Prophetic examples, sometimes referred to as “paper”, “speculative”, “fictitious” or “hypothetical” examples, are examples that are sometimes included into a patent specification that describe experiments that have not yet been performed. There are a number of reasons patent applicants may consider using them.
In contrast to a working example, which describes work actually performed or experimental results actually achieved, prophetic examples may also describe predicted or simulated results (i.e., in silico or other modelled data).
In academic circles, and in most contexts, making up data is considered fraudulent or misleading and is generally frowned upon. However, this is not the case with patent applications, where it is perfectly acceptable to supply predictive rather than measured data (provided it is clearly identified as such), and there may be a variety of valid reasons to include such examples. There are, however, some important caveats.
Such prophetic examples can be important in demonstrating that the patent applicant has in fact arrived at the purported invention, and in supporting the breadth of claim scope being pursued (or, in oppositions or litigation, defended). In particular, soundly reasoned and presented prophetic examples may be used in a patent specification to extrapolate the applicability of a new idea to other applications to which there is some plausible scientific basis that the new idea will successfully operate, and to therefore justifiably draw a patent claim to that new use.
Why include prophetic examples in a patent specification?
A patent specification usually describes one or more examples of how the invention can be put into practice. However, at the time the patent application is filed (taking account of the imperative to secure the earliest possible priority date for novelty and inventive step purposes), these examples may not have been physically undertaken in the laboratory and put into effect.
There may be a number of reasons for this, including a lack of time, e.g., in rapidly evolving technologies where there can be a race to file patent applications for new technology. Other reasons may be the expense required to do the work in the laboratory is prohibitive, or that the number of experiments required is physically impossible to do within a reasonable time period.
Examples in a patent application are not strictly required, but generally assist the patent applicant in complying with the various written description requirements for a valid patent in Australia and other jurisdictions. In Australia, these written description requirements are stipulated in section 40 of the Patents Act 1990 (Cth) and include requirements to provide a clear enough and complete enough description of the invention (sufficiency, across the full scope of the claims), support across the scope of the claims of the claims, and disclosure of the best method of performing the invention known to the patent applicant.
Under Australian law, the claimed invention must be described in a manner which is “clear enough and complete enough for the invention to be performed by a person skilled in the relevant art” (the “sufficiency” requirement). This requires that the patent specification provide sufficient information to enable the skilled person to perform the invention across the full scope of the claims (not just one embodiment within the scope of each claim) without undue burden or the need for further invention.
Ideally, the patent applicant would physically perform many examples of the invention to show that it can be implemented over the entire scope of the claims, but because it may be impractical to do so it is sometimes necessary to create prophetic (yet to be performed) or predictive protocols that describe how the invention is to be performed (including how effectiveness can be measured or observed, etc).
Providing prophetic examples can therefore help to meet the requirements of sufficiency, by clearly disclosing to the skilled reader how to perform the invention across the scope of all claims.
When to include prophetic examples in a patent application
Circumstances where prophetic examples might be employed include where the patent applicant has developed a new and inventive material, and where it is scientifically plausible that the new material would perform the same or similarly to prior art materials in a known process. Under these circumstances, a prophetic example directed to the use of the new material in that prior art process may be sufficient, particularly if reasoning as to why the new material might be suitable for that use is included.
Similarly, prophetic examples may be employed where the patent applicant has devised a new concept which has certain advantages over the prior art, and undertaking each of the individual steps of the method is known with a predictable outcome. In this case there may be an invention in a new combination of those steps (particularly if performed in a particular order or manner). Under these circumstances, it may be scientifically plausible that the new combination of those (known) method steps will result in those advantages, and prophetic examples will be sufficient.
Prophetic examples can be distinguished from examples which provide a proxy for actual test results. For example, in the pharmaceutical arts some data or information that demonstrates some substantial likelihood that the invention will work as a human pharmaceutical is required. Often, animal studies or at least in vitro testing results will be provided and are usually sufficient to provide the required enablement, depending upon the invention and the type and scope of claims to be pursued.
Importantly, Australia permits patent claims directed to methods of treatment, and the patent specification often includes prophetic examples setting out clinical trial protocols with only limited, or potentially without any results included because the patent application was filed before any results were available. The inclusion of such prophetic examples generally assists in satisfying sufficiency requirements, but care should be taken to account for the publication of protocols and other documentation concerning the clinical trial (including relevant “grace periods” in Australia and some other jurisdictions, such as the US).
Another written description requirement which can be impacted by the use (or not) of prophetic examples is “support”, which in Australia now prohibits patent claims from having a scope that goes beyond the technical contribution disclosed in the specification. Prophetic examples, including reasoning or hypotheses as to why the scientific principle(s) underpinning the invention would reasonably be expected to have applications as broad as the claim language (e.g., in different products, conditions, etc) can prove vital in satisfying the Examiner, and any later opposition hearing officer or Federal Court judge, that the claims are adequately supported.
