Patent: 10,220,075

Summary for Patent: 10,220,075

Title:	Amine pegylation methods for the preparation of site-specific protein conjugates
Abstract:	Examples include a method of making a protein-PEG conjugate. The method may include providing an aqueous protein solution. The aqueous protein solution may include a protein, a pH buffer, and a chelating agent. The chelating agent may be chosen from the group consisting of an aminopolycarboxylic acid, a hydroxyaminocarboxylic acid, an N-substituted glycine, 2-(2-amino-2-oxocthyl) aminoethane sulfonic acid (BES), and deferoxamine (DEF). The method may also include introducing sodium cyanoborohydride and a methoxy polyethylene glycol aldehyde to the aqueous protein solution. The sodium cyanoborohydride in the methoxy polyethylene glycol aldehyde may have a molar ratio ranging from about 5:1 to about 1.5:1. The method may further include reacting the methoxy polyethylene glycol aldehyde with the protein to form the protein-PEG conjugate. The pH buffer may maintain a pH of the aqueous protein solution ranging from 4.0 to 4.4 during the reaction.
Inventor(s):	Rosendahl; Mary S. (Broomfield, CO), Mantripragada; Sankaram B. (Windsor, CO)
Assignee:	REZOLUTE, INC. (Louisville, CO)
Application Number:	15/158,898
Patent Claims:	see list of patent claims

Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,220,075

Introduction

Understanding the intricacies of a patent, particularly one like United States Patent 10,220,075, involves a deep dive into its claims, the patent examination process, and the broader patent landscape. This analysis will cover the key aspects of patent claims, the challenges in the patent examination process, the value of patents, and how to conduct a thorough review of patent applications.

Understanding Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention and what is protected by the patent. For a patent like 10,220,075, the claims must meet the conditions of novelty, non-obviousness, and usefulness as determined by the patent examiner[3].

Conditions of Patentability

• Novelty: The invention must be new and not obvious to someone skilled in the relevant field.
• Non-obviousness: The invention must be significantly different from existing technology.
• Usefulness: The invention must have a practical application.

The Patent Examination Process

The examination process for a patent is complex and involves multiple stages.

Initial Examination and Continuations

When a patent application is filed, it undergoes an initial examination. If rejected, the applicant can file continuations, which are closely related applications that may ultimately result in a patent. This process can be lengthy and involves tracking multiple related applications[1].

Allowance Rates

The probability of receiving a patent can be measured in several ways:

• First-action allowance rate: The proportion of applications allowed without further examination.
• Progenitor allowance rate: The proportion of applications allowed without any continuation procedure.
• Family allowance rate: The proportion of applications that produce at least one patent, including continuations[1].

Challenges in Patent Examination

Several factors complicate the calculation of patent allowance rates and the examination process itself.

Continuations and Serialized Continuations

Continuations, including continuations-in-part and divisional applications, can introduce new subject matter or separate distinct inventions. This can result in multiple patents from a single progenitor application, making the calculation of allowance rates complex[1].

Prior Art and Rejections

Examiners review prior art to determine if the claims are novel and non-obvious. If rejected, applicants must narrow or limit the scope of their claims to overcome the examiner's arguments[3].

The Value of a Patent

Patents can be highly valuable, and their value can be determined through several methods.

Valuation Methods

• Cost Approach: Based on the cost of developing the patent.
• Income Approach: Based on the future benefits provided by the patent.
• Market Approach: Based on what a willing buyer would pay for a similar asset[4].

For example, the median asking price for a patent can range from $108,000 to $250,000 per family, highlighting the significant financial value of patents[4].

Competitive Intelligence and Patent File Wrappers

Patent file wrappers are valuable tools for competitive intelligence, providing insights into the examination process and prior art.

Analyzing File Wrappers

By examining the file wrapper of a patent like 10,220,075, one can gain insights into the arguments made by the examiner, the prior art cited, and the adjustments made to the claims during the examination process. This information can be crucial for understanding the patent's strength and potential vulnerabilities[3].

Objective Application Review

Before submitting a patent application, an objective review is essential to avoid future problems.

Using Patent Analysis Tools

Tools like LexisNexis PatentOptimizer® can help in conducting a thorough review of the patent application, identifying potential issues such as procedural objections, Section 112 rejections, and post-grant challenges. This can significantly reduce patent prosecution delays and costs[5].

PTAB Trial Proceedings and Patent Validity

The Patent Trial and Appeal Board (PTAB) plays a crucial role in challenging the validity of issued patents.

Government Challenges

The Supreme Court has ruled that government agencies cannot challenge patent validity in PTAB trial proceedings, such as inter partes reviews (IPRs), due to the interpretation of the term "person" in the Leahy-Smith America Invents Act (AIA)[2].

Advantages of PTAB Proceedings

For parties seeking to invalidate a patent, PTAB proceedings offer advantages over federal court litigation, including a lower burden of proof and faster, less costly proceedings[2].

Key Takeaways

• Patent Claims: Must meet conditions of novelty, non-obviousness, and usefulness.
• Examination Process: Involves initial examination, continuations, and complex allowance rate calculations.
• Valuation: Can be determined through cost, income, and market approaches.
• Competitive Intelligence: Patent file wrappers provide valuable insights into the examination process and prior art.
• Objective Review: Essential for avoiding future problems and reducing prosecution costs.
• PTAB Proceedings: Important for challenging patent validity, but with specific limitations.

FAQs

What are the conditions for a patent to be granted?

A patent must meet the conditions of novelty, non-obviousness, and usefulness as determined by the patent examiner.

How do continuations affect the patent examination process?

Continuations can introduce new subject matter or separate distinct inventions, resulting in multiple patents from a single progenitor application and complicating the calculation of allowance rates.

What is the significance of prior art in the patent examination process?

Prior art is crucial as it helps the examiner determine whether the claims are novel and non-obvious, and if rejected, applicants must adjust their claims to overcome the examiner's arguments.

How can the value of a patent be determined?

The value of a patent can be determined through the cost approach (development cost), income approach (future benefits), and market approach (what a willing buyer would pay).

Why is an objective application review important before submitting a patent application?

An objective review helps avoid future problems such as procedural objections, Section 112 rejections, and post-grant challenges, reducing patent prosecution delays and costs.

Can government agencies challenge patent validity in PTAB trial proceedings?

No, the Supreme Court has ruled that government agencies cannot challenge patent validity in PTAB trial proceedings due to the interpretation of the term "person" in the AIA.

Sources

1. Hegde, D., & Marco, A. What Is the Probability of Receiving a US Patent? [PDF].
2. BIPC. Supreme Court: Government Cannot Challenge Patent Validity in IPR.
3. IP Checkups. Patent file wrappers as a tool for competitive intelligence.
4. Perpetual Motion Patents. The value of a patent.
5. LexisNexis IP. Patent Analysis Tools for Objective Application Review.

Details for Patent 10,220,075

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	October 28, 1982		2034-12-02
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	December 29, 2015		2034-12-02
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	August 06, 1998		2034-12-02
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	March 31, 1994		2034-12-02
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	May 25, 2018		2034-12-02
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	June 25, 1991		2034-12-02
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938	June 01, 2018		2034-12-02