- Aroma360, LLC v. Air Esscentials, Inc.Some claims unpatentablePTAB · Oct 6, 2026 · IPR2025-00707 · APJ Eric C Jeschke · IPR · Final written decision
Claim 5 is unpatentable over Gao-2 and over Gao-2 with Goubet; claims 1, 3, 4, and 6–8 were not shown unpatentable on any ground, and substitute claim 17 was denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“As noted in the Decision on Institution, Petitioner’s proposed definition appears generally consistent with the record, including the prior art. See Dec. Inst. 8 (citing In re GPAC Inc., 57 F.3d at 1579). We remove the phrase “at least” in both listed options, however, as that phrase adds ambiguity. Further, Patent Owner has not argued at trial that Petitioner’s proposal for the level of ordinary skill leads to an improper understanding of how a skilled artisan would have understood either the challenged patent or the prior art. In the analysis below, we continue to apply the level of ordinary skill in the art adopted in the Decision on Institution, as proposed by Petitioner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Neither Petitioner nor Patent Owner propose explicit constructions for any claim terms. Pet. 16–17; PO Resp. 5–6. Based on the complete record, we need not construe explicitly any claim terms because doing so would not change the outcome of the analysis below. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for patent owner
“As an initial matter, the record here does not support any sound basis to disregard the entirety of Dr. Micklow’s Declaration for allegedly not reviewing the parties’ claim constructions. See Pet. Reply 2–3 (citing Ex. 1046, 115:15–18). Contrary to Petitioner’s argument, in the cited 11 This refers to the recitation in clauses 1F and 5F that the “diffusion assembly is disposed between said upper chamber and said lower chamber.” discussion, Dr. Micklow does not indicate that he applied an incorrect understanding of a claim term. Cf. Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1357–58 (Fed. Cir. 2011) (disregarding testimony “based on an incorrect understanding of the claim construction”), cited at Pet. Reply 1; see also Pet. Reply 3 (arguing that “Dr. Micklow’s opinion that the prior art does not render the claims obvious is premised on an interpretation of certain claim limitations that are inconsistent with both parties’ constructions” (emphasis added)). Instead, we read Dr. Micklow’s testimony as clarifying that he was not involved in claim construction at all and that, as stated, he “made [his] opinions based on what [he] read in the patents.” Ex. 1046, 112:11–12; see also id. at 115:15–18 (“I don’t know if I would even apply claim construction. I applied engineering principles to a document that had been published with the patent office.”).” slip op. at 12
- BurdenNot shown unpatentable
“referring to the same direction as the separation of the “upper chamber” and “lower chamber” (vertically in both Figure 6 of the challenged patent and Figure 1 of Goubet), we turn back now to Petitioner’s discussion of clause 1F, which includes the limitation at issue. There, Petitioner does not discuss why the “diffusion assembly” is allegedly “disposed between” the “upper chamber” and “lower chamber,” but instead, Petitioner discusses why a component of the “diffusion assembly”—the “atomizer assembly”—is allegedly “disposed between” the “upper chamber” and “lower chamber”: Pet. 39. In the end, we need not assess whether the “atomizer assembly” identified by Petitioner is “disposed between” the “upper chamber” and “lower chamber” under the proper construction of that term (which, again, we need not and do not determine here) because the “disposed between” limitation does not involve the “atomizer assembly.” Instead, we find that, by failing to address why the identified “diffusion assembly” is “disposed between” the identified “upper chamber” and “lower chamber,” Petitioner has failed to provide persuasive evidence that Goubet discloses or suggests the “disposed between” limitation. Pet. 38–39 (discussing the claim language “said diffusion assembly is disposed between said upper chamber and said lower chamber” but only discussing the location of the “atomizer assembly”); see 35 U.S.C. § 316(e) (“In an inter partes review . . . , the petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence.”). For the reasons above, we find, based on the complete record, that Petitioner has not shown by a preponderance of the evidence that Goubet discloses or suggests the “disposed between” limitation.” slip op. at 22
