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  • PTAB · May 1, 2025 · IPR2025-00136 · APJ Jeffrey N Fredman · IPR · Institution

    Institution of inter partes review was denied for claims 1–10 because Petitioner did not establish a reasonable likelihood of prevailing on any asserted ground.

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

      “Accordingly, we find that on the current record Petitioner has not shown that it has a reasonable likelihood that it would prevail on these obviousness grounds. XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5. XIII. CONCLUSION After reviewing the information presented in the Petition and the Preliminary Response, we determine that, based on the evidence of record, Petitioner has not established a reasonable likelihood that claims 1–10 of the ’841 patent are unpatentable. XIV. ORDER Accordingly, it is ORDERED that, pursuant to 35 U.S.C. § 314(a), institution of an inter partes review of all challenged claims on all grounds presented in the Petition is denied.” slip op. at 35

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

      “However, neither Petitioner nor Dr. Jansky provide specific data on the record before us showing the actual measured homozygosity of either of the inbred lines, US-W 5309 and US-W 5315. And Phumichai experimentally demonstrates that Dr. Jansky’s assumption that theoretical heterozygosity reduction of 50% per generation is not necessarily accurate, stating the “observed average percentage of reduction of heterozygosity per generation (38.4% or 38.5%) was lower than the theoretically expected value of 50%.” Ex. 1005, 982. Indeed, Phumichai disclosed that the “SOPH [Section-based observed percentage of heterozygosity] decreased steadily from the original 100% in 99H2–1 (S0) to the family means of 62.4% in 3H2 (S1), 37.9% in 3H3 (S2).” Id. at 981. That is, Phumichai experimentally shows that in an S2 generation of a potato line, the heterozygosity was 37.9%, resulting in homozygosity of about 62.1%, below the 75% theoretically expected and the 75% required by claim 1 of the ’841 patent. Therefore, the evidence of record does not show that the S2 generation of potato lines in Jong necessarily satisfies the homozygosity recitation in claim 1 of the ’841 patent, and so cannot establish on the record before us that Jong inherently teaches this limitation.” slip op. at 15

    • Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentableNot shown unpatentable

      “Owner is telling. Petitioner does not refute Patent Owner’s evidence of objective indicia. On the current record, the objective indicia evidence is compelling. As to long felt need, Patent Owner cited evidence on record before the Examiner that showed a persistent need recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). For example, Dr. Huang states “This research is the breakthrough we have been waiting for since nearly a century . . . This is crucial for the potato breeding worldwide.” Ex. 2009, 687. There is no evidence that this long-felt need was satisfied by another before Appellant’s invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt need or, indeed, a problem to be solved . . . .”). Lastly, Dr. Lindhout explains that this invention satisfies the long-felt need, stating “I have discovered, and disclosed in the present application for patent, how a fertile homozygote in” slip op. at 33

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached

      “XII. DISCRETIONARY DENIAL – 35 U.S.C. § 325(d) In view of our determination that the Petitioner does not meet the threshold for instituting review on the merits, we need not address the parties’ dispute about whether the Board should exercise its discretion to deny institution under 35 U.S.C. § 325(d). Pet. 74–75; Prelim. Resp. 38–54; Pet. Reply 1–5; PO Sur-Reply 1–5.” slip op. at 35

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham
    Patents in suitUS 11,140,841
  • PTAB · Jan 29, 2025 · IPR2024-01178 · APJ Erica A Franklin · IPR · Institution

    The Board denied institution because Bio-Rad did not show a reasonable likelihood of proving any challenged claim unpatentable, as relied-upon Saxonov disclosures were not shown to qualify as prior art.

