United States Patent 10,918,723: scope and claim map for split-dose colon cleansing using PEG plus ascorbate/ascorbate salts
US Drug Patent 10,918,723 is directed to a two-solution colon cleansing regimen used before a surgical, therapeutic or diagnostic procedure (including colonoscopy), where (i) a first colon cleansing solution is administered on a first time window and (ii) a second colon cleansing solution is administered on a second time window. The distinguishing feature is that the second solution contains PEG (10–200 g/L) plus ascorbate anion provided by a controlled ascorbic acid / ascorbate salt molar ratio (1:4.5 to 1:7.0) and a defined ascorbate concentration (350–650 mmol/L ascorbate anion). Dependent claims then narrow timing, dosing volumes, and specific formulation exemplars.
What is the inventive core of US 10,918,723 and how is the claim scope structured?
Core protected concept (Claim 1):
A subject is cleansed by administering:
- an effective amount of a first colon cleansing solution over a dosing duration t(d1) (plus optional clear fluid t(cf1)), then after a dose interval t(dose interval), and
- an effective amount of a second colon cleansing solution over t(d2) (plus optional clear fluid t(cf2)), where the second solution includes:
- Ascorbate anion at 350–650 mmol/L, supplied by:
- ascorbic acid and
- one or more ascorbate salts
- Components (ascorbic acid and ascorbate salts) present in a molar ratio 1:4.5 to 1:7.0 (ascorbic acid : ascorbate salt)
- Polyethylene glycol (PEG) at 10–200 g/L
- Then the subject undergoes the medical procedure at time t2 after the beginning of the method, with an additional timing constraint t(procedure interval) between the end of second optional clear fluid and the start of the procedure.
Claim construction practicalities (scope levers):
- The claim is a method-of-cleansing with two sequential administrations. It does not require a specific colon cleansing endpoint (no explicit LOD thresholds in the excerpt), but it is framed functionally (“method of cleansing the colon”).
- The second solution’s composition bounds are the primary chemical gate:
- ascorbate anion (350–650 mmol/L)
- ascorbic acid:ascorbate salt molar ratio (1:4.5 to 1:7.0)
- PEG concentration (10–200 g/L)
- Timing is a second major gate: the method specifies a multi-parameter time structure (dosing durations, clear fluid windows, procedure timing).
Which parts are likely to be broad vs narrow?
- Broadest element: “method of cleansing the colon” using first and second solutions with sequencing and timing concepts.
- Narrowest element: specific chemical range and ratio for the second solution plus explicit timing relationships in dependent claims.
What patents protect the same colon-cleansing regimen concept (split dosing + PEG + ascorbate/ascorbate salts)?
Only the text of US 10,918,723 claims is provided. A reliable landscape normally requires publication numbers, application families, continuations, related patents in the same family, and the Orange Book and FDA product listings showing which solutions map to commercial drugs. With only the claim text, a complete and accurate cross-patent “who else owns this” mapping cannot be produced.
Result: No multi-patent protection map can be generated from the provided input alone.
How do the dependent claims narrow the regimen and formulation for US 10,918,723?
Timing and administration pattern claims (Claims 2, 9, 16)
These claims lock down the regimen around a procedure day or the evening before.
Claim 2 (day-of procedure regimen):
- First and second cleansing solutions taken on the day of the diagnostic/therapeutic/surgical procedure.
- Timing ranges:
- t(d1): 15 min to 1 hr
- t(cf1): 15 min to 1 hr
- t(dose interval): 0 to 8 hr
- t(d2): 15 min to 1 hr
- t(cf2): 15 min to 1 hr
- t2 (from start of method to procedure): 3 to 14 hr
- t(procedure interval): 30 min to 10 hr
Claim 9 (evening-before regimen):
- First and second cleansing solutions in the evening before the procedure day.
- Timing ranges:
- t(d1): 15 min to 1 hr
- t(cf1): 15 min to 1 hr
- t(dose interval): 0 to 8 hr
- t(d2): 15 min to 1 hr
- t(cf2): 15 min to 1 hr
- t2: 10 to 36 hr
- t(procedure interval): 8 to 20 hr
Claim 16 (split evening then morning):
- First solution in the evening before.
- Second solution in the morning of the procedure day.
- Timing ranges:
- t(d1): 15 min to 1 hr
- t(cf1): 15 min to 1 hr
- t(dose interval): 8 to 20 hr
- t(d2): 15 min to 1 hr
- t(cf2): 15 min to 1 hr
- t2: 10 to 36 hr
- t(procedure interval): 30 min to 10 hr
Volume limitation claims (Claims 3–5, 10–12, 17–19)
These limit administration volumes for the first and second solutions.
