Two-Step Eligibility for Genomic Analysis Systems

February 4, 2021 – Article

For practitioners at the USPTO, the reversal of a 101 rejection in Ex parte Patil (PTAB January 7, 2021), APJs Grimes, Scneider and Valek, in Appeal 2020-002775 should be interesting if not provide some light on the dance floor for doing the two-step with the USPTO.

The invention focused on assessing genetic variability with a system including databases and processors and as recited in Claim 27 U.S. 15/169,498:

27. A system for genomic analysis to determine pharmacogenomic-related genetic loci without a priori knowledge of the location of said loci, the system comprising:

one or more databases that store information obtained from genotyping genomic DNA of individuals in a case population which comprises individuals who exhibit a response to a drug to determine frequency of one or more informative genetic variations in the case population and information obtained from genotyping genomic DNA of individuals in a control population which comprises individuals who do not exhibit the response to the drug to determine frequency of one or more informative genetic variations in the control population, wherein the one or more informative genetic variations distinguish one haplotype pattern from other haplotype patterns of a haplotype block;

a server comprising:

one or more processors; and

a computer memory comprising processor executable instructions that, when executed by the one or more processors, cause the one or more processors to perform the following:

access the one or more databases;

compare frequencies of the one or more informative genetic variations between the case population and the control population;

select the one or more informative genetic variations which have a frequency in the case population which is significantly different to the control population as pharmacogenomic-related genetic loci; and

provide a report to a client device in communication with the server across a communications network, wherein the report includes a description of the one or more informative genetic variations which have a frequency in the case population which is significantly different to the frequency in the control population as pharmacogenomics-related genetic loci.

The claims were rejected under 35 USC 101 because according to the Examiner:

“[t]he one or more databases recited in claims 27–29 are directed to abstract ideas while all method steps recited in claims 30–34 are directed to a process comprising performing abstract ideas.”

“do not show that the claimed invention can improve computer-related technology or computer functionality.”

“[c]laims 27 and 30 do not have additional limitations that constitute conventional [sic, unconventional?] steps appended to the abstract ideas,”

            The PTAB referencing Mayo, Alice and the USPTO 101 revised guidance (January 2019) that articulated the Two Prong test (Steps 2A and 2B) determined whether the claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application. The rejection was reversed because the rejection failed at the first prong (Step 2A).

            APJ Grimes reasoned (and in a footnote 6 (emphasis added): “The Revised Guidance describes the extra measures that an Examiner should apply in the rare circumstances of an “abstract idea” that does not fall in one of the enumerated categories. Id. at 56–57. Those measures were not taken in the present case.”):

The Revised Guidance identifies three groupings of subject matter included in the abstract idea exception: “Mathematical concepts,” “Certain methods of organizing human activity,” and “Mental processes.” 84 Fed. Reg. at 52. The Revised Guidance states that, except in rare circumstances, “[c]laims that do not recite matter that falls within these enumerated groupings of abstract ideas should not be treated as reciting abstract ideas.” Id. at 53.

The Examiner therefore has not shown that claims 27–29 recite an abstract idea within the categories set out in the Revised Guidance.

the Examiner has provided no analysis showing that any of the steps of claim 30 recites a mathematical process, a method of organizing human activity, or a mental process.

In other words, the PTAB reversed the 101 rejection because the Examiner did not follow the USPTO’s guidance. In addition, this case should be a reminder that when the law (or guidance changes), it would be advisable to determine how, if at all, the respective positions should be revisited. For instance, should a 101 rejection still remain (maybe in a pending Appeal) in an application that stems from pre-January 2019 Patent Office guidance, it would be wise to review that rejection to determine if additional argument and, where applicable, briefing could be beneficial noting this final comment in the decision:

The Examiner points out that the rejection in the Final Office Action could not have followed the Revised Guidance because that Office Action was mailed before the Revised Guidance was issued. Ans. 16. While this is true, it is also true (as Appellant has pointed out, Reply Br. 2) that the Examiner could have applied the appropriate analysis in the rejection set out in the Answer, but failed to do so. The Examiner’s conclusory statement that “rewriting the rejection under 35 U.S.C. 101 according to ‘Revised Guidance’ will not change the results” (Ans. 16) does not take the place of a proper analysis.