Inter Partes Review of US 10,010,567
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`RIMFROST AS
`Petitioner
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`v.
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`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
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`CASE IPR: IPR2020-01534
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`U.S. Patent No. 10,010,567 B2
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`PATENT OWNER’S RESPONSE TO PETITION FOR
`INTER PARTES REVIEW
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`RIMFROST AS
`Petitioner
`
`v.
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`AKER BIOMARINE ANTARCTIC AS
`Patent Owner
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`
`CASE IPR: IPR2020-01534
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`U.S. Patent No. 10,010,567 B2
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`PATENT OWNER’S RESPONSE TO PETITION FOR
`INTER PARTES REVIEW
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Inter Partes Review of US 10,010,567
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`TABLE OF CONTENTS
`TABLE OF AUTHORITIES ........................................................................................................3
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`I.
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`II.
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`INTRODUCTION AND SUMMARY OF ARGUMENT ..............................................4
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`CLAIM CONSTRUCTION ..............................................................................................6
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`III. COLLATERAL ESTOPPEL DOES NOT APPLY ........................................................8
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`IV. GROUND 1 SHOULD BE DENIED ..............................................................................12
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`V.
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`GROUNDS 2, 3 AND 4 SHOULD BE DENIED ...........................................................17
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`VI. CERTIFICATE OF COMPLIANCE ............................................................................18
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`VII. CONCLUSION AND PRECISE RELIEF REQUESTED ...........................................18
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`CERTIFICATE OF SERVICE ..................................................................................................20
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`TABLE OF AUTHORITIES
`AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285,
`1295 (Fed. Cir. 2014) .............................................................................................. 9
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`Aspex Eyewear, Inc. v. Zenni Optical Inc., 713 F.3d 1377, 1380 (Fed. Cir. 2013) .. 9
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`B & B Hardware, Inc. v. Hargis Indus., Inc., 575 U.S. 138, (2015) ......................... 9
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`Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013) 8,
`9, 10, 11
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`Phillips v. AWH, 415 F.3d 1303, 1312 (Fed. Cir. 2005) ........................................... 6
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`Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 452 (Fed. Cir. 1985) .......... 7
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`Stephen Slesinger, Inc. v. Disney Enterprises, Inc., 702 F.3d 640, 644 (Fed. Cir.
`2012) ................................................................................................................ 9, 11
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`United Access Techs., LLC v. CenturyTel Broadband Services LLC, 778 F.3d 1327,
`1331 (Fed. Cir. 2015) .............................................................................................. 9
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`Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ............ 7
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`INTRODUCTION AND SUMMARY OF ARGUMENT
`Antarctic krill (Euphausia superba, hereafter referred as krill), at between
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`I.
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`300 and 500 million tons, has the largest biomass of any multicellular wild animal
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`species on the planet. The Southwest Atlantic sector of the Southern Ocean, where
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`70% of the krill population resides, is the main focus of the modern krill fishery,
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`which is managed by the Commission for the Conservation of Antarctic Marine
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`Living Resources (CCAMLR). The annual krill catch in the SW Atlantic sector has
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`been increasing steadily since 2010 and, in the 2019 fishing season (December
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`2018 to November 2019) it reached 390,195 tons.
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`The inventors sought to develop methods for efficient production of high-
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`quality krill oil containing phospholipids from krill caught in the South Ocean.
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`They did so by producing krill meal, a denatured krill product, from krill caught in
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`the Southern Ocean on board a ship and then extracting that krill meal after it had
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`been stored for a period of time to provide a phospholipid-rich krill oil. As
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`described in the speciifcation of the U.S. Patent No. 10,010,567 (the ‘567 patent),
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`the methods “avoid decomposition of glycerides and phospholipids in krill oil and
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`compositions produced by those methods. The product obtained by these new
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`methods is virtually free of enzymatically decomposed oil constituents.” Ex. 1001
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`at 0030 (col. 9, l. 64 – col. 10, l. 1). Decomposition of glycerides and
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`phospholipids results in an increase in the free fatty acid content of the krill oil.
