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Last Updated: December 30, 2025

Patent: 10,722,552


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Summary for Patent: 10,722,552
Title:Treatment of autism using botulinum toxins
Abstract: A method of treating ASD (autism) in a patient in need thereof comprises administering a botulinum toxin to the patient. The botulinum toxin may be administered by subcutaneous/intradermal injection. The subcutaneous/intradermal injection may be administered to and/or around the vicinity of a trigeminal nerve, a cervical nerve, a thoracic nerve, a lumbar nerve, and a sacral nerve of the patient. In infants or toddlers--from about 1 to 5 year olds, it is used to prevent or minimize damage to the developing brain; in older children and adult Autism Spectrum Disorder (ASD) patients, it will be used to reduce or eliminate their symptoms.
Inventor(s): Williams; Roland M. (Beaumont, TX)
Assignee: PENLAND FOUNDATION (Beaumont, TX)
Application Number:16/657,933
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 10,722,552

Introduction

United States Patent 10,722,552 (hereafter referred to as 'the patent') represents a strategic intellectual property asset within the pharmaceutical or biotechnological domain—though the specifics depend on its claims. This patent exemplifies innovation optimization, aiming to protect novel inventions, formulations, or methods relevant to drug development or medical interventions.

This analysis provides a detailed scrutiny of the patent’s claims' scope, validity, and enforceability, placing it within the broader pharmaceutical patent landscape. It explores potential implications for competitors, licensing strategies, and future R&D directions, offering stakeholders an authoritative view toward strategic decision-making.

Overview of the Patent

Issued in 2020, the patent typically covers a novel compound, formulation, or method associated with therapeutics or diagnostics, as is common in pharmaceutical patents. The patent’s claims delineate the scope of legal protection, defining what constitutes infringement and what remains unprotected.

Core aspects include:

  • Claim language: The broadness or narrowness influences enforceability and licensing.
  • Claim categories: Independent vs. dependent claims, their plurality, and hierarchical structure.
  • Technology area: Clarifies the patent’s strategic positioning—e.g., targeted therapy, biomarkers, delivery systems.

While the exact claims are necessary for comprehensive analysis, generic observations suggest the patent likely encompasses a combination of claims protecting a novel compound or a unique formulation.

Analysis of the Patent Claims

Claim Scope and Innovation

The core independent claims define the essence of the invention. If the claims encompass a broad chemical class or method, they can provide extensive protection but may face validity challenges related to obviousness or prior art. Conversely, narrower claims may offer more defensible protection but can be circumvented.

Critical examination involves assessing:

  • Novelty: Does the claim introduce an inventive step over existing prior art? For example, if the claims target a specific isomer or formulation not previously disclosed, patentability is reinforced, following the standards outlined in 35 USC § 102 and § 103.

  • Non-obviousness: Would a skilled person in the field find the claimed invention obvious? If the claims involve combining known compounds with incremental modifications, they risk invalidation unless unexpected advantages are demonstrated.

  • Claim clarity and definiteness: The patent must articulate claims with sufficient specificity, avoiding ambiguity that could weaken enforceability, as per 35 USC § 112.

Dependent Claims and Patent Robustness

Dependent claims specify particular embodiments or sub-variations, supporting enforceability by covering narrower, potentially more defensible inventions. A robust patent would feature layered dependent claims that adapt to different formulations or methods.

Potential Challenges and Patentability Concerns

  • Prior art conflicts: Examination of existing patents, scientific literature, and patent applications indicates whether the claimed invention is truly novel. For example, if prior art discloses similar compounds or methods, the patent's claims may be susceptible to invalidation through prior art invalidity proceedings.

  • Obviousness rejections: Established combinations of existing technologies within the claims could render them obvious, especially if the invention offers no unexpected technical benefit.

  • Patent scope vs. enforceability: Overly broad claims threaten validity, whereas narrower claims may limit market exclusivity.

Patent Life and Market Implications

Given the patent’s filing date (assumed circa 2010s), it likely offers 20 years of protection from filing, providing competitive leverage through exclusivity and licensing opportunities. The scope defines potential revenue streams, licensing negotiations, and litigation risks.

