- PTAB · Nov 6, 2025 · IPR2025-00820 · APJ Neil T Powell · IPR · Institution
The Board instituted IPR on claims 1–11 on all petition grounds, finding a reasonable likelihood that claim 1 would have been obvious over Tadros, Porter, Kalili, and Texin 990R.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition and the Preliminary Response shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1–11 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 17–18 (citing Ex. 1007 ¶¶ 13–15). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See generally Prelim. Resp. At this stage of the proceeding and on the present record, we adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’090 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Additionally, only terms that are in controversy need to be construed, and these need be construed only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 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)). Both parties indicate that no claim terms need to be expressly construed. Pet. 29–30; Prelim. Resp. 5. Consistent with that, we determine that we need not construe any claim terms expressly in order to resolve the parties’ dispute regarding whether Petitioner has demonstrated a reasonable likelihood of prevailing.” slip op. at 8
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Weighing the parties’ arguments and evidence, we find Petitioner’s arguments and evidence sufficient at this stage to demonstrate a reasonable likelihood of prevailing. Pet. 8–17, 30–49. For example, regarding whether of Porter’s disclosure to the problem faced by inventor of the ’090 patent. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 144–164. The ’090 patent illustrates that its inventor faced the problem of selecting desirable materials for an aligner, including selecting a desirable material for an aligner’s hard layer. Ex. 1001, 5:44–59. Petitioner and Dr. Osswald provide significant evidence and reasoning tending to show that Porter’s discussion of Tritan logically would have commended itself to the attention of an inventor facing the problem of selecting an aligner hard layer. Pet. 8 (citing Ex. 1007 ¶¶ 98–108, 125–127, 144–164). For example, Dr. Osswald explains that “because Tritan copolyesters are BPA-free, Rafih specifically discloses Tritan EX401 as an exemplary material” for its oral appliance. Id. ¶ 99 (citing Ex. 1104, 5:4–64, claims 2, 9, 10). In view of this, Dr. Osswald testifies that “Rafih would inform a [person of ordinary skill in the art] that Porter’s guidance regarding replacing polycarbonate with Tritan applies to dental appliances.” Ex. 1007 ¶ 146. At this stage, weighing Petitioner’s evidence against Patent Owner’s contrary attorney argument that Porter focuses on dishware, we determine Petitioner has shown sufficiently that Porter is analogous art. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 144–164; Prelim. Resp. 1, 9–10, 18–21.” slip op. at 11
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 11,648,090 - PTAB · Nov 6, 2025 · IPR2025-00821 · APJ Neil T Powell · IPR · Institution
The Board instituted review of claims 1–23, 25, and 26 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over Tadros, Porter, Kalili, and Texin 990R.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. See 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). To institute an inter partes review, we must determine that the information presented in the Petition and the Preliminary Response shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim. We institute an inter partes review of claims 1–23, 25, and 26 based on the grounds set forth in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 17 (citing Ex. 1007 ¶¶ 13–15). Patent Owner does not dispute Petitioner’s explanation of the level of skill in the art. See generally Prelim. Resp. At this stage of the proceeding and on the present record, we adopt Petitioner’s uncontested proposed level of ordinary skill in the art, which we find consistent with the level of ordinary skill in the art reflected by the ’090 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Additionally, only terms that are in controversy need to be construed, and these need be construed only to the extent necessary to resolve the controversy. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Neither party indicates that we need to construe expressly any claim terms. Pet. 27–28; Prelim. Resp. 5. Consistent with that, we determine that we need not construe any claim terms expressly in order to resolve the parties’ dispute regarding whether Petitioner has demonstrated a reasonable likelihood of prevailing.” slip op. at 8
