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  • PTAB · May 18, 2022 · IPR2020-01534 · APJ Susan L C Mitchell · IPR · Final written decision

    Claims 1–20 were not shown unpatentable under § 103 because the petitioner did not establish that Bottino II taught the claimed free fatty acid limit.

    RulingsFinal written decision
    • PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner

      “have been fully and fairly tried in a previous action and adversely resolved against a party-opponent.” Ohio Willow Wood Co. v. Alps S., LLC, 735 F.3d 1333, 1342 (Fed. Cir. 2013) (citing Pharmacia & Upjohn Co. v. Mylan Pharm., Inc., 170 F.3d 1373, 1379 (Fed. Cir. 1999)). To prove collateral estoppel, a party must show the following: (1) that in the prior action the party against whom estoppel is sought had a full and fair opportunity to litigate the issue: (2) the issue was actually litigated; (3) the controlling facts and applicable legal rules were the same in both actions; (4) resolution of the particular issue was essential to the final judgment in the first action; and (5) the identical issue was decided in the first action. See Comair Rotron, Inc. v. Nippon Densan Corp., 49 F.3d 1535, 1537 (Fed. Cir. 1995) (emphasis added). In considering collateral estoppel of adjudicated patent claims, the patent claims do not have to be identical; rather, “it is the identity of the issues that were litigated that determines whether collateral estoppel should apply.” Ohio Willow Wood, 735 F.3d at 1342. Here, Petitioner provides us with an overview of the similarity of the art used in the previous cases before us involving related patents to the ’567 patent and a general overview of the various components of allegedly “virtually identical krill oil compositions” without addressing a comparison of specific unpatentable claims of these related patents as compared to the specific claims at issue here. See Pet. 42–44. Notably, this overview of similar components of claimed krill oil compositions in the related patents does not address free fatty acids that are at the center of the dispute in this case. Id. Most notably, Petitioner fails to address the five criteria that we have listed above to establish that collateral estoppel applies in this case. Id. We agree with Patent Owner that this is a fatal flaw. Nowhere in the Petition does Petitioner provide an analysis of a previous Board decision where the issue of whether Bottino II teaches an extract with less than 3% free fatty acids w/w of said krill oil (an issue central to resolution of the case here) was litigated, resolved by the Board, and essential to the judgment in that previous case. See Pet. 42–44. Therefore, Petitioner cannot show that the identical issue was decided in any previous case before us. Petitioner’s discussion of the similarity of art previously applied and a generalized overview of different components of various challenged claims of related patents is insufficient. Because Petitioner failed to apply the correct framework, we find that collateral estoppel does not preclude Patent Owner from addressing the issues raised in this inter partes review.” slip op. at 16

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Petitioner makes arguments for the first time at oral hearing concerning our alleged previous reliance on Table 2 of Bottino II in finding claims of related patents unpatentable and provides new evidence of Patent Owner’s alleged failure to challenge the reliability of Table 2 of Bottino II. See Tr. 8:7–9:3; Petitioner’s Demonstratives, slide 8. We find that these belated arguments and evidence are inappropriately raised for the first time at oral argument, and we need not consider them. See Patent Trial and Appeal Board Consolidated Trial Practice Guide 73 (Nov. 2019) (“Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.”) (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1077–78 (Fed. Cir. 2015)).” slip op. at 18

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner’s declarant, Dr. Jaczynski, accepted Petitioner’s definition of a POSITA, see Ex. 2001 ¶ 8, and further commented that “[t]he relevant field for the ’567 patent includes extraction of lipids from natural sources,” see id. ¶ 7. Dr. Jaczynski further stated that he considers himself to be an expert in the relevant field. Id. We find that Petitioner’s definition of a POSITA is consistent with the level of skill reflected in the Specification and the asserted prior art references, and apply it for purposes of this decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art). We also find that both Dr. Tallon and Dr. Jaczynski are qualified to opine about how one of skill in the art would view the teachings of the asserted combinations of art in Petitioner’s challenges to the claims. See Ex. 1006 ¶¶ 7–21, Appendix D (Curriculum Vitae of Dr. Tallon); Ex. 2002, Appendix A (Curriculum Vitae of Dr.Jaczynski).” slip op. at 11

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

      “At this final stage of the proceeding, we again determine that no construction of any claim term for which Petitioner has proposed a 13 Petitioner points out that Dr. Tallon testified that his constructions would be the same under the Phillips standard. Reply 6, n.2 (citing Ex. 1086 ¶ 6). definition is necessary to resolve the disputes between the parties here as the limitation upon which we resolve this case does not involve these claim terms.” slip op. at 13

    Patent outcomesUS 10,010,567 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,010,567
  • PTAB · May 16, 2022 · IPR2021-00184 · APJ Erica A Franklin · IPR · Final written decision

    Claims 1–16 and 21–25 were not shown unpatentable because Banin’s gold clusters were not shown to be molecular cluster compounds, and the Zaban combinations lacked motivation to combine.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 18–19 (citing Ex. 1002 ¶ 70). Patent Owner neither addresses Petitioner’s description of the level of ordinary skill in the art nor provides its own description. See PO Response. Accordingly, we adopt Petitioner’s definition as we find it is unopposed and consistent with the level of skill in the art at the time of the invention as reflected by the prior art in this proceeding.” slip op. at 10

