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Last Updated: December 22, 2024

Patent: 10,265,291


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Summary for Patent: 10,265,291
Title:Disulfur bridge linkers for conjugation of a cell-binding molecule
Abstract: The present invention relates to novel disulfur bridge linkers containing hydrazine used for the specific conjugation of compounds/cytotoxic agents to a cell-binding molecule, through bridge linking a pair of thiols on the cell-binding molecule. The invention also relates to methods of making such linkers, and of using such linkers in making homogeneous conjugates, as well as of application of the conjugates in treatment of cancers, infections and autoimmune disorders.
Inventor(s): Zhao; Robert Yongxin (Lexington, MA)
Assignee: HANGZHOU DAC BIOTECH CO., LTD. (Hangzhou, CN)
Application Number:15/431,154
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Claims and Patent Landscape of United States Patent 10,265,291

Introduction

Patent 10,265,291, like any other patent, is a complex document that requires a thorough analysis to understand its claims, scope, and position within the broader patent landscape. This article will delve into the key components of this patent, including the statutory requirements for patentability, the structure of the claims, and strategic considerations for patent drafting and prosecution.

Patent 10,265,291: Overview

To begin, it is essential to identify the subject matter of the patent. However, without specific details from the patent itself, we will use general principles to analyze its components.

Statutory Requirements for Patentability

For any patent to be granted, it must meet the criteria outlined in Sections 101, 102, and 103 of U.S. Patent Law.

Section 101: Patentable Subject Matter

This section determines what constitutes patentable subject matter. The Supreme Court's decision in Alice Corp. v. CLS Bank International (2014) established 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: Assess if the claim is directed to a law of nature, natural phenomenon, or abstract idea.
  • Step 2B: Evaluate if the claim includes additional elements that constitute significantly more than the judicial exception[2].

Section 102: Novelty

This section deals with the novelty of the invention. The patent must be novel, meaning it must not have been previously disclosed or used by others. Section 102(e) is particularly relevant when considering international applications under the Patent Cooperation Treaty (PCT), as it specifies that an international application must designate the U.S. and be published in English to be considered prior art[5].

Section 103: Non-Obviousness

The invention must also be non-obvious, meaning it must represent a significant improvement over existing technology. This involves demonstrating that the invention is not an obvious combination of prior art elements[2].

Structure of the Claims

The claims of a patent are its most critical component, as they define the scope of the invention.

Types of Claims

Claims can be categorized into several types, including product claims, process claims, and product-by-process claims. Each type has its own set of rules and considerations:

  • Product Claims: These claims define the invention as a product, including its composition and structure.
  • Process Claims: These claims define the invention as a method or process.
  • Product-by-Process Claims: These claims define the invention as a product that is made by a specific process[3].

Drafting Claims

Drafting claims requires precision and clarity. Claims must be clear, concise, and fully supported by the description. Here are some key considerations:

  • Broad and Narrow Claims: Claims should be broad enough to offer substantial protection but specific enough to circumvent prior art.
  • Clarity and Consistency: Avoid using relative terms and ensure consistency in the claim language.
  • Support from the Description: The description must support the claims, providing clear and concrete embodiments of the invention[3].

Strategic Considerations for Patent Drafting and Prosecution

Balancing Act

Patent drafting involves a delicate balance between broadness and specificity. Claims must be broad enough to protect the invention but specific enough to avoid prior art and ensure eligibility under Section 101[2].

Prior Art Analysis

Conducting extensive prior art searches is essential to identify potential obstacles and refine claims to reinforce novelty and non-obviousness. This involves analyzing existing patents and publications in the relevant field[2].

Effective Argumentation

Building compelling arguments around eligibility, novelty, and non-obviousness is crucial. This involves explaining the technological advancements brought about by the invention and distinguishing it clearly from the existing state of the art[2].

Prosecution of Patent Applications

Responding to Office Actions

During the prosecution process, applicants must respond to office actions, which are official letters from the USPTO that detail the examiner's findings and any objections or rejections. Drafting responses and making amendments to the claims are critical steps in this process[3].

Continuation Applications

Continuation applications can be filed to pursue additional claims related to the original application. These can include continuation-in-part applications, which allow for the addition of new matter. Understanding the allowance rates and the use of continuation procedures is vital, as only about 55.8% of applications are granted without using these procedures[1].

Key Takeaways

  • Statutory Compliance: Ensure that the patent application meets the criteria outlined in Sections 101, 102, and 103 of U.S. Patent Law.
  • Claim Precision: Draft claims that are clear, concise, and fully supported by the description.
  • Prior Art Analysis: Conduct thorough prior art searches to reinforce novelty and non-obviousness.
  • Strategic Argumentation: Build compelling arguments to distinguish the invention from prior art and demonstrate its technological advancements.
  • Prosecution Strategies: Effectively respond to office actions and consider the use of continuation applications to pursue additional claims.

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 the invention is not directed to abstract ideas, laws of nature, or natural phenomena[2].

Q: How does Section 102(e) impact international patent applications? A: Section 102(e) requires that an international application under the PCT must designate the U.S. and be published in English to be considered prior art in the U.S.[5].

Q: What is the importance of claim drafting in patent applications? A: Claim drafting is critical as it defines the scope of the invention. Claims must be clear, concise, and fully supported by the description to ensure broad yet specific protection[3].

Q: Why is prior art analysis essential in patent drafting? A: Prior art analysis helps identify potential obstacles and refine claims to reinforce novelty and non-obviousness, ensuring the invention is distinct from existing technology[2].

Q: What are continuation applications, and how are they used in patent prosecution? A: Continuation applications allow applicants to pursue additional claims related to the original application. They can include continuation-in-part applications, which permit the addition of new matter[1].

Sources

  1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
  2. TT Consultants. (2023). Exploring Sections 101, 102, & 103 of U.S. Patent Law.
  3. WIPO. (n.d.). WIPO Patent Drafting Manual: Second Edition.
  4. PubChem. (n.d.). Conjugates of Cell Binding Molecules with Cytotoxic Agents - Patent US-2018021448-A9.
  5. Finnegan. (2024). Navigating the Nuances of ยง 102(e): A Critical Look at State Designation in PCT Applications and Its Impact on Patent Litigation.

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Details for Patent 10,265,291

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 ⤷  Subscribe 2035-07-15
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 ⤷  Subscribe 2035-07-15
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 ⤷  Subscribe 2035-07-15
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 ⤷  Subscribe 2035-07-15
Bel-mar Laboratories, Inc. CHORIONIC GONADOTROPIN chorionic gonadotropin Injection 017054 March 26, 1974 ⤷  Subscribe 2035-07-15
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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