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Last Updated: April 24, 2025

Patent: 10,112,994


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Summary for Patent: 10,112,994
Title:Methods of producing two chain proteins in bacteria
Abstract:Provided herein are methods of producing a polypeptide containing two chains, such as an antibody including a light chain and a heavy chain. In particular, methods are provided for producing heterologous secretory proteins in bacteria through utilization of optimized expression vectors and culture processes.
Inventor(s):Giulianotti James, Reilly Dorothea
Assignee:GENENTECH, INC.
Application Number:US14934100
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Patent Landscape: A Comprehensive Analysis of U.S. Patent 10,112,994

Introduction

The U.S. patent system is a cornerstone of innovation, designed to protect and encourage the development of new and useful inventions. However, the landscape of what constitutes patent-eligible subject matter has evolved significantly, particularly with recent judicial, administrative, and legislative developments. This article will delve into the critical aspects of patent eligibility, using U.S. Patent 10,112,994 as a case study, and explore the broader implications for innovators and patent practitioners.

Patent-Eligible Subject Matter: An Overview

Section 101 of the U.S. Patent Act defines what constitutes patent-eligible subject matter, including "any new and useful process, machine, manufacture, or composition of matter"[1][4][5].

Judicially Developed Exceptions

The Supreme Court has established implicit exceptions to patent eligibility, excluding "laws of nature, natural phenomena, and abstract ideas" when claimed as such. These exceptions have been refined through several landmark cases, such as Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., and Association for Molecular Pathology v. Myriad Genetics, Inc.[1][4].

The Alice/Mayo Test

To determine patent eligibility, the Supreme Court introduced the Alice/Mayo test, a two-step framework:

  1. Step One: Determine if the claims are directed to an ineligible concept (e.g., abstract idea, natural law, or natural phenomenon).
  2. Step Two: If the claims are directed to an ineligible concept, assess whether the elements of each claim, both individually and as an ordered combination, contain an inventive concept that "transforms the nature of the claim" into a patent-eligible application[1][4].

Case Study: U.S. Patent 10,112,994

While the specific details of U.S. Patent 10,112,994 are not provided here, we can apply the principles outlined above to understand how it might be evaluated.

Alignment with Section 101

For a patent like 10,112,994 to be eligible, it must align with the requirements of Section 101. This involves highlighting the tangible and applicable aspects of the invention. The patent application should provide clear, concrete embodiments of the invention and explicitly detail its practical applications to avoid issues related to abstract ideas[2].

Application Precision

Precision in the patent application is crucial. The application should clearly articulate how the invention operates in a specific, tangible manner. Portraying the invention’s practical utility and concrete implementation can help navigate the nuances of Section 101[2].

Non-Obviousness and Novelty

In addition to Section 101, the patent must also meet the requirements of Sections 102 and 103 of the Patent Act. Section 102 deals with novelty, ensuring the invention is new and not anticipated by prior art. Section 103 addresses non-obviousness, requiring that the invention be significantly different from existing knowledge in the field[2].

Strategic Patent Drafting

Crafting patent applications with a focus on clarifying the non-obvious aspects of the invention is pivotal. Clear differentiation of the inventive steps and meticulous illustration of the differences from prior art are essential. This includes in-depth prior art analysis to anticipate potential objections on obviousness grounds and to frame arguments and claims that robustly showcase the invention’s non-obviousness[2].

Impact of Recent Guidance

The U.S. Patent and Trademark Office (USPTO) issued new guidance in 2019 to clarify how to apply the Alice/Mayo framework, particularly for computer-related inventions. This guidance has been incorporated into the Manual of Patent Examining Procedure and has generally been perceived as lowering Section 101 barriers to patentability, especially for AI-related inventions. However, this guidance is not binding on the courts when issued patents are challenged in litigation[1].

Stakeholder Views and Jurisprudence

Stakeholder views on the Alice/Mayo framework vary. Some argue it has negatively affected investment in technology and innovation, while others see it as a necessary filter to prevent the patenting of abstract ideas. The evolving jurisprudence continues to shape the patent landscape, with ongoing debates about the balance between encouraging innovation and preventing the misuse of patents[1].

Examples and Case Studies

  • Ex Parte Cassio Wallner: This case illustrates the challenges faced by aerospace innovators when their claims focus heavily on data analysis processes without sufficient incorporation of other claim elements. The USPTO rejected the patent application because the process could be performed in the human mind, highlighting the need for tangible improvements to physical devices[5].
  • Wisk v. Archer: Similar to Ex Parte Cassio Wallner, this case emphasizes the importance of tying data analysis processes to practical applications and showing technical improvements to overcome Section 101 challenges[5].

Patent Assertion Entities (PAEs)

The landscape of patent assertion also involves PAEs, which can significantly impact the patent ecosystem. PAEs, such as Litigation PAEs and Portfolio PAEs, generate revenue through patent assertion, often targeting a broad range of industries. The FTC study on PAE activity highlights the need for transparency and the potential negative repercussions of PAE behavior, particularly in sectors like ICT and software patents[3].

Key Takeaways

  • Section 101 Eligibility: Ensure the patent application aligns with Section 101 by highlighting tangible and applicable aspects of the invention.
  • Precision in Application: Clearly articulate the invention’s operation and practical applications.
  • Non-Obviousness and Novelty: Meet the requirements of Sections 102 and 103 by demonstrating novelty and non-obviousness.
  • Strategic Drafting: Focus on clarifying the non-obvious aspects and differentiating from prior art.
  • Recent Guidance: Understand the impact of the 2019 USPTO guidance on patent eligibility, especially for AI and computer-related inventions.
  • Stakeholder Views: Be aware of the varying views on the Alice/Mayo framework and its impact on innovation.

FAQs

Q1: What are the categories of patentable inventions under Section 101 of the U.S. Patent Act?

  • Section 101 includes "any new and useful process, machine, manufacture, or composition of matter"[1][4][5].

Q2: What are the judicially developed exceptions to patent-eligible subject matter?

  • The exceptions include "laws of nature, natural phenomena, and abstract ideas" when claimed as such[1][4].

Q3: How does the Alice/Mayo test determine patent eligibility?

  • The test involves two steps: determining if the claims are directed to an ineligible concept and assessing if the elements of each claim contain an inventive concept that transforms the nature of the claim[1][4].

Q4: What is the significance of the 2019 USPTO guidance on patent eligibility?

  • The guidance clarifies how to apply the Alice/Mayo framework, particularly for computer-related inventions, and has been perceived as lowering Section 101 barriers to patentability[1].

Q5: How do Patent Assertion Entities (PAEs) impact the patent landscape?

  • PAEs generate revenue through patent assertion, often targeting a broad range of industries, and their activities can have significant implications for innovation and litigation[3].

Sources

  1. Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024.
  2. TT Consultants. Navigating the Nuances: A Comprehensive Exploration of Sections 101, 102, and 103 of U.S. Patent Law. October 5, 2023.
  3. Federal Trade Commission. Patent Assertion Entity Activity: An FTC Study. 2023.
  4. BitLaw. Section 101 Subject Matter Eligibility Index.
  5. Finnegan. Section 101 Patent Subject Matter Eligibility Requirements. October 4, 2024.

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Details for Patent 10,112,994

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 June 30, 2006 10,112,994 2035-11-05
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 August 10, 2012 10,112,994 2035-11-05
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 October 13, 2016 10,112,994 2035-11-05
Genentech, Inc. LUCENTIS ranibizumab Injection 125156 March 20, 2018 10,112,994 2035-11-05
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 4 of 4 entries

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