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed

      “suggested formula” assigned to them is “based on a calculation that relied on the average of a wide distribution of particle sizes reported in the literature by Hutchison.” Ex. 2030 ¶ 103(citing Ex. 2017, 12891). We assign persuasive weight to her testimony because it is based upon the disclosures in Hutchison, which Banin explicitly identifies as the published procedures by which it synthesized its clusters. In particular, Dr. Cossairt’s testimony is supported by the following discussion in Hutchison: To calculate an average molecular formula for 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, Hutchison explains that it calculated an average molecular formula for its synthesized nanoparticles by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt has recognized, Banin’s “suggested formula” is exactly the same molecular formula that Hutchison discloses as the “average molecular formula” for its nanoparticles. Thus, we determine that the record as a whole supports finding that a person of ordinary skill in the art would have understood that Banin’s “suggested formula” represents an average molecular formula for a disperse mixture of gold clusters that are not identical and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs. slip op. at 23

    • Prior constructionPrior construction adoptedDecided for patent owner

      “Specification expressly defines the term “molecular cluster” in a manner that refers to the cluster compound. According to the Specification, “Molecular cluster” is a term which is widely understood in the relevant technical field but for the sake of clarity should be understood herein to relate to clusters of 3 or more metal or nonmetal atoms and their associated ligands of sufficiently well defined chemical structure such that all molecules of the cluster compound possess the same relative molecular mass. Ex. 1001, 5:3–9. We note that the District Court determined that “the term ‘molecular formula’ as opposed to ‘molecular mass’ is most appropriate. By necessity, a compound with the same molecular formula will necessarily have the same molecular mass.” Ex. 1091, 16. The District Court explained also, “it appears that the difference between a molecular formula and a molecular mass, at least for purposes of this claim construction, in inconsequential.” Id. We agree and do not find any dispute on the current record from the parties on this matter. Accordingly, for purposes of this Decision, we agree with the District Court that the term “molecular cluster compound” means “clusters of 3 or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula.” Id. at 18.” slip op. at 12

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

      “that Petitioner has not shown persuasively that a person of ordinary skill in the art would have considered Banin’s small Au clusters to be MCCs. According to Petitioner and Dr. Green, Banin’s gold clusters are MCCs because they are clusters of three or more metal atoms with their associated ligands and “each cluster is ‘identical to one another.’” Ex. 1002 ¶ 90; Pet. 23. To begin, we do not find that the record supports Petitioner’s contention or Dr. Green’s opinion that “each cluster is ‘identical to one another.’” Ex. 1002 ¶ 90; Pet. 23. Petitioner and Dr. Green do not identify any disclosure in Banin describing the clusters as being identical. Instead, they refer to Banin’s disclosure that the Au clusters have “the suggested formula Au101(PPh3)21Cl5” and are “1.4 nm in mean diameter.” In doing so, Petitioner and Dr. Green do not meaningfully address or adequately explain how Banin derived its “suggested” molecular formula for the gold clusters or why Banin reported a “mean” diameter for those clusters. To that end, Petitioner and Dr. Green have failed to provide any reason why a skilled artisan would have understood Banin’s disclosures of a “suggested formula” and a “mean diameter” to convey that the Au clusters are identical.” slip op. at 22

    Patent outcomesUS 7,803,423 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,803,423
  • PTAB · May 16, 2022 · IPR2021-00183 · APJ Erica A Franklin · IPR · Final written decision

    Claims 1, 3–6, and 8–14 were not shown unpatentable because the asserted combinations failed to establish the claimed molecular cluster compounds or a reason to combine the references.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 20 (citing Ex. 1002 ¶¶ 72–75). Patent Owner neither addresses Petitioner’s description of the level of ordinary skill in the art, nor provides its own description. See PO Resp. Accordingly, we adopt Petitioner’s definition as we find it is unopposed and consistent with the level of skill in the art at the time of the invention as reflected by the prior art in this proceeding.” slip op. at 9

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed

      “on the average of a wide distribution of particle sizes reported in the literature by Hutchison.” Ex. 2030 ¶ 102 (citing Ex. 2017, 12891). We assign persuasive weight to her testimony because it is based upon the disclosures in Hutchison, which Banin explicitly identifies as the published procedures by which it synthesized its clusters. In particular, Dr. Cossairt’s testimony is supported by the following discussion in Hutchison: To calculate an average molecular formula for 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, Hutchison explains that it calculated an average molecular formula for its synthesized nanoparticles by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt has recognized, Banin’s “suggested formula” is exactly the same molecular formula that Hutchison discloses as the “average molecular formula” for its nanoparticles. Thus, we determine that the record as a whole supports finding that a person of ordinary skill in the art would have understood that Banin’s “suggested formula” represents an average molecular formula for a disperse mixture of gold clusters that are not identical and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs.” slip op. at 24

