Patent: 10,335,464

Summary for Patent: 10,335,464

Title:	Device for titrating basal insulin
Abstract:	The invention relates to a novel administration regime useful in the treatment of diseases or conditions where administration of insulin will be of benefit. In particular, the invention relates to a long-acting or ultra-long acting insulin for use in treating a disease or condition where administration of insulin will be of benefit, wherein the administration of said insulin includes or consists of one or more of the following steps: (a) obtaining a first data set of the subject, (b) obtaining a second data set of the subject, (c) obtaining a first data structure of the subject, and (d) obtaining a second data structure of the subject. When a determination is made that the at least first data structure, second data structure, first data set, and second data set collectively do contain the set of evaluation information, the device further includes providing the long-acting or ultra-long-acting insulin dose guidance recommendation.
Inventor(s):	Michelich; Alan John (Seattle, WA), Miller; Thomas Dedenroth (Seattle, WA), Shvets; Oleksandr (Everett, WA), Imanbayev; Anuar (Seattle, WA), Van Orden; Brad (Seattle, WA)
Assignee:	Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:	16/020,478
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,335,464

Introduction

Patent analysis is a crucial step in understanding the intellectual property landscape, particularly for businesses and inventors looking to protect their innovations. This article will provide a comprehensive and critical analysis of the claims and the broader patent landscape surrounding United States Patent 10,335,464.

Understanding the Patent

To begin, it is essential to understand the specifics of the patent in question. United States Patent 10,335,464, like any other patent, includes several key components:

• Title and Abstract: These provide a brief overview of the invention.
• Background of the Invention: This section explains the context and prior art related to the invention.
• Summary of the Invention: A concise description of the invention and its main features.
• Detailed Description of the Invention: A thorough explanation of the invention, including drawings and examples.
• Claims: The most critical part of the patent, as these define the scope of the invention and what is protected[3].

Claims Analysis

The claims section of a patent is where the legal boundaries of the invention are defined. Here are some key points to consider:

Claim Types

• Independent Claims: These stand alone and define the invention without reference to other claims.
• Dependent Claims: These refer back to an independent claim and further limit the scope of the invention[3].

Claim Construction

The language used in the claims is crucial. It must be precise and clear to avoid ambiguity. Tools like LexisNexis PatentOptimizer can help in drafting and analyzing claims to ensure they are defensible and broad enough to cover the invention but not so broad as to be invalid[3].

Novelty and Non-Obviousness

Claims must satisfy the statutory requirements of novelty (Section 102 of Title 35 U.S.C.) and non-obviousness (Section 103 of Title 35 U.S.C.). This involves ensuring that the invention is new and not an obvious extension of prior art[5].

Patent Landscape Analysis

Understanding the broader patent landscape is vital for several reasons:

Geographical Distribution

Patent activity can vary significantly by geographical location. For instance, patent intensity, defined as the number of patents issued per population, can highlight regions of high innovation activity. This data can be obtained from sources like the USPTO’s PatentsView database, which provides detailed county-level data on patenting activity[1].

Technology Fields

Patents are classified into various technology fields using schemes like the International Patent Classification (IPC). This classification helps in identifying trends and patterns in specific technological areas. For example, AI patents can be analyzed over time, by technology category, and by country to understand global innovation trends[1].

Ownership and Inventorship

Patent data can be analyzed based on where inventors live and where the ownership rights are assigned. This distinction is important as it can reveal different patterns and trends in patenting activity. For instance, a patent might be owned by a company in one location but invented by individuals in another[1].

Legal and Regulatory Framework

The legal framework governing patents in the United States is complex and evolving.

Patent Eligibility Requirements

The subject matter eligibility requirement (Section 101 of Title 35 U.S.C.) has been a subject of debate. Clarifying these requirements is essential to ensure that inventions meet the necessary criteria for patentability. Recent court decisions and legislative initiatives aim to provide more clarity on this issue[5].

Administrative Procedures

The Leahy-Smith America Invents Act of 2011 introduced procedures like inter partes review and post-grant review, allowing third-party challenges to patent validity. These procedures have been criticized for creating uncertainty and undermining the patent system[5].

