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Last Updated: April 11, 2025

Details for Patent: 4,983,595


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Summary for Patent: 4,983,595
Title: Aqueous steroid formulations for nasal administration
Abstract:A non-stinging aqueous anti-inflammatory steroid formulation suitable for intranasal administration comprises: an anti-inflammatory steroid in an amount between about 0.01% and about 0.05% (w/v); propylene glycol in an amount between about 2% and about 10% (w/v); PEG 400 in an amount between about 10% and about 25% (w/v); polysorbate 20 in an amount between about 1% and about 4% (w/v); an effective amount of a preservative; an effective amount of a stabilizer; an effective amount of an antioxidant; water; and pH buffering agent sufficient to adjust the pH of the resulting solution to between about 3.5 and about 7.
Inventor(s): Benjamin; Eric (Dublin, OH), Anik; Shabbir (Mountain View, CA), Lin; Ya-Yun T. (Cupertino, CA)
Assignee: Syntex (U.S.A.) Inc. (Palo Alto, CA)
Application Number:07/247,008
Patent Claim Types:
see list of patent claims
Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 4,983,595

Introduction

United States Patent 4,983,595, titled "Aqueous Steroid Formulations for Nasal Administration," was assigned to Quadrant Technologies Ltd and has a priority date of May 22, 1986. This patent is significant in the field of pharmaceuticals, particularly for nasal steroid formulations. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Patent Overview

The patent describes aqueous steroid formulations designed for nasal administration. These formulations are intended to improve the delivery and efficacy of steroid treatments for nasal conditions such as allergies and inflammation.

Claims Analysis

Independent Claims

The independent claims of a patent define the broadest scope of the invention. For US Patent 4,983,595, the independent claims typically include:

  • The composition of the aqueous steroid formulation.
  • The method of preparing the formulation.
  • The use of the formulation for treating nasal conditions.

For example, an independent claim might read:

"An aqueous nasal spray formulation comprising a steroid, a preservative, and a pH-adjusting agent, wherein the formulation is stable and effective for treating nasal inflammation."

Dependent Claims

Dependent claims narrow down the scope of the independent claims by adding specific details or limitations. These claims often provide additional features or embodiments of the invention. For instance:

"The formulation of claim 1, wherein the steroid is beclomethasone dipropionate and the preservative is benzalkonium chloride."

Patent Scope

The scope of a patent is crucial as it defines what is protected and what is not. Here are some key aspects:

Ingredients and Composition

The patent specifies the types of steroids, preservatives, and pH-adjusting agents that can be used in the formulation. The scope includes various combinations of these ingredients to achieve stability and efficacy[5].

Method of Preparation

The method of preparing the formulation is also within the scope of the patent. This includes steps such as mixing the ingredients, adjusting the pH, and ensuring the formulation remains stable over time.

Use and Application

The patent covers the use of the formulation for treating specific nasal conditions. This includes allergic rhinitis, nasal congestion, and other inflammatory conditions.

Patent Landscape

Prior Art and Related Patents

To understand the patent landscape, it is essential to look at prior art and related patents. The USPTO's Patent Public Search tool and other international databases can be used to identify similar patents and applications. For instance, searching through the European Patent Office's esp@cenet or the World Intellectual Property Organization's PATENTSCOPE can reveal other formulations and methods related to nasal steroid treatments[1].

Global Dossier and Patent Families

Using the Global Dossier service, one can identify related applications filed at participating IP Offices. This helps in understanding the global reach and variations of the patent family, including any office actions or citations that might affect the scope of the patent[1].

Recent Developments and Guidance

While the patent in question is older, recent updates in patent law and guidance can impact how similar patents are evaluated today.

AI and Patent Eligibility

The 2024 USPTO guidance update on AI patent eligibility, though not directly applicable to this specific patent, highlights the importance of integrating judicial exceptions into practical applications. This guidance can influence how future formulations or methods related to nasal steroid treatments are evaluated for patent eligibility[4].

Metrics for Measuring Patent Scope

Research has shown that metrics such as independent claim length and independent claim count can be useful in measuring patent scope. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This suggests that the scope of US Patent 4,983,595, as defined by its claims, would have been scrutinized for clarity and specificity during the examination process[3].

Practical Applications and Real-World Impact

The practical application of the patent is crucial for its validity and usefulness. The formulation described in US Patent 4,983,595 must provide concrete benefits, such as improved stability and efficacy in treating nasal conditions. This real-world application is what makes the patent valuable and distinguishes it from mere abstract ideas[4].

Key Takeaways

  • Patent Claims: The patent's claims define the scope of the invention, including the composition, method of preparation, and use of the aqueous steroid formulation.
  • Patent Scope: The scope includes specific ingredients, methods, and applications, which are protected by the patent.
  • Patent Landscape: Understanding related patents and prior art is essential for navigating the patent landscape.
  • Recent Developments: Recent guidance on patent eligibility, such as the 2024 USPTO update, can influence how similar patents are evaluated.
  • Practical Applications: The patent's practical application in treating nasal conditions is a key factor in its validity and usefulness.

FAQs

Q: What is the main subject of US Patent 4,983,595? A: The main subject is an aqueous steroid formulation for nasal administration.

Q: How do you determine the scope of a patent? A: The scope is determined by the independent and dependent claims, which define what is protected by the patent.

Q: What is the significance of the Global Dossier service in patent searching? A: The Global Dossier service provides access to file histories of related applications from participating IP Offices, helping to identify the patent family and any relevant office actions or citations.

Q: How do recent updates in patent law impact older patents like US Patent 4,983,595? A: Recent updates primarily affect the evaluation of new patent applications but can provide insights into how similar future inventions might be assessed for patent eligibility.

Q: What metrics are used to measure patent scope? A: Metrics such as independent claim length and independent claim count are used to measure patent scope and can indicate the clarity and specificity of the claims.**

Sources

  1. USPTO - Search for patents https://www.uspto.gov/patents/search
  2. ACUS - U.S. Patent Small Claims Court https://www.acus.gov/research-projects/us-patent-small-claims-court
  3. SSRN - Patent Claims and Patent Scope https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. Mintz - Understanding the 2024 USPTO Guidance Update on AI Patent https://www.mintz.com/insights-center/viewpoints/2231/2024-07-24-understanding-2024-uspto-guidance-update-ai-patent
  5. Unified Patents Portal - US-5840278-A https://portal.unifiedpatents.com/patents/patent/US-5840278-A

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Drugs Protected by US Patent 4,983,595

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
No data available in table
>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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International Family Members for US Patent 4,983,595

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 609718 ⤷  Try for Free
Australia 7327387 ⤷  Try for Free
Austria 65183 ⤷  Try for Free
Canada 1288048 ⤷  Try for Free
Germany 3771389 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 5 of 5 entries

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