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Last Updated: December 25, 2024

Patent: 4,720,385


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Summary for Patent: 4,720,385
Title: Protein compositions substantially free from infectious agents
Abstract:Compositions containing therapeutically or immunologically active proteins are rendered substantially free from infectious agents such as viable viruses and bacteria without substantial loss of therapeutic or immunologic activity by mixing the protein composition with a complex formed from transition metal ions, such as copper ions, and an angularly-fused, polynuclear heterocyclic arene having two nitrogen atoms in a \"cis-ortho\" relationship, such as phenanthroline, and a reducing agent such as a thiol or ascorbic acid or ascorbate salt or mixtures of ascorbic acid or ascorbate with a thiol in amounts and at a temperature and for a time sufficient to inactivate substantially all of the viruses and bacteria contained therein. Compositions containing therapeutically active proteins substantially free from viral and bacterial infectivity, which have heretofore been unattainable, can be prepared by the method of the invention.
Inventor(s): Lembach; Kenneth J. (Danville, CA)
Assignee: Miles Laboratories, Inc. (Elkhart, IN)
Application Number:06/736,197
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 4,720,385

Introduction

United States Patent 4,720,385, though not specifically detailed in the provided sources, can be analyzed within the broader context of patent law, trends, and the processes involved in patenting and challenging patents. This analysis will delve into the key aspects of patent claims, the patent landscape, and the relevant legal and procedural frameworks.

Understanding Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention for which protection is sought. For a patent to be granted, the claims must meet the criteria of novelty, nonobviousness, and utility[1].

  • Novelty: The invention must be new and not previously known or used.
  • Nonobviousness: The invention must be significantly different from existing technology and not obvious to someone with ordinary skill in the relevant field.
  • Utility: The invention must be useful and have a practical application.

The Patent Landscape in the United States

The U.S. patent landscape is dynamic and influenced by various factors, including technological advancements, legal changes, and global trends.

Patent Activity and Trends

In recent years, the U.S. Patent and Trademark Office (USPTO) has seen significant activity in patent filings. For instance, in 2018, the USPTO awarded 309,000 utility patents, with a nearly equal split between foreign and domestic inventors. Businesses received the majority of these patents, highlighting the commercial importance of intellectual property[1].

Technology Areas and Patent Trends

Patents are classified into various technology areas, with electrical and mechanical engineering being among the most prominent. The rise of information and communication technologies (ICT) has particularly driven the increase in electrical engineering patents, with fields like computer technology and digital communication contributing significantly[1].

Legal Framework and Challenges

The legal framework governing patents in the U.S. has undergone significant changes, particularly with the enactment of the Leahy-Smith America Invents Act (AIA) in 2011.

The Leahy-Smith America Invents Act (AIA)

The AIA introduced several key changes, including the creation of the Patent Trial and Appeal Board (PTAB) and new procedures for challenging patents, such as inter partes review (IPR) and post-grant review (PGR). These procedures aim to improve patent quality by providing a more efficient and cost-effective means to adjudicate patent validity issues compared to federal court litigation[2].

Patent Trial and Appeal Board (PTAB) and Inter Partes Review

PTAB has been a focal point of debate due to its role in challenging patent validity.

  • Efficiency and Cost: PTAB procedures are generally faster and less expensive than federal court litigation, with a lower burden of proof required to invalidate patents. This makes them more advantageous for entities accused of patent infringement[2].
  • Criticism: Despite its benefits, PTAB has faced criticism for making it too easy to challenge patents, potentially stifling innovation and creating uncertainty in patent rights[2].

Prior Art and Patentability

Prior art is crucial in determining the novelty and nonobviousness of an invention. The AIA introduced changes to how prior art is considered, including exceptions for certain disclosures made by the inventor or collaborators within a year before the effective filing date of the claimed invention[3].

Patent Quality and Examination

The quality of patents is a recurring theme in discussions about the USPTO's role. The Government Accountability Office (GAO) has recommended that the USPTO define patent quality more consistently and articulate this definition in agency documents and guidance. This includes ensuring that patents meet statutory requirements for novelty, clarity, and other criteria[4].