Patent outcomesUS 10,092,918 mixedClaim construction§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,092,918 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-01531 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious; claims 2, 7, and 15 were not shown unpatentable because the prior art did not establish the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- ExcludeMotion to exclude, deniedDenied
“Petitioner, as the moving party, bears the burden of proving that the material sought to be excluded is inadmissible under the Federal Rules of Evidence. See 37 C.F.R. §§ 42.20(c), 42.62(a); see also Trial Practice Guide (“TPG”)15 § II.K (“A motion to exclude must explain why the evidence is not admissible.”). For the reasons explained below, we deny Petitioner’s Motion.” slip op. at 17
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). Whether a reference qualifies as a “printed publication” involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to the public. In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). A reference is publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it. Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350–51 (Fed. Cir. 2008). Conroy was published on May 12, 2011. Ex. 1003, 1. Conroy refers to Conroy Protocol (Ex. 1004), stating that “[t]he protocol, including the statistical analysis plan, is available with the full text of this article at NEMJ.org.” Ex. 1003, 3. When questioned whether he has “any reason to believe that the protocol would not have been provided on NEJM.org with this text when it was published,” Dr. Oberstein testified that “if they say they provided it, then I think they probably provided it.” Ex. 1210, 165:20–166:2. 17 Alternatively, to the extent necessary, under the circumstances of this case, we waive the requirement of § 42.63(b). See 37.C.F.R. § 42.5(b). In addition, Dr. Ratain testified that “most top journals require that the protocol be submitted at the time of initial submission, and it’s always published alongside any major paper.” Ex. 2073, 42:2–5. According to Dr. Ratain, “[c]ertainly, New England Journal of Medicine does that.” Id. at 42:6–7. We credit the testimony from both Dr. Oberstein and Dr. Ratain on this issue. Accordingly, we find Exhibit 1004 was publicly accessible at the same time Conroy was published. slip op. at 28
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.Some claims unpatentablePTAB · Aug 13, 2026 · IPR2025-00505 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1, 3–6, and 8–14 are unpatentable as obvious over the first § 103 combination; claims 2, 7, and 15 were not shown unpatentable because the art did not support the claimed drug sequence.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that [t]he person of ordinary skill in the art (POSA) would have been an M.D. and/or Pharm. D who would have completed training in medical oncology, particularly in the field of gastrointestinal (GI) cancers, or a Ph.D. in clinical pharmacology, pharmaceutical sciences, pharmaceutics, and/or drug delivery, also particularly in the field of GI cancers, or their equivalents, along with at least 1-2 years of post-doctoral experience. Pet. 26 (citing Ex. 1002 ¶¶ 44–46). Patent Owner states that, for purposes of this proceeding, it does not dispute Petitioner’s proposed definition of a POSA. PO Resp. 8. Based on the entirety of the trial record, we adopt Petitioner’s proposed definition of a POSA’s skill level because it is consistent with the skill level reflected in the disclosures of the ’552 patent and prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art may reflect an appropriate level of skill in the art).” slip op. at 9
- Expert testimonyPatent owner expert creditedDecided for patent owner