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed

      “Based on our consideration of the record as a whole, we find that the Specification expressly defines the term “molecular cluster” in a manner that refers to the cluster compound. According to the Specification, “Molecular cluster” is a term which is widely understood in the relevant technical field, but for the sake of clarity should be understood herein to relate to clusters of three or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess approximately the same relative molecular formula. Ex. 1001, 3:28–34 (emphasis added). As there is no dispute that the term “molecular cluster compound” refers to “clusters of three or more metal atoms and their associated ligands of sufficiently well-defined chemical structure such that all molecules of the cluster compound possess approximately the same relative molecular formula,” we agree with the parties that no further construction of the claim is necessary for purposes of rendering this Decision. Additionally, we find that express construction of any remaining claim terms is unnecessary for purposes of rendering 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))).” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “Moreover, we agree with Patent Owner that Petitioner has not demonstrated persuasively that a skilled artisan would have been motivated to replace Banin’s metal catalyst with Herron’s cluster compound. PO Resp. 44–49. Petitioner’s expert, Dr. Green, does not dispute that Banin’s SLS process requires the use of a metal catalyst. Ex. 1002 ¶ 79; Ex. 1005, 4:3–9, 6:9–16. Nor does Dr. Green dispute that Herron’s Cd32S14(SC6H5)36 cluster is not a metal, but rather a cadmium sulfide semiconductor. Ex. 1002 ¶ 80; Ex. 1016, 1426. According to Patent Owner and Dr. Cossairt, there is no indication on the record that anyone has ever tried or succeeded in using a semiconductor as a catalyst in SLS nanorod synthesis. PO Resp. 53; Ex. 2030 ¶ 137. We agree and determine that Petitioner has not shown otherwise by referring to the use of a semiconductor in a different type of nanoparticle synthesis, i.e., a vapor-liquid-solid nanoparticle synthesis. See Pet. Reply 12. In any event, we find that the Petition fails to support a motivation to combine Herron’s cadmium sulfide semiconductor with Banin’s process because the Petition fails to address sufficiently (or at all) the differences between metal catalysts and Herron’s semiconductor material and to explain why a person of ordinary skill in the art would have used such a semiconductor material in place of the metal as the catalyst in Banin’s process, despite Banin’s teachings that the catalyst must be a metal. Accordingly, for the foregoing reasons, we determine that Petitioner has failed to establish persuasively that a person of skill in the art would have been motivated to modify Banin’s nanoparticle synthesis by replacing its gold metal catalyst with Herron’s cadmium-based semiconductor.” slip op. at 30

    Patent outcomesUS 7,588,828 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,588,828
  • PTAB · May 16, 2022 · IPR2021-00186 · APJ Grace Karaffa Obermann · IPR · Final written decision

    Claims 1–23 were not proven unpatentable; Petitioner failed to show Banin’s gold clusters were molecular cluster compounds or establish the proposed combinations.

    RulingsFinal written decision
    • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

      “Dr. Green’s annotated side-by-side comparison of the TEM images in Banin and Hutchison (Reply 3; Ex. 1093 ¶ 17), we are unable to discern any meaningful distinction between the images. We do not assign Dr. Green’s testimony on that point persuasive weight, as he does not supply sufficient facts and data to support his opinion that a skilled artisan would have understood that the differences in the appearances of the clusters in Banin’s TEM images are attributable to a different orientation of the non-spherical clusters and/or the aggregation of the clusters next to one another, as opposed to a size distribution among the clusters. See Ex. 1093 ¶¶ 19–20. As discussed in the Patent Trial and Appeal Board Consolidated Trial Practice Guide,18 expert testimony must be based on sufficient facts and data. See CTPG 35 (citing Fed. R. Evid. 702; 37 C.F.R. §42.65(a)). Although Dr. Green testifies that Banin’s gold clusters, as depicted in the TEM image, reflect “purified and size-selected” MCCs (Ex. 1093 ¶ 18), we remain unpersuaded by that testimony, because Dr. Green does not direct us to any disclosure in Banin reporting a size selection of the gold clusters, after being synthesized by Hutchison’s process, or prior to the TEM imaging (Ex. 1093 ¶¶ 17–21). Here again, we observe, a centrifugation step in Banin, to which Dr. Green refers as supporting his opinion in that regard, relates to the purification of the size-selected nanorods, not the gold metal clusters. See Ex. 1005, 7:4–5 (“The purification is carried out by centrifugation that affords purified nanorods having selected size.”); id. at 20:24–25 (“The rods were purified and size-selected by centrifugation.”); id. at 22:29–30 (“The rods were purified and size-selected by centrifugation.”).” slip op. at 28

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Our rules require a petitioner to explain with particularity, at the outset in the petition, why the patent it challenges is unpatentable. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). “Unlike district court litigation—where parties have greater freedom to revise and develop their arguments over time and in response to newly discovered material—the expedited nature of” inter partes review proceedings “bring with it an obligation for petitioners to make their case in their petition to institute.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Accordingly, Petitioner carries a burden to “identify with particularity” at the outset, in the Petition, “the grounds on which the challenged to each claim is based, and the evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a)(3). Although “the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings,” Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016), the shifting of arguments is not, Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017).” slip op. at 31

    • Prior constructionPrior construction adoptedDecided for patent owner

      “Based on our consideration of the record as a whole, we agree with the District Court that the molecular cluster compound of the claimed invention must have “sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula.” Ex. 1091, 18. To the extent that this or any other claim term requires further discussion, we provide it in our analysis of the challenges. No further express claim construction is necessary 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))).” slip op. at 10

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent a more specific definition is required, we adopt Petitioner’s definition for purposes of this Decision, because that definition is unopposed and consistent with the disclosures of the asserted prior art references.” slip op. at 9

    Patent outcomesUS 8,524,365 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,524,365
  • PTAB · May 16, 2022 · IPR2021-00185 · APJ Grace Karaffa Obermann · IPR · Final written decision

