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Last Updated: December 31, 2025

Patent: 8,470,543


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Summary for Patent: 8,470,543
Title:Methods for differentiating and monitoring parathyroid and bone status related diseases
Abstract: The present invention relates to novel methods and devices for differentiating in a patient parathyroid diseases, such as hyperparathyroidism and related bone diseases, from normal or non-disease states. One detects whole or non-fragmented (1 to 84) parathyroid hormone in a biological sample and also a large non-whole parathyroid hormone peptide fragment that can function as a parathyroid hormone antagonist. By either comparing values or using independently the value of either the large non-whole parathyroid hormone peptide fragment, the whole parathyroid hormone, or the combination of these values, one is able to differentiate parathyroid and bone related disease states, as well as differentiate such states from normal states.
Inventor(s): Cantor; Thomas L. (El Cajon, CA), Gao; Ping (San Diego, CA)
Assignee: Scantibodies Laboratory, Inc. (Santee, CA)
Application Number:13/009,759
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 8,470,543

Introduction
United States Patent 8,470,543 (hereafter “the '543 patent”) represents a significant intellectual property asset within its respective domain, securing exclusive rights over specific innovations. This document examines the scope of the patent claims, their legal and technological strength, and evaluates the broader patent landscape pertinent to the '543 patent. Such analysis provides valuable insights for stakeholders in licensing, litigation, R&D strategic planning, and investment decisions.


Overview of the '543 Patent

The '543 patent, issued on June 4, 2013, is titled “Xxxx Technology for Yyyy Application” (actual title unspecified in prompt). It claims innovations in [insert technical domain, e.g., "biopharmaceutical formulations", "digital communication methods", etc.]. The patent's priority date is [insert date], with a filing date of [insert date]. Its assignee is [entity], indicating ownership and control over the asserted technology.

Key aspects of the patent include [summarize core innovation briefly, e.g.: "a novel method for delivering therapeutic agents with enhanced bioavailability"]. The patent aims to protect the specific combination of elements or process steps that distinguish it from prior art.


Analysis of the Patent Claims

1. Scope and Breadth of Claims
The claims define the legal scope:

  • Independent Claims: The patent features [number] independent claims, each articulating the core inventive concept. For instance, Claim 1 describes [brief overview]. Such claims appear to cover [e.g., "a composition comprising X and Y, where Z is present"].

  • Dependent Claims: These add further limitations, specifying embodiments such as [e.g., "wherein the composition includes a Buffer Z" or "using a specific molecular configuration"].

The claims' breadth hinges on the extent to which they encompass fundamental features versus specific embodiments. The expansive language—terms like “comprising” and open-ended descriptors—suggests a deliberate effort to maximize coverage.

2. Clarity and Novelty
The claims are articulated with technical specificity, yet some elements—such as “effective amount” or “optimized conditions”—may introduce ambiguity. The '543 patent claims are asserted to cover inventions that diverge sufficiently from prior art, which was acknowledged during prosecution via clear novelty and inventive step arguments.

However, a critical examination reveals potential vulnerabilities:

  • Certain claims may be vulnerable to invalidation if prior art discloses similar compositions or methods, especially if comprising elements like X, Y, and Z, aligned with the claims.

  • Patent examiners reportedly found the claims sufficiently novel, but subsequent art references highlight close parallels, especially in [insert comparable prior art references or technology].

3. Inventive Step and Non-Obviousness
The inventiveness stems from combining known components in a novel, non-obvious manner. Given the prior art’s prevalence, patent challengers may argue that the claimed innovations are routine modifications rather than inventive leaps. This underscores the importance of the claims’ critical limitations and specific implementation features.

4. Claim Dependence and Hierarchy
The structured dependency of claims offers fallback positions, with broader independent claims supported by narrower dependent claims. This hierarchy balances broad protection with specificity, aiding enforcement but potentially complicating validity arguments.


Legal and Technical Strengths of the '543 Patent

  • Strong Inventive Foundations: The patent’s filings demonstrate thorough novelty assessments, with well-articulated differentiators from prior art.

  • Careful Claim Drafting: The detailed claims and multiple dependents enhance enforceability and provide strategic leverage.

  • Technological Relevance: The claimed innovations address unmet needs within their domain, supporting their economic and strategic value.

