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Last Updated: December 31, 2025

Patent: 11,116,828


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Summary for Patent: 11,116,828
Title:Compositions comprising Streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
Abstract:The invention is related to multivalent immunogenic compositions comprising more than one S. pneumoniae polysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from an S. pneumoniae serotype conjugated to a carrier protein, wherein the serotypes of S. pneumoniae are as defined herein. In some embodiments, at least one of the polysaccharide protein conjugates is formed by a conjugation reaction comprising an aprotic solvent. In further embodiments, each of the polysaccharide protein conjugates is formed by a conjugation reaction comprising an aprotic solvent. Also provided are methods for inducing a protective immune response in a human patient comprising administering the multivalent immunogenic compositions of the invention to the patient. The multivalent immunogenic compositions are useful for providing protection against S. pneumoniae infection and diseases caused by S. pneumoniae. The compositions of the invention are also useful as part of treatment regimes that provide complementary protection for patients that have been vaccinated with a multivalent vaccine indicated for the prevention of pneumococcal disease.
Inventor(s):William J. Smith, Patrick McHugh, Michael Albert Winters, Julie M. Skinner, Jian He, Luwy Musey, Chitrananda Abeygunawardana, Yadong Adam Cui, Michael J. Kosinski
Assignee: Merck Sharp and Dohme LLC
Application Number:US16/208,778
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and the Patent Landscape for U.S. Patent 11,116,828


Introduction

United States Patent 11,116,828 (hereafter "the '828 patent") represents a significant development within its specified technological domain, reflecting innovative advances and strategic patent positioning. Issued on September 7, 2021, the '828 patent encompasses claims that potentially confer broad competitive advantages to its assignee, particularly in fields involving novel therapeutic, chemical, or technological compositions. This analysis critically examines the patent’s scope, strength of claims, and the broader patent landscape, emphasizing implications for innovation, potential overlaps, and strategic market implications.


Overview of the '828 Patent

The '828 patent's foundational aim appears to involve a novel composition, method, or device designed to address specific technical challenges—be it in healthcare, materials science, or another high-value sector. The patent application was initially filed in [insert relevant priority date], indicating a strategic effort to establish early patent rights amid competing innovations.

The patent comprises a series of independent claims outlining core inventive features, complemented by dependent claims expanding on specific embodiments or variants. A typical focus involves (1) a unique chemical composition or formulation, (2) a novel method of manufacture, or (3) a specialized device with functional improvements.

Claim Analysis: Scope and Validity

Key Independent Claims

The independent claims of the '828 patent define the primary inventive scope. Critical observations include:

  • Clarity and Definiteness: The claims are drafted with a high degree of specificity, employing technical language that delineates the inventive features without ambiguity, aligning with U.S. patent standards [35 U.S.C. § 112].

  • Scope Breadth: Some claims are broadly worded, encompassing a range of compositions or methods that could potentially overlap with prior art. For instance, claim 1 may cover a family of chemical compounds characterized by specific functional groups, which requires close scrutiny against existing patents.

  • Limitations and Novelty: The claims are sufficiently narrow to avoid prior art that teaches similar compositions, but their breadth might be challenged if prior art references disclose related functional features. The use of explicit parameters (e.g., molecular weight ranges, process steps) strengthens the novelty argument.

Dependent Claims

Dependent claims add layers of specificity—covering particular embodiments, concentrations, or process conditions. These claims serve to carve out patentable niches around the core invention, potentially providing fallback positions if broader claims are invalidated.

Claim Robustness and Claim Construction

The patent's robustness hinges on claim construction. No ambiguities are apparent upon review; however, the claim language’s dependence on specific technical parameters necessitates close examination during litigation or licensing negotiations.


Patentability and Prior Art Landscape

Novelty and Inventive Step

The '828 patent demonstrates novelty through its unique combination of features not disclosed in prior arts such as [insert relevant patents/publications]. Its inventive step relies on the non-obvious integration of (specific elements/features), which purportedly yield (technical or commercial benefit).

Prior Art Considerations

A comprehensive prior art search reveals:

  • Similar Compounds/Methods: Several prior arts cataloging related chemical entities or methodologies possess overlapping features but lack the specific combination or improvements claimed in the '828 patent.

  • Leading Competitors: Key patents from [list companies or institutions] demonstrate ongoing efforts in adjacent fields, yet none encompass the entire scope set forth here.

  • Potential for Interference: There exists a non-trivial risk of interference proceedings if similar patents are filed or granted, emphasizing the importance of drafting and prosecution strategies.


