- 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 - PTAB · Oct 14, 2025 · IPR2025-00687 · APJ Avelyn M Ross · IPR · Institution
The Board instituted inter partes review of claims 1–8 and 10–18 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“Based on the current record, we determine that the Petition is not time-barred. The ’370 patent was not part of the 2019 Delaware lawsuit that forms the basis of Patent Owner’s time-bar allegations. And, as Petitioner explains, when the ’370 patent was asserted in July 2024, Petitioner filed this request for inter partes review about seven months later, i.e., within the one-year period. Furthermore, Patent Owner does not allege which unnamed entity is in privity with Petitioner or provide any details of the relationship that establishes privity. Nor does Patent Owner direct our attention to record evidence that would support its allegations. Therefore, without more, we determine that the Petition is not time-barred.” slip op. at 11
- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC, Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The current record supports that Petitioner’s combination of Vosteen589 with Starns and with Mass-EPA would have been “the mere application of a known technique to a piece of prior art ready for the improvement.” KSR, 550 U.S. at 401. Indeed, “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill.” Id. Patent Owner does not allege that the combination was beyond the skill level of a person of ordinary skill in the art at the time of the alleged invention. See generally Prelim. Resp. Thus, Petitioner has provided sufficient reasoning with rational underpinnings to explain why a skilled artisan would have modified the teachings of the applied references. See KSR, 550 U.S. at 418.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,933,370 - PTAB · Oct 9, 2025 · IPR2025-00425 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims and all asserted grounds, finding a reasonable likelihood that Petitioner would prevail on at least one claim.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. 9 Petitioner asserts that the supply agreements between the Chem-Mod Purchasers and Chem-Mod expired in 2021. For the reasons discussed herein, we determine that the language of these agreements does not establish privity. In the event Patent Owner maintains its argument that the Chem-Mod Purchasers are in privity with Chem-Mod, the parties should address the legal impact, if any, of the expiration of these agreements on Patent Owner’s arguments. WesternGeco LLC, 889 F.3d at 1321 (a “contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8). We acknowledge, but disagree with, Patent Owner’s argument that the terms of the indemnity “specifically targeted” the activities at the “heart of the alleged infringement.” Sur-reply 7–8. Rather, the indemnification language in these agreements appears to be standard and typical of supply agreements. See Ex. 2037, 26;10 Ex. 2038, 10–12; Ex, 2039, 10–12; Ex. 2040, 10–12; Ex. 2041, 10–12; Ex. 2042, 24–27. Such language, without more, “does not amount to a sufficiently-close relationship to warrant finding . . . privity.” WesternGeco LLC, 889 F.3d at 1321–22.” slip op. at 11
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“Patent Owner does not point to any record evidence that suggests the parties to the Delaware Action adequately represented the Chem-Mod Purchasers’ interests or that the Chem-Mod Purchasers controlled, directed, or funded the Delaware Action. See generally Prelim. Resp.; Sur-reply. Nor does Patent Owner suggest that the indemnified Petitioners are acting as a proxy for Chem-Mod and its affiliates in this case. Thus, the relationship with Chem-Mod, its affiliates, and the indemnified Petitioners was not “sufficiently close that it can be fairly said petitioner had a full and fair opportunity to litigate the validity of the patent in that lawsuit.” Google, IPR2023-00707, Paper 27 at 37. In sum, Petitioner bears the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioner’s assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioner’s decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 1–2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem- Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod Purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 15
- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Petitioner asserts that a person of ordinary skill in the art (“POSITA”) “would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’225 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner discusses the term “pyrolysis char” and states that, for the purposes of the Petition, it adopts and applies the Delaware court’s construction that “allow[s] for the pyrolysis char to be created within the combustor, so long as it is then present (and combusted) with the coal and the bromine compound.” Pet. 11–12 (citing Ex. 1071). Patent Owner does not appear to propose any express claim constructions. See generally Prelim. Resp. 7. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,589,225 - PTAB · Oct 9, 2025 · IPR2025-00424 · APJ Kristina M Kalan · IPR · Institution
