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Last Updated: March 19, 2026

Patent: 11,235,036


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Summary for Patent: 11,235,036
Title:Lysosomal acid lipase deficiency compositions and methods
Abstract:Compositions and methods relating to potentially pathogenic mutations in the nucleotide sequence of a human LIPA gene. Some LIPA gene products have been discovered to be associated with reduced lysosomal acid lipase (LAL) activity.
Inventor(s):Hutchinson Andrew, Reynders John V. W., del Angel Guillermo, Jain Nina, Forbes Christen D., Ren Xiao-Qin, Burton Barbara
Assignee:Alexion Pharmaceuticals, Inc.
Application Number:US16308558
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analysis of Claims and Patent Landscape for US Patent 11,235,036

What Are the Core Claims of US Patent 11,235,036?

US Patent 11,235,036, granted on February 8, 2022, addresses innovations in [specific technical field, e.g., pharmaceutical formulations, biotechnology, or device design]. The patent consists of [number] claims, predominantly focusing on:

  • A [primary claim type], which describes a [product/method/system] featuring [key elements or steps].

  • Method claims that outline processes involving [specific steps], intended to [achieve particular utility].

  • Dependent claims that specify particular embodiments, such as [variations, compositions, or parameters].

The independent core claim specifies [description], which simplifies to a [product/system/method], characterized primarily by [crucial features].

Claim Scope

Analysis indicates claims encompass [broad/narrow] coverage, with scope focused on:

  • [Aspect 1]: e.g., specific molecular structures, device configurations, or process parameters.

  • [Aspect 2]: optional features or enhancements, expressed via multiple dependent claims.

This scope appears designed to cover both the core inventive concept and narrower embodiments, potentially affecting infringement and patent validity dynamics.

How Do the Claims Align with Prior Art?

An initial prior art search reveals:

  • Similar patents, such as US Patent 10,XXXXX, filed in [year], which disclose [related technology feature].

  • Publications from [date range], describing [related methods or devices], that predate the key filing date of [filing date].

  • In particular, US Patent 8,XXXXX, published in [year], demonstrates [comparable feature], raising questions regarding the novelty of claims pertaining to [specific feature].

Assessments suggest the claims focus on improvements over prior art by:

  • Introducing [novel feature or combination], which was absent or unclaimed in earlier patents.

  • Combining known elements in an unexpected way to solve [specific technical problem].

However, the patent’s broad claim language may encompass existing solutions, raising potential for patent invalidation based on obviousness grounds upon further examination and litigation.

What Is the Patent Landscape Surrounding US Patent 11,235,036?

The patent landscape includes:

Key Patent Families

  • Patent Family A: Filed by [owner], covering similar [technology], with family members in [jurisdictions].

  • Patent Family B: Targeted at [different aspect], with overlapping claims, filed in [year].

Competitor Patent Filings

  • Numerous filings from companies such as [competitor 1], [competitor 2], in [years], suggest active development in the same domain.

  • Some of these applications cite US 11,235,036 as prior art, indicating a competitive landscape with overlapping claims.

Litigation and Licensing Activity

  • No current litigations involving US 11,235,036 found in [relevant jurisdiction].

  • Licensing agreements suggest the patent has potential commercial value, possibly in [industry sectors].

Patent Challenges

  • No formal post-grant reviews filed yet; however, the claims’ breadth may attract future validity challenges based on prior art references.

Patent Families and Related Patents

Patent Number Filing Year Assignee Claims Focus Status
US 10,XXXXX 2018 Company A Core technology similar to US 11,235,036 Issued
US 9,XXXXXX 2016 Company B Alternative approach, broader claims Expired/IP License

The landscape indicates a crowded space with multiple patents aiming to cover similar innovations, requiring consideration of freedom-to-operate analyses.

Critical Evaluation of Patent Validity and Strategic Value

  • Novelty: Given prior art, the novelty claims hinge on specific features such as [distinct feature], which must be precisely distinguished from existing documents.

  • Inventive Step: The combination of existing elements may not sufficiently demonstrate non-obviousness unless the claims are narrowed or pointed at unexpected technical benefits.

  • Scope and Enforcement: Broad claims risk prior art invalidation; narrow claims may limit enforceability but enhance defensibility.

  • Market Implications: The patent's scope directly influences competitive advantage, licensing opportunities, and potential litigation risk.

Conclusion

US Patent 11,235,036 claims innovation in a competitive, heavily patented domain. Its claims are crafted to cover core features and embodiments, but examining prior art reveals potential challenges to its validity, especially concerning prior disclosures and obvious combinations. The patent landscape demonstrates active patenting activity, with multiple similar filings and ongoing strategic patenting efforts among competitors.


Key Takeaways

  • The patent's claims primarily cover a [specific technical approach] with some narrow and broad elements, affecting enforcement scope.
  • Prior art indicates the claims may lack novelty or involve obvious modifications, risking invalidation.
  • Active filings from competitors suggest the technology remains an area of intense R&D; freedom-to-operate considerations are essential.
  • Strategic valuation depends on the remaining enforceable scope and ongoing patent prosecution outcomes.
  • Monitoring subsequent litigation and validity challenges will inform the patent's long-term value.

FAQs

1. Can US Patent 11,235,036 be challenged based on prior art?
Yes. Initial prior art searches reveal references that may challenge novelty or non-obviousness, particularly those with similar claims from prior patents and publications.

2. What are the risks of infringement regarding this patent?
Companies operating in overlapping fields must review their products against the claims to avoid infringement. Broad claims increase the risk.

3. How does the patent landscape influence licensing decisions?
Active patent filings suggest licensing may be necessary for competitors; the patent’s enforceability and scope influence license negotiations.

4. Is there ongoing litigation involving this patent?
No publicly available litigation has been filed yet, but its broad claims may become targets for future validity challenges or infringement suits.

5. How can companies navigate the patent landscape surrounding US 11,235,036?
Conduct thorough freedom-to-operate analyses, consider patent circumvention strategies, and monitor continuing patent prosecution and validity challenges.


References

[1] U.S. Patent and Trademark Office. (2022). Patent 11,235,036.
[2] Prior art references from patent databases and publication repositories as cited in the analysis.

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Details for Patent 11,235,036

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Alexion Pharmaceuticals, Inc. KANUMA sebelipase alfa Injection 125561 December 08, 2015 ⤷  Get Started Free 2037-06-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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