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Last Updated: December 28, 2024

Patent: 8,562,978


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Summary for Patent: 8,562,978
Title:Stable digestive 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 (Cinisello Balsamo, IT), Mapelli; Luigi (Milan, IT)
Assignee: Aptalis Pharma Limited (Wicklow, IE)
Application Number:12/832,596
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 8,562,978

Introduction

United States Patent 8,562,978, like any other patent, is a complex document that requires a thorough analysis to understand its claims, validity, and position within the broader patent landscape. This analysis will delve into the key aspects of the patent, including its claims, subject matter eligibility, potential issues with double patenting, and the impact of recent USPTO guidance.

Understanding the Patent Claims

Claim Structure and Scope

To analyze the patent, it is crucial to start with the claims, which define the scope of the invention. Claims in a patent are divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.

Subject Matter Eligibility

The subject matter eligibility of the claims under 35 U.S.C. § 101 is a critical aspect. The USPTO uses a two-pronged framework, known as the Alice/Mayo test, to determine if claims are eligible for patent protection. This involves:

  • Prong One: Determining whether the claim is directed to a judicial exception (e.g., abstract ideas, natural phenomena, laws of nature).
  • Prong Two: Evaluating whether the claim elements, either individually or in combination, add enough to transform the nature of the claim into a patent-eligible application[2].

For AI-related inventions, the 2024 Guidance Update emphasizes the importance of demonstrating that the claims are directed to a specific, concrete technological advancement or solution to a technical problem under Prong Two[2].

Double Patenting Issues

Obviousness-Type Double Patenting (ODP)

Double patenting issues, particularly obviousness-type double patenting (ODP), can significantly impact the validity of a patent. ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a previously granted patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA)[1].

In the case of In re Cellect LLC, the Federal Circuit clarified that ODP analysis must consider the adjusted expiration date of the patent, including any PTA granted. This ensures that the patent term does not extend beyond the date of a terminal disclaimer, which is often used to overcome ODP rejections[1].

Impact of Recent USPTO Guidance

AI Inventions and Subject Matter Eligibility

Recent USPTO guidance, such as the 2024 Guidance Update, is crucial for understanding how AI-related inventions are treated. This guidance confirms that AI inventions are patentable if they meet the criteria of subject matter eligibility. Specifically, it emphasizes that the question of inventorship is not an issue as long as one or more persons made a significant contribution to the claimed invention[2].

Use of AI Tools in Patent Drafting

The USPTO has also issued guidance on the use of AI tools in drafting patent specifications and claims. Practitioners must ensure that any contributions made by AI systems are verified for accuracy and do not introduce inaccurate statements or omit material information[5].

Patent Term Adjustment and Terminal Disclaimers

PTA and Expiration Dates

Patent Term Adjustment (PTA) can extend the term of a patent due to delays in the USPTO's processing. However, when considering ODP, the adjusted expiration date, including any PTA, is crucial. This ensures that the patent term does not extend beyond what is legally permissible[1].

Terminal Disclaimers

Terminal disclaimers are often used to overcome ODP rejections by disclaiming the term of a later-expiring patent to ensure it does not extend beyond the term of an earlier-expiring patent. The Federal Circuit has clarified that terminal disclaimers and ODP analyses should be considered after any PTA has been granted[1].

Practical Applicability Analysis

Step 2A, Prong Two

For patents facing section 101 rejections, particularly those involving AI, a strong argument under Prong Two of the Alice/Mayo test is essential. This involves demonstrating that the claims are directed to a specific, concrete technological advancement or solution to a technical problem. For example, improvements in computer functionality or other technical fields can be critical in overcoming section 101 rejections[2].

Challenges in Patent Examination

Variability in Examiner Application

The application of the subject matter eligibility framework can vary among patent examiners. Some examiners may insist on specific improvements, such as data processing speed or memory capacity, while others may consider broader technical fields. This variability poses a challenge for applicants, who must craft arguments that are persuasive to different decision-makers[2].

Drafting and Presenting Effective Arguments

Understanding Examiner Perspectives

To successfully navigate section 101 rejections, it is vital to understand how the assigned patent examiner applies the subject matter eligibility analysis. This includes recognizing that different examiners may have different interpretations of the framework and tailoring arguments accordingly[2].

Role of Supervisory Patent Examiners

In some cases, the primary examiner may not be the main driving force behind the issuance of section 101 rejections. Supervisory patent examiners or section 101 specialists may instruct the examiner, making it necessary for applicants to craft arguments that are persuasive to these decision-makers[2].

Key Takeaways

  • Subject Matter Eligibility: Ensure that claims meet the criteria under 35 U.S.C. § 101, particularly by demonstrating practical applicability under Prong Two of the Alice/Mayo test.
  • Double Patenting: Be aware of ODP issues and ensure that any PTA and terminal disclaimers are properly considered to avoid extending the patent term beyond what is legally permissible.
  • AI Inventions: Understand the recent USPTO guidance on AI inventions, including the use of AI tools in drafting and the importance of human inventorship.
  • Patent Term Adjustment: Consider the impact of PTA on the expiration date of the patent and its implications for ODP analyses.

FAQs

Q: What is the significance of Prong Two in the Alice/Mayo test for AI inventions?

A: Prong Two is crucial for AI inventions as it requires demonstrating that the claims are directed to a specific, concrete technological advancement or solution to a technical problem, which helps in overcoming section 101 rejections[2].

Q: How does Patent Term Adjustment (PTA) affect the analysis of obviousness-type double patenting (ODP)?

A: PTA must be considered in ODP analyses to ensure that the patent term does not extend beyond the date of a terminal disclaimer, thus preventing an inventor from securing a second, later-expiring patent[1].

Q: Can AI systems contribute to the drafting of patent specifications and claims?

A: Yes, AI systems can contribute, but practitioners must verify the accuracy of these contributions and ensure they do not introduce inaccurate statements or omit material information[5].

Q: What is the role of terminal disclaimers in overcoming ODP rejections?

A: Terminal disclaimers are used to disclaim the term of a later-expiring patent to ensure it does not extend beyond the term of an earlier-expiring patent, thus overcoming ODP rejections[1].

Q: How do different patent examiners' interpretations affect the application of the subject matter eligibility framework?

A: Different examiners may apply the framework differently, so applicants must tailor their arguments to the specific examiner's perspective and any supervisory instructions they may be following[2].

Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, 2023.
  2. The Importance of Prong Two of Step 2A for AI Inventions, Baker Botts, 2024.
  3. Chisum on Patents, LexisNexis Store.
  4. Invention, Knowledge Transfer, and Innovation, National Science Foundation, 2022.
  5. U.S. Patent Office Issues Additional Guidance on Use of AI Tools, Buchanan Ingersoll & Rooney PC, 2024.

More… ↓

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Details for Patent 8,562,978

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 8,562,978 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 April 30, 2009 8,562,978 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 June 10, 2011 8,562,978 2027-02-20
Abbvie Inc. CREON pancrelipase Capsule, Delayed Release 020725 March 14, 2013 8,562,978 2027-02-20
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 May 17, 2012 8,562,978 2027-02-20
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 October 06, 2016 8,562,978 2027-02-20
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 8,562,978

Country Patent Number Estimated Expiration
South Africa 200905630 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2008102264 ⤷  Subscribe
United States of America 8562981 ⤷  Subscribe
United States of America 8562980 ⤷  Subscribe
United States of America 8562979 ⤷  Subscribe
United States of America 8293229 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration

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