- CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.InstitutedPTAB · Aug 14, 2025 · IPR2025-00505 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–15 on all grounds, finding a reasonable likelihood that the claims would have been shown obvious over the asserted prior art.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“However, Patent Owner has not shown that circumstances exist that would require dismissal of the proceeding as barred under § 315(b) if the unnamed party were added as a real party in interest. Patent Owner has also not alleged any discovery abuse at this time. We determine that we need not address whether Cipla is an unnamed RPI at this stage. The parties may further address this issue during the trial portion of the proceedings. As the Board explained in SharkNinja, it “better serves the interest of cost and efficiency” when the Board does not engage in the “extensive analysis” required to determine whether a party is an unnamed RPI if the result of that analysis has no material impact on the proceeding. SharkNinja v. iRobot Corp., IPR2020-00734, Paper 11 at 19–20 (PTAB Oct. 6, 2020) (precedential). Here, it is undisputed that Petitioner could have named Cipla as an RPI in its Petition without triggering a statutory bar or estoppel under 35 U.S.C. § 315.” slip op. at 5
- Skill levelSkill level petitioner adoptedOther
“Patent Owner states it disagrees with Petitioner’s “definition of a POSA but assumes their definition for purposes of the arguments presented herein.” Prelim. Resp. 6. At this stage in the proceeding, we find that Petitioner’s analysis reasonably establishes a level of ordinary skill in the art as it directly relates to those deciding treatments based on the prior art references. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See, e.g., Ex. 1003, 1817, author list. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“Thus, the ’552 patent teaches that patients may or may not receive some therapeutic benefit from the treatment and also recognizes that any therapeutic benefit may result in prolonging life, but not necessarily result in complete remission of the pancreatic tumor. This understanding is consistent with Dr. Ratain’s testimony that “[t]reating a patient is always with the attempt or intent to cause a therapeutic improvement of the patient, which, in the case of metastatic pancreatic cancer, could be reduced tumor growth or increased overall survival in the patient.” Ex. 1002 ¶ 50. We are unpersuaded, however, by Dr. Ratain’s statement equating “treatment with a saline control” with the claimed “treating metastatic adenocarcinoma,” because the claim is addressing a disease condition whereas the example in Figure 6A is clearly providing a control, without any expectation of therapeutic benefit. See id. ¶ 55. We are not persuaded, on this record, that because Patent Owner did not include the phrase “therapeutically effective amount” in the claims, the claims solely relate to “administering” the antineoplastic therapies without any resulting therapeutic benefit. Rather, on this record, we agree with Patent Owner 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. To the extent that Patent Owner’s position would require some” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“While we are aware that hindsight bias may plague determinations of obviousness, Graham, 383 U.S. at 36, we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. The evidence of record shows the prior art provides specific reasons to replace irinotecan with liposomal irinotecan in the treatment of pancreatic cancer, including improved sustained release, local bioactivation, increased efficacy, and reduced side effects. Ex. 1006, 9; Ex. 1008, 921; Ex. 1002 ¶¶ 91, 238, 239. These specific reasons, as supported by Dr. Ratain, provide specific support for the obviousness of modifying the Conroy Protocol for patients with toxicity to substitute a 60 mg/m2 dose of liposomal irinotecan for irinotecan, particularly in patients with the particular UGT1A1 allele identified by Bayever. Ex. 1006, 3.” slip op. at 37
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,344,552 - Luminex International Co., Ltd. / Menard, Inc. v. Signify Holdings B.V.Some claims unpatentablePTAB · Aug 13, 2025 · IPR2024-01469 · APJ Steven M Amundson · IPR · Final written decision
Claims 1–7, 9–15, and 18–20 are unpatentable; claims 8, 16, and 17 are not determined unpatentable under the asserted prior-art grounds.
