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.
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 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
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.
December 16, 1999 Q. TODD DICKINSON
Assistant Secretary of Commerce and
Commissioner of Patents and Trademarks