Patent: 10,076,557

Summary for Patent: 10,076,557

Title:	Botulinum toxin therapy for skin disorders
Abstract:	Methods for treating skin disorders by local administration of a Clostridial toxin, such as a botulinum toxin, to a patient with a skin disorder.
Inventor(s):	First; Eric R. (Morristown, NJ)
Assignee:	Allergan, Inc. (Irvine, CA)
Application Number:	14/493,756
Patent Claims:	see list of patent claims

Understanding the Complexities of Patent Claims and the US Patent Landscape: A Comprehensive Analysis

Introduction

The world of patents is intricate and ever-evolving, with thousands of applications filed every year at the United States Patent and Trademark Office (USPTO). This article delves into the complexities of patent claims, the current patent landscape, and the critical factors influencing the granting and assertion of patents, using the context of a specific patent as a case study.

The Growing Number of Patent Applications

The number of patent applications has seen a significant increase over the years. From approximately 100,000 applications per year in the 1960s and 1970s, the number jumped to 326,508 in 2001 alone[2]. This growth is driven by technological innovation and facilitated by advancements in technology such as word processing and remote electronic database searching.

The Complexity of Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention. The number of claims per patent has also increased, with some applications including hundreds or even thousands of claims. For instance, the maximum number of claims identified in a single patent application is 7,976[2].

Automated Systems for Claims Analysis

To manage the vast number of claims, automated systems like the Patent Claims Analysis System have been developed. These systems automate the import, parsing, and hierarchical arrangement of claims, making it easier to review and analyze patent claims[2].

Patent Allowance Rates and Continuation Procedures

Calculating patent allowance rates is complex due to the various continuation procedures that can be filed after an initial rejection. There are three key measures of patent allowance rates:

• First-action allowance rate: The proportion of progenitor applications allowed without further examination.
• Progenitor allowance rate: The proportion of progenitor applications allowed without any continuation procedure.
• Family allowance rate: The proportion of progenitor applications that produce at least one patent, including the outcomes of continuation applications[1].

Continuation procedures, such as Requests for Continued Examination (RCEs) and serialized continuations, can significantly impact the allowance rates. For example, 31% of progenitor applications utilize at least one continuation procedure, and 15.8% result in at least one serialized continuation[1].

The Role of AI in Patent Applications

The use of Artificial Intelligence (AI) in drafting and editing patent applications is becoming more prevalent. However, the USPTO has issued guidance emphasizing the need for practitioners to review and verify the accuracy of documents generated or assisted by AI tools. This includes ensuring that AI-generated content does not introduce inaccurate statements or omit material information[3].

Disclosure Requirements

If AI tools are used in a way that is material to patentability, their use must be disclosed to the USPTO. This includes situations where AI assists in drafting alternative embodiments or contributes to the specification and claims in a way that could affect inventorship[3].

Patent Assertion Entities (PAEs)

PAEs play a significant role in the patent landscape, particularly in asserting patents against alleged infringers. There are two main types of PAEs:

• Portfolio PAEs: These entities negotiate licenses covering large portfolios of patents without necessarily litigating. They generate significant revenue, often in the millions of dollars.
• Litigation PAEs: These entities frequently litigate to enforce their patents, with a high percentage of licenses following patent infringement suits[4].

PAEs primarily focus on Information and Communication Technology (ICT) and software patents, asserting these patents against a broad range of industries, including retail trade[4].

Patent Eligibility and Legal Precedents

The eligibility of patent claims is scrutinized under legal precedents such as the Alice test. This test involves determining whether the claims are directed to an abstract idea and, if so, whether they contain an inventive concept that transforms the abstract idea into a patent-eligible invention. For example, in the case of Electric Power Group, LLC v. Alstom S.A., the claims were found to fail the Alice test because they did not go beyond requiring the collection, analysis, and display of available information in a particular field without limiting them to technical means for performing the functions[5].

Case Study: United States Patent 10,076,557

To illustrate the complexities and considerations in patent claims and the patent landscape, let's consider a hypothetical analysis of United States Patent 10,076,557.

Claim Structure and Scope

The claims of this patent would need to be carefully analyzed to determine their scope and whether they meet the criteria for patent eligibility. This involves examining the hierarchical structure of the claims, identifying independent and dependent claims, and ensuring that the claims are specific and not overly broad.

Continuation Procedures and Allowance Rates

If this patent resulted from a progenitor application that underwent continuation procedures, understanding the impact of these procedures on the allowance rate would be crucial. This includes tracking any RCEs or serialized continuations that may have been filed.

Use of AI Tools

If AI tools were used in drafting or editing the patent application, it would be essential to disclose this to the USPTO and ensure that the contributions made by AI do not affect the inventorship or the accuracy of the claims.

Assertion and Litigation

If the patent is held by a PAE, understanding the business model of the PAE (whether it is a Portfolio PAE or a Litigation PAE) would be important. This could influence how the patent is asserted and whether litigation is likely.

Key Takeaways

• Increasing Complexity: The number of patent applications and claims is increasing, making the review and analysis process more complex.
• Role of AI: AI tools can assist in patent applications but require careful review to ensure accuracy and compliance with USPTO guidelines.
• Continuation Procedures: Understanding continuation procedures is crucial for calculating patent allowance rates and tracking the lifecycle of a patent application.
• PAEs: PAEs play a significant role in patent assertion, with different models influencing how patents are enforced.
• Legal Precedents: Ensuring that patent claims meet legal precedents such as the Alice test is essential for maintaining patent eligibility.

FAQs

What is the significance of continuation procedures in patent applications?

Continuation procedures, such as RCEs and serialized continuations, can significantly impact the allowance rates of patent applications and complicate the calculation of these rates.

How do AI tools affect patent applications?

AI tools can assist in drafting and editing patent applications but must be reviewed carefully to ensure accuracy and compliance with USPTO guidelines. Their use must also be disclosed if material to patentability.

What are the different types of PAEs and how do they operate?

There are two main types of PAEs: Portfolio PAEs, which negotiate licenses without litigating, and Litigation PAEs, which frequently litigate to enforce their patents.

What is the Alice test, and how does it impact patent claims?

The Alice test is a legal precedent used to determine whether patent claims are directed to an abstract idea and whether they contain an inventive concept that transforms the abstract idea into a patent-eligible invention.

Why is the hierarchical structure of patent claims important?

The hierarchical structure of patent claims is important because it helps in understanding the scope of the invention, identifying independent and dependent claims, and ensuring that the claims are specific and not overly broad.

Sources

1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
2. US20110138338A1 - Patent Claims Analysis System and Method. (n.d.). Google Patents. Retrieved from https://patents.google.com/patent/US20110138338A1/en
3. U.S. Patent Office Issues Additional Guidance on Use of AI Tools. (2024, April 15). Buchanan Ingersoll & Rooney PC. Retrieved from https://www.bipc.com/united-states-patent-office-issues-guidance-on-use-of-ai-tools
4. Patent Assertion Entity Activity: An FTC Study. (n.d.). Federal Trade Commission. Retrieved from https://www.ftc.gov/system/files/documents/reports/patent-assertion-entity-activity-ftc-study/p131203_patent_assertion_entity_activity_an_ftc_study_0.pdf
5. Electric Power Group, LLC v. Alstom S.A.. (2016, July 28). United States Court of Appeals for the Federal Circuit. Retrieved from https://cafc.uscourts.gov/opinions-orders/15-1778.opinion.7-28-2016.1.pdf

Details for Patent 10,076,557

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Solstice Neurosciences, Llc	MYOBLOC	rimabotulinumtoxinb	Injection	103846	December 08, 2000	10,076,557	2023-12-09