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`The compositions claims in the ‘567 patent are characterized in having a low
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`amount of free fatty acids (i.e., less than 3% w/w).
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`This proceeding involves Petitioner’s challenge of the validity of the claims
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`of the ’567 patent based on four different but related grounds. First, Petitioner
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`alleges in Ground 1 that claims 1-5, 7-11, and 15-17 are obvious over the
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`combination of Sampalis I, Bottino II, and Randolph. Second, Petioner alleges in
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`Ground 2 that claims 6, 14, and 20 are obvious over the combination of Sampalis I,
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`Bottino II, Randolph, and Breivik II. Third, Petitioner alleges in Ground 3 that
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`claims 12 and 18 are obvious over the combination of Sampalis I, Bottino II,
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`Randolph, and Bottino I. Fourth, Petitioner alleges in Ground 4 that claims 13 and
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`19 are obvious over the combination of Sampalis I, Bottino II, Randolph,
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`Yamaguchi, Hardardottir, and Fricke.
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`All of the asserted Grounds rely on Bottino II for the “less than 3% w/w free
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`fatty acids” limitation, including Ground 1 which is the Ground asserted against
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`both independent claims (claims 1 and 15). Petitioner’s asserted grounds for
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`unpatentability should be denied because the combination of references asserted
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`in Ground 1 against the independent claims do not teach or suggest the claim
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`limitation of “less than 3% w/w free fatty acids.” Specifically, Petitioner argues
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`that the “unknown” fraction of the Bottino II krill oil is listed as 2 ± 22% and that
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`the unknown fraction would include free fatty acids. However, Petitioner’s
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`interpretation of the data in Bottino II is incorrect. As detailed in the
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`accompanying Jaczynski Declaration (Ex. 2001), the “unknown” fraction of the
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`Bottino II extracts includes only lipids that have a retardation factor between that
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`of diglycerides and triglycerides on thin later chromatography. Free fatty acids
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`have a much lower retardation factor and thus cannot be within the “unknown”
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`fraction of Bottino II. As a result, Bottino II provides no information on free fatty
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`acid content and Petitioner has not established a prima facie case of obviousness
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`with respect to the independent claims in Ground 1 or the dependent claims in the
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`remaining Grounds.
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`II. CLAIM CONSTRUCTION
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`The first step in analyzing Petitioner’s grounds for unpatentability is to
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`determine the meaning of the terms in the involved claims of the ’567 patent. The
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`words of a patent claim are generally given their ordinary and customary
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`meanings, which are the meanings that would have been understood by a person of
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`ordinary skill in the art at the time of the invention. Phillips v. AWH, 415 F.3d
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`1303, 1312 (Fed. Cir. 2005). Since the instant IPR was filed after November 13,
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`2018, the Phillips claim construction standard applies.
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`The person of ordinary skill in the art is deemed to read claim terms not only
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`in the context of the claim itself but also in the context of the specification. Id. at
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`1313. Thus, in determining the ordinary and customary meanings of the claim
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`terms, the specification is “always highly relevant” and is “the primary basis for
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`construing the claims.” Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc.,
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`90 F.3d 1576, 1582 (Fed. Cir. 1996) and Standard Oil Co. v. Am. Cyanamid Co.,
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`774 F.2d 448, 452 (Fed. Cir. 1985)). In addition, the prosecution history can often
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`inform the meaning of the claim language. Id. at 1317.
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`Patent Owener does not believe that comstruction of the terms is necessry to
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`address the issues raised in this case. Furthermore, Petitioner’s analysis relies
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`heavily o the testimony of Dr. Tallon. That analysis and testimony should be
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`disregarded because it appears that Dr. Tallon applied the wrong standard for claim
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`construction. At ¶30 of his Declaration (Ex. 1006) he states “I have been informed
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`that claim terms are interpreted according to their broadest reasonable construction
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`in light of the specification of the ‘567 Patent . . . .” Since the instant IPR was filed
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`after November 13, 2018, the broadest reasonable construction standard no longer
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`applies. Thus, his analysis (and the Petitioner’s analysis which relies on the Tallon
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`Decl.) should be given little or no weight.
