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Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,717,958

Introduction

Understanding the intricacies of a patent, particularly one like United States Patent 10,717,958, involves a deep dive into its claims, the patent landscape, and the broader legal and regulatory context. This analysis will cover the key aspects of the patent, including its claims, the patentability criteria, the role of the Patent Trial and Appeal Board (PTAB), and the implications of recent judicial and administrative developments.

Understanding the Patent Claims

Structure of Patent Claims

Patent claims are the paragraphs located at the end of the specification that define the scope of protection for the invention. These claims must be clear and specific, outlining what the inventor is seeking to protect. For example, in a typical patent, the first claim might describe the core components and functionality of the invention, such as a "portable electronic device" with specific features like housings, antennas, and frequency shields[4].

Claims in US Patent 10,717,958

To analyze the claims of US Patent 10,717,958, one must review the patent document itself. Here are some general steps to understand these claims:

Identify the Independent Claims: These are the broadest claims that stand alone and do not depend on other claims.
Analyze the Dependent Claims: These claims build upon the independent claims and add additional limitations.
Determine the Scope of Protection: The claims collectively define the legal boundaries of the invention, similar to how a property deed defines physical boundaries[4].

Patentability Criteria

Novelty Requirement

For a patent to be granted, the claimed invention must be novel, meaning it must not have been previously disclosed in the prior art. The USPTO cannot issue a patent if the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[2].

Nonobviousness Requirement

Even if an invention is novel, it must also be nonobvious. This means that the invention must be significantly different from existing technology and not obvious to someone with ordinary skill in the same technical field. The examiner must determine whether the claims overcome the technical features disclosed in the prior art[3].

Utility Requirement

The invention must also be useful, meaning it must have a practical application. This requirement ensures that the patent system incentivizes inventions that contribute to the advancement of technology and society[2].

Patent-Eligible Subject Matter

Section 101 of the Patent Act

Section 101 of the Patent Act sets out four categories of patentable inventions: processes, machines, manufactures, and compositions of matter. However, the Supreme Court has established implicit exceptions, including laws of nature, natural phenomena, and abstract ideas, which are not patentable when claimed as such[1].

The Alice/Mayo Test

The Supreme Court's decisions in Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories, Inc. introduced a two-step test to determine patent eligibility:

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, determine if the claims have an inventive concept that transforms the nature of the claim into a patent-eligible application of the ineligible concept[1].

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

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

The PTAB, established by the Leahy-Smith America Invents Act (AIA), provides a more efficient and cost-effective way to challenge the validity of patents compared to federal court litigation. IPR and PGR allow anyone to challenge patents before the USPTO, using a lower standard of proof and typically resulting in a final determination within one year[2].

Advantages of PTAB Procedures

PTAB procedures are often more advantageous for accused patent infringers due to their speed, lower costs, and lower burden of proof. This makes it a popular route for challenging patents asserted in other forums, such as federal courts or the U.S. International Trade Commission (ITC)[2].

Stakeholder Views and Recent Developments

USPTO Guidance on Patent-Eligible Subject Matter

In 2019, the USPTO issued new guidance to clarify how to apply the Alice/Mayo framework, which was incorporated into the Manual of Patent Examining Procedure. This guidance was seen as lowering Section 101 barriers to patentability, especially for computer-related inventions, and led to an increase in the allowance rate for AI-related patent applications[1].

Director Review and Appeals

Recent changes, such as the revised interim process for Director Review, allow for further review of PTAB decisions by an independent Delegated Review Panel (DRP). This process ensures that decisions are thoroughly scrutinized and can be corrected if necessary, adding another layer of oversight to the patent review process[5].

Competitive Intelligence and Patent Landscape Analysis

Patent File Wrappers

Analyzing patent file wrappers, which contain the detailed correspondence between the patent applicant and the patent examiner, provides valuable insights into the patent application process. This information can help in understanding the arguments made, the prior art cited, and the legal status of the invention, which is crucial for competitive intelligence and patent landscape analysis[3].

Implications for Business and Innovation

Encouraging Innovation

The patent system is designed to encourage innovation by providing exclusive rights to inventors. However, the scope of patent-eligible subject matter can significantly impact the ability to incentivize innovation in emerging technology sectors like AI and biotechnology. Recent judicial and administrative developments aim to balance the need for innovation with the need to prevent the patenting of ineligible subject matter[1].

Managing Patent Risks

For businesses, understanding the patent landscape and the claims of relevant patents is critical for managing risks and making informed investment decisions. This involves analyzing file wrappers, monitoring PTAB proceedings, and staying updated on legal and regulatory changes.

