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  • PTAB · Sep 23, 2026 · IPR2025-00878 · APJ Carl M Defranco · IPR · Final written decision

    Claims 1–3 and 11 are unpatentable as anticipated by Cleveland and obvious over Nakagawa and over Nakagawa combined with Tanner.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “would have at least a bachelor’s degree in mechanical or chemical engineering, materials science, polymer science, or equivalent coursework, at least a year of experience developing paper-based laminates involving the application of polymer coatings to a substrate, and the appropriate industry familiarity with biodegradability standards and degradability techniques [and] . . . [l]ess work experience may be compensated by a higher level of education, such as a master’s degree, and vice versa. Pet. 16 (citing Ex. 1003 ¶ 50). Clearwater’s definition is uncontested, and we apply that definition here, as it accords with the level of skill reflected in the asserted prior art and the problems addressed in the specification of the ’126 patent. C. Claim Construction” slip op. at 6

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “We have reviewed the cited testimony of Clearwater’s expert, including their calculations for arriving at a coat weight in Nakagawa that falls within the claimed range. See Ex. 1003 ¶¶ 132–33. We find that testimony, which is unrebutted, both credible and supported by the evidence of record. Thus, in light of Clearwater’s contentions, the cited portions of Nakagawa, and the unrebutted testimony of Clearwater’s expert, we are persuaded that Nakagawa discloses or otherwise suggests each and every element of claim 1. See Pet. 45–54, 60–64. Clearwater also persuades us that Cleveland discloses the additional subject matter of dependent claims 2, 3, and 11. See Pet. 64–66. Thus, we determine that Clearwater demonstrates that claims 1–3 and 11 are unpatentable as obvious over Nakagawa. F. Ground 3—Obviousness Over Nakagawa and Tanner” slip op. at 17

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner

      “qualifies as prior art under 35 U.S.C. § 102(e)(1) “based on both its provisional and non-provisional filing dates.” Inst. Dec. 4 n.5. We were persuaded by Clearwater’s proof that Cleveland’s provisional (Ex. 1006) is “virtually identical” to Cleveland itself (Ex. 1005) and that the provisional provides written description support for at least claim 1 of Cleveland. See Pet. 18–21 (citing Ex. 1006, 2–6, 9). We were also persuaded by Clearwater’s showing that the provisional provides written support for the subject matter relied upon in Cleveland. Id. at 21–40 (citing Ex. 1006, 1–9). We are still persuaded by Clearwater’s showing. Thus, we see no reason to disturb our earlier finding that Cleveland is prior art to the ’126 patent.” slip op. at 7

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

      “protectant layers has “a coat weight of from 5 to 30 lbs/3000 ft2.” As noted by Clearwater, Cleveland discloses a total coat weight for layers 14 and 16 as falling within the claimed range. Pet. 32–34 (citing Ex. 1005 ¶ 32). In particular, Cleveland discloses that “the coextruded layer of copolyester (irrespective of which side of the substrate the layer is disposed) is of a total coat weight of between about 10 and about 40 lb/3000 ft2 in any combination of between about 80/20 to 20/80 parts by weight of Ecoflex to Biomax,” of which “a total coat weight of 25 lb/3000 ft2 is preferred.” Ex. 1005 ¶ 32. As disclosed, Cleveland’s total coat weight range of 10–40 lb/3000 ft2 falls almost entirely within the claimed range, and the preferred total coat weight of 25 lb/3000 ft2 falls squarely within the claimed range. Thus, Cleveland satisfies claim elements [1.3.2] and [1.5.2]. See Titanium Metals Corp. v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) (“[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is anticipated if one of them is in the prior art.”) (citation omitted). As such, we find that Clearwater adequately demonstrates that Cleveland discloses all the elements of claim 1. 4. Dependent Claims” slip op. at 12

    Patent outcomesUS 8,637,126 unpatentable
    § 102 anticipation§ 103 obviousnesscites Phillips
    Patents in suitUS 8,637,126
  • PTAB · Sep 8, 2026 · PGR2025-00023 · APJ Per Curiam · PGR · Final written decision

    Claims 1–9 are unpatentable as anticipated by the ’629 publication; the claims are not entitled to the 2013 priority date.

