`571-272-7822
`
`.
`
`Paper No. 9
`Entered: August 16, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROSTAS,
`Petitioner,
`
`V.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`
`Case IPR2017-00745
`Patent 9,078,905 B2
`
`Before LORA M. GREEN, ERICA A. FRANKLIN,and
`JACQUELINE T. HARLOW,Administrative Patent Judges.
`
`HARLOW,Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 CFR. $ 42.108
`
`
`
`IPR2017-00745
`Patent 9,078,905 B2
`
`I. INTRODUCTION
`
`Rimfrost AS (“Petitioner”) filed a Petition requesting an inter partes
`
`review of claims 1—20 of U.S. Patent No. 9,078,905 B2 (Ex. 1001, “the
`
`°905 patent”). Paper 2 (“Pet.”). Aker Biomarine Antarctic AS (“Patent
`Owner”) declinedto file a Preliminary Response. Wehaveauthority to
`determine whetherto institute an inter partes review under 35 U.S.C. § 314,
`
`which provides that an inter partes review may notbe instituted unless the
`
`information presented in the petition “showsthat there is a reasonable
`
`likelihood that the petitioner would prevail with respect to at least 1 of the
`
`claims challengedin the petition.”
`
`For the reasonsset forth below, weinstitute an inter partes review of
`
`claims 1—20 of the ’905 patent.
`
`A. Related Matters
`
`The ’905 patent is asserted in Aker Biomarine Antarctic AS v. Olympic
`
`Holding AS, Case No. 1:16-CV-00035-LPS-CJB (D. Del.). Pet. 2; Paper 3,
`
`1. Petitioner has additionally challenged the claims of the °905 patentin
`
`IPR2017-00747.' Paper 5,2. Theparties have notidentified any further,
`
`currently pending, related proceedings concerning the ’905 patent.”
`
`' Petitioner also challenges U.S. Patent No. 9,028,877 B2 in IPR2017-00746
`and IPR2017-00748. Paper 5, 2. Both the’905 patent and the ’877 patent
`are continuations of Application No. 12/057,775, filed March 28, 2008.
`
`* The ’905 patent was also asserted in Jn the Matter ofCertain Krill Oil
`Products and Krill Mealfor Production ofKrill Oil Products, Investigation
`No. 337-TA-1019 (USITC) (Pet. 2-3; Paper 3, 1); however, Petitioner states
`that the investigation has been terminated with regard to the ’905 patent.
`2
`
`
`
`IPR2017-00745
`Patent 9,078,905 B2
`
`B. The ’905 Patent
`
`The ’905 patent, titled “Bioeffective Krill Oil Compositions,” issued
`
`July 14, 2015, from U.S. Patent Application No. 14/490,221, filed
`
`September 18, 2014. Ex. 1001, at [54], [45], [21], [22]. The ’905 patentis a
`
`continuation of U.S. Patent Application No. 12/057,775, filed March 28,
`
`2008. Jd. at [63]. The °905 patent claimspriority to U.S. Provisional Patent
`
`Application No. 60/920,483, filed March 28, 2007; U.S. Provisional Patent
`
`Application No. 60/975,058, filed September 25, 2007; U.S. Provisional
`
`Patent Application No. 60/983,446, filed October 29, 2007; and
`
`U.S. Provisional Patent Application No. 61/024,072,filed January 28, 2008.
`
`Id. at [60].
`
`The ’905 patent describes extracts from Antarctic krill that include
`
`bioactive fatty acids. Ex. 1001, 1:19-20. In particular, the °905 patent
`
`discloses krill oil compositions having “high levels of astaxanthin,
`
`phospholipids, includ[ing] enriched quantities of ether phospholipids, and
`
`omega-3 fatty acids.” Jd. at 9:28-31. The °905 patent purports to improve
`
`upon knownkrill oil extraction techniques and the resulting products by
`
`disclosing a method for performing extraction on krill meal, in order to
`
`eliminate the need to transport frozen krill over long distancesprior to
`
`processing. Jd. at 1:65-2:16, 9:31-43.
`
`The ’905 patent acknowledgesthat krill 011 compositions, including
`
`compositions having up to 60% w/w phospholipid content and as much as
`
`35% w/w EPA/DHA content, were knownin theart prior to the time of
`
`Pet. 3, n.1.
