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  • PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

    RulingsRemand decision
    • RemandOther

      “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

    • BurdenNot shown unpatentable

      “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

      “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

    Patent outcomesUS 10,760,127 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 10,760,127
  • PTAB · Apr 15, 2026 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Final written decision

    Claims 1–9 were not shown unpatentable because the asserted references failed to disclose the claimed correcting step, and Chee was not prior art to claims 1–3 and 9.

    RulingsFinal written decision
    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner

      “We have considered both parties’ arguments and evidence and determine that Patent Owner has presented sufficient evidence of reasonable the invention to practice every day during the critical period in order to demonstrate reasonable diligence. See Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed. Cir. 2016). “[D]iligence need not be perfectly continuous—only reasonably continuous.” Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). The key question is whether, “in light of the evidence as a whole, the invention was not abandoned or unreasonably delayed.” Id. (internal quotations omitted). Applying this standard, we determine that Patent Owner sufficiently demonstrates reasonably continuous diligence throughout the critical period.” slip op. at 32

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

      “introduced during said workflow by collapsing target:differentiator tag combinations observed more than once into a single count.” Ex. 1001, 131:46–48 (emphasis added). The “determining step” of claim 2 recites “determining a consensus base call for the target nucleic acid molecule sequences,” but performs “collapsing all sequence reads comprising a same differentiator tag into a single read,” before the “determining step.” Id. at 131:49–53. Patent Owner proposes an interpretation of these “collapsing” and “determining” steps recited in claims 1 and 2 and asserts that they should be construed as distinct steps performed in a particular order in which the “collapsing step” is performed before the “determining step.” PO Resp. 42–45. We agree. First, Patent Owner asserts a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from, and must occur before, the “determining step” of claim 2 based on the plain language of claims 1 and 2. PO Resp. 42–43. Patent Owner argues that the “collapsing step” and the “determining step” are distinct steps because claims 1 and 2 use different terms to describe these distinct steps that are performed sequentially according to the claim language. Id. (citing Ex. 1001, 131:47–54; Ex. 2023 ¶ 133; Ex. 2024, 57:11–58:22). More specifically, Patent Owner explains that claim 1 recites a “collapsing step,” followed by claim 2, which depends from claim 1 and refers to “collapsing” before “determining a consensus base call” such that “claim 2 describes determining a consensus base call from collapsed reads, not performing ‘collapsing’ by determining a consensus base call.” Id. at 42 (citing Ex. 1001, 131:47–54). collapsing corrects for skewing, an issue related to over- or under-amplification, which is a separate and distinct problem from the sequence errors that a consensus base call is designed to address.” Id. at 43 (citing Ex. 1001, 27:47–50, 32:29–34). Patent Owner contends further that “‘[c]ollapsing’ is a different step, performed separately from determining any consensus base call, to provide even greater accuracy when subsequently determining a consensus base call” such that “if one were to collapse by determining the consensus base call, errors from amplification bias could still be represented in the consensus base call generated.” Id. at 43–44 (emphasis omitted, citing Ex. 2023 ¶¶ 134–37). Second, Patent Owner argues a person of ordinary skill in the art would have understood that the “collapsing step” of claim 1 is distinct from the “determining step” based on the specification of the ’730 patent. PO Resp. 43–45. For example, Patent Owner explains that the specification states that “[f]or any target:differentiator tag combination observed more than once, all such reads are ‘collapsed’ into a single read before consensus basecalls are determined. This will cancel the effect of bias on consensus basecall accuracy.” Id. at 43 (emphasis omitted) (quoting Ex. 1001, 72:63– 73:5) (citing Ex. 2023 ¶¶ 133, 138–142).” slip op. at 11

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

      “We have considered both parties’ arguments and evidence and agree with Patent Owner’s position. As discussed above, we agree with Patent Owner that the “collapsing step” recited in claim 1 and the “determining step” recited in claim 2 are two different steps required by the challenged claims such that “collapsing” does not mean determining a consensus base call or sequence, and must occur before any determining step. As a result, we determine Chee’s step of determining a consensus sequence does not disclose the “collapsing step” recited in claim 1 that requires collapsing “target:differentiator tag combinations.” We are also unpersuaded by Petitioner’s reliance on Chee’s process of correcting for amplification bias as disclosing the claimed collapsing step. As recognized by Patent Owner, the claim language of the “collapsing step” requires “collapsing target:differentiator tag combinations,” rather than collapsing only differentiator tags. In view of this requirement, Chee does not disclose the “collapsing step” because Chee teaches quantifying the starting nucleic acid molecules using their unique identifiers, rather than target:differentiator tag combinations. As Petitioner admits, “Chee’s technique for correcting amplification bias corrects quantitative errors without correcting sequencing errors” (Reply 15), whereas claim 1’s “collapsing step” corrects both quantitative errors and sequencing errors by using target:differentiator tag combinations. See Ex. 1001, 131:47–49 target:differentiator tag combinations).” slip op. at 41

