[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 ``<a href="/cdn-cgi/l/email-protection#91f2fefcfcf4ffe5e2bc9bf3f8fee5f4f2f9d1e4e2e1e5febff6fee7">comments-
<span class="__cf_email__" data-cfemail="4e2c27213a2b2d260e3b3d3e3a2160292138">[email protected]</span></a>.'' 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 <a href="/cdn-cgi/l/email-protection#b0dbc5c3d8d1def0c5c3c0c4df9ed7dfc6"><span class="__cf_email__" data-cfemail="721907011a131c32070102061d5c151d04">[email protected]</span></a>, 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

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