• 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
• Qiagen Sciences, LLC v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · May 13, 2026 · IPR2025-00028 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–15 and 17–22 are unpatentable as obvious over the specified combinations of Shapero, Delseny, and, for certain claims, Hamady or Jones.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “In the DI, we addressed Patent Owner’s arguments disputing Petitioner’s proposed definition. DI 17–18 (citing Prelim. Resp. 11–12). We stated that 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. Id. at 18. After institution, Patent Owner states that, for purposes of this proceeding, it adopts the Board’s definition of a POSA. PO Resp. 12. Based on the entirety of the trial record, we maintain our finding of a POSA’s skill level.” slip op. at 9

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

    “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). 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 9

  • 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

    “A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” Id.” slip op. at 29

  Patent outcomesUS 10,036,012 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,036,012
• 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
• Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.All claims unpatentable
  PTAB · Apr 8, 2026 · IPR2024-01504 · APJ Georgianna W Braden · IPR · Final written decision

  Claims 1–4, 6, 7, 9, and 10 are unpatentable under § 102 over Bielas and § 103 over Iafrate and Kivioja and Bielas.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “On the initial trial record, we agreed with Patent Owner that Petitioner’s asserted level of ordinary skill in the art is higher than warranted when Petitioner argues that a person of ordinary skill “further would have had specific experience with implementing and designing library preparation methods.” Pet. 21–22. We disagreed with Patent Owner, however, that an ordinarily skilled artisan only needs to “have had experience with DNA sequencing methods” (see Prelim. Resp. 8) because an artisan with experience based only on pre-NGS sequencing methods would not qualify as a person of ordinary skill. 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. 9. We specifically found that “[t]he person of ordinary skill would have had experience with NGS sequencing methods and a working knowledge of how those methods functioned.” Id.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “1. “indexing site” Petitioner argues that the ’357 patent defines “indexing site” as a sample index, specifically, “a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing.” Pet. 23 (citing Ex. 1004, 4:40–44). Patent Owner did not disagree initially with Petitioner’s proposed construction other than to argue that no claim requires construction. Prelim. Resp. 9. In our Institution Decision, we noted that the ’357 patent states: An indexing site is a nucleic acid sequence that acts as an index for multiple polynucleotide samples, thus allowing for the samples to be pooled together into a single sequencing run, which is known as multiplexing. the ’357 patent to provide a definition for “indexing site,” and we construed the term in accordance therewith. The parties do not dispute this definition and we maintain that construction for our analysis here. See PO Resp. 9; Reply 6–14.” slip op. at 11

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

    “In some embodiments, duplicate sequencing reads are differentiated from one another as being true duplicates versus apparent or perceived duplicates. Apparent or perceived duplicates may be identified from sequencing libraries and using conventional measures of duplicate reads (i.e., reads were mapped using bowtie), where all reads with the same start and end nucleic acid coordinates were counted as duplicates. True duplicates may be identified from sequencing libraries having had an identifier site introduced through ligation to differentiate between fragments of DNA that randomly have the same start and end mapping coordinates. Ex. 1004, 14:21–31; see id. at Fig. 5; see also Example 1, 18:6-15 (When evaluating two million random reads, the apparent duplicates were found to comprise 39% of all reads. However, the true duplicates, identified through The methods employing the use of an identifier site were found to considerably increase the resolution of the true number of duplicates within the pool of reads.). The ’357 patent also discloses in Example 5: “Any read that has identical sequence to any other read is identified as a duplicate and removed from the population, thus, only a single copy is retained within the file.” Ex. 1004, 20:60–62. Analyzing the patent disclosure in light of the parties’ arguments, we determine that “duplicates” in claim 1 of the ’357 patent means the sequences possess an identical sequence for both the identifier and the length of the sequence read that is obtained. Additionally, we agree with the parties that there is no temporal requirement for “identifying sequence reads” using the identifier and the target sequence, and the two do not have to be used simultaneously. Rather, based on both Examples 1 and 5 of the ’357 patent, the claims only require that the two data points be used for “identifying sequence reads.”” slip op. at 15

