[Federal Register Volume 64, Number 244 (Tuesday, December 21, 1999)]
[Notices]
[Pages 71440-71442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-33054]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office
[Docket No. 991027289-9289-01]
RIN 0651-AB09


Revised Utility Examination Guidelines; Request for Comments

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice and request for public comments.

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SUMMARY: The Patent and Trademark Office (PTO) requests comments from 
any interested member of the public on the following Revised Utility 
Examination Guidelines. The PTO is publishing a revised version of 
guidelines to be used by Office personnel in their review of patent 
applications for compliance with the utility requirement based on 
comments received in response to the 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. 63 FR 50887 (September 23, 1998). These 
Revised Utility Guidelines will be used by PTO personnel in their 
review of patent applications for compliance with the ``utility'' 
requirement of 35 U.S.C. 101. This revision supersedes the Utility 
Examination Guidelines that were published at 60 FR 36263 (1995) and at 
1177 O.G. 146 (1995).

DATES: Written comments on the Revised Utility Examination Guidelines 
will be accepted by the PTO until March 22, 2000.

ADDRESSES: Written comments should be addressed to Box 8, Commissioner 
of Patents and Trademarks, Washington, DC 20231, marked to the 
attention of Mark Nagumo, or to Box Comments, Assistant Commissioner 
for Patents, Washington, DC 20231, marked to the attention of Linda S. 
Therkorn. Alternatively, comments may be submitted to Mark Nagumo via 
facsimile at (703) 305-9373 or by electronic mail addressed to 
``mark.nagumo@uspto.gov''; or to Linda Therkorn via facsimile at (703) 
305-8825 or by electronic mail addressed to 
``linda.therkorn@uspto.gov.''

FOR FURTHER INFORMATION CONTACT:
Mark Nagumo by telephone at (703) 305-8666, by facsimile at (703) 305-
9373, by electronic mail ``mark.nagumo@uspto.gov,'' or by mail marked 
to his attention addressed to the Commissioner of Patents and 
Trademarks, Box 8, Washington, DC 20231; or Linda Therkorn by telephone 
at (703) 305-9323, by facsimile at (703) 305-8825, by electronic mail 
at ``linda. therkorn@uspto.gov,'' or by mail marked to her attention 
addressed to Box Comments, Assistant Commissioner of Patents and 
Trademarks, Washington, DC 20231.

SUPPLEMENTARY INFORMATION: The PTO requests comments from any 
interested member of the public on the following Revised Utility 
Examination Guidelines. As of the publication date of this notice, this 
revision will be used by PTO personnel in their review of patent

[[Page 71441]]

applications for compliance with the ``utility'' requirement of 35 
U.S.C. 101. Because this revision governs internal practices, it is 
exempt from notice and comment rulemaking under 5 U.S.C. 553(b)(A).
    Written comments should include the following information: (1) Name 
and affiliation of the individual responding, and (2) an indication of 
whether the comments offered represent views of the respondent's 
organization or are respondent's personal views.
    Parties presenting written comments are requested, where possible, 
to provide their comments in machine-readable format in addition to a 
paper copy. Such submissions may be provided by electronic mail 
messages sent over the Internet, or on a 3.5'' floppy disk formatted 
for use in a Macintosh, Windows, Windows for Workgroups, Windows 95, 
Windows 98, Windows NT, or MS-DOS based computer.
    Written comments will be available for public inspection on or 
about April 19, 2000, in Suite 918, Crystal Park 2, 2121 Crystal Drive, 
Arlington, Virginia. In addition, comments provided in machine readable 
format will be available through the PTO's Website at http://
www.uspto.gov.

