Patents: Biotechnological applications; written description requirements; guidelines; comment request,

[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]

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.

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:

1. 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

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   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).

2. 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 filedapplication.

   9. What impact will the guidelines have on issued patents, currently pending applications, or applications to be filedafter 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.

3. 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.

4. 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

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   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).

5. 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. 98-25355Filed9-22-98; 8:45 am]

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