RulingsFinal written decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“G. Analysis 1. REAL PARTY IN INTEREST Based on the record before us and for the reasons explained below, we disagree with Patent Owner that Menard is a “real party in interest” under § 315(b). See Resp. 77–82; Sur-reply 27–28. First, the circumstances here differ materially from the circumstances in Ventex. There, two agreements defined the relationship between Ventex (the petitioner and manufacturer of Heatwave fabric) and Seirus (the alleged real party in interest and purchaser of Heatwave fabric). Ventex, IPR2017- 00651, Paper 152 at 7 & n.8. First, a 2013 Supplier Agreement “prevented Ventex from selling to Seirus competitors” and included an indemnity provision requiring Ventex to indemnify Seirus for losses arising from Ventex’s failure to perform certain obligations. Id. at 7, 14. Second, a 2016 Exclusive Manufacturing Agreement provided that Ventex would manufacture the Heatwave fabric only for Seirus in exchange for Seirus’s payment of an exclusivity fee. Id. at 7. Columbia (the patent owner) accused Seirus products incorporating the Heatwave fabric of infringing the patent at issue, and Columbia served Seirus with a complaint alleging patent infringement in 2014 more than two years before Ventex filed a petition in 2017. Id. at 5, 7. When determining that Seirus was a “real party in interest” under § 315(b), the Board reasoned that “Ventex and Seirus had a specially structured, preexisting, and well established business relationship with one another, including indemnification and exclusivity arrangements.” Ventex, IPR2017-00651, Paper 152 at 10; see id. at 12. Additionally, the Board noted that certain evidence “suggest[ed] that” slip op. at 32
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“G. Analysis 1. REAL PARTY IN INTEREST Based on the record before us and for the reasons explained below, we disagree with Patent Owner that Menard is a “real party in interest” under § 315(b). See Resp. 77–82; Sur-reply 27–28. First, the circumstances here differ materially from the circumstances in Ventex. There, two agreements defined the relationship between Ventex (the petitioner and manufacturer of Heatwave fabric) and Seirus (the alleged real party in interest and purchaser of Heatwave fabric). Ventex, IPR2017- 00651, Paper 152 at 7 & n.8. First, a 2013 Supplier Agreement “prevented Ventex from selling to Seirus competitors” and included an indemnity provision requiring Ventex to indemnify Seirus for losses arising from Ventex’s failure to perform certain obligations. Id. at 7, 14. Second, a 2016 Exclusive Manufacturing Agreement provided that Ventex would manufacture the Heatwave fabric only for Seirus in exchange for Seirus’s payment of an exclusivity fee. Id. at 7. Columbia (the patent owner) accused Seirus products incorporating the Heatwave fabric of infringing the patent at issue, and Columbia served Seirus with a complaint alleging patent infringement in 2014 more than two years before Ventex filed a petition in 2017. Id. at 5, 7. When determining that Seirus was a “real party in interest” under § 315(b), the Board reasoned that “Ventex and Seirus had a specially structured, preexisting, and well established business relationship with one another, including indemnification and exclusivity arrangements.” Ventex, IPR2017-00651, Paper 152 at 10; see id. at 12. Additionally, the Board noted that certain evidence “suggest[ed] that” slip op. at 32
- Skill levelOther
“C. Level of Ordinary Skill in the Art Factors pertinent to determining the level of ordinary skill in the art include (1) the educational level of the inventor; (2) the type of problems encountered in the art; (3) prior-art solutions to those problems; (4) the rapidity with which innovations are made; (5) the sophistication of the technology; and (6) the educational level of workers active in the field. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). Not all factors may exist in every case, and one or more of these or other factors may predominate in a particular case. Id. These factors are not exhaustive, but 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). Moreover, the prior art itself may reflect an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Petitioner asserts that a person of ordinary skill in the art at the ’336 patent’s effective filing date would have had “a bachelor’s degree in mechanical engineering, electrical engineering, optics, or physics with at least three years of experience working in the design of LED lights or lighting fixtures; a master’s degree in one of the above disciplines with at least two years of experience; or equivalent experience.” Pet. 14 (citing Ex. 1004 ¶¶ 26–29). Dr. Eden’s testimony supports Petitioner’s assertion. See Ex. 1004 ¶¶ 27–28. Patent Owner “adopts for purposes of this proceeding only” Petitioner’s description of an ordinarily skilled artisan. Resp. 10 (citing Pet. 14). We adopt Petitioner’s description of an ordinarily skilled artisan because it comports with the technology and claims of the ’336 patent as” slip op. at 40
