[Federal Register: February 9, 2010 (Volume 75, Number 26)]
[Notices][Page 6348-6349]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09fe10-31]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Deposit of Biological Materials
ACTION: Proposed collection; comment request.
To view the complete text of this comment request see:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2010_register&docid=fr09fe10-31
SUPPLEMENTARY INFORMATION:
I. Abstract
The deposit of biological materials as part of a patent application is required by 35 U.S.C. 2(b)(2) and outlined in 37 CFR Ch. 1, Subpart G, 1.801-1.809. Every patent must contain a description of the invention sufficient to enable a person (knowledgeable in the relevant science), to make and use the invention as specified by 35 U.S.C. 112. The term biological includes material that is capable of self- replication either directly or indirectly. When the invention involves a biological material, sometimes words alone cannot sufficiently describe how to make and use the invention in a reproducible or repeatable manner. In such cases, the required biological material must be both known and readily available (neither condition alone is sufficient) or be deposited in a suitable depository that has been recognized as an International Depository Authority (IDA) established under the Budapest Treaty, or a depository recognized by the USPTO to meet the requirements of 35 U.S.C. 112.
In cases where a deposit is necessary, it must be made under conditions that assure access to those entitled thereto under 37 CFR 1.14 and 35 U.S.C. Sec. 122
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and upon issuance as a patent that all restriction to public access permanently removed.
In order to meet and satisfy requirements for international patenting, all countries signing the Budapest Treaty must recognize the deposit of biological material with any International Depository Authority (IDA).
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