____________
`
`RIMFROST AS
`Petitioner,
`
`v.
`
`AKER BIOMARINE ANTARTIC AS.,
`Patent Owner.
`____________
`
`Case No. PGR2018-00033
`Patent 9,644,170 B2
`____________
`
`
`
`Before TINA E. HULSE, JACQUELINE T. HARLOW and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`
`
`
`
`Trials@uspto.gov
`571.272.7822
`
`
`Paper No. 9
`
` Entered: August 29, 2018
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`DECISION
`Denying Institution of Post Grant Review
`35 U.S.C. § 324(a)
`
`
`
`
`
`

`

`PGR2018-00033
`Patent 9,644,170 B2
`
`
`I.
`
`INTRODUCTION
`
`A. Background
`Rimfrost AS (“Petitioner”) filed a Petition for post grant review of
`claims 1–20 of U.S. Patent No. 9,644,170 B2 (Ex. 1001, “the ’170 Patent”).
`Paper 2 (“Pet”). Aker Biomarine Antarctic AS (“Patent Owner”) filed a
`timely Preliminary Response. Paper 7 (“Prelim. Resp.”). Based on the
`information presented in the Petition and Preliminary Response, we hold that
`Petitioner has not demonstrated adequately that the ’170 patent is eligible for
`post grant review.
`Accordingly, we deny the petition.
`
`B. Related 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.). Pet. 2. Petitioner indicates that the ’905 patent
`and ’877 were also at issue in In the matter of Certain Krill Products and
`Krill Meal for Production of Krill Oil Products, Investigation No. 337-TA-
`1019, which Petitioner states has been terminated. Id. at 2–3. In addition,
`Petitioner indicates that the ’905 patent was challenged in IPR2017-0745
`and IPR2017-0747, and that the ’877 patent was challenged in IPR2017-
`0746 and IPR2017-0748. Id. On August 10, 2018, the Board issued final
`written decisions in those matters, finding that the claims of the ’905 patent
`have been shown to be unpatentable in IPR2017-0745, but not IPR2017-
`0747, and that the claims of the ’877 patent have been shown to be
`unpatentable in IPR2017-0746, but not IPR2017-0748. IPR2017-0745,
`Paper 24; IPR2017-0746, Paper 23; IPR2017-0747, Paper 24; IPR2017-
`
`2
`
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`

`PGR2018-00033
`Patent 9,644,170 B2
`
`0748, Paper 23. Petitioner states that the district court action has been
`stayed pending resolution of the above identified IPRs. Id. Petitioner
`additionally represents that a petition for inter partes review was filed
`challenging related U.S. Patent No. 9,320,765, now IPR2018-00295. Pet. 3.
`C. The ’170 Patent (Ex. 1001)
`The ’170 patent, titled “Bioeffective Krill Oil Compositions” issued
`on May 9, 2017, from U.S. Patent Application No. 15/180,439 (’439
`application”), filed on June 13, 2016. See Ex. 1001, [54], [45], [21], [22].
`The ’170 patent is a continuation of U.S. Patent Application No. 14/020,162,
`filed September 6, 2013, which is a continuation of U.S. Patent Application
`No. 12/057,775, filed on March 28, 2008. The ’170 patent claims priority to
`U.S. Provisional Patent 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 60/983,446, filed on October 29, 2007;
`and U.S. Provisional Application No. 61/024,072, filed on January 28, 2008.
`Id. at [60]. This history is important because this case turns on whether
`Petitioner shows sufficiently that at least one claim has an effective filing
`date after March 16, 2013 — a showing necessary to demonstrate that the
`’170 patent is eligible for post grant review. Pet. 19–44.
`The ’170 patent purports to disclose krill oil compositions
`characterized by having “high amounts of phospholipids, astaxanthin esters
`[and] omega-3 contents.” Ex. 1001, Abstract. The compositions disclosed
`in the ’170 patent purport to be effective “in a number of areas such as anti-
`inflammation, antioxidant effects, improving insulin resistances and
`improving blood lipid profile.” Id.
`
`3
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`

`PGR2018-00033
`Patent 9,644,170 B2
`
`
`The ’170 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 ’170 patent recognizes that myriad health benefits
`have been attributed to krill oil in the prior art. For example, the ’170 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. 48–54.