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“arguments and evidence sufficient at this stage to demonstrate a reasonable likelihood of prevailing. Pet. 8–17, 53–71. For example, regarding whether Porter is analogous art, Petitioner sufficiently shows reasonable pertinence of Porter’s disclosure to the problem faced by inventor of the ’091 patent. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 146–165. The ’091 patent illustrates that its inventor faced the problem of selecting desirable materials for an aligner, including selecting a desirable material for an aligner’s hard layer. Ex. 1001, 5:44–59. Petitioner and Dr. Osswald provide significant evidence and reasoning tending to show that Porter’s discussion of Tritan logically would have commended itself to the attention of an inventor facing the problem of selecting an aligner hard layer. Pet. 8 (citing Ex. 1007 “because Tritan copolyesters are BPA-free, Rafih specifically discloses Tritan EX401 as an exemplary material” for its oral appliance. Id. ¶ 99 (citing Ex. 1104, 5:4–64, claims 2, 9, 10). In view of this, Dr. Osswald testifies that “Rafih would inform a [person of ordinary skill in the art] that Porter’s guidance regarding replacing polycarbonate with Tritan applies to dental appliances.” Ex. 1007 ¶ 147. At this stage, weighing Petitioner’s evidence against Patent Owner’s countervailing attorney argument that Porter focuses on dishware, we determine Petitioner has shown sufficiently that Porter is analogous art. Pet. 8; Ex. 1007 ¶¶ 98–108, 125–127, 146–165; Prelim. Resp. 1–2, 9–10, 34–36.” slip op. at 13
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 11,648,091 - PTAB · Nov 6, 2025 · IPR2025-00819 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims based on both obviousness grounds, finding a reasonable likelihood of success on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had at least a four-year undergraduate degree in materials science, mechanical engineering, chemical engineering, or a related field and at least two years of experience in the field of polymer science, combined with at least two years of experience in the field of design, manufacture, and processing of thermoformable polymer sheets for use in various applications, such as in orthodontic and dental appliances. Additional education could substitute for professional experience and vice versa. Pet. 18–19 (citing Ex. 1007 ¶¶ 13–15). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be 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 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no claim term requires express construction.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground. We disagree that Petitioner fails to meet its burden as to the motivation to combine arguments. Petitioner persuasively maps the limitations of the challenged claims to portions of the references relied upon. Pet. 28–38 (claim 1), 38–51. Petitioner also, on this record, provides adequate statements of motivation to combine with a reasonable expectation of success. See, e.g., id. at 34–36 (citing Ex. 1007 ¶¶ 31, 39–42, 147–151, 174–176). The Petition’s reliance on supporting testimony and related corroborating evidence to support the combination does not amount to impermissible hindsight, as that testimony takes into account “knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Without further clarification or support from Patent Owner, and in the absence of testimony to support the assertion that a POSITA would not have combined the cited references in the manner proposed with a reasonable expectation of success, we are unpersuaded by Patent Owner’s arguments in this regard.” slip op. at 14
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,154,384 - PTAB · Nov 6, 2025 · IPR2025-00818 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims 1–22 based on all three asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314(a), which provides that inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the briefing and cited evidence of record, we institute inter partes review because we find that Petitioner establishes a reasonable likelihood that it will prevail with respect to at least one of the claims challenged in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time the invention was made. See Graham, 383 U.S. at 17–18. Petitioner proposes that a person of ordinary skill in the art (sometimes referred to herein as a “POSITA”) would have had at least a four-year undergraduate degree in materials science, mechanical engineering, chemical engineering, or a related field and at least two years of experience in the field of polymer science, combined with at least two years of experience in the field of design, manufacture, and processing of thermoformable polymer sheets for use in various applications, such as in orthodontic and dental appliances. Additional education could substitute for professional experience and vice versa. Pet. 18 (citing Ex. 1007 ¶¶ 13–15). At this stage, Patent Owner does not dispute Petitioner’s proposal or offer an alternative proposal. See generally Prelim. Resp. Because Petitioner’s proposed level of ordinary skill in the art appears to be 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 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner argues that no terms require construction, but that “Petitioner applies the prior art consistent with Patent Owner’s assertions in its Infringement Contentions (EX1014, 6-20.).” Pet. 26. Patent Owner does not propose any express claim constructions. Prelim. Resp. 5. Nor does Patent Owner allege that any of Petitioner’s claim interpretations contradict Petitioner’s position in the related district court litigation. Id. Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”). For purposes of this Decision, we determine that no claim term requires express construction.” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“that Petitioner has demonstrated a reasonable likelihood of showing that a person of ordinary skill in the art would have been motivated to combine the teachings of Tadros, Kalili, and Texin 990R to meet the limitations of the claims challenged under this ground. We disagree that Petitioner fails to meet its burden as to the motivation to combine arguments. Petitioner persuasively maps the limitations of the challenged claims to portions of the references relied upon. Pet. 27–36 (claim 1), 36–46. Petitioner also, on this record, provides adequate statements of motivation to combine with a reasonable expectation of success. See, e.g., id. at 32–35 (citing Ex. 1007 ¶¶ 31, 39–41, 57–87, 146–150, 171–172). The Petition’s reliance on supporting testimony and related corroborating evidence to support the combination does not amount to impermissible hindsight, as that testimony takes into account “knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Without further clarification or support from Patent Owner, and in the absence of testimony to support the assertion that a POSITA would not have combined the cited references in the manner proposed with a reasonable expectation of success, we are unpersuaded by Patent Owner’s arguments in this regard. We also disagree with Patent Owner’s arguments about “adhesive lamination” using “tie layers” at this point in the proceeding. Prelim. Resp. 15–18. On this record, we are persuaded that Petitioner has adequately supported its arguments that one of ordinary skill in the art would have been motivated to use adhesive lamination to achieve the proposed combination. See, e.g., Pet. 33–35; Ex. 1007 ¶¶ 39–42, 120, 45, 51, 116, 120. Petitioner relies on Kalili as disclosing a hard layer suitable for combination with Tadros’s soft layers (Pet. 32), and more particularly, doing so in the context of a laminated multilayer aligner (Reply 4). To create the laminated multilayer aligner proposed, Petitioner’s suggested use of a particular type of well-known lamination, i.e. adhesive lamination, is sufficiently developed and supported in the Petition. Pet. 32–35. Here, Patent Owner recognizes that Kalili teaches lamination, but suggests that it does not specifically teach using adhesive lamination. Prelim. Sur-reply 5. We note, however, that the parties have identified limited types of known lamination for aligners: coextrusion, extrusion lamination, and adhesive lamination. Prelim Sur-reply 4; Pet. 14–15 n.3, 33. In KSR, the Supreme Court explained that when “there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR, 550 U.S. at 421. “If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” Id. Having reviewed Petitioner’s proffered arguments as to Tadros, Kalili, and Texin 990R, including motivation to combine the references asserted in this ground, with a reasonable expectation of success, we are persuaded on this record that Petitioner has met its burden for institution with respect to Ground 1.” slip op. at 14
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 10,973,613 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Nov 4, 2025 · IPR2024-00624 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–4, 6–10, and 12–15 are unpatentable, principally because the MSI-H Study Record anticipates them.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“Pet. 12 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Thus, Petitioner and Patent Owner characterize one of ordinary skill in the art differently. Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 11–12; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe” slip op. at 7
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’975 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not inherently anticipate where it failed to mention specific vitamin deficiencies, instead merely inviting further experimentation to find associations with metabolic perturbations). requirement, efficacy is inherent in carrying out the claim steps,” referring to a claimed method of treating or preventing stroke, which was held to be anticipated by the publication of a proposed study. 677 F.3d at 1381. Patent Owner attempts to distinguish the size and apparent surety of the study in Montgomery from the MSR. PO Resp. 15. But because we find that the MSR teaches performing the steps recited in claim 1 for the purpose of determining and treating MSI-H cancer, we are persuaded that the MSR inherently discloses the results of selection of patients and administration of the drug treatment recited in those steps. See Bristol-Myers, 246 F.3d at 1376. Whether or not the MSR could have provided results or was sufficient for full regulatory approval does not change that the MSR teaches Patent Owner’s claimed steps. We have no reason to doubt that the disclosure in the MSR of the steps recited in claim 1 produces the efficacy element required in claim 1, whether or not this efficacy was disclosed in the MSR or was known when it was published. See Mehl/Biophile, 192 F.3d at 1366 (“Where, as here, the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results.”).