- Claim 3: second solution 250–1000 mL
- Claim 4: first solution 400–1100 mL
- Claim 5: exemplar volumes: first solution 500 or 750 mL; second solution 500 mL
Analogous dependent volume claims exist for the evening-before strategy (Claims 10–12) and split evening-to-morning strategy (Claims 17–19).
Clear fluid add-on claims (Claims 6–8, 13–15, 20–22)
The method allows additional clear fluid after one or both solutions.
- Claim 6: additional clear fluid after one or both solutions
- Claim 7: additional clear fluid after each solution: 300–1000 mL
- Claim 8: fixed timing exemplars (30-minute windows and constrained intervals):
- t(d1)=30 min
- t(cf1)=30 min
- t(dose interval)=1–2 hr
- t(d2)=30 min
- t(cf2)=30 min
- t2=4–8 hr
- t(procedure interval)=1–6 hr
Similar clear-fluid and fixed-time examples appear for Claims 13–15 and Claims 20–22 for other administration patterns.
What specific formulation ranges are claimed for the second colon cleansing solution (ascorbate + PEG)?
Claim 1 composition gate for the second solution (broad range):
- Ascorbate anion: 350–650 mmol/L
- PEG: 10–200 g/L
- Ascorbate anion source: mixture of
- ascorbic acid and
- one or more ascorbate salts
- Molar ratio of components: 1:4.5 to 1:7.0 (ascorbic acid : ascorbate salt)
- (As stated in Claim 1 excerpt) additional electrolytes within:
- 10–200 g/L PEG
- 3–8 g/L sodium chloride
- 1–7 g/L potassium chloride
- flavoring agents and sweeteners are optional components in the recited formulation
Claim 23 (narrower exemplar composition window):
- 14–16 g/L ascorbic acid
- 92–100 g/L sodium ascorbate
- Weight ratio constraint (as recited):
- ascorbic acid sodium ascorbate weight ratio 1:50.63 to 1:7.875 (as written in the excerpt; the claim text appears inconsistent in ratio formatting, but it is still a limiting dependency as provided)
- PEG:
- 60–100 g/L PEG, average molecular weight 3000–4000 Da
- Electrolytes:
- 3–8 g/L sodium chloride
- 1–7 g/L potassium chloride
- Plus flavoring agents and sweeteners
Claim 29 (another narrower exemplar composition window):
- 15.08 g/L ascorbic acid
- 96.22 g/L sodium ascorbate
- PEG:
- 80 g/L PEG, MW 3000–4000 Da
- Electrolytes:
- 6.4 g/L sodium chloride
- 2.4 g/L potassium chloride
- Flavoring agents and sweeteners
What specific formulation ranges are claimed for the first colon cleansing solution (PEG + salts)?
Claim 24 (narrow exemplar composition for the first solution):
- PEG:
- 90–200 g/L PEG, MW 2500–4500 Da
- Alkali metal sulphates and/or alkaline earth sulphates (or mixture):
- Electrolytes:
- 0.5–5.0 g/L sodium chloride
- 0.05–5.0 g/L potassium chloride
- Plus flavoring agents and sweeteners
Claim 30 (another narrower exemplar for the first solution):
- PEG:
- 200 g/L PEG, MW 2500–4500 Da
- Sulphate:
- 18 g/L alkali/alkaline earth sulphates or mixture
- Electrolytes:
- 4 g/L sodium chloride
- 2 g/L potassium chloride
- Plus flavoring agents and sweeteners
How do the claims treat concrete “product-like” recipes and dosing schedules?
Fixed-time colonoscopy example with two 500 mL formulations (Claim 25)
Claim 25 provides a concrete schedule and two explicit solutions:
- Approximately 05:00H take solution S2:
- 500 mL water
- taken over 30 minutes, 250 mL every 15 minutes
- followed by additional water 500 mL over next 30 minutes
- observe 1 hour liquid-free break
- Approximately 07:00H take solution T1:
- 500 mL water over 30 minutes, 250 mL every 15 minutes
- drink 500 mL additional water
- Colonoscopy at least 1 hour after last additional water
Formulation specifics in Claim 25:
- First cleaning solution S2:
- 100.00 g PEG 3350
- 9.00 g Na2SO4 (anhyd)
- 2.00 g NaCl
- 1.00 g KCl
- 0.40 g sucralose
- 0.500 g Fruit Punch Flavouring
- 0.75 g Citric Acid
- to 500 mL
- Second cleaning solution T1:
- 40.00 g PEG 3350
- 3.20 g NaCl
- 1.20 g KCl
- 1.93 g Aspartame
- 0.60 g Orange Flavouring
- 48.11 g Sodium Ascorbate
- 7.54 g Ascorbic Acid
- to 500 mL
Day-before colonoscopy example (Claim 26) and evening-into-morning example (Claim 27)
Claim 26 mirrors the two-solution structure with timing anchored to 18:00H the day before, then procedure the next day. Claim 27 is a simplified labeled schedule using “Formulation S2” and “Formulation T1” but retains the same explicit compositions as Claim 25.
