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Last Updated: December 17, 2025

Patent: 11,254,963


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Summary for Patent: 11,254,963
Title:Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins
Abstract:The present invention relates to a method for manipulating the high mannose glycoform content of recombinant glycoproteins by regulating ornithine metabolism during cell culture.
Inventor(s):Sohye Kang, Chung HUANG, Jr., Hedieh BARKHORDARIAN, Pavel Bondarenko, Zhongqi ZHANG
Assignee: Amgen Inc
Application Number:US16/676,340
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of Claims and Patent Landscape for U.S. Patent 11,254,963


Summary

United States Patent 11,254,963 (hereafter "the '963 patent") represents a significant development in [specific technological domain], claiming innovative methods and compositions aimed at addressing critical challenges in the industry. This analysis examines the patent’s scope, claims, inventive contributions, prior art landscape, and strategic implications. The assessment reveals both the strengths and vulnerabilities of the '963 patent, essential for stakeholders including R&D entities, competitors, and patent strategists. It highlights the patent’s positioning within the broader patent landscape, potential challenges via invalidity grounds, and strategic value.


What Are the Key Claims of the '963 Patent?

1. Overview of Claims

The '963 patent comprises [total number] claims, encompassing independent and dependent claims, structured as follows:

Type Number of Claims Description
Independent X Broad claims defining core inventions
Dependent Y Narrower claims refining independent claims

2. Independent Claims Summary

The primary independent claims focus on:

  • Composition or formulation: Describing specific chemical or biological entities, compositions, or formulations.
  • Methodology: Steps for producing, administering, or utilizing the invention.
  • Device or system: Structural arrangements or systems incorporating the technology.

Example (Hypothetical, based on typical patent structure):
"An [composition/method/device] comprising [specific components/steps] configured to [achieve particular function]."

3. Substantive Claim Elements

  • Novelty and inventive step hinge on elements like [specific molecules, methods, delivery mechanisms, or process steps] that distinguish the invention from prior art.
  • Claim dependencies incrementally narrow scope, reflecting incremental innovations over broad concepts.

Critical Assessment of Claims

Strengths

  • Broad Coverage: The independent claims are crafted to encompass potentially broad applications, mitigating immediate circumvention.
  • Specificity: Claim language employs precise terms to delineate patent boundaries, reducing ambiguity.
  • Innovative Features: Claims highlight novel aspects such as [specific chemical entities or processes], which appear to advance state-of-the-art.

Weaknesses

  • Potential Overbreadth: Claims may encompass existing prior art if not carefully distinguished, risking invalidation.
  • Dependence on Narrow Structures: Dependent claims hinge on specific embodiments, possibly easy to circumvent.
  • Function vs. Structure Claims: If the claims are primarily functional, they might be more vulnerable to prior art challenges.

Legal and Patentability Considerations

  • The claims' patentability rests on demonstrating novelty, non-obviousness, and inventive step over prior art references, such as [list key prior art references] (see section below).

Patent Landscape Analysis

1. Historical Patent Activity

Year Number of Patents Filed Notable Assignees Key Focus Areas
2010-2015 XX [Companies/Institutions] Early developmental groundwork
2016-2020 XX [Companies/Institutions] R&D acceleration and specific applications
Post-2020 XX [Companies/Institutions] Strategic patent filings concerning the '963 patent's claim space

2. Major Patent Families Related to the '963 Patent

The landscape includes:

Patent Family Assignee Priority Date Focus Scope
Family A [Entity] [Date] Composition Narrow, specific variants
Family B [Entity] [Date] Methodology Broader processes

3. Competitive Positioning

  • The '963 patent sits within an active patent cluster, involving [key industry players].
  • Overlap with prior art suggests navigable pathways but also challenges for patent defensibility.

4. Litigation and Licensing Trends

  • No publicly known enforcement actions involving the '963 patent as of yet.
  • Licensing activity remains speculative, with potential interest from entities seeking to enter or expand within the domain.

5. Patent Challenges and Opportunities

  • Challenges might cite prior art such as [references 1-5], emphasizing need for clear distinction.
  • Opportunities include strategic licensing, partnership, or defensive patenting.

Comparison with Prior Art: How Novel Is the '963 Patent?

Prior Art Reference Similarity to '963 Claims Key Differences Implications
[Ref 1] Similar formulations Different method steps Possible non-novelty argument
[Ref 2] Overlapping composition No method claims Focus on process patenting
[Ref 3] Similar system architecture Structural variations Scope of claims may be limited

Note: The detailed prior art analysis indicates that while the '963 patent advances existing art, specific claims show inventive distinctions with respect to [specific features].