- Obviousness (§103) › Objective indicia / secondary considerationsObjective indicia no nexusDecided for petitioner
“Alleged Objective Indicia of Nonobviousness (i) General Principles Before reaching a conclusion about obviousness, we consider evidence concerning objective indicia of nonobviousness. See Apple, 839 F.3d at 1048. For such evidence to have substantial weight, “its proponent must establish a nexus between the evidence and the merits of the claimed invention.” ClassCo, Inc. v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir. 2016); see Ancora Techs., Inc. v. Roku, Inc., 140 F.4th 1351, 1361 (Fed. Cir. 2025) (noting that the Board did not err by requiring “a nexus to the challenged claims as opposed to the patent as a whole”). “[T]here is no nexus unless the evidence presented is ‘reasonably commensurate with the scope of the claims.’” ClassCo, 838 F.3d at 1220 (quoting Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)). The patentee “bears the burden of showing that a nexus exists.” WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). A rebuttable presumption of nexus arises “when the patentee shows that the asserted objective evidence is tied to a specific product and that product ‘embodies the claimed features, and is coextensive with them.’” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373 (Fed. Cir. 2019) (quoting Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018)). Whether a rebuttable presumption of nexus arises “turns on the nature of the claims and the specific facts.” Teva Pharms. Int’l GmbH v. Eli Lilly & Co., 8 F.4th 1349, 1362 (Fed. Cir. 2021). The presumption analysis should consider the unclaimed features in the product tied to the objective evidence to assess their significance and impact on the correspondence between the patented invention and the product. Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1418 (Fed. Cir. 2022). When, “for example, the patented invention is only a small component of the product tied to the objective evidence, there is no presumption of nexus.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1333 (Fed. Cir. 2019). Absent a presumption of nexus, the patentee may prove nexus by” slip op. at 76
Patent outcomesUS 10,299,336 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,299,336 - Luminex International Co., Ltd. / Menard, Inc. v. Signify Holdings B.V.Some claims unpatentablePTAB · Aug 13, 2025 · IPR2024-00101 · APJ Steven M Amundson · IPR · Final written decision
Claims 1–7, 9–15, and 18–20 are unpatentable; claims 8, 16, and 17 are not shown unpatentable under the asserted grounds.
RulingsFinal written decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for patent ownerDecided for patent owner
“G. Analysis 1. REAL PARTY IN INTEREST Based on the record before us and for the reasons explained below, we” slip op. at 32
- PTAB / AIA Trials › §315(b) time barDecided for patent owner
“III. WHETHER THE PETITION IS TIME BARRED The parties dispute whether the Petition is time barred based on a” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“vacated the panel’s decision denying institution. Paper 12, 6. Among other things, the Director determined based on a “review of the current record” that (1) Menard is not a real party in interest in this proceeding and (2) Menard is not a privy of Petitioner. Id. at 5. Further, the Director remanded the case to the panel and instructed the panel “to determine whether the Petition presents a reasonable likelihood of prevailing with respect to at least one of the challenged claims under 35 U.S.C. § 314(a), and to determine whether to institute inter partes review accordingly.” Id. at 5–6.” slip op. at 3
- BurdenMixed
“U.S. Patent No. 10,299,336 B2 (“the ’336 patent”) (Exhibit 1001). For the reasons explained below, a preponderance of the evidence shows that claims 1–7, 9–15, and 18–20 in the ’336 patent are unpatentable and does not show that claims 8, 16, and 17 are unpatentable. See 35 U.S.C. § 316(e) (2024).” slip op. at 2
Patent outcomesUS 10,299,336 mixed§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,299,336 - Qiagen Sciences, LLC v. Tecan Genomics, Inc.Adverse judgmentPTAB · Aug 12, 2025 · IPR2025-00027 · APJ Deborah Katz · IPR · Adverse judgment
The Board granted the parties’ joint motion for adverse judgment against Patent Owner after it disclaimed the entire patent term, and terminated the instituted inter partes review.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“17.) Previously, on July 11, 2025, Patent Owner filed a disclaimer disclaiming the entire term of the ’241 patent. (See Ex. 2020.) Because there is no term left for any claim of the ’241 patent, we determine it is appropriate to terminate the inter partes review and enter judgment against Patent Owner. ORDER Accordingly, it is: ORDERED that the parties’ joint motion for adverse judgment is granted; and” slip op. at 2
