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Last Updated: April 12, 2025

Patent: 10,053,498


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Summary for Patent: 10,053,498
Title:Compositions comprising serum albumin and p53 peptides fusion proteins
Abstract: The present invention relates to compositions useful in inhibiting Bcl-XL or MCL-1 and disrupting p53-MDM2 and p53-MDMX interactions, and methods of using those compositions for treating a subject for conditions responsive to increasing p53 mediated activity or promoting p53 independent apoptosis, such as treating cancer. In some aspects, the compositions of this invention relate to fusion polypeptides comprising a human serum polypeptide and a p53-peptide, which can be, in some aspects, a p53 derived peptide and/or a p53 activating peptide.
Inventor(s): Li; Zhiyu (Woodstock, MD), Parker; Michelle (Leander, TX)
Assignee: University of the Sciences of Philadelphia (Philadelphia, PA)
Application Number:14/948,010
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,053,498

Introduction

Patent law in the United States is complex and continually evolving, especially when it comes to the eligibility of patent claims under 35 U.S.C. § 101. This article will provide a comprehensive and critical analysis of the claims and the patent landscape, using the example of United States Patent 10,053,498, although the specific details of this patent are not provided here. We will delve into the key aspects of patent claims analysis, the two-step test for patent eligibility, and the implications of recent court decisions and regulatory proposals.

Understanding Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention for which protection is sought. These claims must be carefully crafted to ensure they are both broad enough to cover the invention and narrow enough to avoid prior art and other legal challenges[2].

The Two-Step Test for Patent Eligibility

The Supreme Court's decision in Alice Corp. v. CLS Bank International introduced a two-step test to determine whether a patent claim is eligible under § 101. This test is crucial in assessing the validity of patent claims.

Step One: Identifying Abstract Ideas

The first step involves determining whether the claim is directed to an abstract idea, a law of nature, or a natural phenomenon. If the claim is found to be directed to one of these ineligible subject matters, the analysis proceeds to the second step. For example, in the case of AI Visualize, Inc. v. Nuance Communications, Inc., the district court concluded that the asserted claims were directed to the abstract idea of "retrieving user-requested, remotely stored information"[1].

Step Two: Transformative Elements

The second step requires examining whether the claim recites elements sufficient to transform the abstract idea into a patent-eligible application. This involves looking for an "inventive step" that adds something more to the abstract idea. In the AI Visualize case, the court found that the claims did not provide such an inventive step, leading to the conclusion that they were patent-ineligible[1].

Patent Claims Analysis System and Method

The complexity of patent claims, especially in cases where there are numerous claims, necessitates advanced tools and methods for analysis. A system for facilitating patent claims examination, such as the one described in US20110138338A1, can automate the process of importing, parsing, and generating hierarchical claims diagrams. This helps in reducing the amount of information users need to review, making the judgment process more efficient[2].

Challenges in Patent Searching and Claims Variation

Patent searching is a critical but complex task, especially due to claims variation. During the prosecution process, claims may be amended or narrowed in response to objections from the examiner or to overcome prior art. This can result in different claims across related patents within the same patent family[4].

Impact of Court Decisions on Patent Eligibility

Recent court decisions have significantly influenced the landscape of patent eligibility. For instance, the Vanda Pharmaceuticals v. West-Ward Pharmaceuticals decision held that diagnostic claims which include an administration step can be patent eligible. This decision has implications for method of treatment claims, suggesting that they are generally patent eligible even if they apply natural relationships[5].

Regulatory Proposals and Their Implications

Regulatory proposals, such as the European Commission's proposal for the regulation of Standard Essential Patents (SEPs), can have far-reaching implications for patent holders and implementers. The proposal's non-binding FRAND determination process and the requirement for patentees to complete this process before bringing a court claim can introduce significant delays and strategic challenges for both parties[3].

Critical Analysis of Patent Eligibility Under § 101

Abstract Ideas and Inventive Steps

The distinction between abstract ideas and inventive steps is often blurry. Courts must carefully analyze whether the claimed advance over prior art is merely an abstract idea or if it includes an inventive step that transforms it into a patent-eligible application. The AI Visualize case highlights the importance of this distinction, where the court found that selectively accessing user-requested data did not constitute an inventive step[1].

