As I explain in my previous blogs, the U.S. patent law relevant to subject matter eligibility is currently in a state of flux and baffling. The lower court’s recent decisions, even when positive for the subject matter eligibility, were splintered. Unfortunately, the U.S. Supreme Court has refused to clarify the confusion and shed light by revisiting the patent eligibility cases. Although the U.S. Patent and Trademark Office (USPTO) has tried to fill in the void to clarify the issue, conventional, routine steps still remain part of the subject matter eligibility test. Thus, the vagueness of what is unconventional or non-routine remains. Arguably, therefore, the USPTO may have tried to shed illumination about this issue but added further to the uncertainty.
Moreover, the courts are not bound by the USPTO’s guidelines as the Federal Circuit has concluded several times. Recently, the Federal Circuit addressed this question in Cleveland Clinic Found. v. True Health Diagnostics LLC, 760 Fed. Appx. 1013 (Fed. Cir. 2019). Federal Circuit stated: “[w]hile we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance.” Id. at 1021.
Due to the courts’ continuing ambiguity, the question remains: what can patent practitioners, patent applicants, and patent owners do to protect their inventions? I detail ten strategies you may consider when drafting patent applications and build a patent portfolio for inventions where patent subject matter eligibility is a concern.
- Be specific, not generic. Avoid overly broad, non-specific, and generic diagnostic claims that recite detection of a natural product. Instead, draft specific and narrow claims because they are more likely to be patent subject matter eligible.
- Ensure that the independent claims are directed to the invention. While drafting independent claims, ensure that the claims will not preclude the use of underlying natural law by others for their novel inventions.
- No conventional or routine statements: You should be careful when describing various steps and techniques to avoid sentences and words that can be construed as conventional or routine steps. If you use such language, be aware of the potential negative repercussions. For example, such statements may be during prosecution and litigation as an applicant admitted admissions resulting in the ineligible subject matter.
- Avoid correlations between natural products and disease states: Courts have considered such correlations like a mathematical equation. For example, in Mayo, the correlation between blood drug metabolite levels and toxicity and efficacy was considered a mathematical relationship similar to Einstein’s E= mc2, etc., and hence, patent ineligible. Thus, no matter how unpredictable and surprising a correlation is, making a diagnostic method patent-eligible is unlikely. Unfortunately, this remains the land law, and currently, the Supreme Court is not interested in further explaining this law.
- Incorporate treatment steps: Wherever possible, claim treatment methods instead of diagnostic processes. As described in another previous blog of this series, recent case law suggests that claims with a treatment step are more likely to be found subject matter eligible by the courts.
- Integrate practical applications: Add extra elements to the claims to integrate the practical application into judicial exception as per USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance. These elements may add meaningful limitations and circumvent subject matter eligibility rejections during prosecution as the Examiners must follow the USPTO’s Guidance.
- Consider relevant case law while drafting and prosecuting patent applications: Be attentive and mindful of pertinent case law while drafting applications to include, exclude, or circumvent relevant subject matter and claims elements. Because the courts frequently decide subject matter patentability cases, it is essential to constantly follow and learn case law.
- Patent other aspects of the technology: It is vital to patent other unique and inventive aspects of your invention, e.g., the composition, device, other methods, etc. Although the diagnostic process claims may be directed to a natural product, which is patent ineligible, the other different claims may be patent subject matter eligible. Therefore, it is best to patent the additional features of your invention for long-term and comprehensive patent protection.
- Fall back continuations applications: In certain situations, it may be best to keep continuation applications alive, which can be done by deferring the continuation examination. The continuation will serve two purposes-first, deter your competitors from seeking invalidation of your patents. Second, you will have the ability to circumvent any potential invalidated claims by filing new claims, if required. For example, in Mayo, the invalidated U. S. Patent No. 6,355,623 contained a dependent claim directed to the High-Pressure Liquid Chromatography (HPLC) technique to determine the metabolite levels. However, the Supreme Court ignored this dependent claim because the independent claim was broad and directed to determining the metabolite blood concentration. Thus, the Court had concluded that the independent claim asked the physician to determine the metabolite blood by any method [added emphasis]. Arguably, it is possible if, in a continuation application, the independent claim had the limitation of the said dependent claim, the new independent claim may be patent-eligible. At least, the owners had a possibility of reclaiming narrower and specific patent protection for their invention. AMP v. Myriad Genetics, the inventors mentioned in their specification Polymerase Chain Reaction (PCR) alternative technologies, such as ligase chain reaction, nucleic acid sequence-based amplification, etc. Still, the Federal Circuit Court invalidated the patented claims as an ineligible patent subject matter. According to the Court, their decision reflected the high level of generality of the independent claim. In both cases, the Courts deemed the independent claim amount to general instructions to physicians to apply routine, conventional techniques to diagnose a disease. However, in both cases, the patent had support for additional claim elements that, arguably, might have assisted in circumventing the invalidated claims. Therefore, be mindful to include alternate embodiments and features and plan to keep a continuation application alive.
- Consider non-USA, worldwide market. If your product has a market outside of the U.S.A, consider those foreign markets. The diagnostic method patents are often easy to obtain and enforce in other countries, unlike in the U.S.A. Therefore, provided the applicant’s business goals permit non-USA markets, filing an application with the Patent Cooperation Treaty (PCT) and seeking patent protection elsewhere may be highly advisable.
Please click here for links to all law cases recited in this series
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