    RulingsFinal written decision
    • Skill levelSkill level board ownOther

      “We find that a rigid requirement as to the subject of a POSITA’s doctoral degree (e.g., biochemical engineering, enzymology), or experience working specifically with horseshoe crab proteins, is not consistent with the evidence of record. See, e.g., Ex. 1067, 20:23–21:2 (Dr. Schaefer testifying that the fact the “name of [his] Ph.D. is immunology . . . does not change the fact that the core of [his] thesis training was really in molecular biology”), 22:3–15 (explaining that “the fact that the production of proteins recombinantly is mostly species agnostic”); Ex. 1069, 45:20–47:17 (Dr. Morris testifying that whether a person is a POSITA depends on the person’s “experience, [ ] publications,” and work done for the Ph.D. rather than the name of the Ph.D. program). We also find that evidence of record supports Petitioner’s assertion that, for purposes of defining a POSITA, “[m]ore education could substitute for experience, and vice versa.” See, e.g., Pet. 22; Ex. 1065, 99:14–100:3. Accordingly, based on the entirety of the trial record, we find a POSITA with respect to the claims of the ’109 patent would have had a two years of experience with cloning genes, expressing cloned genes as proteins, and/or characterizing such cloned genes and proteins, with more education being able to substitute for experience, and vice versa. A POSITA may also have collaborated with others, including those with specific experience in utilizing or assessing horseshoe crab Factor C for endotoxin detection and quantitation.” slip op. at 9

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

      “Neither party proposes an express construction of any claim term. See Pet. 22–23 (not proposing any constructions); PO Resp. 23 (“Patent Owner agrees that the terms can be afforded their plain and ordinary meaning.”). However, Patent Owner states that some of Petitioner’s arguments implicitly construe claim 1 in an erroneous manner. PO Resp. 23–28. “For example, Petitioner argues that ‘an adequate written description would have to either disclose representative examples of the possible working cascades of various proteins or some accurate structural feature of the claimed proteins that allow them to function in the claimed assay as a whole.’” Id. at 23 (quoting Pet. 35). Patent Owner argues that, contrary to what Petitioner’s argument allegedly implies, “Claim 1 is directed to a method for producing an endotoxin assay agent” and does not require the use – Owner that claim 1 does not require the use of endotoxin assay agent. However, the claimed endotoxin assay agent must be capable of performing the assay, as counsel for Patent Owner acknowledged. Tr. 83:5–9.” slip op. at 10

    • BurdenNot shown unpatentable

      “In this case, to show that the claims of the ’109 patent are unpatentable for lack of written description, Petitioner would have needed to show that the specification as filed (i.e., the ’420 application) fails to reasonably convey to those skilled in the art that Patent Owner had possession of the claimed subject matter as of the July 3, 2023, filing date. Petitioner did not. Pet. 23–24. Nor does Petitioner’s declarant offer testimony that could support such a showing. See Ex. 1003 ¶50 (“I have been asked to provide my opinions as to the state of the art in this field for purposes of determining what the inventors disclosed as their invention as of December 10, 2013.”), ¶51 (“Whenever I offer an opinion in this declaration about the knowledge of a POSA, the manner in which a POSA would have understood the claims of the ’109 patent or its description, the manner in have been led to do based on the prior art, I am referencing the December 10, 2013 timeframe.”). In our Institution Decision, we stated: Although the ’420 application is essentially identical to the ’767 application, the person of ordinary skill in 2013 is not the same as in 2023. See Ariad, 598 F.3d at 1351 (“[T]he [written description] test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” (emphasis added)). Thus, the information presented in the Petition, which is limited to the perspective of a 2013 POSITA, does not demonstrate that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable for lack of written description. Inst. Dec. 12 (alterations in original). During trial, Petitioner did not present any further arguments in support of Ground 1. See generally Pet. Reply. Petitioner has failed to prove that claims 1–9 are unpatentable for failing to meet the written description requirement set forth in 35 U.S.C. § 112(a).” slip op. at 12

    • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable

      “Although the evidence before us shows that, in 2013, a POSITA knew how to recombinantly express genes in expression systems such as CHO or HEK-293 cell lines, the evidence shows that this was true only for genes whose genetic sequences were known or readily available. See, e.g., Ex. 1069, 34:11–22 (“Q. Okay. So you would agree that the creation of the recombinant protein requires the underlying sequence of, as you said, the original animal? A. Of course.”) Because it is undisputed that, in 2013, the genetic sequence for Limulus polyphemus Factor C was unknown, or least not publicly available, Falko-Gunter does not support a finding of adequate written description here. See, e.g., Tr. 48:18–19 (“Patent Owner agrees that there had not been, as of 2013, the full length cDNA sequence for Limulus polyphemus Factor C published.”).” slip op. at 23

    Patent outcomesUS 11,959,109 unpatentable
    Claim construction§ 102 anticipation§ 112 disclosure
    Patents in suitUS 11,959,109
  • PTAB · Aug 4, 2026 · IPR2025-00249 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 1 and 4–8 are unpatentable: claims 1 and 4–6 as obvious over Huang2 and Kuo, and claims 7–8 as anticipated by Huang2; claims 2–3 were not shown unpatentable.

