3.1 PTO Utility Guidelines

Patents / Biotechnology / US Biotechnology Practice

Criticism of the PTO on the ground that the tests that it was employing for determination of utility were too tough, especially in the field of biotechnology led to a number of public hearings in 1994 following which new utility examination guidelines and accompanying legal analysis were finalized on July 14, 1995 and are applicable to all inventions. These guidelines were then criticized as being too liberal in their approach and as having swung too far in the opposite direction. They have been replaced by new guidelines that were issued in January 2001. [29] The guidelines include specific provisions concerning inventions for biotechnology and human therapy but are stated to be of general application.

The guidelines provide that the Examiner is to review the application to determine if the applicant has asserted any specific, substantial and credible utility for the claimed invention. [30] The requirement that the utility disclosed is “specific and substantial” is new and aimed mainly at problems that have arisen in the biotechnology industry where, for example an invention may involve a new protein whose function has not yet been determined. The USPTO is trying to discourage claims that such an invention meets the utility requirements simply because it could be used, for example as land fill.

The development of the biotechnology industry has presented new problems in defining utility, especially when what is claimed is a piece of DNA. Under the guidelines, the current test being applied by the USPTO is to enquire whether or not what is claimed has a specific, substantial and credible utility. This test adds the requirement of substantiality to the guidelines used previously. The reason for the change was to avoid the claims, for example to a new protein which claimed its utility as an animal feed because, although the protein had been isolated from a cell, no-one yet knew what it function was. Similar problems arise with pieces of DNA which are stated to be probes but no information is given as to what they are probes for. Products that require further research to find out what their “real world” function is will be regarded as lacking utility, an approach that seems fully consistent with Brenner v. Mason. Such an analysis is now used by the USPTO not only to reject applications in which no specific, substantial and credible utility is disclosed but also to narrow claims in applications where such utility has been shown, but only for specific materials so that the claims are commensurate in scope with the utility shown. Such an approach may be used, for example, to force the applicant to replace the word “comprising” when referring to a piece of DNA by the words “consisting of”.

The utility guidelines should be read in conjunction with the USPTO’s training materials. The Examiners are advised that if the applicant has asserted that the claimed invention is useful for any particular purpose and this assertion would be considered credible by a person of ordinary skill in the art, in view of all the evidence of record, or if the invention has a well established utility wherein a person of ordinary skill in the art would immediately appreciate why the invention is useful then a rejection based on lack of utility is not to be made. If the applicant asserts that the claimed process is useful for treating a human or animal and this utility is credible, the Examiner should not require that the applicant demonstrate that the therapeutic agent is safe or fully effective. The applicant has to provide a "reasonable correlation between the activity and the asserted use." Data from in vitro or animal testing even if not in an art recognized model is generally sufficient to support the asserted utility and the Examiner should not require the submission of clinical data.

If the applicant, however, has not asserted any specific utility for the claimed invention and the invention does not have a well-established utility, a lack of utility rejection under 35 USC § 101 is to be made. A separate rejection under 35 USC § 112, first paragraph, is also to be made, "on the basis that the applicant has not shown how to use the invention due to lack of disclosure of a specific utility."

In order to support the utility rejection, the Examiner must establish a prima facie showing 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:

(i) a well reasoned statement that clearly sets forth the reasoning used in concluding that the asserted utility is not credible; (ii) support for the factual findings relied upon by the Examiner in reaching this conclusion; and (iii) support for any 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.

The guidelines provide that the Examiner whenever possible must provide documentary evidence to support the factual basis needed to establish a prima facie showing of no utility.

Once the Examiner has made a prima facie showing, the burden shifts to the applicant to rebut the prima facie showing. This can be done, inter alia , by amending the claims, providing reasoning or arguments, or by providing evidence in the form of a declaration under 37 CFR 1.132 or printed publications.

The Examiner is then to review the original disclosure, the evidence of record and the applicant's submission and "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."

The most recent problem that has arisen is in respect of research tools. As noted above, Brenner v Manson emphasized that for protection an invention had to be more than experimental. This has raised questions as to whether, for example probes consisting of short sequences of DNA, for example expression sequence tags used for identifying longer pieces of DNA such as genes are patentable. Although this issue has attracted most attention in the field of expression sequence tags (EST's - pieces of DNA that can be used to try to find new genes by hybridizing to them), it is in fact part of a broader issue as to the proper scope of research tool patents in general and whether they should be permitted to cover products obtained by their use or just the use of the research tool itself.

The PTO’s current approach to EST’s is set out in the current training materials. Essentially these indicate that an examiner should ask the following questions when assessing issues of utility:

1) Does the claimed invention have a well established utility that is specific, substantial and credible?
2) If not, has the applicant made any assertion of utility?
3) If yes, is that assertion specific?
4) If yes, does that assertion identify a substantial utility?
5) If yes, is the assertion of specific and substantial utility credible?

Applying these tests to the issue of a claim for DNA fragments the training materials indicate that if the specification lacks evidence of an activity for the DNA or proteins coded therefrom and simply asserts utility as a probe to obtain a gene, the proper approach to take is to reject the claim on the ground that there is no specific or substantial utility asserted. The training materials indicate that in such a case, the use of the DNA fragment is not particular to the sequence being claimed (almost any DNA fragment can be used as a probe) and so is not specific and that in the absence of knowledge as to whether the protein that would be coded by any gene found by the probe has any substantial utility, the probe lacks substantial utility.

Other specific situations addressed in the training materials include:

Claims to methods of treating a disease where either the disease is unspecified, in which case the claim should be rejected as lacking substantial utility because too much research would be required to determine the diseases that can be treated, or where the disease is defined simply by way of reference to an underlying mechanism (e.g. inhibiting a particular enzyme), in which case the claim should be rejected as lacking substantial utility unless the applicant can show by literature references or evidence that one skilled in the art would know that such underlying mechanism was associated with particular diseases.

Claims to receptors which meet the requirement for substantial utility only if there is disclosure of a disease or condition associated with the receptor. Without disclosure of such a specific disease or condition, simply saying that the receptor can be used to identify compounds that can bind to it or make monoclonal antibodies that bind to it does not meet the requirement of “real world” utility since too much research would still be required to make practical use of the invention.

[29] Federal Register Vol 66 1092 - 1099 (January 5, 2001). The changes that were finally promulgated in 2001 followed the issue of interim guidelines and training materials in 1999. The major change between the 1995 guidelines and the 2001 guidelines was to add the requirement that the claimed utility had to be “substantial” as well as specific and credible. The training materials can be found on the Internet at http://www.uspto.gov/web/menu/utility.pdf.

[30] These terms are defined as follows:

Credibility: An assertion is credible unless (A) the logic underlying the assertion is seriously flawed or (B) the facts on which the assertion is based are inconsistent with the logic underlying the assertion.

Specificity: a utility that is specific to the subject matter claimed. ... For example, a claim to a polynucleotide whose use is disclosed simply as a “gene probe” or a “chromosome marker” would not be considered to be specific in the absence of disclosure of a specific DNA target.

Substantiality: a utility that defines a “real world” use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use are not substantial utilities.

For example claiming a new protein as an animal food supplement or a shampoo ingredient would, according to the PTO materials meet neither the requirement of being substantial nor specific since the only properties claimed are properties common to all proteins.

[Home] [About Ladas & Parry LLP] [Contact Us] [Search]
[Trademarks] [Domain Names & E-Commerce] [Patents & Copyrights]
[Litigation] [IP Rights Maintenance] [IP as Property] [News & Bulletins]