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Last Updated: December 28, 2024

Patent: 8,293,229


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Summary for Patent: 8,293,229
Title:Methods of producing stable pancreatic enzyme compositions
Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.
Inventor(s): Ortenzi; Giovanni (Monza, IT), Marconi; Marco (Balsamo, IT), Mapelli; Luigi (Milan, IT)
Assignee: Aptalis Pharma Limited (Wicklow, IE)
Application Number:12/034,491
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Scope and Claims of United States Patent 8,293,229: A Detailed Analysis

Introduction

Patent 8,293,229, like any other patent, is a complex document that outlines the scope of protection for an invention. To analyze this patent, it is crucial to delve into its claims, the patent landscape, and the relevant legal and technical contexts.

Patent Claims: The Heart of the Patent

Claim Structure and Types

Patent claims are the legal definitions of the invention and define the scope of the patent protection. They are typically divided into independent and dependent claims. Independent claims stand alone and define the invention broadly, while dependent claims refer back to and further limit the independent claims[3].

Claim 1 of Patent 8,293,229

To analyze the scope of Patent 8,293,229, one must start with Claim 1, which is usually the broadest independent claim. This claim sets the foundation for understanding what the invention is and what it does. For example, if Claim 1 describes a method or system, it will outline the key elements and steps involved.

Dependent Claims

Dependent claims build upon the independent claims by adding additional limitations or features. These claims help to narrow down the scope and provide more specific details about the invention. By analyzing these claims, one can understand the various embodiments and variations of the invention.

Subject Matter Eligibility

The Alice Test and Judicial Exceptions

The eligibility of patent claims under 35 U.S.C. ยง 101 is a critical aspect. The Alice test, established by the Supreme Court, is used to determine whether a claim is directed to patent-eligible subject matter. This involves assessing whether the claim integrates a judicial exception (such as an abstract idea or a law of nature) into a practical application. The 2024 USPTO guidance update on AI patents emphasizes this point, highlighting the need for claims to demonstrate concrete technological improvements[1].

Practical Applications

For a claim to be patent-eligible, it must show a practical application that goes beyond mere abstract ideas. For instance, if a claim involves using a mathematical model, it must apply the data in a specific manner that improves technology or provides a practical application. This is illustrated in the 2024 USPTO guidance through examples such as Claim 2 in Example 48, which specifies the use of separated audio components in a real-time speech recognition system to enhance accuracy[1].

Patent Scope and Breadth

Metrics for Measuring Patent Scope

The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation and Litigation

The breadth of patent claims can influence innovation and litigation costs. Overly broad claims can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. Therefore, it is important to draft claims that are clear, specific, and narrowly tailored to the invention[3].

Inventorship and Ownership

Determining True and Only Inventors

Correctly identifying the inventors is crucial for the validity of a patent. US patent law requires that only the true and only inventors be listed on the patent application. Errors in inventorship can lead to the patent being unenforceable if there is deceptive intent. Ensuring accurate inventorship involves a thorough disclosure of the invention and the roles of each contributor[2].

Patent Landscape and Prior Art

Global Dossier and Public Search Facilities

To understand the patent landscape, tools like the Global Dossier and the USPTO Public Search Facility are invaluable. These resources provide access to file histories, patent families, and citation data, helping to identify prior art and related applications. This information is essential for assessing the novelty and non-obviousness of the invention[4].

Inter Partes Review (IPR) and Litigation

The patent landscape also includes the potential for inter partes review (IPR) and litigation. IPRs can challenge the validity of patent claims, and courts may stay litigation pending the outcome of such reviews. Understanding the legal precedents, such as those set by the Federal Circuit, is crucial for navigating these processes[5].

Claim Construction and Indefiniteness

Legal Standards and Judicial Review

Claim construction is a question of law reviewed de novo on appeal. The Federal Circuit has established that claim indefiniteness is also a legal conclusion, subject to de novo review. Ensuring that claims are clear and definite is vital to avoid issues of indefiniteness, which can render a patent invalid[5].

Real-World Applications and Benefits

Demonstrating Practical Utility

To bolster the argument for patent eligibility, it is essential to highlight the real-world applications and benefits of the claimed method or system. This involves demonstrating how the invention solves specific problems or provides concrete benefits in the relevant field. For example, in the context of AI inventions, specifying how the technology improves existing systems or solves particular challenges can make the claim more robust[1].

Key Takeaways

  • Subject Matter Eligibility: Claims must integrate judicial exceptions into practical applications to be patent-eligible.
  • Practical Applications: Specifying real-world applications and benefits is crucial for demonstrating patent eligibility.
  • Patent Scope: Metrics such as independent claim length and count can help measure the breadth and clarity of patent claims.
  • Inventorship: Accurate identification of true and only inventors is essential for patent validity.
  • Patent Landscape: Tools like the Global Dossier and Public Search Facilities are vital for understanding prior art and related applications.
  • Claim Construction: Ensuring clear and definite claims is critical to avoid issues of indefiniteness.

FAQs

Q: What is the significance of the Alice test in patent eligibility?

A: The Alice test is used to determine whether a claim is directed to patent-eligible subject matter by assessing whether it integrates a judicial exception into a practical application.

Q: How does the 2024 USPTO guidance update impact AI patent applications?

A: The update clarifies that AI-assisted inventions are evaluated on equal footing with other technologies, focusing on the claimed invention itself rather than the method of development.

Q: Why is accurate inventorship important in patent applications?

A: Accurate inventorship is crucial because errors, especially those made with deceptive intent, can render the patent unenforceable.

Q: What tools are available for searching and analyzing patent information?

A: Tools such as the Global Dossier and the USPTO Public Search Facility provide comprehensive access to patent and trademark information.

Q: How does claim construction impact the validity of a patent?

A: Claim construction is a question of law, and ensuring that claims are clear and definite is vital to avoid issues of indefiniteness, which can render a patent invalid.

Sources

  1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
  2. Determining Inventorship for US Patent Applications - Oregon State University
  3. Patent Claims and Patent Scope - SSRN
  4. Search for patents - USPTO
  5. VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC. - CAFC

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Details for Patent 8,293,229

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc. COTAZYM pancrelipase Capsule, Delayed Release 020580 December 09, 1996 ⤷  Subscribe 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 April 30, 2009 ⤷  Subscribe 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 June 10, 2011 ⤷  Subscribe 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 March 14, 2013 ⤷  Subscribe 2027-02-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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