`
`
`
`IPR2017-00745
`Patent 9,078,905 B2
`
`invention. Jd. at 1:52-57. The ’905 patentalso indicates that supercritical
`
`fluid extraction with solvent modifier was knownto be a useful method for
`
`extracting marine phospholipids from salmon roe. /d. at 1:65-67.
`
`In addition, the ’905 patent recognizes that myriad health benefits
`
`have beenattributed to krill oil in the prior art. For example, the 905 patent
`
`states that “[k]rill oil compositions have been described as being effective
`
`for decreasing cholesterol, inhibiting platelet adhesion, inhibiting artery
`
`plaque formation, preventing hypertension, controlling arthritis symptoms,
`
`preventing skin cancer, enhancing transdermal transport, reducing the
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`symptoms of premenstrual symptomsor controlling blood glucoselevels in
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`a patient.” Jd. at 1:46—52.
`
`C. Illustrative Claim
`
`Independentclaim 1, reproducedbelow,isillustrative of the claimed
`
`subject matter.
`
`1.
`
`Encapsulated krill oil comprising:
`
`a capsule containing an effective amountofkrill oil,
`said krill oil comprising from about 3% to about 15% w/w
`ether phospholipids.
`
`Ex. 1001, 35:47-50. Independent claims 12 and 18 further specify the lipid
`
`composition ofthe krill oil, the type of krill used, and the material in which
`
`the krill oil is encapsulated. Jd. at 36:29-36, 36:48-56.
`
`
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`IPR2017-00745
`Patent 9,078,905 B2
`
`D. Prior Art Relied Upon
`
`Petitioner relies upon the following asprior art references (Pet. 8-9):
`
`Randolph
`
`US 2005/0058728 Al
`
`Mar. 17, 2005
`
`(Ex. 1011)
`
`Catchpole
`
`WO 2007/123,424
`
`Nov. 1, 2007
`
`(Ex. 1009)
`
`Bottino, The Fatty Acids ofAntarctic Phytoplankton and Euphausiids. Fatty
`Acid Exchange among Trophic Levels of the Ross Sea, 277 MARINE BIOLOGY
`197-204 (1974) (Ex. 1007).
`
`Fricke et al., Lipid, Sterol and Fatty Acid Composition ofAntarctic Krill
`(Euphausia superba Dana), 19(11) LIPIDS 821-827 (1984) (Ex. 1010).
`
`Sampaliset al., Evaluation ofthe Effects ofNeptune Krill Oil™ on the
`Management ofPremenstrual Syndrome and Dysmenorrhea, 8(2) ALT.
`MED.REV. 171-179 (2003) (Ex. 1012).
`
`Petitioneralso relies on the Declaration of Stephen J. Tallon, Ph.D.
`
`(Ex. 1006).
`
`E. The Asserted Grounds of Unpatentability
`
`Petitioner challenges the patentability of claims 1—20 of the
`
`°905 patent on the following grounds(Pet. 7):
`
`
`
`
`
`Cui) [tase|__Retrenes
`
`
`
`1-4, 9, and 10 § 103(a)|Catchpole and Sampalis
`
`§ 103(a)|Catchpole, Sampalis, and Randolph
`
`
`6, 12, 15, 16, and 18 § 103(a)|Catchpole, Sampalis, and Fricke
`
`
`7,
`8,
`13, 14, 17, 19,
`Catchpole, Sampalis, Fricke, and
`
`$1030)|Sorin
`
`§ 103(a)|Catchpole, Sampalis, and Bottino
`
`
`
`IPR2017-00745
`Patent 9,078,905 B2
`
`Il. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, the Board interprets claim terms in an
`
`unexpired patent according to the broadest reasonable construction in light
`
`of the specification of the patent in which they appear. 37 C.F.R.
`
`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016)
`
`(affirming applicability of broadest reasonable construction standard to inter
`
`partes review proceedings). Underthat standard, and absent any special
`
`definitions, we give claim terms their ordinary and customary meaning, as
`
`would be understood by oneofordinary skill in the art at the time of the
`
`invention, in the context of the entire disclosure. Jn re Translogic Tech.,
`
`Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms that are in
`
`controversy need be construed, and only to the extent necessary to resolve
`
`the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795,
`
`803 (Fed. Cir. 1999).
