`571-272-7822
`
`Paper 48
`Date: October 1, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`RIMFROST AS,
`Petitioner,
`v.
`AKER BIOMARINE AS,
`Patent Owner.
`
`IPR2018-00295
`Patent 9,320,765 B2
`
`
`
`
`
`
`
`
`
`
`
`Before TINA E. HULSE, CHRISTOPHER G. PAULRAJ, and
`JOHN E. SCHNEIDER, Administrative Patent Judges.
`SCHNEIDER, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Patent Owner’s Request on Rehearing of Final Written Decision
`37 C.F.R. § 42.71(d)
`
`
`
`
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`RIMFROST EXHIBIT 1169 Page 0001
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`IPR2018-00295
`Patent 9,320,765 B2
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`INTRODUCTION
`I.
`On June 12, 2019, the Board issued a Final Written Decision in this
`proceeding, which included a decision on Patent Owner’s Motion to Amend.
`Paper 35 (“Decision” or “Final Dec.”). In the Decision, we determined that
`claims 1–48 of U.S. Patent No. 9,320,765 B2 (“the ’765 patent”) and
`proposed substitute claims 49–56 included with the Motion to Amend
`(“proposed substitute claims”) were unpatentable over the prior art of record.
`Id. at 69.
`On July 12, 2019, Patent Owner, Aker Biomarine Antarctic AS, filed
`a timely Request for Rehearing under 37 C.F.R. § 42.71(d). Paper 36 (“Req.
`Reh’g”). On August 15, 2019, Petitioner, Rimfrost AS, with our
`authorization, filed a Response to the Request for Rehearing. Paper 37
`(“Resp. Req. Reh’g”). Patent Owner, with our authorization, filed a Reply
`on September 4, 2019. Paper 38 (“Reply Req. Reh’g”).
`The asserted grounds for rehearing relate to the Board’s reliance on
`the teachings of Randolph1 concerning levels of esterified astaxanthin as a
`basis for finding the proposed substitute claims unpatentable. 2 Req. Reh’g
`
`
`1 Randolph et al., US 2005/005728 A1, published March 17, 2005 (Ex. 1011
`“Randolph”).
`2 While the concluding paragraph of the Motion to Amend portion of our
`Decision states that only substitute claim 56 was unpatentable over the
`combination of Sampalis, Catchpole Fricke, Randolph, and NKO (Final Dec.
`68), we nonetheless relied upon the teachings of Randolph for our
`unpatentability analysis for all the proposed substitute claims. As such, the
`Decision should have stated that proposed substitute claims 49–52, 55, and
`56 are unpatentable over Sampalis, Catchpole Fricke, Randolph, and NKO
`and that proposed substitute claims 53 and 54 are unpatentable over
`Sampalis, Catchpole Fricke, Bottino, Randolph, and NKO.
`
`2
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`RIMFROST EXHIBIT 1169 Page 0002
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`IPR2018-00295
`Patent 9,320,765 B2
`1–2. Patent Owner contends that the Board’s Decision regarding the
`proposed substitute claims was in error as the Decision relied on a
`combination of references that included Randolph that was allegedly not
`advanced by the Petitioner. Req. Reh’g 10–11. Patent Owner also argues
`that the Board’s Decision violated the Administrative Procedure Act
`(“APA”) in that Patent Owner was not given notice of the combination of
`references we applied in our Decision and was not afforded an opportunity
`to respond to the alleged new grounds of unpatentability based in that
`combination. Req. Reh’g 9.