    Claims 1–6, 16, and 17 were not proven unpatentable: Banin’s gold clusters were not shown to be MCCs, the Zaban combinations lacked adequate support, and the Lucey ground was withdrawn.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “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)). In Petitioner’s view, an ordinarily skilled artisan would have had “at least a Ph.D. in chemistry, physics, chemical engineering, material science, or equivalent technical degree or equivalent work experience, with knowledge regarding nanoparticles and methods of synthesizing them” and “[a]dditional education might supplement practical experience and vice-versa.” Pet. 22 (citing Ex. 1002 ¶ 76). Patent Owner does not address Petitioner’s view or propose a counter definition. We determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))). To the extent a more specific definition is required, we adopt Petitioner’s definition for purposes of this Decision, because that definition is unopposed and consistent with the disclosures of the asserted prior art references.” slip op. at 9

    • Prior constructionPrior construction adoptedDecided for patent owner

      “Based on our consideration of the record as a whole, we agree with the District Court that the molecular cluster compound of the claimed invention must have “sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula.” Ex. 1091, 18. To the extent that this or any other claim term requires further discussion, we provide it in our analysis of the challenges. No further express claim construction is necessary 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))).” slip op. at 11

    • Expert testimonyPatent owner expert creditedPetitioner expert discountedMixed

      “opinion, with supporting citations to evidence, that Banin describes gold clusters that range in size and, further, why the reference indicates that the suggested formula assigned to those clusters is based on a calculation that relies on the average of a wide distribution of particle sizes reported in the literature by Hutchison. Ex. 2030 ¶¶ 102–125; Ex. 2017, 12891. We assign persuasive weight to her testimony because it is supported by clear disclosures in Hutchison, which Banin explicitly identifies as the source of the procedures by which Banin synthesizes its gold clusters. In particular, Dr. Cossairt’s testimony comports with this discussion in Hutchison: To calculate an average molecular formula for [gold nanoparticle] 1 it is necessary to know the number of gold atoms in the metal core. Given the average particle size (1.5 nm) this number is estimated to be ~101 by the method of Whetten et al. and leads to an estimated formula of Au101(PPh3)21Cl5. Ex. 2017, 12891. In other words, as this disclosure makes plain, Hutchison calculates an average molecular formula for its gold clusters by estimating the number of gold atoms in the metal core based upon the average particle size of 1.5 nm. Id. Indeed, as Dr. Cossairt recognizes, Banin’s suggested molecular formula is exactly the same formula that Hutchison calculates based on the average molecular formula for the variably-sized gold clusters produced according to its process. Ex. 2030 ¶¶ 102–105. Dr. Cossairt provides persuasive reasons why a person of ordinary skill in the art would have understood that Banin’s suggested formula represents an average molecular formula for a disperse mixture of gold clusters that are not identical in size and do not have sufficiently well-defined chemical structure such that all molecules of the cluster compound possess the same relative molecular formula, as required for MCCs. Id. ¶¶ 102–125.” slip op. at 26

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Our rules require a petitioner to explain with particularity, at the outset in the petition, why the patent it challenges is unpatentable. Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). “Unlike district court litigation — where parties have greater freedom to revise and develop their arguments over time and in response to newly discovered material — the expedited nature of” inter partes review proceedings “bring with it an obligation for petitioners to make their case in their petition to institute.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Accordingly, Petitioner carries a burden to “identify with particularity” at the outset, in the Petition, “the grounds on which the challenged to each claim is based, and the evidence that supports the grounds for the challenge to each claim.” 35 U.S.C. § 312(a)(3). Although “the introduction of new evidence in the course of the trial is to be expected in inter partes review trial proceedings,” Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc., 825 F.3d 1360, 1366 (Fed. Cir. 2016), the shifting of arguments is not, Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286 (Fed. Cir. 2017).” slip op. at 30

    Patent outcomesUS 7,867,557 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,867,557
  • PTAB · Jan 18, 2022 · IPR2020-01200 · APJ Susan L C Mitchell · IPR · Final written decision

    Petitioner failed to show claims 1, 2, 6, 7, 10–22, 24, and 27–36 unpatentable because the asserted references did not teach an apparatus capable of identifying a single biomolecule.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We find Petitioner has the better argument. The claims at issue in this inter partes review involve a molecular sensor, its components, or a method of using or manufacturing the sensor. See Ex. 1001, 26:11–37, 27:64–30:6. An in-depth understanding of molecular sequencing would not be required to understand these claims, the ’441 patent, the prior art asserted against these claims, or the problems solved by the claimed apparatus and methods. Therefore, we will continue to apply Petitioner’s definition of one of skill in the art as set forth above. Moreover, even under Patent Owner’s proposal for the level of ordinary skill, we find that Dr. Neikirk is qualified to offer the opinions in his declaration. “There is . . . no requirement of a perfect match between the expert’s experience and the relevant field” and one need “not be a person of ordinary skill in the art in order to testify as an expert under Rule 702” so long as they are “qualified in the pertinent art.” PTAB Consolidated Trial Practice Guide (Nov. 2019) 34 (citing precedent). Here, the record demonstrates that Dr. Neikirk is qualified in the art of molecular sensors. See Ex. 1003 ¶¶ 4–20; Ex. 1004 (describing Dr. Neikirk’s technical background and expert qualifications). Therefore even if one of ordinary skill would have had experience in molecular sequencing, as Patent Owner proposes, it does not follow that all of the testimony in Dr. Neikirk’s declarations should be accorded “little or no weight.”” slip op. at 11

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “We find persuasive Dr. Harris’ analysis of Hassibi’s teachings set forth above describing BRC analysis and its sensitivity capability. Petitioner did not file a rebuttal declaration from Dr. Neikirk addressing Dr. Harris’ testimony here. We credit Dr. Harris’ testimony over Dr. Neikirk’s testimony that, as explained below, does not address the complete disclosure of Hassibi.” slip op. at 35

