Trials@uspto.gov
`571.272.7822
`
` Paper No. 7
` Entered: March 12, 2019
`
`
`
`
`
`
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`RIMFROST AS.,
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARCTIC AS,
`Patent Owner.
`____________
`
`Case No. IPR2018-01730
`Patent 9,072,752 B2
`____________
`
`
`DECISION
`Institution of Inter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`
`
`
`
`
`Before TINA E. HULSE, JACQUELINE T. HARLOW,
`and JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`
`

`

`IPR2018-01730
`Patent 9,072,752 B2
`
`INTRODUCTION
`
`I.
`A. Background
`Rimfrost AS. (“Petitioner”) filed a Petition requesting inter partes
`review of claims 1–20 of U.S. Patent No. 9,072,752 (“the ’752 patent”).
`Paper 1, (“Pet.”). Aker Biomarine Antarctic AS (“Patent Owner”) did not
`file a Preliminary Response.
`We have authority to determine whether to institute inter partes
`review under 35 U.S.C. § 314, which provides that an inter partes review
`may not be instituted unless the information presented in the Petition “shows
`that there is a reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.” Having
`considered the arguments and the evidence presented, for the reasons
`described below, we determine that Petitioner has demonstrated that there is
`a reasonable likelihood that it would prevail with respect to at least one of
`the claims challenged by the Petition. Accordingly, we institute an inter
`partes review of all claims and all grounds asserted in the Petition.
`B. Additional Proceedings
`Petitioner represents that two related patents, U.S. Patent No.
`9,078,905 (“’905 patent”) and U.S Patent No. 9,028,877 (“’877 patent”) are
`at issue in Aker Biomarine v. Olympic Holding AS, Case No 1:16-CV-00035
`LPS-CJB (D.Del.) and in In re Certain Krill Products and Krill Meal for
`Production of Krill Oil Products, Investigation No. 337-TA-1019. Pet. 2.
`Petitioner represents that the ITC proceeding has terminated. Id. at 3.
`Petitioner also represents that petitions for inter partes review have been
`filed challenging the ’905 patent, which are now IPR2017-00745 and
`IPR2017-00747. Id. Petitioner represents that petitions for inter partes
`review have been filed challenging the ’877 patent, now IPR2017-00746 and
`
`2
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`IPR2018-01730
`Patent 9,072,752 B2
`IPR2017-00748. Id. The district court action has been stayed pending
`resolution of the IPRs. Id. The Board has issued Final Written Decisions
`addressing challenges to claims of the ’877 patent (IPR2017-00746, Paper
`23, claims 1–19 shown to be unpatentable; IPR2017-00748, Paper 23, claims
`1–19 not shown to be unpatentable), and challenges to claims of the ’905
`patent (IPR2017-00745, Paper 24, claims 1–20 shown to be unpatentable;
`IPR2017-00747, Paper 24, claims 1–20 not shown to be unpatentable).
`Petitioner represents that a petition for inter partes review was filed
`challenging U.S. Patent No. 9,320,752 now IPR2018-00295. Id. at 4. The
`Board instituted inter partes review on June 14, 2018. IPR2018-00295,
`Paper 7.
`Petitioner represents that a request for Post Grant Review was filed
`challenging U.S. Patent No. 9,644,170 now PGR 2018-00033. Id. The
`Board determined that the ’170 patent was not eligible for post grant review.
`Id.
`
`Petitioner represents that petitions for inter partes review were filed
`challenging U.S. Patent 9,375,453 now IPR-2018-01178 and IPR2018-
`01179. Id. The board instituted inter partes review in both cases on January
`14, 2019. IPR2018-01178, Paper 7; IPR2018-01179, Paper 7.
`C. The ’752 Patent (Ex. 1001)
`The ’752 patent, titled “Bioeffective Krill Oil Compositions” issued
`on July 7, 2015, from U.S. Patent Application No. 14/620,784 filed on
`February 12, 2015. Ex. 1001, at [54], [45], [21], [22]. The ’752 patent is a
`continuation of U.S. Patent Application No. 12/057,775, filed on March 28,
`2008. The ’752 patent claims priority to U.S. Provisional Application No.