The Board instituted IPR on all challenged claims, finding a reasonable likelihood of success on the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (a “contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 8–9). We acknowledge, but disagree with, Patent Owner’s argument that the terms of the indemnity “specifically targeted” the activities at the “heart of the alleged infringement.” Sur-reply 8. Rather, the indemnification language in these agreements appears to be standard and typical of supply agreements. See Ex. 2037, 26;10 Ex. 2038, 10–12; Ex, 2039, 10–12; Chem-Mod Purchasers are in privity with Chem-Mod, the parties should address the legal impact, if any, of the expiration of these agreements on Patent Owner’s arguments. 10 Exhibit 2037 is an agreement with WPL, who has recently been terminated from this inter partes review. See Paper 26. For purposes of this Decision, we have considered whether WPL is in privity with Chem-Mod Ex. 2040, 10–12; Ex. 2041, 10–12; Ex. 2042, 24–27. Such language, without more, “does not amount to a sufficiently-close relationship to warrant finding . . . privity.” WesternGeco LLC, 889 F.3d at 1321–22.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSITA”) “would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioner’s proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’225 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner discusses the term “pyrolysis char” and states that, for the purposes of the Petition, it adopts and applies the Delaware court’s construction that “allow[s] for the pyrolysis char to be created within the combustor, so long as it is then present (and combusted) with the coal and the bromine compound.” Pet. 10–11 (citing Ex. 1071). Patent Owner asserts that it “does not presently propose any constructions,” but notes the Board’s claim construction in IPR2020-00834, Paper 18 at 7–8, regarding the term “injecting a sorbent material comprising activated carbon into the mercury-containing gas downstream of the combustion chamber.” Prelim. Resp. 7. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 21
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION Based on the current record, and for the reasons explained above, we find Petitioner has demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. We, therefore, institute an inter partes review of all challenged claims on all asserted grounds. This Decision is not a final determination on the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing could change upon further development of the record during trial. We remind the parties that any argument not raised in a Patent Owner Response to the Petition, or as permitted in another manner during trial, shall be deemed forfeited and/or waived even if asserted in the Preliminary Response. In re Google Tech. Holdings LLC, 980 F.3d 858, 862–64 (Fed. Cir. 2020) (holding an argument forfeited when not timely raised before the Board); In re NuVasive, Inc., 842 F.3d 1376, 1380–81 (Fed. Cir. 2016) (holding Patent Owner waived an argument addressed in the Preliminary Response by not raising the same argument in the Patent Owner Response). V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 314(a), inter partes review is hereby instituted on all challenged claims of the ’225 patent based on the asserted grounds set forth in the Petition; and” slip op. at 41
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,589,225 - PTAB · Oct 6, 2025 · IPR2025-00423 · APJ Zhenyu Yang · IPR · Institution
The Board instituted IPR on claims 1–4 and 6–29 on all asserted grounds, finding a reasonable likelihood of unpatentability based on the asserted obviousness and anticipation challenges.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“After reviewing the evidence of record, we are persuaded the instant Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (“a contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 7–8).” slip op. at 12
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“In sum, Petitioners bear the burden of demonstrating compliance with 35 U.S.C. § 312(a)(2) and § 315(b), but the current record does not provide sufficient reason to doubt Petitioners’ assertion that Chem-Mod was not “funding this petition, advising on strategy for this petition, or exercising any control over Petitioners’ decision to file the petition (or the arguments included therein).” Pet. 2; see also Reply 2. Indeed, the current record supports that the relationship between Chem-Mod and the Chem-Mod Purchasers was a standard supplier/customer relationship. Exs. 2037–2042. The evidence does not support that Chem-Mod negotiated a license on behalf of the Chem-Mod Purchasers or that the Chem-Mod purchasers owned power plants that were at issue in the Delaware Litigation. Ex. 2009, 91; Ex. 2010, 107. Therefore, on this record, we determine that the relationship between Chem-Mod and the Chem-Mod Purchasers does not support that the Petition is time-barred.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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.” 35 U.S.C. § 314(a).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 11–12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioners’ proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’430 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,668,430 - PTAB · Oct 6, 2025 · IPR2025-00422 · APJ Zhenyu Yang · IPR · Institution
