Professional Documents
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Inherently unpredictable
Patents that deal with the use of biological material would need to
explain in detail the structural and functional details to meet the
requirements of ‘enablement’
• (2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the
depositor on the availability to the public of the deposited material will be
irrevocably removed upon the granting of the patent.
Non-Budapest Treaty deposits must include the assurance noted
on the previous slide, as well as a viability statement
addressing:
• The name and address of the depository;
• The name and address of the depositor;
• The date of deposit;
• The identity of the deposit and the accession number given by the
depository;
• The date of the viability test;
• The procedures used to obtain a sample if the test is not done by the
depository; and
• A statement that the deposit is capable of reproduction.
• The depositor may contract with the depository
to require that samples of a deposited biological
material shall be furnished during the term of
the patent only if a request for a sample:
(1) Is in writing or other tangible form and dated;
(2) Contains the name and address of the
requesting party and the accession number of the
deposit; and
(3) Is communicated in writing by the depository to
the depositor, along with the date on which the sample
was furnished and the name and address of the party
to whom the sample was furnished.
• Currently there is no provision for an applicant to withdraw a deposit from
the public when the deposit was made to satisfy the requirements for
patentability.
– Reexamination is not available to address 112 issues.
– Applicant may file a reissue application.
• If an applicant fails to authorize release of biological material upon the
issuance of the patent the party requesting the biological material may
seek redress to invalidate the patent.
• An applicant’s agreement with an IDA concerning the conditions of
deposit is independent from any agreement regarding the deposit of
biological material necessary for patentability of an invention.
– All restrictions on the deposit must be irrevocably removed upon issue.
• Only IDAs which are certified by the USPTO are
acceptable for compliance with statutory
requirements in patent applications filed in the
United States.
– “(b) When the original deposit is made after the effective filing date of an
application for patent, the applicant must promptly submit a statement from a
person in a position to corroborate the fact, stating that the biological material
which is deposited is a biological material specifically identified in the
application as filed.”
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• Access to the deposited material will be available during
pendency of the application to a person who has been
determined by the Director to be entitled thereto under 37
CFR 1.14 and 35 USC 122.
• If the deposit was necessary for compliance with statutory
requirements, and has been stated to have been made
under conditions which make it available to the public as of
the issue date of the patent, then the Office will certify that
the deposit is available. The Office will provide a BP/12
form to submit to a depository for release the sample,
assuming that the requestor meets any other requirements
to receive a sample. (37 CFR 1.808(c))