`60/920,483 filed on March 28, 2007; U S. Provisional Application No.
`60/975,058 filed on September 25, 2007; U.S Provisional Application
`
`3
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`

`IPR2018-01730
`Patent 9,072,752 B2
`60/983,446, filed on October 29, 2007; and U.S. Provisional Application No.
`61/024,072, filed on January 28, 2008. Id. [60].
`The ’752 patent teaches krill oil compositions characterized by having
`“high amounts of phospholipids, astaxanthin esters and omega-3 contents.”
`Ex. 1001, Abstract. According to the specification, the compositions
`disclosed in the ’752 patent are effective “in a number of areas such as anti-
`inflammation, antioxidant effects, improving insulin resistances and
`improving blood lipid profile.” Id.
`The ’752 patent acknowledges that krill oil compositions, including
`compositions having up to 60% w/w phospholipid content and as much as
`35% w/w EPA/DHA content, were known in the art at the time of the
`invention. Id. at col. 1, ll. 52-57. In addition, the ’752 patent recognizes that
`a myriad of health benefits have been attributed to krill oil in the prior art.
`For example, the ’752 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 symptoms of premenstrual symptoms or
`controlling blood glucose levels in a patient.” Id. at col. 1, ll. 46–52.
`D. Illustrative Claims
`Of the challenged claims, claims 1 and 14 are independent. Claims 2–
`13 depend from claim 1 and claims 15–20 depend from claim 14. Claim 1
`reads as follows:
`1. A polar krill oil comprising greater than about 40%
`phosphatidylcholine w/w of said krill oil and greater than
`about 5% ether phospholipids w/w of said krill oil.
`Ex. 1001, col. 34, ll. 65–67 5.
`
`4
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`

`

`IPR2018-01730
`Patent 9,072,752 B2
`Ex. 1001, col. 36, ll. 1–11.
`Claim 14 reads as follows:
`14. A Euphausia superba krill oil comprising greater than
`about 45% phosphatidylcholine w/w of said krill oil, greater
`than about 5% ether phospholipids w/w of said krill oil, less
`than about 25% triglycerides w/w of said krill oil, at least 36%
`omega-3 fatty acids w/w of said krill oil, and astaxanthin.
`
`
`Basis
`§ 102(e)
`§ 103(a)
`§ 103(a)
`
`§ 103(a)
`§ 103(a)
`
`1–3, 5, 6, and 11
`14–16, and 20
`
`Claims Challenged
`1, 5, 6, and 11
`4, 7, 12, and 13.
`8–10
`
`E. The Asserted Grounds of Unpatentability
`Petitioner contends that the challenged claims are unpatentable on the
`following grounds. Pet. 7.
`References
`Catchpole1
`Catchpole and Sampalis2
`Catchpole, Grynbaum3 and
`Randolph4
`Catchpole and Enzymotec5
`Catchpole, Enzymotec and
`Sampalis
`Catchpole, Enzymotec, Sampalis,
`Grynbaum and Randolph
`
`1 Catchpole and Tallon, WO 2007/123424 A1, published Nov. 1, 2007
`(“Catchpole”) (Ex. 1009).
`2 F. Sampalis, WO 03/011873 A2, published Feb. 13, 2003 (“Sampalis”) (Ex.
`1013).
`3 Grynbaum et al., Unambiguous detection of astaxanthin and astaxanthin
`fatty acid esters in krill (Euphausia superba Dana), 28 J. SEP. SCI. 1685
`(2005) (“Grynbaum”) (Ex. 1039)
`4 Randolph et al., US 2005/0058728 A1, published Mar. 17, 2005
`(“Randolph”) (Ex. 1011).
