News

How NOT to get a Bioinformatics Patent

Tuesday 6 August 2019

Multidisciplinary inventions have become more commonplace in recent years, particularly as artificial intelligence (AI) is being used as a tool in a wide range of biotech applications, such as medical image analysis and drug discovery. However, whereas biotech inventions may generally be considered to relate to inherently patentable subject matter, biotech inventions that are implemented using a computer or AI may have an additional hurdle to pass. In this article, we explore this additional hurdle by looking at why a patent application that relates to bioinformatics has been objected to by both the UK and US Patent Offices.

Subject Matter of the Patent Applications

GB1514871.1 and US14/824,678 both relate to identifying primers. Primers are typically short fragments of single-stranded DNA which are complementary to a region of interest in a target DNA strand. Primers are typically used in polymerase chain reaction (PCR) experiments to very quickly make multiple copies of a DNA strand (or a segment of it). Having thousands or millions of copies of a DNA strand makes it easier to perform experiments such as medical or forensic tests.  These patent applications relate to a method of identifying primer pairs within large-scale genomic or DNA sequence datasets. Primer pairs provide the starting point for the PCR experiment to begin the copying process. 

The method described in the patent applications enables all potential primer pairs to be identified for particular sequence data. The method is a single computer program which includes all the design steps which are normally performed separately. Thus, the method can be performed efficiently over a large amount of sequence data, such that it can identify all potential primer pairs for that dataset. This was considered by the Applicant to be an advantage of the invention.

Patentable Subject Matter in the UK

From the summary above, it seems that the claimed method has a real-world effect, namely that of finding better potential primers for use in DNA amplification reactions (such as PCR), which are used in a variety of different fields such as medical testing, diagnosis of infectious diseases, criminal forensics, research and even identifying the remains of Egyptian mummies and English king Richard III. 

However, the UK Patent Office considered the claimed method related to subject matter that is excluded from patentability under Section 1(2) of the UK Patents Act 1977 (UKPA), which states that “a program for a computer” is not considered to be patentable subject matter as such.

In the UK, a program for computer is only considered patentable subject matter if it can be shown that the contribution provided by the computer program is technical in nature. This was established in Aerotel (Aerotel Ltd v Telco Holdings Ltd and Macrossan’s Application [2006] EWCA Civ 1371).

In his analysis, the Hearing Officer at UK Patent Office considered the contribution of the computer program defined by claim 1 to be “the provision of the parallelized algorithm that allows the implementation of the primer search and filtering on a computer cluster”. The Applicant tried to argue that the contribution was of a technical nature for the same reasons that the invention in Halliburton (Halliburton Energy Services Inc’s Patent Application [2012] RPC 12) was considered to provide a technical contribution. In Halliburton, a method of designing a drill bit using a computer was not considered to relate to excluded subject matter because the method claim included the step of “manufacturing a drill bit to any optimized design”. However, the Hearing Officer was not convinced that the present case was comparable to Halliburton, because the result of the claimed method in the present case is a database of all potential pairs for a given set of sequence data. In other words, the result may be a reduced, but still large, dataset of sequences of primer pairs, which is not a narrow result or set of results as per Halliburton. Furthermore, the Hearing Officer did not consider this result to be something specific and external to the computer. That is, the identification of the primer pairs was too generic and not identified or further filtered for a specific technical purpose.  As a result, the UK application was refused.

The Corresponding US Patent Application

The corresponding US patent application is still pending, but earlier this year the USPTO Examiner raised an inherent patentability objection against the pending claims. Specifically, the US Examiner considers the claims to be directed to a judicial exception, i.e. an abstract idea, without significantly more. In the US, following Alice (Alice Corp. v. CLS Bank International, 573 U.S. 208, 134 S. Ct. 2347 (2014)) and more recent Federal Circuit decisions, determining whether a patent application relates to patentable subject matter (i.e. “statutory subject matter”) generally involves determining if the combination of the elements or steps in a claim amount to significantly more than the judicial exception by meaningfully limiting the judicial exception. 

The USPTO Examiner considers the claims to relate to an abstract idea because the method relies on “organizing, and comparing sequence data…through mathematical correlations and performing mathematical operations”. Furthermore, the Examiner considers it possible to perform each of the steps of the claimed method as a mental process or on paper.  Further still, the Examiner considers generic computer structures and functions to be used to perform the method, such that the claimed method does not amount to significantly more than an abstract idea.

Conclusion

Patent applications for biotech inventions which use computer programs or AI to perform some analysis or processing will likely be considered to relate to computer-implemented inventions. Therefore, these patent applications may be treated slightly differently by the Patent Offices compared to more typical biotech inventions. Specifically, the patent applications will need to meet the same requirements for patentability as other software or computer-implemented inventions. At the patent drafting stage, we can work with you to both draw out the technical advantages and present them in a such way that the invention meets the patentability requirements of multiple jurisdictions, as we understand the current viewpoints of the Patent Offices in, for example, Europe, China, the US and the UK. We also routinely work in customised teams, bringing together patent attorneys with the relevant backgrounds to work on a multidisciplinary invention. Contact us for a confidential conversation if you have any questions about the above or think this may impact your patent portfolio.

By continuing to use this site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close