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Analyzing the Claims and Patent Landscape of United States Patent 8,536,126

Introduction

United States Patent 8,536,126, like many patents, is part of a complex and evolving patent landscape. To understand its significance and the challenges it may face, it is crucial to delve into the specifics of the patent claims, the broader patent landscape, and the relevant legal and regulatory frameworks.

Patent Claims and Subject Matter Eligibility

When analyzing the claims of a patent like U.S. Patent 8,536,126, one must consider the subject matter eligibility criteria set forth by the USPTO and interpreted by the courts.

Abstract Ideas and Practical Applications

The USPTO's 2024 guidance update on AI patents emphasizes the importance of integrating abstract ideas into practical applications to meet patent eligibility criteria. For example, claims involving AI technologies must demonstrate concrete technological improvements or real-world applications to be considered patent-eligible[2].

Claim Construction and Eligibility Analysis

Each claim of U.S. Patent 8,536,126 would need to be evaluated to determine if it integrates an abstract idea into a practical application. This involves assessing additional elements in the claim to see if they impose meaningful limits on the exception, transforming the claim into patent-eligible subject matter. The USPTO's examples, such as those involving artificial neural networks, provide practical guidance on how to meet these eligibility criteria[2].

Obviousness-Type Double Patenting (ODP)

Another critical aspect is the potential for obviousness-type double patenting (ODP), particularly if the patent is part of a family of patents with overlapping claims.

ODP Analysis and Terminal Disclaimers

The case of In re Cellect highlights the importance of ODP analysis, especially for patents that are continuations-in-part or have received Patent Term Adjustments (PTA). The Federal Circuit has ruled that ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent filed at the same time but with a different patent term due to PTA[1].

Impact on Patent Term

For U.S. Patent 8,536,126, if it is part of a patent family with similar claims, an ODP analysis would be necessary to ensure that the patent does not extend beyond the terminal disclaimer date. This is crucial because the Board has reasoned that terminal disclaimers arise almost exclusively to overcome ODP rejections, and Congress effectively addresses ODP through the statutory language of § 154[1].

Patent Assertion Entities (PAEs) and Litigation

The patent landscape is also influenced by the activities of Patent Assertion Entities (PAEs), which can significantly impact the validity and enforcement of patents.

PAE Business Models

The FTC study on PAEs identifies two main business models: Litigation PAEs and Portfolio PAEs. Litigation PAEs often precede licenses with patent infringement suits, while Portfolio PAEs negotiate licenses covering large portfolios without initial litigation. This distinction is important because it can affect how patents like U.S. Patent 8,536,126 are asserted and defended[3].

Impact on Patent Owners

For the owner of U.S. Patent 8,536,126, understanding the PAE landscape is vital. PAEs can target patents across various industries, including those held by small businesses or independent innovators with limited resources. This can lead to significant legal and financial burdens, highlighting the need for robust patent strategies and potential legislative reforms[3][4].

Legislative and Regulatory Frameworks

The patent landscape is shaped by legislative and regulatory changes, which can impact the validity and enforcement of patents.

PREVAIL Act and PTAB Reforms

The PREVAIL Act proposes several reforms to the Patent Trial and Appeal Board (PTAB) to promote fairness and efficiency. This includes requiring standing for PTAB challengers, limiting repeated petitions, and ensuring the USPTO has the necessary resources by eliminating fee diversion. These reforms could affect how patents like U.S. Patent 8,536,126 are challenged and defended[4].

USPTO Guidance and Judicial Interpretations

The USPTO's guidance updates, such as the 2024 AI patent guidance, reflect the integration of recent case law and provide clearer standards for patent eligibility. This ensures consistency and clarity in the application of patent eligibility criteria, which is crucial for navigating the complex patent landscape[2].

Economic and Innovation Policy

Patents play a critical role in U.S. economic growth, national security, and technological leadership.

Role of Patents in Innovation

The U.S. patent system is designed to incentivize innovation by offering a limited-time monopoly over the use of an invention in exchange for public disclosure. This system has been in place since 1790 and is a cornerstone of U.S. innovation policy[5].

IP-Intensive Industries

IP-intensive industries account for a significant portion of the U.S. GDP and employment. Patents like U.S. Patent 8,536,126 contribute to this ecosystem by protecting inventions and encouraging further innovation[5].