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

      “review. 35 U.S.C. § 314. Upon considering the parties’ arguments and 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 decline to institute an inter partes review of the challenged claims.” slip op. at 2

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

      “benefit of its provisional application’s filing date for pre-AIA 35 U.S.C. § 102(e) prior art purposes when two conditions are met: (1) the provisional provides sufficient support for at least one claim in the reference patent or published patent application; and (2) the provisional application provide sufficient support for the subject matter relied upon for prior art purposes in the reference patent or application. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1377, 1381–82 (Fed. Cir. 2015); MPEP §§ 2136 (I), 2136.03 (III), 2136 (Examples 2, 4, 7); see, e.g., Google LLC v. Ikorongo Tech, LLC, IPR 2021-00058, Paper 14 at 10–12 (PTAB May 10, 2021). The burden of production is on the Petitioner to show in its Petition that the asserted references qualify as prior art. See Dynamic Drinkware, 800 F.3d at 1380 (explaining that a petitioner bears the initial burden of production to establish that the asserted references qualify as prior art).” slip op. at 18

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

      “Each of the remaining grounds asserted in the Petition relies on Saxonov to reach a number of limitations of independent claim 1 and the challenged dependent claims. Because Petitioner has not shown that all of the relied-upon portions of Saxonov are prior art to the ’170 patent, we determine that Petitioner has failed to demonstrate a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim of the ’170 patent in any of the remaining grounds.” slip op. at 24

    • PTAB / AIA Trials › Discretionary denialNot reached

      “Because we deny institution upon consideration of the merits of Petitioner’s challenges, Patent Owner’s argument that we should exercise our discretion under 35 U.S.C. § 314(a) to deny institution is moot.” slip op. at 25

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · Graham
    Patents in suitUS 10,770,170
  • PTAB · Jan 29, 2025 · IPR2024-01177 · APJ Erica A Franklin · IPR · Institution

    Institution was denied for claims 1–9 because Bio-Rad did not show a reasonable likelihood of unpatentability on any ground relying on Saxonov, which was not established as prior art.

    RulingsInstitution decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “At this stage in the proceeding, Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 26. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’051 patent and the cited art, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 10

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

      “Petitioner has identified certain claim terms for which it has proposed constructions in a parallel proceeding. Pet. 27–29. Petitioner notes that it has that “[o]ther terms, as used herein, are consistent with Patent Owner’s arguments and positions in the parallel proceeding,” without identifying those terms. Id. at 28. Patent Owner requests that the Board adopt Patent Owner’s proposed constructions from the parallel proceeding for certain claim terms. PO Prelim. Resp. 26–27. Neither party provides a discussion for their proposed constructions. In any event, for purposes of this Decision, we determine there is no need to expressly construe any claim term, as the parties appear to agree to the ordinary and customary meaning of the identified terms.” slip op. at 10

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artDecided for patent owner

      “benefit of its provisional application’s filing date for pre-AIA 35 U.S.C. § 102(e) prior art purposes when two conditions are met: (1) the provisional provides sufficient support for at least one claim in the reference patent or published patent application; and (2) the provisional application provides sufficient support for the subject matter relied upon for prior art purposes in the reference patent or application. See Dynamic Drinkware, LLC v. Nat'l Graphics, Inc., 800 F.3d 1375, 1377, 1381–82 (Fed. Cir. 2015); MPEP §§ 2136 (I), 2136.03 (III), 2136 (Examples 2, 4, 7); see, e.g., Google LLC v. Ikorongo Tech, LLC, IPR2021-00058, Paper 14 at 10–12 (PTAB May 10, 2021). The burden of production is on the Petitioner to show in its Petition that the asserted references qualify as prior art. See Dynamic Drinkware, 800 F.3d at 1380 (explaining that a petitioner bears the initial burden of production to establish that the asserted references qualify as prior art).” slip op. at 18

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

      “explains how each of the relied-upon disclosures in Saxonov Figures 9 and 10, and Saxonov paragraphs 17, 18, 37, 76, and 79, which are not present in the ’013 provisional, are supported by the ’013 provisional, we determine that Petitioner has not shown that those cited portions of Saxonov are entitled to the priority date of the ’013 provisional. Accordingly, on this record, we determine that those relied-upon portions of Saxonov do not qualify as prior art to the ’051 patent.” slip op. at 24

    Claim construction§ 102 anticipationcites Phillips · Graham
    Patents in suitUS 10,068,051
  • PTAB · Dec 16, 2024 · IPR2024-00977 · APJ Christopher M Kaiser · IPR · Institution

    The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 7–13 and 15–20 unpatentable on any asserted ground.