`
`Wedetermine that, for purposes of this Decision, none of the terms in
`
`the challenged claims require express construction at this stage of the
`
`proceeding.
`
`B. Level ofOrdinary Skill in the Art
`
`Thelevel of ordinary skill in the art is a factual determination that
`
`provides a primary guarantee of objectivity in an obviousness analysis. Al-
`
`Site Corp. v. VSI Int’l Inc., 174 F.3d 1308, 1324 (Fed. Cir. 1999) (citing
`
`Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966); Ryko Mfg. Co. v. Nu-
`
`Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991)).
`
`6
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`
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`IPR2017-00745
`Patent 9,078,905 B2
`
`At this stage in the proceeding, we determine that Petitioner’s
`
`description of a relevant skilled artisan as possessing “an advanced degree in
`
`marine sciences, biochemistry, organic (especially lipid) chemistry,
`
`chemical or process engineering, or associated sciences”(Pet. 6), as well as
`
`having a complementary understanding of “organic chemistry and in
`
`particular lipid chemistry, chemical or process engineering, marine biology,
`
`nutrition, or associated sciences; and knowledge of or experiencein the field
`
`of extraction”(id.), in addition to “at least five years applied experience”
`(id.)is supported by the current record. See Ex. 1006 927. For purposes of
`
`this Decision, therefore, we adopt Petitioner’s description.
`
`Wealso note that the applied prior art reflects the appropriate level of
`
`skill at the time of the claimed invention. See Okajima v. Bourdeau, 261
`
`F.3d 1350, 1355 (Fed. Cir. 2001).
`
`C. Obviousness Ground of Unpatentability
`Based on Catchpole and Sampalis
`
`Petitioner asserts that claims 1-4, 9, and 10 are unpatentable under
`
`§ 103(a) as obvious in view of Catchpole and Sampalis. Pet. 26~34.
`
`The question of obviousnessis resolved on the basis of underlying
`
`factual determinations including (1) the scope and contentof the priorart,
`
`(2) any differences between the claimed subject matter andthe priorart,
`
`(3) the level of skill in the art, and (4) where in evidence, so-called
`
`secondary considerations. Graham, 383 U.S. at 17-18. Ifthe differences
`
`between the claimed subject matter and the prior art are such that the subject
`
`matter, as a whole, would have been obviousat the time the invention was
`
`
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`IPR2017-00745
`Patent 9,078,905 B2
`
`madeto a person having ordinary skill in the art to which said subject matter
`
`pertains, the claim is unpatentable under 35 U.S.C. § 103(a). KSR Int’l Co.
`
`v. Teleflex Inc., 550 U.S. 398, 406 (2007).
`
`I. Catchpole?
`Catchpole discloses ‘“‘a process for separating lipid materials
`
`containing phospholipids” (Ex. 1009, 1:5-6) in order to produce a product
`
`containing “desirable levels of particular phospholipids”(id. at 3:27-28).
`
`Catchpole states that phospholipids “have been implicated in conferring a
`
`numberofhealth benefits including brain health, skin health, eczema
`
`treatment, anti-infection, wound healing, gut microbiota modifications, anti-
`
`canceractivity, alleviation of arthritis, improvement of cardiovascular
`
`health, and treatment of metabolic syndromes. They canalso be used in
`
`sports nutrition.” /d. at 1:29-2:2. Catchpole further discloses that products
`
`having high levels of particular phospholipids “may be employedin a
`number of applications, including infant formulas, brain health, sports
`nutrition and dermatological compositions.” Jd. at 25:9-13.
`
`3 Petitioner contends that Catchpole qualifies as prior art to the ’905 patent
`pursuant to pre-AIJA § 102(a) and §102(e). Pet. 7-9, n. 2; Ex. 1006 ¥ 34. In
`this regard, Petitioner asserts that each claim of the ’905 patent requires the
`presence of ether phospholipids in a particular range, and that support for the
`inclusion of such ether phospholipid amounts was not introducedpriorto the
`filing of U.S. Patent Application No. 61/024,072 on January 28, 2008.
