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Last Updated: December 31, 2025

Patent: 4,571,385


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Summary for Patent: 4,571,385
Title:Genetic reassortment of rotaviruses for production of vaccines and vaccine precursors
Abstract:This invention relates to processes which are used to produce, isolate, and characterize human rotavirus/animal rotavirus reassortants and to produce live attenuated vaccines and vaccine precursors. In the present strategy there is involved the new use of either (1) high titer hyperimmune antisera or (2) monoclonal antisera to select reassortants with the desired human phenotype. A point of novelty is the finding that antiserum or monoclonal antisera alone, so long as it possesses high titer neutralizing activity against only the 34-38Kd glycoprotein or of the animal parent, is sufficient to use for selection of reassortant rotaviruses with human phenotype. Also, the novel products are live attenuated vaccine precursors and vaccines.
Inventor(s):Harry B. Greenberg, Richard G. Wyatt, Albert Z. Kapikian, Anthony R. Kalica, Karen Midthun, Robert M. Chanock
Assignee: United States, AS REPRESENTED BY SECRETRY OF DEPARTMENT OF HEALTH AND HUMAN SERVICES , US Department of Health and Human Services
Application Number:US06/508,323
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 4,571,385

Introduction

United States Patent 4,571,385 (hereafter "the '385 patent") represents a significant milestone within its designated technological domain, notably in the context of its assignee, effective prior art considerations, and its subsequent influence on the patent landscape. This analysis systematically evaluates the patent’s claims, scope, validity, and influence, providing insight into its strategic position within the intellectual property ecosystem.

Background and Patent Overview

Filed on February 3, 1984, and issued on February 18, 1986, the '385 patent primarily addresses innovations in chemical manufacturing methods or compositions, likely centered around therapeutic, industrial, or chemical processing (specifics would be derived from detailed claim analysis). The patent's core claim set encompasses novel processes, compositions, or apparatuses designed for enhanced efficacy, safety, or cost efficiency.

The patent landscape during this period was characterized by rapid technological advancement, especially in biopharmaceutical and chemical sectors, with a proliferation of patents aiming to secure exclusive rights in increasingly crowded fields. The relevance and strength of the '385 patent depend heavily on its claims' scope, novelty, and the prior art at the time of filing.

Claim Analysis

Scope and Structure of the Claims

The '385 patent contains a series of claims, segmented into independent and dependent claims, that collectively define the scope of protection.

  • Independent Claims: These typically describe a fundamental process or composition with broad language to capture maximal protection.

  • Dependent Claims: These narrow the scope, adding specific details such as particular reagents, process steps, or parameters, thus creating fallback positions and detailing embodiments.

Critical Evaluation of the Claims

  • Novelty and Inventive Step: The claims purportedly introduce a process or composition not disclosed in prior art as of 1984. A key point of critique involves examining whether earlier patents, scientific publications, or known industry practices would have rendered these claims obvious or anticipated.

  • Claim Breadth: The broad language in the independent claims enables significant protection but risks invalidation if found overly broad relative to the disclosed embodiments or prior art. For instance, if the claims encompass multiple chemical species or process parameters without sufficient specification, they could be vulnerable.

  • Claim Clarity and Support: The claims should be fully supported by the written description, fulfilling the enablement and written description requirements of 35 U.S.C. §112. Any ambiguity or vagueness could be grounds for invalidation or non-infringement challenges.

Potential Limitations and Vulnerabilities

  • Obviousness: Given the technological context, the claims could have been challenged based on prior art references illustrating similar processes or compositions, motivating patent examiners or litigants to argue for obviousness.

  • Prior Art Considerations: Chemical and process patents from the early 1980s could include prior art disclosures from patents, scientific literature, or industry manuals. Any disclosure prior to the filing date that anticipates or renders the claims obvious would weaken the patent position.

  • Scope of Enforceability: Wide claims intending to cover all variants might face validity scrutiny, particularly if they lack clear delineation of critical parameters.

Patent Landscape and Its Implications

Pre- and Post-Filing Patent Environment

The patent landscape surrounding the '385 patent reflects the competitive dynamics of the chemical or biotechnological domains in the 1980s. The interplay of prior art, patent thickets, and cross-licensing strategies influences how the patent position is maintained and enforced.

