[Federal Register: September 23, 1998 (Volume 63, Number 184)]
[Notices]
[Page 50887-50889]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23se98-47]
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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 scott.chambers@uspto.gov, or to
linda.therkorn@uspto.gov.
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
scott.chambers@uspto.gov; 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
linda.therkorn@uspto.gov.
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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