“We decline to discount Dr. Oberstein’s opinion based on the alleged conflict of interest and bias. Dr. Oberstein testified that the consulting fees he receives from Patent Owner reflect a small fraction of his income. Ex. 1210, 402:21–403:9. We also agree with Patent Owner that an oncologist prescribing an FDA-approved regimen does not evince bias. See Sur-reply 23; see also Ex. 1206, 49 (showing NALIRIFOX is a category 1, NCCN-preferred first-line therapy for metastatic pancreatic cancer), 69 (explaining category 1 is based upon high-level evidence). Petitioner also contends that Dr. Oberstein “offers conclusory opinions,” “fails to properly apply the law, continues to look at each reference in isolation, refuses to acknowledge logical suggestions in the art, and imports new limitations into the claims.” Reply 3–4. We evaluate each piece of evidence, including Dr. Oberstein’s opinion, as it relates to our substantive patentability analysis, and accord it proper weight.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“In the DI, the Board stated that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. DI 14. We, however, rejected the notion that the claims “would require some particular degree of clinical efficacy” because “the level of clinical efficacy is not a claim limitation.” Id.” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Not reached
“The parties, however, disagree over whether each recited dose must be the starting dose. Petitioner argues that “claim 1 requires that the method of treatment is a first-line therapy, but does not require that the claimed doses be used as a starting dose.” Paper 51, 1. In contrast, Patent Owner argues that “[t]he specification describes that the recited dose of each drug is a ‘starting’ or ‘initial’ dose.” Paper 50, 2 (citing Ex. 1001, 13:38–45, 30:5–7). For purposes of this Decision, we do not need to resolve this dispute. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy). As explained below, we agree with Petitioner that, even if claim 1 recites the starting dose for each drug, Petitioner has shown, by a preponderance of the evidence, that the prior art teaches each dose and a POSA would have had a reason to start with the recited doses. See infra Section II.G.3; Paper 51, 3 n.2. Because we find that the prior art teaches or suggests the claimed subject matter even under Patent Owner’s proposed narrower claim interpretation, we need not further construe the disputed claim language.” slip op. at 16
Patent outcomesUS 11,344,552 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,344,552 - Kubota North America Corporation v. Vermeer Manufacturing CompanySome claims unpatentablePTAB · Jun 30, 2026 · IPR2025-00169 · APJ Meredith C Petravick · IPR · Final written decision
Claims 50–54 are unpatentable as obvious over KR996 and JP705; claims 55–63, 68, 69, and 80–85 were not shown unpatentable over KR996, JP705, Bares, and Beltrami.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“(“This language is merely exemplary, using reference numerals to refer to the embodiment’s features and qualifying ‘single weldment’ as referring ‘generally’ to specific embodiments.”). The Iowa District Court reached the same conclusion. See Ex. 1020 at 4 (holding that “‘mainframe’ will be given its plain and ordinary meaning and does not require a single weldment” (emphasis added)), cited at Pet. Init. CC Br. 2; see also 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning a term of the claim in a civil action, or a proceeding before the International Trade Commission, that is timely made of record in the inter partes review proceeding will be considered.”).” slip op. at 35
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness.” slip op. at 57
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“e) Conclusion as to the Independent Claim 50 For the reasons discussed above, the evidence presented by Petitioner” slip op. at 67
- ExcludeMotion to exclude, grantedGranted in part
“For these reasons, we are persuaded by Petitioner to exclude, as” slip op. at 19
Patent outcomesUS 9,321,386 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,321,386 - Kubota North America Corporation v. Vermeer Manufacturing CompanySome claims unpatentablePTAB · Jun 30, 2026 · IPR2025-00167 · APJ Meredith C Petravick · IPR · Final written decision