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

      “determine whether to institute an inter partes review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a). Inter partes review may not be instituted unless “the information presented in the petition filed under [35 U.S.C.] section 311 and any response filed under [35 U.S.C.] section 313 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). “When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a) (2023).” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “had at least a Bachelor’s degree in electrical engineering, computer science, physics, or a similar field and at least two years of experience designing semiconductor display devices, including LCD displays.” Pet. 19. Petitioner also asserts that “[a]dditional relevant work experience can compensate for less education, and vice versa.” Id. On the record presented, Patent Owner “does not dispute the level of skill for a person of ordinary skill in the art . . . set forth in the Petition.” Prelim. Resp. 8. Neither party explains why the outcome of this case would be affected by the adoption of any particular proffered definition of a person of ordinary skill in the art. For purposes of this Decision, we adopt Petitioner’s assessment of the level of ordinary skill in the art, as it appears consistent with the ’606 patent and the asserted prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 7

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

      “As discussed below, we are able to determine whether to institute review without resolving the construction of any claim terms. Accordingly, we need not and do not construe any terms expressly. 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

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

      “view. First, as Petitioner admits, data line 6a is not connected to image signal line 101d and line 109 other than when sample hold circuit 101c connects them due to shift register 101b outputting an enabling signal. Pet. 49. This is supported by the layout of the four elements in Fujikawa’s Figure 2. Ex. 1005, Fig. 2 (depicting sample hold circuits 101c between and connecting data lines 6a and signal lines 101d). In addition, Patent Owner’s declarant, Dr. E. Fred Schubert, testifies that “two separate lines straddling circuitry are [not] one line.” Ex. 2001 ¶ 64. The dispute between the parties on this issue is largely one of claim construction: should the term “wiring line” in claim 7 be construed broadly enough to encompass a collection of lines separated by a sample hold circuit? In order to determine that Fujikawa discloses or teaches the recited wiring lines, we would need to answer this question in the affirmative. Yet, as discussed above, neither party proposes construing “wiring line,” or any other term used in the claims of the ’606 patent. Pet. 18; Prelim. Resp. 7. The failure to argue for and sufficiently support a broad construction of the term “wiring line” means that Petitioner does not show sufficiently, for purposes of supporting institution of review, that Fujikawa discloses or teaches the “wiring line” limitation of claim 7. b) Conclusion Regarding Claim 7 Based on the record presented, we determine that Petitioner has not shown that there is a reasonable likelihood that Petitioner will prevail in demonstrating that claim 7 is unpatentable as anticipated by or obvious in view of Fujikawa.” slip op. at 11

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,557,606
  • PTAB · May 17, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Institution

    The Board denied institution because Petitioner did not show it was more likely than not that any challenged claim was unpatentable over Perkins or the asserted combinations.

    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. § 324(a), which provides that a post-grant review may not be instituted “unless . . . the information presented in the petition . . ., if such information is not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon considering the arguments and evidence presented by the parties, we determine Petitioner has not shown that it is more likely than not that at least one of the claims challenged in the Petition is unpatentable. Accordingly, we deny institution of post-grant review.” slip op. at 2

