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Last Updated: January 7, 2025

Patent: 11,031,102


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Summary for Patent: 11,031,102
Title:Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor
Abstract:This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy (“REMS”) and a safety support program (“SSP”) for reinforcing the REMS. The REMS and SPP are implemented using one or more computer devices with software tools programmed to enforce conditions of the REMS and/or prompt follow-ups by registered nurses enrolled in the SSP. The software tool(s) determines whether a prescriber requesting the complement inhibitor has agreed to abide by the REMS, and can prompt a provider of the complement inhibitor to provide updated educational materials to the prescriber at predetermined times or intervals, to monitor the prescriber for compliance with the REMS, and/or to monitor patients for signs of adverse events. Using exemplary embodiments described herein, a risk of adverse events (especially, but not limited to, meningococcal infections) can be managed and an incidence of the adverse events can be reduced.
Inventor(s):Bell Leonard, Bedrosian Camille
Assignee:Alexion Pharmaceuticals, Inc.
Application Number:US14941080
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 11,031,102

Introduction

When evaluating a patent, such as United States Patent 11,031,102, it is crucial to delve into the specifics of the claims, the broader patent landscape, and the legal frameworks that govern patentability. This analysis will help in understanding the patent's validity, its position within the industry, and potential challenges it might face.

Understanding the Patent Claims

To analyze the claims of a patent, one must first identify what the patent covers. This involves a detailed review of the claim language, which outlines the specific elements and limitations of the invention.

Claim Structure

Patent claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. Each claim must be carefully crafted to ensure it meets the criteria for patentability under U.S. Patent Law, particularly Sections 101, 102, and 103[3].

Patentability Under U.S. Patent Law

Section 101: Patentable Subject Matter

Section 101 of the U.S. Patent Law determines what constitutes patentable subject matter. The Supreme Court's decision in Alice Corp. v. CLS Bank International set a two-step test to determine eligibility:

  • Step 1: Determine if the claim is directed to a process, machine, manufacture, or composition of matter.
  • Step 2A: If yes, determine if the claim is directed to a law of nature, a natural phenomenon, or an abstract idea. If so, proceed to Step 2B to see if there is an inventive concept that transforms the abstract idea into something more[3].

For a patent like 11,031,102, it is essential to ensure that the claims do not fall into the category of abstract ideas without an inventive concept.

Section 102: Novelty

Section 102 deals with the novelty of the invention. A claimed invention can be rejected if it is anticipated by prior art, meaning every element of the claim must be found in a single prior art reference or, in some cases, multiple references that collectively disclose the invention[4].

Section 103: Non-obviousness

Section 103 focuses on non-obviousness, requiring that the invention must not be obvious to a person having ordinary skill in the art (PHOSITA). This involves a multifaceted analysis, including factors such as the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of ordinary skill in the pertinent art[3].

Case Studies and Legal Precedents

Alice Corp. v. CLS Bank International

This landmark case highlights the importance of ensuring that patent claims do not merely cover abstract ideas without an inventive concept. For example, in Electric Power Group, LLC v. Alstom S.A., the court held that claims related to monitoring and analyzing data from disparate sources were too abstract and lacked an inventive concept, thus failing under Section 101[2].

Glidden and Incremental Innovations

Cases like Glidden illustrate that even incremental innovations can secure patent rights if they demonstrate significant improvement over previous models. This emphasizes the importance of commercial success and practical utility in establishing grounds for patents[3].

Patent Search and Documentation

Global Dossier

Tools like the Global Dossier provide access to the file histories of related applications from participating IP Offices, allowing users to see the patent family and related documentation. This can be crucial in conducting thorough prior art searches and ensuring the novelty and non-obviousness of the invention[1].

Public Search Facility and PTRCs

The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer resources and training for conducting patent searches, which are essential for verifying the uniqueness of the invention and avoiding potential infringement issues[1].

Practical Insights for Patent Drafting

Strategic Alignment with Section 101

To navigate the complexities of Section 101, innovators should focus on highlighting the tangible and applicable aspects of the invention. Clear, concrete embodiments and explicit details of practical applications can help circumvent issues related to abstract ideas[3].

Precision in Patent Applications

Precision in the patent application is key. Clearly articulating how the invention operates in a specific, tangible manner is critical. Portraying the invention’s practical utility and concrete implementation can aid in navigating the nuances of Section 101[3].

Non-obviousness and Prior Art Analysis

In-depth Prior Art Analysis

Comprehensive knowledge and analysis of existing prior art are indispensable. This helps in anticipating potential objections on obviousness grounds and in framing arguments and claims that robustly showcase the invention’s non-obviousness[3].

Evolving Jurisprudence

The jurisprudence surrounding patent law is continually evolving. Innovators and IP lawyers must stay abreast of recent court decisions and updates to the legal framework to ensure their patents remain valid and enforceable.

Key Takeaways

  • Patent Claims: Ensure claims are specific, tangible, and meet the criteria for patentability under Sections 101, 102, and 103.
  • Legal Frameworks: Understand and align with the legal precedents and tests set by cases like Alice Corp. v. CLS Bank International.
  • Prior Art Search: Conduct thorough prior art searches using tools like the Global Dossier and Public Search Facility.
  • Precision in Drafting: Craft patent applications with clear, concrete embodiments and explicit details of practical applications.
  • Non-obviousness: Ensure the invention is non-obvious by conducting a multifaceted analysis and differentiating it from prior art.

FAQs

Q: What is the significance of Section 101 in U.S. Patent Law? A: Section 101 determines what constitutes patentable subject matter, ensuring that claims do not cover abstract ideas without an inventive concept.

Q: How does the Global Dossier help in patent searches? A: The Global Dossier provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family and related documentation.

Q: What is the importance of prior art analysis in patent drafting? A: Prior art analysis helps in anticipating potential objections on obviousness grounds and in framing arguments and claims that robustly showcase the invention’s non-obviousness.

Q: Can incremental innovations secure patent rights? A: Yes, incremental innovations can secure patent rights if they demonstrate significant improvement over previous models and show commercial success and practical utility.

Q: What are the key elements to consider when drafting patent claims to avoid issues under Section 101? A: Innovators should focus on highlighting the tangible and applicable aspects of the invention, providing clear, concrete embodiments, and explicitly detailing practical applications.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Electric Power Group, LLC v. Alstom S.A.: https://cafc.uscourts.gov/opinions-orders/15-1778.opinion.7-28-2016.1.pdf
  3. Navigating the Nuances of Sections 101, 102, & 103 of U.S. Patent Law: https://ttconsultants.com/navigating-the-nuances-a-comprehensive-exploration-of-sections-101-102-and-103-of-u-s-patent-law/
  4. MPEP - Anticipation — Application of 35 U.S.C. 102: https://www.uspto.gov/web/offices/pac/mpep/s2131.html

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Details for Patent 11,031,102

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Alexion Pharmaceuticals, Inc. SOLIRIS eculizumab Injection 125166 March 16, 2007 ⤷  Subscribe 2035-11-13
Glaxosmithkline Biologicals BEXSERO meningococcal group b vaccine Injection 125546 January 23, 2015 ⤷  Subscribe 2035-11-13
Wyeth Pharmaceuticals Llc TRUMENBA meningococcal group b vaccine Injection 125549 October 29, 2014 ⤷  Subscribe 2035-11-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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