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  • PTAB · Nov 1, 2024 · PGR2024-00025 · APJ Jeffrey W Abraham · PGR · Institution

    The Board denied institution because Petitioner did not show that claims 1–20 were more likely than not unpatentable over either obviousness ground, for lack of utility, or as indefinite.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’033 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–22, 44–45). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’033 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level”” slip op. at 6

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

      “Petitioner does not offer a specific construction for any claim terms. Pet. 19–20. Rather, Petitioner contends that “the outer boundary of the Challenged Claims lacks reasonable certainty,” and, therefore, “the Challenged Claims are unpatentable as indefinite under §112(b).” Pet. 20. Petitioner further contends that the challenged claims are unpatentable as obvious “regardless of the outer boundary of the claims.” Pet. 21. Patent Owner disagrees with Petitioner’s arguments regarding indefiniteness, and does not construe any claim terms. See generally Prelim. Resp. As explained in detail below, based on the record before us, we are not persuaded by Petitioner’s indefiniteness arguments, and determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary” slip op. at 7

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

      “Patent Owner is correct that Petitioner focuses its obviousness challenge on 1PNZQ23’s phenotype, and does not address its genotype. Prelim. Resp. 41–42; see Pet. 26–32 (comparing 1PNZQ23’s phenotype with the phenotypes of the asserted prior art). Petitioner does not direct us to, nor do we discern, any information in the Petition or Reply regarding 1PNZQ23’s genotype that supports Petitioner’s arguments regarding obviousness. Furthermore, Patent Owner offers information suggesting that “the breeding of 1PNZQ23 was unpredictable even with both parents being known in the art.” Prelim. Resp. 47. Dr. Schnable addresses unpredictability in the breeding process, stating: distinct even when the F1 plant itself results from a cross of two inbreds. A [person of ordinary skill in the art] would not expect that a cross of the same parents will produce F2 or D1 progeny identical to 1PNZQ23. . . . [T]he genome of a progeny plant is the result of genetic segregation and recombination in the F1 plant of the two parental genomes and the chance of the exact same child resulting from that initial biparental cross is infinitesimally small. Ex. 2004 ¶ 123. This information undermines Petitioner’s arguments regarding an expectation of success in achieving the claimed invention.” slip op. at 13

    Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips
    Patents in suitUS 11,707,033
  • PTAB · Oct 15, 2024 · PGR2024-00023 · APJ Jeffrey W Abraham · PGR · Institution

    The Board denied institution on claims 1–20 because the petition did not show they were unpatentable on any asserted obviousness, utility, written-description, or enablement ground.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’545 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist as along with genetics specialists) and field-side personnel.” Pet. 16 (citing Ex. 1003 ¶¶ 50–51). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 16. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 24. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’545 patent, and we adopt it for purposes” slip op. at 6

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

      “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.200(b) (2019). Under that standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 21. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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 7

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

      “additional reasons. For example, we agree with Patent Owner that Petitioner fails to demonstrate sufficiently that a person of ordinary skill in the art would have had a reasonable expectation of success in arriving at PH4CYJ based on Smalley’s disclosure alone. Prelim. Resp. 51–52. According to the ’545 patent specification, the claimed PH4CYJ inbred maize variety is a cross between inbred line PH1VNA and inbred line PH1KTF. Ex. 1001, 37:62–64. In the simplest terms, PH1VNA and PH1KTF are the parents, and their cross ultimately resulted in the inbred variety PH4CYJ. The ’545 patent explains that after the initial crossing of the parental lines, the” slip op. at 14

    Claim construction§ 101 eligibility§ 103 obviousness§ 112 disclosurecites Phillips
    Patents in suitUS 11,696,545
  • PTAB · Sep 24, 2024 · PGR2024-00019 · APJ Ulrike W Jenks · PGR · Institution

    The Board denied institution of PGR on claims 1–20 because the Petition did not show they were more likely than not unpatentable on any asserted ground.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner failed to demonstrate that it is more likely than not that claims 1–20 of the ’803 patent are unpatentable. Accordingly, we deny institution of a post-grant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art” and “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 24. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’803 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7

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

      “Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 20. Patent Owner also does not construe and based on the record before us, we determine that none of the claim terms requires an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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 7

