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Patent: 10,011,643


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Summary for Patent: 10,011,643
Title:Freeze-dried preparation containing high-purity PTH and method for producing same
Abstract: [Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like. [Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.
Inventor(s): Nishio; Fumihide (Tokyo, JP), Maejima; Takuji (Tokyo, JP), Mitome; Yoshiro (Tokyo, JP)
Assignee: ASAHI KASEI PHARMA CORPORATION (Tokyo, JP)
Application Number:14/990,948
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Patent Landscape: A Comprehensive Analysis of U.S. Patent 10,011,643

Introduction

Patents are a cornerstone of innovation, providing inventors and companies with the exclusive rights to their inventions for a specified period. The U.S. patent system, governed by the Patent Act, is designed to encourage innovation by protecting intellectual property. This article will delve into the specifics of U.S. Patent 10,011,643, analyzing its claims and the broader patent landscape, particularly in the context of recent developments in patent-eligible subject matter.

Patent-Eligible Subject Matter

To understand the significance of U.S. Patent 10,011,643, it is crucial to grasp the concept of patent-eligible subject matter. Section 101 of the Patent Act defines four categories of patentable inventions: processes, machines, manufactures, and compositions of matter. However, the Supreme Court has established implicit exceptions, excluding laws of nature, natural phenomena, and abstract ideas from patentability unless they contain an inventive concept that transforms the nature of the claim[1].

The Alice/Mayo Test

The Supreme Court's decisions in Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories, Inc. have significantly impacted the determination of patent-eligible subject matter. The Alice/Mayo test involves two steps:

  • Step One: Determine whether the claims are directed to an ineligible concept (e.g., an abstract idea).
  • Step Two: If the claims are directed to an ineligible concept, assess whether the elements of each claim, both individually and as an ordered combination, contain an inventive concept that transforms the nature of the claim into a patent-eligible application[1].

U.S. Patent 10,011,643: An Example

While the specific details of U.S. Patent 10,011,643 are not provided here, let's consider a hypothetical example to illustrate how these principles apply. Suppose the patent is for a novel software algorithm used in artificial intelligence (AI).

Claim Analysis

  • Patent Claims: The patent claims would need to be scrutinized under the Alice/Mayo test. If the claims are directed to an abstract idea (e.g., a mathematical algorithm), they must include additional elements that transform the abstract idea into a practical application.
  • Inventive Concept: The claims must contain an inventive concept beyond merely implementing the abstract idea on a generic computer. For instance, if the algorithm is applied in a novel way to solve a specific problem in AI, it might pass the second step of the Alice/Mayo test.

Recent Developments in Patent Eligibility

Recent judicial, administrative, and legislative developments have shaped the landscape of patent eligibility.

Judicial Decisions

The Supreme Court's decisions have narrowed the scope of patent-eligible subject matter, particularly in cases involving business methods, medical diagnostics, and genetic material. For example, the Court held that isolated human DNA segments are not patentable unless they are significantly altered by human intervention[1].

Administrative Guidance

The U.S. Patent and Trademark Office (USPTO) has issued guidance to clarify the application of the Alice/Mayo framework. The 2019 Guidance aimed to lower Section 101 barriers to patentability, especially for computer-related inventions, and has led to an increase in the allowance rate for AI-related patent applications. However, this guidance is not binding on courts and does not have the force of law[1].

Use of AI in Patent Applications

The increasing use of AI tools in drafting and editing patent applications has introduced new complexities.

Disclosure Requirements

If AI tools are used in the patent application process, their use must be disclosed to the USPTO, especially if it is material to patentability. This includes situations where AI systems assist in drafting claims or introducing alternative embodiments not conceived by the inventors[3].

Accuracy and Verification

Practitioners must ensure that all statements and evidence provided in patent applications, including those generated or assisted by AI, are accurate and have appropriate evidentiary support. This is crucial to avoid introducing inaccurate statements or omitting material information[3].

Prior Art and Novelty

The America Invents Act (AIA) and relevant regulations (35 U.S.C. §102) govern prior art and novelty requirements.

Prior Art Exceptions

Under 35 U.S.C. §102(b)(1) and (2), certain disclosures made by the inventor or joint inventors within one year of the effective filing date can be excluded from prior art. This can be established through affidavits or declarations that show the subject matter was publicly disclosed by the inventor or obtained directly or indirectly from the inventor before the effective filing date[4].

Stakeholder Views and Impact

Stakeholders have varying views on the impact of the current patent eligibility framework.

Encouraging Innovation

Some argue that the Alice/Mayo framework has negatively affected investment in technology and innovation, particularly in emerging fields like AI and biotechnology. Others see the framework as necessary to prevent the patenting of abstract ideas and natural phenomena, which could stifle innovation by limiting access to fundamental concepts[1].

Legislative Proposals

Proposals like the Patent Eligibility Restoration Act (PERA 2023) aim to clarify and potentially broaden the scope of patent-eligible subject matter. For instance, PERA 2023 suggests that natural material could be considered modified (and thus patentable) if it is isolated, purified, enriched, or otherwise altered by human activity[1].

Key Takeaways

  • Patent-Eligible Subject Matter: The scope of patent-eligible subject matter is defined by Section 101 of the Patent Act and has been shaped by judicial decisions.
  • Alice/Mayo Test: This test is crucial for determining whether patent claims are directed to an ineligible concept and whether they contain an inventive concept.
  • AI in Patent Applications: The use of AI tools must be disclosed and carefully reviewed to ensure accuracy and compliance with patent regulations.
  • Prior Art and Novelty: Understanding prior art exceptions is vital for overcoming rejections based on novelty and nonobviousness.
  • Stakeholder Views: The impact of the current patent eligibility framework on innovation is a subject of ongoing debate.

FAQs

Q: What are the four categories of patentable inventions under Section 101 of the Patent Act? A: The four categories are processes, machines, manufactures, and compositions of matter.

Q: How does the Alice/Mayo test determine patent eligibility? A: The test involves two steps: determining if the claims are directed to an ineligible concept and assessing if the claims contain an inventive concept that transforms the nature of the claim.

Q: What are the implications of using AI tools in patent applications? A: AI tools must be disclosed if their use is material to patentability, and practitioners must ensure the accuracy of all statements and evidence generated or assisted by AI.

Q: How do prior art exceptions work under the AIA? A: Certain disclosures made by the inventor or joint inventors within one year of the effective filing date can be excluded from prior art through affidavits or declarations.

Q: What is the current debate surrounding patent eligibility and innovation? A: Stakeholders debate whether the current framework encourages or hinders innovation, particularly in emerging technology sectors.

Sources

  1. Patent-Eligible Subject Matter Reform: An Overview - CRS Reports
  2. US20110138338A1 - 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
  4. Prior Art Exceptions under AIA 35 U.S.C. 102(b)(1) and (2) - USPTO Manual of Patent Examining Procedure

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Details for Patent 10,011,643

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Takeda Pharmaceuticals U.s.a., Inc. NATPARA parathyroid hormone For Injection 125511 January 23, 2015 10,011,643 2031-06-07
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
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