[Federal Register Volume 61, Number 49 (Tuesday, March 12, 1996)]
[Notices]
[Pages 9980-9982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5840]
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DEPARTMENT OF COMMERCE
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.
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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, 1996.
Written comments and transcripts of the hearings will be available
for public inspection on or about Monday, May 13, 1996.
addresses: The April 16 hearings 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
sequences@uspto.gov.
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: sequences@uspto.gov.
for further information contact: Esther Kepplinger by telephone at
(703) 308-2339, by facsimile transmission at (703) 305-3601, by
electronic mail at ekepplin@uspto.gov, or by mail marked to her
attention addressed to the Assistant Commissioner for Patents, Box
Comments-Patents, Washington, D.C. 20231.
SUPPLEMENTARY INFORMATION:
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 public.
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
[[Page 9981]]
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 search.
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 resources?
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 interest.
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 comments.
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.
[[Page 9982]]
Dated: March 6, 1996.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 96-5840 Filed 3-11-96; 8:45 am]
BILLING CODE 3510-16-M