I. Discussion of Public Comments

    Comments received by the Office in response to the request for 
public comment on the Interim Written Description Guidelines regarding 
the patentability of expressed sequence tags (ESTs) suggested the need 
for revision or clarification of the final Utility Examination 
Guidelines as published at 60 FR 36263 (1995) and 1177 O.G. 146 (1995). 
All comments have been carefully considered. Many comments stated that 
sufficient patentable utility has not been shown when the sole 
disclosed use of an EST is to identify other nucleic acids whose 
utility was not known, and the function of the corresponding gene is 
not known. Moreover, several comments opined that ESTs are genomic 
research tools that should be available for unencumbered research to 
advance the public good. One comment stated that asserted utilities for 
ESTs, such as mapping the genome or tissue typing, would probably not 
satisfy the requirements of 35 U.S.C. 101 if the length of the attached 
DNA sequence were greatly extended. Other comments stated that the 
disclosure of a DNA sequence alone is insufficient to enable scientists 
to use ESTs for mapping or tissue typing. Some comments suggested that 
PTO examination procedures would result in granting patents based on 
nonspecific and nonsubstantial utilities, contrary to established case 
law. See Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695 
(1966) (requiring disclosure of ``specific utility,'' and of 
``substantial utility,'' ``where specific benefit exists in currently 
available form''); accord, In re Ziegler, 992 F.2d 1197, 1201, 26 
USPQ2d 1600, 1603 (Fed. Cir. 1996) (requiring that a specific and 
substantial or practical utility for the invention be disclosed as a 
condition of meeting the practical utility requirement of Sec. 101). 
Consequently, a number of changes have been made to the Utility 
Examination Guidelines to clarify the position of the Patent and 
Trademark Office. Updated training material will be developed in the 
examination corps to address technology-specific issues.

II. Guidelines for Examination of Applications for Compliance With 
the Utility Requirement

A. Introduction

    The following guidelines establish the policies and procedures to 
be followed by Office personnel in the evaluation of any patent 
application for compliance with the utility requirements of 35 U.S.C. 
101 and 112. These guidelines have been promulgated to assist Office 
personnel in their review of applications for compliance with the 
utility requirement. The guidelines do not alter the substantive 
requirements of 35 U.S.C. 101 and 112, nor are they designed to obviate 
the examiner's review of applications for compliance with all other 
statutory requirements for patentability.

B. Examination Guidelines for the Utility Requirement

    Office personnel are to adhere to the following procedures when 
reviewing patent applications for compliance with the ``useful 
invention'' (``utility'') requirement of 35 U.S.C. 101 and 112, first 
paragraph.
    1. Read the claims and the supporting written description.
    (a) Determine what the applicant has claimed, noting any specific 
embodiments of the invention.
    (b) Ensure that the claims define statutory subject matter (i.e., a 
process, machine, manufacture, composition of matter, or improvement 
thereof).
    2. Review the claims and the supporting written description to 
determine if the applicant has asserted for the claimed invention any 
specific and substantial utility that is credible.
    (a) If the invention has a well-established utility, regardless of 
any assertion made by the applicant, do not impose a rejection based on 
lack of utility. An invention has a well-established utility if a 
person of ordinary skill in the art would immediately appreciate why 
the invention is useful based on the characteristics of the invention 
(e.g., properties or applications of a product or process).
    (b) If the applicant has asserted that the claimed invention is 
useful for any particular practical purpose (i.e., it has a ``specific 
and substantial utility'') and the assertion would be considered 
credible by a person of ordinary skill in the art, do not impose a 
rejection based on lack of utility.
    (1) A claimed invention must have a specific and substantial 
utility. This requirement excludes ``throw-away,'' ``insubstantial,'' 
or ``nonspecific'' utilities, such as the use of a complex invention as 
landfill, as a way of satisfying the utility requirement of 35 U.S.C. 
101.
    (2) Credibility is assessed from the perspective of one of ordinary 
skill in the art in view of the disclosure and any other evidence of 
record (e.g., test data, affidavits or declarations from experts in the 
art, patents or printed publications) that is probative of the 
applicant's assertions. An applicant need only provide one credible 
assertion of specific and substantial utility for each claimed 
invention to satisfy the utility requirement.
    (c) If no assertion of specific and substantial utility for the 
claimed invention made by the applicant is credible, and the claimed 
invention does not have a well-established utility, reject the claim(s) 
under section 101 on the grounds that the invention as claimed lacks 
utility. Also reject the claims under Sec. 112, first paragraph, on the 
basis that the disclosure fails to teach how to use the invention as 
claimed. The section 112, first paragraph, rejection imposed in 
conjunction with a section 101 rejection should incorporate by 
reference the grounds of the corresponding section 101 rejection.
    (d) If the applicant has not asserted any specific and substantial 
utility for the claimed invention and it does not have a well-
established utility, impose a rejection under section 101, emphasizing 
that the applicant has not disclosed a specific and substantial utility 
for the invention. Also impose a separate rejection under section 112, 
first paragraph, on the basis that the applicant has not disclosed how 
to use the invention due to the lack of a specific and substantial 
utility. The sections 101 and 112 rejections shift the

