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  • PTAB · Oct 14, 2026 · IPR2022-00817 · APJ Zhenyu Yang · IPR · Remand

    On remand, the Board found Travers ’075 did not enable RCR amplification followed by SMRT sequencing and held claims 1–30 not shown unpatentable under the asserted obviousness grounds.

    RulingsRemand decision
    • RemandOther

      “B. Scope on Remand On remand, we are bound by the terms of the Federal Circuit’s mandate. Intell. Pixels Ltd. v. Sony Interactive Ent. LLC, 181 F.4th 1216, 1220 (Fed. Cir. 2026) (“An administrative agency is bound by the mandate of a reviewing court much as a lower court is bound by the mandate of a higher court.”). According to the Federal Circuit, on appeal, Patent Owner “UW argues that ‘Travers ’075 does not enable the sequencing of an RCR concatemer using PacBio’s SMRT sequencing,’ and therefore because paragraph 122 is not enabled, it cannot be relied on for disclosing amplification followed by sequencing.” Paper 50, 14. Because “[t]he Board did not reach this issue,” the Federal Circuit “remand[ed] the case for consideration of this issue by the Board in the first instance.” Id. Thus, consistent with the court’s mandate, we must decide “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Id. at 8.” slip op. at 4

    • BurdenNot shown unpatentable

      “A prior art reference is presumed to be enabled. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003) (holding that “a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled”); In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (extending the presumption to prior art printed publications). A patent owner, however, may present persuasive evidence that the relevant disclosures of a prior art are not enabled and therefore are not pertinent prior art. Amgen, 314 F.3d at 1355; In re Antor Media, 689 F.3d at 1289 (discussing the applicant’s burden to submit rebuttal evidence of nonenablement during prosecution); Apple Inc. v. Corephotonics, Ltd., 861 Fed. App’x. 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). “[T]here is no absolute requirement for a relied-upon reference to be self-enabling in the § 103 context, so long as the overall evidence of what was known at the time of invention establishes that a skilled artisan could have made and used the claimed invention.” Raytheon Techs. Corp. v. Gen. Elec. Co., 993 F.3d 1374, 1376–77 (Fed. Cir. 2021). But, “if an obviousness case is based on a non-self-enabled reference, and no other prior art reference or evidence would have enabled a skilled artisan to make the claimed invention, then the invention cannot be said to have been obvious.” Id. at 1377.” slip op. at 15

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

      “The Federal Circuit stated that “the elements of the challenged claim are expressly taught by Travers ’075. Travers ’075 discloses performing RCR amplification followed by SMRT sequencing in a single embodiment.” Paper 50, 14. As a result, “no finding regarding a motivation to combine to arrive at those claimed elements is required.” Id. at 9. In addition, it was error to require Petitioner to show that a skilled artisan “would have had a reasonable expectation of success in performing RCR replication of SMRTbell templates followed by SMRT sequencing.” Id. at 13. “Unless remanded by [an appellate] court, all issues within the scope of the appealed judgment are deemed incorporated within the mandate and thus are precluded from further adjudication.” Engel Indus., Inc. v. Lockformer Co., 166 F.3d 1379, 1383 (Fed. Cir. 1999). Therefore, the only issue for us to decide is “whether Travers ’075 enabled RCR amplification followed by SMRT sequencing.” Paper 50, 8.” slip op. at 14

    • Expert testimonyPatent owner expert creditedDecided for patent owner

      “polymerase-template complexes in the same ZMW.” Id. (citing Ex. 1035, 39). Citing the Larrea Declaration, Petitioner contends that loading of multiple templates “is easily mitigated.” Id. at 18 (citing Ex. 1033 ¶ 19; Ex. 1035, 39). We are not persuaded by this argument either. Dr. Larrea testifies that one of the two methods to “easily mitigate[]” loading multiple templates into a single ZMW is “bioinformatically trimming the read to only the high-quality region (HQR).” Ex. 1033 ¶ 19. Dr. Larrea, however, provides no support for this testimony. In fact, he does not even explain what a “high-quality region (HQR)” is. We, thus, accord little weight to this testimony. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (precedential) (holding “conclusory and unsupported” declaration testimony is entitled to little weight).” slip op. at 26

