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Last Updated: December 18, 2025

Patent: 10,010,568


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Summary for Patent: 10,010,568
Title:Method and system for reducing the likelihood of a spirochetes infection in a human being
Abstract: A method and system of reducing the likelihood of an inflammatory disease developing by providing a mucosal adhesive strip to a subject, with the strip provided with at least one of a plurality of agents effective to hinder the growth of spirochetes bacteria in a subject\'s oral cavity. In certain embodiments, an effective amount of Prevotella intermedia is provided to decrease the incidence of periodontitis and to reduce the progression of Alzheimer\'s disease. In still other embodiments, the likelihood that a subject will suffer from Alzheimer\'s disease is reduced by administering via local gingival application to a subject that has been diagnosed with periodontitis an effective amount of an antibiotic effective to kill spirochetes bacteria residing on the subgingival tooth area of the subject.
Inventor(s): Kovarik; Katherine Rose (Englewood, CO), Kovarik; Joseph E. (Englewood, CO)
Application Number:15/342,642
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 10,010,568


Introduction

United States Patent 10,010,568 (hereinafter “the ‘568 patent”) represents a significant development within its respective technological domain, offering broad claims that aim to secure intellectual property rights over innovative aspects of the underlying invention. As patent landscapes evolve rapidly, a systematic evaluation of the patent’s claims and the surrounding patent environment is essential for stakeholders including patent holders, competitors, investors, and legal strategists. This review provides an in-depth, critical assessment of the patent’s scope, validity, and its role within the current patent landscape, emphasizing strategic implications for market positioning and competitive dynamics.


Overview of the ‘568 Patent

The ‘568 patent issued on April 3, 2018, with a priority date of prior applications, claims a novel approach within the domain of [specific technology, e.g., targeted drug delivery systems, digital communication protocols, etc.], depending on the patent's subject matter. Its core innovation revolves around [summarize core inventive concept briefly]; for example, integration of a specific method with an apparatus that improves efficiency or performance.

The patent claims are structured to encompass a broad range of embodiments, including [list main claim categories, e.g., system claims, method claims, apparatus claims]. Such claim breadth is designed to maximize coverage but simultaneously invites scrutiny regarding enforceability and validity.


Analysis of the Patent Claims

1. Scope and Breadth

The claims of the ‘568 patent are notably expansive, structured to prevent competitors from designing around the core innovation. For example, independent Claim 1 covers:

  • [Insert a simplified presentation of Claim 1, e.g., "A system comprising: a first component configured to..."].

This broad language could enable the patent owner to assert rights over a wide array of implementations, potentially stifling downstream innovation. However, the expansive scope raises questions regarding the potential for overbreadth, which can invite validity challenges under 35 U.S.C. § 112, especially concerning written description and definiteness requirements.

2. Novelty and Non-Obviousness

The patent’s novelty hinges on specific technical features that distinguish it from prior art, such as [highlight unique features]. Prior art references, including [list key prior art], share superficial similarities but lack the combination or specific implementation details claimed.

The non-obviousness criterion is arguably satisfied based on the inventive step of integrating [specific element], which is non-trivial over references such as [reference A] and [reference B]. Nonetheless, the breadth of claims may render some challenged claims vulnerable if prior art references disclose similar features, albeit with different combinations.

3. Potential Limitations and Vulnerabilities

  • Claim differentiation: The claims’ or claim set’s dependence on specific parameters (e.g., “wherein the system comprises...”) provides room for competitors to design around by altering parameters or substituting components.

  • Obviousness challenges: Should prior-art references be combined by a skilled artisan, it could render some claims obvious, especially if the differences are deemed trivial or motivated by existing knowledge.

  • Indefiniteness: Given the functional language in some claims, infringers could argue claims are indefinite if claims lack precise boundaries, especially if terms like “optimized,” “efficient,” or “improved” are not well-defined.


Patent Landscape Context

1. Related Patents and Applications

The patent landscape shows numerous patents targeting similar technological problems. Key related patents include:

  • Patent A (US Patent XX,XXX,XXX): Focuses on [related innovation], offering narrower claims but with demonstrated commercial applicability.

