Analyzing the Claims and Patent Landscape of United States Patent 7,138,371
Introduction
United States Patent 7,138,371, titled "Methods for the synthesis of glycoconjugated proteins," is a significant patent in the field of biotechnology, particularly in the area of protein engineering and glycoconjugation. This analysis will delve into the claims of the patent, its technological context, and the broader patent landscape it inhabits.
Background of the Patent
The patent, issued on November 20, 2006, describes methods for synthesizing glycoconjugated proteins, which are proteins modified with carbohydrate (glycan) structures. These modifications can enhance the stability, pharmacokinetics, and efficacy of therapeutic proteins, such as insulin and other biologics[1].
Claims of the Patent
The patent includes several claims that outline the specific methods and compositions related to the synthesis of glycoconjugated proteins. Here are some key claims:
Claim 1: General Method
The first claim describes a general method for synthesizing a glycoconjugated protein, involving the steps of providing a protein, providing a glycan moiety, and conjugating the glycan moiety to the protein.
Claim 2: Specific Glycan Moieties
Subsequent claims specify different types of glycan moieties that can be used, such as N-glycans, O-glycans, and polysaccharides.
Claim 3: Conjugation Methods
The patent also claims various methods for conjugating the glycan moieties to the protein, including chemical conjugation and enzymatic conjugation.
Claim 4: Applications
Claims related to the applications of these glycoconjugated proteins are also included, such as their use in therapeutic compositions and pharmaceutical formulations.
Technological Context
The technology described in this patent is part of a broader field of protein engineering and glycoconjugation. Glycoconjugation is a critical process in biotechnology because it can significantly impact the biological activity and stability of proteins.
Glycoconjugation Techniques
The patent builds upon existing techniques in glycoconjugation, such as PEGylation (the attachment of polyethylene glycol molecules to proteins), which is mentioned in related patents and publications[1].
Biomedical Applications
Glycoconjugated proteins have various biomedical applications, including the development of improved insulin analogs. For instance, glycoconjugated insulin molecules can have enhanced pharmacokinetic profiles, making them more effective and longer-lasting than traditional insulin formulations.
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 7,138,371 includes a number of related patents and publications. For example, other patents have disclosed methods for remodeling peptides, including insulin, to include glycan structures for PEGylation and similar modifications[1].
Competing Technologies
Competing technologies in the field of glycoconjugation include phage display methods, where proteins of interest are expressed as polypeptide fusions to bacteriophage coat proteins and screened for binding to specific ligands[1].
Industry Trends
The biotechnology industry has seen a significant increase in the development of glycoconjugated proteins due to their potential therapeutic benefits. Companies are investing heavily in research and development to create novel glycoconjugates with improved properties.
Legal and Regulatory Aspects
Disclosure Requirements
The use of AI tools in patent drafting, including those related to glycoconjugated proteins, must be disclosed to the USPTO if material to patentability. This is in line with recent USPTO guidance on the use of AI tools in patent practice[2].
Patent Assertion Entities (PAEs)
The patent landscape is also influenced by the activities of PAEs, which can assert patents in various industries, including biotechnology. PAEs like Portfolio PAEs and Litigation PAEs have different business models that impact how patents are licensed and litigated[3].
Search and Analysis Tools
USPTO Resources
To analyze the patent landscape, one can use various resources provided by the USPTO, such as the Patent Public Search tool, Global Dossier, and the Common Citation Document (CCD) application. These tools help in identifying prior art, related applications, and the status of patent families[4].
International Patent Offices
Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), is also crucial for a comprehensive analysis[4].
Impact on the Biotechnology Industry
The methods described in U.S. Patent 7,138,371 have the potential to significantly impact the biotechnology industry by enabling the creation of more stable and effective therapeutic proteins.
Enhanced Therapeutics
Glycoconjugated proteins can offer improved therapeutic outcomes due to their enhanced stability and pharmacokinetics. This can lead to better patient compliance and treatment efficacy.
Research and Development
The patent encourages further research and development in the field of glycoconjugation, driving innovation and the creation of new therapeutic products.
Key Takeaways
- Methodology: The patent describes specific methods for synthesizing glycoconjugated proteins, including various conjugation techniques.
- Applications: Glycoconjugated proteins have significant biomedical applications, particularly in the development of improved therapeutic proteins.
- Patent Landscape: The patent is part of a broader landscape that includes related patents, competing technologies, and industry trends.
- Legal and Regulatory: Disclosure requirements and the activities of PAEs are important considerations in the patent landscape.
- Tools and Resources: Various USPTO and international resources are available for searching and analyzing patents related to glycoconjugation.
FAQs
What is the main focus of U.S. Patent 7,138,371?
The main focus of U.S. Patent 7,138,371 is the methods for synthesizing glycoconjugated proteins, particularly the attachment of glycan moieties to proteins.
How do glycoconjugated proteins differ from traditional proteins?
Glycoconjugated proteins differ from traditional proteins in that they are modified with carbohydrate structures, which can enhance their stability, pharmacokinetics, and therapeutic efficacy.
What are some common applications of glycoconjugated proteins?
Common applications include the development of improved insulin analogs and other therapeutic proteins with enhanced biological activity.
How does the USPTO guide the use of AI tools in patent drafting?
The USPTO requires that the use of AI tools be disclosed if material to patentability and ensures that practitioners verify the accuracy of factual assertions made with AI assistance[2].
What role do Patent Assertion Entities (PAEs) play in the biotechnology industry?
PAEs can assert patents in various industries, including biotechnology, and their activities can significantly impact licensing and litigation practices[3].
Sources
- WO2013043582A1 - Cell surface display of ligands for the insulin and/or insulin growth factor 1 receptor and applications thereof - Google Patents
- U.S. Patent Office Issues Additional Guidance on Use of AI Tools - BIPC
- Patent Assertion Entity Activity: An FTC Study - FTC
- Search for patents - USPTO - USPTO