    Patent outcomesUS 10,760,127 not shown unpatentable
    § 103 obviousness
    Patents in suitUS 10,760,127
  • PTAB · Oct 8, 2026 · IPR2025-00685 · APJ Ryan H Flax · IPR · Final written decision

    Claims 1–23 are unpatentable as obvious over Wei and Liu, and over Leanna, Wei, and Liu.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “appears to be generally consistent with the level of skill presented in the cited prior art. See generally, e.g., Exs. 1005–1008; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself may reflect an appropriate level of skill in the art). However, as at institution, we reject the portion of Petitioner’s proposed definition that includes having “access to other individuals with that knowledge and experience,” as not reflecting the individual level of skill of a given skilled artisan. See, e.g., Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (holding that “[t]he person of ordinary skill is a hypothetical person who is presumed to be aware of all the pertinent prior art.”) (emphasis added, footnotes omitted); but see Indivior Inc. v. Dr. Reddy’s Labys., S.A., 930 F.3d 1325, 1343 (Fed. Cir. 2019) (no clear error in determination that “a person of ordinary skill . . . ‘would be on a team with an engineer or scientist . . . .’”). Consequently, we find the person of ordinary skill in the art was a person who had a Ph.D. in immunology, molecular biology, cellular biology, or a similar field, or an M.D. with similar experience, and had at least five years of experience with antibodies and antibody engineering.” slip op. at 11

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

      “Petitioner submits that no term of the Challenged Claims requires construction to resolve the challenges in this Petition.” Pet. 32. We did not construe any terms in our Institution Decision. See DI 6–7. Patent Owner presents no express positions on claim construction. See generally Resp. For the purposes of this Decision, no terms of the challenged claims require construction. Phillips, 415 F.3d at 1312–13. D. slip op. at 12

    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “2 G. Wei et al., US 2015/0071923 Al, pub. March 12, 2015. Ex. 1005 (“Wei”). 3 J. Liu, CN 103772504 A, pub. May 7, 2014. Ex. 1007. The Liu reference is published in Simplified Chinese and Petitioner filed a certified English translation, to which we refer herein. See Ex. 1008 (“Liu”). Patent Owner does not contest the accuracy of the translation. See generally Resp. 4 M.R. Leanna & C.L. Becker, WO 2014/152199 A1, pub. Sept. 25, 2014. Ex. 1006 (“Leanna”). 5 Based on our review of each deposition transcript in view of the record as a whole, although each witness appears competent, we are left with the impression that Dr. Bournazos’s testimony is somewhat more credible than Dr. Atanackovic’s. This conclusion is based, inter alia, on each witness’s ability to recall the relevant record and respond to questions on evidentiary and technical issues.” slip op. at 8

