You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 24, 2024

Patent: 10,953,073


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,953,073
Title:XTEN conjugate compositions and methods of making same
Abstract:The present invention relates to extended recombinant polypeptide (XTEN) compositions, conjugate compositions comprising XTEN and XTEN linked to cross-linkers useful for conjugation to pharmacologically active payloads, methods of making highly purified XTEN, methods of making XTEN-linker and XTEN-payload conjugates, and methods of using the XTEN-cross-linker and XTEN-payload compositions.
Inventor(s):Schellenberger Volker, Podust Vladimir, Wang Chia-Wei, McLaughlin Bryant, Sim Bee-Cheng, Ding Sheng, Gu Chen
Assignee:Amunix Pharmaceuticals, Inc.
Application Number:US16133444
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,953,073

Introduction

Patent 10,953,073, like any other patent, operates within the complex and evolving landscape of U.S. patent law. To understand its implications and validity, it is crucial to delve into the specifics of the patent claims, the current state of patent-eligible subject matter, and the relevant legal and administrative frameworks.

Understanding Patent-Eligible Subject Matter

The foundation of patent eligibility in the U.S. is laid out in Section 101 of the Patent Act (35 U.S.C. §101), which defines patentable inventions as "any new and useful process, machine, manufacture, or composition of matter"[1].

Judicially Developed Exceptions

The Supreme Court has established implicit exceptions to patent-eligible subject matter, including "laws of nature, natural phenomena, and abstract ideas" when claimed as such. These exceptions were reinforced in cases such as Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., and Association for Molecular Pathology v. Myriad Genetics, Inc.[1].

The Alice/Mayo Test

To determine patent eligibility, the Alice/Mayo test is applied:

  • Step One: Determine if the claims are directed to an ineligible concept (law of nature, natural phenomenon, or abstract idea).
  • Step Two: If the claims are directed to an ineligible concept, assess whether the elements of each claim, individually and as an ordered combination, contain an inventive concept that transforms the nature of the claim into a patent-eligible application[1][5].

Analysis of Patent 10,953,073 Claims

Without specific details on the claims of Patent 10,953,073, a general analysis based on common issues in patent eligibility is necessary.

Claim Construction and Eligibility

  • Step One: If the claims are directed to abstract ideas, laws of nature, or natural phenomena, they must be evaluated under the Alice/Mayo test.
  • Step Two: The claims must include additional elements that impose meaningful limits on the ineligible concept, transforming it into a practical application. For example, if the patent involves AI, the method of invention development using AI does not impact subject matter eligibility, but the claimed invention itself must show significant human contribution and concrete technological improvement[3].

Practical Application and Technological Improvement

To be patent-eligible, the claims must demonstrate how the abstract idea is applied in a way that provides concrete benefits or solves specific problems in the relevant field. For instance, if the patent involves AI-related inventions, highlighting real-world applications such as enhancing speech recognition systems can bolster the argument for patent eligibility[3].

Recent USPTO Guidance and Its Implications

The USPTO has issued several guidance updates to clarify the process for determining patent eligibility, particularly for AI-related inventions.

2024 USPTO Guidance Update

  • This update emphasizes evaluating whether a claim integrates a judicial exception into a practical application.
  • It provides examples of patent-eligible and ineligible claims directed to AI technology, helping practitioners draft claims that avoid Section 101 rejections.
  • The update clarifies that AI-assisted inventions are evaluated on equal footing with other technologies, ensuring that AI’s role as a tool does not exclude inventions from eligibility, provided there is significant human contribution[3].

Stakeholder Views and Legislative Developments

Stakeholders have varying views on the impact of the Alice/Mayo framework on innovation and investment in technology.

Legislative Efforts

  • The Patent Eligibility Restoration Act (PERA) 2023 includes provisions that could alter the exclusions for unmodified human genes or other natural materials, potentially allowing the patenting of isolated DNA segments if they are "isolated, purified, enriched, or otherwise altered by human activity"[1].

Administrative and Judicial Challenges

Patents can face challenges through various administrative and judicial avenues.

