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Last Updated: December 25, 2024

Patent: 10,406,278


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Summary for Patent: 10,406,278
Title:Unified drug mixer and dispenser
Abstract: A unified dispenser for holding, mixing, and dispensing a drug includes a housing holding a diluent reservoir, a drug reservoir, and a tubing set connecting and defining a fluid communication path therebetween. A first occlusion is at the diluent reservoir, and a second occlusion is at the drug reservoir. In a storage state of the dispenser, the first and second occlusions are entirely encased within the housing and occlude the fluid communication path. First and second pull assemblies extend outside the housing. The first and second pull assemblies are coupled to the first and second occlusions, respectively, so that removal of the first and second pull assemblies removes the first and second occlusions and joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set, thereby arranging the dispenser from the storage state to a use state.
Inventor(s): McNall, III; Ralph I. (Belmont, CA), Donze; Thomas T. (San Bruno, CA), MacDonell; Andrew M. (San Francisco, CA), Joshi; Serena (San Francisco, CA)
Application Number:15/687,393
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 10,406,278

Introduction

Patent 10,406,278, like any other patent, is subject to a complex set of rules and regulations that govern its validity, enforceability, and the landscape in which it operates. This analysis will delve into the critical aspects of patent claims, inventorship, and the broader patent landscape, using the framework provided by U.S. patent law and recent developments.

Understanding Patent Claims

Patent claims are the heart of any patent application, as they define the scope of the invention for which protection is sought. According to 35 U.S.C. § 112(b), the claims must "particularly point out and distinctly claim the subject matter" of the invention[2].

Definiteness Requirement

The definiteness requirement ensures that the claims inform those skilled in the art about the scope of the invention with "reasonable certainty." This means that each claim term must be unambiguous from the patent’s specification or other intrinsic evidence. AI techniques can be employed to analyze patent claim indefiniteness by processing the patent’s text to extract relevant information, such as undefined terms or vague measurements[2].

Determining Inventorship

Inventorship is a crucial aspect of patent law, as only the true and only inventors are entitled to a patent. The process involves two steps: conception of the idea and reduction to practice.

Conception of the Idea

Conception is the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention. This idea must be sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[1].

Reduction to Practice

While reduction to practice is an important step, it does not necessarily qualify someone as an inventor. Only those who conceived the subject matter of at least one claim of the patent are considered inventors. Technicians who simply perform experiments or reduce an invention to practice using ordinary skill are not inventors[1].

The Importance of Correct Inventorship

Correct inventorship is vital to ensure the patent remains enforceable. Errors in inventorship can be corrected, but if there is deceptive intent in naming inventors, the patent is invalid and unenforceable. A thorough job of invention disclosure can assure that a patent remains enforceable regardless of later challenges[1].

Patent Trial and Appeal Board (PTAB) and Inter Partes Review

The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the PTAB and the process of Inter Partes Review (IPR).

PTAB and IPR

PTAB provides a faster, cheaper, and more efficient means to adjudicate patent validity issues compared to federal court litigation. IPR allows anyone to challenge patents before the USPTO, and if successful, can cancel patent claims that should not have issued. This process is particularly advantageous for entities accused of patent infringement, as it requires a lower burden of proof to invalidate patents[3].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," play a significant role in the patent landscape. They can be categorized into two main types:

Portfolio PAEs

These entities negotiate licenses covering large portfolios of patents, often without first suing the alleged infringer. They generate significant revenue, typically in the millions of dollars, and are funded by investors[4].

Litigation PAEs

These entities typically sue potential licensees and settle shortly afterward with license agreements covering small portfolios. Their behavior is often consistent with nuisance litigation, as the licenses yield relatively low royalties compared to the costs of defending a patent infringement suit[4].

Impact on Innovation and Litigation

The activities of PAEs and the processes of PTAB and IPR have significant implications for innovation and litigation.