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for patent owner

      “Having considered the parties’ positions and evidence of record, summarized above, we agree with Patent Owner that Perkins is prior art to the ’366 patent only to the extent that the subject matter disclosed in Perkins is likewise described in the Perkins Provisional. Accordingly, we do not consider Petitioner’s arguments that rely on subject matter unsupported by the Perkins Provisional. For example, support for Petitioner’s argument that Perkins discloses “mutant VSV-G envelope protein containing only four mutations at N180, I182, T352, and E353” is not found in the Perkins Provisional and is therefore not considered. Pet. 73 (quoted with Petitioner’s emphasis). Thus, insofar as Petitioner is suggesting that Perkins describes a list of mutations that is narrowed to four positions including a mutation at I182, rather than a listing of thirteen potential positions for mutations (and various combinations thereof with hypothetical mutations at a variety positions), we find no such narrower listing in the Perkins Provisional. Compare Ex. 1005, 22:2–5, with Ex. 1006, 17–18.” slip op. at 19

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

      “genus even if the species are not themselves recited.” Bristol–Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001); see also, Atofina, 441 F.3d at 999 (“[A] very small genus can be a disclosure of each species within the genus.” (citing In re Petering, 301 F.2d at 682)). In Petering, for example, the prior art disclosed a small genus of only 20 compounds that included the claimed species. In re Petering, 301 F.2d at 682. In its discussion concluding that a small genus may anticipate a species of that genus, the Court of Customs and Patent Appeals explained that “it is not the mere number of compounds in this limited class which is significant here, but rather, the total circumstances involved, including such factors as the limited number of variations for R, only two alternatives for Y and Z, no alternatives for the other ring positions, and a large unchanging parent structural nucleus.” Id. at 681–682. Having considered the parties’ positions and evidence of record, summarized above, we do not find that Perkins discloses a limited class as exemplified in Petering. To begin, while it is undisputed that Perkins discloses a class of mutant VSV-G envelope proteins that encompasses the recited I182E or I182D mutations, it is also undisputed that Perkins does not disclose the I182E or I182D mutations. Prelim. Resp. 22. Furthermore, and by contrast to the limited class of compounds at issue in Petering, Perkins discloses a class of mutant VSV-G envelope proteins defined as proteins containing one or more of 20 possible mutations or alterations, a class that includes at least 254 proteins. Ex. 1006, 17–18; Prelim. Resp. 26–27. Furthermore, as Patent Owner correctly points out, “[t]he Perkins Provisional does not include any disclosure of the specific mutations to be made at any of these locations. That is, the Perkins Provisional does not indicate the other amino acid(s) to be substituted at the listed locations.” Prelim. Resp. 26. Thus, Perkins fails to provide a POSA with a “‘pattern of preferences’ that serves to narrow the genus.” See, e.g., Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1377 (Fed. Cir. 2006) (“there is no such clear ‘pattern of preferences’ [as found in Petering] that serves to narrow the genus in claim 2 to a narrow class that includes clopidogrel bisulfate”).” slip op. at 22

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

      “Obviousness is a question of law based on underlying findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed. Cir. 2009). A conclusion of obviousness is appropriate where the prior art “contain[s] detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” In re O’Farrell, 853 F.2d 894, 902 (Fed. Cir. 1988); see also, In re Kubin, 561 F.3d at 1359 (KSR “actually resurrects [the Federal Circuit]’s own wisdom in In re O’Farrell”). However, to render a claim obvious, prior art cannot be “vague” and must collectively, although not explicitly, guide an artisan of ordinary skill towards a particular solution. Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341, 1347 (Fed. Cir. 2009). That is, when a field is “unreduced by direction of the prior art,” and when prior art gives “no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention is not obvious. Bayer Schering, 575 F.3d at 1347 (citing In re O’Farrell, 853 F.2d at 903). Having considered the parties’ positions and evidence of record, summarized above, we are not persuaded that Perkins discloses a finite set or limited class of 19 mutations. Pet. 66. Rather, we agree with Patent Owner that Perkins discloses a large genus of mutant VSV-G polypeptides containing at least 254 species—“Perkins Provisional discloses mutations at I182 among a group of 20 other possible locations for modifications[,] . . . [13] of these 20 positions are specific amino acids that . . . can be changed to any of the 19 other natural amino acids” —each species combinable to create a vast number of species. Prelim. Resp. 32. Perkins does not indicate any preference among the 13 disclosed mutations, does not indicate any preference among the 19 other amino acids, and does not indicate any preference as to which mutations should be combined to successful effect. Ex. 1006, 17–18. Thus, while Perkins discloses that one or more mutations “inhibit the envelope protein’s ability to bind its native target, while preserving the envelope protein’s fusogenic properties,” beyond that, a POSA would have no direction for selecting the route to create the I182E or I182D mutations specified by the challenged claims among the various unpredictable alternatives suggested by Perkins. Ex. 1006 at 16; Ex. 1002 ¶ 193. We do not find this to be the easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness. KSR, 550 U.S. at 402. slip op. at 34

