Department of Commerce
Patent and Trademark Office
Request for Comments on Proposed
Utility Examination Guidelines
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 proposed internal guidelines that will
be used by patent examiners in their review of patent applications for
compliance with 35 U.S.C. 101. Because these guidelines govern internal
practices, they are exempt from notice and comment rulemaking under 5
U.S.C. 553(b)(A).
Dates: Written comments on the proposed guidelines will be accepted by the
PTO until February 24, 1995.
Addresses: Written comments should be addressed to the Commissioner of
Patents and Trademarks, marked to the attention of Jeff Kushan. Comments
submitted by mail should be sent to Commissioner of Patents and
Trademarks, Box 4, Patent and Trademark Office, Washington, D.C. 20231.
Comments may also be submitted by telefax at (703) 305-8885 and by
electronic mail through the Internet to "comments-biotech@uspto.gov."
Written comments should include the following information:
- name and affiliation of the individual responding;
-an indication of whether comments offered represent views of the
respondent's organization or are the respondent's personal views; and
-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.
Parties presenting written comments are requested, where possible, to
provide their comments in machine readable format. Such submissions may be
provided by electronic mail messages sent over the Internet, or on a 3.5"
floppy disk formatted for use in either a Macintosh or MSDOS based
computer. Machine-readable submissions should be provided as unformatted
text (e.g., ASCII or plain text).
Written comments will be available for public inspection on or about
March 1, 1995, in Room 902 of Crystal Park Two, 2121 Crystal Drive,
Arlington, Virginia. In addition, comments provided in machine readable
format will be available on or around March 1, 1995, 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: Jeff Kushan by telephone at (703)
305-9300, by fax at (703) 305-8885, by electronic mail at
kushan@uspto.gov, or by mail marked to his attention addressed to the
Commissioner of Patents and Trademarks, Box 4, Washington, D.C. 20231.
Supplementary Information
I. 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 Examiners when examining applications for compliance with the
utility requirement of 35 U.S.C. 101. The guidelines also address
issues that may arise during examination of applications claiming
protection for inventions in the field of biotechnology and human therapy.
The guidelines are accompanied by an overview of applicable legal
precedent governing the utility requirement.
B. Guidelines for Examination of Applications for Compliance With 35
U.S.C. 101
Examiners must adhere to the following procedures when examining
applications for compliance with 35 U.S.C. 101.
1. Determine what the applicant has claimed as his or her invention. This
is done to:
a) ensure that the applicant has claimed statutory subject matter
(e.g., a process, a machine, a composition or a manufacture); and
b) ascertain what the invention is for purposes of determining whether
it is "useful."
2. Review the specification and claims to determine if the applicant has
disclosed or asserted or any credible utility for the claimed invention.
a) If the applicant has asserted that the claimed invention is useful
for any particular purpose and that assertion would be considered credible
by a person of ordinary skill in the art, the Examiner should not impose a
rejection based on 101. Credibility is to be assessed from the
perspective of one of ordinary skill in the art in view of any evidence of
record (e.g., data, statements, opinions, references, etc.) that is
relevant to the applicant's assertions.
b) If the applicant has not asserted that the claimed invention is
useful for a particular purpose but such a use would be readily apparent
to a person of ordinary skill in the art, the Examiner should not impose a
rejection under 101.
3. If the applicant has not asserted any credible utility for the claimed
invention or a utility would not be readily apparent to one of ordinary
skill in the art, reject the claims under 101. To be considered
appropriate by the Office, a rejection under 101 must include the
following elements:
a) A prima facie showing that the claimed invention has no utility. A
prima facie showing of no utility must establish that it is more likely
than not that a person of ordinary skill in the art would not consider
credible any utility for the claimed invention that has been asserted by
the applicant. Where no utility has been asserted in the disclosure, the
prima facie showing must support a finding that a person of ordinary skill
would not be able to ascertain any use for the claimed invention. A prima
facie showing must contain:
i) a well-reasoned statement by the Examiner that clearly sets forth the
reasoning used in reaching his or her conclusions;
ii) support for factual findings relied upon by the Examiner in reaching
his or her conclusions; and
iii) support for conclusions of the Examiner that evidence provided by the
applicant to support an asserted utility would not be considered
persuasive to a person of ordinary skill in the art.
b) Evidence that supports any factual assertions relied upon by the
Examiner in establishing the prima facie showing. Whenever possible, the
Examiner must provide documentary evidence that supports the factual basis
of a prima facie showing of no utility (e.g., scientific or technical
journals. excerpts from treatises or books, or U.S. or foreign patents).
If documentary evidence is not available, the Examiner should note this
fact and specifically explain the scientific basis for his or her
conclusions.
4. A rejection under 101 should not be maintained if an asserted
utility for the claimed invention would be considered credible by a person
of ordinary skill in the art in view of all evidence of record.
Once a prima facie showing of no 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 prima facie showing. Once a response
has been received by the Examiner, he or she should review the original
disclosure, any evidence relied upon in establishing the prima facie
showing, any claim amendments and any new reasoning or evidence provided
by the applicant in support of an asserted utility. It is essential that
the Examiner recognize, fully consider and respond to each substantive
element of any response to a rejection under 101.
Examiners are reminded that they must treat as true credible statements
made by an applicant or a declarant in the specification or in a
declaration provided under 37 CFR 1.132, unless they can show that one
of ordinary skill in the art would have a rational basis to doubt the
truth of such statements. Thus, not accepting the opinion of a qualified
expert that is based on an appropriate factual record would clearly be
improper.
II. Additional Information
The PTO has prepared an analysis of the law goveming 35 U.S.C. 101
to support the guidelines outlined above. Interested members of the public
are invited to comment on the legal analysis as well as the guidelines.
Copies of the legal analysis can be obtained from Jeff Kushan, who can be
reached using the information indicated above.
December 23, 1994 BRUCE A. LEHMAN
Assistant Secretary of Commerce and
Commissioner of Patents and Trademarks