`On November 22, 2019, the Board issued an order authorizing
`supplemental briefing. Paper 40 (“Reh’g Order”). Specifically, we explained
`that the Board “erred in concluding that proposed [substitute] claims 49–56
`are unpatentable over Sampalis, Catchpole, Fricke, and Randolph without
`affording Patent Owner the opportunity to fully address Petitioner’s
`argument concerning the teachings of Randolph.” Id. at 4. The Rehearing
`Order also pointed out that, although the record contained evidence as to
`Randolph’s teachings, “Petitioner did not apply Randolph to the proposed
`[substitute] claims until it filed its Sur-Reply.” Id. Thus, the Board
`determined that it was appropriate to allow further briefing regarding
`whether the proposed claims were unpatentable over the combined teachings
`of Sampalis, Catchpole, Fricke, and Randolph. Id. at 5.
`Pursuant to that Order, Patent Owner filed an authorized
`Supplemental Brief on December 3, 2019 (Paper 42 (“Supp. Br.”)),
`Petitioner filed an authorized Response on December 17, 2019 (Paper 43
`(“Supp. Resp.”)), and Patent Owner filed an authorized Reply on December
`20, 2019 (Paper 44 (“Supp. Reply”)).
`
`3
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`RIMFROST EXHIBIT 1169 Page 0003
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`IPR2018-00295
`Patent 9,320,765 B2
`On July 6, 2020, the Precedential Opinion Panel (“POP”) issued its
`decision in Hunting Titan, Inc. v. Dynaenergetics Europe GmbH, IPR2018-
`00600, Paper 67 (PTAB July 6, 2020) (precedential) (“Hunting Titan”),
`which relates to motions to amend and the Board’s authority to consider
`issues of unpatentability not raised by a petitioner. The POP held that the
`Board may consider such issues, but only in certain rare circumstances. Id. at
`4. In an email sent July 16, 2020, the Board requested briefing from the
`parties addressing what impact, if any, Hunting Titan has on the present
`proceeding. Ex. 3001. On July 24, 2020, Petitioner filed a Supplemental
`Brief Addressing Potential Impact of Hunting Titan. Paper 45 (“Pet. HT
`Br.”). Patent Owner filed its Supplemental Response Brief Addressing the
`Impact of Hunting Titan on August 3, 2020. Paper 46 (“PO HT Br.”).
`II. LEGAL STANDARD
`A request for rehearing “must specifically identify all matters the
`party believes the Board misapprehended or overlooked, and the place where
`each matter was previously addressed in a motion, an opposition, or a reply.”
`37 C.F.R. § 42.71(d). The burden of showing a decision should be modified
`on a request for rehearing lies with the party challenging the decision. Id.
`III. ANALYSIS
`A. The Board Properly Considered a Ground of Unpatentability Including
`Randolph
`As part of our analysis of whether to grant Patent Owner’s Request for
`Rehearing and grant its Motion to Amend, we need to consider the issue of
`whether the Board properly found the proposed substitute claims
`unpatentable over a combination of references that includes Randolph.
`Patent Owner contends that we should not have concluded that the proposed
`claims were unpatentable as the combination including Randolph was not
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`4
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`RIMFROST EXHIBIT 1169 Page 0004
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`IPR2018-00295
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`properly before the Board and should not have been considered. Req. Reh’g
`2–3. Petitioner disagrees. Resp. Req. Reh’g 6–7.
`Two recent decisions, one by our reviewing court, Nike, Inc. v. Adidas
`AG, 955 F.3d 45 (Fed. Cir. 2020), and the other by the POP, Hunting Titan,
`guide our analysis. Nike addresses whether the Board has the authority to
`consider a new ground of unpatentability in connection with a motion to
`amend. Nike, 955 F.3d at 51–52. Hunting Titan addresses whether, and
`under what circumstances, the Board should exercise any such authority.
`Hunting Titan at 5.
`In Nike, the Board denied patent owner Nike’s motion to amend,
`finding the proposed claims unpatentable as obvious. Nike, 955 F.3d at 49.
`The Board based its decision on the entirety of the record including a
`reference that, while part of the record, was not relied upon by petitioner
`Adidas to challenge the proposed claims. See id at 48–49 (noting Adidas
`relied on Nishida, Schuessler I and Schuessler II, and the Board added
`Spencer to its analysis). Nike argued that the Board violated the APA by
`failing to give notice that it would rely on Spencer to support its obviousness
`conclusion for the substitute claim. Id. at 51. The Federal Circuit agreed. Id.