Reducing Unwarranted Litigation

The creation of PTAB and IPR was aimed at reducing unwarranted litigation costs and improving patent quality by weeding out poor-quality patents. However, critics argue that PTAB has made it too easy to challenge patents, creating uncertainty in patent rights and stifling innovation[3].

Promoting or Hindering Innovation

While PTAB and IPR aim to promote innovation by ensuring only high-quality patents are granted, some argue that these processes can hinder innovation by discouraging investments in patent-intensive industries. The balance between promoting innovation and reducing litigation remains a contentious issue[3].

Case Law and Judicial Precedents

Recent case law, such as the Alice/Mayo framework, has established a two-step test for determining patentable subject matter. This framework ensures that patent claims are not directed to ineligible subject matter, such as laws of nature, natural phenomena, or abstract ideas, unless they contain an "inventive concept" that transforms the nature of the ineligible concept[3].

AI in Patent Analysis

AI techniques are increasingly being used to analyze patent claims, particularly for indefiniteness. These tools can rapidly process a patent’s text to extract relevant information, providing insights about the patent much faster than manual analysis. This can help in identifying potential issues with the claims before they become contentious[2].

Key Takeaways

  • Patent Claims: Must be definite and distinctly claim the subject matter of the invention.
  • Inventorship: Focuses on the conception of the idea, and correct inventorship is crucial for the patent's enforceability.
  • PTAB and IPR: Provide efficient means to challenge patent validity, but their impact on innovation is debated.
  • PAEs: Can significantly influence the patent landscape through their assertion activities.
  • AI in Patent Analysis: Can assist in identifying potential issues with patent claims more efficiently.

FAQs

Q: What is the definiteness requirement for patent claims? A: The definiteness requirement ensures that patent claims inform those skilled in the art about the scope of the invention with "reasonable certainty," meaning each claim term must be unambiguous from the patent’s specification or other intrinsic evidence[2].

Q: Who is considered an inventor in U.S. patent law? A: An inventor is a person who conceives the subject matter of at least one claim of the patent. This can include individuals or collaborative efforts, but excludes those whose only contribution is reducing the invention to practice using ordinary skill[1].

Q: What is the role of PTAB in the patent landscape? A: PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents. It provides a faster and cheaper alternative to federal court litigation for adjudicating patent validity issues[3].

Q: How do PAEs impact the patent landscape? A: PAEs, or patent assertion entities, can significantly impact the patent landscape through their licensing and litigation activities. They can generate substantial revenue but are often criticized for engaging in nuisance litigation[4].

Q: How can AI be used in patent analysis? A: AI can be used to analyze patent claims for indefiniteness by processing the patent’s text to extract relevant information, such as undefined terms or vague measurements, providing insights much faster than manual analysis[2].

Sources

  1. Determining Inventorship for US Patent Applications - Oregon State University
  2. Using AI to Analyze Patent Claim Indefiniteness - Indiana University
  3. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service
  4. Patent Assertion Entity Activity: An FTC Study - Federal Trade Commission
"Conception is complete when an idea is sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation."[1]

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Details for Patent 10,406,278

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Pfizer Inc. ELELYSO taliglucerase alfa For Injection 022458 May 01, 2012 10,406,278 2036-02-11
Takeda Pharmaceuticals U.s.a., Inc. VPRIV velaglucerase alfa For Injection 022575 February 26, 2010 10,406,278 2036-02-11
Recordati Rare Diseases, Inc. PANHEMATIN hemin for injection For Injection 101246 July 20, 1983 10,406,278 2036-02-11
Amgen Inc. NEUPOGEN filgrastim Injection 103353 February 20, 1991 10,406,278 2036-02-11
Amgen Inc. NEUPOGEN filgrastim Injection 103353 June 28, 2000 10,406,278 2036-02-11
Partner Therapeutics, Inc. LEUKINE sargramostim For Injection 103362 March 05, 1991 10,406,278 2036-02-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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