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

      “Given this claim interpretation requiring collapsing target:differentiator tag combinations, it is undisputed that McCloskey, who uses unique barcodes alone, does not teach this limitation. Petitioner does not rely on Bignell as teaching this collapsing step. Accordingly, we conclude Petitioner has not shown that the combination of Bignell and McCloskey teaches the “collapsing step” recited in claim 1. Because claims 4 through 6 depend from claim 1, they also require the “collapsing step” of claim 1 that is not taught by the combination of Bignell and McCloskey.” slip op. at 54

    Patent outcomesUS 11,840,730 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
    Patents in suitUS 11,840,730
  • PTAB · Apr 6, 2026 · IPR2025-00016 · APJ Zhenyu Yang · IPR · Final written decision

    The Board found claims 1–3, 5–12, and 14–19 not shown unpatentable because Meyer did not disclose the claimed enrichment, which the obviousness grounds did not supply.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. 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 knowledge of how those methods functioned. Id. at 12.” slip op. at 8

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

      “As an initial matter, we acknowledge that the definition “to process so as to add or increase the proportion of a desirable ingredient” has two possible interpretations. In the first interpretation, “add or increase” shares the same object “the proportion of a desirable ingredient.” When the proportion of one ingredient goes higher, the proportion of at least another ingredient would necessarily go lower. Thus, the enrichment process under this interpretation results in a higher proportion of the desirable ingredient relative to other ingredients. Patent Owner adopts this interpretation. See PO Resp. 17 (“In the context of preparing a sequencing library, [Patent Owner] Tecan proposes that a nucleic acid sequence of interest is ‘enriched’ when the proportion of nucleic acid fragments containing the sequence of interest is increased relative to other nucleic acid fragments in the sample.”). According to Patent Owner, “amplifying the one or more oligonucleotide extension products . . . thereby enriching the nucleic acid sequence of interest, by generating amplified products comprising the enriched nucleic acid sequence of interest” in step (c) means “increas[ing] the proportion of the nucleic acid sequence of interest relative to the nucleic acid fragments in the solution not containing the sequence of interest by amplifying the oligonucleotide extension product and its complement.” Id. at 19–20. Under the second interpretation, the object for “add” is “a desirable ingredient,” whereas the object for “increase” is “the proportion of a desirable ingredient.” This interpretation is broader than the first one in that the result of the enrichment process not only encompasses a higher proportion of the desirable ingredient relative to other ingredients, but also more desirable ingredient in raw number.” slip op. at 11

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

      “We agree with Dr. Sims. As explained above, the amplification step must result in at least some enrichment of the sequence of interest, even though it does not have to be the only cause. See supra Section II.C.2.b. Indeed, Petitioner acknowledges that “at least some of the enrichment must result from the recited steps.” Reply 12. Because Meyer’s enrichment for mRNA using the SMART protocol occurred before any recited steps of claim 1, we find it does not meet the claimed “enrichment” under our construction.” slip op. at 22

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

      “shown that Meyer discloses step (c) of claim 1, and Petitioner does not address that limitation in this ground, we find Petitioner has not met its burden to show that claims 8, 17, and 18 would have been obvious over Meyer. F. Alleged Obviousness over Meyer and Siebert Claim 2 depends from claim 1, and further recites “the nucleic acid fragment comprises genomic DNA.” Petitioner asserts that claim 2 would have been obvious over the combination of Meyer and Siebert. Pet. 62–65. Petitioner relies on Siebert for teaching the additional limitation recited in claim 2 only. Id. Because Petitioner has not shown that Meyer discloses step (c) of claim 1, and Petitioner does not rely on Siebert for teaching that limitation, we find Petitioner has not met its burden to show that claim 2 would have been obvious over the combination of Meyer and Siebert.” slip op. at 34