Claims 1–13, 21, 22, 64, and 65 are unpatentable over the asserted grounds; claims 15, 17, 19, 20, 23–30, 66, and 67 were not shown unpatentable over KR996, JP705, and Beltrami.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“B. Analysis “The moving party has the burden of proof to establish that it is” slip op. at 9
- Skill levelOther
“B. Level of Ordinary Skill in the Art We review the grounds of unpatentability in view of the” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownPrior construction adoptedDecided for petitioner
“lexicographical, we agree with the parties that “mainframe” is not limited to a single weldment. Pet. Init. CC Br. 1; PO Init. CC Br. 1–2. Instead, a single-weldment “mainframe” is merely one disclosed embodiment. See Pet. Init. CC Br. 3 (stating that “by including the term ‘generally’ in a statement, the feature (i.e., single weldment) is expressly identified as merely included in some, but not all embodiments”); PO Init. CC Br. 3 (“This language is merely exemplary, using reference numerals to refer to the embodiment’s features and qualifying ‘single weldment’ as referring ‘generally’ to specific embodiments.”). The Iowa District Court reached the same conclusion. See Ex. 1020 at 4 (holding that “‘mainframe’ will be given its plain and ordinary meaning and does not require a single weldment” (emphasis added)), cited at Pet. Init. CC Br. 2; see also 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning a term of the claim in a civil action, or a proceeding before the International Trade Commission, that is timely made of record in the inter partes review proceeding will be considered.”).” slip op. at 33
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness.” slip op. at 55
Patent outcomesUS 9,321,386 mixedClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,321,386 - Kubota North America Corporation v. Vermeer Manufacturing CompanySome claims unpatentablePTAB · Jun 30, 2026 · IPR2025-00171 · APJ Eric C Jeschke · IPR · Final written decision
Claims 1–13 and 28 are unpatentable over KR996; claims 14–16 and 19–27 were not shown unpatentable over Bares and Beltrami.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“(“This language is merely exemplary, using reference numerals to refer to the embodiment’s features and qualifying ‘single weldment’ as referring ‘generally’ to specific embodiments.”). The Iowa District Court reached the same conclusion. See Ex. 1020 at 4 (holding that “‘mainframe’ will be given its plain and ordinary meaning and does not require a single weldment” (emphasis added)), cited at Pet. Init. CC Br. 2; see also 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning a term of the claim in a civil action, or a proceeding before the International Trade Commission, that is timely made of record in the inter partes review proceeding will be considered.”). Turning to the prosecution history, neither Petitioner nor Patent Owner has highlighted any specific statements that impact the scope of the term “mainframe.” And from our independent review, we do not discern any such statements. For these reasons, the intrinsic evidence as a whole supports construing “mainframe” as a primary supporting structure.” slip op. at 35
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusNot shown unpatentable
“probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness analysis includes consideration and weighing of Patent Owner’s objective indicia of non-obviousness.” slip op. at 54
- ExcludeMotion to exclude, grantedMotion to exclude, deniedGranted in part
“For these reasons, we are persuaded by Petitioner to exclude, as” slip op. at 28
Patent outcomesUS 10,202,266 mixedClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 10,202,266 - Kubota North America Corporation v. Vermeer Manufacturing CompanySome claims unpatentablePTAB · Jun 30, 2026 · IPR2025-00170 · APJ Eric C Jeschke · IPR · Final written decision
Claims 1–18 are unpatentable over KR996 and the KR996/Bares combination; Petitioner did not prove claims 19–36 unpatentable over KR996, Bares, and Beltrami.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableNot shown unpatentableMixed
“(10) Conclusion as to Objective Indicia We have considered, as a whole, all of Patent Owner’s arguments and admissible evidence concerning secondary considerations. If we were to presume nexus, we give some weight to Patent Owner’s admissible evidence of industry praise and skepticism at the time of invention. d. Conclusion as to Claim 1 For the reasons discussed above (§§ II.F.2.a–b), the evidence” slip op. at 62