Patent Analysis and Its Importance

Patent analysis is vital for various purposes, including prior art searches, valuation of intellectual property, R&D strategy, legal and regulatory compliance, and technology transfer.

  • Prior Art Searches: Conducting thorough prior art searches is essential to determine whether an invention is novel and non-obvious. Effective patent analysis helps identify relevant prior art, which is crucial for the success of the patent application[5].
  • Valuation and Strategy: Patent analysis aids in assessing the value of intellectual property portfolios and refining R&D strategies by identifying areas with fewer patents, indicating potential opportunities for innovation[5].

Critical Analysis of Patent 4,720,385

While specific details about Patent 4,720,385 are not provided, a critical analysis would involve several steps:

Review of Claims

  • Analyze the claims to ensure they meet the criteria of novelty, nonobviousness, and utility.
  • Evaluate the scope of the claims to determine their breadth and potential impact on the market.

Prior Art Search

  • Conduct a thorough prior art search to identify any existing technologies or innovations that may affect the validity or patentability of the invention.
  • Use patent databases and other resources to find relevant prior art.

Legal Compliance

  • Ensure that the patent complies with all relevant legal requirements, including those introduced by the AIA.
  • Review any challenges or disputes related to the patent, including PTAB proceedings if applicable.

Market Impact

  • Assess the competitive landscape and the potential barriers to entry in the market related to the patented invention.
  • Evaluate how the patent fits into the broader technology area and its potential for innovation and commercialization.

Key Takeaways

  • Patent Claims: The claims of a patent are critical and must meet the criteria of novelty, nonobviousness, and utility.
  • Patent Landscape: The U.S. patent landscape is influenced by technological trends, legal changes, and global factors.
  • Legal Framework: The AIA and PTAB play significant roles in patent challenges and quality.
  • Prior Art: Thorough prior art searches are essential for determining patentability.
  • Patent Analysis: Patent analysis is crucial for various business and legal purposes.

FAQs

Q: What are the key criteria for a patent to be granted? A: A patent must meet the criteria of novelty, nonobviousness, and utility.

Q: How has the AIA impacted patent law in the U.S.? A: The AIA introduced PTAB and new procedures like IPR and PGR to improve patent quality and provide a more efficient means to challenge patents.

Q: What is the role of PTAB in patent challenges? A: PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, providing a faster and less expensive alternative to federal court litigation.

Q: Why is prior art important in patent applications? A: Prior art is essential to determine whether an invention is novel and non-obvious, affecting the patentability of the invention.

Q: How does patent analysis benefit businesses and inventors? A: Patent analysis aids in valuing intellectual property, refining R&D strategies, ensuring legal and regulatory compliance, and facilitating technology transfer.

Sources

  1. National Science Foundation. Invention: U.S. and Comparative Global Trends. January 15, 2020.
  2. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. June 29, 2023.
  3. United States Patent and Trademark Office. Prior Art Exceptions under AIA 35 U.S.C. 102(b)(1) and (2). MPEP ยง 717.
  4. Government Accountability Office. Intellectual Property: Patent Office Should Define Quality, Reassess Incentives. June 30, 2016.
  5. Evalueserve. Patent Analysis.

More… ↓

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Details for Patent 4,720,385

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Grifols Therapeutics Llc PLASMANATE plasma protein fraction (human) Injection 101140 October 02, 1958 ⤷  Subscribe 2005-01-19
Takeda Pharmaceuticals U.s.a., Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 December 21, 1979 ⤷  Subscribe 2005-01-19
Takeda Pharmaceuticals U.s.a., Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 July 31, 2000 ⤷  Subscribe 2005-01-19
Takeda Pharmaceuticals U.s.a., Inc. AUTOPLEX, FEIBA NF, FEIBA VH anti-inhibitor coagulant complex For Injection 101447 August 11, 2005 ⤷  Subscribe 2005-01-19
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 May 21, 2004 ⤷  Subscribe 2005-01-19
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 March 26, 2007 ⤷  Subscribe 2005-01-19
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 July 11, 2014 ⤷  Subscribe 2005-01-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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