[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Notices]
[Pages 50887-50889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25355]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office
[Docket No. 980605148-8148-01]


Request for Comments on Interim Guidelines for Examination of 
Patent Applications Under the 35 U.S.C. 112 para. 1 ``Written 
Description'' Requirement; Extension of Comment Period and Notice of 
Hearing

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of hearings, extension of comment period 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 the ``written 
description'' requirement under 35 U.S.C. 112 para. 1. 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 Wednesday, November 4, 1998, and 
Friday, November 6, 1998, starting each day at 9 a.m. and ending no 
later than 5:00 p.m.
    Those wishing to present oral testimony at either of the hearings 
must request an opportunity to do so no later than Friday, October 30. 
Speakers may provide a written copy of their testimony for inclusion in 
the record of the proceedings no later than November 12, 1998.
    To ensure consideration, written comments should be received at the 
PTO by November 12, 1998. Written comments and transcripts of the 
hearings will be available for public inspection on or about Monday, 
November 16, 1998.

ADDRESSES: The November 4th hearing will be held at the Marriott Long 
Wharf, Salons D, E, F, 296 State Street, Boston, MA 02109. Questions 
regarding the facilities and lodging should be directed to the Marriott 
Long Wharf, TEL (617) 227-0800, FAX (617) 227-2867.
    The November 6th hearing will be held at The Sheraton San Diego 
Hotel & Marina, West Tower, Coronado Ballroom, 1590 Harbor Island 
Drive, San Diego, CA 92101-1092. Questions regarding the facilities and 
lodging should be directed to The Sheraton San Diego Hotel & Marina, 
West Tower, TEL (619) 291-2900, FAX (619) 692-2337.
    Requests to testify should be sent to Mary Critharis by telephone 
at (703) 305-9300, by facsimile transmission at (703) 305-8885, or by 
mail marked to attention of Mary Critharis addressed to the Assistant 
Commissioner for Patents, Box 4, Washington, DC 20231. No requests for 
oral testimony will be accepted through electronic mail.
    Written comments should be addressed to Box 8, Commissioner of 
Patents and Trademarks, Washington, D.C. 20231, marked to the attention 
of Scott A. Chambers, Associate Solicitor, or to Box Comments, 
Assistant Commissioner for Patents, Washington, D.C. 20231, marked to 
the attention of Linda S. Therkorn. Comments may be submitted by 
facsimile transmission to Scott A. Chambers at (703) 305-9373, or to 
Linda S. Therkorn at (703) 305-8825. Comments may be submitted by 
electronic mail to [email protected], or to 
[email protected].
    Written comments and transcripts of the hearings will be maintained 
for public inspection in Suite 918 of Crystal Park Two, 2121 Crystal 
Drive, Arlington, Virginia. Transcripts and comments provided in 
machine readable format will be available through anonymous file 
transfer protocol (ftp) via the Internet (address: comments.uspto.gov) 
and through the World Wide Web (address: www.uspto.gov).

FOR FURTHER INFORMATION CONTACT: Scott A. Chambers by telephone at 
(703) 305-9035, by facsimile transmission at (703) 305-9373, by mail to 
his attention addressed to Box 8, Commissioner of Patents and 
Trademarks, Washington, DC 20231, or by electronic mail at 
[email protected]; or Linda S. Therkorn by telephone at (703) 
305-8800, by facsimile at (703) 305-8825, by mail to her attention 
addressed to Box Comments, Assistant Commissioner for Patents, 
Washington, D.C. 20231, or by electronic mail at 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Interim Guidelines for Examination of Patent Applications Under the 
35 U.S.C. 112 para. 1, ``Written Description'' Requirement were 
published at 63 FR

[[Page 50888]]

