In a recent decision, Ex Parte Buck, Appeal no. 2017-005470 (PTAB, April 20, 2018), the Board affirmed the examiner’s ruling that a composition claim reciting two natural products was patent-ineligible as an attempt to claim a natural phenomenon:
7. A kit comprising multiple, separate weekly or
monthly doses of
a) Vitamin D, and
b) 25-OH D3 [a metabolite of Vitamin D],
wherein a dosage ratio of the Vitamin D3 to the 25-OH D3
is from about 6:1 to 1:6; a single weekly dosage contains from
7 μg to 350 μg each of Vitamin D and 25-OH D3; and a single
monthly dosage contain from 30 μg. (The last 4 words are not a [typo; they were construed to read “contain at least 30 μg.”)
Before I dig into this decision, please re-read my March 19, 2018 post on In re Bhaghat, where I attempt to set out the rules of 101 inquiries for claims directed to “natural products.” In brief, if a claim is directed to two or more natural products, the nature-based combination is examined to see if the combination of components has “markedly different” characteristics due to the interactions of the components of the composition.
This requires evidence of some interaction between the natural products. If this analysis leads to the conclusion that the nature-based components of the combination are significantly different from their natural state, the combination is not a product of nature and the inquiry stops.
If, however, the claim encompasses no more than a simple combination of natural products, and marked difference is absent, the examiner will subject the claim to the dreaded 2B analysis set forth in the MPEP 2106 Table, in which to reach patent-eligibility , the claim must possess a further inventive concept that provides “significantly more” and which cannot be satisfied by the combination itself.
Perhaps the best place to drill into Buck is to review the basis for the PTAB finding that the composition claim was not anticipated or obvious in view of the cited prior art. While both Vitamin D and 25-OH D3 had been provided to animals in combination as a feed supplement, Appellants discovered that if they were given together in the recited ratio and in spaced weekly and monthly doses, the concentration of 25-OH D3 was synergistically raised and sustained so that the once-a-week or once-a-month dosing would be effective. The Board accepted Appellants’ arguments:
“[T]here is no factual basis that would lead a skilled artisan to reasonab[ly] assume that an ingredient fed to human and animals once a day would also be effective if fed once weekly or monthly ass the Examiner finds….According to Appellants, a [POSA] would have known that daily doses of beneficial ingredients (including vitamins and foods) cannot be linearly multiplied by seven or thirty into weekly doses and monthly doses without possible toxic or lethal side effects.” Slip op. at 11. “[T]he Examiner did not establish that Chung teaches a kit comprising multiple separate weekly or monthly dosages of Vitamin D, and 25-OH D3 at the dosages required by the claims.” Slip op. at 13.
But wait, there’s more! The big question, that I have been trying to tee up, is how the Board managed to find these claims s. 101 patent-ineligible. I think that the Examiner, in an attempt to rely on the Mayo/Alice Rule, rejected the claims as directed to a different statutory exception to patentability, namely that they were directed to a natural phenomenon.
If you have read this far, it should be clear that the reversal of the 102/103 rejections was based on the Board’s belief that Appellants had demonstrated a beneficial interaction between the Vitamin D and 25-OH D3, following administration at the recited temporal and concentration limitations. This should have controlled the outcome of the 101 inquiry, but the Examiner, using the rationale behind decisions like Cleveland Clinic – that a diagnostic claim directed to a natural correlation (“If A, then B”) must be examined for a further inventive concept that adds significantly more to the correlation – only had to argue that the additional non-natural products in the kit, like the packaging, did not fulfill this requirement. The Board agreed, citing Funk Bros and Bhaget. (Note the paucity of case law in the natural products area.)
In other words, neither the Examiner nor the Board gave any weight to the properties of the claimed composition, the same properties that so effectively rebutted the 102/103 rejections. How did the Examiner convince the Board to see it her way?
While arguing that Appellants are attempting to claim a natural phenomenon, the Examiner and the Board never identify what natural correlation Appellants are attempting to claim. Instead, the Examiner begins by noting that the claims are directed to a kit comprising two natural products. The entirety of the Step 2A natural product analysis is simply that “the Examiner finds the characteristics of each component are not significantly [read: “markedly”] different from their naturally-occurring counterparts because they have the same structure and function as they do in nature.”
But once they are administered at the dosages and intervals recited in the claim, there is a synergistic effect on the 25-OH D3 levels that the Board accepted as unexpectedly beneficial a few pages later. The disconnect is hard to spot, but as I read and re-read this opinion, it is clear that the Appellants were arguing the standards applicable to a mixture of natural products, while the Examiner was arguing the standard applicable to a natural phenomenon.
At page 5 of the slip op. the Board notes that “[Appellants argue that] the claimed kit has characteristics that are not found in a natural product and which would be unexpected in a natural product.” In contrast, while the Board, following the Examiner’s “logic”, jumped from a simple finding that the two components “by themselves, are products of nature and consequently unpatentable” to conclude, citing Funk Bros. and Bhaget, that the “remaining claims [claim elements?] taken individually and as a whole do not add significantly more to the claim than reciting the phenomenon of nature itself.”
By now, I am sure you are aware that I think that Buck was wrongly decided; it is manifest that “the thing speaks for itself.” Perhaps, the only take-away from this decision is to be sure that you and the Examiner are arguing about the same judicial exception.