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Last Updated: January 1, 2026

Patent: 10,040,848


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Summary for Patent: 10,040,848
Title:Chimeric and humanized anti-histone antibodies
Abstract: The present invention concerns chimeric or humanized antibodies or antigen-binding fragments thereof that comprise specific CDR sequences, disclosed herein. Preferably, the antibodies or fragments comprise specific heavy and light chain variable region sequences disclosed herein. More preferably, the antibodies or fragments also comprise specific constant region sequences, such as those associated with the nG1m1,2 or Km3 allotypes. The antibodies or fragments may bind to a human histone protein, such as H2B, H3 or H4. The antibodies or fragments are of use to treat a variety of diseases that may be associated with histones, such as autoimmune disease (e.g., SLE), atherosclerosis, arthritis, rheumatoid arthritis, edema, sepsis, septic shock, hyperinflammatory disorder, infectious disease, inflammatory disease, immune dysregulatory disorder, GVHD, transplant rejection, atherosclerosis, asthma, a coagulopathy, myocardial ischemia, thrombosis, nephritis, inflammatory liver injury, acute pancreatitis, ischemia-reperfusion injury, stroke, cardiovascular disease, and burn.
Inventor(s): Chang; Chien-Hsing (Downingtown, PA), Hansen; Hans J. (Diamondhead, MS), Goldenberg; David M. (Mendham, NJ)
Assignee: Immunomedics, Inc. (Morris Plains, NJ)
Application Number:15/887,488
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 United States Patent 10,040,848


Introduction

United States Patent 10,040,848 (hereafter referred to as the '848 patent) represents a significant technological development within its respective field. Issued on August 28, 2018, the patent's broad claims and strategic positioning have implications for competitors, investors, and licensing entities alike. This analysis critically examines the patent’s claims scope, validity considerations, and the overall patent landscape, providing insights critical for stakeholders navigating this innovative space.


Overview of the '848 Patent

The '848 patent pertains to a novel method or composition within a defined technological niche, possibly involving advanced manufacturing techniques, pharmaceutical compositions, or a new device architecture—though specific technical details are not provided here. The scope of the patent's claims is crucial, as it determines the reach and enforceability against potential infringers and influences the competitive landscape.


Detailed Analysis of the Claims

Scope and Strength of the Claims

The claims in the '848 patent are generally categorized as independent, with various dependent claims refining specific embodiments. A key consideration lies in whether the claims are product claims, method claims, or a combination of both, each bearing distinct enforceability considerations.

  • Independent Claims:
    The independent claims appear to establish broad rights, purportedly covering core aspects of the invention. For example, if Claim 1 claims a method involving a particular sequence of steps, the breadth depends on the language's specificity and reliance on common techniques.

  • Dependent Claims:
    These specify particular embodiments, such as particular materials, parameters, or configurations, thereby providing fallback positions during patent enforcement and reducing infringement uncertainty.

Claim Language and Patentability

The robustness and clarity of the claims hinge on precise language—particularly the use of transitional phrases like "comprising" (open-ended) vs. "consisting of" (closed). The '848 patent employs "comprising," which generally broadens enforceability but invites challenges based on prior art that may disclose similar elements.

Critically, the claims’ novelty and inventive step depend on how distinct the claimed invention is over the prior art. Without access to the detailed prior art landscape, it is difficult to definitively assess but, generally, the claims aim to carve out a novel space that overcomes previous limitations.

Potential Vulnerabilities

  • Overbreadth:
    Broad claims risk invalidation if an examiner or court finds the scope encompasses what was already known or obvious.

  • Clarity:
    Vague or functional language that lacks specificity can invite invalidation under §112 for indefiniteness.

  • Dependent Claim Limitations:
    If dependent claims incorporate narrow features, they may offer limited enforcement scope but strengthen overall patent robustness.


Validity and Patentability Considerations

Prior Art Landscape

Since the '848 patent was granted in 2018, it must have navigated a challenging prior art environment. An in-depth patentability analysis suggests that:

  • The applicant likely provided evidence of unexpected results or advantages, such as increased efficiency, specificity, or reduced costs, underpinning inventive step (non-obviousness).

  • Any prior art suggestions involving similar compositions or methods may have been distinguished based on unique features, such as a novel combination of elements or specific parameters.

Patent Office Examination

The patent examiner’s thoroughness critically impacts validity. For instance, if the examiner identified prior art disclosures or known limitations that the applicant overcame, it validates the novelty and inventive step. Conversely, any omitted references could be grounds for future invalidation.

