Claim Scope and Biological Deposits
The U.S. Patent Trial and Appeal Board (PTAB) recently issued a post-grant review decision, denying a post-grant review challenge to U.S. Patent No. 11,696,545 submitted by Inari Agriculture, Inc. against the patent owner Pioneer Hi-Bred International, Inc. The Board ruled that because the claims cited representative seeds deposited at the National Center for Marine Algae and Microbiota (NCMA), the claim scope encompasses both the plant variety’s phenotype and genotype, even though the genotype is not explicitly recited in the claims. Thus, the post-grant review challenge was denied because the Board agreed with Patent Owner’s arguments that the claimed material was properly enabled by the specification and was also nonobvious. This decision raises more questions than it answers regarding claim construction.
The recent post-grant review decision[1] regarding U.S. Patent No. 11,696,545 in Inari Agriculture, Inc. v. Pioneer Hi-Bred International, Inc. illustrates the importance of carefully selecting both claim language and quantifiable materials such as biological deposits.
The ’545 Patent generally relates to the maize inbred variety, PH4CYJ, achieved through the crossing of two parental seed lines, PH1KTF and PH1VNA, to produce maize varieties and hybrids that are stable and high yielding.
Claim 1 recites:
A seed, plant, plant part, or plant cell of inbred maize variety PH4CYJ, representative seed of the variety having been deposited under NCMA accession number 202212062.
Inari Agriculture, Inc. (Inari) challenged the claims of the ’545 Patent on multiple grounds, asserting that the claims are invalid for obviousness, lack utility, and fail to satisfy the requirements of sufficient written description and enablement. Specifically regarding obviousness, Inari argued that because U.S. Patent No. 8,895,819 B1 discloses one of the two parent varieties of PH4CYJ and states that it may be used to develop new maize inbred varieties, a person of ordinary skill in the art would have had a reasonable expectation of success in using the parent seed lines to arrive at other inbred lines. Additionally, Inari asserted that the disclosed characteristics of PH4CYJ are quite similar to the known parent PH1KTF, and nothing in the specification suggests any property of PH4CYJ that would be viewed as surprising or unexpected over PH1KTF.
Patent Owner Pioneer argued that Inari’s obviousness arguments were deficient for failing to challenge the actual claims. Specifically, Pioneer argued that the obviousness arguments outlined by Inari simply posit that it would have been obvious to make a hypothetical maize inbred with similar phenotypical characteristics to those of the claimed variety, instead of arguing that it would be obvious to obtain the claimed maize inbred variety PH4CYJ based on the prior art. Pioneer further argued that the phrase “of inbred maize variety PH4CYJ, representative seed of the variety having been deposited under NCMA accession number 202212062,” inherently encompasses the phenotype and the genotype of the claimed maize inbred variety, and therefore, Inari’s obviousness challenge would need to address the genetic composition of PH4CYJ compared to the asserted prior art. Thus, Pioneer’s arguments hinge on the specific genetics of PH4CYJ, which are not explicitly recited in claim 1.
In defense of nonobviousness of the claimed invention, Pioneer cited established case law that appears significant to the enablement issue, rather than relating to any kind of obviousness analysis. From Enzo Biochem, Inc. v. Gen-Prove Inc.,[2] it is known that “reference in the specification to a deposit in a public depository, which makes its contents accessible to the public when it is not otherwise available in written form, constitutes an adequate description of the deposited material sufficient to comply with the written description requirements….” Additionally, Monsanto Co. v. Scruggs[3] teaches that failure to disclose a specific DNA sequence for a genus claim will not render the claim invalid if a person of ordinary skill in the art could determine the DNA sequence based on the identification of the genus and publicly available biological deposits referenced in the patent specification. However, the cited precedent does not address whether specific properties of biological deposits, such as genotype, can be read into the claims without explicit claim language directed to those characteristics. As such, claim construction should have been a key discussion by the Board, but was not.
Surprisingly, the Board agreed with Pioneer, stating that by depositing the seeds, the exemplary seed “deposited under NCMA accession number 202212062” necessarily encompasses both the genotype and phenotype associated with that particular seed. With this statement, the Board appears to have taken a strong stance on claim construction with regards to how a biological deposit is read into the claims. This has potentially interesting implications for the prosecution and litigation of other patents that reference biological deposits. For example, it is unclear whether patent examiners should now read genetic information into claims that include biological deposit information when that genetic information is not explicitly recited. Similarly, could patents be challenged based on a new claim construction including genetic information that was not previously considered during prosecution?
The Board further stated that Inari’s arguments focus on the obviousness of PH4CYJ’s phenotype without addressing the genotype, rendering their arguments unpersuasive.
The decision concluded that Inari failed to show that it is more likely than not that the claims, as represented by claim 1, would have been obvious over the cited references.
Regarding alleged insufficiency of disclosure, Inari further argued that the phrase “representative seed” could be interpreted to indicate that the inventor did not view the invention as limited to what was deposited, and that therefore the claims are not limited to the deposited seed but instead merely recite the deposited seed as representative without further defining the scope. Based on this interpretation, Inari argued that the ’545 Patent does not satisfy the written description or enablement requirements.
The Board found these arguments unpersuasive. The Board stated that the claims suggest that the deposited seeds “represent” the claimed variety, and that it is well known that publicly-accessible deposited biological materials, combined with the phenotypic information and breeding history provided, satisfy both the written description and enablement requirements. While the case law cited above supports this decision, we believe the Board did not adequately address the enablement issues raised by Inari. The Board did not remark on what it means to be “representative” of a plant variety in terms of claim scope. As this language in the claims describes the biological deposit, a discussion of what it means to be “representative” seems key to the overall decision and completely lacking in the Board’s analysis.
The Board’s decision is further complicated by the dependent claims, which include subject matter directed towards genetic variants of the “representative” seed as well as progeny obtained by crossing the “representative” seed with “a different maize plant.” Inari’s argument that the claims are not limited to the deposited seed would appear to warrant more discussion that is likewise absent from the Board’s decision.
As we have explained, this decision raises more questions than it answers, and we hope to see future cases regarding the nature of claimed biological deposits that will provide some clearer answers.
