A recent post-grant review decision once again reminds patentees of the increasing scrutiny that claims are facing under the written description and enablement requirements under 35 U.S.C. § 112 (a). In this case, Commonwealth Scientific and Industrial Research Organisation ("Petitioner") filed a petition requesting post-grant review of claims 1-23 from U.S. Patent No. 10,301,638 ("the '638 patent") owned by BASF Plant Science GMBH ("Patent Owner"). The '638 patent relates to a process for the production of various long chain fatty acids in a transgenic Brassica plant by introducing nucleotide sequences coding for polypeptides with different elongase and desaturase activity, and claims the resulting oils, lipids and/or fatty acids. After close review of the examples presented in the '638 patent, the Board found all of the claims unpatentable for failing to comply with the written description and the enablement requirements.
With respect to its written description analysis, the Board first addressed Claims 8-16, which required that the fatty acids produced by the transgenic Brassica plant comprise at least 54% polyunsaturated ω3-fatty acid. The example in the patent directed to a transgenic Brassica plant disclosed that seed oil only reached a level of 17.2% to 19.6% polyunsaturated ?3-fatty acid, far below the 54% recited in the claims. The Patent Owner, however, argued that the 54% level reached in examples involving transgenic O. violaceous and A. thaliana plants was representative of the amount of ω3-fatty acid present in transgenic Brassica, because a POSA would understand that the construct coding for the same polypeptides in those varieties would also generate the 54% level in the Brassica transgenic plant. The Board found that a POSA would understand that the identity of the fatty acids would be conserved across the different plant species, but not necessarily at the same levels. The Board found it significant that the patent did not teach that the amount of ω3-fatty acids in transgenic O. violaceous or A.thaliana plants was representative of the amounts in transgenic Brassica plants. Additionally, the Board rejected Patent Owner's arguments to disregard the Brassica examples with unsatisfactory levels of ω3-fatty acid, where a different construct was used, or where the fatty acids produced were localized to the seeds, because claims were sufficiently broad to encompass this construct and fatty acids isolated from seeds. Accordingly, the Board concluded that Claims 8-16, requiring the fatty acids produced by the Brassica plant to be at least 54% polyunsaturated ω3-fatty acid, were unsupported by the disclosure.
Claim 1, and its dependent claims, required that the fatty acids produced by the transgenic Brassica plant comprise at least 20% eicosapentaenoic acid (EPA), at least 2% docosapentaenoic acid (DPA), and at least 4% docosahexaenoic acid (DHA), as a percentage of total fatty acids in the form of triacylglycerides. Once again, the sole Brassica example in the '638 patent did not meet the claim limitation as it contained only 4.1-4.5% EPA, far below the 20% recited in the claim. The '638 patent did, however, disclose a transgenic O. violaceious that produced at least 20% EPA and was made with the same construct as the transgenic Brassica. As with claims 8-16, the Board found a lack of written description because a POSA would have understood that the identity of the fatty acids would be the same in the different transgenic plants, but not that the same amounts would be produced.
Finally, in an analysis that mirrored its written description analysis, the Board concluded the claims failed to satisfy the enablement requirement. The Board found that the '638 patent did not teach how to create a transgenic Brassica plant that produces fatty acids that are at least 54% polyunsaturated ω3-fatty acid. Rather, the '638 patent explains how to make a transgenic Brassica plant that merely elevates levels of polyunsaturated C20- and C22- fatty acid. Similarly, the Board found that the '638 patent did not provide guidance on how a POSA may increase the level of EPA in a transgenic Brassica plant above the level of 4.1-4.5% to the 20% level as recited in the claims.
The outcome here is consistent with the current trend throughout U.S. patent litigation of increased scrutiny under Section 112 for certain classes of broad claims. In particular, this case highlights the danger of "mixing and matching" aspects of differing embodiments to support claims during prosecution. If a person of ordinary skill would not recognize the equivalence or interchangeability of these embodiments, and it is not taught by the patent, this could prove fatal under both the written description and enablement requirements.
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