What is the relationship between biological deposits and the enablement requirement?
The relationship between biological deposits and the enablement requirement is crucial in patent law, particularly for biotechnology inventions. According to MPEP 2406.01, the description of biological material must be sufficient to meet the enablement requirement of 35 U.S.C. 112.
The MPEP states:
“However, it must be clear from the application as filed that the invention claimed and described in the specification ‘was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process).’” (Citing Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975))
This means:
- The biological deposit must enable a person skilled in the art to make and use the invention.
- The application must show that the invention can be reduced to practice without undue experimentation.
- The deposit, along with the written description, should provide sufficient information for the invention to be reproducible.
Biological deposits can help satisfy the enablement requirement by providing access to materials that might be difficult or impossible to describe adequately in writing alone.
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