`Pet. 7—-8; Ex. 1006 734. At this stage in the proceeding, and for purposes of
`this Decision, we are satisfied by Petitioner’s showing that Catchpole
`qualifies as prior art to the °905 patent.
`8
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`
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`IPR2017-00745
`Patent 9,078,905 B2
`
`Catchpole describes, in Example 18, the fractionation of krill lipids
`
`from krill powder using a process that employs supercritical COin a first
`
`extraction, and a CO; and absolute ethanol mixture in a second. /d. at 24:1—
`
`16. Table 16, reproduced below,reports the phospholipid concentrations
`
`present in the krill oil extract obtained by Catchpole.
`
`
`
`| pc 2|CL|AAPC| AAPE
`
`Table 16tit
`; i
`Othercompounds
`
`LtoS
`
`As shownin Table 16, the composition of Extract 2 includes 39.8%
`
`phosphatidylcholine (“PC”). Jd. at Table 16. The ether phospholipids
`
`alkylacylphosphatidylcholine (‘AAPC”) and
`
`alkylacylphosphatidylethanolamine (“AAPE”) werealso present in
`
`Extract 2, representing 4.6% and 0.2%, respectively, of the extracted
`
`composition. Jd. In addition, summing each ofthe reported phospholipid
`
`amounts reported for Extract 2 yields a total phospholipid concentration
`
`of 45.1%. Id.
`
`2. Sampalis
`
`Sampalis describesa clinical trial “[t]o evaluate the effectiveness of
`
`NeptuneKrill Oil™ (NKO™)for the management of premenstrual
`
`syndrome and dysmenorrhea.” Ex. 1012, 1. Sampalis explains that Neptune
`
`Krill Oil is “extracted from Antarctic krill also known as Euphausia
`
`superba. Euphausia superba, a zooplankton crustacean,is rich in
`
`phospholipids and triglycerides carrying long-chain omega-3
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`9
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`IPR2017-00745
`Patent 9,078,905 B2
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`polyunsaturated fatty acids, mainly EPA and DHA,andin various potent
`
`antioxidants including vitamins A andE, astaxanthin, and a novel
`
`flavonoid.” Jd.at 4.
`
`Sampalis discloses that each patient in the clinical trial was “asked to
`
`take two 1-gram soft gels of either NKO or omega-3 18:12 fish oil (fish oil
`
`containing 18% EPA and 12% DHA)once daily with meals duringthefirst
`
`month ofthetrial.” Jd. Sampalis reports that “[t]he final results of the
`
`present study suggest within a high level of confidence that Neptune Krill
`
`Oil can significantly reduce the physical and emotional symptomsrelated to
`
`premenstrual syndrome,andis significantly more effective for the
`
`managementof dysmenorrhea and emotional premenstrual symptoms than
`
`fish oil.” Jd. at 8.
`
`3. Obviousness Analysis
`
`Petitioner asserts that Catchpole discloses a krill oil extract including
`
`from about 3% to about 15% w/w ether phospholipids. Pet. 28-29. In this
`
`regard, Petitioner points out that Catchpole expressly describes, in Table 16,
`
`a krill extract having 4.8% ether phospholipids, including 4.6% AAPC and
`
`0.2% AAPE. Pet. 28-29; Ex. 1006 ff 88-92, 193; Ex. 1009, 24:1-19,
`
`Table 16.
`
`Petitioner additionally contends that Sampalis discloses the
`
`administration of an effective amount of encapsulatedkrill oil in the form of
`
`a soft gel. Pet. 29; Ex. 1006 {fj 68, 69; Ex. 1012, 4. In support of this
`
`position, Petitioner’s expert, Dr. Tallon, testifies that Sampalis “discloses the
`
`10
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`IPR2017-00745
`Patent 9,078,905 B2
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`use of an amountofkrill oil in soft gel (encapsulated capsules) to effectively
`
`treat symptomsrelated to PMS.” Ex. 1006
`
`193.
