• Bio-Rad Laboratories, Inc. v. California Institute Of TechnologyNo claims unpatentable
  PTAB · Mar 23, 2026 · IPR2024-01451 · APJ Tawen Chang · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

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

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

  Patent outcomesUS 11,827,921 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,827,921
• Inergy Technology, Inc. v. Force Mos Technology Co., Ltd.No claims unpatentable
  PTAB · May 16, 2025 · IPR2024-00093 · APJ Grace Karaffa Obermann · IPR · Final written decision

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

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

  • BurdenNot shown unpatentable

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

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

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

  Patent outcomesUS 7,629,634 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,629,634
• 3M Company v. Bay Materials, LLCNo claims unpatentable
  PTAB · Jan 16, 2024 · IPR2022-01214 · APJ Grace Karaffa Obermann · IPR · Final written decision

  Claims 1–4, 7–11, and 13 were not shown unpatentable because Petitioner did not establish the flexural-modulus limitation over Hinz and the Durasoft data sheets, with or without Sun.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “The parties disagree about the appropriate definition of the ordinarily skilled artisan and, in particular, whether that artisan would have had experience or familiarity with processing “thermoformable polymer sheets” to form “orthodontic and dental appliances.” Resp. 8; see Pet. 10–11 n.1 (disagreeing with that proposition). We agree with Patent Owner for the following reasons.” slip op. at 8

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “B. Conflicting Opinion Testimony Petitioner’s own witness, Dr. Giacomin, opines that an ordinarily skilled artisan “would have been familiar with various machines and methods that would have enabled the thermoforming of multilayer dental sheets into shapes that conform with the teeth (i.e., creating a dental appliance).” Ex. 1002 ¶ 25. Nonetheless, Petitioner does not contest Patent Owner’s evidence that Dr. Giacomin himself lacks that qualification. Compare Resp. 9–10 (citing Ex. 1002 ¶¶ 1–9, 17 & n.1), with Reply (nowhere contesting that evidence). Petitioner also leaves uncontested Patent Owner’s evidence that Dr. Osswald, by contrast, possesses “the required experience” with dental appliances, including thermoforming processes for their manufacture. Compare Resp. 10 (citing Ex. 2006 ¶¶ 2–8; Ex. 2007), with Reply (nowhere contesting that evidence). Dr. Giacomin possesses excellent qualifications in the field of polymer rheology, but on this record, he demonstrates no, or inadequate, familiarity or experience with methods of thermoforming dental appliances from polymeric materials, which by his own admission is a minimum qualification of the hypothetical person of ordinary skill in the art. Ex. 1002 ¶¶ 1–11 (statement of qualifications), App’x A (curriculum vitae). Patent Owner’s witness, Dr. Osswald, by contrast, has “experience with polymer materials used in dental appliances” and “shaping operations, including thermoforming” processes for such applications. Ex. 2006 ¶¶ 5, 6. Against that backdrop, where the two witnesses’ opinions differ about the level of ordinarily skill in the art of thermoforming processes for dental appliances at the time of the invention, we credit Dr. Osswald’s opinions over those of Dr. Giacomin. We take note, moreover, that Dr. Osswald’s opinions would not change under Petitioner’s somewhat different definition of the level of ordinary skill in the art. Ex. 2006 ¶ 14.” slip op. at 11

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

    “C. Claim Construction Claim terms are given their ordinary and customary meaning, as understood by one of ordinary skill in the art in the context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). We construe only terms in controversy and then only to the extent necessary to resolve the controversy. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017). No claim term requires express construction for purposes of this Decision.” slip op. at 12