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

      “(“POSITA”) “would be a Ph.D. student with a minimum of two years of experience in their faculty advisor’s laboratory” and would have an understanding of “electrospinning fibers, including for tissue engineering, tissue engineering techniques, and using/performing FFT analysis.” Pet. 20– 21 (citing Ex. 1003 § II.C7). Patent Owner does not dispute Petitioner’s proposal but specifies the set of disciplines within which the Ph.D. would have been earned, namely “bioengineering, chemical engineering, mechanical engineering, or a related engineering discipline.” PO Resp. 6. We adopt and apply Petitioner’s proposal as clarified by Patent Owner regarding the Ph.D. discipline.” slip op. at 7

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

      “At the outset, we agree with Patent Owner that the Specification purports to define “major peaks” in the following sentence: “The ‘major peaks’ herein refer to peaks higher than the average of the peaks in the result.” Ex. 1001, 13:28–29. We determine that this language satisfies at least two of the criteria set forth in Alnylam. Specifically, the sentence at “refers to” to explain what qualifies as major peaks. That is not the end of the inquiry, however, as we find there is still some ambiguity as to whether the patentee intended to define “major peaks” so as to require so-called “minor peaks” in the claimed invention. See Bell Atlantic, 262 F.3d at 1268 (“[T]he intrinsic evidence must ‘clearly set forth’ or ‘clearly redefine’ a claim term so as to put one reasonably skilled in the art on notice that the patentee intended to so redefine the claim term.”). Importantly, the Specification does not treat the existence of minor peaks as prerequisites for the existence of major peaks. Indeed, the Specification does not discuss “minor peaks” at all. See generally Ex. 1001. Likewise, none of the claims of the ’227 patent, whether challenged or unchallenged, recites “minor peaks” or any additional peaks beyond the disputed “major peaks.” Id. at 23:30–24:42. Nor does the Specification include an example of FFT analysis results in which the average of the peaks therein is calculated and those higher than the average are identified as major peaks.8” slip op. at 9

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

      “Petitioner has the better position. Huang2 teaches crosslinking and provides a reason for doing so (stability). In particular, Huang2 states: “To better mimic skin ECM, electrospun collagen fibers have been fabricated, however, the rapid degradation and poor mechanical properties determine that either crosslinking or combination with other materials is necessary to obtain a stable scaffold.” Ex. 1005, 1791 (emphasis added). It is true that, in describing work actually carried out, Huang2 states that blending with PCL was performed and does not mention crosslinking. See id. at 1792 (“Nanofibrous matrices of PCL and Collagen at a weight ratio of 3:1 were fabricated using electrospinning as previously described.”). However, the prior art – here, Huang2 – is not limited to that which it describes having created. See In re Mills, 470 F.2d 649, 651 (C.C.P.A. 1972) (“a reference is not limited to the disclosure of specific working examples”); see also In re Lemelson, 397 F.2d 1006, 1009 (CCPA 1968) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”); In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992) (“It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art.”). Huang2 teaches two stabilization methods when using collagen in scaffolds. Huang2 states that one or the other “is necessary to obtain a stable scaffold” (when using collagen), but it does not preclude or teach away from using Patent Owner-cited testimony of Dr. Mikos is not as definitive as Patent Owner suggests; Dr. Mikos’s testimony is that a person of ordinary skill in the art “typically would not have done both.” Ex. 2015 ¶64 (emphasis added). The bottom line is that Huang2 teaches the person of ordinary skill in the art two ways to stabilize scaffolds/matrices comprised of collagen, provides a reason for doing so (stability), and does not teach away from using both. We are persuaded that a “scaffold comprising crosslinked fibers comprising collagen” would have been obvious in view of the cited teachings of Huang2.” slip op. at 33

