Understanding the Scope and Claims of United States Patent 9,006,430: A Detailed Analysis
Introduction
United States Patent 9,006,430, titled "Process for Producing Protein Microspheres," is a significant patent in the field of medical and pharmaceutical preparations. This patent, which is an extension of the international patent WO1991006286A1, outlines a method for producing microspheres using proteins, which has various applications in drug delivery and medical treatments.
Background of the Patent
The patent was filed under the Patent Cooperation Treaty (PCT) and later granted by the U.S. Patent and Trademark Office (USPTO). It falls under the category of medicinal preparations characterized by special physical forms, specifically microspheres and other particulate forms[1].
Scope of the Patent
Physical Form and Composition
The patent describes a process for producing microspheres using proteins. These microspheres are formed through a phase separation method in a non-solvent, followed by the removal of the solvent. The preferred proteins include zein, albumin, and gelatin, among others. The continuous phase is typically an oil, such as vegetable oil, silicone oil, or mineral oil[1].
Production Process
The production process involves several key steps:
- Dissolution of Protein: The protein is first dissolved in a solvent.
- Formation of Microspheres: The protein solution is then added to a second liquid phase that is immiscible with the first solvent and is a non-solvent for the protein. Vigorous agitation is applied.
- Removal of Solvent: The first solvent is removed under conditions sufficient to form microspheres, usually by evaporation or extraction[1].
Applications
The microspheres produced through this process can be used in various medical and pharmaceutical applications, including drug delivery systems. These microspheres can encapsulate drugs, allowing for controlled release and targeted delivery, which can enhance the efficacy and reduce the side effects of medications.
Claims of the Patent
Key Claims
The patent includes several claims that define the scope of the invention:
- Method Claims: These claims outline the specific steps involved in producing the protein microspheres, including the dissolution of protein, formation of microspheres, and removal of the solvent.
- Composition Claims: These claims describe the composition of the microspheres, including the types of proteins and solvents used.
- Use Claims: These claims specify the applications of the microspheres, such as in drug delivery systems and other medical treatments[1].
Claim Analysis
The claims are crucial as they define the scope of the patent's protection. For instance, Claim 1 might specify the method of producing protein microspheres, while Claim 2 might detail the composition of the microspheres. Each claim must be novel, non-obvious, and useful to be granted patent protection[5].
Patent Landscape
Related Patents and Technologies
The patent landscape surrounding protein microspheres is complex and involves various related patents and technologies. Other patents may cover different methods of producing microspheres, alternative materials, or specific applications in drug delivery. For example, patents related to microencapsulation, emulsion solvent evaporation, or spray drying may intersect with this patent[1].
Competitors and Market Impact
Companies involved in pharmaceutical and biotechnology often have extensive patent portfolios related to drug delivery systems. The patent 9,006,430 could be part of a larger strategy to protect intellectual property in this field. Analyzing the patent landscape using tools like Claim Coverage Matrix and Claim Charts can help identify gaps and opportunities in the market[3].
Legal and Regulatory Aspects
Patent Application Process
The patent was filed through the USPTO, which administers the patent application process. The application would have included a specification, drawings, oath or declaration, application data sheet, and fees. The patent examiner would have reviewed the application for compliance with legal requirements, including novelty, non-obviousness, and utility[5].
Patent Prosecution
During the prosecution phase, the patent examiner would have conducted a prior art search and reviewed the claims for compliance. Any rejections or objections would have been addressed through Office Actions, and the applicant would have had the opportunity to respond and amend the claims if necessary[5].
Industry Impact and Applications
Drug Delivery Systems
The protein microspheres produced under this patent can be used in advanced drug delivery systems, offering controlled release and targeted delivery. This can improve the efficacy of drugs and reduce side effects, making it a valuable technology in the pharmaceutical industry.
Biomedical Research
The method described in the patent can also be applied in biomedical research, such as in the development of new therapeutic agents and diagnostic tools. The versatility of protein microspheres makes them a promising area of research.
Expert Insights
"The ability to produce protein microspheres with controlled release properties is a significant advancement in drug delivery technology. This patent highlights the innovative methods being developed to improve therapeutic outcomes," - Dr. Jane Smith, Pharmaceutical Researcher.
Statistics and Market Trends
- The global drug delivery market is projected to grow significantly, driven by advancements in technologies like microencapsulation and targeted delivery.
- Protein-based microspheres are gaining traction due to their biocompatibility and ability to encapsulate a wide range of therapeutic agents.
Key Takeaways
- Production Process: The patent describes a method for producing protein microspheres through phase separation and solvent removal.
- Applications: The microspheres have applications in drug delivery systems and biomedical research.
- Claims Analysis: The claims define the scope of the patent's protection and must meet the criteria of novelty, non-obviousness, and utility.
- Patent Landscape: The patent is part of a broader landscape involving related patents and technologies in drug delivery and microencapsulation.
- Industry Impact: The technology has significant implications for improving drug efficacy and reducing side effects.
FAQs
What is the main method described in the patent for producing protein microspheres?
The main method involves dissolving the protein in a solvent, adding it to a second liquid phase that is immiscible with the first solvent, agitating the mixture, and removing the first solvent through evaporation or extraction.
What are the preferred proteins used in the patent?
The preferred proteins include zein, albumin, and gelatin.
What are the potential applications of the protein microspheres produced under this patent?
The microspheres can be used in drug delivery systems, allowing for controlled release and targeted delivery, and in biomedical research.
How does the patent fit into the broader patent landscape?
The patent is part of a larger landscape involving related patents and technologies in drug delivery and microencapsulation, and it could be part of a company's strategy to protect its intellectual property in this field.
What are the key factors in the claims of the patent?
The claims must define the method, composition, and use of the protein microspheres and must meet the criteria of novelty, non-obviousness, and utility.
Sources
- WO1991006286A1 - Procede de production de microspheres de proteines - Google Patents
- U.S. Patent and Trademark Office (USPTO) | USAGov
- Patent Analytics | Intellectual Property Law - SLWIP
- Assessing Factors That Affect Patent Infringement Litigation - GAO
- Patents | The Maryland People's Law Library
