Patent: 8,557,256

Summary for Patent: 8,557,256

Title:	Treatment for cervical dystonia with the neurotoxic component of a botulinum toxin
Abstract:	A method and composition for treating a patient suffering from a disease, disorder or condition and associated pain include the administration to the patient of a therapeutically effective amount of a neurotoxin selected from a group consisting of Botulinum toxin types A, B, C, D, E, F and G.
Inventor(s):	Aoki; Kei Roger (Coto De Caza, CA), Grayston; Michael W. (Irvine, CA), Carlson; Steven R. (San Mateo, CA), Leon; Judith M. (San Juan Capistrano, CA)
Assignee:	Allergan, Inc. (Irvine, CA)
Application Number:	10/460,898
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 8,557,256

Introduction

United States Patent 8,557,256, hereafter referred to as the '256 patent, is a utility patent that was granted by the U.S. Patent and Trademark Office (USPTO). To provide a comprehensive and critical analysis, we need to delve into the specifics of the patent, its claims, and the broader patent landscape in which it exists.

Background on the Patent

Patent Details

• Patent Number: 8,557,256
• Grant Date: This information is not provided in the sources, but it can be found through the USPTO database.
• Inventors and Assignees: The inventors and assignees are crucial for understanding the ownership and potential applications of the patent. Typically, this information includes the names of the inventors and the companies or individuals to whom the patent is assigned[1].

Claims Analysis

Claim Structure

Patent claims are the heart of any patent, defining the scope of protection granted by the patent. The '256 patent would include a set of claims that describe the invention in detail. These claims are categorized into independent and dependent claims.

• Independent Claims: These claims stand alone and define the invention without reference to other claims. They are crucial for determining the scope of the patent.
• Dependent Claims: These claims refer back to and further limit the independent claims, often adding specific details or features to narrow the scope[3].

Subject Matter Eligibility

The subject matter eligibility of the '256 patent would be evaluated under 35 U.S.C. § 101, which determines whether the invention falls within one of the four statutory categories: processes, machines, manufactures, or compositions of matter. The 2024 Guidance Update on AI inventions emphasizes the importance of demonstrating practical applicability and a specific, concrete technological advancement to overcome section 101 rejections[2].

Patent Landscape

Technological Field

The '256 patent would be classified under one of the 35 technical fields described by the World Intellectual Property Organization (WIPO). This classification helps in understanding the broader technological area in which the patent operates. For example, if the patent falls under electrical engineering, it would be part of a field that has seen significant growth, particularly in areas like computer technology and digital communication[1].

Industry Trends

The industry trends in the technological field of the '256 patent are crucial for understanding its relevance and potential impact. For instance, if the patent is in the computer and electronics manufacturing industry, it would be part of a sector that has seen rapid growth in patenting activity and R&D expenditures. This sector received nearly 30,000 utility patents in 2017 alone, with domestic R&D expenditures reaching about $79 billion[1].

Patenting Activity and R&D Expenditures

Historical Context

The number of patents granted in the technological field of the '256 patent has likely followed broader trends. For example, between 2002 and 2017, patents issued to U.S. firms almost doubled, reflecting an increased importance of intellectual property protection, especially in digitizable information[1].

Industry-Specific Trends

High R&D industries generally have high rates of patenting. The computer systems design and related services industry, for instance, shows relatively high levels of U.S. patenting, even though other industries may outspend it in domestic R&D[1].

Challenges and Validity

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

The '256 patent, like any other patent, could be subject to administrative challenges such as IPR and PGR through the Patent Trial and Appeal Board (PTAB). These procedures, established by the Leahy-Smith America Invents Act (AIA), allow parties to challenge the validity of an already-issued patent in an administrative forum, which can be more efficient and less costly than litigation in federal court[4].

Subject Matter Eligibility Challenges

Given the evolving landscape of patent subject matter eligibility, the '256 patent might face challenges under section 101. The USPTO's two-pronged framework, as outlined in the 2019 Revised Patent Subject Matter Eligibility Guidance, would be crucial in determining whether the patent claims are directed to ineligible subject matter and whether they contain an "inventive concept" to overcome such challenges[4].

Legal and Jurisprudential Context

Federal Circuit and Supreme Court Precedents

The validity and scope of the '256 patent would be influenced by Federal Circuit and Supreme Court decisions. For example, the Federal Circuit has warned that the USPTO’s guidance on patent subject matter eligibility is not binding and that judicial precedents must control in cases of conflict[2].

Design Patents and Recent Jurisprudence

If the '256 patent involves design elements, recent decisions by the U.S. Court of Appeals for the Federal Circuit (CAFC) on design patent jurisprudence would be relevant. These decisions could impact how prior art is compared in infringement analyses and whether the design patent obviousness analysis needs modification[5].

Practical Implications

Enforcement and Litigation

The '256 patent's practical implications would depend on its enforcement and potential litigation. Patents carry a presumption of validity, but challenging their validity in court or through PTAB proceedings can be time-consuming and costly. Effective enforcement requires strong claims that are resistant to invalidity challenges[4].

Licensing and Commercialization

The commercial value of the '256 patent would depend on its licensing and commercialization potential. Patents in high R&D industries often have significant commercial value, especially if they represent a specific, concrete technological advancement[2].

Key Takeaways

• Claims Analysis: The '256 patent's claims define its scope and are crucial for determining its validity and enforceability.
• Subject Matter Eligibility: The patent must comply with section 101 requirements, demonstrating practical applicability and a specific technological advancement.
• Industry Trends: The patent's technological field and industry trends influence its relevance and potential impact.
• Challenges and Validity: The patent could face administrative challenges like IPR and PGR, and its validity would be influenced by judicial precedents.
• Commercial Value: The patent's commercial value depends on its licensing and commercialization potential, as well as its enforcement and litigation history.

FAQs

Q: What is the significance of the 2024 Guidance Update for AI inventions? A: The 2024 Guidance Update clarifies that AI inventions are patentable and emphasizes the importance of demonstrating practical applicability and a specific, concrete technological advancement to overcome section 101 rejections[2].

Q: How does the Patent Trial and Appeal Board (PTAB) impact patent validity? A: PTAB allows parties to challenge the validity of an already-issued patent in an administrative forum, providing an alternative to costly and time-consuming federal court litigation[4].

Q: What are the key elements of a patent claim? A: Patent claims include independent and dependent claims, with independent claims defining the invention and dependent claims further limiting the independent claims[3].

Q: How do industry trends affect the value of a patent? A: Industry trends, particularly in high R&D sectors, can significantly impact the value and relevance of a patent. Patents in growing technological fields tend to have higher commercial value[1].

Q: What is the role of the Federal Circuit in patent law? A: The Federal Circuit plays a crucial role in interpreting patent law and setting precedents that influence the validity and scope of patents. Their decisions can override USPTO guidance in cases of conflict[2].

Details for Patent 8,557,256

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	December 08, 2000		2013-12-28