`5 Enzymotec, GRAS Notice No. GRN 000226 for “Krill-based
`Lecithin in Food” and “Krill-derived lecithin”
`https://www.fda.gov/downloads/Food/Ingredients
`PackagingLabeling/GRAS/NoticeInventory/ucm263930.pdf,
`dated May 26, 2007 and filed by the FDA May 31, 2007 (“Enzymotec”) (Ex.
`1048).
`
`§ 103(a)
`
`17–19
`
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`

`IPR2018-01730
`Patent 9,072,752 B2
`Petitioner also relies on the Declarations of Stephen J. Tallon, Ph.D.
`(Ex 1006), Robert McQuate, Ph.D., (Ex. 1044), Rakesh Kapoor, Ph.D. (Ex.
`1045) and the Affidavit of Internet Archive (WayBack Machine) (Ex. 1061).
`
`II. ANALYSIS
`
`A. Priority Date
`Petitioner asserts that each claim of the ’752 patent requires the
`presence of ether phospholipids, and that support for ether phospholipids
`was not introduced until the filing of U.S. provisional application No.
`61/024,072 on January 28, 2008. Pet. 8–9. Petitioner thus contends “the
`earliest effective priority date for the claims of the ’752 patent is no earlier
`than January 28, 2008.” Pet. 8.
`Petitioner argues, however, that the ’752 patent claims require certain
`percentages of ether phospholipids with open-ended ranges and that none of
`the priority documents contains any written description support for the
`claimed range. Id. at 8–9. Petitioner thus asserts that the ’752 patent is not
`entitled to a priority date earlier than the filing of the date of the application
`that issued as the ’752 patent (i.e., July 7, 2015). Id.
`At this stage of the proceeding, we are persuaded that Petitioner has
`made a sufficient showing that the earliest effective filing date of the claims
`of the ’752 patent is no earlier than January 28, 2008. For purposes of this
`Decision, we need not address whether the effective filing date of the claims
`of the ’752 patent is later than January 28, 2008.
`B. 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. § 100(b);
`
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`IPR2018-01730
`Patent 9,072,752 B2
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming
`applicability of broadest reasonable construction standard to inter partes
`review proceedings). 6 Under that standard, and absent any special
`definitions, we generally give claim terms their ordinary and customary
`meaning, as would be understood by one of ordinary skill in the art at the
`time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). Any special definitions for claim terms must be set forth
`with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30
`F.3d 1475, 1480 (Fed. Cir. 1994).
`We determine that it is unnecessary to expressly construe any claim
`terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem.
`Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be
`construed ‘to the extent necessary to resolve the controversy.’”) (quoting
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir.
`1999)).
`
`C. Level of Ordinary Skill in the Art.
`The level 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 The Office recently changed the claim construction standard to be
`employed in an inter partes review. See Changes to the Claim Construction
`Standard for Interpreting Claims in Trial Proceedings Before the Patent
`Trial and Appeal Board, 83 Fed. Reg. 51340 (October 11, 2018). However,
`based on the filing date of the Petition in this proceeding, the applicable
`claim construction standard remains as set forth in 37 C.F.R. § 42.100(b)
`(2016).
`
`7
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`

`IPR2018-01730
`Patent 9,072,752 B2
`Petitioner asserts that a relevant skilled artisan would have possessed
`“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
`experience in the field of extraction” id., in addition to “at least five years
`applied experience” id. At this stage of the proceeding, and without
`opposition from Patent Owner at this time, we determine that Petitioner’s
`description of the level of ordinary skill in the art is supported by the current
`record. See Ex. 1006 ¶ 34. For purposes of this Decision, therefore, we
`adopt Petitioner’s description.
`We also 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).
`D. Anticipation by Catchpole.
`Petitioner asserts that claims 1, 5, 6, and 11 are unpatentable under
`35 U.S.C. § 102(e) as anticipated by Catchpole. Pet. 28–34.
