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Biotechnology Referenced Items (169, 170, 171, 172, 173)
(171)                     Biosequence Internet Filing
                 Related to: 37 CFR 1.824 Form and Format for
               Nucleotide and/or Amino Acid Sequence Submissions
                           in Computer Readable Form

Description:

This electronic filing project represents the first public release of an
electronic filing system (EFS) to test direct electronic submission of
application information to the U.S. Patent and Trademark Office. It is
called EFS BIO and it is focused on computer readable amino acid and/or
nucleotide sequence listings. It moves the USPTO closer to attaining the
goal of electronic filing of all patent application submissions by 2003.
The sequence listing(s) to be transmitted electronically via the
Internet will correspond only to biotechnology patent utility
applications already filed in USPTO on paper under current rules in
Title 37 C.F.R. 1.821-1.825.

The electronic filing system will provide a mechanism for certain
qualified patent applicants and certain practitioners to conduct a `real
time' electronic filing of the computer readable form (CRF) of the amino
acid and/or nucleotide sequence listing required in a pending paper
biotechnology patent application. The electronic filing system provides
"real time" feedback to the filer acknowledging the USPTO's receipt of
the CRF copy of the sequence listing. The system will accommodate input
created by a sequence listing authoring tool, PatentIn, as well as
accommodate input created by other standard methods or editors.

Participants:

The use of the electronic filing system to submit computer readable
format sequence listing ASCII file(s) via the Internet is voluntary. To
electronically file a a nucleotide and/or amino acid sequence with the
USPTO via the Internet, a participant must be identified as one of the
following authorized patent application filers (applicant, assignee,
attorney or agent or assignee undivided part) as set forth in 37 CFR
(1.33(b)).

Authorized filers must have a pending utility patent application that
requires a nucleotide and/or amino acid sequence submission in computer
readable form (37 CFR 1.824). Filers must be familiar with the use of
the PatentIn sequence authoring application or another acceptable
sequence authoring tool.

Authorized filers must submit a request to the USPTO Office of
Enrollment and Discipline (OED) for a set of public key certificates (a
digital signing certificate and a confidentiality certificate).

Interested filers should contact OED to obtain a copy of the USPTO
Certificate Action Form and USPTO Public Key Infrastructure Subscriber
Agreement. They will be contacted by USPTO regarding the approval of the
submitted request. Individuals who already have certificates that were
obtained from the USPTO via the above procedure for other purposes are
also qualified to participate. Upon approval of the submitted request,
the USPTO will provide a software installation package that enables the
authorized patent application filer to securely communicate with USPTO
Electronic Business Center (EBC) application systems.

During the initial release of the electronic filing system for a
Biosequence Internet filing, participation will be limited to those
authorized patent application filers whose offices are located in the
Washington, D.C. metro area. Later releases will expand that limitation.
Authorized filers located either in or outside the Washington, D.C.
metro area, and who are interested in filing biosequences via the
Internet are asked to submit a request to obtain a copy of the USPTO
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public key certificates starting in October 1999.

Guidance on registration to use EFS BIO to file computer readable format
sequence listing will be available at the USPTO web site Electronic
Business Center. Applicants or practitioners' who have registered with
the USPTO to obtain a digital certificate will download the EFS desktop
application called the Electronic Packaging And Validation Engine
(ePave) from the Electronic Business Center patent electronic filing web
page.

When:

This initial release of the electronic filing system for biosequences
via the Internet is now available.

Features of EFS-BIO:

. Authorized filers will obtain valid public key certificates and
security related software from the USPTO.

. Authorized filers with valid certificates will download electronic
filing desktop software (called ePave) from Electronic Business Center
Electronic Filing Web page.

. The filers will submit an ASCII text file of the biosequences using
the electronic filing system.

. Only the following file formats may be used: .zip (compressed file),
.app. (Patent In file format), .txt (ASCII text file)

. The biosequence electronic filing submission must be accompanied by an
electronic transmittal file created by the software.

. The transmittal file must be signed by the person intending the
electronic mark to be his or her signature. This means that the person
verifying a patent application must personally make the mark in the
appropriate section of the "electronic" patent application submission
(e.g. transmittal, declaration)

. The USPTO electronic filing desktop software will automatically save a
complete copy of the electronically signed transmittal document and make
the electronic document available for printing.

. Electronic Filing certificate practice is similar to current fax
practice, including use of a certificate of mailing or transmission, in
accordance with 37 C.F.R. 1.8.

. The official date/stamp on the biosequence electronically filed
submission will occur at the date and time the last byte of the
electronic file is received by the USPTO Electronic Mailroom Server.

. Authorized electronic filers will be presented with a "confirmation"
screen that displays the document being electronically submitted to the
USPTO and requires the applicant to confirm his intention to submit it.
The verification of a confirmation screen is a necessary step to assure
that the USPTO's electronic record(s) have the required authenticity.

. Filers will not be permitted to submit a sequence listing via the
Internet without entering a valid USPTO assigned national application
number.

. Most information will be error-checked by the software. Filers will be
allowed to override some of these discovered errors if desired.

. After completion of an electronic filing of a biosequence, the
electronic filer will submit a paper that refers to the Internet filing
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of the sequence listing and include a copy of the acknowledgement
receipt provided by USPTO.

Business rule modifications:

This procedure will serve, for the patent applications concerned, in
lieu of the procedures for the computer readable form as specified in 37
C.F.R. 1.821 (e) and 1.824. Procedures for all other patent applications
are not affected.

.

For more information on this program, please consult the EFS Web Page at
Electronic Business Center http://pto-ebc.uspto.gov or the USPTO web
site at www.uspto.gov. It is preferred that questions and comments
should be addressed to USPTO at the following e-mail address:
EFS@uspto.gov. If e-mail is unavailable or inappropriate, contact Diane
Lewis at telephone number 703-305-9892.

November 4, 1999                                         NICHOLAS P. GODICI
                                              Deputy Assistant Commissioner

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