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

      “We find that combining Liu’s BA03 antibody with Wei’s ADC platform would have been desirable, predictable, and routine for the ordinarily skilled artisan based on the facts that: (1) cetuximab was a wellknown and well-studied, U.S. regulatory approved, anti-EGFR antibody that would have served as a starting point for new cancer therapies; (2) humanization of therapeutic antibodies is generally desired (and “[e]very antibody can be humanized” and it is advantageous according to Patent Owner’s counsel); (3) BA03 was a well-known humanized version of cetuximab that had several known advantages over cetuximab in addition to lower immunogenicity from humanization; and (4) Wei taught a similar cetuximab-derived antibody, and a humanized cetuximab-derived antibody, each provided in an ADC with a well-known and validated off-the-shelf linker-drug platform, i.e., vc-MMAE, that exhibited a strong anti-tumor response. See, e.g., Ex. 1001, 1:57–2:32, 2:50–3:1, 5:6–53, 18:3–33, 19:26– 29; Ex. 1002 ¶¶ 14, 38, 42–43, 45–53, 56–73, 84–92, 109–117, 178–189, 202–271; Ex. 1005 ¶¶ 9–10, 229–232, 434, 437, 476, 491–506, 664–675, 685, 688, 715, 732, 1103, 1092–1141; Ex. 1008 ¶¶ 3–6, 60, 74, 141–160; Ex. 2027 ¶¶ 7–8, 38, 50, 57 (confirming our understandings regarding the claimed antibody and linker-drug payload); Ex. 2023, 173, 300; see also Resp. 1, 5–6, 23 (Patent Owner made the “choice” to use the prior-art-known BA03 antibody, and known-candidate cytotoxic payload MMAE); Hr’g Tr. 34:20–23, 36:6–38:20, 47:16–50:16 (Patent Owner’s counsel’s argument). When Liu’s BA03 antibody is provided in an ADC with a vc- MMAE or a Mc-vcPAB-MMAE platform (and used as cancer therapy as the references instruct) the invention of the challenged claims is achieved.” slip op. at 52

    Patent outcomesUS 10,792,370 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 10,792,370
  • PTAB · Oct 5, 2026 · IPR2025-00677 · APJ Ryan H Flax · IPR · Final written decision

    Claims 1–7, 10, 13, 16, 18, and 19 are unpatentable as anticipated by Douglas and Ganesh; the revised contingent motion to amend is denied.

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

      “record before us, we conclude that Petitioner proves by a preponderance of the evidence that each challenged claim of the ’811 patent is anticipated by Douglas and by Ganesh. Accordingly, we find that claims 1–7, 10, 13, 16, 18, and 19 of the ’811 patent are unpatentable. Moreover, we find that Patent Owner’s Revised Contingent Motion to Amend adds new matter in every proposed substitute claim, and, therefore, the motion is denied.” slip op. at 80

    • 112 supportMotion to amend, deniedDenied

      “Because the RMTA does not meet the foundational statutory and regulatory requirements, we decline to reach Petitioner’s arguments as to the asserted unpatentability of the proposed substitute claims. C. CONCLUSION ON REVISED MOTION TO AMEND Because the RMTA does not meet foundational statutory and regulatory requirements for a motion to amend, it is denied.” slip op. at 80

    Patent outcomesUS 10,430,811 unpatentable
    § 102 anticipationcites Phillips
    Patents in suitUS 10,430,811
  • PTAB · Sep 29, 2026 · IPR2025-01122 · APJ Carl M Defranco · IPR · Final written decision

    Claims 1–16 are unpatentable as obvious over Liao or Liao and Cheng; Rolicki is not prior art, and the challenge over Offord ’341 and Offord ’797 fails.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “A. Level of Ordinary Skill in the Art Baby Jogger does not dispute Evenflo’s definition of the level of ordinary skill in the art, which is that a person of ordinary skill in the art (hereinafter, “one skilled in the art”) would have had “a bachelor’s degree in a relevant field (e.g., mechanical engineering or industrial design) and at least two years of product design experience and/or industry experience with juvenile products” and that “[m]ore education can replace product design experience, and vice versa.” Pet 8 (citing Ex. 1001 ¶¶ 31–33); PO Resp. generally. We apply that definition here, as it accords with the problems addressed in the prior art and the specification of the ’682 patent.” slip op. at 7

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

      “At the outset, we note that the claim language requires only that “the first seat and the second seat” be arranged in an inline descending configuration, not that the seat’s mounting points or other physical connections be so arranged. Ex. 1010, 17:31–33. Baby Jogger improperly reads “seats” out of the claim and substitutes the seat’s “mounting points” on the frame. A proper reading of the claim language focuses on what happens when both seats are connected to the frame, not where they are so connected. In other words, “when connected to the frame” simply emphasizes that both seats must be connected to the frame to form the inline descending configuration, as opposed to the single stroller embodiment of Figure 1, where there cannot be an inline descending configuration because only one seat is connected to the frame and the other seat is removed, i.e., not connected to the frame. That reading is supported by the specification of the ’682 patent,” slip op. at 9

    • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

      “We find that testimony persuasive, for it shows what one skilled in the art would have recognized the 2008 Provisional as necessarily disclosing. The relevant inquiry is whether the disclosure of the prior application “convey[s] with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention.” PowerOasis, 522 F.3d at 1306 (emphasis in original; citation omitted). “While a prior application need not contain precisely the same words as are found in the asserted claims, . . . the prior application must indicate to a person skilled in the art that the inventor was ‘in possession’ of the invention as later claimed.” Id. In other words, “to satisfy the written description requirement, ‘the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.’”7 Id. (quoting Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998) (emphasis added). “This requires that the written description actually or inherently disclose the claim element.” Id. at 1306–07. Moreover, a drawing may supply written description for the arrangement it depicts even though the text describes that arrangement in different terms. See Cooper Cameron Corp. v. Kvaerner Oilfield Prods., Inc., 291 F.3d 1317, 1319–23 (Fed. Cir. 2002).” slip op. at 16

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

      “Instead, Evenflo’s argument rests on isolating the statement—“A similar sub-frame arrangement is disclosed in [Offord ’797]”—from the remainder of the passage in which that statement appears in order to arrive at a reason to incorporate the reversibility teaching of Offord ’797. However, when that statement is read in the context of the full passage in which it appears, nowhere does that passage suggest reversibility as the reason for referencing Offord ’797. More accurately, it suggests a different reason that relates to a curved lug 108 by which sub-frame 100 rests on the stroller’s main frame 4 to carry the weight of the stroller’s two occupants— When the interface components 100 are attached to the frame assembly 4 they form a sub-frame of the frame assembly 4, and when the child-carrying units are mounted thereon, one behind the other, they are in a compact echelon formation, one of the connector sockets 106 of each component 100 being at a higher level in relation to the ground than the other connector sockets 106. The higher connector socket 106 and further connecting leg 102 are both connected to the respective opposite ends of an upper mounting piece 107. In addition, on the inner side of the lower connector sockets 106 there is a downwardly curved lug 108 which serves to rest upon a part of the basket frame 44, such that the weight of two infants is fully supported by the frame assembly 4. A similar sub-frame arrangement is disclosed in [Offord ’797]. Ex. 1051, 9:23–36 (emphasis added). That passage shows that, rather than reversibility of the sub-frame, the reference to Offord ’797 is more aptly directing the reader to the arrangement and details of a similarly curved lug structure in the stroller sub-frame of Offord ’797. Indeed, Figures 5 and 6 of Offord ’797, reproduced below, disclose just such a curved lug in the context of “corner pieces 20” having “channel 21.” Ex. 1054, 4:10–23.” slip op. at 53

    Patent outcomesUS 11,731,682 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousness
    Patents in suitUS 11,731,682
  • PTAB · Sep 25, 2026 · IPR2025-00554 · APJ Barry L Grossman · IPR · Final written decision

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

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

    • Expert testimonyPetitioner expert creditedDecided for petitioner

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

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

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

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

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

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedDecided for petitioner

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

    • Skill levelSkill level petitioner adoptedDecided for petitioner

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

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

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

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

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

    Patent outcomesUS 11,813,381 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,813,381
  • PTAB · 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 29, 2026 · IPR2025-00246 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 15–29 are unpatentable as obvious over the asserted combinations; the contingent motion to amend claims 30–41 is denied for lack of written-description support.