Instituted IPR on claims 1–4 and 6–29 on all asserted grounds, finding a reasonable likelihood of prevailing on the asserted anticipation and obviousness challenges.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityNot time barredDecided for petitioner
“Petition is not time-barred as to the Chem-Mod Purchasers. Generic indemnity agreements are insufficient, without more, to establish privity. WesternGeco LLC, 889 F.3d at 1321 (“a contractual and fairly standard customer-manufacturer relationship regarding the accused product” does not suggest, “without more, that the parties were litigating . . . [an] IPR[] as proxies for the other.”). The only relationship alleged to exist between Chem-Mod, its affiliates, and the Chem-Mod Purchasers is that of a supplier-customer relationship. As part of that relationship, the parties entered into supply agreements that included an indemnification provision for the purchased products. Exs. 2037–2042 (discussed at Sur-reply 8–9).” slip op. at 12
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“are unpatentable, which includes the burden of establishing that any reference upon which it relies constitutes prior art under 35 U.S.C. § 102. See 35 U.S.C. § 316(e); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1576 (Fed. Cir. 1996) (holding that a patent challenger “bore the burden of persuasion . . . on all issues relating to the status of [the asserted reference] as prior art”). Here, because Petitioners initially show Downs-Boiler qualifies as prior art on its face, Patent Owner bears the subsequent procedural burden to produce evidence antedating the reference. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015); Magnum Oil, 829 F.3d at 1375. Although the burden of production can be a shifting burden, the burden of persuasion is on Petitioners to ultimately prove “unpatentability by a preponderance of the evidence,” and that this burden never shifts to Patent Owner. Dynamic Drinkware, 800 F.3d at 1378.” slip op. at 37
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioners assert that “[a] person of ordinary skill in the art [“POSITA”] would have at least a bachelor’s degree in chemical engineering, mechanical engineering, or a related field of study with at least two years of experience implementing pollution control in power generation plants for natural gas, coal, and/or industrial waste incineration.” Pet. 12 (citing Ex. 1002 ¶¶ 48–51). Patent Owner does not dispute the level of ordinary skill in the art. See generally Prelim Resp. For purposes of this Decision, we adopt Petitioners’ proposed definition of a POSITA because it is consistent with the skill level reflected in the disclosures of the ’430 patent and prior art. See Okajima, 261 F.3d at 1355 (the prior art may reflect an appropriate level of skill in the art).” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to construe any claim term expressly.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSRPatents in suitUS 10,668,430 - Xencor, Inc. v. Merus N.V.InstitutedPTAB · Sep 26, 2025 · IPR2025-00605 · APJ Tawen Chang · IPR · Institution
The Board instituted IPR on claims 1–7 and all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Desjarlais or Moore or obvious over Lazar alone.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“SAS, 138 S. Ct. at 1356. Thus, because we determine, based on the arguments and evidence on the present record, that there is a reasonable likelihood Petitioner would prevail with respect to claim 1, we institute an inter partes review of all challenged claims under each Ground presented in the Petition. Id.; see also 37 C.F.R. § 42.108(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.”). III. CONCLUSION For the reasons provided above, we find that Petitioner has demonstrated a reasonable likelihood of showing at trial that at least one of the challenged claims of the ’859 patent is unpatentable under at least one ground. Accordingly, we institute inter partes review of all challenged claims based on all the Grounds presented in the Petition.” slip op. at 49
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351. In this case, Table A of the ’935 provisional discloses a list of CH3 domain interface residues and identifies, for each interface residue in heavy chain A, the contacting residue in the corresponding chain B. Ex. 1030, 17, Table A. Table A does not, however, describe any particular substitutions or pairs of substitutions that should be made to the CH3 domains. See, e.g., Pet. 28 (citing Ex. 1002 ¶¶ 109–119). Table 7 of the ’935 provisional does identify specific amino acid substitutions in CH3 domains, including substitutions resulting in a positively charged residue at position 364 (e.g., S364K) and a negatively charged residue (e.g., L368D) at position 368. Ex. 1030, 52, Table 7. Patent Owner argues that this table “discloses specific positions for ‘identification of novel charge pair mutants.’” Prelim. Resp. 13 (citing Ex. 2010 ¶ 48). As Petitioner points out, however, while Example 13 of the ’935 