United States Patent 11,617,793: Scope, Claim Architecture, and US Patent Landscape for Sodium Thiosulfate/Boric Acid Solutions
US Patent 11,617,793 claims a narrow chemical-composition window for a pharmaceutical formulation of sodium thiosulfate with boric acid at specific molar concentrations and a defined pH range. The claim set is structured around (i) composition identity and (ii) optional co-addition of common pH-adjusters (HCl and NaOH), with a dependent claim narrowing to a ~100 mL total volume and a tighter pH band (about 8.6 to about 8.8). The patent’s enforceable scope is primarily limited to formulations that meet the recited concentration and pH parameters simultaneously.
What exactly does US Patent 11,617,793 claim: sodium thiosulfate + boric acid concentration and pH?
Answer: A pharmaceutical composition defined by sodium thiosulfate at ~0.5 M, boric acid at ~0.004 M, and pH between ~6.5 and ~8.9.
Claim 1 is the independent claim and sets the compositional “gate” for infringement.
Claim 1 (independent): composition window
- Component system
- Sodium thiosulfate: about 0.5 M
- Boric acid: about 0.004 M
- Physicochemical constraint
- pH between about 6.5 and about 8.9
- Product form
- “A pharmaceutical composition,” which in practice typically covers an aqueous solution intended for systemic or local administration, but the claim language is not limited to a specific dosage form beyond being a composition with a measurable pH.
Dependent claims narrow without changing the core chemistry
The dependent claims add allowable adjustments:
- Claim 2: total volume about 100 mL
- Claims 3, 4, 6, 7: presence of either hydrochloric acid and/or sodium hydroxide
- Claims 5 and 8: pH constrained to about 8.6 to about 8.8
Practical infringement “test”
To infringe any claim in the set, an accused composition must satisfy:
- Sodium thiosulfate is at about 0.5 M
- Boric acid is at about 0.004 M
- The measured formulation pH is within the claim’s range
- If asserted as dependent, additional limitations apply (100 mL volume; optional inclusion of HCl or NaOH; narrower pH band)
Because the claim is concentration-and-pH bounded, off-target formulations that move outside either the molarity targets or the pH band can avoid literal coverage.
How broad are the “about” ranges and what do they do to claim scope?
Answer: The claims recite molar targets (“about 0.5 M” and “about 0.004 M”) and pH windows; enforceable breadth depends heavily on how “about” is construed for the intrinsic record (specification and prosecution).
The claim text uses “about” for:
- sodium thiosulfate concentration (about 0.5 M)
- boric acid concentration (about 0.004 M)
- pH lower and upper bounds (about 6.5 to about 8.9; and about 8.6 to about 8.8)
- total volume (about 100 mL)
In US practice, “about” is often treated as a range, not a point. Exact capture depends on the specification’s working examples, measurement conditions (temperature, ionic strength, formulation matrix), and prosecution history. From a landscape standpoint:
- Competitors can reduce infringement risk by staying clearly outside the molar targets and especially the pH windows, not merely by making modest shifts.
- Claim 5/8’s narrower pH band is a key litigation lever because it creates a tighter “sweet spot” that is easier to separate by formulation design.
Do HCl and NaOH create separate claim coverage or just enable pH control?
Answer: The claims allow HCl and NaOH as co-components in claims tied to claim 2’s 100 mL limit and claim 1’s pH base range; presence of either is only relevant when asserted as part of a dependent claim set.
Claims specifically reference pH adjusters:
- Claim 3 (depends on claim 2): further comprises hydrochloric acid
- Claim 4 (depends on claim 2): further comprises sodium hydroxide
- Claim 6 (depends on claim 1): further comprises hydrochloric acid
- Claim 7 (depends on claim 1): further comprises sodium hydroxide
These are not standalone claims. They function as optional inclusions that preserve coverage for compositions that use strong acid/base for pH adjustment while still meeting the underlying concentration and pH requirements.
Design-around implication
- If a competitor forms the desired pH without using HCl or NaOH, it may avoid dependent claims 3/4/6/7 while still risking independent claim 1 and dependent claim 2/5/8 if pH and concentration requirements are met.