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

      “their cross ultimately resulted in the inbred variety 1PFLQ21. The ’803 patent explains that after the initial crossing of the parental lines, the selection of the progeny was based on genetic analysis predicting disease, insect, and agronomic phenotypic performance. Id. 37:64–66. “Inbred 1PFLQ21 was developed by producing a doubled haploid from the F1 plants, selfing and using pedigree selection amongst the D1 lines, and selfing and bulking from the subsequent generations.” Id. 37:66–38:3. The ’803 patent specification, therefore, makes it clear that simply crossing both parental inbred maize lines is not reasonably expected to result in the claimed inbred maize variety; rather, it explains that more plant breeding work is required to arrive at the 1PFLQ21 inbred maize line than just having both parental inbred maize lines available.” slip op. at 15

    Claim construction§ 101 eligibility§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 11,659,803
  • PTAB · Sep 24, 2024 · PGR2024-00020 · APJ Jeffrey W Abraham · PGR · Institution

    Denied institution of PGR on claims 1–20 because Petitioner did not show a reasonable likelihood equivalent under § 324 that any challenged claim was unpatentable.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “Institution of a post-grant review is authorized by statute when “the information presented in the petition filed under [35 U.S.C. §] 321 . . . demonstrates that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons set forth below, we determine that Petitioner has failed to demonstrate that it is more likely than not that at least one of claims 1–20 of the ’020 patent is unpatentable. Accordingly, we deny institution of a postgrant review of claims 1–20 based on the grounds set forth in the Petition.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “Petitioner asserts that a person of ordinary skill in the art “had a high level of skill, with a doctoral degree in plant breeding or a related field, at least five years of experience with corn breeding, and additional experience interfacing with laboratory-side personnel (including a computational biologist . . . along with genetics specialists) and field-side personnel.” Pet. 15 (citing Ex. 1003 ¶¶ 19–21). Petitioner also states that, “[a]lternatively, additional experience could take the place of an advanced degree.” Pet. 15. Patent Owner states that it “does not dispute Petitioner’s definition of the qualifications of person of skill in the art,” but “reserves its right to challenge Petitioner’s definition and to provide its own definition, should trial be instituted.” Prelim. Resp. 25. Petitioner’s unopposed proposed definition is consistent with the cited prior art and the disclosure of the ’020 patent, and we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself may “reflect[] an appropriate level” of ordinary skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 6

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

      “Petitioner contends that “[b]ecause Petitioner’s grounds plainly render the claims unpatentable under any plausible construction, no outer boundary constructions are necessary.” Pet. 22. Patent Owner also does not construe any claim terms. See generally Prelim. Resp. For purposes of this Decision, and based on the record before us, we determine that none of the claim terms require an explicit construction to determine whether to institute post-grant review. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only 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 7

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

      “Based on these disclosures in Smalley, we agree with Petitioner that a person of ordinary skill in the art would have understood that the parental line PH1D84 could have been used as a starting point to arrive at other inbred lines. See Pet. 41. Petitioner, however, fails to demonstrate sufficiently how or why a person of ordinary skill in the art would have had a reasonable expectation of success in developing 1PFHC43 specifically, when its other parent was not known in the art at the relevant time. As Dr. Schnable explains, 1PFHC43’s genome is derived from its parents. Ex. 2004 ¶ 115. Petitioner does not address how a person of ordinary skill in the art would have been able to produce the claimed seed, including its unique genotype, without having access to PH1VNA or its genomic and phenotypic information.” slip op. at 15

    Claim construction§ 101 eligibility§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 11,666,020
  • PTAB · Apr 18, 2024 · IPR2024-00070 · APJ Zhenyu Yang · IPR · Institution

    The Board denied institution because the Petition did not show a reasonable likelihood that claims 1–15 were anticipated by Radianingtyas or obvious over either asserted combination.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2

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

      “claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under this standard, we construe the claim term “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id.; see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (holding that the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application”). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term.” slip op. at 6

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner does not provide a definition of the level of ordinary skill in the art. See Prelim. Resp. 19. Patent Owner also states that any differences between the parties’ proposed definition of the skill level would not impact its arguments. Id. For purposes of this Decision, we adopt Petitioner’s definition of the skill level because it is consistent with the prior art’s demonstration of the level of ordinary skill at the relevant time. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 7