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
    Patents in suitUS 11,767,366
  • 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 · Feb 21, 2024 · PGR2023-00046 · APJ Susan L C Mitchell · PGR · Institution

    The Board denied institution because Atea did not show claim 1 was more likely than not unpatentable for lack of written description, lack of enablement, or anticipation.

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

      “Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] 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; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that claim 1 is unpatentable.” slip op. at 2

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The major differences between Petitioner’s and Patent Owner’s definitions of a skilled artisan include the number of years of drug discovery experience that is necessary and the breadth of the fields of endeavor with which a POSA should be familiar. We agree with Patent Owner that a POSA includes a team of skilled artisans with skill sets in the various aspects of drug development, but determine that Petitioner has addressed those necessary skill sets in its definition. We also determine on this record that Petitioner has assessed adequately the level of experience needed, and do not agree with Patent Owner that greater years of experience are necessary for a POSA in this instance. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.”). Because Petitioner’s definition of a person of skill in the art appears commensurate with the level of skill reflected in the asserted art in this case as well as the ’361 patent itself, we apply Petitioner’s proposed level of ordinary skill in the art to determine whether it is more likely than not that Petitioner would prevail on its challenges to claim 1. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 10

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

      “C. Claim Construction We construe claims “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. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would be understood by a person of ordinary skill in the art, at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., Matal, 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)). Both parties agree that we need not construe any claim terms here to resolve the issues in this proceeding. See Pet. 16; Prelim. Resp. 18–19. We agree with the parties that we need not construe any claim terms in this proceeding to resolve whether to institute a post-grant review.” slip op. at 11

    • BurdenNot shown unpatentable

      “In applying the rubric set forth in Ariad to determine whether claim 1 has appropriate written description support, we can look for structural features common to the members of the subgenus of claim 1 so that one of skill in the art can “visualize or recognize” the members of the subgenus. See Ariad, 598 F.3d at 1350. To do this, we look “for blaze marks within the disclosure that guide attention to the claimed species or subgenus.” See Regents of the Univ. of Minn., 61 F.4th at 1356. In this regard, the fourteenth aspect of the third embodiment is the blaze mark that points to the subgenus of claim 1. We do not need to find blaze marks that identify the fourteenth aspect of the third embodiment as the only formula of merit or the only one that should be claimed. Rather, we look to the written description to see if it describes sufficient structural features common to the members of the subgenus of claim 1 such that a POSA can visualize or recognize the members of that subgenus, thereby demonstrating that the inventors possessed the subject matter of the claim at the time they filed their application.” slip op. at 20

    Claim construction§ 102 anticipation§ 112 disclosurecites KSR
    Patents in suitUS 11,642,361
  • PTAB · Dec 15, 2023 · IPR2023-00937 · APJ Hubert C Lorin · IPR · Institution

    The Board denied institution on claims 1–21 because Petitioner did not show a reasonable likelihood that the relied-upon Slivka Appendices qualified as prior art.

