[Federal Register Volume 60, Number 135 (Friday, July 14, 1995)]
[Notices]
[Pages 36263-36265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17304]



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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. 950706172-5172-01]


Utility Examination Guidelines

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice.

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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 [email protected], 
or by mail marked to his attention addressed to the Commissioner of 
Patents and Trademarks, Box 4, Washington, DC 20231.

SUPPLEMENTARY INFORMATION:

I. Discussion of Public Comments

    Forty-four comments were received by the Office in response to the 
request to 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 section 101 should be accompanied 
by a rejection based upon section 112, first paragraph. The guidelines 
also specify that the procedures for imposition and review of 
rejections based on lack of utility under section 101 shall be followed 
with respect to the section 112 rejection that accompanies the section 
101 rejection.
    A suggestion was made that the guidelines should be modified to 
provide that an application shall be presumed to be compliant with 
section 112, first paragraph, if there is no proper basis for imposing 
a section 101 rejection. This suggestion has not been followed. 
Instead, the guidelines specify that section 112, first paragraph, 
deficiencies other than those that are based on a lack of utility be 
addressed separately from those based on a lack of utility for the 
invention.
    Several individuals suggested that the guidelines address how 
section 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 section 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 section 
101. The guildeines 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 

[[Page 36264]]
rights or obligations of any party. Rather, the guidelines define the 
procedures to be followed by Office personnel in their review of 
applications for section 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 Section 101 and Section 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 
sections 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 or 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;
    (b) Ensure that the claims define statutory subject matter (e.g., a 
process, machine, manufacture, or composition of matter);
    (c) Note is 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 section 101, emphasizing that the applicant 
has not disclosed a specific utility for the invention. Also impose a 
separate rejection under section 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 sections 101 and 112, 
rejections should shift the burden to the applicant to:

--Explicityly identify a specific utility for the claimed invention, 
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 section 101 
on the grounds that the invention as claimed lacks utility. Also reject 
the claims under section 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 and should be set out as a 
rejection distinct from any other 

[[Page 36265]]
rejection under section 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 he 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 section 101, withdraw the section 101 
rejection and the corresponding rejection imposed under section 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.

    Dated: July 3, 1995.
Bruce A. Lehman,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 95-17304 Filed 7-13-95; 8:45 am]
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