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

    “In the absence of explanation by Petitioner, we are left to wonder why either of those two ranges reported in Sun would have been recognized as applicable, without modification, to the three-layer dental splint of Hinz. Starting with a commercially-available, two-layer sheet of hard-soft PC-TPU or hard-soft PETG-TPU thermoplastic polymers, Hinz bonds a third layer, consisting of hard PC or hard PETG, to the soft TPU layer of the two-layer material by a process of thermoforming. No prior art reference explains how that process would have been understood to affect the overall flexural modulus of the resulting three-layer, hard-soft-hard composition. Petitioner does not supply an adequate reason for combining Sun’s preferred flexural modulus range, reported for Sun’s dental appliances at a temperature of 23˚ C, to dental splints formed by Hinz from fundamentally different polymers and a fundamentally different process. See Pet. 65–68 (entirety of four-page analysis on this ground); Resp. 32–38; Sur-reply 7–14 (well-supported explanation of those fundamental differences); Reply 8–16 (Petitioner’s unpersuasive responsive positions). The flexural modulus of Sun’s dental appliance not only is temperature dependent but also varies with the flexural strength of the polymeric material at hand. Ex. 1018 ¶ 12. Too late in the Reply, Petitioner raises fact-intensive reasons why those differences would not have mattered to an ordinarily skilled artisan. Reply 8–16. In any event, we agree with Patent Owner that Petitioner glosses over “[f]undamental differences” between the polymers and processes of Sun and Hinz, differences that “are central to [the] motivation to combine inquiry” and undercut Petitioner’s view that an ordinarily skilled artisan would have understood either of Sun’s flexural modulus ranges to apply, without modification, to Hinz’s polymers and process. Resp. 33 (quoting Adidas AG v. Nike, Inc., 963 F.3d 1355, 1359 (Fed. Cir. 2020)) (first alteration in original); see Sur-reply 8–16 (Patent Owner’s persuasive arguments and evidence on point). The ground based on Sun is deficient for the above reasons.” slip op. at 25

  Patent outcomesUS 10,946,630 not shown unpatentable
  Claim construction§ 103 obviousnesscites Graham
  Patents in suitUS 10,946,630
• Sigray, Inc. v. Carl Zeiss X-Ray Microscopy, Inc.No claims unpatentable
  PTAB · May 22, 2023 · IPR2022-00218 · APJ Elizabeth M Roesel · IPR · Final written decision

  Claims 1–15 were not shown unpatentable because the prior art did not establish the claimed projection magnification or scintillator; the revised contingent motion to amend was dismissed as moot.

  RulingsFinal written decision

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “We determine that the level of ordinary skill in the art, as articulated by Patent Owner, more accurately reflects the subject matter of the ’704 Patent and the asserted prior art than does Petitioner’s articulation. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself reflects an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Petitioner does not explain how “control theory” and “applied mathematics” (Pet. 16) relate to the subject matter of the ’704 Patent and the asserted prior art, and Petitioner’s reference to requisite level of skill. Furthermore, whereas Petitioner requires a POSITA to have “x-ray and computing imaging experience” (id.), Patent Owner more particularly specifies “x-ray microtomography experience” (PO Resp. 5), which is the field of art for the ’704 Patent, as well as many of the asserted prior art references. Ex. 1001, code (54) (“High resolution direct-projection type x-ray microtomography system using synchrotron or laboratory-based x-ray source”); Ex. 1007 (discussing X-ray microcomputed tomography); Ex. 1008 (discussing X-ray nanotomography and microtomography); Ex. 1010, code (54) (“Method and apparatus for utilizing an electro-optic detector in a microtomography system”); Ex. 1011 (title: “Three-dimensional X-ray Microtomography”). For these reasons, we apply Patent Owner’s definition of a POSITA. Even if we applied Petitioner’s definition of a POSITA, however, the outcome would be the same because our resolution of the controversy does not turn on the differences between the parties’ contentions about level of ordinary skill in the art.” slip op. at 9

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

    “In an inter partes review, we apply the same claim construction standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.100(b). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). (“all claim terms should receive their plain and ordinary meaning”); PO Resp. 5 (applying the same constructions as Petitioner). We determine that no claim term requires express construction for purposes of resolving any controversy between the parties. Realtime Data LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner

    “On balance, we find that the testimony of Drs. Bentley and Arce about Jorgensen is more credible than Dr. Kia’s testimony, which is often conclusory and insufficiently supported by the evidence. Drs. Bentley and Arce do a better job of explaining and reconciling Jorgensen’s varying descriptions of the X-ray beam than does Dr. Kia. For example, although Dr. Kia relies on Jorgensen’s repeated references to a “cone-beam,” we find that Petitioner’s evidence does not outweigh the explanations provided by Drs. Bentley and Arce, particularly in view of Jorgensen’s description of the X-ray beam as “collimated” and “shielded by a lead-wrapped brass tube.” See II.D.2.d. and e., supra. Even if we consider Petitioner’s improper new reply argument about filling the CCD, we find that argument insufficient and does not outweigh Patent Owner’s unrebutted evidence about CCD pixel size. See II.D.2.f. and g., supra. In sum, viewing the record as a whole, we find that Petitioner has not shown persuasively that Jorgensen inherently discloses projection magnification within the claimed range.” slip op. at 38

