Details for Patent: 7,189,761

Summary for Patent: 7,189,761

Title:	Nitric oxide donor composition and method for treatment of anal disorders
Abstract:	A pharmaceutical composition contains a nitric oxide donor and advantageously an optional corticosteroid and/or topical anesthetic. The composition is useful in a method for treating anal disorders such as anal fissure, anal ulcer, hemorrhoidal disease, levator spasm, and so forth, by topical application to or proximate the affected area.
Inventor(s):	Stephen R. Gorfine
Assignee:	Strakan International SA
Application Number:	US10/669,099
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 7,189,761: Scope, Claim-by-Claim Coverage, and US Landscape for Topical/Local Nitric Oxide Donors for Anal-Disorder Pain

What does US 7,189,761 claim in plain technical terms?

US 7,189,761 is directed to methods for ameliorating pain from anal disorders by administering an organic nitric oxide (NO) donor formulated for local delivery proximate to, or directly to, the affected area. The claims cover multiple anal indications (anal fissure, anal ulcer, hemorrhoidal disease) and multiple formulation routes (topical compositions and suppositories), with composition-strength ranges and optional adjunct actives (corticosteroid, local anesthetic).

The independent claim set is structured as:

• Claim 1: method of ameliorating pain associated with selected anal disorders using an organic NO donor, delivered proximate to or at the affected area, where pain is ameliorated.
• Claim 23: broader parallel method claim framed around applying a composition that includes an organic compound releasing NO under physiological or anal-disease treatment conditions plus a carrier, again with pain amelioration.

Claim chart: coverage and legal scope

1. Independent claims

Claim 1 (method; pain amelioration; organic NO donor; location proximate to/at lesion; anal disorders)

• Preamble/indication scope: “anal disorder selected from… anal fissure, anal ulcer, and hemorrhoidal disease”
• Core activity: administering an “effective amount of an organic nitric oxide donor proximate to, or to, the affected area”
• Mechanism limitation (functional): NO donor is “capable of releasing nitric oxide under physiological conditions” (pulled through dependent claims 4 and later by limitation flow)
• Outcome: “pain is ameliorated”

Practical scope implication: The independent claim anchors the case on (i) organic NO donor, (ii) local proximity/targeting to anal lesion, and (iii) pain amelioration outcome. If a product delivers NO locally to those conditions, it sits within the core theory even if the carrier or exact formulation differs, subject to dependent-claim limitations not being required for infringement.

Claim 23 (method; pain amelioration; apply composition; organic compound releases NO under physiological or anal-disease treatment conditions; carrier)

• Preamble/indication scope: pain associated with anal fissure, anal ulcer, or hemorrhoid
• Core activity: applying a composition comprising
  • an “organic compound which can release nitric oxide under physiological or anal disease treatment conditions”
  • a physiologically acceptable carrier
• Location: “to an area proximate to, or to, the affected area”
• Outcome: pain is ameliorated

Practical scope implication: Claim 23 is the “composition-application” variant. It captures products where the formulation is explicitly “applied” with an organic NO-releasing compound plus carrier. It does not, on its face, require the same formulation type as Claim 1; it is compatible with topical or suppository approaches depending on additional dependent claims.

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2. Dependent claims tied to indication type

Claim 2: anal fissure or ulcer (narrows within fissure/ulcer subset)
Claim 3: hemorrhoidal disease (narrows within hemorrhoid subset)
Claims 24-25 (dependent on Claim 23):

• Claim 24: affected area has hemorrhoid
• Claim 25: affected area has anal ulcer or anal fissure

Infringement relevance: These are indication-specific fallbacks. A product used for hemorrhoids maps to Claim 3/24. One used for fissures/ulcers maps to Claim 2/25.

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3. Dependent claims tied to NO donor capability (functional release limits)

Claim 4 (dependent on Claim 1): organic NO donor “capable of releasing nitric oxide under physiological conditions”
Claim 11: NO donor capable of releasing NO under “anal disease treatment conditions”

Infringement relevance: The claim set does not require a specific donor chemistry in the text you provided, but it does require the donor to be “capable of releasing” NO in relevant conditions. This becomes the main technical test: whether the compound is an organic NO donor and whether NO is released under physiological/anal-disease conditions.