Key Takeaways

Patent Claims: Define the scope of protection and must be novel, nonobvious, and useful.
Patent-Eligible Subject Matter: Section 101 and the Alice/Mayo test determine what can be patented.
PTAB: Provides an efficient and cost-effective way to challenge patent validity.
USPTO Guidance: Recent guidance has clarified the application of the Alice/Mayo framework.
Competitive Intelligence: Analyzing patent file wrappers is essential for understanding the patent landscape.
Innovation and Risk Management: Understanding the patent system is crucial for encouraging innovation and managing patent risks.

FAQs

What are the main categories of patentable inventions under Section 101 of the Patent Act?

The main categories are processes, machines, manufactures, and compositions of matter[1].

How does the Alice/Mayo test determine patent eligibility?

The test involves two steps: determining if the claims are directed to an ineligible concept, and if so, whether the claims have an inventive concept that transforms the nature of the claim[1].

What is the role of the Patent Trial and Appeal Board (PTAB)?

PTAB hears administrative challenges to the validity of patents, including inter partes review (IPR) and post-grant review (PGR), providing a faster and less expensive alternative to federal court litigation[2].

How does the USPTO's 2019 Guidance impact patent eligibility?

The 2019 Guidance clarified how to apply the Alice/Mayo framework, generally lowering Section 101 barriers to patentability, especially for computer-related inventions[1].

What information can be found in a patent file wrapper?

A patent file wrapper contains the detailed correspondence between the patent applicant and the patent examiner, including arguments made, prior art cited, and the legal status of the invention[3].

Sources

Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024.
Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024.
IP Checkups. Patent file wrappers as a tool for competitive intelligence. February 5, 2023.
Queens University Library. How to Read a U.S. Patent. August 20, 2024.
Sterne Kessler. 2023 Changes in Director Review. February 8, 2024.

