On September 6, 2024, the results of the first substantive examination of Lykos’ U.S. application (US 18/611,564) posted. The Non-Final Office Action (NFOA) introduced a number of new challenges for Lykos, not least because it was from an Examiner with notably high standards (her “difficulty ranking” according to one widely-used platform is “Extremely Hard”—in the 94th percentile, with only a 23% chance of getting an issued patent after three years of prosecution).
First, through the course of examining Lykos’ claims, the Examiner found that none of the company’s four provisional applications “provide adequate support or enablement … for one or more claims of this application.” Specifically, the Examiner took aim at the upper limit of the average particle size range in the company’s claims.
Lykos, in claim 33, included an upper limit for its average MDMA particle size of 610 µm. However, the Examiner asserted that “such a value for the average particle size was not disclosed in any of” Lykos’ provisional applications. Consequently, the Examiner found that Lykos could not claim the benefit of the priority dates of its provisional applications. Instead, the company’s effective filing date (and now the priority date for its claims) was found to be December 4, 2023, the day Lykos’ PCT was filed.
Such a finding meant that Lykos could have had to contend with another year’s worth of prior art, and any relevant “intervening” disclosures published before December 4, 2023, but after its provisionals, could be used to argue against the patentability of the company’s claims.
Though, for some of the company’s claims, third party prior art was not even required for the Examiner to issue a rejection. Instead, the contents of Lykos’ own specification, or in this case what was not included, was sufficient for the Examiner to reject claims 41-52 for failing to comply with the written description requirements.
Each of dependent claims 41 through 52 were directed to compositions with pharmacokinetic limitations (e.g., Cmax, Tmax, and area under the curve). However, the Examiner found that Lykos’ “specification does not even provide general guidelines as to a structure-function relationship between the pharmaceutical composition and the resultant pharmacokinetic parameters.”
The claims were therefore found to not be supported by a specification that contains “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art … to make and use the same”, and were rejected accordingly.
Unfortunately for the company, the Examiner’s initial rejection of Lykos’ amended U.S. claims was not limited only to claims 41-52. As we discussed above, while a PCT Examiner’s WO is a preliminary and non-binding assessment, it is often instructive for an applicant as it can point to how an Examiner may treat their claims during national prosecution.
For Lykos this appears to have been especially true, with their assigned Examiner citing the same piece of prior art referenced in the WO, the Awakn PCT (WO2022/150525), this time in a rejection of all of the company’s presented claims.
Awakn’s application was used by the Examiner both alone and in combination with other references to find all of Lykos’ claims obvious. As aforementioned, Awakn’s application discloses compositions of MDMA and mentions the necessity of “provid[ing] the appropriate particle size” in “preparing a formulation”.
In Awakn’s application, the company states that certain active agents can be “ordinarily milled to a particle size less than about 200 mesh”, which, as Lykos’ Examiner explained, “corresponds to openings of about 89 microns … or about 74 microns.”
While Awakn did not provide any working examples for compositions of MDMA with particular average particle sizes or ranges, the Examiner found that it would have nevertheless been obvious for one of skill in the art “to mill the MDMA active agent to an appropriate particle size such as less than 200 Mesh” and that in doing so, arrive at a particle size that falls within the range claimed by Lykos.
This overlap in particle size ranges is, according to the Examiner, “prima facie obvious absent evidence as to the criticality or unexpected properties of the claimed particle size and/or particle size distribution.” In the absence of such evidence, Lykos’ claims were all rejected.
It appeared then that Lykos needed to show that their particle sizes are demonstrably—and unexpectedly—better than those disclosed in the prior art (e.g., Awakn’s <200 mesh / <~74 micron), or otherwise find a way to carve out specific ranges (or add other limitations) that it can convince the notoriously difficult Examiner are not obvious.