(90) Department of Commerce
Patent and Trademark Office
[Docket No. 950706172-5172-01]
Utility Examination Guidelines
Agency: Patent and Trademark Office, Commerce.
Action: Notice.
Summary: The Patent and Trademark Office (PTO) is publishing the final
version of guidelines to be used by Office personnel in their review of
patent applications for compliance with the utility requirement. Because
these guidelines govern internal practices, they are exempt from notice
and comment and delayed effective date rulemaking requirements under 5
U.S.C. 553(b)(A).
Effective Date: July 14, 1995.
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. Discussion of Public Comments
Forty-four comments were received by the Office in response to the
request for public comment on the proposed version of utility guidelines
published on January 3, 1995 (60 FR 97). All comments have been
carefully considered. A number of changes have been made to the
examining guidelines and the legal analysis supporting the guidelines in
response to the comments received.
Many of the individuals responding to the request for public comments
suggested that the Office address the relationship between the
requirements of 35 U.S.C. 112, first paragraph, and 35 U.S.C. 101.
The Office has amended the guidelines to provide a clarification
consistent with these requests. The guidelines now specify that any
rejection based on a "lack of utility" under 101 should be
accompanied by a rejection based upon 112, first paragraph. The
guidelines also specify that the procedures for imposition and review of
rejections based on lack of utility under 101 shall be followed with
respect to the 112 rejection that accompanies the 101 rejection.
A suggestion was made that the guidelines should be modified to
provide that an application shall be presumed to be compliant with
112, first paragraph, if there is no proper basis for imposing a 101
rejection. This suggestion has not been followed. Instead, the
guidelines specify that 112, first paragraph, deficiencies other than
those that are based on a lack of utility be addressed separately from
those based on lack of utility for the invention.
Several individuals suggested that the guidelines address how 101
compliance will be reviewed for products that are either intermediates
or whose ultimate function or use is unknown. The Office has amended the
guidelines to clarify how it will interpret the "specific utility"
requirement of 101.
Some individuals suggested that the guidelines be amended to preclude
Examiners from requiring that an applicant delete references made in the
specification to the utility of an invention which are not necessary to
support an asserted utility of the claimed invention. The guidelines
have been amended consistent with this suggestion.
One individual suggested that the legal analysis be amended to
emphasize that any combination of evidence from in vitro or in vivo
testing can be sufficient to establish the credibility of an asserted
utility. The legal analysis has been amended consistent with this
recommendation.
A number of individuals questioned the legal status of the
guidelines, particularly with respect to situations where an applicant
believes that a particular Examiner has failed to follow the
requirements of the guidelines in imposing a rejection under 101. The
guidelines and the legal analysis supporting the guidelines govern the
internal operations of the Patent and Trademark Office. They are not
intended to, nor do they have the force and effect of law. As such they
are not substantive rules creating or altering the rights or obligations
of any party. Rather, the guidelines define the procedures to be
followed by Office personnel in their review of applications for 101
compliance. The legal analysis supporting the guidelines articulates the
basis for the procedures established in the guidelines. Thus, an
applicant who believes his or her application has been rejected in a
manner that is inconsistent with the guidelines should respond
substantively to the grounds of the rejection. "Non-compliance" with the
guidelines will not be a petitionable or appealable action.
Some individuals suggested that the guidelines and legal analysis be
amended to specify that the Office will reject an application for
lacking utility only in those situations where the asserted utility is
"incredible." This suggestion has not been adopted. The Office has
carefully reviewed the legal precedent governing application of the
utility requirement. Based on that review, the Office has chosen to
focus the review for compliance with 101 and 112, first paragraph,
on the "credibility" of an asserted utility.
Some individuals suggested that the guidelines be amended to address
how a generic claim that covers many discrete species will be assessed
with regard to the "useful invention" requirements of 101 and 112
when one or more, but not all, species within the genus do not have a
credible utility. The guidelines have been amended to clarify how the
Office will address applications in which genus claims are presented
that encompass species for which an asserted utility is not credible.
The legal analysis makes clear that any rejection of any claimed subject
matter based on lack of utility must adhere to the standards imposed by
these guidelines. This is true regardless of whether the claim defines
only a single embodiment of the invention, multiple discrete embodiments
of the invention, or a genus encompassing many embodiments of the
invention. As cast in the legal analysis and the guidelines, the focus
of examination is the invention as it has been defined in the claims.
Some individuals questioned whether the guidelines and the legal
analysis govern actions taken by Examining Groups other than Group 1800
or the Board of Patent Appeals and Interferences. The guidelines apply
to all Office personnel, and to the review of all applications,
regardless of field of technology.