`“Anticipation requires that all of the claim elements and their
`limitations are shown in a single prior art reference.” In re Skvorecz, 580
`F.3d 1262, 1266 (Fed. Cir. 2009). “[U]nless a prior art reference discloses
`within the four corners of the document not only all of the limitations
`claimed but also all of the limitations arranged or combined in the same way
`as recited in the claim, it cannot be said to prove prior invention of the thing
`claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN,
`Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
`
`8
`
`

`

`IPR2018-01730
`Patent 9,072,752 B2
`1. Catchpole7
`Catchpole discloses “a process for separating lipid materials
`containing phospholipids” (Ex. 1009, 1, ll. 5–6) in order to produce a
`product containing “desirable levels of particular phospholipids” (id. at 3, ll.
`27–28). Catchpole states that phospholipids “have been implicated in
`conferring a number of health benefits including brain health, skin health,
`eczema treatment, anti-infection, wound healing, gut microbiota
`modifications, anti-cancer activity, alleviation of arthritis, improvement of
`cardiovascular health, and treatment of metabolic syndromes. They can also
`be used in sports nutrition.” Id. at 1, l. 29–2, l. 2. Catchpole further
`discloses that products having high levels of particular phospholipids “may
`be employed in a number of applications, including infant formulas, brain
`health, sports nutrition and dermatological compositions.” Id. at 25, ll. 9–13.
`Catchpole describes products that preferably contain greater than 5%
`acylalkyphospholipids8, more preferably greater than 10%
`acylalkyphospholipids, and most preferably greater than 25%
`acylalkyphospholipids. Id. at 9, ll. 18–21.
`Catchpole describes, in Example 18, the fractionation of krill lipids
`from krill powder using a process that employs supercritical CO2 in a first
`extraction, and a CO2 and absolute ethanol mixture in a second. Id. at 24, ll.
`
`
`7 Petitioner contends that Catchpole qualifies as prior art to the ’752 patent
`pursuant to pre-AIA § 102(a) and §102(e). Pet. 8–9, n. 2; Ex. 1006 ¶ 40. As
`explained above, we are persuaded that Petitioner has shown sufficiently that
`the earliest possible effective filing date of the claims of the ’752 patent is
`January 28, 2008. Thus, 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 ’752 patent.
`8 Alkylacylphospholipids and acylalkyphospholipids are known as ether
`phospholipids. Exhibit 1006 ¶¶ 210, 212, 214.
`
`9
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`

`IPR2018-01730
`Patent 9,072,752 B2
`1–16. Table 16, reproduced below, reports the phospholipid concentrations
`present in the krill oil extract obtained by Catchpole.
`
`
`
`As shown in Table 16 above, the composition of Extract 2 includes 39.8%
`phosphatidylcholine (“PC”). Id. at Table 16. The ether phospholipids
`alkylacylphosphatidylcholine (“AAPC”) and
`alkylacylphosphatidylethanolamine (“AAPE”) were also present in Extract
`2, representing 4.6% and 0.2%, respectively, of the extracted composition
`for a total of 4.8% ether phospholipids. Id.; Ex 1006 ¶¶ 145, 146.
`2. Anticipation Analysis
`As shown above, claim 1 recites a krill oil composition comprising
`greater than about 40% phosphatidylcholine w/w of said krill oil and greater
`than about 5% ether phospholipids w/w of said krill oil. Petitioner contends
`that the krill oil composition disclosed in Table 16 of Catchpole meets these
`limitations in that Extract 2 contained 39.8% phosphatidylcholine and 4.8%
`ether phospholipids. Pet. 33–34 (citing Ex. 1001, 24, ll. 17–19). Petitioner
`contends that as used in claim 1 the terms “about 40%” and “about 5%”
`embrace the values of 39.8% and 4.8% respectively. Id. Appellant relies on
`the testimony of Dr. Tallon to support this contention. Ex. 1006, ¶¶ 166–
`168. At this stage in the proceeding, for the reasons discussed by Petitioner
`(see Pet. 28–34), we are satisfied that Petitioner has established a reasonable
`likelihood that it would prevail in showing that claim 1 is anticipated by
`Catchpole.
