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Last Updated: December 26, 2024

Patent: 10,479,868


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Summary for Patent: 10,479,868
Title:Polymeric stabilizing formulations
Abstract: The present invention provides compositions of a therapeutic agent and a polymeric stabilizing agent for stabilizing the reservoir of an implantable drug delivery system. The present invention also includes an implantable drug delivery system incorporating the composition of the present invention, as well as methods of treating diabetes using the compositions and implantable drug delivery system of the present invention.
Inventor(s): Mendelsohn; Adam (Emeryville, CA), Duong; Au (Emeryville, CA), Fischer; Kathleen (Emeryville, CA), Roorda; Wouter (Emeryville, CA)
Assignee: NANO PRECISION MEDICAL, INC. (Emeryville, CA)
Application Number:15/508,572
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Complexities of Patent Claims: A Comprehensive Analysis of the Patent Landscape

Introduction

Patent claims are the heart of any patent application, defining the scope of the invention and the rights granted to the patent holder. The landscape of patent claims, particularly in the United States, is complex and evolving, influenced by technological advancements, legal precedents, and administrative processes. This article delves into the intricacies of patent claims, using the example of United States Patent 10,479,868, to provide a comprehensive and critical analysis.

The Importance of Patent Claims

Patent claims are the legal descriptions of the invention that define what is protected by the patent. They are crucial for determining the scope of the patent and for distinguishing the invention from prior art[2].

Historical Context of Patent Claims

The number of patent applications and the complexity of claims have increased significantly over the years. From approximately 100,000 patent applications per year in the 1960s and 1980s, the number rose to 326,508 in 2001 alone. This trend is driven by technological innovation and facilitated by advancements in technology such as word processing and electronic database searching[2].

The Role of the USPTO and PTAB

The United States Patent and Trademark Office (USPTO) is responsible for reviewing patent applications and granting patents. The Patent Trial and Appeal Board (PTAB), established by the Leahy-Smith America Invents Act (AIA) in 2011, plays a critical role in administrative challenges to patent validity, including inter partes review (IPR) and post-grant review (PGR)[3].

Inter Partes Review and Post-Grant Review

IPR and PGR allow parties to challenge the validity of issued patents in an administrative forum, providing an alternative to costly and time-consuming federal court litigation. These processes are decided by a panel of administrative patent judges (APJs) and are subject to specific standards of proof and procedural rules[3].

Determining Patentability

For a patent to be granted, the claims must be directed to patentable subject matter. The USPTO follows guidelines to determine whether patent claims are eligible, particularly under the Alice/Mayo test, which assesses whether the claims are directed to ineligible subject matter such as laws of nature, natural phenomena, or abstract ideas[3].

The Alice/Mayo Test

If the claims are directed to ineligible subject matter, they must contain an "inventive concept" to be patentable. This means the claims must include elements that ensure the patent in practice amounts to significantly more than a patent on the ineligible concept itself[3].

Claims Analysis and Management

Given the increasing complexity and number of claims, automated systems have been developed to facilitate the review and management of patent claims. For example, the Patent Matrix software automates the import, parsing, and hierarchical arrangement of claims, allowing users to compress and expand claims for easier review[2].

Automated Claims Analysis

This technology is crucial for navigating the vast number of claims, especially in cases where a single patent application can include hundreds or even thousands of claims. The ability to rapidly and consistently review claims is essential for keeping pace with the growing patent prior art[2].

Patent Family Searching and Claims Variation

Patent family searching, which involves analyzing related patents across different jurisdictions, is complicated by claims variation. During the prosecution process, claims may be amended or narrowed, resulting in differences between related patents within the same patent family[4].

Challenges in Patent Family Searching

Complete patent family searching is time-consuming due to multi-jurisdiction filing, indexing inconsistencies, language barriers, and the scientific sophistication of the innovations. Understanding these variations is critical for making informed decisions about licensing, challenging patent validity, and allocating resources for R&D initiatives[4].

Inventorship and Its Implications

Determining the true and only inventors is a critical aspect of patent law. Inventorship focuses on the conception step, requiring the identification of each person who conceived the idea or subject matter of the patent claims[5].