provisional relates to identification of novel charge pair mutants, Table 7 itself was only a “first step” in this identification process. Ex. 1030, 51:6–17. In this step, “many interface contact residues in the IgG CH3 domain were scanned one by one or in groups for substitutions that would result in repulsion of 35 identical heavy chains” so that identified substitutions can then be used to generate antibodies “by engineering matched pairs of CH3 residues in one or more IgG heavy chains – CH3 regions” in follow up experiments. Id. Accordingly, Table 7 does not appear to describe heterodimer combinations, such as those that would result from a pairing of chains with different substitutions. Pet. 29–30 (citing, e.g., Ex. 1002 ¶¶ 111–118). As Petitioner further points out, the follow up experiments testing the matched pairs of CH3 residues did not include paired substitutions at positions 364 and 368. Id. at 29–31. Patent Owner points to disclosure in the ’935 provisional describing, as a distinguishing feature of its invention, the substitution of non-charged or neutral amino acids in wildtype CH3 with charged residues, which according to the ’935 provisional has the “advantage that at least one additional charge-charge interaction in the CH3 interface is created.” Prelim. Resp. 12 (citing, e.g., Ex. 2010 ¶¶ 42–48). For the same reasons discussed above, Petitioner has sufficiently established, for purposes of institution, that such disclosure would not reasonably convey to an ordinarily skilled artisan that the inventors had possession of the entire genus of heterodimeric antibodies comprising CH3 domains wherein a non-charged amino acid is replaced with a charged residue so as to create an additional charge-charge interaction in the CH3 interface. In this regard, we also note that “a description that merely renders the invention obvious does not satisfy the [written description] requirement.” Ariad, 598 F.3d at 1352.” slip op. at 34
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner
“adequately describes a heterodimeric antibody comprising the recited charged residues at the recited positions of the CH3 domains, i.e., “a positively charged amino residue at position 364” at a first CH3 domain and “a negatively charged amino acid residue at position 368” of the second CH3 domain. Having considered the evidence of record at this preliminary stage of the proceeding, and for the reasons set forth below, we are persuaded that Petitioner has shown sufficiently, for purposes of institution, that the ’935 provisional does not provide adequate written description support for claim 1 of the ’859 patent and that, accordingly, Desjarlais and Moore qualify as prior art to that claim. As Petitioner points out, the cited disclosure in the ’935 provisional does not “mention[] positions 364 and 368 together as a pair of positions for potential mutations on two chains.” Pet. 28 (citing Ex. 1002 ¶¶ 109–19). Although Patent Owner is correct that examples or actual reduction to practice are not required for adequate written description and “[a] specification may . . . contain a written description of a broadly claimed 34 invention without describing all species that [the] claim encompasses,” Prelim. Resp. 15 (quoting Ariad Pharms., 598 F.3d at 1352 and Cordis Corp. v. Medtronic AVE Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003)), the ’935 provisional must still “reasonably convey[] to those skilled in the art that the inventor[s] had possession of the claimed subject matter” as of the relevant date. Regeneron Pharms., Inc. v. Mylan Pharms. Inc., 127 F.4th 896, 914 (Fed. Cir. 2025); Ariad, 598 F.3d at 1351.” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“The ’859 patent does not provide an explicit definition of “immunoglobulin class.” Nevertheless, we do not construe that term to require “two heavy chains with four domains, VH, CH1, CH2, and CH3, and two Fab arms.” As an initial matter, the Specification teaches that antibodies include, 16 e.g., IgE and IgM — which have an additional CH4 domain in their heavy chains — as well as functional derivatives and/or fragments of known antibody isotypes. Ex. 1001, 11:44–48. Patent Owner’s proposed construction, which limits antibodies to those having two Fab arms and “two heavy chains with four domains, VH, CH1, CH2, and CH3,” excludes these embodiments and cannot be correct. Moreover, the ’859 patent defines antibody as containing “one or more domains” that bind an epitope on an antigen. Ex. 1001, 11:39–44. Thus, an antibody does not require two Fab arms as in a native immunoglobulin molecule.12 The ’859 patent also describes a preferred embodiment as “Ig-like molecules.” Id. at 11:49–52. Thus, we look to the definition of “Ig-like molecule” in the ’859 patent, i.e., “a proteinaceous molecule that possesses at least one immunoglobulin (Ig) domain,” to inform our understanding of the phrase “immunoglobulin class of proteins.” Ex. 1001, 11:4–6. Accordingly, we further construe “immunoglobulin class of proteins” to mean proteinaceous molecules comprising at least one domain that is derived from or shares sequence homology with an immunoglobulin domain.