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner

    “4. “comprising” The Board preliminarily construed “comprising” as an open-ended transition that is not limited to the listed steps. See Inst. Dec. 13 (citing Vivid Techs., Inc., 200 F.3d at 811). Patent Owner agrees that the “comprising” transitional phrase of the challenged claims leaves open the possibility that additional steps can be included in the method, but argues that it should not “be interpreted so broadly as to effectively eliminate the step of identifying duplicates as claimed.” PO Resp. 18. Patent Owner argues that a “broad interpretation of the claims cannot be read to include a method in which the identifying duplicates step only identifies sequences with PCR or SBS errors and does not identify duplicates in the manner include only identification of reads without duplicate sequences (those that contain PCR or SBS errors) makes this limitation superfluous and cannot be the correct interpretation.” Id. Patent Owner argues that the proper construction of the claims (1) covers a method of identifying sequence reads that are identical as duplicates through a process that uses both the identifier and at least a portion of the target sequence, and (2) does not exclude methods that include a step of identifying PCR errors in addition to the claimed step of identifying duplicates. Id. at 19. Petitioner agrees with Patent Owner and states “[a]ll claim 1 requires is that two sequences are identified as duplicates using the claimed method, even if the method identifies as duplicates additional sequences that are not 100% identical.” Reply 14 (citing Ex. 1124, 55:11–57:3; Ex. 1117). The Board agrees with the parties and we construe “comprising” as an open-ended transition, meaning the claims require, but are not limited to, the listed steps.” slip op. at 16

  Patent outcomesUS 11,098,357 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 11,098,357
• 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
• Illumina Inc. v. Molecular Loop Innovations LLCAll claims unpatentable
  PTAB · Jan 16, 2026 · IPR2024-00965 · APJ Annette R Reimers · IPR · Final written decision

  Claims 1–6 are unpatentable: Gloor anticipates them, Parameswaran and Gloor render them obvious, and Parameswaran, Binladen, and Bentley render claim 6 obvious.

  RulingsFinal written decision

  • 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. 18 (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 ¶¶ 20–23). After reviewing the record, 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 9

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

    “We acknowledge the ambiguous nature of the disputed claim language. On its face, it could require two or more identifier sequences together be uniquely associated with the nucleic acid of interest, as Petitioner argues; or it could require two or more identifier sequences, each individual identifier sequence must be uniquely associated with the nucleic acid of interest, as Patent Owner asserts. See Reply 2–3; Sur-reply 1–6. We, therefore, must examine the words of the claim and the specification to ascertain the scope of this limitation. The specification states that “[w]hile the pair of barcodes associated with any given template is unique, individual barcode sequences can be used with multiple templates as long as no pair is used across two different samples.” Ex. 1001, 2:50–53 (emphasis added). Elsewhere, it states that [t]he first and second identifiers are designed such that each set of identifiers is correlated to a particular sample (e.g., material obtained from a particular patient or group of patients), allowing samples to be distinguished and/or validated. The first and second identifiers may be the same or different, so long as the combination is unique with respect to the sample or sub-sample that one seeks to distinguish and/or validate. Id. at 3:15–22 (emphases added). We agree with Petitioner that the specification supports its proposed construction. See Reply 2.” slip op. at 10

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner

    “Claim 5 recites “homopolymer region.” The ’200 patent specification provides an express definition for the term, stating that “the barcode sequences can be designed to have minimal or no homopolymer regions, i.e., 2 or more of the same base in a row such as AA or CCC, within the barcode sequence.” Ex. 1001, 9:6–10. Thus, we agree with Patent Owner that the term “homopolymer region” should be construed as “two or more of the same base in a row.” See PO Resp. 13 (citing Ex. 2001 ¶ 24). 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 other claim term.” slip op. at 13

