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Last Updated: April 24, 2025

Patent: 5,545,403


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Summary for Patent: 5,545,403
Title: Method for treating a mammal by administering a CHO-glycosylated antibody
Abstract:The invention relates to a CHO cell-line capable of producing antibody, the cell-line having been co-transfected with a vector capable of expressing the light chain of the antibody and a vector capable of expressing the heavy chain of the antibody wherein the vectors contain independently selectable markers; also included is a CHO cell-line capable of producing a human antibody or an altered antibody, the cell-line having been transfected with a vector capable of expressing the light chain of the antibody and the heavy chain of the antibody; process for the production of antibody using a CHO cell-line and antibody having CHO glycosylation.
Inventor(s): Page; Martin J. (Beckenham, GB)
Assignee: Burroughs Wellcome Co. (Research Triangle Park, NC)
Application Number:08/155,864
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 5,545,403

Introduction

United States Patent 5,545,403, though not directly provided in the sources, can be analyzed through the lens of general patent analysis principles and the broader patent landscape. This article will delve into the critical aspects of patent claims, the importance of patent landscape analysis, and how these elements interact within the U.S. patent system.

Understanding Patent Claims

Claim Construction

The construction of patent claims is a crucial step in determining the scope and validity of a patent. Claims are construed from the perspective of a person of ordinary skill in the art at the time of the invention. This involves looking at the intrinsic evidence, including the claims themselves, the specification, and the prosecution history[3].

Claim Scope and Boundaries

High-quality patents have claims that clearly define and provide clear notice of their boundaries. In contrast, low-quality patents often contain unclear property rights or overly broad claims, which can lead to disputes and litigation[2].

The Importance of Patent Landscape Analysis

What is Patent Landscape Analysis?

Patent landscape analysis is a comprehensive approach that provides strategic insights into the intellectual property (IP) landscape. It involves analyzing a broad range of patents to understand the geographical spread, saturation, and trends within a specific technology area[3].

Key Questions in Patent Landscape Analysis

  • Geographical Spread: Understanding where patents are being filed geographically helps in advising clients on where to focus their patent prosecution efforts.
  • Saturation Level: Determining how saturated a patent space is crucial for advising on the potential rewards or risks of entering that space.
  • New Entrants: Identifying new entrants into a patent space can reveal emerging trends and competitors.
  • Time-Slicing: Analyzing changes over time helps in understanding the evolution of a technology area[3].

Case Study: Glaxo Wellcome Inc. v. Genentech

While the specific patent 5,545,403 is not detailed, the case of Glaxo Wellcome Inc. v. Genentech provides insights into the challenges and considerations in patent claims and landscape analysis.

Claim Specificity and Obviousness

In the Glaxo Wellcome case, the examiner rejected claims for a stabilized immunoglobulin composition due to obviousness under 35 U.S.C. § 103. The examiner argued that mixing a chelator of copper ions with an antibody to stabilize it would have been obvious to one of ordinary skill in the art, citing prior art references such as U.S. Patent No. 5,367,060[1].

Restriction Requirements and Enablement

The case also highlights the importance of restriction requirements and enablement. The examiner required the applicants to elect a single invention and criticized the lack of enablement for certain claims, noting that only specific chelators were disclosed in the specification[1].

Patent Quality Assurance

USPTO's Quality Assurance Practices

The U.S. Patent and Trademark Office (USPTO) has faced challenges in ensuring the quality of issued patents. The Office of the Inspector General (OIG) has identified areas of concern, including ineffective performance appraisal plans, underrepresentation of error rates, lack of data collection, and inadequate responses to patent abuse[2].

Programs for Quality Review

The USPTO employs several programs to review patent examination quality, including performance appraisal reviews, independent reviews by the Office of Patent Quality Assurance (OPQA), and signatory authority reviews. These programs aim to ensure that examiners are issuing high-quality decisions and to identify areas for additional training[2].

Inter Partes Review and the PTAB

The Role of the PTAB

The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the Patent Trial and Appeal Board (PTAB). The PTAB hears administrative challenges to the validity of patents, providing a mechanism for post-grant review[5].

Eligibility and Inventive Concept

The PTAB also addresses whether patent claims are directed to ineligible subject matter, such as laws of nature, natural phenomena, or abstract ideas. If so, the claims must contain an "inventive concept" to be patentable[5].

Tools for Patent Landscape Analysis

Global Dossier and Public Search Facilities

Tools like the Global Dossier and the USPTO Public Search Facility provide access to file histories, classification data, and citation data for related applications. These resources are essential for conducting thorough patent landscape analyses[4].

Common Citation Document (CCD)

The CCD application consolidates prior art cited by participating IP offices, enabling a single-point access to up-to-date citation data. This facilitates a more integrated global patent system[4].

Strategic Insights from Patent Landscape Analysis

Identifying Niche Areas

A comprehensive patent landscape analysis can uncover underappreciated niche areas within a technology space. For example, identifying a company that focuses a significant portion of its resources on a niche technology can guide strategic decisions about research, development, and patent prosecution[3].

Time-Slicing and Trend Analysis

Time-slicing involves analyzing changes in patent activity over time. This can reveal trends such as the cessation of patent activity in certain areas or the emergence of new technologies[3].

Key Takeaways

  • Clear Claim Construction: Ensuring that patent claims are clear and well-defined is crucial for avoiding disputes and litigation.
  • Comprehensive Landscape Analysis: Conducting a thorough patent landscape analysis helps in understanding the geographical spread, saturation, and trends within a technology area.
  • Quality Assurance: The USPTO's quality assurance practices are critical for ensuring that high-quality patents are issued.
  • Post-Grant Review: Mechanisms like the PTAB provide avenues for challenging the validity of patents post-grant.
  • Strategic Decision-Making: Patent landscape analysis provides valuable insights for strategic decision-making in research, development, and patent prosecution.

FAQs

What is the purpose of patent landscape analysis?

Patent landscape analysis is used to provide strategic insights into the intellectual property landscape, helping attorneys, portfolio managers, and decision-makers understand the geographical spread, saturation, and trends within a specific technology area.

How does the USPTO ensure patent quality?

The USPTO employs several programs, including performance appraisal reviews, independent reviews by OPQA, and signatory authority reviews, to ensure that examiners are issuing high-quality decisions.

What is the role of the PTAB in patent law?

The PTAB hears administrative challenges to the validity of patents, including inter partes review, and addresses whether patent claims are directed to ineligible subject matter.

What tools are available for conducting patent landscape analysis?

Tools such as the Global Dossier, Public Search Facilities, and the Common Citation Document (CCD) provide access to necessary data for conducting thorough patent landscape analyses.

Why is time-slicing important in patent landscape analysis?

Time-slicing helps in understanding changes in patent activity over time, revealing trends such as the emergence of new technologies or the cessation of activity in certain areas.

Sources

  1. United States District Court, D. Delaware. GLAXO WELLCOME INC v. GENENTECH.
  2. USPTO Needs to Strengthen Patent Quality Assurance Practices.
  3. Patent Landscape Analysis - Uncovering Strategic Insights.
  4. Search for patents - USPTO.
  5. The Patent Trial and Appeal Board and Inter Partes Review.

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Details for Patent 5,545,403

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 May 07, 2001 5,545,403 2013-08-13
Genzyme Corporation LEMTRADA alemtuzumab Injection 103948 November 14, 2014 5,545,403 2013-08-13
Genzyme Corporation CAMPATH alemtuzumab Injection 103948 October 12, 2004 5,545,403 2013-08-13
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 3 of 3 entries

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