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

      “On this record, Petitioner does not establish a reasonable likelihood that the Slivka Appendices are “(1) an application for patent, published under section 122(b), . . . or (2) a patent granted on an application for patent.” 35 U.S.C. 102(e). Accordingly, the relied-upon Slivka Appendices do not qualify as prior art under § 102(e) as Petitioner asserts. Pet. 9. III. CONCLUSION Petitioner’s invalidity contentions rely, in part, on disclosures from the Slivka Appendices, which Petitioner asserts qualify as prior art under § 102(e). Pet. 9. Because Petitioner has not established a reasonable likelihood of showing that the material it relies on was available as prior art at the time of the invention, we determine that the Petitioner has not satisfied its burden from the onset to show with particularity why the patent it challenges is unpatentable. 35 U.S.C. § 312(a)(3).” slip op. at 18

    • BurdenDenied

      “We determine that Petitioner has not satisfied its burden from the onset to show with particularity why the patent it challenges is unpatentable. Our determination is based on finding that Petitioner’s challenge relies on appendices (Ex. 1005, 69–245) missing from the ’695 patent (Ex. 1004) and insufficient indication on the record that the appendices have been incorporated into the ’695 patent, and that as a result, the relied-upon appendices do not qualify as prior art under 35 U.S.C. § 102(e) as Petitioner asserts. Pet. 9.” slip op. at 9

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference not prior artNot shown unpatentable

      “Appendices (Ex. 1005, 69–245) missing from the ’695 patent (Ex. 1004) as published because the Slivka Appendices were not incorporated by reference into the ’695 patent specification. Thus, there is no sufficient indication on this record to establish a reasonable likelihood that the Slivka Appendices are available prior art for an inter partes review, as they are neither part of the patent. 35 U.S.C. § 311(b); see Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper No. 29 at 12–13 (December 20, 2019) (precedential) (discussing the standard at institution for a showing regarding the public availability of non-patent art). On this record Petitioner has not sufficiently shown that the Slivka Appendices, as separately-filed documents should be accorded their stamped “DEC 6 1996,” date for prior art purposes. As Patent Owner correctly explains, “the rule requiring publication of applications ‘after the expiration of a period of eighteen months from the earliest filing date for which a benefit is sought’ was not effective until November 29, 2000.” Prelim. Resp. 21 (citing 65 Fed. Reg. 57,024; 35 U.S.C. § 122(b)(1)). For applications filed before November 29, 2000, as here, “the prosecution history of an application remain[ed] confidential until the application itself issue[d] as a patent.” Hyatt v. U.S. Patent and Trademark Office, 797 F.3d 1374, 1378 (Fed. Cir. 2015). The current record, at most, might support a likelihood that the Slivka Appendices could be accorded the date they were first made publicly available, which is May 9, 2000, the date the ’695 patent issued. See 37 C.F.R. 1.11 (a) (“After a patent has been issued or a statutory invention registration has been published, the specification, drawings, and all papers relating to the case in the file of the patent or statutory invention registration are open to inspection by the public, and copies may be obtained by paying the fees therefore.”). As Patent Owner points out, however, this is “at least thirteen months after the ’545 patent’s effective filing date,” i.e., April 26, 1999 (based on a claim for priority to, inter alia, U.S. Provisional Application Ser. No. 60/131,083). Prelim. Resp. 29; Ex. 1001, code (60), 1:13–15. In addition, Petitioner only presents a case for availability of the Slivka reference under pre-AIA § 102(e). On this record, Petitioner does not establish a reasonable likelihood that the Slivka Appendices are “(1) an application for patent, published under section 122(b), . . . or (2) a patent granted on an application for patent.” 35 U.S.C. 102(e). Accordingly, the relied-upon Slivka Appendices do not qualify as prior art under § 102(e) as Petitioner asserts. Pet. 9.” slip op. at 17

    § 102 anticipation
    Patents in suitUS 9,369,545
  • PTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution

    Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.

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

      “APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19

    • BurdenDecided for patent owner

      “As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner

      “Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

      “A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20

    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,253,572
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