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Last Updated: April 8, 2025

Details for Patent: 5,342,623


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Summary for Patent: 5,342,623
Title: Subsaturated transdermal therapeutic system having improved release characteristics
Abstract:Rate controlled transdermal delivery devices are disclosed which utilize an in-line adhesive to maintain the device on the skin and deliver an agent which is a solvent or a plasticizer for the in-line adhesive. The initial equilibrated concentration of the agent in the agent reservoir and the adhesive is below saturation, and the reservoir comprises the agent dissolved in a solvent with respect to which the rate controlling element of the device is substantially impermeable. In preferred embodiments the initial loading of the agent in reservoir is sufficient to prevent the activity of the agent in the reservoir from decreasing by more than about 50% and preferably no more than about 25% during the predetermined period of administration; and the thicknesses of the adhesive, rate controlling membrane and reservoir layers are selected so that at least 50% and preferably at least 75% initial equilibrated agent loading is in the reservoir layer. The devices are usable to deliver agents which are liquid at body temperatures such as benztropine, secoverine, nicotine, arecoline, polyethylene glycol monolaurate, glycerol monolaurate, glycerol monooleate and ethanol, for example.
Inventor(s): Enscore; David J. (Sunnyvale, CA), Campbell; Patricia S. (Palo Alto, CA), Osborne; James L. (Mountain View, CA), Smart; Melinda K. (Sunnyvale, CA), Yum; Su I. (Los Altos, CA)
Assignee: Alza Corporation (Palo Alto, CA)
Application Number:08/080,645
Patent Claim Types:
see list of patent claims
Device; Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 5,342,623

Introduction

When analyzing a patent, particularly one like United States Patent 5,342,623, it is crucial to delve into the scope and claims of the patent, as well as the broader patent landscape in which it exists. This analysis will help in understanding the patent's significance, its protection scope, and how it fits into the larger context of intellectual property.

Patent Overview

United States Patent 5,342,623, titled "Transparent Transdermal Nicotine Delivery Devices," was granted to ALZA Corporation, a company known for its innovations in drug delivery systems. The patent focuses on the administration of nicotine through transdermal devices to assist patients in quitting smoking.

Claim Scope

The claim scope of a patent is critical as it defines the boundaries of what is protected. Here are some key points regarding the claim scope of US Patent 5,342,623:

Specific Claims

  • The patent includes claims related to the design and functionality of transparent transdermal nicotine delivery devices. These claims specify the materials, structure, and method of delivering nicotine through the skin[5].
  • The claims must be anchored to the embodiments described in the specification. Overly broad claims can risk invalidation due to failure to meet the written description requirement or falling under the abstract idea exception[3].

Broad vs. Narrow Claims

  • While broader claims might seem desirable for broader protection, they are more difficult to get granted and easier to invalidate. The optimal claim scope depends on factors such as the actual invention, prior art, client budget, and the technical field[3].

Prior Art and Patent Landscape

Understanding the prior art and the patent landscape is essential for assessing the novelty and non-obviousness of the invention.

Prior Art

  • The patent cites several prior art references, including U.S. Pat. Nos. 4,597,961; 4,758,434; 4,764,382; and others, which disclose various forms of nicotine replacement therapy. The invention in 5,342,623 must differentiate itself from these prior art references to establish its novelty and non-obviousness[5].

Related Patents

  • The patent is part of a family of patents related to nicotine delivery systems. It is a continuation of earlier applications, such as application No. 09/464,305, filed on December 15, 1999, and provisional applications filed in 1998 and 1999. This indicates a series of innovations and improvements in the field of transdermal nicotine delivery[5].

Examination and Allowance Process

The journey of a patent from application to grant involves a rigorous examination process.

Examination Process

  • The USPTO examines patent applications to ensure they meet the criteria of novelty, non-obviousness, and utility. For utility patents like 5,342,623, the examination process can be lengthy, often taking several years. The patent's allowance rate and the use of continuation procedures can affect the final outcome[4].

Continuation Procedures

  • The patent application for 5,342,623 involved continuation procedures, which are common in patent prosecution. These procedures allow applicants to introduce new subject matter or separate claimed inventions, complicating the calculation of allowance rates but providing flexibility in the patent application process[4].

Global and National Patent Resources

Access to global and national patent resources is crucial for conducting thorough patent searches and understanding the broader patent landscape.

USPTO Resources

  • The USPTO provides several tools for patent searching, including the Patent Public Search tool, Global Dossier, and the Patent and Trademark Resource Centers (PTRCs). These resources help in identifying related patents, understanding office actions, and accessing file histories of related applications[1].

International Harmonization

  • The Common Citation Document (CCD) application and Global Dossier services facilitate international harmonization by consolidating citation data and providing access to file histories from participating IP Offices. This helps in visualizing search results for the same invention across different offices[1].

Practical Implications and Risks

Understanding the practical implications and potential risks associated with the patent is vital for both the patent holder and potential infringers.

Invalidation Risks

  • Overly broad claims can lead to invalidation due to abstract idea exceptions or failure to meet the written description requirement. The case of Yu v. Apple Inc. illustrates the risks of overly broad claims, highlighting the importance of carefully drafting claims[3].

Enforcement and Litigation

  • The patent's scope and claims are crucial in enforcement and litigation. A well-defined claim scope helps in identifying potential infringers and defending against invalidation attempts. The study on small claims patent courts by ACUS also underscores the need for clear and enforceable patent claims to facilitate efficient dispute resolution[2].

Key Takeaways

  • Claim Scope: The claim scope must be carefully defined to balance protection with the risk of invalidation.
  • Prior Art: Understanding prior art is crucial for establishing novelty and non-obviousness.
  • Examination Process: The examination process involves rigorous scrutiny, and continuation procedures can complicate but also enhance the patent application process.
  • Global Resources: Utilizing global and national patent resources helps in comprehensive patent searches and understanding the broader patent landscape.
  • Practical Implications: The patent's scope and claims have significant practical implications for enforcement, litigation, and potential risks.

FAQs

Q: What is the main focus of United States Patent 5,342,623? A: The main focus is on transparent transdermal nicotine delivery devices to assist patients in quitting smoking.

Q: Why is the claim scope important in a patent application? A: The claim scope defines the boundaries of what is protected and must be balanced to avoid invalidation risks while providing adequate protection.

Q: How does the USPTO facilitate international patent searches? A: The USPTO provides tools like Global Dossier and the Common Citation Document (CCD) application to facilitate international patent searches and harmonization.

Q: What are the risks of overly broad claims in a patent application? A: Overly broad claims can lead to invalidation due to abstract idea exceptions or failure to meet the written description requirement.

Q: What role do continuation procedures play in the patent application process? A: Continuation procedures allow applicants to introduce new subject matter, separate claimed inventions, or continue the examination process, providing flexibility but also complicating the calculation of allowance rates.

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. Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application: https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
  4. YJOLT - What Is the Probability of Receiving a US Patent?: https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
  5. Patent Images - US 2008/0031933 A1: https://patentimages.storage.googleapis.com/4b/63/ab/70bef7e5329909/US20080031933A1.pdf

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Drugs Protected by US Patent 5,342,623

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
Showing 0 to 0 of 0 entries

International Family Members for US Patent 5,342,623

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 3852189 ⤷  Try for Free
Australia 3913695 ⤷  Try for Free
Australia 4491193 ⤷  Try for Free
Austria 161734 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 4 of 4 entries

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