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedDecided for petitioner
“probative and cogent evidence in the record” and “may often establish that an invention appearing to have been obvious in light of the prior art was not.” Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Thus, notwithstanding what the teachings of the prior art would have suggested to one skilled in the art, secondary considerations (objective evidence of non-obviousness) may lead to a conclusion that the challenged claims would not have been obvious. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). Our obviousness” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“lexicographical, we agree with the parties that “mainframe” is not limited to a single weldment. Pet. Init. CC Br. 1; PO Init. CC Br. 1–2. Instead, a single-weldment “mainframe” is merely one disclosed embodiment. See Pet. Init. CC Br. 3 (stating that “by including the term ‘generally’ in a statement, the feature (i.e., single weldment) is expressly identified as merely included in some, but not all embodiments”); PO Init. CC Br. 3 (“This language is merely exemplary, using reference numerals to refer to the embodiment’s features and qualifying ‘single weldment’ as referring ‘generally’ to specific embodiments.”). The Iowa District Court reached the same conclusion. See Ex. 1020 at 4 (holding that “‘mainframe’ will be given its plain and ordinary meaning and does not require a single weldment” (emphasis added)), cited at Pet. Init. CC Br. 2; see also 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning a term of the claim in a civil action, or a proceeding before the International Trade Commission, that is timely made of record in the inter partes review proceeding will be considered.”). Turning to the prosecution history, neither Petitioner nor Patent Owner has highlighted any specific statements that impact the scope of the term “mainframe.” And from our independent review, we do not discern any such statements. For these reasons, the intrinsic evidence as a whole supports construing “mainframe” as a primary supporting structure.” slip op. at 33
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“2. Analysis “The moving party has the burden of proof to establish that it is entitled to the requested relief.” 37 C.F.R. § 42.20. a. Exhibits 1005, 1006, and 1014 Exhibit 1005 is an English language translation of Korean Patent No. 10-1041996. Exhibit 1006 is an English language translation of Japanese document JP2004-17705A. Exhibit 1014 is an English language translation of Korean Patent No. 10-1023528. A Certification of Translation signed by Takashi Maeshiro of HC Language Solutions, Inc., accompanies each of Exhibits 1005, 1006, and 1014. Ex. 1005 at 28; Ex. 1006 at 16; Ex. 1014 at 16. Each Certification of Translation is worded substantially the same except for the references to the document at issue and the source language being either Korean or Japanese. Exhibit 1005’s Certification of Translation, for example, states: I, Takashi Maeshiro, on behalf of HC Language Solutions, Inc., do solemnly and sincerely declare, to the best of my knowledge and belief, that the attached text represents a translation of Korean Patent No. 10-1041996, that the translation was performed by HC Language Solutions, Inc., and that the translation represents a true, correct, and faithful translation from Korean to English in a form that reflects the intention and meaning of the original text. I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code. Ex. 1005 at 28 (emphasis added). Patent Owner argues that the Certifications of Translation do not” slip op. at 18
Patent outcomesUS 9,975,750 mixedClaim construction§ 103 obviousnesscites PhillipsPatents in suitUS 9,975,750 - Recor Medical, Inc. / Otsuka Medical Devices Co., Ltd. v. Medtronic Ireland Manufacturing Unlimited Co.Some claims unpatentablePTAB · Nov 3, 2025 · IPR2022-00431 · APJ Eric C Jeschke · IPR · Remand
On remand, claims 1–3 and 8–12 are unpatentable over the instituted grounds; claim 4 was not shown unpatentable.
