[Federal Register Volume 60, Number 1 (Tuesday, January 3, 1995)]
[Notices]
[Pages 97-98]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32314]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. 941259-4359]
Request for Comments on Proposed Utility Examination Guidelines
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 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, DC
20231. Comments may also be submitted by telefax at (703) 305-8885 and
by electronic mail through the Internet to ``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 [[Page 98]]
--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 MS-
DOS 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, DC 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 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 section 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 section 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 section 101. To be
considered appropriate by the Office, a rejection under section 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 section 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 section 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 governing 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.
Dated: December 23, 1994.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and
Trademarks.
[FR Doc. 94-32314 Filed 12-30-94; 8:45 am]
BILLING CODE 3510-16-M