    Patent outcomesUS 10,876,108 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,876,108
  • PTAB · Apr 6, 2026 · IPR2025-00015 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–3 and 5–22 were not shown unpatentable because Meyer does not disclose the claimed enrichment, and the other grounds rely on Meyer for that limitation.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for patent owner

      “for purposes of this Decision, we find a POSA would have had a Ph.D. in the field of chemistry, molecular biology, or biochemistry. 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. Id. at 14. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 18. After reviewing the record developed during trial, we see no reason to change our finding on this issue. As we stated in the DI, our “definition of a POSA is consistent with the skill level reflected in the disclosures of the ’012 patent and prior art.” DI 14.” slip op. at 11

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

      “to “enrich” means to “increase[] relative to the rest of the fragments.” Tr. 12:25–26. The panel asked: “In the starting material, there are three components, A, B, C, that say it’s 30 percent, 50 percent and 20 percent. You do PCR and it -- they all get amplified and the end result is still 30 percent, 50 percent, and 20 percent. Anything got enriched?” Id. at 12:18–21. Petitioner responded that “petitioner’s position is that in that situation, there is no enrichment.” Id. at 12:22–23. In other words, Petitioner does not disagree with Patent Owner that mere increase in the raw number is not enrichment. See also id. at 13:7–9 (“[W]e would agree that if it is truly unbiased amplification, that does not result in an increase in the proportion, and so that does not meet the plain meaning of enrich.”). We find the record, including the testimony from all three declarants, supports Patent Owner’s argument. See Sur-reply 1–5 (citing Ex. 1125, 283:1–6, 286:22–287:14; Ex. 1126, 170:18–171:1; Ex. 2037, 150:18–22, 173:15–17; Ex. 2038 ¶ 95), 8 (citing Ex. 1125, 271:10–15; Ex. 2037, 188:22–189:1). Thus, we adopt Patent Owner’s proposal that “a nucleic acid sequence of interest is ‘enriched’ when the proportion of nucleic acid fragments containing the sequence of interest is increased relative to other nucleic acid fragments in the sample.”9 See PO Resp. 19.” slip op. at 15

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

      “We agree with Dr. Sims. As explained above, the amplification step must result in at least some enrichment of the sequence of interest, even though it does not have to be the only cause. See supra Section II.C.2.b. Indeed, Petitioner acknowledges that “at least some of the enrichment must result from the recited steps.” Reply 12. Because Meyer’s enrichment for mRNA using the SMART protocol occurred before any recited steps of claim 1, we find it does not meet the claimed “enrichment” under our construction.” slip op. at 27

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

      “F. Alleged Obviousness over Meyer and Siebert Claim 2 depends from claim 1, and further recites “the nucleic acid fragment comprises genomic DNA.” Petitioner asserts that claim 2 would have been obvious over the combination of Meyer and Siebert. Pet. 69–72. Petitioner relies on Siebert for teaching the additional limitation recited in claim 2 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Siebert for teaching that limitation, we find Petitioner has not met its burden to show that claim 2 would have been obvious over the combination of Meyer and Siebert. G. Alleged Obviousness over Meyer and Kelley Claim 9 depends from claim 1, and further recites “the barcode sequence is 12 nucleotides in length.” Petitioner asserts that claim 9 would have been obvious over the combination of Meyer and Kelley. Pet. 72–74. Petitioner relies on Kelley for teaching the additional limitation recited in claim 9 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Kelley for teaching that limitation, we find Petitioner has not met its burden to show that claim 9 would have been obvious over the combination of Meyer and Kelley. H. Alleged Obviousness over Meyer, Caruccio, and Bronner Each of claims 15 and 17–19 depends from claim 1. Claim 15 further recites “the second strand of the partial duplex adaptor is ligated to a 3′ end of the nucleic acid fragment.” Claim 17 recites “[t]he method of claim 1, further comprising performing bridge amplification of the annealed strand after step e).” Claim 18 further recites “the sequencing comprises use of four labeled reversible terminators.” And claim 19 further recites “the sequencing comprises semiconductor sequencing.” Petitioner asserts that claims 15 and 17–19 would have been obvious over the combination of Meyer, Caruccio, and Bronner. Pet. 75–80. Petitioner relies on Caruccio and Bronner for teaching the additional limitation recited in claims 15 and 17–19 only. Id. Because Petitioner has not shown that Meyer discloses step (d) of claim 1, and Petitioner does not rely on Caruccio and Bronner for teaching that limitation, we find Petitioner has not met its burden to show that claims 15 and 17–19 would have been obvious over the combination of Meyer, Caruccio, and Bronner.” slip op. at 38