Practical takeaway on infringement design space
From a freedom-to-operate lens, the fixed recipes in Claims 25–27 can create a direct infringement risk for “near-identical” marketed products or clinical instructions using the same electrolyte profile, PEG MW, and ascorbate salt system.
What “diet/fasting” instructions are claimed?
Claim 28 adds behavioral instructions to the method:
- advised not to eat heavy meals and/or
- fast for 12 hours before starting, and/or
- follow a “white diet” for a day before or the day of starting, with “white diet” defined as food restricted to white and cream-coloured foods.
This is an additional limiting component only if the claim is asserted as written with the diet instruction included.
Key scope boundaries for designing around US 10,918,723
Chemical/design-around levers (second solution):
- Move PEG concentration outside 10–200 g/L (or outside dependent exemplars, where PEG is much narrower).
- Use an ascorbate system outside ascorbate anion 350–650 mmol/L.
- Change the ascorbic acid:ascorbate salt molar ratio outside 1:4.5 to 1:7.0.
- Remove or substantially change the required electrolyte levels and/or the specific Na/K chloride ranges in dependent clauses.
Regimen/design-around levers (timing):
- Avoid the specific dosing schedule windows captured in dependent claims (15–60 minute dosing windows, clear fluid windows, dose interval ranges, and procedure interval ranges).
- Avoid the evening-before, split evening-to-morning, or day-of procedure patterns if asserting dependent claims.
Recipe levers:
- Avoid matching the explicit PEG 3350 + Na2SO4 electrolytes in the “S2” first solution and the PEG 3350 + sodium ascorbate + ascorbic acid profile in the “T1” second solution as exemplified.
Litigation, Orange Book, and FDA exclusivity status for US 10,918,723
No Orange Book linkages, FDA product identifiers, patents listed for any colon cleansing drug, or litigation docket details are provided in the input. A complete status analysis cannot be produced without those data.
Result: No litigation or regulatory/exclusivity timeline can be stated from the claim excerpt alone.
Which competitive landscape companies are exposed?
No assignees, family members, or connected commercial products are provided. Without ownership and mapped FDA listings, an exposure ranking across companies cannot be generated.
Result: No competitive exposure list can be produced from the provided input alone.
Key Takeaways
- US 10,918,723 protects a two-part colon cleansing method combining a first PEG/salt cleansing solution with a second solution that contains PEG (10–200 g/L) plus ascorbate anion (350–650 mmol/L) supplied by ascorbic acid and ascorbate salts at an ascorbic acid:ascorbate salt molar ratio of 1:4.5 to 1:7.0.
- Dependent claims narrow the regimen to specific time windows for dosing, clear fluid administration, and procedure timing (day-of, evening-before, split evening-to-morning).
- Dependent claims also narrow the composition of both solutions, including explicit “product-like” exemplars: PEG 3350/Na2SO4 for the first solution and sodium ascorbate + ascorbic acid for the second, both in 500 mL recipes with specified flavoring/sweetener systems.
- The highest-risk infringement scenario is execution that matches both (i) the second-solution ascorbate/PEG chemistry and (ii) the specific two-dose timing pattern captured in dependent claims or the fixed schedules and recipes in Claims 25–27.
FAQs
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How would changing only the ascorbic acid:sodium ascorbate molar ratio affect infringement risk under US 10,918,723?
It directly targets the Claim 1 composition requirement for the second solution, and also constrains dependent ascorbate-specific embodiments.
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If a regimen uses the same second-solution chemistry but a different two-dose timing (outside t(dose interval) or t(procedure interval)), does it still fall within Claim 1?
Claim 1 includes procedure timing relationships; changing those parameters can take the method outside the claim’s defined time structure.
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Do the claims require the same PEG molecular weight for both solutions?
Dependent exemplars impose PEG MW ranges (e.g., 3000–4000 Da for the ascorbate/PEG second solution and 2500–4500 Da for the first solution), while Claim 1 itself is PEG concentration-focused.
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Are flavoring agents and sweeteners mandatory?
In the provided claim excerpt, they are recited as part of the second solution formulation description and first solution exemplar formulations in dependent claims; whether they are strictly required depends on the specific asserted claim.
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Does the claimed method cover dietary instructions like fasting or a “white diet”?
Those instructions are included in dependent Claim 28 as a further limitation tied to the method.
References
- US Patent 10,918,723 (claims provided in prompt).
