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 USC 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 USC 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 USC 101 and 35 USC 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 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 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:

- explicitly 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 is 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 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 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 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.