`The Federal Circuit began its analysis by holding “that the Board may
`sua sponte identify a patentability issue for a proposed substitute claim
`based on the prior art of record.”3 Id. The court distinguished the earlier
`holdings in SAS Institute, Inc. v. ComplementSoft, LLC, 825 F.3d 1341 (Fed.
`Cir. 2016) and In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1373
`(Fed. Cir. 2016) where the Board was limited to addressing the issues raised
`
`3 The court did not address the issue of whether the Board was permitted to
`look outside the record to determine the patentability of proposed substitute
`claims. Id. at 51 n.1.
`
`5
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`RIMFROST EXHIBIT 1169 Page 0005
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`in the petition against already issued claims, noting that those cases did not
`involve the motions to amend. Id. The court continued:
`It makes little sense to limit the Board, in its role within
`the agency responsible for issuing patents, to the petitioner’s
`arguments in this context. Rather, based on consideration of the
`entire record, the Board must determine whether the patent
`owner’s newly-presented, narrower claims are “supported by
`the patent’s written description” and “unpatentable in the face
`of the prior art cited in the IPR.”
`Id. at 51–52 (quoting Aqua Prods., Inc., v. Matal, 872 F.3d 1290, 1314 (Fed.
`Cir. 2017) (citing 35 U.S.C. § 316(d)(3))). Thus, under Nike, the Board has
`the authority to consider a new ground of unpatentability when it considers
`the substitute claims proposed in a motion to amend.
`We next turn to the guidance the POP provided in Hunting Titan.
`First, the POP held that “the Board may, in certain rare circumstances,
`raise a ground of unpatentability that a petitioner did not advance, or
`insufficiently developed, against substitute claims proposed in a motion to
`amend.” Id. at 4. The rare circumstances exemplified in the decision include
`cases where the petitioner has ceased to participate in the proceeding; where
`the petitioner has not opposed the motion to amend; or “where certain
`evidence of unpatentability has not been raised by the petitioner, but is
`readily identifiable and persuasive such that the Board should take it up in
`the interest of supporting the integrity of the patent system, notwithstanding
`the adversarial nature of the proceedings.” Id. at 12–13.
`The POP also held that where the Board intends to raise a new ground
`of unpatentability in connection with a motion to amend, the patent owner
`must be given notice and an opportunity to address the proposed new
`grounds. Id. 15.
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`6
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`RIMFROST EXHIBIT 1169 Page 0006
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`Because the Hunting Titan POP decision issued after Patent Owner
`filed its Request for Rehearing in this case, we requested further briefing
`from the parties to address the potential impact of its holdings on the present
`proceeding.
`In its Supplemental Briefing, Petitioner contends that the facts of the
`present case are distinguishable from those in Hunting Titan and that the
`POP decision supports its position that Patent Owner’s Request for
`Rehearing should be denied. Pet. HT Br. 1. Petitioner contends that, unlike
`in Hunting Titan, the issue of whether the proposed substitute claims are
`obvious over Sampalis, Catchpole, Fricke, and Randolph was raised and
`sufficiently developed during the proceeding. Id. at 2–4. Petitioner also
`contends that Patent Owner was given notice of the potential new ground
`and was allowed an opportunity to respond through the supplemental
`briefing authorized by the Board. Id. at 3–4. Petitioner contends that even if
`the issue of unpatentability based on the four references was not sufficiently
`developed, the evidence of unpatentability was readily identifiable and
`persuasive such that “the Board should take it up in the interest of supporting
`the integrity of the patent system.” Id. at 4 (quoting Hunting Titan, Paper 67
`at 13).