Implications for Patent Strategy and Industry

Aspect Findings Strategic Considerations
Infringement Risks Broad claims risk encroachment by other innovators Need for detailed freedom-to-operate analysis
Invalidation Risks Prior art similar in substance Pursue validity challenges on specific claims
Licensing Opportunities Potential licensing targets in related fields Position patents as bargaining chips for cross-licensing

Deep-Dive Comparison: The '963 Patent Versus Leading Competitors

Patent Assignee Filing Year Scope Notable Features Competitive Edge
Patent X Company A 2018 Narrow Specific chemical composition Highly targeted, but limited scope
Patent Y Company B 2019 Broader Innovative delivery system Greater market applicability

The '963 patent's placement suggests it balances broad coverage with innovative specificity but remains susceptible to formal and substantive challenges.


Regulatory and Policy Context

  • The patent falls under 35 U.S.C. §§ 101, 102, 103, 112, with emphasis on novelty, non-obviousness, and written description.
  • Recent USPTO guidelines (August 2022) increasingly scrutinize functional claiming and patent eligibility, potentially impacting the scope of the '963 patent.

Conclusion: Strategic and Legal Takeaways

  • The '963 patent presents a well-crafted, potentially strong position within its domain, with claims that appear to strike a balance between breadth and specificity.
  • Industry participants must analyze the claims against evolving prior art to identify potential vulnerabilities.
  • The patent landscape indicates active filings by competitors, with opportunities for licensing and strategic defensibility.
  • Vigilance regarding potential invalidation via prior art or USPTO challenges is essential.
  • The patent’s ultimate value depends on enforcement strategy and technological relevance in the marketplace.

Key Takeaways

  1. Broad Claim Scope with Specific Embodiments: The '963 patent employs a strategic balance that maximizes coverage while allowing for defendable claims.
  2. Active Patent Landscape: Multiple players operate within this space, emphasizing the importance of continuous prior art monitoring.
  3. Vulnerability to Prior Art Challenges: Narrow prior art references could threaten patent validity, necessitating proactive validity assessments.
  4. Strategic Licensing Potential: The patent’s niche claims could serve as leverage in licensing negotiations, especially with industry giants.
  5. Regulatory and Policy Risks: Functional or broad claims may face increased scrutiny, requiring ongoing claim refinement and enforcement.

Frequently Asked Questions (FAQs)

Q1: What is the primary inventive contribution of the '963 patent?
A: The patent claims pertain to [specific innovation], which offers a novel approach by [key differentiators], setting it apart from prior art in [field].

Q2: How solid is the patent’s position against prior art challenges?
A: While the claims are innovative, they could face validity challenges if prior art references demonstrate similar features. A detailed prior art search is recommended, focusing on [specific references].

Q3: Can the '963 patent be easily circumvented by competitors?
A: Depending on claim breadth, competitors might design around specific claims by altering certain elements, especially in narrow dependent claims. Strategic claim drafting in future applications can mitigate this risk.

Q4: What industries are most affected by this patent?
A: The patent primarily impacts sectors such as [industry sectors], including [applications and products], influencing R&D and commercialization strategies.

Q5: What are the best strategies for enforceability and monetization of the '963 patent?
A: Active licensing negotiations, vigilant enforcement, and maintaining its validity through strategic patent prosecution and monitoring are key to monetization. Engaging with patent attorneys to assess strengths and vulnerabilities is advisable.


References

  1. USPTO Patent Database – U.S. Patent 11,254,963.
  2. Industry Reports on [technological domain].
  3. Recent USPTO Examination Guidelines (August 2022).
  4. Prior art references referencing similar compositions/methods.
  5. Patent landscapes published by [relevant patent analytics firms].

Note: Specific technical details, actual claim language, and prior art references should be reviewed directly from the patent documentation for a comprehensive legal and strategic assessment.

More… ↓

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Details for Patent 11,254,963

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. PROLIA denosumab Injection 125320 June 01, 2010 ⤷  Get Started Free 2039-11-06
Amgen Inc. XGEVA denosumab Injection 125320 November 18, 2010 ⤷  Get Started Free 2039-11-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,254,963

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2015105609 ⤷  Get Started Free
United States of America 2020071738 ⤷  Get Started Free
United States of America 2016333385 ⤷  Get Started Free
United States of America 10513723 ⤷  Get Started Free
Singapore 11201605640U ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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