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Last Updated: December 27, 2024

Patent: 10,954,549


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Summary for Patent: 10,954,549
Title:Detection and classification of an anticoagulant using a clotting assay
Abstract:In some embodiments, the invention provides methods for detecting and/or classifying an anticoagulant at a therapeutically relevant amount or higher in a patient, including subjecting a sample of a control blood component (known not to contain the anticoagulant) to a clotting assay in the presence of a Factor Xa reagent to obtain a control clotting measurement; and subjecting a sample of a blood component from a patient suspected of having the anticoagulant to the clotting assay in the presence of the Factor Xa reagent to obtain a patient clotting measurement, wherein the patient clotting measurement sample greater than the control clotting measurement indicates the presence of the anticoagulant at a therapeutically relevant amount or higher in the patient. In some embodiments, the invention includes methods for classifying an anticoagulant as an anti-Factor Xa or a direct thrombin inhibitor anticoagulant using a clotting assay in the presence of an ecarin reagent.
Inventor(s):Zaman Fowzia S., Doubleday Marc
Assignee:Haemonetics Corporation
Application Number:US16674334
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Complexities of U.S. Patent Claims: A Comprehensive Analysis of US Patent 10,954,549

Introduction

Patent law in the United States is a complex and evolving field, filled with nuances that can significantly impact the validity and enforceability of a patent. This article delves into the intricacies of U.S. patent claims, using US Patent 10,954,549 as a case study, to provide a comprehensive and critical analysis of the patent landscape.

What is a Patent and Why is it Important?

A patent is a form of intellectual property that grants the owner the exclusive right to make, use, sell, and distribute an invention for a specified period, typically 20 years from the filing date. Patents are crucial for innovators as they provide a monopoly over the invention, allowing the inventor to recoup investment and profit from their work[3].

The Patent Application Process

The journey to obtaining a U.S. patent involves several steps, starting with the filing of a patent application. This application must include a detailed description of the invention, drawings, and claims that define the scope of the invention. The application is then examined by the United States Patent and Trademark Office (USPTO) to determine if it meets the criteria for patentability: novelty, non-obviousness, utility, and subject matter eligibility[3].

Criteria for Patentability

For a patent to be granted, the invention must be novel, non-obvious, useful, and fall within the category of patentable subject matter.

Novelty and Non-obviousness

An invention is considered novel if it has not been previously disclosed in any form. Non-obviousness requires that the invention is not an evident solution to someone skilled in the field. This is assessed by comparing the invention against prior art to ensure it offers innovative steps that are not readily apparent[5].

Utility and Subject Matter Eligibility

The invention must be useful and serve a practical purpose. Additionally, it must fall within the category of patentable subject matter, which often requires it to be tied to a specific technological implementation or to improve the functioning of a machine[5].

The Role of Claims in a Patent Application

Claims are the heart of a patent application, defining the scope of the invention and what the applicant seeks to protect. There are different types of claims, including independent and dependent claims, each serving a specific purpose in delineating the invention's boundaries.

Independent Claims

Independent claims stand alone and define the invention without reference to other claims. They are crucial as they set the broadest scope of protection for the invention.

Dependent Claims

Dependent claims refer back to an independent claim and narrow down the scope of the invention. They are used to provide additional protection for specific embodiments of the invention[3].

Continuation Applications and Their Impact

Continuation applications are a critical aspect of the patent landscape. These applications allow applicants to file new applications related to an earlier filed application, often to introduce new subject matter or to pursue additional claims.

Types of Continuation Applications

  • Continuations: These are new applications that continue the prosecution of an earlier application without introducing new subject matter.
  • Continuations-in-Part (CIPs): These allow applicants to introduce new subject matter to an existing application.
  • Divisional Applications: These enable applicants to separate claimed inventions when two or more distinct inventions are claimed in the same application[1].

The Complexity of Patent Allowance Rates

Calculating patent allowance rates is more complex than it seems. The USPTO tracks several measures, including the first-action allowance rate, progenitor allowance rate, and family allowance rate. These rates help in understanding the likelihood of a patent being granted, including the outcomes of continuation applications[1].

Double Patenting and Its Implications

Double patenting, particularly obviousness-type double patenting (ODP), is a doctrine that prevents a subsequent patent from being granted on the same invention as an earlier granted patent or an obvious modification thereof. This doctrine is crucial in ensuring that inventors do not extend the term of a patent unjustifiably.

