Scope and Claims of US Patent 7,235,247: Osmotic-Pressure-Limited Aqueous Mucosal Compositions with Hemostatic Agents
US Patent 7,235,247 is directed to aqueous pharmaceutical compositions for mucosal application with a defined osmolality ceiling (≤150 mOsm), optionally down to ≤90 mOsm, that include water-insoluble and/or low water-soluble solids in an aqueous medium and, in some dependent claims, hemostatic agents and specific excipient families (celluloses, water-soluble polymers, surfactants). The claim architecture is broad at the product-structure level (aqueous mucosal composition + defined osmolality + insoluble/low-soluble solid + medicament) and narrows along four main axes: (1) osmolality, (2) medicament/hymostatic payload, (3) solid excipient identity and dispersion state, and (4) osmotic-pressure-control and formulation excipients.
What matters for freedom-to-operate (FTO) and claim-scope coverage is that the independent claim is not limited to a specific drug, specific mucosal site beyond “mucosa,” or a specific dosage form class beyond an aqueous composition for mucosal application, but it is tightly constrained by the osmolality threshold and by the presence of water-insoluble and/or low water-soluble substances in the aqueous matrix (with additional constraints in dependent claims).
What is the independent claim scope of US 7,235,247 (mucosa + osmotic pressure ≤150 mOsm + insoluble/low-soluble solid)?
Claim 1 (independent) covers:
- Product type: an aqueous pharmaceutical composition
- Intended site: application to the mucosa
- Core formulation elements:
- one or more water-insoluble and/or low water soluble substance(s)
- one or more medicament
- Critical functional limitation: the composition has an osmotic pressure of 150 mOsm or less
Immediate implication:
A composition that is aqueous, mucosal-applied, contains a low-solubility/insoluble solid phase, and is adjusted to ≤150 mOsm is within the claim’s structural and functional envelope, regardless of the medicament class.
Claim 1: what is and is not required
Required
- Aqueous medium
- Mucosal application
- At least one “water-insoluble and/or low water soluble substance”
- At least one medicament
- Osmotic pressure limit ≤150 mOsm
Not required
- Any specific medicament identity in Claim 1
- Any specific mucosal subtype (nasal mucosa is added later in dependent claims)
- Any particular particle size, unless later limited by “solid particles” language in dependent claims
- Any particular water-soluble polymer or surfactant (dependent claims add these)
When does the patent narrow to ≤90 mOsm, and why does it matter for design-around?
Claim 3 (dependent) narrows Claim 1/2 by adding:
- Osmotic pressure is 90 mOsm or less
Practical claim-scope effect:
- Claim 3 defines a stricter subclass within the base ≤150 mOsm concept.
- From a design-around perspective, any composition with osmolality between 90 and 150 mOsm avoids Claim 3 but may still fall within Claim 1/2 if all other elements are present.
Key point for litigation/FTO mapping:
You can’t treat Claim 3 as irrelevant because it can broaden downstream settlements. Parties often negotiate around the tightest dependent claim once a payer/regulator requires particular osmolality targets.
Which hemostatic agents are explicitly claimed for mucosal delivery, and does the list create strong coverage or safe harbors?
Claim 2 (dependent) adds a specific payload structure on top of Claim 1:
- Still aqueous mucosal composition
- Includes one or more hemostatic agent
- Still includes water-insoluble and/or low water soluble substance(s)
- Still includes medicament
- Osmotic pressure ≤150 mOsm
- Hemostatic agent is one or more selected from:
- tranexamic acid
- epsilon aminocaproic acid
- carbazochrome
- carbazochrome sulfonate
- carbazochrome sodium sulfonate
- phytonadione
- etamsylate
- monoethanol amine oleate
- thrombin
- hemocoaglase
- adrenochrome monoaminoguanidine mesilate
How Claim 2 affects scope
Coverage logic
- If a composition uses one of the listed hemostatics and meets the osmolality ceiling and insoluble/low-soluble solid requirement, it is directly within Claim 2.
Safe-harbor logic
- The hemostatic agent list is explicit; however, Claim 1 still covers “one or more medicament” generally.
- So even if you pick a non-listed hemostatic, Claim 1 can still capture the composition if all Claim 1 requirements are met (aqueous mucosal, insoluble/low-soluble solid, osmolality ≤150 mOsm, medicament included).
Bottom line: Claim 2 strengthens coverage for the specific hemostatic subset but does not eliminate Claim 1 exposure for alternative medicaments.
Does US 7,235,247 require an osmotic-pressure-controlling agent?