    Patent outcomesUS 10,036,012 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,036,012
  • PTAB · Mar 23, 2026 · IPR2024-01451 · APJ Tawen Chang · IPR · Final written decision

    Claims 1–19 were not shown unpatentable: Larson did not establish the claimed detection in a single sample volume, and the asserted obviousness combinations did not cure the deficiencies.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Patent Owner states that, “[f]or purposes of this IPR proceeding, PO does not contest Petitioner’s description of qualifications for a person of ordinary skill in the art (POSA) set forth [above].” PO Resp. 23. In view of the above, and because Petitioner’s uncontested description of one of ordinary skill in the art is reasonable and consistent with the ’921 patent and the cited art, we adopt Petitioner’s definition of a POSA for purposes of this Decision, except that we replace the phrase “at least a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection” with “around a year of experience in quantitative and/or dPCR and fluorescence-based analyte detection.” Pet. 9 (emphasis added).13” slip op. at 14

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

      “We begin with “the context in which a term is used in the asserted claim,” which can be “highly instructive.” Phillips, 415 F.3d at 1314. In this case, claim 1 recites that the claimed assay is “capable of unambiguously detecting the presence or absence of each of said at least M analytes, in any combination of presence or absence, in a single sample volume, . . . wherein the analytes are amplified in the single sample 15 In this regard, we note that Petitioner’s claim construction position is not predicated on the collection of droplets being reconstituted into its original, pre-partition form prior to amplification; rather, the droplets remain compartmentalized from each other in the PCR thermal cycling tube. Tr. 65:21–66:9 (Petitioner’s counsel explaining that the droplets do not combine in the PCR thermal cycling tube but, rather, are “suspended in an immiscible fluid and analyzed en masse”). indicates that the first instance of single sample volume, i.e., the single sample volume in which the presence or absence of each M analytes are to be detected, is the antecedent basis for the second instance of “single sample volume,” i.e., the single sample volume in which the analytes are amplified. Thus, as the parties appear to agree, the single sample volume in which amplification takes places must be the same single sample volume in which the presence or absence of analytes are to be detected. We are not persuaded that, when accorded its plain and ordinary meaning, a single sample volume divided into a collection of droplets would be considered the “same” single sample volume prior to its partition.” slip op. at 17

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

      “With respect to the limitation, “wherein the analytes are amplified in the single sample volume,” Petitioner asserts that “Larson discloses PCR assays that amplify target polynucleotide in a single sample volume, specifically a portion of the reaction mixture that is subsequently partitioned into droplets.” Pet. 31 (emphasis added). There is no dispute that the amplification of the analytes in Larson occurs in the droplets. Larson ¶¶ 6–7 (explaining that “[d]igital PCR (dPCR) is an alternative quantitation method in which dilute sample are divided into many separate reactions” and that “[t]he template is amplified in the droplet for detection”) (emphasis added). Because the claims require that amplification of the analytes be in the same sample volume in which the at least M analytes, in any combination of presence or absence, is unambiguously detected, and because the pre-partition single sample volume is not the same single sample volume as the collection of droplets after partition under our claim construction set forth above, we find Petitioner has not shown, by a preponderance of evidence, that claims 1–10 and 13–19 are anticipated by Larson.17 Tr. 68:12–69:14 (Petitioner’s counsel” slip op. at 27

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

      “Although we agree with Petitioner that Larson contemplates scenarios in which droplets may contain more than one target molecule and does not require the exclusion of such multiple occupancy droplets in all embodiments, we are nevertheless not persuaded Petitioner has shown, based on a preponderance of evidence, that Larson renders obvious an assay capable of unambiguously detecting, in such multiple occupancy droplets, the presence or absence of each of at least M analytes, in any combination of presence or absence, when M is greater than F and F is at least 2.” slip op. at 32

    Patent outcomesUS 11,827,921 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,827,921
  • PTAB · Jan 13, 2026 · IPR2024-00964 · APJ Annette R Reimers · IPR · Final written decision

    Claims 1–8 were not shown unpatentable over either asserted §103 combination because the prior art did not teach the discarding step or establish a reasonable expectation of success.