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

      “triglyceride, DHA, and heptadecanoic acid content recited therein. In order to anticipate a claim, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements arranged as in the claim.” NetMoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (quotation marks omitted). A reference, however, can anticipate a claim “even if it does not expressly spell out all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would at once envisage the claimed arrangement or combination.” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1068 (Fed. Cir. 2017) (quotation marks and brackets omitted). As explained below, here, Petitioner has not shown Radianingtyas discloses a microbial oil comprising the required triglyceride, DHA and heptadecanoic acid content. Specifically, although the exemplified strain ONC-T18 produces oil that meets the claimed triglyceride fraction and heptadecanoic acid level, Petitioner has not shown the same oil contains the recited DHA level.” slip op. at 10

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 8,207,363
  • PTAB · Feb 23, 2024 · IPR2023-01342 · APJ Jon B Tornquist · IPR · Institution

    The Board denied institution because the petition did not show a reasonable likelihood that any challenged claim was anticipated or obvious over the asserted references.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). Having considered the arguments and evidence presented by Petitioner and Patent Owner, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims of the ’959 patent. Accordingly, we deny institution of an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that, as of the earliest claimed priority date of the ’959 patent, an ordinarily skilled artisan “would have had a Master of Science degree in an academic discipline emphasizing chemistry, chemical engineering, or biochemistry, in combination with training or at least two to three years of related work experience with lipid chemistry technologies, including but not limited to lipid extraction technologies.” Pet. 6 (citing Ex. 1003 ¶¶ 63–64). Alternatively, Petitioner proposes that an ordinarily skilled artisan “could have also had a Doctorate degree in a relevant academic discipline with one to two years of related work experience in the same discipline.” Id. Petitioner argues that an ordinarily skilled artisan “would have been familiar with microbial oils” and “would have understood the benefits of polyunsaturated fats (PUFAs), microbial sources for obtaining them, and methods for culturing and extracting oils from those microbial sources.” Id. (citing Ex. 1003 ¶¶ 36–48, 64). Patent Owner does not provide a definition of the level of ordinary skill in the art, but “reserves its right to proffer what it contends to be the appropriate level of ordinary skill in the art should the Board institute review.” Prelim. Resp. 15. Patent Owner asserts, however, that a person of ordinary skill in the art would have a detailed understanding of the information provided in its Technology Background section, including “the expected impact of cellular biomass growth characteristics on the proportion of triglycerides and phospholipids produced during a microbial fermentation.” Id. For purposes of this Decision, we adopt Petitioner’s definition of the skill level of an ordinarily skilled artisan as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that the prior art itself can reflect the appropriate level of ordinary skill in the art). As to the background knowledge possessed by the ordinarily skilled artisan, we agree that such an artisan would have been aware of methods for culturing and extracting oils from microbial sources, including the impact of growth characteristics on the proportions of triglycerides and phospholipids produced during microbial fermentation. Pet. 6; Prelim. Resp. 15.” slip op. at 7

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

      “Petitioner contends that all claim terms of the ’959 patent “should be given their plain and ordinary meaning.” Pet. 3. Patent Owner does not contend that any claim terms require construction. Prelim. Resp. 14–15. For purposes of this Decision, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 8

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

      “3. Analysis In order to anticipate a claim, a prior art reference “must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” NetMoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Radianingtyas discloses microbial oils with various levels of DHA and arachidonic acid. There is no disclosure of an individual microbial oil, however, that contains at least 45% DHA and 1.5% or less arachidonic acid by weight as required by claim 1. With respect to the level of DHA, although Radianingtyas might be interpreted to disclose that some microorganisms can produce up to 60% DHA,8 Radianingtyas discloses that the DHA content of ONC-T18 is “typical[ly]” 35% of the total intracellular fatty acids, and in each experiment disclosed in Radianingtyas DHA was produced by ONC-T18 at 8 Radianingtyas discloses that “the oil producing microbe can produce a lipid composition comprising from about 25% to about 40% of an omega-3 fatty acid, such as n-3 DHA.” Ex. 1007, 26:31–33. It then gives examples that include 15%, 20%, 45%, 50%, 55%, and 60%, which are outside of the disclosed range. Id. at 26:33–34. Dr. Curtis contends the disclosure as a whole should be read as “from about 15% to about 60% of an omega-3 fatty acid, such as n-3 DHA.” Ex. 1003, 39 n.1. Dr. Curtis identifies no microbe in Radianingtyas, however, that is shown to produce more than 40% DHA, and Radianingtyas expressly notes that the typical DHA content produced by ONC-T18 is 35%. Thus, we question Dr. Curtis’ conclusions regarding the DHA content disclosure of Radianingtyas. levels less than “at least 45%.”9 Ex. 1007, 32:21–25 (noting that the “typical composition of fatty acids” produced by ONC-T18 includes 25% DHA), 34:4–37:14 (noting that the control microorganism produced 13.54%, 19.98%, 18.77%, 18.77%, 21.48%, 28.48%, and 14.13% DHA) (Figure 12), 91 (Table 5) (noting that total DHA produced by ONC-T18 was from 24- 34.2%), 99:22–24 (“Of particular interest is ONC-T18 which produces up to 90% of its C20 to C22 content as DHA which is approximately 35% of the total intracellular fatty acids.”). Thus, we are not persuaded that Radianingtyas discloses microbial oils produced by ONC-T18 that have a DHA content of “at least 45%.” As noted by Petitioner, Radianingtyas provides a definition of “purify” and “purifying,” and notes that when these terms are used, it means that a composition could be, for example, 90% pure. Pet. 11; Ex. 1007, 7:26–8:2. As an example of how the term “purified” may be used, Radianingtyas states “[f]or example, if a disclosed eukaryotic microorganism, for example, produces 35% DHA, this could be further ‘purified’ such that the final lipid composition was greater than 90% DHA.” Id. at 8:2–4. We are directed to no actual microbial oil in Radianingtyas, however, that was purified to have increased levels of DHA. Rather, Petitioner only proffers what Radianingtyas might say if such an oil existed or had been purified to increase levels of DHA.10” slip op. at 12

