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  • PTAB · Sep 25, 2026 · IPR2025-00554 · APJ Barry L Grossman · IPR · Final written decision

    Claims 17–19 and 21–33 are unpatentable as obvious under each asserted § 103 ground.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Factors pertinent to a determination of the level of ordinary skill in the art include: (1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field. Env’t Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Moreover, these factors are not exhaustive but are merely a guide to determining the level of ordinary skill in the art. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007). In determining a level of ordinary skill, we also may look to the prior art, which may reflect an appropriate skill level. Okajima, 261 F.3d at 1355.” slip op. at 17

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

      “according to the Phillips standard,” and that “no formal claim constructions are necessary for purposes of resolving controversies in this proceeding. Pet. 3. We agree. Given the lack of dispute on this record, we do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 18

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully.” slip op. at 26

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

      “We find Mr. Bauer’s testimonial evidence persuasive and undisputed as to why a person of ordinary skill, a degreed engineer with two years of experience designing human breast pump equipment, would modify Furrer to use a battery as a power source, and have a reasonable degree of confidence that it would work successfully. Concerning the proposed combination of Furrer and Alvarez, Mr. Bauer testifies why a person of ordinary skill would combine Furrer and Alvarez, explaining that: a POSITA6 would have turned to the teachings of Alvarez to implement Furrer’s vacuum pump using a conventional pump controller having a portable, battery-powered pump to not only increase portability and to allow the user to move about when using the device but also to provide improved control for the system. Ex. 1003 ¶ 138. Mr. Bauer also testifies: a POSITA would have recognized that Alvarez advantageously provides details for such a conventional vacuum pump suitable for safely and controllably delivering negative pressure using a “[c]ontroller 115 [that] “houses the power source and drive mechanism for pumping device 100, and also contains hardware for various functions, such as controlling pumping device 100, milk production quantification, and communication with other devices. 6 “POSITA” is a patent law acronym for a “person of ordinary skill in the art.” Id. ¶ 139 (citing Ex. 1005 ¶ 69). Mr. Bauer further explains that Alvarez discloses that a “pump unit2100 [disclosed in Alvarez] preferably include[es] a controller and processor 2104 as well as a motor 2102 for actuating the device.” Id. (citing Ex. 1005 ¶ 115); see also id. ¶¶ 140–142 (providing “second,” “third,” and “fourth” reasons why a person of ordinary skill would have been motivated to combine Furrer and Alvarez). Mr. Bauer concludes from his analysis that “a person skilled in the art” slip op. at 26

    Patent outcomesUS 11,806,454 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,806,454
  • 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
  • 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
  • PTAB · Jul 30, 2026 · IPR2025-00560 · APJ Barry L Grossman · IPR · Final written decision

    Claims 1–29 are unpatentable under each asserted obviousness ground, including Chang and Fang, because Petitioner proved unpatentability by a preponderance of the evidence.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Additionally, we note that Patent Owner did not cross-examine Mr. Ryan Bauer, who provided a detailed, 169-page expert report providing, on behalf of Petitioner, his opinions about the issues in this proceeding. See Exhibit 1003. Mr. Bauer’s testimonial evidence in this proceeding remains unrebutted.” slip op. at 3

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner asserts that a person of ordinary skill in the art would have had “bachelor’s degree in mechanical engineering or a similar field and at least two years of experience designing human breast pump equipment. More education could substitute for experience and vice versa.” Pet. 8 (citing Ex. 1003 ¶¶ 15–18). Mr. Bauer’s Declaration testimony states he considered some of the factors listed above. Ex. 1003 ¶ 17. Mr. Bauer testifies that based on his background and experience, in his opinion, the level of ordinary skill is as stated by Petitioner. Id. at 18. Based on the prior art, the sophistication of the disclosed technology in the ’381 patent, and Mr. Bauer’s undisputed testimony, we adopt Petitioner’s definition of the level of ordinary skill.” slip op. at 17