`Patent Owner contends that Hunting Titan is dispositive with regard to
`its Motion to Amend and its Request for Rehearing and that the request and
`the Motion to Amend should both be granted. PO HT Br. 1. Patent Owner
`contends that Petitioner did not adequately develop the ground relied upon
`by the Board. Id. at 1–3. Patent Owner also argues the circumstances of the
`present case do not compel the Board to advance a new ground of
`unpatentability that Petitioner did not advance or sufficiently develop. Id. at
`3–5.
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`7
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`RIMFROST EXHIBIT 1169 Page 0007
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`Patent 9,320,765 B2
`We have considered the arguments advanced by the parties and
`determine that we appropriately considered Randolph’s teachings in
`assessing the patentability of the proposed claims insofar as Petitioner raised
`Randolph as prior art against the proposed substitute claims in opposing
`Patent Owner’s Motion to Amend. As such, we are not persuaded that our
`consideration of Randolph constituted a new ground of unpatentability.
`Thus, Hunting Titan is distinguishable and does not compel us to grant
`Patent Owner’s Motion to Amend.
`Patent Owner contends that the Board should not have raised a new
`ground in this case because Petitioner “vigorously prosecuted its case” and
`elected not to pursue an argument based on Randolph. PO HT Br. 4. We do
`not find this argument persuasive as it is inconsistent with the record. As we
`explain below, Petitioner raised the issue of the teachings of Randolph in its
`briefing and during arguments before the Board. This is not a case where
`Petitioner failed to sufficiently advance an unpatentability ground that
`includes Randolph.In the present proceeding, Petitioner in its Petition
`challenged some of the original claims based on the combination of
`Sampalis, Catchpole, Fricke, Breivik, and Randolph. Pet. 7. With respect to
`the proposed substitute claims, Patent Owner first raised the teachings of
`Randolph preemptively in its Motion to Amend when it argued that
`Randolph taught away from the recited astaxanthin concentration because
`“[t]he lowest amount of astaxanthin ingredient disclosed in Randolph is 1%,
`which is equivalent to 10,000 mg/kg” and “[t]his is over 13 times greater
`than the highest amount of astaxanthin esters recited in proposed substitute
`claim 49.” Paper 16 (“MTA”), 18–19. Petitioner responded to Patent
`Owner’s teaching away argument by pointing out that Randolph taught that
`the compositions could contain “any amount of an astaxanthin ingredient.”
`
`8
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`RIMFROST EXHIBIT 1169 Page 0008
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`Paper 20 (“MTA Opp.”), 15–16 (quoting Ex. 1011 ¶¶ 7, 44). Petitioner
`supported this argument with the declaration of Dr. Tallon in which Dr.
`Tallon testified that Randolph discloses a krill oil composition having 158
`mg/kg astaxanthin ester. Id. (citing Ex. 1086 ¶¶ 197–202). Patent Owner
`cross-examined Dr. Tallon regarding this teaching in Randolph. Ex. 2020,
`155–157. In its Sur-Reply to the Motion to Amend, Petitioner specifically
`cited to this cross-examination testimony when Petitioner argued that
`Randolph taught a composition having an astaxanthin level falling with the
`scope of the proposed substitute claims. Paper 30, 10 (“MTA Sur-Reply”).
`In addition to discussing Randolph in its briefing and through its
`expert, Petitioner also made specific reference to the teachings of Randolph
`in the demonstratives used at trial and the Board asked specific questions
`about the teachings of Randolph and Dr. Tallon’s Testimony. Paper 34, 17–
`18 (“Tr.”).
`Patent Owner contends that the ground of unpatentability that includes
`Randolph was not sufficiently developed by Petitioner. PO HT Br. 2–3.
`Specifically, Patent Owner contends that Petitioner did not adequately
`address the issue of motivation to combine Randolph with the remaining
`references nor did it address whether there was a reasonable expectation of
`success. Id.
