- 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 - PTAB · Sep 19, 2025 · PGR2025-00025 · APJ Kimberly Mcgraw · PGR · Institution
The Board instituted PGR on claims 1–19 and all asserted grounds, finding it more likely than not that claim 1 is anticipated by the Gatorade Label.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“if “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Post-grant review is available for patents that issue from applications that at one point contained at least one claim with an effective filing date on or after March 16, 2013. See Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), §§ 3(n)(1), 6(f)(2)(A). After considering the briefing and the evidence of record, for the reasons set forth below, we determine that Petitioner has shown that the ’422 Patent is eligible for post-grant review and has shown it is more likely than not that at least one challenged claim of the ’422 Patent is unpatentable under § 324(a). Accordingly, we institute a post-grant review of the challenged claims of the ’422 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would possess at least (1) a Bachelor’s degree in chemistry or a related field, with (2) five years of experience in material identification and characterization using multiple analytical methods and field sampling, or equivalent research or professional experience.” Pet. 12 (citing Ex. 1014 ¶ 24). Patent Owner does not dispute Petitioner’s definition for one of ordinary skill in the art nor provide a proposed definition of its own. See generally Prelim. Resp. For the purposes of this Decision, we adopt Petitioner’s undisputed proposal regarding the level of one of ordinary skill in the art.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“336. The applicant explained that not all combinations of shrink films and light blocking materials are recyclable. Id. at 335. The applicant explained that films can be compatible with PET recycling in two ways, (1) the film can float in water and be separated from PET that sinks in water or (2) the PET films crystallize and “can be recovered with the PET stream.” Id. at 336 (citing “A Resource Document by the Association of Plastic Recyclers (APR)”) (found at Ex. 1002, 323–332) (emphasis omitted). The applicant explained that “removing the label before or during the recycling process is not evidence of the recyclability of the label” and that “[r]emoving the label during the recycling process is not equivalent to actually recycling the label.” Id. at 335. As such, a POSITA reading the prosecution history would understand that a label is not recyclable with a PET container, as recited by the independent claims, by removing the label from the PET recycle stream before or during the recycling process.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“To determine how a person skill in the art would determine if a shrink label is “recyclable” as recited in the independent claims, we look to how the Specification of the ’422 Patent describes or defines recyclable shrink labels. For example, the ’422 Patent states that PET shrink films are generally considered recyclable if no inks are retained on the film after a caustic wash cycle typically used in PET reclaiming processes. Ex. 1001, 6:61–65. The ’422 Patent further states that labels are fully recyclable if the polymers used are clear, preferably clear PET, and the labels include inks that can be washed off in a “typical PET recycling wash (caustic wash).” Id. at 11:44– 49; see also id. at 11:49–54 (describing embodiments in which the labels are free or substantially free of inks that cannot be washed off in a caustic wash or where the labels are free or substantially free of color plastics that cannot be recycled). The ’422 Patent further discusses “industry standards” for determining whether various embodiments of shrink labels are recyclable. See, e.g., id. at 11:29–53. For example, the Specification states that the “Association for Plastic Recyclers (APR) Critical Guidance Protocol for Clear PET Articles with Labels and Closures (PET-CG-02)” (Ex. 1005) can certify that a film is fully recyclable with a container or bottle. Id. at 11:34– 38. Additionally, the Specification states that labels “are recyclable according to the Evaluation of the Near Infrared (NIR) Sorting Potential of a Whole Plastic Article (SORT-B-01)” (Ex. 1010) and/or the “Evaluation of Sorting Potential for Plastic Articles Utilizing Metal, Metalized, or Metallic Printed Components (SORT-B-03)” (Ex. 1011). Ex. 1001, 11:39–44. The ’422 Patent further states that embodiments of the labels “are fully recyclable. For example, the labels may include inks that can be washed off in a typical PET recycling wash (caustic wash) and the polymers” are preferably clear PET. Id. at 11:44–48. The ’422 Patent thus provides various descriptions or standards to determine the recyclability of shrink labels. For the purposes of addressing the anticipation and obviousness grounds, we determine that any of these standards can be used to determine if a shrink label is “recyclable.” We note that our construction is preliminary and is based on the present record. We invite the parties to further the address the construction of “wherein the recyclable shrink label is recyclable with a PET container” during trial.