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable

    “standard.” Amgen Inc. v. Sandoz Inc., No. 2022-1147, 2023 WL 2994166, at *10 (Fed. Cir. Apr. 19, 2023). “Inherency . . . may not be established by probabilities or possibilities.” Oelrich, 666 F.2d at 581. “The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” Id. (emphasis added). Rather, the patent challenger must “show that the natural result flowing from the operation as taught would result in the performance of the questioned function.” Id.; see PersonalWeb Technologies, LLC v. Apple, Inc., 917 F.3d 1376, 1382–83 (Fed. Cir. 2019) (determining that the Board’s reliance on inherency was improper because the structure relied upon to meet a claim element “does not necessarily exist” in the reference). As discussed above, it is undisputed that there can be no projection magnification unless the X-ray beam is diverging, and there is a vigorous dispute about whether Jorgensen teaches a diverging X-ray beam. See negatively impacted by Petitioner’s and Dr. Kia’s admittedly incorrect interpretations of Jorgensen’s disclosures concerning “projected at a 4° angle” and “the X-ray beam geometry is used to achieve magnification.” Ex. 1007, H1104; see II.D.2.b. and c., supra. On balance, we find that the testimony of Drs. Bentley and Arce about Jorgensen is more credible than Dr. Kia’s testimony, which is often conclusory and insufficiently supported by the evidence. Drs. Bentley and Arce do a better job of explaining and reconciling Jorgensen’s varying descriptions of the X-ray beam than does Dr. Kia. For example, although Dr. Kia relies on Jorgensen’s repeated references to a “cone-beam,” we find that Petitioner’s evidence does not outweigh the explanations provided by Drs. Bentley and Arce, particularly in view of Jorgensen’s description of the X-ray beam as “collimated” and “shielded by a lead-wrapped brass tube.” See II.D.2.d. and e., supra. Even if we consider Petitioner’s improper new reply argument about filling the CCD, we find that argument insufficient and does not outweigh Patent Owner’s unrebutted evidence about CCD pixel size. See II.D.2.f. and g., supra. In sum, viewing the record as a whole, we find that Petitioner has not shown persuasively that Jorgensen inherently discloses projection magnification within the claimed range.” slip op. at 37

  Patent outcomesUS 7,400,704 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,400,704
• Hanwha Solutions Corporation / Hanwha Q Cells USA, Inc. v. Rec Solar Pte. Ltd.No claims unpatentable
  PTAB · Dec 9, 2022 · IPR2021-00989 · APJ Brian D Range · IPR · Final written decision

  Claims 1–6, 11, and 13 were not shown unpatentable under either obviousness ground because Petitioner did not establish a motivation to combine Yagiura and Shimasaki.

  RulingsFinal written decision

  • ExcludeMotion to exclude, deniedDenied

    “Petitioner’s position is persuasive. We agree that documents from the Japanese Patent Office are self-authenticating official government documents. The technical issues regarding missing pages in the originally filed version of the document do not cause us to question authenticity. We also agree that Petitioner uses the documents to establish what the documents teach rather than establishing the truth of what the documents teach. In Reply, Patent Owner argues that Petitioner relies on the date printed on the document to prove up the truth of when the document was published. Mot. Excl. Reply 1–2. To the extent this is the case, an exception to hearsay applies because the document is a record of a public office. Fed. R. Evid. 803(8)(B) (a record of public office is an exception to the hearsay rule if the opponent does not show that the source of information or other circumstances “indicate a lack of trustworthiness”). Here, Patent Owner does not persuasively demonstrate a lack of trustworthiness; Patent Owner does not identify any substantively meaningful distinction in the missing pages of the originally filed document and does not identify any evidence to suggest that the missing pages were anything more than a harmless clerical error. For the reasons above, Patent Owner’s motion to exclude is denied with respect to these documents. B.” slip op. at 8