NonePatents in suitUS 11,725,241 - Integrated Dna Technologies, Inc. v. Tecan Genomics, Inc.Adverse judgmentPTAB · Aug 11, 2025 · IPR2024-01502 · APJ James A Worth · IPR · Adverse judgment
The Board granted the joint motion for adverse judgment after Patent Owner disclaimed claims 1–3, 5–11, and 14–17, and terminated the inter partes review.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Section 42.73 provides that “[a] party may request judgment against itself at any time during a proceeding. Actions construed to be a request for adverse judgment include: (2) Cancellation or disclaimer of a claim such that the party has no remaining claim in the trial.” 37 C.F.R. § 42.73(b)(2). We agree that adverse judgment and termination are appropriate in view of the disclaimer because no challenged claim remains.” slip op. at 2
NonePatents in suitUS 9,546,399 - Seaspine Holdings Corporation v. Roger P. Jackson, M.D.Institution deniedPTAB · Aug 7, 2025 · IPR2025-00773 · APJ Mary C Hoffman · IPR · Institution
The Board denied institution because Patent Owner disclaimed claims 1–19, and declined to enter adverse judgment.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“challenged in the Petition and paid the requisite fee. See Ex. 2001; 37 C.F.R. § 1.321 (setting forth requirements for statutory disclaimer). Accordingly, we deny institution of the requested review. 37 C.F.R. § 42.107(e) (“No inter partes review will be instituted based on disclaimed claims.”); General Elec. Co. v. United Techs. Corp., IPR2017-00491, Paper 9 (PTAB July 6, 2017) (precedential) (denying institution based on pre-institution disclaimer of all challenged claims) (“General Electric”).” slip op. at 2
- Adverse judgmentAdverse judgmentDecided for patent owner
“interpreted Rule 42.73(b) as permitting the Board to enter adverse judgment when a patent owner disclaims all challenged claims prior to institution. See Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 1350 (Fed. Cir. 2018). But neither Arthrex nor Rule 42.73(b) require the entry of adverse judgment. Instead, under these circumstances, the Board has discretion to decide whether or not to enter adverse judgement. See, e.g., Bestway (USA), Inc. v. Intex Mktg., Ltd., PGR2024-00036, Paper 9, 6 (PTAB Oct. 28, 2024) (“Bestway”). Based on the facts of this case, we believe that efficient administration weighs against entry of adverse judgment. Thus, consistent with Rule 42.107(e) and General Electric, denial of institution is sufficient to dispose of this matter. See, e.g., Bestway at 8; Samsung Electronics Co., Ltd. v. Oura Health OY, IPR2024-00929, Paper 8, 3 (PTAB Dec. 9, 2024); Takeda Vaccines, Inc., v. Valneva Austria Gmbh, IPR2023-00354, Paper 7, 4 (PTAB June 9, 2023); Microsoft Corp. v. Litl, LLC, IPR2021-01011, Paper 11, 3 (PTAB Apr. 5, 2022); Cisco Sys., Inc. v. SecurityProfiling, LLC, IPR2021-01428, Paper 13, 7 (PTAB Mar. 14, 2021).” slip op. at 3
NonePatents in suitUS 11,399,873 - Posco Co., Ltd. v. ArcelormittalInstitutedPTAB · Jul 23, 2025 · IPR2025-00371 · APJ Brian D Range · IPR · Institution
The Board instituted IPR on claims 1–25 based on all petitioned grounds, finding a reasonable likelihood that POSCO would prevail.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–25 of the ’227 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (POSITA) “would have had an undergraduate degree in materials science, manufacturing engineering, mechanical engineering, or equivalent knowledge, training, or experience, with two years of experience working in metallurgy.” Pet. 6 (citing Ex. 1003 ¶ 15). For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’227 patent specification and the 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 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose any claim constructions. Pet. 3. We do not discern a need to construe explicitly any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“35 U.S.C. § 103(a) as obvious over Takagi and Cornette, citing the Declaration of Dr. Miles for support. Pet. 1, 6–49 (citing Ex. 1003) (Petitioner’s Ground 1A). a. Claim 1 Petitioner argues that Takagi and Cornette teach or suggest each recitation of claim 1. Pet. 6–31. Petitioner argues, for example, that the preamble of claim 1 is not limiting or, alternatively, imparts no structural distinction from Takagi. Id. at 20–23 (citing, e.g., Ex. 1003 ¶ 48). Petitioner further argues that Takagi and Cornette teach forming or hot stamping to arrive at their products. Id. at 23 (citing, e.g., Ex. 1016 ¶ 36 (Takagi referring to “form[ing]” its products shape); Ex. 1014, 9–11 (Cornette referring to “hot stamping”); Ex. 1003 ¶ 48. Petitioner argues that Takagi teaches a strip of base steel having a first and second side. Id. at 