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Last Updated: January 7, 2025

Patent: 10,545,135


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Summary for Patent: 10,545,135
Title:Compositions comprising human embryonic stem cells and their derivatives, methods of use, and methods of preparation
Abstract: The present invention relates to a pharmaceutical composition comprising of preparations of human embryonic stem (hES) cells and their derivatives and methods for their transplantation into the human body, wherein transplantation results in the clinical reversal of symptoms, cure, stabilization or arrest of degeneration of a wide variety of presently incurable and terminal medical conditions, diseases and disorders. The invention further relates to novel processes of preparing novel stem cell lines which are free of animal products, feeder cells, growth factors, leukaemia inhibitory factor, supplementary mineral combinations, amino acid supplements, vitamin supplements, fibroblast growth factor, membrane associated steel factor, soluble steel factor and conditioned media. This invention further relates to the isolation, culture, maintenance, expansion, differentiation, storage, and preservation of such stem cells.
Inventor(s): Shroff; Geeta (New Delhi, IN)
Application Number:12/224,839
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,545,135
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Complexities of U.S. Patent 10,545,135: A Comprehensive Analysis

Introduction

Patent 10,545,135, like many other patents, operates within a complex and evolving landscape of U.S. patent law. This analysis will delve into the key aspects of this patent, including its claims, the broader patent landscape, and the legal frameworks that govern it.

Patent Claims and Their Significance

What are Patent Claims?

Patent claims are the heart of a patent application, defining the scope of the invention for which protection is sought. They must be clear, concise, and supported by the patent's specification[4].

The Claims of U.S. Patent 10,545,135

To analyze the claims of U.S. Patent 10,545,135, one must review the patent document itself. Typically, claims are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.

Patentability Requirements

Novelty, Non-Obviousness, and Subject Matter Eligibility

For a patent to be granted, the invention must meet the statutory requirements outlined in Title 35 of the U.S. Code. This includes novelty (Section 102), non-obviousness (Section 103), and subject matter eligibility (Section 101)[3].

Novelty

The invention must be new and not anticipated by prior art. This means that the invention cannot be identical to something already known or used by others before the filing date of the patent application.

Non-Obviousness

The invention must be significantly different from existing technology and not obvious to a person of ordinary skill in the relevant field. This requirement ensures that the invention is innovative and not merely an incremental improvement.

Subject Matter Eligibility

The invention must fall within a category of subject matter that is eligible for patent protection. This has been a contentious area, particularly since the U.S. Supreme Court's decision in 2014, which has led to ongoing debates and legislative efforts to clarify these requirements[3].

The Role of the Patent Trial and Appeal Board (PTAB)

Inter Partes Review (IPR) and Post-Grant Review (PGR)

The Leahy-Smith America Invents Act (AIA) of 2011 introduced significant changes to U.S. patent law, including the creation of PTAB and the processes of IPR and PGR. These administrative challenges allow third parties to contest the validity of patents before the USPTO, providing a faster and less expensive alternative to federal court litigation[5].

Impact on Patent 10,545,135

If U.S. Patent 10,545,135 is challenged through IPR or PGR, PTAB would review the claims to determine if they should have been granted. This process involves a lower burden of proof compared to federal court proceedings, making it a critical consideration for patent holders and challengers alike.

Double Patenting and Terminal Disclaimers

Obviousness-Type Double Patenting (ODP)

ODP prevents an inventor from securing multiple patents for the same invention, ensuring that a single invention does not receive extended patent protection through multiple filings. This is particularly relevant for continuation-in-part patents, as seen in the case of In re Cellect LLC[1].

Terminal Disclaimers

To overcome ODP rejections, patent applicants may file terminal disclaimers, which limit the term of the later patent to the term of the earlier patent. This practice is crucial in managing patent portfolios and ensuring compliance with ODP rules[1].

Patent Term Adjustment (PTA) and Patent Term Extension (PTE)

PTA

PTA extends the term of a patent to compensate for delays in the USPTO's processing. However, as seen in In re Cellect LLC, PTA does not extend the term past the date of a terminal disclaimer, unlike PTE, which can extend the term based on different criteria[1].