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

      “We are not persuaded by Appellant’s citations to either reference. As discussed above, Petitioner’s Ground 1 is premised on a person of ordinary skill in the art altering the native flat sheet structure of Huang2 by rolling it into a jelly-roll structure as taught by Kuo. See Pet. 41 (Beginning its claim 2 arguments with the following: “Claim 1 is obvious for the reasons expressed above in § X.A., supra, which are incorporated herein.”); see also Pet. Reply 17 (“[B]ased on the explicit teaching of Kuo, a POSA would have been motivated to take the electrospun flat scaffold made by the techniques of Huang2, seed it with the desired cells, and roll it to treat a tendon and ligament.” (emphasis added)). Indeed, the paragraphs of Kuo that Petitioner cites for disclosing “scaffold sheets,” explicitly describe rolling them into jelly-roll like structures. See Ex. 1018 ¶7 (stating that “the sheet is spirally contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct”), ¶22 (describing a method comprising “forming a tissue construct by contacting a scaffold sheet of fibrous material with a cell; and rolling the scaffold sheet in a jelly-roll like manner to form a spirally wound tissue construct” and implanting it in a patient). Petitioner fails to argue that that “one or more elongated sheets” recited in claim 2 would encompass the rolled structure of its proposed modification. Nor does Petitioner articulate a claim construction argument that could support such an argument. Petitioner has failed to prove, by a preponderance of the evidence, that claim 2 would have been obvious over Huang2 and Kuo.” slip op. at 42

    Patent outcomesUS 11,318,227 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Markman · KSR
    Patents in suitUS 11,318,227
  • PTAB · Jul 22, 2026 · IPR2024-01095 · APJ Garth D Baer · IPR · Remand

    On remand, the Board maintained its finding that claims 2 and 17 are unpatentable under §103 over Diekmann and Ma, and Suzuki and Ma.

    RulingsRemand decision
    • RemandDecided for petitioner

      “that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

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

      “Dependent claims 2 and 17 require an electron transport layer (ETL) that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “that is both n-doped and comprised of 8-hydroxy-quinolinolato-lithium (Liq). The district-court defendant’s first invalidity challenge relied primarily on Clix2, which lacked an n-doped ETL. Paper 48, 2, Paper 50, 3. Thus, the asserted combination required modifying Clix2’s non-doped ETL by adding an n-dopant. Clix2’s missing n-doped ETL appeared to be a focus at trial. See Ex. 2034, 917:1–18, 920:8–14. Here, in contrast, Petitioner proposed a more modest modification to materially different primary references, Suzuki and Diekmann, which both already have n-doped ETLs. See Paper 50, 2–3; Paper 54 8–9. As we explained in our Final Written Decision, because Patent Owner did not contest that Liq acts as an n-dopant in Ma, Petitioner’s combinations were obvious because they merely “substitute one known n-dopant for another to further the same goal of improving ETL conductivity.” Paper 54, 12. That simple-substitution analysis would not be the same when n-doping Clix2’s non-doped ETL. For this reason, we agree with Petitioner that the district-court Clix2-based combination “is a different combination with a materially different motivation-to-combine analysis,” as compared to the Diekmann/Suzuki and Ma combinations that are at issue here. Paper 50, 3.” slip op. at 2

    Patent outcomesUS 11,828,425 unpatentable
    § 103 obviousness
    Patents in suitUS 11,828,425
  • PTAB · Jun 3, 2026 · IPR2025-00257 · APJ Lilan Ren · IPR · Final written decision

    Claims 1–15 are unpatentable because Petitioner proved by a preponderance of the evidence that the asserted § 103 grounds render them unpatentable.

    RulingsFinal written decision
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “proceeding, we determine Petitioner has proven by a preponderance of the evidence that each of claims 1–15 of the ’660 patent is unpatentable.” slip op. at 85

    Patent outcomesUS 9,592,660 unpatentable
    § 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 9,592,660
  • PTAB · Mar 10, 2026 · IPR2024-01209 · APJ Susan L C Mitchell · IPR · Final written decision

    Claims 1–27 are unpatentable as obvious over the asserted combinations, principally Racz, Fitz, and Lee; both parties’ motions to exclude are dismissed as moot.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “PO Resp. 30 (citing Ex. 2006 ¶ 58). Patent Owner’s proposal is too narrow in two respects. First, it mandates certain education and experience in RF neurotomy specifically. This is too narrow as the description of the scope of the invention set forth in the ’782 patent as described above is not limited to RF neurotomy. Second, it requires the POSA to be both a physician who performs thermal ablation (RF neurotomy specifically) and an engineer with training and experience “in the design and development of devices and methods” for performing the same. Id. This is too narrow because it excludes physicians and other advanced degree holders who research and design devices and methods for performing thermal ablation but do not actually operate on patients. We adopt the Petitioner’s definition of a POSA, quoted above, as it is reflective of the level of skill in the art when viewed in light of the disclosure of the ’782 patent. Supra (quoting Pet. 11).” slip op. at 16

