Chapter 2400: Biotechnology
The biotechnology chapter focuses on the rules for biological deposits and sequences. Due to the nature of biological based inventions, it may not always be sufficient for the applicant to list the steps necessary to create the product. In these cases, the PTO will request that a “deposit” is made so that members of the public desiring to use the particular product will have access to it. An example of this would be a specific tissue culture cell type.
In other cases, when the invention seeking to be patented involves a nucleotide or amino acid sequence, that sequence must be listed in the patent.
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This biotechnology chapter refers to the guidelines for submitting a deposit or a sequence. We will cover these in more detail in subsequent sections.
Basically, if an invention involves living matter (biological material) that cannot be described with written words alone, then the applicant may need to supply a sample of the biological material.
Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.
Biological material includes material that is capable of self-replication whether it can do so directly or indirectly. Examples include; bacteria, fungi, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, patent tissue cells, lichens and seeds. Non-living material that exists within a living cell may be deposited through the deposit of the host cell.
This section covers the need to make a deposit. For instance, a deposit may not be necessary if the biological material is known and readily available to the public or if the biological materials required to make and use the invention can be made or isolated without undue experimentation.
A deposit must be made to an acceptable depository which includes any International Depositary Authority (IDA) or any other depository recognized as suitable by the Office.
This section covers the time for making an original deposit. It is recommended that a deposit be made to an acceptable depository before the filing date of the application (but, it can be made any time during the pendency of the application). This section covers further details on the time for making a deposit.
A replacement deposit may be made to replace one deposit for another. A replacement is typically made where the earlier deposit is no longer viable. A supplement deposit may also be made to replace one deposit for another.
A supplement is typically used when the earlier deposit is still viable, but has lost a quality that it allegedly possessed at the time the application was filed.
A deposit shall be made for a term of at least 30-years and at least 5 years after the most recent request for furnishing of a sample. Samples must be stored under agreements that would make them available beyond the enforceable life of the patent.
A deposit must be viable at the time of the deposit and throughout its term. This section covers more details on the viability of the deposit.
Access to the deposit must be available throughout the pendency of the application. This section covers further details on the conditions of the deposit.
The burden is on the Office to establish that a deposit is needed to meet the requirements of 35 U.S.C. 112. Once this burden has been met by the Office, the applicant must demonstrate that access to such biological material is either not necessary, is already available, or that a deposit will be made. This section covers further details on the examination procedures.
When submitting a DNA or protein sequence to the USPTO, the sequence must be submitted in a standard format. This section of the biotechnology chapter explicitly details the procedures.
There is a standardized format for the descriptions of nucleotide and amino acid sequence data submitted as a part of patent applications. As of September 8, 2000, sequences can be submitted on compact discs.
This section includes an overview of the sequence rules. The sequence rules define a set of symbols and procedures that must be followed when the application involves a sequence listing.
Applications containing nucleotide and/or amino acid sequences contain the nucleotide and/or amino acid sequence using the format and symbols required in a separate part of the disclosure on paper or compact disc. This section includes further details on nucleotide and/or amino acid sequence disclosures in patent applications.
Submission of either substitute sheets or substitute compact discs of the sequence listing or substitute copies of the computer readable from along with statements supporting the amendment are valid. No new matter may be included in the amendments.
A replacement compact disc containing the amended files must also contain all the files of the original compact disc that were not amended.
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