• Guardant Health, Inc. v. University Of WashingtonNo claims unpatentable
  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
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentable
  PTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9

  • Expert testimonyPatent owner expert creditedDecided for patent owner

    “We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9

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

    “In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached

    “The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16

  Patent outcomesUS 11,344,552 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,344,552
• Berkshire Hathaway Energy Company / Pacificorp v. Birchtech Corp.Institution denied
  PTAB · May 20, 2026 · IPR2025-00423 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution of IPR challenging claims 1–4 and 6–29 because it instituted the ranked IPR2025-00422 under the Director’s instruction to maintain at most one IPR.

  RulingsInstitution decision

  • Parallel petitionsInstitution denied discretionary otherDenied

    “Paper 34. Birchtech Corp. (“Patent Owner”) filed a Request for Director Review in each case. See Paper 40; IPR2025-00422, Paper 39. The Director denied the request without prejudice in each case and remanded the cases to the Board to “allow discovery, narrowly tailored to resolve the RPI and privity issues.” Paper 49, 4. The Director later issued an Order Supplementing Director Review Decision in each case, instructing that “if the Board determines that Petitioners met their burden to identify all RPIs in the Petitions, then the Board should maintain at most one IPR challenging” the ’430 patent. Paper 72, 3.” slip op. at 2

  Discretionary denial
  Patents in suitUS 10,668,430
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · May 13, 2026 · IPR2025-00029 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–12 and 14–19 are unpatentable as obvious over the listed combinations; Petitioner’s motion to strike is denied.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “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.” slip op. at 7

  • 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 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

  Patent outcomesUS 10,876,108 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,876,108
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · May 12, 2026 · IPR2025-00026 · APJ Georgianna W Braden · IPR · Final written decision

  Claims 1–10 are unpatentable: claims 1–3 and 5–10 are anticipated by Porreca and obvious over Schmitt and McCloskey; claims 4 and 7 are also obvious over the listed Illumina combinations.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “On the initial trial record, we agreed with Patent Owner that one of ordinary skill in the art would have had experience with next generation sequencing, but were not persuaded that this would only be possible in the field of molecular biology. Instead, we found that a person of ordinary skill would have had either (1) a Ph.D. in the field of chemistry, molecular biology, or biochemistry or (2) a B.S. or M.S. degree with three to five years of experience working in any of those fields. Inst. Dec. 8. We specifically found that “[t]he person of ordinary skill would have had experience with next generation sequencing methods and a working knowledge of how those methods functioned.” Id. at 8–9. Patent Owner now submits that it does not dispute the definition of a person of ordinary skill in the art as laid out in the Institution Decision. PO Resp. 13. Reviewing the entire trial record, we maintain the same definition of a person of ordinary skill in the art and note that it is consistent with the skill level reflected in the disclosures of the ’357 patent and prior art. We further note that the skill level does not affect our analysis or our final decision.” slip op. at 10

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

    “In the Institution Decision, the Board adopted Petitioner’s construction of the term “adaptor.” Inst. Dec. 9. Patent Owner does not dispute this construction. PO Resp. 13–14. During oral argument, Petitioner argued that claim 1 requires “an adapter to be ligated onto a target DNA, and that adapter needs to have two different sequences of DNA that are used for identification” including a “socalled identifier that's one to eight nucleotides in an indexing site.” Tr. 6:19–7:2. Patent Owner, again, did not dispute this characterization of “adaptor.” See generally Tr. Based on the entirety of the trial record, we continue to apply Petitioner’s construction of the term “adaptor,” although we note that it does not affect our analysis.” slip op. at 12

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

    “Based on the entirety of the trial record, we do not agree with Patent Owner’s reading of either the claims or the prior art because Patent Owner takes too narrow a view of both. First, based on the plain language of Porreca, we find it uses a combination of the sequence reads of the target sequence and differentiator tag sequences to determine whether there is duplication. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. All that the claim requires is that the method identifies sequence reads with identical identifier and target sequences as duplicates. Because claim 1 contains the transition “comprising,” the claim is still satisfied if the category of identified duplicate reads contains identical labels and also contains more. Patent Owner admits that the identifier and target sequence do not have to be used simultaneously. Tr. 46:16–48:4. Instead, Patent Owner challenges whether Porreca uses the required elements in combination as recited in the challenged claims. Based on the record before us, we agree with Petitioner’s position especially in view of the open-ended nature of the claims and Patent Owner’s own admission that there is no temporal requirement for the use of target sequences and differentiator tag sequences. Specifically, we find that Porreca teaches using the combination of the target sequences and the differentiator tag sequence to determine whether particular sequence reads are unique or PCR duplicates. See Ex. 1006 ¶¶ 139–140, 143, 148, 153. The use of both such sequences meet the claim limitations. This finding is consistent with the prosecution history of the ’357 patent and how the applicant and examiner interpreted the claims. See Ex. 1013, 69–70, 78–79. Second, we find the disclosure of Porreca sufficient to demonstrate to an ordinarily skilled artisan that “collapsing” is done by comparing target sequences and differentiator tag sequences. Porreca specifically explains that: after multiple reads have been collected for a given locus, it is possible that due to bias (e.g., caused by PCR amplification steps), a large fraction of the reads are derived from a single originating molecule. This would skew the population of target sequences observed, and would affect the outcome of the genotype call.” slip op. at 30