  • Skill levelSkill level board ownOther

    “Petitioner’s proposal is too broad. PO Resp. 8. For example, a person who merely installs solar panels for three years (satisfying “professional experience in solar energy”) while having some familiarity with module manufacturing would not be of ordinary skill in the design aspects of the ’060 patent as, for example, reflected by the claims at issue and the ’060 patent’s text and figures. See, e.g., Ex. 1101, Figs. 2a, 2b, 3a, 3b, 4a, 4b, 3:22–7:44. On the other hand, we also determine that Patent Owner’s proposal is too narrow. A person could, for example, have ordinary skill in the art of the ’060 patent by virtue of non-professional experience (for example, academic experience). When assessing relevant experience, research work done for a university (beyond mere classroom study) would have been just as valuable as research work done for a corporation. Also, ordinary skill in the art could be demonstrated by work that requires understanding of the ’060 patent’s field even if not “designing, developing, and/or researching” in the field itself We, thus, determine that a person of ordinary skill in the art of the ’060 patent would have been someone with a bachelor’s degree in electrical engineering, applied physics, or the like, and at least two years of (a) experience designing, developing, and/or researching in the field or (b) experience in solar energy that required an understanding of the ’060 patent’s field. Alternatively, that person would have had an advanced degree in electrical engineering, applied physics, or the like and at least one year of” slip op. at 11

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “qualifies as evidence in this matter. The Federal Circuit has held that expert testimony about the perspective of person of ordinary skill in the art (as Dr. Kimball provides here) must come from a person having at least ordinary skill in the art. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–78 (Fed. Cir. 2022) (quoting Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1362, 1364–65 (Fed. Cir. 2008)) (holding that ITC Administrative Law Judge abused discretion by admitting expert testimony of witness who lacked the experience of a person having ordinary skill in the art); see Mot. Excl. 6–7 (arguing this point). Patent Owner, however, cites no authority that expert testimony on such matters come from a person having ordinary skill in the art at the time of the invention. Cf. Scentair Tech., LLC v. Prolitiec Inc., IPR2021-00012, Paper 22 at 61 (PTAB Apr. 22, 2022) (similarly noting a party’s lack of authority on this point). Beyond needing to come from a person of ordinary skill in the art, expert testimony is admissible if the expert has the “scientific, technical, or other specialized knowledge [that] will help the trier of fact to understand the evidence or to determine a fact in issue.” Fed. R. Evid. 702. Furthermore, “[t]here is … no requirement of a perfect match between the expert’s experience and the relevant field.” USPTO, Patent Trial and Appeal Board Consolidated Trial Practice Guide, 34 (Nov. 2019). Here, Petitioner adequately establishes that Dr. Kimball qualifies as a” slip op. at 12

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

    “The Petition argues that all claim terms should be given their plain and ordinary meaning. Pet. 18. Patent Owner does not dispute this. PO Resp. 13. We determine that no claim term requires express construction for purposes of this Final Written Decision. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms that are in controversy, and only to the” slip op. at 15

  Patent outcomesUS 10,749,060 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,749,060
• Illumina, Inc. v. Natera, Inc.No claims unpatentable
  PTAB · Dec 11, 2020 · IPR2019-01201 · APJ Cynthia M Hardman · IPR · Final written decision

  Claims 1–27 were not shown unpatentable: the single-cell Dhallan theories lacked a reasonable expectation of success, and Rabinowitz was not established as prior art.

  RulingsFinal written decision

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

    “In sum, Petitioner’s evidence in the Petition establishes that single cells were used for genetic analysis, amplification techniques were known, and SNP arrays could be used to analyze chromosome imbalances. Petitioner’s evidence, however, does not persuasively address the interplay between the amount of DNA in a single cell and the amount of DNA or amplified DNA needed to carry out the claimed method using a SNP 22 genotyping array and Dhallan’s aneuploidy analysis. This is important because Patent Owner cites evidence demonstrating that at the relevant time, “various researchers had determined that very low amounts of DNA could not be reliably used for SNP genotyping arrays (even with intervening amplification).” PO Resp. 47.” slip op. at 22

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “On this record, we agree with Patent Owner and Dr. Quackenbush that the ’406 application and ’741 provisional together demonstrate to persons of 23 The ’741 provisional is incorporated by reference into the ’406 application. Ex. 1026, 1:5–13. 48 ordinary skill that the inventors understood pyrosequencing could be used for high-throughput sequencing, if expensive machines were purchased. In other words, the ’741 provisional gives context to the statement in the ’406 application, and we agree with Dr. Quackenbush that “‘[s]uitability’, as the provisional makes clear to a person of ordinary skill in the art, is a cost issue, rather than a technical one.” Ex. 2012 (Quackenbush Decl.) ¶ 277; see also id. ¶¶ 276–80 (opining on disclosures in the ’741 provisional).” slip op. at 48