Claim 4 (dependent) adds:
- Further comprises an osmotic pressure-controlling agent
Claims 5–8 further specify examples:
- Claim 5: the osmotic pressure-controlling agent is a salt
- Claim 6: salt example is sodium chloride
- Claim 7: osmotic pressure-controlling agent is a water-soluble sugar
- Claim 8: sugar example is glucose
Claim-scope interpretation
- Claim 4 is optional (dependent), so the base Claim 1 does not require an osmotic-pressure-controlling agent.
- In product development and FTO, that matters: even if a formulation reaches ≤150 mOsm “intrinsically” through component selection and excludes NaCl or glucose, Claim 1 can still apply.
What solid excipient families are claimed (cellulose, crystalline cellulose, and “homogeneous dispersion”)?
Claim 9 (dependent):
- The water-insoluble and/or low water soluble substance is a cellulose
Claim 10:
- The cellulose is crystalline cellulose
Claims 11–12 control the physical presentation of the solid:
- Claim 11: water-insoluble/low-soluble substance present as solid particles in an aqueous medium
- Claim 12: substance is homogeneously dispersed as solid particles in an aqueous medium
Scope implications
- These dependent claims narrow the excipient identity (cellulose/crystalline cellulose) and the dispersion state.
- They do not narrow the base claim’s “water-insoluble and/or low water soluble substance” broadly.
If a competitor uses a different insoluble/low-soluble solid (e.g., crosslinked polymers, salts, hydrophobic excipients), they can still be within Claim 1 as long as the osmolality and aqueous mucosal application requirements are satisfied.
Which water-soluble polymers are claimed (and how do they constrain formulation variants)?
Claim 13 (dependent) adds:
- further comprising a water-soluble polymer substance
Claim 14 lists representative polymers:
- alginic acid
- polyethylene glycol
- glycerin
- polyoxyethylene polyoxypropylene glycol
- propylene glycol
- pectin
- low methoxyl pectin
- guar gum
- gum arabic
- carrageenan
- methyl cellulose
- carboxymethyl cellulose sodium
- xanthan gum
- hydroxypropyl cellulose
- hydroxypropyl methyl cellulose
Claims 15–17 single out:
- Claim 15: carboxymethyl cellulose sodium
- Claim 16: xanthan gum
- Claim 17: hydroxypropyl methyl cellulose
Claim 18 specifies a particular excipient pairing:
- combination of crystalline cellulose + carmellose sodium
Interpretation for product design
- The base invention does not require any polymer. Polymer choice matters most for Claim 13+ dependent coverage.
- If a competitor uses cellulose/crystalline cellulose plus a listed polymer while holding osmolality ≤150 mOsm, they likely overlap multiple dependent claims simultaneously (13 and 14, plus 9/10 and 18 depending on exact pairing).
Are surfactants required, and what specific surfactant is called out?
Claim 19 (dependent):
- further comprising a surfactant
Claim 20 specifies:
- polyoxyethylene (20) sorbitan monooleate
Surfactant is not required for Claim 1, but if a formulation includes one and it matches the dependent constraints, the claim coverage tightens.
Is the medicament required to be water-soluble or liposoluble?
Claims 21–22 (dependent):
- Claim 21: medicament is a water-soluble medicament
- Claim 22: medicament is a liposoluble medicament
Practical reading
- These dependent claims indicate the inventor intended to cover a range of medicament solubility classes.
- Neither limits Claim 1. They function as additional coverage lanes for different APIs or excipient-solubilized actives.
What mucosal targets are expressly covered (including nasal mucosa)?
Claim 23 (dependent):
Claim 24 (dependent):
- for nasal mucosa, medicament is selected from:
- antiallergic agent
- antihistamic agent
- anticholinergic agent
- steroid
- vaccine
- substance for gene therapy
Claim 25 (dependent):
Interpretation
- The invention begins broad on “mucosa” but adds nasal specifics through dependent claims.
- A nasal product with ≤150 mOsm and insoluble/low-soluble solids can land in multiple dependent claim groupings depending on therapeutic class and whether the drug is a steroid.
How are concentration limits added, and do they create additional patent exposure?
Claim 27 (dependent) sets ranges:
- water-insoluble/low-soluble substance: 1% w/w to 10% w/w
- medicament: 0.01% w/w to 1% w/w
Claim 28 ties those ranges to Claim 3 (≤90 mOsm subclass).
Claim 29 ties those ranges to Claim 2 (hemostatic agent subclass).
Scope impact
- Concentration ranges provide another narrowing dimension.
- A composition that meets Claim 1’s structural requirements but uses outside those ranges may avoid Claims 27–29 while still being within Claim 1 (depending on how the claim is construed by a court for the “aqueous pharmaceutical composition” element and the role of excipient quantities).
What claim groups create the highest overlap risk for generic or competitor formulations?
From the claim text, overlap risk clusters around combinations of (a) osmolality threshold, (b) insoluble/low-soluble solid class, and (c) mucosal target.
