Patent and Trademark Office

Notice of Hearings and Request for Comments on Issues Relating to
Patent Protection for Nucleic Acid Sequences

AGENCY:  Patent and Trademark Office, Commerce.

ACTION:  Notice of Hearings and Request for Comments.

SUMMARY:  The Patent and Trademark Office (PTO) will hold public
hearings, and it requests comments, on issues relating to patent
protection for nucleic acid sequences.  Interested members of the
public are invited to testify at public hearings and to present
written comments on any of the topics outlined in the
supplementary information section of this notice.

DATES:  Public hearings will be held on Tuesday, April 16, 1996,
from 9:00 a.m. until 1:00 p.m., and Tuesday, April 23, 1996, from
9:00 a.m. until 1:00 p.m.
     Those wishing to present oral testimony at any of the
hearings must request an opportunity to do so no later than
Friday, April 12, 1996, for the April 16 hearing, or Friday,
April 19, 1996, for the April 23 hearing.
     Speakers may provide a written copy of their testimony for
inclusion in the record of the proceedings no later than Monday,
May 6, 1996.
     Written comments will be accepted by the PTO until April 23,
     Written comments and transcripts of the hearings will be
available for public inspection on or about Monday, May 13, 1996.

ADDRESSES:  The April 16 hearing will be held from 9:00 a.m.
until 1:00 p.m. at the University of California, San Diego,
International Center, 9500 Gilman Drive, La Jolla, California.
     The April 23 public hearing will be held from 9:00 a.m.
until 1:00 p.m. in Suite 912, Commissioner's Conference Room,
Crystal Park Two, 2121 Crystal Drive, Arlington, Virginia.
     Requests to testify should be sent to Esther Kepplinger by
telephone at (703) 308-2339, by facsimile transmission at (703)
305-3601, or by mail marked to her attention addressed to the
Assistant Commissioner for Patents, Box Comments-Patents,
Washington, D.C. 20231.  No request for oral testimony will be
accepted through electronic mail.
     Written comments should be addressed to the Assistant
Commissioner for Patents, Box Comments-Patents, Washington, D.C.
20231, marked to the attention of Esther Kepplinger.  Comments
may also be submitted by facsimile transmission at (703)
305-3601, with a confirmation copy mailed to the above address,
or by electronic mail over the Internet to
     Written comments and transcripts of the hearings will be
maintained for public inspection in Suite 520 of Crystal Park
One, 2011 Crystal Drive, Arlington, Virginia.  Transcripts and
comments provided in machine readable format will also be
available through anonymous file transfer protocol (ftp) via the
Internet (address:

FOR FURTHER INFORMATION CONTACT:  Esther Kepplinger by telephone
at (703) 308-2339, by facsimile transmission to (703) 305-3601,
by electronic mail at, or by mail marked to
her attention addressed to the Assistant Commissioner for
Patents, Box Comments-Patents, Washington, D.C. 20231.


I.  Background

     Biotechnology is projected to be an important growth
industry from now until well into the twenty-first century,
particularly in the United States, which has been a leader in
this rapidly developing industry.  The PTO has taken a very
active role in working together with its customers to simplify
and standardize PTO policies and procedures and to encourage and
promote the growth of this industry.  Nevertheless, PTO needs to
continue to seek ways to improve its responsiveness to its
customers and to more effectively address the needs of the
industry.  In order to address both current and future
challenges, the PTO is seeking the assistance and advice of the
     With the growth of the biotechnology industry have come
significant changes in the process of research, development and
commercialization of biotechnology inventions.  For at least a
decade, patent applications claiming nucleic acid sequences, such
as genes composed of deoxyribonucleic acid ("DNA"), have been
examined and granted patent rights by the PTO pursuant to 35
U.S.C. 131.  These sequences typically encode known proteins or
proteins for which an applicant has discovered a function.
Scientific and technological advances have permitted researchers
to identify large numbers of gene fragments rapidly.  The ease of
using automated techniques for sequencing large numbers of random
nucleic acid fragments has resulted in the filing of a growing
number of patent applications each claiming thousands of nucleic
acid sequences.  Handling patent applications containing large
numbers of sequences creates a significant processing problem for
the PTO.  While the PTO has acquired sophisticated and costly
computer hardware and software necessary to process and search
applications containing such sequences, the search and
examination of the sequences will significantly overtax the
existing system and may necessitate the acquisition of many
additional, expensive, massively parallel processor computers to
complete the search of the prior art and examination in a
reasonable time.  Human resources to analyze the computer search
results greatly exceeds the computer time necessary to run the
     PTO estimates that the computer search time for one hundred
sequences, each of which do not exceed several hundred
nucleotides in length, is about fifteen hours and the examiner
time for evaluating the sequence search results is about sixty-five hours.
Based on searching 100,000 sequences a year, the
estimated cost for computer search time for one hundred sequences
is $1,800.  Although the number of cases involving large numbers
of sequences presently before the PTO is relatively small, it is
estimated that the cost to search and examine these cases alone
will be $12 million.  These estimates represent searches of
commercially available databases by a massively parallel
processor computer.
     As in any technology, the PTO must search the entire scope
of the claimed invention.  Typical biotechnology patent
applications drawn to DNA sequences claim the exact sequence
disclosed but include various other broader claims.  For example,
typical claims include the sequence and any sequence having a
certain percentage identity or homology to the sequence or any
sequence which hybridizes to the sequence, with or without the
conditions of binding being recited.  Others recite the sequence
or any fragment of the sequence having a particular length of
nucleotides.  These claims are largely responsible for the
lengthy search and evaluation times and the high resultant costs
to the PTO.  Additionally, the presence of thousands of
individual sequences per application represents an enormous
search and examination challenge.  This is particularly true if
the sequences represent different proteins because the search for
one sequence provides no useful data for another sequence.
     The number of applications with large numbers of nucleic
acid sequences continues to grow and, because of technological
advances in the identification of genes, it is believed that the
growth will continue.
     Applications that claim excessively long sequences present
similar challenges, since the claimed sequence must be broken up
into numerous smaller sequences in order to be searched.
     Appropriate policies must be established to address these
challenges in ways that help protect the inventions of all
applicants without creating an imbalance in the appropriation of
resources within and among the technologies and Examining Groups
of the PTO.  These policies must permit the timely and thorough
examination of all applications which require the same physical
and human resources for completion.