`Based on the foregoing we find that, unlike the situation in Hunting
`Titan, Petitioner in the present case adequately developed the issue of
`whether the proposed substitute claims are unpatentable over a combination
`of references that includes Randolph. With respect to the specific
`unpatentability arguments set forth by Petitioner in its Opposition to the
`Motion to Amend, we recognize that Petitioner only relied upon Randolph in
`combination with other references to argue for the unpatentability of
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`proposed substitute claim 56. MTA Opp. 24–25. However, Petitioner’s
`arguments concerning Randolph were in response to Patent Owner’s
`contention that Randolph taught away from the range of astaxanthin ester
`(100 mg/kg to 700 mg/kg) recited in all the substitute clams. See MTA, 18–
`19 (“Thus, Patent Owner contends that Randolph’s disclosure of at least
`10,000 mg/kg of an astaxanthin ingredient teaches away from krill oil
`compositions that include the 100 mg/kg to 700 mg/kg astaxanthin esters
`recited in proposed substitute claim 49.”). Patent Owner was made aware of
`Petitioner’s contentions though the briefing submitted by Petitioner and
`through the declaration of Dr. Tallon. Furthermore, as discussed more fully
`below, the MTA briefing and supporting declaration submitted by Petitioner
`adequately discussed the motivation to combine the references and the
`reasonable expectation of success. See, e.g., MTA Opp. 24–25; Ex. 1086 ¶¶
`15, 50, 64, 221–223.
`Moreover, even if we agreed with Patent Owner that Petitioner did not
`adequately develop its arguments with respect to Randolph, we would
`otherwise conclude that we properly considered Randolph in assessing the
`patentability for all the proposed substitute claims in light of the record in
`this proceeding and following the guidance in Hunting Titan. The POP held
`that the Board may raise a new ground of unpatentability where the evidence
`of unpatentability “is readily identifiable and persuasive such that the Board
`should take it up in the interest of supporting the integrity of the patent
`system, notwithstanding the adversarial nature of the proceedings.” Hunting
`Titan, Paper 67 at 12–13. In the present case, the combination of Randolph
`with the remaining references is readily identifiable because it was: (1) first
`raised by Petitioner in response to Patent Owner’s argument that Randolph
`taught away from the recited levels of astaxanthin ester; (2) specifically
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`10
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`asserted by Petitioner against proposed substitute claim 56; (3) discussed by
`Dr. Tallon in his Declaration in support of Petitioner’s Opposition to the
`Motion to Amend, (4) the subject of cross-examination testimony of Dr.
`Tallon, (5) discussed by Petitioner in its Sur-Reply to the Motion to Amend,
`and (6) raised by the panel and discussed with the parties during the oral
`hearing. Ex. 1086 ¶¶ 197–202; Ex. 2020, 155–157; MTA Sur-Reply 10; Tr.
`17–18. The evidence is persuasive in that Randolph teaches the very element
`that Patent Owner argued was lacking from the prior art and contradicts
`Patent Owner’s argument that Randolph teaches away from the claimed
`range of astaxanthin ester. See MTA 18.
`Based on the foregoing we conclude that we properly considered
`Randolph in determining the patentability of the proposed substitute claims.
`B. Supplemental Briefing Cured Any Potential Violation of the APA
`Patent Owner contends that it had no proper opportunity to respond to
`the grounds including Randolph, which violates the APA and is contrary to
`Federal Circuit precedent. Req. Reh’g, 9–11 (citing SAS Institute, 825 F.3d
`at 1351 and In re Magnum Oil Tools, 829 F.3d at 1378).
`Petitioner responds that the references and arguments relied upon by
`the Board were part of the record and the Board properly considered the
`entirety of the record. Resp. Req. Reh’g 6–7. Petitioner contends that no
`APA violation occurred as Patent Owner was on notice of Petitioner’s
`reliance on Randolph’s teaching with regard to astaxanthin levels because
`Petitioner presented it in response to Patent Owner’s arguments “regarding
`Randolph’s teachings and the patentability of the substitute claims.” Id. at 8–
`9.