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`III. COLLATERAL ESTOPPEL DOES NOT APPLY
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`Petitioner alleges that collateral estoppel precludes Patent Owner from
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`advancing the same patentability arguments rejected in the Final Written Decisions
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`in the following IPRs: 2017-00745, 2017-00746, 2018-00295, 2018-01178, 2018-
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`01179 and 2018-01730. Petition at 42-44. Petitioner does not argue in its Petition
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`that those decisions should be applied to directly invalidate the claims at issue
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`through a theory of collateral estoppel.
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`Petitioner cites to the Federal Circuit’s decision in Ohio Willow Wood for
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`the proposition that collateral estoppel “protects a party from having to litigate
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`issues that have been fully and fairly tried in a previous action and adversely
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`resolved against a party-opponent.” Petition at 42, citing Ohio Willow Wood Co. v.
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`Alps South, LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013). However, Petitioner
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`provides no analysis under Ohio Willow Wood or any other precedent to establish
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`that collateral estoppel should apply to the claims of the ‘567 patent. The lack of
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`any analysis under the applicable standards for collateral estoppel is a failure in
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`Petitioner’s burden of proof and for that reason alone collateral estoppel should not
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`be applied here. Furthermore, as explained in detail below, collateral estoppel does
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`not apply to the arguments advanced in this Response under the applicable
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`standards because the “less than 3% w/w free fatty acids” claim element was not
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`present in any of the claims examined in the prior IPRs.
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`The law of the regional circuit governs the application of general collateral
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`estoppel principles. AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech,
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`Inc., 759 F.3d 1285, 1295 (Fed. Cir. 2014). “However, for any aspects that may
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`have special or unique application to patent cases, Federal Circuit precedent is
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`applicable.” Aspex Eyewear, Inc. v. Zenni Optical Inc., 713 F.3d 1377, 1380 (Fed.
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`Cir. 2013). Under Federal Circuit precedent, a party is collaterally estopped from
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`relitigating an issue if: (1) a prior action presents an identical issue; (2) the prior
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`action actually litigated and adjudged that issue; (3) the judgment in that prior
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`action necessarily required determination of the identical issue; and (4) the prior
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`action featured full representation of the estopped party. Stephen Slesinger, Inc. v.
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`Disney Enterprises, Inc., 702 F.3d 640, 644 (Fed. Cir. 2012); United Access
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`Techs., LLC v. CenturyTel Broadband Services LLC, 778 F.3d 1327, 1331 (Fed.
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`Cir. 2015). Collateral estoppel or “issue preclusion applies where the[se] ...
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`[elements] of collateral estoppel are carefully observed.” B & B Hardware, Inc. v.
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`Hargis Indus., Inc., 575 U.S. 138, (2015) (quotations omitted).
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`In the context of patent invalidity, collateral estoppel is not limited to
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`identical claims. Ohio Willow Wood, 735 F.3d at 1342. Instead, “[i]f the
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`differences between the unadjudicated patent claims and adjudicated patent claims
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`do not materially alter the question of invalidity, collateral estoppel applies.” Id.
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`(finding collateral estoppel where the patentee failed to explain how the specific
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`limitation of a “block copolymer gel” in the unadjudicated claim would change the
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`invalidity analysis of a substantially identical claim requiring a more general
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`“polymeric gel”).
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`The independent claims of the ‘567 patent both include the claim limitation
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`of “less than 3% w/w free fatty acids. The claims examined by the Board in the
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`previous IPRs did not include this limitation and Petitioner has not alleged that
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`claims with this limitation have been the subject of any final decision. As a result,
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`this is the first time that the issue of whether or not Bottino II teaches an extract
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`with less than 3% free fatty acids w/w has been presented to the Board.