In addition to the changes made in response to comments from the
public, the Office has amended the guidelines to clarify the procedure
to be followed when an applicant has failed to identify a specific
utility for an invention. The guidelines now provide that where an
applicant has made no assertion as to why an invention is believed
useful, and it is not immediately apparent why the invention would be
considered useful, the Office will reject the application as failing to
identify any specific utility for the invention. The legal analysis has
also been amended to address evaluation of this question.
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 application for
compliance with the utility requirements of 35 U.S.C. 101 and 112.
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. The guidelines have been promulgated to assist Office
personnel in their review of applications for compliance with the
utility requirement. The guidelines and the legal analysis do not alter
the substantive requirements of 35 U.S.C. 101 and 112, nor are
they designed to obviate review of applications for compliance with this
statutory requirement.
B. Examination Guidelines for the Utility Requirement
Office personnel shall adhere to the following procedures when
reviewing applications for compliance with the "useful invention"
("utility") requirement of 35 U.S.C. 101 and 35 U.S.C. 112, first
paragraph.
1. Read the specification, including the claims, to:
a) determine what the applicant has invented, noting any specific
embodiments of the invention;
a) ensure that the claims define statutory subject matter (e.g., a
process, machine, manufacture, or composition of matter);
b) note if applicant has disclosed any specific reasons why the
invention is believed to be "useful."
2. Review the specification and claims to determine if the applicant has
asserted any credible utility for the claimed invention:
a) If the applicant has asserted that the claimed invention is useful
for any particular purpose (i.e., a "specific utility") and that
assertion would be considered credible by a person of ordinary skill in
the art, do not impose a rejection based on lack of utility. 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. An
applicant must provide only one credible assertion of specific utility
for any claimed invention to satisfy the utility requirement.
b) 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 of a product or obvious application of a process).
c) If the applicant has not asserted any specific utility for the
claimed invention and it does not have a well established utility,
impose a rejection under 101, emphasizing that the applicant has not
disclosed a specific utility for the invention. Also impose a separate
rejection under 112, first paragraph, on the basis that the applicant
has not shown how to use the invention due to lack of disclosure of a
specific utility. The 101 and 112, rejections should shift the
burden to the applicant to:
-- explicitly identify a specific utility for the claimed inven
tion, and
-- indicate where support for the asserted utility can be
found in the specification.
Review the subsequently asserted utility by the applicant using the
standard outlined in paragraph (2)(a) above, and ensure that it is fully
supported by the original disclosure.
3. If no assertion of specific 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 101 on the
grounds that the invention as claimed lacks utility. Also reject the
claims under 112, first paragraph, on the basis that the disclosure
fails to teach how to use the invention as claimed. The 112, first
paragraph, rejection imposed in conjunction with a 101 rejection
should incorporate by reference the grounds of the corresponding 101
rejection and should be set out as a rejection distinct from any other
rejection under 112, first paragraph, not based on lack of utility
for the claimed invention.
To be considered appropriate by the Office, any rejection based on
lack of utility 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 skilled in the art would not consider
credible any specific utility asserted by the applicant for the claimed
invention. A prima facie showing must contain the following elements:
i) a well-reasoned statement that clearly sets forth the reasoning used
in concluding that the asserted utility is not credible;
ii) support for factual findings relied upon in reaching this
conclusion; and
iii) support for any conclusions regarding evidence provided by the
applicant in support of an asserted utility.
b) Specific evidence that supports any fact-based assertions needed to
establish the prima facie showing.
Whenever possible, Office personnel must provide documentary evidence
(e.g., scientific or technical journals, excerpts from treatises or
books, or U.S. or foreign patents) as the form of support used in
establishing the factual basis of a prima facie showing of no utility
according to items (a)(ii) and (a)(iii) above. If documentary evidence
is not available, Office personnel shall note this fact and specifically
explain the scientific basis for the factual conclusions relied on in
sections (a)(ii) and (a)(iii).
4. A rejection based on lack of utility 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 basis or logic of
the prima facie showing. If the applicant responds to the prima facie
rejection, Office personnel shall 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 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 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 101, withdraw the 101 rejection and the
corresponding rejection imposed under 112, first paragraph, per
paragraph (3) above.
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.
III. Additional Information
The PTO has prepared an analysis of the law governing the utility
requirement to support the guidelines outlined above. Copies of the
legal analysis can be obtained from Jeff Kushan, who can be reached
using the information indicated above.
July 3, 1995 BRUCE A. LEHMAN
Assistant Secretary of Commerce
and Commissioner of Patents
and Trademarks
[1177 OG 146]