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.

During the week of June 24–28, 2019, the Patent Trial and Appeal Board (“Board”) issued one IPR institution decision and one IPR final written decision in TC 1600.

Ocular Therapeutix, Inc. v. Mati Therapeutics, Inc. – IPR2019-00448

In this institution decision, Petitioner Ocular Therapeutix, Inc. (“Ocular”) challenged the patentability of U.S. Patent 9,849,082 (“the ’082 patent”) on five grounds: one ground of anticipation over Pritchard and four grounds of obviousness including Pritchard and one or more references.  As explained below, the Board found a reasonable likelihood of success only for Grounds 1–3 but instituted on all grounds pursuant to SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). IPR2019-00448, Paper 8.

The ’082 patent, titled “Nasolacrimal drainage system implants for drug therapy,” relates to a colored, cylindrical, hydrogel-composed device for treating certain conditions and/or incorporating therapeutic agents for ocular drug delivery.  Exemplary independent claim 1 recites:

A drug delivery system for insertion into a lacrimal canaliculus of a patient, comprising:

a therapeutic agent, a distinguishing color to show placement of the system in the lacrimal canaliculus of the patient and a body of material to hold the therapeutic agent wherein the body of material comprises hydrogel polymers and wherein the body of material is a cylindrical rod.

Grounds 1 and 2: Anticipation by Pritchard or Obviousness over Pritchard and Gillespie

Ocular contended that Pritchard was directed to the same field of invention (canalicular inserts) and taught the same therapeutic agent, distinguishing color, and cylindrical-swellable-body as the independent claims.  To the extent Pritchard lacked the claimed “distinguishing color,” Ocular relied on Gillespie’s teaching of punctum plugs, colored to improve visualization and contrast with surrounding tissue.  The Patent Owner accused Petitioner of “cherry pick[ing],” arguing that Pritchard provided “15 separate embodiments and numerous sub-embodiments” and lacked the claimed improvement in visibility.  Regarding obviousness, Patent Owner argued that Gillespie focused on a different field and included color additives not suited for Pritchard’s drug delivery implants.

Although Ground 1 presented a “reasonably close question” because Pritchard “does not disclose a single, stand-alone example of a lacrimal canalicular plug” as claimed, Ocular met its burden for institution.  The Board also agreed that Pritchard provided sufficient disclosure of coloring a device and held that Pritchard need not disclose a specific intent for such coloring.

Ground 3: Obviousness over Pritchard, Gillespie, and Hellberg

            Several dependent claims recited the therapeutic agent travoprost, a glaucoma drug taught by neither Pritchard nor Gillespie.  Hellberg, however, taught travoprost topical administration.  For purposes of institution, the Board credited Ocular’s asserted motivation to combine the references.

Grounds 4 and 5: Obviousness over Pritchard and Handbook and over Pritchard, Handbook, and Hellberg

            Grounds 4 and 5 substituted Handbook in place of Gillespie.  Handbook discussed using coloring agents in medicinal products to prevent counterfeiting and to improve uniformity of appearance.  Patent Owner argued that such color was unpredictable and not suitable for application to Pritchard’s medical devices, and the Board agreed.  Accordingly, although instituted pursuant to SAS, the Board found that Petitioner did not show a reasonable likelihood of success for Grounds 4 and 5.

Trans Ova Genetics, LC v. XY, LLC – IPR2018-00250

In this Final Written Decision, the Board determined that claims 1–16 of U.S. Patent 8,652,769 (“the ’769 patent”) were not proven unpatentable because the petitioner’s primary reference did not qualify as pre-AIA § 102(a) prior art.  IPR2018-00250, Paper 35.

The ’769 patent relates generally to methods of separating and sorting frozen sperm based on sex chromosomes.  The ʼ769 patent identified several problems with existing separation technologies including a significant error rate, staining affecting sperm viability, and the decreased viability time of cryopreserved sperm.  Petitioner Trans Ova Genetics raised five obviousness grounds, all based on Lu.  The Patent Owner argued that Lu was not the work of “another” under 35 U.S.C. § 102(a).

The Board determined that Petitioner did not meet its burden in showing that Lu qualified as prior art.  The ʼ769 patent identified Lu, Cran, and Seidel as inventors.  The Lu reference identified Lu, Cran, and Seidel as authors with a footnote thanking Green (and four other individuals), which showed that Green’s contribution “was insufficient to deem him an author of the Lu reference.”  Additionally, Green gave “permission” to use certain data—despite not being named an author—which provided more evidence that Green did not consider himself an author.

The Board rejected any “conspiracy” arguments about purposefully omitting Green as an inventor and agreed that Green was a “bench technician” rather than a true inventor.  While the Board agreed that Green’s permission to cite his work suggested “material contributions,” the Board ultimately held that Green’s contribution did not rise to the level required to consider Lu to be the work of another. Petitioner thus failed to establish that Lu qualified as pre-AIA § 102(a) prior art.

Judge Obermann filed an opinion concurring in the judgment (and reiterating her dissent from the Institution Decision).  According to Judge Obermann, the Petition did not argue that Green was an unidentified coauthor of Lu—indeed, that issue was not raised until institution.  In her view, the Board unfairly reached outside the Petition and Preliminary Response to identify a triable issue regarding whether Green’s contributions sufficed for Lu to qualify as prior art, which cut off Patent Owner’s opportunity to address the issue before institution and unnecessarily increased the parties’ litigation costs.