Key Takeaways

Subject Matter Eligibility: Ensure that patent claims integrate abstract ideas into practical applications to meet eligibility criteria.
ODP Analysis: Conduct thorough ODP analysis, especially for patents within a family of patents, to avoid extending patent terms beyond terminal disclaimers.
PAE Activities: Be aware of PAE business models and their impact on patent assertion and litigation strategies.
Legislative and Regulatory Changes: Stay updated on reforms like the PREVAIL Act and USPTO guidance updates to navigate the evolving patent landscape effectively.
Economic Impact: Recognize the role of patents in driving economic growth and innovation.

FAQs

Q: What is the significance of ODP analysis in patent law? A: ODP analysis prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent filed at the same time but with a different patent term due to PTA.

Q: How do PAEs impact patent owners? A: PAEs can significantly impact patent owners by asserting patents through litigation or portfolio licensing, which can lead to legal and financial burdens, especially for small businesses or independent innovators.

Q: What are the key changes proposed by the PREVAIL Act? A: The PREVAIL Act proposes requiring standing for PTAB challengers, limiting repeated petitions, and ensuring the USPTO has the necessary resources by eliminating fee diversion.

Q: How does the USPTO's 2024 guidance update affect AI-related patents? A: The update clarifies that AI-assisted inventions are evaluated on equal footing with other technologies, focusing on whether the claimed invention integrates an abstract idea into a practical application.

Q: What is the economic significance of patents in the U.S.? A: Patents play a critical role in U.S. economic growth, national security, and technological leadership, with IP-intensive industries accounting for a significant portion of U.S. GDP and employment.

Sources

In re Cellect - United States Court of Appeals for the Federal Circuit[1]
Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz[2]
Patent Assertion Entity Activity: An FTC Study - Federal Trade Commission[3]
PREVAIL Act Fact Sheet - U.S. Senate[4]
Patents and Innovation Policy - Congressional Research Service[5]

