§ 112 Enablement and Written Description in Post-Grant Review

When are written description and enablement requirements of 35 U.S.C. § 112 met, and what is a Petitioner’s burden of showing those requirements are not met in a PTAB proceeding? In Instrumentation Laboratory Co. v. Hemosonics LLC, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review of U.S. Patent 9,977,039 (“the ‘039 patent”). The PTAB declined institution because if found that Instrumentation Laboratory Co. (“Petitioner”) didn’t meet its burden of proof to support the challenges under 35 U.S.C. § 112 it was alleging against the ‘039 patent.

Hemosonics LLC (“Patent Owner”) is the owner of the ‘039 patent, which is directed toward devices, systems and methods for evaluating hemostasis of blood. The invention uses test chambers for holding blood, and “transducers associated with each of the plurality of test chambers in the interrogation of the test sample.” ‘039 Patent, claim 1 (identified as representative by the PTAB). The ‘039 patent issued from a continuation application filed on July 7th, 2017.  The ‘039 patent is a continuation of a series of a US patent application and prior US provisional application having priority dates of Feb. 15, 2012 and Feb. 15, 2011, respectively (“priority applications”).

Remember, post-grant review is available for applications having a priority date that is on or after March 16th, 2013. The PTAB institutes a post-grant review only if the petitioner shows that the challenges raised in the petition are more likely than not to invalidate at least one of the challenged claims.

Petitioner challenged the claims of the ‘039 patent under § 112. Specifically, Petitioner alleged that the priority applications did not meet the enablement or written description requirements to support the claims of the ‘039 patent. Petitioner further alleged that the ‘039 was invalid under 35 U.S.C. § 102 and § 103. However, for the PTAB to consider the allegations § 102 and § 103, Petitioner’s § 112 challenges to the priority applications of the ‘039 patent would have to be successful, as the priority date of the ‘039 patent based on the priority applications makes post-grant review unavailable.

To break the priority chain, and make post-grant review available, Petitioner argued that the disclosure of priority applications provides written description and enablement that is narrower than what is claimed in the ‘039. Specifically, Petitioner argued that the specification of the priority applications only disclosed a single species that used an “ultrasonic method,” and that the broader generic claims of the ‘039 included a scope of protection outside the “ultrasonic method.” Petitioner supported its argument by citing Lizardtech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005). In LizardTech the district court found (and the Federal Circuit later upheld) the claims at issue to be invalid because only the single species was disclosed, and it was not sufficient to support the broader claims.

In response, Patent Owner argued that Petitioner failed to me their burden because they ignored teachings of the specification that described and enabled more than just the “ultrasonic method.” The additional teachings were based on techniques for testing blood that a person of ordinary skill would be familiar with, and as such, did not include as much detail as the “ultrasonic method.”

The PTAB sided with the Patent Owner, finding that Petitioner failed to meet its burden relating to the written description requirement. Notably, the PTAB cited admissions from Petition’s arguments relating to a person of ordinary skill’s knowledge of the other techniques of testing blood as undermining Petitioner’s arguments that only one species is disclosed by the speciation of the ‘039. The PTAB found the present case distinguishable from LizardTech because the specification of the priority applications disclose more than just a single species.

Petitioner’s enablement arguments were similar to their written description arguments, and further alleged that a person of ordinary skill in the art would have to conduct undue experimentation to practice the invention. However, the PTAB was again not persuaded as Petitioner’s expert merely testified that embodiments beyond the disclosed species “may require experimentation” and did not testify that such experimentation rose to the level required to render a claim invalid.

 

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