PTE

PTE, under 35 U.S.C. ยง 156, can extend the term of a patent due to regulatory delays, such as those related to FDA approval. This extension is not foreclosed by a terminal disclaimer, providing additional protection for certain types of inventions[1].

The Increasing Complexity of Patent Applications

Rise in Patent Applications and Claims

The number of patent applications and claims has significantly increased over the years, driven by technological innovation and facilitated by advancements in technology. This trend complicates the process of understanding and communicating patent property and competitive positions[2].

Automated Systems for Patent Analysis

Given the complexity, there is a growing need for automated systems to analyze and manage patent claims. Such systems can reduce the information overload and help in making informed judgments about patent claims and applications[2].

Expert Insights and Legal Precedents

Chisum on Patents

Donald S. Chisum's treatise, Chisum on Patents, is a seminal work that provides authoritative analysis on all aspects of patent law, including doctrines, rules, and case law. It is a valuable resource for understanding the intricacies of patent claims and the legal landscape[4].

Judicial Decisions

Cases such as Festo Corporation v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd. and Novartis AG v. Ezra Ventures LLC have shaped the interpretation of patent claims and the application of doctrines like prosecution history estoppel and the doctrine of equivalents[2][1].

Strengthening the U.S. Intellectual Property System

Legislative and Administrative Initiatives

To build a strong and predictable IP ecosystem, several initiatives have been proposed, including clarifying patent eligibility requirements, improving data collection and transparency, and enhancing the efficiency of the patent system[3].

Key Takeaways

  • Patent Claims: Clear and concise claims are crucial for defining the scope of an invention.
  • Patentability Requirements: Inventions must meet novelty, non-obviousness, and subject matter eligibility criteria.
  • PTAB and Administrative Challenges: IPR and PGR provide alternative paths for challenging patent validity.
  • Double Patenting and Terminal Disclaimers: ODP and terminal disclaimers are essential for managing patent portfolios.
  • Patent Term Adjustments: PTA and PTE have different implications for patent term extensions.
  • Complexity of Patent Applications: Automated systems can help manage the increasing complexity of patent claims.

FAQs

What are the key requirements for a patent to be granted in the United States?

A patent must meet the requirements of novelty (Section 102), non-obviousness (Section 103), and subject matter eligibility (Section 101) as outlined in Title 35 of the U.S. Code[3].

How does the Patent Trial and Appeal Board (PTAB) impact patent validity?

PTAB allows third parties to challenge patent validity through IPR and PGR, providing a faster and less expensive alternative to federal court litigation. This process can result in the cancellation of patent claims if they are found to be invalid[5].

What is the difference between Patent Term Adjustment (PTA) and Patent Term Extension (PTE)?

PTA extends the term of a patent to compensate for USPTO processing delays, while PTE extends the term due to regulatory delays, such as FDA approval. Unlike PTA, PTE is not foreclosed by a terminal disclaimer[1].

Why is it important to clarify patent eligibility requirements?

Clarifying patent eligibility requirements helps in building a predictable IP ecosystem, reducing disputes, and ensuring that only eligible subject matter receives patent protection[3].

How do automated systems help in patent claims analysis?

Automated systems reduce the information overload by facilitating the importation of patent claims, analyzing large volumes of data, and helping users make informed judgments about patent claims and applications[2].

Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. US20110138338A1 - Patent Claims Analysis System and Method, Google Patents.
  3. Four Actions to Strengthen the U.S. Intellectual Property System, Center for Strategic and International Studies.
  4. Chisum on Patents, LexisNexis Store.
  5. The Patent Trial and Appeal Board and Inter Partes Review, Congressional Research Service.

More… ↓

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Details for Patent 10,545,135

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bavarian Nordic A/s RABAVERT rabies vaccine For Injection 103334 October 20, 1997 ⤷  Subscribe 2026-03-07
Sanofi Pasteur Sa IMOVAX RABIES rabies vaccine For Injection 103931 February 04, 2000 ⤷  Subscribe 2026-03-07
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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