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

      “With respect to the challenged claims, Petitioner contends that no claim term requires express construction. Pet. 12 (citing Ex. 1031 ¶106 (Dr. Robert D. Tucker’s11 testimony that “the terms in the Challenged Claims would be understood by a POSA to have their plain and ordinary meaning and do not require a special construction or definition”)). In instituting the IPR, we found no need to provide an express construction of any claim term. Inst. Dec. 12. We likewise find no need to do so now, as neither party has proposed a construction for any claim term and none of the parties’ arguments turns on a disputed meaning of any claim language.” slip op. at 11

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “(Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Clay, 966 F.2d at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 34. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 18.” slip op. at 24

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 148 of his declaration. Ex. 1031 ¶148. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶110–117 (Racz), ¶¶118–123 (Fitz), ¶¶124–131 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶132–147). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he has “been a Professor at the University of Iowa where [he] direct[s] an active research program in radiofrequency electrosurgical procedures and instrumentation.” Ex. 1031 ¶3. He has a Ph.D. in biophysics, and he is also a medical doctor (albeit he is not Board certified as pointed out by Patent Owner19). Id. ¶2. He also has additional training and experience that is relevant, but which is not necessary, but further establishes that he is well qualified to offer the opinions set forth in his declaration. Id. ¶¶2–11. Patent Owner argues that Dr. Tucker is not qualified to testify here because “he is not Board certified” and he is “not a pain-specialist physician and has never performed a neurotomy.” PO Resp. 30. Dr. Tucker explained, however, that he is not Board certified nor does he operate on 19 See PO Resp. 30 (citing Ex. 2020, 10:19–12:20). patients because his work focuses on the development of instrumentation, not the use of it, explaining on cross-examination:” slip op. at 39

    Patent outcomesUS 10,966,782 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,966,782
  • PTAB · Mar 6, 2026 · IPR2024-01211 · APJ Michael J Fitzpatrick · IPR · Final written decision

    Claims 18–47 and 53–74 are unpatentable as obvious over the asserted combinations of Racz, Fitz, Lee, and the additional references in Grounds 2–8.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “In sum, the field of the invention is thermal ablation. It encompasses RF neurotomy, but it is not limited to RF neurotomy. With that settled, we turn now to the person of ordinary in the field/art (POSITA or POSA).” slip op. at 17

    • Expert testimonyPetitioner expert creditedDecided for petitioner

      “Dr. Tucker’s testimony is not a bald conclusion. His conclusion as to a reasonable expectation of success is set forth in paragraph 162 of his declaration. Ex. 1033 ¶162. It is supported extensively with testimony regarding what the prior art teaches (see id. ¶¶124–131 (Racz), ¶¶132–137 (Fitz), ¶¶138–145 (Lee)) and why and how a POSA would have combined the prior art teachings (see id. ¶¶146–161). Dr. Tucker’s testimony clearly is entitled to weight. Since 1983, he” slip op. at 39

    • Obviousness (§103) › Analogous artAnalogous artDecided for petitioner

      “35. “Although § 103 does not, by its terms, define the ‘art to which [the] subject matter [sought to be patented] pertains,’ this determination is frequently couched in terms of whether the art is analogous or not, i.e., whether the art is ‘too remote to be treated as prior art.’” In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (quoting In re Sovish, 769 F.2d 738, 741 (Fed. Cir. 1985)). “Whether a reference in the prior art is ‘analogous’ is a fact question.” Id. at 658. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Id. at 658–59. Patent Owner argues that Lee is not analogous art under the first criterion because “Lee does not relate to neurotomy at all.” PO Resp. 33. However, as discussed above, the field of the invention is not limited to neurotomy. The field of the invention is thermal ablation generally, which encompasses RF neurotomy, but which is not limited to RF neurotomy. Accordingly, we are not persuaded by Patent Owner’s argument. To the contrary, we are persuaded by Petitioner’s argument that Lee is analogous art, under at least the first Clay criterion, because it “discloses various techniques for deploying electrodes from the tip of an RF ablation device.” Pet. 17.” slip op. at 25

    • BurdenDecided for petitioner

      “Patent Owner does not identify any legal requirement for petitions to illustrate proposed combinations of prior art features. Indeed, the very statute identified by Patent Owner as “requiring petitions to set forth challenge grounds ‘with particularity’” (see PO Resp. 36) calls for the requisite particularity to be “in writing,” not by illustration. See 35 U.S.C. § 312(a)(3) (“A petition filed under section 311 may be considered only if . . . (3) the petition identifies, in writing and with particularity . . . the grounds on which the challenge to each claim is based.”). Simply put, there is no legal requirement to provide multiple illustrations of a proposed combination of prior art features (as Patent Owner implies), let alone a single illustration (as Petitioner has done).” slip op. at 28

    Patent outcomesUS 10,736,688 unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,736,688
  • PTAB · Mar 5, 2026 · IPR2024-01212 · APJ Arthur M Peslak · IPR · Final written decision

    Claims 1–29 are unpatentable because Petitioner showed by a preponderance of the evidence that the asserted prior-art combinations rendered them obvious under §103.