`
`D. Illustrative Claim
`Of the challenged claims, claims 1 and 11 are independent. Claims 2–
`10 depend from claim 1 and claims 12–20 depend from claim 11. Claim 1 is
`illustrative of the claimed subject matter and reads as follows:
`1. A krill oil composition comprising a capsule containing
`Euphausia superba krill oil suitable for oral administration,
`said krill oil comprising from 3% to 15% ether phospholipids
`w/w of said krill oil and astaxanthin esters in amount of
`greater than about 100 mg/kg of said krill oil.
`
`Ex. 1001, col. 35, ll. 49–53. The other independent clam, claim 11, is
`similar to claim 1 and adds the requirement that the capsule be a softgel
`capsule. Id. at col. 36, ll. 31–34.
`
`
`
`4
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`

`PGR2018-00033
`Patent 9,644,170 B2
`
`
`Claims Challenged
`1–20
`
`1–20
`
`1–20
`
`E. The Alleged Grounds of Unpatentability
`Petitioner contends that the challenged claims of the ’170 patent are
`unpatentable on the following grounds.1
`Applicable References
`Basis
`No references cited for this ground § 112(a)
`Lack of
`enablement
`and lack of
`written
`description
`No references cited for this ground § 101
`Product of
`Nature
`No references cited for this ground § 101
`Inventorship
`§ 102(a)
`§ 103(a)
`
`‘388 Application2
`Bruheim3 and Neptune’s GRAS.4
`
`1–20
`1, 3-5, 7, 9-
`11, 13-16,
`18, 20
`
`
`1 Petitioner supports its challenge with the Declaration of Stephen J. Tallon
`(“Ex. 1006”).
`2 Bruheim et al., US 2008/0274203 A1, published Nov. 6, 2008. This later
`matured into US 9,034,388 (“’388 Application”) (Ex. 1043).
`3 Bruheim et al., US 2012/0149867 A1, published June 14, 2012
`(“Bruheim”) (Ex. 1085).
`4 Robert S. McQuate, GRAS Assessment for Neptune Technologies &
`Bioresources, GRAS Notification – High Phospholipid Krill Oil, Food and
`Drug Administration, Center for Food Safety & Applied Nutrition, Neptune
`Biosciences, 1–96, (2008).
`https://www.fda.gov/downloads/Food/IngredientsPackageLabeling/GRAS/N
`oticeInventory/ucm269133.pdf, last visited Aug. 2018 (“Neptune GRAS”)
`(Ex. 1075).
`
`5
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`

`PGR2018-00033
`Patent 9,644,170 B2
`
`
`Bruheim, Neptune’s GRAS and
`Sampalis.5
`Bruheim, Neptune’s GRAS and
`Randolph.6
`Bruheim, Neptune’s GRAS and
`Bottino.7
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`2, 12
`
`6, 17
`
`8, 19
`
`
`
`II. ANALYSIS
`
`Post grant review is available only for patents “described in section
`3(n)(1)” of the Leahy-Smith America Invents Act (“AIA”), Pub L. No. 112-
`29, 125 Stat. 284 (2011). AIA § 6(f)(2)(A). Those are patents that issue
`from applications “that contain[] or contained at any time . . . a claim to a
`claimed invention that has an effective filing date in section 100(i) of title
`35, United States Code, that is on or after” “the expiration of the 18-month
`period beginning on the date of the enactment of” the AIA. See AIA
`§ 3(n)(1).
`Because the AIA was enacted on September 16, 2011, post grant
`review is available only for patents that issue from applications that, at one
`point, contained at least one claim with an “effective filing date,” as defined
`by 35 U.S.C. § 100(i), on or after March 16, 2013. Our rules require a
`petitioner for post grant review to certify that the challenged patent is
`
`
`5 Sampalis et al., WO 2009/132463 A1, published Nov. 5, 2009
`(“Sampalis”) (Ex. 1064).
`6 Randolph et al., US 2005/0058728 A1, published Mar. 17, 2005
`(“Randolph”) (Ex. 1011).
`7 N.R. Bottino, The Fatty Acids of Antarctic Phytoplankton and
`Euphausiids: Fatty Acid Exchange among Trophic Levels of the Ross Sea,
`Department of Biochemistry and Biophysics, Texas A&M University,
`Marine Biology, Vol. 27, 197–204 (1974) (“Bottino”) (Ex. 1007).