`
`10
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`

`

`IPR2018-01730
`Patent 9,072,752 B2
`Claims 5 and 6 depend from claim 1 and recite the limitation that the
`ether phospholipid is present in amounts greater than about 6% and greater
`than about 7% respectively. Ex. 1001, col. 35, ll. 10–15. Petitioner
`contends that Catchpole anticipates these claims in that Catchpole discloses
`that the compositions can be prepared from marine animals such as Krill and
`preferably contain greater than 5% acylalkyphospholipids. Pet. 34–35.
`Petitioner also contends that Catchpole claims compositions prepared from
`marine animals that contain greater than 5% or greater than 10%
`acylalkyphospholipids. Id. Petitioner supports this contention with the
`testimony of Dr. Tallon. Ex. 1006 ¶¶ 213–261, 424.
`With respect to claims 5 and 6, we are not satisfied that Petitioner has
`established a reasonable likelihood that it would prevail in showing that
`dependent claims 5 and 6 are anticipated by Catchpole. While we agree
`with Petitioner that Catchpole teaches compositions that can contain greater
`than 10% acylalkyphospholipids, we do not agree that Catchpole discloses a
`krill oil composition having that amount of acylalkyphospholipids.
`Catchpole teaches a method of separating lipid materials from a feed
`material. Ex. 1009, 4. The feed material used in Catchpole may be derived
`from “terrestrial animals, marine animals, terrestrial plants, marine plants, or
`micro-organisms such as microalgae, yeast and bacteria. Preferably the feed
`material is derived from sheep, goat, pig, mouse, water buffalo, camel, yak,
`horse, donkey, llama, bovine or human.” Id. at 7. Catchpole does not
`specifically disclose a Krill extract that contains greater than 10%
`acylalkyphospholipids. The only specific disclosure of the
`acylalkyphospholipid content of krill oil is in Table 16, discussed above,
`which discloses an acylalkyphospholipid content of 4.8%, less than the 6%
`and 7% recited in claims 5 and 6. At this stage of the proceeding, we find
`
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`IPR2018-01730
`Patent 9,072,752 B2
`that Petitioner has not demonstrated a reasonable likelihood that Petitioner
`would prevail in showing that claims 5 and 6 are anticipated by Catchpole.
`Claim 11 depends from claim 1 and adds the limitation that the krill
`oil composition is for oral administration to a human. Ex. 1001, col. 35, ll.
`25–26. Petitioner contends that the compositions of Catchpole meet this
`limitation as Catchpole discloses that compositions can be employed in baby
`food and sports nutrition. Pet. 35. Petitioner relies on the testimony of Dr.
`Tallon to support this contention. Ex. 1006, ¶¶ 217-218. At this stage in the
`proceeding, for the reasons discussed by Petitioner (see Pet. 35), we are
`satisfied that Petitioner has established a reasonable likelihood that it would
`prevail in showing that dependent claim 11 is anticipated by Catchpole.
`E. Obviousness Based on Catchpole and Sampalis,
`Petitioner asserts that claims 4, 7, 12, and 13 are unpatentable under
`35 U.S.C. § 103(a) as obvious over Catchpole and Sampalis. Pet. 35–43.
`The question of obviousness is resolved on the basis of underlying
`factual determinations including (1) the scope and content of the prior art,
`(2) any differences between the claimed subject matter and the prior art, (3)
`the level of skill in the art, and (4) where in evidence, so-called secondary
`considerations. Graham, 383 U.S. at 17–18. If the differences between the
`claimed subject matter and the prior art are such that the subject matter, as a
`whole, would have been obvious at the time the invention was made to 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).
