Patent: 10,040,848

Summary for Patent: 10,040,848

Title:	Chimeric and humanized anti-histone antibodies
Abstract:	The present invention concerns chimeric or humanized antibodies or antigen-binding fragments thereof that comprise specific CDR sequences, disclosed herein. Preferably, the antibodies or fragments comprise specific heavy and light chain variable region sequences disclosed herein. More preferably, the antibodies or fragments also comprise specific constant region sequences, such as those associated with the nG1m1,2 or Km3 allotypes. The antibodies or fragments may bind to a human histone protein, such as H2B, H3 or H4. The antibodies or fragments are of use to treat a variety of diseases that may be associated with histones, such as autoimmune disease (e.g., SLE), atherosclerosis, arthritis, rheumatoid arthritis, edema, sepsis, septic shock, hyperinflammatory disorder, infectious disease, inflammatory disease, immune dysregulatory disorder, GVHD, transplant rejection, atherosclerosis, asthma, a coagulopathy, myocardial ischemia, thrombosis, nephritis, inflammatory liver injury, acute pancreatitis, ischemia-reperfusion injury, stroke, cardiovascular disease, and burn.
Inventor(s):	Chang; Chien-Hsing (Downingtown, PA), Hansen; Hans J. (Diamondhead, MS), Goldenberg; David M. (Mendham, NJ)
Assignee:	Immunomedics, Inc. (Morris Plains, NJ)
Application Number:	15/887,488
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,040,848

Introduction

Understanding the claims and patent landscape of a specific patent is crucial for businesses, inventors, and legal professionals. This analysis will delve into the details of United States Patent 10,040,848, examining its claims, the broader patent landscape, and the implications of recent legal and administrative developments.

Understanding the Patent Claims

To analyze the patent claims of US Patent 10,040,848, it is essential to break down the invention into its core components.

Claim Structure

Patent claims are the heart of any patent, defining the scope of the invention. For US Patent 10,040,848, each claim must be scrutinized to determine what is being patented. Here are some key aspects to consider:

• Claim Types: Are the claims directed to processes, machines, manufactures, or compositions of matter? These categories are defined under Section 101 of the Patent Act[1].
• Claim Specificity: How specific are the claims? Overly broad claims may face challenges under the Alice/Mayo test, which requires that claims not be directed to abstract ideas, laws of nature, or natural phenomena without an inventive concept[1][3].

Patent-Eligible Subject Matter

The patent-eligible subject matter is a critical factor in determining the validity of the patent claims.

Judicial Developments

Recent judicial decisions have significantly impacted what can be patented. The Supreme Court's decisions in cases like Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., and Association for Molecular Pathology v. Myriad Genetics have narrowed the scope of patent-eligible subject matter. These decisions have broadened the judicially developed exceptions to patent-eligible subject matter, making it more challenging for certain types of inventions to be patented[1].

The Alice/Mayo Test

The Alice/Mayo test is a two-step framework used to determine if a patent claim is eligible under Section 101 of the Patent Act. First, it must be determined if the claim is directed to an ineligible concept (e.g., an abstract idea). If so, the second step assesses whether the claim contains an inventive concept that transforms the nature of the claim into a patent-eligible application[1][3].

Patent Landscape Analysis

A comprehensive patent landscape analysis provides strategic insights into the technological and competitive environment surrounding the patent.

Geographical Spread and Saturation

• Geographical Spread: Where are the key players and patents in this technology area located? Understanding the geographical distribution can help identify potential partners, competitors, and markets[4].
• Saturation Level: How saturated is the patent space? High saturation can indicate a mature technology area with limited room for new entrants, while low saturation might suggest opportunities for innovation and investment[4].

Competitor Analysis

Identifying key competitors and their patent portfolios is essential.

• Known Competitors: Who are the established players in this technology area? Analyzing their patent portfolios can reveal trends, strengths, and weaknesses[4].
• New Entrants: Are there new companies entering this patent space? New entrants can bring fresh ideas and innovations, but they may also face significant barriers to entry[4].

Time-Slicing and Trends

• Time-Slicing: How have patent filings in this area changed over time? This can help identify emerging trends and areas where innovation is accelerating or slowing down[4].
• Niche Areas: Are there underappreciated niche areas within the broader technology space? Identifying these niches can provide opportunities for focused innovation and market differentiation[4].

Impact of Recent Administrative and Legislative Developments

USPTO Guidance

The USPTO's 2019 Guidance on patent subject matter eligibility has had a significant impact on the patent landscape. This guidance aimed to clarify how to apply the Alice/Mayo framework, particularly for computer-related inventions. The guidance has been seen as lowering the barriers to patentability under Section 101, especially for AI-related inventions[1].