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burden of coming forward with evidence to the applicant to:
    (1) Explicitly identify a specific and substantial utility for the 
claimed invention; and
    (2) Provide evidence that one of ordinary skill in the art would 
have recognized that the identified specific and substantial utility 
was well established at the time of filing. The examiner should review 
any subsequently submitted evidence of utility using the criteria 
outlined above. The examiner should also ensure that there is an 
adequate nexus between the showing and the application as filed.
    3. Any rejection based on lack of utility should include a detailed 
explanation why the claimed invention has no specific and substantial 
credible utility. Whenever possible, the examiner should provide 
documentary evidence (e.g., scientific or technical journals, excerpts 
from treatises or books, or U.S. or foreign patents) to support the 
factual basis for the prima facie showing of no specific and 
substantial credible utility. If documentary evidence is not available, 
the examiner should specifically explain the scientific basis for his 
or her factual conclusions.
    (a) Where the asserted specific and substantial utility is not 
credible, a prima facie showing of no specific and substantial credible 
utility must establish that it is more likely than not that a person 
skilled in the art would not consider credible any specific and 
substantial utility asserted by the applicant for the claimed 
invention.
    The prima facie showing must contain the following elements:
    (1) An explanation that clearly sets forth the reasoning used in 
concluding that the asserted specific and substantial utility is not 
credible;
    (2) Support for factual findings relied upon in reaching this 
conclusion; and
    (3) An evaluation of all relevant evidence of record.
    (b) Where no specific and substantial utility is disclosed or 
known, a prima facie showing of no specific and substantial utility 
must establish that it is more likely than not that a person skilled in 
the art would not be aware of any well-established credible utility 
that is both specific and substantial.
    The prima facie showing must contain the following elements:
    (1) An explanation that clearly sets forth the reasoning used in 
concluding that there is no known well established utility for the 
claimed invention that is both specific and substantial;
    (2) Support for factual findings relied upon in reaching this 
conclusion; and
    (3) An evaluation of all relevant evidence of record.
    4. A rejection based on lack of utility should not be maintained if 
an asserted utility for the claimed invention would be considered 
specific, substantial, and credible by a person of ordinary skill in 
the art in view of all evidence of record.
    Office personnel are reminded that they must treat as true a 
statement of fact made by an applicant in relation to an asserted 
utility, unless countervailing evidence can be provided that shows that 
one of ordinary skill in the art would have a legitimate basis to doubt 
the credibility of such a statement. Similarly, Office personnel must 
accept an opinion from a qualified expert that is based upon relevant 
facts whose accuracy is not being questioned; it is improper to 
disregard the opinion solely because of a disagreement over the 
significance or meaning of the facts offered.
    Once a prima facie showing of no specific and substantial credible 
utility has been properly established, the applicant bears the burden 
of rebutting it. The applicant can do this by amending the claims, by 
providing reasoning or arguments, or by providing evidence in the form 
of a declaration under 37 CFR 1.132 or a printed publication that 
rebuts the basis or logic of the prima facie showing. If the applicant 
responds to the prima facie rejection, the Office personnel should 
review the original disclosure, any evidence relied upon in 
establishing the prima facie showing, any claim amendments, and nay new 
reasoning or evidence provided by the applicant in support of an 
asserted specific and substantial credible utility. It is essential for 
Office personnel to recognize, fully consider and respond to each 
substantive element of any response to a rejection based on lack of 
utility. Only where the totality of the record continues to show that 
the asserted utility is not specific, substantial, and credible should 
a rejection based on lack of utility be maintained.
    If the applicant satisfactorily rebuts a prima facie rejection 
based on lack of utility under section 101, withdraw the Sec. 101 
rejection and the corresponding rejection imposed under section 112, 
first paragraph.

    Dated: December 16, 1999.
Q. Todd Dickinson,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 99-33054 Filed 12-20-99; 8:45 am]
BILLING CODE 3510-16-M