Takeaway: Establishing written description support for a genus claim in an earlier filed application requires showing “a representative number of species falling within the scope of the genus, precisely defined, such as by structure, formula, chemical name, physical properties, or other properties,” or “structural features common to the members of the genus.”
In its Final Written Decision, the Board held that Petitioner had shown by a preponderance of the evidence that all challenged claims, claims 1-9 and 11-19, of the ’565 patent are unpatentable. The Board did not institute review of claim 10. The ’565 patent is “directed to recombinant yeast microorganisms with increased activity of dihydroxy acid dehydratase (‘DHAD’).”
The Board first stated that it was adopting Petitioner’s uncontested proposed standard for the level of ordinary skill in the art. Next, the Board addressed claim construction, stating that claims are given their broadest reasonable construction in light of the specification. The Board presumes that the claim terms have their ordinary and customary meaning unless the patentee gives the term “a particular meaning in the specification with ‘reasonable clarity, deliberateness, and precision.’”
The Board explicitly defined the term “inactivated” as used in claim 1. Petitioner argued that the term should be defined to mean “that the GRX3 and/or GRX4 protein lacks allactivity and excludes GRX3 and/or GRX4 proteins having reduced, attenuated or partial activities” primarily based upon statements made during prosecution of the patent application. The Board found the plain and ordinary meaning to require “a lack of all activity or functionality,” and that the usage of the term in the specification “neither elucidates the meaning of the term nor indicates any deviation from its ordinary and customary meaning.” The inventors did not act as their own lexicographer, and thus, the term was construed to mean “lacking all activity or functionality.”
Turning to the prior art, the Board first addressed whether the Flint reference, alleged to anticipate claims 1-4, 6-8, and 11-19, is prior art. In particular, the dispute centered on whether the challenged ’565 patent was entitled to the benefit of its provisional filing date. The Board noted that Petitioner bears the “burden of persuasion to establish by a preponderance of the evidence that Flint is prior art to the ’565 patent, including that the ’565 patent is not entitled to the benefit of the earlier filing date of the ’952 provisional.” Petitioner argued in its Petition, with supporting expert testimony, that claim 1 was not entitled to the provisional filing date because of an alleged lack of written description support.
The Board explained that claim 1 “is a functionally-defined genus claim because it recites the function, or desired or useful result, of ‘inactivat[ion]’ of ‘at least one’ Grx3 and Grx4 proteins, and further recites that this inactivation ‘results from’ any one of a number of different means: ‘deletion of one or more nucleotides of an endogenous gene encoding’ the protein, ‘insertion of one or more nucleotides into an endogenous gene encoding’ the protein, or ‘combinations thereof.’” According to Petitioner, “the provisionals describe, at best, only complete deletion of endogenous GRX3 and GRX4 genes,” and therefore “fail to describe adequately the full scope of the broadly claimed deletions, insertions, or combinations of deletions and insertions in the endogenous GRX3 and GRX4 genes.”
The Board stated that, with respect to written description support for a genus claim, “the specification must disclose either: (1) ‘a representative number of species falling within the scope of the genus,’ ‘precise[ly] defin[ed], such as by structure, formula, chemical name, physical properties, or other properties,’ or (2) ‘structural features common to the members of the genus.’” The written description standards “are premised on the basic principle that one of ordinary skill in the art ‘must be able to ‘visualize or recognize the identity of the members of the genus’’ upon reviewing the disclosure.”
The Board reviewed the disclosures of the provisional applications and credited Petitioner’s expert testimony in finding that the disclosures failed to provide written description support for the claims. In particular, the Board concluded that “the only species falling within the scope of claim 1 that is defined with any precision in the disclosures of the ’952 and ’209 provisionals is complete deletion of either or both the GRX3 and GRX4genes.” This disclosure did not represent adequately the full scope of the genus recited in claim 1, which also extends to inactivated proteins resulting from deleting less than all nucleotides, inserting one or more nucleotides, and combinations of deleting and inserting nucleotides in either or both genes.”
The Board rejected Patent Owner’s arguments that the disclosures of the provisionals would have rendered the claimed subject matter obvious and that a person of skill in the art would have been enabled based on the disclosures, finding these arguments to be inapplicable in the context of written description. Thus, the Board concluded that the claims were not entitled to an earlier filing date such that Flint constituted prior art.
Having found that Flint was prior art, the Board next found that Petitioner had established by a preponderance of the evidence that Flint anticipated claims 1-4, 6-8, and 11-19.
The Board next addressed the obviousness grounds of unpatentability. With regard to the alleged obviousness of claims 1-4, 6-8, 11, 13, 14, and 16-19 based on Anthony, Puig, and Ojeda, Petitioner argued and the Board agreed that it would have been obvious in light of the prior art to inactivate both the Grx3 and Grx4 proteins. According to the Board, it was unnecessary to decide whether it would have been obvious to delete only one of the two proteins because inactivation of both proteins was within the broad genus claimed, and Petitioner need only show that one species within the broad genus was obvious. In concluding that the claims were obvious, the Board credited Petitioner’s expert testimony that one of ordinary skill in the art would have been motivated to combine the asserted prior art, and found that Patent Owner’s attorney argument did not provide reliable evidence to dispute the proposed prior art combination.
Patent Owner also submitted evidence of purported secondary considerations of nonobviousness. In particular, Patent Owner submitted as an exhibit a pending patent application (“the ’921 application”) filed by Petitioner in which Petitioner allegedly made admissions regarding “the unexpected ability of GRX3 deletion to increase DHAD activity.” The Board was not persuaded. First, the Board found the claims obvious because it would have been obvious to inactivate both proteins, whereas the alleged admission of unexpected results related to deletion of only one. Second, the Board disagreed with Patent Owner characterization of the “admission,” finding the cited portions of the ’921 application consistent with a statement that the extent of increased activity was unexpected and not that any increase in activity was unexpected. Finally, the Board found the evidence not to be commensurate in scope with the claims because the evidence of unexpected results concerned exclusively “deletions in the GRX3 gene—not the GRX4gene, or the GRX3 and GRX4 genes.” Thus, the Board concluded that Petitioner had established that claims 1-4, 6-8, 11, 13, 14, and 16-19 were obvious based on Anthony, Puig, and Ojeda.
Finally, the Board found that Petitioner had established by a preponderance of the evidence that claims 5 and 9 were unpatentable as obvious for similar reasons discussed above.
ButamaxTM Advanced Biofuels LLC v. Gevo, Inc., IPR2013-00539
Paper 33: Final Written Decision
Dated: March 3, 2015
Patent: 8,273,565 B2
Before: Rama G. Elluru, Christopher L. Crumbley, and Kerry Begley
Written by: Begley