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Last Updated: January 8, 2025

Patent: 10,335,489


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Summary for Patent: 10,335,489
Title:Injectable solution at pH 7 comprising at least one basal insulin the pi of which is between 5.8 and 8.5 and a substituted co-polyamino acid
Abstract: A composition in the form of an injectable aqueous solution, the pH of which is between 6.0 and 8.0, including at least (a) a basal insulin, the isoelectric point pI of which is between 5.8 and 8.5; and (b) a co-polyamino acid bearing carboxylate charges and substituted with hydrophobic radicals. In one embodiment, the compositions also include a prandial insulin and/or a gut hormone.
Inventor(s): Soula; Olivier (Meyzieu, FR)
Assignee: ADOCIA (Lyons, FR)
Application Number:14/922,663
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of United States Patent 10,335,489

Introduction

United States Patent 10,335,489, hereafter referred to as the '489 patent, is a utility patent that protects a specific invention. To conduct a comprehensive and critical analysis, we need to delve into the patent's claims, the patent landscape, and the legal and technical aspects surrounding it.

Understanding the Patent Claims

Claim Structure and Scope

The '489 patent includes a set of claims that define the scope of the invention. These claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims build upon the independent claims and provide additional details or limitations[3].

Key Claim Elements

  • Independent Claims: These claims outline the core elements of the invention. For example, if the patent is for a new process or machine, the independent claims will describe the essential steps or components.
  • Dependent Claims: These claims narrow down the invention by adding specific details or features that are not present in the independent claims. They often start with phrases like "The [invention] of claim [X], wherein...".

Claim Interpretation

The interpretation of claims is crucial for understanding the patent's scope. Claims must be "particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention"[3]. This means that the language used must be clear and precise to avoid ambiguity.

Patentability Criteria

For any patent, including the '489 patent, the invention must meet the criteria of novelty, non-obviousness, and utility.

Novelty

The invention must be new and not previously disclosed in any form. This includes prior art, which encompasses all publicly available information before the patent application date[5].

Non-obviousness

The invention must not be an obvious solution to someone skilled in the field. Patent examiners evaluate this by comparing the invention against prior art to ensure it offers innovative steps that are not readily apparent[5].

Utility

The invention must have a practical application and be useful. This ensures that the patent protects something that has real-world value[5].

Geographical and Technological Context

Geographical Distribution

Patent activity, including the '489 patent, can be analyzed based on the residence of the inventors or the ownership rights. This analysis helps in understanding the geographical distribution of patenting activity and can be crucial for identifying innovation hubs and trends[1].

Technological Classification

The '489 patent would be classified under specific technology areas using the International Patent Classification (IPC) system. This classification helps in categorizing the patent within broader technological fields and facilitates the analysis of trends and patterns in patenting activity[1].

Inventorship and Ownership

Determining Inventorship

Inventorship is determined based on who conceived the subject matter of at least one claim of the patent. This involves identifying individuals who contributed to the idea or ideas of the patent claims, ensuring that only those who made significant conceptual contributions are listed as inventors[4].

Ownership Rights

The ownership rights of the '489 patent can be different from the residence of the inventors. This distinction allows for two types of analysis: one based on where the inventors live and another based on where the ownership rights have been assigned[1].

Use of AI Tools in Patent Applications

Disclosure Requirements

If AI tools were used in the development or drafting of the '489 patent, it is crucial to disclose this information to the USPTO. This includes any material contributions made by AI systems, such as alternative embodiments not conceived by the inventors[2].

Verification and Accuracy

Practitioners must verify the accuracy of all documents prepared with the assistance of AI tools to ensure they do not introduce inaccurate statements or omit material information. This is essential for maintaining the integrity of the patent application process[2].

Legal and Regulatory Compliance

Substantive Legal Requirements

The '489 patent must comply with substantive legal requirements such as utility, statutory subject matter, enablement, written description, best mode, novelty, and non-obviousness. These requirements are outlined in sections 35 U.S.C. §101, §112, and §103[3].

Special Claim Terms

The patent application must define any special terms used in the claims to avoid issues related to definiteness. This ensures that the claims are clear and distinctly define the subject matter that will be protected by the patent grant[3].

Patent Landscape Analysis

Prior Art Search

A thorough search of prior art is essential to ensure the novelty and non-obviousness of the '489 patent. This involves searching patent databases using specific keywords, examining classifications, and reviewing cited references of pertinent patents[3].

Competitor Analysis

Analyzing the patent landscape includes identifying competitors and their patent portfolios. This helps in understanding the market position and potential challenges or opportunities related to the '489 patent.

Critical Analysis and Implications

Strengths and Weaknesses

  • Strengths: A well-crafted patent with clear and distinct claims can provide strong protection for the invention. If the '489 patent meets all the patentability criteria, it can be a valuable asset.
  • Weaknesses: Any ambiguity or lack of clarity in the claims can lead to challenges during litigation. Additionally, if the patent does not adequately address prior art, it may face validity challenges.

Market Impact

The '489 patent can have significant market implications if it protects a groundbreaking invention. It can provide a competitive edge to the patent holder, allowing them to monopolize the market for the patented technology.

Key Takeaways

  • Clear Claims: The patent claims must be clear, distinct, and particularly point out the subject matter of the invention.
  • Patentability Criteria: The invention must meet the criteria of novelty, non-obviousness, and utility.
  • Inventorship and Ownership: Accurate determination of inventorship and ownership is crucial for the validity and enforceability of the patent.
  • AI Tool Disclosure: Any use of AI tools in the patent application process must be disclosed to the USPTO.
  • Market Impact: A strong patent can provide significant market advantages but requires careful drafting and compliance with legal requirements.

FAQs

What are the key elements of a patent claim?

The key elements of a patent claim include the independent and dependent claims, which define the scope and details of the invention. Independent claims outline the core elements, while dependent claims add specific details or limitations.

How is inventorship determined in a patent application?

Inventorship is determined based on who conceived the subject matter of at least one claim of the patent. This involves identifying individuals who made significant conceptual contributions to the invention.

What is the significance of geographical distribution in patent analysis?

Geographical distribution helps in understanding the innovation hubs and trends by analyzing patent activity based on the residence of inventors or ownership rights.

Can AI tools contribute to the drafting of a patent application?

Yes, AI tools can assist in drafting portions of the patent application, but any material contributions must be disclosed to the USPTO, and practitioners must verify the accuracy of all documents prepared with AI assistance.

What are the substantive legal requirements for a patent application?

The substantive legal requirements include utility, statutory subject matter, enablement, written description, best mode, novelty, and non-obviousness, as outlined in sections 35 U.S.C. §101, §112, and §103.

Sources

  1. NCSES, Invention, Knowledge Transfer, and Innovation, 2024.
  2. BIPC, U.S. Patent Office Issues Additional Guidance on Use of AI Tools, 2024.
  3. USPTO, Drafting a Provisional Application, 2013.
  4. Oregon State University, Determining Inventorship for US Patent Applications, 2024.
  5. PatentLawyer.io, Can You Patent an Algorithm? Understanding Legal Boundaries, 2024.

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Details for Patent 10,335,489

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 October 28, 1982 10,335,489 2032-01-09
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 December 29, 2015 10,335,489 2032-01-09
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 August 06, 1998 10,335,489 2032-01-09
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 March 31, 1994 10,335,489 2032-01-09
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 May 25, 2018 10,335,489 2032-01-09
Novo Nordisk Inc. NOVOLIN R insulin human Injection 019938 June 25, 1991 10,335,489 2032-01-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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