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

      “Petitioner asserts that the Examiner construed the term “self- contained, in-bra wearable device” to mean “complete, or having all that is needed, in itself’ and is capable of being worn in a bra.” Pet. 8 (citing Ex. 1005, 2290).14 According to Petitioner, “[Patent Owner] did not dispute this construction, and Petitioner applies it herein.” Id. Petitioner contends that all other terms “should receive their plain and ordinary meaning.” Id. We do not perceive the need to construe any claim limitation. Claims must be construed “only to the extent necessary to resolve the controversy.” AstraZeneca AB v. Mylan Pharms. Inc., 19 F.4th 1325, 1345 (Fed. Cir. 2021) (quoting Vivid Techs., Inc. v. American Science & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“Because we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy,’ we need not construe the claim preambles here where the construction is not ‘material to the [obviousness] dispute.’” (citations omitted)).” slip op. at 17

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

      “(3) 1[a][1] a diaphragm configured to prevent milk from reaching an air pump by forming a seal around its outer edge; Petitioner relies on Fang for the disclosure of a diaphragm, as stated in this clause. Pet. 25–26. Petitioner asserts the proposed combination of elements suggest a breast pump device that would have used a diaphragm pump including first and second diaphragm housing components and an elastic diaphragm, “in accordance with Fang’s suggestions.” Id. at 25. As also asserted by Petitioner, Fang discloses that flexible diaphragm 7 (i.e., a membrane) is configured to prevent milk from reaching the pump. Id. at 26 (citing Ex. 1009 ¶ 19 (“The elastic diaphragm 7 is used to prevent milk from flowing into the air pump main unit 8.”). Mr. Bauer testifies: The flexible diaphragm [diaphragm 7 in Fang] forms a watertight and airtight seal around its outer edge. In doing so, the diaphragm prevents the passage of milk from reaching the air pump and facilitates generation of negative pressure during operation. Fang also explains that the elastic diaphragm 7 deforms away from the nipple tunnel when a vacuum is created on a pumping chamber, which then creates negative air pressure in the nipple tunnel when a vacuum is created on a pumping chamber.” slip op. at 28

    Patent outcomesUS 11,813,381 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,813,381
  • 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
  • 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
  • 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
  • PTAB · Apr 15, 2026 · IPR2024-01419 · APJ Susan L C Mitchell · IPR · Final written decision

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

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

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

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

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

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

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

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

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

    Patent outcomesUS 11,840,730 not shown unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites Graham
    Patents in suitUS 11,840,730
  • PTAB · Apr 15, 2026 · IPR2025-00187 · APJ Debra L Dennett · IPR · Final written decision

    Claims 1–17 are unpatentable under § 103, principally because Chang in view of Jin renders them obvious; the Jin/Feldmann grounds were not shown.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “Petitioner contends that a person of ordinary skill in the art would have been someone with an advanced degree involving the disciplines of electrical engineering, applied physics, chemistry, or materials science, and at least two years of experience designing, developing, or researching in the field. Alternatively, that person would have had a bachelor’s degree in electrical engineering, applied physics, or materials science, and at least three years of experience designing, developing, or researching in the field. Pet. 4 (citing Ex. 1003 ¶ 49).” slip op. at 10

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

      “Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 24. Patent Owner does not address claim construction. See generally Resp.; Sur-reply. For purposes of this Decision, we need not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 11

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “gap-T isolation region would prevent shorting and that extending the tunnel oxide layer the edge “could trap impurities and create negative fixed oxide charges, which could then create a p-type inversion in the n-type base substrate, leading to a leakage path to the p-type emitter on the front of the solar cell” (Ex. 1003 ¶ 116 (emphasis added)) but are not convinced by his equivocal testimony. Notably too, neither Jin nor Feldmann discuss issues relating to trapped impurities and Petitioner, as well as Dr. Banerjee, fail to direct our attention to any record evidence to support their contentions. Rather, we are persuaded by Dr. Peckerar’s testimony that as a general rule in semiconductor process technology, a bare silicon surface should not be left unpassivated after processing. Elemental silicon is highly chemically reactive. As such, the bare surface is a “magnet” for defects and contamination. Leaving the tunnel oxide in place across the entire substrate backside would reduce this problem. Ex. 2001 ¶ 142. Dr. Peckerar further explains that a person of ordinary skill in the art would have known how to avoid shorting and leakage. In particular, he testifies that the manner by which charge is transported through a tunnel oxide can be controlled by adjusting manufacturing parameters such as time, temperature, thickness, and ambient impurities. A POSITA would plainly have adjusted these parameters to ensure that the tunnel oxide operates as intended (i.e., minimizes recombinant losses while transporting charge carriers to the backside of the solar cell) while avoiding undesirable leakage current. Because unwanted leakage charge can be avoided via other means during manufacture, there would have been no reason to reduce the physical extent of the tunnel oxide. Ex. 2001 ¶ 152 (referring to Ex. 2001 ¶¶ 149–151). Moreover, Dr. Peckerar testifies that “Dr. Banerjee also appears to be arguing that incorporation of impurities into the oxide will produce a MOSFET-like structure, with the contaminated oxide acting as a MOS gate leading to enhanced leakage,” but, for that to occur, “the source and drain areas would need to be of the same type.” Ex. 2001 ¶ 159. Here however, “the tunnel oxide layer is located between an n-type polysilicon layer and p-type frontside emitter layer” so “[n]o MOSFET-like structure can form because the source and drain are of different types.” Ex. 2001 ¶ 159. Neither Petitioner nor Dr. Banerjee address or dispute this testimony. See generally Reply; Ex. 1037. We credit Dr. Peckerar’s testimony in this regard. Without an apparent reason to modify the teachings of Jin and Feldmann to” slip op. at 19