Title:	Conjugated factor VIII molecules
Abstract:	The present invention relates to B-domain truncated Factor VIII molecules with a modified circulatory half life, said molecule being covalently conjugated with a hydrophilic polymer. The invention furthermore relates to methods for obtaining such molecules as well as use of such molecules.
Inventor(s):	Bolt Gert, Vandahl Brian Berg Stidsen, Thim Lars, Stennicke Henning Ralf, Steenstrup Thomas Dock, DeFrees Shawn
Assignee:	Novo Nordisk A/S
Application Number:	US13759261
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Analyzing the Claims and Patent Landscape of United States Patent 8,536,126 Introduction United States Patent 8,536,126, like many patents, is part of a complex and evolving patent landscape. To understand its significance and the challenges it may face, it is crucial to delve into the specifics of the patent claims, the broader patent landscape, and the relevant legal and regulatory frameworks. Patent Claims and Subject Matter Eligibility When analyzing the claims of a patent like U.S. Patent 8,536,126, one must consider the subject matter eligibility criteria set forth by the USPTO and interpreted by the courts. Abstract Ideas and Practical Applications The USPTO's 2024 guidance update on AI patents emphasizes the importance of integrating abstract ideas into practical applications to meet patent eligibility criteria. For example, claims involving AI technologies must demonstrate concrete technological improvements or real-world applications to be considered patent-eligible[2]. Claim Construction and Eligibility Analysis Each claim of U.S. Patent 8,536,126 would need to be evaluated to determine if it integrates an abstract idea into a practical application. This involves assessing additional elements in the claim to see if they impose meaningful limits on the exception, transforming the claim into patent-eligible subject matter. The USPTO's examples, such as those involving artificial neural networks, provide practical guidance on how to meet these eligibility criteria[2]. Obviousness-Type Double Patenting (ODP) Another critical aspect is the potential for obviousness-type double patenting (ODP), particularly if the patent is part of a family of patents with overlapping claims. ODP Analysis and Terminal Disclaimers The case of In re Cellect highlights the importance of ODP analysis, especially for patents that are continuations-in-part or have received Patent Term Adjustments (PTA). The Federal Circuit has ruled that ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent filed at the same time but with a different patent term due to PTA[1]. Impact on Patent Term For U.S. Patent 8,536,126, if it is part of a patent family with similar claims, an ODP analysis would be necessary to ensure that the patent does not extend beyond the terminal disclaimer date. This is crucial because the Board has reasoned that terminal disclaimers arise almost exclusively to overcome ODP rejections, and Congress effectively addresses ODP through the statutory language of § 154[1]. Patent Assertion Entities (PAEs) and Litigation The patent landscape is also influenced by the activities of Patent Assertion Entities (PAEs), which can significantly impact the validity and enforcement of patents. PAE Business Models The FTC study on PAEs identifies two main business models: Litigation PAEs and Portfolio PAEs. Litigation PAEs often precede licenses with patent infringement suits, while Portfolio PAEs negotiate licenses covering large portfolios without initial litigation. This distinction is important because it can affect how patents like U.S. Patent 8,536,126 are asserted and defended[3]. Impact on Patent Owners For the owner of U.S. Patent 8,536,126, understanding the PAE landscape is vital. PAEs can target patents across various industries, including those held by small businesses or independent innovators with limited resources. This can lead to significant legal and financial burdens, highlighting the need for robust patent strategies and potential legislative reforms[3][4]. Legislative and Regulatory Frameworks The patent landscape is shaped by legislative and regulatory changes, which can impact the validity and enforcement of patents. PREVAIL Act and PTAB Reforms The PREVAIL Act proposes several reforms to the Patent Trial and Appeal Board (PTAB) to promote fairness and efficiency. This includes requiring standing for PTAB challengers, limiting repeated petitions, and ensuring the USPTO has the necessary resources by eliminating fee diversion. These reforms could affect how patents like U.S. Patent 8,536,126 are challenged and defended[4]. USPTO Guidance and Judicial Interpretations The USPTO's guidance updates, such as the 2024 AI patent guidance, reflect the integration of recent case law and provide clearer standards for patent eligibility. This ensures consistency and clarity in the application of patent eligibility criteria, which is crucial for navigating the complex patent landscape[2]. Economic and Innovation Policy Patents play a critical role in U.S. economic growth, national security, and technological leadership. Role of Patents in Innovation The U.S. patent system is designed to incentivize innovation by offering a limited-time monopoly over the use of an invention in exchange for public disclosure. This system has been in place since 1790 and is a cornerstone of U.S. innovation policy[5]. IP-Intensive Industries IP-intensive industries account for a significant portion of the U.S. GDP and employment. Patents like U.S. Patent 8,536,126 contribute to this ecosystem by protecting inventions and encouraging further innovation[5]. Key Takeaways Subject Matter Eligibility: Ensure that patent claims integrate abstract ideas into practical applications to meet eligibility criteria. ODP Analysis: Conduct thorough ODP analysis, especially for patents within a family of patents, to avoid extending patent terms beyond terminal disclaimers. PAE Activities: Be aware of PAE business models and their impact on patent assertion and litigation strategies. Legislative and Regulatory Changes: Stay updated on reforms like the PREVAIL Act and USPTO guidance updates to navigate the evolving patent landscape effectively. Economic Impact: Recognize the role of patents in driving economic growth and innovation. FAQs Q: What is the significance of ODP analysis in patent law? A: ODP analysis prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent filed at the same time but with a different patent term due to PTA. Q: How do PAEs impact patent owners? A: PAEs can significantly impact patent owners by asserting patents through litigation or portfolio licensing, which can lead to legal and financial burdens, especially for small businesses or independent innovators. Q: What are the key changes proposed by the PREVAIL Act? A: The PREVAIL Act proposes requiring standing for PTAB challengers, limiting repeated petitions, and ensuring the USPTO has the necessary resources by eliminating fee diversion. Q: How does the USPTO's 2024 guidance update affect AI-related patents? A: The update clarifies that AI-assisted inventions are evaluated on equal footing with other technologies, focusing on whether the claimed invention integrates an abstract idea into a practical application. Q: What is the economic significance of patents in the U.S.? A: Patents play a critical role in U.S. economic growth, national security, and technological leadership, with IP-intensive industries accounting for a significant portion of U.S. GDP and employment. Sources In re Cellect - United States Court of Appeals for the Federal Circuit[1] Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz[2] Patent Assertion Entity Activity: An FTC Study - Federal Trade Commission[3] PREVAIL Act Fact Sheet - U.S. Senate[4] Patents and Innovation Policy - Congressional Research Service[5] More… ↓ ⤷ Try for Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate

Novo Nordisk Inc.	ESPEROCT	antihemophilic factor (recombinant), glycopegylated-exei	For Injection	125671	February 19, 2019	8,536,126	2033-02-05
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 8,536,126

Summary for Patent: 8,536,126