[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 
[email protected].
    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: [email protected].

for further information contact: Esther Kepplinger by telephone at 
(703) 308-2339, by facsimile transmission at (703) 305-3601, by 
electronic mail at [email protected], 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