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  • PTAB · May 15, 2025 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Institution

    The Board instituted IPR on claims 1–15 and 17–22 on all asserted obviousness grounds, finding a reasonable likelihood that Shapero and Delseny render claim 1 obvious.

    RulingsInstitution decision
    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner

      “To accord substantial weight to evidence of secondary considerations, it “must have a nexus to the claims, i.e., there must be a legally and factually sufficient connection between the evidence and the patented invention.” Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1417 (Fed. Cir. 2022) (internal quotation marks omitted); see also In re Kao, 639 F.3d 1057, 1069 (Fed. Cir. 2011) (instructing that “the Board, in considering the evidence of unexpected results, should determine whether there is a nexus between the unexpected [results] and aspects of the claimed invention not already present in the prior art”). Moreover, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Laboratories, 952 F.2d 388, 392 (Fed. Cir. 1991). On this record, it is unclear what Dr. Brooks considered to be the closest prior art when he alleged unexpected results. See Ex. 1002, 2013–17. We also find no persuasive evidence in either Brooks Declaration or the Examiner’s analysis on the requisite nexus. See id., 2055–56. As a result, we agree with Petitioner that “the Examiner erred in exclusively relying on Dr. Brooks’ declaration” to withdraw the obviousness rejection based on Jones and Tucker. See Pet. 58.” slip op. at 16

    • Skill levelSkill level board ownDecided for petitioner

      “We find Patent Owner’s proposed definition of the skill level insufficient. As Patent Owner recognizes, the challenged claims relate to sequencing methods using a next-generation sequencing (“NGS”) platform. See id. at 8; see also Ex. 1001, 35:56–57 (claim 1 reciting “sequencing the enriched nucleic acid sequence of interest on a massively parallel sequencing platform”). Also, as Patent Owner recognizes, [c]ompared to traditional, Pre-NGS sequencing methods, NGS sequencing utilized a new design that no longer relied upon disassembling and then piecing together a single original template DNA strand. Instead, NGS now allowed for hundreds of thousands of original template strands to be sequenced in the same reaction. With NGS, a user could perform massively parallel sequencing, allowing for elements of the genome to be sequenced in a fast, scalable manner. Prelim. Resp. 5 (internal citations omitted). As such, we disagree with Patent Owner that a POSA only need to have education “in a field related to molecular biology” or experience “in a molecular biology lab,” because an artisan having only experience with pre-NGS sequencing methods would not qualify as a POSA. Instead, for purposes of this Decision, we find a POSA would have had a Ph.D. in molecular biology, molecular genetics, bioinformatics, biochemistry, or a related field. Alternatively, a POSA would have had a B.S. or M.S. degree with three to five years of experience working in any of those fields. Additionally, the POSA would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned. This definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art. We further note” slip op. at 18

    • 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) (2020). Under that standard, 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). 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 expressly.” slip op. at 19

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted

      “It is true that Delseny recognizes the limitations and challenges of NGS. Ex. 1007, 411, 417. But the language in Delseny that Patent Owner identifies does not amount to teaching away, which requires that prior art references “criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Instead, Delseny notes the limitations of hybridization technology in genotyping. Ex. 1007, 417. According to Delseny, “[t]he ultimate resolution is at the base-pair level and NGSTs now open the possibility to genotype a line by sequencing it.” Id. In fact, Delseny specifically teaches that NGS “can substitute for the genotyping microarray strategy because of its higher resolution.” Id.” slip op. at 22

    Claim construction§ 103 obviousnessDiscretionary denialcites Phillips
    Patents in suitUS 10,036,012
  • PTAB · Sep 23, 2024 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Institution

    The Board instituted IPR on claims 1–4, 6–10, and 12–15 on all petitioned grounds, finding a reasonable likelihood of success on at least one challenge and declining Fintiv denial.

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

      “To institute an inter partes review, we must determine that the information presented in the Petition shows “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). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–4, 6–10, and 12–15 of the ’975 patent are unpatentable.” slip op. at 2

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted

      “invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the . . . .” 35 U.S.C. § 102(a). To be anticipated, each and every element of the claim must be found, either expressly or inherently described, in a single prior art reference. See Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). When claim elements are inherently taught, the result must be a necessary consequence of what was deliberately intended, but the prior art need not demonstrate that the authors appreciated the results. See Mehl/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); see Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1377 (Fed. Cir. 2003) (“At the outset, this court rejects the contention that inherent anticipation requires recognition in the prior art.”).” slip op. at 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted

      “Obviousness is determined by looking to the scope and content of the prior art, differences between the prior art and the claims at issue, and the level of ordinary skill in the pertinent art resolved. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 10

    • PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner

      “pending Maryland litigation has been stayed in its entirety pending resolution of IPR2024-00240, which involves a related patent that is also involved in the litigation. Reply, 1 (citing Order in Maryland litigation, dated June 29, 2024, Ex. 1100, 1); see Sur-Reply, 1 (acknowledging “the recent stay of the parties’ co-pending litigation involving the ’975 Patent.”). In its Memorandum Opinion, the court acknowledged that inter partes reviews of additional patents involved in the litigation could be instituted. See Ex. 1101, 3. Accordingly, the first Fintiv factor weighs heavily in favor of not exercising discretion to deny institution of inter partes review. Because of the stay, the second and third Fintiv factors also weigh heavily in favor of not exercising discretion to deny institution of inter partes review. The stay indicates that the court’s trial date will not be close to the Board’s projected statutory deadline for a final written decision and that neither the court nor the parties will invest further in the parallel proceeding. See Fintiv, at 6 (“A district court stay of the litigation pending resolution of the PTAB trial allays concerns about inefficiency and duplication of efforts. This fact has strongly weighed against exercising the authority to deny institution under NHK.”); see also Memorandum Opinion in Maryland litigation issued June 29, 2024, Ex. 1101, 2 (noting that the” slip op. at 32

    Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 11,325,975

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