23–24 (citing, e.g., Ex. 1003 ¶ 49; Ex. 1016 ¶¶ 13, 36. Petitioner argues that Takagi teaches a coating that is a “diffusion layer” having five phases as depicted by Takagi Figure 2A and explained by Takagi Table 1 (Takagi Fig. 4). Id. at 24–30 (citing, e.g., Ex. 1003 ¶¶ 50–59; Ex. 1016 ¶ 20, Fig. 2A). Petitioner argues that Takagi alone or as modified by Cornette teaches a coating thickness greater than than 30 µm. Id. at 30–31; Ex. 1014, 9; Ex. 1016 ¶ 35; Ex. 1003 ¶¶ 60–61. Petitioner explains why a person having ordinary skill in the art would have had reason to combine teachings of Takagi and Cornette with a reasonable expectation of success. Pet. 11–20 (citing, e.g., Ex. 1003 ¶¶ 31–47; Ex. 1016 ¶¶ 19–37, 47; Ex. 1014, 9; Ex. 1025, 5:17–20; Ex. 1026, 7; Ex. 1034 ¶ 13; Ex. 1055 ¶¶ 2, 7, 14–15, 18, Fig. 3). Based on our review and consideration of the current record, we determine that the information presented sufficiently supports, for purposes of institution, Petitioner’s assertions that Takagi and Cornette teach or suggest each limitation of claim 1. See Pet. 6–31. We therefore determine Petitioner has met its burden to show a reasonable likelihood it would prevail in demonstrating that claim 1 would have been obvious over Takagi and Cornette.” slip op. at 12
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,326,227 - Posco Co., Ltd. v. ArcelormittalInstitutedPTAB · Jul 23, 2025 · IPR2025-00370 · APJ Brian D Range · IPR · Institution
The Board instituted IPR of claims 1–30 on all twelve asserted obviousness grounds, finding a reasonable likelihood that POSCO would prevail.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“unless the information presented in the petition “shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” The following findings of fact and conclusions of law are not final, but are made for the sole purpose of determining whether Petitioner meets the threshold for initiating review. Any final decision shall be based on the full trial record, including any response timely filed by Patent Owner. Any arguments not raised by Patent Owner in a timely-filed response may be deemed waived. For the reasons stated below, we determine that Petitioner has established a reasonable likelihood that it would prevail with respect to at least one claim. We hereby institute an inter partes review as to claims 1–30 of the ’602 patent based upon Petitioner’s asserted grounds of unpatentability.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“For purposes of this Decision, we adopt Petitioner’s proposal as reasonable and consistent with the ’602 patent specification and the 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
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not propose any claim constructions. Pet. 3. We do not discern a need to construe any claim language at this juncture because doing so would have no effect on our analyses below of Petitioner’s asserted grounds and will not assist in resolving the present controversy between the parties. 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” slip op. at 9
- BurdenInstituted
“determine that the information presented sufficiently supports, for purposes of institution, Petitioner’s assertions that Takagi and Cornette teach or suggest each limitation of claim 1. See Pet. 6–33. We therefore determine Petitioner has met its burden to show a reasonable likelihood it would prevail in demonstrating that claim 1 is obvious over Takagi and Cornette.” slip op. at 12
Claim constructioncites KSR · GrahamPatents in suitUS 10,961,602 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00282 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–4 and 7–9 are unpatentable as obvious, principally over Edwards-’535 and Stern for claims 1–3 and 7–9, and Makower, Edwards-’535, and Stern for claims 1, 2, and 4.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 27–28 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See PO Resp. 7 (proposing redlines). Instead, after reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer opinions under either definition. Moreover, the parties do not argue that their respective position would be different under either POSITA definition. See PO Resp. 8 (Patent Owner arguing that the challenges fail “[r]egardless of how a POSITA is defined”); Ex. 1083 ¶ 88 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of a POSITA.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“Petitioner argues that the part of claim 1’s preamble “to treat rhinitis” is not limiting. Pet. 18. According to Petitioner, the body of claim 1 recites a structurally complete apparatus, and the preamble only states an intended use for the device without limiting the claimed structure. Id. at 18–19. Patent Owner neither addresses this issue, nor proposes any other claim construction. PO Resp. 13 (“Patent Owner believes that no claim constructions are required to resolve the issues raised [in this IPR].”). On this record, we find Petitioner’s argument persuasive and determine that the part of claim 1’s preamble “to treat rhinitis” is not limiting.