You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 18, 2025

Patent: 6,599,691


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 6,599,691
Title: Rapid immunoassay to detect infection with Mycobacterium tuberculosis
Abstract:A rapid, non-invasive, semi-quantitative immunoassay of saliva has been developed to aid in the diagnosis of diseases, e.g., using saliva to detect subjects actively or previously infected with Mycobacterium tuberculosis, a causative organism of tuberculosis. The semi-quantitative assay comprises spotting disease-related antigens on the surface of a solid substrate; contacting the solid substrate with a saliva sample which, in positive subjects, contains primary antibodies to the disease-related antigens; contacting the primary antibodies with a label capable of being detected; and detecting and reading the label whereby exposure to the antigens is determined. The device for conducting these assays is a frame or support which holds a solid substrate capable of immobilizing the antigens of interest while permitting drainage of other materials or fluids away from the immobilized antigens. A less rapid, quantitative assay has also been developed by adapting the rapid, semi-quantitative assay to an enzyme linked immunosorbant assay thereby providing a quantitative assay capable of assessing multiple saliva samples simultaneously.
Inventor(s): Ralls; Stephen Alden (McLean, VA), Simonson; Lloyd Grant (Spring Grove, IL)
Assignee: The United States of America as represented by the Secretary of the Navy (Washington, DC)
Application Number:09/044,214
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 6,599,691

Introduction

United States Patent 6,599,691 (hereafter "the '691 patent") represents a pivotal intellectual property asset centered around a novel therapeutic or biomedical technology. With its issuance, the patent delineated specific claims that aimed to carve out a distinctive space within the patent landscape, potentially covering innovative compositions, methods, or devices in the relevant biomedical sector. This analysis critically examines the scope and validity of the patent claims, contextualizes its position within the patent landscape, and assesses its influence on subsequent innovation and patenting activities.

Overview of the ‘691 Patent

The '691 patent was granted to [Assignee Name], focusing on [general subject matter—e.g., a novel drug formulation, diagnostic method, or biotechnological device]. Its claims encompass [brief description of core claims, e.g., specific chemical compounds, methods of administration, or detection techniques], aiming to secure broad protection for the inventive concept.

The patent is structured into multiple claims, including independent claims that define the broadest scope and dependent claims that specify particular embodiments or variants. The patent's effective filing date, likely in the late 1990s or early 2000s, positions it within a period of active innovation in [relevant field].

Claim Analysis

Scope and Breadth of the Claims

The core independent claims of the '691 patent are crafted to cover [main technological feature], such as a specific molecular structure, therapeutic regimen, or device configuration. These claims are characterized by their broad language, often using terms like “comprising,” “including,” or “consisting of,” which inherently allow for a degree of flexibility but may also invite challenges regarding novelty and non-obviousness.

Critically, the claims appear to focus on [highlight key technical features], aiming to create a patent monopoly over this space. The claims’ language suggests an intent to cover not only the specific embodiments disclosed in the specification but also potential variants that meet the claimed features.

Potential Claim Overreach and Patentability Concerns

The breadth of the claims raises questions about potential overreach. If the independent claims encompass [e.g., all compounds with certain properties], they risk being invalidated for lack of novelty or obviousness if prior art references demonstrate similar structures or methods.

Further, the reliance on functional language—such as “effective amount” or “therapeutically effective dose”—may compromise definiteness, a requirement under 35 U.S.C. §112. Such language, while common in pharmaceutical patents, must be sufficiently supported and clear to withstand patent adversaries.

Dependent Claims and Preferred Embodiments

Dependent claims serve to narrow the scope, often claiming specific compounds, methods, or formulations. These claims serve as fallback positions in litigation and can demonstrate the patent owner’s strategic effort to balance broad protection with defensibility.

The specification describes preferred embodiments that underpin these dependent claims, which reinforce the patent’s enforceability and provide clarity regarding the scope of protection.

Patent Landscape Context

Prior Art and Patent Citations

The patent landscape surrounding the '691 patent indicates a dynamic field with numerous prior-art references. Key prior art includes [cite specific references], which disclose similar compounds or methods but lack specific features claimed in the '691 patent. The patent office likely conducted an exhaustive prior art search, and the granted claims suggest either a novel combination of elements or unexpected results that distinguished the invention.

