During the week of June 10–14, 2019, the Patent Trial and Appeal Board (“Board”) issued one IPR final written decision in TC 1600.

Rimfrost AS v. Aker BioMarine Antarctic AS, IPR2018-00295 (Final Written Decision Entered June 12, 2019)

The Board issued a final written decision on a patent challenged by Rimfrost AS (“Petitioner”), U.S. Patent No. 9,320,765 B2 (“’765 patent”), titled “Bioeffective Krill Oil Compositions,” and assigned to Aker BioMarine Antarctic AS (“Patent Owner”), finding all claims (1–48) unpatentable. The patent at issue claimed a krill oil composition comprising Euphausia superba krill oil suitable for oral administration. Petitioner argued that all claims are obvious under 35 U.S.C § 103(a).

The ’765 patent describes extracts from Antarctic krill, small shrimp-like animals, that include bioactive fatty acids. According to the specification, the compositions disclosed in the ’765 patent are effective in areas such as anti-inflammation, antioxidant effects, improving insulin resistance and improving blood lipid profile. See IPR2018-00295, Paper 35 (Final Written Decision), at 4 (quoting ’765 patent abstract).

Claim 1 of the ’765 patent is illustrative:

A krill oil composition comprising E. superba krill oil suitable for oral administration, said krill oil comprising greater than about 3% ether phospholipids w/w of said krill oil; from about 27% to 50% non-ether phospholipids w/w of said krill oil so that the amount of total phospholipids in the composition is from about 30% to 60% w/w of said krill oil; from about 20% to 50% triglycerides w/w of said krill oil, and astaxanthin esters in amount of greater than about 100 mg/kg of said krill oil.

Id. at 8 (citing ’765 patent, 34:1–35:5). Independent claim 25 adds the limitation that the krill oil composition is encapsulated. Id. (citing ’765 patent, 36:1–11).

Because the Petition was filed before November 13, 2018, the Board applied 37 C.F.R. § 42.100(b) (2018) and interpreted the claim terms according to the broadest reasonable construction in light of the specification. Petitioner contended the term “greater than about 5% w/w” in Claims 18 and 42 should be construed to mean “greater than 4.5% w/w,” while Patent Owner contended that the term should be construed to mean “greater than 4.95%.” And, as one could have guessed, the asserted prior art references disclosed krill oil compositions between 4.5% and 4.95% w/w ether phospholipids. The Board held that, although “it is rarely feasible to attach a precise limit to ‘about,’ the usage can usually be understood in light of the technology embodied in the invention.” Id. at 12 (quoting Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554 (Fed. Cir. 1996)). The Board looked to an example in the ’765 patent reporting the analysis of phospholipid fractions of a product of the invention and a commercially available Krill product, and a table that reports the calculated values for the various phospholipids. The data in the patent are rounded to the nearest whole number, not the nearest tenth, which the Board determined is consistent with the approach advanced by Petitioner. See id. (citing ’765 patent, 32:11–15). The Board therefore construed the term “greater than about 5% w/w” to mean “greater than 4.5% w/w.”

According to Petitioner, it would have been obvious to a person of ordinary skill in the art to combine a prior art krill oil composition, disclosed as having the claimed components, with an oral mode of administration, to create a krill oil having the health benefits disclosed by the prior art. Petitioner further asserted that a skilled artisan would have had reason to use krill extract because the prior art described processing and consumer benefits from using a prior art extraction method. See id. at 30 (citing Pet. 42–46).

Patent Owner only argued that an ordinarily-skilled artisan would not have had reason to combine the references. The Board, however, agreed with Petitioner that one skilled in the art would have been motivated to create a krill oil composition with higher levels of ether phospholipids and include the krill oil composition in a soft gel capsule, and would have had a reasonable expectation of success in creating such a composition. The Board credited Petitioner’s expert’s testimony that a POSA “would have known that the relative proportions of krill oil constituents could be varied in predictable ways by applying a single solvent or combination of solvents including super critical fluid extraction to selectively extract specific groups of lipid components based on their different solubility, and by blending these selective extracts in known and predictable ways to produce a desired krill oil composition.” Id. at 34, 38.