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Last Updated: January 7, 2025

Patent: 5,843,705


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Summary for Patent: 5,843,705
Title: Transgenically produced antithrombin III
Abstract:This invention relates to transgenically produced human Antithrombin III (tgATIII). The human ATIII produced by the transgenic process of the present invention has a monosaccharide composition which comprises N-acetylgalactosamine (GaINAc) along with fucose, N-acetylglucosamine, galactose, mannose, and N-acetylneuraminic acid/N-glycolyneuraminic acid. The monosaccharide composition differs with that of plasma derived ATIII (phATIII). It has been found that tgATIII has an increased clearance rate when compared to phATIII.
Inventor(s): DiTullio; Paul (Framingham, MA), Meade; Harry (Newton, MA), Cole; Edward S. (Mendon, MA)
Assignee: Genzyme Transgenic Corporation (Framingham, MA)
Application Number:08/391,743
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of United States Patent 5,843,705: A Critical Examination

Introduction

United States Patent 5,843,705, issued in December 1998, is a patent that has been part of the complex and evolving landscape of intellectual property. To conduct a comprehensive and critical analysis of this patent, we need to delve into several key aspects, including the patent's claims, the patentability analysis, the current patent landscape, and the implications of recent legal and regulatory changes.

Background of the Patent

Patent Overview

The patent in question, US 5,843,705, would typically involve a detailed description of an invention, including its background, summary, detailed description, and claims. Understanding the specific subject matter of the patent is crucial for any analysis.

Historical Context

Issued in 1998, this patent would have been subject to the patent laws and regulations in effect at that time. This includes the 20-year patent term from the filing date, as per the Uruguay Round Agreements Act[3].

Patent Claims Analysis

Claim Structure

Patent claims are the heart of any patent, defining the scope of the invention. A thorough analysis involves examining each claim for its clarity, novelty, and non-obviousness. Here, we would review the independent and dependent claims to understand what is specifically protected by the patent.

Prior Art Search

A prior art search is essential to determine the novelty and non-obviousness of the claims. This involves searching existing patents, publications, and other relevant documents to identify any overlapping or similar inventions[5].

Patentability Analysis

Novelty and Non-Obviousness

To be patentable, an invention must be novel and non-obvious. This means that the invention must not have been previously disclosed or obvious to someone skilled in the relevant field. A detailed analysis of prior art helps in determining whether the claims meet these criteria[5].

Utility and Enablement

The invention must also be useful and enable others to make and use the invention. The Manual of Patent Examining Procedures (MPEP) provides guidelines for these standards[5].

Current Patent Landscape

Trends in Patent Litigation

Recent trends in patent litigation, such as the increase in patent infringement lawsuits and the concentration of these cases in certain districts like the Eastern District of Texas, highlight the importance of robust patent quality. The USPTO's Enhanced Patent Quality Initiative aims to address these issues[1].

Covered Business Method (CBM) Reviews

The Leahy-Smith America Invents Act introduced CBM reviews, which allow for the challenge of "covered business method" patents. This has significant implications for patents related to data processing and other business methods, potentially affecting the validity of patents like US 5,843,705 if they fall within this category[2].

Regulatory and Legal Changes

Patent Term Adjustments

Changes in patent term regulations, such as those under 35 U.S.C. § 154, can affect the duration of patent protection. Patents issued before June 8, 1995, have different term calculations compared to those issued after this date[3].

Performance Incentives and Examiner Time

The USPTO has been working to improve patent quality by analyzing performance incentives and adjusting the time allotted for patent examinations. These changes aim to ensure that examiners have sufficient time to conduct thorough reviews, which can impact the quality and validity of patents[1].

Impact on Patent Validity

Challenges to Patent Validity

Patents can be challenged through various proceedings, including CBM reviews and inter partes reviews. The PTAB's decision in cases like Symphony Health Solutions Corp. v. IMS Health Inc. highlights the potential for patents to be invalidated if they do not meet the statutory requirements for patentability[2].

Application Readiness

The quality of the patent application itself is crucial. The USPTO's Application Readiness Review Form (ARRF) helps in assessing whether an applicant has provided sufficient information for an effective application, which can impact the patent's validity and pendency[1].

Case Studies and Examples

Real-World Implications

To illustrate the practical implications, consider a scenario where a patent similar to US 5,843,705 is challenged in a CBM review. If the patent is found to be a "covered business method" patent, it could be subject to invalidation, as seen in the Symphony Health case[2].

Key Takeaways

  • Patent Claims: The clarity, novelty, and non-obviousness of patent claims are critical for the patent's validity.
  • Prior Art Search: A thorough prior art search is essential to ensure the invention meets the standards of novelty and non-obviousness.
  • Regulatory Changes: Recent changes in patent laws and regulations, such as CBM reviews and adjustments in patent term calculations, can significantly impact the validity and duration of patents.
  • Patent Quality Initiatives: The USPTO's efforts to improve patent quality through enhanced examination processes and performance incentives are crucial for maintaining the integrity of the patent system.

FAQs

What is the significance of a prior art search in patentability analysis?

A prior art search is crucial for determining the novelty and non-obviousness of a patent's claims. It helps identify any existing inventions or publications that could render the claims invalid.

How do Covered Business Method (CBM) reviews affect patents?

CBM reviews allow for the challenge of "covered business method" patents, which can lead to the invalidation of patents directed to data processing or other business methods if they do not meet the statutory requirements for patentability.

What are the key factors in determining patent quality?

Patent quality is determined by factors such as the clarity and specificity of the claims, the thoroughness of the examination process, and the absence of any issues related to novelty, non-obviousness, utility, and enablement.

How have recent trends in patent litigation impacted the patent landscape?

Recent trends, such as the increase in patent infringement lawsuits and the concentration of cases in certain districts, have highlighted the need for robust patent quality and led to initiatives like the USPTO's Enhanced Patent Quality Initiative.

What is the role of the USPTO's Application Readiness Review Form (ARRF)?

The ARRF helps assess whether an applicant has provided sufficient information for an effective patent application, which can impact the patent's validity and pendency.

Sources

  1. GAO Report: Intellectual Property: Patent Office Should Define Quality, Reassess Incentives, and Improve Application Readiness. GAO-16-490, June 30, 2016.
  2. HKLAW Insights: Healthcare Data Analytics Patent Subject to “CBM” Review at USPTO. September 29, 2015.
  3. USPTO Manual of Patent Examining Procedures: Patent Term. USPTO, MPEP § 2701.
  4. Clemson University Library Guides: Advanced Patent Searching. May 23, 2024.
  5. InterSECT Job Simulations: IP: Patentability Analysis.

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Details for Patent 5,843,705

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc THROMBATE III antithrombin iii (human) For Injection 103196 December 30, 1991 5,843,705 2040-01-28
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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