What does “known and readily available” mean in the context of biological materials for patent applications?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-30 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. “Known and readily available” refers to the level of public accessibility to a necessary component of an invention disclosure that is consistent with the ability to make and use the invention. According to MPEP 2404.01 : “To avoid the need for a deposit on this basis, the biological material must be both known and readily available – neither concept alone is sufficient.” This means that the biological material must be publicly known (e.g., its existence has been published) and accessible to those who wish to obtain it. The term “readily” is used to define a reasonable degree of availability under the circumstances. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Biological Material Must Be Known and Readily Available MPEP 2404.01 Required Biological Material Must Be Known and Readily Available MPEP 2404.01 Availability of Biological Material Must Be Known and Accessible MPEP 2404.01 Permitted Requirement for Known and Readily Available Biological Material MPEP 2404.01 Required Material Known and Readily Available Must Be Described Adequately MPEP 2404.01 Indicia for Known and Readily Available Biological Materials MPEP 2404.01 Permitted Commercial Availability as Known and Readily Available Evidence MPEP 2404.01 Description of Biological Material Must Be Adequate MPEP 2404.01 Permitted Patent Application May Reference Biological Material Deposit MPEP 2404 Permitted Factors Indicating Public Accessibility of Biological Material MPEP 2404.01 Other Related FAQs 5 FAQs Collapse What is the significance of a Budapest Treaty deposit for biological materials in patent applications? How does commercial availability affect the determination of whether a biological materi...