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

      “specification to interpret the meaning of a claim and importing limitations from the specification into the claim can be a difficult one to apply in practice.” Phillips, 415 F.3d at 1323. “[T]he line between construing terms and importing limitations”, however, “can be discerned with reasonable certainty and predictability if [our] focus remains on understanding how a person of ordinary skill in the art would understand the claim terms.” Id. Ultimately, we construe claim terms to “capture the scope of the actual invention more accurately than either strictly limiting the scope of the claims to the embodiments disclosed in the specification or divorcing the claim language from the specification.” Id. at 1324. Here, we are tasked with resolving the dispute between the parties as to the scope of the source of the claimed cross-over error. See Sur-reply 2. Although claim 1 does not explicitly recite cross-over error is created during cluster amplification, the specification shows otherwise. It repeatedly, consistently, and exclusively describes cross-over errors as arising from the formation of chimeric molecules during the amplification step of the sequencing workflow. See Ex. 1001, Fig. 1, Fig. 2, 4:29–52 (describing “improper molecular overlap via formation of a heteroduplex between patient A’s nucleic acid template and patient B’s nucleic acid template” “[w]hen the amplification process begins”), 5:29–58 (the same), 6:25–44 (the same), 6:64–7:23 (the same).” slip op. at 15

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of skill in the art (“POSA”) “would have had (i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field and at least two years of experience in high-throughput sequencing technologies or (ii) a Master’s degree in one of the same fields with at least four years of experience in high-throughput sequencing technologies.” Pet. 17 (citing Ex. 1003 ¶¶ 19–20). Patent Owner states that it adopts Petitioner’s proposal for a POSA for purposes of this proceeding. PO Resp. 13 (citing Ex. 2001 ¶¶ 19–22). We adopt Petitioner’s proposed definition of the skill level as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. We find both Dr. Spellman and Dr. Adalsteinsson are qualified to opine from the perspective of a POSA, because each has at least ordinary skill in the art. See Ex. 1003 ¶¶ 4–15; Ex. 2001 ¶¶ 4–9.” slip op. at 8

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

      “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 9 Because, as explained below, we find Petitioner has not met its burden to show reasonable expectation of success, we do not need to address whether Petitioner has shown sufficient reason to combine the asserted references. 821 F.3d 1359, 1367 (Fed. Cir. 2016); see also Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (stating that “failure to consider the appropriate scope of the . . . patent’s claimed invention in evaluating the reasonable expectation of success . . . constitutes a legal error”). Here, the claimed invention is a method for reducing template cross-over error. Thus, we must determine whether, in December 2010, an ordinarily skilled artisan would have reasonably expected that the combination of Parameswaran and Gloor would reduce template cross-over error. slip op. at 26

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

      “Thus, on this record, we are persuaded by Patent Owner’s argument that Parameswaran’s “unexpected perfect pairings of unmatched forward and reverse barcodes” are not cross-over error. PO Resp. 31 (citing Ex. 2001 ¶¶ 116–123). In addition, as Petitioner acknowledges, Parameswaran merely “distinguished,” but did not “discard” sequences with mismatches. Pet. 34. Parameswaran states that “[t]he low false-discovery rate for perfect matches strengthens the argument that any sequence with both 5’ and 3’ barcode motifs will be placed with reasonable accuracy into the correct bin.” Ex. 1004, 8. But, because Parameswaran achieved a “remarkably low misassignment rate,” it did not discard, but included any sequence with a matched barcode. Id. Indeed, Parameswaran explains that “[f]or our purposes, all sequences with a match to one of the two expected sequence motifs were considered as true members of the corresponding dataset.” Id. In its Reply, Petitioner emphasizes Parameswaran’s language “[f]or our purposes.” Reply 14 (citing Ex. 1004, 8). According to Petitioner, “[a] POSA would have understood from Parameswaran that chimeric sequences could be kept or discarded, depending on the sequencing ‘purpose.’” Id. (citing Ex. 1054 ¶¶ 79–82). Petitioner is asking us to deem unpatentable a claim based on its reading of “for our purposes,” a broad, undefined statement, to mean something specific—a suggestion to discard perfect unexpected pairings, which Parameswaran explicitly did not do. See Ex. 1004, 8. Petitioner has not presented sufficient evidence and persuasive argument for us to do so.” slip op. at 24

    Patent outcomesUS 11,041,852 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,041,852
  • PTAB · Nov 18, 2025 · IPR2024-01014 · APJ Zhenyu Yang · IPR · Final written decision

    Petitioner did not show claims 1–8 unpatentable because they are entitled to the 2004 priority date, making Barbour unavailable as prior art.

