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USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the US and Europe

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At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent applications in the areas of precision medicine and bioinformatics, disciplines that are at the epicenter of rapidly changing law on patent eligibility of software and medical diagnostic inventions. In this post, we share some of their tips for applicants in both the United States and Europe.

At the September 21, 2017 symposium, Fenwick’s Kevin Kabler moderated the panel. Sharing insights* into patent eligibility and obviousness considerations in the U.S. were speakers Marjorie Moran (USPTO) and Andrew Whitehead (Fenwick). On the European side, our guests were Georg Wimmer (EPO) and Frances Salisbury (Partner, Mewburn Ellis, UK).

Following are edited highlights from the program.

Q: What is considered a bioinformatics invention by the EPO?

A: Examples of bioinformatics inventions can include a method of determining a genotype, or a method of diagnosing based on the presence of one or more biomarkers. Generally, bioinformatics inventions include at least one step that is carried out on a computer, where the technical purpose of the invention as a whole relates to some sort of biological or health-related aspect. These types of inventions, as long as they comprise at least one so-called technical feature—like a physical step of measuring or an execution by a computer as well as algorithmic mathematical steps—are often called mixed-type inventions.

Q: What type of considerations exist with respect to exclusion to patentability in Europe?

A: In addition to other considerations under novelty and clarity, the two most common hurdles for bioinformatics-based inventions before the EPO are the exclusion from patentability, governed in the European Patent Convention under Article 52, and inventive step, governed under Article 56. Patent applicants trying to address these two hurdles often fall victim to two pitfalls: one is insufficient detail in the claims and the other is insufficient detail in the original application.

Q: In the United States post-Alice, what are the key takeaways when addressing an eligibility challenge?

A: Our approach to addressing eligibility rejections in the U.S. is generally similar regardless of whether the application has an Alice-type rejection or a biological or diagnostic Myriad or Mayo-type of rejection. What helps get claims to patent eligibility is specificity in the claim. It is not so different from the EPO where what matters is your actual “technical purpose” of the invention and how the specificity of your claim helps achieve that technical purpose. Unlike the EPO, however, simply having such specific steps performed by a computer often is not sufficient to achieve eligibility in the U.S.

To get to eligibility, it has proven effective to tell U.S. examiners what the improvement is and provide evidence that the claims achieve that improvement. Examiners look to your specification, so specificity in the disclosure is important as well. If the application illustrates a sufficient improvement relative to the art, then often no further steps are needed. However, we do have a concern for those claims where the end result is merely the acquisition of information alone. Currently, claims along the lines of “data in, perform analysis, information out” are generally going to be difficult to obtain in the U.S. in the face of an eligibility rejection.

Q: What are some key takeaways when addressing an inventive step challenge at the EPO?

A: When drafting your applications for Europe, applications that describe computer implemented inventions should emphasize a technical implementation of the invention and make clear the technical purpose of the invention, including discussion of different real-world applications of the invention. Any effects that go beyond the normal function of a computer should be explicitly mentioned, often several times.

There are four key points to heed: Claims should contain at least one technical feature, they should address the technical purpose of the invention, the steps of the claim should be sufficiently detailed to serve the technical purpose, and any basis for an amendment should be in the application as originally filed. If you keep all that in mind you should have an easier time obtaining an issued patent before the EPO.

Q: Are you seeing any inklings of eligibility challenges on the European side, either directly or in the form of inventive step challenges?

A: The EPO, relative to the U.S., shifted the emphasis of its analysis away from eligibility toward inventive step. EPO practitioners generally don’t see eligibility challenges for claims of the “data in, analysis, information out” variety as long as some kind of computer is involved. For example, claims for determining or using biomarkers in diagnosing a disease are generally eligible. Once the claim indicates it is computer-implemented or there is some kind of physical step, a case is typically in the clear from an eligibility perspective. For inventive step, the EP examiner is looking at the technology as a whole and coming to a conclusion accordingly, and is not considering the features in isolation.

Q: What are some best practices that are most valuable to push cases through to allowance?

A: In Europe, make sure you’ve got some intermediates in the application and make sure your technical case is clearly stated. In the U.S., talk to your examiners. At the USPTO, you’ll find that going back and forth in writing, especially with the constantly changing landscape of patent eligibility, causes more confusion sometimes than it solves; so if your case has been picked up for examination, call your examiner at any point in time, it will help shorten your prosecution path considerably in the vast majority of cases.

*Disclaimer: The opinions discussed in this article are those of the speakers and not the USPTO or the EPO. Individual examining divisions may come to different conclusions depending on the context of each individual case.

For more on trends in the life sciences please visit our Life Sciences Legal Insights blog.​​​​