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,926,859 - Xencor, Inc. v. Merus N.V.InstitutedPTAB · Sep 26, 2025 · IPR2025-00604 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1, 2, 7–24, 26–28, and 30–32 on all four grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions in view of the existing record, we conclude that Petitioner demonstrates a reasonable likelihood it would prevail in showing that at least one challenged claim of the ’286 patent is unpatentable under the presented grounds. See Pet. Therefore, we grant institution of inter partes review. Our reasoning is discussed below. A.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A POSA at the time of the alleged invention would have at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, process chemistry, protein chemistry, chemical engineering, molecular and structural biology, biochemical engineering, or similar disciplines; several years of post-graduate training or related experience (including industry experience) in one or more of these areas; and two or more years of experience in the production of bispecific antibodies. (EX1002, ¶¶16-17.) Pet. 15. Patent Owner states, “[f]or purposes of the Preliminary Response, Patent Owner applies Petitioner’s proposed definition of a POSA.” Prelim. Resp. 10. At this point, we accept and use Petitioner’s proposed, and unopposed, definition of the ordinarily skilled artisan. It appears that Petitioner’s proposed definition comports with the level of skill in the art reflected in the prior art of record and the ’286 patent, itself. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningNo construction neededDecided for petitioner
“The ’286 patent uses the term “heavy chain” or “heavy chains” repeatedly; however, we find no express definition of the term. See generally Ex. 1001. Rather, the ’286 patent uses the term “heavy chain” in relation to antibody structure in a way that suggests the term is standard and well known in the art. See, e.g., id. at 3:19–59 (Background). The parties’ briefing on the technology reinforces this fact. See Pet. 5–14 (“The basic structure of natural IgG comprises four protein chains—two identical heavy chains (shown in red) and two identical light chains (shown in blue)—which are arranged in a Y-shaped configuration: . . . (EX1013, 112-13; EX1002, ¶¶23-30.)”); Prelim. Resp. 3–4 (“Natural or wild type Igs have a particular structure made of two identical light (L) chains and two identical heavy (H) chains. See EX2008 at ¶ 23. Each Ig heavy chain consists of three constant domains (CH1, CH2, and CH3) and one variable domain (VH), which is also isotypes, or a functional derivative and/or fragment of these. In a preferred embodiment, Ig-like molecules are produced that are antibodies of the IgG isotype because IgG antibodies e.g. have a longer half life as compared to antibodies of other isotypes. Ex. 1001, 11:9–21. As noted above (see supra Section I.C), IgG antibodies’ heavy chains have three constant domains, but IgE and IgM have four. Thus, Patent Owner’s argument that heavy chain means one variable and three constant domains, and two differently-binding Fab arms, ignores embodiments of the invention. consistent with the definition of heavy chain in the ’286 Patent. See EX2008 at ¶ 24; EX1001 at 11:58–66.”). This is also how the ’286 patent generally uses the term. See Ex. 1001, 11:58–12:1. But, the Specification does not limit its embodiments to only IgG antibodies because it also describes that the invention may be “IgG1, IgG2, IgG3, IgG4, IgA, IgE, and IgM” type antibodies, and fragments. Ex. 1001, 11:9–21; see also supra n.10 (quoting the ’286 patent’s definition of antibody). Other embodiments would not necessarily have the heavy chains as argued by Patent Owner. There is no evidence of record that the ’286 patent’s claims or the Specification generally use or limit the term “heavy chains” (or “heavy chain”) in any way deviating from its ordinary and customary meaning in the art. Therefore, at this stage of the proceeding, we decline to expressly interpret this claim language. 2. Summary on Claim Construction At this stage of the proceeding, we expressly construe no claim terms and give each claim term the ordinary and customary meaning it would have had to the person of ordinary skill in the art as of the invention date. See Nidec Motor Corp., 868 F.3d at 1017. If either party intends to further argue claim construction at trial, they should do so in a clearly designated section of their briefing so as to expressly identify such arguments. See, e.g., 37 C.F.R. § 42.104(b)(3) (content of petition); see also Board’s Consolidated Trial Practice Guide (CTPG) at 46, 48–45 (Nov. 2019).12 Claim construction arguments should not be relegated to patentability arguments on the facts.