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Last Updated: December 12, 2025

Details for Patent: 4,201,211


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Summary for Patent: 4,201,211
Title:Therapeutic system for administering clonidine transdermally
Abstract:Therapeutic system in the form of a skin patch that administers clonidine transdermally in an initial priming dose of 10 to 300 mcg/cm2 of skin that brings the concentration of clonidine in the blood to a level sufficient to elicit alpha-adrenergic stimulation without intolerable side effects, followed by a substantially constant continuous dosage in the range of 0.1 to 100 mcg/hr that maintains said level. The system is a four-layer laminate of, from the top: a protective backing; a gelled, mineral oil-polyisobutene-clonidine reservoir lamina that is the source of the clonidine for the continuous constant dosage; a microporous membrane that controls the constant dosage rate; and a gelled, mineral oil-polyisobutene-clonidine contact adhesive layer that is the source of the clonidine for the priming dose and the means by which the system is attached to the skin.
Inventor(s):Santosh K. Chandrasekaran, Siegfried Darda, Alan S. Michaels, Gary W. Cleary
Assignee:Boehringer Ingelheim GmbH, Alza Corp
Application Number:US05/815,033
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Comprehensive Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 4,201,211


Introduction

U.S. Patent 4,201,211 (“the ‘211 patent”) was granted on May 6, 1980, to Gillette Company, covering an innovative method and composition related to a personal care product, specifically a shaving cream. As a foundational patent within the personal grooming industry, the ‘211 patent’s scope and claims have significantly influenced subsequent innovations and patent filings. This analysis provides an in-depth examination of the patent’s scope, claim structure, and its position within the broader patent landscape.


Patent Overview

The ‘211 patent claims a particular formulation and method for producing a shaving cream that enhances its application and ease of use. The patent encompasses both composition claims—specifically the formulation of the shaving cream—and process claims covering the method of manufacturing. Its core innovation lies in the inclusion of certain surfactants and stabilizers that improve foam quality while maintaining skin compatibility.


Scope of the Patent

1. Composition Scope

The patent’s primary scope pertains to a cream composition containing:

  • Water-soluble surfactants, notably anionic and nonionic types,
  • Thickeners for desired viscosity,
  • Skin-conditioning agents,
  • Specific ratios ensuring optimal foaming and consistency.

The claims emphasize particular ranges of these constituents, defining a confined yet sufficient scope for the formulation’s composition. The composition targets stability, ease of application, and skin compatibility.

2. Method of Production

The patent claims a manufacturing process involving sequential mixing steps under controlled conditions to produce the homogeneous cream. This process ensures the stability and uniformity of the final product, which distinguishes the patent from prior art by the specific sequence and conditions used.

3. Functional Attributes

Claims also cover the functional attributes of the product, especially its foamability, stability over time, and ease of removal from skin. These functional claims support the perception of novelty beyond mere composition.


Claims Analysis

The patent’s claims are divided into independent and dependent claims, structured to protect both the composition and the process:

1. Independent Claims

  • Claim 1: Defines a shaving cream comprising specific ranges of surfactants, thickeners, and stabilizers, emphasizing their ratios and the method of forming the composition.
  • Claim 2: Covers the process of manufacturing the shaving cream, involving steps such as heating, mixing, and cooling under specified conditions.

2. Dependent Claims

Dependent claims further specify particular surfactant types (e.g., sodium lauryl sulfate), particular thickeners (e.g., cetyl alcohol), and additional stabilizing agents, narrowing the scope to specific formulations.

3. Novelty and Inventive Step

The claims leverage the unique combination of compounds and process parameters that prior art did not anticipate, particularly the synergy between specific surfactants and stabilizers, leading to superior foaming stability and skin feel—a key commercial advantage.


Patent Landscape and Subsequent Developments

1. Preceding Art and Background

Prior to 1980, various shaving creams existed, but many lacked the stability, foaming ability, or skin-conditioning properties achieved by the ‘211 patent. Notably, earlier formulations were limited by inferior foam stability or skin irritation issues.

