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Last Updated: January 1, 2025

Patent: 10,227,403


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Summary for Patent: 10,227,403
Title:Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
Abstract: Embodiments of the invention provide shaped masses (SM) comprising one or more drugs such as proteins or polypeptides and methods for forming and delivering such SM\'s. One embodiment provides a SM comprising a drug e.g., a protein or polypeptide having a biological activity in the body of a mammal. The SM is formed by compression of a precursor material (PM) comprising the drug wherein an amount of biologically active drug in the SM is a minimum level to that in the PM. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-.alpha.-inhibiting antibodies. Embodiments of the invention are particularly useful for the oral delivery of drugs which would be degraded within the GI tract, wherein the SM containing the drug is formed as or incorporated into a tissue penetrating member which is inserted into the intestinal wall after oral ingestion.
Inventor(s): Imran; Mir (Los Altos Hills, CA), Morales; Mercedes (San Jose, CA), Korupolu; Radhika (San Jose, CA), To; Elaine (San Jose, CA), Harris; Joel (Mountain View, CA), Hashim; Mir (Fremont, CA)
Assignee: InCube Labs, LLC (San Jose, CA)
Application Number:15/144,733
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Complexities of Patent Claims: A Comprehensive Analysis of the U.S. Patent Landscape

Introduction

Patent claims are the heart of any patent application, defining the scope of protection for an invention. In the United States, the landscape of patent claims is governed by a complex set of rules, regulations, and legal precedents. This article delves into the critical aspects of patent claims, using the context of U.S. Patent 10,227,403 as a reference point, although the specific details of this patent are not provided here. We will explore the criteria for patentability, the process of drafting and examining patent claims, and the legal framework that shapes the patent landscape.

Criteria for Patentability

For a patent to be granted, the invention must meet several stringent criteria, including novelty, non-obviousness, and eligibility as patentable subject matter.

Novelty and Non-obviousness

An invention must be novel, meaning it has not been previously disclosed in any form. It must also be non-obvious, requiring that the invention is not an evident solution to someone skilled in the field. Patent examiners assess this by comparing the invention against prior art to ensure it differs sufficiently from existing inventions[3].

Eligibility as Patentable Subject Matter

The invention must meet the requirements set forth by patent law, often requiring it to be tied to a specific technological implementation or to improve the functioning of a machine. This is particularly crucial for algorithms and software-based inventions, which must go beyond abstract ideas to be patentable[3].

Drafting Patent Claims

Drafting patent claims is a meticulous process that requires careful consideration of several factors.

Types of Claims

Patent claims can be categorized into various types, including product claims, process claims, and product-by-process claims. Each type has its own set of rules and best practices. For example, computer-implemented inventions require specific claim formats that align with technological enhancements[4].

Clarity and Specificity

Claims must be clear and specific to avoid ambiguity. This includes defining terms, distinguishing elements, and avoiding relative terms and inconsistencies. The WIPO Patent Drafting Manual emphasizes the importance of clarity and consistency in claim word choice[4].

Broad and Narrow Claims

A well-drafted patent application typically includes a mix of broad and narrow claims. Broad claims define the invention in general terms, while narrow claims provide more specific details. This strategy helps in securing a robust patent that can withstand challenges[4].

Examination Process

The examination process is a critical phase where the patentability of the claims is assessed.

Role of Patent Examiners

Patent examiners review the application, searching prior art to verify the novelty and non-obviousness of the invention. They may issue office actions, which include rejections or requests for additional information. Responding promptly and addressing the examiner's concerns is essential for expediting the examination process[3].

Addressing Office Actions

Applicants must respond to office actions by addressing the examiner's objections and providing necessary clarifications. This may involve amendments to the claims, which must be done carefully to avoid introducing new matter or broadening the claims beyond the original disclosure[4].

Legal Precedents and Case Law

The patentability of claims is heavily influenced by legal precedents and case law.

Supreme Court Decisions

Cases such as Alice Corp. v. CLS Bank International and Bilski v. Kappos have significantly shaped the landscape for patenting algorithms and software-based inventions. These decisions emphasize that abstract ideas implemented through computers are not eligible for patents unless they are tied to specific technological innovations or applications[3].

Court Rulings on Patent Eligibility

The Federal Circuit and district courts have also issued rulings that affect patent eligibility. For instance, the case of Electric Power Group, LLC v. Alstom S.A. highlights that claims must define subject matter that is eligible for patenting under § 101 and must include an inventive concept beyond abstract ideas[5].

Patent Quality and Its Impact

The quality of patent claims is a critical issue that affects the overall validity and enforceability of the patent.