    RulingsFinal written decision
    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, ResMed Inc., as a real party in interest. Paper 39. Petitioner filed an opposition. Paper 42. Patent Owner filed a reply. Paper 43. We denied the Motion to Terminate. Paper 51.” slip op. at 3

    • Skill levelSkill level board ownOther

      “understanding of a person of ordinary skill in the art at the time the invention was made.10 See Graham, 383 U.S. at 17–18. The parties agree that a person of ordinary skill in the art (sometimes referred to herein as “POSITA”) would have had: at least a bachelor’s degree in mechanical engineering, electrical engineering, computer science, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience working with diagnostic sensor systems and network data systems, such as networked PAP machines. Additional experience could substitute for less education, and additional education could likewise substitute for less experience. Pet. 3–4 (citing Ex. 1003 (Kirkness Decl.) ¶ 44); PO Resp. 4. 9 Patent Owner does not assert any objective indicia of nonobviousness. See generally PO Resp. 10 For purposes of this Decision, we apply a priority date of November 4, 2005. See supra n.4. Because the proposed level of ordinary skill in the art is consistent with the cited prior art and is undisputed on this record, we adopt it for purposes of this Decision. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 9

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

      “Patent Owner does not persuade us to construe the term as “a value [or calculated value] that indicates how dire a patient’s symptoms are.” Patent Owner points to nothing in the intrinsic record that purportedly supports this construction, and we agree with Petitioner that “the patent specification’s disclosures regarding determining a level of symptom severity are broad, establishing that it can generally be derived from any sensor data and/or breathing events.” Pet. Reply 3–4; see also Ex. 1001, 3:44–46 (“Signals from the[] sensors are then analyzed to determine the level of severity of the symptoms of the subject’s sleep disorder.”). Patent Owner relies only on expert declarations to support its construction. But as indicated by the Federal Circuit, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable here, where neither Dr. D’Ambrosio’s nor Dr. Schwartz’s declaration was prepared for this proceeding, and neither declarant was subject to cross examination on their opinions. Moreover, neither of the declarants was opining on claim construction; rather, they were addressing indefiniteness and/or written description issues. See Ex. 1058 at 7 (heading addressing definiteness); Ex. 2026 at 18 (heading addressing written description). Further, Dr. Schwartz appears to have been making an argument about certain patent claims (not the challenged ’333 patent) based on Patent Owner’s own statements made during prosecution of a separate patent application. See Ex. 2026 ¶ 47 (“[T]he similar term used in the ’284 patent claims (‘data of severity of sleep disorder symptoms’) does not find written description support in the specification by a disclosure of the same statistics disclosed in Wright, because CleveMed argued those statistics are not related to severity of sleep disorder symptoms.” (emphasis added)). Patent Owner has not persuaded us that Dr. Schwartz’s testimony has direct applicability to the claim term at issue here. Dr. Borkholder’s testimony is likewise unpersuasive. Aside from citing Dr. D’Ambrosio’s and Dr. Schwartz’s declarations, Dr. Borkholder cites Exhibits 2027 and 2016. These exhibits discuss indices such as AHI and RDI that are used to assess the severity of a patient’s symptoms, but Patent Owner has not adequately explained how they bear on construction of the claim term at issue here, which is not addressed in these exhibits. Ex. 2022 ¶¶ 32–33. Accordingly, we accord Dr. Borkholder’s claim construction opinions little weight, because they are unsupported by reference to objective, corroborating evidence of record. See, e.g., Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual support for expert opinion going to factual determinations . . . may render the testimony of little probative value in a validity determination.”); Xerox Corp. v. Bytemark, IPR2022-00624, Paper 9, 15 (PTAB 2023) (precedential) (explaining that declaration testimony that “is conclusory and unsupported” and which “adds little to the conclusory assertion for which it is offered to support . . . is entitled to little weight”).” slip op. at 23