`
`According to Petitioner, it would have been obviousto a person of
`
`ordinary skill in the art to combine the ether phospholipid-containing krill oil
`
`extract of Catchpole with the mode of administration taught by Sampalis in
`
`order to formulate a krill 011 dosage form including an effective amount of
`
`krill extract and having the health benefits disclosed by Catchpole and
`
`Sampalis. Pet. 32-33; Ex. 1006 J] 28-32, 193-195. Petitioner further
`
`asserts that a relevant skilled artisan would have had reasonto use thekrill
`
`extract taught by Catchpole in the mode of administration taught by
`
`Sampalis because Catchpole describes an array of processing and consumer
`
`benefits that derive from the disclosed supercritical fluid extraction method.
`Pet. 33-34; Ex. 1006 J 193-195. In particular, Petitioner explains that
`extracts prepared according to Catchpole are “considered to be more
`
`‘natural’ than extracts produced using other solvents”(Pet. 33 (citing
`
`Ex. 1009, 2:18-25)), and that “Catchpole discloses that it is an object of the
`
`invention described therein to provide a process for producing a productthat
`
`contains desirable levels of particular phospholipids” (id. (citing Ex. 1009,
`
`3:27-29)).
`
`In addition, Dr. Tallon testifies that the lipid components described in
`
`the claims of the ’905 patent “are the natural lipid componentsin the krill oil
`
`that can be extracted using any of a numberofsuitable solvents” (Ex. 1006
`
`4 194), and that the relative proportions of those lipid components “can also
`be varied ina predictable way by applying a combinationof solvents with
`different polarity to selectively concentrate groups of compounds based on
`
`11
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`IPR2017-00745
`Patent 9,078,905 B2
`
`their different solubility” using methods and solvents that would have been
`
`well-knownbya relevant skilled artisan (id.), indicating that an ordinarily
`
`skilled artisan would have had a reasonable expectation of success in making
`
`the proposed combination.
`
`Based upon ourreview ofthe current record, we discern no deficiency
`
`in Petitioner’s characterization of the cited references and the knowledgein
`
`the art, or in Petitioner’s assertions as to the reasonable inferences an
`
`ordinary artisan would make from those references. Thus, based on the
`
`information presented at this stage of the proceeding, Petitioner has shown
`
`sufficiently that there is a reasonable likelihood that it would prevail in
`
`establishing the unpatentability of independent claim 1 over the combined
`
`references. Further, at this stage in the proceeding, for reasons discussed by
`
`Petitioner (see Pet. 30-32), we are satisfied that Petitioner has established a
`
`reasonable likelihood that it would prevail in showing the unpatentability of
`
`dependentclaims 2-4, 9, and 10.
`
`D. Obviousness Ground of Unpatentability
`Based on Catchpole, Sampalis, and Randolph
`
`Petitioner asserts that claim 5 is unpatentable under § 103(a) as
`
`obvious in view of Catchpole, Sampalis, and Randolph. Pet. 34-38.
`
`Claim 5 depends from claim 1 and further requires that the “capsule
`
`contains a phytonutrient derived from a source other than krill.” Ex. 1001,
`
`35:57-59. Petitioner relies on Randolphto address this claim requirement.
`
`Pet. 34-38. At this stage in the proceeding, for the reasons discussed by
`
`Petitioner (see id.), we are satisfied that Petitioner has established a
`
`12
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`IPR2017-00745
`Patent 9,078,905 B2
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`reasonable likelihood that it would prevail in showing the unpatentability of
`
`dependent claim 5 in view of Catchpole, Sampalis, and Randolph.
`
`E. Obviousness Ground of Unpatentability
`Based on Catchpole, Sampalis, and Fricke
`
`Petitioner asserts that claims 6, 12, 15, 16, and 18 are unpatentable
`
`under § 103(a) in view of Catchpole, Sampalis, and Fricke. Pet. 38-44.
`
`1. Fricke
`
`Fricke discloses the “lipid classes, fatty acids of total and individual
`
`lipids and sterols of Antarctic krill (Euphausia superba Dana) from two
`
`areas of the Antarctic Ocean” as determined by thin layer chromatography,
`gas liquid chromatography, and gasliquid chromatography/mass
`spectrometry analyses. Ex. 1010, 1.
`
`Table | of Fricke is reproduced below.
`TABLE 1
`
`Lipid Composition of Antarctic Krill
`(Euphausia superba Dans)
`
`Sample
`
`12/1977
`
`3/1933
`
`Total lipid content
`(% wet weight)
`
`2.740.2
`
`6.2 + 0.3
`
`Phospholipids
`Phosphatidytcholine
`Phosphatidylethanolamine
`Lysophosphatid ylcholine
`Phosphatidylinosito!
