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The Federal Circuit in recent decisions considers the two step test for patent eligibility under section 101 from Mayo and Alice "now well established" and digs its heels in on life sciences, but continues to provide a lifeline for certain software inventions that solve computer related problems.

June 8, 2016 – The Federal Circuit issued two recent decisions concerning section 101 patent eligible subject matter challenges. Unfortunately, there is no change in direction on the issues concerning 101 from the Court.

The decision Genetic Technologies Limited v. Merial concerns methods for detecting genetic variations, which can be useful for diagnosis and treatment of various genetic disorders/diseases. The invention relies on the discovery that there is a relationship between the non-coding and coding sequences and the tendency of such non-coding DNA sequences to be representative of linked coding sequences. As such, more valuable information could be obtained by a method for analyzing even short non-coding sequences than direct prior art analysis of longer coding sequences.

The method claim at issue has two steps, one for amplifying a non-coding sequence and one for analyzing that sequence, both of which were conventional techniques at the time of patenting. Moreover, the analyzing step was held to be a routine comparison that could be performed by the human mind, which type of step was held in previous decisions to be the kind that is "free to all men and reserved exclusively to none."

The Federal Circuit indicated a strong reliance on previous decisions in the life sciences area by confirming that the two step test for patent eligibility under section 101 from Mayo and Alice are “now well established” and restated from various recent decisions that a claim is unpatentable if it merely informs about a law of nature and any additional steps amount only to well-understood, routine, conventional activity already known in the art.

The Court held that the claim at issue is directed to the relationship between the coding and non-coding sequences, which is a law of nature, and because the non-coding sequences in the claim can be amplified and analyzed by well-known conventional methods, these additional steps are insufficient to provide the inventive concept necessary to transform the claim to be patent eligible.

Patentees argued that no one had before analyzed man-made, in terms of the claim – amplified, non-coding DNA in order to detect a coding region allele, and that this additional feature provides sufficient inventive concept to pass the Mayo/Alice test. The apparently unimpressed Federal Circuit however concluded that such an argument is merely a restatement of the natural law itself.

This decision very closely follows the relatively recent Ariosa v. Sequenom decision, which considered a genetic testing method of detecting fetal DNA by amplifying and analyzing cell-free fetal DNA sampled from a pregnant woman’s blood, where the focus of the claimed advance over the prior art was allegedly newly discovered information about human biology: paternally inherited cffDNA is to be found in maternal blood (using established detection techniques). In Ariosa, likewise to this case, the information obtained was very valuable and useful. But, according to these decisions, a method can be useful, but still invalid under 101 since even groundbreaking, innovative or even brilliant discovery is not alone adequate.

The decision Enfish, LLC v. Microsoft Corp. concerns a logical model for a computer database (without any hardware components), which has various advantages over prior art database models, e.g., faster searching, more effective storage of data, and more flexibility in configuring the database. The database concerns a logical model that includes all data entities in a single table, with column definitions provided by rows in that same table, which is termed a "self-referential" property. In simpler terms, a newly added row creates a column in the same table to provide the characteristics for the data in the row and serves as the reference function for locating the data in that row. Prior art models used multiple tables to achieve the same objective with reference columns in each table for correlating the data from the various tables, which tables had to be pre-constructed and the data thereafter had to fit the tables. The database model in this case did not have to be pre-constructed, as it modified its format as the data was added by each time adding a row as described above.

The Federal Circuit here too followed the Mayo/Alice test and as the first step inquired whether the claims at issue are directed to a patent ineligible concept, and more precisely in this case whether the focus of the claims is on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an "abstract idea" for which computers are invoked merely as a tool.

The focus of the claims in this case is held to be on an improvement to computer functionality itself, i.e., concerns a specific improvement to the way computers operate. Accordingly, the claim is not directed to an abstract idea. The Court contrasted this decision with numerous others where the outcome was contrary by stating that those decisions concerned situations where conventional computer components were added to well-known business practices, or recited a purely conventional computer implementation of a mathematical formula, or recited generalized steps to be performed on a computer using conventional computer activity, but did not concern improvement to computer functioning itself.

Thoughts and musings:

One may ask whether there is something positive for analysis under section 101 that could be gleaned from Enfish that could be useful in the arena of life sciences, including diagnostics. Unfortunately, the Court seems antagonistic to life sciences/diagnostics and typically characterizes the additional steps as routine even in cases where the actual analysis considers reviewing and making sense of results that were never considered in the prior art or whose relevance or meaning was unknown. Particularly difficult is a situation where the analysis part is so simple that it could be done by the human mind, which is often the situation in diagnostics cases where the objective as a practical matter is to efficiently obtain clear results from the tests performed. However, in a situation where the analysis part of the obtained data may be more complex, there could be an argument for a more specific type of data analysis providing the required inventive concept, especially if the analysis is so complex that a computer may need to be involved. Perhaps it would have helped applicants in Genetic Technologies Limited if the disclosure would have described the analysis steps as more efficient or more reliable if performed by some more complex specific set of steps of analysis that was not routine, e.g., which may have required correlating data obtained from the non-coding sequences to a particular disease. Where applicable, useful may be to enumerate in the specification various advantages of the methodology used over prior art methodologies at every step of the method, including in life sciences/diagnostics applications, as such was clearly indicated to be important in achieving a favorable decision to patentees in the Enfish decision.

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