32639, June 15, 1998, and at 1212 O.G. 15, July 7, 1998. The period for 
comment on the Interim Guidelines was originally set to end September 
14, 1998. The period for comment is now extended. Comments will be 
accepted by the PTO until November 12, 1998.
    These guidelines are intended to assist examiners at the PTO in 
finding the attributes necessary to support the written description 
requirement of 35 U.S.C. 112 para. 1, in view of University of 
California v. Eli Lilly, 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 
1997), and the earlier cases Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 
1601 (Fed. Cir. 1993), and Amgen, Inc. v. Chugai Pharmaceutical Co., 
927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991). The PTO endeavors to 
provide clear guidance to Office personnel in their task of 
administering the law so that consistent results are achieved. To 
ensure that examiners know when applicants have satisfied the 
requirements, the guidelines identify criteria supporting the 
determination that an application is in compliance with statutory 
requirements. The PTO invites the public to assist it in identifying 
the appropriate descriptive attributes that Office personnel should 
rely on in their determinations.
    The PTO requests comments from any interested member of the public 
on the interim guidelines. Although the guidelines are directed 
primarily to written descriptions of biotechnological inventions, they 
reflect the current understanding of the PTO and apply across the board 
to all relevant technologies. Because these guidelines govern internal 
practices, they are exempt from notice and comment rulemaking under 5 
U.S.C. 553(b)(A).

II. Issues for Public Comment

    Interested members of the public are invited to testify or to 
present written comments related to the written description 
requirement, including the following issues.
    1. Is the methodology in the interim guidelines accurate? If not, 
please:
    (a) Identify any legal and/or technical inaccuracies;
    (b) Identify any changes to the guidelines that would improve their 
accuracy; and
    (c) Provide explanations and/or legal basis for your comments.
    2. Do the guidelines list the appropriate relevant factors and 
descriptive attributes to consider in determining whether the written 
description requirement of 35 U.S.C. 112 para. 1, is satisfied? If not, 
please:
    (a) Identify factors and descriptive attributes which have been 
omitted;
    (b) Identify any examples or parts of the analysis which are over 
inclusive; or
    (c) Explain any changes which would improve the analysis.
    3. Should the scope of these guidelines be limited to certain 
technologies? If so, please:
    (a) Identify the technologies that should be encompassed, and
    (b) Give reasons why the guidelines should not encompass other 
technologies generally.
    4. Should the scope of these guidelines encompass all technologies? 
If so, please:
    (a) State reasons why the guidelines should encompass technologies 
in addition to those discussed in the interim guidelines;
    (b) Give specific, factual examples that the guidelines should 
address, and how 35 U.S.C. 112 para. 1, applies to the examples; and
    (c) If these examples are subject to a rejection, how that 
rejection could be overcome.
    5. How should ``possession of the invention'' be defined for 
purposes of applying the written description requirement?
    6. How should the transition terms ``having'' and ``consisting 
essentially of'' be treated within the context of nucleotide and amino 
acid sequence claims?
    7. How should the guidelines be expanded to specifically address 
process and/or product-by-process claims?
    (a) Please suggest examples of process or product-by-process claims 
you want to see addressed in the guidelines, and how 35 U.S.C. 112 
para. 1, applies to the examples;
    (b) Suggest how the examples of process or product-by-process 
claims should be analyzed under the guidelines; and
    (c) If these examples are subject to a rejection, how that 
rejection could be overcome.
    8. How should the final guidelines address the deposit of a 
biological material made under 37 CFR 1.801?
    (a) Please suggest how the date of deposit should be considered 
with respect to establishing possession of the invention at the time of 
filing;
    (b) Suggest what significance should be assigned to a deposit in 
assessing compliance with the written description requirement; and
    (c) Comment on the extent to which a deposit of biological material 
may be relied on to support the addition of sequence information or the 
correction of sequence information in the originally filed application.
    9. What impact will the guidelines have on issued patents, 
currently pending applications, or applications to be filed after 
publication of the final written description guidelines?
    10. Is there any basis in law or fact for treating expressed 
sequence tags (ESTs) differently than any other nucleic acid under the 
written description requirement?
    11. Are there additional issues related to other statutory 
requirements of Title 35 invoked in the patenting of ESTs? If so, 
please set forth those issues separately and specifically.

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 have 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

[[Page 50889]]

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., ASCII 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.

    Dated: September 16, 1998.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 98-25355 Filed 9-22-98; 8:45 am]
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