  • ExcludeMotion to exclude, deniedDenied

    “As to Dr. Quackenbush’s qualifications, although Petitioner characterizes his expertise as relating to statistics, the record reflects that he also has adequate experience in the fields of genetics and biotechnology. For example, he is Professor of Computational Biology and Bioinformatics, the Chair of the Department of Biostatistics, and the Director of the Health Data Science Center at the Harvard TH Chan School of Public Health. Ex. 2013, 1. He has almost three decades of experience in research and teaching in the fields of genetics and biotechnology (id. at 1–8, 12), has published hundreds of articles in these fields (id. at 13–52), was the Editor-in-Chief of the journal Genomics for over a decade (id. at 8), and has served as a peer reviewer, or on the editorial board, of a dozen other publications relating to genetics and biotechnology (id. at 7–8). Paper 49, 2. Given that experience in genetics and biotechnology, we find that Dr. Quackenbush has sufficient 54 specialized knowledge, experience, and education in the techniques of the ’592 Patent and prior art, such as DNA amplification, genotyping, and analysis of genetic data, for his testimony to be helpful to us. Moreover, even if Dr. Quackenbush did not personally work in fetal diagnostics at the relevant time, there is no requirement that a declarant must actually be a person of ordinary skill in the art to present testimony as to what such a person would have understood at the time of the invention. See, e.g., SEB S.A., 594 F.3d at 1373 (stating there is no requirement of a perfect match between an expert’s experience and the field of the art in question, provided the expert has “sufficient relevant technical experience” to testify). The remaining arguments raised in Petitioner’s motion relate to the sufficiency, rather than admissibility, of evidence. Such arguments are improperly advanced in a motion to exclude. See TPG 79 (stating that a motion to exclude may not be used to challenge the sufficiency of the evidence to prove a particular fact); see also Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 19 (PTAB May 1, 2014) (“[T]he Board, sitting as a non-jury tribunal, is well-positioned to determine and assign appropriate weight to the evidence presented in this trial.”). Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00010, Paper 59 at 40 (PTAB February 24, 2014). Rather than excluding evidence that is allegedly 55 confusing, misleading, or incorrect, we simply give it the appropriate weight in our analysis.” slip op. at 54

  • Strike new argumentNew argument disregardedDecided for patent owner

    “success arguments focus solely on Dhallan’s single cell disclosure, while “ignor[ing] Dhallan’s disclosure that its methodology can be performed using 2–32 cells, which also falls within the claims.” Reply 18 (citing, e.g., Pet. 13–14). Patent Owner responds that this is an improper attempt to change the thrust of the obviousness theory presented in the Petition. Sur-reply 16–17. We agree with Patent Owner. Although the Petition references portions of Dhallan that address using sources of DNA other than a single cell (see, e.g., Pet. 13–14, citing Ex. 1002 ¶¶ 44, 74), this is by way of background only, falling within a section titled “Introduction to Dhallan.” See Pet. 11. Petitioner’s detailed obviousness arguments for claim 1 are limited to use of DNA from a single cell, and do not extend to DNA from multiple cells.15 See, e.g., id. at 19–20 (arguing that, because Dhallan’s preferred embodiment is one embryo cell, Dhallan teaches the claimed limitation reciting “wherein the small amount of genetic material from the individual is from fifty or fewer of the individual’s 15 As noted above, claim 1 recites several possible sources for the claimed “small amount of genetic data.” See supra n.9. Here we focus on Petitioner’s unpatentability arguments based on option [i], but note that Petitioner’s unpatentability arguments under options [ii] and [iii] also did not extend to use of DNA from multiple cells. See, e.g., Pet. 20 (cross-referencing arguments for claims 4, 5, and 17); id. at 34 (for claim 4, arguing option [ii] based on “a single human cell”); id. at 35 (for claim 5, arguing option [iii] based on “extracellular fetal DNA from maternal blood”); id. at 42 (for claim 17, arguing option [iii] based on a “single fetal cell”). 30 cells”); id. at 29 (“A POSA would have been motivated to use a single cell as the source of genetic material . . . .”); id. at 31 (“A POSA would have reasonably expected success in using Dhallan’s methodology, for example as described in Example 14, on one embryonic cell.”). Accordingly, we agree with Patent Owner that Petitioner is impermissibly attempting to change the thrust of its obviousness theory on reply. Sur-reply 16–17. We will not consider Petitioner’s belated attempt to argue a reasonable expectation of success in using more than a single cell in the claimed method. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the . . . patent owner response.”).” slip op. at 30