`Cardiolipin
`Phosphatidic acid
`
`Neutral lipids
`Triacylglycerols
`Free fatty acids?
`Diacyiglycerols
`Sterols
`Monoacylgycerols
`
`Others>
`
`Total
`
`35.6 £ 0.4
`6.1 £ 0.4
`1,540.2
`0.9+0.1
`1.0404
`0.6 £0.4
`
`33.3 + 0.5
`§.2£0.5
`2.6+0.4
`1.34 0.4
`1.620.2
`
`33.340.5
`16.1 t 1.3
`1340.1
`1.7401
`0.4 + 0.2
`
`404+ 06.1
`B.S+t 2.0
`3.6 £ 0.1
`1420.1
`0.9201
`
`0.92 0.1
`
`0.50.1
`
`98.9
`
`99.3
`
`13
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`IPR2017-00745
`Patent 9,078,905 B2
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`Table 1 showsthe total lipid content and the lipid composition data for the
`
`two krill samples analyzed by Fricke. Jd. at 2. As indicated in Table 1, the
`
`krill samples respectively included approximately 33.3% +/- 0.5% w/w and
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`40.4% +/- 0.1% w/w triacylglycerols. Jd.
`
`2. Obviousness Analysis
`
`Petitioner relies on the same teachings of Catchpole and Sampalis
`
`described above concerning claim 1 to support its contention that an
`
`“(e]ncapsulated krill oil comprising: a capsule containing an effective
`
`amountofkrill oil, said krill oil comprising from about 3% to about
`
`10% w/w ether phospholipids” (Ex. 1001, 36:30-33) would have been
`
`obvious to an ordinarily skilled artisan at the time of invention of the
`
`°905 patent. Pet. 38-39, 41. In this regard, Petitioner points out that 4.8%
`
`ether phospholipid concentration disclosed by Catchpole falls within the
`
`range of about 3% to about 10% w/w ether phospholipids recited in claim
`
`12.
`
`Petitioner also asserts that the krill extract disclosed by Catchpole
`
`includes from about 27% to 50% w/w non-ether phospholipids, such that the
`
`amountof total phospholipids in the composition is from about 30% to about
`
`60% w/w. Pet. 39, 41. In support of this contention, Petitioner explains that
`
`Table 16 of Catchpole teachesthat krill Extract 2 includes 40.3% non-ether
`
`phospholipids and 4.8% ether phospholipids, and has a total phospholipid
`
`concentration of 45.1%. Pet. 39, 41; Ex. 1006 ff 91, 92, 214, 217; Ex. 1009,
`
`Table 16.
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`14
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`IPR2017-00745
`Patent 9,078,905 B2
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`Concerning the claim 12 requirementthat the krill extract include
`
`from about 20% to 50% w/wtriglycerides, Petitioner asserts that Fricke’s
`
`disclosure, in Table 1, of the lipid composition of Antarctic krill satisfies this
`
`claim requirement. Pet. 39-40, 41; Ex. 1006 4 97; Ex. 1010, Table 1.
`
`Specifically, Petitioner identifies disclosure by Fricke of Antarctic krill
`
`-
`
`samples including 33.3% +/- 0.5% w/w and 40.4% +/- 0.1% w/w
`
`triacylglycerols as meeting this claim element. Pet. 39-40; Ex. 1006 § 97;
`
`Ex. 1010, Table 1.
`
`According to Petitioner, an ordinarily skilled artisan would have
`
`sought to combine Catchpole, Sampalis, and Fricke “because it was well
`
`knownto extract lipids from krill and utilize the resulting oil as a dietary
`
`supplement as taught by Catchpole and Sampalis.” Pet. 43. In support of
`
`this position, Dr. Tallon testifies that a relevant skilled artisan would have
`
`had reason to make the proposed combination because “Sampalis I discloses
`
`the health benefits of the encapsulated krill oil to treat symptoms associated
`
`with PMS, Catchpole teaches that phospholipids are known to have
`
`application in treatment of a range of health conditions and Fricke discloses
`
`the variouskrill oil lipid components.” Ex. 1006 § 222. Dr. Tallon
`
`additionally testifies that an ordinarily skilled artisan would have been aware
`
`of the “laundry list of reasons” whykrill extract provides a superior source
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`of phospholipids, and would have looked to Catchpole and Fricke to
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`ascertain the componentsofkrill oil as yielded by standard extraction
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`methods in order to develop an encapsulated krill oil supplement. /d.