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`The question before the Board is not whether the additional limitation
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`renders the claim non-obvious, but whether the addition of the new limitation
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`would alter an obviousness analysis. See Ohio Willow Wood, 735 F.2d at 1343
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`(finding collateral estoppel appropriate where the plaintiff failed to explain how the
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`new limitation “changes the invalidity analysis”). In Ohio Willow Wood, the
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`Federal Circuit’s analysis focused on minor additional limitations that narrowed
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`the scope of a broader claim element– “polymeric gel” to “block copolymer gel.”
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`See Ohio Willow Wood, 735 F.2d at 1342.
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`In contrast to the claims in Ohio Willow Wood, the claims at issue in this
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`proceeding contain an entirely new limitation (less than 3% w/w free fatty acids)
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`that was not subject to any determination by the Board in the previous IPRs. As
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`explained in detail below in the discussion of the instituted grounds, this new claim
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`element raises new questions of fact with regard to disclosures of the prior art (e.g.,
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`as discussed below none of the references teach the newly added limitation). Thus,
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`the new limitation materially alters the question of invalidity and Ohio Willow
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`Wood does not apply.
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`Further, as discussed above, the Federal Circuit requires that following
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`factors be met before collateral estoppel applies: (1) a prior action presents an
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`identical issue; (2) the prior action actually litigated and adjudged that issue; (3)
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`the judgment in that prior action necessarily required determination of the identical
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`issue; and (4) the prior action featured full representation of the estopped party.
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`Stephen Slesinger, Inc. v. Disney Enterprises, Inc., 702 F.3d 640, 644 (Fed. Cir.
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`2012). Here, Petitioner has provided no analysis under these factors. However, it
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`is apparent that the previous IPRs did not 1) present an identical issue as none of
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`the claims in the patents involved in those IPRs contained the “less than 3% w/w
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`free fatty acids” limitation and 2) the actual issue of whether claims containing the
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`“less than 3% w/w free fatty acids” limitation are obvious was not adjudicated.
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`Thus, collateral estoppel does not apply to the claims at issue in this IPR under the
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`relevant analysis applied by the Federal Circuit.
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`IV. GROUND 1 SHOULD BE DENIED
`Petitioner asserts that Claims 1-5, 7-11, and 15-17 of the ‘567 patent
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`should be canceled because they purportedly would have been obvious in view
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`of the combination of Sampalis II, Bottino II and Randolph under 35
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`U.S.C. § 103. (Petition at 45-59.) Petitioner is incorrect because as explained
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`below the combined references do not teach each element of the claims.
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`Independent claims 1 and 15 both require that the claimed encapsulated
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`krill oil comprise less than 3% w/w free fatty acids. Petitioner argues: “As
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`detailed previously, Table 2 of Bottino II discloses a Euphausia superba extract
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`with 48% phosphatidylcholine and at most 2% free fatty acids.” Petition at 46.
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`As detailed in the claim charts provided by Petitioner: “Table 2 reports that the
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`level of “unknown” lipid components of the Euphausia superba extract was 2 ±
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`22 (i.e., 2 ± 22%). Free fatty acids would be represented by this “unknown”
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`component so that the free fatty acid content of this extract would be at most
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`2%. Tallon Decl. (Exhibit 1006), ¶ 174.” See Petition at 74, 81. As specifically
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`testified by Dr. Tallon:
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`The ‘Unknown’ lipid fraction in Bottino II Table 2 is noted in the footnote
`as presenting between the triglyceride and diglyceride fractions, and that
`the amount recovered was too small to characterize further. A POSITA
`would understand that, while not identified, this fraction would include any
`free fatty acids that are present in the krill lipids. Thus Bottino II discloses
`a free fatty acid content for Station 11 of at most 2%.
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`Ex. 1006 (Tallon Decl.) at ¶174.
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`Dr. Tallon’s position on what is contained in the “unknown” fraction in
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`Table II of Bottino II, and Petitioner’s reliance thereon, are not based on sound
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`scientific reasoning. As explained below, the “unknown” fraction of Bottino II
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`cannot have included free fatty acids. As a result, Bottino II is silent with respect
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`to free fatty acid content of its extract for some unexplained reason.