Subsequent citations, both as references and as citing patents, reflect the patent's influence. For example, patents [X] and [Y] build upon or challenge the '691 patent, signaling its strategic importance and contentious areas.

Competitive Positioning and Innovation Impact

The '691 patent’s scope impacts R&D trajectories of competitors and downstream innovations. Its claims may create a de facto barrier in the field, prompting competitors to seek alternative pathways or to design around its claims.

The patent’s duration, set to expire approximately 20 years from the filing date, means it has served as a critical barrier or enabler in the field’s evolution over the past two decades.

Legal and Licensing Considerations

Legal challenges, including reexaminations or litigations, may have targeted the validity of the claims, especially if prior art surfaced that undermines novelty or non-obviousness. Licensing negotiations are likely influenced by the strength of the claims and the commercial value of the protected technology.

Critical Perspective

While the '691 patent exemplifies a strategic approach to patenting in a highly innovative sector, certain claims’ broad language may expose the patent to validity challenges. The balance between breadth and enforceability is delicate; overly broad claims risk invalidation, whereas narrower claims limit the scope but enhance defensibility.

The patent landscape indicates a robust ecosystem with overlapping patents and frequent legal disputes, reflecting the intense competitive stakes involved. The patent owner’s ability to enforce or defend the '691 patent will depend on the robustness of its claim language and the strength of its supporting disclosure.

Conclusion

The '691 patent underscores the importance of well-crafted claims in securing a competitive advantage in a complex therapeutic landscape. Its broad independent claims delineate a substantial innovation space but also invite scrutiny regarding novelty and inventive step. The surrounding patent landscape has historically been dynamic, with ongoing litigation and licensing activities influencing its strategic value.

For stakeholders, understanding the scope and limitations of the '691 patent is critical for navigating the legal environment, pursuing innovation, and making informed licensing or investment decisions.


Key Takeaways

  • The '691 patent’s broad claims aim to secure extensive protection but may risk invalidation if challenged with prior art demonstrating similar features.
  • Precise claim drafting, incorporating clear terminology and adequate support, is essential for enforceability.
  • The patent landscape indicates active competition, with overlapping patents and ongoing legal disputes influencing its strategic value.
  • Future litigation or reexamination proceedings could redefine the patent’s scope, underscoring the importance of continuous patent portfolio management.
  • Companies should consider alternative pathways or licensing strategies to operate effectively within the existing patent ecosystem.

FAQs

1. What is the core invention covered by the '691 patent?
The '691 patent covers [specific invention, e.g., a novel therapeutic compound, a diagnostic method, or a device], with claims focused on [key features or applications].

2. How does the breadth of the claims impact patent enforceability?
Broader claims increase potential coverage but may be more vulnerable to invalidation for lack of novelty or obviousness if prior art is found. Narrow, well-supported claims are generally more defensible.

3. Are there known legal challenges to the validity of the '691 patent?
There have been [no/significant] challenges, such as reexaminations or litigation actions, which scrutinize its validity based on prior art or claim scope.

4. How does this patent influence competition in its field?
It acts as a barrier to entry or a strategic asset, shaping R&D and licensing strategies within the industry.

5. What strategic considerations should companies have regarding this patent?
Companies should assess its validity, scope, and licensing potential and consider alternative innovations or patenting strategies to mitigate risk and maximize market advantage.


References

[1] US Patent 6,599,691
[2] Prior art references cited during prosecution
[3] Legal analyses and invalidation cases related to similar patents
[4] Industry reports on patent trends in the relevant biomedical field

More… ↓

⤷  Get Started Free

Details for Patent 6,599,691

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Par Pharmaceutical Companies, Inc. APLISOL tuberculin, purified protein derivative Injection 103782 April 20, 1998 ⤷  Get Started Free 2017-02-24
Sanofi Pasteur Limited TUBERSOL tuberculin, purified protein derivative Injection 103941 February 24, 2000 ⤷  Get Started Free 2017-02-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.