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4. Dependent claims tied to route and dosage form (topical vs suppository)

Claims 5-9 (dependent on Claim 4):

• Claim 5: topical; NO donor in ointment/cream/gel/lotion
• Claim 6: applied to a hemorrhoid
• Claim 7: applied to an anal fissure or anal ulcer
• Claim 8: topical; liquid or semisolid
• Claim 9: suppository

Claims 12-15 (dependent on Claim 1):

• Claim 12: administering is topical
• Claim 13: administering via suppository
• Claim 14: applied proximate
• Claim 15: applied to affected area (direct application)

Claims 13 and 15 split between “proximate” and “to” the affected area. For product scope, that matters: a suppository/rectal formulation used to contact the lesion plausibly matches “to,” while an external peri-anal topical may map to “proximate.”

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5. Dependent claims tied to composition strength ranges

Claim 10 (dependent on Claim 5/16 structure as provided):

• NO donor amount from 0.0 1% to 10% by weight (the text shows “0.0 1%”; read as 0.01% in typical patent formatting) Claim 16: NO donor amount from 0.01% to 10% by weight

Claims 17 (carrier list): Carrier selected from:

• white petrolatum
• mineral oil
• lanolin
• distilled water
• acetone
• cocoa butter

Infringement relevance:

• If a challenger product’s NO donor concentration falls outside 0.01% to 10%, it may avoid the dependent-claim fallbacks, but it may still infringe independent Claim 1 or 23 depending on how “effective amount” is argued and whether “carrier” is required (Claim 23 does require a carrier; Claim 1 does not explicitly require carrier in the text you provided).
• Claim 17 limits to listed carriers if asserted under that dependent claim path.

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6. Dependent claims with optional adjunct actives (combo therapy)

Claim 18: composition further comprises a corticosteroid
Claim 19: composition further comprises a local anesthetic

Infringement relevance:

• These are “add-on” limitations. A mono-therapy product (NO donor only) still potentially infringes independent claims. Combo products that include corticosteroid or local anesthetic can be targeted by these narrower dependent claims if other elements are met.

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7. Dependent claims tying formulation type to Claim 16/23

Claims 20-22: topical ointment/cream/gel/lotion; liquid/semisolid; suppository (all dependent on Claim 16)
Claim 26: organic compound formulated as a suppository (dependent on Claim 23)

Infringement relevance: These claims close gaps for different presentation forms.

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What is the practical claim “center of gravity” for infringement risk?

Across Claims 1 and 23, the center of gravity is:

1. Indication: anal fissure, anal ulcer, or hemorrhoid pain
2. Active: “organic nitric oxide donor” (or organic NO-releasing compound)
3. Delivery: “proximate to, or to,” the affected area
4. Functional requirement: “pain is ameliorated”
5. Composition optionality:
   • Claim 23 explicitly requires a carrier
   • Dependent claims specify formulation types and NO donor concentration ranges

A product that matches these elements will be positioned to hit independent claims regardless of whether it also matches the specific dependent limitations (e.g., corticosteroid inclusion or particular carriers), depending on construction of “effective amount” and the factual record around pain amelioration.

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Patent landscape: where US 7,189,761 sits against common US filing clusters

Without the rest of the patent family and without the full specification text or citation list, the landscape analysis must focus on the claim scope you provided: topical/local NO-donor delivery for pain associated with anal disorders.

Landscape segmentation by technology axis

1) NO-donor chemistry axis

• Targets compounds that are organic NO donors (functional NO release).
• Competitive risk comes from later-developed organic nitro/NO donor classes used in rectal or peri-anal pain contexts, even if framed around different mechanisms.

2) Formulation and route axis

• Claims cover topical semisolids/liquids and suppositories.
• Competitive products often differentiate by:
  • delivery vehicle (vehicle choice, viscosity, penetration enhancers)
  • dosage form (cream vs suppository)
  • dosing concentration of the NO donor

3) Indication and symptom axis

• The patent is symptom-linked: pain amelioration for:
  • anal fissure
  • anal ulcer
  • hemorrhoidal disease/hemorrhoid

This indication tailoring can protect against broader NO donor art that targets other anorectal endpoints (e.g., healing, bleeding, inflammation) without a direct pain amelioration claim structure.

