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Last Updated: December 26, 2024

Patent: 10,245,348


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Summary for Patent: 10,245,348
Title:Process for making dry and stable hemostatic compositions
Abstract: Described is a process for making a dry and stable hemostatic composition, said process comprising a) providing a first component comprising a dry preparation of a coagulation inducing agent, b) providing a second component comprising a dry preparation of a biocompatible polymer suitable for use in hemostasis, c) providing said first component and said second component in a combined form in a final container, c1) either by filling said first component and said second component into said final container so as to obtain a dry mixture in said final container, c2) or by providing said first component or said second component in said final container and adding said second component or said first component so as to obtain a combination of said first component with said second component in said final container, d) finishing the final container to a storable pharmaceutical device containing said first component and said second component in a combined form as a dry and stable hemostatic composition.
Inventor(s): Goessl; Andreas (Vienna, AT), Osawa; Atsushi Edward (San Francisco, CA), Reich; Cary J. (Los Gatos, CA)
Assignee: Baxter International Inc. (Deerfield, IL) Baxter Healthcare SA (Glattpark (Opfikon), CH)
Application Number:14/804,084
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Complexities of Patent Claims and the Patent Landscape: A Case Study of US Patent 10,245,348

Introduction

Patents are a cornerstone of innovation, protecting intellectual property and encouraging the development of new technologies. The landscape of patent law and the process of patent application and examination are complex and evolving. This article will delve into the intricacies of patent claims, using US Patent 10,245,348 as a case study, and explore the broader patent landscape in the United States.

The Importance of Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention and the rights granted to the patent holder. The business and legal value of a patent resides primarily in its claims, which must be carefully crafted to ensure they are valid, enforceable, and distinguishable from prior art[2].

The Evolution of Patent Applications

The number of patent applications has been increasing steadily over the years, driven by technological innovation and the need for capital to develop and commercialize new technologies. From approximately 100,000 patent applications per year in the 1960s and 1970s to over 326,000 in 2001, the trend continues with an annual growth rate of about 11%[2].

Challenges in Patent Claims Review

With the increasing number of patent applications and the rising complexity of claims, reviewing and analyzing patent claims has become a daunting task. Some patent applications now include hundreds or even thousands of claims, necessitating automated systems to manage and analyze these claims efficiently. For instance, the Patent Matrix software developed by Spore automates the import, parsing, and compression/expansion of patent claims to facilitate rapid review[2].

The Leahy-Smith America Invents Act (AIA) and Its Impact

The 2011 Leahy-Smith America Invents Act (AIA) is a significant milestone in U.S. patent law, introducing new administrative procedures such as inter partes review (IPR) and post-grant review (PGR). These procedures allow challenges to the validity of already-issued patents in an administrative forum, rather than solely in court. The AIA also established the Patent Trial and Appeal Board (PTAB) within the USPTO, which hears these challenges[3].

Patentable Subject Matter: The Alice/Mayo Test

The AIA and subsequent court decisions, such as the Alice/Mayo test, have refined what constitutes patentable subject matter. The two-step test determines whether patent claims are directed to ineligible subject matter (e.g., laws of nature, natural phenomena, or abstract ideas) and whether they contain an "inventive concept" that transforms the nature of the ineligible concept[3].

Advanced Patent Searching Techniques

Comprehensive patent searching is crucial for understanding the scope and coverage of related patents within a family. However, this process is complicated by multi-jurisdiction filing, indexing inconsistencies, language barriers, and scientific sophistication. Claims variation during the prosecution process further complicates this task, as claims may be amended or narrowed in response to examiner objections or prior art[4].

Case Study: US Patent 10,245,348

Overview

To illustrate the complexities and considerations involved in patent claims, let's examine US Patent 10,245,348. This patent, like many others, involves a detailed description of the invention, background of the invention, summary of the invention, and detailed descriptions of the drawings.

Claims Analysis

The claims section of US Patent 10,245,348 would typically include a set of independent and dependent claims that define the scope of the invention. Each claim must be carefully drafted to ensure it meets the requirements of patentability, including novelty, non-obviousness, and utility.

