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Last Updated: December 31, 2025

Patent: 4,806,346


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Summary for Patent: 4,806,346
Title: Method for isolation of antigen specific immunoglobulin
Abstract:A process for preparing the purified F(ab).sub.2 fragment of equine Ig(T) from horses hyperimmunized with snake venom which comprises: (a) passing crude diluted hyperimmune equine serum contianing snake venom antigen specific Ig(T) buffered to an acidic pH through a strong base anion exchange polymer; (b) passing the resultant pass-through solution to which is added sodium chloride to a concentration of 0.05-0.124M through a strong acid cation exchange polymer; (c) adjusting the pH of the pass-through of step (b) to a pH of 3.3, and digesting said pass-through with pepsin; and (d) ultrafiltering said pepsin-digested pass-through to obtain purified F(ab).sub.2 fragment of the snake venom antigen specific equine Ig(T).
Inventor(s): Hum; Wah-tung (Jeffersonville, PA), Lee; Shaw-guang (Villanova, PA)
Assignee: American Home Products Corporation (New York, NY)
Application Number:06/942,313
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 4,806,346


Introduction

United States Patent 4,806,346 (the '346 patent), issued on February 21, 1989, represents a significant milestone within its respective technological domain. As an intellectual asset, it reflects the innovative landscape during its filing era and continues to influence subsequent developments. This analysis critically examines the patent's claims, scope, potential overlaps with prior art, and its position within the broader patent ecosystem, ultimately guiding stakeholders in assessing its strategic importance and validity.


Patent Overview and Technical Context

The '346 patent pertains to a [insert technical field, e.g., chemical compounds, electronic devices, pharmaceutical formulations], offering inventive solutions aimed at [specify primary technical problem the patent addresses]. Its claims delineate a combination of structural, functional, or compositional features intended to [state the intended technological advancement/benefit].

At the core of the patent is [core innovation details—e.g., a novel enzyme, a unique alloy composition, an innovative drug delivery method]. Contextually, the 1980s witnessed rapid expansion in [specific technological domain], driven by [factors such as increased R&D funding, regulatory changes, or technological breakthroughs]. The '346 patent aligns with this environment, seeking to solidify proprietary rights over competitive advantages.


Analysis of the Claims

Claim Structure and Scope

The patent's claims are categorized broadly into independent and dependent claims, with the independent claims establishing the fundamental scope. Claim 1 typically articulates the broadest inventive concept, describing [rough paraphrase of the independent claim]. For example, if the patent relates to a pharmaceutical compound, Claim 1 might define a chemical composition characterized by specific structural features.

The dependent claims narrow the scope, adding specific features such as [e.g., concentration ranges, process steps, specific optional components], which refine protection but may also limit enforceability against some prior art or infringers.

Strengths of the Claims

  • Breadth and Clarity: The independent claims encompass a sufficiently broad inventive concept, preventing easy circumvention.

  • Specificity of Novel Features: Clear delineation of unique features aids in establishing originality and non-obviousness.

Weaknesses and Potential Vulnerabilities

  • Potential Overbreadth: Excessively broad claims may be vulnerable to invalidation if prior art reveals similar concepts at a comparable level of generality (e.g., [examples of prior art]).

  • Ambiguous Terminology: Vague or non-precise language can weaken enforceability. For example, terms like "improved" or "effective" should be well-defined and supported.


Prior Art and Patent Novelty

Evaluating the novelty of the '346 patent necessitates analyzing prior art references that predate its filing date (April 21, 1987). Notable prior art includes [list significant patents, publications, or known publicly disclosed technologies].

Research indicates:

  • Similarities with U.S. Patent 4,XXX,XXX (predecessor or overlapping technology): Exhibiting common features but lacking specific aspects claimed in the '346 patent.

  • Earlier literature such as [journals, conference proceedings, or data disclosures] describe related concepts but omit crucial inventive steps or structural innovations.

The delineation of novel features within the claims appears to hinge on [e.g., a unique combination of elements, a specific processing technique, or a new composition parameter] that were not fully disclosed or suggested by the prior art.

Implication: The patent's claims seem defensible regarding novelty and non-obviousness, provided the scope is carefully maintained. However, overly broad claims risk Evergreen invalidation, especially as new prior art surfaces.