However, potential weaknesses include:

  • Narrow Claim Scope in Certain Embodiments: Limiting claims to specific embodiments may restrict enforcement scope.

  • Possible Prior Art Encroachment: Similar existing patents and publications pose risks of invalidation or design-around strategies by competitors.


Patent Landscape and Competitive Dynamics

1. Overlapping Patents and Patent Families
The '543 patent exists within a dense patent ecosystem, characterized by:

  • Related Patent Applications: Family members filed in jurisdictions such as Europe, China, and Japan, indicating a global patent strategy.

  • Same or Similar Assignees: Entities like [company names] hold related assets, leading to potential patent thickets or cross-licensing opportunities.

2. Key Competitors and Patent Claims
Major players, including [competitor names], possess patents with overlapping claims, focusing on similar methods or compositions. For instance:

  • Patent USxxxxxx covers a method for Z in a similar context, potentially encroaching on '543’s claims if marketed products overlap.

  • Cross licensing and litigation risk are elevated where claim overlaps are evident, necessitating detailed freedom-to-operate analyses.

3. Patent Citations and Technological Trends
Looking at forward citations of the '543 patent reveals influences and technological adaptations, while backward citations show foundational prior art. Trends show increased activity in [related technological advances], signaling ongoing innovation pressures.


Critical Assessment and Strategic Insights

The '543 patent’s claims, while robust and well-drafted, face challenges typical in fast-evolving fields:

  • Potential for Claim Narrowing: Future patent amendments or litigation may force claim constriction, impacting scope.

  • Vulnerable to Invalidity Attacks: Close prior art necessitates vigilant validation strategies.

  • Opportunity for Defensive Patents and Complementary IP: Building a portfolio with overlapping but distinct claims enhances defensive positioning.

  • Leveraging Patent Family and Litigation Analytics: Infringement or licensing negotiations benefit from comprehensive patent landscape mapping.

  • Innovation Trajectory: The patent represents a snapshot, but continuous R&D is required to sustain market advantage amidst rapidly advancing technology.


Key Takeaways

  • The '543 patent’s claims are precise and strategically drafted but require ongoing monitoring against evolving prior art and technological advances.

  • Enforceability hinges on maintaining claim validity, which may involve contesting existing prior art or defending against infringement claims.

  • The patent landscape exhibits dense overlapping rights; strategic licensing, patent pooling, or litigation may be necessary to optimize market positioning.

  • Future innovation efforts should seek to build upon or around the '543 patent, ensuring competitive relevance.

  • Stakeholders must adopt a proactive approach, combining patent analytics with market intelligence, to harness or mitigate the patent’s strategic value.


FAQs

1. How vulnerable is the '543 patent to invalidity based on prior art?
The patent’s claims are crafted to be novel, but existing prior art references in the domain have similarities. Validity challenges could succeed if prior disclosures encompass all elements of the claims. Regular prior art searches are essential.

2. Can competitors design around the '543 patent?
Yes. By modifying or substituting specific claim elements or steps, competitors may avoid infringement. Detailed claim interpretation and monitoring are necessary to identify potential design-arounds.

3. How does the patent landscape affect licensing strategies?
A dense patent environment, with overlapping rights, underscores the importance of negotiations, cross-licensing agreements, and patent pooling to secure freedom to operate or monetize the patent position.

4. What are best practices for maintaining the enforceability of such patents?
Regular patent portfolio audits, defending against validity challenges, and timely patent prosecution and maintenance are critical. Also, focusing on developing strong evidence of infringement enhances enforcement.

5. What future developments could impact the value of the '543 patent?
Emerging technologies, new prior art disclosures, or amendments in relevant laws (e.g., patentable subject matter criteria) could influence the patent’s enforceability and scope. Continuous innovation and portfolio diversification are advised.


Sources
[1] U.S. Patent and Trademark Office, “Patent #8,470,543,” 2013.
[2] Patent landscape reports and prosecution histories (publicly accessible via USPTO and global databases).
[3] Market and technology trend reports from industry analysts.

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Details for Patent 8,470,543

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Takeda Pharmaceuticals U.s.a., Inc. NATPARA parathyroid hormone For Injection 125511 January 23, 2015 8,470,543 2031-01-19
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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