What is the relationship between claim 1 and claim 5 (pH 8.6–8.8)?
Answer: Claim 5 is a narrower subset of claim 1 based on pH.
- Claim 1: pH between about 6.5 and about 8.9
- Claim 5: pH between about 8.6 and about 8.8
- Both maintain sodium thiosulfate and boric acid concentrations.
So any composition meeting claim 5 automatically meets claim 1 (subject to “about” constructions). This matters for enforceability and litigation strategy:
- Claim 1 can be asserted even if the accused product targets pH levels between ~6.5 and ~8.9.
- Claim 5 gives a second, tighter hook for products formulated near the upper pH end.
How do claim 2 and claim 5 combine: is 100 mL tied to the narrower pH?
Answer: Claim 5 depends on claim 2, so 100 mL total volume and pH 8.6–8.8 are co-limitations in that dependent claim.
- Claim 2: total volume about 100 mL
- Claim 5: composition of claim 2 with pH about 8.6–8.8
So a 50 mL version at pH 8.7 can still fall under claim 1 if the base claim constraints are met, but it may not meet claim 2 or claim 5 depending on how “total volume about 100 mL” is construed.
What formulation variants fall inside vs outside the claim set (high-level design map)?
Likely inside coverage
- Sodium thiosulfate at ~0.5 M with boric acid at ~0.004 M
- pH in ~6.5–8.9
- If marketed/packaged at ~100 mL, claim 2 adds volume limitation
- If pH is tuned to ~8.6–8.8, claim 5/8 is implicated
- Use of HCl or NaOH for pH adjustment does not remove coverage if concentration/pH constraints are met
Likely outside coverage
- Any meaningful deviation in boric acid molarity away from ~0.004 M
- pH moved below ~6.5 or above ~8.9
- pH set outside ~8.6–8.8 (for dependent claim targeting)
- Packaging substantially away from ~100 mL if dependent claims 2/5/8 are asserted
What is the patent estate context for US 11,617,793: continuation, related filings, and typical claim strategy?
Answer: US 11,617,793’s claims are composition-only (no method-of-use, no manufacturing steps) and therefore usually sit within a broader set that includes related chemical concentration/pH or dosing regimen patents.
Without the underlying publication family data in the prompt, it is not possible to enumerate the full US family members, but the claim architecture is consistent with a formulation-focused strategy:
- One independent composition claim (Claim 1)
- Dependent claims covering packaging volume and pH sub-ranges
- Dependent claims covering optional acid/base components
Implication for landscape
- If there are related patents in the same family, they typically differ by:
- different boric acid concentrations
- different pH ranges
- different sodium thiosulfate concentrations
- inclusion of stabilizers or buffers
- specific dosage forms and pack sizes
In licensing or generic entry risk assessments, this means the key question is not just whether a competitor avoids pH 8.6–8.8, but whether it avoids the full combination of thiosulfate ~0.5 M, boric acid ~0.004 M, and the broader pH band.
How does the claim language translate into FDA and “Orange Book” risk (if the product is an FDA-listed drug)?
Answer: Composition and pH-bound claims can still be Orange Book-listed if the NDA/BLA has protected formulations, but the enforceability hinges on whether the listed patent corresponds to an approved product and the specific dosage form/pH.
For business professionals, the actionable bridge is:
- Identify whether the patent is listed in the FDA Orange Book for any US-approved drug product containing sodium thiosulfate + boric acid at the claimed concentrations and pH.
- For Paragraph IV challenges, the usual attack line is to dispute infringement and/or invalidity with respect to the claim’s concentration-and-pH limitations.
Landscape effect
- Because the claim is not a method-of-use claim, generic developers can more readily design around by reformulating, provided they still meet safety and efficacy requirements for the active pharmaceutical ingredient and the approved dosage form.
Which competing formulation approaches create the biggest generic entry risk?
Answer: Products that match the exact concentration pair and pH range create the highest risk; products that diverge in either boric acid molarity or pH have lower infringement exposure.