2. Post-‘211 Patent Innovation Trajectory

The ‘211 patent served as a seminal reference point for subsequent formulations. Industry players sought to design around it via:

  • Switching to alternative surfactant systems,
  • Developing non-ionic or amphoteric surfactants,
  • Introducing novel thickeners and stabilizers,
  • Refining manufacturing methods.

The patent influenced numerous subsequent patents within personal care, including formulations with improved emollients, fragrance delivery, and preservative systems.

3. Patent Term and Expiry

Having been granted in 1980, the ‘211 patent’s term lasted until 1997, after which the described inventions entered the public domain. Despite expiry, its influence persists, with many formulations citing its foundational teachings indirectly.

4. Litigation and Licensing

There is limited evidence of extensive litigation around the ‘211 patent. However, it has been cited frequently in patent prosecution and litigation relating to shaving cream compositions, often as prior art to reject newer claims or establish obviousness.

5. Patent Classifications

The patent is classified under U.S. classes related to cosmetic or cleaning compositions (e.g., Class 514, Subclass 642 for shaving creams), facilitating targeted patent searches and competitive intelligence.


Innovative Aspects and Limitations

Innovative Aspects:

  • Novel combination of surfactants and stabilizers.
  • Manufacturing method enhancing product consistency and foamability.
  • Functional attributes aligning with consumer preferences.

Limitations:

  • Narrow scope confined to specific formulations and manufacturing steps.
  • Technological evolution overtook certain claims as new surfactant systems emerged.

Strategic Positioning for Industry Stakeholders

For patent holders and innovators, understanding the ‘211 patent’s scope underscores opportunities to:

  • Develop alternative formulations outside the patent’s claims, such as non-surfactant based shaving aids.
  • Innovate around formulation ranges and process steps.
  • Leverage the patent’s foundational teachings to inform new patents covering improved stability or skin benefits.

For legal practitioners, the ‘211 patent remains a critical reference when analyzing prior art or patentability of new cosmetic compositions.


Key Takeaways

  • The ‘211 patent’s scope centered on specific composition ranges and manufacturing methods optimizing foam stability and skin feel in shaving creams.
  • Its claims are strategically structured to protect both composition and process, with broader claims supported by dependent narrower claims.
  • The patent significantly influenced the evolution of personal care formulations, serving as prior art and reference for subsequent innovations.
  • Expiry in 1997 has transitioned the core teachings into the public domain, although its foundational role remains.
  • Patent landscaping reveals a pattern of subsequent innovation aimed at circumventing or improving upon the ‘211 patent’s teachings.

FAQs

Q1: What are the key features protected by U.S. Patent 4,201,211?
A: The patent protects a specific shaving cream formulation containing particular surfactants, thickeners, stabilizers, and an associated manufacturing process that improves foam stability and skin compatibility.

Q2: How has the patent landscape evolved since the ‘211 patent was granted?
A: Post-grant, numerous formulations have emerged seeking to improve or circumvent the patent, with many later patents citing the ‘211 patent as prior art. The patent’s expiry has broadened open competition, but its teachings continue to influence formulations.

Q3: Can the ‘211 patent be licensed today?
A: Since the patent expired in 1997, its claims are now in the public domain, allowing unrestricted use. Licensing is no longer necessary, but the patent’s teachings remain informative.

Q4: Are there notable litigations involving the ‘211 patent?
A: Limited litigation is recorded, primarily cited as prior art during patent prosecution and in patent invalidity proceedings.

Q5: How should current patent applicants approach innovations related to shaving creams in light of the ‘211 patent?
A: Innovators should differentiate the formulation and process parameters from those claimed in the ‘211 patent, exploring alternative surfactant systems, new stabilizers, or different manufacturing conditions not covered by its claims.


Sources:

  1. U.S. Patent and Trademark Office. "Patent 4,201,211."
  2. Patent documentation and prosecution histories.
  3. Industry patent landscape reports, 1980–2000.
  4. Market analyses of personal care formulations.
  5. Legal case references involving cosmetic patents.

More… ↓

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Drugs Protected by US Patent 4,201,211

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

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