WHAT MAKES A CHEMICAL INVENTION USEFUL? - Patent law

Now,let’s turn our attention to the second component of the utility requirement,which requires that the claimed subject matter must be useful. As one court opined:“a simple everyday word [such as useful] can be pregnant with ambiguity when applied to the facts of life.” The contours of the utility requirement can be defined by two principles. First, the claimed invention must have “specific” and “substantial”utility and must provide sufficient information to make its use “readily apparent to those familiar with the technological field of the invention.”Second, the alleged utility must be credible.

Great . . . so what does this all mean? First, one can think of the requirements of specific and substantial as being one, where the combination means that the claimed invention is applicable to a real-world utility. Probably the easiest way to discern whether an invention has the requisite specificity and substantiality is to look to whether the claimed invention in question can be of immediate use or whether it’s utility would require further work or analysis to verify. This means that the utility cannot be speculative. Firming up this definition as it might be applied to chemistry related inventions, some situations lacking a specific and substantial utility are listed:9

  • Basic research, including such things as analyzing or studying the properties of a compound or material.

  • A method of treating an unspecified disease or condition. Likewise, a compound alleged to be useful in treating unspecified disorders or possessing useful biological properties, without more, is unlikely to meet the test.

  • WHAT-MAKES-A-CHEMICAL-INVENTION-USEFUL

    FIGURE :Compound claim from In re Joly.

  • An intermediate product for use in making a final product, where the final product itself has no specific, substantial, and credible utility.

  • A method for making a material where the material has no specific, substantial or credible utility.

  • A method of assaying or identifying a material where the material itself has no specific, substantial or credible utility.

To better elucidate the utility requirement as it relates to the chemical arts, let’s look at a federal court case dealing with the issue of when claims in a patent application to a novel chemical moiety and a process for making that moiety lack a specific and substantial utility. The case of In re Joly10 arose out of a patent application for a group of steroid precursor compounds. The first compound claim of the patent application on appeal is reproduced in Figure above and is considered illustrative for purposes of the remaining discussion. Additional composition of matter claims 2and 3 were directed to specific compounds falling within the genus of claim 1, and claims 8 through 12 were directed to processes for making the claimed compounds. In the applicant’s specification, he explained the utility of the compounds of the invention as follows: “The products obtained by the invention, the lower organic carboxylic esters of enols in the 2-position of _1,2-steroids, are particularly useful as intermediates in the preparation of steroids, especially steroids having a ketone group in the 2-position, such as 21-acetoxy-pregnane-17_-ol,2,3,11,20-tetraone and16_-methyl-pregnane-17_-ol-2,3,11,20-tetraone by acid hydrolysis and customary separation steps.” The USPTO examiner rejected these claims, stating “the applicants have stated only that the (claimed) final products may be converted to the corresponding 2-keto compounds, which compounds have no known utility.”

The applicant appealed the rejected claims to the USPTO Board of Appeals, which affirmed the examiner’s rejections:
The portions of this specification . . . show that the claimed compounds can be used to prepare the corresponding 2,3-keto compounds. Having arrived at this point, what has been accomplished? Appellants do not assert that the latter compounds have known utility . . . such conversion does not constitute a disclosure of utility for the claimed compounds because there is no disclosed utility nor any indication of a known utility for the 2,3-keto derivatives. A useless product does not become useful by virtue of conversion into another useless product.

The applicants subsequently appealed the rejection to the U.S. Court of Custom sand Patent Appeals (CCPA). In affirming the Board’s rejection, the CCPA refuted the applicant’s argument that the 2,3-diketosteroids that could be prepared from the claimed compounds, using the claimed processes, were “closely related” in chemical structure to compounds of known usefulness, the glucocorticoids predn is one and cort is one. The CCPA found that there was no evidence in the record that the claimed compounds possessed activity in common with the allegedly closely related compound spredn is one and cortisone. Since the rejection of all of the claims was upheld includingthe process claims 8 through 12, it is useful to read the CCPA’s relation al logic between the two types of claims (compound and process for making compound)as they apply to the utility requirement. Quoting from a sister case decided at the same time, the majority stated:

From this opinion, we not only can derive the principle that the claimed compounds themselves are not patentable where their utility is only speculative, but also that the process for converting those intermediates to their final products is also not patentable,where the final products have speculative utility only.

The second aspect of the useful portion of the utility requirement is that the utility asserted in the patent application must be credible. Normally, when we think of credibility in the legal context our thoughts automatically go to a courtroom scene,with a perspiring witness being questioned on the witness stand before a judge and jury—every facial tic or downward glance of the eyes considered as evidence of deceit. In the patent prosecution process, there is no judge or jury in the normal sense but there is a standard by which the application is judged and the jury, if you will, is our ever present touchstone: the hypothetical person having ordinary skill in the art.

Since this is an objective standard, we know that the measure of credibility is not the apparent veracity of the applicant’s own belief (that would be a subjective standard)but whether one of ordinary skill in the art would find the asserted utility credible in view of the teachings in the specification itself, arguments by the applicant together with what is known in that particular art at the time the patent application was filed.
Naturally, the burden is much greater on the applicant where the utility being asserted is incredible by its very nature (e.g., “solar powered, anti-gravity, pull yourself up and fly by your own bootstrap boots”). In such an instance, the evidence put forward by the applicant must be sufficient to satisfy the hypothetical jury of person shaving ordinary skill in the art that the claimed invention is likely to demonstrate sufficient utility. Please appreciate, however, that the claimed invention need not be safe, it need not be the best, it need not even be very good at all.