Patent Trial and Appeal Board (PTAB)

  • PTAB, established by the Leahy-Smith America Invents Act (AIA), provides a faster and less expensive way to challenge patent validity through inter partes review (IPR) and post-grant review (PGR).
  • These processes allow entities to challenge patents before the USPTO, potentially canceling patent claims that should not have issued[5].

Federal Court Litigation

  • Litigating patent cases in federal court is time-consuming and expensive, with a higher burden of proof required to invalidate patents compared to PTAB processes[5].

Managing and Maintaining Patents

Once a patent is granted, managing it involves several considerations.

Patent Term Adjustments and Extensions

  • Patents may be eligible for term adjustments or extensions due to delays in the patent application process.
  • Reissue patents can be granted to correct defects in the original patent, but new matter cannot be added[4].

Reexamination and Disclaimer

  • Anyone can request reexamination of issued patent claims based on prior art.
  • Patent holders can disclaim one or more claims from their patent to avoid potential invalidity issues[4].

Key Takeaways

  • Patent Eligibility: The Alice/Mayo test remains crucial in determining the eligibility of patent claims, especially for abstract ideas and AI-related inventions.
  • USPTO Guidance: Recent updates provide clearer guidelines for evaluating the patentability of AI-related inventions, emphasizing practical applications and human contribution.
  • Administrative Challenges: PTAB processes offer a faster and more cost-effective way to challenge patent validity compared to federal court litigation.
  • Legislative Changes: Ongoing legislative efforts, such as PERA 2023, may alter the landscape of what is considered patent-eligible subject matter.

FAQs

Q: What is the Alice/Mayo test, and how does it affect patent eligibility? A: The Alice/Mayo test is a two-step process to determine if a patent claim is eligible. It first checks if the claim is directed to an ineligible concept (law of nature, natural phenomenon, or abstract idea). If so, it then assesses whether the claim includes an inventive concept that transforms the nature of the claim into a patent-eligible application[1][5].

Q: How does the USPTO's 2024 guidance update impact AI-related patent applications? A: The update clarifies the process for determining patent eligibility of AI-related inventions, emphasizing the integration of judicial exceptions into practical applications and ensuring AI-assisted inventions are evaluated on equal footing with other technologies[3].

Q: What is the role of the Patent Trial and Appeal Board (PTAB) in challenging patent validity? A: PTAB provides administrative processes like inter partes review (IPR) and post-grant review (PGR) to challenge the validity of issued patents, offering a faster and less expensive alternative to federal court litigation[5].

Q: Can isolated DNA segments be patented under current law? A: Currently, isolated DNA segments are not patentable as per the Supreme Court's Myriad decision. However, proposed legislation like PERA 2023 could change this by allowing the patenting of isolated DNA segments if they are modified by human activity[1].

Q: How can patent holders manage and maintain their patents effectively? A: Patent holders can manage their patents through patent term adjustments, reissue patents to correct defects, and reexamination to evaluate the patentability of issued claims. They can also disclaim claims to avoid potential invalidity issues[4].

Cited Sources:

  1. Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024.
  2. U.S. Court of Appeals for the Federal Circuit. Sunoco Partners Marketing & Terminals L.P. v. U.S. Venture, Inc.. April 29, 2022.
  3. Mintz. Understanding the 2024 USPTO Guidance Update on AI Patent. July 25, 2024.
  4. United States Patent and Trademark Office. Managing a patent. April 27, 2023.
  5. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. May 28, 2024.

More… ↓

⤷  Subscribe

Details for Patent 10,953,073

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 January 15, 1974 10,953,073 2038-09-17
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 December 27, 1984 10,953,073 2038-09-17
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 15, 1985 10,953,073 2038-09-17
Ferring Pharmaceuticals Inc. NOVAREL chorionic gonadotropin For Injection 017016 February 16, 1990 10,953,073 2038-09-17
Bel-mar Laboratories, Inc. CHORIONIC GONADOTROPIN chorionic gonadotropin Injection 017054 March 26, 1974 10,953,073 2038-09-17
Ferring Pharmaceuticals Inc. A.P.L. chorionic gonadotropin For Injection 017055 December 13, 1974 10,953,073 2038-09-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.