Patent Trial and Appeal Board (PTAB)

The PTAB, established by the Leahy-Smith America Invents Act (AIA), provides a faster and less expensive way to challenge patent validity compared to federal court litigation. This can affect the strategic decisions around patent prosecution and enforcement, as entities can use inter partes review (IPR) and post-grant review (PGR) to challenge patents more efficiently[3].

Stakeholder Views and Industry Impact

AI and Emerging Technologies

The patentability of AI inventions is a contentious issue. Despite an increase in AI-related patent applications, stakeholders have expressed concerns that these inventions may be at risk of patent ineligibility under the current framework. The USPTO's analysis suggests that the Alice/Mayo framework has differentially impacted AI technologies, highlighting the need for clear guidance and potential legislative reforms[1].

Legislative Initiatives

There have been calls for legislative reforms to clarify and potentially broaden the scope of patent-eligible subject matter. Introduced legislation in the 117th and 118th Congresses reflects ongoing efforts to address concerns over the impact of current patent subject matter eligibility standards on innovation[1].

Case Law and Judicial Precedents

Recent Court Decisions

Decisions like Electric Power Group, LLC v. Alstom S.A. and In re Cellect illustrate the ongoing judicial scrutiny of patent claims under Section 101. These cases emphasize the importance of ensuring that patent claims are not directed to ineligible concepts and that they contain an inventive concept to be patentable[2][5].

Strategic Implications

Investment and Innovation

The patent landscape and the eligibility of subject matter can significantly influence investment decisions in technology. A clear and predictable patent system is crucial for encouraging innovation, especially in emerging fields like AI and biotechnology[1].

Competitive Strategy

Understanding the patent landscape helps companies develop competitive strategies. By identifying gaps, trends, and competitor activities, businesses can make informed decisions about research and development, patent prosecution, and market entry[4].

Key Takeaways

• Patent Claims: The specificity and structure of patent claims are critical in determining their validity under Section 101.
• Judicial and Administrative Developments: Recent judicial decisions and USPTO guidance have significantly impacted what can be patented, particularly affecting AI and computer-related inventions.
• Patent Landscape Analysis: A comprehensive analysis helps identify trends, competitors, and opportunities within the technology space.
• Stakeholder Views: There is ongoing debate about the impact of current patent subject matter eligibility standards on innovation, with calls for legislative reforms.
• Strategic Implications: A clear understanding of the patent landscape is essential for making informed investment and competitive strategy decisions.

FAQs

1. What is the Alice/Mayo test, and how does it affect patent eligibility? The Alice/Mayo test is a two-step framework used to determine if a patent claim is eligible under Section 101 of the Patent Act. It first determines if the claim is directed to an ineligible concept (e.g., an abstract idea) and then assesses whether the claim contains an inventive concept that transforms the nature of the claim into a patent-eligible application[1][3].

2. How has the USPTO's 2019 Guidance impacted patent eligibility for AI inventions? The USPTO's 2019 Guidance has been seen as lowering the barriers to patentability under Section 101, especially for AI-related inventions. It has led to an increase in the allowance rate for patent applications containing AI[1].

3. What is the role of the Patent Trial and Appeal Board (PTAB) in challenging patent validity? The PTAB provides a faster and less expensive way to challenge patent validity compared to federal court litigation through inter partes review (IPR) and post-grant review (PGR)[3].

4. How does patent landscape analysis help in making strategic decisions? Patent landscape analysis provides insights into the technological and competitive environment, helping companies identify trends, competitors, and opportunities. It guides decisions on research and development, patent prosecution, and market entry[4].

5. What are the implications of recent judicial decisions on patent eligibility? Recent judicial decisions have emphasized the importance of ensuring that patent claims are not directed to ineligible concepts and that they contain an inventive concept to be patentable. This has narrowed the scope of what can be patented, particularly affecting AI and computer-related inventions[1][2][5].

Sources Cited

1. Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024.
2. United States Court of Appeals for the Federal Circuit. Electric Power Group, LLC v. Alstom S.A. August 1, 2016.
3. Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024.
4. AcclaimIP. Patent Landscape Analysis - Uncovering Strategic Insights.
5. United States Court of Appeals for the Federal Circuit. In re Cellect. August 28, 2023.

Details for Patent 10,040,848

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	January 10, 1978	10,040,848	2033-02-15
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015	10,040,848	2033-02-15