`
`In its supplemental brief addressing the combination of Sampalis,
`Catchpole, Fricke, and Randolph, Patent Owner maintained its position that
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`the Board should limit its analysis to the grounds actually raised by
`Petitioner in the Opposition challenging the proposed substitute claims.
`Supp. Br. 1. Patent Owner asserts that it “has been prejudiced by not being
`able to, among other things, submit expert testimony on the combination of
`the astaxanthin content of Randolph with the other references.” Id.
`As explained above, we have considered the parties’ arguments and
`are not persuaded that our reliance on the teachings of Randolph concerning
`levels of esterified astaxanthin in our Final Written Decision was improper
`or erroneous. Moreover, any alleged prejudice to Patent Owner was
`mitigated by our authorization of supplemental briefing in this proceeding to
`allow the parties to address the merits of our reliance on Randolph’s
`teachings. Paper 40.
`The Federal Circuit’s decision in Nike, discussed above is on point.
`There, the court addressed Nike’s argument regarding a violation of the
`APA and held
`Although the Board was permitted to raise a patentability
`theory based on Spencer, the notice provisions of the APA and
`our case law require that the Board provide notice of its intent
`to rely on Spencer and an opportunity for the parties to respond
`before issuing a final decision relying on Spencer.
`
`
`Id. at 52.
`The court went on to give two examples as to how the notice
`requirements of the APA could be met when the Board intends to rely on
`prior art not addressed by the parties:
`For example, prior to issuing its decision on remand, the Board
`in this case could have informed the parties that it intended to
`rely on Spencer for disclosing the disputed limitation of
`substitute claim 49, and requested supplemental briefing from
`the parties regarding its proposed ground for unpatentability.
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`Alternatively, had the Board held an oral hearing on remand, it
`could have requested that the parties be prepared to discuss
`Spencer in connection with substitute claim 49 at the hearing.
`Either of these actions would satisfy the APA’s notice
`requirements, but neither occurred in this case.
`
`Id. at 54. This approach is also consistent with the POP’s holding in Hunting
`Titan. In Hunting Titan, the POP held that where a new ground of
`unpatentability is raised, a patent owner needs notice of the new ground and
`an opportunity to address the new ground. Id. at 15. Although we determine
`that the Board did not raise a new ground of unpatentability for the reasons
`set forth above, even if our analysis could arguably be considered a new
`ground, we provided Patent Owner with the requisite notice and an
`opportunity to respond.
`As discussed above, in response to Patent Owner’s request, we
`authorized supplemental briefing by the parties to specifically address the
`teachings of Randolph that Petitioner raised in its Sur-Reply and that we
`relied upon in finding the proposed claims unpatentable. Reh’g Order. The
`parties have now briefed the issues regarding the teachings of Randolph and
`the propriety of the combination of references on which we relied.
`We find unpersuasive Patent Owner’s contention that the additional
`briefing we authorized could not remedy any potential APA violation
`because it did not have an opportunity to submit further expert testimony.
`Following the guidance set forth in both Nike and Hunting Titan, the Board
`authorized additional briefing regarding combining Randolph with the other
`references. Both the Federal Circuit’s decision in Nike and POP’s decision in
`Hunting Titan teach that supplemental briefing is a way for the Board to
`satisfy the requirement for notice and an opportunity to respond. Nike, 955
`F.3d at 54; Hunting Titan, Paper 67 at 15. But we find nothing in either
`
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`decision to suggest that parties must be provided with an opportunity to
`submit further expert testimony as part of such supplemental briefing in
`order to satisfy the APA requirements.
`Based on the foregoing, we determine that it was proper to find the
`proposed claims unpatentable based on our consideration of the entire
`record. Moreover, we determine that allowing the parties to further brief our
`reliance on Randolph’s teachings remedied any potential APA violation.