    RulingsFinal written decision
    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Entitled to earlier dateDecided for patent owner

      “For a claim to a biological material, the enablement requirement of § 112, first paragraph, does not require such assured access to a microorganism deposit as of the filing date; what is required is assurance of access (to the microorganism culture by the public upon issuance of a patent on the application) prior to or during the pendency of the application, so that, upon issuance of a U. S. patent on the application, the public will, in fact, receive something in return for the patent grant. Feldman, 517 F.2d at 1355. Patent Owner has persuaded us that such exception not only applies to a deposit, but also extends to a biological material known and readily available. See 52 Fed. Reg. 34080, 34081. In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art.” slip op. at 15

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

      “In this case, it is undisputed that TC1507 germplasm was known and readily available to the public by Barbour’s publication date in 2006 (Pet. 49–53), years before the 2014 issuance date of the ’378 patent (Ex. 1001, code 45). Thus, based on the record developed through trial, we agree with Patent Owner that the 2004 application satisfies the enablement requirement as of its application date in 2004. PO Resp. 16–18 (citing 52 Fed. Reg. 34080, 34081). As a result, the challenged claims are entitled to the 2004 priority date and, thus, Barbour does not qualify as prior art. Because all of Petitioner’s challenges rely on Barbour (Pet. 6), all those challenges fail.” slip op. at 15

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

      “would understand that the term “‘flanked by’ permits overlap between the expression cassette and the DNA sequence it is flanked by.” Pet. 24–26. Patent Owner does not propose any claim construction. PO Resp. 6–7. On this record and for purposes of this Decision, we see no need to expressly construe any claim term.” slip op. at 9

    Patent outcomesUS 8,901,378 not shown unpatentable
    Claim construction§ 102 anticipation§ 112 disclosurecites Phillips
    Patents in suitUS 8,901,378
  • PTAB · Jun 23, 2025 · IPR2024-00313 · APJ Tawen Chang · IPR · Final written decision

    Claims 1–54 were not shown unpatentable because Petitioner failed to establish a reasonable expectation of success for the proposed combinations; objective indicia also supported non-obviousness.

    RulingsFinal written decision
    • Skill levelSkill level patent owner adoptedDecided for patent owner

      “As to the first issue, we agree with Patent Owner that defining the level of skill in view of the solution described in the patent risks improper hindsight. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) 18 (“[T]he level of skill in the art is a . . . lens through which . . . the Board views the prior art and the claimed invention,” which “prevents . . . factfinders from using their own insight or . . . hindsight[] to gauge obviousness.”). We therefore do not include “practical knowledge about . . . the deuterium isotope effect, including the patents and publications discussed [in the Petition],” as part of our definition of a person of ordinary skill in the art.” slip op. at 18

    • Expert testimonyPetitioner expert creditedMixed

      “person of ordinary skill in the art would employ” in an obviousness analysis, we give some weight to Dr. Guengerich’s testimony. KSR, 550 U.S. at 418; Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (explaining that “motivation to combine may be found. . . in . . . the background knowledge, creativity, and common sense of the person of ordinary skill”). Nevertheless, even if we were to agree that an ordinarily skilled artisan would have seen the 1,5-shift in NRPE in Mata’s A2E biosynthetic pathway as a particularly desirable location for intervention, we are not persuaded that such a person would have been motivated to substitute C20 deuterated vitamin A for the vitamin A in Ortho Pharma’s composition and method, because Petitioner has not shown, by a preponderance of evidence, that such an artisan would have reasonably expected the substitution to retard the accumulation of A2E or to treat macular degeneration.” slip op. at 42

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

      “In our Institution Decision, we preliminarily construed the preamble of claim 28 as limiting. Inst. Dec. 30–31. Petitioner did not take issue with our construction, or dispute Patent Owner’s construction of the preambles of claims 1 and 29 as also limiting. After consideration of the full trial record, we maintain our construction of the preamble of claim 28 as limiting for the reasons set forth in our Institution Decision. For similar reasons and the reasons set forth in Patent Owner’s Response, we further construe the preambles of claims 1 and 29 as limiting. See PO Resp. 12–14. We further determine that we do not need to construe any other claim term in order to resolve the controversy between the parties. 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 26

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “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.” slip op. at 25

    Patent outcomesUS RE47,045 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  • PTAB · May 16, 2025 · IPR2024-00093 · APJ Grace Karaffa Obermann · IPR · Final written decision