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

      “Here, we find that the preamble reciting “a single biomolecule” for claim 1 provides antecedent basis for the claim term “the biomolecule” that is affixed to a linker site and recited in the body of claim 1. See Ex. 1001, 26:11–18. Claims must also be read in view of the specification of which they are an integral part. See Phillips, 415 F.3d at 1315. The Specification of the ’441 patent, like the language of the preamble itself, repeatedly refers to the detection apparatus as identifying a “single” biomolecule. See, e.g., Ex. 1001, 1:67–2:6 (stating devices should be capable of sequencing single molecules), 2:16–17 (stating each sequencing reaction uses a single molecule as the template), 3:55–4:16 (stating each optical detection apparatus 20 may be operated independently to detect and identify a single biomolecule, and by integrating a huge number of optical detection apparatuses 20 on substrate 10, a huge number of single biomolecules can be detected and identified in parallel). Accordingly, both the claim language and the Specification support Patent Owner’s position that the preamble is limiting. We find Petitioner’s argument that the preamble is not limiting and that one can “identify” a single molecule from a signal from multiple copies of the same molecule is inapposite when the challenged claims are read in light of the Specification of the ’441 patent. See Reply 2–4. Although such a method for identification of a molecule exists and, as Petitioner identifies, is done by the Illumina sequencing platform, that is not what is described in the Specification of the ’441 patent and the claims at issue here. See Phillips, 415 F.3d at 1317 (“However, while extrinsic evidence ‘can shed useful light on the relevant art,’ we have explained that it is ‘less significant than the intrinsic record in determining “the legally operative meaning of claim language.”’”) (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004)). The Specification of the ’441 patent describes a bioassay system in which a very large number of the apparatuses described and claimed in the ’441 patent, in some embodiments over 10,000, are used in parallel “to determine, for example, the sequence of a genome or the profile of expressed genes in a tissue sample with high throughput.” Ex. 1001, 3:58– 65. In such a bioassay system, the Specification indicates that “[e]ach optical detection apparatus may sense the existence of a fluorophore on the single molecule by detecting photons emitted from the fluorophore.” Id. at 3:60–61 (emphasis added). The Specification of the ’441 patent contemplates running myriad optical detection apparatuses in parallel to detect a single or individual biomolecule in each such apparatus. The fact that other “Sequencing Modalities” are mentioned that may be used with the claimed apparatus of the ’441 patent, and which involve the detection of signal from multiple molecules of the same species, does not undercut this fulsome description of what is disclosed in the ’441 patent. See Reply 6–8.” slip op. at 17

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

      “Accordingly, we determine that the preamble of claim 1 is limiting, requires an apparatus capable of identifying a single biomolecule, and provides antecedent basis for “the biomolecule” as used in the body of the independent claims, which should be read as “the single biomolecule” introduced in the preamble.” slip op. at 21

    Patent outcomesUS 7,767,441 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
    Patents in suitUS 7,767,441
  • PTAB · Sep 20, 2021 · IPR2020-00750 · APJ Elizabeth M Roesel · IPR · Final written decision

    Claims 1, 3, and 4 were not shown unpatentable under either § 103 ground because the Reply introduced an improper new theory and lacked a sufficient rationale and proof for the claimed inclined side surfaces.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Pet. 12–13 (citing Ex. 1001 at 1:24–28; Ex. 1003 ¶¶ 28–33). Dr. Krames applies the foregoing description of a POSITA. Ex. 1057 ¶ 21. Patent Owner and Dr. Doolittle accept Petitioner’s description of a POSITA’s level of skill. PO Resp. 12; Ex. 2008 ¶ 47.8 In our analysis below, we apply Petitioner’s uncontested definition of a POSITA, which is supported by Dr. Shackle’s testimony (Ex. 1003 ¶¶ 32, 33) and is consistent with the scope and content of the ’946 Patent and the asserted prior art.” slip op. at 12

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Neither party proposes any express claim constructions. See Pet. 13–14; see generally PO Resp. We determine that no claim term requires express construction for purposes of resolving the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of inter partes review).” slip op. at 13