`
`6
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`

`PGR2018-00033
`Patent 9,644,170 B2
`
`available for post grant review. 37 C.F.R. § 42.204(a) (“The petitioner must
`certify that the patent for which review is sought is available for post-grant
`review.”). Petitioner includes the requisite certification, and further, asserts
`that each challenged claim has an effective filing date of June 13, 2016,
`which is the actual filing date of the ’439 application. Pet. 5.
`Petitioner advances several arguments in support of a finding that at
`least one challenged claim of the ’170 patent has an effective filing date after
`March 16, 2013. Petitioner contends that the following limitations in claims
`1 and 11 of the ’170 patent do not satisfy the written description and
`enablement requirements of 35 U.S.C. § 112(a):
`- 3% to 15% ether phospholipids w/w of said krill oil.
`
`Pet. 31–36.
` astaxanthin esters in amount of greater than about 100 mg/kg
`-
`of said krill oil.
`Pet. 36–40.
`Petitioner also contends that the prior filed applications also lack support for
`these claim limitations. Id. at 27–28.
`Petitioner also contends that at least one of the claims originally filed
`in the ’439 application has an effective filing date after March 16, 2013,
`rendering the ’170 patent eligible for post grant review. Pet. 21–22 and 40–
`41. Petitioner contends that the originally filed claims 1 and 11 contained
`the limitation “trimethylamine in an amount of less than 1mg/kg of said krill
`oil.” Pet. 40–41. Petitioner contends that this claim limitation does not
`satisfy the written description and enablement requirements and that there is
`no support for the term in the prior applications. Pet. 27–28 and 40–44.
`We address each of these arguments in turn.
`
`7
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`

`PGR2018-00033
`Patent 9,644,170 B2
`
`
`A. 3% to 15% ether phospholipids w/w krill oil.
`We note that while Petitioner contends that the claim limitation 3% to
`15% phospholipids w/w krill oil does not comply with either the written
`description requirement or the enablement requirement, Petitioner does not
`present a separate analysis for each ground. See Pet. 31–36. We shall,
`however, address each requirement separately.
`
`1. Written Description
`Petitioner contends that the ’170 patent and its prior applications do
`not show that the inventors were in possession of the entire breath of the
`claimed range of ether phospholipids (i.e., 3% to 15% w/w of the krill oil).8
`Pet. 31. In support of this contention, Petitioner points to the data in
`Table 22 of the ’170 patent where it shows that for a product of the
`concentration, the ether phospholipid content is about 7.4%. Pet. 33.
`Petitioner argues that since Patent Owner argued during prosecution that a
`difference of as little as 0.54% ether phospholipid was critical, the single
`example does not demonstrate that the inventors were in possession of the
`full range recited in the claims. Pet. 34–35. Petitioner also contends that the
`teachings of the prior applications are the same as the instant Specification
`thereby establishing a lack of priority. Pet. 36.
`
`
`8 Petitioner and Dr. Tallon often refer to lack of possession of the invention.
`See, e.g., Pet. 33; Ex. 1006 ¶ 92. We understand these arguments to refer to
`the written description requirement, which requires the Specification to
`convey to those skilled in the art that the inventors were in possession of the
`claimed invention. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F3d 1336,
`1351 (Fed. Cir. 2010). There is no requirement for possession of the
`invention separate from the written description requirement. See 35 U.S.C.
`§ 112(a).
`
`8
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`

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`Patent 9,644,170 B2
`
`
`Patent Owner contends that Petitioner failed to consider the teachings
`of the entire Specification, particularly the teaching that the amount of ether
`phospholipid may range from 3% to 15%. Prelim. Resp. 39.
`We have considered the parties’ arguments and find that Petitioner has
`not adequately established, for purposes of institution, that there is a lack of
`written description support with regards to the recited range of ether
`phospholipids.
`“[T]he test for sufficiency [of the written description requirement] is
`whether the disclosure of the application relied upon reasonably conveys to
`those skilled in the art that the inventor had possession of the claimed
`subject matter as of the filing date.” Ariad, 598 F.3d at 1351. The written
`description requirement does not demand the presence of specific examples.
`Id. at 1352. Instead, “the test requires an objective inquiry into the four
`corners of the [S]pecification from the perspective of a person of ordinary
`skill in the art. Based on that inquiry, the [S]pecification must describe an
`invention understandable to that skilled artisan and show that the inventor
`actually invented the invention claimed.” Id.
