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Last Updated: April 23, 2025

Patent: 10,137,172


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Summary for Patent: 10,137,172
Title:Administration regime
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, as well as to kits for use in the same. 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 comprises or consists of the following steps: (a) optionally providing a blood sample to be tested from an individual in need of treatment; (b) taking a single fasting blood (or plasma) glucose measurement from said individual in need of treatment; (c) using the single fasting blood (or plasma) glucose measurement to determine the insulin dose to be administered; and (d) administering the long-acting or ultra-long insulin to the individual at the dose determined in step (c).
Inventor(s): Johansen; Thue (Koebenhavn OE, DK), Francisco; Ann Marie Ocampo (Copenhagen V, DK), Christensen; Torsten (Princeton, NJ), Kongsoe; Jens Harald (Hoersholm, DK), Ahlgreen; Trine (Frederiksberg C, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:14/888,118
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Navigating the Complexities of Patent Claims: A Comprehensive Analysis of the Patent Landscape for US Patent 10,137,172

Introduction

Patent law in the United States is a intricate and evolving field, crucial for protecting innovations and driving technological advancement. This article delves into the complexities of patent claims, particularly focusing on the landscape surrounding US Patent 10,137,172. We will explore the key sections of U.S. patent law, the challenges in patent application and examination, and the strategic considerations for drafting and defending patent claims.

Understanding U.S. Patent Law: Sections 101, 102, and 103

Section 101: Patentable Subject Matter

Section 101 of the U.S. Patent Law defines what constitutes patentable subject matter. It stipulates that a claim must be directed to a process, machine, manufacture, or composition of matter to be eligible for patent protection. The landmark case of Alice Corp. v. CLS Bank International (2014) introduced a two-step test to determine eligibility: first, whether the claim is directed to a judicial exception (law of nature, natural phenomenon, or abstract idea), and second, whether the claim contains an inventive concept that transforms the nature of the claim into something more than the exception itself[3].

Section 102: Novelty

Section 102 addresses the novelty requirement, ensuring that the invention is new and not obvious from prior art. This section is critical in preventing the patenting of existing knowledge or inventions that have been publicly disclosed before the patent application. The first-to-file principle, emphasized in cases like Glidden, highlights the importance of timely filing and the commercial success of an invention in establishing novelty[3].

Section 103: Non-obviousness

Section 103 focuses on non-obviousness, requiring that the invention must not be readily apparent to a person having ordinary skill in the art (PHOSITA). Determining non-obviousness involves a multifaceted analysis, including factors such as the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of ordinary skill in the pertinent art[3][4].

The Patent Examination Process

Allowance Rates and Continuation Applications

The patent examination process is complex, with multiple stages and potential continuations. The USPTO tracks several measures of patent allowance rates, including the first-action allowance rate, progenitor allowance rate, and family allowance rate. These rates account for the various continuation procedures, such as continuations, continuations-in-part, and divisional applications, which can significantly impact the final outcome of a patent application[1].

Rejection of Claims

An examiner must reject a claim if it is more likely than not that the claim is unpatentable based on prior art and evidence of record. The standards of patentability are uniform across all arts, and all requirements (patent eligible, useful, novel, nonobvious, enabled, and clearly described) must be met before a claim is allowed[4].

Strategic Considerations for Patent Drafting

Detailed Prior Art Analysis

Conducting extensive prior art searches is essential to identify potential obstacles and refine claims to reinforce novelty and non-obviousness. This analysis helps in anticipating potential objections and framing arguments that robustly showcase the invention’s non-obviousness[3].

Crafting Claims

Crafting claims that are broad enough to offer substantial protection yet specific enough to circumvent prior art is crucial. The focus should be on highlighting the unique aspects of the invention that render it eligible, novel, and non-obvious. Effective claim drafting involves explaining the technological advancements brought about by the invention and distinguishing it clearly from the existing state of the art[3].

Automated Tools for Patent Claims Analysis

Given the increasing complexity and volume of patent applications, automated tools like the Patent Matrix software can significantly aid in the review and analysis of patent claims. These tools can import, parse, and compress claims, making it easier to navigate the hierarchical structure of patent claims and identify key elements[2].

Case Study: US Patent 10,137,172

While specific details of US Patent 10,137,172 are not provided here, applying the principles outlined above is crucial for its analysis.

Eligibility Under Section 101

To determine if the patent claims of US Patent 10,137,172 are eligible under Section 101, one must apply the Alice test. This involves identifying whether the claims are directed to a judicial exception and if they contain an inventive concept that transforms the nature of the claim.

Novelty and Non-obviousness

Ensuring the claims meet the novelty and non-obviousness requirements under Sections 102 and 103 is vital. This involves a thorough prior art search and analysis to demonstrate that the invention is new and not obvious to a PHOSITA.

Examination and Prosecution

Understanding the patent examination process, including the potential for continuation applications, is essential. The allowance rates and the specific measures used by the USPTO can provide insights into the likelihood of patent grant and the strategies needed to navigate the examination process.

Practical Insights for Innovators and IP Lawyers

Staying Abreast of Prior Art

Innovators and IP lawyers must stay updated on the latest developments in their field to avoid inadvertent infringement and to ensure their inventions meet the criteria for patentability[3].

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[3].

Leveraging Technology

Utilizing automated tools and technologies can streamline the patent application and examination process, making it more efficient and reducing the burden of reviewing large volumes of claims[2].

Key Takeaways

  • Understanding Patent Law: Sections 101, 102, and 103 are pivotal in determining the patentability of an invention.
  • Detailed Analysis: Conducting thorough prior art searches and analyzing existing patents are essential for drafting robust patent claims.
  • Strategic Claim Drafting: Crafting claims that balance breadth and specificity is crucial for securing substantial protection.
  • Automated Tools: Leveraging technology can aid in the efficient review and analysis of patent claims.
  • Continuation Applications: Understanding the complexities of continuation procedures is vital for navigating the patent examination process.

FAQs

What is the significance of Section 101 in U.S. Patent Law?

Section 101 defines what constitutes patentable subject matter, ensuring that claims are directed to a process, machine, manufacture, or composition of matter and are not judicial exceptions without an inventive concept[3].

How does the USPTO calculate patent allowance rates?

The USPTO calculates three measures: the first-action allowance rate, progenitor allowance rate, and family allowance rate, which account for various continuation procedures[1].

What is the role of prior art in patent examination?

Prior art is crucial in determining novelty and non-obviousness. A thorough prior art search helps in identifying potential obstacles and refining claims to ensure they meet the criteria for patentability[3].

How can automated tools aid in patent claims analysis?

Automated tools like the Patent Matrix software can import, parse, and compress claims, making it easier to navigate the hierarchical structure of patent claims and identify key elements[2].

What are the key factors in determining non-obviousness under Section 103?

Determining non-obviousness involves factors such as the scope and content of the prior art, the differences between the prior art and the claimed invention, and the level of ordinary skill in the pertinent art[3][4].

Sources

  1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent? The Yale Journal of Law & Technology.
  2. *US20110138338A1 - Patent Claims Analysis System and Method. (n.d.). Google Patents.
  3. *Navigating the Nuances: A Comprehensive Exploration of Sections 101, 102, and 103 of U.S. Patent Law. (2023, October 5). TT Consultants.
  4. *706-Rejection of Claims - USPTO. (n.d.). United States Patent and Trademark Office.

More… ↓

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Details for Patent 10,137,172

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 September 25, 2015 ⤷  Try for Free 2033-04-30
Novo Nordisk Inc. TRESIBA insulin degludec Injection 203314 November 21, 2018 ⤷  Try for Free 2033-04-30
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
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