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Last Updated: April 25, 2025

Patent: 11,426,520


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Summary for Patent: 11,426,520
Title:Medicament delivery devices for administration of a medicament within a prefilled syringe
Abstract:An apparatus includes a housing, a medicament container and a movable member. The medicament container is movable within the housing between a first position and a second position in response to a force produced by an energy storage member. A proximal end portion of the medicament container includes a flange and has a plunger disposed therein. A first shoulder of the movable member exerts the force on the flange to move the medicament container from the first position to the second position. A portion of the first shoulder deforms when the medicament container is in the second position such that at least a portion of the force is exerted upon the plunger. A second shoulder of the movable member exerts a retraction force on the flange to move the medicament container from the second position towards the first position.
Inventor(s):Edwards Eric S., Edwards Evan T., Licata Mark J., Meyers Paul F.
Assignee:kaleo, Inc.
Application Number:US16504725
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 11,426,520

Introduction

When analyzing a patent, particularly one like United States Patent 11,426,520, it is crucial to delve into the specifics of the claims, the broader patent landscape, and the legal and technical implications surrounding it. This analysis will help business professionals and inventors understand the patent's strengths, weaknesses, and its position within the intellectual property ecosystem.

Understanding the Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention and what is protected by the patent. Here are some key points to consider:

Independent and Dependent Claims

  • Independent claims stand alone and define the invention without reference to other claims. They are critical because they set the broadest scope of protection for the invention[2].
  • Dependent claims, on the other hand, refer back to and further limit the independent claims. They often provide additional details or specific embodiments of the invention.

Claim Structure and Analysis

  • The structure of the claims in U.S. Patent 11,426,520 should be examined to understand how the independent and dependent claims interact. This includes identifying the key elements and sub-elements of each claim.
  • Tools like the patent claims analysis system described in U.S. Patent 9,922,383 can be useful for visualizing and analyzing the claim structure, helping to identify potential areas of infringement or overlap with other patents[2].

Patent Family and Continuations

Understanding the patent family and any continuations or continuations-in-part is vital:

Continuations and Continuations-in-Part

  • Continuations and continuations-in-part are used to file additional patent applications based on an earlier application. This can extend the life of the patent and allow for additional claims to be added[1].
  • For example, in the case of In re Cellect, the patents were continuations-in-part of earlier patents, which affected their patent term adjustments and obviousness-type double patenting (ODP) analyses[1].

Impact on Patent Term

  • The patent term adjustment (PTA) and any terminal disclaimers can significantly impact the expiration date of the patent. Ensuring that ODP analyses are performed considering these adjustments is crucial to avoid extending the patent term beyond what is legally permissible[1].

Obviousness-Type Double Patenting (ODP)

ODP is a critical issue that must be addressed:

Definition and Implications

  • ODP prevents an inventor from securing a second, later-expiring patent for an invention that is obvious in light of an earlier patent. This is particularly relevant for patents within the same family[1].

Legal Precedents

  • Cases like In re Cellect highlight the importance of performing ODP analyses after any PTA has been granted. This ensures that the patent term is not extended beyond what is legally allowed[1].

Use of AI Tools in Patent Drafting

The increasing use of AI tools in patent drafting raises several issues:

Disclosure Requirements

  • If AI tools are used in drafting the patent application, especially if they introduce alternative embodiments not conceived by the inventors, this must be disclosed to the USPTO. This is to ensure that the contributions of natural persons meet the criteria for inventorship[3].

Verification of Accuracy

  • Practitioners must verify the accuracy of all documents prepared with the assistance of AI to avoid introducing inaccurate statements or omitting material information[3].

Advanced Patent Searching Techniques

Conducting a comprehensive patent search is essential for understanding the patent landscape:

Claims Variation

  • Claims can vary significantly across related patents within a patent family due to amendments during the prosecution process. This variation must be accounted for when searching and analyzing patents[4].

Prior Art and Infringement Analysis

  • Advanced tools and techniques are necessary to identify prior art and potential infringement. This includes real-time analysis of claims to determine infringement by competitors[2].