RulingsRemand decision- RemandOther
“Federal Circuit (Paper 33), which vacated the original Final Written Decision and remanded the proceeding to the Board. See ReCor Med., Inc. v. Medtronic Ir. Mfg. Unlimited Co., No. 2023-2251, 2025 WL 944511 (Fed. Cir. Mar. 27, 2025) (“the Appeal Decision” or “Appeal Dec.”); see also Paper 41 (copy of the Appeal Decision). The Federal Circuit’s mandate issued on May 5, 2025. See Paper 40. We have jurisdiction under 35 U.S.C. § 6, and we issue this Final Written Decision on Remand under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons below, on the complete record, we conclude that Petitioner has proven, by a preponderance of the evidence, the unpatentability of claims 1–3 and 8–12 of the challenged patent, and we conclude that Petitioner has not proven, by a preponderance of the evidence, the unpatentability of claim 4.” slip op. at 2
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia outweighedNot shown unpatentable
“and Petitioner’s rebuttal evidence. Objective evidence of nonobviousness, when present, must be considered as part of an obviousness inquiry. Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012). Notwithstanding what the teachings of the prior art would have suggested to one of ordinary skill in the art, the totality of the evidence submitted, including objective evidence of nonobviousness, may lead to a conclusion that one or more of the challenged claims would not have been obvious to one of ordinary skill in the art. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984).” slip op. at 50
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“1. Claims 1–3 and 8–11 Because the obviousness ground based on Levin and Acker is dispositive as to challenged claims 1–3 and 8–11, we need not reach this additional ground as to those claims. See SAS Inst. Inc. v. Iancu, 584 U.S. 357, 371 (2018) (holding that a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Boston Sci. Scimed, analysis in the appeal to the Federal Circuit. See Appeal Dec. *1–*2 (summarizing grounds at issue on appeal and not discussing anticipation based on Acker). Inc. v. Cook Grp. Inc., 809 F. App’x 984, 990 (Fed. Cir. 2020) (nonprecedential) (stating that the “Board need not address issues that are not necessary to the resolution of the proceeding,” such as “alternative arguments with respect to claims [the Board] found unpatentable on other grounds”); SK Hynix Inc. v. Netlist, Inc., IPR2017-00692, Paper 25 at 40 (PTAB July 5, 2018) (determining all challenged claims to be unpatentable and not addressing additional grounds). 2. Dependent Claim 4 As to dependent claim 4, in the context of this ground, Petitioner relies on Acker as to the additional limitations in claim 4 in the same manner as relied on in the context of the ground based on Levin and Acker. See Pet. 73 (“The combination teaches this element for the same reasons described in [the obviousness ground based on Levin and Acker], claim 4, with the exception that [one of ordinary skill in the art] would have been motivated based on his or her knowledge of prior renal denervation work, as noted above.”). Thus, for the same reasons discussed above (see § II.C.3.c), we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 4 would have been obvious based on Acker and the knowledge of one of ordinary skill in the art. G. Asserted Obviousness of Claim 12 Based on Acker, the Knowledge of a Person of Ordinary Skill in the Art, and Yock Petitioner asserts that claim 12, which depends from independent claim 1, would have been obvious based on Acker, the knowledge of one of ordinary skill in the art, and Yock. Pet. 12, 75; Pet. Reply 35–36. Patent Owner provides arguments addressing this ground. PO Resp. 57–60; PO” slip op. at 75
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“1. Independent Claim 1 Petitioner contends that Acker discloses each limitation of claim 1. Pet. 61–63; Pet. Reply 35. In the “Overview of the Ground” section, Petitioner references its proposed construction of the phrase “configured to” and states that “it is proper to consider whether the prior art is ‘capable of’ performing the recited functions, as opposed to requiring that a designer of a prior art device have actually conceived of the recited functional language.” Pet. 61. Petitioner continues: “If the PTAB agrees that this is the proper approach to claim construction, then Acker also anticipates the claims challenged in this ground.” Id. For the reasons below, we determine, based on the complete record, that Petitioner has not demonstrated by a preponderance of the evidence that claim 1 is anticipated by Acker. As to element 1d, which includes the phrase “configured to,”16 Petitioner states that Acker is capable of being used to target renal neural fibers outside of the blood vessel to thermally induce modulation of target neural fibers while protecting non-target tissue in the blood vessel wall from thermal injury for the reasons discussed under claim 1, limitation [1d] and in the section entitled “Reasonable Expectation of Success”, beginning on page 37 [of the Petition]. Pet. 62–63 (citing Daft Pet. Decl. ¶ 179) (first bracketed text added by Petitioner). Patent Owner argues that, in the context of this asserted ground based” slip op. at 71
Patent outcomesUS 8,845,629 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 8,845,629 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Fusion Orthopedics, LLC v. Extremity Medical, LLCSome claims unpatentablePTAB · Nov 4, 2024 · IPR2023-00894 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–10 and 12–15 are unpatentable; claim 11 was not shown unpatentable. Substitute claims 16–25 and 27–30 are unpatentable over Mazur; claim 26 was not reached.