The largest infringement drivers are:
- Boric acid at ~0.004 M
- Thiosulfate at ~0.5 M
- pH 6.5–8.9 (and especially 8.6–8.8 for dependent claims)
In practice, companies typically vary:
- buffer systems
- ionic strength and pH control strategy
- excipient package and final fill volume
So the “most dangerous” competitor is one offering the same final aqueous composition designed to deliver the same pH and buffering effect.
How strong is the patent’s scope likely to be in litigation?
Answer: Scope is strong against identical formulation parameters, but it is narrow by construction because it is limited to a specific concentration combination and pH range.
A court will construe:
- concentration targets with “about”
- pH ranges based on the intrinsic record
- volume limits similarly
From a risk perspective:
- If a defendant’s product falls squarely inside the parameter window, infringement arguments are straightforward.
- If the defendant sits near range edges, the “about” construction becomes decisive.
- If a defendant chooses a different boric acid level or a different pH regime, they can reduce or eliminate literal coverage.
Claim-by-claim map (quick reference)
| Claim |
Additional limits beyond independent composition |
What must be present |
| 1 |
Independent baseline |
Na2S2O3 ~0.5 M; boric acid ~0.004 M; pH ~6.5–8.9 |
| 2 |
Packaging |
Total volume ~100 mL |
| 3 |
pH adjuster |
Includes HCl (and satisfies claim 2) |
| 4 |
pH adjuster |
Includes NaOH (and satisfies claim 2) |
| 5 |
Narrow pH band |
pH ~8.6–8.8 (and satisfies claim 2) |
| 6 |
pH adjuster |
Includes HCl (and satisfies claim 1) |
| 7 |
pH adjuster |
Includes NaOH (and satisfies claim 1) |
| 8 |
Narrow pH band + volume dependent |
pH ~8.6–8.8 (and satisfies claim 1) |
What to monitor in the patent landscape around US 11,617,793
Answer: Track the presence of sodium thiosulfate/bórate buffered formulations with matching pH and concentration; the competitive landscape will turn on parametric similarity rather than on excipient branding.
Action items for monitoring, in litigation, licensing, or investment due diligence:
- Identify patents with adjacent formulation windows:
- different molarity of sodium thiosulfate around ~0.5 M
- different boric acid levels around ~0.004 M
- different pH ranges overlapping ~6.5–8.9 or ~8.6–8.8
- Identify process or container-closure patents if they coexist:
- even though this patent is composition-only, the surrounding estate often includes stability and packaging protections
- Identify any related regulatory labeling or CMC disclosures:
- labels and chemistry filings can reveal buffer system and target pH, which correlates strongly with claim proximity
Key Takeaways
- US 11,617,793 is a narrow composition patent defined by sodium thiosulfate ~0.5 M plus boric acid ~0.004 M with pH ~6.5–8.9.
- The main enforceable pivot points are the boric acid molarity and the pH windows, with a tighter subset at pH ~8.6–8.8.
- Dependent claims add ~100 mL total volume and optionally include HCl or NaOH, but those depend on the asserted dependent claim.
- Generic or competitor risk is highest for products that match the full parametric set, not merely for sodium thiosulfate formulations generally.
FAQs
1. What would be the simplest formulation design-around for US 11,617,793?
Change either the boric acid concentration away from ~0.004 M or shift the final pH outside ~6.5–8.9, with additional attention if targeting pH 8.6–8.8.
2. Does using hydrochloric acid or sodium hydroxide automatically infringe dependent claims?
No. HCl or NaOH presence matters only for the dependent claims that require those components, and the independent concentration-and-pH limits still must be met.
3. Can a product avoid infringement by using a different buffer system?
Yes, if it still keeps the formulation outside the claimed boric acid concentration and pH ranges. Avoiding “boric acid ~0.004 M” is typically the critical move.
4. If a competitor uses the same concentrations but ships a different fill volume than 100 mL, is it still covered?
Claim 1 can still be implicated because it does not require the ~100 mL fill. The ~100 mL limitation applies only to claims that depend on claim 2.
5. Does the patent cover methods of treating patients with sodium thiosulfate?
Based on the provided claims, the coverage is composition-focused, not method-of-use focused.
References
No external sources were cited because only claim text was provided and no publication, assignee, family, or FDA/Orange Book listing information was included in the prompt.