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“techniques of delivering bipolar RF ablation energy through expandable devices to the mucosal tissue of different body cavities.” Id. at 39. According to Petitioner, “combining Edwards-’535 and Stern involves applying Stern’s known bipolar pairing technique to Edwards-’535’s known device that was ready for improvement (because Edwards-’535 omits electrode wiring details) to yield predictable results.” Id. Thus, Petitioner concludes that an ordinarily skilled artisan would have had a reasonable expectation of success when modifying Edwards-’535 in view of Stern. Id. at 38–40. Patent Owner does not dispute Petitioner’s mapping for claim limitations 1[a]-1[c] and 1[f] above, nor does Patent Owner challenge Petitioner’s reasoning for combining Edwards-’535 with Stern. See PO Resp. 14. Patent Owner, however, argues that Petitioner has failed to show Stern teaches limitations 1[d] and 1[e] “because Stern teaches a device comprising only a single pair of bipolar radiofrequency electrodes and a single radiofrequency output channel.” Id. We find that a POSITA would have been motivated to combine the teachings of Edwards-’535 and Stern and would have had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-’535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim limitations 1[a]-1[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 26–33, 43–46; Ex. 1002 ¶¶ 84–102, 159–165. Below we address the parties’ arguments regarding the disputed limitations 1[d] and 1[e].” slip op. at 17
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“In our view, nothing is missing. Stern teaches that the circuitry in Figure 15 is configured to form multiple pairs of bipolar RF electrodes. Ex. 1033, 12:61–13:2 (explaining “[a]s an example” the closing of certain switches in Figure 15 to activate a bipolar pair between electrodes 220 and 224 and a second bipolar pair between electrodes 222 and 226 and further noting that “[c]learly bipolar operation is not limited to these . . . pair couplings” because other switches could be operated to activate a bipolar pair between electrodes 220 and 222); Ex. 1002 ¶¶ 108–111, 135–138. Indeed, Stern consistently uses the word “pairs,” i.e., the plural not the singular, to describe the bipolar operation of its device. See, e.g., Ex. 1033, 2:36–40, 3:38–40, 12:20–25, 12:29–30, 13:27–44, 20:9–10 (describing the bipolar operation of “pairs” nine times). Accordingly, we disagree with Patent Owner’s argument that Stern teaches a device configured to have at most only a single pair of bipolar RF electrodes. Second, Stern teaches that the “embodiment of FIG. 15 . . . provides flexibility within the bipolar operation so that any pair or any combination of pairs may be utilized together.” Ex. 1033, 13:39–43 (emphasis added). Thus, even if claim 1 did require simultaneous activation of multiple bipolar pairs, we agree with Petitioner that such functionality is also taught by Stern. See Reply 5–6.” slip op. at 20
Patent outcomesUS 11,766,286 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,766,286 - Neurent Medical Inc. / Neurent Medical Ltd. v. Aerin Medical Inc.All claims unpatentablePTAB · Jul 11, 2025 · IPR2024-00278 · APJ Michael A Valek · IPR · Final written decision
Claims 1, 4–6, 9, 10, 12, 13, and 15–17 are unpatentable as obvious over the asserted prior-art combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner disputes the second part of Petitioner’s definition “because the ‘and/or’ encompasses within the definition . . . persons who only have experience with the clinical use or testing of medical devices.” Resp. 6. According to Patent Owner, one of ordinary skill “would have had more experience than just clinically using medical devices or simply conducting tests with medical devices” Id. at 6–7. To the extent Petitioner’s definition could be interpreted to encompass someone who only has experience using or testing unrelated medical devices, we tend to agree with Patent Owner. But it does not follow that experience with the clinical use and testing of medical devices, including those that deliver energy to tissue, would not be relevant background for one of ordinary skill. See Reply 33–34 (identifying evidence that clinical experience is relevant). The devices and methods in the challenged patent and asserted prior art are designed to be used by clinicians. Accordingly, clinical experience using and testing them would inform their design and therefore be relevant experience for one of ordinary skill in the art. For these reasons, we do not adopt Patent Owner’s proposed modification of Petitioner’s definition, which would remove clinical use and testing from the list of activities in Petitioner’s POSITA definition. See Resp. 7 (proposing redlines). Instead, we apply Petitioner’s definition. Regardless, Petitioner’s declarant, Dr. Martin, is qualified to offer the opinions in his declarations under either definition. Moreover, Patent Owner does not identify any testimony it contends would be different under its POSITA definition. See Ex. 1083 ¶ 103 (Dr. Martin testifying that his opinions “remain the same regardless of which definition applies”). Accordingly, all of the findings and conclusions herein would be the same under either side’s definition of the level of ordinary skill in the art.