Case No. IPR2016-01679 (U.S. Pat. No. 7,146,202 B2)
Final Written Decision (Feb. 28, 2018)
Brief summary: PTAB FWD found claims 1-3, 6, 8, and 11 (but not claim 10) of Waveform’s ‘202 patent relating to continuous glucose monitoring to be anticipated but others not obvious.
Summary: This FWD relates to Dexcom’s petition for IPR against Waveform’s ‘202 patent related to a “sensing element adapted to be inserted…into a mammalian body” that “may be used…for continuous sensing of…glucose” (Dexcom’s area of technology) for anticipation or obviousness. Litgation regarding the ‘433 patent is ongoing (3:16-cv-00536-MO (D. Or.)) as are two IPRs regarding additional Waveform patents (IPR2017-01051 (US 7,529,574 (ongoing)) and IPR2016-01680 (US 8,187,433 B2 (2/28/18 FWD, not unpatentable)). Under the broadest reasonable interpretation (BRI (§ 42.100(b); Cuozzo, US 2016; In re Translogic, FC 2007 (“in the context of the entire patent disclosure”); Microsoft, FC 2015 (BRI “does not include giving claims a legally incorrect interpretation”, “PTO should…consult the patent’s prosecution history” (PH))), the PTAB construed “structurally flexible core” not to to be “robust” based on the PH as “it was removed by Applicants during prosecution” (Laryngeal, FC 2010 (imporpoper to “read such limitations back into the claim…‘regardless of why [applicant] amended its claims’”)); instead the term was determined to mean “able to be flexed or bent repeatedly”. The PTAB also construed “in contact with” to mean “touching” (and the parties agree; “consistent with the ordinary meaning”, “not an ‘intervening layer,’ as disclaimed during prosecution”). The PTAB explained that the “Petitioner bears the burden of proving unpatentability of the challenged claims, and the burden of persuasion never shifts to the Patent Owner” (Dynamic Drinkware, FC 2015; § 316(e), § 42.1(d) (preponderance of the evidence)). An anticipatory reference (§ 102) must be show to “disclose…not only all of the limitations but also…arranged or combined in the same way” (Net MoneyIN, FC 2008), and obviousness is considered using the Graham factors (Graham, US 1966; KSR, US 2007). The PTAB agreed with the parties regarding the definition of a person of ordinary skill in the art (POSA). The PTAB concluded that “Petitioner has not shown by a preponderance of the evidence that the” first combination of references “teaches or suggests the ‘in contact with’ limitation” of claims 1-3, 5, 6, or 9-11 (e.g., “Rosenblatt teaches that an intervening alloy later is essential”, supported by expert testimony). The PTAB also concluded claim 5 was not shown by a preponderance of evidence to be obvious (e.g., the combination does not teach or suggest the “‘in contact with’ limitation”). The PTAB found claims 1-3, 6, 8, and 11 (but not claim 10) to be anticipated by the “Hagiwara” reference (e.g., disclosed claim 1’s preamble and the “structurally flexible core” and the coating thereof, placing the sensor into an animal, and measuring the electrical current). The PTAB also dismissed as moot Dexcom’s motions to exclude an expert declaration and an exhibit related to the construction of “outer surface”, and granted Waveform’s petition to exclude an exhibit improperly relied upon “to assert new grounds of unpatentability” (§ 42.23(b); Belden, FC 2015; EmeraChem, FC 2017).