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,757,959
  • PTAB · Jul 28, 2023 · IPR2023-00503 · APJ Cynthia M Hardman · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that any of claims 1–14 would have been obvious under the asserted grounds.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied

      “review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments and cited evidence, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we do not institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedOther

      “understanding of a person of ordinary skill in the art (sometimes referred to herein as a “POSITA”) as of November 16, 2018. See supra n.1. Petitioner contends that [a] POSITA with respect to the ’962 Patent would have had a Ph.D. in a relevant field of organic chemistry or biochemistry, with several years of research experience gained during those studies or afterwards in organic synthesis, including chiral synthesis, and the use of enzymes in reactions. Winkler ¶ 51. A POSITA could also include a person with a lesser academic degree, but with several years’ experience sufficient to develop equivalent experience in synthetic organic chemistry, such as in pharmaceutical applications or in the chiral synthesis of compounds with biological activity. Pet. 13 (citing Ex. 1002 (Winkler Decl.) ¶¶ 51–52). Patent Owner does not dispute Petitioner’s proposal. Prelim. Resp. 5–6. Because Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision.” slip op. at 7

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

      “Having reviewed the arguments and evidence of record (including the claim construction order in the Texas Case), we determine that no construction of any claim term is needed to decide whether to institute this Petition. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only 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 8

    • Expert testimonyPetitioner expert discountedOther

      “Petitioner’s only support for its assertion that a person of ordinary skill in the art would have modified Divi’s process to “avoid[] a resolution step” is a citation to an identical, conclusory statement by Dr. Winkler. See Pet. 14, 21; Ex. 1002 (Winkler Decl.) ¶¶ 94, 119–20. We agree with Patent Owner that Dr. Winkler’s testimony is entitled to little or no weight, because it does not disclose the underlying facts or data on which the opinion is based. See 37 C.F.R. § 42.65(a); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”). Obviousness arguments “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). On this record, Petitioner and Dr. Winkler fail to adequately explain why a person of ordinary skill in the art would have wanted to modify Divi’s process to “avoid[] a resolution step,” or why converting Divi’s process to an enantioselective synthesis would have “improve[d] the reaction,” particularly in view of Divi’s teaching that “enantioselective synthesis is too expensive on an industrial scale.” Ex. 1003 (Divi), 2:8–11; see also id. at 1:64–2:4 (discussing expense of chiral intermediates and catalysts and their lack of suitability for industrial production).” slip op. at 19

    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,913,962
  • PTAB · Jan 13, 2023 · IPR2022-01159 · APJ Zhenyu Yang · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 6, 7, and 9–26 were obvious over Kinde and Craig.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “In sum, Petitioner has not met its burden to sufficiently explain the reason to combine the teachings of Kinde and Craig. Thus, Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing that claim 1, as well as claims 6, 7, and 9–26, which depend from claim 1, would have been obvious over the combination of Kinde and Craig.” slip op. at 14