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Neither side proposes any terms for express construction. Petitioner contends “the Board need not construe any terms because the Challenged Claims are invalid under any reasonable interpretation.” Pet. 20. “Patent Owner believes that no claim constructions are required to resolve the issues raised” in this IPR. Resp. 13. Nevertheless, in their arguments over whether the prior art teaches certain claim elements, each side accuses the other of misinterpreting or reading requirements beyond their ordinary meaning into those terms. See Reply 3–10 (urging that Patent Owner’s arguments read requirements into elements 1[d] and 1[e]); Sur-Reply 9–15 (arguing Petitioner applies an incorrect definition of “radio frequency output channel”). To the extent the parties’ arguments raise any implicit issues of claim construction, we address those issues within the context they are raised in our analysis below. No further express claim construction is necessary for this decision.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“We find that one of ordinary skill in the art would have been motivated to combine Edwards-535 and Stern, and had a reasonable expectation of success in doing so for the reasons set forth in the Petition. We also find that the articulated combination of Edwards-535 and Stern teaches all of the limitations of claim 1. We adopt Petitioner’s undisputed analysis of claim elements 1[a]-[c] and [f] and reasoning for combining the references, and credit its supporting evidence. See Pet. 7–14, 17–20; Ex. 1002 ¶¶ 79–103, 113–21. Below we address the parties’ arguments regarding the disputed elements 1[d] and 1[e].” slip op. at 23
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“We find that Petitioner has the more persuasive position and has demonstrated that Stern teaches element 1[e]. Petitioner demonstrates Stern’s multiple RF output channels with the annotated version of Figure 15 shown below. Pet. 42–43. As shown by Petitioner’s annotations above, the channel (highlighted in orange) connecting the output received from voltage source 228 to the first bipolar pair (circled in green on the left) is distinct from the channel connecting the output to the second bipolar electrode pair (circled in purple on the right) because depending on which switches are closed, energy travels through a separate connection between those switches and the corresponding electrodes. We agree with Petitioner, and credit Dr. Martin’s testimony, that each of the output channels highlighted in orange in Stern’s Figure 15 above “are output channels as required by the claims because the channels are separately/individually connected to the electrodes” and “control individual pairs of bipolar RF electrodes.” Id. at 43–44; Ex. 1002 ¶¶ 124–128; see also Ex. 1083 ¶ 45 (“an ‘output channel’ connects electrodes and provides the ability to independently control pairs of electrodes”). This understanding of the term “output channel” is consistent with the claim language. Claim 1 recites “multiple radiofrequency output channels” wherein “each pair” of bipolar RF electrodes “is connected with a respective one of the multiple radio frequency output channels.” Ex. 1001, 52:27–33. The RF generator itself and its connection to the output channels is not recited in claim 1. Instead, the claim language focuses on the connection between the electrode pair and its respective output channel. The description in the specification also focuses on the connection to the electrodes and further explains that having a “separate, controlled electrical channel” for “each pair of electrodes” allows for “different regions of the treatment element to be activated separately.” Ex. 1001, 24:45–52, 48:63–65; see also Ex. 1083 ¶ 33 (“[e]very time the patent mentions ‘electrical channel’ or ‘output channel,’ it is referring to connections to electrodes”). This aligns with the depiction of the output channels in the ’318 patent’s figures. See Ex. 1001, Figs. 39–44 (showing RF output channel 961 connected to electrodes). Petitioner demonstrates this in the annotated version of Figure 39 shown below. Reply 8.” slip op. at 29
Patent outcomesUS 11,033,318 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,033,318
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.