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

      “On this complete trial record, we agree with Patent Owner. It is improper to base a conclusion of obviousness upon facts gleaned only through hindsight. “The invention must be viewed not after the blueprint has been drawn by the inventor, but as it would have been perceived in the state of the art that existed at the time the invention was made.” Sensonics, Inc. v. Aerosonic Corp., 81 F.3d 1566, 1570 (Fed. Cir. 1996) (citing Interconnect Planning Corp. v. Feil, 774 F.2d 1132, 1138 (Fed. Cir. 1985)). Therefore, “to establish a prima facie case of obviousness based on a combination of elements disclosed in the prior art, the [Petitioner] must articulate the basis on which it concludes that it would have been obvious to make the claimed invention.” Id. Impermissible hindsight is inferred when the specific understanding or principle within the knowledge of one of ordinary skill in the art that would motivate one (with no knowledge of the claimed invention) to make the proposed combination has not been explained. In re Rouffet, 149 F.3d 1350, 1358 (Fed. Cir. 1998).” slip op. at 17

    Patent outcomesUS 10,230,009 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,230,009
  • PTAB · Apr 15, 2026 · IPR2025-00006 · APJ Debra L Dennett · IPR · Final written decision

    Claims 1–17 are unpatentable under § 103, principally over Chang and Jin; the Board rejected the Jin and Feldmann combinations for lack of a reason to combine.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In light of the record before us, we adopt Petitioner’s proposal regarding the level of ordinary skill in the art. Based on our review of the ’009 patent and the prior art of record, we determine that the definition offered by Petitioner comports with the qualifications a person would have needed to understand the ’009 patent and the prior art.” slip op. at 10

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

      “Petitioner contends that “[n]o claim construction is believed to be necessary to resolve this Petition.” Pet. 24. Patent Owner does not address claim construction. See generally Resp.; Sur-reply. For purposes of this Decision, we need not expressly construe any claim terms. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (holding that “only those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs. in the context of an inter partes review).” slip op. at 11