  Patent outcomesUS 8,682,592 not shown unpatentable
  Claim construction§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,682,592
• Skechers U.S.A., Inc. v. Nike, Inc.No claims unpatentable
  PTAB · Jun 28, 2018 · IPR2017-00621 · APJ Grace Karaffa Obermann · IPR · Final written decision

  The sole challenged claim was not shown unpatentable because Petitioner failed to identify a qualifying Rosen reference for its obviousness challenges.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “Petitioner bears “the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). Our rules require a successful petition to include “a detailed explanation of the significance of the evidence including material facts.” 37 C.F.R. § 42.22(a)(2)). An issue bearing on the challenge is whether and how the claimed channel element impacts the “visual impression created by the patented design as a whole.” Durling, 101 F.3d at 103; see Ex. 1001, Fig. 1 (depicting an elongated region, of relatively darker shading, superimposed over about two thirds of a sipe that bisects the claimed heel region).” slip op. at 18

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “ordinary skill in the art would have had either (1) a degree in Industrial Design combined with some work experience as a designer of footwear designs; or (2) two years of direct experience creating footwear designs. 9 The Petition asserts U.S. Patent No. 6,115,945 (Ex. 1006, “the ’945 patent”) as a background reference. See, e.g., Pet. 5, 34. Dec. 7. That definition is consistent with Petitioner’s proposed definition. Pet. 36 (Petitioner’s definition); Reply 2 (Petitioner, reasserting that definition). Patent Owner, for its part, raises no persuasive information tending to establish a different definition. Resp. 2 (Patent Owner, essentially acquiescing to Petitioner’s definition). That definition also is consistent with the disclosures reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 4

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

    “D. Claim Construction The claim of the ’781 patent does not require express construction for the purposes of this decision. On that point, we observe that Figures 1–3 of the ’781 patent (Ex. 1001) reflect the scope of the patented design. To the extent any explanation of that scope is necessary to our decision, we provide it below in our analysis of the asserted challenge. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

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

    “Conclusions Regarding the First Prong of the Durling Test A preponderance of the evidence supports a conclusion that Petitioner fails to take account adequately of the channel element of the patented design and, therefore, fails also to identify “the correct visual impression created by the patented design as a whole”—a required first step in identifying a Rosen reference. Durling, 101 F.3d at 103. That failure, standing alone, justifies our conclusion that Petitioner fails also to prove by a preponderance of the evidence that the challenged claim of the ’781 patent is unpatentable.” slip op. at 20

  Patent outcomesUS D723,781 not shown unpatentable
  Claim construction§ 103 obviousness
• Skechers U.S.A., Inc. v. Nike, Inc.No claims unpatentable
  PTAB · Jun 28, 2018 · IPR2017-00620 · APJ Grace Karaffa Obermann · IPR · Final written decision

  The Board held the challenged claim not shown unpatentable because Petitioner failed to identify a Rosen reference creating basically the same overall visual impression.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “C. The Designer of Ordinary Skill As we did in our institution decision, we find that a designer of ordinary skill in the art would have had either (1) a degree in Industrial Design combined with some work experience as a designer of footwear designs; or (2) two years of direct experience creating footwear designs. 9 The Petition asserts U.S. Patent No. 6,115,945 (Ex. 1006, “the ’945 patent”) as a background reference. See, e.g., Pet. 5, 33. Dec. 7. That definition is consistent with Petitioner’s proposed definition. Pet. 35 (Petitioner’s definition); Reply 2 (Petitioner, reasserting that definition). Patent Owner, for its part, raises no persuasive information tending to establish a different definition. Resp. 2 (Patent Owner, essentially acquiescing to Petitioner’s definition). That definition also is consistent with the disclosures reflected in the asserted prior art references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 4

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

    “D. Claim Construction The claim of the ’783 patent does not require express construction for the purposes of this decision. On that point, we observe that Figures 1–3 of the ’783 patent (Ex. 1001) reflect the scope of the patented design. To the extent any explanation of that scope is necessary to our decision, we provide it below in our analysis of the asserted challenge. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 5