    Claims 1–9 were not proven unpatentable because the asserted references did not establish the claimed epitaxial layer or the required coverage of the trench sidewalls.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner defines a person of ordinary skill in the art as having “a Master’s degree in electrical engineering, and at least two years of relevant work experience in the field of integrated circuit design and manufacturing.” Pet. 13 (citing Ex. 1003 ¶¶ 32–37, 57). Patent Owner does not dispute Petitioner’s definition. PO Resp. 6. We adopt Petitioner’s proposed definition of the level of ordinary skill in the art because it is supported by unopposed declaration testimony and appears to be consistent with the disclosures of the ’634 patent and the asserted prior art references. See Ex. 1001, 1:6–2:33 (describing the invention and related art in terms of integrated circuit design and fabrication); see also Ex. 1006 ¶¶ 1–6 (Hirler); Ex. 1008 ¶¶ 1–37 (Kobayashi); Ex. 1009 ¶¶ 2–29 (Shiraishi). Neither party, moreover, indicates the overall result would change based on a different definition.” slip op. at 7

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

      “Petitioner argues that “the sidewalls of said trenches in said base layer are covered” should be construed to mean that “the entire sidewalls of” those trenches are covered. Pet. 18–19. We refer to this as “the sidewall limitation.” Petitioner shows persuasively that the disclosure and file history of the ’634 patent support its position on the sidewall limitation. Id. Patent Owner, for its part, observes that, after the filing of the Petition. two District Courts adopted the construction proposed by Petitioner.” PO Resp. 21 (citing Ex. 2010, 6–9; Ex. 2011, 23). Patent Owner also agrees to apply Petitioner’s construction for purposes of this proceeding. Id. We agree with Patent Owner that an express construction of the sidewall limitation is necessary to this Decision, id., and adopt Petitioner’s undisputed definition because it is supported by the record. No other claim term requires express construction for purposes of this Decision.” slip op. at 8

    • BurdenNot shown unpatentable

      “On this record, Petitioner fails to demonstrate that any claim is unpatentable under any ground asserted in the Petition. IV. CONCLUSION For the above reasons, we determine that Petitioner fails to establish by a preponderance of the evidence that claims 1–9 of the ’634 patent are unpatentable.” slip op. at 34

    • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

      “Alternatively, even if we set aside that timing issue, Dr. Liu’s bare opinion, advanced for the first time during cross-examination, that an epitaxial layer is “obvious” from Hirler’s disclosure is inadequate to support the challenges. Id. at 24–25. We accord little weight to Dr. Liu’s opinion because it is conclusory. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (precedential). In any event, Petitioner does not meet, on this record, the “high standard” required to establish an inherent disclosure of an epitaxial layer in Hirler. PO Resp. 24.6 Dr. Liu opined for the first time during cross-examination “that it would have been impossible to create Hirler’s more lightly doped n- drift zone layer on top of its more heavily doped n+ substrate layer other than via epitaxy.” Id. at 25 (citing Ex. 2014, 164:16– 165:20). But Patent Owner effectively refutes that proposition with evidence that such a layer “could be created by counter-doping,” even if, as Dr. Liu contends, counter-doping may have been less ideal due to “disadvantageous mobility.” Id. (citing Ex. 2012 ¶ 133; Ex. 2014, 166:15–167:8).” slip op. at 11

    Patent outcomesUS 7,629,634 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 7,629,634
  • PTAB · Oct 7, 2024 · IPR2023-00614 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 1–3, 6–18, 21–24, and 27–29 were not shown unpatentable under either § 103 ground because the evidence did not establish all limitations or a reason to combine the cited teachings.

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

      “Claim Construction In an inter partes review, we construe a claim term “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. § 42.100(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). The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 14; PO Resp. 10. 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 expressly construe any claim term.” slip op. at 8

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Here, Petitioner argues that a person of ordinary skill in the art (“POSITA”) would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LEDs.” Pet. 14 (citing Ex. 1003 ¶ 32). Patent Owner argues that a POSITA would have had “2 to 4 years’ experience in electrical engineering/design of film and television lighting systems, including the design and use of LED lights, combined with two to three years of work experience as a set lighting technician in television and/or motion picture industry.” PO Resp. 9 (citing Ex. 2047 ¶¶ 16–17; Ex. 2100 ¶¶ 156–161). Patent Owner does not identify any specific instance in which the differences between the parties’ respective descriptions of the level of ordinary skill in the art impacts the analysis or conclusions of either party, or either party’s declarant, in this case. In fact, Patent Owner acknowledges that any differences between the parties’ respective descriptions do not impact the conclusions in this case. Id. (“Regardless of which definition of a POSITA is applied, the conclusion(s) would be the same.”). For purposes of this Decision, and to the extent necessary, we adopt Petitioner’s definition of a POSITA because it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9