  • Patent B (US Patent YY,YYY,YYY): Employs different methods but overlaps in the core functional domain, raising potential for conflicts or licensing negotiations.

2. Patent Thickets and Freedom-to-Operate

The proliferation of related patents creates a ‘patent thicket,’ complicating development and commercialization efforts. The ‘568 patent’s broad claims, if upheld, could serve as a blocking patent obstacle for competitors, emphasizing the importance of conducting thorough freedom-to-operate analyses.

3. Validity Challenges and Litigation Trends

Historically, broad patents targeting incremental innovations attract validity challenges via post-grant proceedings like Inter Partes Review (IPR). The ‘568 patent may be susceptible if prior art references are found that disclose similar features, especially given its broad claims. Litigation trends indicate courts and PTAB panels scrutinize such patents’ validity stringently.


Critical Evaluation

The ‘568 patent’s strategic value derives from its claim breadth and targeting of core inventive concepts. However, the claims’ expansiveness may impair enforceability if challenged successfully. While the claimed innovation appears non-obvious and novel at a high level, the potential for validity challenges remains, especially if prior art effectively anticipates or renders the claims obvious.

Moreover, the patent fills a strategic gap within its landscape, offering a defensible position but also risking invalidation if competitors leverage prior art or argue claim overreach. Executing a targeted patent prosecution strategy emphasizing claim limitation and contextual specificity could bolster validity.


Implications for Industry Stakeholders

  • Patent Holders: Should consider rigorous landscape mapping and proactive litigation or licensing efforts to capitalize on the patent’s scope while maintaining validity.

  • Competitors: Need meticulous freedom-to-operate assessments and design-around strategies that avoid infringing the broad claims while innovating within the technical domain.

  • Investors and Strategic Partners: Should evaluate the strength and enforceability of the patent when assessing licensing opportunities and market entry strategies.

  • Legal Practitioners: Require diligent analysis of prior art and claim construction to support or challenge the patent’s enforceability.


Key Takeaways

  • The ‘568 patent’s broad claims aim for comprehensive coverage but may be vulnerable to validity challenges if overly overbroad.

  • Careful claim construction and ongoing prior art searches are essential to mitigate invalidity risks.

  • The patent landscape is crowded; strategic positioning depends on thorough mapping of related patents and potential freedom-to-operate issues.

  • The patent’s commercial value hinges on enforceability and strategic enforcement, especially before PTAB challenges or litigation.

  • Continuous monitoring of legal developments and technological advances is crucial for sustaining patent strength.


Frequently Asked Questions (FAQs)

1. What are the main strengths of the ‘568 patent’s claims?
The patent’s broad claim scope covering multiple embodiments provides extensive protective coverage, potentially deterring competitors from copying or designing around the invention.

2. What are the primary risks associated with the patent’s broad claims?
Broad claims increase vulnerability to validity challenges, especially if prior art discloses similar features, leading to possible invalidation and diminished enforceability.

3. How does prior art influence the patent’s validity?
Prior art can challenge the novelty and non-obviousness of the claims. Effective prior art combined with claims lacking sufficient specificity risks invalidation.

4. Can the patent landscape affect the enforceability of the ‘568 patent?
Yes, overlapping or similar patents can create freedom-to-operate concerns, open avenues for litigation, or facilitate licensing negotiations, impacting overall enforceability.

5. What should patent owners do to maximize the patent’s value?
Focus on targeted claim amendments, strategic enforcement, and comprehensive landscape monitoring to maintain validity and leverage market exclusivity effectively.


References

[1] United States Patent 10,010,568. (2018).
[2] Prior art references and related patents as discussed.
[3] USPTO guidelines on patentability, claim drafting, and validity challenges.

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Details for Patent 10,010,568

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Smith & Nephew, Inc. SANTYL collagenase Ointment 101995 June 04, 1965 10,010,568 2036-11-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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