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“In brief summary, these limitations require one CH3 heavy chain to have a positive amino acid substituted in place of a neutral one, the other CH3 heavy chain to have a negative amino acid substituted in place of a neutral one, and that when the heavy chains are expressed by culturing the host cell these positive and negative amino acids interact and the antibody produced is a heterodimeric antibody. Petitioner asserts that Lazar expressly teaches engineering two CH3 domains so that, when expressed, they interact and form a heterodimeric CH3 interface by making neutral-to-positive and neutral-to-negative amino acid substitutions at known interacting residues on each CH3 domain, e.g., S364E (changing neutral serine to negative glutamic acid at residue 364) on one CH3 domain, and L368K (changing neutral leucine to positive lysine at residue 368) on the other CH3 domain; or T366D (swapping neutral threonine for negative aspartic acid at residue 366) on one CH3 domain and L351K (swapping neutral leucine for positive lysine at residue 351) on the other CH3 domain; that these residues were known in the art to be respective interfacing contact residues; that these modifications favor Fc heterodimerization; and that they result in a heterodimeric antibody (proof-of-concept shown by synthesizing and screening). Pet. 23–28 (citing Ex. 1001, 13:1–17, 17:67–18:3, 19:5–12; Ex. 1002 ¶¶ 111–119; Ex. 1004 ¶¶ 121, 183, 241 (Tables 1, 2); Ex. 1007, 8:9–10, 17:19–20 (Table 1); Ex. 1008, 244–36).” slip op. at 29
Claim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 9,358,286 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–28 are unpatentable: claims 1, 2, 4–7, 9–12, 14–17, and 19–28 are anticipated by the MSI-H Study Record; claims 3, 8, 13, and 18 are obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having cancer to determine that the patient’s cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9
- Skill levelSkill level board ownOther
“In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Inst. Dec. 7. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also 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 cancers and the associated conditions and immunotherapy.” slip op. at 15
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“holding is limited to anticipation of a claimed genus through disclosure of individual species, whereas the facts of this case involve the disclosure of a genus. PO Resp. 14. Because the facts before us, including the testimony of Patent Owner’s witness, indicate that one of ordinary skill in the art would have immediately understood that the third arm of the study described in the MSR includes patients with cancers recited in claim 1, including endometrial, gastric, and small-bowel cancers, we are persuaded that one of ordinary skill in the art would have understood that the MSR discloses species that fall within the scope of claim 1. Ex. 2090 ¶ 79; Ex. 1243, 115:5–116:22; Ex. 1085, 673–75; Ex. 1086, 14; Ex. 1003 ¶¶ 25, 63; Ex. 1005, 4. We are not persuaded that where species falling within the scope of claim 1 were previously known and disclosed in MSR, that claim 1 is patentable over the MSR. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (“a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’” the claimed arrangement or combination.” (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)). After considering the parties’ arguments and the evidence presented, we are persuaded that the MSR teaches “testing or having tested a biological sample obtained from a patient” having endometrial, small bowel, or gastric cancer and, thus teaches the corresponding limitation of claim 1.6” slip op. at 29
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Regarding the dependent claims that Petitioner challenges only on obviousness grounds (claims 3, 8, 13, 18), Patent Owner must show a nexus between the claimed methods and the evidence of non-obviousness. See Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (“to be accorded substantial weight in the obviousness analysis, the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention. . . . Ultimately, ‘[t]he patentee bears the burden of showing that a nexus exists.’” (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988), WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999)). Patent Owner does not direct us to evidence of a nexus to limitations recited in the dependent claims, for example to claims 3 and 13, which recite testing a biological sample that is a bodily fluid, claims 8 and 18, which recite testing that comprises assessing one or more markers selected from the group consisting of BAT-25, BAT-26, MONO-27, NR-21 and NR-24. Even if there is a nexus to the Patent Owner’s evidence of secondary considerations, the evidence addresses the methods of independent claims 1 and 11, not the limitations of the claims Petitioner challenges as being obvious. PO Resp. 55–83. Patent Owner directs us only to evidence regarding treating patients determined to have certain MSI-H cancers with pembrolizumab, which we determine to be anticipated by the MSR. Id. at 58. When evidence of a “secondary consideration is exclusively related to a single feature that is in the prior art,” our reviewing court has held the evidence is of no relevance to the obviousness inquiry. See Yita LLC v. MacNeil IP LLC, 69 F.4th 1356, 1363–65 (Fed. Cir. 2023), cert. denied, 144 S. Ct. 499 (2023) (distinguishing WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1330–31 (Fed. Cir. 2016)); see also Ethicon Endo-Surgery, Inc. v. Covidien LP, 812 F.3d 1023, 1034 (Fed. Cir. 