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`Dr. Tallon also testifies that it “would have been a simple matter” for
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`an ordinarily skilled artisan to combine Catchpole, Sampalis, and Fricke to
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`arrive at the recited composition. /d. In particular, as set forth above with
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`regard to claim 1, Dr. Tallon explains that a relevant skilled artisan would
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`have been familiar with the myriad solvents for extracting the lipid
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`componentsofkrill oil, and would have understoodthat the proportions of
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`those lipid components present in the extract could be varied in predictable
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`ways based on solventselection. Jd. at { 194.
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`Claim 18 differs from claim 12 by reciting in its preamble that the
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`claimed krill oil is Antarctic krill oil, and further requiring that the recited
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`capsule is a soft gel capsule. Compare Ex. 1001, 36:49—56,with id. at
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`36:30-36. Petitioner contends that Sampalis and Fricke each disclose the
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`extraction ofkrill oil from Antarctic krill, and that Sampalis discloses the
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`use of a soft gel capsule dosage form for Antarctic krill oil. Pet. 42;
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`Ex. 1006 J 68, 93, 220-221; Ex. 1010, Table 1; Ex. 1012, 4. Petitioner
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`relies on the same arguments concerning the reason to combine, and
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`reasonable expectation of success in combining Catchpole, Sampalis, and
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`Fricke described above concerning claim 12.
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`Based upon our review ofthe current record, we discern no deficiency
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`in Petitioner’s characterization of the cited references and the knowledge in
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`the art, or in Petitioner’s assertions as to the reasonable inferences an
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`ordinary artisan would make from those references. Thus, based on the
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`information presented at this stage of the proceeding, Petitioner has shown
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`sufficiently that there is a reasonable likelihood that it would prevail in
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`establishing the unpatentability of independent claims 12 and 18 overthe
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`combined references. Further, at this stage in the proceeding, for reasons
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`discussed by Petitioner (see Pet. 38-44), weare satisfied that Petitioner has
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`established a reasonable likelihood that it would prevail in showing the
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`unpatentability of dependent claims 6, 15, and 16.
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`F. Obviousness Ground of Unpatentability
`Based on Catchpole, Sampalis, Fricke, and Bottino
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`Petitioner asserts that claims 7, 8, 13, 14, 17, 19, and 20 are
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`unpatentable under § 103(a) as obvious in view of Catchpole, Sampalis,
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`Fricke, and Bottino. Pet. 44-55.
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`Dependent claims 7, 13,4 and 19 further define the encapsulatedkrill
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`oil, and specify that the claimed krill oil “comprises from about 20% to 35%
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`omega-3 fatty acids as a percentageoftotal fatty acids in said composition.”
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`Ex. 1001, 36:17-19, 36:37-39, 36:57—59. Petitioner relies on Bottino to
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`address this claim requirement. Pet. 44-48, 54. At this stage in the
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`proceeding, for the reasons discussed by Petitioner (see id.), we are satisfied
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`that Petitioner has established a reasonable likelihood that it would prevail in
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`showing the unpatentability of dependent claims 7, 13, and 19 in view of
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`Catchpole, Sampalis, Fricke, and Bottino.
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`Claims 8, 14, and 20 depend respectively from claims 7, 13, and 19,
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`and additionally require that “from about 70% to 95% of said omega-3 fatty
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`acids are attached to said phospholipids.” Ex. 1001, 36:20~—22, 36:40-42,
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`36:60-62. Petitioner relies on Fricke to address this claim element. Pet. 48-
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`‘ As Petitioner explains (Pet. 45), it appears that claim 13 includes a
`typographical error, and should depend from claim 12, rather than claim 6,
`as claim 13 is identical to claim 7 in its current form. Our unpatentability
`determination applies with equal force regardless of whether claim 6 or
`claim 12 provides the antecedent basis for claim 13.