`1. Sampalis
`Sampalis discloses the preparation of phospholipid compositions from
`natural marine or aquatic sources. Ex. 1013, 25. Sampalis teaches that the
`
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`IPR2018-01730
`Patent 9,072,752 B2
`preferred source for the phospholipid compositions is krill such as
`Euphausia superba. Id. at 25. Sampalis teaches that the phospholipid
`compositions have a phospholipid content of “at least 40% w/w, preferably
`at least 45% w/w. More preferably, the amount of phospholipid is from
`about 45-60% w/w.” Id. at 26.
`Sampalis teaches that the phospholipid composition may also contain
`fatty acids with omega-3 and omega-6 fatty acids preferred. Id. Sampalis
`teaches “[p]olyunsaturated fatty acids, in particular omega-3 fatty acids,
`preferably make up at least 15% w/w, more preferably at least 40% w/w, and
`even more preferably at least 45% w/w, of the total lipids in the extract.” Id.
`at 28.
`Sampalis teaches that the phospholipid compositions may also contain
`antioxidants such as astaxanthin. Id. at 30. Sampalis teaches that the
`phospholipid composition can be in the form of foods, beverages, energy
`bars, sports drinks, supplements and the like. Id. at 35. Sampalis teaches
`that the compositions can be in the form of a capsule. Id.
`2. Obviousness Analysis
`Claim 4 further defines claim 1 wherein the krill oil composition
`includes at least about 36% omega-3 fatty acids by weight of the krill oil
`composition. Ex. 1001, col. 35, ll. 7–9. Petitioner relies on Sampalis for a
`teaching of this claim requirement, asserting that Sampalis teaches a krill oil
`composition comprising between 15% w/w and 45% w/w omega-3 fatty
`acids. Pet. 36. Petitioner also asserts that a person of ordinary skill in the art
`would have had a reason to combine the omega-3-fatty acid levels taught in
`Sampalis with the krill oil disclosed in Catchpole because of the known
`significant health benefits of omega-3-fatty acids. Pet. 39 (citing Ex. 1006
`¶¶ 93, 94, 97, and 99). At this stage in the proceeding, for the reasons
`
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`IPR2018-01730
`Patent 9,072,752 B2
`discussed by Petitioner (see Pet. 47–50, 55), we are satisfied that Petitioner
`has established a reasonable likelihood that it would prevail in showing the
`unpatentability of dependent claim 4 in view of Catchpole, and Sampalis.
`Claim 7 further defines claim 1, wherein the krill oil includes
`astaxanthin. Ex. 1001, col. 35, ll. 16–17. Petitioner relies on Sampalis for a
`teaching of this requirement. Pet. 36–37. At this stage in the proceeding,
`for the reasons discussed by Petitioner (see id.), we are satisfied that
`Petitioner has established a reasonable likelihood that it would prevail in
`showing the unpatentability of dependent claim 7 in view of Catchpole, and
`Sampalis.
`Claim 12 further defines claim 1, wherein the polar krill oil is
`extracted from Euphausia Superba. Ex. 1001, col. 36, ll. 1–2. Petitioner
`relies on Sampalis for a teaching of this requirement. Pet. 38. At this stage
`in the proceeding, for the reasons discussed by Petitioner (see id.), we are
`satisfied that Petitioner has established a reasonable likelihood that it would
`prevail in showing the unpatentability of dependent claim 12 in view of
`Catchpole and Sampalis.
`Claim 13 further defines claim 1, wherein the krill oil is in a capsule.
`Ex. 1001, col. 36, l. 3. Petitioner relies on Sampalis for teaching this
`requirement. Pet. 39. At this stage in the proceeding, for the reasons
`discussed by Petitioner (see id.), we are satisfied that Petitioner has
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of dependent claim 13 in view of Catchpole and Sampalis.
`F. Obviousness Based on Catchpole, Grynbaum and
`Randolph
`Petitioner asserts that claims 8–10 are unpatentable under 35 U.S.C.
`§ 103(a) over Catchpole, Grynbaum and Randolph.
`
`14
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`

`IPR2018-01730
`Patent 9,072,752 B2
`1. Grynbaum
`Grynbaum reports the results of a series of experiments to detect and
`measure the presence of astaxanthin and astaxanthin fatty acid esters in krill.