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How competitors can design around (claim-relevant pathways)

Design-around levers mapped to the claim set

1. Avoid the NO donor category

   • If a competitor uses a non-organic NO source or a mechanism that does not fit “organic nitric oxide donor” / “organic compound which can release nitric oxide,” independent claims become harder to reach.

2. Change the delivery target

   • Products that treat systemic pain or general anorectal inflammation without local “proximate to, or to” the affected area lose a key spatial limitation.

3. Change the concentration envelope

   • Dependent claims 10 and 16 recite 0.01% to 10% by weight. A product outside that range can target a gap in the dependent claim fallbacks (though independent claim exposure remains because “effective amount” can still be argued).

4. Route change is not a full escape

   • The claims already include both topical and suppository routes. Changing between those does not automatically avoid infringement.

5. Adjunct-only changes do not avoid the core

   • Adding or removing corticosteroid or local anesthetic affects dependent claims 18-19, but not the basic NO-donor pain amelioration concept in independent claims 1 and 23.

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Freedom-to-operate posture implied by the claim structure

Key practical risk profile

• High risk for companies selling:
  • rectal or peri-anal NO donor creams/ointments/gels/lotions or suppositories
  • with an indication for pain from anal fissure/ulcer/hemorrhoids
  • and backed by pharmacology or clinical language asserting pain relief
• Moderate risk for:
  • products aimed at healing or reducing bleeding but marketed or used with pain-related claims
  • products with nonmatching concentration (dependent-claim gap but not a true avoidance of independent claims)
• Lower risk for:
  • products that do not release NO via an organic NO-donor mechanism
  • products used systemically or applied without local proximity to the lesion
  • products where the claimed therapeutic effect is not “pain amelioration,” and the product is not positioned in that way

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Key Takeaways

• US 7,189,761 claims local, organic NO donor delivery for pain amelioration in anal fissure, anal ulcer, and hemorrhoids.
• The enforceable core is Claims 1 and 23: administer/apply an organic NO donor/NO-releasing organic compound “proximate to, or to” the lesion, using an effective amount, where pain is ameliorated.
• The patent also covers detailed fallbacks on:
  • topical vs suppository routes (and direct vs proximate application)
  • NO donor concentration (0.01% to 10% by weight in dependent claims)
  • listed carriers (white petrolatum, mineral oil, lanolin, distilled water, acetone, cocoa butter)
  • adjunct combo therapy (corticosteroid; local anesthetic)
• Design-around pathways that actually reduce exposure focus on:
  • leaving the “organic NO donor” / organic NO-releasing mechanism
  • removing local lesion-proximate delivery
  • avoiding pain-amelioration positioning (as used in the claim construction and evidence)

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FAQs

1) What elements must a product satisfy to fall under US 7,189,761 Claim 1?
A method for ameliorating pain in a patient with anal fissure/anal ulcer/hemorrhoidal disease using an organic NO donor administered proximate to, or to, the affected area, where pain is ameliorated.

2) Does the patent cover both creams and suppositories?
Yes. Dependent claims explicitly cover topical ointments/creams/gels/lotions and suppositories.

3) What concentration limits appear in the claims?
Dependent claims recite NO donor amounts from 0.01% to 10% by weight.

4) Can a competitor avoid infringement by removing corticosteroid or local anesthetic?
Removing those adjuncts helps only against the narrower combo-dependent claims (e.g., corticosteroid/local anesthetic). It does not remove the core NO-donor pain amelioration claims.

5) Is the patent limited to one anal disorder?
No. It covers anal fissure, anal ulcer, and hemorrhoidal disease/hemorrhoid.

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References

[1] User-provided claim text for US Patent 7,189,761 (claims 1-26).

Drugs Protected by US Patent 7,189,761

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,189,761

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	196082
Austria	374607
Australia	2282395