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

      “We find that Petitioner has the better argument. Tidal volume refers to “the volume of air that is inspired or expired during a respiratory cycle.” Ex. 2028, 13–14; PO Resp. 10. “[H]ypopnea events are defined as a reduction of ≥50 % or 74 % in tidal volume from baseline and apnea events as absence of tidal volume for at least 10s.” Ex. 2028, 13–14 (emphasis omitted). Toge teaches that a control unit analyzes collected data (e.g., the flow rate) and calculates tidal volume. Ex. 1044 (Toge) ¶¶ 34–38. The calculated tidal volume is “a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy” because it represents, e.g., the “level of airway obstruction the patient experiences during the sleep apnea treatment using the PAP device.” Pet. 15. As Dr. Chatterjee explains: Toge discloses that tidal volume Fp is a quantified level of data because Toge discloses that Fp is monitored with respect to threshold values (id., [0051]) and because Fp is a function of Ft, Fa, and Fb, which are quantitative values. Toge discloses that tidal volume Fp is severity data because Toge discloses that tidal volume is indicative of whether the patient’s breathing warrants “emergency measures” (id., [0039]) and whether to “send an alert” in “an emergency where the patient’s breathing has drastically weakened” (id., [0055]). . . . . Because Toge discloses determining tidal volume (determine a quantified level of severity data) based on Ft, Fa, and Fb (id., [0035]), which corresponds to the subject’s condition (subject’s sleep apnea symptoms) while using the device (during the therapy) (id., [0036], [0037]), Toge discloses determin[ing] a quantified level of severity data based on the subject’s sleep apnea symptoms during the therapy. Ex. 1005 (Chatterjee Decl.) ¶¶ 122–125. Patent Owner’s attempt to dismiss tidal volume as a mere “breathing metric” is unavailing. First, Petitioner correctly “notes that in the paragraph PO cites to in Dr. Schwartz’s declaration, he indicates that breathing metrics are a level of severity data.” Pet. Reply 8 (citing Ex. 2026 ¶ 46 (“standard sleep disordered breathing metrics” [ ] were well validated indicators of the type and severity of sleep disordered breathing”)). Second, Dr. Kirkness explains that tidal volume represents the level of airway obstruction, e.g., apnea “is the most severe form of reduction in airflow [and] the absence of airflow results in quantified tidal volume of zero milliliters per breath.” Ex. 1003 (Kirkness Decl.) ¶¶ 157, 159; see also PO Resp. 10–11 (Patent Owner recognizing that an apnea is defined as absence of tidal volume for at least 10 seconds). The calculated tidal volume thus indicates severity because it is used to adjust the PAP system, e.g., in the case of decreasing tidal volume, a medical professional can change the airflow settings “to counter/treat the more severe level of airway obstruction observed from the decreasing tidal volume.” Ex. 1003 (Kirkness Decl.) ¶ 158; Pet. 15–16; Ex. 1044 (Toge) ¶ 39.” slip op. at 26

    Patent outcomesUS 11,857,333 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 11,857,333
  • PTAB · Jun 29, 2026 · IPR2025-00247 · APJ Cynthia M Hardman · IPR · Final written decision

    Claims 1–19 were not shown unpatentable under any of six obviousness grounds because Truitt did not teach or suggest the claimed severity calculation and index, and the Mumford combinations lacked the required sensor disclosures.

    RulingsFinal written decision
    • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

      “Patent Owner filed an authorized Motion to Terminate, alleging that Petitioner failed to name its corporate parent, Resmed Inc., as a real party in interest. Paper 29. Petitioner filed an opposition. Paper 31. Patent Owner filed a reply. Paper 32. We denied the Motion to Terminate. Paper 40.” slip op. at 2

