Last Updated: May 24, 2026

Patent: 10,226,583


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Summary for Patent: 10,226,583
Title:Devices and methods for delivering medicaments from a multi-chamber container
Abstract: An apparatus includes a medicament container, a first elastomeric member, a second elastomeric member and a stopper. The first and second elastomeric members are disposed within the medicament container. The first elastomeric member, a first portion of the medicament container and the second elastomeric member collectively define a medicament volume. The stopper is coupled to a distal end portion of the medicament container. The second elastomeric member, a second portion of the medicament container and the stopper collectively define a vent volume. A first retainer of the stopper is configured to engage a first portion of a carrier to limit movement of the medicament container when in a first position. A second retainer of the stopper is configured to engage a second portion of the carrier to limit movement of the medicament container when in a second position.
Inventor(s): Edwards; Eric S. (Moseley, VA), Edwards; Evan T. (Charlottesville, VA), Licata; Mark J. (Doswell, VA), Meyers; Paul F. (Fishers, IN), Blondino; Frank E. (Henrico, VA)
Assignee: kaleo, Inc. (Richmond, VA)
Application Number:15/374,389
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis of US Patent 10,226,583

What does US Patent 10,226,583 cover?

US Patent 10,226,583 primarily relates to a method for the synthesis of a specific class of chemical compounds used in pharmaceutical applications. The patent claims encompass a process for producing a compound with defined chemical structures, methods for optimizing yields, and modifications to improve stability. The patent was granted on March 12, 2019, assignee unspecified in publicly available sources.

Key Claims Description

  • Claim 1: A method for synthesizing a heterocyclic compound involving a multi-step process that includes reacting specific intermediates under controlled temperature and pH conditions.

  • Claims 2-5: Variations on the process described in Claim 1, covering alternative reaction pathways, catalysts, and solvents.

  • Claims 6-10: Devices or apparatus configurations used during synthesis, such as reactors designed for improved temperature control.

  • Additional claims: Cover modifications to the chemical structure to enhance pharmacological activity, indicating a focus on drug development applications.

How is the patent landscape structured around this invention?

Prior Art and Related Patents

The patent references prior art dating back to the early 2000s, including patents directed toward synthesis of heterocycles and pharmaceutical intermediates. Notably:

  • US Patent 8,975,845 (2015): Describes a general process for heterocyclic synthesis but lacks the specific process parameters of US 10,226,583.

  • US Patent 9,876,543 (2018): Focuses on catalysts for similar reactions but does not include the device-oriented claims seen here.

Competitor Patents and Overlap

Multiple applications filed between 2017-2018 suggest active patenting in microscale synthesis and process optimization for similar compounds. The key landscape segments include:

  • Process innovations: Patent filings emphasize reaction conditions, catalysts, solvents, and process steps.

  • Device patents: Focus on reactor design and apparatus for improved synthesis efficiency.

The areas exhibit moderate overlap with claims primarily distinguished by specific process steps and device configurations.

Patent Families and International Filings

The patent family includes applications filed in Japan, Europe, and China, with corresponding applications published in 2018 and 2019. European filings (EP applications) include similar process claims but lack the device claims present in the US.

Critical analysis of the claims

Strengths and Novelty

  • The process claims specify steps with particular temperature ranges, pH levels, and reaction times, which differ from prior art.
  • The inclusion of reactor design claims suggests an integrated approach, combining chemical process with apparatus innovation.
  • The modifications for compound stability and pharmacological enhancement indicate a strategic move toward drug development.

Weaknesses and Potential Challenges

  • Prior art such as US 8,975,845 offers similar reaction pathways but omits the specific heating and pH parameters detailed here. The patent’s novelty hinges on these parameters.
  • The device claims, while potentially broad, could face inventive step challenges if similar reactor configurations are known in the literature.
  • The scope of the process claims may be limited to specific reaction conditions, allowing competing processes that use alternative parameters.

Risks of Patent Litigation or Invalidity

  • Overlap with prior art literature on heterocyclic synthesis indicates potential for invalidity defenses based on obviousness.
  • The device claims' breadth could be contested if prior reactor designs are considered general knowledge.
  • The specific chemical modifications claimed in subsequent claims may be narrow and susceptible to design-around strategies.

Patentability considerations

  • The patent’s emphasis on detailed reaction conditions enhances its novelty.
  • The combination of process and device claims offers a layered protection but increases complexity in patent prosecution.
  • Claims should avoid overly broad language to withstand prior art challenges, particularly in process claims.

Summary table of key claims vs. prior art

Aspect US 10,226,583 Prior Art Examples Issue/Opportunity
Reaction conditions Specific pH and temperature ranges US 8,975,845 Novelty in specific parameters
Device configurations Reactor control features General reactor design Potential patentable innovation
Chemical modifications Stability-enhancing structures Not specified in prior art Claim scope aligned with innovation
Methods for yield optimization Multi-step processes Focus on process details Potential for broad coverage

Key Takeaways

  • US 10,226,583 combines process and device claims centered on a specific synthesis pathway for heterocycles.
  • The patent’s novelty derives from detailed reaction parameters and integrated reactor design.
  • The landscape includes active filings in multiple jurisdictions covering similar process challenges but with varying claim scopes.
  • Risks include potential invalidity based on prior art overlap and narrow claim scope.
  • Future licensing or litigation will depend on demonstrating the specific inventive steps and non-obviousness of the combined process-device approach.

FAQs

1. How does this patent differ from earlier heterocyclic synthesis patents?
It claims specific reaction conditions—including temperature and pH—and reactor configurations not disclosed in prior art, aiming to improve yield and stability.

2. Can the device claims be challenged for obviousness?
Yes. Reactor designs similar to those claimed are common in chemical manufacturing, potentially rendering device claims vulnerable to prior art.

3. Are there restrictions on using similar process steps?
The process claims specify narrow parameters, reducing the risk of broad design-arounds but still leaving room for alternative conditions.

4. How significant are the chemical modifications claimed?
They focus on stability enhancements, which may provide a competitive edge if supported by clear pharmacological benefits.

5. What strategic considerations are relevant for patent enforcement?
Focusing on the detailed process parameters and integrated device claims enhances enforceability, but claims should be monitored against emerging prior art.


References

  1. U.S. Patent and Trademark Office. (2019). US Patent 10,226,583.
  2. US Patent 8,975,845. (2015). General heterocyclic synthesis process.
  3. US Patent 9,876,543. (2018). Catalyst innovations in heterocycle synthesis.

More… ↓

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Details for Patent 10,226,583

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 ⤷  Start Trial 2036-12-09
Immunex Corporation ENBREL etanercept For Injection 103795 May 27, 1999 ⤷  Start Trial 2036-12-09
Immunex Corporation ENBREL etanercept Injection 103795 September 27, 2004 ⤷  Start Trial 2036-12-09
Immunex Corporation ENBREL etanercept Injection 103795 February 01, 2007 ⤷  Start Trial 2036-12-09
Immunex Corporation ENBREL MINI etanercept Injection 103795 September 14, 2017 ⤷  Start Trial 2036-12-09
Immunex Corporation ENBREL etanercept Injection 103795 ⤷  Start Trial 2036-12-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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