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

      “would have been obvious to combine the cited teachings of Kit and Katzir. Petitioner argues that “Katzir further discloses daylight and tungsten temperature ranges within the claimed temperature ranges.” Pet. 24 (citing Ex. 1006 ¶¶ 53, 54, Figs. 5A, 5B). Petitioner relies on the Holmes Declaration to show that “[a] POSITA would have been motivated to look to Katzir to design an LED array to be retrofit in a fluorescent tube.” Id. at 19 (citing Ex. 1003 ¶ 102). Mr. Holmes testifies that [b]oth Kit and Katzir teach using LEDs of various colors in a fluorescent tube form factor, like a T8 or T12 fluorescent tube. Katzir also discloses various LED array layouts that a POSITA would have a looked to when designing an LED tube lighting like that disclosed in Kit. A POSITA would have had strong motivation to look to Katzir to design an LED array to be retrofit in a fluorescent tube form factor. Ex. 1003 ¶ 102 (internal citations omitted). As discussed above, however, the cited passages of Kit describe a light with LEDs that produces a single, consistent temperature of warm white, commercial white, or cool white. Ex. 1004, 3:28–36, 22:9–25. Neither Petitioner nor Mr. Holmes sufficiently explains why a POSITA would have modified Kit to include Katzir’s particular layout that includes both cool white LEDs and warm white LEDs. See Pet. 19, 24; Ex. 1003 ¶ 102; In re Nuvasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016) (instructing that we must articulate a reason why a POSITA would combine the prior art references). We identified the aforementioned deficiencies for this asserted challenge in the Decision on Institution. DI 21–23. Petitioner did not address those deficiencies in the Reply. See generally Reply; Tr. 6:16–7:10. Thus, based on the entire record developed at trial, and for the foregoing reasons, Petitioner has not shown that claim 1 would have been obvious over Kit, Ianiro, Ducharme, and Katzir.” slip op. at 13

    • Expert testimonyPetitioner expert discountedOther

      “Petitioner asserts that Mr. Holmes cited Hasnain’s heat dissipation techniques. Reply 10 (citing Ex. 1003 ¶ 490; Ex. 1049 ¶¶ 41–49). Paragraph 490 of Exhibit 1003 relates to Ducharme, not Hasnain, and thus, does not support Petitioner’s argument. Although paragraphs 41 to 49 of Exhibit 1049 span more than seven pages, other than the single citation in the Reply, Petitioner does not discuss any of the testimony presented therein. We, thus, do not consider this portion of the Holmes Supplemental Declaration. See 37 C.F.R. §§ 42.6(a)(3). Furthermore, we would not be persuaded by Mr. Holmes’ testimony even if we considered it. For example, Mr. Holmes testifies that Hasnain’s heat-dissipating structure “a variety of heat dissipating techniques are disclosed by Hasnain, any one of which could readily be used in a T12 form factor LED light, as expressly recognized by Hasnain.” Ex. 1049 ¶ 46. We disagree with Mr. Holmes that Hasnain teaches enclosing its heat-dissipating structure in a fluorescent light tube. Hasnain teaches “a replacement LED light source for fluorescent tube 22 [that] plug[s] into the same connectors and operate[s] from the voltage patterns generated by the ballasts.” Ex. 1008, 3:23–26. Hasnain also teaches that “the replacement LED light source has a plurality of LEDs mounted on a heat-dissipating substrate that has a width that is less than or equal to the diameter of the fluorescent tube that the light source is designed to replace.” Id. at 5:52–56. Thus, Hasnain teaches that its LED light fits into, and connects with, an existing structure that previously held a fluorescent light tube. Id. at 2:50–56, 3:23–26, 4:58–64, 5:52–56, Figs. 1A, 4. As discussed above, however, Hasnain’s heat-dissipating structure is not enclosed in a tubular housing in order to dissipate heat to the surrounding air or via thermal contact with the existing structure that a fluorescent light tube is inserted into. Id. at 2:50–56, 4:23–28, 4:51–64, Figs. 1A, 3, 4.” slip op. at 22

    Patent outcomesUS 10,566,895 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,566,895
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