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Last Updated: December 21, 2024

Patent: 10,286,058


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Summary for Patent: 10,286,058
Title:Vaccines against HPV and HPV-related diseases
Abstract:Embodiments relate to novel vaccines against human papillomavirus (HPV) and HPV-related diseases, including multiple types of cancers. The HPV vaccines are composed of anti-human dendritic cell (DC) surface receptor antibodies, including CD40, and E6/7 proteins of HPV 16 and 18. The technology described is not limited to making vaccines against HPV16- and HPV18-related diseases and can be applied to making vaccines carrying E6/7 from any type of HPV. The HPV vaccines described can target DCs, major and professional antigen presenting cells (APCs), and can induce and activate potent HPV E6/7-specific and strong CD4+ and CD8+ T cell responses. The HPV vaccines can be used for the prevention of HPV infection and HPV-related diseases as well as for the treatment of HPV-related diseases, including cancers.
Inventor(s):Oh SangKon, Zurawski Sandra, Zurawski Gerard
Assignee:Baylor Research Institute
Application Number:US15111357
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,286,058

Introduction

Understanding the intricacies of a specific patent, such as United States Patent 10,286,058, involves a detailed analysis of its claims, the broader patent landscape, and relevant legal precedents. This article will delve into the key aspects of patent law, recent judicial decisions, and the implications for patent holders and innovators.

Patent-Eligible Subject Matter

To begin, it is crucial to understand what constitutes patent-eligible subject matter. Under Section 101 of the Patent Act (35 U.S.C. ยง101), only certain types of inventions are eligible for patent protection. The Supreme Court has narrowed the scope of patent-eligible subject matter through several key decisions, including Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., and Association for Molecular Pathology v. Myriad Genetics[1].

The Alice/Mayo Test

The Alice/Mayo test is a two-step framework used to determine if a patent claim is directed to an abstract idea, law of nature, or natural phenomenon, which are not patentable. First, the court determines if the claim is directed to an ineligible concept. If it is, the court then assesses whether the claim contains an inventive concept that transforms the nature of the claim into a patent-eligible application of the ineligible concept[1].

Obviousness-Type Double Patenting (ODP)

Obviousness-type double patenting is an equitable doctrine that prevents a patentee from obtaining a second patent on the same invention or an obvious modification of it, effectively extending the life of the first patent. Recent decisions by the Federal Circuit have clarified the application of ODP, particularly in cases involving patent term adjustments (PTA).

Federal Circuit Decisions on ODP

In Allergan USA, Inc. v. MSN Laboratories Private Ltd., the Federal Circuit held that a first-filed, first-issued, later-expiring patent claim cannot be invalidated for ODP by a later-filed, later-issued, earlier-expiring reference patent claim with a common priority date. This decision emphasizes the importance of filing and issuance dates in ODP analysis[2].

In contrast, the In re Cellect case highlighted the risks associated with receiving PTA on patents that are not subject to terminal disclaimers. The Federal Circuit ruled that PTA can result in unjustified extensions of patent term, leading to the invalidation of claims for ODP[3][5].

Patent Term Adjustments (PTA)

PTA compensates applicants for delays caused by the USPTO during the prosecution of a patent application. However, PTA can interact complexly with ODP. The USPTO and Federal Circuit have clarified that PTA must be considered when evaluating ODP, ensuring that the patent term is not improperly extended[3][4].

Managing Patents and Avoiding ODP

To avoid ODP issues, patent owners must be proactive. This includes filing terminal disclaimers to ensure that later patents do not extend the term of earlier patents. The In re Cellect decision underscores the importance of vigilance during the prosecution process to avoid invalidation of claims due to ODP[3].

Reexamination and Reissue of Patents

Patent owners can request reexamination of their patents based on prior art, and the USPTO may issue a reissue patent to correct defects in the original patent. However, new matter cannot be added during the reissue process. This mechanism allows for the refinement of patent claims but does not permit the introduction of new inventions[4].

Stakeholder Views and Innovation

Stakeholder views on patent-eligible subject matter and ODP vary widely. Some argue that the current framework discourages investment in technology and innovation, while others see it as necessary to prevent the extension of patent terms on indistinct inventions. The balance between encouraging innovation and preventing abuse of the patent system remains a contentious issue[1].

Case Study: United States Patent 10,286,058

While the specific details of United States Patent 10,286,058 are not provided here, a comprehensive analysis would involve:

Claim Construction

  • Analyzing each claim to determine if it is directed to an ineligible concept under the Alice/Mayo test.
  • Evaluating whether the claims contain an inventive concept that transforms the nature of the claim.

ODP Analysis

  • Reviewing the filing, issuance, and expiration dates of the patent and any related patents.
  • Assessing whether PTA has been granted and its impact on ODP.

Patent Term Adjustments

  • Examining if any delays during prosecution led to PTA and how this affects the patent term.
  • Ensuring that terminal disclaimers are filed if necessary to avoid ODP issues.

Reexamination and Reissue

  • Considering whether reexamination or reissue might be necessary to address any defects or challenges to the patent.

Key Takeaways

  • Patent-Eligible Subject Matter: Ensure that patent claims are not directed to abstract ideas, laws of nature, or natural phenomena.
  • ODP: Be aware of the filing, issuance, and expiration dates of related patents and the impact of PTA on ODP.
  • PTA: Understand how PTA interacts with ODP and ensure terminal disclaimers are filed to avoid invalidation.
  • Reexamination and Reissue: Utilize these mechanisms to correct defects and refine patent claims.
  • Stakeholder Views: Recognize the ongoing debate about the balance between encouraging innovation and preventing patent term extensions.

FAQs

Q: What is the Alice/Mayo test, and how is it applied?

A: The Alice/Mayo test is a two-step framework to determine if a patent claim is patent-eligible. It first checks if the claim is directed to an ineligible concept, and if so, assesses whether the claim contains an inventive concept that transforms it into a patent-eligible application.

Q: How does obviousness-type double patenting (ODP) affect patent claims?

A: ODP prevents a patentee from obtaining a second patent on the same invention or an obvious modification, effectively extending the life of the first patent. Recent decisions emphasize the importance of filing and issuance dates and the impact of PTA.

Q: What is the role of Patent Term Adjustments (PTA) in patent law?

A: PTA compensates applicants for delays during patent prosecution but can interact complexly with ODP. It is crucial to consider PTA when evaluating ODP to avoid unjustified extensions of patent term.

Q: Can a patent be reexamined or reissued, and what are the limitations?

A: Yes, a patent can be reexamined based on prior art, and a reissue patent can be granted to correct defects. However, new matter cannot be added during the reissue process.

Q: How do stakeholder views impact the patent landscape?

A: Stakeholders have varying opinions on whether current patent laws encourage or discourage innovation. The debate centers around balancing the encouragement of innovation with the prevention of patent term extensions on indistinct inventions.

Sources

  1. CRS Reports: Patent-Eligible Subject Matter Reform: An Overview.
  2. Whitecase: Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family.
  3. Mintz: Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent.
  4. USPTO: Managing a patent.
  5. United States Court of Appeals for the Federal Circuit: In re Cellect.

More… ↓

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Details for Patent 10,286,058

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Llc GARDASIL human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant Injection 125126 June 08, 2006 ⤷  Subscribe 2035-01-13
Glaxosmithkline Biologicals CERVARIX human papillomavirus bivalent (types 16 and 18) vaccine, recombinant Injection 125259 October 16, 2009 ⤷  Subscribe 2035-01-13
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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