  • Independent Claims: These claims stand alone and define the broadest scope of the invention. They are critical in determining the patent's enforceability and the extent of the rights granted.
  • Dependent Claims: These claims build upon the independent claims and provide additional specificity. They often narrow the scope of the invention but can offer additional protection by covering various aspects of the invention.

Prosecution History

During the prosecution process, the claims of US Patent 10,245,348 may have been amended or narrowed in response to objections from the patent examiner or to overcome prior art. This process can significantly impact the final scope of the patent, as seen in cases like Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd., where narrowing amendments can limit the patent claims' scope[2].

Geographic and Economic Analysis of Patents

Patent data can also be analyzed geographically and by economic sector. For instance, the USPTO provides county-level patent data based on the residence of the inventor and the location of the patent owner. This allows for regional economic analysis and insights into where innovation is concentrated[1].

Quality of Patents

The quality of patents is another critical aspect of the patent landscape. The USPTO has been working to define and improve patent quality through various measures, including statutory compliance rates and the use of additional clarity tools. The Government Accountability Office (GAO) has recommended that the USPTO more consistently define patent quality and reassess the time allotted for examination to ensure thorough and accurate patent reviews[5].

Inter Partes Review and Post-Grant Review

The PTAB, established by the AIA, plays a significant role in the patent landscape by providing an administrative forum for challenging the validity of issued patents. Inter partes review (IPR) and post-grant review (PGR) allow parties to challenge patents without going to court, which can be a more efficient and cost-effective process[3].

Key Takeaways

  • Patent Claims are Crucial: The claims section of a patent is vital and must be carefully crafted to ensure validity and enforceability.
  • Evolving Patent Landscape: The AIA and subsequent court decisions have significantly impacted the patent landscape, particularly in terms of what constitutes patentable subject matter.
  • Advanced Searching Techniques: Comprehensive patent searching is essential but challenging due to various complexities such as multi-jurisdiction filing and claims variation.
  • Geographic and Economic Analysis: Patent data can provide valuable insights into regional innovation and economic activity.
  • Patent Quality: Ensuring high-quality patents is a continuous effort, involving statutory compliance and clarity tools.

FAQs

  1. What is the significance of the Leahy-Smith America Invents Act (AIA) in U.S. patent law?

    • The AIA is a landmark legislation that introduced new administrative procedures such as inter partes review (IPR) and post-grant review (PGR), and established the Patent Trial and Appeal Board (PTAB) to hear challenges to patent validity[3].
  2. How do patent claims impact the value of a patent?

    • Patent claims define the scope of the invention and the rights granted to the patent holder, making them the most valuable part of a patent application[2].
  3. What challenges are associated with reviewing and analyzing patent claims?

    • The increasing number of patent applications and claims, along with the complexity of claims, makes reviewing and analyzing them a challenging task, often requiring automated systems[2].
  4. How does the Alice/Mayo test affect patentability?

    • The Alice/Mayo test is a two-step process that determines whether patent claims are directed to ineligible subject matter and whether they contain an "inventive concept" that transforms the nature of the ineligible concept[3].
  5. Why is geographic analysis of patent data important?

    • Geographic analysis of patent data provides insights into regional innovation and economic activity, helping in regional economic analysis and policy-making[1].

Sources

  1. National Science Foundation. Invention, Knowledge Transfer, and Innovation. 2022.
  2. Google Patents. US20110138338A1 - Patent Claims Analysis System and Method.
  3. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. 2024.
  4. CAS.org. Advanced patent searching techniques - CAS.org. 2023.
  5. Government Accountability Office. Intellectual Property: Patent Office Should Define Quality, Reassess ... 2016.

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Details for Patent 10,245,348

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Omrix Biopharmaceuticals Ltd EVITHROM thrombin, topical (human) Solution 125247 August 27, 2007 10,245,348 2030-06-01
Omrix Biopharmaceuticals Ltd EVITHROM thrombin, topical (human) For Injection 125247 September 17, 2009 10,245,348 2030-06-01
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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