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 11,961,422 - Champion Laboratories, Inc. / First Brands Group, LLC v. Hengst SENo claims unpatentablePTAB · Sep 8, 2025 · IPR2024-00603 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1, 3, 5, 8–11, 15–17, 19, 23–25, and 28–30 were not shown unpatentable over Yokoyama, Yokoyama and Cline, or Honermann and Cline.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“On this record, we determine that the level of ordinary skill is reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (specific findings on the ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163–64 (Fed. Cir. 1985))). Because the level of ordinary skill in the art is not in dispute, and because the parties’ definition is consistent with the disclosures in the ʼ203 patent, the prior art, and the declaration testimony of Mr. Nranian and Dr. Basirat, we view the prior art and arguments through this lens when determining whether the claims are unpatentable as obvious over the prior art.5 See Graham, 383 U.S. at 17 (identifying “the level of ordinary skill in the pertinent art” as an underlying factual inquiry to be resolved in deciding obviousness, which is a question of law).” slip op. at 12
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Although the parties spend significant portions of their briefing discussing the term “eccentric” and how it applies to certain figures from the ʼ203 patent and the relied-upon prior art, we determine that it is not necessary to expressly construe the term “eccentric” beyond the parties’ agreed-upon definition. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (holding that only claim terms in controversy need to be construed, and only to the extent necessary to resolve the controversy (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). Rather, we adopt Patent Owner’s proffered definition because it is consistent with the intrinsic record and because it is not in dispute. Specifically, Patent Owner asserts that the plain meaning of the term “eccentric” is defined as “located elsewhere than at the geometric center; also: having the axis or support so located.” PO Resp. 18–19 (citing the Merriam-Webster online dictionary definition of the term “eccentric” for support). Petitioner agrees with this definition. Pet. 35 (asserting that certain prior art elements are eccentric “because they are not located at the center of the filter insert or housing”); Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”); see also Ex. 2017 ¶ 33 (Dr. Basirat testifying that “[a] POSITA would understand that ‘eccentric’ in the context of [the] ʼ203 patent, means that central axis is located elsewhere than at the geometric center [and] not placed centrally or not having its axis or other part placed centrally”). The parties’ definition of “eccentric” is also consistent with the usage of the term in the ʼ203 patent. Ex. 1001, 10:23–31; Fig. 17.” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Rather, we adopt Patent Owner’s proffered definition because it is consistent with the intrinsic record and because it is not in dispute. Specifically, Patent Owner asserts that the plain meaning of the term “eccentric” is defined as “located elsewhere than at the geometric center; also: having the axis or support so located.” PO Resp. 18–19 (citing the Merriam-Webster online dictionary definition of the term “eccentric” for support). Petitioner agrees with this definition. Pet. 35 (asserting that certain prior art elements are eccentric “because they are not located at the center of the filter insert or housing”); Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”); see also Ex. 2017 ¶ 33 (Dr. Basirat testifying that “[a] POSITA would understand that ‘eccentric’ in the context of [the] ʼ203 patent, means that central axis is located elsewhere than at the geometric center [and] not placed centrally or not having its axis or other part placed centrally”). The parties’ definition of “eccentric” is also consistent with the usage of the term in the ʼ203 patent. Ex. 1001, 10:23–31; Fig. 17.” slip op. at 14
- Expert testimonyPetitioner expert discountedDecided for patent owner