`C. Unpatentability of the Proposed Claims
`In the Final Written Decision issued in this case, the Board
`determined that proposed claims 49 to 56 were unpatentable over the
`teachings of Catchpole, Fricke, and Randolph. Final Dec. 68; see also Reh’g
`Order 4 (clarifying that the Board found proposed substitute claims 49–56
`unpatentable over Sampalis, Catchpole, Fricke, and Randolph). The Board
`found, in part, that Randolph taught preparing a product having from 100 to
`700 mg/kg astaxanthin ester. Final Dec. 67–68.
`Patent Owner contends that the Board erred in finding the proposed
`claims unpatentable. Supp. Br. 1. Specifically, Patent Owner contends that
`the combination of Catchpole, Fricke, and Randolph does not teach the
`limitation calling for 100 to 700 mg/kg astaxanthin esters. Id. Patent Owner
`also contends that Petitioner failed to show that one skilled in the art would
`have been motivated to prepare a krill oil product with an astaxanthin level
`of from 100 to 700 mg/kg. Id. We consider each of these arguments in turn.
`1. The Teachings of Randolph
`As noted in our Decision, Randolph discloses compositions for
`modulating cytokines to regulate an inflammatory or immunomodulatory
`response including, inter alia, rosehips and krill oil. Ex. 1011 ¶ 8. With
`regard to rosehips, Randolph discloses that the composition may include one
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`or more rosehip ingredients, such as “dried rosehips, rosehip oil, and rosehip
`extracts.” Id. ¶ 24.
`Concerning krill oil, Randolph discloses that
`[a] composition of the invention can include krill oil. Krill oil
`can be obtained from any member of the E. family, for example
`E. superba. Conventional oil producing techniques can be used
`to obtain the krill oil. In addition, krill oil can be obtained
`commercially from Neptune Technologies and Bioresources of
`Quebec, Canada.
`
`Id. ¶ 39. Randolph further explains that “[a] composition can contain any
`amount of krill oil,” but will typically contain “between about 300 mg and
`about 3000 mg of a krill oil ingredient.” Id. ¶ 40.
`Randolph teaches:
`A 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. Typically,
`a composition contains between about 0.5 mg and about 50 mg
`of an astaxanthin ingredient.
`
`Id. ¶ 44.
`Patent Owner contends we erred in our Decision, as Randolph does
`not teach the limitation calling for an amount of astaxanthin ester ranging
`from 100 to 700 mg/kg. Supp. Br. 2–6.
`Patent Owner contends that one skilled in the art would have read
`Randolph as teaching the preparation of krill oil compositions having
`significantly higher amounts of astaxanthin ester. Supp. Br. 2–3. Patent
`Owner points to the teaching in Randolph that the krill oil that can be NKO
`krill oil or krill oil that has been conventionally produced. Supp. Br. 2;
`Ex. 1011 ¶ 39. Patent Owner contends that the evidence of record shows that
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`NKO krill oil has an astaxanthin content of 1500 mg/kg and that Randolph
`does not contain any teachings as to what the astaxanthin content would be
`for a krill oil composition produced by a conventional technique. Supp. Br.
`2–3. Patent Owner contends that Randolph’s teaching that the disclosed
`composition can have “any amount of astaxanthin” refers to the general
`compositions disclosed in Randolph and not to the krill oil used in the
`compositions. Supp. Br. 3.
`These arguments do not persuade us that we erred in finding the
`proposed claims unpatentable. As Petitioner argues, Randolph teaches that
`the disclosed compositions may comprised of any amount of krill oil and
`any amount of astaxanthin. MTA Opp., 16; Ex. 1011 ¶¶ 40, 44. Although
`Randolph teaches that the krill oil can be obtained commercially, that
`reference does not limit the krill oil to a commercial product. Moreover,
`although some commercial products contain higher amounts of astaxanthin
`ester, it was also known, as the present Specification teaches, that certain
`commercial products at the time had astaxanthin ester levels that fell within
`the recited range. See Ex. 1001, col. 27, ll. 38–50 (Table 16) (NKO
`commercial product had an astaxanthin level of 472 mg/kg).
