PGR2017-00008 (US 9,283,239 B2)
Final Written Decision
June 22, 2018
Brief summary: FWD decision following PGR finding AB’s method of treatment claims invalid for lack of written description (claimed dosage range not described).
Summary: Grünenthal’s petition for post-grant review (PGR) of AB’s US 9,283,239 B2 alleged that claims 1-17 are unpatentable for lack of written description (WD). Sole independent claim 1 is described in the FWD as illustrative, and claims “[a] method of treating complex regional pain syndrome comprising orally administering zoledronic acid” at “about 80 to about 500 mg…within a period of six months.” The FWD explains that “[i]n a [PGR], the claims of an unexpired patent are interpreted using the broadest reasonable construction [BRC] in light of the specification” (37 CFR § 42.200(b); Cuozzo, US 2016; In re Translogic, FC 2007 (under BRC, “claim terms are given their orindary and customary meaning” as understood in view of “the entire disclosure”); In re Paulson, FC 1994 (“special definition…must be set forth in the specification”)). The Board did not construe any of the claim terms (Wellman, FC 2011). Grünenthal argued that the claims did not provide a WD for the “about 80 to about 500 mg…within six months” limitation, and separately challenged claim 17 for lacking WD of “an oral dosage form containing ‘at least 10% zoledronic acid’”. The FWD explained that the WD “does not have to provide exact or verbatim textual support” (Fujikawa, FC 1996) but must “reasonably convey…that the inventor has possession at that time of the later claimed subject matter” (Vas-Cath, FC 1991; Capon, FC 2005 (neither examples nor an actual reduction to practice are required, “determined on a case-by-case basis”)). Grünenthal argued that the ‘239 specification “describes the administration of virtually any amount of zoledronic acid over virtually any period of time” and “does not clearly disclose…that the inventors considered the claimed range to be part of their invention” (citing Vas-Cath, FC 1991; Purdue, FC 2000; In re Ruschig, CCPA 1967 (“no guide or indicating or directing that this particular selection should be made”)). AB argued the specification describes “about 50 mg to about 500 mg”, and separately disclosed the lower end of the range (e.g., 10 mg/day for eight days, repeated “once every six months”) and the higher end (e.g., 10 mg/day for eight days “repeated once monthly”), and in ‘239 Examples 3 and 7. The Board found the specification “does not clearly allow persons of ordinary skill in the art to recognize the ‘about 80 mg’ endpoint as part of the invention” (no “description suggesting the importance or criticality of the ‘about 80 mg’ endpoint”). The Board disagreed that “one of skill in the art could derive the claimed ranges from the specification” as “a non-original claim recites a dosage regimen range with endpoints derived from an inordinate amount of picking an choosing from disparate disclosures of various embodiments reciting broader ranges” (e.g., Ralston, FC (“disclosure of 25%-27% water…did not support “at least 20%,” “between 20% and 40%,”, or “in the range of 20%-30%”); Purdue, FC 2000 (“no blaze marks directing the skilled artisan to the Cmax/C24 ratio”)). The Board also found that the “at least 10%” limitation of claim 17 was properly described and “that the ‘inventor’…did not overreach” (Univ. Rochester, FC 2004).