Nippon Suisan Kaisha Ltd. v. Pronova Biopharm Norge AS

Docket No. 2017-2620 (US 9,447,360)
Post-Grant Review PGR2017-00033
Final Written Decision (January 16, 2019)

Brief summary: Board PGR decision finding claims 1-21 and 26 of Nippon’s fish oil-related claims unpatentable for indefiniteness, anticipation and obviousness affirmed (claims 22-25 were cancelled).

Summary: In this PGR, Pronova alleged that the challenged claims of Nippon’s US ‘360 patent directed to “[a] process for reducing the amount of…undesired hydrophilic components, undesired lipophilic compositions components chosen from environmental pollutants and cholesterol, and free fatty acids” “in a marine oil composition” using an “aqueous fluid processing step” and “a short parth distillation or molecular distillation”, the composotions per se. Pronova alleged PGR availability because at least one of ‘360 claims 24 and 25 “was not fully disclosed until at least the filing of” PCT/EP2013/072807 (“PCT ‘807”) “on October 31, 2013” while Nippon argued the claims “are entitled to a priority date before March 16, 2013.” Pronova also alleged indefiniteness under § 112(b), anticipation under § 102(a)(1) and (2) based on four different references, and obviousness under § 103(a) based on three different combinations of references. Each party submitted declarations by their respective experts. Pronova’s definition of a person of ordinary skill in the art was undisputed by Nippon and adopted by the Board (e.g., “master’s degree or Ph.D. in organic chemistry…accompanied by more experience”). The Board determined that it did not “need to expressly construe any claim term” (Nidec, FC 2017 (“[W]e need only construe terms ‘that are in controversy’….” (Vivid Techs., FC 1999)). The Board agreed with Pronova’s argument that claims 1-21 “are indefinite under the Nautilus standard or the Packard standard” (Nautilus, US 2014 (claim invalid if it “fails to inform, with reasonable certainty…the scope of the invention”); Packard, FC 2014 (“claim is indefinite when it contains words or phrases whose meaning is ‘unclear in describing and defining the claimed invention’”)). Pronova argued several limitations “impart[] more than one scope of coverage for the same limitation, and the specification provides no insight into how the compounded terms should be understood”, and the Board agreed (by a preponderance of the evidence). The Board explained that the claims include “both broader and narrower limitations for the same components”, as in claim 1 which “recites that ‘lipophilic components [] are separated from the marine oil composition,’ but it is not clear whether those separated lipophilic components must be ‘undesired lipophlic components’ as also recited in claim 1” (or claim 4’s “polyunsaturated fatty acids” and “particularly polyunsaturated omega-3 fatty acids” or “more particularly EPA and DHA”). Thus, the Board found claims 1-21 invalid for indefiniteness for containing “words or phrases whose meaning is ‘unclear’…and are ‘amenable to two or more plausible claim constructions’” (Packard; Ex Parte Miyazaki, BPAI 2018 (precedential); Ex parte McAward, PTAB Aug. 25, 2017 (precedential)) or under Nautilus. The Board also found claims 1-7, 11-21, and 26 to have been shown by a preponderance of the evidence to be anticipated by at least one of the references (and did not therefore reach the other references). The Board also found that Pronova showed claims 8-10 to be invalid for obviousness by a preponderance of the evidence (e.g., “normal desire…to improve what is already generally known” (Jazz Pharm., FC 2018); “obviousness cannot be avoided simply by a showing of some degree of unpredictability” (Pfizer, FC 2007); see also FN20 (“we may consider a prior art reference to show the state of the art at the time of the invention, regardless of whether it was relied on in the petition or cited in the institution decision” (Ariosa, FC 2015; Genzyme, FC 2016)).

Nippon’s contingent motion to substitute claims 1-21 with new claims was denied since the Board found “neither of [the] two sets of proposed substitute claims patentably distinct from issued claims 1-21” with respect to the prior art and only addressed the indefiniteness issues (35 U.S.C. § 326(d), 37 C.F.R. § 42.221, Aqua Prods., Western Digital (PTAB April 25, 2018 (informative)), while its request to cancel claims 22-25 was granted.

This entry was posted in Anticipation (35 USC 102), Inter Parties Review (IPR), IPR, Obviousness, Obviousness-Teaching Away. Bookmark the permalink.

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