    • Strike new argumentNew argument disregardedDecided for patent owner

      “Our rules require that a petition include “[a] full statement of the reasons for the relief requested” and that “[a] reply may only respond to arguments raised in the corresponding . . . patent owner response.” 37 C.F.R. §§ 42.22(a)(2), 42.23(b). The trial practice guide elaborates on these rules, explaining that “Petitioner may not submit new evidence or argument in reply that it could have presented earlier, e.g. to make out a prima facie case of unpatentability.” Consolidated Trial Practice Guide November 2019 (“CTPG”)13 at 73. “While replies . . . can help crystalize issues for decision, a reply . . . that raises a new issue or belatedly presents evidence may not be considered. The Board is not required to attempt to sort proper from improper portions of the reply . . . .” Id. at 74. As one example of impermissible new argument or evidence, the trial practice guide identifies a “newly raised rationale to combine the prior art references that was not expressed in the petition.” Id. Applying the foregoing legal authority, we agree with Patent Owner that Petitioner’s Reply improperly introduces new argument and new evidence. As discussed above, Petitioner changed its obviousness theory from one that relied on combining Hochstein’s or Masatoshi’s LEDs with Krames’ TIP geometry and Rossner’s phosphors, as asserted in the Petition 13 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. Krames’ TIP geometry and Rossner’s phosphors, as asserted in the Reply (Pet. Reply 7). GaN-on-SiC LEDs are not disclosed in Hochstein, Masatoshi, or any of the other references asserted in the Petition. As support for its contention that GaN-on-SiC LEDs were known, Petitioner relies on two new references—the ’499 patent and the Cree article—that were not cited in the Petition or the Shackle Declaration. Petitioner argues that its reply argument and evidence are not new, but were presented to “show[] that Patent Owner’s statements were false and contrary to what was known in the prior art; namely, that you can cut the substrates related to GaN-based LEDs, specifically, silicon carbide substrates, using a beveled blade.” Tr. 34:4–8. We disagree. The Petition relied on Hochstein in view of Krames or Masatoshi as teaching “a light emitting cell array . . . comprising a plurality of light emitting cells connected in series on a substrate,” as recited in claim element 1a. Pet. 36–37, 54–55. In its Response, Patent Owner argued that the LEDs disclosed in Hochstein, Masatoshi, or Krames would not work in Petitioner’s proposed combination with Rossner. PO Resp. 17. In the Reply, Petitioner agreed with Patent Owner, asserting for the first time that GaN-based LEDs, more specifically GaN-on-SiC LEDs, would have been used. Pet. Reply 2, 7. To show that GaN-on-SiC LEDs were in the prior art, Petitioner relied on two new references: the ’499 patent and the Cree article. Exs. 1035, 1058. Rather than explaining how its original petition was correct, Petitioner’s reply argument and evidence “amount to an entirely new theory of prima facie obviousness absent from the petition. Shifting arguments in this fashion is foreclosed by statute, our precedent, and Board guidelines.” Wasica, 853 F.3d at 1286. determination that Petitioner failed to prove that claims 1, 3, and 4 of the ’946 Patent are unpatentable. Petitioner abandoned its original theory of obviousness and presented a new theory of obviousness based on new evidence in the Reply. Under our rules, this is procedurally improper and leaves us with no properly presented ground of unpatentability on which we could hold for Petitioner. 37 C.F.R. § 42.23(b); CTPG 73–74.” slip op. at 28

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “4. Obviousness Rationale As presented in the Reply, Petitioner’s new obviousness theory requires a combination of Hochstein’s driving circuit, Rossner’s storage phosphors, Krames’ TIP geometry, and GaN-on-SiC LEDs, as disclosed in the ’499 patent or the Cree article. See Pet. Reply 7 (arguing that Krames’ TIP geometry could have been implemented in GaN-on-SiC LEDs). Alternatively, Petitioner’s new obviousness theory requires a combination of Masatoshi’s circuit, Rossner’s storage phosphors, Krames’ TIP geometry, and GaN-on-SiC LEDs, as disclosed in the ’499 patent or the Cree article. Id. Petitioner does not, however, present a sufficient evidence-supported rationale for combining GaN-on-SiC LEDs with either Hochstein’s driving circuit or Masatoshi’s circuit. No such rationale is presented in the Petition or the Shackle Declaration, which do not mention GaN-on-SiC LEDs. Although Petitioner’s Reply and the Krames Declaration discuss GaN-on- SiC LEDs, neither document explains why a POSITA would have had reason to combine them with Hochstein’s driving circuit or Masatoshi’s circuit. In fact, the Krames Declaration makes no mention of either has not provided sufficient evidence or reasoning to support its new obviousness theory based on GaN-on-SiC LEDs.” slip op. at 30

    Patent outcomesUS 8,716,946 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 8,716,946
  • PTAB · May 27, 2020 · IPR2019-00189 · APJ Wesley B Derrick · IPR · Final written decision

    Claims 1, 9, and 11 were not shown unpatentable under either § 103 ground because the petitioner did not establish that the combinations taught or suggested transmission to an end user.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Absent opposition from Patent Owner, we adopt Petitioner’s description of the level of ordinary skill in the art because it is consistent with the level of skill reflected in the Specification and the asserted prior art references. In that regard, and supporting our determination of the level of ordinary skill in the art, we determine that the prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that “specific findings on the level of skill in the art . . . [are not required] ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 9

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner

      “The cited portions of the Specification are generally consistent with Petitioner’s position. See Phillips, 415 F.3d at 1315 (“[T]he specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’”). For example, the ’000 patent states that “[t]he central computing facility receives communications from all of the remote apparatuses monitoring a facility, facilities, line, or lines under measurement,” which is consistent with a “central computing site” or “central facility” being a single location. Ex. 1002, 3:35–36. The prosecution history includes limited discussion of the concept of a central station. Ex. 1010, 120–121, 134, 146, 163, 169–170. For example, the Examiner determines that a “ground station [disclosed in cited prior art] includes provisions for conversion of data to the form and parameters required by the central station” (id. at 120–121, 146, 163) and applicant contests the Examiner’s position (id. at 134, 169–170), but the limited discussion is not particularly directed to the meaning of “central station” as being a single location. For purposes of this Decision, we maintain our construction from the Institution Decision—construing the terms “central computing site” and “central facility” to mean a “single physical location distinct from monitors”—as this construction is consistent with the ordinary meaning of these terms, the portions of the written description of the ’000 patent cited by Petitioner, and the prosecution history of the ’000 patent.” slip op. at 11