  • BurdenFwd all claims patentableNot shown unpatentable

    “Petitioner bears “the burden of proving a proposition of unpatentability by a preponderance of the evidence.” 35 U.S.C. § 316(e). Our rules require a successful petition to include “a detailed explanation of the significance of the evidence including material facts.” 37 C.F.R. § 42.22(a)(2)). An issue bearing on the challenge is whether and how the claimed channel element impacts the “visual impression created by the patented design as a whole.” Durling, 101 F.3d at 103; see Ex. 1001, Fig. 1 (solid concentric ovals, which depict a channel element near the center of the claimed grid-like pattern of pads).” slip op. at 16

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

    “As a starting point, to make out a successful obviousness challenge, Petitioner must identify “a reference, a something in existence, the design characteristics of which are basically the same as the claimed design in order to support a holding of obviousness. Such a reference is necessary whether the holding is based on the basic reference alone or on the basic reference in view of modifications suggested by secondary references.” Rosen, 673 F.2d at 391. Accordingly, “the first step in an obviousness analysis for a design patent requires a search of the prior art for a primary reference,” which requires the tribunal “to: (1) discern the correct visual impression created by the patented design as a whole; and (2) determine whether there is a single reference that creates ‘basically the same’ visual impression.” Durling v. Spectrum Furniture Co., 101 F.3d 100, 103 (Fed. Cir. 1996). We address the two prongs of the Durling test in turn below.” slip op. at 6

  Patent outcomesUS D723,783 not shown unpatentable
  Claim construction§ 103 obviousness
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01835 · APJ Lora M Green · IPR · Final written decision

  Claims 1–10 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success substituting lomitapide into Pink Sheet’s dosing protocol.

  RulingsFinal written decision

  • BurdenFwd all claims patentableNot shown unpatentable

    “We have jurisdiction under 35 U.S.C. § 6. Petitioner bears the burden of proving unpatentability of the challenged claims, and that burden never shifts to Patent Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail, Petitioner must establish facts supporting its challenge by a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Based on the record before us, we conclude that Petitioner has failed” slip op. at 3

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedDecided for patent owner

    “under 35 U.S.C. § 102 “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). “Because there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b).” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (citing In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). “A given 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.” SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008) (quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)).” slip op. at 14

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation not foundMixed

    “Although we find this issue to be very close, we find that the Petitioner has established by a preponderance of the evidence that the ordinary artisan would have looked at other MTP inhibitors, such as lomitapide as taught by Chang, that could be used in the dosing protocol taught by Pink Sheet. Specifically, Pink Sheet teaches a dosing method with the MTP inhibitor, implitamide, wherein, as discussed above, the dosing schedule meets the dosing schedule required by claim 1. Ex. 1013. In addition, Pink Sheet discusses MTP inhibitors generally, and notes that they may have efficacy in situations where high-dose statins are ineffective or inadequate, such as homozygous and severe heterozygous familial hypercholesterolemia. Id. Pink Sheet also acknowledges that the toxicity seen with MTP inhibitors may have been due to the high doses used during the clinical trials. Id. Chang discusses the clinical efficacy of MTP inhibitors, including implitapide (BAY-13-9952) and lomitapide (BMS-201038). Ex. 1015, 566. Specifically, Chang discusses the clinical efficacy of CP-346086, and then notes that similar efficacy was reported for implitapide and lomitapide. Id. Given that implitapide and lomitapide are from the same class of therapeutics, that is, MTP inhibitors, and that they are known to have similar clinical efficacy, based on the record before us, we determine that Petitioner has demonstrated a reasonable basis as to why the ordinary artisan would have substituted lomitapide as taught by Chang for implitapide in the method of Pink Sheet.” slip op. at 32

  • Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia with nexusDecided for patent owner

    “Initially, we note that Petitioner does not contest that Juxtapid is a commercial success, and, thus, in view of the unrebutted evidence provided by Patent Owner, we find that Patent Owner has established that Juxtapid is a commercial success. As to Petitioner’s argument that the Juxtapid website does not suggest a forced titration, as set forth in our section on claim construction above, we decline to construe independent challenged claim 1 as requiring a forced titration. Moreover, as shown in the table below, the dosing schedule of independent claim 1 encompasses the dosing method that is given to doctors on the Juxtapid website (Ex. 2301, 1):” slip op. at 43

  Patent outcomesUS 8,618,135 not shown unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,618,135

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.