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`52,54. At this stage in the proceeding, for the reasons discussed by
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`Petitioner (see id.), we are satisfied that Petitioner has established a
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`reasonable likelihood that it would prevail in showing the unpatentability of
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`dependentclaims 8, 14, and 20 in view of Catchpole, Sampalis, Fricke, and
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`Bottino.
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`Claim 17 depends from claim 12 and additionally recites that the
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`claimedkrill oil “comprises less than about 0.45% w/w arachadonic acid.”
`Id. at 36:47-48. Petitionerrelies on Bottino to address this claim
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`requirement. Pet. 52-54. At this stage in the proceeding, for the reasons"
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`discussed by Petitioner (see id.), we are satisfied that Petitioner has
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`established a reasonable likelihood that it would prevail in showing the
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`unpatentability of dependent claim 17 in view of Catchpole, Sampalis,
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`Fricke, and Bottino.
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`G. Obviousness Ground of Unpatentability
`Based on Catchpole, Sampalis, and Bottino
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`Petitioner asserts that claim 11 is unpatentable under § 103(a) as
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`obvious in view of Catchpole, Sampalis, and Bottino. Pet. 55-56.
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`Claim 11 depends from claim 1 and further requires that the “krill oil
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`comprises less than about 0.45% w/w arachadonicacid.” Ex. 1001, 36:27-
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`28. Petitioner relies on Bottino to address this claim requirement. Pet. 55—
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`56. At this stage in the proceeding, for the reasons discussed by Petitioner
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`(see Pet. 55-56), we are satisfied that Petitioner has established a reasonable
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`likelihood that it would prevail in showing the unpatentability of dependent
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`claim 11 in view of Catchpole, Sampalis, and Bottino.
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`Ill. CONCLUSION
`For the foregoing reasons, we conclude that the information presented
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`in the Petition establishes that there is a reasonable likelihood that Petitioner
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`would prevail in showing that claims 1-20 of the ’905 patent are
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`unpatentable. Accordingly, we institute an inter partes review of those
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`claims.
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`At this stage in the proceeding, the Board has not madea final
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`determination as to the construction of any claim term or the patentability of
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`any challenged claim.
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`In consideration of the foregoing,it is hereby:
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`IV. ORDER
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`ORDEREDthat pursuant to 35 U.S.C. § 314(a), an inter partes
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`review is instituted as to claims 1-20 of the ’905 patent on the following
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`grounds of unpatentability:
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`A.
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`Claims 1-4, 9, and 10 under 35 U.S.C. § 103(a) as obvious over
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`Catchpole and Sampalis;
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`B.
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`Claim 5 under 35 U.S.C. § 103(a) as obvious over Catchpole,
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`Sampalis, and Randolph;
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`C.
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`Claims 6, 12, 15, 16, and 18 under 35 U.S.C. § 103(a) as
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`obvious over Catchpole, Sampalis, and Fricke;
`D.
`Claims 7, 8, 13, 14, 17, 19, and 20 under 35 U.S.C. § 103(a) as
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`obvious over Catchpole, Sampalis, Fricke, and Bottino; and
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`E.
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`Claim 11 under 35 U.S.C. § 103(a) as obvious over Catchpole,
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`Sampalis, and Bottino; and
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`FURTHER ORDEREDthat no other ground of unpatentability
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`asserted in the Petition is authorized for this inter partes review; and
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`FURTHER ORDEREDthat pursuant to 35 U.S.C. § 314(c) and
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`37 C.F.R. § 42.4, notice is hereby given ofthe institution of a trial
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`commencingonthe entry date of this Decision.
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`PETITIONERS:
`
`James Harrington
`Michael Chakansky
`Ronald Baron
`John Gallagher
`HOFFMANN & BARON,LLP
`jfhdocket@hbiplaw.com
`mchakansky@hbiplaw.com
`rbaron@hbiplaw.com
`jgallagher@hbiplaw.com
`jtgdocket@hbiplaw.com
`
`PATENT OWNER:
`
`David Casimir
`J. Mitchell Jones
`CASIMIR JONES S.C.
`dacasimir@casimirjones.com
`jmjones@casimirjones.com
`docketing@casimirjones.com
`
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