`The present Specification teaches “[i]n some preferred embodiments,
`the krill oil compositions of the present invention comprise from about 1%,
`2%, 3% or 4% to about 8%, 10%, 12% or 15% w/w ether phospholipids or
`greater than about 4%, 5%, 6%, 7%, 8%, 9% or 10% ether phospholipids.”
`Ex. 1001 col. 12, ll. 5–9. Again, in the same paragraph the Specification
`teaches
`In some embodiments, the krill oil compositions comprise from
`about 1%, 2%, 3% or 4% to about 8%, 10%, 12% or 15% w/w
`ether phospholipids and from about 30%, 33%, 40%, 42%,
`45%, 48%, 50%, 52%, 54%, 55% 56%,58% to about 60% non-
`ether phospholipids so that the total amount of phospholipids
`
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`PGR2018-00033
`Patent 9,644,170 B2
`
`
`(both ether and non-ether phospholipids) ranges from about
`40% to about 60%.
`
`Id. at col. 12, ll. 13–19 (emphasis added). This same teaching appears in the
`prior applications, which led to the ’170 patent. See, e.g., Ex. 1043 ¶ 71.
`The Specification, and in particular, the above-described disclosures,
`demonstrates to one skilled in the art that the inventors of the ’170 patent
`had in their possession krill oil compositions comprising from 3% to 15%
`ether phospholipids. The same written description is present in the
`applications filed prior to March 16, 2013. Ex. 1043 ¶ 71.
`
`2. Enablement
`Petitioner contends that the Specification does not enable one skilled
`in the art to make a krill oil composition having from 8% to 15% w/w ether
`phospholipid without undue experimentation. Pet. 35. Petitioner again
`points to the data in Table 22 of the Specification and related Example 7,
`which show how to make a krill oil composition having 7.4% w/w ether
`phospholipids. Pet. 31–35. Petitioner and its expert, Dr. Tallon, contend
`that the narrow disclosure in Example 7 does not enable one skilled in the art
`to make a composition having greater that 7.4% w/w ether phospholipid.
`Pet. 34–35; Ex. 1006 ¶ 99.
`Patent Owner contends that Petitioner failed to properly analyze the
`issue of enablement using the Wands factors. Prelim. Resp. 19. Patent
`Owner contends that when the Wands factors are considered, one skilled in
`the art would conclude that the claims are enabled for the full range of
`phospholipid values recited in the claims. Prelim Resp. 20–25.
`We have considered the parties’ arguments and conclude that, based
`on the record before us, Petitioner has not adequately established, for
`
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`Patent 9,644,170 B2
`
`purposes of this decision, that the claim limitation relating to ether
`phospholipids is not enabled for the full range of percentages recited in the
`claims.
`“[T]o be enabling, the [S]pecification of a patent must teach those
`skilled in the art how to make and use the full scope of the claimed invention
`without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed.
`Cir. 1993). “Factors to be considered in determining whether a disclosure
`would require undue experimentation . . . . include (1) the quantity of
`experimentation necessary, (2) the amount of direction or guidance
`presented, (3) the presence or absence of working examples, (4) the nature
`of the invention, (5) the state of the prior art, (6) the relative skill of those in
`the art, (7) the predictability or unpredictability of the art, and (8) the breadth
`of the claims.” In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
`“[A] patent need not teach, and preferably omits, what is well known
`in the art.” Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
`1384 (Fed. Cir. 1986).
`Beginning with the breadth of the claims, we agree with Patent Owner
`and its declarant, Dr. Nils Hoem, that the specific ranges are modest. Prelim
`Resp. 20; Ex. 2001 ¶ 42.
`Turning to the level of ordinary skill in the art, the parties agree that
`for purposes of this proceeding, a person of ordinary skill in the art
`would have held an advanced degree in marine sciences,
`biochemistry, organic (especially lipid) chemistry, chemical or
`process engineering, or associated sciences with
`complementary understanding, either through education or
`experience, of organic chemistry and in particular lipid
`chemistry, chemical or process engineering, marine biology,
`nutrition, or associated sciences; and knowledge of or
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`PGR2018-00033
`Patent 9,644,170 B2
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`
`experience in the field of extraction. In addition, a POSITA
`would have had at least five years’ applied experience.
`
`Pet. 6; Ex. 1006 ¶ 35; Prelim Resp. 21. We agree with Patent Owner that the
`level of skill in the art as defined by the parties is high. Prelim. Resp. 21.