“(opining that “Patent Owner’s construction of ‘having an axis no located in a geometric center’ is too narrow”). Mr. Nranian’s Declaration testimony in this respect is not persuasive for several reasons. First, it is internally inconsistent. Compare Ex. 1016 ¶ 3 (criticizing the “axis” language in Patent Owner’s definition), with id. ¶¶ 9, 11 (relying on that very language to support an argument). Also, Mr. Nranian’s proposed definition of “eccentric” to merely mean “not located at the center” begs the question of what, precisely, is “the center”? Mr. Nranian does not persuasively explain how far a person of ordinary skill in the art would understand she could travel from the exact center point of an object and still be in “the center” of that object. See Tr. 10:13–19 (Judge McGee asking whether the center is “a miniscule point in the middle of [the] disc”); see also id. at 10:25–12:26 (Judge Weatherly highlighting the significant ambiguity in referring to something as in “the center”). Also, Mr. Nranian’s opinion is inconsistent with how the ʼ203 patent compares something that is “central,” i.e., “at the center,” and something that is “eccentrically” located. Ex. 1001, 7:13–14 (describing pipe nozzle 15 as “central”); id. at 8:53–56 (describing a “through hole” as “located in the center of the front panel 22” depicted in Figures 7 and 8); id. at 10:23–31 (describing return 12 as “in the center” and outlet 13 as “eccentrically thereto” in Figure 17). Patent Owner’s colorized and annotated Figure 7 is reproduced below: Patent Owner’s colorized and annotated version of Figure 7 of the ʼ203 patent illustrates “central pipe nozzle 15” in yellow passing through the “through hole” located in “the center” of front panel 22. PO Resp. 20. Significantly, pipe nozzle 15 and the through hole in panel 22 are both described as “central” and in “the center” but must have different diameters; otherwise, “central pipe nozzle 15” would not be capable of traveling through “through hole 22.” Ex. 1001, Fig. 7. Thus, the ʼ203 patent intrinsically bases whether an element is “central” or “in the center” on whether its axis is located at the geometric center. This is also illustrated in Figure 17 of the ʼ203 patent, reproduced below: Figure 17 of the ʼ203 patent illustrates filter housing 10 with return 12 “in the center . . . and, eccentrically thereto, the outlet 13 with the seat 14 for the blocking element 24.” Ex. 1001, 10:23–30. Finally, Mr. Nranian’s narrow interpretation of “eccentric”––which excludes the “having the axis or support so located” in the geometric center language––is at odds with the arguments it was proffered to support. Cf. Pet. Reply 9 (arguing that certain elements are eccentric because they “do not have an axis located at the geometric center”); id. at 10 (arguing the eccentricity of an element that does “not have an axis in the center” which has “an off-center axis”).” slip op. at 29
Patent outcomesUS 9,023,203 not shown unpatentableClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 9,023,203 - Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Some claims unpatentablePTAB · Aug 26, 2025 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–17, 20, 21, 24, 26, and 29–31 are unpatentable; claims 25 and 32–34 were not shown unpatentable, and the motion to exclude was dismissed as moot.
RulingsFinal written decision- RemandOther
“review of claims 1–17, 20, 21, 24–26, and 29–34 of the ’682 patent. Paper 2 (“Pet.”), 1, 3. Patent Owner, Hangzhou DAC Biotech Co., Ltd., filed a Preliminary Response (Paper 9, “Prelim. Resp.”). We initially determined that the information presented in the Petition did not establish a reasonable likelihood that Petitioner would prevail with respect to at least one of the challenged claims, and did not institute inter partes review. Paper 17. Petitioner requested Director review of our decision denying institution (Paper 18 (“Request”)). The Director delegated review of the decision to a Delegated Rehearing Panel (“DRP”). Paper 19. Patent Owner was granted the option to file a response to Petitioner’s Request (Paper 22 (“Request Resp.”)). The Delegated Review Panel vacated our decision and remanded the case to this panel with a revised claim construction for claim 1. Paper 23 (“DRP Dec.”). On August 30, 2024, we instituted an inter partes review after remand from the Director. Paper 25 (“Inst. Dec.”). Patent Owner subsequently filed a Patent Owner Response (Paper 31, “Resp.”), Petitioner filed a Reply (Paper 36, “Reply”), Patent Owner filed a Sur-reply (Paper 44, “Sur-reply”), and Petitioner filed a Sur-sur-reply (Paper 48, “Sur-sur-reply”).” slip op. at 2
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“I. Patent Owner’s Motion to Exclude Evidence Patent Owner moves to exclude Exhibits 1089 and 1090. Paper 50. As we did not rely on either of Exhibits 1089 or 1090 in deciding this matter, Patent Owner’s motion is dismissed as moot.” slip op. at 96
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableMixed
“For these reasons, Patent Owner’s arguments and cited evidence also” slip op. at 31
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“function as R2, and the ethyl group may function as R4, which can be a linear alkyl having 1–6 carbon atoms. We note that claim 3 permits R5 and R6 to be absent. For these reasons, the arguments presented in the Petition demonstrate that claim 3 would have been obvious over Singh’s Compound 3 when modified in view of Harris.” slip op. at 73