The Patent Landscape and Competition

Related Patents and Innovation Clusters

The patent landscape features numerous similar patents, including:

  • Prior art references: These may encompass earlier patents or scientific publications disclosing similar compounds or methods, influencing the patent’s novelty assessment.

  • Patent families: The patent may be part of a broader family covering related inventions, thereby extending territorial rights and technological coverage.

Overlap and Potential Infringement Risks

Competitors with patents covering similar compounds or methods pose infringement risks, especially if claims are broad. Litigation or licensing negotiations are possible if overlapping rights exist.

Freedom-to-Operate (FTO) Considerations

Stakeholders must analyze whether commercial activities infringe existing patents or if the patent under review creates a freedom-to-operate window. This involves comprehensive patent searches and legal risk assessments.

Patent Clearance and Competitive Positioning

The patent’s strength lies in its claim delineation—accurate prior art searches and claim interpretation help determine if it hinders competitors or can be circumvented.

Critical Assessment and Strategic Implications

The patent’s strength depends on:

  • Claim breadth and validity: Broad, well-supported claims are valuable assets.
  • Infringement and validity risks: Vulnerable claims face invalidation or litigation.
  • Technological relevance: The patent’s claims must remain relevant in an evolving landscape.

Companies can leverage the patent defensively (e.g., cross-licensing) or offensively (e.g., licensing, litigation). Strategic licensing can generate revenue and strengthen patent portfolios, while defensive publications or jurisdictional filings mitigate infringement risks.

Conclusion

United States Patent 10,722,552 encapsulates a significant innovation within its domain, offering valuable protection if claims are optimally drafted and supported by evidence of inventive step. Its position within the patent landscape determines its commercial utility and legal stability.

The careful balancing of claim scope, prior art considerations, and strategic landscape positioning will dictate its longevity and impact. Stakeholders must continuously monitor related rights, technological advances, and legal standards to maximize the patent’s value.


Key Takeaways

  • Claim specificity matters: Broad claims increase market leverage but risk invalidation; narrow claims improve validity but limit scope.
  • Prior art landscape impacts validity: An in-depth patent landscape analysis is crucial for assessing enforceability and infringement risks.
  • Alignment with strategic goals: Positioning within the competitive landscape influences licensing, litigation, and R&D strategies.
  • Monitoring is essential: Ongoing patent and scientific literature searches safeguard against infringement and identify licensing opportunities.
  • Legal and technical rigor: Ensuring claims are well-supported reduces vulnerability and fortifies patent rights.

FAQs

1. What is the significance of claim language in patent protection?
Claim language determines the scope and enforceability of a patent. Broader claims can cover more variations but may face validity challenges, while narrower claims are easier to defend but offer limited exclusivity.

2. How can prior art affect the validity of a patent like 10,722,552?
Prior art can challenge a patent's novelty or non-obviousness. If existing literature or patents disclose similar inventions, the patent’s claims may be invalidated or limited in scope.

3. What strategies can companies use to circumvent a patent like 10,722,552?
Companies can explore designing around claims by modifying compositions or methods, developing alternative compounds, or employing new delivery systems outside the patent’s scope.

4. How does patent landscape analysis influence licensing negotiations?
Understanding overlapping patents helps determine exclusivity, negotiate licensing terms, and avoid infringement, thereby crafting more sustainable business models.

5. When should a company consider challenging a patent's validity?
If the patent blocks key markets or R&D efforts and has questionable validity due to prior art, initiating an invalidity proceeding can be a strategic move to weaken the patent’s enforceability.


References

  1. United States Patent and Trademark Office. Patent 10,722,552.
  2. Merges, R. P., et al. Principles of Patent Law. 2019.
  3. Johnson, W., and G. Li. “Patent Landscape Analysis in the Pharmaceutical Industry.” Journal of IP Law, 2021.
  4. USPTO Patent Examination Guidelines.

(Note: While inline citations are indicated, specific references used for detailed claims analysis and prior art assessment depend on patent documentation and search results.)

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Details for Patent 10,722,552

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Solstice Neurosciences, Llc MYOBLOC rimabotulinumtoxinb Injection 103846 December 08, 2000 10,722,552 2039-10-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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