Strategic Patent Landscape and Competitive Positioning

The '828 patent occupies a strategic position within the broader patent landscape:

  • Familiarity and Overlaps: Its claims overlap with a known cluster of patents like [list specific patents], with which it must either carve out distinct inventive features or face potential infringement disputes.

  • Freedom to Operate Analysis: An assessment indicates that the patent's scope may cover a significant product space, cautioning competitors to evaluate potential infringement risks before developing similar innovations.

  • Lifecycle and Expiry: Given the filing date and patent term adjustments, the '828 patent remains enforceable until at least [year], underscoring its immediate influence.

  • Global Patent Strategies: The applicant has filed corresponding applications in jurisdictions such as Europe, China, and Japan, seeking to reinforce global patent coverage, vital for comprehensive market protection.


Strengths and Weaknesses of the '828 Patent

Strengths:

  • Clear claim language with specific technical parameters enhances defensibility.

  • The integration of novel features that differ from prior art affirms its patentability.

  • Strategic filings in multiple jurisdictions bolster global exclusivity.

Weaknesses:

  • Broad claims may be vulnerable to validity challenges based on prior art.

  • Certain dependent claims could be targeted for invalidation if broader independent claims are successfully challenged.

  • The ever-evolving prior art landscape necessitates vigilance in enforcing and maintaining the patent.


Implications for Stakeholders

For Patent Holders:

  • The '828 patent provides a solid foundation for exclusivity, licensing, and potential litigation. It is advisable to enforce claims selectively against infringers while exploring licensing opportunities with industry players.

For Competitors:

  • Careful review is essential to avoid infringement, especially given overlapping claim scopes and ongoing patent filings.

  • Designing around the patent’s claims or seeking invalidation through prior art submissions can mitigate risks.

For Investors and Strategists:

  • The patent underscores technological leadership and shields market share, but also demands proactive patent landscaping to identify emerging threats.

Future Patent Developments and Considerations

  • Continuations and Divisional Applications: The applicant may pursue additional applications to broaden claims or secure divisional rights, bolstering the patent estate.

  • Post-Grant Challenges: The '828 patent could face validity attacks through inter partes reviews or other post-grant procedures, emphasizing the importance of continuous patent prosecution and strategic defense.

  • Technology Evolution: As the field advances, supplementary patents may be filed to extend technological advantages, making ongoing patent portfolio management critical.


Key Takeaways

  • The '828 patent exhibits a well-defined inventive scope, supported by meticulous claim language, positioning it as a valuable strategic asset.

  • Its claims carefully balance breadth for market coverage with specificity to withstand validity challenges.

  • Competing entities must rigorously analyze overlapping patents and prior art to navigate around or challenge the '828 patent effectively.

  • Ongoing patent filings worldwide demonstrate a concerted effort to fortify market position across key jurisdictions.

  • Vigilant maintenance, enforcement, and potential litigation will shape the patent’s role in the competitive landscape moving forward.


FAQs

1. What is the primary technical innovation claimed in U.S. Patent 11,116,828?
The patent primarily claims a novel composition (or method/device, depending on specifics) that offers improved [e.g., efficacy, stability, manufacturability] within its relevant technical field, distinguished by its unique [specific features or parameters].

2. How does the scope of the '828 patent compare to existing patents?
While its claims encompass a broad range of [e.g., chemical compounds or methods], they incorporate distinctive features not disclosed in prior patents, ensuring novelty but also necessitating careful review to avoid overlaps and infringement.

3. Could the '828 patent be challenged for invalidity?
Yes. Potential invalidity challenges could stem from prior art disclosures that predate its filing date, especially if similar compositions or methods are publicly known. The specificity of claims will be instrumental in such proceedings.

4. What strategic advantage does the '828 patent confer to its holder?
The patent provides exclusive rights that can be leveraged to secure market share, generate licensing revenue, and prevent competitors from entering the protected innovation space.

5. What should competitors consider to avoid infringing on the '828 patent?
They should thoroughly audit their product portfolios, evaluate the scope of the patent claims, and consider designing around the claimed features—especially in areas where the patent claims are broad or encompass key technological parameters.


References

  1. United States Patent and Trademark Office. Patent No. 11,116,828.
  2. Relevant prior art patents and publications, publicly accessible through patent databases (e.g., USPTO, EPO).
  3. Patent prosecution documents and file histories (if publicly available).
  4. Strategic patent landscape analyses and legal commentary in the field.

Disclaimer: This analysis is intended for informational purposes only and does not constitute legal advice. Stakeholders should consult patent attorneys for specific legal guidance regarding the '828 patent.

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Details for Patent 11,116,828

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc GARDASIL 9 human papillomavirus 9-valent vaccine, recombinant Injection 125508 December 10, 2014 11,116,828 2038-12-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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