RulingsFinal written decision- BurdenMixed
“It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the grounds for the challenge to each claim.’” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)). Here, however, not until its Reply does Petitioner belatedly suggest that Ferrante’s disclosure of bone screws with self-tapping ends equally meets the limitation of claim 10 (with respect to the first member) as with claim 11 (with respect to the second member), and that both claims are obvious in light of “evidence” from Ferrante “that it was well known to equip bone screws with self-tapping ends.” Reply 26–27. We do not discern these arguments in the Petition, and consider them waived. See Netflix, Inc. v. DivX, LLC, 84 F.4th 1371,1377 (Fed. Cir. 2023) (“While the Board should not take an overly mechanistic view of a petition and decline to address an argument because the petitioner did not present it with ideal vigor and clarity, the Board should also not have to decode a petition to locate additional arguments beyond the ones clearly made.”). In sum, Petitioner’s error in failing to first address limitations of claim 10 in the Petition specific to the Cognet/Ferrante combination indicates a failure to meet the particularity requirements for what must be in the petition and cannot be left to be filled in on reply. See 35 U.S.C. § 312(a)(3); 37 C.F.R. §§ 42.22(a)(2) (requiring, among other things, “a detailed explanation of the significance of the evidence”), 42.104(b)(4)–(5) (requiring that petition “specify where each element of the claim is found in the prior art patents or printed publication relied upon” and, regarding submitted evidence, state “the relevance of the evidence to the challenge raised, including identifying specific portions of the evidence that support the challenge”). Microsoft, 2022 WL 989403, at *6. Accordingly, Petitioner has not shown persuasively that claim 11 would have been obvious in light of Cognet and Ferrante for the reasons set forth in the Petition. slip op. at 41
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We also find persuasive Mr. Dominguez’s explanation that one of ordinary skill in the art would have understood “bore” as including stepped diameter holes, sometimes described as a bore having a counterbore. See generally Ex. 1018 ¶¶ 4–29; Reply 3–10. Three of Mr. Dominguez’s illustrative examples are reproduced in the annotated figures below. The above figures show Mr. Dominguez’s annotated illustrations from the Jackson (Ex. 1019, Fig. 3), Brånemark (Ex. 1021, Fig. 4), and Ray (Ex. 1025, Fig. 1) references as discussed at paragraphs 10, 12, and 13, respectively, of Mr. Dominguez’s Second Declaration. With reference to the above figures, Mr. Dominguez testifies that “Jackson describes a bone repair set screw in which ‘[t]he bore 27 comprises a first bore section 31, a second bore section 32,’ etc. delineated by shoulders 41, 42, etc. (Ex. 1019, 5:24– 43)” (Ex. 1018 ¶ 10); “Brånemark describes an osseous implantation device having body 1ʺ with first and second holding portions 21ʺ, 31ʺ and ‘an inner through bore with a first portion 4ʺ in the first holding portion and a second portion 5ʺ in the second holding portion.’” Ex. 1021, 4:44–46” (id. ¶ 12); and Ray discloses surgical calipers including “handle 12 having ‘stepped cylindrical bore 14,’” wherein “[c]ollar 20 of a shaft inserted in the bore ‘rests against a step of the bore 14’ (2:14–15)” (id. ¶ 13). Patent Owner responds that Mr. Dominguez’s examples “that allegedly show a single bore encompassing two or more stepped-diameter holes or a counterbore . . . . are specific to these references and divorced from the disclosures of the ’166 patent.” Sur-Reply 7. Insofar as the ’166 patent makes no mention of the term “bore” outside the claims, and Mr. Dominguez’s examples are all taken from the field of orthopedic surgery, we do not find this argument persuasive. Patent Owner further appears to contend that exemplary references to a “cylindrical stepped down bore” or a “stepped cylindrical bore” are too specific to be within the scope of the term “bore.” Sur-Reply 7–8. As these terms merely describe species within a larger genus, and Patent Owner presents no cogent