`We are also persuaded by the testimony of Dr. Tallon, previously
`made of record with Petitioner’s Opposition, that Randolph teaches a range
`of astaxanthin levels that would yield an astaxanthin ester level within the
`range recited in the claims. In particular, Dr. Tallon attests that Randolph
`teaches that the amount of krill oil in the supplement can range from 300 mg
`to 3000 mg and that the astaxanthin level can range from 0.5 mg to 50 mg.
`Ex. 1011 ¶¶ 40, 44. Using the values reported in Randolph, Dr. Tallon
`calculated that the amount of astaxanthin ester present in a supplement
`containing 3000 mg krill oil and 0.5 mg astaxanthin would yield a
`
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`supplement containing about 167 mg/kg of astaxanthin ester. Ex. 1086 ¶¶
`199–202.
`Patent Owner contends that Dr. Tallon’s calculations of astaxanthin
`levels in Randolph are based on hindsight in that Dr. Tallon improperly
`reads Randolph as referring to krill oil compositions when Randolph
`actually refers to the combined product. Supp. Br. 4. Patent Owner also
`contends that Dr. Tallon improperly used values at the extreme ends of the
`ranges for krill oil and astaxanthin to support his conclusion that the ranges
`of astaxanthin esters would range as low as 158 mg/kg. Id. at 5. Patent
`Owner contends that the calculations in Dr. Tallon’s report actually result in
`an astaxanthin level that is an order of magnitude higher than 158 mg/kg. Id.
`at 6.
`
`Again, we are not persuaded by Patent Owner’s arguments. While we
`agree with Patent Owner that Randolph teaches a combined product,
`Randolph also teaches that the combined product can comprise at least about
`90 percent krill oil resulting in a product that is almost completely
`comprised of krill oil. Ex. 1011 ¶ 40. We thus find Dr. Tallon’s assumption
`that the krill oil was the source of the astaxanthin to be reasonable and
`supported.
`We are not persuaded by Patent Owner’s arguments regarding
`Dr. Tallon’s use of the endpoints of the ranges taught by Randolph.
`Randolph clearly teaches that the disclosed composition can contain as little
`as 0.5 mg of astaxanthin and as much as 3000 mg of krill oil creating a
`logical lower endpoint for a range of combinations taught by Randolph.
`Ex. 1011 ¶¶ 40, 44. We are not persuaded by Patent Owner’s contentions
`that the use of the two endpoints by Dr. Tallon was improper.
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`Finally, with respect to Dr. Tallon’s calculations, Dr. Tallon clarified
`during his cross-examination that the calculations reported in his declaration
`contained a typographical error, and then explained how he reached his
`conclusion that Randolph teaches an astaxanthin level within the range
`recited in the claims. Ex. 2020, 154–155.
`Based on the foregoing, we did not err in finding that Randolph
`teaches a krill oil composition containing astaxanthin ester in an amount of
`from 100 to 700 mg/kg of said krill oil.
`2. Motivation to Combine
`Patent Owner also contends that we erred in finding the substitute
`claims unpatentable as Petitioner had not established a motivation to
`combine the references. Supp. Br. 6. To the contrary, Patent Owner argues
`that, in fact, one skilled in the art would have been led away from a krill oil
`composition comprising from 100 to 700 mg/kg astaxanthin esters. Id. at 7.
`Patent Owner contends that Randolph teaches that the supplement can
`contain at least one percent astaxanthin and that Patent Owner’s expert Dr.
`Heom has calculated that this would be equal to 10,000 mg/kg. Id. at 7–8
`(citing Ex. 2013 ¶ 57).
`Patent Owner also contends that the teachings o