Title:	Method for producing a product (e.g. polypeptide) in a continuous cell culture fermentation process
Abstract:	A method for improving productivity in microbial fermentations and mammalian cell culture bioreactors.
Inventor(s):	Laustsen; Mads (Gentofte, DK)
Assignee:	CMC BIOLOGICS A/S (Soborg, DK)
Application Number:	16/400,201
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,717,958 Introduction Understanding the intricacies of a patent, particularly one like United States Patent 10,717,958, involves a deep dive into its claims, the patent landscape, and the broader legal and regulatory context. This analysis will cover the key aspects of the patent, including its claims, the patentability criteria, the role of the Patent Trial and Appeal Board (PTAB), and the implications of recent judicial and administrative developments. Understanding the Patent Claims Structure of Patent Claims Patent claims are the paragraphs located at the end of the specification that define the scope of protection for the invention. These claims must be clear and specific, outlining what the inventor is seeking to protect. For example, in a typical patent, the first claim might describe the core components and functionality of the invention, such as a "portable electronic device" with specific features like housings, antennas, and frequency shields[4]. Claims in US Patent 10,717,958 To analyze the claims of US Patent 10,717,958, one must review the patent document itself. Here are some general steps to understand these claims: Identify the Independent Claims: These are the broadest claims that stand alone and do not depend on other claims. Analyze the Dependent Claims: These claims build upon the independent claims and add additional limitations. Determine the Scope of Protection: The claims collectively define the legal boundaries of the invention, similar to how a property deed defines physical boundaries[4]. Patentability Criteria Novelty Requirement For a patent to be granted, the claimed invention must be novel, meaning it must not have been previously disclosed in the prior art. The USPTO cannot issue a patent if the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[2]. Nonobviousness Requirement Even if an invention is novel, it must also be nonobvious. This means that the invention must be significantly different from existing technology and not obvious to someone with ordinary skill in the same technical field. The examiner must determine whether the claims overcome the technical features disclosed in the prior art[3]. Utility Requirement The invention must also be useful, meaning it must have a practical application. This requirement ensures that the patent system incentivizes inventions that contribute to the advancement of technology and society[2]. Patent-Eligible Subject Matter Section 101 of the Patent Act Section 101 of the Patent Act sets out four categories of patentable inventions: processes, machines, manufactures, and compositions of matter. However, the Supreme Court has established implicit exceptions, including laws of nature, natural phenomena, and abstract ideas, which are not patentable when claimed as such[1]. The Alice/Mayo Test The Supreme Court's decisions in Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories, Inc. introduced a two-step test to determine patent eligibility: 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, determine if the claims have an inventive concept that transforms the nature of the claim into a patent-eligible application of the ineligible concept[1]. The Role of the Patent Trial and Appeal Board (PTAB) Inter Partes Review (IPR) and Post-Grant Review (PGR) The PTAB, established by the Leahy-Smith America Invents Act (AIA), provides a more efficient and cost-effective way to challenge the validity of patents compared to federal court litigation. IPR and PGR allow anyone to challenge patents before the USPTO, using a lower standard of proof and typically resulting in a final determination within one year[2]. Advantages of PTAB Procedures PTAB procedures are often more advantageous for accused patent infringers due to their speed, lower costs, and lower burden of proof. This makes it a popular route for challenging patents asserted in other forums, such as federal courts or the U.S. International Trade Commission (ITC)[2]. Stakeholder Views and Recent Developments USPTO Guidance on Patent-Eligible Subject Matter In 2019, the USPTO issued new guidance to clarify how to apply the Alice/Mayo framework, which was incorporated into the Manual of Patent Examining Procedure. This guidance was seen as lowering Section 101 barriers to patentability, especially for computer-related inventions, and led to an increase in the allowance rate for AI-related patent applications[1]. Director Review and Appeals Recent changes, such as the revised interim process for Director Review, allow for further review of PTAB decisions by an independent Delegated Review Panel (DRP). This process ensures that decisions are thoroughly scrutinized and can be corrected if necessary, adding another layer of oversight to the patent review process[5]. Competitive Intelligence and Patent Landscape Analysis Patent File Wrappers Analyzing patent file wrappers, which contain the detailed correspondence between the patent applicant and the patent examiner, provides valuable insights into the patent application process. This information can help in understanding the arguments made, the prior art cited, and the legal status of the invention, which is crucial for competitive intelligence and patent landscape analysis[3]. Implications for Business and Innovation Encouraging Innovation The patent system is designed to encourage innovation by providing exclusive rights to inventors. However, the scope of patent-eligible subject matter can significantly impact the ability to incentivize innovation in emerging technology sectors like AI and biotechnology. Recent judicial and administrative developments aim to balance the need for innovation with the need to prevent the patenting of ineligible subject matter[1]. Managing Patent Risks For businesses, understanding the patent landscape and the claims of relevant patents is critical for managing risks and making informed investment decisions. This involves analyzing file wrappers, monitoring PTAB proceedings, and staying updated on legal and regulatory changes. Key Takeaways Patent Claims: Define the scope of protection and must be novel, nonobvious, and useful. Patent-Eligible Subject Matter: Section 101 and the Alice/Mayo test determine what can be patented. PTAB: Provides an efficient and cost-effective way to challenge patent validity. USPTO Guidance: Recent guidance has clarified the application of the Alice/Mayo framework. Competitive Intelligence: Analyzing patent file wrappers is essential for understanding the patent landscape. Innovation and Risk Management: Understanding the patent system is crucial for encouraging innovation and managing patent risks. FAQs What are the main categories of patentable inventions under Section 101 of the Patent Act? The main categories are processes, machines, manufactures, and compositions of matter[1]. How does the Alice/Mayo test determine patent eligibility? The test involves two steps: determining if the claims are directed to an ineligible concept, and if so, whether the claims have an inventive concept that transforms the nature of the claim[1]. What is the role of the Patent Trial and Appeal Board (PTAB)? PTAB hears administrative challenges to the validity of patents, including inter partes review (IPR) and post-grant review (PGR), providing a faster and less expensive alternative to federal court litigation[2]. How does the USPTO's 2019 Guidance impact patent eligibility? The 2019 Guidance clarified how to apply the Alice/Mayo framework, generally lowering Section 101 barriers to patentability, especially for computer-related inventions[1]. What information can be found in a patent file wrapper? A patent file wrapper contains the detailed correspondence between the patent applicant and the patent examiner, including arguments made, prior art cited, and the legal status of the invention[3]. Sources Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024. IP Checkups. Patent file wrappers as a tool for competitive intelligence. February 5, 2023. Queens University Library. How to Read a U.S. Patent. August 20, 2024. Sterne Kessler. 2023 Changes in Director Review. February 8, 2024. More… ↓ ⤷ Try for Free

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

Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130	January 24, 1974	10,717,958	2033-03-19
Takeda Pharmaceuticals U.s.a., Inc.	HEMOFIL M	antihemophilic factor (human)	For Injection	101448	March 14, 2001	10,717,958	2033-03-19
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997	10,717,958	2033-03-19
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,717,958

Summary for Patent: 10,717,958