reason to exclude them, we do not find this argument availing. Relatedly, we are also not persuaded by Patent Owner’s argument that “the prior art treats a ‘bore’ as an element that is distinct from a ‘counterbore.’” Id. at 8. Rather, we credit Mr. Dominguez’s testimony that “[a] counterbore is not a structure unto itself, a counterbore is part of a larger structure” as exemplified by numerous examples including Laps (Ex. 1028 ¶ 33 (sensor assembly wherein “bore 16 includes a counterbore 18”)); Martinez (Ex. 1029, 3:61 (surgical cutting instrument wherein “bore 56 has a counterbore 64”)); Zang (Ex. 1030, 2:49 (bone anchor having a “bore [that] includes a counterbore”)); Ledet (Ex. 1022, 29:3–5 (vertebral fixation plate having “through holes . . . . countersunk, or counterbored to accommodate the head of a bone screw”)); Seo (Ex. 1031, 3:45 (chair leg employing “counterbored bore 23”)); and Exner (Ex. 1032, 2:16 (extrusion press including “counterbored axial bore 6”)). Ex. 1018 ¶¶ 17–23. That a reference may refer to a figure as showing “bore 103” with “counterbore 105 . . . formed on one end” does not indicate that they are distinct structures as Patent Owner contends, but merely that the focus of each term is directed to the entire bore or to a particular aspect of the bore, i.e., its counterbore. See” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner subsequently proposed an alternative definition, as a person having “[a] Bachelor’s Degree in biomedical and/or mechanical engineering or similar training and . . . at least three years of experience with implant devices used for internal fixation of bones.” POR 5 (citing Ex. 2012 ¶¶ 32–33). According to Patent Owner, “[t]his hypothetical person would be capable of performing various design tasks and would understand the basic mechanical features and operation of orthopaedic implant devices [and] have an appreciation for orthopaedic fusion techniques and the medical issues and concerns faced by a doctor/surgeon charged when performing operations to implant orthopaedic devices.” Id. Despite some differences in wording, Patent Owner asserts (and Petitioner does not contest) that any “distinction between the parties’ proposed definitions of a POSITA does not affect the arguments set forth herein.” Id. (citing Ex. 2012 ¶ 34). Consistent with this view, we find the parties’ constructions equally applicable in light of the prior art of record and the disclosure of the ’166 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). We adopt, for convenience, Petitioner’s definition, but our analysis does not change depending on which of the two articulations are applied here. H.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“one of ordinary skill in the art would understand that “bore,” as used in the context of claims 1 and 12, encompasses a multi-diameter passage, and in particular, one having stepped longitudinal cross sections such as that shown in Cognet’s Figure 1. See generally DI 11–13. For the reasons that follow, we conclude that one of ordinary skill in the art would have understood “bore” as such. Relying on the testimony of Mr. Dominguez, Petitioner initially proposed a construction of “bore” as “a usually cylindrical hole made by or as if by the turning or twisting movement of a tool.” Pet. 16 (citing Ex. 1002 ¶ 58). Petitioner’s proposal relied on Mr. Dominguez’s testimony that “[a] bore is a cylindrical hole made by the spinning rotation of a twist drill cutting tool. It is typically made by removing material from a solid or hollow object, similar to a tunnel or orifice.” Ex. 1002 ¶ 58. Pointing to its annotation of Cognet’s Figure 1, above, Patent Owner argued that that the term “bore” excludes a tunnel made by “two adjacent bores.” See Prelim. Resp. 21–25. In view of the then-available evidence, we provisionally construed “bore” as a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have cylindrical lateral cross-sections, and which do not exclude holes or passages having tapered or stepped longitudinal cross-sections. DI 13.” slip op. at 19
Patent outcomesUS 11,298,166 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 11,298,166
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.