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner

      “disorder symptoms” require a “quantitative” calculation or use of an algorithm, we also disagree. See PO Resp. 14–16. First, nothing in the language of the claims themselves describes or requires a “quantitative” calculation or an algorithm. See generally Ex. 1001, 23:6–26:59. To be sure, the ’029 patent discloses embodiments that use known algorithms to “quantify the level of severity of the subject’s sleeping disorder or symptoms.” See, e.g., id. at 20:16–19. But the Specification does not require an algorithm. The Specification also indicates that quantification is merely “preferable” (i.e., not required), and is merely one embodiment. See, e.g., id. at 19:8–12 (“The signals from the one or more sensors used in various embodiments of the present invention are preferably analyzed using a processor and software that can quantitatively estimate or determine the severity of the subject’s sleeping disorder or symptoms.”) (emphasis added), 4:51–59 (“Finally, in still another embodiment, the present invention includes a sleeping disorder treatment system comprising a device for diagnosing and creating a quantitative output of a level of severity of a subject’s sleeping disorder or symptoms . . . .”) (emphasis added); see also Reply 5–6 (citing Ex. 1001, 4:3–59 and 19:8–12 and stating that the ’029 patent lists “numerous embodiments where only one of seven include a quantitative assessment”). Elsewhere, the Specification more generally states that signals from sensors are “analyzed to determine the level of severity of the symptoms,” without specifying that such analysis must be “quantitative” or performed by an algorithm. See Ex. 1001, 3:41–44. In view of these disclosures, Patent Owner does not persuade us to adopt its narrowing claim construction. Indeed, our reviewing court has “repeatedly warned against confining the claims” to specific embodiments disclosed in the Specification. Phillips, 415 F.3d at 1323. Patent Owner’s reliance on a prior Board decision in PGR2024- 00012, which related to the parent of the ’029 patent, is unavailing. See PO Resp. 15–16. We agree with Petitioner that in the cited case, “[t]he Board made no findings about the meaning of the term calculating ‘the data of a severity of the sleep disorder symptoms of the subject’ for claim construction.” Reply 8. Indeed, neither party offered any claim construction, and the Board determined that no claim construction was necessary for purposes of that decision. See ResMed Corp., PGR2024- 00012, Paper 7 at 8. The page of the decision Patent Owner cites addresses written description support in the specification for the claims challenged in that PGR, not claim construction. See id. at 16. In any event, the cited decision is a decision on institution. The Board’s statements there are, by nature, preliminary findings and conclusions based on a preliminary record, and are not binding here. For at least the above reasons, Patent Owner does not persuade us to adopt its narrowing claim construction and we find that the term “data of a severity” does not need construction because the words of the term are clear on their face.” slip op. at 31

    • Strike new argumentNew argument disregardedDecided for patent owner

      “skilled artisan would have incorporated only portions of Mumford’s algorithm into Truitt’s PAP (i.e., only those portions related to “the detection of sleep disordered events” and not the portions of the algorithm related to “determin[ing] sleep stage”) comes too late because this argument was not in the Petition. See, e.g., Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017) (rejecting petitioner’s “attempts to cure the petition’s deficiencies in its subsequent briefing to the Board”). The Petition does not discuss modifying Mumford’s sleep efficacy algorithm before incorporating it into Truitt’s PAP device or incorporating only certain features of the algorithm. Indeed, the Petition and Dr. Kirkness rely on Mumford’s ability to detect sleep arousals when mapping Mumford to the claimed “data of a severity” and “index.” See Pet. 69–70; Ex. 1003 (Kirkness Decl.) ¶¶ 323–325. Mumford discloses that the mask electrodes detect arousals. See Ex. 1009 (Mumford) 2:4–10, 11:39–48. The same lack of disclosure plagues Petitioner’s belated Reply argument that Truitt’s ports 74 and 76 can incorporate electric sensing elements that would have functioned similar to Mumford’s electrodes. See Reply 22. The Petition did not mention ports 74 and 76 or otherwise suggest that a skilled artisan would have added functionality similar to Mumford’s electrodes to Truitt’s PAP, and we find that it is too late on Reply for Petitioner to posit this modification.” slip op. at 40