Tools and Resources for Patent Analysis

Several tools and resources are available to help in patent analysis:

LexisNexis PatentOptimizer

This tool streamlines patent analysis and drafting, providing comprehensive error reports and helping to fortify patent applications before submission to the USPTO. It also aids in generating IDS forms and ensuring that claims can withstand §112 review[3].

Patent Search and Analytics

Tools like LexisNexis TotalPatent One and PatentAdvisor provide high-performance patent search capabilities and advanced examiner analytics, respectively. These tools help in identifying relevant patents, assessing the competitive landscape, and implementing effective prosecution strategies[3].

Case Law and Judicial Precedents

Judicial decisions play a significant role in shaping the patent landscape.

United States Court of Appeals for the Federal Circuit

Cases like In re Cellect highlight the complexities in patent law, particularly regarding issues like Patent Term Adjustment (PTA) and the determination of unpatentability under obviousness-type double patenting (ODP)[2].

Supreme Court Decisions

Decisions such as Patent and Trademark Office v. Booking.com B.V. emphasize the importance of consumer perception in trademark law, which can have implications for how patents are viewed in terms of their descriptive and generic nature[4].

Strategic Implications

Understanding the claims and patent landscape of a specific patent like 10,335,464 has several strategic implications:

Innovation Strategy

Companies can use patent analysis to identify gaps in the market and areas where innovation is needed. This helps in aligning R&D efforts with market demands.

Competitive Analysis

Analyzing the patent portfolios of competitors can reveal their technological strengths and weaknesses. This information can be used to develop competitive strategies.

Licensing and Collaboration

Identifying key patents and their owners can facilitate licensing agreements and collaborative research initiatives.

Key Takeaways

• Precise Claim Drafting: Ensuring that patent claims are clear, broad, and defensible is crucial.
• Regulatory Compliance: Understanding and complying with statutory requirements such as novelty, non-obviousness, and subject matter eligibility is essential.
• Geographical and Technological Trends: Analyzing patent data by geography and technology field can provide valuable insights into innovation trends.
• Legal Framework: Staying updated with the evolving legal and regulatory framework is vital for effective patent strategy.
• Tools and Resources: Utilizing advanced tools and resources can streamline patent analysis and drafting.

FAQs

1. What is the importance of claim construction in patent drafting? Claim construction is critical because it defines the legal boundaries of the invention. Clear and precise claims help avoid ambiguity and ensure that the patent is defensible.

2. How does the USPTO classify patents by technology fields? The USPTO uses internationally agreed-on technology fields from the World Intellectual Property Organization (WIPO), such as the International Patent Classification (IPC), to classify patents[1].

3. What are the implications of the Leahy-Smith America Invents Act on patent challenges? The Act introduced administrative procedures like inter partes review and post-grant review, which allow third-party challenges to patent validity. This has created a more complex landscape for patent owners, with lower hurdles for raising challenges[5].

4. How can tools like LexisNexis PatentOptimizer aid in patent analysis? LexisNexis PatentOptimizer streamlines patent analysis and drafting by providing comprehensive error reports, ensuring claims can withstand §112 review, and automating tasks like generating IDS forms[3].

5. What role do judicial decisions play in shaping patent law? Judicial decisions, especially from the Federal Circuit and the Supreme Court, provide interpretations of patent laws and regulations, which can significantly impact how patents are granted, challenged, and enforced[2][4].

Sources

1. National Center for Science and Engineering Statistics. Invention, Knowledge Transfer, and Innovation. 2024.
2. United States Court of Appeals for the Federal Circuit. In re Cellect. 2023.
3. LexisNexis Intellectual Property Solutions. PatentOptimizer.
4. Supreme Court of the United States. Patent and Trademark Office v. Booking.com B.V. 2020.
5. Center for Strategic and International Studies. Four Actions to Strengthen the U.S. Intellectual Property System. 2023.

Details for Patent 10,335,464

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	September 25, 2015	10,335,464	2040-04-01
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	November 21, 2018	10,335,464	2040-04-01