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

    “A reference is considered publicly accessible if it is “made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347, 1355 (Fed. Cir. 2018). To “determine whether an interested researcher would have been sufficiently capable of finding the reference and examining its contents,” we “must consider all of the facts and circumstances surrounding the disclosure.” In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009); see also In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004) (explaining that a determination of 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 members of the public”).” slip op. at 15

  Patent outcomesUS 11,768,200 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,768,200
• GE Healthcare Ltd. v. The Johns Hopkins UniversityInstituted
  PTAB · Jan 14, 2026 · PGR2025-00059 · APJ Devon Zastrow Newman · PGR · Institution

  The Board instituted post-grant review of claims 1–4 on all four asserted grounds, finding a sufficient preliminary showing of obviousness and lack of enablement.

  RulingsInstitution decision

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

    “V. CONCLUSION Petitioner has, at this stage, established that it will more likely than not prevail in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. VI. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(a) post grant review of claims 1–4 of the ’233 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 324(d) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial; and” slip op. at 40

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Patent Owner does not proffer a description of a POSA. See generally, Prelim. Resp. For the purposes of this decision, on the record at this time, we find that Petitioner’s definition appears consistent with the level of skill shown in the prior art references of record, and apply it herein. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). We invite the parties to further address the definition of a POSA during trial should they find it necessary.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “In addition, the opinion stated in the Pomper Declaration that “the term of ‘low molecular weight’ is well accepted in the chemical arts” and the declarant “recognize[s] that low molecular weight compounds would have a molecular weight of typically from about 50 Daltons to about 1,500 Daltons” is offered by a co-inventor. We, as factfinder, have discretion to weigh the credibility of expert witnesses and to give each item of evidence such weight as appropriate. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). In this case, we find that the published references on metabolites do not support the opinion. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368 (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”) US-121, of which Dr. Pomper is lead inventor, also uses the term “low molecular weight”—without further characterization of the term—and is uninformative as to the meaning of the term. See Ex. 1006, ¶ 12. In addition, Patent Owner’s definition does not appear to apply to all compounds claimed in US-121.5” slip op. at 11

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

    “limited to Patent Owner’s proposed “from about 50 Daltons to about 1,500 Daltons.” The cited evidence relied on in the Pomper Declaration to define “low molecular weight” as a term well accepted in the chemical arts relates to metabolomics and metabolites. See Ex. 1002, 169, (specifically, ¶ 17 of Dr. Pomper’s declaration). Patent Owner admits that Dr. Pomper’s testimony is about molecules that differ from the claimed imaging and radiotherapeutic agents targeting FAP-α, but argues that the testimony is still relevant for purposes of explanation. Prelim Resp. 21. While it may be relevant, the testimony is not persuasive in light of the Specification. We find the uncontested fact that several of the B moieties alone—without the A moiety or L linker—specifically identified in the ’233 patent fall outside of Patent Owner’s proposed definition persuasive, as we normally do not interpret claim terms in a way that excludes examples disclosed in the specification. See, e.g., Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (rejecting proposed claim interpretation that would exclude disclosed examples in the specification). The cases cited by Patent Owner supporting that a claim term may be construed to exclude embodiments where the prosecution history supports such construction are factually distinguishable from the instant case as they regard instances of specific prosecution history disclaimer, clear prosecution disavowal, or relate to a specific definition of the terms in the Specification for the term being construed. Here, “low molecular weight” is not defined in the Specification, but, as Petitioner argues (see Pet. 21–25) is characterized as “demonstrat[ing] faster pharmacokinetics and a higher specific signal within clinically convenient times after administration” and that it “can be synthesized in radiolabeled form more easily.” Ex.1001, 13:33–50, 14:56– 16:14, 17:9–20. We are persuaded by the testimony of Dr. Zeglis, Petitioner’s declarant, that compounds weighing over 1500 Da may share those same behaviors, along with certain identified B moieties disclosed as embodiments. See Ex. 1003 ¶ 83.” slip op. at 10

  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 12,115,233
• Inari Agriculture, Inc. v. Corteva Agriscience LLCNo claims unpatentable
  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

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.