`With respect to the nature of the invention and state of the art, the
`invention relates to a krill oil composition with specific amounts of lipids
`such as ether phospholipids. Ex. 1001, Abstract. Blending various lipid
`components to create a krill oil composition was within the ability of one
`skilled in the art. As Petitioner’s expert Dr. Tallon states in his declaration,
`The relative proportions can be varied in predictable
`ways by applying a single solvent or combination of solvents
`including super critical fluid extraction to selectively extract
`specific groups of lipid components based on their different
`solubility, and by blending these selective extracts in known
`and predictable ways to produce a desired composition. These
`methods and solvents were well known to the POSITA prior to
`the earliest priority date to which the ’170 Patent is entitled.
`
`Ex. 1006 ¶¶ 44, 46. Dr. Tallon has taken the same positon in related
`proceedings before the Patent Office. See, e.g., Ex. 2012 ¶ 186.
`The Specification, including the examples, also provides guidance to
`one skilled in the art as to how to make a composition containing the recited
`amounts of ether phospholipids. The Specification teaches that “[i]n some
`embodiments, krill oil compositions comprises a blend of lipid fractions
`obtained from krill.” Ex. 1001, col. 2, l. 66– col. 3, l. 1. The Specification
`also teaches “[i]n some embodiments, the blended krill oil composition
`comprises a blend of lipid fractions obtained from Euphausia superba.”
`Ex. 1001, col. 5, ll. 49–51. The Specification goes on to teach that the krill
`oil compositions can be prepared by separating out the neutral and polar
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`Patent 9,644,170 B2
`
`fractions of the lipids using various extraction techniques and then blending
`the extracts to provide the desired composition. Ex. 1001, col. 12, ll. 33–57.
`These teachings are present in the parent applications. See, e.g., Ex 1043 ¶¶
`17, 18, 30, 72.
`In addition, as Petitioner points out, the Specification includes two
`working examples showing how to make a krill oil composition having 7.4%
`ether phospholipids. Pet. 33. Other Examples demonstrate that by
`combining different amounts of lipid fractions the proportions of the
`different lipids can be varied. See, e.g., Example 4, Ex. 1001, col. 28, ll. 33–
`50 (Tables 19A and 19B); Ex. 2001 ¶ 35; Example 5, Ex. 1001, col. 30, ll.
`59–67 (Tables 20A–C); Ex. 2001 ¶ 55. These examples appear in the parent
`applications. See, e.g., Ex. 1043 ¶¶ 100, 101, 103, 104.
`Lastly, with respect to the amount of experimentation needed to
`recreate the claimed invention, Petitioner has offered no persuasive evidence
`that the amount of experimentation would be undue.9 See Pet. 35. Given
`the level of skill possessed by one in the art as well as the guidance in the
`
`
`9 While Petitioner cites to paragraphs 93–94, 100–01 and 252 of Dr. Tallon’s
`declaration to support this contention, close reading of those paragraphs
`shows that Dr. Tallon did not offer any testimony about the experimentation
`that would be necessary to recreate the claimed invention. Paragraphs 93
`and 94 address the written description requirement. Ex. 1006 ¶¶ 93–94.
`Paragraph 100 contains the naked assertion that the Specification does not
`teach how to make a krill oil composition with greater than 8% w/w ether
`phospholipid. Id. ¶ 100. Paragraph 101 simply states “[n]one of the claims
`of the ’170 Patent find adequate § 112(a) support in the priority documents
`or the ’170 Patent.” Id. ¶ 101. Paragraph 252 simply states that there is no
`support for the upper part of the range of ether phospholipids recited in the
`claims. Id. ¶ 252. None of these paragraphs address the issue of undue
`experimentation.
`
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`Specification, little if any experimentation would be required to create krill
`oil compositions within the scope of the claims.
`Petitioner and its expert Dr. Tallon improperly limited their analysis
`to the examples of the ’170 patent. While the examples are one factor that
`should be considered, they are not the only factor in the Wands analysis. As
`Patent Owner has demonstrated, when all the Wands factors are considered,
`it is evident that the claim limitation calling for 3% to 15% ether
`phospholipids is enabled.
`Based on the foregoing we conclude that, based on the evidence
`before us, Petitioner has failed to demonstrate that the claim limitations
`calling for specific ranges of ether phospholipids are not enabled and are
`entitled to a priority date before March 16, 2013.