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

      “adapter-DNA molecules.” Id. at 19. But, the Y-shaped adapters in Kinde are different from those in Craig: the former do not contain barcodes, whereas the latter do. Compare Ex. 1006, S9 (showing the adapters used in the endogenous method do not contain barcodes), with Ex. 1007, Supplementary Table 3 (showing adapters with barcodes). To the extent Petitioner argues that an ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig’s, that is insufficient for our analysis. See Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”). To answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe-SeqS approach, Petitioner contends that “Kinde cites Craig in discussing exogenous barcodes with DNA molecules.” Pet. 19; see also id. at 22–23 (“[C]iting to Craig, Kinde discusses methods including assigning exogenous barcodes to nucleic acid fragments.”). But, as Patent Owner points out, Kinde does not use Craig’s approach. Prelim. Resp. 1. Instead, immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Ex. 1006, 9531. Thus, Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs.” slip op. at 11

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

      “The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 15; 2 Kinde et al., Detection and quantification of rare mutations with massively parallel sequencing, 108 PNAS 9530–35 (2011) (Ex. 1006, “Kinde”). Petitioner also submits, as part of Exhibit 1006, Supporting Information for Kinde. See Ex. 1006, S1–S10. 3 Craig et al., Identification of genetic variants using bar-coded multiplexed sequencing, 5 NATURE METHODS 887–93 (2008) (Ex. 1007, “Craig”). Petitioner also submits, as part of Exhibit 1007, supplementary figures and text associated with Craig. See Ex. 1007, 10–19. Prelim. Resp. 7. The parties nevertheless seek to provide context, or reiterate the plain meaning, of certain claim terms. Pet. 15–17; Prelim. Resp. 7–8. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term.” slip op. at 6

    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 10,752,951
  • PTAB · Nov 17, 2022 · IPR2022-00935 · APJ John G New · IPR · Institution

    The Board denied institution on all grounds because the petition did not show a reasonable likelihood that claims 1–23 were unpatentable over the asserted obviousness combinations.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition and Preliminary Response, and the evidence of record, we determine that the evidence presented does not demonstrate a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of the challenged claims of the ’631 patent.” slip op. at 2

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

      “Neither Petitioner nor Patent Owner proposes a construction for any claim terms apart from their plain and customary meaning. Pet. 17–18; Prelim. Resp. 5. Nor do we perceive, at this stage of the proceeding, a need to construe any claim term of the ’631 patent for purposes of determining whether to institute trial. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need to 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 an inter partes review).” slip op. at 13

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “filing would typically have had an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field. Pet. 15 (citing Ex. 1002, ¶¶ 53–54). Alternatively, Petitioner proposes, a skilled artisan could have less education but significant professional experience in one or more of these fields. Id. Patent Owner does not contest Petitioner’s proposed definition of a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding and for purposes of our analysis in this Decision, we therefore adopt Petitioner’s proposed definition. We find that this definition is consistent with the level of skill in the art as reflected by the prior art. See, e.g., Exs. 1003, 1006, 1007, 1010, 1021; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting” slip op. at 13

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

      “ordinarily skilled artisan could have swapped Kinde’s Y-shaped adapters with Craig was insufficient for our analysis. IPR2022-00816, Paper 16 at 14 (citing Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015) (holding that “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention”)). In the ’816 IPR, we further observed that, to answer the question why the artisan would have used Craig’s adapters with barcodes in Kinde’s Safe- SeqS approach, Petitioner contends that “Kinde identifies Craig in expressly discussing exogenous barcodes with DNA molecules.” IPR2022-00816, Paper 16 at 14 (citing Paper 3 at 22, 30). Again, Petitioner repeats the same argument in the present Petition. See Pet. 44; see also Ex. 1002 ¶ 42. But, as we observed in the ’816 proceeding, Kinde does not use Craig’s approach. IPR2022-00816, Paper 16 at 14. Instead, we found that immediately after citing Craig as teaching attaching exogenous UIDs through ligation, Kinde introduces its endogenous method as an “[e]ven more simpl[e]” approach. Id. (quoting Ex. 1006, 9531). We therefore found that Kinde appears to teach Craig as an alternative, not an additional, method to assign UIDs. Id. The same reasoning applies equally here.” slip op. at 33

    Claim construction§ 103 obviousnesscites Phillips
    Patents in suitUS 10,287,631
  • PTAB · Mar 21, 2022 · IPR2021-01279 · APJ Barbara A Parvis · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–13 obvious over any asserted ground.