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

    “We do not agree with Patent Owner for at least two reasons. First, Patent Owner fails to address the fact that Schmitt cites to McCloskey 2007. We find that the citation of McCloskey 2007 in Schmitt indicates that the ordinarily skilled artisan would have considered the teachings of McCloskey to be highly relevant to the teachings of Schmitt and would have considered them to be both useful in the field of sequencing. See Ex. 1005 ¶ 6. Second, Patent Owner fails to explain or even identify the purported structural differences between Schmitt and McCloskey that would prevent the teachings of McCloskey from being relevant to Schmitt. In addition, we credit the testimony of Dr. Metzker that one of ordinary skill in the art would have understood the benefits of adding a barcode to target sequences and would have looked to McCloskey and the batch-stamps it teaches because both Schmitt and McCloskey are in the same field and address the same problems. See Ex. 1003 ¶¶ 110, 114. Accordingly, we find that Petitioner has demonstrated by a preponderance of the evidence that a person of ordinary skill in the art at the critical time would have had sufficient reason to combine the teachings of Schmitt and McCloskey to arrive at challenged claim 1.” slip op. at 48

  Patent outcomesUS 11,098,357 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,098,357
• Illumina, Inc. v. Molecular Loop Biosciences, Inc.No claims unpatentable
  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
• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.No claims unpatentable
  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
• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.No claims unpatentable
  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
• Biofrontera Inc. / Biofrontera Bioscience GmbH et al. v. Sun Pharmaceutical Industries, Inc.All claims unpatentable
  PTAB · Feb 23, 2026 · IPR2024-01312 · APJ Mary C Hoffman · IPR · Final written decision

  Claims 1, 2, 4–6, 16, 17, and 19–21 are unpatentable as obvious over Lundahl and Larsen; Ground 2 was conceded, and the motion to exclude was denied.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “Patent Owner asserts that Petitioner has not provided a valid justification for requiring a POSITA to have both an engineering degree and a medical degree. Prelim. Resp. 22. We agree, insofar as Petitioner has not clearly set out any particular explanation or evidence in support of its dual-degree requirement. In all other respects, we note that the parties’ proposed definitions are largely similar. Because we determine that Patent Owner’s proposed definition is reasonable and consistent with the ’028 patent and the cited art, we adopt Patent Owner’s definition. In any event, our Decision does not turn on this level of skill determination. B.” slip op. at 12

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

    “device “[f]or the treatment of large-area tissues,” such as the backs of human patients, wherein several applicators 13 are “flexibly connected to each other through hinges.” Id. (quoting Ex. 1004 ¶ 72). Petitioner asserts that a POSITA would have been motivated “to incorporate Larsen’s solution of connecting light applicators by hinges, to allow for adjustability of Lundahl’s device to provide the desired irradiance and irradiance uniformity to all target areas during PDT.” Id. (citing Ex. 1015 ¶ 127). According to Petitioner, a “POSITA would have had a reasonable expectation of success in combining Lundahl with Larsen, because both references describe similar illuminators for using light to treat conditions on a patient’s skin.” Id. at 31 (citing Ex. 1015 ¶ 128). Petitioner’s proposed modification of Lundahl also involves using LEDs as a light source instead of Lundahl’s fluorescent tubes. Id. According to Petitioner, a POSITA would have been motivated to make this change because: (1) LEDs had a lower cost and a longer lifetime than fluorescent tubes; (2) fluorescent tubes were known to have inconsistent light output within the tube itself; and (3) “the use of LEDs would be more practical to reduce spacing between light sources and the edges of the panels, as opposed to the bulky metal couplings at the end of fluorescent tubes, to reduce optical dead space across the light surface.” Id. (citing Ex. 1014, 4:41–42, 6:31–42; Ex. 1015 ¶ 129). Petitioner asserts that a POSITA would have had a reasonable expectation of success with this modification because Lundahl and Larsen “describe similar illuminators and the conversion from fluorescent tubes to LEDs was a routine practice prior to 2015.” Id. at 32 (citing Ex. 1015 ¶ 131). Patent Owner does not meaningfully dispute the Petitioner’s proposed reasons to combine Lundahl and Larsen. See generally PO Resp. To the extent Patent Owner argues that a POSITA would not have been motivated to make the combination because it would negatively affecting uniform illumination (PO Resp. 24), the motivating benefit here—using adjustable LED panels instead of monolith fluorescent tubes—outweighs the alleged disadvantages for the many reasons given by Petitioner, including greater adjustability and improved LED performance. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) (“[t]he fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify.”); Reply 14. We are persuaded that a POSITA would have been motivated to combine Lundahl and Larsen for the reasons advanced by Petitioner.” slip op. at 20