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`As explained by Dr. Jaczynski, the data reported in Table II were obtained
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`by the Thin Layer Chromatography (“TLC”) technique. Ex. 2001 (Jaczynski
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`Decl.) at ¶26. TLC separates lipids in a sample on a thin layer of adsorbent
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`material such as silica gel on a glass or plastic support or plate. Id. As disclosed in
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`Bottino II, the particular method used in Bottino II was a variation of the TLC
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`method described in Freeman and West 1966 (Ex. 2002). Id. The method
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`involved separation of lipids by TLC followed by a gravimetric (i.e., weight-
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`based) quantitation of the lipid preset in individual spots on the TC plates. Id.
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`The footnote for the unknown fraction in Table II, as specifically noted by
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`Dr. Tallon, provides:
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`§Rf between those of triglycerides and diglycerides. The recovered amount
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`of this fraction was too small for further characterization.
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`Ex. 1038 at 0003; See also Ex. 1006 (Tallon Decl.) at ¶174. Rf refers to the
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`retardation factor, which in thin layer chromatography (TLC) is defined as the
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`ratio of the distance traveled by the center of a spot to the distance traveled by the
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`solvent front. Ex. 2003; Ex. 2001 (Jaczynski Decl.) ¶27. As explained by Dr.
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`Jaczynski, in lay terms, Rf TLC is a measure of the how far an analyte travels on
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`a TLC plate. Id. A high Rf value indicates that the compound has travelled far up
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`the plate and is less polar, while a lower Rf value indicates that the compound has
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`not travelled far, and is more polar. Id.
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`Importantly, when the data presented in Table 2 of Bottino II is viewed in
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`light of Freeman and West (Ex. 2002), it is apparent that Dr. Tallon’s conclusion
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`that the free fatty acids are in the “unknown” fraction is incorrect. Ex. 2001
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`(Jaczynski Decl.) ¶28. Bottino II does not provide photographs of the TLC plates
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`on which Table 2 is based. However, Freeman and West provides photographs of
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`developed TLC plates:
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`Ex. 2020 at 0002.
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`As explained by Dr. Jaczynski, in each solvent system utilized, free fatty
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`acids (designated FA in Figure 1) travel less distance than triglycerides (TG in
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`Figure 1) and diglycerides (DG in Figure 1), and more distance than
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`phospholipids (PL in Figure 1). Ex. 2001 (Jaczynski Decl.) ¶28. Thus, Bottino
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`II’s “unknowns,” which traveled between the triglycerides and diglycerides, could
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`not include free fatty acids as concluded by Dr. Tallon. Id.
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`It cannot be disputed that Bottino II fails to directly disclose the amount
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`free fatty acids contained in the E. superba extracts. As a result of this failure,
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`Petitioner relies on unfounded speculation that the “unknowns” necessarily
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`include free fatty acids. Petitioner’s argument appears to follow an obviousness
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`by inherency rationale to provide the claim element of “less than 3% w/w free
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`fatty acids.” Although inherency may supply a missing element in an
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`obviousness analysis, it is Petitioner’s burden to show that the limitation at issue
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`is necessarily present in the cited reference (i.e., Bottino II). PAR Pharm., Inc. v.
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`TWI Pharm., Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014).
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`Here, Petitioner has not shown that that the claim limitation of “less than
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`3% w/w free fatty acids” is necessarily present in Bottino II or for that matter in
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`any of the combined references in Ground 1 because the “unknown” fraction of
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`Bottino II cannot include free fatty acids. Furthermore, the data presented in
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`Table 2 of Bottino II on lipid composition is of such poor quality that a POSITA
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`cannot determine what amount of free fatty acids could be present in the extract.
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`For example, the value reported for “unknowns” in Table 2 for the Station 11 E.
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`superba extract is 2% ± 22%. Ex. 1038 at 0003. The standard deviation is over
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`1000% greater than the actual value it represents. As testified by Dr. Jaczynski,
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`this data cannot be considered to be reliable, even anecdotally. Ex. 2001
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`(Jaczynski Decl.) ¶30.
