We recently reported on the United States Patent and Trademark Office’s current interpretation of section 101 with respect to diagnostic method patents (catch up here). As clearly stated in that article, the current situation is bleak. Never has it been more important to be smart and creative with your patent prosecution strategy from the outset. When drafting your patent specifications (or even if you engage the services of a patent attorney to draft your patent applications) it is imperative to stay familiar with, and strategise around, the current interpretation of key statute in your key commercial jurisdictions. Carefully considering your approach will give you the best chances of securing robust patent protection for your valuable diagnostic method technology.

With more and more diagnostic method technologies being developed in Australia – it is important to ensure that the opportunity is not lost by failing to navigate the perilous 35 USC §101 (the Section of the U.S. patent statute governing patent eligible subject matter). Here, we present five creative strategies to help get your United States diagnostic method patents over the line.

1. Define a “minimum combination” of components required to perform the method.

Typically, a diagnostic method measures the level of one or more molecules and equates that level to a particular status (for example, diseased or not diseased). Although there is a huge availability of methods for characterising the abundance of particular types of markers, think about whether a particular technique (or similar techniques) fit your method better than the rest? If so – try putting together a list of the essential components required to perform your particular method – and claim this novel and inventive combination. If your diagnostic method is the only reason as to why you would put together that specific combination, then this combination could serve as the basis of a patentable invention.

One such example could be a couple of specific probes directed to the best markers of your diagnostic, plus a cassette or chip that is necessary for performing the assay.

2. Recast the diagnostic into something else.

Diagnostic methods may not currently be considered patentable – but methods of treatment are! Why not reformat your diagnostic method into another type of method claim – where the patentability will not be under such heavy scrutiny. For example, if the diagnostic method is for diagnosing a specific disease, why not claim a method of treatment that includes a step of performing the diagnostic method before administering a drug. This reformatted method becomes patent eligible for a number of reasons including – the physical administration of a therapeutic to the patient; and causing a tangible change in the health of the patient.

The downside, is that we risk stepping into the realm of “split infringement” for such claims, as different steps may be performed by different parties. This makes enforcing your patent more complex – a trade off for navigating section 101.

3. Create a new tool with which to perform the method.

The current interpretation of section 101 prohibits claiming diagnostic methods that use nothing but techniques that are routine in the art. However, should the detection of a marker require a new tool (for example, a new fluorescent probe), then the use of that tool in the method may be sufficient to render the diagnostic method patentable. It is currently unclear just “how inventive” the new tool needs to be to make an impact – but the current Guidance issued from the USPTO appears to indicate, for example, that the use of a porcine antibody for the detection of human proteins is not used routinely – and as such – this would appear sufficient to confer patentability.

4. Wait it out.

It’s hard to think that the interpretation of section 101 can get any more onerous. Provisional applications filed today are unlikely to be examined in the United States for well over five years. Hopefully by the time your new application reaches examination – the interpretation will be more favourable for exciting new technologies in the diagnostic method space.

In light of the backlash that the current interpretation is having on the medical biotechnology community as a whole … it is whispered that a change (and hopefully, a relaxation) of the law is likely in the medium term.

5. Ensure your patent specification is drafted with as much detail as possible.

One message that the USPTO has always been clear on when discussing section 101, is that high level “diagnosis,” “detection,” and “identifying” steps are more likely to be considered patent ineligible than detailed claims that enunciate each individual step. Therefore, it will likely be advantageous, to have a laundry list of features that could be used to bring the method as far away as possible from being a mere natural phenomenon. Of course, as a patent Applicant you have a right to feel like you are entitled to the broadest claims that the prior art allows – and introducing additional limitations should not be performed without careful consideration. Having a clear commercial vision as to the most important embodiments of the technology will likely assist with the inclusion of potential features into claims whilst retaining robust protection for your primary commercial embodiments. This, along with filing one or more divisional applications to pursue claims from a slightly different perspective, is likely to be an effective strategy for ensuring eventual broad patent protection of your technology.

Of course, the particular strategy that is best suited to protect your technology will vary in accordance with your specific circumstances. Therefore – it is essential that you discuss the strategy for combatting 35 USC section 101 with your patent attorney before proceeding with filing your medical diagnostic method patent.