Further, the inclusion of prophetic examples can be crucial in satisfying the now Australian-centric requirement that a patent applicant disclose in a patent specification the best method known to it, at the Australian filing date (often the PCT filing date), of performing the invention. This has become a powerful ground of revocation during the past decade and is now emerging as an objection during examination.
If a protocol for making the claimed product or performing the claimed process has been conceived before the Australian/PCT filing date, it should be included in a patent specification rather than withheld. If multiple alternative protocols have been conceived, it is generally advisable to include them all in the specification, to protect against that any of them might later be argued in a revocation proceeding to have been “the best” (the criteria for which will vary for each patent and can be difficult to predict at the time of filing and prosecution).
If any results or measurements have been obtained from the protocol(s) conceived and practised by the Australian/PCT filing date, those results/measurements should also be included in the Examples included in the patent specification. However, if there are no results or measurements available, prophetic examples are still important to include wherever possible to address the best method requirement.
Are there any restrictions on the use of prophetic examples?
Some jurisdictions explicitly require that examples are presented in a patent specification in a manner that clearly distinguishes between prophetic examples that describe predicted experimental results, and working examples that report actual experimental results.
In July 2021, the USPTO published a Notice on this topic explaining that prophetic examples should not be described using the past tense and instead should be written in future or present tense, as this drafting technique assists readers in differentiating between actual working examples and prophetic examples.
The USPTO’s notice also highlights that: “[k]nowingly asserting in a patent application that a certain result ‘was run’ or an experiment ‘was conducted’ when, in fact, the experiment was not conducted or the result was not obtained is fraud… [and that distinguishing] … prophetic examples from working examples in a clear manner will avoid raising issues relating to the patent applicant’s duty of disclosure”.
In Australia, a ground of revocation (post-grant) is that the patent was obtained through fraud, false suggestion or misrepresentation. This highlights the importance of presenting prophetic examples only in a way that is soundly reasoned, with any predictions justified. Including any data or prediction which overstates, or unjustifiably predicts, the effectiveness of the invention or its improvement over the prior art, can jeopardise the validity of the entire patent.
Complications resulting from use of prophetic examples
If, during prosecution, an Examiner were to take issue with a prophetic example, the patent applicant may respond by providing an example that has been conducted post-filing which verifies that prophetic example. Additionally, it may be useful to provide a series of actual test results to demonstrate reproducibility. An alternative may be to provide relevant arguments or a declaration from a suitably-qualified expert that there is a plausible scientific basis to believe the predicted results would be obtained.
As noted above, the validity of a patent could be challenged by a third party in post-grant revocation proceedings in the Federal Court on the basis of inadmissible prophetic examples as the foundation for a “false suggestion” challenge. The challenger in such proceedings would have the burden of proving there was a fraud, false suggestion or misrepresentation that occurred and that it was material to the grant of the patent.
If prophetic examples are pointed to, or introduced, in response to objections during examination based on the written description or prior art, a challenger may seek to prove those prophetic examples were somehow incorrect or misleading, and that the patent applicant knew that at the time.
A challenger could potentially seek discovery from the patent applicant of documents relevant to its knowledge of the prophetic examples, leaving the patent applicant with difficult decisions about whether to claim privilege in advice received during preparation of the patent and more generally involving cost and complication. Accordingly, it is generally highly desirable for there to be some reasonable, plausible or credible scientific basis underpinning those prophetic examples.
Another complication arises where disclosing too much information can create prior art that will prevent a patent applicant from obtaining non-prophetic patents later.
Another factor to consider is the level of predictability of the field of technology. In general, mechanical and electrical arts tend to be considered predictable, while chemistry and biology tend to be unpredictable. It therefore follows that the use of prophetic examples should be calibrated according to the degree of predictability, and supplying actual working examples is much more important in the unpredictable arts. Additionally, an example which merely states a desired outcome is likely to be inadequate as a prophetic example.
Advice for patent applicants
Prophetic examples allow patent applicants to provide clear and sufficient disclosure and support for broad claims without having to undertake time-consuming and costly experiments. They can also be crucial in satisfying the best method requirement in Australia. However, care must always be taken to include only reasoned and justifiable prophetic examples, particularly where predictive data or analysis is included.
In terms of practical advice for patent applicants, it would be useful to consider the unpredictability of the technical effect of the invention. The greater the unpredictability of that effect, the more real experimental data/information will be required to support a claim to that technical effect.
Accordingly, where there is greater unpredictability, patent applicants should generally rely on fewer prophetic examples, while ensuring no aspect of the best method of performing the invention know to the patent applicant is withheld. Prophetic examples are generally perfectly acceptable especially where there are plausible technical explanations or theories underpinning the technical effect/advantage of the invention that enable a reasonable extrapolation or generalisation to those prophetic examples.
Patent applicants should carefully review any examples included in their applications before filing to ensure that they are not misleading, that they have a reasonable scientific basis, and are reproducible.
Engaging with a patent attorney early in the process will ensure all of these complex and interweaving considerations are considered to achieve the broadest and most effective patent protection possible for each invention.
If you have questions, or require advice for your innovation, please reach out to the team.