`
`B. Astaxanthin esters
`Petitioner contends that the limitations regarding astaxanthin esters
`are not enabled and do not satisfy the written description requirement. Here
`again, Petitioner does not distinctly set forth separate arguments relating to
`these contentions but refers to lack of Section 112(a) support or simply
`states that there is no possession or enablement of the upper range of
`astaxanthin esters.10 Pet. 36 and 46–47. We shall, however, address each
`issue separately.
`
`1. Written Description
`Petitioner contends that the limitations regarding the amount of
`astaxanthin esters do not comply with the written description requirement.
`Pet. 40–44, and 46–47. To support this contention, the Petitioner construes
`
`
`10 See footnote 8, supra.
`
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`Patent 9,644,170 B2
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`the claims as calling for up to 87% or 95% astaxanthin esters. Pet. 37.
`Petitioner arrives at this amount by construing the claim as possibly
`containing only ether phospholipids and astaxanthin esters. Id. at 36–37.
`Petitioner then subtracts the amount of ether phospholipids from the total
`resulting in an upper limit of from 85% to 97%. Id. Petitioner then argues
`that the Specification only describes an upper limit of 2.5%, which is well
`below the upper limit permitted by the claims. Id. at 38–40.
`Patent Owner contends that the written description requirement is met
`in that the Specification specifically discloses astaxanthin levels greater than
`100mg/kg of krill oil. Prelim Resp. 40–41. Patent Owner contends that
`nothing further is required to satisfy the written Description requirement. Id.
`We have considered the parties’ arguments and conclude that, based
`on the evidence before us that Petitioner has not adequately demonstrated,
`for purposes of this decision, that the limitation regarding astaxanthin esters
`does not comply with the written description requirement.
`Petitioner’s argument is based on the premise that the claim should be
`interpreted to call for an upper limit of 78% to 95% astaxanthin esters. Pet.
`37. We are not persuaded that this is a proper interpretation of the claims.
`While the claims in a post grant review should be given their broadest
`interpretation that interpretation should still be made in light of the
`Specification. See In re Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983) (“It is
`axiomatic that, in proceedings before the PTO, claims in an application are
`to be given their broadest reasonable interpretation consistent with the
`[S]pecification []and that claim language should be read in light of the
`[S]pecification as it would be interpreted by one of ordinary skill in the art.”)
`As Patent Owner points out, the limitation at issue only sets forth the
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`minimum amount of astaxanthin esters. Prelim. Resp. 26. We agree with
`Patent Owner that by reading the claims and the Specification, one skilled in
`the art would understand that the
`upper boundary is not infinity, but rather is bound by the nature
`of the starting material used to make the krill oil and the
`extraction processes utilized as admitted previously by Dr.
`Tallon and does not, for example, extend into ranges such as the
`85% ramnge [sic] hypothetically raised by Petitioner. See Ex.
`2012, Tallon IPR2017-00745 Decl., ¶186. The breadth of the
`claims extends to a range that a POSITA would consider
`reasonable based on the admitted data in the specification
`demonstrating astaxanthin ester levels of 25 times the claimed
`lower boundary of 100 mg/kg.
`Prelim. Resp. 26–27.
`
`In addition, as Petitioner points out, the Specification contains over 50
`recitations of amounts of astaxanthin esters including the teaching that “the
`krill lipid extract comprising at least 500, 100, 1500, 2000, 2100, or 2200
`mg/kg astaxanthin esters.” Ex. 1001, col. 3, ll. 64–65; Pet. 38–39. This
`range is repeated elsewhere in the Specification. See, e.g., Ex. 1001 col. 13.
`ll. 26–28. In addition, the Specification teaches “[i]n further embodiments,
`the present invention provides a krill lipid extract comprising at least 100
`mg/kg astaxanthin esters.” Ex. 1001, col. 3, l. 66–col. 4, l. 1. These same
`ranges and amounts appear in the parent application of the ’170 patent. Ex.
`1043 ¶¶ 20, 73.
`
`2. Enablement
`Petitioner contends that the “[t]he ’170 patent does not enable a
`POSITA, without undue experimentation, to make a krill oil composition
`containing ‘astaxanthin esters in amount of greater than about 100 mg/kg
`[.01%] of said krill oil.’” Pet. 36. Petitioner supports this contention with
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`the Declaration of Dr. Tallon where he states that “[t]he ’170 Patent does not
`enable a POSITA to make a krill oil composition containing the entire range
`of astaxanthin esters specified in the challenged claims. The ranges claimed
`by the ’170 Patent for astaxanthin esters do not recite an upper bound.” Pet.
