In earlier posts, I discussed at least one groups of claims directed to the difficulties in claiming manipulations of “big data.” In ex parte Hazokaki, Appeal 2018-003293 (PTAB, Feb. 5, 2019), the Examiner and the Board were confronted with claims to a four-step method of formulating a skin-lightening composition, with six sub-steps reciting how to construct a database of “stored instances” created by generating gene differential expression profiles of, e.g., the wild type of a human skin cells and the skin cells after treatment with different “perturbagens” (skin lightening agents). Claim 1 reads as follows:

1. A method of formulating a skin lightening composition, comprising:
   1. Constructing a database for use in identifying connections between perturbagens as genes associated with skin tone comprising:
      1. Providing a gene expression profile for a control human cell, wherein the control cell is from a human cell line selected from the group consisting of [w, x, y and z];
      2. Generating a skin expression profile for a human cell exposed to a perturbagen, wherein the cell is form the same cell line as the control cell line;
      3. Identifying genes differentially expressed in response to the perturbagen by comparing the gene expression profiles of (a)(i) and (a)(ii);
      4. Creating an ordered list comprising identifiers representing the differentially expressed genes, wherein the identifiers are ordered according to the differential expression of the genes;
      5. Storing the ordered list as an instance on a non-transitory computer readable medium, wherein the instance includes metadata identifying the cell line from the selection in (a)(i),
      6. Constructing a database of stored instances by repeating (a)(i)-(a)(v), wherein the at least one perturbagen of step (a)(ii) is different….for each instance,
   2. Querying the database to identify at least one putative skin lightening agent; and
   3. Confirming that the putative skin active agent provides skin pigmentation modifying efficacy using in vitro assays or clinical methods;
   4. Mixing the putative skin active agent with a dermatologically acceptable carrier to provide a skin lightening composition.

Luckily for the applicant, the Examiner rejected the claim as directed to an abstract idea, in which steps (a) (i-vi) were identified as an abstract idea and steps (c) and (d) were routine, conventional, etc. This gave the Board an easy button to push since, if it just followed the recent PTO Guidance on the application of s. 101, this claim would not fall into the three groupings of “abstract ideas”: mathematical concepts, certain methods of organizing human interactions or mental processes. Furthermore, even if the claims is “directed to” an abstract idea, it could qualify as patent-eligible under Step 2A if there are additional elements that integrate the judicial exception into a practical application of the abstract idea. And that is just the analytical path that the Board followed, leading them to hold that the claim was directed to a patent-eligible chemical process.

In fact, the Board even addressed the 2A analysis, holding that, at least in the case of a chemical process, the confirming and the mixing step integrated any “mathematical concept into a practical application.” Regarding Step 2B, the Board found that the Examiner had not adequately supported a finding that the confirming step was routine and conventional, citing Berkheimer.

Taken as a whole this outcome seems correct but, amongst all the terms of art, take a second look at steps i – iii, and throw in vi. Don’t these steps look a lot like investigation the correlation between the gene expression profile of the human cell before and after exposure to perturbagen(s). Would the outcome of this appeal have been different if the Examiner had rejected the claim as directed to the discovery of the utility of naturally-occurring correlations? The claim might have survived as a practical application of the correlations to making a skin lightening composition, but I wouldn’t have bet on it.

The fact of the matter is that the method involved some very complicated computer-driven gene expression profiling. There is no way that, given the time that Examiners are given to issue office actions, this – or any other Examiner, could describe the essential steps iv, v and (b) of the claim to the Board or anyone else in plain English. In fact, the language essential to claim this type of gene profiling and its use to identify targets for known agents or to identify the activity of new agents is still being developed. One seminal paper in this area is T. R. Hughes, et al., “Functional Discovery via a Compendium of Expression Profiles,” Cell, Vol.102, 109-126 (July 7, 2000). There are about 20 co-authors. Enjoy.