II.  Issues for Public Comment

     Interested members of the public are invited to testify or
to present written comments related to the above topics,
including the following issues:

1.   Is there a more cost-effective way to search and examine
applications containing large numbers of sequences or excessively
long sequences, in view of the PTO's limited human and computer

2.   How should the significantly higher cost associated with
searching applications claiming large numbers of sequences or
very long sequences be underwritten?  For example:
     a)   By fees from all applications?
     b)   By fees from the biotechnology industry applications only?
     c)   By fees from those specific applications involving large numbers
          of sequences or extraordinarily long sequences?

3.  To assist PTO in addressing the described challenges, do you
have any specific suggestions which would facilitate the
implementation of short-term solutions?  Do you have any
suggestions on how the PTO can address long-term solutions?

III.  Guidelines for Oral Testimony

     Individuals wishing to testify at the hearings must adhere
to the following guidelines:

1.   Requests to testify must include the speaker's name,
affiliation, title, phone number, fax number, mailing address,
and Internet mail address (if available).

2.   Speakers will be provided between seven and fifteen minutes
to present their remarks.  The exact amount of time allocated per
speaker will be determined after the final number of parties
testifying has been determined.  All efforts will be made to
accommodate requests presented before the day of the hearing for
additional time for testimony.

3.   Requests to testify may be accepted on the date of the
hearing if sufficient time is available on the schedule.  No one
will be permitted to testify without prior approval.

     A schedule providing approximate times for testimony will be
provided to all speakers the morning of the day of the hearing.

     Speakers are advised that the schedule for testimony may be
subject to change during the course of the hearings.

IV.  Guidelines for Written Comments

     Written comments should include the following information:

1.   Name and affiliation of the individual responding.

2.   If applicable, an indication of whether comments offered
represent views of the respondent's organization or are the
respondent's personal views.

3.   If applicable, information on the respondent's organization,
including the type of organization (e.g., business, trade group,
university, non-profit organization) and general areas of

     Information that is provided pursuant to this notice will be
made part of the public record.  In view of this, parties should
not provide information they do not wish publicly disclosed.
Parties who would like to rely on confidential information to
illustrate a point being made are requested to summarize or
otherwise provide the information in a way that will permit its
public disclosure.
     Parties offering testimony or written comments should
provide their comments in machine readable format, if possible.
Such submissions should be provided by electronic mail messages
over the Internet, or on a 3.5" floppy disk formatted for use in
either a Macintosh or MS-DOS based computer.  Machine readable
submissions should be provided as unformatted text (e.g., ACSII
or plain text), or as formatted text in one of the following file
formats:  Microsoft Word (Macintosh, DOS or Windows versions) or
WordPerfect (Macintosh, DOS or Windows versions).

V.  Guidelines for Comments via Internet

     Comments received via the Internet should include the same
information requested in the guidelines set out for written

VI.  Other Information

     Questions regarding the facilities and lodging in the
La Jolla, California, area should be directed to the University
of California, San Diego, Special Events, by telephone at
(619) 534-6386, or by fax to (619) 534-0905.  Parking permits are
required for on-campus parking and may be purchased in advance
through the Parking Office or on April 16 at Information booths
at the university.  Questions regarding parking should be
directed to the Special Events Parking Office at (619) 534-9682,
or by fax to (619) 534-9685.

_______________     _______________________________________
Date                BRUCE A. LEHMAN
                    Assistant Secretary of Commerce and
                      Commissioner of Patents and Trademarks