Determining Inventorship

Proper inventorship is a critical aspect of patent law:

Conception Step

  • Inventorship is determined primarily by the conception step, which involves the formation of a definite and permanent idea of the complete and operative invention. Only those who conceived the idea or made a working example of the claimed invention should be listed as inventors[5].

Ordinary Skill Requirement

  • The idea must be sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[5].

Legal and Equitable Considerations

When analyzing a patent, legal and equitable considerations are paramount:

Review Standards

  • Decisions by the Patent and Trademark Appeal Board (PTAB) or courts are reviewed under specific standards, such as whether the decision was arbitrary, capricious, or unsupported by substantial evidence[1].

Equitable Concerns

  • Equitable concerns, such as the fairness of the patent term adjustments and the impact of ODP, must be considered to ensure that the patent system is fair and does not unfairly extend patent terms[1].

Industry Expert Insights

Industry experts often provide valuable insights into the complexities of patent law and practice:

Practical Advice

  • Experts advise that practitioners should be cautious when using AI tools and ensure that all contributions are properly disclosed and verified. This helps in maintaining the integrity of the patent application process[3].

Statistics and Trends

Understanding current trends and statistics can provide context:

AI Adoption

  • The increasing use of AI in patent drafting and analysis is a significant trend. According to recent guidance, the use of AI must be disclosed and managed carefully to avoid legal issues[3].

Patent Filings

  • The number of patent filings and the complexity of patent families are on the rise, making comprehensive patent searches and analyses more critical than ever[4].

Key Takeaways

  • Claims Analysis: Thoroughly analyze the independent and dependent claims to understand the scope of protection.
  • Patent Family: Consider the impact of continuations and continuations-in-part on the patent term and ODP analyses.
  • ODP: Ensure that ODP analyses are performed after any PTA has been granted to avoid extending the patent term.
  • AI Tools: Disclose and verify the use of AI tools in patent drafting to maintain the integrity of the application.
  • Advanced Searching: Use advanced techniques to account for claims variation and identify prior art and potential infringement.
  • Inventorship: Determine inventorship based on the conception step and ensure that only those who conceived the idea are listed as inventors.

FAQs

Q: What is the significance of independent and dependent claims in a patent? A: Independent claims define the broadest scope of protection for the invention, while dependent claims further limit the independent claims and provide additional details.

Q: How does the use of AI tools affect patent applications? A: The use of AI tools must be disclosed if it is material to patentability, and practitioners must verify the accuracy of all documents prepared with AI assistance.

Q: What is obviousness-type double patenting (ODP), and why is it important? A: ODP prevents an inventor from securing a second, later-expiring patent for an invention that is obvious in light of an earlier patent, ensuring that the patent term is not unfairly extended.

Q: How do patent term adjustments (PTA) impact the expiration date of a patent? A: PTA can extend the patent term due to delays during prosecution, but ODP analyses must be performed considering these adjustments to avoid extending the term beyond what is legally permissible.

Q: What are the key considerations for determining inventorship in a patent application? A: Inventorship is determined by the conception step, requiring the identification of those who formed a definite and permanent idea of the complete and operative invention.

Sources

  1. In re Cellect, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. US9922383B2 - Patent claims analysis system and method, Google Patents.
  3. U.S. Patent Office Issues Additional Guidance on Use of AI Tools, Buchanan Ingersoll & Rooney PC, April 15, 2024.
  4. Advanced patent searching techniques, CAS.org, July 24, 2023.
  5. Determining Inventorship for US Patent Applications, Oregon State University.

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Details for Patent 11,426,520

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Genzyme Corporation CEREZYME imiglucerase For Injection 020367 May 23, 1994 11,426,520 2039-07-08
Genzyme Corporation CEREZYME imiglucerase For Injection 020367 September 22, 1999 11,426,520 2039-07-08
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 May 05, 2004 11,426,520 2039-07-08
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 December 02, 2004 11,426,520 2039-07-08
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 October 26, 2004 11,426,520 2039-07-08
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 11,426,520 2039-07-08
Amgen Inc. EPOGEN/PROCRIT epoetin alfa Injection 103234 June 01, 1989 11,426,520 2039-07-08
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 7 of 7 entries

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