For chemists working in the pharmaceutical industry, this requirement often raises the question of the credibility of a claim directed to the treatment of a human disease.It is often the case that an invention is alleged to have a certain utility whereby that utility is proved indirectly by showing some effect on an experimental parameter that is believed to relate to a particular outcome in animals, especially humans.For example, imagine a patent application that claims compounds allegedly useful for the treatment of acquired immune deficiency syndrome (AIDS). It is unlikely that such an application will contain data from a clinical trial. Rather the claim maybe supported by disclosing results from in vitro assays where the compounds of the invention demonstrate activity, such as inhibition of various viral proteins produced by the human immunodeficiency virus (HIV), which causes AIDS in humans.In such a case, an appreciation of the mechanism whereby the claimed compounds function, through their interaction with certain components of HIV, is helpful for establishing the ultimate utility of treating HIV infection in humans.As a practical matter, the ability to establish utility indirectly is an important aspect for credibly asserting utility, especially for chemical inventions that are designed ultimately for use in humans. As just mentioned, a company or organization probably will not have human data related to the use of their particular compound or composition before their filing of a patent application containing those compounds or compositions. This is logical when one considers that (1) most chemical invention shaving pharmaceutical utility never even make it to human testing and (2) once a promising compound or composition is identified, it is usually desirable to file a patent application as quickly as is consistent with preparing a well-drafted and well supported application. Given the large investment of time, money, and resources required for running human clinical trials, it is not surprising that an organization would want to ensure that the patents are filed and even preferably granted before embarking on such an expensive proposition. Fortunately for those companies making such investments, the courts have found that utility can be established by in vitro data alone, but this does not mean in vitro data will always be sufficient. The following statement is an instructive insight to the CAFC’s perspective on the sufficiency of in vitro data for establishing utility:
We perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the compound in question. Successful in vitro testing will marshal resources and direct the expenditure of effort to further in vivo testing of the most potent compounds,thereby providing an immediate benefit to the public, analogous to the benefit provided by the showing of an in vivo utility.

The types of data required to credibly support an alleged utility will depend on whether, and to what extent, the claimed invention and supporting disclosure comport with established scientific principles. Applying this to chemical inventions asserting pharmacological utility, the courts have found that there need only be a “reasonable correlation” between the demonstrated activity of the compounds and the asserted utility. The reasonable correlation can be established by relying on statistically relevant data, argument or reasoning, or teachings of relevance in the art (journals,
etc.). Furthermore, evidence of structural similarity to compounds having known activity may also be taken into consideration. From this, we can discern that the utility determination will be a factual inquiry sensitive to several variables.
As a practical matter, the USPTO examiners are instructed to find a utility assertion credible if it would be believable to one of ordinary skill in the art in the pertinent subject matter based on the totality of the evidence and reasoning provided. A utility assertion is found not credible only if the logic underlying the assertion is not consistent with the facts used to support the assertion.The USPTO bears the burden of making the initial showing that a utility is not credible, and examiners are cautioned against rejecting an application for lack of credible utility. Where such rejections have been upheld, they have been typically upheld only when an applicant either asserts no utility in the application or when an assertion of utility would be “incredible in view of contemporary knowledge and where nothing offered by the candidate would counter what the contemporary knowledge might otherwise suggest.”

While it is not a typical chemical case, the following finding of no utility due to an incredible assertion is instructive. Professors Dash and Keefe (Dash) appealed to the CAFC to challenge the USPTO’s final rejection of claims 4–11 of their patent application for alleged lack of utility and enablement.26 Dash and Keefe’s patent application disclosed an electric cell that generated heat energy from a palladium cathode and inert anode. The cell contained H2SO4 and D2O and was alleged by the applicants in their patent application to produce heat energy, hydrogen, deuterium,oxygen gases, and possibly heavy water through the recombination of deuterium and oxygen. The USPTO argued that the heat energy was used to mean “excess” heat energy and that the invention was directed to achieving cold fusion. The USPTO further produced a significant amount of scientific literature casting doubt on the ability of electrolytic cells to produce cold fusion. The CAFC upheld the rejected claims on appeal, finding that the examiner needed only to “establish that a person of ordinary skill in the art would reasonably doubt the asserted utility” and that the examiner fulfilled that duty “based on the number and quality of cited references that debunked claims of cold fusion.” Dash’s attempted rebuttals were found lacking by the CAFC. For example, Dash alleged that a comparison of their D2O cell with aH2O cell demonstrated that their D2O cell generated more heat. However, the USPTO examiner asserted that such an increase heat was predicated on known difference sin the properties of D2O and H2O, such as their different heats of absorption. The examiner’s response was found persuasive by the court and likewise for the additional responses offered by the examiner to the numerous other evidence and arguments introduced by the applicants.

So let’s briefly summarize what we know about utility. The utility of the invention must be statutory subject matter, meaning that it must describe a process, a composition of matter, a machine, or a manufacture. It must be tangible; a purely mental process, scientific law, or mathematical relationship will not do. Further, the utility must be substantial and specific, meaning that the utility must be of immediate and real value and cannot be speculative. Finally, the utility asserted in the patent application must be credible. Fulfill these criteria, and you are on your way to a patent.But don’t get too excited yet—as we have seen, the utility rejection hurdle is actually rather low.


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