[Federal Register Volume 64, Number 244 (Tuesday, December 21, 1999)]
[Notices]
[Pages 71440-71442]
From the Federal Register Online via the Government Publishing 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