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

      “However, Petitioner proposes to remove the tunnel oxide layer from the edge and offers little explanation of why the skilled artisan would apply Jin’s gap- T isolation region to both of Feldmann’s polysilicon and tunnel oxide layers. As noted above, Petitioner states that the skilled artisan would have included Jin’s gap-T isolation region in order to prevent shorting. Pet. 26. Petitioner’s reasoning is questionable—supported only by the conclusory testimony of Dr. Banerjee. Dr. Banerjee’s testimony offers no more evidentiary support than provided in the Petition. Compare Ex. 1003 ¶ 116 with Pet. 26). Petitioner cannot satisfy its burden of proving obviousness by employing “mere conclusory statements.” See Magnum, 829 F.3d at 1380. We acknowledge Dr. Banerjee’s testimony that the combination of Jin’s gap-T isolation region would prevent shorting and that extending the tunnel oxide layer the edge “could trap impurities and create negative fixed oxide charges, which could then create a p-type inversion in the n-type base substrate, leading to a leakage path to the p-type emitter on the front of the solar cell” (Ex. 1003 ¶ 116 (emphasis added)) but are not convinced by his equivocal testimony. Notably too, neither Jin nor Feldmann discuss issues relating to trapped impurities and Petitioner, as well as Dr. Banerjee, fail to direct our attention to any record evidence to support their contentions. Rather, we are persuaded by Dr. Peckerar’s testimony that as a general rule in semiconductor process technology, a bare silicon surface should not be left unpassivated after processing. Elemental silicon is highly chemically reactive. As such, the bare surface is a “magnet” for defects and contamination. Leaving the tunnel oxide in place across the entire substrate backside would reduce this problem. Ex. 2001 ¶ 142. Dr. Peckerar further explains that a person of ordinary skill in the art would have known how to avoid shorting and leakage. In particular, he testifies that the manner by which charge is transported through a tunnel oxide can be controlled by adjusting manufacturing parameters such as time, temperature, thickness, and ambient impurities. A POSITA would plainly have adjusted these parameters to ensure that the tunnel oxide operates as intended (i.e., minimizes recombinant losses while transporting charge carriers to the backside of the solar cell) while avoiding undesirable leakage current. Because unwanted leakage charge can be avoided via other means during manufacture, there would have been no reason to reduce the physical extent of the tunnel oxide. Ex. 2001 ¶ 152 (referring to Ex. 2001 ¶¶ 149–151). Moreover, Dr. Peckerar testifies that “Dr. Banerjee also appears to be arguing that incorporation of impurities into the oxide will produce a MOSFET-like structure, with the contaminated oxide acting as a MOS gate leading to enhanced leakage,” but, for that to occur, “the source and drain areas would need to be of the same type.” Ex. 2001 ¶ 159. Here however, “the tunnel oxide layer is located between an n-type polysilicon layer and p-type frontside emitter layer” so “[n]o MOSFET-like structure can form because the source and drain are of different types.” Ex. 2001 ¶ 159. Neither Petitioner nor Dr. Banerjee address or dispute this testimony. See generally Reply; Ex. 1037. We credit Dr. Peckerar’s testimony in this regard.” slip op. at 19

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable

      “configuration in which the emitter area and back surface field area are not adjacent to each other, thus eliminating “the necessity of performing an isolation process when the emitter area [] and the back surface field are [] are formed to be adjacent to each other.” Resp. 42 (citing Ex. 1013 ¶ 76). In so doing, Patent Owner side steps Chang’s unambiguous definition that “‘entirely formed’ means that an element such as a layer is formed over an entire surface without an empty area or a non-coverage area, or is formed over an entire area excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like.” Ex. 1013 ¶¶ 45, 51, 56, 62 (emphasis added). Chang discloses that a first tunneling layer, a first portion of an emitter area, a second tunneling layer, and a back surface field area may each be “formed over an entire area excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like.” Id. Chang’s definition of “entirely formed” (“excluding pre-designated or inevitably formed regions such as periphery region, isolation region or the like”) implies use of a mask. See Chang ¶ 62; Tr. 15:20–17:11. Dr. Banerjee testifies that the need to electrically isolate the emitter region from the back surface field was well known in the field, and both Chang and Jin teach backside isolation regions. Ex. 1003 ¶¶ 73, 217 (citing Ex. 1023 § 1). Chang also discloses that the emitter area may be formed by thermal diffusion, ion implantation or the like. Ex. 1013 ¶ 98. Petitioner persuasively argues that Chang’s disclosure of thermal diffusion of the emitter layer would result in dopants diffused into not only the top surface of the substrate, but also the exposed lateral surfaces, a problem also noted in Jin. See Pet. 11–12; Reply 6–7; Ex. 1003 ¶ 71; Ex. 1009 ¶¶ 57–58. Jin discloses avoiding shorting of the emitter layer and back surface field layer by edge isolation on the back surface field layer using a mask to create a “gap-T.” Ex. 1009 ¶¶ 57–58, 83. Chang discloses excluding a tunneling layer and a base surface field area from periphery region and isolation region. Ex. 1013 ¶¶ 56, 62. Using a mask, as implied in Chang and explicitly disclosed in Jin, would “pre-designate” and/or “inevitably form” the regions where the tunneling layer and back surface field area are excluded. We credit Dr. Banerjee’s testimony that one of ordinary skill in the art reviewing Chang would therefore understand the importance of implementing the isolation region in Chang’s device, and would therefore be motivated to look to other references, such as Jin (which was assigned to the same original assignee as Chang, LG Electronics, EX1009-Jin, face; EX1013-Chang, face) to understand details regarding Chang’s isolation region.” slip op. at 32

    Patent outcomesUS 10,230,009 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 10,230,009
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