  • Obviousness (§103) › KSR rationalesMotivation foundDecided for petitioner

    “Patent Owner further argues that Petitioner’s reasoning (i.e., that it would have been obvious to try placing the hinges on the inner side surfaces) is unsupported and conclusory. PO Reps. 53–54. Patent Owner argues that Petitioner fails to identify a single prior art reference showing hinged structures on inner side surfaces. Id. This argument ignores that Larsen expressly identifies hinges on at least bottom side surfaces, and Petitioner merely proposes modifying their location from the bottom sides to inner sides. We find credible Dr. Grove’s testimony that relocating hinges would have been within the level of ordinary skill in the art. Ex. 1015 ¶ 155. Dr. Jokerst testifies that a POSITA would have been discouraged from placing hinges between Larsen’s adjustable applicators, because the hinges would create gaps that interfere with uniform illumination as well as the panels’ wiring, and create issues with the use and alignment of the panels. Ex. 2050 ¶ 175. However, a system with discrete panels connected by hinges (like in Larsen) will already have wiring, use and alignment technical challenges, regardless of the location of the hinges— the expected consequence of connecting multiple movable electronic panels. Moreover, the ’028 patent acknowledges in its discussion of conventional illuminators that placing hinges between panels was already known. Ex. 1001, 2:7–15. With respect to Dr. Jokerst’s opinion that the hinges would create gaps negatively affecting uniform illumination, we are persuaded that it would have been within the skill of a POSITA to locate the hinges on the inside surfaces “in a nearly flush arrangement,” such that the gaps would be minimized. Id.; Ex. 1015 ¶ 155. We also credit Dr. Grove’s supplemental testimony on this issue, directly refuting Dr. Jokerst’s testimony regarding gaps and uniform illumination (and therefore within the proper scope of reply, contrary to Patent Owner’s argument otherwise (Mot. 9). See Ex. 1026 ¶¶ 17–20 (explaining LED light divergence and that the physical space caused by hinges “is easily addressed” to maintain uniform illumination).9 We further point out that the ’028 patent also suggests that gaps do” slip op. at 24

  • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

    “Dr. Jokerst testifies that a POSITA would have been discouraged from placing hinges between Larsen’s adjustable applicators, because the hinges would create gaps that interfere with uniform illumination as well as the panels’ wiring, and create issues with the use and alignment of the panels. Ex. 2050 ¶ 175. However, a system with discrete panels connected by hinges (like in Larsen) will already have wiring, use and alignment technical challenges, regardless of the location of the hinges— the expected consequence of connecting multiple movable electronic panels. Moreover, the ’028 patent acknowledges in its discussion of conventional illuminators that placing hinges between panels was already known. Ex. 1001, 2:7–15. With respect to Dr. Jokerst’s opinion that the hinges would create gaps negatively affecting uniform illumination, we are persuaded that it would have been within the skill of a POSITA to locate the hinges on the inside surfaces “in a nearly flush arrangement,” such that the gaps would be minimized. Id.; Ex. 1015 ¶ 155. We also credit Dr. Grove’s supplemental testimony on this issue, directly refuting Dr. Jokerst’s testimony regarding gaps and uniform illumination (and therefore within the proper scope of reply, contrary to Patent Owner’s argument otherwise (Mot. 9). See Ex. 1026 ¶¶ 17–20 (explaining LED light divergence and that the physical space caused by hinges “is easily addressed” to maintain uniform illumination).9” slip op. at 24

  Patent outcomesUS 11,697,028 unpatentable
  § 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,697,028

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.