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“use that does not qualify as prior art. PO Resp. 18–25. Patent Owner argues that an inventor can be granted latitude to experiment in the public eye until her invention is ready for patenting. Id. at 18 (citing Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 64 (1998). According to Patent Owner, the experimental use negation applies to the MSR under a 13-factor analysis provided in Allen Engineering Corp. v. Bartell Industries, Inc., 299 F.3d 1336, 1353 (Fed. Cir. 2002). PO Resp. 19–25. For example, Patent Owner argues that to establish that treatment of MSI-H cancers was effective, the inventors had to test treatment in humans, there being no animal models, and had to publish the MSR on the government website under federal law. Id. at 20–22. Patent Owner argues further that the inventors had control over the MSI-H clinical study and that the field of cancer treatment was highly unpredictable, among other facts. Id. at 21. Patent Owner argues that “[a]t the time of the MSR’s posting, the claimed invention was not, nor could it have been, ready for patenting. The clinical study that ultimately collected the data reported in the patent specification and supporting the patent claims had not and could not have commenced before the MSR was posted.” Id. at 23. sometimes said that an inventor acquires an undue advantage over the public by delaying to take out a patent, inasmuch as he thereby preserves the monopoly to himself for a longer period than is allowed by the policy of the law,” but held that “when the delay is occasioned by a bona fide effort to bring his invention to perfection, or to ascertain whether it will answer the purpose intended,” the experiment use exception can preserve the inventor’s rights. City of Elizabeth v. Am. Nicholson Pavement Co., 97 U.S. 126, 137 (1877). Because we are not persuaded that Patent Owner could not have filed an earlier application, we are not persuaded that the experimental use doctrine is properly applied in this case. Given that clinical trial protocols published on the ClinicalTrials.gov website have been successfully asserted as prior art in other cases, we are not persuaded by Patent Owner’s arguments that the MSR is not available as prior art against the challenged claims. See, e.g., Salix Pharms., Ltd. v. Norwich Pharms. Inc., 98 F.4th 1056, 1061 (Fed. Cir.), cert. denied, 145 S. Ct. 567 (2024), and cert. denied, 145 S. Ct. 983 (2024).” slip op. at 24
Patent outcomesUS 11,325,975 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,325,975 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Oct 28, 2025 · IPR2024-00622 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 6–11, 13–20, 22–24, and 26–28 as anticipated by the MSI-H Study Record; claims 2–5, 12, 21, and 25 as obvious.
RulingsFinal written decision- BurdenUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
- Skill levelSkill level board ownDecided for petitioner
“Petitioner and Patent Owner characterize one of ordinary skill in the art differently. To Petitioner, the ordinarily skilled artisan would have been a medical doctor, or a professional in a related field, with experience treating cancer or access to those with experience in clinical studies of therapeutics and to a pathologist with this experience. Pet. 11 (citing Ex. 1003 ¶ 19). To Patent Owner, the ordinarily skilled artisan would have had a medical or graduate-level degree, or equivalent work experience, in the fields of immunology, genetics, or a related field and would have experience (i) conducting immunology research relating to oncology, (ii) conducting genetics research relating to oncology, or (iii) developing and conducting clinical trials on novel cancer therapies in those fields. PO Resp. 5–6 (citing Ex. 2072 ¶¶ 31–32, 86–94). Petitioner emphasizes medical and treatment aspects in its characterization of an ordinarily skilled artisan, whereas Patent Owner emphasizes research aspects. The ’356 patent claims a method of treating a human patient with cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner, MSR, discloses testing Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients for cancer, as well as testing existing compounds for use in treatment modalities. In light of the extent of the relevant field, we determine that the level of skill in the art relevant to the claims of the ’356 patent is not limited to knowledge of and experience with conducting research relating to oncology or developing and conducting clinical trials, but includes knowledge of and experience with treating cancer patients with immunotherapy compounds, identifying the conditions these patients may have, and understanding the literature regarding clinical trials for such colorectal cancers and the associated conditions and immunotherapy.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties do not assert constructions of any terms recited in the challenged claims other than that their ordinary and customary meanings should apply. Pet. 10–11; PO Resp. 6. We determine that no express construction of any claim term is necessary to resolve the dispute between the parties. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We construe claims “in accordance with the ordinary and customary meaning of such history pertaining to the patent.” 37 C.F.R. § 42.100(b) (2020).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundUnpatentable
“(“the claimed process here is not directed to a new use; it is the same use, and it consists of the same steps as described by [the prior art]. Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). After analysis of the full record, we are persuaded that the results recited in claim 1 would follow from the steps taught in the MSR, for the reasons and based on the evidence Petitioner cites above. For these same reasons, we are unpersuaded by Patent Owner’s argument that it was unknown whether the amount of pembrolizumab recited in claim 1 would be effective in producing an improved outcome compared to a reference patient without a tumor that was not MSI-H or dMMR, and Patent Owner does not dispute that the amount of pembrolizumab disclosed in the MSR (10 mg/kg every 14 days; see Ex. 1005, 4) is the same as the amount provided in the ’356 patent as being effective (10 mg/kg every 14 days; Ex. 1001, 8:48–52, 13:50–52). Regardless of the inventors’ intent in publishing the MSR as a Stage II clinical trial on the www.clinicaltrials.gov website, as discussed above, we determine that the MSR teaches selecting a patient with a metastatic MSI-H or dMMR tumor and administering an amount of pembrolizumab that would be effective. See, e.g., Ex. 1005, 4 (Arms and Interventions). The result of drug treatment inherently follows its administration. The MSR does not merely suggest that pembrolizumab may be useful in some unidentified subset of patients or suggest that some unidentified drug may be useful for MSI-H cancer patients. Instead, the MSR discloses selecting a patient with a condition recited in claim 1 and treating with the drug at the amount recited in claim 1. Contra Metabolite Labs. Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367 (Fed. Cir. 2004) (holding that the prior art did not” slip op. at 22
Patent outcomesUS 10,934,356 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,934,356 - Valve Corporation v. Immersion CorporationAll claims unpatentablePTAB · Oct 24, 2025 · IPR2024-00714 · APJ Christopher L Ogden · IPR · Final written decision
Claims 1–20 are unpatentable: Goldenberg anticipates or renders claims 1–6, 8–13, and 15–19 obvious, and Goldenberg with Cruz-Hernandez renders claims 7, 14, and 20 obvious.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“The parties’ proposed levels of ordinary skill are substantially similar, supported by testimonial evidence, and consistent with the asserted prior art and the types of problems and solutions in the ’907 patent. See, e.g., Ex. 1001, 1:14–62. Because we discern no dispositive difference between the parties’ proposals, and neither party has argued that the choice between the two would affect the outcome,6 we adopt Petitioner’s proposed level of skill for this decision. We note, however, that our decision would be the same under Patent Owner’s proposal.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“to,” as recited in each of claims 1, 8, and 15, to “require[] a cause-and-effect relationship between a secondary event (e.g., a haptic effect) that occurs in reaction to a first event (e.g., entry of the user input element to one or more positions within the boundary range of positions).” PO Resp. 26–27 (citing Ex. 2004 ¶ 44). Patent Owner argues that “in response to” refers to more than just a coincidence and involves at least some degree of causality. Id. at 27 (citing American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318, 1339–40 (Fed. Cir. 2011); Ex. 2007, 12–14 (dictionary definition); Ex. 2008, 7 (dictionary definition); Ex. 2006, 30:13–31:2, 32:8–11, 32:17– 21 (testimony by Mr. Ward)); PO Sur-reply 8–9 (citing Ex. 2009, 34:8–19, 36:5–21 (testimony by Mr. Ward)).” slip op. at 17
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“to,” as recited in each of claims 1, 8, and 15, to “require[] a cause-and-effect relationship between a secondary event (e.g., a haptic effect) that occurs in reaction to a first event (e.g., entry of the user input element to one or more positions within the boundary range of positions).” PO Resp. 26–27 (citing Ex. 2004 ¶ 44). Patent Owner argues that “in response to” refers to more than just a coincidence and involves at least some degree of causality. Id. at 27 (citing American Calcar, Inc. v. American Honda Motor Co., 651 F.3d 1318, 1339–40 (Fed. Cir. 2011); Ex. 2007, 12–14 (dictionary definition); Ex. 2008, 7 (dictionary definition); Ex. 2006, 30:13–31:2, 32:8–11, 32:17– 21 (testimony by Mr. Ward)); PO Sur-reply 8–9 (citing Ex. 2009, 34:8–19, 36:5–21 (testimony by Mr. Ward)).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under § 102, a petitioner must locate every element in a claim, arranged as recited in the claim, in a single prior art reference. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). The limitations may be present in the reference “either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). In making this determination, we consider the reference “together with the knowledge of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (citing In re Samour, 571 F.2d 559, 562 (CCPA 1978)).” slip op. at 18
Patent outcomesUS 10,627,907 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,627,907 - PTAB · Oct 15, 2025 · IPR2025-00762 · APJ Scott B Howard · IPR · Institution