Definition of Patent Quality

The U.S. Patent and Trademark Office (USPTO) has been working to improve patent quality through its Enhanced Patent Quality Initiative. A quality patent is one that meets statutory requirements for novelty, clarity, and other criteria, and would be upheld if challenged in a lawsuit[1].

Effects of Low Patent Quality

Low patent quality can lead to unclear and overly broad claims, which can result in unintentional infringement and legal disputes. Stakeholders have emphasized the need for consistent definitions and measures of patent quality to ensure that patents are robust and enforceable[1].

Application Readiness and Compact Prosecution

The readiness of the patent application and the policies of compact prosecution also impact patent quality.

Application Readiness Review Form (ARRF)

USPTO has developed the ARRF to score applications based on their readiness. This form helps determine whether an applicant has provided enough information for an effective application, which in turn affects the quality and pendency of the patent[1].

Compact Prosecution Policies

USPTO has studied the effects of compact prosecution and other policies on patent quality. These studies aim to identify any adverse effects and make necessary adjustments to ensure that policies do not compromise patent quality[1].

International Perspectives

While the focus here is on the U.S. patent system, international perspectives and guidelines also play a significant role.

WIPO Guidelines

The World Intellectual Property Organization (WIPO) provides comprehensive guidelines for drafting and prosecuting patent applications. These guidelines are widely adopted and help in ensuring consistency across different jurisdictions[4].

Challenges in Patenting Algorithms

Patenting algorithms is particularly challenging due to the stringent criteria and legal precedents.

Specific Application Requirement

Algorithms can only be patented if they are tied to a specific application or technological implementation. This distinction is crucial for navigating the complex legal landscape of algorithm patentability[3].

Automated Systems for Claims Analysis

The increasing complexity of patent claims, especially in the context of algorithms, has led to the development of automated systems for claims analysis. These systems help reduce the amount of information users need to review, making the process more efficient[2].

Key Takeaways

  • Patentability Criteria: Inventions must meet criteria of novelty, non-obviousness, and eligibility as patentable subject matter.
  • Claim Drafting: Claims must be clear, specific, and include a mix of broad and narrow claims.
  • Examination Process: Prompt responses to office actions and careful amendments are crucial.
  • Legal Precedents: Supreme Court decisions and lower court rulings significantly influence patent eligibility.
  • Patent Quality: Consistent definitions and measures of patent quality are essential for robust and enforceable patents.
  • International Guidelines: WIPO guidelines provide a framework for consistency across jurisdictions.

FAQs

Q: What are the key criteria for patenting an algorithm in the United States?

A: An algorithm must be novel, non-obvious, and tied to a specific technological implementation or practical application to be patentable[3].

Q: How does the USPTO ensure patent quality?

A: The USPTO uses various measures, including the Enhanced Patent Quality Initiative, to improve patent quality. This includes defining patent quality consistently and assessing compliance through correctness measures[1].

Q: What is the significance of the Alice Corp. v. CLS Bank International decision?

A: This decision ruled that abstract ideas implemented through computers are not eligible for patents unless they include an inventive concept beyond the abstract idea itself[3].

Q: How do automated systems help in patent claims analysis?

A: Automated systems reduce the amount of information users need to review, making the process of analyzing patent claims more efficient, especially for complex applications with numerous claims[2].

Q: What is the role of the Application Readiness Review Form (ARRF) in patent applications?

A: The ARRF helps determine whether an applicant has provided enough information for an effective application, impacting the quality and pendency of the patent[1].

Sources

  1. GAO Report: Intellectual Property: Patent Office Should Define Quality, Reassess Policies[1].
  2. Patent Claims Analysis System: US20110138338A1 - Patent Claims Analysis System and Method[2].
  3. Patent Lawyer.io: Can You Patent an Algorithm? Understanding Legal Boundaries[3].
  4. WIPO Patent Drafting Manual: Second Edition[4].
  5. Federal Circuit Opinion: Electric Power Group, LLC v. Alstom S.A.[5].

More… ↓

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Details for Patent 10,227,403

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Janssen Biotech, Inc. REMICADE infliximab For Injection 103772 August 24, 1998 ⤷  Subscribe 2032-06-25
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 ⤷  Subscribe 2032-06-25
Immunex Corporation ENBREL etanercept For Injection 103795 May 27, 1999 ⤷  Subscribe 2032-06-25
Immunex Corporation ENBREL etanercept Injection 103795 September 27, 2004 ⤷  Subscribe 2032-06-25
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
Showing 1 to 4 of 4 entries

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