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

      “improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In this case, we must determine whether one of ordinary skill in the art would recognize that applying the teachings of Fitz and Lee of deploying multiple filaments to increase and control the ablation volume to Racz’s distal tip would improve Racz’s device in the same way. For us to resolve this question in Petitioner’s favor, Petitioner must provide “some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (citing In re Kahn, 441 F.3d at 988). However, bodily incorporation, i.e., “an actual physical substitution of” Lee’s filaments into Racz is not required. See In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a determination of obviousness based on teachings from multiple references does not require an actual, physical substitution of elements.”); In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).” slip op. at 30

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “11. Balancing the Graham Factors After weighing all the evidence submitted by the parties in light of the Graham factors, we determine Petitioner has demonstrated by a preponderance of the evidence that the claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. As discussed above, Petitioner’s evidence establishes that the combination of Racz, Fitz, and Lee teaches every limitation of claims 1, 3–10, 18–26, 28, and 29 and that an ordinarily skilled artisan would have been motivated to combine Racz, Fitz, and Lee with a reasonable expectation of success. Further, as discussed above, Patent Owner’s evidence of secondary considerations is entitled to little, if any, weight because Patent Owner fails to establish nexus. Consequently, after considering all the evidence in the record both for and against patentability, we determine that Petitioner has shown by a preponderance of the evidence that claims 1, 3–10, 18–26, 28, and 29 would have been obvious over Racz, Fitz, and Lee. E. Ground B: Obviousness in view of Racz, Fitz, Lee and Young ’965 Petitioner contends that claims 1–10, 18–26, and 28–29 are also obvious over Racz, Fitz, Lee, and Young ’965. Pet. 62–67. Patent Owner argues that Young ’965 does not cure the alleged deficiencies in Ground 1, is directed to tumor ablation not neurotomy, would require a substantial redesign of Racz’s modified device, and there is no motivation to combine. PO Resp. 59–60. We start with a brief overview of Young ’965 and address the parties’” slip op. at 78

    • ExcludeMotion to exclude, deniedDenied

      “Accordingly, both Motions are dismissed as moot.” slip op. at 94

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of” slip op. at 12

    Patent outcomesUS 10,925,664 unpatentable
    § 103 obviousnesscites KSR · Graham
    Patents in suitUS 10,925,664
  • PTAB · Mar 4, 2026 · IPR2024-01222 · APJ Garth D Baer · IPR · Final written decision

    Claims 34–37 and 40–46 are unpatentable as obvious over the Yamazaki-based and Weaver-based grounds.

    RulingsFinal written decision
    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportDecided for petitioner

      “Patent Owner bears the burden of production to establish that its claimed invention is entitled to an earlier priority date for this fact-intensive issue. See In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1375–76 (Fed. Cir. 2016). We agree with Petitioner that the email chain does not support Patent Owner’s conception claim because it “does not discuss depositing a planarization layer, as required by both independent claims.” Pet. Reply 3. Patent Owner asserts that the inventor’s discussion of “PML” (polymer multi-layer) encapsulation in the email chain shows their conception of the claimed planarization layer because the ’389 patent describes that PMLs “‘[t]ypically’ include[e] ‘a planarization layer’ that ‘is provided to give a planar surface’ for deposition of an upper layer,” and “‘address ‘any point defects (i.e. pin holes)’ that might appear in the barrier layer’s surface.” PO Resp. 6 (quoting Ex. 1001, 1:31–37, 1:41–44, 1:56–62). We disagree with Patent Owner for two reasons. First, the challenged patent’s specification does not corroborate that the inventors conceived the claimed planarization before the challenged patent’s priority because it did not exist at the time of the email. Whether the inventors, at the time of filing, considered PMLs to typically include a planarization layer as of the claimed priority date does not support the allegation that they conceived of that same planarization layer more than a year earlier. Moreover, the ’389 patent’s teaching that “[t]ypically, for PML structures, a planarization layer 106 is formed” (Ex. 1001, 1:30–31) shows that the inventors recognized PML structures and planarization layers were distinct because only a subset of PML structures formed planarization layers, even if they do so typically. Thus, the inventor’s discussion of a PML layer in the email chain does not evidence their conception of the claimed planarization layer, as Patent Owner contends. Additionally, even if we were to understand the inventors’ mention of PML encapsulation in the emails, together with the discussion of patterning techniques for an organic layer, as discussing a planarization layer, such discussions are evidence of brainstorming ideas, rather than documenting the path taken with the claimed invention. For instance, the inventors use phrases like “don’t know if this will work,” “these are all just ‘undeveloped’ ideas,” and “looking forward to keep this discussion rolling.” Ex. 2006, 1; see also Ex. 1034, 59:22−59:18. As Petitioner argues, and we agree, these are more theoretical and future-development discussions than an exchange of a definite idea. Pet. Reply 2−3 (citing Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986). For these reasons, we agree with Petitioner that Patent Owner has not” slip op. at 6

    • Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artDecided for petitioner

      “B. Whether Petitioner Relies on Applicant Admitted Prior Art Patent Owner asserts we should “not consider” Yamazaki-based challenges because Petitioner included Applicant Admitted Prior Art (AAPA) in those grounds. See PO Resp. 16 (citing Qualcomm Incorporated v. Apple Inc., 134 F.4th 1355 (Fed. Cir. 2025)) (holding that AAPA may not be part of the basis for an inter partes review). We disagree. As Petitioner notes, it “utilizes the AAPA in the alternative with Ghosh, to show that it was known to manufacture OLED devices in bulk (which [Patent Owner] does not dispute).” Pet. Reply 9. Because “[t]he Petition identifies disclosures in Ghosh that independently demonstrate the same teachings for which the AAPA is cited,” we agree with Petitioner that it does not improperly rely on AAPA for any of its challenges. Id.” slip op. at 8

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

      “C. Whether Yamazaki, Weaver, and Palanisamy Are Printed Publications under 35 U.S.C. § 311(b) Patent Owner asserts that Yamazaki, Weaver, and Palanisamy do not qualify as printed publications under 35 U.S.C. § 311(b) because they only qualify as prior art under § 102(e). PO Resp. 17. According to Patent Owner, “[e]ven though the Federal Circuit has held that such references are ‘printed publications’ under 311(b), to preserve arguments on appeal, Patent Owner submits that such an interpretation is inconsistent with the plain statutory language, the precedent, and non-public accessibility of an unpublished patent application.” Id. We disagree with this argument because the Federal Circuit has rejected it, as Patent Owner acknowledges. See Lynk Labs, Inc. v. Samsung Electronics Co., 2023-2346, Slip. Op. (Fed. Cir. Jan. 14, 2025).” slip op. at 8

