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Last Updated: April 15, 2025

Patent: 10,220,076


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Summary for Patent: 10,220,076
Title:Pharmaceutical compositions and methods for fabrication of solid masses comprising glucose regulating proteins
Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.
Inventor(s): Morales; Mercedes (San Jose, CA), Imran; Mir (Los Altos Hills, CA), Korupolu; Radhika (San Jose, CA), Hashim; Mir (Fremont, CA)
Assignee: InCube Labs, LLC (San Jose, CA)
Application Number:14/714,146
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Patent Landscape for United States Patent 10,220,076

Introduction

Patent 10,220,076, like any other patent, operates within a complex and evolving patent landscape in the United States. This analysis will delve into the key aspects of patent-eligible subject matter, the impact of recent judicial and administrative developments, and the strategies for overcoming section 101 rejections, all of which are crucial for understanding the viability and implications of this patent.

Patent-Eligible Subject Matter Under Section 101

The foundation of patent eligibility in the U.S. is laid out in Section 101 of the Patent Act (35 U.S.C. §101), which defines patentable inventions as "any new and useful process, machine, manufacture, or composition of matter"[1].

Judicially Developed Exceptions

The Supreme Court has established implicit exceptions to patent-eligible subject matter, excluding "laws of nature, natural phenomena, and abstract ideas" when claimed as such. These exceptions have been refined through several landmark cases, including Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., Association for Molecular Pathology v. Myriad Genetics, and Alice Corp. Pty. v. CLS Bank[1].

The Alice/Mayo Framework

The Alice/Mayo test is a two-step framework for determining patent eligibility:

  • Step 1: Determine if the patent claims are "directed to" an ineligible concept (law of nature, natural phenomenon, or abstract idea).
  • Step 2: If the claims are directed to an ineligible concept, assess whether they contain an "inventive concept" that transforms the nature of the claim into a patent-eligible application[1][5].

Impact on Emerging Technologies

The narrowing of patent-eligible subject matter, particularly through the Alice/Mayo framework, has significantly impacted fields like computer software, business methods, and biotechnology. For AI inventions, for instance, the 2019 Guidance and the 2024 Guidance Update by the USPTO aim to clarify how to apply the Alice/Mayo framework, emphasizing the importance of demonstrating specific, concrete technological advancements or solutions to technical problems[1][2].

Practical Applicability Analysis

For AI inventions facing section 101 rejections, the practical applicability analysis under Step 2A, Prong Two, is critical. This involves demonstrating that the claims are directed to a specific technological improvement or solution to a technical problem. The narrative must highlight the practical utility and real-world impact of the claimed innovation, supported by the specification and technical explanations[2].

Crafting Effective Arguments

When developing arguments under Prong Two, it is essential to build a compelling narrative around the main novelty of the claimed invention. This narrative should emphasize how the claimed innovation is distinguishable from mere abstract ideas or conventional practices. The argument must be supported by the specification and should guide the examiner through a clear and logical progression from the technical problem to the claimed innovation[2].

Challenges in Overcoming Section 101 Rejections

Patent examiners may apply the framework differently, and the primary examiner may not be the main decision-maker. In some cases, supervisory patent examiners or section 101 specialists may direct the issuance of section 101 rejections, posing a greater challenge for applicants. This requires crafting arguments that are persuasive to these decision-makers, often without direct engagement[2].

Patent Assertion Entities (PAEs)

The landscape is also influenced by the activities of Patent Assertion Entities (PAEs), which can impact the patent ecosystem significantly. PAEs, such as Litigation PAEs and Portfolio PAEs, generate revenue through patent assertion, often targeting a broad range of industries. Their activities can lead to significant litigation and licensing revenue, but also raise concerns about the negative repercussions on innovation and competition[3].

Quality of Patents

The quality of patents is another critical aspect. The USPTO has taken steps to improve patent quality through initiatives like the Enhanced Patent Quality Initiative. However, there is a need for a consistent definition of patent quality, articulated in agency documents and guidance, to ensure that patents meet statutory requirements and are upheld if challenged[4].

Inter Partes Review and the Patent Trial and Appeal Board

The Patent Trial and Appeal Board (PTAB) plays a significant role in the patent landscape, particularly through Inter Partes Review (IPR) proceedings. These proceedings allow for the challenge of issued patents, and the PTAB must determine whether the patent claims are directed to ineligible subject matter under the Alice/Mayo test[5].

Key Takeaways for Patent 10,220,076

  • Eligibility Under Section 101: The patent must navigate the Alice/Mayo framework, ensuring that its claims are not directed to ineligible concepts and, if they are, that they contain an inventive concept.
  • Technological Advancements: The patent should demonstrate specific, concrete technological advancements or solutions to technical problems to overcome section 101 rejections.
  • Narrative and Specification: A compelling narrative supported by the specification is crucial for convincing patent examiners of the claimed innovation’s practical utility and real-world impact.
  • PAE Activities: The patent holder should be aware of the potential impact of PAEs and the need to defend against assertions from these entities.
  • Patent Quality: Ensuring that the patent meets the statutory requirements for novelty, clarity, and nonobviousness is essential for its validity and enforceability.

FAQs

Q: What is the significance of the Alice/Mayo framework in patent eligibility? A: The Alice/Mayo framework is a two-step test that determines whether patent claims are directed to ineligible concepts (laws of nature, natural phenomena, or abstract ideas) and, if so, whether they contain an inventive concept that transforms the claim into a patent-eligible application.

Q: How do recent USPTO guidelines impact AI-related inventions? A: The 2019 Guidance and the 2024 Guidance Update by the USPTO aim to clarify how to apply the Alice/Mayo framework for AI-related inventions, emphasizing the need to demonstrate specific technological advancements or solutions to technical problems.

Q: What role do Patent Assertion Entities (PAEs) play in the patent landscape? A: PAEs generate revenue through patent assertion, often targeting various industries, and their activities can lead to significant litigation and licensing revenue but also raise concerns about negative repercussions on innovation and competition.

Q: Why is patent quality important, and what initiatives has the USPTO taken? A: Patent quality is crucial for ensuring that patents meet statutory requirements and are upheld if challenged. The USPTO has initiated the Enhanced Patent Quality Initiative and is working to define and measure patent quality consistently.

Q: How does the Patent Trial and Appeal Board (PTAB) influence patent validity? A: The PTAB, through Inter Partes Review proceedings, determines whether patent claims are directed to ineligible subject matter under the Alice/Mayo test, which can impact the validity of issued patents.

Sources

  1. Congressional Research Service. "Patent-Eligible Subject Matter Reform: An Overview." January 3, 2024.
  2. Baker Botts. "The Importance of Prong Two of Step 2A for AI Inventions." August 26, 2024.
  3. Federal Trade Commission. "Patent Assertion Entity Activity: An FTC Study."
  4. Government Accountability Office. "Intellectual Property: Patent Office Should Define Quality, Reassess Incentives." June 30, 2016.
  5. Congressional Research Service. "The Patent Trial and Appeal Board and Inter Partes Review." June 29, 2023.

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Details for Patent 10,220,076

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 October 28, 1982 10,220,076 2034-05-15
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 December 29, 2015 10,220,076 2034-05-15
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 August 06, 1998 10,220,076 2034-05-15
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 March 31, 1994 10,220,076 2034-05-15
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 May 25, 2018 10,220,076 2034-05-15
Novo Nordisk Inc. NOVOLIN R insulin human Injection 019938 June 25, 1991 10,220,076 2034-05-15
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
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