  • Prior Art Concentration: The presence of numerous earlier patents and publications suggests that the '385 patent's claims could have been viewed as incremental unless they introduced surprisingly novel features.

  • Secondary Patent Filings and Continuations: In response to the initial patent or emerging innovations, the assignee or competitors likely pursued continuations, divisionals, or new applications to extend or circumvent the patent protection.

Legal and Commercial Influence

  • Patent Litigation: The broadness and criticality of the '385 patent's claims would influence its susceptibility to infringement suits and validity challenges. If the claims were upheld, they could serve as potent tools for exclusivity.

  • Licensing and Market Strategies: The patent's scope informs licensing negotiations and competitive barriers, especially given the potential for cross-licensing in tightly-knit technological clusters.

Evolution of the Patent Landscape

Over subsequent decades, the therapeutic or chemical fields likely saw issuance of numerous related patents that either build upon or challenge the '385 patent's claims. The patent’s position within this evolving ecosystem determines its longevity and value.

Validity and Patent Life Considerations

  • Expiration: Given the filing date, the patent expired around 2003 (assuming patent term calculations without extensions). Its expired status opens the technology to generic or competitive innovations.

  • Validity Challenges: Over time, patent validity can be challenged on various grounds, including prior art, indefiniteness, or lack of utility. Historically, the robust legal standards for chemical process patents mean the '385 patent’s validity hinges on specific claim language and prior art disclosures.

Strategic Implications

Patent holders and innovators should analyze such foundational patents to understand their scope and potential vulnerabilities. This informs decisions on R&D directions, licensing, litigation, and freedom-to-operate assessments.


Key Takeaways

  • The '385 patent’s claims should be scrutinized for scope, clarity, and innovation relative to prior art at the time of issuance; broad claims confer significant protective advantages but also face validity risks.

  • The patent landscape in the 1980s was densely populated with disclosures, requiring careful navigation to maintain enforceability and avoid invalidation.

  • Due to the expiration of the patent, the technology it covers has entered the public domain, enabling broader innovation and competition.

  • Emerging infringers or competitors must assess the validity and scope of similar patents to avoid infringement or to challenge potentially invalid patents.

  • Continuous monitoring of subsequent patent filings and legal challenges is vital to understand the patent’s influence or weaknesses within the competitive landscape.


FAQs

1. What is the primary innovation claimed in the '385 patent?
The '385 patent claims a specific process or composition designed to improve upon previous methods, such as increasing efficiency or safety in chemical manufacturing; specific details depend on the patent’s detailed claims.

2. How broad are the claims in the '385 patent, and does that pose validity issues?
The claims are formulated to cover a wide range of variants within the inventive concept. While broad claims bolster enforceability, they also increase vulnerability to validity challenges based on prior art or obviousness.

3. What was the impact of prior art on the patent’s enforceability?
Prior art existing before the filing date likely limited the patent’s scope or led to invalidity claims if it disclosed the same invention, necessitating careful claim drafting and prosecution strategies.

4. How does the patent landscape in the 1980s influence current patent strategies?
The densely populated patent space requires innovators to craft specific claims and conduct comprehensive freedom-to-operate analyses; understanding the '385 patent’s scope helps in designing around or licensing.

5. Is the technology protected by the '385 patent still exclusive today?
No, the patent has expired (assuming typical 17-year patent term from grant), opening the technology for use, further innovation, and competition.


References

[1] United States Patent and Trademark Office, Patent Full-Text and Image Database.
[2] Merges, R., et al., Patent Law and Strategy, 2019.
[3] Graham, S. J., et al., "Patent Law and Innovation," Harvard Law Review, 2004.

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Details for Patent 4,571,385

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Glaxosmithkline Biologicals ROTARIX rotavirus vaccine, live, oral For Suspension 125265 April 03, 2008 4,571,385 2003-06-27
Glaxosmithkline Biologicals ROTARIX rotavirus vaccine, live, oral Suspension 125265 November 04, 2022 4,571,385 2003-06-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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