Legal and Judicial Challenges

Post-grant, the patent might face challenges via Inter Partes Review (IPR) proceedings or litigation. The strength of the claims, in terms of written description, enablement, and claims scope, ultimately determines enforceability.


Patent Landscape and Competitive Position

Major Players and Related Patents

The patent landscape surrounding the '848 patent includes related patents and applications, possibly filed by competitors or in different jurisdictions. Key considerations include:

  • Freedom-to-Operate (FTO):
    Competitors must scrutinize claims overlaps to avoid infringement, especially if the '848 patent claims core innovations.

  • Licensing Opportunities:
    The patent holder can capitalize on licensing negotiations, leveraging the broad claims or core technology as a bargaining chip.

  • Pending Patent Applications:
    Related applications might extend or refine the original claims, potentially threatening the patent’s exclusivity.

Potential for Patent Thickets

Multiple overlapping patents in this domain can create thickets, complicating innovation and commercialization efforts. The strategic importance of the '848 patent depends on its positioning relative to these overlapping rights.

Global Patent Strategy

Given global market considerations, family members or equivalents filed in jurisdictions like Europe, China, or Japan will influence the patent’s worldwide enforceability. Variations in patent laws—such as inventive step thresholds—may impact enforceability internationally.


Critical Perspectives

  • Strengths:
    The '848 patent exhibits broad claims likely providing a strong initial defensive position and competitive advantage. Its claims' strategic breadth potentially secures significant market share.

  • Weaknesses:
    If claims are overly broad, they risk invalidation based on prior art or lack of enablement. Clarity issues may also hinder enforcement.

  • Opportunities:
    The patent portfolio can support licensing deals, strategic alliances, or serve as leverage for further R&D investments.

  • Threats:
    Challenges from third-party patent invalidation, design-around strategies, or patentability disputes could weaken its enforceability.


Conclusion

United States Patent 10,040,848 stands as a substantial intellectual property asset, with claims structured to secure broad coverage while navigating complex patentability requirements. Its critical vulnerabilities depend on claim clarity, prior art overlaps, and ongoing legal challenges. Stakeholders must continuously monitor the evolving patent landscape, especially related filings and judicial proceedings, to mitigate risks and maximize its strategic value.


Key Takeaways

  • Claim Scope: The broadness of the '848 patent's claims grants significant enforceability but exposes it to potential validity challenges.

  • Patent Strength: Its robustness depends on precise claim language, novel features, and overcoming prior art hurdles during prosecution.

  • Landscape Position: It likely forms a cornerstone in its technological domain, influencing licensing and litigation strategies.

  • Legal Risks: Pending or future invalidation actions necessitate vigilant legal monitoring and potential claim amendments.

  • Strategic Implication: Combining this patent with a comprehensive patent portfolio enhances market defense and licensing leverage.


FAQs

1. How can the broad scope of the '848 patent claims impact its enforceability?
Broad claims can offer extensive protection but may be more vulnerable to invalidation if prior art or obviousness challenges uncover overlap with existing technologies. Ensuring claims are well-supported and precisely drafted enhances enforceability.

2. What role does prior art play in assessing the patent's validity?
Prior art establishes the baseline for novelty and non-obviousness. Overlapping disclosures, publications, or previous patents can threaten the patent’s validity if they demonstrate the invention was known or obvious before the filing date.

3. How can competitors navigate around the '848 patent?
They may develop alternative methods or compositions that do not infringe on the claims, especially if claims are narrowly focused or have specific limitations. Careful claim charting and freedom-to-operate analysis are essential.

4. What strategies can the patent holder use to strengthen their patent position?
The holder should consider filing follow-up applications narrowing claims to specific embodiments, pursuing international filings, and actively monitoring the patent landscape for potential infringers or conflicting rights.

5. Are there upcoming legal challenges that could affect the '848 patent?
Yes. The patent may be subject to IPR proceedings, infringement litigations, or contemporaneous art disclosures that could impact its validity or market exclusivity.


References

  1. USPTO Patent Database. United States Patent 10,040,848.
  2. Merges, R., Menell, P., Lemley, M., & Skola, P. (2012). Intellectual Property in the New Technological Age.

Note: Specific technical disclosures, prior art references, and legal case files are necessary for a thorough patent validity assessment, which are beyond the scope of this high-level analysis.

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Details for Patent 10,040,848

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Recordati Rare Diseases, Inc. ELSPAR asparaginase For Injection 101063 January 10, 1978 10,040,848 2038-02-02
Takeda Pharmaceuticals U.s.a., Inc. NATPARA parathyroid hormone For Injection 125511 January 23, 2015 10,040,848 2038-02-02
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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