Conception and Reduction to Practice

Conception is defined as the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention. This must be sufficient to permit one with ordinary skill in the field to reduce the invention to practice without undue experimentation[5].

Correcting Inventorship Errors

Errors in inventorship can have severe consequences, including the invalidation of the patent if there is deceptive intent. Correct inventorship is essential to ensure the patent remains enforceable against challenges[5].

Case Study: United States Patent 10,479,868

Overview of the Patent

To illustrate the complexities and critical aspects of patent claims, let's consider United States Patent 10,479,868. This patent, like many others, involves a detailed set of claims that define the scope of the invention.

Claims Structure and Hierarchy

The patent claims are structured in a hierarchical manner, with independent claims and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations[2].

Automated Analysis Tools

Using tools like the Patent Matrix software, one can import, parse, and arrange these claims in a hierarchical order. This facilitates the review process, allowing users to focus on the independent claims initially and expand to dependent claims as needed[2].

Patentability and Eligibility

The claims of US Patent 10,479,868 must comply with the eligibility criteria under the Alice/Mayo test. If the claims are directed to ineligible subject matter, they must include an inventive concept to be patentable[3].

Inventorship Considerations

Ensuring that the true and only inventors are listed is crucial. Any errors or deceptive intent in naming inventors can lead to the patent being unenforceable. The conception step and reduction to practice must be clearly documented to support the inventorship claims[5].

Challenges and Debates in the Patent Landscape

Standing and Burdens of Proof

Current debates surround the standing requirements and burdens of proof in PTAB proceedings. These debates highlight the ongoing evolution of patent law and the need for clear guidelines to ensure fairness and consistency[3].

Proposed Reforms

Proposed reforms to PTAB and IPR/PGR processes aim to address issues such as discretionary institution of reviews and the standard of proof required. These reforms are crucial for maintaining the balance between patent protection and the public interest[3].

Key Takeaways

  • Patent Claims are Critical: Patent claims define the scope of the invention and are essential for determining patentability and enforceability.
  • Automated Tools: Automated systems like the Patent Matrix software are vital for managing and reviewing the increasing number and complexity of patent claims.
  • Inventorship: Correct determination of inventorship is crucial to ensure the patent's validity and enforceability.
  • Administrative Challenges: PTAB and IPR/PGR processes provide alternative avenues for challenging patent validity, but they are subject to specific rules and standards.
  • Legal Precedents: The Alice/Mayo test and other legal precedents significantly influence the patentability of claims.

FAQs

What is the role of the Patent Trial and Appeal Board (PTAB)?

The PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, including inter partes review (IPR) and post-grant review (PGR)[3].

How do automated tools help in patent claims analysis?

Automated tools like the Patent Matrix software facilitate the import, parsing, and hierarchical arrangement of claims, making it easier to review and manage large numbers of claims[2].

What is the significance of the Alice/Mayo test in patent law?

The Alice/Mayo test determines whether patent claims are directed to ineligible subject matter and whether they contain an inventive concept to be patentable[3].

Why is correct inventorship important in patent applications?

Correct inventorship is essential to ensure the patent's validity and enforceability. Errors or deceptive intent in naming inventors can lead to the patent being unenforceable[5].

What are the challenges in patent family searching?

Patent family searching is complicated by multi-jurisdiction filing, indexing inconsistencies, language barriers, and claims variation during the prosecution process[4].

Sources

  1. Records of the Patent and Trademark Office - National Archives.
  2. US20110138338A1 - Patent Claims Analysis System and Method.
  3. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service.
  4. Advanced patent searching techniques - CAS.org.
  5. Determining Inventorship for US Patent Applications - Oregon State University.

More… ↓

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Details for Patent 10,479,868

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 June 23, 1987 10,479,868 2034-09-04
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 October 16, 1986 10,479,868 2034-09-04
Eli Lilly And Company HUMATROPE somatropin For Injection 019640 February 04, 1999 10,479,868 2034-09-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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