`Ex. 1039 1685. Grynbaum reports that the extraction technique used
`resulted in an extract containing 7842 µg/g astaxanthin fatty acid esters.
`2. Randolph
`Randolph discloses a composition to “treat diseases and/or abnormal
`conditions associated with inflammatory response, for example
`cardiovascular conditions, arthritis, osteoporosis and Alzheimer’s disease.”
`Exhibit 1011, Abstract; ¶ 5. Randolph teaches that the composition may
`contain krill oil obtained from Euphausia superba. Id. ¶ 39. Randolph also
`teaches that the composition “can contain any amount of an astaxanthin
`ingredient. For example, at least about 1 percent (e.g., at least about 2, 3, 4,
`5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, or 90 percent) of a dietary
`supplement can be astaxanthin.” Id. ¶44
`3. Obviousness Analysis
`Claims 8–10 further define claim 1, wherein the krill oil includes
`greater than 1000 mg/kg, greater than 1500 mg/kg and greater than 2000
`mg/kg of astaxanthin esters. Ex. 1001 col. 35, ll. 19–24. Petitioner relies on
`Grynbaum for a teaching of this requirement, asserting that Grynbaum
`teaches preparing an extract from krill that comprises 7842 µg/g (equivalent
`of 7842 g/kg) astaxanthin fatty acid esters. Pet. 43. Petitioner also
`contends that Randolph teaches preparing a krill oil composition having as
`low as 1% of an astaxanthin ingredient, which equates to 10,000 mg/kg. Pet.
`44–45. Petitioner supports this argument by referring to Patent Owner’s
`admission in prior proceedings that 1% of an astaxanthin ingredient is
`equivalent to 10,000 mg/kg. Id.; Ex. 1105, 18-19; Ex. 1106, 38-39.
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`Petitioner further asserts that a person of ordinary skill in the art would have
`had a reason to combine the astaxanthin levels taught in Grynbaum and
`Randolph with the krill oil disclosed in Catchpole because of the known
`significant health benefits of astaxanthin. Pet. 46–47 (citing Ex. 1006 ¶¶ 76,
`89, 218, 297, 334, 402, 439, 450, and 488). At this stage in the proceeding,
`for the reasons discussed by Petitioner (see Pet. 43–49), we are satisfied that
`Petitioner has established a reasonable likelihood that it would prevail in
`showing the unpatentability of dependent claims 8–10 in view of Catchpole,
`Grynbaum and Randolph.
`G. Obviousness Based on Catchpole and Enzymotec
`Petitioner asserts that claims 1–3, 5, 6, and 11 are unpatentable under
`35 U.S.C. § 103(a) over Catchpole and Enzymotec.
`1. Enzymotec9
`Enzymotec is a submission by Enzymotec Ltd. to the FDA requesting
`a “Generally Recognized as Safe” (GRAS) exemption for the use of krill
`based lecithin extracts. Ex. 1048, 3. Enzymotec teaches that lecithin is
`phosphatidylcholine. Id. at 6–7. Enzymotec teaches that the use of various
`extraction techniques can be used to enrich the phospholipid fraction of a
`krill based extract creating what Enzymotec refers to as Grade B extract.
`Id.at 8. Enzymotec teaches that Grade B extracts contain from 60.2% to
`
`
`9 Petitioner contends that Enzymotec is a printed publication in that the FDA
`submission was publically accessible to persons of ordinary skill exercising
`reasonable diligence before the effective filing date of the ’752 patent. Pet.
`9–13. In support of its contention that Emzymotec is a printed publication,
`Petitioner offers the testimony of Drs. McQuate and Kapoor. Id.; Ex. 1044;
`Ex. 1045. At this stage in the proceeding, for the reasons discussed by
`Petitioner (see Pet. 9–13), we are satisfied that Petitioner has made a
`threshold showing that Enzymotec is a printed publication and is prior art to
`the ’752 patent.