    RulingsInstitution decision
    • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

      “The standard for institution is set forth in 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless the information presented in the Petition and the Preliminary Response shows that “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314 (2019); see also 37 C.F.R § 42.4(a) (“The Board institutes the trial on behalf of the Director.”). Upon consideration of the parties’ contentions and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing in demonstrating the unpatentability of any challenged claim of the ’895 patent. Accordingly, we do not grant Petitioner’s request and do not institute an inter partes review.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “B. Level of Ordinary Skill in the Art Petitioner asserts the following: On or before 5/10/2016, a [person of ordinary skill in the art] POSITA would have had a bachelor’s degree in biomedical engineering, electrical engineering, physics, or [a] related field, and two or more years of professional experience working with the design, development, and/or use of devices that apply electromagnetic energy to stimulate biological tissue. Additional graduate education could substitute for professional experience, or significant experience in the field could substitute for formal education. Pet. 9–10 (citing Ex. 1002 ¶¶ 1–36). Patent Owner does not provide a response on this issue. See generally Prelim. Resp. We find Petitioner’s proposal that the skilled artisan would have had “two or more” years of experience to be too vague as it encompasses skill levels beyond the proposal level without a defined limit. We adopt Petitioner’s proposal except we do not adopt the “or more” terminology above. We determine that with our changes Petitioner’s proposal is consistent with the level of skill reflected in the ’895 patent Specification” slip op. at 10

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

      “C. Claim Construction We construe the challenged claims by applying the standard used in federal courts, in other words, “the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b),” which is articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2020). Neither party seeks claim construction other than the plain and ordinary meaning of claim terms. See Pet. 10; see generally Prelim. Resp. Petitioner states “[p]ursuant to §42.104(b)(3), regarding the term ‘control unit,’ the Board has denied institution on Allergan’s PGRs of related patents (sharing substantially the same specification) determining that the term is not indefinite and does not invoke §112(f).” Pet. 10 (citing Allergan, Inc. et al v. BTL Healthcare Technologies A.S., PGR2021-00017, Paper 16 (PTAB, Filed Dec. 14, 2020) (“Allergan-17,” Paper 16); Allergan, Inc. et al v. BTL Healthcare Technologies A.S., PGR2021-00021, Paper 17 (PTAB, Filed Dec. 14, 2020)). The decision denying institution in Allergan-17 states the following: Consistent with Patent Owner’s contentions, the Specification does not treat the “control unit” as simply a black box recitation of any structure capable of performing the claimed function, but rather treats the term as referring to known structures such as a personal computer, a human machine interface includ[ing] or alternatively, a “PD and/or PID controller.” Ex. 1005, 8:57–9:5, 14:34–48, 75:18–20. Consistent with this, Figures 5a and 5b depict control unit 115 as a physical structure positioned between the power supply and switch. Ex. 1005, Figs. 5a, 5b. Because the term “control unit” refers to these known structures it is not a means plus function claim limitation. processing unit” was not a means plus function limitation where the term referred to “a class of known structures – central processing units – that could be found in any general-purpose computer”). Allergan-17, Paper 16, 13. Our Decision here is consistent with that prior determination.” slip op. at 11

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

      “Element 1.q requires “applying the first time-varying magnetic field . . . to a muscle fiber, a neuromuscular plate, or muscle within the body region of the patient.” Ex. 1001, 109:6–13. In other words, the magnetic field is applied within bodily tissue. Also, element 1.q requires that the application of the first time-varying magnetic field is “such that a muscle contraction within the body region is caused by each of the first, the second, and the third pluralities of the pulses of the first time-varying magnetic field.” Id. In other words, the magnetic field produces the effect. Consistent with Patent Owner’s arguments, Simon describes that its device is an improvement over conventional magnetic stimulators that operate differently. Simon describes conventional magnetic stimulators as having disadvantages. Ex. 1004 ¶ 19 (describing conventional magnetic stimulators as “generally complex and expensive”), ¶ 20 (describing that conventional magnetic stimulators “overheat when used over an extended period of time”), ¶ 21 (describing that conventional magnetic stimulators cause “unpleasantness or pain”). Simon describes that its stimulation devices overcome problems with conventional magnetic stimulators. See, e.g., id. ¶ 37 (describing that Simon’s stimulators have “virtually no unpleasant peripheral nerve stimulation” and “produce virtually no heating”).” slip op. at 16

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 10,709,895
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