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Last Updated: April 9, 2025

Patent: 10,016,338


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Summary for Patent: 10,016,338
Title:Trilayer coated pharmaceutical packaging
Abstract: An article is described including an article surface and a coating set comprising a tie coating or layer of SiO.sub.xC.sub.y or Si(NH).sub.xC.sub.y applied to the article surface, a barrier coating or layer of SiO.sub.x, and a pH protective layer of SiO.sub.xC.sub.y or Si(NH).sub.xC.sub.y. The respective coatings or layers can be applied by chemical vapor deposition of a polysiloxane or polysilazane precursor in the presence of oxygen. Examples of such an article are a prefilled thermoplastic syringe or thermoplastic pharmaceutical vial with a coated interior portion containing a pharmaceutical preparation or other fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic syringe or vial, and the tie coating or layer and pH protective coating or layer together protect the barrier layer from the contents of the syringe or vial.
Inventor(s): Weikart; Christopher (Auburn, AL), Clark; Becky L. (Auburn, AL), Stevenson; Adam (Opelika, AL), Felts; John T. (Alameda, CA)
Assignee: SIO2 MEDICAL PRODUCTS, INC. (Auburn, AL)
Application Number:15/385,150
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,016,338

Introduction

Understanding the intricacies of a patent, particularly one like United States Patent 10,016,338, involves a deep dive into its claims, the broader patent landscape, and the legal and technical contexts in which it exists. This analysis will cover the key aspects of patent claims, the role of AI in patent applications, and the critical factors influencing the patent's validity and enforceability.

Understanding Patent Claims

Definition and Importance

Patent claims are the heart of a patent application, defining the scope of the invention and what is protected by the patent. They must be clear, concise, and supported by the specification[5].

Types of Claims

  • Independent Claims: These claims stand alone and define the invention without reference to other claims.
  • Dependent Claims: These claims refer back to and further limit an independent claim.
  • Method Claims: These describe a process or method.
  • Apparatus Claims: These describe a device or system.

Claim Construction

The interpretation of patent claims is crucial for determining the scope of protection. Claim construction involves identifying the meaning of each term in the claim, which can be influenced by the specification, prosecution history, and prior art[5].

The Role of AI in Patent Applications

AI-Assisted Inventions

AI is increasingly being used to assist in the invention process, but it cannot be named as an inventor. According to the USPTO, AI-assisted inventions are not categorically unpatentable, but the inventorship must focus on human contributions[1].

Significant Human Contribution

For an AI-assisted invention to be patentable, a human being must have made a significant contribution to the conception of the claimed invention. This contribution must be evidenced, and the USPTO has provided guidelines to help determine what constitutes a significant contribution[1].

Disclosure Requirements

If AI tools are used in the patent application process, their use must be disclosed to the USPTO. This includes any material information that could affect patentability, such as evidence that an AI system made contributions that the named inventor did not conceive[3].

Patent 10,016,338: A Case Study

Overview of the Patent

To analyze the specific patent, one would need to review the patent document itself, which includes the background, summary, detailed description, and claims. Here, we will focus on general principles applicable to such patents.

Claim Analysis

  • Claim Scope: Determine the exact subject matter claimed in the patent. This involves analyzing each claim to understand what is protected.
  • Claim Dependency: Identify whether the claims are independent or dependent and how they relate to each other.
  • Claim Validity: Assess whether the claims are valid by checking for novelty, non-obviousness, and utility.

Prior Art Search

A thorough prior art search is essential to determine the novelty and non-obviousness of the invention. This involves searching global patent publications and non-patent literature to identify any similar inventions[4].

Patent Landscape and Competitors

Global Patent Landscape

Understanding the global patent landscape helps in identifying potential competitors and similar inventions. This can be achieved through comprehensive patent search services that provide a view of the global patent landscape[4].

Patent Validity and Invalidity Searches

Conducting patent validity and invalidity searches can help defend against patent infringement claims and assess the strength of the patent. These searches involve comparing the key features of the invention to relevant prior art[4].

Legal Considerations

Inventorship Determination

Proper inventorship is crucial for the validity of a patent. The determination focuses on the conception step, requiring the identification of each person who conceived the idea or ideas of the patent claims[5].

Deceptive Intent and Fraud

Errors in inventorship can lead to the patent being unenforceable if there was deceptive intent. Ensuring accurate and complete disclosure of inventors is vital to maintain the enforceability of the patent[5].

Practical Implications for Patent Holders and Practitioners

Disclosure and Verification

Practitioners must ensure that all documents, including those prepared with AI assistance, do not introduce inaccurate statements or omit material information. This includes verifying the accuracy of factual assertions and ensuring that AI-generated content does not misrepresent the invention[3].

Litigation and Disputes

Sorting out the contribution of human beings versus AI systems can lead to disputes and litigation. Attorneys need to understand how AI was used and gather appropriate evidence to support the inventorship claims[1].

Key Takeaways

  • Human Contribution: AI cannot be named as an inventor; human beings must make significant contributions to the invention.
  • Disclosure: The use of AI tools must be disclosed to the USPTO if it is material to patentability.
  • Claim Analysis: Thoroughly analyze the claims to understand the scope of protection.
  • Prior Art Search: Conduct comprehensive prior art searches to ensure novelty and non-obviousness.
  • Legal Compliance: Ensure accurate and complete disclosure of inventors to maintain the enforceability of the patent.

FAQs

Q: Can AI be named as an inventor on a patent application?

A: No, AI systems cannot be named as inventors on patent applications. Only human beings qualify as inventors under U.S. patent law[1].

Q: What constitutes a significant contribution in AI-assisted inventions?

A: A significant contribution involves a human being making a substantial input to the conception of the claimed invention, such as constructing specific prompts or conducting experiments with AI output[1].

Q: Why is it important to disclose the use of AI tools in patent applications?

A: Disclosing the use of AI tools is crucial if it is material to patentability, as it helps ensure that the contributions made by natural persons are accurately represented and verified[3].

Q: How can one determine the validity of patent claims?

A: Validity is determined through a thorough analysis of novelty, non-obviousness, and utility, often involving prior art searches and claim construction[4][5].

Q: What are the consequences of incorrect inventorship in a patent application?

A: Incorrect inventorship, especially with deceptive intent, can render the patent unenforceable. Accurate and complete disclosure of inventors is essential to maintain the patent's validity[5].

Sources

  1. U.S. Patent and Trademark Office Issues Guidance on Inventorship for AI-Assisted Inventions - Fredrikson & Byron P.A.
  2. Patent Claims Research Dataset - USPTO
  3. U.S. Patent Office Issues Additional Guidance on Use of AI Tools - Buchanan Ingersoll & Rooney PC
  4. Patent Search Services - Clarivate
  5. Determining Inventorship for US Patent Applications - Oregon State University College of Agricultural Sciences

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Details for Patent 10,016,338

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Emd Serono, Inc. PERGONAL menotropins For Injection 017646 August 22, 1975 10,016,338 2033-03-11
Emd Serono, Inc. PERGONAL menotropins For Injection 017646 May 20, 1985 10,016,338 2033-03-11
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 June 23, 1987 10,016,338 2033-03-11
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 October 16, 1986 10,016,338 2033-03-11
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 February 04, 1999 10,016,338 2033-03-11
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 5 of 5 entries

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