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

      “Yamazaki does not involve multiple devices on a substrate” and Ghosh teaches “non-selective deposition of at least the barrier layer.” PO Resp. 31. We disagree with this argument because it attacks Yamazaki and Ghosh individually, rather than the combination of Yamazaki’s selective deposition and Ghosh’s plurality of devices that Petitioner asserts. See In re Keller, 642 F.2d 413, 426 (CCPA 1981). We also disagree with Patent Owner’s criticism that Petitioner fails to explain why skilled artisans would have ignored Ghosh’s non-selective deposition method for barrier layers on multiple devices. PO Resp. 32. This argument attacks a straw man as Petitioner does not propose modifying Ghosh’s method with Yamazaki’s selective deposition. See Pet. 21–23. Rather, Petitioner proposes modifying Yamazaki’s selective deposition method by applying it to Ghosh’s teaching of encapsulating a plurality of OLED devices. Id. Next, Patent Owner asserts that skilled artisans would not have extended Yamazaki’s single-device fabrication/encapsulation method to a plurality of devices on a substrate because doing so would “multiply defects and errors, drop the yield exponentially, and increase the cost.” PO Resp. 34. Patent Owner asserts that precision/defect problems would be particularly acute when using Yamazaki’s inkjet method to print devices’ electro luminescence layers. Id. at 35–36. We disagree. Even if extending Yamazaki’s method to Ghosh’s multiple devices comes at a cost of potential defects, that tradeoff would not undermine Petitioner’s proffered combination given Petitioner’s articulated benefits outline above, including facilitating manufacturing display panels for OLEDs with improved throughput, improved productivity, and reduced manufacturing costs, as compared to fabricating/encapsulating just a single device. See Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another.”). It also does not matter that “inkjet printing yielded devices of half the efficiency than spin coating,” as Patent Owner asserts (PO Resp. 35), because Petitioner does not need to show that Yamazaki’s inkjet printing would be the best option for batch fabrication/encapsulation, only that it would was a suitable one from which the prior art did not teach away. See Par Pharm., Inc. v. TWi Pharms., Inc., 773 F. 3d 1186, 1197–98 (Fed. Cir 2014). That is, Petitioner does not need to show that Yamazaki’s inkjet method was an improvement over other known fabrication/encapsulation methods, so long as it was a known fabrication/encapsulation method and skilled artisans would understand that implementing it for a plurality of devices had known advantages over fabricating/encapsulating a single device, which Petitioner identifies. See Pet. 22. We also agree with Dr. Subramanian that skilled artisans would have a reasonable expectation of success in making the proposed combination given similarities between the references (both are directed to encapsulation of an OLED display device with multiple thin-film layers and at least the first encapsulation is selectively deposited) and because “as the ’389 patent admits, in the prior art it was conventional to use batch fabrication to manufacture OLED display devices with thin-film encapsulation.” Ex. 1003 ¶ 86. As Dr. Subramanian explains, a particular advantage of inkjet printing is that it scales well to larger areas and it was known at the time of the ’389 patent that inkjet could be used to print multiple devices on a glass substrate. Ex. 1032 ¶¶ 2, 27–28. Patent Owner’s argument that “Yamazaki’s methods are far from ready for manufacturing” (PO Resp. 34) goes well beyond what is necessary to show that skilled artisans would have had a reasonable expectation of achieving what is claimed. See Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). Given Petitioner’s analysis outlined above, we agree with Petitioner that it would have been obvious to skilled artisans to fabricate and encapsulate multiple OLED devices on a substrate using Yamazaki’s ink-jet methods. slip op. at 15

    Patent outcomesUS 6,949,389 unpatentable
    § 102 anticipation§ 103 obviousnesscites KSR
    Patents in suitUS 6,949,389
  • PTAB · Feb 17, 2026 · IPR2024-01187 · APJ Garth D Baer · IPR · Final written decision

    Claims 1, 2, 8–11, and 16 are unpatentable as obvious over Ingle and Hasei; claims 3, 5, and 6 were not shown unpatentable because the Hanamura-based grounds lack the claimed trench.

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

      “isolation, rather than in the claims’ context, and in light of the ’492 patent’s specification. In the trench/layers context of the ’492 patent, the word in requires more than it does in the circle/square context.” slip op. at 6

    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “a bachelor’s degree in Electrical Engineering, Physics, or a comparable field of study, and at least three years of research or industrial experience with semiconductor (organic or inorganic) optoelectronic devices and/or lighting or displays. An individual with additional education could have less research or industrial experience and vice-versa. Pet. 9. Patent Owner does not dispute Petitioner’s proposed definition. We adopt Petitioner’s uncontested proposed definition because it is consistent with the disclosures of the asserted prior art.” slip op. at 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “rather than the combination of Ingle’s capacitor and Hasei’s droplet discharge application that Petitioner asserts. See In re Keller, 642 F.2d 413, 426 (CCPA 1981). Even if Ingle falls short of teaching structured application for its capacitor’s cathode, as Patent Owner argues, that does not undermine Petitioner’s challenge because Petitioner proposes using Hasei’s structured application (i.e., a droplet discharge device) to form the cathode of Ingle’s capacitor. See Pet. 24–25. Patent Owner’s additional argument that “Hasei contains no discussion of forming capacitors” (PO Resp. 36; see PO Sur-reply 17–18) is similarly flawed—it attacks Hasei individually, while ignoring Ingle’s capacitor teaching. We agree with Petitioner—the combination of Ingle and Hasei teaches structured application of the capacitor’s cathode. In addition, we disagree with Patent Owner that “Petitioner provides no reason why a POSITA would have extended Hasei’s method for producing its OLED to a capacitor.” PO Resp. 36; see PO Sur-reply 17 (asserting “pure conjecture”). To the contrary, as noted above, Petitioner explains, with relevant support from Hasei, that its structured application method reduced electrode-material waste and shortened manufacturing times as compared to photolithography. Pet. 25 (citing Ex. 1007 ¶¶ 5, 7). Given those benefits, Petitioner has articulated sufficient reasoning with rational underpinning to support that its proffered combination would have been obvious. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).” slip op. at 13

    Patent outcomesUS 9,257,492 mixed
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 9,257,492
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