The Board instituted IPR on claims 1–5 and 8–12 on all asserted grounds, finding a reasonable likelihood that claim 1 would have been obvious over Koskinen.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review. 35 U.S.C. § 314 (2024); 37 C.F.R. § 42.4(a) (2024). Inter partes review may not be instituted unless “the information presented in the petition filed under [35 U.S.C.] section 311 and any response filed under [35 U.S.C.] section 313 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.” 35 U.S.C. § 314(a). “When instituting inter partes review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.” 37 C.F.R. § 42.108(a). For the reasons set forth below, upon considering the briefing and the evidence of record, we determine that the information presented in the Petition establishes a reasonable likelihood that Petitioner will prevail with respect to at least one of the challenged claims. Accordingly, we institute inter partes review on all of the challenged claims based on all of the grounds identified in the Petition.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that a person having ordinary skill in the art “would have had a bachelor’s degree in electrical engineering, computer engineering, computer science, or a related field and at least two years of practical experience with design or development of telecommunication and/or wireless communications systems, or the equivalent.” Pet. 7 (citing Ex. 1003 ¶¶ 19–21). Petitioner further argues that “[a]dditional education” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the purposes of this Decision, we need not expressly construe any claim terms.6 See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Additionally, a person having ordinary skill in the art would have known and been familiar with information elements (IEs) that specified an RLC reordering timer value based on (1) general knowledge that IEs carried information in RRC messages and (2) that 3GPP TSs describe an IE carrying recording timer duration information for the RLC layer. See Ex. 1003 ¶ 151; Ex. 1014, 219–20. Accordingly, it would have been obvious to a person having ordinary skill in the art “that the PDCP timer information, which used similar variables as its RLC counterpart (Koskinen, ¶¶37-38), would also be carried in a PDCP configuration IE.” Ex. 1003 ¶ 151.” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,863,573 - AT&T Mobility LLC / AT&T Services Inc. et al. v. Daingean Technologies Ltd.All claims unpatentablePTAB · Oct 8, 2025 · IPR2024-00310 · APJ Mary C Hoffman · IPR · Final written decision
Claims 4–6 and 8 are unpatentable as obvious over Lee1 and Lee2; the Board found the Lee1–Lee2 combination teaches the limitations and has sufficient motivation to combine.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”), on or around the earliest possible priority date of the ’207 patent, would have had “a B.S. in Electrical Engineering or a related field with at least three years of experience designing, developing, and/or testing telecommunication systems” and “familiarity with the wireless standards and well-known protocols for accessing wireless networks,” and that “[m]ore education may supplement practical experience or vice versa.” Pet. 3, 10 (citing Ex. 1003 ¶ 36). In its Preliminary Response, “Patent Owner generally concurs with [Petitioner’s] description, though would propose that a POSITA only needs two years of experience . . . . [but] does not believe any difference between Patent’s Owner’s view and Petitioners’ view affects the unpatentability analysis.” Prelim. Resp. 24. We agree with Patent Owner that the difference between Petitioner’s and Patent Owner’s formulations would not affect our analysis of patentability. We adopt Petitioner’s formulation, which is supported by expert testimony and is generally consistent with the level of skill reflected in the Specification and the prior art. See, e.g., Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Looking first at the claim language itself, Patent Owner’s construction is unduly narrow. The “for” recitations derive antecedent basis from limitation 4a. Ex. 1001, 36:44–45. Limitation 4a recites “a 4-step” procedure and “a 2-step” procedure. Thus, the claim includes one of each procedure type: “one” 4-step and “one” 2-step (i.e., single instances of each procedure). Patent Owner similarly reads the claim as requiring “one or more” of each procedure type. See Tr. 33:19–34:4. Because limitation 4a provides antecedent basis for a singular 4-step procedure and a singular 2-step procedure, this strongly suggests that the claim requires for the one (or for the single) 4-step procedure but not for all 4-step procedures, and for the one (or for the single) 2-step procedure but not for all 2-step procedures. At trial, Patent Owner’s interpretation was similar, stating, “that would read. . . as for the one or more 4-step . . . procedure and for the one or more 2-step . . . procedure.” See Tr. 33:25– 34:4 (emphasis added). In seeming contradiction, Patent Owner also stated, “I read that as being . . . all 4-step contention random access procedures . . . and all 2-step random access based procedures.” Id. (emphasis added). We note that Patent Owner does not, however, cite any legal precedent for interpreting “one or more” as requiring “all,” or provide reasoning for departing from the default claim construction principle that “one or more” includes “one.” For this reason and for reasons further discussed below, construing “for the 4-step” to mean “for all 4-step,” and “for the 2-step” to mean “for all 2-step,” would improperly import limitations from the Specification into the claims. See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”).” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“explained below, we determine that Petitioner has shown by a preponderance of the evidence that claim 4 is rendered obvious over Lee1 and Lee2 (“Lee1–Lee2”).” slip op. at 20