Patent outcomesUS 10,131,682 mixed§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - CSPC Pharmaceutical Group Limited / CSPC Ouyi Pharmaceutical Co., Ltd. et al. v. Ipsen Biopharm Ltd.InstitutedPTAB · Aug 14, 2025 · IPR2025-00505 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted inter partes review of claims 1–15 on all grounds, finding a reasonable likelihood that the claims would have been shown obvious over the asserted prior art.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“However, Patent Owner has not shown that circumstances exist that would require dismissal of the proceeding as barred under § 315(b) if the unnamed party were added as a real party in interest. Patent Owner has also not alleged any discovery abuse at this time. We determine that we need not address whether Cipla is an unnamed RPI at this stage. The parties may further address this issue during the trial portion of the proceedings. As the Board explained in SharkNinja, it “better serves the interest of cost and efficiency” when the Board does not engage in the “extensive analysis” required to determine whether a party is an unnamed RPI if the result of that analysis has no material impact on the proceeding. SharkNinja v. iRobot Corp., IPR2020-00734, Paper 11 at 19–20 (PTAB Oct. 6, 2020) (precedential). Here, it is undisputed that Petitioner could have named Cipla as an RPI in its Petition without triggering a statutory bar or estoppel under 35 U.S.C. § 315.” slip op. at 5
- Skill levelSkill level petitioner adoptedOther
“Patent Owner states it disagrees with Petitioner’s “definition of a POSA but assumes their definition for purposes of the arguments presented herein.” Prelim. Resp. 6. At this stage in the proceeding, we find that Petitioner’s analysis reasonably establishes a level of ordinary skill in the art as it directly relates to those deciding treatments based on the prior art references. The level of ordinary skill in the art usually is evidenced by the prior art references themselves. See, e.g., Ex. 1003, 1817, author list. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“Thus, the ’552 patent teaches that patients may or may not receive some therapeutic benefit from the treatment and also recognizes that any therapeutic benefit may result in prolonging life, but not necessarily result in complete remission of the pancreatic tumor. This understanding is consistent with Dr. Ratain’s testimony that “[t]reating a patient is always with the attempt or intent to cause a therapeutic improvement of the patient, which, in the case of metastatic pancreatic cancer, could be reduced tumor growth or increased overall survival in the patient.” Ex. 1002 ¶ 50. We are unpersuaded, however, by Dr. Ratain’s statement equating “treatment with a saline control” with the claimed “treating metastatic adenocarcinoma,” because the claim is addressing a disease condition whereas the example in Figure 6A is clearly providing a control, without any expectation of therapeutic benefit. See id. ¶ 55. We are not persuaded, on this record, that because Patent Owner did not include the phrase “therapeutically effective amount” in the claims, the claims solely relate to “administering” the antineoplastic therapies without any resulting therapeutic benefit. Rather, on this record, we agree with Patent Owner that the ordinary understanding of a claim reciting a “method of treating metastatic adenocarcinoma of the pancreas” that comprises “administering an antineoplastic therapy to the patient” in order “to treat the metastatic adenocarcinoma of the pancreas” is that the “treatment” would have more than a de minimis therapeutic benefit or efficacy for the patient being treated. To the extent that Patent Owner’s position would require some” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“While we are aware that hindsight bias may plague determinations of obviousness, Graham, 383 U.S. at 36, we are also mindful that the Supreme Court has clearly stated that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. The evidence of record shows the prior art provides specific reasons to replace irinotecan with liposomal irinotecan in the treatment of pancreatic cancer, including improved sustained release, local bioactivation, increased efficacy, and reduced side effects. Ex. 1006, 9; Ex. 1008, 921; Ex. 1002 ¶¶ 91, 238, 239. These specific reasons, as supported by Dr. Ratain, provide specific support for the obviousness of modifying the Conroy Protocol for patients with toxicity to substitute a 60 mg/m2 dose of liposomal irinotecan for irinotecan, particularly in patients with the particular UGT1A1 allele identified by Bayever. Ex. 1006, 3.” slip op. at 37
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 11,344,552
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.