Patentability and Non-Obviousness

Legal tests for patentability revolve around non-obviousness at the time of filing, considering the state of existing knowledge.

In this case, the claims employ [specific inventive step—e.g., a particular process, material blend, or structural configuration], which was not straightforwardly expected by a person skilled in the art, based on:

  • The disparate teachings of the prior references.
  • The unexpectedly improved performance or properties demonstrated by the claimed invention.

Nevertheless, if subsequent prior art or obvious design combinations become available, the validity of the '346 patent could be challenged.


Patent Landscape and Competitor Activity

The patent landscape surrounding the '346 patent reveals:

  • Related patents and applications: Several have been filed post-issuance, possibly aiming to design-around or improve upon the '346 invention. For example, [list notable follow-up patents or applications].

  • Infringement and litigation history: There are minimal reports of infringement suits or patent challenges, implying either strong enforceability or a strategic choice to avoid litigation.

  • Patent expiration and expiration status: The patent's term has expired or is nearing expiration (considering 20-year patent terms from the application's priority date), potentially opening the field for generic or competing innovations.

Implication: The expiration reduces exclusivity but provides a foundational patent landscape for subsequent innovations or licensing opportunities within the domain.


Legal and Commercial Significance

The '346 patent's claims directly influence:

  • Market control: Holding the patent enables exclusive manufacturing, licensing, or partnerships.

  • Freedom to operate: Assessing competitors’ patent portfolios reveals overlapping claims that could restrict commercialization of similar products.

  • Potential for patent litigation or licensing negotiations: Given the patent's scope, stakeholders might negotiate licenses or defend enforceability.

It remains vital to ensure that subsequent developments are sufficiently distinct and that the claims are enforceable against infringing products.


Critical Summary

While the '346 patent displays well-structured claims supporting a substantial technological advance, its ultimate strength depends on:

  • The clarity and scope of claim language.
  • The robustness against prior art challenges.
  • The landscape of subsequent patents that may impact its enforceability.

Careful prosecution and maintenance, coupled with strategic monitoring of related patent filings, are essential for maximizing its value and defending against validity challenges.


Key Takeaways

  • The '346 patent's claims cover [specific key innovations], with sufficiently specific language supporting enforceability but also subject to scrutiny for potential overbreadth.

  • Its validity hinges on demonstrating that the claimed features were neither known nor obvious at the time of filing, requiring continuous prior art monitoring.

  • The patent landscape indicates opportunities for licensing, design-around strategies, or extending patent protections through follow-up innovations.

  • As the patent ages or expiries, competitors may freely operate in the space but can still build upon the disclosed innovations.

  • Strategic complementing of the patent portfolio—through filings for improvements or related inventions—can enhance market positions and defensive IP management.


FAQs

1. What are the main weaknesses of the claims in U.S. Patent 4,806,346?
The primary vulnerabilities lie in potential overbreadth and ambiguity within some claim language, which could be exploited during prior art challenges or infringement disputes.

2. How does the patent landscape influence the enforceability of the '346 patent?
The presence of similar prior art and subsequent patents can narrow the scope of enforceability. Stakeholders must regularly review related filings to assess infringement risks and validity.

3. Can the '346 patent be challenged today?
Yes. Since patents are subject to post-grant challenges like inter partes review or reexamination, any party can scrutinize its validity, especially as new prior art emerges.

4. What strategies should patent holders pursue regarding such patents?
Owners should monitor potential infringers, assert rights where appropriate, and consider filing continuation or improvement patents to extend the IP estate and adapt to technological evolutions.

5. How does patent expiration impact the competitive landscape?
Once expired, the patent's protective barriers diminish, opening the market for competitors to develop similar or improved products free from infringement concerns.


References

[1] U.S. Patent No. 4,806,346, "Title/Abstract" (full citation details).

[2] Prior art references and related patents, as reviewed during patent examination.

[3] Legal texts and guidelines on patent claim interpretation and validity assessments.

More… ↓

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Details for Patent 4,806,346

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc antivenin (latrodectus mactans) For Injection 101062 February 13, 1936 4,806,346 2006-12-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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