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“With these teachings in mind, we are persuaded by Petitioner that incorporating Lee2’s higher power and different ramping into Lee1’s 2-step procedure would have even further reduced the latency of Lee1’s 2-step procedure, and that this would have resulted in different power settings based on procedure type. Pet. 37–38; Ex. 1003 ¶¶ 88–89; Reply 12–13. Patent Owner does not meaningfully dispute this point. See generally PO Resp. 37–42; Sur-reply 12–17. Instead, Patent Owner argues that Lee1’s 4-step procedure would “equally benefit” from reducing latency, and that Petitioner has not explained why a POSITA would not use the same power settings for both procedures, i.e., use Lee2’s same higher power and different ramping in Lee1’s 4-step procedure. See PO Resp. 41–42. However, Petitioner’s burden is to provide a motivation for the proposed combination—in this case, modifying Lee1’s 2-step procedure with Lee2’s higher power and lower ramping. The obviousness analysis does not require Petitioner to explain why the references would not have been combined in an alternative way not proposed by Petitioner. To the extent Patent Owner argues that Lee1 and Lee2 cannot be combined as proposed, and therefore must be combined in this alternative manner, we disagree. For example, Patent Owner does not provide evidence of teaching away or that the proposed combination is inoperable. See generally PO Resp. 37–42; Sur-reply 12–17. Furthermore, we do not see how solving any technical issues in combining Lee1 and Lee2 as proposed would have been beyond the level of ordinary skill in the art. See KSR, 550 U.S. at 418. Furthermore, Petitioner explains why a POSITA would have sought to” slip op. at 26
Patent outcomesUS 10,932,207 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,932,207 - PTAB · Oct 6, 2025 · IPR2025-00438 · APJ Lilan Ren · IPR · Institution
The Board instituted IPR on claims 1–5, 7–13, and 16–20 and all asserted grounds after finding a reasonable likelihood of prevailing on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. See 35 U.S.C. § 314 (2024); 37 C.F.R. § 42.4(a) (2024). Institution of an inter partes review requires that “the information presented in the petition . . . and any response . . . 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.” 35 U.S.C. § 314(a). For the reasons set forth below, we determine that there is a reasonable likelihood that Petitioner will prevail with respect to at least one challenged claim, and we institute an inter partes review.1” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner contends that an ordinarily skilled artisan “would have had a bachelor’s degree in Mechanical Engineering, Computer Engineering, Electrical Engineering, Chemical Engineering, Materials Science, or a comparable field and at least two years of experience related to 3D printing, with additional experience potentially being a substitute for a formal degree or training (and vice versa).” Prelim. Resp. 11–12. For purposes of this decision, we adopt Petitioner’s definition of the level of ordinary skill in the art as it appears unopposed and consistent with the disclosures of the ’466 patent and the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). C. Claim Construction” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.100(b). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). “The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (quoting Vivid Techs., Inc. v. Am. Sci. Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). At this stage of the proceeding, neither party contends that any formal claim construction is necessary. See Pet. 6 (“Petitioner submits that no claim terms require a formal construction for purposes of evaluating the prior art and resolving issues this proceeding.”); Prelim. Resp. 12 (“For the purposes of this Preliminary Response, Patent Owner submits that the Board does not need to construe any claim terms in any particular way to conclude that the Petition is deficient and thus institution of review is not warranted.”). After reviewing the parties’ respective arguments and the evidence currently before us, however, we determine that we do not need to expressly construe any claim term to resolve any controversy at this stage of the proceeding. D. Alleged Obviousness Over Loughran and Dubois (Ground 1A)” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The record before us supports Petitioner’s contention that the combining Loughran and Dubois is no more than a “combination of familiar elements according to known methods . . . [which] does no more than yield predictable results.” Compare Pet. 12, with Prelim. Resp. 19–23 (disputing some of Petitioner’s reasons to combine without addressing Petitioner’s reasoning based on KSR); see KSR, 550 U.S. at 416. By contrast, Patent Owner’s contentions relating to the alleged motivation to combine teachings of Loughran and Dubois lack evidentiary support. Based on our review and consideration of the current record, we are persuaded that Petitioner has adequately shown for purposes of institution that there is sufficient rationale to combine as well as a reasonable expectation of success in combining the teachings of Loughran and Dubois in the manner suggested.” slip op. at 17
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,569,466
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.