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`82.5% phosphatidylcholine. Id. Table B-1, Appendix B. Enzymotec also
`discloses that Grade B extracts contain no detectable amount of
`triglycerides. Id.
`2. Obviousness Analysis
`Claim 1 is directed to a polar krill oil composition that comprises
`greater than about 40% phosphatidylcholine w/w of said krill oil and greater
`than about 5% ether phospholipids w/w of said krill oil. Ex. 1001, col. 34,
`ll. 65–67. Petitioner relies on Catchpole and Enzymotec for teaching these
`requirements, asserting that Catchpole teaches krill oil compositions
`comprising greater than about 5% ether phospholipids and that Enzymotec
`teaches forming krill extracts with greater than 45% phosphatidylcholine.
`Pet. 49-54. Petitioner further asserts that a person of ordinary skill in the art
`would have had a reason to combine the teachings of Catchpole with
`Enzymotec because of the known significant health benefits of claimed
`components. Pet. 56. At this stage in the proceeding, for the reasons
`discussed by Petitioner (see Pet. 49–54), we are satisfied that Petitioner has
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claim 1 in view of Catchpole and Enzymotec.
`Claim 2 further defines claim 1, wherein the krill oil comprises greater
`than 45% phosphatidylcholine w/w of the krill oil. Ex. 1001, col. 35, ll. 1–3.
`Petitioner relies on Enzymotec for this requirement as Enzymotec teaches
`krill extracts comprising 60% phosphatidylcholine or greater. Pet. 55. At
`this stage in the proceeding, for the reasons discussed by Petitioner (see Pet.
`55), we are satisfied that Petitioner has established a reasonable likelihood
`that it would prevail in showing the unpatentability of dependent claim 2 in
`view of Catchpole and Enzymotec.
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`Claim 3 further defines claim 1, wherein the krill oil comprises less
`than 25% triglycerides. Ex. 1001, col. 35, ll. 4–6. Petitioner relies in
`Enzymotec for this requirement as Enzymotec teaches krill extracts having
`no detectable amounts of triglycerides. Pet. 55. At this stage in the
`proceeding, for the reasons discussed by Petitioner (see Pet. 55), we are
`satisfied that Petitioner has established a reasonable likelihood that it would
`prevail in showing the unpatentability of dependent claim 3 in view of
`Catchpole and Enzymotec.
`Claims 5 and 6 depend from claim 1 and recite the limitation that the
`ether phospholipid is present in amounts greater that about 6% and greater
`that about 7% respectively. Ex. 1001, col. 35, ll. 10–15. Petitioner contends
`that Catchpole anticipates these claims in that Catchpole discloses that the
`compositions can be prepared from marine animals such as Krill and
`preferably contain greater than 5% acylalkyphospholipids. Pet. 55–56.
`Petitioner also contends that Catchpole claims compositions prepared from
`marine animals which contain greater than 5% or greater that 10%
`acylalkyphospholipids. Id. Petitioner supports this contention with the
`testimony of Dr. Tallon. Ex. 1006, ¶¶ 461–463. . At this stage in the
`proceeding, for the reasons discussed by Petitioner (see Pet. 55–56), we are
`satisfied that Petitioner has established a reasonable likelihood that it would
`prevail in showing the unpatentability of dependent claims 5 and 6 in view
`of Catchpole and Enzymotec.
`Claim 11 depends from claim 1 and adds the limitation that the krill
`oil composition for oral administration to a human. Ex. 1001, col. 35, ll. 25–
`26. Petitioner contends that the compositions of Catchpole meet this
`limitation as Catchpole discloses that compositions can be employed in baby
`food and sports nutrition. Pet. 56. Petitioner relies on the testimony of Dr.
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`Tallon to support this contention. Ex. 1006, ¶¶ 465-467. At this stage in the
`proceeding, for the reasons discussed by Petitioner (see Pet. 56), we are
`