`62; Ex. 1006 ¶ 102. Petitioner also cites to paragraphs 253–55 of Dr.
`Tallon’s declaration where he opines that there is no section 112 support for
`the upper ranges of the amount of astaxanthin esters. Ex. 1001 ¶¶ 253–55.
`Patent Owner contends that Petitioner has failed to apply the factors
`set forth in Wands for determining if a claim is enabled. Prelim Resp. 25.
`Patent Owner contend that when the Wands factors are properly applied, it is
`evident that the claims are enabled. Id. at 25–32.
`We have considered the parties’ arguments and conclude that, based
`on the evidence before us, Petitioner has not demonstrated that the claims
`are not enabled for the limitations directed to astaxanthin ester. Petitioner
`has offered no evidence to support its contention that the claims are not
`enabled other than Dr. Tallon’s naked statements to that effect. Dr. Tallon’s
`opinions, without more, are insufficient to shown non-enablement. See
`Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294
`(Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual
`determinations” is sufficient to “render the testimony of little probative
`value in a validity determination.”).
`In addition, Patent Owner has demonstrated that when the Wands
`factors are applied to the present facts, the factors support a conclusion that
`the claims are enabled. Prelim Resp. 25–32. Perhaps most telling are the
`statements by Dr. Tallon in this proceeding and in the related proceeding
`where Dr. Tallon states that one skilled in the art would know how to
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`predictably vary the relative proportions of various components of krill oil to
`a desired composition. Ex. 1006 ¶¶ 44–45; Ex. 2012 ¶ 186. This coupled
`with the teachings in the Specification that the disclosed composition can be
`achieved by blending various fractions supports the conclusion that the
`claims are enabled. See e.g., Ex. 1001, col. 2, l. 66–col. 3, l. 1, col. 3, ll. 31–
`32, and col. 6, ll. 60–66.
`
`C. Trimethylamine
`Petitioner contends that the limitations regarding trimethylamine are
`not enabled and do not satisfy the written description requirement. 11 Once
`again, Petitioner does not offer separate arguments regarding these
`contentions. Pet. 40–44. We shall consider each issue separately.
`
`1. Written Description
`Petitioner contends that the claims lack proper written description in
`that the examples of the patent only show krill oil compositions having less
`than 1mgN/100g of krill oil which Dr. Tallon calculates to be equal to less
`than 42mg/kg. Pet. 43; Ex. 1006 ¶¶ 128–31. Petitioner contends “nowhere
`in the ’170 patent is there a disclosure of [trimethylamine] less than 1mg/kg
`of said krill oil.” Pet. 43.
`Patent Owner contends that the Specification provides specific
`support for the limitation. Prelim Resp. 42. Patent Owner also contends
`what when the teachings of the Specification are properly analyzed, the
`written description requirement is met. Id.
`
`
`11 Petitioner does not refer to the written description requirement but states
`that there is lack of possession. Pet. 44. As discussed in footnote 8 supra,
`we construe this phrase to mean lack of written description.
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`We have considered the parties’ arguments and find that, based on the
`evidence before us, Petitioner has not demonstrated that the claim limitation
`calling for less than 1mg trimethylamine per kg of krill oil lacks sufficient
`written description.
`The Specification of the ’170 patent teaches “in some embodiments,
`the substantially odorless krill oil composition comprises less than 10, 5, or
`1 milligrams trimethylamine.” Ex. 1001, col. 13, ll. 54–56. This same
`teaching is in the parent applications of the ’170 patent. Ex. 1046 ¶ 76.
`Petitioner’s argument that the examples of the ’170 patent do not
`disclose krill oil compositions with less than 1mg/kg trimethylamine is not
`persuasive. The lack of an example showing the limitation does not mean
`that the Specification does not provide sufficient written support; rather, the
`entire Specification must be examined to determine if there is adequate
`written description. Ariad, 598 F.3d at 1352. The present Specification
`provides specific support for the limitation.
`2. Enablement
`In support of its contention of non-enablement, Petitioner again points
`to the examples of the ’170 patent which show production of a krill oil
`composition that contains 42