    • Expert testimonyPetitioner expert creditedPatent owner expert creditedMixed

      “significant than the intrinsic record in determining ‘the legally operative meaning of claim language.’” Phillips v. AWH Corp., 415 F.3d 1303, 1317 (Fed. Cir. 2005). This is especially applicable to Dr. Jafari’s opinions. His declaration was not prepared for this proceeding and thus Dr. Jafari was not subject to cross examination in this proceeding. See Reply 6 n.3. Moreover, Dr. Jafari was not opining on claim construction; rather, he was addressing the alleged indefiniteness. See Ex. 2020 (Jafari Decl.) 12 (heading addressing definiteness), ¶¶ 41–42, 46. Additionally, paragraphs 41–42 of Dr. Jafari’s declaration discuss claim terms phrases in a different patent (US 11,375,921), which explicitly include the terms “quantified” and “quantitative.” See Reply 6–7; Ex. 2020 (Jafari Decl.) ¶ 34. For at least these reasons, Patent Owner has not persuaded us that Dr. Jafari’s testimony is applicable here. Further, regarding the portion of Patent Owner’s proposed construction reciting “the degree of deviation from the baseline characteristics of a patient without sleep disorder symptoms,” Dr. Borkholder does not do his own analysis, but instead simply states that he “agree[s] with the litigation claim construction opinions of Dr. Jafari.” Ex. 2019 (Borkholder Decl.) ¶ 53. This is insufficient, and thus we do not credit Dr. Borkholder’s testimony regarding claim construction. We instead credit Dr. Kirkness’s statement that “[s]everity data is frequently calculated as the deviation from baseline characteristics of the patient himself, not a generic person ‘without sleep disorder symptoms.’” Ex. 1071 (Kirkness Reply Decl.) ¶ 13; Reply 9. As Dr. Kirkness explains, and Patent Owner does not dispute (see generally Sur-reply), “[t]he ‘baseline characteristics of a [generic] patient without sleep disorder symptoms’ would be irrelevant to any particular patient with their own unique breathing patterns and sleep disorder symptoms.” Ex. 1071 (Kirkness Reply Decl.) ¶ 13 (second alteration in original). For at least these reasons, we reject Patent Owner’s proposed claim construction.” slip op. at 30

    Patent outcomesUS 11,872,029 not shown unpatentable
    Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
    Patents in suitUS 11,872,029
  • PTAB · Jun 29, 2026 · PGR2025-00031 · APJ Ryan H Flax · PGR · Final written decision

    Claims 1–14 are unpatentable as obvious under each of four asserted grounds: Kerr; Aplex and Stanton; Blume, Stanton, and Wilkinson; and the sale of the Kerr Pump.

    RulingsFinal written decision
    • Skill levelSkill level petitioner adoptedDecided for petitioner

      “The person of ordinary skill in the art would have a minimum of a bachelor’s degree in mechanical or petrochemical engineering, or a comparable engineering discipline, and a minimum of 3-5 years of work experience in the design and/or manufacturing of reciprocating pumps and valves, including fluid ends and/or comparable high pressure fluid components, for industrial applications, including for use in the oil and gas industry. See, e.g., EX1003, ¶32.” slip op. at 12

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

      “[W]e need only construe terms ‘that are in controversy, and 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) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We decline to expressly construe any claim language. slip op. at 12

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

      “Regarding the combining of Aplex and Stanton, Petitioner asserts that the ordinarily skilled artisan would have understood that providing a packing/stuffing arrangement, as taught by Stanton, within a fluid end housing, as taught by Aplex, would improve pressure and fluid isolation compared with an arrangement where the packing was bolted to the outside of the fluid end as in Aplex unmodified. Pet. 66 (citing Ex. 1003 ¶¶ 189, 236). Patent Owner does not dispute this rationale. We find this to be a reason, with rationale underpinning, why the person of ordinary skill in the art would have combined these references with a reasonable expectation of success.” slip op. at 29

    • Adverse judgmentOther

      “The record indicates that Patent Owner has statutorily disclaimed claim 15 as of April 28, 2025. Ex. 2206.” slip op. at 8

    Patent outcomesUS 12,152,582 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 12,152,582
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