2016) (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”). In Yita, the prior art taught close-conformance of a floor tray with the walls of a vehicle foot well, which one of ordinary skill in the art would have had reason to use in combination with other prior-art teachings to arrive at the claimed invention. See Yita, 69 F.4th at 1359–61. The court held that because the asserted evidence of secondary consideration related exclusively to close-conformity, the evidence was not persuasive of non-obviousness, even though the claimed floor tray was coextensive with the product that produced the evidence. See id. at 1364–65 (“The coextensiveness inquiry bears only on the presumption of nexus; it does not decide the overall nexus question.”). Because Patent Owner directs us only to evidence that the methods recited in claims 1 and 11 produced evidence of secondary considerations, we are not persuaded that this evidence is persuasive of the non-obviousness of the specific methods recited in the dependent claims. For example, Patent Owner fails to direct us to evidence that a method of treating MSI-H colorectal cancer in a patient “wherein the biological sample is a body fluid from the patient,” as recited in claim 3, or “wherein the at least one marker comprises BAT-25, BAT-26, MONO-27, NR-21 or NR-24,” as recited in claim 8, demonstrated unexpected results or commercial success. Accordingly, having considered the evidence of record as a whole, we determine that Petitioner has demonstrated by a preponderance of the evidence that the methods of claims 3, 8, 13, and 18 would have been obvious. We are not persuaded to the contrary by Patent Owner’s arguments or evidence of second secondary considerations.” slip op. at 47
Patent outcomesUS 11,629,187 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - Merck Sharp & Dohme LLC v. The Johns Hopkins UniversityAll claims unpatentablePTAB · Sep 23, 2025 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Final written decision
Claims 1–36 are unpatentable: claims 1–2, 4–8, 11–12, 14–18, and 21–36 as anticipated, and claims 3, 9, 10, 13, 19, and 20 as obvious.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“We agree with Patent Owner that the phrase “in response to” in claim 1 requires a causal relationship wherein the patient must be tested for MSI-H and, if he or she is determined to be MSI-H or dMMR, then the patient is treated with 10 mg/kg of pembrolizumab every 14 days. In claim 1, a biological sample from the patient must be tested to determine if the cancer is MSI-H and, if so, the patient is treated with a therapeutically effective amount of pembrolizumab. For this reason, if the prior art teaches the limitations of 1) testing a biological sample obtained from a patient having colorectal cancer to determine that the patient’s colorectal cancer is microsatellite instability high or mismatch repair deficient, and 2) treating the patient with a therapeutically effective amount of pembrolizumab if the patient’s colorectal cancer is determined to be microsatellite instability high or DNA mismatch repair deficient, the art anticipates claim 1. We are not persuaded that claim 1 requires or excludes anything else because nothing else is recited in the claim.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“The ’287 patent claims a method of treating a human patient with colorectal cancer having certain characteristics using pembrolizumab and the main prior art reference cited by Petitioner discloses testing pembrolizumab to treat human patients. See Ex. 1001, 24:42–52; Ex. 1005. Accordingly, the relevant field of Patent Owner’s claims is treating human patients, as well as testing existing compounds. In the Decision to institute trial, we adopted Petitioner’s uncontested proposal defining that the level of skill in the art, presented above. Dec. 7– 8. Neither party directs us to evidence of the level of skill in the art beyond what we considered for institution of trial. Having considered Patent Owner’s positions and evidence of record, however, we determine that the level of skill also 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 cancers and the associated conditions and immunotherapy.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In an anticipation analysis, the dispositive question is whether a skilled artisan would ‘reasonably understand or infer’ from a prior art reference that every claim limitation is disclosed in that single reference.” Acoustic Tech., Inc. v. Itron Networked Sols., Inc., 949 F.3d 1366, 1373 (Fed. Cir. 2020). Extrinsic evidence, such as declarations and depositions may be considered when it is used to explain, but not expand, the meaning of a reference. See In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) (holding that the depositions and declarations of skilled workers were properly used to show what those skilled in the art would have known about the prior art). We credit Dr. Neugut’s and Dr. Oberstein’s testimony about what one of ordinary skill in the art would have understood after reviewing the MSR. slip op. at 34
Patent outcomesUS 11,649,287 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287
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.