Impact on Medical and Technological Innovations

Patents related to medical and technological innovations, such as those involving medical scans and data visualization, face unique challenges. These patents must overcome the hurdles of § 101 eligibility while addressing the complexities of transmitting and processing large datasets. The AI Visualize patents, for example, aimed to solve the problem of accessing large medical scans over low-bandwidth internet connections but were ultimately found ineligible under § 101[1].

Best Practices for Drafting Patent Claims

Clarity and Specificity

Drafting patent claims requires a balance between clarity and specificity. Claims must be clear enough to be understood by those skilled in the art but specific enough to avoid being overly broad and thus ineligible under § 101.

Avoiding Abstract Ideas

Claim drafters should be cautious to avoid claims that are directed to abstract ideas. This involves ensuring that the claims include concrete, tangible steps that go beyond mere conceptual processes.

Adapting to Prosecution

Claims may need to be amended during the prosecution process. Understanding how these amendments can affect the scope and eligibility of the claims is crucial for maintaining patent validity.

Conclusion

The landscape of patent claims and eligibility is intricate and dynamic. Understanding the two-step test, the impact of court decisions, and the complexities of patent searching and claims variation is essential for navigating this landscape. Here are some key takeaways:

  • Patent Eligibility: The two-step test under § 101 is critical in determining the eligibility of patent claims.
  • Abstract Ideas: Claims directed to abstract ideas must include an inventive step to be patent-eligible.
  • Claims Variation: Claims can change during prosecution, affecting their scope and eligibility.
  • Regulatory Implications: Regulatory proposals can significantly impact patent strategies and disputes.
  • Best Practices: Clarity, specificity, and avoiding abstract ideas are key in drafting valid patent claims.

Key Takeaways

  • Understand the Two-Step Test: Ensure that claims are not directed to abstract ideas and include an inventive step if necessary.
  • Monitor Court Decisions: Recent court decisions can significantly impact patent eligibility and strategies.
  • Use Advanced Tools: Utilize automated systems for patent claims analysis to streamline the review process.
  • Adapt to Regulatory Changes: Stay informed about regulatory proposals and their potential impacts on patent law.
  • Draft Claims Carefully: Balance clarity and specificity in drafting claims to avoid eligibility issues.

FAQs

Q: What is the two-step test for patent eligibility under § 101? A: The two-step test involves determining if the claim is directed to an abstract idea, law of nature, or natural phenomenon (Step One), and then examining if the claim recites elements sufficient to transform it into a patent-eligible application (Step Two)[5].

Q: How do court decisions impact patent eligibility? A: Court decisions, such as Vanda Pharmaceuticals v. West-Ward Pharmaceuticals, can clarify what types of claims are eligible, influencing the drafting and prosecution of patent applications[5].

Q: What are the challenges in patent searching due to claims variation? A: Claims variation during prosecution can result in different claims across related patents, making comprehensive searching more complex[4].

Q: How do regulatory proposals affect patent strategies? A: Regulatory proposals, like the EC's SEP regulation, can introduce new procedures and timelines that affect how patentees and implementers interact and resolve disputes[3].

Q: What are best practices for drafting patent claims to ensure eligibility? A: Best practices include ensuring clarity and specificity, avoiding abstract ideas, and being prepared to adapt claims during the prosecution process[4][5].

Sources

  1. AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC., CAFC, 2024.
  2. US20110138338A1 - Patent Claims Analysis System and Method, Google Patents.
  3. A Critical Analysis of the EC Proposal for SEP Regulation, Kluwer IP Law.
  4. Advanced patent searching techniques, CAS.org.
  5. How To Do The Two-Step In The United States, Sterne Kessler.

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Details for Patent 10,053,498

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Recordati Rare Diseases, Inc. ELSPAR asparaginase For Injection 101063 January 10, 1978 ⤷  Try for Free 2034-11-21
Iovance Biotherapeutics Manufacturing Llc PROLEUKIN aldesleukin For Injection 103293 May 05, 1992 ⤷  Try for Free 2034-11-21
Amgen Inc. NEUPOGEN filgrastim Injection 103353 February 20, 1991 ⤷  Try for Free 2034-11-21
Amgen Inc. NEUPOGEN filgrastim Injection 103353 June 28, 2000 ⤷  Try for Free 2034-11-21
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 4 of 4 entries

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