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Last Updated: December 22, 2024

Patent: 10,124,040


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Summary for Patent: 10,124,040
Title:Method for preparing crystalline insulin or insulin analog compositions
Abstract: A method for crystallizing insulin or insulin analogs under alkaline conditions in the presence of zinc, purifying the crystals by filtering through a filter, and drying the crystals captured on the filter to produce crystalline insulin or insulin analog compositions is described. Method has been exemplified with insulin lispro.
Inventor(s): Watson; Douglas S. (Harrisonburg, VA), Ortigosa; Allison C. (Harrisonburg, VA), Sleevi; Mark C. (Longmont, CO), Story; Kathryn M. (Harrisonburg, VA)
Assignee: Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:15/505,124
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,124,040

Introduction

The United States Patent 10,124,040, like many other patents, exists within a complex and evolving patent landscape. This analysis will delve into the key aspects of the patent, including its claims, the current patent landscape, particularly focusing on recent updates and guidelines from the United States Patent and Trademark Office (USPTO), and the implications for innovators and patent practitioners.

Understanding the Patent Claims

To analyze the patent, it is crucial to understand the claims made within it. Patent claims define the scope of the invention and are critical in determining the patent's validity and enforceability. Here, we need to examine whether the claims are directed to a statutory category (processes, machines, manufactures, and compositions of matter) and whether they avoid judicial exceptions such as abstract ideas, laws of nature, or natural phenomena[3].

The Current Patent Landscape

Recent USPTO Guidance on AI Patents

The USPTO has recently issued significant guidance updates, particularly in response to the rapid advancements in artificial intelligence (AI). The 2024 guidance update, prompted by Executive Order 14110, aims to clarify the process for determining the patent eligibility of AI-related inventions. This update is crucial for understanding how AI inventions are evaluated for patent eligibility.

Integration into Practical Applications

A key takeaway from the 2024 guidance is the emphasis on integrating judicial exceptions into practical applications. For a claim to be patent-eligible, it must demonstrate that the claimed invention improves the functioning of a computer or another technology or technical field. This is illustrated through new examples provided by the USPTO, such as Example 48, which shows how claims involving specific applications of neural networks can meet the eligibility criteria by demonstrating an improvement in computer technology[2][3].

AI-Assisted Inventions

The guidance clarifies that the method of invention development, including the use of AI, does not impact subject matter eligibility. Instead, the focus remains on the claimed invention itself, ensuring that AI-assisted inventions are evaluated on equal footing with other technologies. This distinction is critical in ensuring that AI’s role as a tool does not exclude inventions from eligibility, provided there is significant human contribution[2][5].

Incorporation of Recent Case Law

The 2024 guidance integrates recent Federal Circuit decisions, offering up-to-date legal standards and interpretations. This integration helps promote consistency and clarity in the application of patent eligibility criteria, reflecting the latest judicial thinking[2][3].

Implications for Innovators and Patent Practitioners

Crafting Effective Claims

For innovators and patent practitioners, the 2024 guidance update provides a clearer framework for evaluating the patent eligibility of AI-related inventions. Here are some key implications:

Focus on Practical Applications

When drafting claims for AI inventions, it is essential to emphasize how the invention integrates the judicial exception into a practical application. Highlighting specific improvements to the functioning of a computer or another technology or technical field is crucial[3][5].

Leveraging Examples

The new examples provided by the USPTO, such as Examples 47-49, can be used to frame claims. These examples illustrate the application of the subject matter eligibility analysis to AI-related claims, providing practical guidance on how to ensure claims meet the eligibility criteria[2][3].

Documenting Technological Improvements

Ensuring that the patent specification clearly describes how the claimed invention improves existing technological processes is critical. This documentation helps demonstrate that the claim is not merely an abstract idea but a practical application that enhances technology[3].

The Role of the Patent Trial and Appeal Board (PTAB)

Oversight and Independence

The PTAB, established in 2012, offers an alternative to federal courts for settling patent disputes. However, there have been concerns about the independence of PTAB judges due to oversight by USPTO directors and PTAB management. A significant majority of PTAB judges have reported that this oversight has affected their independence, particularly in discretionary factors such as whether to institute a trial[1].

Management Review Processes

The USPTO has implemented various review processes, including pre-issuance reviews by PTAB management and interim director reviews. These processes aim to ensure consistency and quality in PTAB decisions but also raise concerns about potential influences on judicial decisions[1].

Conducting a Preliminary Patent Search

To understand the broader patent landscape, conducting a preliminary patent search is essential. The USPTO provides several tools and databases, such as the Patent Public Search database and the Cooperative Patent Classification (CPC) database, to help in this process. These tools allow for full-text searching of patent grants and applications from the United States and over 100 other patent offices worldwide[4].

Key Takeaways

  • Integration into Practical Applications: Ensure that AI-related claims integrate judicial exceptions into practical applications to meet patent eligibility criteria.
  • AI-Assisted Inventions: The method of invention development, including AI, does not impact subject matter eligibility; focus on the claimed invention itself.
  • Recent Case Law: The 2024 guidance incorporates recent Federal Circuit decisions to promote consistency and clarity in patent eligibility evaluations.
  • Effective Claim Drafting: Emphasize specific improvements to technology and leverage new examples provided by the USPTO to frame claims.
  • PTAB Oversight: Be aware of the potential influences of USPTO directors and PTAB management on PTAB decisions.

FAQs

Q: How does the 2024 USPTO guidance update affect AI-related patent claims?

A: The update clarifies the process for determining patent eligibility of AI-related inventions by emphasizing the integration of judicial exceptions into practical applications and incorporating recent Federal Circuit decisions.

Q: Can AI-assisted inventions be patented?

A: Yes, AI-assisted inventions can be patented as long as the claimed invention itself meets the patent eligibility criteria, and there is significant human contribution to the invention.

Q: What is the role of the PTAB in patent disputes?

A: The PTAB offers an alternative to federal courts for settling patent disputes, deciding whether to convene a trial and whether patents are valid, but its independence is subject to oversight by USPTO directors and PTAB management.

Q: How can innovators ensure their AI-related claims are patent-eligible?

A: Innovators should focus on drafting claims that integrate judicial exceptions into practical applications, highlight specific technological improvements, and leverage the new examples provided by the USPTO.

Q: What tools are available for conducting a preliminary patent search?

A: The USPTO provides tools such as the Patent Public Search database, the Cooperative Patent Classification (CPC) database, and the PATENTSCOPE database to facilitate comprehensive patent searches.

Sources

  1. GAO Report: "Patent Trial and Appeal Board: Preliminary Observations on Oversight Practices and Policies" - GAO-22-106121.
  2. Mintz Insights: "Understanding the 2024 USPTO Guidance Update on AI Patent Eligibility" - Mintz.
  3. Greenberg Traurig Insights: "USPTO Issues New Guidance on Patent Subject Matter Eligibility for AI Inventions" - Greenberg Traurig.
  4. Clemson University Library Guide: "Advanced Patent Searching" - Clemson University.
  5. Baker Botts Thought Leadership: "The Importance of Prong Two of Step 2A for AI Inventions" - Baker Botts.

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Details for Patent 10,124,040

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 14, 1996 ⤷  Subscribe 2034-08-26
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 August 06, 1998 ⤷  Subscribe 2034-08-26
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 September 06, 2007 ⤷  Subscribe 2034-08-26
Eli Lilly And Company HUMALOG insulin lispro Injection 020563 June 06, 2017 ⤷  Subscribe 2034-08-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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