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable

      “In sum, the deficiencies outlined above undercut Petitioner’s position that the combined prior art teaches or suggests the inventions of the challenged claims. The conclusory statements by Petitioner and Dr. Olsen as to the recited end user, as discussed above, fail to address how the relied upon element in Fernandes, i.e., the SCADA receiver, meets the recited limitation of transmitting to an “end user,” and are thus insufficient to satisfy Petitioner’s burden of proving obviousness.7 Magnum Oil Tools, 829 F.3d at 1380–81. Accordingly, we determine that Petitioner has not carried its burden to present sufficient evidence and support that the combination of Libove, Blatt, and Fernandes teaches or suggest limitations 1[G], 9[G], and 11[G].” slip op. at 23

    Patent outcomesUS 6,714,000 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 6,714,000
  • PTAB · Aug 10, 2018 · IPR2017-00748 · APJ Jacqueline T Harlow · IPR · Final written decision

    Claims 1–19 were not shown unpatentable under § 103 because the petitioner did not establish that the cited combinations disclosed or suggested the claimed ether phospholipid range.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not address the level of ordinary skill in its Response; however, Patent Owner’s declarant, Dr. Hoem opines that the definition proposed by Petitioner “is consistent with the literature, credentials of individuals working on lipid extractions, and the skill necessary to perform these extractions and interpret their results” Ex. 2001 ¶ 15. Based on that assessment, Dr. Hoem adopts the definition of the level of ordinary skill in the art advanced by Petitioner. Id. We agree with Petitioner, Dr. Tallon, and Dr. Hoem, and find that Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’877 patent is consistent with the type of problems encountered in the art, prior art solutions to those problems, rapidity with which innovations are made, sophistication of the technology, and educational level of active workers in the field. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). 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).” slip op. at 10

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “unexpired patent according to the broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable construction standard to inter partes review proceedings). Under that standard, and absent any special definitions, we 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, in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Although both Petitioner (Pet. 19‒29) and Patent Owner (PO Resp. 11‒14) offer several claim constructions, we determine that no explicit construction of any claim term is necessary for purposes of this Decision. In reaching this conclusion, we observe that the parties’ proposed constructions are largely coextensive with each other, and to the extent those constructions differ, they do so in ways that do not impact our analysis. For example, our 11 analysis below remains the same irrespective of whether we apply Petitioner’s construction of “krill oil” as meaning “lipids extracted from krill” (Pet. 21) or Patent Owner’s interpretation, “oil produced from krill” (PO Resp. 11). Similarly, our analysis is unaffected by whether we apply Petitioner’s definition of “to denature lipases and phospholipases,” i.e., “to alter the conformational structure of lipases and phospholipases to reduce lipid and phospholipid decomposition” (Pet. 24), or Patent Owner’s construction, “to treat the lipases and phospholipases to rupture hydrogen bonds thereby changing the molecular structure of the lipases and phospholipases” (PO Resp. 12–13).3” slip op. at 11

    • BurdenNot shown unpatentable

      “We agree with Patent Owner that Petitioner has not carried its burden to establish by a preponderance of the evidence that the combination of Grantham, Fricke 1984, and Tanaka I teaches or suggests a krill oil “with from about 3% to about 10% w/w ether phospholipids” (Ex. 1001, 34:64–65, 36:2–3), as required by the challenged claims. Petitioner does not rely on a direct measurement of the ether phospholipids present in krill oil to satisfy this claim element. Instead, as explained above, Petitioner’s declarant, Dr. Tallon estimates the amount of ether phospholipids present in the krill extract of Fricke 1984 based on Tanaka I’s disclosure that 23% of the total phosphatidylcholine extracted from krill is AAPC, and Fricke 1984’s disclosure that phosphatidylcholine comprises approximately 34% w/w of krill oil extract. Ex. 1006 ¶ 102. But Petitioner does not adequately explain why an ordinarily skilled artisan would have turned to Tanaka I to discern the ether phospholipid content of Fricke 1984, when Tanaka I did not use the then-preferred method for ether phospholipid analysis, and when more accurate measurements of krill oil ether phospholipid content were known in the art.” slip op. at 29

    • Expert testimonyPetitioner expert discountedDecided for patent owner

      “Ex. 1086 ¶¶ 72–73)), and the fact that NMR measurements of krill oil ether phospholipid content were known in the art (id. at 7 (citing Ex. 1009, 14; Ex. 1006 ¶ 94)), however, we are not persuaded that an ordinarily skilled artisan would have looked to Tanaka I to determine the phospholipid content of Fricke 1984 (Reply 9 (citing Ex. 1006 ¶¶ 134–136)). Tanaka I measures the percentages of the PC subclasses present in krill oil using a process of “successive degradations of PC with mild alkali and acid.” Ex. 1014, 2. Petitioner fails to adequately explain why an ordinarily skilled artisan would have turned to Tanaka I, which, like Fricke 1986, discloses a degradation process for measuring ether phospholipid levels, when more reliable NMR analyses were available. Even if, as Petitioner contends, the method of Tanaka I is more accurate than that of Fricke 1986 because it involves fewer degradation steps (Reply 9), Petitioner has not sufficiently established the reliability of Tanaka I’s degradation analysis for purposes of this Decision. 31 In particular, Petitioner does not adequately explain how the results obtained by Tanaka I compare to results acquired using other methods, such as 31P NMR, or why an ordinarily skilled artisan would have relied on Tanaka I when NMR analyses of krill oil ether phospholipid levels were available. The absence of evidence sufficient to establish the reliability of Tanaka I is of particular importance where, as here, Petitioner and its declarant, Dr. Tallon, go to great lengths both to tout the superiority of a quantification technique different from that used by Tanaka I––NMR (Reply 7–9; Ex. 1086 ¶¶ 71–74)––as well as to disparage the accuracy of other degradation-based analyses––namely, that used by Fricke 1986 (Reply 5–7; Ex. 1086 ¶¶ 67, 69).” slip op. at 31