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`In summary, the combined references in Ground 1 fail to teach element of
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`independent claims 1 and 15. Petitioner has failed to establish a prima facie case
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`of obviousness with respect to the independent claims and the claims dependent
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`thereon. Ground 1 must be denied.
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`V. GROUNDS 2, 3 AND 4 SHOULD BE DENIED
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` Under Ground 2, Petitioner that claims 6, 14, and 20 are obvious over the
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`combination of Sampalis I, Bottino II, Randolph, and Breivik II. Under Ground 3,
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`Petitioner asserts that claims 12 and 18 are obvious over the combination of
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`Sampalis I, Bottino II, Randolph, and Bottino I. Under Ground 4, Petitioner
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`asserts that claims 13 and 19 are obvious over the combination of Sampalis I,
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`Bottino II, Randolph, Yamaguchi, Hardardottir, and Fricke.
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`Ground 2, 3, and 4 all apply to claims that are dependent on claims 1 and 15,
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`which are covered in Ground 1. In each of Grounds 2, 3, and 4, Petitioner begins
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`by asserting that the discussions regarding the unpatentability of claims 1-5 and
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`15-17 (i.e., Ground 1) are incorporated by reference. See Petition at 59, 62, and
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`64. Thus, in each of these Grounds, Petitioner relies on Bottino II to provide the
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`claim element of “less than 3% w/w free fatty acids” in the underlying independent
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`claims. Grounds 2, 3, and 4 thus fail because Bottino II does not provide the claim
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`element of “less than 3% w/w free fatty acids” as discussed in Section IV supra.
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`VI. CERTIFICATE OF COMPLIANCE
`Pursuant to 37 C.F.R. § 42.24(d), the undersigned certifies that this Petition
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`complies with the type-volume limitation of 37 C.F.R. § 42.24(a). The word count
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`application of the word processing program used to prepare this Petition indicates
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`that the Petition contains 3,096 words, excluding the parts of the brief exempted by
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`37 C.F.R. § 42.24(a) (that is, the word count does not include the table of contents,
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`the exhibit list, certificate of compliance, conclusion, or the certificate of service).
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`VII. CONCLUSION AND PRECISE RELIEF REQUESTED
`For the foregoing reasons, Petitioner has failed to meet its burden to show
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`that the claims of the ’567 Patent are unpatentable over the combined art in the
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`Grounds upon which trial was instituted. Accordingly, Patent Owner requests
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`that the Board confirm the patentability of Claims 1-20 of the ’567 patent.
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` Respectfully submitted,
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`Dated: August 12, 2021
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`CASIMIR JONES SC
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`By /John Mitchell Jones/
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` John Mitchell Jones, Reg. No, 44,174
`Email: jmjones@casimirjones.com
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`David Casimir, Reg. No. 42,395
`Email: dacasimir@casimirjones.com
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`Attorneys for Patent Owner
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`18
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`Inter Partes Review of US 10,010,567
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`Aker Biomarine Antarctic AS
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`19
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`Inter Partes Review of US 10,010,567
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on this 12th day of August 2021, a
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`copy of the foregoing Patent Owner’s Response to Petition for Inter Partes
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`Review of U.S. Patent No. 10,010,567, Patent Owner’s Exhibit List and
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`Exhibits 2001-2003 and 2019 were served in their entirety electronically (as
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`consented to by Petitioner) to the attorneys of record as follows:
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`567ipr@hbiplaw.com
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`James F. Harrington
`jfhdocket@hbiplaw.com
`Hoffmann & Baron, LLP
`6900 Jericho Turnpike
`Syosset, NY 11791
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`Michael I. Chakansky
`micdocket@hbiplaw.com
`Hoffmann & Baron, LLP
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`John T. Gallagher
`jtgdocket@hbiplaw.com
`Hoffmann & Baron, LLP
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`By: /John Mitchell Jones/
`John Mitchell Jones, Ph.D.
`Registration No. 44,174
`Counsel for Patent Owner
`CASIMIR JONES, S.C.
`2275 Deming Way, Suite 310
`Middleton, Wisconsin 53562
`(608) 662-1277
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`20
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