w |
Change concentration outside window |
| Excipients |
Preservative and acidulant; colorant optional |
Remove/alter required categories |
| Contact site |
Nasal mucous membrane |
Use different anatomic site |
| Contact duration |
Up to ~20 minutes |
Change duration |
| Removal |
Remove pledgets from mucous contact |
Change removal step (hard biologically) |
| Procedure (dep.) |
Nasal endoscopy / laryngoscopy / debridement / nasopharyngeal laryngoscopy / laryngoscopy |
Use procedure outside listed types |
| eGFR (dep.) |
15 to <60; or 15 to <29 |
Treat outside ranges |
| Absorptivity (dep.) |
Cocaine absorptivity factor in defined ranges |
Use different formulation/contact protocol affecting PK |
What generic entry risks exist for products competing with the patented method?
Risk profile is method-centric.
- Generic entry risk depends less on whether the generic product duplicates the same NDC strength and more on whether generic competitors adopt the same clinical administration method for renally impaired patients using the specified concentration/duration/pledget workflow.
High-risk scenario:
- A competitor uses a cocaine product formulated within 3.6% to 4.4% and applies it via soaked pledgets to nasal mucosa for up to 20 minutes in a CKD patient population, with packaging/workflow consistent with “ready-to-use.”
Lower risk scenario:
- A competitor uses a different strength outside the window or uses a different delivery form (not pledgets), while targeting the same procedures in renally impaired patients.
How does US 10,973,811 compare to typical local anesthesia patent estates (what is different here)?
Typical local anesthesia estates may cover:
- chemical compositions
- device-specific delivery systems
- general topical anesthesia methods without patient renal stratification or without kinetic performance metrics
This patent is distinctive in three ways based on the claims provided:
- It ties a specific cocaine HCl concentration window to a specific pledget soak/contact/removal workflow.
- It restricts the method to renally impaired subjects, with specific eGFR-dependent fallbacks.
- It includes absorptivity factor ranges, which can make the patent enforcement posture more pharmacokinetics-dependent than purely procedural.
Key Takeaways
- US 10,973,811 claims a nasal pledget-based pre-procedure cocaine local anesthesia method for renally impaired patients.
- Claim 1 is anchored to: ready-to-use cocaine HCl 3.6% to 4.4% w/w, preservative + acidulant, pledgets soaked in up to ~4 mL, nasal mucous membrane contact up to ~20 minutes, then removal.
- Dependent claims narrow renal function to eGFR 15 to <60 (Claim 2) and 15 to <29 (Claim 3), and limit procedures to nasal endoscopy, nasal laryngoscopy, nasal debridement, nasopharyngeal laryngoscopy, and laryngoscopy.
- Claims 9 and 10 further constrain the method by requiring cocaine absorptivity factor outcomes: 0.640 to 0.687 h−1 or 0.483 to 0.789 h−1.
- Competitive and licensing risk is primarily driven by adherence to the concentration, pledget soak/contact time, and renally impaired patient population, with additional evidentiary burden for the absorptivity-dependent claims.
FAQs
- Can a method that uses nasal sprays infringe US 10,973,811? Only if the method still uses “pledgets” that are soaked and contacted with nasal mucosa as claimed; a spray modality typically changes the delivery element.
- If the patient’s eGFR is 60 mL/min/1.73 m², does it avoid Claim 2 and Claim 3? Yes for the eGFR bands in Claims 2 and 3; Claim 1 still requires “renally impaired,” which can be contested outside those bands.
- Does changing contact time from 19 minutes to 25 minutes avoid infringement? It would avoid the “up to about 20 minutes” limitation if the facts do not fall within the claim’s “about” range.
- How do competitors validate infringement of Claims 9/10 absorptivity factors? By matching the patent’s absorptivity determination approach and generating comparable absorptivity outcomes for the cocaine dosing and contact parameters.
- Is US 10,973,811 limited to a specific anatomical location beyond nasal mucosa? It requires nasal mucous membrane contact; dependent claims further reference specific endoscopic and laryngoscopic procedure types.
References (APA)
- US Patent 10,973,811.