Highest-risk “claim stacks” (based on your provided claims)
-
Base claim exposure (broadest):
- Claim 1: aqueous mucosal composition + insoluble/low-soluble solid(s) + medicament + ≤150 mOsm
-
Nasal and therapeutic-class exposure (next layer):
- Claim 23: nasal mucosa
- Claim 24/25: medicament class (including steroid)
-
Hemostatic agent-specific exposure (parallel layer):
- Claim 2: hemostatic agent list + ≤150 mOsm + insoluble/low-soluble solid(s)
-
Excipient identity and physical presentation exposure (formula-centric layer):
- Claim 9/10: cellulose/crystalline cellulose
- Claim 11/12: solid particles and homogeneous dispersion
- Claim 13–18: water-soluble polymer list and specific combinations
-
Formulation adjunct exposure (process/formulation layer):
- Claim 4–8: osmotic pressure-controlling agent including NaCl and glucose
- Claim 19–20: surfactant including polysorbate-like agent (polyoxyethylene (20) sorbitan monooleate)
-
Concentration and tight osmolality exposure:
- Claim 3: ≤90 mOsm
- Claim 27–29: specific concentration ranges (with linkage to the tightest subclasses)
What is the practical “osmolality-first” design constraint implied by the claims?
US 7,235,247’s decisive functional limitation is osmotic pressure ≤150 mOsm, with an additional dependent threshold at ≤90 mOsm. In the context of mucosal tolerance, osmolality also tends to be a formulation driver, so competitors may inadvertently remain inside the claim if they pursue hypo-osmotic nasal tolerability.
Even if a competitor changes:
- the medicament identity,
- the hemostatic agent,
- the polymer,
- the surfactant,
- or the solid excipient identity,
they can still fall inside Claim 1 if they meet the core requirement: aqueous mucosal composition with insoluble/low-soluble solids and osmolality ≤150 mOsm.
Patent landscape framing: what would typically be paired with this formulation claim in US practice?
You asked for “scope and claims and patent landscape,” but the only provided landscape-relevant content is the claim text and the patent number. A full landscape requires the patent’s specification, prosecution history, related continuations, family members, and Orange Book/relevant litigations. Without that, the only defensible “landscape” statement is the claim-driven scope map above.
Within that map, this patent would typically be relevant as a formulation-composition barrier for mucosal aqueous products that use:
- insoluble/low-soluble solid dispersions, and
- osmolality-controlled hypo-osmotic targeting.
Key Takeaways
- US 7,235,247 is anchored by osmotic pressure ≤150 mOsm for aqueous mucosal compositions containing water-insoluble and/or low water-soluble substances and a medicament.
- The broadest coverage is Claim 1. Dependent claims add constraints on ≤90 mOsm, hemostatic agent list, nasal mucosa, specific solid excipients (cellulose/crystalline cellulose), polymer families, surfactant, osmotic-pressure-control agents (NaCl, glucose), and concentration ranges.
- Design-around focus should prioritize osmolality (≤150 vs. >150 mOsm) and whether the formulation includes a “water-insoluble and/or low water-soluble” solid phase in an aqueous mucosal application.
FAQs
1. Does US 7,235,247 cover nasal sprays or only nasal drops?
The claims state “aqueous pharmaceutical composition for application to the mucosa” and specify “nasal mucosa” in dependent claims. The claim text does not restrict to a specific dosage form beyond aqueous mucosal application.
2. If a formulation uses a non-listed hemostatic agent, can it still infringe?
Yes. Claim 1 is not limited to hemostatic agents and covers “one or more medicament” in an aqueous mucosal composition with insoluble/low-soluble substance(s) and osmotic pressure ≤150 mOsm.
3. What excipients most directly map to dependent claim coverage beyond the base invention?
Cellulose and crystalline cellulose (Claims 9–10), water-soluble polymers listed in Claims 13–18, osmotic pressure-controlling agents like NaCl and glucose (Claims 5–8), and the surfactant polyoxyethylene (20) sorbitan monooleate (Claims 19–20).
4. How do the concentration ranges function relative to the osmolality limit?
Claims 27–29 add explicit w/w ranges for the insoluble/low-soluble substance (1%–10%) and medicament (0.01%–1%), layered on top of specific claim dependencies (Claim 3 and/or Claim 2).
5. Is homogeneous dispersion of particles required for infringement?
No. “Solid particles” (Claim 11) and “homogeneously dispersed” (Claim 12) are dependent. Claim 1 does not require homogeneous dispersion language.
References
No sources were provided for the patent text beyond the claim list itself, and no additional documents (specification, file history, USPTO record, or Orange Book listings) were cited in the input.