Recent Court Decisions

The Federal Circuit's decision in In re Cellect highlights the importance of terminal disclaimers in avoiding ODP issues. The court emphasized that patent owners must disclaim any term in a second or further patent application that would extend the term of already-issued patents[2].

Case Study: US Patent 10,954,549

To illustrate these concepts, let's consider US Patent 10,954,549. While the specific details of this patent are not provided here, we can apply the general principles discussed above.

Claims Analysis

  • Independent Claims: These would define the broadest scope of the invention.
  • Dependent Claims: These would narrow down the scope, providing additional protection for specific embodiments.

Continuation Applications

If US Patent 10,954,549 is part of a family of patents, understanding the continuation applications and their impact is crucial. This includes whether there are continuations, CIPs, or divisional applications that could affect the patent's validity and scope.

Double Patenting Considerations

Ensuring that the patent does not fall under the doctrine of ODP is vital. This involves checking if the patent claims priority from the same application as an earlier granted patent and if any terminal disclaimers were filed to avoid extending the patent term unjustifiably.

Practical Considerations for Patent Applicants

For applicants seeking to navigate the U.S. patent system, several practical considerations are essential:

Preparation and Examination

The application must be meticulously prepared, including detailed descriptions and drawings. The examination process by the USPTO is rigorous, and applicants must be prepared to address any objections or rejections[5].

Continuation Strategies

Applicants should have a clear strategy regarding continuation applications. This includes deciding when to file continuations, CIPs, or divisional applications to maximize the scope of protection[1].

Avoiding Double Patenting

Applicants must be vigilant about ODP issues. Filing terminal disclaimers and ensuring that subsequent patents do not extend the term of earlier patents unjustifiably are critical steps[2].

Key Takeaways

  • Patent Claims: The claims in a patent application are crucial and define the scope of the invention.
  • Continuation Applications: These can significantly impact the patent landscape and must be strategically managed.
  • Double Patenting: Ensuring compliance with ODP doctrine is essential to avoid invalidation of patents.
  • Patent Allowance Rates: Understanding these rates can help in predicting the likelihood of a patent being granted.
  • Practical Considerations: Applicants must be meticulous in preparing and prosecuting their applications.

FAQs

  1. What is the significance of independent and dependent claims in a patent application? Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope to provide additional protection for specific embodiments.

  2. How do continuation applications affect the patent landscape? Continuation applications allow applicants to pursue additional claims or introduce new subject matter, which can extend the protection and scope of the original invention.

  3. What is obviousness-type double patenting (ODP), and why is it important? ODP is a doctrine that prevents a subsequent patent from being granted on the same invention as an earlier granted patent or an obvious modification thereof. It is crucial to avoid extending the term of a patent unjustifiably.

  4. How do patent allowance rates help in understanding the patent process? Patent allowance rates, such as first-action allowance rate, progenitor allowance rate, and family allowance rate, provide insights into the likelihood of a patent being granted and the outcomes of continuation applications.

  5. What is the role of terminal disclaimers in patent applications? Terminal disclaimers are filed to disclaim any term in a second or further patent application that would extend the term of already-issued patents, thus avoiding ODP issues.

Sources

  1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
  2. Mintz. (2023, September 7). Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent. Retrieved from https://www.mintz.com/insights-center/viewpoints/2231/2023-09-07-federal-circuit-puts-onus-patent-owners-disclaim-patent
  3. Chisum on Patents. (n.d.). Retrieved from https://store.lexisnexis.com/products/chisum-on-patents-skuusSku10111
  4. National Science Foundation. (2022, March 8). Invention, Knowledge Transfer, and Innovation. Retrieved from https://ncses.nsf.gov/pubs/nsb20224/technical-appendix
  5. Patent Lawyer. (2024, June 20). Can You Patent an Algorithm? Understanding Legal Boundaries. Retrieved from https://patentlawyer.io/can-you-patent-an-algorithm/

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Details for Patent 10,954,549

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Astrazeneca Ab ANDEXXA coagulation factor xa (recombinant), inactivated-zhzo Injection 125586 May 03, 2018 ⤷  Subscribe 2039-11-05
Astrazeneca Ab ANDEXXA coagulation factor xa (recombinant), inactivated-zhzo Injection 125586 December 31, 2018 ⤷  Subscribe 2039-11-05
Boehringer Ingelheim Pharmaceuticals, Inc. PRAXBIND idarucizumab Injection 761025 October 16, 2015 ⤷  Subscribe 2039-11-05
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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