    Patent outcomesUS 9,028,877 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,028,877
  • PTAB · Aug 10, 2018 · IPR2017-00747 · APJ Jacqueline T Harlow · IPR · Final written decision

    Claims 1–20 were not shown unpatentable under § 103 because the evidence did not establish that the cited combinations taught the claimed ether phospholipid ranges.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “We agree with Petitioner, Dr. Tallon, and Dr. Hoem, and find that Petitioner’s description of the level of ordinary skill in the art at the time of invention of the ’905 patent is consistent with the type of problems encountered in the art, prior art solutions to those problems, rapidity with which innovations are made, sophistication of the technology, and educational level of active workers in the field. See In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). 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).” slip op. at 9

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Although both Petitioner (Pet. 18‒25) and Patent Owner (PO Resp. 11‒12) offer several claim constructions, we determine that no explicit construction of any claim term is necessary for purposes of this Decision. In reaching this conclusion, we observe that the parties’ proposed constructions are largely coextensive with each other, and to the extent those constructions differ, they do so in ways that do not impact our analysis. For example, our 10 analysis below remains the same irrespective of whether we apply Petitioner’s construction of “krill oil” as meaning “lipids extracted from krill” (Pet. 20) or Patent Owner’s interpretation, “oil produced from krill” (PO Resp. 11). Similarly, our analysis is unaffected by whether we apply Petitioner’s definition of “effective amount of krill oil,” i.e., “at least the range of between 0.2 grams to 10 grams of krill oil” (Pet. 21), or Patent Owner’s construction, “0.2 grams to 10 grams of krill oil” (PO Resp. 12).3” slip op. at 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable

      “Ex. 1086 ¶¶ 72–73)), and the fact that NMR measurements of krill oil ether phospholipid content were known in the art (id. at 6 (citing Ex. 1009, 14; Ex. 1006 ¶ 90)), however, we are not persuaded that an ordinarily skilled artisan would have looked to Tanaka to determine the phospholipid content of Fricke 1984 (Reply 8 (citing Ex. 1006 ¶¶ 130–131)). Tanaka measures the percentages of the PC subclasses present in krill oil using a process of “successive degradations of PC with mild alkali and acid.” Ex. 1014, 2. Petitioner fails to adequately explain why an ordinarily skilled artisan would have turned to Tanaka, which, like Fricke 1986, discloses a degradation process for measuring ether phospholipid levels, when more reliable NMR analyses were available. Even if, as Petitioner contends, the method of Tanaka is more accurate than that of Fricke 1986 because it involves fewer degradation steps (Reply 8), Petitioner has not sufficiently established the reliability of Tanaka’s degradation analysis for purposes of this Decision. In particular, Petitioner does not adequately explain how the results obtained by Tanaka compare to results acquired using other methods, such as 31P NMR, 27 or why an ordinarily skilled artisan would have relied on Tanaka when NMR analyses of krill oil ether phospholipid levels were available. The absence of evidence sufficient to establish the reliability of Tanaka is of particular importance where, as here, Petitioner and its declarant, Dr. Tallon, go to great lengths both to tout the superiority of a quantification technique different from that used by Tanaka––NMR (Reply 6–8; Ex. 1086 ¶¶ 71–74)– –as well as to disparage the accuracy of other degradation-based analyses–– namely, that used by Fricke 1986 (Reply 4–6; Ex. 1086 ¶¶ 67, 69). Accordingly, having reviewed Petitioner’s evidence and arguments, we determine that Petitioner has failed to demonstrate by a preponderance of the evidence that independent claims 1, 12, and 18 are rendered obvious by the combination of Sampalis, Tanaka, and Fricke 1984. We have also reviewed Petitioner’s evidence and arguments as to dependent claims 2–4, 6, 9, 10, 15, and 16, and determine, for the reasons set forth with respect to the independent claims, that Petitioner has failed to demonstrate by a preponderance of the evidence that those claims are rendered obvious by the combination of Sampalis, Tanaka, and Fricke 1984. Thus, Petitioner has failed to demonstrate by a preponderance of the evidence that claims 1–4, 6, 9, 10, 12, 15, 16, and 18 are rendered obvious by the combination of Sampalis, Tanaka, and Fricke 1984.” slip op. at 27

    • Expert testimonyPetitioner expert creditedOther

      “We find Petitioner’s arguments concerning the superior accuracy and reliability of 31P NMR relative to other ether phospholipid quantification techniques persuasive. We likewise credit Petitioner’s assertions that an ordinarily skilled artisan would have had “compelling reason” to use NMR to measure krill oil ether phospholipid content. Indeed, Dr. Hoem, Patent 26 Owner’s declarant, also recognizes NMR as the preferred method for analyzing the components of krill oil. Ex. 1079, 1, 3‒4, 11; Ex. 1090, 97:23–98:5; Ex. 1086 ¶¶ 72‒74). Moreover, as set forth in the accompanying Final Written Decision in IPR2017–00745, we determine that claims 1–20 of the ’905 patent would have been obvious over combinations that rely on Catchpole, which discloses the use of 31P NMR to quantify krill oil ether phospholipids as disclosing a krill oil extract that meets the required ether phospholipid ranges.” slip op. at 26

    Patent outcomesUS 9,078,905 not shown unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,078,905
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